[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5070-5201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00957]
[[Page 5069]]
Vol. 88
Thursday,
No. 17
January 26, 2023
Part II
Federal Trade Commission
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HISA Anti-Doping and Medication Control Rule; Notice
Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 /
Notices
[[Page 5070]]
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FEDERAL TRADE COMMISSION
[Matter No. P222100]
HISA Anti-Doping and Medication Control Rule
AGENCY: Federal Trade Commission.
ACTION: Notice of Horseracing Integrity and Safety Authority (HISA)
proposed rule; request for public comment.
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SUMMARY: The Horseracing Integrity and Safety Act of 2020 recognizes a
self-regulatory nonprofit organization, the Horseracing Integrity and
Safety Authority, which is charged with developing proposed rules on a
variety of subjects. Those proposed rules and later proposed rule
modifications take effect only if approved by the Federal Trade
Commission. The proposed rules and rule modifications must be published
in the Federal Register for public comment. Thereafter, the Commission
has 60 days from the date of publication to approve or disapprove the
proposed rule or rule modification. The Authority submitted to the
Commission a proposed rule on Anti-Doping and Medication Control on
December 30, 2022. The Office of the Secretary of the Commission
determined that the proposal complied with the Commission's rule
governing such submissions. This document publicizes the Authority's
proposed rule's text and explanation, and it seeks public comment on
whether the Commission should approve or disapprove the proposed rule.
This document is substantially similar to the document published on
October 28, 2022, as corrected on November 4, 2022, and the Commission
will consider all comments filed in response to that document as well
as all comments filed in response to this document.
DATES: If approved, the HISA proposed rule would take effect
immediately, and the Commission must approve or disapprove the rule by
March 27, 2023. Comments must be received on or before February 9,
2023.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Comment Submissions part of the
SUPPLEMENTARY INFORMATION section below. Write ``HISA Anti-Doping and
Medication Control'' on your comment and file your comment online at
https://www.regulations.gov under docket number FTC-2023-0009. If you
prefer to file your comment on paper, mail your comment to the
following address: Federal Trade Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC
20580.
FOR FURTHER INFORMATION CONTACT: Austin King (202-326-3166), Associate
General Counsel for Rulemaking, Office of the General Counsel, Federal
Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Self-Regulatory Organization's Statement of the Background,
Purpose of, and Statutory Basis for, the Proposed Rule
a. Background and Purpose
b. Statutory Basis
II. Self-Regulatory Organization's Statement of the Terms of
Substance of the Proposed Rule and Discussion of Alternatives
III. Self-Regulatory Organization's Summary of Comments Received
Pre-Submission and Its Responses to Those Comments
IV. Legal Authority
V. Effective Date
VI. Request for Comments
VII. Comment and Submissions
VIII. Communications by Outside Parities to the Commissioners or
Their Advisors
IX. Self-Regulatory Organization's Proposed Rule Language
Background
The Horseracing Integrity and Safety Act of 2020 \1\ recognizes a
self-regulatory nonprofit organization, the Horseracing Integrity and
Safety Authority, which is charged with developing proposed rules on a
variety of subjects. Those proposed rules and later proposed rule
modifications take effect only if approved by the Federal Trade
Commission.\2\ The proposed rules and rule modifications must be
published in the Federal Register for public comment.\3\ Thereafter,
the Commission has 60 days from the date of publication to approve or
disapprove the proposed rule or rule modification.\4\
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\1\ 15 U.S.C. 3051 through 3060.
\2\ 15 U.S.C. 3053(b)(2).
\3\ 15 U.S.C. 3053(b)(1).
\4\ 15 U.S.C. 3053(c)(1).
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Pursuant to Section 3053(a) of the Horseracing Integrity and Safety
Act of 2020 and Commission Rule Sec. 1.142, notice is hereby given
that, on December 30, 2022, the Horseracing Integrity and Safety
Authority (``HISA'' or the ``Authority'') filed with the Federal Trade
Commission a proposed Anti-Doping and Medication Control rule and
supporting documentation as described in Items I, II, III, IV, and IX
below, which Items have been prepared by HISA. The Office of the
Secretary of the Commission determined that the filing complied with
the Commission's rule governing such submissions.\5\ The Commission
publishes this Notice to solicit comments on the proposed rule from
interested persons. This document is substantially similar to the
document published on October 28, 2022, 87 FR 65292, as corrected on
November 4, 2022, 87 FR 66705, and the Commission will consider all
comments filed in response to that document as well as all comments
filed in response to this document.
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\5\ 16 CFR 1.140 through 1.144; see also Fed. Trade Comm'n,
Procedures for Submission of Rules Under the Horseracing Integrity
and Safety Act, 86 FR 54819 (Oct. 5, 2021).
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I. Self-Regulatory Organization's Statement of the Background, Purpose
of, and Statutory Basis for, the Proposed Rule
a. Background and Purpose
The Act recognizes that the establishment of a national set of
uniform standards for racetrack safety and medication control will
enhance the safety and integrity of horseracing. As part of this
endeavor, section 3053(a) of the Act directs the Authority to develop
proposed rules relating to ``(2) a list of permitted and prohibited
medications, substances, and methods, including allowable limits of
permitted medications, substances, and methods; (3) laboratory
standards for accreditation and protocols; [. . .] (8) a description of
safety, performance, and anti-doping and medication control rule
violations applicable to covered horses and covered persons; (9) a
schedule of civil sanctions for violations; and (10) a process or
procedures for disciplinary hearings.'' \6\
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\6\ 15 U.S.C. 3053(a)(2)-(3), (8)-(10).
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With the review, input, and ultimate approval of the Anti-Doping
and Medication Control Standing Committee (``ADMC'') and the
Authority's Board of Directors, the proposed rules: (1) set forth a
list of anti-doping and controlled medication rules; (2) set forth a
list of prohibited substances and methods; (3) set forth a framework
for the testing of covered horses and the investigation of possible
rule violations by the Horseracing Integrity and Welfare Unit (the
``Agency''); (4) set forth a framework by which laboratories will be
accredited and will analyze samples for prohibited substances and
markers of prohibited methods; (5) specify the civil sanctions that
apply to anti-doping and controlled medication violations; (6) create
procedures for disciplinary hearings, tailored to the nature of the
charge. The Agency participated in the development of the proposed rule
and approves of the rules as filed.
[[Page 5071]]
In compliance with 16 CFR 1.142(a), the Authority states that the
reason for adopting the Protocol is that the Horseracing Integrity and
Safety Act of 2020 (``Act'') mandates and empowers the Horseracing
Integrity and Safety Authority (the ``Authority'') to establish a
uniform anti-doping and controlled medication program to improve the
integrity and safety of horseracing in the United States (``Program'').
The Equine Anti-Doping and Controlled Medication Protocol
(``Protocol'') has been developed and issued by the Authority as part
of that mandate. It contains or incorporates by reference rules,
standards, and procedures to improve and protect the integrity and
safety of horseracing in the United States by deterring and penalizing
the improper administration or application of Prohibited Substances and
Prohibited Methods to Covered Horses. The Protocol is split into five
chapters: (1) the purpose, scope, and organization of the Protocol; (2)
the Prohibited List, rules of proof, and testing and investigations;
(3) the Equine Anti-Doping Rules; (4) the Equine Controlled Medication
Rules; and (5) other violations and general procedure/administration.
The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except if specified otherwise.
The Protocol and related rules are intended to address the need for
uniformity in horseracing, to protect the welfare of Covered Horses, to
safeguard the integrity of horseracing, and to ensure the confidence of
stakeholders (including the betting public) in the sport. Prior to the
implementation of the Authority, horseracing has been regulated in the
United States by the States. By its nature, this results in a lack of
uniformity in the rules of horseracing, including in many vital areas
of equine safety and the proper regulation of the use of prohibited
substances. Congress acted to impose a comprehensive program that would
effectively regulate horseracing with a common set of rules. The
Protocol was developed in collaboration with industry experts and
stakeholders who brought to the endeavor an unparalleled depth of
equine safety, anti-doping, veterinary medicine, sports integrity, and
compliance experience. The Protocol will provide one standard set of
rules that apply to doping and medication control, laboratory drug
testing methods and techniques, sample collection procedures,
investigatory procedures, and hearing and adjudication procedures that
will enhance the effective regulation of horse safety and medication
issues.
In considering reasonable alternatives to the proposed rule or
modification that may accomplish the stated objective, it is important
to underline that the Authority and the development of the Protocol is
unprecedented. As a consequence, there are of course countless
``alternatives'' on various issues, but the Authority has sought to
combine the best practice elements from various sources, including
rules and practices developed by the global anti-doping community,
horseracing authorities (national and international), and other equine
sport organizations.
The Protocol will affect Covered Persons, Covered Horses, and
Covered Horseraces by ensuring that horseracing is conducted in a
manner that is consistent with the highest standards of integrity and
that prioritizes the safety of Covered Horses and Covered Persons. The
welfare of Covered Horses is secured by rules that strictly ban and
penalize the use of doping substances and methods, and that sanction
the misuse of therapeutic medications. All Covered Persons are required
to comply with the Protocol and related rules, and to cooperate with
the Authority and the Agency in relation to all aspects of doping and
medication control, including sample collection, testing, and
investigation procedures. The manner in which the Protocol implements
these requirements is outlined in detail in Item II of this Notice.
In developing the Protocol and related rules in a manner that is
consistent with the Act and the rules and regulations applicable to the
Authority, the Authority took the following principles and mandates
into consideration, as directed by section 3055(b) of the Act:
(1) Covered Horses should compete only when they are free from the
influence of medications, other foreign substances, and methods that
affect their performance. The entire Protocol is dedicated to this
principle, and the elaborate anti-doping and controlled medication
rules work toward the objective of ensuring that Covered Horses compete
in a manner that is free of the influence of doping substances,
medications, and methods that affect their performance. The Prohibited
List and related Technical Document prescribe the substances and
methods that are prohibited and permitted under certain circumstances.
The Standards (Rules 5000 and 6000 Series) set out comprehensive
investigatory and sample collection provisions and an accreditation
system that ensures accurate laboratory testing, and the Arbitration
Procedures establish a set of disciplinary procedures to deal fairly
but firmly with violations of the rules.
(2) Covered Horses that are injured or unsound should not train or
participate in covered races, and the use of medications, other foreign
substances, and treatment methods that mask or deaden pain in order to
allow injured or unsound horses to train or race should be prohibited.
In the Protocol, Rule 3111 operates together with the Prohibited List
to ban substances and methods for which there exists medical,
veterinary, or other scientific evidence or experience to a support
their actual or potential masking properties (``Banned Substances'' and
``Banned Methods'') and to restrict the use of medications during the
Race Period (``Controlled Medication Substances'' and ``Controlled
Medication Methods''). Certain Controlled Medication Substances are
also prohibited during workouts, as set out in the Prohibited List. The
Protocol also operates in conjunction with the Rule 2000 Racetrack
Safety Program, which sets forth stringent rules for placing Covered
Horses on the Veterinarians' List and requires the Regulatory
Veterinarian to oversee removal from the list. These processes help to
ensure that injured and unsound horses do not train or participate in
Covered Horseraces. It should also be noted that Rule 2271 in the
Racetrack Safety Program prohibits the ``[u]se of physical or
veterinary procedures to mask the effects or signs of injury so as to
allow training or racing to the detriment of the Horse's health and
welfare.''
(3) Rules, standards, procedures, and protocols regulating
medication and treatment methods for Covered Horses and Covered
Horseraces should be uniform and uniformly administered nationally. The
Protocol preempts state laws and provides instead a uniform set of
comprehensive rules that embrace all of the areas previously addressed
in state anti-doping and medication
[[Page 5072]]
control regulation schemes. The entire scheme will be administered
nationally by the Authority and the Agency to ensure uniform and
consistent application of the law. The Protocol and related rules will
create a comprehensive program that is unprecedented in horseracing as
previously conducted and regulated in the United States.
(4) Consideration should be given to international anti-doping and
medication control standards of the International Federation of
Horseracing Authorities (``IFHA'') and the Principles of Veterinary
Medical Ethics of the American Veterinary Medical Association. As
directed by the Act, the ADMC has scrutinized the IFHA standards and
rules very closely and also considered the Principles of Veterinary
Medical Ethics of the American Veterinary Medical Association in
preparing the Protocol. The World Anti-Doping Code also provided much
of the inspiration for the Protocol, adapted as necessary for
horseracing, taking into account national and international horseracing
rules and Equine Anti-Doping and Controlled Medication Regulations of
the International Equestrian Federation (i.e., the global governing
body for equestrian sport).
(5) The administration of medications and treatment methods to
Covered Horses should be based upon an examination and diagnosis that
identifies an issue requiring treatment for which the medication or
method represents an appropriate component of treatment. The Protocol
addresses the requirement for a sound diagnosis as a prerequisite for
treatment and the need for such treatment not to be administered in a
manner contrary to horse welfare. Specifically, Rule 3040(b)(3) states
that it is the personal responsibility of each Responsible Person to
ensure that treatments and medications administered to his or her
Covered Horses (i) are administered only on the advice of a
Veterinarian or (if a prescription is not required) following
sufficient due diligence regarding the treatment or medication; (ii)
are not administered in a manner detrimental or contrary to horse
welfare; (iii) are the minimum necessary to address the diagnosed
health concerns identified during the veterinary examination and
diagnostic process; (iv) do not contain a Banned Substance or involve a
Banned Method; and (v) do not otherwise violate the Protocol. Further,
Rule 3314 penalizes use of a Controlled Medication Substance or Method
in a manner that is contrary to horse welfare. In particular, Rule
3314(a) specifically mandates that any use of a Controlled Medication
Substance or a Controlled Medication Method on a Covered Horse must
``(i) be justified by the Covered Horse's medical condition(s) as
diagnosed by a Veterinarian, (ii) have been recommended by a
Veterinarian in the context of a valid veterinarian-patient-client
relationship, (iii) go no further than the minimum necessary to address
the diagnosed health concerns, and (iv) be in the best interests of the
Covered Horse's health and welfare.'' Rule 3314(b) also states that it
is ``the personal and non-delegable duty of the Responsible Person'' to
ensure the above requirements in Rule 3314(a) are complied with. The
Protocol also establishes in Rules 3227 and 3327 that an aggravating
circumstance that may be taken into account in assessing sanctions for
a rule violation may include ``administration of a Controlled
Medication Substance that is detrimental to the health and welfare of
the horse or is designed to deceive the betting public.'' It should
also be noted that Rule 2221 (of the previously approved Racetrack
Safety Rule) also establishes examination and diagnoses requirements in
the context of the veterinarian-client-patient relationship.
(6) The amount of therapeutic medication that a Covered Horse
receives should be the minimum necessary to address the diagnosed
health concerns identified during the examination and diagnostic
process. As noted above, Rule 3040(b)(3) and Rule 3314 specifically
address the requirement that any use of a Controlled Medication
Substance or a Controlled Medication Method on a Covered Horse must go
no further than ``the minimum necessary to address the diagnosed health
concerns.''
(7) The welfare of Covered Horses, the integrity of the sport, and
the confidence of the betting public require full disclosure to
regulatory authorities regarding the administration of medications and
treatments to Covered Horses. The Protocol addresses this issue in
several ways. It requires all Covered Persons to cooperate promptly and
completely with the Authority and the Agency in the exercise of their
respective powers under the Act and the Protocol and related rules
(Rule 3040(a)). Each Responsible Persons is required to maintain
accurate, complete, and up-to-date treatment records of his or her
Covered Horses in a form specified by the Agency, and to provide the
records on request to the Agency (Rule 3040(b)(8)). Responsible Persons
must declare to the Agency any use of Banned Substances or Banned
Methods on a horse prior to it becoming a Covered Horse (Rule
3040(b)(9)). To facilitate out-of-competition testing, Responsible
Persons must file whereabouts information if their Covered Horses are
moved to a private facility (Rule 3040(b)(10)). Attending Veterinarians
must keep updated treatment records in an electronic database
designated by the Agency or in any other form designated by the Agency
and must provide access on request to copies of these records (Rule
3040(d)). Refusal or failure to cooperate with the Authority or the
Agency, or the commission of a Whereabouts Failure, constitutes a
violation of the Protocol under Rule 3510. Several provisions in the
Rule 2000 Series complement the Protocol's disclosure requirements.
Rule 2551, for example, requires every Veterinarian who examines or
treats a Covered Horse to submit to the Authority, within 24 hours of
such examination or treatment medications, treatment records with
details as prescribed in the Rule.
In further compliance with the Act, the Protocol establishes a
comprehensive set of violations and hearing procedures to prohibit
certain conduct, to provide a process for determining the existence of
a violation; of charging a Covered Person with a violation; and with
resolving the matter in a full and fair hearing process. The Protocol
authorizes the imposition of sanctions that comport with the severity
of the violation. Consistent with 15 U.S.C. 3057(d)(2), the violation
and sanction system is tailored to the unique aspects of horseracing in
that it has the power to declare a Covered Person or Covered Horse
ineligible to race for a specified time, imposes substantial fines upon
Covered Persons, and establishes a points system to implement a system
of penalties for multiple violations of the Protocol. These penalties
are common in the adjudication and sanction of violations in the world
of horseracing. The sanctions also include forfeiture of purse,
disqualification of horses, and changes to the order of finish in horse
races. The elaborate hearing procedures and penalty rules ensure that
violations are consistently and fairly penalized, which in turn deters
future violations, and maintains the integrity and conduct of fair and
transparent horseraces. Effective sample collection and testing
techniques, as set forth in Rule Series 5000 and 6000 also serve to
enhance successful prosecution of violations, which deter future
violations. The goal of transparency is also served by operation of the
public disclosure rules in the Protocol, which
[[Page 5073]]
mandate that the public be informed of information concerning specific
cases as the cases are adjudicated or otherwise resolved.
The components of the Protocol and related rules comport with the
baseline standards in 15 U.S.C. 3055(g)(2)(a), which include: (1) the
lists of permitted and prohibited substances (including drugs,
medications, and naturally occurring substances and synthetically
occurring substances) in effect for the International Federation of
Horseracing Authorities, including the International Federation of
Horseracing Authorities International Screening Limits for urine, dated
May 2019, and the International Federation of Horseracing Authorities
International Screening Limits for plasma, dated May 2019; (2) the
World Anti-Doping Agency International Standard for Laboratories
(version 10.0), dated November 12, 2019; (3) the Association of Racing
Commissioners International out-of-competition testing standards, Model
Rules of Racing (version 9.2); and (4) the Association of Racing
Commissioners International penalty and multiple medication violation
rules, Model Rules of Racing (version 6.2). Any deviations from the
baseline standards have been approved by the Authority and the Agency
following detailed consideration and adoption of an approach that is
either stricter or more consistent with horseracing.
b. Statutory Basis
The Horseracing Integrity and Safety Act of 2020, 15 U.S.C. 3051
through 3060.
II. Self-Regulatory Organization's Statement of the Terms of Substance
of the Registration Proposed Rule and Discussion of Alternatives
a. Existing Standards
Anti-doping and controlled medication rules currently vary from
State to State, but the overall structure of the rules governing
horseracing is generally consistent among the States. In particular,
the rules of horseracing center around a number of common subject
areas, including the licensing of racing associations and of individual
participants in horseracing, medication control rules, pari-mutuel
wagering rules, the operation of various incentive funds, rules
concerning the running of the race, and rules establishing disciplinary
measures and hearing procedures. The basic precepts of many of the
rules pertaining to violations, sanctions, hearing procedures, and
investigatory powers have been in force in racing states for many
years, and the Authority has reviewed and considered key provisions
from numerous states in developing these rules.
The Association of Racing Commissioners International (``ARCI'')
sets forth standards and protocols in its Model Rules of Racing (``ARCI
Rules''). Relying upon the collective expertise of regulatory personnel
in member jurisdictions in consultation with regulated entities,
industry stakeholders, and individuals, ARCI committees regularly
consider ways to improve and enhance the regulation of racing. The
Authority considered the ARCI Model Rules of Racing when developing the
Protocol and related rules. Likewise, the Authority considered rules
from other racing jurisdictions such as the British Horseracing
Authority's Rules of Racing.
The Authority also considered and relied heavily on international
anti-doping standards, including the World Anti-Doping Code (applicable
to human athletes) and the International Equestrian Federation
(``FEI'') Equine Anti-Doping and Controlled Medication Regulations
(applicable at the international level to various equestrian
disciplines). Those regulations provide a robust anti-doping framework
that has been tested before arbitration tribunals for many years, and
that has generated a well-developed body of precedent and guidance for
interpreting the provisions in those frameworks.
The Authority, in consultation with the ADMC and the Agency,
reviewed these existing standards and tailored them to the Authority's
regulatory structure and goals, and to the specificities of
horseracing.
The provisions of these Series were made publicly available on the
Authority website at www.hisaus.org/regulations on June 1, 2022. A
number of stakeholder comments were received, which are addressed
further in Item III below. Additionally, the Authority consulted
directly with a number of industry officials and participants in
obtaining feedback on the proposed rules. The Authority is submitting
those comments along with this Notice of Filing as Exhibit A, which is
available for public inspection at the corresponding docket at https://www.regulations.gov. Furthermore, all the important source materials on
which the Authority relied in developing its proposed rule are also
collected at that docket as Exhibit B.
b. Terms of Substance: Rule Series 3000--Equine Anti-Doping and
Controlled Medication Protocol
1. Purpose, Scope, and Organization--Rules 3010-3090
Chapter I of the Protocol has been developed taking account of the
requirements of the Act, including, in particular, those set out at
sections 3054 and 3055 of the Act.
The Protocol will go into effect if and when the Commission
approves the proposed rule. The Protocol contains or incorporates by
reference rules, standards, and procedures to improve and protect the
integrity and safety of horseracing in the United States by deterring
and penalizing the improper administration or application of Prohibited
Substances and Prohibited Methods to Covered Horses. The Protocol is
divided into five substantive chapters: (1) the purpose, scope, and
organization of the Protocol; (2) the Prohibited List, rules of proof,
and testing and investigations; (3) the Equine Anti-Doping Rules; (4)
the Equine Controlled Medication Rules; and (5) other violations and
general procedure/administration.
The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except if specified otherwise. This division accords with international
best practices. However, the two distinct processes share many common
features and rules, and therefore the Protocol is streamlined to make
the processes consistent with each other wherever possible.
The Protocol will be implemented and enforced on behalf of the
Authority by the Agency, which has created an entity designated as the
Horseracing Integrity and Welfare Unit (``Agency''). In addition, and
only where so agreed, State Racing Commissions acting under the
delegated authority of the Authority
[[Page 5074]]
or the Agency (Rule 3010(e)) may also assist in implementation.
In accordance with section 3055(a)(1) of the Act, the Protocol
applies to all Covered Horses, Covered Persons, and Covered Horseraces
(Rule 3020). Pursuant to section 3054 of the Act, Covered Persons must
register with the Authority.
In developing the Protocol, the Authority reviewed and considered
various anti-doping and controlled medication rules, including:
Exhibit B.2. ARCI Model Rules of Racing, including, in particular, the
penalty provisions and rules on multiple medication violation.
Exhibit B.3. FEI Equine Anti-Doping & Controlled Medication
Regulations.
Exhibit B.4. FEI Atypical Findings Policy.
Exhibit B.5. World Anti-Doping Code.
Exhibit B.6. British Horseracing Authority Equine Anti-Doping Rules.
2. Prohibited List, Rules of Proof, and Testing and Investigations--
Rules 3110-3140
The Protocol incorporates the Prohibited List, which identifies the
Banned Substances and Banned Methods that are prohibited at all times
on the basis of the Agency's determination that medical, veterinary, or
other scientific evidence or experience supports their actual or
potential (i) ability to enhance the performance in Covered Horses,
(ii) masking properties, or (iii) detrimental impact on horse welfare.
The Prohibited List also identifies Controlled Medication Substances
and Controlled Medication Methods, which are prohibited for Use on or
Administration to a Covered Horse during the Race Period and must not
be present in a Post-Race Sample or Post-Work Sample, except as
specified otherwise. In other words, the phrase ``Prohibited Substances
and Prohibited Methods'' refers to Banned Substances and Banned Methods
as well as Controlled Substances and Controlled Medication Methods that
are only restricted during the Race Period. The Prohibited List will be
published at least annually (Rule 3112).
The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances
that fall into the general categories listed in the Prohibited List and
sets forth detection times, screening limits, and thresholds for those
Prohibited Substances. The Technical document also designates certain
Prohibited Substances as Specified Substances, which are those that
pose a higher risk of being the result of contamination and that are,
therefore, subject to more flexible sanctions.
In disciplinary cases brought under the Protocol, the Agency will
have the burden of establishing that a violation of the Protocol has
occurred to the comfortable satisfaction of the hearing panel, bearing
in mind the seriousness of the allegation made (Rule 3121), and facts
may be established by any reliable means (Rule 3122). The ``comfortable
satisfaction'' standard of proof is greater than a mere balance of
probability (i.e., a preponderance of the evidence) but less than clear
and convincing evidence or proof beyond a reasonable doubt (Rule 3121).
Only the Agency (and those authorized by the Agency) may initiate
and direct testing on any Covered Horse. The Agency will have broad
authority to conduct testing both in and out of competition (Rule
3132), and samples collected will be owned by the Authority (Rule
3135). Samples obtained from Covered Horses will be analyzed primarily
to detect the presence of Prohibited Substances (Rule 3137).
State Racing Commissions, Racetracks, Race Organizers, and Training
Facilities shall not initiate or direct any Testing of Covered Horses.
However, they may request that the Agency initiate and direct enhanced
or additional Testing (e.g., in relation to a particular Covered
Horserace). The Agency may accept or decline such request at its
absolute discretion. Where the Agency accepts the request, the costs of
Sample collection and analysis shall be borne by the entity requesting
the additional or enhanced Testing. The Agency may conduct the Testing
itself or delegate the Testing to the relevant State Racing Commission.
(Rule 3132).
3. Equine Anti-Doping Rules--Rules 3210-3260
The Equine Anti-Doping Rules set out in Chapter III of the Protocol
apply to conduct involving Banned Substances or Banned Methods, i.e.,
substances and methods prohibited at all times. The violations set out
in this Chapter are included as directed by section 3057(a)(2) of the
Act, and are also substantively modelled on World Anti-Doping Code
violations. The violations prohibit use, possession, trafficking, and
administration to a Covered Horse of Banned Substances or Banned
Methods (Rules 3213 and 3214). It is a violation to evade, refuse or
fail to submit a Covered Horse to sample collection (Rule 3215), and
the presence of a Banned Substance in a sample collected from a Covered
Horse is also a violation (Rule 3212). In accordance with section
3057(a)(2) of the Act, presence and use violations are strict liability
offenses for the Responsible Person, although other Covered Persons may
also be liable to the same extent if they are complicit in the
violation. Other prohibited conduct includes tampering with doping
control, complicity with another person's violation, associating with a
person who is banned, and improper retaliation against actual or
potential whistle-blowers or intimidation of witnesses (Rule 3216).
Attempts to commit Anti-Doping Rule Violations are also sanctionable.
As directed by the Act, the Authority has developed a list of civil
sanctions for Anti-Doping Rule Violations. The Protocol and Prohibited
List establish uniform rules imposing civil sanctions against Covered
Persons and Covered Horses for Anti-Doping Rule Violations (and also
for Controlled Medication Rule Violations, addressed under chapter IV
of the Protocol), as directed by section 3057(d) of the Act. The range
of civil sanctions (a) take into account the unique aspects of
horseracing; (b) are designed to ensure fair and transparent Covered
Horseraces; and (c) are intended to deter violations. The severity of
the sanctions depends on the nature of the violation, and allows an
opportunity for adjustment in penalty depending on the violation and
facts involved.
A mandatory part of each sanction will include Public Disclosure of
relevant information, including the Covered Person's name, the
violation, and consequences imposed (Rules 3231 and 3620).
If the violation arises from a Post-Race Sample or occurs during
the Race Period, the Covered Horse's results at that Covered Horserace
will automatically be disqualified, because the horse competed with a
Banned Substance in its system, irrespective of the reason why the
Banned Substance was there or any degree of fault on the part of the
Covered Person (Rule 3221(a)). Subsequent results may also be
disqualified (Rule 3221(b)) and in any case of disqualification, all
purses and other compensation, prizes, trophies, points, and rankings
are forfeited and must be repaid or surrendered to the race organizer,
and the results of the other Covered Horses in the race in question
must be adjusted accordingly (Rule 3221(c)).
The Protocol now also specifies what happens to the race
classification pending the outcome of the disciplinary proceedings
(Rules 3221 and 3321). Further, Rule 3221(a) allows for the Agency, the
Responsible Person, and the
[[Page 5075]]
Owner of the Covered Horse in question to agree (or to ask the
Arbitral) to apply Rule 3221 immediately, i.e., prior to adjudication
of any other issue.
In presence or use cases, the Covered Horse will be subject to a
period of ineligibility, the length of which depends on the particular
Banned Substance(s) detected, as set out in the Prohibited List. During
any period of ineligibility, the Covered Horse shall not participate in
any Workout or Covered Horserace, but will remain subject to testing
(Rule 3229).
The Covered Person will be sanctioned with a period of
ineligibility commensurate to his or her level of fault, in accordance
with a detailed sanctioning framework. The starting point for presence,
use, possession, or administration violations is a period of
ineligibility of two years, subject to elimination or reduction if the
Covered Person can demonstrate that he or she bears no or no
significant fault or negligence, or subject to increase if aggravating
circumstances are present (Rules 3223(b), 3224, and 3225). For other
violations, the rules specify other starting points or ranges for the
applicable period of ineligibility that reflect the seriousness of the
violation (Rule 3223(b)). The rules also provide the Authority with the
ability to eliminate or reduce an applicable period of ineligibility in
circumstances where a Covered Person provides Substantial Assistance or
admits the violation early or in the absence of other evidence (Rule
3226). There are also increased sanctions for repeat offenders (Rule
3228). During any period of ineligibility, the Covered Person shall not
participate in any capacity in any activity involving Covered Horses or
in any other activity (other than authorized anti-doping education or
rehabilitation programs) taking place at a Racetrack or Training
Facility; nor shall he or she permit anyone to participate in any
capacity on his or her behalf in any such activities (Rule 3229(a)).
The Covered Horse(s) of an Owner or Trainer subject to a Provisional
Suspension or period of Ineligibility shall also be subject to
restrictions (Rule 3229(b)).
The Covered Person may also be required to pay a fine, depending on
the violation, and some or all of the Agency's legal costs (Rule
3223(b)).
Where a Covered Person is found based on the same facts to have
committed a violation involving both (i) one or more Banned
Substance(s) or Banned Method(s), and (ii) one or more Controlled
Medication Substance(s) or Controlled Medication Method(s), the Covered
Person shall be considered to have committed one Anti-Doping Rule
Violation and the sanction imposed shall be based on the Banned
Substance or Banned Method that carries the most severe sanction. Rule
3227 (Aggravating Circumstances) may also be applied to increase the
sanction imposed (Rule 3228(d)).
The Equine Anti-Doping Rules provide a framework for the results
management of potential anti-doping rule violations, as directed by the
Act. Different types of Samples may be collected from Covered Horses,
including urine, blood, and hair. Unless specified otherwise in the
rules, at the time of collection, the Sample will be divided into an
``A'' and a ``B'' Sample. Review of ``A Sample'' adverse analytical
findings or other evidence leads to an initial notification by the
Agency to the Covered Person that he or she may have committed an anti-
doping rule violation (Rule 3245). In some cases, the Covered Person
will be provisionally suspended pending determination of the matter
(Rule 3247), and the ``B Sample'' may be tested (Rule 3246). The
Covered Person is entitled to respond to the Agency's initial
notification, and if he or she does, the Agency will take any comments
and additional information into account before deciding whether to
formally charge the Covered Person with an anti-doping rule violation
and request a more formal response (Rule 3248)).
The Covered Person is entitled to have the charge determined by the
Arbitral Body (the panel hearing will consist of either one or three
impartial arbitrators) in accordance with the Arbitration Procedures
(Series 7000). The final decision of the Arbitral Body is subject to
review in accordance with the Act (Rule 3264). The rules also provide
for the Agency and Covered Person to agree to a resolution to the
charge without a hearing (Rule 3249).
4. Equine Controlled Medication Rules--Rules 3310-3360
The Equine Controlled Medication Rules set out in Chapter IV of the
Protocol apply to conduct involving Controlled Medication Substances or
Controlled Medication Methods (i.e., substances prohibited for use on
or administration to a Covered Horse during the Race Period and
prohibited to be present in a Post-Race Sample or Post-Work Sample,
except as otherwise specified in the Prohibited List). The violations
set out in this Chapter are drawn from similar provisions to those
relating to Anti-Doping Rule Violations, modified to reflect the
differing approaches to the use of Controlled Medication Substances and
Controlled Medication Methods, as opposed to Banned Substances and
Banned Methods. The violations include the use, possession, or
administration to a Covered Horse of Controlled Medication Substances
or Controlled Medication Methods during the Race Period (Rules 3313 and
3315). Other violations include use of a Controlled Medication
Substance that is not justified by the horse's medical condition or
does not meet other criteria (Rule 3314), tampering with medication
control (Rule 3316), and the presence of a Controlled Medication
Substance in a sample collected from a Covered Horse (Rule 3312). In
accordance with section 3057(a)(2) of the Act, presence and use
violations are considered strict liability offenses. Attempts to commit
Controlled Medication Rule Violations are also sanctionable.
As directed by the Act, the Authority has developed a list of civil
sanctions for Controlled Medication Rule Violations. The Protocol and
Prohibited List establish uniform rules imposing civil sanctions
against Covered Persons and Covered Horses for Controlled Medication
Rule Violations, as directed by section 3057(d) of the Act. The range
of civil sanctions (a) take into account the unique aspects of
horseracing; (b) are designed to ensure fair and transparent Covered
Horseraces; and (c) are intended to deter violations. The severity of
the sanctions depends on the nature of the violation, and allows an
opportunity for adjustment depending on the violation and facts
involved.
A mandatory part of each sanction will include Public Disclosure of
relevant information, including the Covered Person's name, the
violation, and consequences imposed (Rules 3331 and 3620).
If the violation arises from a Post-Race Sample or occurs during
the Race Period, the Covered Horse's results at that Covered Horserace
will automatically be disqualified, with all resulting consequences,
because the horse competed with a Controlled Medication Substance in
its system. The results will be automatically disqualified irrespective
of the reason why the Controlled Medication Substance was detected or
of any degree of fault on the part of the Covered Person (Rule
3321(a)). Subsequent results will not be disqualified (Rule 3321(b)).
The Covered Horse will not be subject to a period of ineligibility
if the violation involves a Controlled Medication Substance, but may be
subject to a period of ineligibility if the violation involves a
Controlled Medication Method as specified in the Prohibited List (Rule
3322).
[[Page 5076]]
Covered Persons shall be sanctioned for any Controlled Medication
Rule Violations in accordance with Rule 3323(b), depending on the
category or class of the violation, and the number of violations
committed within that same category/class in the previous two-year
period. Presence, use, and administration violations are divided into
three different classes (Class A, Class B, Class C) with Class A
carrying the more severe sanctions. The sanctions for Controlled
Medication Rule Violations are subject to elimination (Rule 3324),
reduction (Rules 3325 and 3326), or increase (Rule 3327), depending on
the violation in issue and the specific circumstances of the case.
The Protocol also establishes a multiple medication violation
penalty points system for repeat offenders which takes account of
violations committed in different categories/classes (Rule 3328). As
directed by section 3055(g) of the Act, the Authority used the
Association of Racing Commissioners International penalty and multiple
medication violation rules, Model Rules of Racing, as a baseline for
the multiple violations penalty points system. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the ADMC and the Agency in accordance with section
3055(g)(3) of the Act.
The penalty points system is not a substitute for the consequences
that apply to the underlying Controlled Medication Rule Violations.
Rather, the penalty points system is intended to apply additional
uniform Consequences where the Covered Person is a repeat offender and
exceeds the permissible number of points. Where the relevant cumulative
point threshold is exceeded, the Covered Person shall receive an
automatic additional period of ineligibility as specified in Rule
3328(c). Penalty points are assigned automatically depending on the
category/class of violation in issue, save where specified otherwise in
Rule 3328. Penalty points and the additional period of Ineligibility
shall be applied automatically at the conclusion of the proceeding on
the underlying violation, without any additional hearing or right of
review. Penalty points shall be applied retroactively to start on the
date on which the Controlled Medication Rule Violation occurred and
shall expire after 2 years (Rule 3328(d)).
During any period of Ineligibility or Provisional Suspension,
Covered Persons shall be prohibited from the same activities as anyone
banned for an Anti-Doping Rule Violation. As for Anti-Doping Rule
Violations, the Covered Horses of a suspended Trainer or Owner may not
participate in any Timed and Reported Workout or Covered Horserace, but
in contrast to Anti-Doping Rule Violations, they may participate in a
Covered Horserace if they were entered in the race before the Trainer
was notified of the Provisional Suspension or the period of
Ineligibility was imposed (whichever is earlier) (Rule 3320(b)).
Further, in contrast to Anti-Doping Rule Violations, the Covered Horses
of a suspended Trainer must only be transferred to another Covered
Person if the period of ineligibility imposed on the Trainer is more
than 30 days (Rule 3329(b)).
The Covered Person may also be required to pay a fine depending on
the category of the violation, and some or all of the Agency's legal
costs (Rule 3323(b)).
The Equine Controlled Medication Rules provide a framework for the
results management of potential controlled medication rule violations
as directed by the Act, from review of ``A Sample'' adverse analytical
findings or other evidence leading to an initial notification by the
Agency to the Covered Person that he or she may have committed a
controlled medication rule violation (Rule 3345). The Covered Person
will not be provisionally suspended pending determination of the matter
unless he or she voluntarily accepts a provisional suspension (Rule
3347), and the B Sample may be tested (Rule 3346). The Covered Person
is entitled to respond to the Agency's initial notification, and if he
or she does, the Agency will take any comments and additional
information into account before deciding whether to formally charge the
Covered Person with a controlled medication rule violation and request
a more formal response (Rule 3348).
The Covered Person is entitled to request a hearing before the
Internal Adjudication Panel. The hearing will ordinarily be conducted
before a single member of the Internal Adjudication Panel, though three
members may be assigned to hear the case where appropriate. The
Internal Adjudication Panel may decide in its sole discretion to
determine the matter on the written submissions alone without a hearing
if the Internal Adjudication Panel considers itself sufficiently well-
informed to render a decision on the written submissions alone. The
Internal Adjudication Panel will issue a final decision, subject to
review in accordance with the Act (Rules 3361-3364).
The rules also provide for the Agency and Covered Person to agree
to a resolution to the charge without a hearing (Rule 3349).
5. Other Violations and General Procedure/Administration--Rules 3500-
3800
Chapter V sets out additional disciplinary offenses that do not
fall within the chapters on Equine Anti-Doping Rules or Equine
Controlled Medication Rules (Rule 3510), and also prescribes sanctions
(periods of ineligibility and fines) for those violations (Rule 3520).
Those violations include engaging in disruptive or offensive conduct
towards doping control personnel, refusing/failing to cooperate in full
with the Authority or Agency in the discharge of his or her respective
responsibilities under this Protocol, and committing a whereabouts
failure (in effect, failing to provide the necessary information to
enable a Covered Horse to be located for testing). Alleged violations
will be determined by the Internal Adjudication Panel (Rule 3361).
In accordance with section 3057(c)(2) of the Act, the rules provide
guidelines for confidentiality and public reporting of decisions (Rules
3610-3630). Rule 3710 also provides for the recognition of decisions by
recognized, official third parties, for example, national horseracing
authorities in other countries applying substantially similar rules
(Rule 3700).
c. Terms of Substance: Rule Series 1000--General Provisions
The Protocol and other Series are supported by the general rules of
interpretation (Rule 1010) and a list of defined terms (Rule 1020) to
assist with clarity of meaning.
d. Terms of Substance: Rule Series 4000--Prohibited List
As directed by sections 3053 and 3055 of the Act, the Authority has
developed a list of permitted and prohibited medications, substances,
and methods, including allowable limits of permitted medications,
substances, and methods, using as a baseline the lists of permitted and
prohibited substances (including drugs, medications, and naturally
occurring substances and synthetically occurring substances) in effect
for the International Federation of Horseracing Authorities (``IFHA''),
including the IFHA International Screening Limits for urine and the
IFHA International Screening Limits for plasma. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the
[[Page 5077]]
ADMC and the Agency in accordance with section 3055(g)(3) of the Act.
The Prohibited List identifies Prohibited Substances and Prohibited
Methods that are: (a) prohibited at all times (``Banned Substances''
and ``Banned Methods'') on the basis of the Agency's determination that
medical, veterinary, or other scientific evidence or experience
supports their actual or potential (i) ability to enhance the
performance in Covered Horses, (ii) masking properties, or (iii)
detrimental impact on horse welfare; or (b) prohibited for Use on or
Administration to a Covered Horse during the Race Period and prohibited
to be present in a Post-Race Sample (which includes samples collected
following a Covered Horserace or Vets' List Workout) or Post-Work
Sample (which includes samples collected following a Timed and Reported
Workout), except as otherwise specified in the Prohibited List
(``Controlled Medication Substances'' and ``Controlled Medication
Methods''). Prohibited Substances and Prohibited Methods may be
included in the Prohibited List by general category (e.g., anabolic
steroids) or by specific reference to a particular substance or method.
The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances
that fall into the general categories listed in the Prohibited List and
sets forth detection times, screening limits, and thresholds for those
Prohibited Substances. The Technical Document also designates certain
Prohibited Substances as Specified Substances, which are those that
pose a higher risk of being the result of contamination and that are
therefore subject to more flexible sanctions.
In accordance with section 3055(d) of the Act, the use or
administration of Controlled Medication Substances and Controlled
Medication Methods is prohibited during the ``Race Period'' (i.e., 48
hours prior to post-time) except where expressly provided otherwise in
the Prohibited List or Protocol. Responsible Persons are strictly
liable for any substance found to be present in a Post-Race Sample or
Post-Work Sample, even if such substance was used or administered
before the Race Period. As specified in section 3055(e) and (f) of the
Act, certain exemptions apply to furosemide (i.e., Lasix/Salix), which
are set out in the Prohibited List.
The Prohibited List and supporting Technical Document were prepared
in consultation with the ADMC and the Agency, and approved by the
Authority, as directed by section 3055(c)(5) of the Act. In preparing
the Prohibited List and the ``Technical Document--Prohibited
Substances,'' the Authority considered lists of prohibited substances
and methods published by other organizations, including the ARCI, World
Anti-Doping Agency (``WADA''), the FEI, and the British Horseracing
Association. Documents considered in preparing the Prohibited List are
exhibited below:
Exhibit B.7. IFHA International Screening Limits for urine.
Exhibit B.8. IFHA International Screening Limits for plasma.
Exhibit B.9. ARCI Uniform Classification Guidelines for Foreign
Substances and Recommended Penalties Model Rule.
Exhibit B.10. WADA 2022 Prohibited List.
Exhibit B.11. 2022 FEI Equine Prohibited Substances List.
Exhibit B.12. British Horseracing Association Equine Prohibited List
Code (2022).
Exhibit B.13. British Horseracing Association Published Detection Times
(June 2019).
Exhibit B.14. Hong Kong Jockey Club Medication and Prohibited
Substances.
The ADMC also considered a number of scientific papers when
developing the Prohibited List and supporting Technical Document:
Exhibit B.15. AAS 16 Detection of Some Designer Steroids in Horse
Urine: Identifies the integrity risks associated with the use of
anabolic steroids in racehorses.
Exhibit B.16. AAS 29 Anabolic Effects of [beta]2-agonists, formoterol
and salbutamol on cancellous bone of ovariectomized (OVX) rat: With the
banning of anabolic steroids, those seeking an anabolic effect turned
to [beta]2-agonists. Their misuse has been well-documented in horses
engaged in racing and training.
Exhibit B.17. ACA 01 Effects of intravenous aminocaproic acid on
exercise-induced pulmonary haemorrhage (EIPH): Although this drug has
extensive anecdotal support for effect in mitigating EIPH, this article
demonstrates no effect on the condition. While not regulated in human
sport, the illicit use of this substance, particularly in races where
furosemide is prohibited, represents an integrity threat.
Exhibit B.18. AU 04 Disposition of the anti-ulcer medications
ranitidine, cimetidine, and omeprazole following administration of
multiple doses to exercised Thoroughbred horses. The results of
multiple RMTC administration studies supporting the use of anti-ulcer
medications up to 24 hours prior to a horse's race.
Exhibit B.19. Bicarb 08 Sodium Bicarbonate as an Ergogenic Aid:
Supports the use of alkalinizing agents as a Prohibited Method.
Exhibit B.20. BP Gen 04 Bisphosphonate Therapy in Equine Sports
Medicine: While having legitimate use in human medicine, the documented
pharmacologic effect of this class of drug (blocking remodeling) on
bone represents a significant increased risk for fracture development
in the racehorse.
Exhibit B.21. Cobalt 01 The Disparate Roles of Cobalt in
Erythropoiesis, and Doping Relevance: Establishes the relevance of the
administration of cobalt salts as a doping threat and justifies the
controls established in the Prohibited List.
Exhibit B.22. Comp 18 The Disparate Roles of Cobalt in Erythropoiesis,
and Doping Relevance: Published by the American Veterinary Medical
Association, this document clarifies what constitutes legal compounding
of drugs as the ethical use of compounded medications is important to
maintaining equine health. However, the compounding or administration
of illicitly compounded substances to circumvent Food and Drug
Administration (``FDA'') oversight represents a substantial risk to
horse health and racing integrity.
Exhibit B.23. EIPH 33 Exercise-induced pulmonary hemorrhage (EIPH):
mechanistic bases and therapeutic interventions: Describes this
condition (rarely, but occasionally, experienced by human athletes)
that affects virtually every race horse at some point(s) in its racing
and training career.
Exhibit B.24. Furos 15 Efficacy of furosemide in the treatment of
exercise-induced pulmonary hemorrhage in Thoroughbred racehorses: The
seminal study that demonstrated the efficacy of furosemide in
mitigating or preventing episodes of EIPH in the racing Thoroughbred.
While not submitted as a justification for the continued use of
furosemide, this study did establish furosemide as the only medication
having efficacy for controlling EIPH and why the WADA total ban on
furosemide cannot be, at this time, applied to horseracing. This
article also then justifies the Prohibited List's exclusion for the use
of furosemide in training exercise.
Exhibit B.25. PAG 13 Intra-Articular Polyacrylamide Hydrogel Injections
[[Page 5078]]
Are Not Innocent: While the use of polyacrylamide hydrogels have a
history of use in human joint disease, their introduction into the
equine market as medical devices, is relatively recent, and the lack of
documented method of action causes reservations about its use in that
it may have the potential to mask pain and allow the progression of
orthopedic disease to the overall detriment of the horse.
Exhibit B.26. PBZ 05 Effectiveness of administration of phenylbutazone
alone or concurrent administration of phenylbutazone and flunixin
meglumine to alleviate lameness in horses: Establishes justification
for the prohibition on ``stacking'' of NSAIDs--medications that are not
controlled in human sport, but require control in equine sport for
safety reasons and ethical considerations.
Exhibit B.27. Ract 04 Effects of Ractopamine HCl on Physical and
Reproductive Parameters in the Horse: This anabolic agent is not
addressed in human sport but has been detected in post-race and out of
competition samples derived from racehorses. Its presence has been both
the result of contamination of commercial feed at the processing site
as well as deliberate administration.
Exhibit B.28. Thyro 07 A randomised, controlled trial to determine the
effect of levothyroxine on Standardbred racehorses: This prescription
medication had widespread use for the (scientifically unsupported)
treatment of a multitude of conditions--other than hypothyroidism which
is exceedingly rare in the horse. This article elucidates the health
risk in its use and justifies the ban as established in the Prohibited
List.
Exhibit B.29. Tryp 03 Effects of a commercial dose of L-tryptophan on
plasma tryptophan concentrations and behaviour in horses: An example of
unregulated, over the counter oral nutraceuticals that have the
potential to impact a horse's health, behavior, or mental state--thus
exerting a drug-like effect while evading regulation by the FDA. It is
for this reason that the Prohibited List is not permissive of the use
of these substances during the race period, to be consistent with FDA-
approved drugs having similar effects.
1. Banned Substances and Banned Methods--Rule Series 4100
Banned Substances and Banned Methods are set out in categories,
including anabolic agents, peptide hormones and growth factors, beta-2
agonists, hormone and metabolic modulators, and diuretics and masking
agents (Rule 4110). Banned Methods include blood manipulation, chemical
castration or immunocastration, and gene and cell doping (Rule 4120).
2. Controlled Medication Substances and Controlled Medication Methods
and Exceptions--Rule Series 4200
Subject to exceptions specified in the Prohibited List (Rule 4212),
only feed, hay, and water are permitted during the Race Period (Rule
4211(a)). Accordingly, subject to Rule 4212, any substance administered
during the Race Period or present in a Post-Race Sample (including any
metabolite(s), artifact(s), and isomer(s) of such substance(s)) that
does not otherwise qualify as a Banned Substance shall constitute a
prohibited Controlled Medication Substance. In addition, certain
Controlled Medication Substances are prohibited from presence in a
Post-Work Sample (Rule 4211(b)). Exceptions are provided in Rule 4212
for emergency veterinary care, for certain substances that are
permitted up to 24 hours prior to Post-Time (e.g., anti-ulcer
medications), electrolyte solutions consumed by the horse by free
choice, furosemide (i.e., Lasix/Salix), and for supplements or feed
additives that do not have an action or effect on listed mammalian body
systems.
Controlled Medication Methods include alkalinization, intra-
articular injections, and use of a nasogastric tube within specified
time periods (Rule 4220).
3. Ineligibility Periods for Covered Horses--Rule Series 4300
Consistent with section 3057(d) of the Act, Rule 4300 establishes
uniform rules setting out the periods of ineligibility that apply to
Covered Horses implicated in Anti-Doping Rule Violations or Controlled
Medication Rule Violations. The Ineligibility period ranges from zero
months to lifetime bans, depending on the category of the substance or
method.
Violations involving Controlled Medication Substances will not
result in a period of Ineligibility for the Covered Horse. However, the
Covered Horse shall be placed on the Veterinarians' List and a Vets'
List Workout must be scheduled (at which the horse may be subject to
Sample collection). Violations involving Controlled Medication Methods
may result in a period of Ineligibility for the Covered Horse where
specified in the Prohibited List at Rule 4320.
Covered Horses are not subject to increased Ineligibility periods
if they are involved in multiple violations.
4. Rule Series 4000 Appendix: Technical Document--Prohibited Substances
The ``Technical Document--Prohibited Substances'' supplements the
Prohibited List (Rule Series 4000) and sets out additional detail
concerning Prohibited Substances. The ``Technical Document--Prohibited
Substances,'' enumerates specific Prohibited Substances that fall into
the general categories listed in the Prohibited List and sets forth
detection times, screening limits, and thresholds for those Prohibited
Substances. The Technical Document also designates certain Prohibited
Substances as Specified Substances, which are those that pose a higher
risk of being the result of contamination and that are therefore
subject to more flexible sanctions. The following paragraphs describe
the rules and specifications applicable to certain categories of
medications that vary from the baseline standards enumerated in 15
U.S.C. 3055(g).
i. Anti-Ulcer Medications (Cimetidine, Omeprazole, Ranitidine)
The IFHA has published a restricted administration period that
prohibits administration of anti-ulcer medications within 48 hours of
the post time for the race in which the horse is entered. HISA in the
Protocol recommends a 24-hour restricted administration period.
The basis for this deviation is two-fold: (1) Withdrawal intervals
of greater than 24 hours have been identified as an equine welfare
issue. Published research demonstrates a rebound effect when anti-ulcer
medications are withdrawn for more than 24 hours with resultant ulcers
more severe than those originally treated. (2) The IFHA's Advisory
Council on Prohibited Substances and Practices will be revisiting the
control of these substances, and it is anticipated that the
international community will adopt a withdrawal interval strategy
similar to the one proposed by HISA.
ii. Non-Steroidal Anti-Inflammatory Drugs (``NSAIDs'') (Flunixin,
Ketoprofen, Phenylbutazone)
The IFHA has published a 48-hour Detection Time (DT) for a single
NSAID--meclofenamic acid. There is no FDA-approved product containing
meclofenamic acid commercially available in the United States. (It is
important to note that a Detection Time is the foundation for
determining a withdrawal interval, but under no circumstances should
the Detection Time be equated with withdrawal guidance. The withdrawal
interval is decided by the veterinarian in
[[Page 5079]]
consultation with the responsible person for the horse in consideration
of their level of risk aversion and their knowledge of the specific
horse's health, management, other medications or foreign substances co-
administered, and other relevant factors. The withdrawal interval
should always be longer than the Detection Time, and in most cases this
means adding 24 hours (at a minimum) to the Detection Time.)
The HISA Protocol establishes Screening Limits corresponding to a
48-hour Detection Time for 3 commercially available NSAIDs having FDA-
approval for use in the horse. The Protocol allows the veterinarian to
select one NSAID that can be administered using a withdrawal interval
based on the 48-hourr Detection Time. All other NSAIDs are then
controlled applying IFHA Detection Times and Screening Limits, and the
detection of more than one NSAID in a horse's sample is a violation.
This is philosophically consistent with the IFHA and represents a far
more restrictive approach to the use of NSAIDs than currently exists in
the United States.
iii. Methocarbamol/Glycopyrrolate
The IFHA is silent on these substances. However, the Asian Racing
Federation (a signatory to the IFHA's International Agreement on
Breeding, Racing, and Wagering (IABRW)) has published a Screening Limit
for methocarbamol. So there is precedent for establishing Screening
Limits in addition to those provided by the IFHA. Further, the IFHA's
IABRW references the adoption of Screening Limits and advises that a
regulatory authority may elect to publish Detection Times.
The Screening Limits and Detection Times for methocarbamol and
glycopyrrolate were derived after reviewing the Racing Medication and
Testing Consortium's administration study pharmacokinetic data. The
elected Screening Limits and corresponding Detection Times ensure
withdrawal intervals of sufficient length to prevent the substances
from having any potential to impact a horse's racing performance.
iv. Ciclesonide/Lidocaine
The Protocol adheres to IFHA Screening Limits, but, consistent with
the requirements of IABRW Article 6, HISA has elected to adopt
Detection Times that vary from those of the IFHA. In the case of
ciclesonide, the Detection Time is consistent with that used by Racing
Australia (also an IFHA member). For lidocaine, HISA elected to use a
lower dose in determining a Detection Time, as it believed that IFHA's
dosing is too permissive and potentially allows illicit low-dose use on
Race Day, which may be undetectable by laboratory testing.
v. Procaine Penicillin
The European Horseracing Scientific Liaison Committee (EHSLC) has
established a detection time of 240 hours (10 days) for procaine
penicillin. (The EHSLC is the scientific body that the IFHA consults
when developing medication control policy.) HISA has determined that
the 240-hour detection time could negatively impact horse welfare,
through the withholding of appropriate medical treatment. HISA has
elected instead to adopt the current ARCI controls, which allow for the
use of this safe and effective antibiotic up to 48 hours prior to a
race, while still effectively controlling against the illicit use of
procaine as a local anesthetic.
e. Terms of Substance: Rule Series 5000--Equine Standards for Testing
and Investigation
In accordance with section 3055 of the Act, the Authority has
developed Equine Standards for Testing and Investigations to manage
test distribution planning (including intelligence-based testing), the
sample collection process, and in-competition and out-of-competition
testing. The Authority considered the Association of Racing
Commissioners International out-of-competition testing standards as a
baseline, but also relied in large part on the WADA International
Standard for Testing and Investigations, given the comprehensive nature
of that standard. All adjustments and modifications to the baseline
rules were approved by the Authority in consultation with the ADMC and
the Agency in accordance with section 3055(g)(3) of the Act.
In preparing the standards, the Authority consulted with the
Agency, the ADMC, and experts in the field to tailor the standards to
horseracing. The Authority considered and relied significantly on the
following rules:
Exhibit B.2. The ARCI out-of-competition testing standards, Model Rules
of Racing (version 11.0). The Authority notes that the Act refers to
version 9.2, but the model rules have since been updated. The most
recent versions of the ARCI documents are available at https://www.arci.com/model-rules-standards/.
Exhibit B.30. WADA International Standard for Testing and
Investigations dated January 1, 2021. The most recent versions of the
WADA documents are available at https://www.wada-ama.org/en/resources/.
1. Testing--Rules 5100-5500 and 5800
The Testing and Investigations Standards sets out how the Agency
will plan effective testing by using risk assessments and prioritizing
between Covered Horses and types of testing (Rule 5100). As directed by
section 3055(c)(4)(C) of the Act, Sample Collection Personnel will
notify the Responsible Person or Nominated Person without advance
notice that his or her Covered Horse has been selected for testing
(Rule 5200), following--as applicable--the procedure set out at Rule
5220 depending on when the sample is collected.
Sample Collection Sessions will be conducted by suitably qualified
personnel (Rule 5450), using suitable equipment (Rule 5320), in a
suitable ``test barn'' environment (Rule 5310). Samples will be
collected in accordance with Rule 5400, in particular to ensure that
the sample is of suitable quality and quantity, is clearly and
accurately identified, is sealed in a tamper evident kit, and has not
been manipulated or tampered with. Further specific procedures and
requirements apply to the collection of urine samples (Rule 5420),
blood samples (Rule 5430), and hair samples (Rule 5440).
Once collected, Samples will be stored and transported by Sample
Collection Personnel in a manner that protects the integrity, identity,
and security of the Samples (Rules 5510 and 5520).
2. Investigations--Rule 5600-5700
As directed by the Act, the Agency will put in place internal
processes and procedures to ensure it is able to gather, analyze, and
process anti-doping and medication control intelligence from all
available sources in order to help deter and detect doping and
medication abuse, to inform effective, intelligent, and proportionate
test distribution planning, to plan intelligence-based Target Testing,
and to conduct investigations (Rule 5600).
Further, the Agency will conduct efficient and effective
investigations into (among other things) atypical findings and other
sample abnormalities, and other analytical or non-analytical
information or intelligence. The purpose of such investigations is to
either rule out or develop evidence that supports an anti-doping or
controlled medication rule violation or other violation of the Protocol
(Rule 5710). The Agency will make use of all investigative resources
available to it, which may include obtaining information from law
enforcement authorities and other
[[Page 5080]]
regulators (Rule 5730). The Agency may also exercise the investigative
powers conferred under applicable rules, including powers of
inspection, examination, seizure, production of documents, request to
the Authority for the issuance of subpoenas, and the conduct of
interviews). All Covered Persons are required to cooperate with the
Agency's investigations in the manner set forth in the rules, and
failure to cooperate may result in the imposition of sanctions (Rule
5720(f)).
f. Terms of Substance: Rule Series 6000--Equine Standards for
Laboratories and Accreditation
As directed by sections 3053, 3055, and 3057 of the Act, the
Authority has developed the Equine Standards for Laboratories and
Accreditation (``Laboratory Standards'') using the WADA International
Standard for Laboratories as a baseline. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the ADMC and the Agency in accordance with section
3055(g)(3) of the Act.
Exhibit B.31. WADA International Standard for Laboratories dated
January 1, 2021. The Authority notes that the Act refers to the WADA
International Standard for Laboratories (version 10.0) dated November
12, 2019, but that version has since been updated by WADA. The most
recent versions of the WADA documents are available at: www.wada-ama.org/en/resources/.
As directed by the Act at section 3057(b), the Laboratory Standards
establish standards of accreditation for laboratories involved in
testing samples from Covered Horses; the process for achieving and
maintaining accreditation; and the standards and protocols for testing
of such samples. The Laboratory Standards will be supported by
technical documents, letters, notes, and laboratory guidelines, as
appropriate.
The Laboratory Standards also cross refer in a number of places to
the ISO/IEC 17025 standard. Laboratories must obtain ISO/IEC 17025
accreditation before receiving HISA Equine Analytical Laboratory
(``HEAL'') accreditation.
Exhibit B.32. ISO/IEC 17025:2017. The Authority consulted with
laboratory experts in order to tailor the Laboratory Standards to
horseracing laboratories and to reflect the specificities of equine
sport. As part of its review, the Authority considered the ILAC-G7:04/
2021 Accreditation Requirements and Operating Criteria for Horseracing
Laboratories, which may inform subsequent Technical Documents.
Exhibit B.33. ILAC-G7:04/2021 Accreditation Requirements and
Operating Criteria for Horseracing Laboratories. The most recent
versions of the International Laboratory Accreditation Cooperation
(``ILAC'') standards are available at: https://ilac.org/publications-and-resources/ilac-guidance-series/.
1. Laboratory Accreditation--Rule Series 6100 and 6500
In accordance with sections 3055(c) and 3057(b) of the Act, the
Laboratory Standards establish the requirements for obtaining HISA
Equine Analytical Laboratory (``HEAL'') accreditation, and the
requirements and standards for maintenance of HEAL accreditation. The
rules set out a procedure by which laboratories may achieve HEAL
accreditation, starting with an application and the granting of
``candidate laboratory'' status. The candidate laboratory must provide
specified information to the Agency, perform pre-probationary testing
to identify prohibited substances in samples, and complete an on-site
assessment. The Agency will assess the outcomes of those processes and
any non-conformities identified, and the candidate laboratory will have
a specified period of time to remedy those non-conformities with
corrective actions (Rule 6110).
If a candidate laboratory is granted probationary accreditation
status, it will be accredited by the Agency, with a probationary period
of two years or until analysis of 2,500 samples has been performed,
whichever occurs first. If the probationary period is successfully
completed and the laboratory successfully completes a final
accreditation test, the Agency will grant accreditation to the
laboratory (Rule 6120).
The rules impose continuing obligations on each laboratory that
must be satisfied in order to maintain HEAL accreditation (Rule 6130),
including maintenance of ISO/IEC 17025 accreditation, satisfactory
participation in the Agency External Quality Assessment Scheme
(``EQAS'') whereby laboratories are sent samples to be analyzed (blind
or for specified substances), compliance with the code of ethics (which
is set out in full at Rule 6600), and continued research and
development activities and sharing of knowledge.
The Agency will regularly monitor and review the compliance of each
laboratory with its ongoing accreditation obligations (Rule 6140). A
laboratory's HEAL accreditation may be suspended or revoked, or
subjected to specified analytical testing restrictions if (among other
things) the laboratory fails to comply with the Laboratory Standards or
other Agency requirements (Rules 6510 and 6520). The rules set out the
effects of such decisions on Agency-related laboratory activity and the
transfer of samples to other laboratories pending resolution of the
matter (Rule 6560), and provide for reinstatement of the laboratory if
it has remedied the non-compliance that resulted in the Agency's
decision.
2. Laboratory Quality Monitoring--Rule Series 6200, 6400, and 6600
The Agency will regularly distribute External Quality Assessment
Scheme (EQAS) samples in order to monitor the capabilities of
laboratories and probationary laboratories, evaluate their proficiency,
and improve test result uniformity between laboratories (Rule 6210).
Some of these samples are blind (the laboratory will know it is an EQAS
sample but will not know its contents), some are double-blind (the
laboratory will not know it is an EQAS sample or know its contents),
and some are educational (the laboratory will know it is an EQAS sample
and will know its contents) (Rule 6220). EQAS samples should be
analyzed in a manner substantially similar to that applied to routine
samples, unless otherwise specified by the Agency, and results reported
to the Agency (Rules 6250 and 6260).
The Agency will evaluate laboratory EQAS results and, as necessary
and appropriate, inform the laboratory of any technical,
methodological, or clerical errors that should be remedied. If such
errors are remedied, no penalty will be imposed (Rule 6410). The Agency
may request corrective action reports that detail actions taken to
correct any non-conformity or other issue (Rule 6420). The annual EQAS
evaluation will be a factor in assessment of HEAL accreditation and
maintenance of HEAL accreditation.
3. Analysis of Samples--Rule Series 6300
The Laboratory Standards set out a process for the withdrawal of
accreditation if the relevant requirements and standards are not met.
The Laboratory Standards also ensure that laboratories report valid
test results based on reliable evidentiary data and facilitate
harmonization in analytical testing of Samples by laboratories.
The rules also contain detailed standards for the analysis of
samples (section 6300). When analyzing a sample, the laboratory will
prepare an aliquot, select the analytical testing
[[Page 5081]]
procedure, and conduct the initial testing procedure, with the
objective of obtaining information about the potential presence of
prohibited substances in the sample (Rule 6308). The laboratory will
then conduct the confirmation procedure to obtain a result that either
supports or does not support the reporting of an adverse analytical
finding or atypical finding, in particular, by identifying and
sometimes quantifying--for example in the case of a threshold
substance--a prohibited substance in the sample (Rules 6309 and 6311).
The laboratory must conduct a detailed review of the analysis (Rule
6315) and report all results to the Agency (Rule 6316).
An important amendment to the baseline rules is that any B sample
analysis will be conducted by a different laboratory than the one that
performed the A sample analysis, unless the Agency considers that is
not possible due to due to (i) reasonable concerns over Sample
integrity or unstable analytes; or (ii) because no other Laboratory is
available to perform the B Sample procedure within a reasonable period
of time (Rule 6312).
If the laboratory reports an adverse analytical finding for the A
sample, and the Covered Person requests or the Agency orders that the B
sample be analyzed, the laboratory will promptly transfer the B sample
to the laboratory specified by the Agency, and that (second) laboratory
will perform the B sample procedure and analysis (Rule 6312). The
samples will be stored and may be subject to further analysis if
directed by the Agency (Rules 6313 and 6319).
e. Terms of Substance: Rule Series 7000--Arbitration Procedures
In accordance with sections 3053(a)(10) and 3057(c) of the Act, the
Arbitration Procedures set out a disciplinary process for the hearing
and adjudication of Anti-Doping Rule Violations, Controlled Medication
Rule Violations, and other related offenses. As directed by section
3057(c)(3), the procedures were developed to provide for adequate due
process, including impartial hearing panels commensurate with the
seriousness of the alleged violation. Different procedures apply to
Anti-Doping Rule Violations (heard by the Arbitral Body) as compared to
Controlled Medication Rule Violations (heard by the Internal
Adjudication Panel, which may adjudicate the matter on written
submissions alone.
1. Dispute Resolution Frameworks--Rules 7010-7050
The arbitrators on the Arbitral Body will be appointed by the
Agency for four-year terms (Rule 7030). Members of the Internal
Adjudication Panel will be appointed by the Agency for four-year terms
(Rule 7040). Members of the Arbitral Body and Internal Adjudication
Panel will receive mandatory annual training and education on issues
relating to the proper handling of cases (Rule 7050).
2. Initiating Proceedings--Rules 7060-7160
If a Covered Person is charged with an Anti-Doping Rule Violation
or Controlled Medication Rule Violation, proceedings will be initiated
with the appropriate adjudicator by the Agency. The adjudicator will be
appointed by the arbitral body or by the coordinator of the Internal
Adjudication Panel, as applicable (Rule 7130), and the rules establish
a process by which parties may challenge the adjudicator's appointment
in appropriate circumstances. The adjudicator has broad powers to
manage the proceedings, including the power to issue orders for
expedited procedures, rule on their own jurisdiction, and consolidate
proceedings.
3. Hearings and Evidence--Rules 7170-7330
In cases involving Anti-Doping Rule Violations or related
violations, the rules set out a procedure for the exchange of written
submissions and evidence (Rule 7170), and for the conduct of hearings
(Rule 7250). The Arbitral Body has broad discretion to determine the
admissibility, relevance and materiality of evidence offered, and may,
if necessary and appropriate, order production (Rule 7260 and 7270) or
interim measures (Rule 7280) or resolve challenges to provisional
suspensions at a provisional hearing (Rule 7290).
In cases involving Controlled Medication Rule Violations and
related violations, and other violations of the Protocol, a more
streamlined and flexible process applies (Rule 7180).
4. Decisions--Rules 7240-7450
In all cases, a final decision will be issued and the adjudicator
may grant any remedy or relief authorized by the Protocol (Rule 7340-
7350). Final decisions issued by the Arbitral Body or Internal
Adjudication Panel are subject to review as specified in section 3058
of the Act (Rule 7400).
III. Self-Regulatory Organization's Summary of Comments Received Pre-
Submission and Its Responses to Those Comments
As encouraged by the Commission's procedural rule, the Authority,
before finalizing this submission to the Commission, made a draft of
the Anti-Doping and Medication Control proposed rule available to the
public for review and comment on the HISA website, https://www.hisausregs.org/, beginning on June 1, 2022. Comments on the Anti-
Doping and Medication Control proposed rule were received from various
individuals and groups in the horseracing industry.
The stakeholder feedback received was constructive and well-
considered. All submitted comments were carefully reviewed by the
Authority as well as by the ADMC and the Agency. Those collected
comments are available as Exhibit A on the docket at https://www.regulations.gov. The Authority also engaged with a number of
stakeholders through follow-up conference calls to further analyze
their comments and discuss any questions raised. The stakeholder
comments informed a number of adjustments and modifications to the
proposed rules, as explained in more detail below. The open
consultation process and stakeholder engagement is an important process
and one that is intended to build consensus where possible within the
industry.
The following is a summary of the substance of the comments
received. The following also summarizes the Authority's response to the
significant issues raised in the comments, and the manner in which the
Authority has addressed those comments in developing the proposed rules
submitted to the Commission. In a few instances the Authority declined
to make a suggested change, though the Authority will consider the
suggestions made in the course of future rulemaking.
1000 Series--General Provisions
The Authority revised the definition of ``Race Day'' based on
comments received, amending it so that the period will end one hour
after the end of the Official Workout or Covered Horserace or at the
end of any Sample collection process, whichever is later, instead of
ending at 23:59 (11:59pm) on the day of the Official Workout/Covered
Horserace as previously stated. This revision was made to take account
of horse welfare, recognizing in particular that once a horse has been
subject to sample collection, or it has been decided that a
[[Page 5082]]
horse will not be selected for sample collection, the horse should not
be prohibited from receiving any necessary therapeutic treatments post-
race that are permitted outside the Race Period. The end of the ``Race
Day'' now also coincides with the end of the ``Race Period.''
The definition of ``Tampering'' was adjusted to make clear that it
does not include the actions of bona fide veterinary personnel
involving a Controlled Medication Substance or Controlled Medication
Method used for genuine and legal therapeutic purposes or other
acceptable justification. This addition mirrors the wording used in the
definition of ``Administration,'' which includes the same important
carve-out.
3000 Series--Equine Anti-Doping and Controlled Medication Protocol
Some commenters expressed the strong opinion that there is a
material difference between the use of doping substances to unfairly
affect the performance of horses, as opposed to errors in the
administration of recognized therapeutic substances. The Authority
agrees that this is a vital distinction, and the Protocol recognizes
the distinction in the penalty structure and other provisions
throughout the Protocol.
Further detail on the meaning of ``Owner'' has been provided to
take account of the varied and sometimes complex ownership structures
in horseracing (Rule 3020(c)).
The term ``Responsible Person'' defined in Rule 3030 has been
simplified to make clear that the trainer of a Covered Horse is the
Responsible Person for that horse. In circumstances where the horse
does not have a Trainer, the Owner is the Responsible Person. The
Responsible Person is personally liable for his or her Covered
Horse(s). However, other Covered Persons (including veterinarians,
among others) who made a relevant decision about the Covered Horse may
be found to be complicit in a violation and may be liable to the same
extent as the Responsible Person.
In response to comments received, the Authority removed the
disciplinary provisions concerning hypodermic needles, because
equivalent provisions are included in the Rule 2000 Series (Racetrack
Safety Program).
Some commenters proposed increasing the sanctions applicable to
repeat medication violation offenders and lengthening the period of
time that such violations would remain on their ``official record.''
The limitation period and roll-off period for Controlled Medication
Rule Violations has been increased from one to two years, and a
multiple violation penalty points system, modelled on the ARCI system,
has been added. As a consequence, in addition to any sanction received
for the underlying Controlled Medication Rule Violation, a Covered
Person will also receive a certain number of penalty points which
accumulate over a two-year period. When the points thresholds are
exceeded, additional sanctions will be imposed (in a manner similar to
the points system in the driver's licensing violation system).
A number of commenters requested that Controlled Medication
Substances be stratified into different classes, with individual
screening limits prescribed for each category. The Authority has done
so by classifying Controlled Medication Substances into Classes A to C
in the Technical Document-Prohibited Substances, which supplements the
Prohibited List. The sanctions in the Protocol in turn depend on the
class of substance in issue.
Commenters requested clarification of the requirement that a
Responsible Person make a Covered Horse available for testing ``at any
time and place.'' The Protocol was clarified to specify that the
Covered Horse must be available for testing at any time and place where
the horse is located (e.g., Racetrack, Training Facility, private
facility). The Protocol was also clarified to specify that Responsible
Persons shall ensure that the Covered Horse is produced for Sample
collection immediately upon notification by a duly authorized Person,
or, if the horse is not available at the location for Testing, within 6
hours of notification by a duly authorized Person (or if the Agency
agrees to extend that time period due to extenuating circumstances,
then within such extended time period). Failure to produce a Covered
Horse for Sample collection within six hours (or any extended period
agreed by the Agency) shall constitute a violation of Rule 3215
(evasion, or refusal or failure to submit to Sample collection). Sample
collection shall ordinarily be conducted where the Covered Horse is
located (e.g., Racetrack, Training Facility, or private facility),
unless the Agency agrees that the Covered Horse may be transported to
another agreed location (e.g., a nearby Racetrack).
In response to comments received, the Authority extended the period
of inactivity of a Covered Horse from 12 to 18 months, after which the
horse may be retired by the Authority, subject to an objection by the
Owner of the horse. This change was based on the rationale that horses
may suffer injuries that require a 12-month recovery period (such as
tendon injuries).
The Protocol was modified to clarify that where a horse's Sample
reveals the presence of more than one Controlled Medication Substance
above the applicable thresholds (if any), each substance may be treated
as a separate presence violation.
The Protocol was revised to clarify that Covered Persons may
request clearance testing to be conducted on their Covered Horses by a
Laboratory, but only if such request is authorized by the Authority in
advance and paid for by the Covered Person, and provided that such
samples will be treated in the same way as official Post-Race Samples,
such that any violation detected may be pursued by the Agency.
Some concerns were expressed regarding how cases involving
environmental contamination would be handled and publicized. The
Authority has incorporated an ``Atypical Findings Policy'' as Appendix
1 to the Rule 3000 Series. The Policy allows for certain substances to
be investigated first as Atypical Findings before being pursued as
Adverse Analytical Findings. If further to such investigation it is
determined that the positive test was the result of environmental
contamination, the matter will not be pursued as an Adverse Analytical
Finding, and the Atypical Finding will not be publicly disclosed.
The Authority has added provisions to the Protocol to clarify the
provisions on claimed horses. Some commenters expressed the concern
that testing every horse in a claiming race would be excessive. In
particular, Rule 3060 provides that a claimed horse may be subject to
Sample collection at a claiming race if elected (and paid for) by the
claimant. If the analysis of such Sample(s) results in an Anti-Doping
Rule Violation or Controlled Medication Rule Violation, the claim may
be voided at the option of the claimant and the claimant shall be
entitled to return of all sums paid for the claimed horse and of all
expenses incurred after the date of the claim.
Commenters also expressed the opinion that use of Lasix should not
be prohibited during training. The Protocol does not prohibit the use
of Lasix during training (see Rule 4212(d)).
4000 Series--Prohibited List
The key change made based on comments received was the development
of the ``Technical Document--Prohibited Substances,'' which supplements
the Prohibited List. The Technical Document provides additional detail
concerning the
[[Page 5083]]
Prohibited Substances that fall into the general categories established
in the Prohibited List, and sets forth detection times, screening
limits, and thresholds for those Prohibited Substances. The Technical
Document also designates certain Prohibited Substances as Specified
Substances. Specified Substances are those substances that pose a
higher risk of being the result of contamination, and that are
therefore subject to more flexible sanctions.
Comments were also received urging that anti-ulcer medications
should be permitted within 24 hours prior to a race. The ADMC
considered that proposition further, including the scientific paper
referenced below, which shows that the pH of gastric fluids returns to
baseline 24 hours after treatment with Omeprazole (an anti-ulcer
medication). Given that pH directly affects the development of ulcers,
the paper supports the use of anti-ulcer medications up to 24 hours
prior to Post-Time. To require a longer withdrawal interval means that
the stomach lining of a horse could be vulnerable to the recrudescence
of gastric ulceration.
Exhibit B.34. Jessica Wise et al., Pharmacokinetic and
pharmacodynamic effects of 2 registered omeprazole preparations and
varying dose rates in horses, J. Veterinary Internal Medicine (Nov.
2020), https://doi.org/10.1111/jvim.15971.
5000 Series--Equine Testing and Investigations Standards
In addition to a number of minor revisions based on the comments
received, the Authority added a section to address procedures for total
carbon dioxide (``TCO2'') testing, i.e., testing blood samples for
total carbon dioxide as evidence of use or administration of the
Controlled Medication Method M4 (alkalinization or use/administration
of an alkalinizing agent) (see Rule 5430).
6000 Series--Equine Standards for Laboratories and Accreditation
A number of minor revisions were made based on the detailed
comments received and further consultation with laboratory experts.
Some duplication with ISO/IEC 17025 was also removed, in particular in
section 6300.
7000 Series--Arbitration Procedures
Some commenters expressed confusion concerning the role of racing
stewards in the adjudication body previously designated as the
``National Stewards Panel.'' The body is now designated as the
``Internal Adjudication Panel,'' with individual members referred to as
Internal Adjudication Panel (``IAP'') members instead of ``stewards.''
The procedure for Controlled Medication Rule Violations was
developed partly in response to requests by commenters to provide for a
simplified hearing process for Covered Persons charged with a
violation. The procedures allow the IAP members adjudicating the case
to dispense with written filings and permit the Covered Person to make
an oral presentation in a hearing context. This procedure allows the
adjudication process to dispense where appropriate with certain of the
more formal and costly aspects of legal proceedings.
The Arbitration Procedures were also clarified to specify that
hearings regarding alleged breaches of the Protocol will not be open to
the media or the public, and to specify the Owners who may attend
hearings involving Covered Horses when the horse is owned by multiple
persons or entities.
The Arbitration Procedures were also clarified to specify that
while document production requests may be permitted, discovery or other
wide-ranging document requests are not permitted.
Minor Corrections Made to October 2022 Proposed Rule
Based on stakeholder comments and further review, the Authority has
made a few minor corrections to the proposed rule previously filed with
the Commission. Minor corrections were made to the Technical Document,
including (i) correcting certain references to thresholds throughout
the Technical Document, to ensure consistency with the approach taken
by the IFHA; (ii) correcting a typographical error regarding the
threshold for ketoprofen, which is 2ng/ml, as approved by the ADMC, as
noted in a correction published November 4, 2022, 87 FR 66705; (iii)
adding a comment about pemoline that was mistakenly deleted from the
previous version; (iv) correcting certain minor typographical errors in
the spelling of substance names; (v) capitalizing defined terms; and
(vi) other minor amendments to ensure consistency across the document,
including deletion of duplicate entries.
Certain other minor corrections were made to the proposed rule,
including (i) clarifying, in the definition of ``Aggravating
Circumstances,'' that one or both of an additional period of
ineligibility or fine may be imposed; (ii) correcting Rule 3346(a) to
clarify that the Responsible Person and Owner and one representative
each may attend the Laboratory to witness the opening and
identification of the B sample; (iii) adding ``to the extent possible''
in Rule 5220(b)(iv)(B) for consistency with other similar provisions;
(iv) specifying in Rule 5320 that sample collection equipment must be
able to withstand -20[deg]C rather than -80[deg]C, consistent with
industry standard; (v) removing the requirement for a signature in Rule
5410(i)(1) because the personnel tagging the horse at the end of the
race will not accompany the horse to the Test Barn and the signing of
the doping control documentation will occur at a later stage in the
sample collection process (see Rule 5410(i)(10)); (vi) minor
corrections to Rules 5420(j) and 5430(e) by striking ``within the
kit,'' as it was not consistent with collection kits available in the
industry; (vii) amending references to the ``BCO or DCO'' in Rule
5430(e) to ``relevant Sample Collection Personnel'' for consistency
with other similar provisions; (viii) amending Rules 5420(n) and
5430(k) to clarify that copies of doping control documentation will be
sent to the Responsible Person subsequently and not instantaneously;
and (ix) adding a reference to ``or refrigerator'' in Rule 5510(b)(1)
because, if urine samples are not shipped on the day of collection,
they will be refrigerated rather than frozen.
Minor typographical errors, such as extra spaces, spelling errors,
and punctuation, were corrected as well.
IV. Legal Authority
This rule is proposed by the Authority for approval or disapproval
by the Commission under 15 U.S.C. 3053(c)(1).
V. Effective Date
This rule would take effect upon approval by the Commission, and
the Commission must approve or disapprove the rule by March 27, 2023.
VI. Request for Comments
Members of the public are invited to comment on the Authority's
proposed rule. The Commission requests that factual data on which the
comments are based be submitted with the comments. The supporting
documentation referred to in the Authority's filing, as well as the
written comments it received before submitting the proposed rule to the
Commission, are available for public inspection at https://www.regulations.gov under docket number FTC-2023-0009.
The Commission seeks comments that address the decisional criteria
provided by the Act. The Act gives the Commission two criteria against
which to measure proposed rules and rule modifications: ``The
Commission shall approve a proposed rule or modification if the
Commission finds that the
[[Page 5084]]
proposed rule or modification is consistent with--(A) this chapter; and
(B) applicable rules approved by the Commission.'' \7\ In other words,
the Commission will evaluate the proposed rule for its consistency with
the specific requirements, factors, standards, or considerations in the
text of the Act as well as the Commission's procedural rule.
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\7\ 15 U.S.C. 3053(c)(2).
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Although the Commission evaluates the Authority's proposed rule for
its consistency with the Act and the Commission's procedural rule, the
Commission may consider broader questions--about the health and safety
of horses and jockeys, the integrity of horseraces and wagering on
horseraces, and the administration of the Authority itself--in another
context: ``The Commission . . . may abrogate, add to, or modify the
rules of the Authority promulgated in accordance with this Act as the
Commission finds necessary or appropriate to ensure the fair
administration of the Authority, to conform the rules of the Authority
to requirements of this Act and applicable rules approved by the
Commission, or otherwise in furtherance of the purposes of this Act.''
\8\ The Commission may exercise this rulemaking power on its own
initiative or in response to a petition from a member from the public.
If members of the public wish to provide comments to the Commission
about its use of the rulemaking power, they are encouraged to submit a
petition requesting that the Commission issue a rule addressing the
subject of interest. The petition must meet all the criteria
established in the Rules of Practice (part 1, subpart D); \9\ if it
does, the petition will be published in the Federal Register for public
comment. In particular, the petition for a rulemaking must ``identify
the problem the requested action is intended to address and explain why
the requested action is necessary to address the problem.'' \10\
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\8\ 15 U.S.C. 3053(e) (as amended by the Consolidated
Appropriations Act, 2023, H.R. 2617, 117th Cong., Division O, Title
VII (2022)).
\9\ 16 CFR 1.31; see Fed. Trade Comm'n, Procedures for
Responding to Petitions for Rulemaking, 86 FR 59851 (Oct. 29, 2021).
\10\ 16 CFR 1.31(b)(3).
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VII. Comment Submissions
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before February 9,
2023. Write ``HISA Anti-Doping and Medication Control'' on your
comment. Your comment--including your name and your State--will be
placed on the public record of this proceeding, including, to the
extent practicable, on the website https://www.regulations.gov.
Because of public health measures and the Commission's heightened
security screening, postal mail addressed to the Commission will be
subject to delay. We strongly encourage you to submit your comments
online through the https://www.regulations.gov website. To ensure that
the Commission considers your online comment, please follow the
instructions on the web-based form.
If you file your comment on paper, write ``HISA Anti-Doping and
Medication Control'' on your comment and on the envelope, and mail your
comment to the following address: Federal Trade Commission, Office of
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B),
Washington, DC 20580.
Because your comment will be placed on the public record, you are
solely responsible for making sure that your comment does not include
any sensitive or confidential information. In particular, your comment
should not contain sensitive personal information, such as your or
anyone else's Social Security number; date of birth; driver's license
number or other State identification number or foreign country
equivalent; passport number; financial account number; or credit or
debit card number. You are also solely responsible for making sure your
comment does not include any sensitive health information, such as
medical records or other individually identifiable health information.
In addition, your comment should not include any ``[t]rade secret or
any commercial or financial information which * * * is privileged or
confidential''--as provided in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule Sec. 4.10(a)(2), 16 CFR 4.10(a)(2)--including in
particular competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule Sec. 4.9(c), 16 CFR
4.9(c). In particular, the written request for confidential treatment
that accompanies the comment must include the factual and legal basis
for the request and must identify the specific portions of the comment
to be withheld from the public record. See FTC Rule Sec. 4.9(c). Your
comment will be kept confidential only if the General Counsel grants
your request in accordance with the law and the public interest. Once
your comment has been posted publicly at https://www.regulations.gov--
as legally required by FTC Rule Sec. 4.9(b), 16 CFR 4.9(b)--we cannot
redact or remove your comment, unless you submit a confidentiality
request that meets the requirements for such treatment under FTC Rule
Sec. 4.9(c), and the General Counsel grants that request.
Visit the FTC website to read this document and the news release
describing it. The FTC Act and other laws that the Commission
administers permit the collection of public comments to consider and
use in this proceeding as appropriate. The Commission will consider all
timely and responsive public comments it receives on or before February
9, 2023. For information on the Commission's privacy policy, including
routine uses permitted by the Privacy Act, see https://www.ftc.gov/siteinformation/privacypolicy.
VIII. Communications by Outside Parties to the Commissioners or Their
Advisors
Written communications and summaries or transcripts of oral
communications respecting the merits of this proceeding, from any
outside party to any Commissioner or Commissioner's advisor, will be
placed on the public record. See 16 CFR 1.26(b)(5).
IX. Self-Regulatory Organization's Proposed Rule Language
1000. General Provisions
Rule 1010. Rules of Interpretation
Unless specified otherwise:
(a) words in the singular include the plural, and words in the
plural include the singular;
(b) references to any ``Rule'' or ``Rule Series'' are references to
the rules or rule series approved by the Commission pursuant to section
3053 of the Act;
(c) any Appendices to a Rule Series form an integral part of such
Rule Series;
(d) any reference to a provision in rules, protocols, policies,
standards, guidelines, or similar includes any modifications or
successor provisions made or issued from time to time;
(e) any reference to legislation includes any modification or re-
enactment of legislation enacted in substitution of that legislation,
and any regulation or other instrument from time to time issued or made
under that legislation;
(f) any term defined in this Rule 1000 Series shall supersede the
definition of that term in the Rule 2000 Series;
[[Page 5085]]
(g) a reference to ``writing,'' ``write,'' or ``written'' includes
communications transmitted by email;
(h) a reference to ``may'' means ``in the sole and absolute
discretion of such person or body'';
(i) a reference to a ``day'' means any day of the week and is not
limited to working days;
(j) any time limits shall begin from the day after which the
relevant notification is received (or the day after the relevant
notification is sent, if sent by email). Official holidays and non-
working days are included in the calculation of time limits. The time
limits fixed under this Protocol are respected if the communications by
the parties are sent before midnight (U.S. Eastern time) on the last
day on which such time limits expire. If the last day of the time limit
is an official holiday or a non-business day in the state or country
where the notification has been made, the time limit shall expire at
the end of the first subsequent business day;
(k) a reference to a ``person'' (with no initial capital letter)
means a natural person; and
(l) any words following the terms ``including,'' ``include,'' ``in
particular,'' ``such as,'' ``for example,'' or any similar expression,
are illustrative only, and do not limit the sense of the words,
description, definition, phrase, or term preceding those terms.
Rule 1020. Definitions
Act means the Horseracing Integrity and Safety Act of 2020 (15
U.S.C. 3051-3060), as amended from time to time.
ADMC means the Anti-Doping and Medication Control Standing
Committee of the Authority.
Administration means providing, supplying, supervising,
facilitating, or otherwise participating in the Use or Attempted Use in
a Covered Horse of a Prohibited Substance or Prohibited Method.
However, this definition shall not include the actions of bona fide
veterinary personnel involving a Controlled Medication Substance or
Controlled Medication Method used for genuine and legal therapeutic
purposes or other acceptable justification.
Adverse Analytical Finding (``AAF'') means a report from a
Laboratory that, consistent with the Laboratory Standards, establishes
in a Sample the presence of a Prohibited Substance or its Metabolites
or Markers or evidence of the Use of a Prohibited Method.
Agency means the anti-doping and controlled medication enforcement
agency known as the Horseracing Integrity and Welfare Unit.
Aggravating Circumstances means circumstances involving, or actions
by, a Covered Person that may justify the imposition of one or both of
a period of Ineligibility or fine greater than the otherwise applicable
standard sanction. Such circumstances and actions include those set
forth in Rule 3227 or Rule 3327 (as applicable).
Aliquot means a portion of the Sample obtained from the Covered
Horse.
Analyte means a substance, compound, or measurand that is analyzed
or determined in a biological matrix using an Analytical Testing
Procedure performed under controlled analytical and laboratory
conditions. For anti-doping and controlled medication purposes, an
Analyte may be a Prohibited Substance, a Metabolite of a Prohibited
Substance, or a Marker of the Use of a Prohibited Substance or
Prohibited Method.
Analytical Method has the same meaning as Analytical Testing
Procedure.
Analytical Testing means the parts of the Doping Control or
Medication Control process performed at the Laboratory, which includes
Sample handling, analysis, and the reporting of results.
Analytical Testing Procedure means a Fit-for-Purpose procedure, as
demonstrated through method validation, that is used to detect,
identify or quantify Analytes in a Sample in accordance with the
Laboratory Standards and relevant Technical Document(s), Technical
Letter(s), Technical Note(s), or Laboratory Guidelines. Unless the
context otherwise requires, Analytical Testing Procedure is also
referred to or known as an Analytical Method or Test Method.
Analytical Testing Restriction (``ATR'') means a restriction on a
Laboratory's application of specified Analytical Testing Procedure(s)
or on the analysis of a particular class(es) of Prohibited Substances
or Prohibited Methods to Samples, as determined by the Agency.
Anti-Doping Rule Violation (``ADRV'') means an anti-doping rule
violation under the Protocol.
Arbitral Body has the meaning given to it in the Rule 7000 Series.
Arbitration Procedures means the arbitration procedures set forth
in the Rule 7000 Series.
Assistant Trainer means a person engaged in the training of Covered
Horses, under the direct or indirect supervision of a Trainer.
Association Veterinarian means a Veterinarian employed by a
Racetrack.
Attempt means purposely engaging in conduct that constitutes a
substantial step in a course of conduct planned to culminate in the
commission of an Anti-Doping Rule Violation or Controlled Medication
Rule Violation; provided, however, that there shall be no Anti-Doping
Rule Violation or Controlled Medication Rule Violation based solely on
an Attempt to commit a violation if the Covered Person renounces the
Attempt prior to it being discovered by a third party not involved in
the Attempt.
Attending Veterinarian means a Veterinarian providing treatment or
services to Covered Horses hired or otherwise authorized by the Trainer
or Owner or his or her respective designee.
Atypical Finding means a report from a Laboratory that requires
further investigation in accordance with the Atypical Findings Policy
set out at Appendix 1 to the Protocol, prior to the determination of
whether it is an Adverse Analytical Finding.
Atypical Findings Policy means the policy set out at Appendix 1 to
the Protocol.
Authority means the Horseracing Integrity and Safety Authority
designated by section 3052(a) of the Act.
Banned Method has the meaning given to it in Rule 3111.
Banned Substance has the meaning given to it in Rule 3111.
Batch means a set of Samples processed as a group.
Bias means deviation of a measured result from the expected or
reference value when using the complete measurement procedure.
Billing Standards means the standards governing compensation for
arbitrators and stewards under the Arbitration Procedures.
Blood Collection Officer (``BCO'') means a Veterinarian or a
veterinary technician who has been authorized by the Agency (or its
delegate) to collect blood Samples from a Covered Horse.
Breeder means a Person who is in the business of breeding Covered
Horses.
Certified Reference Material (``CRM'') means Reference Material
characterized by a metrologically valid procedure for one or more
specified properties, which is accompanied by a certificate that
provides the value of the specified property, its associated
uncertainty, and a statement of metrological traceability.
Certifying Scientists means personnel appointed by a Laboratory to
review all pertinent analytical data, Analytical Method validation
results, quality control results, Laboratory Documentation Packages,
and to attest to the validity of the Laboratory's test results.
Chain of Custody means the sequence of individuals or organizations
who
[[Page 5086]]
have responsibility for the custody of a Sample from the provision of
the Sample until the Sample has been delivered to the Laboratory for
analysis.
Chaperone means a person authorized by the Agency (or its delegate)
to carry out the responsibilities given to Chaperones in the Testing
and Investigations Standards or by the DCO.
Charge Letter has the meaning given to it in (as the context
requires) Rule 3248 or Rule 3348.
Claim means, in the context of a Claiming Race, the purchase of a
Covered Horse for a designated amount.
Claiming Race means a Covered Horserace in which a Covered Horse
after leaving the starting gate may be claimed in accordance with the
rules and regulations of the applicable State Racing Commission.
Code of Ethics means the Code of Ethics for Laboratories set forth
at Rule 6610.
Commission means the Federal Trade Commission.
Confirmation Procedure (``CP'') means an Analytical Testing
Procedure that has the purpose of confirming the presence in a Sample--
or, when applicable, confirming the concentration, ratio, or score, or
establishing the origin (exogenous or endogenous)--of one or more
specific Prohibited Substances, Metabolite(s) of a Prohibited
Substance, or Marker(s) of the Use of a Prohibited Substance or
Prohibited Method.
Consequences means the penalties resulting from the occurrence of
one or more violations of the Protocol, as set forth in the Rule 3000
Series. The Consequences for an Anti-Doping Rule Violation or a
Controlled Medication Rule Violation may include one or more of the
following:
(1) Disqualification;
(2) Ineligibility;
(3) Provisional Suspension;
(4) financial penalties; and
(5) Public Disclosure.
Contaminated Product means a product other than feed, hay, or
water, that contains a Prohibited Substance that (i) is not disclosed
on the product label, and (ii) a Veterinarian or Trainer would not
otherwise reasonably be aware might be included in the product.
Controlled Medication Method means any method so described on the
Prohibited List.
Controlled Medication Rule Violation has the meaning given to it in
Rule 3311(a).
Controlled Medication Substance means any substance so described on
the Prohibited List or the Technical Document-Prohibited Substances.
Corrective Action Report (``CAR'') means a report describing the
Root Cause Analysis of a nonconformity and the corrective actions
implemented to rectify it. If appropriate, it shall also describe the
improvements adopted to minimize the risk of recurrence of the
nonconformity.
Covered Horse means any Thoroughbred horse, or any other horse made
subject to the Act by election of the applicable State Racing
Commission or the breed governing organization for such horse under
section 3054(l), during the period: (A) beginning on the date of the
horse's first Timed and Reported Workout at a Racetrack that
participates in Covered Horseraces or at a training facility; and (B)
ending on the date on which the horse is deemed retired pursuant to
Rule 3050(b).
Covered Horserace means any horserace involving Covered Horses that
has a substantial relation to interstate commerce, including any
Thoroughbred horserace that is the subject of interstate off-track or
advance deposit wagers.
Covered Person means all Trainers, Owners, Breeders, Jockeys,
Racetracks, Veterinarians, Persons licensed by a State Racing
Commission, and the agents, assigns, and employees of such Persons; any
other Persons required to be registered with the Authority; and any
other horse support personnel who are engaged in the care, treatment,
training, or racing of Covered Horses.
Decision Limit means the value of the result for a Threshold
Substance in a Sample, above which an Adverse Analytical Finding shall
be reported.
Designated Owner has the meaning given to it in Rule 3020(c).
Detection Time means the interval after a medication is
administered during which it is detectable in a specific matrix (serum,
plasma, urine, or hair) from any member(s) of a group of test horses.
Detection times are determined from analysis of samples collected at
specific time points following an administration of a medication to
group of, potentially as few as 2, test horses. A detection time is not
the same as a withdrawal time. The withdrawal time for a medication
must be decided upon by a Veterinarian (in consultation with the
Responsible Person) and is likely to be based on the Detection Time and
an added safety margin. This margin should be determined using
professional judgment and discretion to take into account the
variability that could be expected to normally occur in a larger
population by considering individual differences between horses, such
as size, metabolism, fitness, health, or recent illness or disease. The
withdrawal interval used for a medication should always be longer than
its Detection Time.
Disqualification means the results of a Covered Horse in a
particular Covered Horserace are invalidated, with all resulting
consequences, including forfeiture of any purses and other
compensation, prizes, trophies, points, and rankings associated with
such Covered Horserace.
Doping Control means all steps and processes from test distribution
planning through to ultimate disposition of any adjudication and review
process pursuant to the Protocol and the Act involving an Anti-Doping
Rule Violation and the enforcement of Consequences, including all steps
and processes in between, including Testing, investigations,
whereabouts program, Sample collection and handling, Laboratory
analysis, Results Management, hearings and reviews, and investigations
and proceedings relating to Anti-Doping Rule Violations not arising
from or related to Testing or violations of Rule 3229.
Doping Control Officer (``DCO'') means an official who has been
authorized by the Agency (or its delegate) to carry out the
responsibilities given to DCOs in the Testing and Investigations
Standards and any related Agency procedures.
EAD Notice has the meaning given to it in Rule 3245.
EAD Violations means Anti-Doping Rule Violations arising out of the
Rule 3000 Series and violations of Rule 3229.
ECM Notice has the meaning given to it in Rule 3345.
ECM or Other Violations means Controlled Medication Rule Violations
arising out of the Rule 3000 Series, violations of Rule 3329, or
violations of Rule 3510.
Equibase means the official database for Thoroughbred horseracing.
Equine Constituencies means, collectively, Owners, Breeders,
Trainers, Racetracks, Veterinarians, State Racing Commissions, and
Jockeys who are engaged in the care, training, or racing of Covered
Horses.
Equine Industry Representative means an organization regularly and
significantly engaged in the equine industry, including organizations
that represent the interests of, and whose membership consists of,
Owners, Breeders, Trainers, Racetracks, Veterinarians, State Racing
Commissions, or Jockeys.
Expanded Measurement Uncertainty means the multiplication of the
coverage factor (q.v.) by the Measurement Uncertainty (q.v.).
External Quality Assessment Scheme (``EQAS'') means a program for
quality
[[Page 5087]]
assessment of Laboratory performance, which includes the periodic
distribution of urine, blood, hair, or other samples to Laboratories
and probationary laboratories by the Agency, to be analyzed for the
presence or absence of Prohibited Substances or their Metabolite(s), or
Marker(s) of Use of Prohibited Substances or Prohibited Methods. EQAS
samples may be open (i.e., educational; in such cases the content may
be indicated), blind or double-blind (in such cases the content is
unknown to the Laboratories).
Fault means any breach of duty or any lack of care appropriate to a
particular situation. Factors to be taken into consideration in
assessing a Covered Person's degree of Fault include (but are not
limited to) the Covered Person's experience and special considerations
such as impairment, the degree of risk that should have been perceived
by the Covered Person, and the level of care and investigation
exercised by the Covered Person in relation to what should have been
the perceived level of risk. With respect to supervision, factors to be
taken into consideration are the degree to which the Covered Person
conducted appropriate due diligence, educated, supervised, and
monitored Covered Persons (including Veterinarians), employees,
personnel, agents, and other Persons involved in any way with the care,
treatment, training, or racing of his or her Covered Horses, and
created and maintained systems to ensure compliance with the Protocol.
In assessing the Covered Person's degree of Fault, the circumstances
considered must be specific and relevant to explain the Covered
Person's departure from the expected standard of behavior. Thus, for
example, the fact that the Covered Person would lose the opportunity to
earn large sums of money during a period of Ineligibility, or the fact
that the Covered Person or Covered Horse only has a short time left in
a career, or the timing of the horseracing calendar, would not be
relevant factors to be considered in reducing the period of
Ineligibility based on degree of Fault.
Fit(ness)-for-Purpose means suitable for the intended purpose and
in conformity with the ISO/IEC 17025, ILAC-G7, the Laboratory
Standards, and relevant Technical Document(s) and Technical Letter(s).
Further Analysis means additional analysis conducted by a
Laboratory on an A Sample or a B Sample after it has reported an
analytical result for that A Sample or that B Sample, save that it
excludes (and, therefore, there is no limitation on a Laboratory's
authority to conduct) repeat or confirmation analysis, and analysis
with additional or different Analytical Methods.
IAP member means a member of the Internal Adjudication Panel.
Immediate Family Member means a spouse, domestic partner, mother,
father, aunt, uncle, sibling, or child.
Ineligibility means the Covered Horse or Covered Person is barred
for a specified period of time from participating in specified
activities, as further particularized in the provisions of the Protocol
relating to Ineligibility.
Initial Testing Procedure (``ITP'') means an Analytical Testing
Procedure whose purpose is to identify those Samples that may contain a
Prohibited Substance, Metabolite(s) of a Prohibited Substance, or
Marker(s) of the Use of a Prohibited Substance or Prohibited Method or
an elevated quantity of a Prohibited Substance, Metabolite(s) of a
Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance
or Prohibited Method.
Interested Party means the Authority, the Owner of the Covered
Horse, the Trainer of the Covered Horse, and the relevant State Racing
Commission (provided that such State Racing Commission has entered into
an agreement incorporating required confidentiality provisions).
Intermediate Precision (sw) means variation in results observed
when one or more factors, such as time, equipment, or operator, are
varied within a Laboratory, and may also be referred to as inter-batch
or inter-run precision.
Internal Adjudication Panel has the meaning given to it in the Rule
7000 Series. The Internal Adjudication Panel shall have the same
meaning as the National Stewards Panel in any other rules approved by
the Commission.
Jockey means a rider or driver of a Covered Horse in Covered
Horseraces.
Laboratory means a laboratory approved by the Agency, applying Test
Methods and processes to provide evidentiary data for the detection or
identification of Prohibited Substances, Metabolites, Markers, or
Prohibited Methods, and, if applicable, quantification of a Threshold
Substance in Samples of urine, blood, hair, and other biological
matrices in the context of Doping Control or Medication Control
activities.
Laboratory Director means a person appointed by a Laboratory to be
responsible for overseeing the professional, organizational,
educational, operational, and administrative responsibilities of the
Laboratory's operations in accordance with the Laboratory Standards.
Laboratory Documentation Package (``LDP'') means the physical or
electronic material produced by a Laboratory upon reporting of an
Adverse Analytical Finding or as requested by the Agency to support an
analytical result such as an Adverse Analytical Finding or an Atypical
Finding.
Laboratory Expert Group (``LabEG'') means the group of laboratory
experts responsible for providing advice, recommendations, and guidance
to the Agency with respect to the overall management of Laboratory
accreditation, disciplinary action, re-accreditation, approval
processes, and monitoring activities.
Laboratory Guidelines (``LGs'') means recommendations of Laboratory
best practices that may be provided by the Agency to address specific
Laboratory operations or to provide technical requirements and guidance
on interpretation and reporting of results for the analysis of specific
Prohibited Substance(s), Metabolites, or Markers, or Prohibited
Method(s), or on the application of specific Laboratory procedures.
Laboratory Internal Chain of Custody means documentation maintained
within the Laboratory to record the chronological traceability of
custody and actions performed on the Sample and any Aliquot of the
Sample taken for Analytical Testing. Laboratory Internal Chain of
Custody is generally documented by a written or electronic record of
the date, location, action taken, and the person performing an action
with a Sample or Aliquot.
Laboratory Standards means the Equine Standards for Laboratories
and Accreditation set forth in the Rule 6000 Series.
Laboratory Supervisory Personnel means personnel appointed by a
Laboratory to serve as Laboratory supervisors.
Limit of Detection (``LOD'') means the analytical parameters of
assay technical performance. Lowest concentration of an Analyte in a
Sample that can be routinely detected, but not necessarily identified
or quantified, under the stated Test Method conditions used.
Limit of Identification (``LOI'') means analytical parameter of
technical performance for chromatographic-mass spectrometric
Confirmation Procedures. The LOI is estimated during method validation
to evaluate the rate of false negative results at a certain
concentration level. The LOI of a Test Method, at 5% false negative
rate, for an Analyte (for which a Reference Material is available)
shall be less than the MRPL. Since the LOI is an estimation of
[[Page 5088]]
the false negative rate, Laboratories may report findings below the
estimated LOI as Adverse Analytical Findings or Atypical Findings, as
applicable, when the Analyte is identified in the Sample according to
the criteria established in a Technical Document.
Limit of Quantification (``LOQ'') means the analytical parameter of
assay technical performance. Lowest concentration of an Analyte in a
Sample that can be quantitatively determined with acceptable precision
and accuracy (i.e., acceptable Measurement Uncertainty) under the
stated Test Method conditions.
Management System refers to the Laboratory's quality system to deal
with control of management system documents and records and with
actions to address risk, test improvements, corrective actions, and
ongoing management reviews.
Managing Owner has the meaning given to it in Rule 3020(c).
Marker means a compound, group of compounds, or biological
variable(s) that indicates the Use of a Prohibited Substance or
Prohibited Method.
Measurement Uncertainty (``MU'') means the parameter associated
with a measurement result that characterizes the dispersion of quantity
values attributed to the measure and provides confidence in the
validity of the measured result.
Medication Control means all steps and processes from test
distribution planning through to ultimate disposition of any
adjudication and review process pursuant to the Protocol and the Act
involving a Controlled Medication Rule Violation and to enforcement of
Consequences, including all steps and processes in between, including
Testing, investigations, whereabouts program, Sample collection and
handling, Laboratory analysis, Results Management, hearings and
reviews, and investigations and proceedings relating to Controlled
Medication Rule Violations not arising from or related to Testing or
violations of Rule 3329.
Metabolite means any substance produced from a Prohibited Substance
by a biotransformation process.
Minimum Reporting Level means the estimated concentration of a
Prohibited Substance or its Metabolite(s) or Marker(s) in a Sample
below which Laboratories will not report that Sample as an Adverse
Analytical Finding.
Minimum Required Performance Level (``MRPL'') means minimum
analytical criterion of Laboratory technical performance established by
the Agency, including the minimum concentration at which a Laboratory
is expected to consistently detect and confirm a Prohibited Substance,
Metabolite of a Prohibited Substance, or Marker of a Prohibited
Substance or Prohibited Method in the routine daily operation of the
Laboratory.
Minor means a natural person who has not reached the age of 18
years.
National Stewards Panel means the Internal Adjudication Panel.
Negative Finding means a test result from a Laboratory that, in
accordance with the Laboratory Standards and any relevant Technical
Document(s) and Technical Letter(s), concludes that no Prohibited
Substance(s) or its Metabolite(s) or Marker(s) or evidence of the Use
of a Prohibited Method(s), included in the requested Analytical Testing
menu, were found in a Sample based on the applied Initial Testing
Procedure(s) or Confirmation Procedure(s).
No Fault or Negligence means the Covered Person establishing that
he or she did not know or suspect, and could not reasonably have known
or suspected, even with the exercise of utmost caution, that he or she
had administered to the Covered Horse (or that the Covered Horse's
system otherwise contained) a Banned Substance or a Controlled
Medication Substance, or that he or she had Used on the Covered Horse a
Banned Method or a Controlled Medication Method, or otherwise committed
an Anti-Doping Rule Violation or Controlled Medication Rule Violation.
For any violation of Rule 3212 or Rule 3312, the Covered Person must
also establish how the Prohibited Substance entered the Covered Horse's
system in order to establish No Fault or Negligence.
No Significant Fault or Negligence means the Covered Person
establishing that his or her fault or negligence, when viewed in the
totality of the circumstances and taking into account the criteria for
No Fault or Negligence, was not significant in relationship to the
Anti-Doping Rule Violation or Controlled Medication Rule Violation in
question. For any violation of Rule 3212 or 3312, the Covered Person
must also establish how the Prohibited Substance entered the Covered
Horse's system in order to establish No Significant Fault or
Negligence.
Nominated Person means a person nominated by a Responsible Person
at the time of notification or through a whereabouts filing to assist,
consent to, and witness Sample collection from a Covered Horse. If the
Responsible Person is not present to nominate a person, or the
designated Nominated Person is not present or willing to assist with
Sample collection, anyone employed by the Responsible Person or Owner
at the stable where the Covered Horse is located shall be the Nominated
Person for that Sample collection. If no Nominated Person is promptly
identified as described above, the person who has custody or control of
the Covered Horse or granted the DCO, BCO, or Chaperone access to the
Covered Horse shall be the Nominated Person for that Sample collection.
In each case, the Nominated Person shall be 18 years or older.
Non-Threshold Substance means a Prohibited Substance for which the
identification, in compliance with any applicable Technical
Document(s), constitutes an Adverse Analytical Finding.
Owner means a person who holds an ownership interest in one or more
Covered Horses.
Person means a natural person or an organization or other entity.
Possession means actual, physical possession, or constructive
possession (which shall be found only if the Covered Person has
exclusive control or intends to exercise exclusive control over the
Prohibited Substance or Prohibited Method or the premises in which a
Prohibited Substance or Prohibited Method exists). If the Covered
Person does not have exclusive control over the Prohibited Substance or
Prohibited Method or the premises in which a Prohibited Substance or
Prohibited Method exists, constructive Possession shall only be found
if the Covered Person knew about the presence of the Prohibited
Substance or Prohibited Method and intended to exercise control over
it. There shall be no Anti-Doping or Controlled Medication Rule
violation based solely on Possession if, prior to receiving
notification of any kind of any violation, the Covered Person has taken
concrete action demonstrating that the Covered Person never intended to
have possession and has renounced possession by explicitly declaring it
to the Agency. Notwithstanding anything to the contrary in this
definition, the act of purchasing (including by any electronic or other
means) a Banned Substance or Banned Method constitutes Possession by
the Covered Person who makes the purchase, whether or not the Banned
Substance or Banned Method purchased is ever delivered to the Covered
Person.
Post-Race Sample means a Sample collected by or on behalf of the
Agency from a Covered Horse where notification of such Sample
collection takes place no more than 1 hour after the end of a Covered
Horserace in which a Covered Horse participates or is entered, or the
[[Page 5089]]
end of a Vets' List Workout in which a Covered Horse participates. All
Banned Substances and all Controlled Medication Substances are
prohibited from being present in a Post-Race Sample.
Post-Time means the start time of a Covered Horserace in which a
Covered Horse participates or is entered, or the start time of a Vets'
List Workout in which a Covered Horse participates.
Post-Work Sample means a Sample collected by or on behalf of the
Agency from a Covered Horse where notification of such Sample
collection takes place no more than 1 hour after the end of a Timed and
Reported Workout. All Banned Substances and any Controlled Medication
Substances specifically identified on the Prohibited List as prohibited
during Timed and Reported Workouts are prohibited from being present in
a Post-Work Sample.
Presumptive Adverse Analytical Finding (``PAAF'') means the status
of a Sample test result from the Initial Testing Procedure which
represents a suspicious finding, but for which a Confirmation Procedure
to render a conclusive test result has not yet been performed.
Program means the anti-doping and medication control program
established under section 3055(a) of the Act.
Program Effective Date means the date on which the Commission
approves the proposed rule.
Prohibited List means the list identifying Prohibited Substances
and Prohibited Methods set forth in the Rule 4000 Series.
Prohibited Method means any method so described on the Prohibited
List.
Prohibited Substance means any substance or class of substances so
described on the Prohibited List or the Technical Document-Prohibited
Substances.
Protocol means the Rule 3000 Series (Equine Anti-Doping and
Controlled Medication Protocol), as amended from time to time.
Provisional Hearing means an expedited abbreviated hearing to
resolve a challenge to a Provisional Suspension, occurring prior to the
adjudication of the violation in issue.
Provisional Suspension means the Covered Horse or Covered Person is
barred temporarily from participating in any Timed and Reported Workout
or Covered Horserace in accordance with Rules 3229 or 3329 (as
applicable).
Public Disclosure means the dissemination or distribution of
information by the Authority or the Agency to the general public.
Quality Manager means the staff member appointed by a Laboratory to
perform that role in accordance with the Laboratory Standards.
Race Day means the period commencing at 12:01 a.m. on the day of a
Vets' List Workout or Covered Horserace and ending (i) 1 hour after the
end of such Vets' List Workout or Covered Horserace or (ii) at the end
of any Sample Collection Session conducted at that Vets' List Workout
or Covered Horserace when the Covered Horse is released from the Test
Barn, whichever is later.
Race Organizer means any Person that arranges, organizes, and has
administrative responsibility for a Covered Horserace.
Race Period means the period:
(a) commencing 48 hours prior to the Post-Time of either (i) any
Vets' List Workout in which the Covered Horse participates or (ii) any
Covered Horserace that the Covered Horse has been entered in, whether
or not the Covered Horse actually starts; and
(b) ending (i) 1 hour after the end of such Vets' List Workout or
Covered Horserace or (ii) at the end of any Sample collection process
conducted at that Vets' List Workout or Covered Horserace when the
Covered Horse is released from the Test Barn, whichever is later.
However, the Prohibited List may specify a Race Period that is
shorter or longer in duration than the above period for certain
Controlled Medication Substances or Controlled Medication Methods.
Racetrack means an organization licensed by a State Racing
Commission to conduct Covered Horseraces.
Racetrack Safety Program means the program set forth in Rule 2000
Series, established pursuant to section 3056(a) of the Act.
Reference Collection (``RC'') means a collection of samples or
isolates of known origin that may be used in the determination of the
identity of an unknown substance. For example, a well-characterized
sample obtained from a controlled administration or from in vitro
studies in which the presence of the substance of interest has been
established.
Reference Material (``RM'') means a Reference Substance or
Reference Standard that is sufficiently characterized, homogeneous, and
stable with respect to one or more specified properties and that has
been established to be fit for its intended use in an Analytical
Testing Procedure.
Regulatory Veterinarian means a Veterinarian who is employed,
contracted, or appointed by a State Racing Commission, Racetrack, the
Authority, or the Agency to monitor the health and welfare of Covered
Horses, in addition to any other duties assigned to him or her by the
Authority or the Agency.
Repeatability (sr) means variability of results obtained within a
laboratory using the same method, over a short time, using a single
operator, item of equipment, etc. It is also referred to as intra-
batch/intra-run precision.
Reproducibility (sR) means variability of results obtained when
different laboratories analyze Aliquots of the same Sample.
Reproducibility is a property of the results obtained and represents a
measurable agreement of analytical results between different
laboratories.
Responsible Person has the meaning given to it in Rule 3030.
Results Management means the process encompassing the timeframe
from provision of an EAD Notice or ECM Notice through the charge until
the final resolution of the matter, including the end of any
adjudication and review process pursuant to the Protocol and the Act.
Revocation means the permanent withdrawal of a Laboratory's Equine
Analytical Laboratory accreditation by the Agency.
Risk Assessment means the assessment of risk of doping and
controlled medication misuse conducted by the Agency and used to
effectively conduct test distribution planning or Target Testing.
RMTC has the meaning given to it in Rule 6070(a).
Root Cause Analysis (``RCA'') means an investigation to identify
one or more fundamental causes of a nonconformity based on the
collection of objective evidence from an assessment of the likely
factors that led to the nonconformity. The removal of a root cause
factor prevents the recurrence of the nonconformity; in contrast,
removing a causal factor can improve the outcome, but it does not
prevent the recurrence of the problem with certainty.
Sample means any biological material collected for the purposes of
Doping Control or Medication Control, including urine, blood, and hair.
Sample Collection Equipment means A and B bottles, kits,
containers, collection vessels, tubes, or other apparatus used to
collect, hold, or store a Sample at any time during or after a Sample
Collection Session.
Sample Collection Personnel means all qualified officials
authorized by the Agency to carry out or assist with duties during
Doping Control or Medication Control, including, but not limited to,
Blood Collection Officers, Doping
[[Page 5090]]
Control Officers, and Chaperones. An individual may be authorized by
the Agency to carry out one or more roles during Doping Control or
Medication Control.
Sample Collection Session means all of the sequential activities
that directly involve the collection of a Sample from a Covered Horse
from the point that initial contact is made with the Responsible Person
or Nominated Person until the Covered Horse provides a Sample and is
discharged from Sample collection obligations.
Screening Limit means a concentration to be used by Laboratories
when screening for certain Non-Threshold Substances during the Initial
Testing Procedure, below which a Laboratory will not pursue the
possible presence of a Prohibited Substance. When the concentration of
an Analyte subject to a Screening Limit exceeds the Screening Limit as
determined by the Initial Testing Procedure, qualitative confirmatory
analysis by mass spectrometry Confirmation Procedure is required to
confirm the presence or absence of the Prohibited Substance.
Quantification is not required. A Screening Limit is not a Limit of
Detection, a Limit of Identification, or a Limit of Quantification.
Selectivity means the ability of the Analytical Testing Procedure
to detect or identify (as applicable) the substance of interest in the
Sample.
Specified Substance has the meaning given to it in Rule 3111(c).
Stacking Violation has the meaning given to it in Rule 3312(e).
Stakes Race means any race so designated by the Racetrack at which
such race is run, including, without limitation, the races the
Breeders' Cup World Championships comprises and the races designated as
graded stakes by the American Graded Stakes Committee of the
Thoroughbred Owners and Breeders Association.
Standard Operating Procedure means a document setting out
prescribed methods or procedures to be followed when performing certain
routine operations.
Standards means the Testing and Investigations Standards and the
Laboratory Standards. Compliance with a Standard (as opposed to another
alternative standard, practice, or procedure) shall be sufficient to
conclude that the procedures addressed by the Standard were performed
properly. Standards shall include any Technical Documents issued
pursuant to the Standards.
State Racing Commission means an entity designated by State law or
regulation that has jurisdiction over the conduct of horseracing within
the applicable state.
Substantial Assistance means, for purposes of Rule 3226(a) and Rule
3326(a), a Covered Person providing the following assistance:
(1) fully disclosing in a signed written statement or recorded
interview all information the Covered Person possesses in relation to
violations of the Protocol; and
(2) fully cooperating with the investigation and adjudication of
any case or matter related to that information, including, for example,
by providing an affidavit and presenting testimony at a hearing if
requested to do so by the Agency or adjudication body.
Further, the information provided must be credible and must
comprise an important part of any case or proceeding which is initiated
or, if no case or proceeding is initiated, must have provided a
sufficient basis on which a case or proceeding could have been brought.
Tamper Evident means to have one or more indicators or barriers to
entry included with or incorporated into the Sample Collection
Equipment, which, if breached, missing, or otherwise compromised, can
provide visible evidence that Tampering or Attempted Tampering of
Sample Collection Equipment has occurred.
Tampering means intentional conduct that subverts the Doping
Control or Medication Control process, but that would not otherwise be
included in the definition of Prohibited Methods. Tampering includes
offering or accepting a bribe to perform or fail to perform an act,
preventing the collection of a Sample, affecting or making impossible
the analysis of a Sample, falsifying documents submitted to the Agency
(or a committee or adjudication body), procuring false testimony from
witnesses, committing any other fraudulent act upon the Agency (or
committee or adjudication body) to affect Results Management or the
imposition of Consequences, and any other similar interference or
attempted interference with any aspect of Doping Control or Medication
Control. However, this definition shall not include the actions of bona
fide veterinary personnel involving a Controlled Medication Substance
or Controlled Medication Method used for genuine and legal therapeutic
purposes or other acceptable justification.
Target Testing means selection of specific Covered Horses for
Sample collection based on criteria set forth in the Testing and
Investigations Standards.
Technical Document (``TD'') means a document adopted and published
by the Authority from time to time containing requirements or guidance
on specific anti-doping or medication control topics.
Technical Letter (``TL'') means a document published containing
mandatory technical requirements provided by the Agency from time to
time to address particular issues on the analysis, interpretation, and
reporting of specific Prohibited Substance(s), Metabolites, Markers, or
Prohibited Method(s), or on the application of specific Laboratory
procedures.
Technical Note (``TN'') means technical guidance provided by the
Agency to Laboratories on the performance of specific Laboratory
methods or procedures.
Test Barn means the location where Sample collection is conducted
on Race Day.
Test Barn Veterinarian means a Veterinarian who is employed,
contracted, or appointed by a State Racing Commission, Racetrack, the
Authority, or the Agency to monitor the health and welfare of Covered
Horses subject to Sample collection in the Test Barn.
Testing means the parts of the Doping Control or Medication Control
process involving Sample collection, Sample handling, and Sample
transport to the Laboratory.
Testing and Investigations Standards means the Equine Testing and
Investigations Standards set forth in the Rule 5000 Series.
Test Method has the same meaning as Analytical Testing Procedure.
Thoroughbred means a horse that is registered in The American Stud
Book or in a foreign stud book approved by the Jockey Club or the
International Stud Book Committee.
Threshold means the maximum permissible level of the concentration,
ratio, or score for a Threshold Substance in a Sample. The Threshold is
used to establish the Decision Limit for reporting an Adverse
Analytical Finding or Atypical Finding for a Threshold Substance.
Thresholds may only be adopted for (i) substances endogenous to the
horse or (ii) substances arising from plants traditionally grazed or
harvested as equine feed.
Threshold Substance means a Prohibited Substance, or Metabolite or
Marker of a Prohibited Substance, for which the identification and
quantitative determination, including, for example, concentration,
ratio, or score, in excess of a pre-determined Decision Limit, or, when
applicable, the establishment of an exogenous origin,
[[Page 5091]]
constitutes an Adverse Analytical Finding.
Timed and Reported Workout means an officially timed and published
running of a Thoroughbred horse over a predetermined distance that is
not a horserace, as reported by Equibase or any official supplier of
racing information and statistics recognized by the Authority. Official
timed workouts shall have the same meaning as Timed and Reported
Workouts. Any official timed workout by a Thoroughbred horse in any
other jurisdiction shall be deemed a Timed and Reported Workout upon
the earliest to occur of the following: (i) the horse is brought to the
United States for purposes of participating in any Covered Horserace;
or (ii) the horse is nominated for a Covered Horserace.
Trafficking means a Covered Person selling, giving, transporting,
sending, delivering, or distributing by any means a Banned Substance or
Banned Method to any other Person, or Possessing a Banned Substance or
Banned Method for any such purpose; provided, however, that Trafficking
shall not include the actions of Veterinarians or other licensed
medical personnel involving a Prohibited Substance used for genuine and
legal therapeutic purposes or other acceptable justification.
Trainer means an individual engaged in the training of Covered
Horses.
Training Facility means a location that is not a Racetrack licensed
by a State Racing Commission that operates primarily to house Covered
Horses and conduct Timed and Reported Workouts.
Use means the utilization, application, ingestion, injection, or
consumption by any means whatsoever of any Prohibited Substance or
Prohibited Method in relation to a Covered Horse.
Veterinarian means a licensed veterinarian who provides veterinary
services to Covered Horses.
Veterinarians' List has the meaning given to it in Rule 2000 Series
(Racetrack Safety Program).
Vets' List Workout means an officially timed running of a Covered
Horse over a predetermined distance that is not a Covered Horserace but
is overseen by a Regulatory Veterinarian or Racetrack steward.
Whereabouts Failure means a failure by the Responsible Person to do
any of the following: (i) provide notice to the Agency that his or her
Covered Horse has been moved from a Racetrack or Training Facility to a
private facility (i.e., a facility not under the jurisdiction of the
Authority/Agency) before such move occurs; (ii) provide whereabouts
information about his or her Covered Horse(s) upon request by the
Agency; (iii) provide sufficient information about the Covered Horse's
whereabouts to enable the Agency to Test the Covered Horse at any time;
or (iv) update any whereabouts information provided to the Agency if it
changes.
Without Prejudice Agreement means a written agreement between the
Agency and a Covered Person that allows the Covered Person to provide
information to the Agency in a defined time-limited setting with the
understanding that, if an agreement for Substantial Assistance or a
case resolution agreement is not finalized, the information provided by
either party may not be used by the other party in any Results
Management proceeding under this Protocol. Such an agreement shall not
preclude the parties from using any information or evidence gathered
from any source.
Workout means a timed running of a horse over a predetermined
distance not associated with a race or its first qualifying race, if
such race is made subject to the Act by election under section 3054(l)
of the Act of the horse's breed governing organization or the
applicable State Racing Commission.
3000. Equine Anti-Doping and Controlled Medication Protocol
3000. General Provisions
Rule 3010. Introduction
(a) The Horseracing Integrity and Safety Act of 2020 (``Act'')
mandates and empowers the Horseracing Integrity and Safety Authority
(``Authority'') to establish a uniform anti-doping and controlled
medication program to improve the integrity and safety of horseracing
in the United States (``Program'').
(b) This Equine Anti-Doping and Controlled Medication Protocol
(``Protocol'') has been developed and issued by the Authority as part
of that mandate. It contains or incorporates by reference rules,
standards, and procedures to improve and protect the integrity and
safety of horseracing in the United States by deterring and penalizing
the improper administration or application of Prohibited Substances and
Prohibited Methods to Covered Horses. The Protocol is split into five
chapters:
(1) the purpose, scope, and organization of the Protocol;
(2) the Prohibited List, rules of proof, and testing and
investigations;
(3) the Equine Anti-Doping Rules;
(4) the Equine Controlled Medication Rules; and
(5) other violations and general procedure/administration.
(c) The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except as otherwise provided in the Prohibited List. For the avoidance
of doubt, the Protocol does not regulate the use of drugs or
medications by human participants in Covered Horseraces.
(d) The Protocol reflects and implements the following principles
set out in section 3055(b) of the Act that:
(1) Covered Horses should compete only when they are free from the
influence of medications, other foreign substances, and treatment
methods that affect their performance;
(2) Covered Horses that are injured or unsound should not train or
participate in Covered Horseraces, and that medications, other foreign
substances, and treatment methods that mask or deaden pain in order to
allow injured or unsound horses to train or race should be prohibited;
(3) rules, standards, procedures, and protocols regulating
medication and treatment methods for Covered Horses and Covered
Horseraces should be uniform and uniformly administered throughout the
United States;
(4) to the extent consistent with the Act, consideration should be
given to international anti-doping and medication control standards of
the International Federation of Horseracing Authorities and the
Principles of Veterinary Medical Ethics of the American Veterinary
Medical Association;
(5) the administration of medications and treatment methods to
Covered Horses should be based upon a veterinary examination and
diagnosis that identifies an issue requiring treatment for which the
medication or method represents an appropriate component of treatment;
(6) the amount of therapeutic medication that a Covered Horse
receives should be the minimum necessary to address the diagnosed
[[Page 5092]]
health concerns identified during the veterinary examination and
diagnostic process; and
(7) the welfare of Covered Horses, the integrity of the sport of
horseracing, and the confidence of its stakeholders (including the
betting public) require full disclosure to regulatory authorities
regarding the administration of medications and treatments to Covered
Horses.
(e) The Protocol will be implemented and enforced on behalf of the
Authority by:
(1) an anti-doping and controlled medication enforcement agency
known as the Horseracing Integrity and Welfare Unit (``Agency''); and
(2) where agreed in accordance with 3060 of the Act, by State
Racing Commissions acting under the delegated authority of the
Authority or the Agency (and references to the Authority or the Agency
in the Protocol will be deemed to encompass such commissions as the
context requires, subject to and consistent with the scope of their
delegated authority).
(f) In accordance with section 3054(b) of the Act, the rules of the
Authority promulgated in accordance with the Act shall preempt any
provision of State law or regulation with respect to matters within the
jurisdiction of the Authority under the Act. Among other things, the
Protocol:
(1) identifies the conduct that will constitute an Anti-Doping Rule
Violation (Rules 3211 to 3216), a Controlled Medication Rule Violation
(Rules 3311 to 3315), or a related violation (Rules 3229, 3329, and
3510);
(2) establishes evidentiary and other rules for proving violations
of the Protocol (Rules 3121 to 3122);
(3) provides for the creation, maintenance, and updating of a
Prohibited List and related Technical Document that identify Prohibited
Substances and Prohibited Methods (Rules 3111 to 3113);
(4) empowers the Agency to perform and manage test distribution
planning and Testing of Covered Horses both in and out of competition,
in accordance with the Testing and Investigations Standards (Rule
3133);
(5) empowers the Agency to gather intelligence and investigate
potential violations of the Protocol, in accordance with the Testing
and Investigations Standards, which incorporate uniform rules and
procedures in accordance with section 3054(c) of the Act (Rule 3133);
(6) empowers the Agency to accredit testing laboratories in
accordance with the Laboratory Standards and to monitor, test, and
audit approved Laboratories to ensure continuing compliance with the
Laboratory Standards; and provides for all samples collected pursuant
to the Protocol to be analyzed at approved Laboratories in accordance
with the Laboratory Standards or by other laboratories, such as
international laboratories accredited by the International Federation
of Horseracing Authorities, in accordance with Rule 3136(d) (Rule
3136);
(7) sets out uniform rules and procedures for the Agency's
management of the results of testing and investigations, and for its
prosecution of any charges that Covered Persons have violated the
Protocol, including incorporating the Arbitration Procedures to ensure
the fair adjudication of those charges;
(8) sets out the sanctions that may be applied in case of
violations of the Protocol, including, but not limited to,
Disqualification of results, forfeiture of prizes and purses, fines,
payment of costs, periods of Ineligibility for Covered Horses or
Covered Persons (including additional periods of Ineligibility for
repeat offenders), and Public Disclosure (sections 3220 and 3320); and
requires the Authority, Racetracks, Race Organizers, Training
Facilities, all Covered Persons, and all other relevant Persons to
recognize, respect, enforce, and give full force and effect to final
decisions issued under the Protocol within their respective spheres of
authority (Rule 3710);
(9) regulates the public reporting and disclosure of cases, and
permits and facilitates statistical reporting to the Authority and to
the U.S. Congress, the Commission, State Racing Commissions, and other
Federal or State governmental bodies or agencies having jurisdiction
over the sport of horseracing in the United States (section 3600); and
(10) empowers the Agency to undertake and commission education and
research activities designed to advance the integrity and safety of
horseracing in the United States (Rule 3810).
(g) The Protocol comes into force on the Program Effective Date and
will apply in full as from that date. In accordance with section
3054(k)(1) of the Act, the Protocol only has prospective effect, i.e.,
it does not apply to, and does not give the Authority or Agency
authority to investigate, prosecute, adjudicate, or penalize conduct
that occurred before the Program Effective Date (Rule 3080).
(h) The Protocol incorporates by reference the supporting rules and
documents approved by the Commission and issued by the Authority,
including Rule 1000 Series (General Provisions), Rule 2000 Series
(Racetrack Safety Program), Rule 4000 Series (Prohibited List), Rule
5000 Series (Testing and Investigations Standards), Rule 6000 Series
(Laboratory Standards), Rule 7000 Series (Arbitration Procedures), Rule
8000 Series (Enforcement Rule), Rule 8500 Series (Methodology for
Determining Assessments), and Rule 9000 Series (Registration of Covered
Persons and Covered Horses).
(i) In accordance with section 3055(c)(4) of the Act, the Agency
may develop further rules, protocols, policies, and guidelines for
approval by the Authority to support the implementation of the
Protocol. These materials will be developed in consultation with the
Anti-Doping and Medication Control Standing Committee (ADMC) of the
Authority and will be consistent with international best practices.
(j) Nothing in the Protocol or in any of its associated rules,
protocols, policies, and guidelines:
(1) is intended to constrain or limit in any way the powers of the
Authority or the Agency under the Act; or
(2) shall be interpreted or applied in a manner that has the effect
of constraining or limiting those powers in any way.
(k) Unless specified otherwise, words and terms in the Protocol
that are capitalized are defined terms that have the meaning given to
them in Rule 1020.
(l) The rules of interpretation included at Rule 1010 and Rule 3070
shall be used as an aid to interpretation of the Protocol.
Rule 3020. Application
(a) The Protocol applies to and is binding on:
(1) any horserace involving Covered Horses that has a substantial
relation to interstate commerce, including any Thoroughbred horserace
that is the subject of interstate off-track or advance deposit wagers
(each, a Covered Horserace);
(2) any Thoroughbred horse, or any other horse made subject to the
Act by election of the applicable State Racing Commission or the breed
governing organization for such horse under section 3054(l), during the
period: (A) beginning on the date of the horse's first Timed and
Reported Workout at a racetrack that participates in Covered Horseraces
or at a Training Facility; and (B) ending on the date on which the
horse is deemed retired pursuant to Rule 3050(b) (each, a Covered
Horse); and
(3) the following persons (each, a Covered Person): all Trainers,
Owners,
[[Page 5093]]
Breeders, Jockeys, Racetracks, Veterinarians, Persons licensed by a
State Racing Commission, and the agents, assigns, and employees of such
Persons; any other Persons required to be registered with the
Authority; and any other horse support personnel who are engaged in the
care, treatment, training, or racing of Covered Horses.
(b) Pursuant to section 3054 of the Act, Covered Persons must
register with the Authority. However, they are bound by the Protocol by
undertaking the activity (or activities) that make(s) them a Covered
Person, whether or not they register with the Authority.
(c) Owners. Covered Horses may be owned by a sole individual,
multiple individuals, or one or more entities. As a consequence of the
various ownership structures and property interests of Covered Horses,
it is necessary to identify which Person shall be responsible as the
Owner for purposes of registration, communication, personal liability,
and other requirements under the Protocol and related rules.
Accordingly:
(1) For purposes of mandatory registration with the Authority, any
Covered Person who owns a 5% or greater ownership or property interest
in a Covered Horse shall register with the Authority as an Owner.
(2) The following person shall be responsible as the Owner for any
communication, notification, and reporting requirements under the
Protocol:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the individual designated in the
Authority's database as the representative for the other owners of the
Covered Horse authorized to receive communications or notifications and
fulfill any reporting requirements on their behalf in respect of the
Covered Horse (Designated Owner).
(3) If Rule 3030 makes the Owner the Responsible Person for a
Covered Horse, that shall mean that the following person is personally
liable for violations involving that Covered Horse:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the individual who manages the Covered
Horse as a matter of fact (Managing Owner). If an individual owns more
than a 50% stake in a Covered Horse or where the entity that owns the
Covered Horse has designated an individual with an ownership interest
in the Covered Horse as the individual who will be personally liable
under the Protocol as the Owner of the Covered Horse, that individual
will be presumed to be the Managing Owner. If an individual with an
ownership or property interest in the Covered Horse who is not the
Managing Owner makes a relevant decision about the Covered Horse that
leads to a violation of the Protocol, that person shall be jointly and
severally liable with the Managing Owner for such decision as an Owner
of the Covered Horse.
(4) Only the following persons may attend hearings under the
Protocol as the Owner of the Covered Horse, unless otherwise agreed by
the hearing panel:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the Designated Owner or Managing Owner.
(5) Unless the context requires otherwise, the individual owner or
Managing Owner of the Covered Horse (as applicable) shall be
responsible for discharging any other requirements imposed on an Owner
under the Protocol or related rules.
Rule 3030. Responsible Persons
(a) ``Responsible Person'' means the Trainer of the Covered Horse.
If the Covered Horse does not have a Trainer, the Responsible Person
shall be the Owner of the Covered Horse. The Responsible Person shall
be personally liable for his or her Covered Horse(s) as set out under
the Protocol. Other Covered Persons who make a relevant decision about
the Covered Horse may also be liable depending on the facts and
circumstances.
(b) If a Covered Horse is claimed in a Claiming Race, the person
designated as the Responsible Person prior to that Claiming Race shall
be liable for any violation resulting from a Sample collected on Race
Day. The person who claims the Covered Horse in the Claiming Race shall
not be liable for such violation, unless he or she was complicit in the
violation.
(c) The Responsible Person shall register their designation as the
Responsible Person for a Covered Horse with the Authority and shall
keep such designation and registration up-to-date. Any transfer of the
Responsible Person designation to another Covered Person shall be done
with the Authority in accordance with its procedures prior to the
effective date of the transfer, except that if a Covered Horse is
claimed in a Claiming Race, the transfer shall be done on the day of
the Claiming Race.
(d) The Responsible Person for a Covered Horse shall be the sole
representative for the interests of that Covered Horse in any matter
arising under the Protocol. The Owner (if not the Responsible Person)
may attend any hearing concerning a violation of the Protocol involving
his or her Covered Horse(s) in accordance with the Arbitration
Procedures.
Rule 3040. Core Responsibilities of Covered Persons
(a) Responsibilities of All Covered Persons
It is the personal responsibility of each Covered Person:
(1) to be knowledgeable of and to comply with the Protocol and
related rules at all times. All Covered Persons shall be bound by the
Protocol and related rules, and any revisions thereto, from the date
they go into effect, without further formality. It is the
responsibility of all Covered Persons to familiarize themselves with
the most up-to-date version of the Protocol and related rules and all
revisions thereto;
(2) to cooperate promptly and completely with the Authority and the
Agency in the exercise of their respective powers under the Act and the
Protocol and related rules, including:
(i) in relation to the Testing program and in relation to the
investigation of potential violations of the Protocol;
(ii) by providing complete and accurate information to the
Authority and the Agency in all interactions and filings; and
(iii) on request by the Agency:
(A) making available for inspection any facility, office, stall, or
equipment or other relevant location that is used in the care,
treatment, training, or racing of Covered Horses, or any feed,
medicine, or other item given to Covered Horses;
(B) submitting to under-oath transcribed interviews about his or
her dealings with or in relation to Covered Horses;
(C) providing immediate and unfettered access to any and all data,
documents, and records used in the care, treatment, training or racing
of any Covered Horse (including, but not limited to, data, documents
and records existing in electronic form, e.g., on computers, mobile
phones, or other devices); and
(D) permitting the Agency to review or make and take away copies of
any such data, documents, or records for analysis, investigation, and
potential
[[Page 5094]]
use as evidence of a violation of the Protocol by a Covered Person;
Failure to cooperate promptly and completely with the Agency may
constitute a violation pursuant to Rule 3510(b); and
(3) not to engage in offensive conduct towards any Sample
Collection Personnel or any representative of the Agency or the
Authority (including engaging in improper, insulting, or obstructive
conduct, or recording any Sample Collection Session contrary to Rule
5410). Failure to comply may constitute a violation pursuant to Rule
3510(a) or Tampering or Attempted Tampering, depending on the
circumstances of the case.
(b) Additional Responsibilities of Responsible Persons
In addition to the duties under Rule 3040(a), it is the personal
responsibility of each Responsible Person:
(1) to ensure that Covered Horses for which he or she is the
Responsible Person are made available for Sample collection at any time
and any place where they are located (e.g., Racetrack, Training
Facility, private facility) upon request by the Agency (or its
delegate). In particular, without limiting the generality of the
foregoing:
(i) The Responsible Person shall ensure that the Covered Horse is
produced for Sample collection immediately upon notification by a duly
authorized person in accordance with the Agency's procedures if the
Covered Horse is present at the location where notification is
attempted. If the Covered Horse is present at the location where
notification is attempted, failure to produce a Covered Horse
immediately upon valid notification shall constitute an Anti-Doping
Rule Violation under Rule 3215.
(ii) If the Covered Horse is not present at the location where
notification is attempted (including due to a Whereabouts Failure), the
Responsible Person shall ensure that the Covered Horse is produced for
Sample collection within 6 hours of notification by a duly authorized
Person in accordance with the Agency's procedures, except that the
Agency may extend the 6-hour period if it determines that extenuating
circumstances justify doing so. If the Covered Horse is not present at
the location where notification is attempted or if a Covered Horse
cannot be located by the Agency, failure to produce a Covered Horse for
Sample collection within 6 hours (or any extended period agreed by the
Agency) of valid notification period shall constitute an Anti-Doping
Rule Violation under Rule 3215.
(2) to either be present during a Sample collection involving his
or her Covered Horse and comply with all Sample collection procedure
requirements, or (if not present) to ensure that a Nominated Person who
is 18 years or older is present to represent him or her and complies
with all Sample collection procedure requirements;
(3) to ensure that treatments and medications administered to his
or her Covered Horses:
(i) are administered only on the advice of a Veterinarian or (if a
prescription is not required) following sufficient due diligence
regarding the treatment or medication;
(ii) are not administered in a manner detrimental or contrary to
horse welfare;
(iii) are the minimum necessary to address the diagnosed health
concerns identified during the veterinary examination and diagnostic
process;
(iv) do not contain a Banned Substance or involve a Banned Method;
and
(v) do not otherwise violate the Protocol;
(4) to inform all Covered Persons (including Veterinarians),
employees, personnel, agents, and other Persons involved in any way
with the care, treatment, training, or racing of his or her Covered
Horses of their respective obligations under the Protocol (including,
in particular, those specified in Rule 3040(a));
(5) to adequately supervise all Covered Persons (including
Veterinarians), employees, personnel, agents, and other Persons
involved in any way with the care, treatment, training, or racing of
his or her Covered Horses, including by (without limitation):
(i) conducting appropriate due diligence in the hiring process
before engaging their services;
(ii) clearly communicating to such Persons that compliance with the
Protocol is a condition of employment or continuing engagement in the
care, treatment, training, or racing of his or her Covered Horses;
(iii) creating and maintaining systems to ensure that those Persons
comply with the Protocol; and
(iv) adequately monitoring and overseeing the services provided by
those Persons in relation to the care, treatment, training, or racing
of his or her Covered Horses;
(6) to bear strict liability for any violations of the Protocol by
such Covered Persons (including Veterinarians), employees, personnel,
agents, and other Persons involved in the care, treatment, training, or
racing of his or her Covered Horses;
(7) to file and update as necessary with the Authority information
identifying what Covered Horses he or she is the Responsible Person
for;
(8) to maintain accurate, complete, and up-to-date treatment
records (including, without limitation, records of medical,
therapeutic, and surgical treatments and procedures, including
diagnostics) of his or her Covered Horses in an electronic or other
form specified by the Agency, and to provide the Agency with access to
those records upon request and without delay so that it may inspect and
make and retain copies of them for purposes of monitoring and ensuring
compliance with the requirements of the Protocol. The records must
include the details required under Rule 2251(b). The Responsible Person
must retain copies of such treatment records for a period of no less
than 3 years, although the Responsible Person is advised to retain them
for the duration of the limitation periods under Rule 3090;
(9) at the time of registering a horse with the Authority and prior
to such horse competing in any Timed and Reported Workout or Covered
Horserace, the Responsible Person shall declare in writing to the
Agency all administrations of Banned Substances and Banned Methods to
the horse since the Responsible Person first owned the horse (or, if
not the Owner, since the Owner at the time of registration first owned
the horse) or since the Program Effective date, whichever is earlier.
On request by the Agency, the Responsible Person shall provide any
related treatment records for the horse during that period. If a Banned
Substance or Banned Method has been administered in that period, the
Agency may impose a stand down period for the horse of up to the period
of Ineligibility that would be applicable for the relevant Banned
Substance or Banned Method and require that (at the Responsible
Person's cost) the Covered Horse provide one or more negative Samples
before subsequently being eligible to participate in a Timed and
Reported Workout or a Covered Horserace. Failure by a Responsible
Person to comply with this Rule 3040(b)(9) may constitute a violation
of Rule 3510(b);
(10) if any Covered Horse is moved from a Racetrack or Training
Facility to a private facility (i.e., a facility not under the
jurisdiction of the Authority or the Agency), the Responsible Person
shall provide sufficient information about the Covered Horse's
whereabouts so that the Agency remains able to collect Samples from the
Covered Horse
[[Page 5095]]
at any time. The Responsible Person shall also provide any further
information about the whereabouts of a Covered Horse that is
specifically requested by the Agency. Failure to do so may constitute a
violation of Rule 3510(d);
(11) to notify the Authority in writing within 7 days of becoming
aware that any of his or her Covered Horses:
(i) is pregnant;
(ii) was pregnant but has foaled or is no longer pregnant;
(iii) has been castrated or hemicastrated (including chemical
castration or immunocastration); or
(iv) has suffered a fatal condition.
In each case, the Responsible Person shall state the name of the
Covered Horse, the date of the event triggering the notice, and (for
paragraph (iv) above) a summary explanation regarding the cause of the
fatal condition.
(c) Additional Responsibilities of Owners
In addition to the duties under Rule 3040(a):
(1) each person with a 5% percent or greater ownership or property
interest in a Covered Horse shall register with the Authority as an
Owner of the Covered Horse, and ensure that any transfer of ownership
is registered with the Authority in accordance with its procedures; and
(2) if a Covered Horse is owned by multiple Owners, they shall
ensure that the Agency is notified in writing of one Designated Owner
authorized to receive communications and notifications and fulfil any
reporting requirements on their behalf.
(d) Additional Responsibilities of Attending Veterinarians
In addition to the duties under Rule 3040(a), and the further
duties and requirements imposed under the Rule 2000 Series (Racetrack
Safety Program), it is the personal responsibility of each Attending
Veterinarian to act in strict compliance with the Protocol and keep
updated treatment records (including, without limitation, records of
medical, therapeutic, and surgical treatments and procedures, including
diagnostics) in an electronic database designated by the Agency or in
any other form designated by the Agency and provide access to the
Agency upon request and without delay to or copies of such treatment
records. The records must include the details required under Rule
2251(b) and must be submitted in an electronic format designated by the
Authority within the deadline specified in that same provision.
Attending Veterinarians must retain copies of such treatment records
for a period of no less than 3 years, or for the retention period
required by the relevant state veterinary practice act, whichever is
longer.
Rule 3050. Retirement and Equine Fatalities
(a) Covered Persons.
(1) Each Responsible Person who wishes to no longer be bound by the
Protocol shall give written notice to the Authority of his or her
retirement from the position that made him or her a Responsible Person.
In each case, the Responsible Person shall be deemed to have retired
(and to be no longer subject to the Protocol) on the later of (i) the
date given in the written notice of retirement and (ii) the date the
notice is received.
(2) Any other Covered Person will continue to be bound by and
required to comply with the Protocol and related rules unless and until
he or she unregisters with the Authority.
(3) If a Covered Person ceases to be subject to the Protocol while
the Agency is conducting a Results Management process in respect of
that person, the Agency retains jurisdiction to complete its Results
Management process. If a Covered Person retires or ceases to be subject
to the Protocol before any Results Management process has begun, and
the Agency had jurisdiction over the Covered Person at the time the
Anti-Doping Rule Violation or Controlled Medication Rule Violation was
committed, the Agency retains jurisdiction to conduct Results
Management in respect of that violation.
(4) If a Covered Person retires while subject to a period of
Ineligibility, he or she must give written notice of such retirement to
the Authority. The Covered Person may not return to the sport (i.e.,
carry out any of the activities prohibited during the period of
Ineligibility pursuant to Rules 3229 and 3329) unless the Covered
Person has given 4 months' prior written notice (or notice equivalent
to the period of Ineligibility remaining as of the date the Covered
Person retired, if that period was longer than 4 months) to the
Authority of his or her intent to return to the sport.
(5) The Agency may forward notifications of retirement of Covered
Persons to Interested Parties or other Persons with a need to know.
(b) Covered Horses.
(1) If an Owner wishes to retire a Covered Horse such that it is no
longer made available for Testing, the Owner must provide written
notice of such retirement to the Agency, in accordance with its
procedures.
(2) A Covered Horse that has been retired in accordance with the
previous clause may not participate in a Timed and Reported Workout or
be entered in a Covered Horserace until the Covered Horse has been made
available for Testing at least 4 months prior to notice being given to
the Agency (in accordance with its procedures) of the intention to
unretire the Covered Horse.
(3) If a Covered Horse is retired from horseracing or suffers a
fatal condition while the Agency is conducting a Results Management
process in respect of it, the Agency retains jurisdiction to complete
its Results Management process. If a Covered Horse is retired or
suffers a fatal condition before any Results Management process has
begun, and the Agency had jurisdiction over the Covered Horse at the
time the Anti-Doping Rule Violation or Controlled Medication Rule
Violation was committed, the Agency retains jurisdiction to conduct
Results Management in respect of that violation. If a Covered Horse
suffers a fatal condition, the Agency retains Testing authority over
that horse in accordance with Rule 3132(d).
(4) If a Covered Horse is retired from horseracing while subject to
a period of Ineligibility, the Owner must notify the Agency in writing
of such retirement. If the Owner wishes that horse to return to
participation in Covered Horseraces or Timed and Reported Workouts, the
Owner must first provide the Agency with written notice and make the
Covered Horse available for Testing for at least 4 months prior to such
participation or for the remainder of the Covered Horse's period of
Ineligibility, whichever is longer.
(5) In order to manage the number of Covered Horses registered with
the Authority, the Agency may retire a Covered Horse based on
inactivity (i.e., where the Covered Horse does not participate in a
Timed and Reported Workout or Covered Horserace for 18 months or more,
excluding periods of inactivity due to a Provisional Suspension or
period of Ineligibility) by sending written notice thereof to the
Authority and the Owner in accordance with the Agency's procedures. If
the Owner disputes that retirement, while the dispute is pending the
Covered Horse may not participate in any Timed and Reported Workout or
Covered Horserace but must be made available for Testing. Upon
resolution of the dispute, the Authority will notify the Agency whether
the horse is retired and, therefore, no longer subject to Testing. If
the Owner wishes to return the Covered Horse to participation in Timed
and Reported Workouts or Covered
[[Page 5096]]
Horseraces, the Owner must first provide the Agency with written notice
and make the Covered Horse available for Testing for at least 4 months
prior to such participation.
(6) The Agency may reduce the 4-month notice period in Rule 3050(b)
to 2 months where the Owner of the Covered Horse submits an application
establishing good cause to do so, and where the Agency approves such
application based on a review conducted in accordance with the
objectives of the Protocol.
(7) The Agency may forward notifications of retirement of Covered
Horses to Interested Parties or other Persons with a need to know.
Rule 3060. Claiming Races and Voidable Claims
(a) Subject to Rule 3132(b), a claimed horse may be subject to
Sample collection at a Claiming Race if requested (and paid for) by the
claimant as part of the claiming procedure on the day of the Claim. If
a Sample collected from the claimed horse results in an Anti-Doping
Rule Violation or Controlled Medication Rule Violation, the Claim may
be voided at the option of the claimant, and the claimant shall be
entitled to the return from the seller of all sums paid for the claimed
horse and of all reasonable expenses incurred after the date of the
Claim. While awaiting test results, a claimant shall: (i) exercise due
care in maintaining and boarding a claimed horse; and (ii) not
materially alter a claimed horse.
(b) Any voided claim shall be recorded in Equibase.
Rule 3070. Amendment and Interpretation of the Protocol
(a) The Authority may amend the Protocol from time to time, as
necessary to ensure that it remains fit for purpose, in accordance with
section 3057(e) of the Act. Unless provided otherwise, any amendments
will come into force on the date specified or (if no date is specified)
on the date the amendment is approved by the Commission.
(b) Subject to Rule 3070(d), the Protocol shall be interpreted as
an independent and autonomous text and not by reference to existing law
or statutes.
(c) The Protocol has been adopted pursuant to the Act and shall be
interpreted, where applicable, in a manner that is consistent with
applicable provisions of the Act and the other rules in Rule 1000-9000
Series. In the event of any conflict between the Act and the Protocol,
the Act shall prevail. In the event of any conflict between the
Protocol and any other rules in Rule 1000-9000 Series, the Protocol
shall prevail.
(d) The World Anti-Doping Code and related International Standards,
procedures, documents, and practices (WADA Code Program), the comments
annotating provisions of the WADA Code Program, and any case law
interpreting or applying any provisions, comments, or other aspects of
the WADA Code Program, may be considered when adjudicating cases
relating to the Protocol, where appropriate.
Rule 3080. Transitional Provisions
(a) The Protocol shall not apply retroactively to matters pending
before the Program Effective Date.
(b) A presence violation under Rule 3212 or Rule 3312 that occurs
after the Program Effective Date as a result of Use or Administration
prior to the Program Effective Date shall not constitute a violation of
the Protocol.
(c) The relevant State Racing Commission retains authority
(including results management) in relation to any anti-doping or
controlled medication matters taking place prior to the Program
Effective Date.
(d) Changes to substances or methods covered by the Prohibited List
or related Technical Document--Prohibited Substances shall not, unless
they specifically provide otherwise, be applied retroactively. However,
a Responsible Person or other Covered Person who is serving a period of
Ineligibility on account of a Prohibited Substance or Prohibited Method
that is later subject to a change in status (either because it is no
longer prohibited or subject to lesser sanctions) may apply to the
Agency for consideration of a reduction in the period of Ineligibility
in light of that change in status. The Responsible Person may also
apply to the Agency for consideration of a reduction in the period of
Ineligibility applicable to his or her Covered Horse(s).
Rule 3090. Statute of Limitations
(a) No charge may be brought against a Covered Person or in
relation to a Covered Horse in respect of an Anti-Doping Rule Violation
unless the Covered Person or Responsible Person for the Covered Horse
has been given notice, or notification has been reasonably attempted,
within 10 years of the date the Anti-Doping Rule Violation is asserted
to have occurred. Any violation of Rule 3229 is also subject to a 10-
year limitation period.
(b) No charge may be brought against a Covered Person or in
relation to a Covered Horse in respect of a Controlled Medication Rule
Violation unless the Covered Person or Responsible Person for the
Covered Horse has been given notice, or notification has been
reasonably attempted, within 2 years of the date the Controlled
Medication Rule Violation is asserted to have occurred. Any violation
of Rule 3329 is also subject to a 2-year limitation period.
(c) Any violation of Rule 3510 is subject to a 4-year limitation
period.
3110. The Prohibited List
Rule 3111. Prohibited Substances and Prohibited Methods
(a) The Prohibited List identifies Prohibited Substances and
Prohibited Methods that are:
(1) prohibited at all times (Banned Substances and Banned Methods)
on the basis of the Agency's determination that medical, veterinary, or
other scientific evidence or experience supports their actual or
potential (i) ability to enhance the performance of Covered Horses,
(ii) masking properties, or (iii) detrimental impact on horse welfare;
or
(2) prohibited for Use or Administration in relation to a Covered
Horse during the Race Period and prohibited to be present in a Post-
Race Sample or Post-Work Sample, except as otherwise specified in the
Prohibited List (Controlled Medication Substances and Controlled
Medication Methods).
(b) Prohibited Substances and Prohibited Methods may be included in
the Prohibited List by general category (e.g., anabolic steroids) or by
specific reference to a particular substance or method.
(c) The Prohibited List is supplemented by the ``Technical
Document--Prohibited Substances,'' which provides guidance on the
Prohibited Substances that fall into the general categories listed in
the Prohibited List and on Screening Limits, Thresholds, or Detection
Times for those Prohibited Substances (as applicable), and also
designates certain Prohibited Substances as Specified Substances, which
are those that pose a higher risk of being the result of contamination
and, therefore, are subject to more flexible sanctions.
(d) Certain Prohibited Substances may first be reported as Atypical
Findings requiring further investigation before being declared as
Adverse Analytical Findings, in accordance with the Atypical Findings
Policy set out at Appendix 1 to the Protocol.
Rule 3112. Review and Publication of the Prohibited List and Related
Technical Documents
The Agency will publish the Prohibited List on its website at least
[[Page 5097]]
annually, following an opportunity for stakeholder comment. The Agency
will review and consider such stakeholder comment and will provide
recommended revisions to the Authority. Each new version of the
Prohibited List will also be sent to the State Racing Commissions.
The Authority (on recommendation of the ADMC, in consultation with
the Agency) may revise the Prohibited List from time to time, subject
to approval by the Commission. Revisions to the Prohibited List will go
into effect on the date specified in the revised Prohibited List (which
will not be any earlier than 90 days following its publication). The
Agency will also publish any Technical Documents supplementing the
Prohibited List (including the Technical Document--Prohibited
Substances) on its website at least annually, following an opportunity
for public comment. Any revisions to such Technical Documents will go
into effect on the date specified in the revised Technical Document.
All Covered Persons shall be bound by the Prohibited List and
related Technical Documents (including the Technical Document--
Prohibited Substances), and any revisions thereto, from the date they
go into effect, without further formality. It is the responsibility of
all Covered Persons to familiarize themselves with the most up-to-date
version of the Prohibited List and related Technical Documents
(including the Technical Document--Prohibited Substances) and all
revisions thereto.
Rule 3113. Validity of the Prohibited List and Related Technical
Documents
The following decisions are final and shall not be subject to any
challenge by any Covered Person or other Person on any basis, including
any challenge based on an argument that the substance or method is not
a masking agent or does not have the potential to enhance the
performance of Covered Horses or have a detrimental impact on horse
welfare:
(a) the Authority's determination of the Prohibited Substances and
Prohibited Methods included on the Prohibited List or Technical
Document--Prohibited Substances;
(b) the approval of the Prohibited List or Technical Document--
Prohibited Substances by the Commission or the Authority;
(c) the classification of substances and methods into categories or
classes on the Prohibited List or Technical Document--Prohibited
Substances;
(d) the classification of a substance or method as a Banned
Substance or Banned Method as opposed to a Controlled Medication
Substance or Controlled Medication Method;
(e) the periods during which Prohibited Substances or Prohibited
Methods are prohibited; and
(f) the classification of Prohibited Substances as either Specified
Substances or non-Specified Substances.
Rule 3114. Monitoring Program
The Agency may approve a monitoring program regarding substances
that are not on the Prohibited List or Technical Document--Prohibited
Substances, if the Agency wishes to research or monitor such
substances, including to identify potential patterns of misuse in
horseracing. Laboratories will report the instances of reported Use or
detected presence of monitored substances to the Agency, but the
results of any such analyses shall not constitute an Anti-Doping Rule
Violation or Controlled Medication Rule Violation. Nothing in this Rule
3114 or elsewhere in the Protocol prevents a Laboratory from sharing
information with the Agency for any anti-doping or controlled
medication purpose or other purpose authorized by the Act. The list of
substances in the monitoring program will be reviewed annually by the
Agency.
3120. Proof of Violations
Rule 3121. Burden and Standard of Proof
(a) The Agency shall have the burden of establishing that a
violation of the Protocol has occurred to the comfortable satisfaction
of the hearing panel, bearing in mind the seriousness of the allegation
that is made. This standard of proof in all cases is greater than a
mere balance of probability (i.e., a preponderance of the evidence) but
less than clear and convincing evidence or proof beyond a reasonable
doubt.
(b) Where the Protocol places the burden of proof on a Covered
Person to rebut a presumption or to establish specified facts or
circumstances, the standard of proof shall be by a balance of
probability (i.e., a preponderance of the evidence), except as provided
in Rules 3122(c) and 3122(d).
Rule 3122. Methods of Establishing Facts and Presumptions
Facts related to violations may be established by any reliable
means, including admissions. The following rules of proof shall apply:
(a) Analytical methods, Minimum Reporting Levels, Thresholds,
Screening Limits, Decision Limits, and any other Laboratory reporting
requirements approved by the Commission are presumed to be
scientifically valid.
(b) Compliance with the Standards (as opposed to an alternative
standard, practice, or procedure) will be sufficient to conclude that
the procedures addressed by those Standards were performed properly.
(c) Laboratories are presumed to have conducted Sample analysis and
custodial procedures in accordance with the Laboratory Standards. A
Covered Person who is alleged to have committed a violation may rebut
this presumption by establishing that a departure from the Laboratory
Standards occurred that could reasonably have caused the Adverse
Analytical Finding or other factual basis for any other violation
asserted. Where the presumption is rebutted, the Agency shall have the
burden of establishing that such departure did not cause the Adverse
Analytical Finding or other factual basis for the violation asserted.
(d) Departures from any other Standards or any provisions of the
Protocol shall not invalidate analytical results or other evidence of a
violation, and shall not constitute a defense to a charge of such
violation; provided, however, that if the Covered Person establishes
that a departure from any other Standards or any provisions of the
Protocol could reasonably have caused the Adverse Analytical Finding or
other factual basis for the violation charged, the Agency shall have
the burden to establish that such departure did not cause the Adverse
Analytical Finding or other factual basis for the violation.
(e) Non-appealable and final factual findings of a court, arbitral
tribunal, professional disciplinary body, or administrative body of
competent jurisdiction shall be irrebuttable evidence against the
Covered Person to whom the decision pertained of those facts, unless
the Covered Person establishes that the decision did not respect due
process.
(f) A hearing panel may draw an inference adverse to a Covered
Person who is asserted to have committed a violation of the Protocol
based on the Covered Person's refusal to cooperate with the Agency,
including any refusal to respond to questions put to him or her as part
of an investigation or to appear at the hearing (either in person or
remotely) and to answer questions put by the Agency or the hearing
panel.
[[Page 5098]]
3130. Testing and Investigations
Rule 3131. Purpose of Testing and Investigations
Testing and investigations may be undertaken to assist in the
effective policing and enforcement of the Protocol, including to obtain
evidence regarding potential violations of the Protocol.
Rule 3132. Authority To Test
(a) Only the Agency (and those authorized by the Agency) may
initiate and direct Testing on Covered Horses. The Agency has authority
to conduct Testing both in and out of competition.
(b) No other entity (including State Racing Commissions,
Racetracks, Race Organizers, and Training Facilities) may initiate or
direct any Testing on Covered Horses. However, a State Racing
Commission, Racetrack, Race Organizer, or other third party may request
that the Agency initiate and direct enhanced or additional Testing
(e.g., in relation to a particular Covered Horserace). The Agency may
accept or decline such request at its absolute discretion. Where the
Agency accepts the request, the costs of Sample collection and analysis
shall be borne by the entity requesting the additional or enhanced
Testing. The Agency may conduct the Testing itself or delegate Testing
(or aspects thereof) to the relevant State Racing Commission, subject
to the applicable State Racing Commission electing to enter into an
agreement with the Agency.
(c) Covered Horses may be subject to Testing at any time and any
place where they are located by or on behalf of the Agency.
(d) A Covered Horse that is subject to a Provisional Suspension or
period of Ineligibility, or that sustains a fatal condition, remains
subject to Testing.
(e) In accordance with the Racetrack Safety Program, a Covered
Horse may be required to submit to Sample collection (at the Owner's
cost) following a Vets' List Workout in order to be released from the
Veterinarians' List. Any Sample collected following a Vets' List
Workout constitutes a Post-Race Sample, and, as a result, is subject to
all of the same requirements that apply to Sample collection at Covered
Horseraces. To schedule a Vets' List Workout, the Responsible Person or
the Owner of the Covered Horse shall make a request to a Regulatory
Veterinarian who shall, in turn, notify the Agency in order to make any
necessary arrangements. The Agency must be given a minimum of 48 hours'
notice of any Vets' List Workout.
Rule 3133. Requirements
(a) Testing. The Agency shall conduct test distribution planning
and Testing in accordance with the Testing and Investigations
Standards. The Agency may delegate authority to third parties,
including State Racing Commissions (see Rule 3132), to conduct Testing
(or aspects thereof) in accordance with the Testing and Investigations
Standards under its supervision.
(b) Investigations and intelligence gathering. The Agency shall
gather intelligence and conduct investigations, or delegate to third
parties to do so under its supervision, in accordance with the Testing
and Investigations Standards, which incorporate uniform rules and
procedures in accordance with section 3054 of the Act providing for:
(1) access for the Agency to books, records, offices, racetrack
facilities, and other places of business of Covered Persons that are
used in the care, treatment, training, or racing of Covered Horses;
(2) the issuance and enforcement of subpoenas and subpoenas duces
tecum by the Authority at the request of the Agency;
(3) the exercise of other investigatory powers similar in nature
and scope to those exercised by State Racing Commissions before the
Program Effective Date; and
(4) the coordination and sharing of intelligence and information
with the Authority, law enforcement (authorized by any government,
including Federal, State, or international), State Racing Commissions,
Racetracks, Race Organizers, Training Facilities, Laboratories, anti-
doping organizations, equine regulatory bodies, or other relevant
regulatory or disciplinary authorities.
Rule 3134. Sample Analysis
Samples shall be analyzed in accordance with the principles set
forth in Rules 3135 through 3139.
Rule 3135. Ownership of Samples
Samples collected under the Protocol are the property of the
Authority, and the Authority is entitled (subject to Rule 3138(b)) to
determine all matters regarding access to and the analysis and disposal
of such Samples.
Rule 3136. Use of Approved Laboratories and Other Laboratories
(a) The Agency will publish a list of approved Laboratories, which
may be revised from time to time.
(b) Subject to paragraph (d) below, Samples collected by or on
behalf of the Agency pursuant to the Protocol will be analyzed by
approved Laboratories. Only approved Laboratories may declare an
Adverse Analytical Finding.
(c) Selection of Laboratories
(1) Subject to paragraph (2) below, a State Racing Commission may
select a Laboratory to analyze A Samples or TCO2 Samples collected in
its State. If a State Racing Commission does not select a Laboratory,
the selection of the Laboratory to analyze such Samples shall be
determined exclusively by the Agency.
(2) The Agency shall have the authority to require specific Samples
to be directed to and analyzed by Laboratories having special expertise
in the required analysis.
(3) The selection of the Laboratory for any B Sample analysis shall
be determined exclusively by the Agency. The B Sample analysis (if
applicable) will be performed in a different Laboratory from the A
Sample analysis, except if provided otherwise in the Laboratory
Standards.
(d) In accordance with Rule 3122, facts related to violations of
the Protocol may be established by any reliable means. This would
include, for example, laboratory analysis or other forensic testing
conducted reliably outside of Agency-approved laboratories.
Rule 3137. Purpose of Sample Analysis
(a) General. Samples, related analytical data, Doping Control
information, and Medication Control information shall be analyzed (1)
to detect the presence of Prohibited Substances and Prohibited Methods
identified on the Prohibited List (or Technical Document--Prohibited
Substances) and other substances as may be directed pursuant to Rule
3114, (2) to assist the Agency in profiling relevant parameters in a
Covered Horse's urine, blood, hair, or other matrix, including for DNA
or genomic profiling, or (3) for any other legitimate purpose.
(b) Research on Samples and Data. Samples, related analytical data,
Doping Control information, and Medication Control information may be
used for anti-doping or medication control research purposes. However,
the results of any analyses performed for such research purposes may
not be used as the basis for pursuing an Anti-Doping Rule Violation or
Controlled Medication Rule Violation.
Rule 3138. Standards for Sample Analysis and Reporting
(a) General. Laboratories may not accept or analyze any Samples
from Covered Horses that were not collected
[[Page 5099]]
by or on behalf of the Agency or otherwise authorized by the Agency.
Laboratories shall analyze Samples and report results in accordance
with the Laboratory Standards. The results of all Sample analyses must
be sent exclusively to the Agency via secure transmission in a form
designated by the Agency. All communications must be conducted in such
a way that the results of the Sample analyses are kept confidential.
(b) Further Analysis of a Sample prior to or during Results
Management. Further Analyses may be conducted, without limitation, on a
Sample prior to the time that it is reported as negative or prior to
the time that the Agency notifies a Covered Person that the Sample is
the basis for an Anti-Doping Rule Violation or Controlled Medication
Rule Violation. If the Agency notifies a Covered Person that the Sample
is the basis for an Anti-Doping Rule Violation or Controlled Medication
Rule Violation, and the Agency wishes to conduct Further Analyses on
that Sample after such notification, it may do so only with the consent
of the Covered Person or the approval of the hearing panel adjudicating
the case against the Covered Person.
(c) Further Analysis of a Sample after it has been reported as
negative or has otherwise not resulted in an Anti-Doping Rule Violation
or Controlled Medication Rule Violation. A Sample that has been
reported as negative or has otherwise not resulted in a charge may be
stored and subjected to Further Analyses for the purpose described in
Rule 3137 at any time exclusively at the direction of the Agency. Any
Sample storage and Further Analysis initiated by the Agency shall be at
the Agency's expense. Further Analysis of Samples shall be conducted in
accordance with the Laboratory Standards.
(d) Split of A or B Sample. Where, in exceptional circumstances,
the Laboratory (on instruction from the Agency) is required to further
split an A or B Sample for the purpose of using the first part of the
resulting split Sample for an A Sample analysis and the second part of
the resulting split Sample for B confirmation, the procedures and
analysis shall be conducted in accordance with the Laboratory
Standards.
Rule 3139. The Agency's Right To Take Possession of Samples and Related
Data
The Agency may at any time, with or without prior notice, take
physical possession of any Sample collected by or on behalf of the
Agency and any related analytical data or information in the possession
of a Laboratory. Upon request by the Agency, the Laboratory in
possession of the Sample or related data shall grant access to and
enable the Agency to take physical possession of the Sample or data as
soon as possible.
Rule 3140. Clearance Testing
Clearance testing for a Covered Horse at the request of a Covered
Person (i.e., testing to determine if Controlled Medications Substances
have cleared the horse's system) may be performed by a Laboratory only
if in advance of such testing (1) the Agency approves such request
(which approval may be subject to conditions determined by the Agency),
and (2) the Covered Person pays for all of the costs of Sample
collection and analysis. The Agency may pursue any violation of the
Protocol that is evidenced by the results of the clearance testing.
3210. Anti-Doping Rule Violations
Rule 3211. Definition of Anti-Doping Rule Violation and Responsibility
for Violations
(a) Doping cases will be initiated based on the assertion that one
or more of Rules 3212 through 3216 has been violated (each, an Anti-
Doping Rule Violation).
(b) The Anti-Doping Rule Violations described below may only be
committed by Covered Persons, but the Consequences for Anti-Doping Rule
Violations may apply to both the Covered Person(s) who commit(s) the
violation and any Covered Horse(s) implicated by the violation.
(c) All Covered Persons are responsible for knowing what
constitutes an Anti-Doping Rule Violation and what Banned Substances
and what Banned Methods are included on the Prohibited List and
Technical Document--Prohibited Substances.
Rule 3212. Presence of a Banned Substance
(a) It is the personal and non-delegable duty of the Responsible
Person to ensure that no Banned Substance is present in the body of his
or her Covered Horse(s). The Responsible Person is therefore strictly
liable for any Banned Substance or its Metabolites or Markers found to
be present in a Sample collected from his or her Covered Horse(s).
Accordingly, it is not necessary to demonstrate intent, Fault,
negligence, or knowing Use on the part of the Responsible Person in
order to establish that the Responsible Person has committed a Rule
3212 Anti-Doping Rule Violation.
(b) Sufficient proof of a Rule 3212 Anti-Doping Rule Violation is
established by any of the following:
(1) the presence of a Banned Substance or its Metabolites or
Markers in the Covered Horse's A Sample where the Responsible Person
waives analysis of the B Sample and the B Sample is not analyzed;
(2) the Covered Horse's B Sample is analyzed and the analysis of
the B Sample confirms the presence of the Banned Substance or its
Metabolites or Markers found in the A Sample; or
(3) where, in exceptional circumstances, the Laboratory (on
instruction from the Agency) further splits the A or B Sample into two
parts in accordance with the Laboratory Standards, the analysis of the
second part of the resulting split Sample confirms the presence of the
same Banned Substance or its Metabolites or Markers as were found in
the first part of the split Sample, or the Responsible Person waives
analysis of the second part of the split Sample.
(c) The general rule is that the presence of any amount of a Banned
Substance or its Metabolites or Markers in a Sample collected from a
Covered Horse constitutes an Anti-Doping Rule Violation by the
Responsible Person of that Covered Horse.
(d) As an exception to the general rule of Rule 3212(c), the
Prohibited List, Standards, or Technical Documents may establish
special criteria for the reporting or the evaluation of certain Banned
Substances, including a Minimum Reporting Level, Screening Limit,
Threshold, or Decision Limit.
Rule 3213. Use or Attempted Use of a Banned Substance or a Banned
Method
(a) Subject to Rule 3213(c), the Use or Attempted Use of a Banned
Substance or Banned Method in relation to a Covered Horse constitutes
an Anti-Doping Rule Violation. The success or failure of that Use or
Attempted Use is not material. For a Rule 3213 violation to be
committed, it is sufficient that the Banned Substance or Banned Method
was Used or Attempted to be Used.
(b) It is the personal and non-delegable duty of the Responsible
Person to ensure that no Banned Substance or Banned Method is Used in
relation to his or her Covered Horse. The Responsible Person is
therefore strictly liable for any Use of a Banned Substance or Banned
Method in relation to his or her Covered Horse(s). Accordingly, it is
not necessary to demonstrate intent, Fault, negligence, or knowing Use
on the part of the Responsible Person in order to establish that the
Responsible Person has committed a Rule 3213 Anti-Doping Rule Violation
of Use. However, in accordance with the definition of
[[Page 5100]]
Attempt, it is necessary to show intent on the part of the Responsible
Person in order to establish that the Responsible Person has committed
a Rule 3213 Anti-Doping Rule Violation of Attempted Use.
(c) The presence of a Prohibited Substance or of evidence of Use of
a Prohibited Method in the Covered Horse's Sample or other evidence of
Use of such Prohibited Substance or Prohibited Method shall not be
considered an Anti-Doping Rule Violation if it is determined to have
resulted from Use of the Banned Substance or Banned Method prior to the
horse becoming a Covered Horse. However, any such Use is subject to
Rule 3040(b)(9) and may be reported to the relevant State Racing
Commission.
Rule 3214. Other Anti-Doping Rule Violations Involving Banned
Substances or Banned Methods
The following acts and omissions constitute Anti-Doping Rule
Violations by the Covered Person(s) in question:
(a) Possession of a Banned Substance or a Banned Method, unless
there is compelling justification for such Possession.
(b) Trafficking or Attempted Trafficking in any Banned Substance or
Banned Method.
(c) Administration or Attempted Administration to a Covered Horse
of any Banned Substance or any Banned Method.
Rule 3215. Evading Collection of a Sample From a Covered Horse;
Refusing or Failing Without Compelling Justification To Submit a
Covered Horse to Sample Collection; or Refusing or Failing To Comply
With All Sample Collection Procedure Requirements
(a) Except as provided in Rule 3215(d), each of the following
constitutes an Anti-Doping Rule Violation: (1) evading collection of a
Sample from a Covered Horse, (2) refusing or failing without compelling
justification to submit a Covered Horse to Sample collection after
notification by a duly authorized person, or (3) refusing or failing to
comply with all Sample collection procedure requirements.
(b) Responsible Persons are responsible for ensuring compliance
with Rules 3040(b)(1) and 3040(b)(2). A Responsible Person may delegate
the submission and supervision of the Covered Horse to a third party,
but the Responsible Person remains responsible for the Covered Horse
throughout the Sample collection process and for the acts and omissions
of his or her delegate. Therefore, the Responsible Person shall be
deemed liable for any evasion by his or her delegate of Sample
collection, any refusal or failure by his or her delegate without
compelling justification to submit the Covered Horse to Sample
collection, or any refusal or failure by his or her delegate to comply
with all Sample collection procedure requirements.
(c) Sample collection shall ordinarily be conducted where the
Covered Horse is located (e.g., Racetrack, Training Facility, or
private facility), unless the Agency agrees that the Covered Horse may
be transported to another agreed location (e.g., a nearby Racetrack).
(d) No violation occurs where a Covered Horse is made available for
Sample collection, but a Sample is not collected because the Covered
Horse is intractable.
Rule 3216. Other Anti-Doping Rule Violations
The following acts and omissions constitute Anti-Doping Rule
Violations by the Covered Person(s) in question:
(a) Tampering or Attempted Tampering by a Covered Person with any
part of Doping Control or Medication Control;
(b) a Covered Person assisting, encouraging, aiding, abetting,
conspiring, covering up, or engaging in any other type of intentional
complicity or Attempted complicity involving (1) an Anti-Doping Rule
Violation or Attempted Anti-Doping Rule Violation, or (2) a violation
of Rule 3229 by another Covered Person.
(c) Prohibited Association:
(1) Association by a Covered Person in a professional or sport-
related capacity with any Person who:
(i) is serving a period of Ineligibility imposed pursuant to the
Protocol or is serving a period of ineligibility imposed pursuant to
anti-doping rules administered by any other equine regulatory body or
anti-doping organization; or
(ii) has been found in a criminal, disciplinary, or professional
proceeding to have engaged in conduct that would have constituted a
violation of the Protocol if it had been applicable to such Person at
the relevant time. The disqualifying status of such Person shall last
for the longer of:
(A) 6 years from the criminal, professional, or disciplinary
decision; and (B) the duration of the criminal, disciplinary, or
professional sanction imposed; or
(iii) is serving as a front or intermediary for an individual
falling within paragraph (i) or (ii) above.
(2) To establish a violation of Rule 3216(c), the Agency must
establish that the Covered Person knew at the relevant time of the
Person's disqualifying status. It is presumed that any association with
the Person described in Rules 3216(c)(1)(i) and (ii) is in a
professional or sport-related capacity, and the burden shall be on the
Covered Person to rebut that presumption.
(3) It shall be a defense to a charge of violation of Rule 3216 if
the Covered Person establishes that the association with the Person
could not have been reasonably avoided.
(d) Acts by a Covered Person to discourage or retaliate against
reporting to authorities.
(1) Where such conduct does not otherwise constitute a violation
under Rule 3216(a) (Tampering or Attempted Tampering), each of the
following constitutes an Anti-Doping Rule Violation under this Rule
3216(d):
(i) any act that threatens or seeks to intimidate another Person
with the intent of discouraging that Person from the good faith
reporting of information that relates to an alleged Anti-Doping Rule
Violation or other alleged non-compliance with the Protocol to the
Agency or other appropriate Person; and
(ii) retaliation against a Person who, in good faith, has provided
evidence or information that relates to an alleged Anti-Doping Rule
Violation or other alleged non-compliance with the Protocol to the
Agency or other appropriate entity or Person.
(2) For purposes of Rule 3216(d), threatening or seeking to
intimidate a Person, and retaliation against a Person, include an act
taken against such Person that lacks a good faith basis or is a
disproportionate response.
3220. Sanctions
Rule 3221. Disqualification of the Covered Horse's Results
(a) Automatic Disqualification of results.
(1) An Anti-Doping Rule Violation that arises from a Post-Race
Sample, or that occurs during the Race Period, automatically leads to
Disqualification of the results of the Covered Horse obtained on the
Race Day(s) that fall(s) within the Race Period, even if any other
sanction for the violation is eliminated or reduced under Rules 3224,
3325, or 3226.
(2) In circumstances where an EAD Notice has been sent as required
under Rule 3245, and the B Sample analysis confirms the A Sample
analysis, or the right to request the analysis of the B Sample is
waived, the Agency, the Responsible Person, and the Owner of the
Covered Horse in question may agree to apply Rule 3221 immediately,
[[Page 5101]]
i.e., prior to adjudication of any other issue, or (in the absence of
such agreement) any one of them may request that the Arbitral Body
apply Rule 3221 immediately.
(b) Disqualification of subsequent results.
(1) Subject to paragraph (2), in addition to the automatic
Disqualification of results under Rule 3221(a), any other results that
the Covered Horse obtained from the date the Anti-Doping Rule Violation
first occurred, as well as during any period of retroactive
Ineligibility, shall be Disqualified, unless it is established by the
Responsible Person that fairness requires otherwise.
(2) If the Anti-Doping Rule Violation occurs in relation to a
Claiming Race in which the Covered Horse is claimed, Rule 3221(b)(1)
shall not apply to any results obtained by the Covered Horse under the
new ownership.
(c) Consequence of Disqualification of results:
(1) If a Covered Horse has results Disqualified under the Protocol,
all purses and other compensation, prizes, trophies, points, and
rankings are forfeited and must be repaid or surrendered (as
applicable) to the Race Organizer, and the results of the other Covered
Horses in the race(s) in question must be adjusted accordingly and the
purses, prizes, and trophies redistributed. Purses, prizes, trophies,
and other compensation shall (where possible) be withheld for the
Covered Horse in issue pending resolution of the relevant charge.
(2) The Covered Horses that participated in a Covered Horserace
involving an alleged Anti-Doping Rule Violation are often entered in
other Covered Horseraces prior to the final adjudication of the
violation. The ultimate Disqualification of a Covered Horse in
connection with final adjudication of a violation shall only impact
that horse's conditions for eligibility. By way of example, a maiden
that is Disqualified after finishing first in a maiden race shall
remain a maiden until it has won another race, but the runner-up in the
disputed Covered Horserace shall not be considered the winner for
purposes of its future condition eligibility. The adjustment to the
Disqualified horse's condition eligibility shall only occur once the
violation has been finally adjudicated.
Rule 3222. Ineligibility for Covered Horses
(a) For a violation of Rule 3212 (presence), 3213 (Use or Attempted
Use), or Rule 3214(c) (Administration or Attempted Administration), the
Covered Horse involved shall be Ineligible for the period designated in
the Prohibited List for the Banned Substance or Banned Method in issue.
(b) For a violation of Rule 3215 involving evasion of Sample
collection, the Covered Horse shall be Ineligible for 18 months. For a
violation of Rule 3215 involving refusal or failure to submit to Sample
collection, or refusal or failure to comply with all Sample collection
procedure requirements, the Covered Horse shall be Ineligible for 18
months, unless it is established by the Responsible Person that
fairness requires otherwise, in which case the period of Ineligibility
may be reduced, depending on the specific circumstances of the case and
considerations of horse welfare.
(c) Rule 3228 on increased periods of Ineligibility for repeat
offenders does not apply to Covered Horses.
(d) The period of Ineligibility for a Covered Horse shall be deemed
to commence on the date that the violation occurred (which, in the case
of a Rule 3212 violation, shall be the date that the positive Sample
was collected, even if the Covered Horse has participated in Timed and
Reported Workouts or Covered Races after that date).
Rule 3223. Ineligibility and Financial Penalties for Covered Persons
(a) General.
(1) The periods of Ineligibility and financial penalties set out in
this Rule 3223 apply to the Covered Person's first doping offense.
Where an offense is not the Covered Person's first doping offense, Rule
3228 applies.
(2) Unless specified otherwise, the periods of Ineligibility set
out in this Rule 3223 are subject to potential elimination, reduction,
or suspension pursuant to Rules 3224 to 3226 or potential increase
pursuant to Rule 3227.
(3) In accordance with Rule 3247(i), any period of Provisional
Suspension served by the Covered Person shall be credited against the
period of Ineligibility ultimately imposed on that Covered Person for
the violation in question.
(b) Consequences.
Subject to Rule 3223(a), and in addition to any other Consequences
that apply under the Protocol (including Disqualification), the periods
of Ineligibility and financial penalties specified below shall apply to
a Covered Person for his or her first Anti-Doping Rule Violation:
------------------------------------------------------------------------
Anti-doping rule violation
(first offense in 10-year Period of Financial
period) ineligibility penalties
------------------------------------------------------------------------
Presence (Rule 3212); Use or 2 years Fine of up to
Attempted Use (Rule 3213); $25,000 or 25% of
Possession (Rule 3214(a)); or the total purse
Administration or Attempted (whichever is
Administration (Rule 3214(c)). greater); and
Payment of some
or all of the
adjudication
costs and the
Agency's legal
costs.
Trafficking or Attempted Minimum of 4 years Fine of up to
Trafficking (Rule 3214(b)). up to lifetime $50,000 or 50% of
Ineligibility, the total purse
depending on the (whichever is
seriousness of greater); and
the violation. Payment of some or
A violation all of the
involving a Minor adjudication
shall be costs and the
considered a Agency's legal
particularly costs.
serious violation
and shall result
in lifetime
Ineligibility for
the Covered
Person who
commits it..
A violation that
may also violate
non-sporting laws
and regulations
shall be reported
to the competent
administrative,
professional, or
judicial
authorities..
[[Page 5102]]
Evading collection of a Sample 4 years, except: Fine up to $50,000
from a Covered Horse; refusing in the case of or 50% of the
or failing without compelling failing to submit total purse
justification to submit a to Sample (whichever is
Covered Horse to Sample collection, if greater); and
collection; or refusing or the Covered Payment of some or
failing to comply with all Person can all of the
Sample collection procedure establish that adjudication
requirements (Rule 3215); or the failure was costs and the
Tampering or Attempted not intentional, Agency's legal
Tampering (Rule 3216(a)). the period of costs.
Ineligibility
shall be in a
range between 3
months to 2
years, depending
on his or her
degree of Fault;.
and, in all other
cases, if the
Covered Person
can establish
exceptional
circumstances
that justify a
reduction of the
period of
Ineligibility,
the period of
Ineligibility
shall be in a
range from 3
months to 4
years, depending
on his or her
degree of Fault..
---------------------------------------
Complicity or Attempted Same Consequences that apply to the
complicity (Rule 3216(b)). principal actor, absent mitigating or
aggravating circumstances.
---------------------------------------
Prohibited Association (Rule 2 years, subject Fine up to $25,000
3216(c)). to a reduction or 25% of the
down to a minimum total purse
of 1 year, (whichever is
depending on the greater); and
Covered Person's Payment of some or
degree of Fault all of the
and other adjudication
circumstances of costs and the
the case. Agency's legal
costs.
Acts to discourage or retaliate 2 years up to Fine of up to
against reporting (Rule lifetime $50,000 or 50% of
3216(d)). Ineligibility, the total purse
depending on the (whichever is
seriousness of greater); and
the violation. Payment of some or
all of the
adjudication
costs and the
Agency's legal
costs.
------------------------------------------------------------------------
(c) Commencement of the period of Ineligibility for a Covered
Person.
(1) Except as otherwise provided in this Rule 3223, the period of
Ineligibility imposed on any Covered Person shall start on the date the
period of Ineligibility is accepted or otherwise imposed in accordance
with the Protocol.
(2) Where a Covered Person is already serving a period of
Ineligibility for another violation of the Protocol, any new period of
Ineligibility shall start to run the day after the original period of
Ineligibility ends.
(3) Where there have been substantial delays in the adjudication
process or other aspects of Doping Control that go well beyond the
standard timeframes for Laboratory analyses and Results Management, and
the Covered Person can establish that such delays are not attributable
to him or her, the start date of the period of Ineligibility may be
deemed back-dated to reflect such delays, but in no event may it be
deemed back-dated to a date before the Anti-Doping Rule Violation last
occurred. All competitive results achieved during the period of
Ineligibility by the Covered Person or Covered Horse in issue,
including retroactive Ineligibility, shall be Disqualified, unless it
is established by the Covered Person that fairness requires otherwise.
Rule 3224. Elimination of the Period of Ineligibility Where There Is No
Fault or Negligence
(a) If a Covered Person establishes in an individual case that he
or she bears No Fault or Negligence for the Anti-Doping Rule
Violation(s) charged, the otherwise applicable period of Ineligibility
and other Consequences for such Covered Person shall be eliminated
(except for those set out in Rule 3221(a) and Rule 3620). When the
violation is of Rule 3212 (presence of a Banned Substance), the Covered
Person must also establish how the Banned Substance entered the Covered
Horse's system as a pre-condition to application of this Rule 3224(a).
In the event the period of Ineligibility otherwise applicable is
eliminated pursuant to this Rule 3224, the Anti-Doping Rule Violation
shall not be considered a prior violation for the purpose of Rule 3228.
(b) Rule 3224 only applies in exceptional circumstances. In
particular, it will not apply where the Banned Substance found to be
present in a Sample: (1) came from a mislabeled or contaminated
supplement; or (2) was administered to the Covered Horse by veterinary
or other support personnel without the knowledge of the Responsible
Person.
(c) A finding that the Covered Person bears No Fault or Negligence
for an Anti-Doping Rule Violation shall not affect the Consequences of
that violation that apply to the Covered Horse (i.e., Ineligibility in
accordance with Rule 3222(a) and Disqualification of results in
accordance with Rule 3221).
Rule 3225. Reduction of the Period of Ineligibility Where There Is No
Significant Fault or Negligence
Reductions under this Rule 3225 are mutually exclusive and not
cumulative, i.e., no more than one of them may be applied in a
particular case.
(a) General rule.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Anti-Doping Rule Violation in
question, then (unless Rule 3225(b) or 3225(c) applies) the period of
Ineligibility shall be fixed between 3 months and 2 years, depending on
the Covered Person's degree of Fault.
(b) Specified Substances.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Anti-Doping Rule Violation in
question, and the violation involves only a Specified Substance, the
period of Ineligibility shall be, at a minimum, a reprimand and no
period of Ineligibility, and, at a maximum, 2 years of Ineligibility,
depending on the Covered Person's degree of Fault.
(c) Contaminated Products or other contamination.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Anti-Doping Rule Violation in
question and that the Banned Substance in question came from a
Contaminated Product or from another form of contamination, the period
of Ineligibility shall be, at a minimum, a reprimand and no period of
[[Page 5103]]
Ineligibility, and, at a maximum, 2 years of Ineligibility, depending
on the Covered Person's degree of Fault.
Rule 3226. Elimination, Reduction, or Suspension of Period of
Ineligibility or Other Consequences for Reasons Unrelated to Degree of
Fault
(a) Substantial Assistance. The Agency may suspend all or part of
the Consequences imposed on a Covered Person in an individual doping
case--other than Disqualification of results pursuant to Rule 3221--
based on the following:
(1) The Covered Person provides Substantial Assistance to the
Agency, the Authority, or a State Racing Commission, a criminal
authority, or a professional disciplinary body that results in:
(i) the Agency discovering or bringing forward an Anti-Doping Rule
Violation or a Controlled Medication Rule Violation by another Covered
Person; or
(ii) a criminal or disciplinary body discovering or bringing
forward a sport-related criminal offense or the breach of professional
or sports rules by another Person, including offenses arising out of a
sport integrity violation or sport safety violation, or the violation
of any rule or requirement in the Act, and the information provided by
the Covered Person providing Substantial Assistance is also made
available to the Agency.
(2) The extent to which the otherwise applicable period of
Ineligibility may be suspended shall be based on the seriousness of the
Anti-Doping Rule Violation committed by the Covered Person and the
degree to which the Substantial Assistance provided by the Covered
Person assists the effort to promote doping-free racing, compliance
with the Protocol, or the integrity of racing. In any event, no more
than three-quarters of the otherwise applicable period of Ineligibility
may be suspended. If the otherwise applicable period of Ineligibility
is a lifetime, the non-suspended period under this section must be no
less than 8 years. For purposes of this Rule 3226, the otherwise
applicable period of Ineligibility shall not include any period of
Ineligibility that could be added under Rule 3228(c)(2).
(3) If so requested, the Agency shall allow the Covered Person who
seeks to provide Substantial Assistance to provide the information to
the Agency subject to a Without Prejudice Agreement.
(4) If the Covered Person fails to continue to cooperate or fails
to provide the complete, accurate, and credible Substantial Assistance
promised, the Agency shall reinstate the original Consequences. That
decision is not subject to review.
(b) Voluntary Admission of an Anti-Doping Rule Violation in the
absence of other evidence. If (1) the Covered Person voluntarily admits
the commission of an Anti-Doping Rule Violation before receiving the
EAD Notice or (in the case of a Rule 3212 violation) before having
received notice of a Sample collection that could establish the Anti-
Doping Rule Violation, and (2) that admission is the only reliable
evidence of the violation at the time the admission is made, the
otherwise applicable period of Ineligibility may be reduced by up to
one-half.
(c) Application of multiple grounds for reduction of a sanction. If
the Covered Person establishes entitlement to a reduction or suspension
of the period of Ineligibility under 2 or more of Rules 3224, 3225, or
3226, the otherwise applicable period of Ineligibility shall be
determined in accordance with Rules 3223, 3224, and 3225 before
applying any reduction or suspension under Rule 3226. If the Covered
Person establishes entitlement to a reduction or suspension of the
period of Ineligibility under Rule 3226, up to three-quarters of the
otherwise applicable period of Ineligibility may be reduced or
suspended.
(d) Reductions for certain Anti-Doping Rule Violations based on
early admission and acceptance of sanction.
(1) If the Agency notifies a Covered Person of a potential Anti-
Doping Rule Violation that carries an asserted period of Ineligibility
of 4 or more years (including any period of Ineligibility asserted
under Rule 3227), if the Covered Person admits the violation and
accepts the asserted period of Ineligibility no more than 7 days after
receiving the Charge Letter, the period of Ineligibility to be served
will be automatically reduced by 1 year (but no further reduction shall
be allowed under any other Rule).
(2) If the Agency notifies a Covered Person of a potential Anti-
Doping Rule Violation that carries an asserted period of Ineligibility
of 2 years or more years, but less than 4 years (including any period
of Ineligibility asserted under Rule 3227), if the Covered Person
admits the violation and accepts the asserted period of Ineligibility
no more than 7 days after receiving the Charge Letter, the period of
Ineligibility to be served will be automatically reduced by 6 months
(but no further reduction shall be allowed under any other Rule).
Rule 3227. Aggravating Circumstances
(a) In an individual case involving an Anti-Doping Rule Violation
that is not a Rule 3214(b) violation (Trafficking or Attempted
Trafficking) or a Rule 3216(d) violation (acts to discourage or
retaliate against reporting), if the Agency establishes that
Aggravating Circumstances are present, the period of Ineligibility
otherwise applicable shall be increased by up to 2 years, depending on
the seriousness of the Aggravating Circumstances, unless the Covered
Person establishes that he or she did not knowingly commit the Anti-
Doping Rule Violation. Where the period of Ineligibility is increased
pursuant to this Rule, an additional fine of up to $10,000 or an
additional 10% of the total purse (whichever is greater) may also be
imposed.
(b) Actions and circumstances constituting Aggravating
Circumstances include:
(1) Administration of a Banned Substance or Use of a Banned Method
that is detrimental to the health and welfare of the horse or is
designed to deceive the betting public;
(2) the presence in the Covered Horse's Sample of a combination of
Banned Substance(s) and Controlled Medication Substance(s);
(3) prior violations under the Protocol; or
(4) the Covered Person engaged in deceptive or obstructive conduct
to avoid the detection or adjudication of an Anti-Doping Rule Violation
or a Controlled Medication Rule Violation, for which the Covered Person
has not been separately sanctioned for Tampering.
(c) For the avoidance of doubt, the examples set out in Rule
3227(b) are not exhaustive and other similar circumstances or conduct
may also be deemed to amount to Aggravating Circumstances that justify
the imposition of a longer period of Ineligibility.
Rule 3228. Increased Sanctions for Repeat Offenders
(a) For purposes of this Rule 3228, the following prior Anti-Doping
Rule Violations shall be disregarded: (1) violations that occurred more
than 10 years prior to the violation now being sanctioned; and (2)
violations for which the Covered Person was found to bear No Fault or
Negligence.
(b) Subject to Rule 3228(a), and in addition to any other
Consequences that apply under the Protocol (including
Disqualification), the periods of Ineligibility and financial penalties
specified below shall apply to any Covered Person who commits a second
or subsequent Anti-Doping Rule Violation:
[[Page 5104]]
------------------------------------------------------------------------
Number of anti-doping rule Period of Financial
violations (in 10-year period) ineligibility penalties
------------------------------------------------------------------------
Second Anti-Doping Rule The period of Fine of up to
Violation. Ineligibility $50,000 or 50% of
shall be the the total purse
greater of: (whichever is
(a) a 6-month greater); and
period of Payment of some or
Ineligibility; or. all of the
(b) a period of adjudication
Ineligibility in costs and the
the following Agency's legal
range, taking costs.
into account the
entirety of the
circumstances and
the Covered
Person's degree
of Fault with
respect to the
second violation:.
(i) the sum of the
period of
Ineligibility
imposed for the
first Anti-Doping
Rule Violation,
plus the period
of Ineligibility
otherwise
applicable to the
second Anti-
Doping Rule
Violation treated
as if it were a
first violation;
and
(ii) twice the
period of
Ineligibility
otherwise
applicable to the
second Anti-
Doping Rule
Violation treated
as if it were a
first violation.
Third (or subsequent) Anti- Lifetime Fine of up to
Doping Rule Violation. Ineligibility, $100,000 or 100%
except if the of the total
third violation purse (whichever
satisfies the is greater); and
conditions for Payment of some or
elimination or all of the
reduction of the adjudication
period of costs and the
Ineligibility Agency's legal
under Rule 3224 costs.
or Rule 3225, in
which case the
period of
Ineligibility
shall be from 8
years to lifetime
Ineligibility.
If the above
exception
applies, the same
rule shall apply
to any subsequent
violation.
------------------------------------------------------------------------
(c) Additional rules for certain multiple violations.
(1) Multiple violations for the same Banned Substance/Method
incurred by a Covered Person in relation to the same Covered Horse
prior to delivery of an EAD Notice may (at the Agency's discretion) be
treated together as a single Anti-Doping Rule Violation, unless the
facts demonstrate that there was more than one administration. Multiple
violations for the same Banned Substance/Method incurred by a Covered
Person in relation to different Covered Horses prior to delivery of an
EAD Notice may (at the Agency's discretion) each be treated as a first
Anti-Doping Rule Violation. Where multiple Banned Substances are
detected in a single Post-Race Sample or Post-Work Sample, each Banned
Substance may (at the Agency's discretion) be treated as a separate
violation.
(2) If the Agency establishes that, prior to receiving an EAD
Notice in respect of one Anti-Doping Rule Violation, the Covered Person
committed an additional Anti-Doping Rule Violation that occurred 12
months or more before or after the violation asserted in that EAD
Notice, the period of Ineligibility for the additional violation shall
be calculated as if the additional violation were a stand-alone first
violation, and that period of Ineligibility will run consecutively to
(rather than concurrently with) the period of Ineligibility imposed for
the first-notified violation. Where this Rule applies, the violations
taken together will constitute a single violation for purposes of Rule
3228.
(3) If a Doping Control process results in the assertion of an
Anti-Doping Rule Violation, and the Agency establishes that the Covered
Person committed an independent violation of Rule 3216(a) (Tampering)
in connection with that Doping Control process, the Rule 3216(a)
(Tampering) violation shall be treated as a stand-alone violation and
the period of Ineligibility for such violation shall be served
consecutively to, rather than concurrently with, the period of
Ineligibility imposed for the other Anti-Doping Rule Violation. Where
this Rule 3228(c)(3) is applied, the violations taken together shall
constitute a single violation for purposes of Rule 3228.
(4) If the Agency establishes that the Covered Person has committed
a further violation of the Protocol during a period of Ineligibility,
any new period of Ineligibility shall start to run the day after the
original period of Ineligibility ends.
(d) Violations involving both a Banned Substance or Method and a
Controlled Medication Substance or Method.
Where a Covered Person is found, based on a common set of facts, to
have committed a (1) violation involving one or more Banned
Substance(s) or Banned Method(s), and (2) a violation involving one or
more Controlled Medication Substance(s) or Controlled Medication
Method(s), they shall be treated as separate violations, but shall be
adjudicated together in consolidated proceedings pursuant to the
procedure that applies to Anti-Doping Rule Violations under the
Arbitration Procedures.
Rule 3229. Status During Provisional Suspension or Ineligibility
(a) While serving a Provisional Suspension or period of
Ineligibility for an Anti-Doping Rule Violation:
(1) a Covered Horse may not participate in any Timed and Reported
Workout or Covered Horserace, but shall remain subject to Testing;
(2) a Covered Person may not participate in any capacity in any
activity involving Covered Horses, or in any other activity (other than
authorized anti-doping education or rehabilitation programs) taking
place at a Racetrack or Training Facility; nor shall he or she permit
anyone to participate in any capacity on his or her behalf in any such
activities, except to the extent that the Covered Person is an Owner
and the activity is necessary to ensure the safekeeping and wellbeing
of the horse during the period of such Owner's Provisional Suspension
or Ineligibility.
(b) The Covered Horse(s) of an Owner or Trainer who is subject to a
Provisional Suspension or period of Ineligibility shall be subject to
the following restrictions:
(1) The Covered Horse(s) of a Trainer who is subject to a
Provisional Suspension or period of Ineligibility may not participate
in any Timed and Reported Workout or Covered Horserace unless and until
they have been transferred to another Covered Person. For the
``transfer'' to be valid, (i) the transfer must be registered with the
Authority in accordance with its procedures, and (ii) the Covered
Horses must also be physically relocated to facilities under the care
or control of a Covered Person who is not affiliated
[[Page 5105]]
with the suspended Trainer (and failure to comply may constitute an
Anti-Doping Rule Violation under Rule 3216(c), i.e., Prohibited
Association).
(2) The Covered Horse(s) of an Owner who is subject to a
Provisional Suspension or period of Ineligibility may not participate
in any Timed and Reported Workout or Covered Horserace unless and until
they have been transferred in a bona fide transaction to a different
Owner. If an Immediate Family Member has any ownership or property
interest in the Covered Horse(s) following such transfer, the transfer
shall not constitute a bona fide transaction to a different Owner.
Rule 3230. Consequences for Violation of the Prohibition on
Participation During Ineligibility or Provisional Suspension Under Rule
3229
(a) Consequences for violation of the prohibition on participation
during Ineligibility.
(1) If a Covered Person violates the prohibition against
participation during Ineligibility described in Rule 3229, any results
obtained from such participation shall be Disqualified and a new period
of Ineligibility equal in length to the original period of
Ineligibility shall be added to the end of the Covered Person's
original period of Ineligibility.
(2) If a Covered Horse participates in any Timed and Reported
Workout or Covered Horserace in violation of the prohibition against
participation during Ineligibility described in Rule 3229, any results
obtained from such participation shall be Disqualified and the
Responsible Person for that Covered Horse shall receive the following
period of Ineligibility:
(i) if the Responsible Person was subject to an original period of
Ineligibility, a new period of Ineligibility equal in length to the
original period of Ineligibility shall be added to the end of the
original period of Ineligibility. If the original period of
Ineligibility has already expired, the new period of Ineligibility
shall start on the date that it is accepted or imposed; or
(ii) if the Responsible Person was not subject to an original
period of Ineligibility, the period of Ineligibility for violating Rule
3229 shall be from a reprimand to 1 year, depending on the Covered
Person's degree of Fault.
(b) Consequences for violation of the prohibition on participation
during Provisional Suspension.
(1) A Covered Person who violates the prohibition against
participation during a Provisional Suspension shall receive no credit
for any period of Provisional Suspension served and the results of such
participation shall be Disqualified.
(2) If a Covered Horse participates in any Timed and Reported
Workout or Covered Horserace in violation of the prohibition against
participation during a Provisional Suspension described in Rule 3229,
the Responsible Person for that Covered Horse and the Covered Horse
shall receive no credit for any period of Provisional Suspension served
and the results of such participation shall be Disqualified.
(c) The consequence of Disqualification under this Rule 3230 shall
be the same as set out in Rule 3221(c).
(d) The Arbitral Body (or the Agency, if the Covered Person admits
the violation and accepts the consequences) shall determine whether
there has been a violation of the prohibition against participation
during Provisional Suspension or Ineligibility and apply the
appropriate consequences pursuant to Rule 3261.
Rule 3231. Automatic Public Disclosure
A mandatory part of each sanction shall include automatic Public
Disclosure in accordance with Rule 3620.
Rule 3232. Conditions Precedent to Reinstatement for Covered Persons
(a) To be reinstated after commission of an Anti-Doping Rule
Violation, the Covered Person must have respected his or her period of
Ineligibility (Rule 3229); and repaid or surrendered any purses and
other compensation, prizes, trophies, points, and rankings forfeited
pursuant to Rule 3221, and paid any fines and reimbursed any costs
imposed or accepted to the Agency, unless an installment plan was
established pursuant to Rule 3232(b), in which case the Covered Person
must have made all payments due under that plan. If any installment(s)
subsequently become(s) overdue under that plan (i.e., after
reinstatement), the Covered Person and the Covered Horses under his or
her ownership or training may not participate in any Timed and Reported
Workout or Covered Horserace until such overdue installment(s) is/are
paid in full.
(b) Where fairness requires, the Agency or the Arbitral Body may
establish an installment plan for repayment of amounts due to be paid
or reimbursed under the Protocol. The payment schedule may extend
beyond any period of Ineligibility imposed upon the Covered Person.
Rule 3233. Conditions Precedent to Reinstatement for Covered Horses
(a) A Covered Horse shall be reinstated once its period of
Ineligibility ends, provided that (1) the Ineligibility has been
respected in full throughout that period in accordance with Rule 3229,
(2) the Covered Horse has been made available for Testing during that
period in accordance with Rule 3132(d), and (3) the Covered Horse has
completed any Vets' List Workout(s) required by the Racetrack Safety
Program or the Agency (for the avoidance of doubt, such workouts may be
scheduled prior to the expiry of the period of Ineligibility and will
not constitute a violation of Rule 3229).
(b) Any reinstatement pursuant to this Rule 3233 is without
prejudice to any rest or stand down period that may be imposed on the
Covered Horse (e.g., due to injuries), and any requirements for release
from the Veterinarians' List, pursuant to the Racetrack Safety Program.
3240. Results Management
Rule 3241. General
Where there is evidence of a potential Anti-Doping Rule
Violation(s), the Agency will conduct Results Management in accordance
with this section 3240 and the Testing and Investigations Standards.
Rule 3242. Review of Adverse Analytical Findings
(a) Upon receipt of an Adverse Analytical Finding in relation to an
A Sample, the Agency will conduct a review of the Laboratory
certificate of analysis supporting the Adverse Analytical Finding and
the relevant Sample collection documentation and Testing documents to
determine whether the Adverse Analytical Finding was caused by any
apparent departure from the Testing and Investigations Standards, the
Laboratory Standards, or any provision of the Protocol. Subject to Rule
3242(b), the Agency may, but does not have to, communicate with the
Responsible Person and Owner during such review.
(b) If the review under Rule 3242(a) reveals an apparent departure
that caused the Adverse Analytical Finding, the entire test shall be
considered negative, and the Agency shall promptly inform the
Responsible Person and each Interested Party of that fact.
(c) If the initial review of an Adverse Analytical Finding under
Rule 3242(a) does not reveal an apparent departure that caused the
Adverse Analytical Finding, the Agency shall promptly send an EAD
Notice to the Responsible
[[Page 5106]]
Person and each Interested Party in accordance with Rule 3245.
Rule 3243. Review of Atypical Findings Relating to Banned Substances
(a) In certain circumstances, Laboratories may report the presence
of certain Banned Substances as ``Atypical Findings'' in accordance
with the Atypical Findings Policy set out at Appendix 1. Upon receipt
of an A Sample Atypical Finding, the Agency will conduct a review to
determine whether the Atypical Finding was caused by a departure from
the Testing and Investigations Standards, the Laboratory Standards, or
any provision of the Protocol. If that review does not reveal any
departure that caused the Atypical Finding, the Agency will conduct an
investigation (including directing any Further Analysis) or take any
other steps required to decide whether the Atypical Finding should be
brought forward as an Adverse Analytical Finding, in accordance with
the Atypical Findings Policy.
(b) The Agency may, but does not have to, provide notice of an
Atypical Finding to anyone until it has made that decision unless one
of the following circumstances exists:
(1) if the Agency determines that the B Sample should be analyzed
prior to the conclusion of its investigation, the Agency may conduct
the B Sample analysis after notifying the Responsible Person and the
Owner, with such notice to include a description of the Atypical
Finding and the information described in Rule 3245; or
(2) if the Atypical Finding is likely connected to a serious
pathology that requires urgent veterinary attention.
(c) If the Agency ultimately decides not to pursue the Atypical
Finding as an Adverse Analytical Finding, the Agency may, but does not
have to, communicate that fact to the Responsible Person and Owner
unless he or she has previously received notice of the Analytical
Finding pursuant to Rule 3243(b).
(d) If the Agency decides to move forward with the matter as an
Adverse Analytical Finding, the Agency shall promptly send an EAD
Notice to the Responsible Person and each Interested Party.
Rule 3244. Review of Other Evidence of a Potential Anti-Doping Rule
Violation
The Agency shall conduct any follow-up investigation required into
any potential Anti-Doping Rule Violation not covered by Rules 3242 or
3243. At such time as the Agency is satisfied that it has sufficient
evidence to establish that an Anti-Doping Rule Violation occurred, it
shall promptly send an EAD Notice to the relevant Covered Person and
each Interested Party.
Rule 3245. EAD Notice
(a) Where it is determined that a Covered Person may have committed
one or more Anti-Doping Rule Violations, the Agency will promptly
notify the Covered Person and each Interested Party in writing of the
following (the EAD Notice):
(1) the alleged Anti-Doping Rule Violation and the Consequences if
it is agreed or determined to have been committed;
(2) the Adverse Analytical Finding (with a copy of the Laboratory
certificate of analysis in a form designated by the Agency) or a brief
summary of the facts relied on by the Agency to assert the alleged
violation (including, where applicable, the name of the Covered Horse
implicated in the alleged violation, whether the alleged violation was
in connection with a particular Covered Horserace, and the date of
Sample collection or of the other relevant facts said to give rise to
the violation);
(3) if applicable, the right of the Responsible Person and the
Owner to receive copies of the A Sample Laboratory Documentation
Package after the B Sample analysis has been completed or after such
analysis is waived;
(4) if applicable, the following details regarding the B Sample
analysis:
(i) that the B Sample has been (or will be) analyzed because the
Agency has authorized immediate analysis to preserve the scientific
integrity of the Sample;
(ii) if the B Sample has not been analyzed, the Responsible
Person's and Owner's right to promptly request the analysis of the B
Sample within no more than 5 days or (failing such request) that the B
sample analysis shall be deemed to be waived;
(iii) an explanation that, where the Responsible Person or Owner
requests the B Sample analysis within the applicable deadline, or where
the Agency decides to proceed with the B Sample analysis, the Agency
will notify the Responsible Person and Owner of the date, time, and
place where the B Sample will be analyzed and (where the analysis is
requested by the Responsible Person or Owner) the amount that the
Responsible Person or Owner must pay to have the B Sample tested and B
Sample Laboratory Documentation Package prepared, and the date by which
such payment must be received, failing which the B Sample analysis
shall be deemed to have been waived; and
(5) the opportunity for the Covered Person to provide an
explanation within a short deadline set by the Agency;
(6) the opportunity to provide Substantial Assistance, to admit the
Anti-Doping Rule Violation, or to seek to resolve the matter without a
hearing under Rule 3249;
(7) all relevant details relating to any Provisional Suspension
(including, if applicable, the possibility to accept a voluntary
Provisional Suspension) in accordance with Rule 3247; and
(8) if applicable, the ability for the automatic Disqualification
of results to be applied immediately in accordance with Rule
3221(a)(2).
(b) Before sending an EAD Notice, for purposes of Rule 3228, the
Agency shall seek to determine whether the Covered Person in question
has committed any prior violations under the Protocol.
(c) Any defect in the EAD Notice (including a failure to identify
the Covered Horseraces implicated in the alleged violation, if any) may
be corrected by the Agency and shall not in any event invalidate the
EAD Notice or affect the due application of the provisions of the
Protocol (including the Disqualification provisions) in relation to
that violation.
Rule 3246. B Sample Analysis
(a) Arrangements shall be made for analysis of the B Sample without
undue delay, in accordance with the Protocol and the Laboratory
Standards. Subject to Rule 3246(b), the Responsible Person or Owner
must pay the costs of the B Sample analysis in advance, but, if the B
Sample analysis does not confirm the A Sample analysis, they will be
reimbursed that cost by the Agency. The Responsible Person and Owner or
one representative each may attend the Laboratory to witness the
opening and identification of the B Sample. They do not have any right
to witness the analysis of the B Sample.
(b) The Responsible Person and Owner may (if they both agree) waive
analysis of the B Sample (in which case they shall be deemed to accept
the A Sample analytical results). If waived, the Agency may nonetheless
elect to proceed with the B Sample analysis at its own expense.
(c) If the B Sample proves negative, the entire Test shall be
considered negative, and the Responsible Person and Owner shall be so
informed. In such circumstances, unless the Agency asserts an Anti-
Doping Rule Violation under Rule 3213 (Use), the EAD Notice will be
withdrawn, any Provisional Suspensions imposed shall be deemed
automatically vacated with immediate effect (without the need for any
order
[[Page 5107]]
from the Arbitral Body), and no further disciplinary action will be
taken against the Responsible Person, other Covered Person, or Covered
Horse by the Agency in relation to the original Adverse Analytical
Finding (provided, however, that the Agency may investigate why the B
Sample did not match the A Sample). If the Agency asserts that a Rule
3213 (Use) violation has occurred, it shall send a Charge Letter to the
Responsible Person and other Covered Person(s), with a copy to each
Interested Party.
(d) If the presence of a Banned Substance or the Use of a Banned
Method is confirmed by the B Sample analysis, or the B Sample analysis
is waived, the Agency shall send a Charge Letter to the Responsible
Person and any other relevant Covered Person(s), with a copy to each
Interested Party, asserting that a Rule 3212 (presence) violation or a
Rule 3213 (Use) violation (as applicable) has occurred.
Rule 3247. Provisional Suspensions
(a) Provisional Suspensions shall be imposed as follows:
(1) For each alleged violation of Rule 3212 (presence), 3213 (Use),
or 3214(c) (Administration or Attempted Administration) that involves a
Banned Substance that is not a Specified Substance, the Agency shall
impose a Provisional Suspension, effective from the date specified by
the Agency in the EAD Notice or in further correspondence up to and
including the Charge Letter, on (i) the Covered Horse, (ii) the
Responsible Person, and (iii) any other Covered Person charged with the
violation.
(2) For each alleged violation of Rule 3215 (evading Sample
collection; refusing or failing to submit to Sample collection; or
refusing or failing to comply with all Sample collection procedure
requirements), the Agency may impose a Provisional Suspension,
effective from the date specified by the Agency in the EAD Notice or in
further correspondence up to and including the Charge Letter, on (i)
the Covered Horse, (ii) the Responsible Person, or (iii) any other
Covered Person charged with the violation.
(3) For all other alleged Anti-Doping Rule Violations, the Agency
may impose a Provisional Suspension, effective from the date specified
by the Agency in the EAD Notice or in further correspondence up to and
including the Charge Letter, on the Responsible Person, or any other
Covered Person alleged to be implicated in the violation, but not on
the Covered Horse.
(b) Where a Provisional Suspension is imposed pursuant to Rule
3247(a), the Responsible Person (on his or her own behalf and on behalf
of the Covered Horse) and any other Covered Person made subject to the
Provisional Suspension shall be given:
(1) an opportunity for a Provisional Hearing before imposition of
the Provisional Suspension;
(2) an opportunity for a Provisional Hearing on a timely basis
after imposition of the Provisional Suspension; or
(3) an opportunity for an expedited final adjudication in
accordance with Rule 3262 on a timely basis after imposition of the
Provisional Suspension.
(c) Provisional Hearings shall be conducted by the Arbitral Body
and heard via telephone or video conference call within the time frame
specified in accordance with the Arbitration Procedures. The sole issue
to be determined by the Arbitral Body will be whether the Agency's
decision to impose a Provisional Suspension shall be maintained. The
Agency's decision to impose a Provisional Suspension shall be
maintained unless the Responsible Person/Covered Person requesting the
lifting of the Provisional Suspension establishes that:
(1) the allegation that an Anti-Doping Rule Violation has been
committed has no reasonable prospect of being upheld, e.g., because of
a material defect in the evidence on which the allegation is based;
(2) the Responsible Person/Covered Person charged bears No Fault or
Negligence for the Anti-Doping Rule Violation that is alleged to have
been committed, so that any period of Ineligibility that might
otherwise be imposed for such offense would be completely eliminated by
application of Rule 3224. (This ground does not apply in respect of any
Provisional Suspension imposed on a Covered Horse);
(3) Rule 3225 applies and the Responsible Person/Covered Person
bears No Significant Fault or Negligence and he or she will likely be
given a period of Ineligibility that is not longer than the period for
which he or she has already been provisionally suspended (this ground
does not apply in respect of any Provisional Suspension imposed on a
Covered Horse); or
(4) exceptional circumstances exist that make it clearly unfair,
taking into account all of the circumstances of the case, to impose a
Provisional Suspension prior to the final hearing on the merits. This
ground is to be construed narrowly and applied only in truly
exceptional circumstances. For example, the fact that the Provisional
Suspension would prevent the Responsible Person, Covered Person, or
Covered Horse from participating in a particular Timed and Reported
Workout, Covered Horserace, or other activity shall not qualify as
exceptional circumstances for these purposes.
(d) If the application is made before the Provisional Suspension
comes into effect, the Provisional Suspension will not come into effect
pending the decision on the application. If the application is made
after the Provisional Suspension has come into effect, the Provisional
Suspension will remain in place pending the decision on the
application.
(e) If it considers it appropriate to do so on the specific facts
of the case, the Agency may lift the Provisional Suspension.
(f) If the application to have a Provisional Suspension not
imposed/lifted is not granted, a further application may not be made to
lift the Provisional Suspension unless: (i) it is based on new and
material evidence that the Responsible Person or other Covered Person
was not aware of and could not reasonably have been aware of at the
time he or she made the original application; or (ii) there has been
some other significant and material change in circumstances since the
original application was decided. If the Responsible Person or other
Covered Person makes a further application that does not meet either of
these requirements, costs may be awarded against him or her.
(g) Voluntary Provisional Suspension.
(1) In all cases where a Responsible Person/Covered Person has been
notified of or charged with an Anti-Doping Rule Violation, but no
Provisional Suspension has been imposed on him or her or on the Covered
Horse, that person may (on his or her own behalf and, if the
Responsible Person, on behalf of the Covered Horse) voluntarily accept
a Provisional Suspension at any time by written notice to the Agency. A
copy of the voluntary Provisional Suspension shall promptly be provided
to each Interested Party.
(2) A Provisional Suspension that is voluntarily accepted will have
effect (in the same manner as if the Provisional Suspension had been
imposed under Rule 3247(a)) from the date that written notice of its
acceptance is received by the Agency.
(h) No admission will be inferred, or other adverse inference
drawn, from the decision of a Covered Person: (1) not to make an
application to lift a Provisional Suspension; or (2) to accept a
voluntary Provisional Suspension.
[[Page 5108]]
(i) If a Provisional Suspension is imposed or voluntarily accepted,
and that Provisional Suspension is respected, then the Responsible
Person/Covered Person and Covered Horse in question shall receive a
credit for such period of Provisional Suspension against any period of
Ineligibility that may ultimately be imposed. If the Responsible
Person/Covered Person or Covered Horse does not respect a Provisional
Suspension, the Responsible Person/Covered Person or Covered Horse
shall receive no credit for any period of Provisional Suspension
served. If a period of Ineligibility is served pursuant to a decision
that is subsequently subject to review, the Responsible Person/Covered
Person or Covered Horse shall receive a credit for such period of
Ineligibility served against any period of Ineligibility that may
ultimately be imposed on review.
(j) Notwithstanding any other provision in this Rule 3247 or
elsewhere in the Protocol, any Provisional Suspension imposed on a
Covered Horse will be automatically lifted (without the need for any
hearing) if it has been in place for a period equal to the period of
Ineligibility specified in the Protocol or Prohibited List.
Rule 3248. Charge Letter
If, after receipt of the Covered Person's explanation, or expiry of
the deadline to provide such explanation, the Agency remains satisfied
that the Covered Person has committed an Anti-Doping Rule Violation(s),
the Agency shall promptly charge the Covered Person with the asserted
Anti-Doping Rule Violation(s). In this letter of charge (Charge
Letter), which will be copied to each Interested Party, the Agency
shall:
(a) set out the Anti-Doping Rule Violation(s) that the Covered
Person is charged with having committed;
(b) provide a summary of the relevant facts upon which the charge
is based, enclosing a copy of the A Sample Laboratory Documentation
Package and (if applicable and if requested) the B Sample Laboratory
Documentation Package;
(c) specify the Consequences that will apply if the charge is
upheld;
(d) grant a deadline of not more than 7 days from receipt of the
Charge Letter (unless otherwise agreed by the Agency) for the Covered
Person to either:
(1) admit the Anti-Doping Rule Violation(s) charged and:
(i) accept the Consequences proposed by the Agency, in which case
the Agency will issue a decision under Rule 3249(b);
(ii) seek to agree to mitigated Consequences with the Agency
pursuant to Rule 3249, failing which the Consequences may still be
disputed at a hearing; or
(iii) dispute or seek to mitigate the proposed Consequences at a
hearing in accordance with Rule 3261 and the Arbitration Procedures; or
(2) deny the Anti-Doping Rule Violation charged and dispute the
proposed Consequences at a hearing in accordance with Rule 3261 and
Arbitration Procedures;
(e) indicate that, if the Covered Person does not challenge the
Agency's assertion of an Anti-Doping Rule Violation or the proposed
Consequences within the prescribed deadline, the Covered Person shall
be deemed to have waived his or her right to a hearing, admitted the
Anti-Doping Rule Violation(s) charged, and accepted the Consequences
specified by the Agency in the Charge Letter (without any mitigation of
those Consequences);
(f) give the opportunity to provide Substantial Assistance in
accordance with Rule 3226(a); and
(g) provide all relevant details relating to any Provisional
Suspensions (including, if applicable, the possibility to accept a
voluntary Provisional Suspension) in accordance with Rule 3247.
Rule 3249. Case Resolution Without a Hearing
(a) At any time prior to a final decision under the Arbitration
Procedures: (1) the Agency may withdraw a Charge Letter for good cause,
in which case any Provisional Suspension will be automatically lifted
and (absent the emergence of new information) no further steps will be
taken in relation to the violations alleged in the Charge Letter; or
(2) the Covered Person may agree to admit the Anti-Doping Rule
Violation(s) charged (or any other violation of the Protocol) and
accede to specified Consequences consistent with the Protocol. In any
such case, an adjudication under the Arbitration Procedures will not be
required.
(b) In the event that the Covered Person admits the Anti-Doping
Rule Violation(s) charged and accedes to Consequences specified by the
Agency (or is deemed to have done so in accordance with Rule
3248(a)(5)), the Agency will (1) promptly issue a final decision
confirming the commission of the Anti-Doping Rule Violation(s) and
setting out the factual basis for the decision and all of the
Consequences to be imposed (including a brief summary of the reasons
for any period of Ineligibility imposed, unless doing so could
compromise an ongoing investigation or proceeding), and (2) send notice
of the decision to each Interested Party. The Agency will also Publicly
Disclose the decision (or a summary thereof, at the discretion of the
Agency) in accordance with Rule 3620.
(c) In the event that the Agency withdraws the Charge Letter, it
will (1) promptly issue a summary decision confirming the withdrawal of
the Charge Letter, (2) send notice of the decision to the Covered
Person concerned, with a copy to each Interested Party, and (3)
Publicly Disclose the decision (or a summary thereof, at the discretion
of the Agency) in accordance with Rule 3620.
Rule 3250. Notification Requirements
(a) Notification of Anti-Doping Rule Violations will take place as
set out in Rule 3245 and Rule 3248. If at any point after an EAD Notice
has been provided the Agency decides not to move forward with the
charge, it will notify the Covered Person(s) concerned and each
Interested Party of that decision.
(b) Notification to a Covered Person by the Agency, for all
purposes of the Protocol, may be accomplished either through actual or
constructive notice. Actual notice may be accomplished by any means.
Constructive notice shall be deemed to have been given when the
information in question is delivered by third-party courier or U.S.
postal mail to the Covered Person's most recent mailing address on file
with the Authority or by email or text message to the Covered Person's
most recent email address or mobile telephone number on file with the
Authority.
3260. Hearings and Review of Final Decisions
Rule 3261. Hearing Before the Arbitral Body
Where a Covered Person is alleged to have committed an Anti-Doping
Rule Violation or to have violated Rule 3229, the Covered Person shall
be entitled to a hearing before the Arbitral Body in accordance with
the Arbitration Procedures. A copy of the final decision of the
Arbitral Body shall be sent to the Covered Person(s) concerned, with a
copy to the Agency and each Interested Party. The decision (or a
summary thereof, at the discretion of the Agency) shall be Publicly
Disclosed as provided in Rule 3620. If an individual case involves
allegations that both an Anti-Doping Rule Violation and a Controlled
Medication Rule Violation have been committed, the matter shall be
referred to and adjudicated by the Arbitral Body in accordance with the
Arbitration Procedures.
[[Page 5109]]
The Arbitral Body may also adjudicate any other matter referred to
it under the Protocol, and any other matter that might arise from time
to time under the Protocol that the Agency considers should be
determined by the Arbitral Body.
Rule 3262. Expedited Hearing
In Anti-Doping Rule Violation cases where the Covered Horse or
Covered Person in question is not Provisionally Suspended and is likely
to participate in a Covered Horserace within 45 days, the Agency may
(if it sees fit) address the case on an expedited basis and shorten any
deadlines in the Protocol or Arbitration Procedures proportionately to
ensure resolution of the matter prior to the Covered Horserace.
Rule 3263. Finality
Subject to Rule 3264, decisions rendered by the Arbitral Body under
the Protocol shall be final and binding.
Rule 3264. Review of Final Decisions
Any final decision by the Agency or the Arbitral Body is subject to
review in accordance with section 3058 of the Act. Any final decision
under review shall remain in effect pending resolution of the review
unless ordered otherwise.
3310. Controlled Medication Rule Violations
Rule 3311. Definition of Controlled Medication Rule Violation and
Responsibility for Violations
(a) Controlled medication cases will be initiated based on the
assertion that one or more of Rules 3312 through 3315 has been violated
(each, a Controlled Medication Rule Violation).
(b) The Controlled Medication Rule Violations described below may
only be committed by Covered Persons, but the Consequences for
Controlled Medication Rule Violations may apply to both the Covered
Person(s) who commit(s) the violation and any Covered Horse(s)
implicated by the violation.
(c) All Covered Persons are responsible for knowing what
constitutes a Controlled Medication Rule Violation and what Controlled
Medication Substances and what Controlled Medication Methods are
included on the Prohibited List and Technical Document-Prohibited
Substances.
Rule 3312. Presence of a Controlled Medication Substance
(a) It is the personal and non-delegable duty of the Responsible
Person to ensure that no Controlled Medication Substance is present in
the Post-Race Sample of his or her Covered Horse(s), and that no
Controlled Medication Substance specifically identified on the
Prohibited List as prohibited during Timed and Reported Workouts is
present in the Post-Work Sample of his or her Covered Horse(s). The
Responsible Person is therefore strictly liable for any Controlled
Medication Substance or its Metabolites or Markers found to be present
in a Post-Race Sample collected from his or her Covered Horse(s), and
for any specifically prohibited Controlled Medication Substance or its
Metabolites or Markers found to be present in a Post-Work Sample
collected from his or her Covered Horse(s). Accordingly, it is not
necessary to demonstrate intent, Fault, negligence, or knowing Use on
the part of the Responsible Person in order to establish that the
Responsible Person has committed a Rule 3312 Controlled Medication Rule
Violation.
(b) Sufficient proof of a Rule 3312 Controlled Medication Rule
Violation is established by any of the following:
(1) the presence of a Controlled Medication Substance or its
Metabolites or Markers in the Covered Horse's A Sample where the
Responsible Person waives analysis of the B Sample and the B Sample is
not analyzed;
(2) the Covered Horse's B Sample is analyzed and the analysis of
the B Sample confirms the presence of the Controlled Medication
Substance or its Metabolites or Markers found in the A Sample; or
(3) where, in exceptional circumstances, the Laboratory (on
instruction from the Agency) further splits the A or B Sample into two
parts in accordance with the Laboratory Standards, the analysis of the
second part of the resulting split Sample confirms the presence of the
same Controlled Medication Substance or its Metabolites or Markers as
were found in the first part of the split Sample, or the Responsible
Person waives analysis of the second part of the split Sample.
(c) The general rule is that the presence of any amount of a
Controlled Medication Substance or its Metabolites or Markers in a
Post-Race Sample or Post-Work Sample collected from a Covered Horse
constitutes a Controlled Medication Rule Violation by the Responsible
Person of that Covered Horse.
(d) As an exception to the general rule of Rule 3312(c), the
Prohibited List, Standards, or Technical Documents may establish
special criteria for the reporting or the evaluation of certain
Controlled Medication Substances, including a Minimum Reporting Level,
Screening Limit, Threshold, or Decision Limit.
(e) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and
corticosteroids, which are Controlled Medication Substances prohibited
during Timed and Reported Workouts and during the Race Period, are
subject to Screening Limits.
(1) If one NSAID or one corticosteroid is detected in the Post-Race
Sample or Post-Work Sample of a Covered Horse above the applicable
Screening Limit, it constitutes a presence violation under Rule 3312.
(2) If more than one NSAID or more than one corticosteroid is
detected in the Post-Race Sample or Post-Work Sample of a Covered
Horse, each NSAID and each corticosteroid above the applicable
Screening Limit constitutes a separate presence violation of Rule 3312.
(3) If more than one NSAID or more than one corticosteroid is
detected in the Post-Race Sample or Post-Work Sample of a Covered
Horse, but each are below the applicable Screening Limits (and so
individually would not constitute a presence violation), they will
together constitute a single presence violation under Rule 3312
(Stacking Violation).
Rule 3313. Use or Attempted Use of a Controlled Medication Substance or
a Controlled Medication Method During the Race Period
(a) Subject to Rule 3313(c), the Use or Attempted Use of a
Controlled Medication Substance or Controlled Medication Method in
relation to a Covered Horse during the Race Period constitutes a
Controlled Medication Rule Violation. The success or failure of that
Use or Attempted Use is not material. For a Rule 3313 violation to be
committed, it is sufficient that the Controlled Medication Substance or
Controlled Medication Method was Used or Attempted to be Used on a
Covered Horse during the Race Period.
(b) It is the personal and non-delegable duty of the Responsible
Person to ensure that no Controlled Medication Substance or Controlled
Medication Method is Used in relation to his or her Covered Horse
during the Race Period. The Responsible Person is therefore strictly
liable for any Use of a Controlled Medication Substance or Controlled
Medication Method in relation to his or her Covered Horse(s).
Accordingly, it is not necessary to demonstrate intent, Fault,
negligence, or knowing Use on the part of the Responsible Person in
order to establish that the Responsible Person has committed a Rule
3313 Controlled
[[Page 5110]]
Medication Rule Violation of Use. However, in accordance with the
definition of Attempt, it is necessary to show intent on the part of
the Responsible Person in order to establish that the Responsible
Person has committed a Rule 3313 Controlled Medication Rule Violation
of Attempted Use.
(c) Use of a Controlled Medication Substance or a Controlled
Medication Method outside the Race Period is not a Rule 3313 violation.
However, if a Controlled Medication Substance or any of its Metabolites
or Markers is still present in a Post-Race Sample or Post-Work Sample,
that constitutes a Rule 3312 (presence) violation.
Rule 3314. Use of a Controlled Medication Substance or a Controlled
Medication Method in a Manner Contrary to Horse Welfare
(a) Any Use of a Controlled Medication Substance or a Controlled
Medication Method in relation to a Covered Horse must (1) be justified
by the Covered Horse's health condition(s), (2) have been recommended
by a Veterinarian in the context of a valid veterinarian-patient-client
relationship or (if a prescription is not required) following
sufficient due diligence regarding the substance or method, (3) go no
further than the minimum necessary to address the health concerns, and
(4) be in the best interests of the Covered Horse's health and welfare.
(b) It is the personal and non-delegable duty of the Responsible
Person to ensure that no Controlled Medication Substance or Controlled
Medication Method is Used on his or her Covered Horse in breach of the
requirements set out in Rule 3314(a). The Responsible Person is
therefore strictly liable for a violation of this Rule 3314.
Accordingly, it is not necessary to demonstrate intent, Fault,
negligence, or knowing Use on the part of the Responsible Person in
order to establish that the Responsible Person has committed a Rule
3314 Controlled Medication Rule Violation.
Rule 3315. Other Controlled Medication Rule Violations Involving
Controlled Medication Substances or Controlled Medication Methods
The following acts and omissions constitute Controlled Medication
Rule Violations by the Covered Person(s) in question:
(a) The Administration or Attempted Administration of a Controlled
Medication Substance or Controlled Medication Method by a Covered
Person to a Covered Horse during the Race Period.
(b) The Possession of a Controlled Medication Substance or
Controlled Medication Method by any Covered Person that is not in
compliance with applicable State or Federal law.
(c) A Covered Person assisting, encouraging, aiding, abetting,
conspiring, covering up, or engaging in any other type of intentional
complicity or Attempted complicity involving (1) a Controlled
Medication Rule Violation or Attempted Controlled Medication Rule
Violation, or (2) a violation of Rule 3329 by another Covered Person.
Rule 3316. Tampering or Attempted Tampering With Medication Control
If the Agency establishes that a Covered Person committed a
violation of Tampering or Attempted Tampering in connection with a
Medication Control process, that will constitute an Anti-Doping Rule
Violation under Rule 3216(a), and the matter will be dealt with in
accordance with the procedures and Consequences applicable to Anti-
Doping Rule Violations.
3320. Sanctions
Rule 3321. Disqualification of the Covered Horse's Results
(a) Automatic Disqualification of results.
(1) A Controlled Medication Rule Violation that arises from a Post-
Race Sample, or that occurs during the Race Period, automatically leads
to Disqualification of the results of the Covered Horse obtained on the
Race Day(s) that fall(s) within the Race Period, even if any other
sanction for the violation is eliminated or reduced under Rules 3324,
3325, or 3326.
(2) In circumstances where an ECM Notice has been sent as required
under Rule 3345, and the B Sample analysis confirms the A Sample
analysis, or the right to request the analysis of the B Sample is
waived, the Agency, the Responsible Person, and the Owner of the
Covered Horse in question may agree to apply Rule 3321 immediately,
i.e., prior to adjudication of any other issue, or (in the absence of
such agreement) any one of them may request that the Internal
Adjudication Panel apply Rule 3321 immediately.
(b) No Disqualification of subsequent results.
Subsequent results obtained by the Covered Horse from the date a
Controlled Medication Rule Violation first occurred through the
commencement of any Provisional Suspension or Ineligibility period for
the Covered Horse shall not be Disqualified.
(c) Consequence of Disqualification of results.
(1) If a Covered Horse has results Disqualified under the Protocol,
all purses and other compensation, prizes, trophies, points, and
rankings are forfeited and must be repaid or surrendered (as
applicable) to the Race Organizer, and the results of the other Covered
Horses in the race(s) in question must be adjusted accordingly and the
purses, prizes, and trophies redistributed. Purses, prizes, trophies,
and other compensation shall (where possible) be withheld for the
Covered Horse in issue pending resolution of the relevant charge.
(2) The Covered Horses that participated in a Covered Horserace
involving an alleged Controlled Medication Rule Violation are often
entered in other Covered Horseraces prior to the final adjudication of
the violation. The ultimate Disqualification of a Covered Horse in
connection with final adjudication of a violation shall only impact
that horse's conditions for eligibility. By way of example, a maiden
that is Disqualified after finishing first in a maiden race shall
remain a maiden until it has won another race, but the runner-up in the
disputed Covered Horserace shall not be considered the winner for
purposes of its future condition eligibility. The adjustment to the
Disqualified horse's condition eligibility shall only occur once the
violation has been finally adjudicated.
Rule 3322. Ineligibility for Covered Horses
(a) There shall be no period of Ineligibility for Covered Horses
implicated in violations involving only Controlled Medication
Substances.
(b) There may be a period of Ineligibility for Covered Horses
implicated in violations involving Controlled Medication Methods. Where
the Prohibited List specifies a period of Ineligibility, it shall be
applied only prospectively (i.e., going forward from the date that it
is imposed), with no Disqualification of any results obtained by the
Covered Horse before the date that the period of Ineligibility starts
to run, other than as provided under Rule 3321(a)(1).
Rule 3323. Ineligibility and Financial Penalties for Covered Persons
(a) General.
(1) The periods of Ineligibility and financial penalties set out in
this Rule 3323 apply to any Controlled Medication Rule Violation
committed by a Covered Person. However:
(i) When determining if a Covered Person has committed multiple
[[Page 5111]]
violations, the following prior Controlled Medication Rule Violations
shall be disregarded: (A) violations that occurred more than 2 years
prior to the violation now being sanctioned; and (B) violations for
which the Covered Person was found to bear No Fault or Negligence.
(ii) A Controlled Medication Rule Violation will be considered a
second or subsequent violation only if the Covered Person committed an
offense in the same category/class in the previous 2 years. Violations
in different categories will be taken into account when assigning
penalty points under Rule 3328.
(iii) Unless specified otherwise, the periods of Ineligibility set
out in this Rule 3323 are subject to potential elimination, reduction,
or suspension pursuant to Rules 3324-3326, or increase pursuant to Rule
3327.
(2) In accordance with Rule 3347(j), any period of Provisional
Suspension served by the Covered Person shall be credited against the
period of Ineligibility ultimately imposed on that Covered Person for
the violation in question.
(3) If a presence violation involves a Controlled Medication
Substance that has not been assigned a Class A-C, the Agency shall
determine the class of the substance. Any supplements or feed additives
used in contravention of Rule 4211(a) of the Prohibited List that have
not been assigned a class shall be designated as Class C substances,
unless the Agency decides otherwise.
(4) If two or more Controlled Medication Rule Violations in the
same category/class are adjudicated separately, the first violation
adjudicated shall constitute the ``first violation'' for sanctioning
purposes, the second violation adjudicated shall constitute the
``second violation,'' and so on, regardless of the chronological order
in which those violations occurred.
(b) Consequences.
Subject to Rule 3323(a), and in addition to any other Consequences
that apply under the Protocol, the periods of Ineligibility, fines, and
Disqualification of results specified below shall apply to any Covered
Person who commits multiple Controlled Medication Rule Violations. The
Covered Person may also be required to pay some or all of the
adjudication costs and the Agency's legal costs.
----------------------------------------------------------------------------------------------------------------
Third or subsequent
Controlled medication rule violation First violation (within Second violation violation (within 2-
2-year period) (within 2-year period) year period)
----------------------------------------------------------------------------------------------------------------
Presence, Use or Attempted Use, or
Administration or Attempted
Administration of a Controlled
Medication Substance (Rules 3312,
3313, and 3315(a)):
Class A.......................... 60 days................ 90 days................ 120 days.
Fine of up to $5,000 or Fine of up to $10,000 Fine of up to $25,000
5% of the total purse or 10% of the total or 25% of the total
(whichever is greater). purse (whichever is purse (whichever is
greater). greater).
Automatic Automatic Automatic
Disqualification of Disqualification of Disqualification of
Race Day results (Rule Race Day results (Rule Race Day results (Rule
3321). 3321). 3321).
Class B.......................... 15 days................ 30 days................ 60 days.
Fine up to $1,000...... Fine up to $2,500...... Fine up to $5,000.
Automatic Automatic Automatic
Disqualification of Disqualification of Disqualification of
Race Day results (Rule Race Day results (Rule Race Day results (Rule
3321). 3321). 3321).
Class C.......................... ....................... 15 days................ 30 days.
Fine up to $500........ Fine up to $1,000...... Fine up to $2,500.
Automatic Automatic Automatic
Disqualification of Disqualification of Disqualification of
Race Day results (Rule Race Day results (Rule Race Day results (Rule
3321). 3321). 3321).
----------------------------------------------------------------------------------------------------------------
Note: Sanctions apply for each Controlled Medication Substance detected in the Sample.
A Stacking Violation shall be treated as a single violation for the purposes of sanctions.
----------------------------------------------------------------------------------------------------------------
Use or Attempted Use or 60 days................ 90 days................ 120 days.
Administration or Attempted Fine of up to $5,000 or Fine of up to $10,000 Fine of up to $25,000
Administration of a Controlled 5% of the total purse or 10% of the total or 25% of the total
Medication Method (Rule 3313). (whichever is greater). purse (whichever is purse (whichever is
Automatic greater). greater).
Disqualification of Automatic Automatic
Race Day results (Rule Disqualification of Disqualification of
3321). Race Day results (Rule Race Day results (Rule
3321). 3321).
Use of a Controlled Medication 60 days................ 90 days................ 120 days.
Substance or a Controlled Medication Fine of up to $5,000 or Fine of up to $10,000 Fine of up to $25,000
Method in a manner contrary to horse 5% of the total purse or 10% of the total or 25% of the total
welfare (Rule 3314). (whichever is greater). purse (whichever is purse (whichever is
greater). greater).
Possession of a Controlled Medication ....................... 15 days................ 30 days.
Substance/Method that is not in Fine up to $500........ Fine up to $1,000...... Fine up to $2,500.
compliance with applicable State or Referral to the Referral to the Referral to the
Federal law (Rule 3315(b)). relevant State or relevant State or relevant State or
Federal authority. Federal authority. Federal authority.
Complicity or Attempted complicity Same Consequences that Same Consequences that Same Consequences that
(Rule 3315(c)). apply to the principal apply to the principal apply to the principal
actor, absent actor, absent actor, absent
mitigating or mitigating or mitigating or
aggravating aggravating aggravating
circumstances. circumstances. circumstances.
----------------------------------------------------------------------------------------------------------------
(c) Commencement of the period of Ineligibility for a Covered
Person.
(1) Except as otherwise provided in this Rule 3323, the period of
Ineligibility imposed on any Covered Person shall start on the date the
period
[[Page 5112]]
of Ineligibility is accepted or otherwise imposed in accordance with
the Protocol.
(2) Where a Covered Person is already serving a period of
Ineligibility for another violation of the Protocol, any new period of
Ineligibility shall start to run the day after the original period of
Ineligibility ends.
(3) Where there have been substantial delays in the adjudication
process or other aspects of Medication Control that go well beyond the
standard timeframes for Laboratory analyses and Results Management, and
the Covered Person can establish that such delays are not attributable
to him or her, the start date of the period of Ineligibility may be
deemed back-dated to reflect such delays, but in no event may it be
deemed back-dated to a date before the Controlled Medication Rule
Violation last occurred.
(d) Additional rules for certain multiple violations.
(1) Multiple violations for the same Controlled Medication
Substance/Method incurred by a Covered Person in relation to the same
Covered Horse prior to delivery of an ECM Notice may (at the Agency's
discretion) be treated together as a single Controlled Medication Rule
Violation, unless the facts demonstrate that there was more than one
administration. Multiple violations for the same Controlled Medication
Substance/Method incurred by a Covered Person in relation to different
Covered Horses prior to delivery of an ECM Notice may each be treated
as a first Controlled Medication Rule Violation within the relevant
category/class. Where multiple Controlled Medication Substances are
detected in a single Post-Race Sample or Post-Work Sample, each
Controlled Medication Substance may be treated as a separate violation
and assigned separate penalty points.
(2) If the Agency establishes that prior to receiving an ECM Notice
in respect of one Controlled Medication Rule Violation the Covered
Person committed an additional Controlled Medication Rule Violation
that occurred 12 months or more before or after the violation asserted
in that ECM Notice, the period of Ineligibility for the additional
violation shall be calculated as if the additional violation were a
stand-alone first violation, and that period of Ineligibility will run
consecutively to (rather than concurrently with) the period of
Ineligibility imposed for the first-notified violation. Where this Rule
applies, the violations taken together will constitute a single
violation for purposes of Rule 3323(b).
(3) If the Agency establishes that the Covered Person has committed
a further violation of the Protocol during a period of Ineligibility,
any new period of Ineligibility shall start to run the day after the
original period of Ineligibility ends.
(e) Violations involving both a Banned Substance or Method and a
Controlled Medication Substance or Method.
Where a Covered Person is found, based on a common set of facts, to
have committed a (1) violation involving one or more Banned
Substance(s) or Banned Method(s), and (2) a violation involving one or
more Controlled Medication Substance(s) or Controlled Medication
Method(s), they shall be treated as separate violations, but shall be
adjudicated together in consolidated proceedings pursuant to the
procedure that applies to Anti-Doping Rule Violations under the
Arbitration Procedures.
Rule 3324. Elimination of the Period of Ineligibility Where There Is No
Fault or Negligence
(a) If a Covered Person establishes in an individual case that he
or she bears No Fault or Negligence for the Controlled Medication Rule
Violation(s) charged, the otherwise applicable period of Ineligibility
and other Consequences for such Covered Person shall be eliminated
(except for those set out in Rule 3321 and Rule 3620). When the
violation is of Rule 3312 (presence of a Controlled Medication
Substance), the Covered Person must also establish how the Controlled
Medication Substance entered the Covered Horse's system as a pre-
condition to application of this Rule 3324. In the event the period of
Ineligibility otherwise applicable is eliminated pursuant to this Rule
3324, the Controlled Medication Rule Violation shall not be considered
a prior violation for the purpose of Rule 3323(b).
(b) Rule 3324 only applies in exceptional circumstances. In
particular, it will not apply where the Controlled Medication Substance
found to be present in a Sample: (1) came from a mislabeled or
contaminated supplement; or (2) was administered to the Covered Horse
by veterinary or other support personnel without the knowledge of the
Responsible Person.
(c) A finding that the Covered Person bears No Fault or Negligence
for a Controlled Medication Rule Violation shall not affect the
Consequences of that violation that apply to the Covered Horse (i.e.,
Ineligibility in accordance with Rule 3322(b) and Disqualification of
results in accordance with Rule 3321).
Rule 3325. Reduction of the Period of Ineligibility Where There Is No
Significant Fault or Negligence (Limited to Class A/B or Equivalent)
This Rule applies only to Controlled Medication Rule Violations
involving Class A or Class B substances or a category of violation with
sanctions equivalent to Class A or Class B substances. Reductions under
this Rule 3325 are mutually exclusive and not cumulative, i.e., no more
than one of them may be applied in a particular case.
(a) General rule.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Controlled Medication Rule
Violation in question, then (unless Rule 3325(b) or 3325(c) applies)
the period of Ineligibility may be reduced, depending on the Covered
Person's degree of Fault, but the reduced period of Ineligibility may
not be less than one-half of the otherwise applicable period of
Ineligibility.
(b) Specified Substances.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Controlled Medication Rule
Violation in question, and the violation involves only a Specified
Substance, the period of Ineligibility shall be, at a minimum, a
reprimand and no period of Ineligibility, and, at a maximum, the
otherwise applicable period of Ineligibility, depending on the Covered
Person's degree of Fault.
(c) Contaminated Products or other contamination.
Where the Covered Person establishes that he or she bears No
Significant Fault or Negligence for the Controlled Medication Rule
Violation in question and that the Controlled Medication Substance in
question came from a Contaminated Product or from another form of
contamination, the period of Ineligibility shall be, at a minimum, a
reprimand and no period of Ineligibility, and, at a maximum, the
otherwise applicable period of Ineligibility, depending on the Covered
Person's degree of Fault.
Rule 3326. Elimination, Reduction, or Suspension of Period of
Ineligibility or Other Consequences for Reasons Unrelated to Degree of
Fault
(a) Substantial Assistance. The Agency may suspend all or part of
the Consequences imposed on a Covered Person in an individual
Controlled Medication Rule Violation case--other
[[Page 5113]]
than Disqualification of results pursuant to Rule 3321--based on the
following:
(1) The Covered Person provides Substantial Assistance to the
Agency, the Authority, or a State Racing Commission, a criminal
authority, or a professional disciplinary body that results in:
(i) the Agency discovering or bringing forward an Anti-Doping Rule
Violation or a Controlled Medication Rule Violation by another Covered
Person; or
(ii) a criminal or disciplinary body discovering or bringing
forward a sport-related criminal offense or the breach of professional
or sports rules by another Person, including offenses arising out of a
sport integrity violation or sport safety violation, or the violation
of any rule or requirement in the Act, and the information provided by
the Covered Person providing Substantial Assistance is also made
available to the Agency.
(2) The extent to which the otherwise applicable period of
Ineligibility may be suspended shall be based on the seriousness of the
Controlled Medication Rule Violation committed by the Covered Person
and the degree to which the Substantial Assistance provided by the
Covered Person assists the effort to promote doping-free racing,
compliance with the Protocol, or the integrity of racing. In any event,
no more than three-quarters of the otherwise applicable period of
Ineligibility may be suspended. For purposes of this Rule 3326, the
otherwise applicable period of Ineligibility shall not include any
period of Ineligibility that could be added under Rule 3323(d)(2).
(3) If so requested, the Agency shall allow the Covered Person who
seeks to provide Substantial Assistance to provide the information to
the Agency subject to a Without Prejudice Agreement.
(4) If the Covered Person fails to continue to cooperate or fails
to provide the complete, accurate, and credible Substantial Assistance
promised, the Agency shall reinstate the original Consequences. That
decision is not subject to review.
(b) Voluntary Admission of a Controlled Medication Rule Violation
in the absence of other evidence. If (1) the Covered Person voluntarily
admits the commission of a Controlled Medication Rule Violation before
receiving the ECM Notice or (in the case of a Rule 3312 violation)
before having received notice of a Sample collection that could
establish the Controlled Medication Rule Violation, and (2) that
admission is the only reliable evidence of the violation at the time
the admission is made, the otherwise applicable period of Ineligibility
may be reduced by up to one-half.
(c) Application of multiple grounds for reduction of a sanction. If
the Covered Person establishes entitlement to a reduction or suspension
of the period of Ineligibility under 2 or more of Rules 3324, 3325, or
3326, the otherwise applicable period of Ineligibility shall be
determined in accordance with Rules 3323, 3324, and 3325 before
applying any reduction or suspension under Rule 3326. If the Covered
Person establishes entitlement to a reduction or suspension of the
period of Ineligibility under Rule 3326, up to three-quarters of the
otherwise applicable period of Ineligibility may be reduced or
suspended.
(d) Reductions for certain Controlled Medication Rule Violations
based on early admission and acceptance of sanction. If the Covered
Person admits the violation and accepts the asserted period of
Ineligibility no more than 7 days after receiving the Charge Letter,
the period of Ineligibility to be served will be automatically reduced
by one-half (but no further reduction shall be allowed under any other
Rule).
Rule 3327. Aggravating Circumstances
(a) If the Agency establishes in an individual Controlled
Medication Rule Violation case that Aggravating Circumstances are
present, the period of Ineligibility otherwise applicable shall be
increased by up to 6 months depending on the seriousness of the
Aggravating Circumstances, unless the Covered Person establishes that
he or she did not knowingly commit the Controlled Medication Rule
Violation. Where the period of Ineligibility is increased pursuant to
this Rule, an additional fine of up to $5,000 or an additional 5% of
the total purse (whichever is greater) may also be imposed.
(b) Actions and circumstances constituting Aggravating
Circumstances include:
(1) Administration of a Controlled Medication Substance or Use of a
Controlled Medication Method that is detrimental to the health and
welfare of the horse or is designed to deceive the betting public;
(2) prior violations under the Protocol; or
(3) the Covered Person engaged in deceptive or obstructive conduct
to avoid the detection or adjudication of a Controlled Medication Rule
Violation, for which the Covered Person has not been separately
sanctioned for Tampering.
(c) For the avoidance of doubt, the examples set out in Rule
3327(b) are not exhaustive and other similar circumstances or conduct
may also be deemed to amount to Aggravating Circumstances that justify
the imposition of a longer period of Ineligibility.
Rule 3328. Penalty Points System for Multiple Controlled Medication
Rule Violations
(a) The penalty points system established in this Rule 3328 does
not replace or lessen in any way the Consequences that apply to the
underlying Controlled Medication Rule Violation. Rather, the penalty
points system is intended to apply additional uniform Consequences
where the Covered Person is a repeat offender and exceeds the
permissible number of points.
(b) Covered Persons shall be assigned penalty points as set out in
the table below for each Controlled Medication Rule Violation that they
commit. The imposition of the specified penalty points is automatic,
without any consideration of mitigating or aggravating circumstances,
except that:
(1) no points shall be assigned for any violations (i) where the
Covered Person was found to bear No Fault or Negligence, or (ii)
resulting from environmental contamination;
(2) fewer or no points may be assigned where the Covered Person
provides Substantial Assistance in accordance with Rule 3326; and
(3) the penalty points for a complicity or Attempted complicity
violation may be adjusted if there are mitigating or aggravating
circumstances.
------------------------------------------------------------------------
Controlled medication rule violation Penalty points
------------------------------------------------------------------------
Presence, Use or Attempted Use, or
Administration or Attempted
Administration of a Controlled Medication
Substance:
Class A............................... 3.
Class B............................... 2.
Class C............................... 1\1/2\.
------------------------------------------------------------------------
[[Page 5114]]
Note: Points are assigned for each Controlled Medication Substance
detected in the Sample. A Stacking Violation shall be treated as a
single violation.
------------------------------------------------------------------------
Use of a Controlled Medication Substance 3.
or a Controlled Medication Method in a
manner contrary to horse welfare.
Use or Attempted Use or Administration or 3.
Attempted Administration of a Controlled
Medication Method.
Possession of a Controlled Medication 1.
Substance or Controlled Medication Method
that is not in compliance with applicable
State or Federal law.
Complicity or Attempted complicity in a Same number of points that
Controlled Medication Rule Violation apply to the Responsible
committed by another Person. Person, absent mitigating
or aggravating
circumstances.
Violation of Rule 3329.................... Same number of points as
were assigned for the
underlying violation.
------------------------------------------------------------------------
(c) In addition to the Consequences applicable to the underlying
Controlled Medication Rule Violation, the following Consequences shall
be imposed based on the cumulative points contained in the Covered
Person's official record:
------------------------------------------------------------------------
Additional period
Cumulative penalty points of ineligibility
(days)
------------------------------------------------------------------------
6-7................................................. 30
7.5-9............................................... 60
9.5-12.............................................. 90
12.5 or more........................................ 180
------------------------------------------------------------------------
(d) Penalty points and the additional period of Ineligibility shall
be applied automatically at the conclusion of the proceeding on the
underlying violation, without any additional hearing or right of
review. Penalty points shall be applied retroactively to start on the
date on which the Controlled Medication Rule Violation occurred and
shall expire after 2 years.
(e) The additional period of Ineligibility imposed based on penalty
points shall run consecutive to any period of Ineligibility imposed for
the underlying Controlled Medication Rule Violation.
(f) A Covered Person's official record of cumulative penalty points
shall be maintained by the Agency.
Rule 3329. Status During Provisional Suspension or Ineligibility
(a) While serving a Provisional Suspension or period of
Ineligibility for a Controlled Medication Rule Violation:
(1) a Covered Horse may not participate in any Timed and Reported
Workout or Covered Horserace, but shall remain subject to Testing;
(2) a Covered Person may not participate in any capacity in any
activity involving Covered Horses, or in any other activity (other than
authorized anti-doping education or rehabilitation programs) taking
place at a Racetrack or Training Facility, nor shall he or she permit
anyone to participate in any capacity on his or her behalf in any such
activities, except to the extent that the Covered Person is an Owner
and the activity is necessary to ensure the safekeeping and wellbeing
of the horse during the period of such Owner's Provisional Suspension
or Ineligibility.
(b) The Covered Horse(s) of an Owner or Trainer who is subject to a
Provisional Suspension or period of Ineligibility shall be subject to
the following restrictions:
(1) The Covered Horse(s) of a Trainer who is subject to a
Provisional Suspension or period of Ineligibility may not participate
in any Timed and Reported Workout or Covered Horserace unless and until
they have been transferred to another Covered Person, except that such
Covered Horses may participate in a Covered Horserace if they were
entered in the race before the Trainer was notified of the Provisional
Suspension or the period of Ineligibility was imposed or accepted
(whichever is earlier). For the ``transfer'' to be valid, (i) the
transfer must be registered with the Authority in accordance with its
procedures, and (ii) if the Trainer is subject to a period of
Ineligibility of more than 30 days, the Covered Horses must also be
physically relocated to facilities under the care or control of a
Covered Person who is not affiliated with the suspended Trainer (and
failure to comply may constitute an Anti-Doping Rule Violation under
Rule 3216(c), i.e., Prohibited Association).
(2) The Covered Horse(s) of an Owner who is subject to a
Provisional Suspension or period of Ineligibility may not participate
in any Timed and Reported Workout or Covered Horserace unless and until
they have been transferred in a bona fide transaction to a different
Owner. If an Immediate Family Member has any ownership or property
interest in the Covered Horse(s) following such transfer, the transfer
shall not constitute a bona fide transaction to a different Owner.
Rule 3330. Consequences for Violation of the Prohibition on
Participation During Ineligibility or Provisional Suspension Under Rule
3329
(a) Consequences for violation of the prohibition on participation
during Ineligibility.
(1) If a Covered Person violates the prohibition against
participation during Ineligibility described in Rule 3329, any results
obtained from such participation shall be Disqualified and a new period
of Ineligibility equal in length to the original period of
Ineligibility shall be added to the end of the Covered Person's
original period of Ineligibility.
(2) If a Covered Horse participates in any Timed and Reported
Workout or Covered Horserace in violation of the prohibition against
participation during Ineligibility described in Rule 3329, any results
obtained from such participation shall be Disqualified, and the
Responsible Person for that Covered Horse shall receive the following
period of Ineligibility:
(i) if the Responsible Person was subject to an original period of
Ineligibility, a new period of Ineligibility equal in length to the
original period of Ineligibility shall be added to the end of the
original period of Ineligibility. If the original period of
Ineligibility has already expired, the new period of Ineligibility
shall start on the date that it is accepted or imposed; or
(ii) if the Responsible Person was not subject to an original
period of Ineligibility, the period of Ineligibility for violating Rule
3329 shall be from a reprimand to 1 year, depending on the Covered
Person's degree of Fault.
(b) Consequences for violation of the prohibition on participation
during Provisional Suspension.
(1) A Covered Person who violates the prohibition against
participation during a Provisional Suspension shall receive no credit
for any period of Provisional
[[Page 5115]]
Suspension served and the results of such participation shall be
Disqualified.
(2) If a Covered Horse participates in any Timed and Reported
Workout or Covered Horserace in violation of the prohibition against
participation during a Provisional Suspension described in Rule 3329,
the Responsible Person for that Covered Horse and the Covered Horse
shall receive no credit for any period of Provisional Suspension served
and the results of such participation shall be Disqualified.
(c) The consequence of Disqualification under this Rule 3330 shall
be the same as set out in Rule 3321(c).
(d) The Internal Adjudication Panel (or the Agency, if the Covered
Person admits the violation and accepts the consequences) shall
determine whether there has been a violation of the prohibition against
participation during Provisional Suspension or Ineligibility and apply
the appropriate consequences pursuant to Rule 3361.
Rule 3331. Automatic Public Disclosure
A mandatory part of each sanction shall include automatic Public
Disclosure in accordance with Rule 3620.
Rule 3332. Conditions Precedent to Reinstatement for Covered Persons
(a) To be reinstated after commission of a Controlled Medication
Rule Violation, the Covered Person must have respected his or her
period of Ineligibility (Rule 3329); and repaid or surrendered any
purses and other compensation, prizes, trophies, points, and rankings
forfeited pursuant to Rule 3321, and paid any fines and reimbursed any
costs imposed or accepted to the Agency, unless an installment plan was
established pursuant to Rule 3332(b), in which case the Covered Person
must have made all payments due under that plan. If any installment(s)
subsequently become(s) overdue under that plan (i.e., after
reinstatement), the Covered Person and the Covered Horses under his or
her ownership or training may not participate in any Timed and Reported
Workout or Covered Horserace until such overdue installment(s) is/are
paid in full.
(b) Where fairness requires, the Agency or the Internal
Adjudication Panel may establish an installment plan for repayment of
amounts due to be paid or reimbursed under the Protocol. The payment
schedule may extend beyond any period of Ineligibility imposed upon the
Covered Person.
Rule 3333. Conditions Precedent to Reinstatement for Covered Horses
(a) A Covered Horse shall be reinstated once its period of
Ineligibility ends, provided that (1) the Ineligibility has been
respected in full throughout that period in accordance with Rule 3329,
(2) the Covered Horse has been made available for Testing during that
period in accordance with Rule 3132(d), and (3) the Covered Horse has
completed any Vets' List Workout(s) required by the Racetrack Safety
Program or the Agency (for the avoidance of doubt, such workouts may be
scheduled prior to the expiry of the period of Ineligibility and will
not constitute a violation of Rule 3329).
(b) Any reinstatement pursuant to this Rule 3333 is without
prejudice to any rest or stand down period that may be imposed on the
Covered Horse (e.g., due to injuries), and any requirements for release
from the Veterinarians' List, pursuant to the Racetrack Safety Program.
3340. Results Management
Rule 3341. General
Where there is evidence of a potential Controlled Medication Rule
Violation(s), the Agency will conduct Results Management in accordance
with this section 3340 and the Testing and Investigations Standards.
Rule 3342. Review of Adverse Analytical Findings
(a) Upon receipt of an Adverse Analytical Finding in relation to an
A Sample, the Agency will conduct a review of the Laboratory
certificate of analysis supporting the Adverse Analytical Finding and
the relevant Sample collection documentation and Testing documents to
determine whether the Adverse Analytical Finding was caused by any
apparent departure from the Testing and Investigations Standards, the
Laboratory Standards, or any provision of the Protocol. Subject to Rule
3342(b), the Agency may, but does not have to, communicate with the
Responsible Person and Owner during such review.
(b) If the review under Rule 3342(a) reveals an apparent departure
that caused the Adverse Analytical Finding, the entire test shall be
considered negative, and the Agency shall promptly inform the
Responsible Person and each Interested Party of that fact.
(c) If the initial review of an Adverse Analytical Finding under
Rule 3342(a) does not reveal an apparent departure that caused the
Adverse Analytical Finding, the Agency shall promptly send an ECM
Notice to the Responsible Person and each Interested Party in
accordance with Rule 3345.
Rule 3343. Review of Atypical Findings Relating to Controlled
Medication Substances
(a) In certain circumstances, Laboratories may report the presence
of certain Controlled Medication Substances as ``Atypical Findings'' in
accordance with the Atypical Findings Policy set out at Appendix 1.
Upon receipt of an A Sample Atypical Finding, the Agency will conduct a
review to determine whether the Atypical Finding was caused by a
departure from the Testing and Investigations Standards, the Laboratory
Standards, or any provision of the Protocol. If that review does not
reveal any departure that caused the Atypical Finding, the Agency will
conduct an investigation (including directing any Further Analysis) or
take any other steps required to decide whether the Atypical Finding
should be brought forward as an Adverse Analytical Finding, in
accordance with the Atypical Findings Policy.
(b) The Agency may, but does not have to, provide notice of an
Atypical Finding to anyone until it has made that decision unless one
of the following circumstances exists:
(1) if the Agency determines that the B Sample should be analyzed
prior to the conclusion of its investigation, the Agency may conduct
the B Sample analysis after notifying the Responsible Person and the
Owner, with such notice to include a description of the Atypical
Finding and the information described in Rule 3345; or
(2) if the Atypical Finding is likely connected to a serious
pathology that requires urgent veterinary attention.
(c) If the Agency ultimately decides not to pursue the Atypical
Finding as an Adverse Analytical Finding, the Agency may, but does not
have to, communicate that fact to the Responsible Person and Owner
unless he or she has previously received notice of the Analytical
Finding pursuant to Rule 3343(b).
(d) If the Agency decides to move forward with the matter as an
Adverse Analytical Finding, the Agency shall promptly send an ECM
Notice to the Responsible Person and each Interested Party.
Rule 3344. Review of Other Evidence of a Potential Controlled
Medication Rule Violation
The Agency shall conduct any follow-up investigation required into
any potential Controlled Medication Rule Violation not covered by Rules
3342 or 3343. At such time as the Agency is
[[Page 5116]]
satisfied that it has sufficient evidence to establish that a
Controlled Medication Rule Violation occurred, it shall promptly send
an ECM Notice to the relevant Covered Person and each Interested Party.
Rule 3345. ECM Notice
(a) Where it is determined that a Covered Person may have committed
one or more Controlled Medication Rule Violations, the Agency will
promptly notify the Covered Person and each Interested Party in writing
of the following (the ECM Notice):
(1) the alleged Controlled Medication Rule Violation and the
Consequences if it is agreed or determined to have been committed;
(2) the Adverse Analytical Finding (with a copy of the Laboratory
certificate of analysis in a form designated by the Agency) or a brief
summary of the facts relied on by the Agency to assert the alleged
violation (including, where applicable, the name of the Covered Horse
implicated in the alleged violation, whether the alleged violation was
in connection with a particular Covered Horserace, and the date of
Sample collection or of the other relevant facts said to give rise to
the violation);
(3) if applicable, the right of the Responsible Person and the
Owner to receive copies of the A Sample Laboratory Documentation
Package after the B Sample analysis has been completed or after such
analysis is waived;
(4) if applicable, the following details regarding the B Sample
analysis:
(i) that the B Sample has been (or will be) analyzed because the
Agency has authorized immediate analysis to preserve the scientific
integrity of the Sample;
(ii) if the B Sample has not been analyzed, the Responsible
Person's and Owner's right to promptly request the analysis of the B
Sample within no more than 5 days or (failing such request) that the B
sample analysis shall be deemed to be waived;
(iii) an explanation that where the Responsible Person or Owner
requests the B Sample analysis within the applicable deadline, or where
the Agency decides to proceed with the B Sample analysis, the Agency
will notify the Responsible Person and Owner of the date, time, and
place where the B Sample will be analyzed and (where the analysis is
requested by the Responsible Person or Owner) the amount that the
Responsible Person or Owner must pay to have the B Sample tested and B
Sample Laboratory Documentation Package prepared, and the date by which
such payment must be received, failing which the B Sample analysis
shall be deemed to have been waived; and
(5) the opportunity for the Covered Person to provide an
explanation within a short deadline set by the Agency;
(6) the opportunity to provide Substantial Assistance, to admit the
Anti-Doping Rule Violation, or to seek to resolve the matter without a
hearing under Rule 3349;
(7) all relevant details relating to any Provisional Suspension
(including, if applicable, the possibility to accept a voluntary
Provisional Suspension) in accordance with Rule 3347; and
(8) if applicable, the ability for the automatic Disqualification
of results to be applied immediately in accordance with Rule
3321(a)(2).
(b) Before sending an ECM Notice, for purposes of Rule 3323, the
Agency shall seek to determine whether the Covered Person in question
has committed any prior violations under the Protocol.
(c) Any defect in the ECM Notice (including a failure to identify
the Covered Horseraces implicated in the alleged violation, if any) may
be corrected by the Agency and shall not in any event invalidate the
ECM Notice or affect the due application of the provisions of the
Protocol (including the Disqualification provisions) in relation to
that violation.
Rule 3346. B Sample Analysis
(a) Arrangements shall be made for analysis of the B Sample without
undue delay, in accordance with the Protocol and the Laboratory
Standards. Subject to Rule 3346(b), the Responsible Person or Owner
must pay the costs of the B Sample analysis in advance, but, if the B
Sample analysis does not confirm the A Sample analysis, they will be
reimbursed that cost by the Agency. The Responsible Person and Owner
and one representative each may attend the Laboratory to witness the
opening and identification of the B Sample. They do not have any right
to witness the analysis of the B Sample.
(b) The Responsible Person and Owner may (if they both agree) waive
analysis of the B Sample (in which case they shall be deemed to accept
the A Sample analytical results). If waived, the Agency may nonetheless
elect to proceed with the B Sample analysis at its own expense.
(c) If the B Sample proves negative, the entire Test shall be
considered negative, and the Responsible Person and Owner shall be so
informed. In such circumstances, unless the Agency asserts a Controlled
Medication Rule Violation under Rules 3313 or 3314 (Use), the ECM
Notice will be withdrawn, any Provisional Suspensions imposed shall be
deemed automatically vacated with immediate effect (without the need
for any order from the Internal Adjudication Panel), and no further
disciplinary action will be taken against the Responsible Person, other
Covered Person, or Covered Horse by the Agency in relation to the
original Adverse Analytical Finding (provided, however, that the Agency
may investigate why the B Sample did not match the A Sample). If the
Agency asserts that a Rule 3313 or 3314 (Use) violation has occurred,
it shall send a Charge Letter to the Responsible Person and other
Covered Person(s), with a copy to each Interested Party.
(d) If the presence of a Controlled Medication Substance or the Use
of a Controlled Medication Method is confirmed by the B Sample
analysis, or the B Sample analysis is waived, the Agency shall send a
Charge Letter to the Responsible Person and any other relevant Covered
Person(s), with a copy to each Interested Party, asserting that a Rule
3312 (presence) violation or a Rule 3313 (Use) violation (as
applicable) has occurred.
Rule 3347. Provisional Suspensions
(a) The Agency shall not impose a Provisional Suspension on a
Covered Horse for a Controlled Medication Rule Violation, unless the
violation involves a Controlled Medication Method for which the
Prohibited List specifies a period of Ineligibility.
(b) The Agency may impose a Provisional Suspension on a Covered
Person for a Controlled Medication Rule Violation where it considers it
appropriate to do so in the circumstances of the case, including where
(1) the Covered Person admits the Controlled Medication Rule Violation
and is likely to be subject to a period of Ineligibility, (2) there is
an Adverse Analytical Finding for more than one Controlled Medication
Substance and those substances are not Specified Substances, (3) the
Covered Person has a pending Anti-Doping Rule Violation or Controlled
Medication Rule Violation or prior violation that is likely to result
in an increased period of Ineligibility, or (4) the individual
represents a threat to the health, safety, or welfare of horses or the
integrity of the sport of horseracing.
(c) Where a Provisional Suspension is imposed pursuant to Rule
3347(a) or (b), the Responsible Person (on his or her own behalf and on
behalf of the Covered Horse) and any other Covered Person made subject
to the Provisional Suspension shall be given:
[[Page 5117]]
(1) an opportunity for a Provisional Hearing before imposition of
the Provisional Suspension;
(2) an opportunity for a Provisional Hearing on a timely basis
after imposition of the Provisional Suspension; or
(3) an opportunity for an expedited final adjudication in
accordance with Rule 3362 on a timely basis after imposition of the
Provisional Suspension.
(d) Provisional Hearings shall be conducted by the Internal
Adjudication Panel and heard via telephone or video conference call
within the time frame specified in accordance with the Arbitration
Procedures, except where the Internal Adjudication Panel decides to
determine the matter based solely on the written submissions without a
hearing. The sole issue to be determined by the Internal Adjudication
Panel will be whether the Agency's decision to impose a Provisional
Suspension shall be maintained. The Agency's decision to impose a
Provisional Suspension shall be maintained unless the Responsible
Person/Covered Person requesting the lifting of the Provisional
Suspension establishes that:
(1) the allegation that a Controlled Medication Rule Violation has
been committed has no reasonable prospect of being upheld, e.g.,
because of a material defect in the evidence on which the allegation is
based;
(2) the Responsible Person/Covered Person charged bears No Fault or
Negligence for the Controlled Medication Rule Violation that is alleged
to have been committed, so that any period of Ineligibility that might
otherwise be imposed for such offense would be completely eliminated by
application of Rule 3324. (This ground does not apply in respect of any
Provisional Suspension imposed on a Covered Horse);
(3) Rule 3325 applies and the Responsible Person/Covered Person
bears No Significant Fault or Negligence and he or she will likely be
given a period of Ineligibility that is not longer than the period for
which he or she has already been provisionally suspended. (This ground
does not apply in respect of any Provisional Suspension imposed on a
Covered Horse); or
(4) exceptional circumstances exist that make it clearly unfair,
taking into account all of the circumstances of the case, to impose a
Provisional Suspension prior to the final hearing on the merits. This
ground is to be construed narrowly and applied only in truly
exceptional circumstances. For example, the fact that the Provisional
Suspension would prevent the Responsible Person, Covered Person, or
Covered Horse from participating in a particular Timed and Reported
Workout, Covered Horserace, or other activity shall not qualify as
exceptional circumstances for these purposes.
(e) If the application is made before the Provisional Suspension
comes into effect, the Provisional Suspension will not come into effect
pending the decision on the application. If the application is made
after the Provisional Suspension has come into effect, the Provisional
Suspension will remain in place pending the decision on the
application.
(f) If it considers it appropriate to do so on the specific facts
of the case, the Agency may lift the Provisional Suspension.
(g) If the application to have a Provisional Suspension not
imposed/lifted is not granted, a further application may not be made to
lift the Provisional Suspension unless: (1) it is based on new and
material evidence that the Responsible Person or other Covered Person
was not aware of and could not reasonably have been aware of at the
time he or she made the original application; or (2) there has been
some other significant and material change in circumstances since the
original application was decided. If the Responsible Person or other
Covered Person makes a further application that does not meet either of
these requirements, costs may be awarded against him or her.
(h) Voluntary Provisional Suspension.
(1) In all cases where a Responsible Person/Covered Person has been
notified of or charged with a Controlled Medication Rule Violation, but
no Provisional Suspension has been imposed on him or her or on the
Covered Horse, that person may (on his or her own behalf and, if the
Responsible Person, on behalf of the Covered Horse where it might be
subject to a period of Ineligibility), voluntarily accept a Provisional
Suspension at any time by written notice to the Agency. A copy of the
voluntary Provisional Suspension shall promptly be provided to each
Interested Party.
(2) A Provisional Suspension that is voluntarily accepted will have
effect (in the same manner as if the Provisional Suspension had been
imposed under Rule 3347(a)) from the date that written notice of its
acceptance is received by the Agency.
(i) No admission will be inferred, or other adverse inference
drawn, from the decision of a Covered Person: (1) not to make an
application to lift a Provisional Suspension; or (2) to accept a
voluntary Provisional Suspension.
(j) If a Provisional Suspension is imposed or voluntarily accepted,
and that Provisional Suspension is respected, then the Responsible
Person/Covered Person and Covered Horse in question shall receive a
credit for such period of Provisional Suspension against any period of
Ineligibility that may ultimately be imposed. If the Responsible
Person/Covered Person or Covered Horse does not respect a Provisional
Suspension, the Responsible Person/Covered Person or Covered Horse
shall receive no credit for any period of Provisional Suspension
served. If a period of Ineligibility is served pursuant to a decision
that is subsequently subject to review, the Responsible Person/Covered
Person or Covered Horse shall receive a credit for such period of
Ineligibility served against any period of Ineligibility that may
ultimately be imposed on review.
(k) Notwithstanding any other provision in this Rule 3347 or
elsewhere in the Protocol, any Provisional Suspension imposed on a
Covered Horse will be automatically lifted (without the need for any
hearing) if it has been in place for a period equal to the period of
Ineligibility specified in the Protocol or Prohibited List.
Rule 3348. Charge Letter
If, after receipt of the Covered Person's explanation, or expiry of
the deadline to provide such explanation, the Agency remains satisfied
that the Covered Person has committed a Controlled Medication Rule
Violation(s), the Agency shall promptly charge the Covered Person with
the asserted Controlled Medication Rule Violation(s). In this letter of
charge (Charge Letter), which will be copied to each Interested Party,
the Agency shall:
(a) set out the Controlled Medication Rule Violation(s) that the
Covered Person is charged with having committed;
(b) provide a summary of the relevant facts upon which the charge
is based, enclosing a copy of the A Sample Laboratory Documentation
Package and (if applicable and if requested) the B Sample Laboratory
Documentation Package;
(c) specify the Consequences that will apply if the charge is
upheld;
(d) grant a deadline of not more than 7 days from receipt of the
Charge Letter (unless otherwise agreed by the Agency) for the Covered
Person to either:
(1) admit the Controlled Medication Rule Violation(s) charged and:
(i) accept the Consequences proposed by the Agency, in which case
the Agency will issue a decision under Rule 3349,
[[Page 5118]]
(ii) seek to agree mitigated Consequences with the Agency pursuant
to Rule 3349 failing which the Consequences may still be disputed at a
hearing; or
(iii) dispute or seek to mitigate the proposed Consequences at a
hearing in accordance with Rule 3361 and the Arbitration Procedures; or
(2) deny the Controlled Medication Rule Violation charged and
dispute the proposed Consequences at a hearing in accordance with Rule
3361 and Arbitration Procedures;
(e) indicate that if the Covered Person does not challenge the
Agency's assertion of a Controlled Medication Rule Violation or the
proposed Consequences within the prescribed deadline, the Covered
Person shall be deemed to have waived his or her right to a hearing,
admitted the Controlled Medication Rule Violation(s) charged, and
accepted the Consequences specified by the Agency in the Charge Letter
(without any mitigation of those Consequences);
(f) give the opportunity to provide Substantial Assistance in
accordance with Rule 3326(a); and
(g) provide all relevant details relating to any Provisional
Suspensions (including, if applicable, the possibility to accept a
voluntary Provisional Suspension) in accordance with Rule 3347.
Rule 3349. Case Resolution Without a Hearing
(a) At any time prior to a final decision under the Arbitration
Procedures: (1) the Agency may withdraw a Charge Letter for good cause,
in which case any Provisional Suspension will be automatically lifted
and (absent the emergence of new information) no further steps will be
taken in relation to the violations alleged in the Charge Letter; or
(2) the Covered Person may agree to admit the Controlled Medication
Rule Violation(s) charged (or any other violation of the Protocol) and
accede to specified Consequences consistent with the Protocol. In any
such case, an adjudication under the Arbitration Procedures will not be
required.
(b) In the event that the Covered Person admits the Controlled
Medication Rule Violation(s) charged and accedes to Consequences
specified by the Agency (or is deemed to have done so in accordance
with Rule 3348(a)(5)), the Agency will (1) promptly issue a final
decision confirming the commission of the Controlled Medication Rule
Violation(s) and setting out the factual basis for the decision and all
of the Consequences to be imposed (including a brief summary of the
reasons for any period of Ineligibility imposed, unless doing so could
compromise an ongoing investigation or proceeding), and (2) send notice
of the decision to each Interested Party. The Agency will also Publicly
Disclose the decision (or a summary thereof, at the discretion of the
Agency) in accordance with Rule 3620.
(c) In the event that the Agency withdraws the Charge Letter, it
will (1) promptly issue a summary decision confirming the withdrawal of
the Charge Letter, (2) send notice of the decision to the Covered
Person concerned, with a copy to each Interested Party, and (3)
Publicly Disclose the decision (or a summary thereof, at the discretion
of the Agency) in accordance with Rule 3620.
Rule 3350. Notification Requirements
(a) Notification of Controlled Medication Rule Violations will take
place as set out in Rule 3345 and Rule 3348. If at any point after an
ECM Notice has been provided the Agency decides not to move forward
with the charge, it will notify the Covered Person(s) concerned and
each Interested Party of that decision.
(b) Notification to a Covered Person by the Agency, for all
purposes of the Protocol, may be accomplished either through actual or
constructive notice. Actual notice may be accomplished by any means.
Constructive notice shall be deemed to have been given when the
information in question is delivered by third-party courier or U.S.
postal mail to the Covered Person's most recent mailing address on file
with the Authority or by email or text message to the Covered Person's
most recent email address or mobile telephone number on file with the
Authority.
3360. Hearings and Review of Final Decisions
Rule 3361. Procedure Before the Internal Adjudication Panel
Where a Covered Person is alleged to have committed a Controlled
Medication Rule Violation, a violation of Rule 3329, or any violation
of Rule 3510, the Covered Person shall be entitled to request a hearing
before the Internal Adjudication Panel in accordance with the
Arbitration Procedures. However, the Internal Adjudication Panel may
decide, in its sole discretion, to determine the matter based solely on
the written submissions without a hearing if the Internal Adjudication
Panel considers itself sufficiently well-informed to render a decision
on the written submissions alone. A copy of the final decision of the
Internal Adjudication Panel shall be sent to the Agency and the Covered
Person(s) concerned. Where the Agency considers it necessary or
appropriate to do so, a copy of the decision may be sent to any
Interested Party. The decision (or a summary thereof, at the discretion
of the Agency) shall be Publicly Disclosed as provided in Rule 3620.
The Internal Adjudication Panel may also adjudicate any other matter
referred to it under the Protocol, and any other matter that might
arise from time to time under the Protocol that the Agency considers
should be determined by the Internal Adjudication Panel.
Rule 3362. Expedited Hearing
In Controlled Medication Rule Violation cases where the Covered
Horse or Covered Person in question is not Provisionally Suspended and
is likely to participate in a Covered Horserace within 45 days, the
Agency may (if it sees fit) address the case on an expedited basis and
shorten any deadlines in the Protocol or Arbitration Procedures
proportionately to ensure resolution of the matter prior to the Covered
Horserace.
Rule 3363. Finality
Subject to Rule 3364, decisions rendered by the Internal
Adjudication Panel under the Protocol shall be final and binding.
Rule 3364. Review of Final Decisions
Any final decision by the Agency or the Internal Adjudication Panel
is subject to review in accordance with section 3058 of the Act. Any
final decision under review shall remain in effect pending resolution
of the review unless ordered otherwise.
3500. Other Violations
Rule 3510. Other Violations Under the Protocol
Where a Covered Person:
(a) engages in disruptive or offensive conduct towards a Doping
Control official or other Person involved in Doping Control that does
not rise to the level of Tampering;
(b) refuses or fails to cooperate promptly and completely with the
Authority or the Agency in the exercise of their respective powers
under the Act and the Protocol and related rules, including any refusal
or failure to comply with Rule 3040(a)(2);
(c) commits a Whereabouts Failure; or
(d) refuses or fails without compelling justification to comply
with any other provision of the Protocol (where such refusal or failure
does not constitute an Anti-Doping Rule Violation);
[[Page 5119]]
the Covered Person will not be deemed to have committed an Anti-Doping
Rule Violation or Controlled Medication Rule Violation. However,
disciplinary proceedings may be brought against him or her before the
Internal Adjudication Panel in accordance with the Arbitration
Procedures or resolved without a hearing applying the rules of proof
set out in Rule 3120 and following the procedures set out in section
3360 (in each case, mutatis mutandis, i.e., amended as required to
reflect the different context). The Agency will send the Covered Person
at issue a notice of the alleged violation, setting out a summary of
the relevant facts upon which the charge is based, and giving the
Covered Person the opportunity to provide an explanation within a short
deadline. If the Internal Adjudication Panel finds the violation
alleged to be proven, or if the Covered Person admits the violation
alleged and does not request a hearing to determine the consequences,
the Internal Adjudication Panel or the Agency (as applicable) may
impose sanctions on Covered Persons as set out in Rule 3520.
Rule 3520. Sanctions for Other Violations Under the Protocol
(a) For a violation of Rule 3510(a) (disruptive or offensive
conduct), the Covered Person shall be subject to, at a minimum, a
reprimand and no period of Ineligibility, and, at a maximum, 30 days of
Ineligibility, depending on the seriousness of the violation. A fine of
up to $5,000 may also be imposed.
(b) For a violation of Rule 3510(b) (refusal or failure to
cooperate), the Covered Person shall be subject to, at a minimum, a
reprimand and no period of Ineligibility, and, at a maximum, a period
of Ineligibility of up to 2 years, depending on the seriousness of the
violation. A fine of up to $15,000 may also be imposed. A failure to
comply with Rule 3040(b)(7) will be considered a particularly serious
violation that will ordinarily warrant the imposition of the maximum
sanction.
(c) For a violation of Rule 3510(c) (Whereabouts Failures), the
Covered Person shall not be subject to any penalty for the first
Whereabouts Failure, but shall be subject to a fine of $250 for the
second Whereabouts Failure, and a fine of $500 for the third
Whereabouts Failure. For any subsequent Whereabouts Failures, the fine
will increase by $500 each time (i.e., $1,000 for the fourth failure,
$1,500 for the fifth failure, etc.).
(d) For a first violation of Rule 3510(d) (refusal or failure to
comply with any other provision of the Protocol), the Covered Person
shall be subject to, at a minimum, a reprimand and no period of
Ineligibility, and, at a maximum, 30 days of Ineligibility, as well as
a fine of up to $2,500, depending on the seriousness of the violation.
(e) For any second or subsequent Rule 3510 violation, the maximum
potential Ineligibility and potential fine will be double what the
maximum potential Ineligibility and potential fine was for the previous
violation.
(f) Where a violation of Rule 3510 is alleged and the Covered
Person represents a threat to the health, safety, or welfare of horses
or the integrity of the sport of horseracing, the Agency may impose a
Provisional Suspension on the Covered Person concerned pending
resolution of the charge. The Covered Person may challenge the
Provisional Suspension in accordance with Rule 3347 (which shall apply
mutatis mutandis, i.e., amended as required to reflect the different
context).
3600. Confidentiality and Reporting
Rule 3610. Notice of Violations and Confidentiality
(a) Notice.
(1) Notice of Anti-Doping Rule Violation or Controlled Medication
Rule Violations shall be sent to the Covered Persons concerned, with a
copy to each Interested Party, as set out in Rules 3245/3248 and 3345/
3348.
(2) Notice of other violations shall be sent to the Covered Persons
concerned. The Agency may send a copy to any Interested Party where it
considers it necessary or appropriate to do so in the circumstances.
(3) State Racing Commissions shall only be entitled to receive
notice of violations of the Protocol as Interested Parties if they
first enter into an agreement with the Agency incorporating
confidentiality provisions required by the Agency pursuant to the Act
or the Protocol. The Agency may, in its sole discretion, delay notice
to the State Racing Commission for case- or investigation-related
reasons.
(b) Confidentiality and public reporting.
(1) Subject to the other provisions of this paragraph (b), the
Agency will use its reasonable endeavors to ensure that Persons under
its control do not publicly identify Covered Horses or Covered Persons
who are alleged to have committed a violation under the Protocol,
unless and until (i) in presence cases, the B Sample confirms the
results of the A Sample analysis, or the B Sample analysis is waived,
(ii) a Provisional Suspension has been imposed or voluntarily accepted,
(iii) a charge has been brought, or (iv) a violation has been admitted,
whichever is earlier.
(2) In such circumstances, subject to paragraph (3) below, the
Agency shall publicly report:
(i) the identity of any Covered Person who is the subject of the
alleged violation;
(ii) the identity of any relevant Covered Horse(s); and
(iii) the rule violated and, where appropriate, the basis of the
asserted violation.
(3) The Agency shall not be required to publicly report a matter
under this paragraph (b) if it would risk compromising an ongoing
investigation or proceeding. When the Agency determines that an ongoing
investigation or proceeding will no longer be compromised by public
reporting, the Agency shall at such time make any public reporting
required under this Rule.
(4) The mandatory public reporting under Rule 3610(b) shall not be
required where the Covered Person who is alleged to have committed a
violation is a Minor. Any optional public reporting in a case involving
a Minor shall be proportionate to the facts and circumstances of the
case.
(5) If at any time information pertaining to an alleged violation
is publicly reported by a Person not affiliated with the Authority or
the Agency, the Agency may respond to such public comment as it
considers necessary.
(6) The Agency may publicly report any relevant information at any
time, including prior to delivery of notice of a violation, if the
Agency determines that such disclosure:
(i) concerns a violation or circumstance that poses a serious and
imminent risk of harm to any Covered Person(s), Covered Horse(s), State
Racing Commission(s), Racetrack(s), Race Organizer(s), Training
Facilities, or the public; or
(ii) is otherwise in the best interest of horseracing conducted at
Covered Horseraces.
(7) The Agency may at any time disclose to other Persons such
information as the Agency considers necessary or appropriate to
facilitate administration or enforcement of the Protocol (including
Interested Parties and other Persons with a need to know), provided
that each Person provides assurance satisfactory to the Agency that the
organization will maintain all such information in confidence.
(8) Interested Parties and other Persons may not publicly report
any information about an alleged violation unless the information has
been
[[Page 5120]]
publicly reported by the Agency or the Covered Person(s) concerned, or
the Agency gives written authorization for him or her to publicly
report the information.
Rule 3620. Public Disclosure
(a) The Agency shall Publicly Disclose the resolution of an alleged
violation of the Protocol no later than 20 calendar days after:
(1) the final decision;
(2) a resolution between the Agency and the Covered Person; or
(3) the withdrawal of a charge or a final decision finding of no
violation.
(b) Public Disclosure shall include:
(1) the name of the Covered Person who committed the violation(s)
and any Covered Horse(s) implicated by the violation;
(2) the Rule(s) violated;
(3) the Prohibited Substance(s) or Prohibited Method(s) involved,
if any;
(4) the Consequences imposed;
(5) any final decision or a summary thereof, unless publishing that
decision could compromise an ongoing investigation or proceeding, and
excluding decisions made by the Agency with respect to Atypical
Findings pursuant to Appendix 1; and
(6) any review rights available in respect of the decision.
(c) The mandatory Public Disclosure required by this 3620 shall not
be required where the Covered Person who has been found to have
committed a violation is a Minor. Any optional Public Disclosure in a
case involving a Minor shall be proportionate to the facts and
circumstances of the case.
(d) Publication shall be accomplished by, at a minimum, placing the
required information on the Agency's website.
Rule 3630. General Reporting
The Agency may publish general statistical reports of its Doping
Control and Medication Control activities and may report as necessary
on its activities to the U.S. Congress, the Commission, the Authority,
the State Racing Commissions, and other federal or state governmental
bodies or agencies having jurisdiction over the sport of horseracing in
the United States. The Agency may also publish reports showing the
names of any Covered Horses Tested and the date of each Sample
collection.
Rule 3640. Data Privacy
The Agency may collect, store, process, or disclose personal
information relating to Covered Persons, Covered Horses, or other
Persons and horses where necessary and appropriate to discharge its
responsibilities under the Protocol, but shall take appropriate steps
to maintain that information and its confidentiality in compliance with
applicable law.
3700. Implementation of Decisions
Rule 3710. Application and Recognition of Decisions
(a) Any final decision issued pursuant to the Protocol that a
violation of the Protocol has taken place and imposing Consequences or
other sanctions for that violation shall be automatically and
immediately recognized, respected, enforced and given full force and
effect by the Authority, Racetracks, Race Organizers, Training
Facilities, all Covered Persons, and all other relevant Persons within
their respective spheres of authority.
(b) Where a third party with its own jurisdiction over Covered
Persons or Covered Horses imposes consequences on them for violation of
anti-doping or controlled medication rules that are consistent with the
Protocol or the World Anti-Doping Code, that decision, upon review and
acceptance by the Authority and the Agency, shall be immediately
recognized, respected, enforced and given full force and effect by the
Agency, the Authority, Racetracks, Race Organizers, all Covered
Persons, and all other relevant Persons within their respective spheres
of authority.
3800. Education
Rule 3810. Education Programs
The Agency shall plan, implement, evaluate, and monitor education
programs for responsible medication use and doping-free horseracing.
Rule Series 3000 Appendix 1: Atypical Finding Policy
Overview
1. Atypical Findings occur when the Laboratory provides the results
of its analysis of a Sample to the Agency and more investigation or
review is needed to determine whether or not it should be treated as an
Adverse Analytical Finding. This Atypical Findings Policy (Atypical
Findings Policy) sets out the process by which the Agency will decide
whether or not Atypical Findings will be pursued as Adverse Analytical
Findings.
Prohibited Substances To Be Treated as Atypical Findings
2. If detected in the Sample of a Covered Horse, the following
Prohibited Substances shall be investigated or reviewed as Atypical
Findings:
(a) Specified Substances;
(b) endogenous substances;
(c) ractopamine; and
(d) zilpaterol.
3. The Laboratory may also report other Atypical Findings in
relation to substances that are not specifically listed in the
Prohibited List or Technical Document-Prohibited Substances.
Decisions Regarding Atypical Findings
4. The Agency is responsible for issuing a decision regarding
whether or not an Atypical Finding will be pursued as an Adverse
Analytical Finding.
5. Subject to the notification requirements set out below, the
deliberations of the Agency shall be confidential.
Preliminary Steps
6. Initial review.
The Agency will first conduct a review to determine whether there
is any apparent departure from any Standards or any provisions of the
Protocol that caused the Atypical Finding. If that review does not
reveal any departure that caused the Atypical Finding, the Agency will
conduct the required investigation in accordance with this Atypical
Findings Policy. The precise nature of the investigation will depend on
basis for the Atypical Finding, including the Prohibited Substance(s)
associated with the Atypical Finding (if applicable), and the level of
cooperation of the Responsible Person.
7. Notification.
The Agency will promptly inform the Responsible Person and
Interested Parties in writing of the Atypical Finding and any relevant
information, such as the Covered Horserace to which the Atypical
Finding relates, and the Responsible Person will have the opportunity
to provide any information that he or she believes might assist the
Agency in deciding whether or not to pursue the Atypical Finding as an
Adverse Analytical Finding, as set forth in the criteria below. Such
information must be provided to the Agency by the deadlines set by the
Agency in order for it to be considered by the Agency.
8. Additional information.
The Agency may request such additional information or explanations
from the Responsible Person as it considers necessary to evaluate the
Atypical Finding, and the Responsible Person must comply fully and
promptly with any such requests.
Criteria
In deciding whether or not an Atypical Finding should be pursued as
an Adverse Analytical Finding, the Agency will consider the following
criteria:
[[Page 5121]]
9. Proving source of the Prohibited Substance(s) as a precondition.
(a) The Responsible Person has the burden of proving how the
Prohibited Substance(s) entered the body of the Covered Horse. If the
Responsible Person is unable to discharge that burden, the Atypical
Finding must be pursued as an Adverse Analytical Finding. If the
Responsible Person proves the source, the Agency will determine whether
or not the Analytical Finding should be pursued as an Adverse
Analytical Finding.
(b) The Agency will take a number of factors into account when
considering whether or not the source of the Atypical Finding has been
established including, but not limited to:
(i) if there were Atypical Findings for the same Prohibited
Substance(s) arising from other Samples collected at the relevant
Covered Horserace;
(ii) if there were Atypical Findings for the same Prohibited
Substance(s) arising from other Samples collected at previous Covered
Horseraces held at the same Racetrack or in the same region;
(iii) if Samples taken from feed or bedding at the relevant Covered
Horserace (if such samples are available) test positive for the
Prohibited Substance(s) in question;
(iv) if there were other (non-Atypical Finding) Prohibited
Substance(s) in the Sample; and
(v) the concentration level of the particular Prohibited
Substance(s) in the Sample.
(c) In addition, the Agency may, in accordance with Rules 3246 and
3346 of the Protocol, request the B Sample analysis.
(d) If the Atypical Finding concerns a Prohibited Substance(s) that
is an endogenous substance, the Agency will request that the
Responsible Person provide any veterinary information that would assist
in establishing if the result is due to a physiological or pathological
condition, and such information shall be taken into account by the
Agency.
(e) When trying to establish the source of the Prohibited
Substance(s) in question, the Agency may consult, as necessary, with
one or more experts to obtain further information on the Prohibited
Substance(s) in order to assess whether or not: (i) the explanations
provided by the Responsible Person (if any) are plausible; or (ii) the
presence of the Prohibited Substance(s) in the Sample is likely to be
due to contamination.
(f) The Agency will consider any measures the Responsible Person
has in place to prevent Prohibited Substances entering the body of his
or her Covered Horse(s), including:
(i) whether or not the Responsible Person keeps up-to-date
treatment records;
(ii) whether or not the Responsible Person keeps a record of the
feed and supplements given to his or her Covered Horses, and whether
samples of such feed or supplements have been stored for potential
analysis;
(iii) the security measures put in place by the Responsible Person
at his or her stables and when travelling to or attending Covered
Horseraces; and
(iv) other measures taken by the Responsible Person to prevent
Prohibited Substances inadvertently entering the body of his or her
Covered Horses.
10. Other factors.
The Agency may also have regard to other factors that it considers
necessary or relevant, including, but not limited to:
(a) the security measures in place at the relevant Covered
Horserace;
(b) the report(s) of the Veterinarians or stewards at the relevant
Covered Horserace;
(c) the prevalence of the use of the Prohibited Substance(s); and
(d) whether or not the Responsible Person has any prior Anti-Doping
Rule Violation(s) or Controlled Medication Rule Violation(s) (excluding
any violations where the Responsible Person was found to bear No Fault
or Negligence).
Conclusion of the Investigation and Notification
11. Following the Agency's investigation of the Atypical Finding in
accordance with the criteria above, the Agency shall decide whether or
not the Atypical Finding should be pursued as an Adverse Analytical
Finding. The Agency shall issue a written decision, with a short
summary of the basis for that decision. The decision of the Agency is
final and is not subject to review. The Agency will send a copy of its
decision to the Responsible Person.
12. If the Agency determines that the Atypical Finding should not
be pursued as an Adverse Analytical Finding, no further action will be
taken, and no case will be opened against the Responsible Person.
13. If the Agency determines that the Atypical Finding should be
pursued as an Adverse Analytical Finding, the Agency will follow the
notification procedure set out in Rules 3250 and 3350 and will refer
the matter for adjudication in accordance with the Arbitration
Procedures (unless the matter is resolved by agreement without a
hearing as permitted under the Protocol). The Agency may rely on any
information submitted or obtained when investigating the Atypical
Finding in the subsequent Adverse Analytical Finding case.
Publication of Atypical Findings
14. At the end of each year, the Agency may publish a report
setting out the following information, on an anonymised basis:
(a) how many Atypical Findings were reported by Laboratories that
year;
(b) how many Atypical Findings were pursued as Adverse Analytical
Findings, and the Prohibited Substances in question;
(c) how many Atypical Findings were not pursued as Adverse
Analytical Findings, and the Prohibited Substances in question; and
(d) how many Atypical Findings remain under investigation.
Public Comment
15. Unless there are compelling reasons (as determined by the
Agency), no Person may make any public comment on the specific details
of an Atypical Finding while the investigation is ongoing. If such a
disclosure is made by a Person not affiliated with the Authority or the
Agency, the Authority or the Agency may respond to such public comment
as it considers necessary.
16. If an Atypical Finding is not pursued as an Adverse Analytical
Finding, no Person may make any public comment on the details of that
Atypical Finding without the prior consent of the Responsible Person.
If such a disclosure is made by a Person not affiliated with the
Authority or the Agency, the Authority or the Agency may respond to
such public comment as it considers necessary.
4000. Prohibited List
4010. Purpose
In accordance with Rule 3111, the Prohibited List identifies
substances and methods that are prohibited at all times (Banned
Substances and Banned Methods) and those that are prohibited for Use or
Administration in relation to a Covered Horse during the Race Period
and prohibited to be present in a Post-Race Sample or Post-Work Sample,
except as otherwise specified in the Prohibited List (Controlled
Medication Substances and Controlled Medication Methods). In accordance
with the definition of ``Race Period'' (see Rule 1020), the Prohibited
List may specify that, for certain specified Controlled Medication
Substances and Controlled Medication Methods, the Race Period shall be
shorter or longer in duration.
[[Page 5122]]
Prohibited Substances and Prohibited Methods may be included in the
Prohibited List by general category (e.g., anabolic steroids) or by
specific reference to a particular substance or method. The Prohibited
List is supplemented by the ``Technical Document--Prohibited
Substances,'' which provides guidance on the Prohibited Substances that
fall into the general categories listed in the Prohibited List and on
the Screening Limits, Thresholds, or Detection Times for those
Prohibited Substances (as applicable), and also designates certain
Prohibited Substances as Specified Substances, which are those that
pose a higher risk of being the result of contamination and, therefore,
are subject to more flexible sanctions. Certain Prohibited Substances
might also first be reported as Atypical Findings requiring further
investigation before being declared as Adverse Analytical Findings, in
accordance with the Atypical Findings Policy set out as Appendix 1 to
the Protocol. The Prohibited List also sets out the periods of
Ineligibility applicable to Covered Horses for Anti-Doping Rule
Violations and Controlled Medication Rule Violations (see Rule 4300).
4100. Banned Substances and Banned Methods
4110. Banned Substances
Rule 4111. S0 Non-Approved Substances
Any pharmacological substance that (i) is not addressed by Rules
4112 through 4117, (ii) has no current approval by any governmental
regulatory health authority for veterinary or human use, and (iii) is
not universally recognized by veterinary regulatory authorities as a
valid veterinary use, is prohibited at all times. For the avoidance of
doubt, compounded products compliant with the Animal Medicinal Drug Use
Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256
(also known as Compounding Animal Drugs from Bulk Drug Substances) are
not prohibited under this section S0.
Rule 4112. S1 Anabolic Agents
The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited at
all times:
(a) anabolic androgenic steroids when administered exogenously;
(b) other anabolic agents, including, but not limited to:
(1) Selective Androgen Receptor Modulators (SARMs);
(2) Zeranol;
(3) Zilpaterol; and
(4) Ractopamine.
Rule 4113. S2 Peptide Hormones, Growth Factors, Related Substances, and
Mimetics
The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited at
all times:
(a) Erythropoietins (EPO) and agents affecting erythropoiesis,
including, but not limited to:
(1) erythropoietin-receptor agonists;
(2) Hypoxia-Inducible Factor (HIF) activating agents;
(3) GATA (Erythroid Transcription Factor) inhibitors;
(4) Transforming Growth Factor-beta (TGF-[beta]) signaling
inhibitors; and
(5) innate repair receptor agonists.
(b) Peptide Hormones and their releasing factors, including, but
not limited to:
(1) Chorionic Gonadotrophin (CG) and Luteinizing Hormone (LH) and
their releasing factors in stallions, ridglings, and geldings;
(2) corticotrophins and their releasing factors (excluding ACTH if
administered outside the Race Period);
(3) Growth Hormone (GH) and its analogues and fragments; and
(4) Growth Hormone (GH) releasing factors.
(c) Growth factors and growth factor modulators affecting muscle,
tendon, or ligament protein synthesis/degradation, vascularization,
energy utilization, regenerative capacity, or fiber type switching.
Rule 4114. S3 Beta-2 Agonists
The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited at
all times: all selective and non-selective beta-2 agonists, including
all optical isomers. Notwithstanding the above, the following are not
prohibited under this section S3:
(a) inhaled beta-2 agonists (e.g., albuterol, salbutamol) when
prescribed by a Veterinarian (in the context of a valid veterinarian-
patient-client relationship) as a bronchodilator; and
(b) clenbuterol when prescribed by a Veterinarian (in the context
of a valid veterinarian-patient-client relationship) for a duration not
to exceed 30 days in a 6-month period and provided that, following
administration of clenbuterol, the Covered Horse shall be placed on the
Veterinarians' List and shall not be eligible to participate in any
Timed and Reported Workout or Covered Horserace until a urine and a
blood Sample have been collected from it by or on behalf of the Agency,
and analysis by a Laboratory of those Samples does not detect the
presence of clenbuterol or its Metabolites or Markers.
Rule 4115. S4 Hormone and Metabolic Modulators
The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited at
all times:
(a) aromatase inhibitors;
(b) anti-estrogenic substances, anti-estrogens, and selective
estrogen receptor modulators (SERMS);
(c) agents preventing activin receptor IIB activation, including,
but not limited to, myostatin inhibitors;
(d) metabolic modulators, including, but not limited to:
(1) insulins and insulin-mimetics;
(2) meldonium; and
(3) trimetazidine; and
(e) thyroid hormone and thyroid hormone modulators.
Rule 4116. S5 Diuretics and Masking Agents
(a) Diuretics and masking agents, and other substances with a
similar chemical structure or similar biological effect(s), are
prohibited at all times.
(b) Notwithstanding the above, the following are not prohibited
under this section S5:
(1) drospirenone, pamabrom, and topical ophthalmic administration
of carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide);
(2) trichlormethiazide for treatment of edema;
(3) plasma expanders for life-saving procedures; and
(4) furosemide (also known as Lasix/Salix), subject to the
limitations set out in Rule 4212(d).
Rule 4117. S6 Miscellaneous Substances
The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited at
all times:
(a) bisphosphonates (except that bisphosphonates may be
administered for the purpose of diagnostic imaging, i.e., gamma
scintigraphy);
(b) toxins (e.g., botulinum toxin, botox);
(c) venoms of any species, their synthetic analogs, or derivatives
thereof;
(d) altrenogest in stallions, ridglings, or geldings;
(e) pitcher plant extract (Sarapin); and
(f) perfluorocarbons.
4120. Banned Methods
Rule 4121. M1 Manipulation of Blood and Blood Components
The following are prohibited at all times:
[[Page 5123]]
(a) The Administration or reintroduction of any quantity of
autologous, allogenic (homologous), or heterologous blood or red blood
cell products of any origin into the circulatory system.
(b) Artificially enhancing the uptake, transport, or delivery of
oxygen, including, but not limited to: perfluorochemicals; efaproxiral
(RSR13); and modified haemoglobin products, e.g., haemoglobin-based
blood substitutes and microencapsulated haemoglobin products; excluding
supplemental oxygen by inhalation.
(c) Any form of intravascular manipulation of the blood or blood
components by physical or chemical means.
(d) Withdrawal of blood for any purpose other than for diagnostic/
Laboratory Testing procedures.
(e) Notwithstanding the above, manipulation of blood or blood
components is not prohibited under this section M1:
(1) procedures performed for life-saving purposes; and
(2) use of veterinary regenerative therapies (i.e., autologous
conditioned serum or platelet-rich plasma) for the treatment of
musculoskeletal injury or disease.
Rule 4122. M2 Chemical Castration or Immunocastration
In case of chemical castration or immunocastration, the Covered
Horse shall remain designated as an intact male. Designating a Covered
Horse that has had chemical castration or immunocastration as a gelding
constitutes Use of a Prohibited Method.
Rule 4123. M3 Gene and Cell Doping
The following, which have the potential to enhance performance or
modify the heritable genome, are prohibited at all times:
(a) the use of nucleic acids or nucleic acid analogues that might
alter genome sequences or alter gene expression by any mechanism. This
includes, but is not limited to, gene editing, gene silencing, and gene
transfer technologies;
(b) the use of normal or genetically modified cells; and
(c) modification of the heritable genome.
4200. Controlled Medication Substances and Controlled Medication
Methods
4210. Controlled Medication Substances
Rule 4211. S7 Controlled Medication Substances
(a) Subject to Rule 4212, only feed, hay, and water are permitted
during the Race Period. Accordingly, subject to Rule 4212, any
substance administered during the Race Period or present in a Post-Race
Sample (including any metabolite(s), artifact(s), and isomer(s) of such
substance(s)) that does not otherwise qualify as a Banned Substance
shall constitute a prohibited Controlled Medication Substance.
(b) The following Controlled Medication Substances are prohibited
from presence in a Post-Work Sample:
(1) analgesics;
(2) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs);
(3) local anesthetics; and
(4) corticosteroids.
(c) S7 Controlled Medication Substances exclude those substances
that fall under section S0, which are Banned Substances.
Rule 4212. Exceptions to Rule 4211
(a) Medications administered or authorized by a Regulatory
Veterinarian or Test Barn Veterinarian to provide medical care to a
Covered Horse as a result of an injury sustained, or other adverse
health event, during the Race Period are not prohibited.
(b) The following may be administered up to 24 hours prior to Post-
Time:
(1) orally administered vitamins;
(2) licensed vaccines against infectious agents;
(3) anti-ulcer medications (e.g., Cimetidine, Omeprazole, and
Ranitidine);
(4) unsupplemented isotonic electrolyte solutions by oral or
intravenous administration;
(5) altrenogest in female horses;
(6) antimicrobials (antibiotics) and other anti-infective agents,
excluding procaine penicillin or other antimicrobial/anti-infective
agents containing or metabolizing to Prohibited Substances; and
(7) antiparasitic/anthelmintics approved and registered for use in
horses, excluding levamisole or other antiparasitic/anthelmintics
metabolizing to or containing other Prohibited Substances.
(c) Unsupplemented isotonic electrolyte solutions may be consumed
by the horse's free choice at any time (but may not be administered
except as provided in paragraph (b) above).
(d) Furosemide (also known as Lasix or Salix):
(1) is permitted during Timed and Reported Workouts and Vets' List
Workouts; and
(2) may be administered during the Race Period in accordance with
specific provisions of the Act and any guidance or exceptions approved
by the Authority, but shall not be administered within the 4 hours
prior to Post-Time.
(e) The Use or Administration of supplements or feed additives
during the Race Period shall not be prohibited if the Responsible
Person or Covered Person establishes, or the Agency expressly accepts,
that such substances are not capable at any time of causing an action
or effect, or both an action and effect, within one or more of the
following mammalian body systems:
(1) the blood system;
(2) the urinary system;
(3) the cardiovascular system;
(4) the digestive system;
(5) the endocrine system;
(6) the immune system;
(7) the musculoskeletal system;
(8) the nervous system;
(9) the reproductive system; or
(10) the respiratory system.
4220. Controlled Medication Method(s)
In addition to any prohibited practices set forth in the Rule 2000
Series (Racetrack Safety Program):
Rule 4221. M4 Alkalinization or Use/Administration of an Alkalinizing
Agent
Alkalinization or Use/Administration of an alkalinizing agent is
prohibited on Race Day. A threshold concentration of total carbon
dioxide (TCO2) in the blood in excess of 37 mmol constitutes prima
facie evidence of alkalinization or Use/Administration of an
alkalinizing agent.
Rule 4222. M5 Intra-Articular Injections
Intra-articular injections are prohibited on Race Day; within 14
days prior to Post-Time; and within 7 days prior to any Timed and
Reported Workout.
Rule 4223. M6 Nasogastric Tube
The use of a nasogastric tube for any purpose is prohibited within
24 hours prior to Post-Time.
Rule 4224. M7 Intra-Articular Injections of Polyacrylamide Hydrogels
Intra-articular injections of polyacrylamide hydrogels are
prohibited within 180 days prior to Post-Time.
Rule 4225. Modification of Race Period
The start of the ``Race Period'' shall be modified for each of the
Controlled Medication Methods above (i.e., each of M4-M7) based on the
restricted administration time period specified for such method (e.g.,
the Race Period for M7 shall start180 days prior to Post-Time).
[[Page 5124]]
4300. Ineligibility Periods for Covered Horse
4310. Violations Involving Prohibited Substances
The period of Ineligibility of a Covered Horse resulting from a
violation involving a Prohibited Substance shall be as set forth in
Table 1 below:
Table 1
------------------------------------------------------------------------
Violation Ineligibility period
------------------------------------------------------------------------
S0 BANNED Substances-non-approved Up to 14 months
substances.
S1 BANNED Substances-anabolic agents... 14 months
S2 BANNED Substances-peptide hormones.. 6 months
S3 BANNED Substances-beta-2 agonists... 14 months
S4 BANNED Substances-hormone and 3 months
metabolic modulators.
S5 BANNED Substances-diuretics and 0 months
masking agents.
S6 BANNED Substances-miscellaneous
substances:
(1) Bisphosphonates................ Life
(2) All other S6 miscellaneous 0 months.
substances.
S7 CONTROLLED Medication Substances.... 0 months.
The Covered Horse may be placed
on the Veterinarians' List,
and if so, a subsequent Vets'
List Workout must be
scheduled. A post-Vets' List
Workout Sample may be required
------------------------------------------------------------------------
4320. Violations Involving Prohibited Methods
The period of Ineligibility of a Covered Horse resulting from a
violation involving a Prohibited Method shall be as set forth in Table
2 below:
Table 2
------------------------------------------------------------------------
Violation Ineligibility period
------------------------------------------------------------------------
M1 Manipulation of blood and blood 6 months.
components.
M2 Chemical castration or 0 months.
immunocastration.
M3 Gene and cell doping................ Life.
M4 Alkalinization...................... 0 months.
M5 Intra-articular injection........... 1 month.
M6 Nasogastric tube.................... 0 months.
M7 Intra-articular injection of 12 months.
polyacrylamide hydrogel.
------------------------------------------------------------------------
4330. Other Violations Leading to a Period of Ineligibility for the
Covered Horse
The period of Ineligibility of a Covered Horse resulting from a
violation of Rule 3215 shall be as set forth in Table 3 below:
Table 3
------------------------------------------------------------------------
Violation Ineligibility period
------------------------------------------------------------------------
Evading collection of a Sample from a Evasion: 18 months.
Covered Horse; refusing or failing Refusal or failure: 18 months,
without compelling justification to unless it is established by
submit a Covered Horse to Sample the Responsible Person that
collection; or refusing or failing to fairness requires otherwise,
comply with all Sample collection in which case the period of
procedure requirements (Rule 3215). Ineligibility may be reduced,
depending on the specific
circumstances of the case and
considerations of horse
welfare.
------------------------------------------------------------------------
Appendix 1 to Rule Series 4000: Technical Document--Prohibited
Substances
[[Page 5125]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Penalty
subclassification Commercial
HISA (specified name(s) Screening limit
HISA listed as status substances are Substance Action (developmental Detection time *
designated with names)
`x')
--------------------------------------------------------------------------------------------------------------------------------------------------------
BANNED........................ S1 ................... [Delta]-1- Anabolic........ Lacks FDA
androstene-3, approval. DEA
17diol. Schedule III.
BANNED........................ S1 ................... [Delta]-1- Anabolic........ Lacks FDA
androstene-3, approval. DEA
17dione. Schedule III.
BANNED........................ S1 ................... [Delta]-1- Anabolic........ Lacks FDA
dihydrotestoste approval. DEA
rone. Schedule III.
BANNED........................ S1 ................... 19- Anabolic........ Lacks FDA
Norandrostenedi approval. DEA
ol. Schedule III.
BANNED........................ S1 ................... 19- Anabolic........ Lacks FDA
Norandrostenedi approval. DEA
one. Schedule III.
BANNED........................ S1 ................... 19- Anabolic........ Lacks FDA
Noretiocholanol approval.
one.
BANNED........................ S1 ................... 1-androstenediol Anabolic........ Lacks FDA
(5[alpha] approval. DEA
androst-1-ene- Schedule III.
3[beta],
17[beta]diol).
BANNED........................ S1 ................... 1- Anabolic........ Lacks FDA
androstenedione approval. DEA
(5[alpha]andros Schedule III.
t-1-ene-3,
17dione).
BANNED........................ S1 ................... 1-testosterone Anabolic........ Lacks FDA
(17[beta]hydrox approval. DEA
y-5[alpha]- Schedule III.
androst-1en-3-
one).
BANNED........................ S0 ................... 2-Aminoheptane Sympathomimetic/ Lacks FDA
(Tuaminoheptane Vasoconstrictor. approval.
).
BANNED........................ S4 ................... 2- Pheromone/ Lacks FDA
androstenol(5[a Reproductive approval.
lpha]- Hormone.
androstane-2-en-
17-ol).
BANNED........................ S4 ................... 2-androstenone Pheromone/ Lacks FDA
(5[alpha]- Reproductive approval.
androst-2-en-17- Hormone.
one).
BANNED........................ S0 ................... 3,4- Stimulant....... Lacks FDA
methylenedioxyp approval.
yrovalerone
(MDVP).
BANNED........................ S4 ................... 3-androstenol Pheromone/ Lacks FDA
(5[alpha]- Reproductive approval.
androst-3-en-17- Hormone.
ol).
BANNED........................ S4 ................... 3-androstenone Pheromone/ Lacks FDA
(5[alpha]- Reproductive approval.
androst-3-en-17- Hormone.
one).
BANNED........................ S4 ................... 4-androstenediol Anabolic........ Lacks FDA
(androst-4-ene- approval. DEA
3[beta],17[beta Schedule III.
]diol).
BANNED........................ S4 ................... 4- Anabolic........ Lacks FDA
chloromethatand approval. DEA
ienone. Schedule III.
BANNED........................ S1 ................... 4- Anabolic........ Lacks FDA
Hydroxytestoste approval. DEA
rone. Schedule III.
BANNED........................ S4 ................... 5- Anabolic........ Lacks FDA
androstenedione approval. DEA
(androst-5- ene- Schedule III.
3,17dione).
BANNED........................ S1 ................... 5[alpha]-Andros- Anabolic........ Lacks FDA
2-ene-17one. approval. DEA
Schedule III.
BANNED........................ S1 ................... 5[alpha]- Anabolic........ Lacks FDA
Androstane- approval. DEA
3[alpha], 17 Schedule III.
[alpha]-diol.
BANNED........................ S1 ................... 5[alpha]- Anabolic........ Lacks FDA
Androstane- approval. DEA
3[alpha], 17 Schedule III.
[beta]-diol.
BANNED........................ S1 ................... 5[alpha]- Anabolic........ Lacks FDA
Androstane- approval. DEA
3[beta], Schedule III.
17[alpha] -diol.
BANNED........................ S1 ................... 5[alpha]- Anabolic........ Lacks FDA
Androstane- approval. DEA
3[beta], Schedule III.
17[beta] -diol.
BANNED........................ S1 ................... 5[beta]- Anabolic........ Lacks FDA
androstane-3 approval. DEA
[alpha], Schedule III.
17[beta]diol,
androst-4-
ene3[alpha],17[
alpha]-diol.
BANNED........................ S1 ................... 7-keto-dhea..... Anabolic........
BANNED........................ S1 ................... 7[alpha]-hydroxy- Anabolic........
dhea.
BANNED........................ S1 ................... 7[beta]-hydroxy- Anabolic........
dhea.
BANNED........................ S5 ................... Acebutolol...... Antihypertensive Generic..........
BANNED........................ S0 ................... Acecarbromal.... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Acefylline...... Bronchodilator.. Lacks FDA
approval.
BANNED........................ S0 ................... Acemetacin...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Acenocoumarol... Anticoagulant... Lacks FDA
approval.
[[Page 5126]]
CONTROLLED.................... S7 B Acepromazine.... Sedative........ PromAce, Detection Time: 10 ng/mL as 2-(1-
Aceproject. 72 hrs 0.15 mg/ hydroxyethyl)
kg single oral promazine
dose (6 sulfoxide
horses). (HEPS) in
Detection Time: urine; 0.02 ng/
48 hrs 0.05 mg/ mL in serum or
kg single IV plasma.
dose (20
horses).
CONTROLLED.................... S7 C Acetaminophen NSAID........... Tylenol..........
(Paracetamol).
BANNED........................ S0 ................... Acetanilide..... NSAID........... Lacks FDA
approval.
BANNED........................ S5 ................... Acetazolamide... Carbonic Generic..........
Anhydrase
Inhibitor.
BANNED........................ S0 ................... Acetohexamide... Insulin Discontinued, no
secretion. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Acetophenazine.. Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Acetophenetidin NSAID........... Lacks FDA
(Phenacetin). approval.
CONTROLLED.................... S7 C Acetylcysteine.. Mucolytic....... Mucomyst,
Parvolex.
BANNED........................ S0 ................... Acetylmorphine.. Opioid Analgesic Lacks FDA
approval.
CONTROLLED.................... S7 C Acetylsalicylic NSAID........... Generic..........
acid (Aspirin).
BANNED........................ S0 ................... Aclidinium Bronchodilator.. Tudorza Pressair;
bromide. Dualkir Pressair
(with
formoterol).
BANNED........................ S0 ................... Adinazolam...... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Adiphenine...... Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Adrafinil....... Stimulant....... Lacks FDA
approval.
BANNED........................ S4 ................... AICAR (5- Metabolic Lacks FDA
Aminoimidazole- modulator. approval.
4-carboxamide
ribonucleotide).
CONTROLLED.................... S7 B Albuterol Bronchodilator.. FDA-approved Detection Time: SL: 0.5 ng/mL in
(Salbutamol). equine product 72 hours at 5 x urine.
Torpex no longer 100 [mu]g
commercially actuations per
available. dose for 2 days
Available as FDA- dosed every 4
approved for hours.
human use via Note: Albuterol
inhalation as administered by
Proair HFA, any route other
Ventolin HFA, than inhalation
and generic is a Banned
formulations. Substance.
Evidence that
albuterol was
administered by
a route other
than
inhalation,
regardless of
the albuterol
concentration
in a urine
sample,
constitutes a
Doping
Violation.
BANNED........................ S0 ................... Alclofenac...... NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 C Alclometasone... Corticosteroid.. Generic..........
BANNED........................ S0 ................... Alcuronium...... Muscle relaxant. Lacks FDA
approval.
BANNED........................ S5 ................... Aldosterone..... Diuretic........ Lacks FDA
approval.
BANNED........................ S6 ................... Alendronate..... Bisphosphonate.. Fosamax, Binosto.
BANNED........................ S2 ................... Alexamorelin.... Growth Hormone.. Lacks FDA
approval.
CONTROLLED.................... S7 A Alfentanil...... Opioid Analgesic Alfenta. DEA
Schedule II.
CONTROLLED.................... S7 B Allopurinol..... Xanthine oxidase Lopurin,
inhibitor. Zyloprim,
Aloprim.
BANNED........................ S0 ................... Almotriptan..... Selective Generic..........
Serotonin
Receptor
Agonist.
BANNED........................ S0 ................... Alpha- Stimulant/ Lacks FDA
pyrrolidinovale Hallucinogen. approval. DEA
rophenone Schedule I.
(Alpha PVP and
``Bath Salts'').
BANNED........................ S2 ................... Alpha-casozepine Sedative........ Lacks FDA
approval.
BANNED........................ S0 ................... Alphadolone Anesthetic...... Lacks FDA
(Alfadolone) approval.
acetate.
BANNED........................ S0 ................... Alphaprodine.... Opioid Analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Alphenal........ Barbiturate/ Lacks FDA
Anticonvulsant. approval.
[[Page 5127]]
BANNED........................ S0 ................... Alpidem......... Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 A Alprazolam...... Sedative/ Xanax. DEA
Anxiolytic. Schedule IV.
BANNED........................ S0 ................... Alprenolol...... Antihypertensive Generic..........
BANNED........................ S0 ................... Althesin........ Anesthetic...... Lacks FDA
approval.
BANNED........................ S5 ................... Althiazide...... Diuretic........ Lacks FDA
approval.
CONTROLLED--fillies and mares. S7 C Altrenogest..... Progestogen/ Regumate.........
Estrus
Suppression.
BANNED--Intact males, S6 ................... Altrenogest..... Progestogen/ Regumate.........
geldings, spayed females. Estrus
Suppression.
BANNED........................ S0 ................... Alverine........ Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Amantadine...... Dopamine agonist Gocovri, Osmolex
ER.
BANNED........................ S0 ................... Ambenonium...... Cholinesterase Discontinued, no
Inhibitor. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Ambroxol........ Mucolytic....... Lacks FDA
approval.
BANNED........................ S0 ................... Ambucetamide.... Antispasmodic... Lacks FDA
approval.
CONTROLLED.................... S7 C Amcinonide...... Corticosteroid.. Generic..........
BANNED........................ S0 ................... Amfepramone..... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Amfetaminil..... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Amidephrine..... Stimulant....... Lacks FDA
approval.
BANNED........................ S5 ................... Amiloride....... Diuretic........ Midamor..........
BANNED........................ S0 ................... Amineptine...... Antidepressant.. Lacks FDA
approval.
CONTROLLED.................... S7 C Aminocaproic Anti- Amicar...........
acid. fibrinolytic.
BANNED........................ S4 ................... Aminoglutethimid Aromatase Discontinued, no
e. inhibitor. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Aminomethylbenzo Anti- Lacks FDA
ic acid. fibrinolytic. approval.
BANNED........................ S0 ................... Aminometradine.. Diuretic........ Lacks FDA
approval.
CONTROLLED.................... S7 B Aminophylline... Bronchodilator.. Generic..........
BANNED........................ S0 ................... Aminopterin..... Anti-neoplastic/ Lacks FDA
Immunosuppressi approval.
ve.
BANNED........................ S0 ................... Aminopyrine Analgesic....... Lacks FDA
(Pyramidon). approval.
BANNED........................ S0 (x) Aminorex........ Stimulant....... Lacks FDA
approval. DEA
Schedule I.
CONTROLLED.................... S7 B Amiodarone...... Antiarrhythmic.. Nexterone,
Pacerone.
BANNED........................ S0 ................... Amiphenazole.... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S5 ................... Amisometradine.. Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Amisulpride..... Antipsychotic... Barhemsys........
CONTROLLED.................... S7 A Amitraz......... Stimulant....... Mitaban..........
CONTROLLED.................... S7 A Amitriptyline... Antidepressant.. Elavil...........
BANNED........................ S5 ................... Amlodipine...... Antihypertensive Norvasc..........
BANNED........................ S0 ................... Ammonium Chemical Generic..........
Chloride. neurectomy.
BANNED........................ S0 ................... Ammonium Chemical Lacks FDA
Sulphate. neurectomy. approval.
BANNED........................ S0 ................... Ammonium Chemical Lacks FDA
Sulphide. neurectomy. approval.
BANNED........................ S0 ................... Amobarbital..... Bartiburate/ Lacks FDA
Anticonvulsant. approval. DEA
Schedule III.
BANNED........................ S0 ................... Amoxapine....... Antidepressant.. Generic..........
BANNED........................ S0 ................... Amperozide...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Amphetamine..... Stimulant....... Adzenys XR-ODT,
Dyanavel XR,
Evekeo. DEA
Schedule III.
BANNED........................ S0 ................... Amphetaminil.... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Ampyrone........ NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 B Amrinone Vasodilator..... Amicor,
(inamrinone). Cardiotone.
BANNED........................ S0 ................... Amyl nitrite.... Antihypertensive/ Lacks FDA
CNS Depressant. approval.
BANNED........................ S0 ................... Amylocaine...... Local anesthetic Lacks FDA
approval.
BANNED........................ S2 ................... Anamorelin...... Growth Hormone.. New Drug
Application
submitted;
currently lacks
FDA approval.
BANNED........................ S4 ................... Anastrozole..... Anti-estrogen... Arimidex.........
BANNED........................ S1 ................... Andarine........ Selective Lacks FDA
Androgen approval.
Receptor
Modulator
(SARM).
BANNED........................ S1 ................... Androst-4-ene- Anabolic........ DEA Schedule III.
3[alpha],17[bet
a] diol.
BANNED........................ S1 ................... Androst-4-ene- Anabolic........ DEA Schedule III.
3[beta],17[alph
a] diol.
BANNED........................ S1 ................... Androst-5-ene- Anabolic........ DEA Schedule III.
3[alpha],17[alp
ha] diol.
BANNED........................ S1 ................... Androst-5-ene- Anabolic........ DEA Schedule III.
3[alpha],17[bet
a] diol.
BANNED........................ S1 ................... Androst-5-ene- Anabolic........ DEA Schedule III.
3[beta],17[alph
a] diol.
[[Page 5128]]
BANNED........................ S4 ................... Androstatrienedi Anabolic........ DEA Schedule III.
one (Androsta-
1,4,6-triene-
3,17-ddione).
BANNED........................ S4 ................... Androstenediol Anabolic........ DEA Schedule III.
(androst-5-ene-
3[beta],
17[beta]diol).
BANNED........................ S4 ................... Androstenedione Anabolic........ DEA Schedule III.
(androst-4-ene-
3, 17dione).
BANNED........................ S4 ................... Androsterone (3 Anabolic........ DEA Schedule III.
[beta]hydroxy-5
[alpha]-
androstan-17-
one).
BANNED........................ S0 ................... Anileridine..... Opioid Analgesic Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule II.
BANNED........................ S0 ................... Anilopam........ Opioid Analgesic Lacks FDA
approval.
BANNED........................ S0 ................... Anisindione..... Anticoagulant... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Anisotropine Anticholinergic. Discontinued, no
(Octatropine FDA-approved
methylbromide). product
commercially
available.
CONTROLLED.................... S7 B Antazoline...... Antihistamine Discontinued, no
(ophthalmic). FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Antipyrine...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Apazone NSAID........... Lacks FDA
(Azapropazone). approval.
BANNED........................ S0 ................... Apocodeine...... Dopamine agonist Lacks FDA
approval.
BANNED........................ S0 ................... Apomorphine..... Opioid Analgesic Kynmobi, Apokyn..
BANNED........................ S0 ................... Aprindine....... Antiarrhythmic.. Lacks FDA
approval.
BANNED........................ S0 ................... Aprobarbital.... Barbiturate..... Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Apronalide...... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S2 ................... ARA-290......... Erythropoiesis.. FDA Orphan Drug
status.
BANNED........................ S0 ................... Arecoline....... Stimulant....... Lacks FDA
approval.
BANNED........................ S3 ................... Arformoterol.... Beta-2 agonist- Brovana..........
bronchodilator.
BANNED........................ S2 ................... Argon........... Hypoxia
Inducible
Factor
activating.
BANNED........................ S4 ................... Arimistane Anabolic........ Lacks FDA
(Anrosta-3,5- approval.
diene-7,17-
dione).
CONTROLLED.................... S7 A Aripiprazole.... Antipsychotic... Abilify..........
CONTROLLED.................... S7 B (x) Arsenic......... Stimulant....... Environmental ................ 0.3 mcg/mL total
substance. (free and
conjugated) in
urine.
CONTROLLED.................... S7 B Articaine....... Local anesthetic Orabloc,
Septocaine.
BANNED........................ S2 ................... Asialo EPO...... Erythropoiesis..
BANNED........................ S0 ................... Atenolol........ Antihypertensive Tenormin.........
CONTROLLED.................... S7 A Atipamezole..... Alpha adrenergic Antisedan,
antagonist. Revertidine.
BANNED........................ S0 ................... Atomoxetine..... Stimulant....... Strattera........
CONTROLLED.................... S7 A Atracurium...... Muscle relaxant. Generic..........
CONTROLLED.................... S7 B (x) Atropine........ Anticholinergic. Atropen.......... ................ 60 ng/mL total
(free and
conjugated) in
urine.
BANNED........................ S0 ................... Azacylonol CNS depressant.. Lacks FDA
([gamma]- approval.
pipradrol).
BANNED........................ S0 ................... Azaperone....... Sedative........ Stresnil.........
BANNED........................ S0 ................... Azapetine....... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Azapropazone.... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Azathioprine.... Immunosuppressor Imuran...........
BANNED........................ S0 ................... Azatidine Antihistamine... Discontinued, no
(Azatadine). FDA-approved
product
commercially
available.
BANNED........................ S5 ................... Azosemide....... Diuretic........ Lacks FDA
approval.
CONTROLLED.................... S7 B Baclofen........ Muscle relaxant. Lyvispah,
Gablofen,
Lioresal,
Ozobax, Fleqsuvy.
BANNED........................ S0 ................... Bambuterol...... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S0 ................... Bamifylline..... Bronchodilator.. Lacks FDA
approval.
BANNED........................ S0 ................... Barbital Sedative/ Lacks FDA
(barbitone). Hypnotic. approval. DEA
Schedule IV.
[[Page 5129]]
BANNED........................ S4 ................... Bazedoxifene.... Selective FDA-approved in
Estrogen combination with
Receptor Premarin as
Modulator Duavee.
(SERM).
BANNED........................ S0 ................... Beclamide....... Anticonvulsant.. Lacks FDA
approval.
CONTROLLED.................... S7 C Beclomethasone.. Corticosteroid.. Qvar, Qnasl,
Beclovent.
BANNED........................ S0 ................... Bemegride....... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Benactyzine..... Anticholinergic. Lacks FDA
approval.
BANNED........................ S0 ................... Benapryzine..... Anticholinergic. Lacks FDA
approval.
BANNED........................ S0 ................... Benazepril...... Antihypertensive Lotensin, Lotrel
(with
amlodipine).
BANNED........................ S5 ................... Bendroflumethiaz Diuretic........ Naturetin,
ide. Corzide.
BANNED........................ S0 ................... Benorilate...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Benoxaprofen.... NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 C Benoxinate(Oxybu Local anesthetic Altafluor Benox
caine, [with
Oxybuprocaine). fluorescein
stain].
BANNED........................ S0 ................... Benperidol...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Bentazepam...... Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 B Benzocaine...... Local anesthetic Orajel, Anbesol,
Lanacane.
BANNED........................ S0 ................... Benzoctamine.... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Benzonatate..... Antitussive..... Tessalon.........
BANNED........................ S0 ................... Benzphetamine... Stimulant....... Generic. DEA
Schedule III.
BANNED........................ S0 ................... Benzquinamide... Antipsychotic/ Discontinued, no
Anti-emetic. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Benzthiazide.... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Benztropine..... Anticholinergic. Generic..........
BANNED........................ S0 ................... Benzydamine..... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Benzylpiperazine Stimulant....... Lacks FDA
(BZP). approval.
BANNED........................ S0 ................... Bepridil........ Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 C Betamethasone... Corticosteroid.. Betavet, ................ 0.2 ng/mL in
Celestone. urine.
BANNED........................ S0 ................... Betaprodine..... Opioid Analgesic Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S0 ................... Betaxolol....... Antihypertensive Betoptic.........
CONTROLLED.................... S7 C Bethanechol..... Cholinergic..... Duovoid..........
BANNED........................ S0 ................... Bethanidine Antihypertensive Discontinued, no
(Betanidine). FDA-approved
product
commercially
available.
BANNED........................ S4 ................... Bimagrumab...... Anabolic........ Lacks FDA
approval (Orphan
drug designation
withdrawn).
BANNED........................ S0 ................... Biperiden....... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Biphenamine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Biprsoprolol.... Antihypertensive Ziac [with
hydrochlorothiaz
ide].
BANNED........................ S0 ................... Biriperone Antipsychotic... Lacks FDA
(Centbutindole). approval.
BANNED........................ S0 ................... Bitolterol...... Beta-2 agonist- Discontinued, no
bronchodilator. FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Bolandiol (estr- Anabolic........ Lacks FDA
4-ene3[beta], approval.
17[beta]-diol).
BANNED........................ S1 ................... Bolasterone Anabolic........ Lacks FDA
(7[alpha], approval. DEA
17[alpha]- Schedule III.
dimethyltestost
erone).
BANNED........................ S1 ................... Boldenone....... Anabolic........ Equipoise. DEA ................ Threshold: 0.015
Schedule III. mcg free and
conjugated
boldenone per
mL in urine in
male horses
(other than
geldings).
BANNED........................ S1 ................... Boldione........ Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S6 ................... Botulinum toxin. Neurotoxin...... Botox, Dysport,
Jeuveau.
BANNED........................ S0 ................... Brallobarbital.. Barbiturate..... Lacks FDA
approval.
CONTROLLED.................... S7 B Bretylium....... Antiarrhythmic.. Generic..........
BANNED........................ S0 ................... Brimonidine..... Antihypertensive Alphagan P,
Qoliana, Lumify.
CONTROLLED.................... S7 B Brinzolamide.... Carbonic Simbrinza, Azopt.
Anhydrase
Inhibitor.
BANNED........................ S0 ................... Bromantan....... Psychostimulant. Lacks FDA
approval.
BANNED........................ S0 ................... Bromazepam...... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
CONTROLLED.................... S7 A Bromfenac....... NSAID........... Prolensa,
Bromsite.
BANNED........................ S0 ................... Bromhexine...... Mucolytic....... Lacks FDA
approval.
BANNED........................ S0 ................... Bromisovalum.... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Bromocriptine... Anticholinergic. Parlodel,
Cycloset.
[[Page 5130]]
CONTROLLED.................... S7 B Bromodiphenhydra Antihistamine... Ambodryl,
mine. Ambrodil.
BANNED........................ S0 ................... Bromophenethylam Psychedelic..... Lacks FDA
ine. approval.
BANNED........................ S0 ................... Bromperidol..... Antipsychotic... Lacks FDA
approval.
CONTROLLED.................... S7 B Brompheniramine. Antihistamine... Dimetapp.........
BANNED........................ S0 ................... Brotizolam...... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Bucetin......... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Buclizine....... Antihistamine/ Discontinued, no
Anti-emetic. FDA-approved
product
commercially
available.
CONTROLLED.................... S7 C Budesonide...... Corticosteroid.. Uceris, Entocort,
Tarpeyo,
Ortikos,
Pulmicor
Flexhaler,
Symbicort (with
formoterol),
Rhinocort
Allergy.
BANNED........................ S0 ................... Bufexamac....... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Buflomedil...... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 (x) Bufotenine...... Hallucinogen.... Lacks FDA ................ 10 mcg/mL Total
approval. DEA (free and
Schedule I. conjugated) in
urine,
BANNED........................ S5 ................... Bumetanide...... Diuretic........ Bumex............
BANNED........................ S0 ................... Bunitrolol...... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Bunolol......... Anti- Betagan..........
hypertensive.
BANNED........................ S0 ................... Buphenine Vasodilator..... Lacks FDA
(nylidrin). approval.
CONTROLLED.................... S7 B Bupivacaine..... Local anesthetic Marcaine,
Sensorcaine,
Exparel.
BANNED........................ S0 ................... Bupranolol...... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 A Buprenorphine... Analgesic....... Simbadol,
Zorbium,
Butrans,
Sublocade,
Belbuca,
Buprenex,
Zubsolv. DEA
Schedule III.
BANNED........................ S0 ................... Bupropion....... Antidepressant.. Wellbutrin, Zyban
BANNED........................ S4 ................... Buserelin....... Gonadotropin Lacks FDA
Releasing approval.
Hormone.
CONTROLLED.................... S7 A Buspirone....... Anxiolytic...... Generic..........
BANNED........................ S0 ................... Butabarbital Barbiturate..... Discontinued, no
(Secbutobarbito FDA-approved
ne). product
commercially
available. DEA
Schedule III.
BANNED........................ S0 ................... Butacaine....... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Butalbital Barbiturate..... Esgic, Fioricet.
(Talbutal). DEA Schedule III.
CONTROLLED.................... S7 C Butamben (butyl Local anesthetic Cetacaine........
aminobenzoate).
BANNED........................ S0 ................... Butanilicaine... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Butaperazine.... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Butoctamide..... Serotonin Lacks FDA
release. approval.
BANNED........................ S0 ................... Butofilolol..... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 B Butorphanol..... Sedative........ Torbugesic, Detection Time: 1 ng/mL in
Tobutrol, 72 hrs. 0.1 mg/ hydrolyzed
Stadol, Dolorex. kg single IV urine or 0.01
DEA Schedule IV. dose (6 horses). ng/mL plasma or
serum.
BANNED........................ S0 ................... Butoxycaine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Cafedrine....... Cardiac Lacks FDA
Stimulant. approval.
CONTROLLED.................... S7 B (x) Caffeine........ Stimulant....... Cafcit, Migergot ................ 50 ng/mL (free
(with and conjugated)
ergotamine), in urine.
combined with
NSAIDs in OTC
formulations.
Recognized by
IFHA as Feed
Contaminant.
BANNED........................ S0 ................... Calcium Vasoprotective.. Lacks FDA
dobesilate. approval.
BANNED........................ S1 ................... Calusterone Anabolic........ Lacks FDA
(Methosarb, approval. (NSC-
Riedemil, NSC- 88536, U-22550)
88536, U-22550). DEA Schedule III.
BANNED........................ S0 ................... Camazepam....... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
CONTROLLED.................... S7 C Camphor......... Local anesthetic Vicks VapoRub....
BANNED........................ S0 ................... Candesartan..... Antihypertensive Atacand..........
CONTROLLED.................... S7 B Cannabidiol Analgesic/anti- Epidiolex........
(CBD). inflammatory.
[[Page 5131]]
BANNED........................ S0 (x) Cannabinoids Psychotropic.... Lack FDA approval
(natural,
synthetic and
other
cannabimimetics
).
BANNED........................ S5 ................... Canrenone....... Diuretic........ Lacks FDA
approval.
BANNED........................ S1 ................... Capromorelin.... Anabolic........ Entyce, Elura....
CONTROLLED.................... S7 B Capsaicin....... Topical Zostrix, Salonpas
analgesic/ Hot.
irritant.
BANNED........................ S0 ................... Captodiame Antihistamine... Lacks FDA
(captodiamine). approval.
BANNED........................ S0 ................... Captopril....... Antihypertensive Generic..........
BANNED........................ S0 ................... Caramiphen...... Anticholinergic. Lacks FDA
approval.
BANNED........................ S0 ................... Carazolol....... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 B Carbachol....... Cholinergic..... Miostat..........
CONTROLLED.................... S7 B Carbamazepine... Anticonvulsant.. Tegretol,
Carbatrol,
Equetro, Teril.
BANNED........................ S2 ................... Carbamylated EPO Erythropoiesi...
(CEPO).
BANNED........................ S0 ................... Carbazochrome Hemostatic...... Lacks FDA
(Adrenochrome approval.
monosemicarbazo
ne).
BANNED........................ S0 ................... Carbetapentane Antitussive..... Lacks FDA
(pentoxyverine). approval.
BANNED........................ S0 ................... Carbidopa....... Decarboxylase Lodosyn; Stalevo,
Inhibitor. Rytary, Duopa,
Dhivy, Sinemet
(all with
levodopa).
BANNED........................ S0 ................... Carbimazole..... Anti- Lacks FDA
hyperthyroidism. approval.
CONTROLLED.................... S7 B Carbinoxamine... Antihistamine... Karbinal ER......
BANNED........................ S0 ................... Carbocysteine... Mucolytic....... Lacks FDA
approval.
BANNED........................ S0 ................... Carbromal....... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Carbuterol...... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S1 ................... Cardarine (GW- Selective Lacks FDA
501, GW516, GSK- Androgen approval.
516). Receptor
Modulator
(SARM).
BANNED........................ S0 ................... Carfentanil..... Opioid Analgesic Lacks FDA
approval. DEA
Schedule II.
CONTROLLED.................... S7 B Carisoprodol.... Muscle relaxant. Soma. DEA
Schedule IV.
BANNED........................ S0 ................... Carphedon....... Psychostimulant. Lacks FDA
approval.
BANNED........................ S0 ................... Carphenazine.... Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Carpipramine.... Antipsychotic... Lacks FDA
approval.
CONTROLLED.................... S7 B Carprofen....... NSAID........... Rimadyl..........
BANNED........................ S3 ................... Carteolol....... Antihypertensive Generic..........
CONTROLLED.................... S7 B Carticaine (see Local anesthetic Septocaine,
Articaine). Orbloc.
BANNED........................ S0 ................... Carvedilol...... Antihypertensive Coreg............
BANNED........................ S0 ................... Cathinone....... Stimulant....... Lacks FDA
approval. DEA
Schedule I.
CONTROLLED.................... S7 B Celecoxib....... NSAID........... Celebrex.........
BANNED........................ S0 ................... Celiprolol...... Anti- Lacks FDA
hypertensive. approval.
BANNED........................ S0 ................... Cephaeline...... Emetic, plant Lacks FDA
alkaloid. approval.
CONTROLLED.................... S7 C Cetirizine...... Antihistamine... Quzyttir, Detection Time: 3 ng/mL in serum
Zerviate, Zyrtec. 48 hours. 0.4 or plasma.
mg/kg twice
daily for 5
doses. (9
horses).
BANNED........................ S0 ................... Chlomethiazole.. Anticonvulsant.. Lacks FDA
approval.
BANNED........................ S0 ................... Chloral (cloral) Sedative/ Lacks FDA
betaine. Hypnotic. approval. DEA
Schedule IV.
BANNED........................ S0 ................... Chloral hydrate. Sedative........ Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Chloralose Anxiolytic...... Lacks FDA
(AlphaChloralos approval.
e).
BANNED........................ S0 ................... Chlorcyclizine.. Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Chlordiazepoxide Anxiolytic...... Librium; Librax
(with
chlordiazepoxide
hydrochloride).
DEA Schedule IV.
BANNED........................ S0 ................... Chlormadinone Reproductive Lacks FDA
acetate. hormone. approval.
BANNED........................ S0 ................... Chlormerodrin... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Chlormezanone... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Chloroform...... Anesthetic...... Lacks FDA
approval.
BANNED........................ S0 ................... Chlorophenylpipe Psychoactive.... Lacks FDA
razine. approval.
CONTROLLED.................... S7 A Chloroprocaine.. Local anesthetic Nesacaine........
BANNED........................ S0 ................... Chloropyramine.. Antihistamine... Lacks FDA
approval.
BANNED........................ S5 ................... Chlorothiazide.. Diuretic........ Diuril...........
BANNED........................ S0 ................... Chlorphenesin... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
[[Page 5132]]
CONTROLLED.................... S7 B Chlorpheniramine Antihistamine... ChlorTrimeton....
BANNED........................ S0 ................... Chlorphenoxamine Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Chlorphentermine Stimulant....... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Chlorproethazine Muscle relaxant. Lacks FDA
approval.
BANNED........................ S0 ................... Chlorpromazine.. Sedative........ Generic..........
BANNED........................ S0 ................... Chlorpropamide.. Hypoglycemic.... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Chlorprothixene. Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S5 ................... Chlorthalidone.. Diuretic........ Thalitone........
BANNED........................ S0 ................... Chlorthenoxazine NSAID........... Lacks FDA
approval.
BANNED........................ S5 ................... Chlorthiazide Diuretic........ Diuril...........
(Chlorothiazide
).
CONTROLLED.................... S7 B Chlorzoxazone... Muscle relaxant. Generic..........
CONTROLLED--fillies and mares. S7 B Chorionic Reproductive Pregnyl--biologic
Gonadotropin hormone. , does not
(CG). require FDA
approval.
BANNED--intact males and S2 ................... Chorionic Reproductive Pregnyl..........
geldings. Gonadotropin hormone.
(CG).
CONTROLLED.................... S7 C Ciclesonide..... Corticosteroid.. Aservo EquiHaler, Detection Time: ................
Alvesco. 48 hours. 5.5
mg/day x 5
days, then 4.1
mg/day x 5 days
via inhalation
(Aservo
Equihaler). (6
horses).
BANNED........................ S0 ................... Cicloprofen..... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Cilazapril...... Anti- Lacks FDA
hypertensive. approval.
CONTROLLED.................... S7 B Cilostazol...... Vasodilator..... Pletal...........
BANNED........................ S0 ................... Cimaterol....... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S3 ................... Cimbuterol...... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
CONTROLLED.................... S7 C Cimetidine...... Anti-ulcer...... Tagamet.......... Restricted 400 ng/mL in
administration serum or
time: 24 hours. plasma.
20 mg/kg orally
twice daily for
a total of 7
doses (9
horses).
BANNED........................ S0 ................... Cinchocaine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Cinchophen...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Cinnarizine..... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Citalopram...... Antidepressant.. Celexa...........
BANNED........................ S0 ................... Clanobutin...... Cholerectic..... Lacks FDA
approval.
CONTROLLED.................... S7 B Clemastine...... Antihistamine... Tavist, Dayhist..
BANNED........................ S0 ................... Clemizole....... Antihistamine... Lacks FDA
approval.
CONTROLLED.................... S7 B Clenbuterol..... Beta-2 agonist- Ventipulmin...... Treated horse
bronchodilator. Vet Listed for
minimum 21 days
after last
treatment.
Official
Workout and
Clearance
Testing (blood
and urine)
required to re-
establish
eligibility to
race. Dosing
specification:
0.8 mcg/kg
orally twice
daily for up to
30 days total
in a 6 month
period.
BANNED........................ S3 ................... Clenpenterol.... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S0 ................... Clibucaine...... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Clidinium....... Anticholinergic. No FDA-approved
produc.
BANNED........................ S0 ................... Clobazam........ Anxiolytic...... Sympazan, Onfi.
DEA Schedule IV.
BANNED........................ S0 ................... Clobenzorex..... Stimulant....... Lacks FDA
approval.
[[Page 5133]]
CONTROLLED.................... S7 C Clobetasol...... Corticosteroid.. Olux, Cormax,
Embeline,
Impoyz, Clobex,
Impeklo.
CONTROLLED.................... S7 C Clocortolone.... Corticosteroid.. Cloderm..........
BANNED........................ S6 ................... Clodronate Bisphosphonate.. OsPhos...........
(Clodronic
acid).
BANNED........................ S5 ................... Clofenamid...... Carbonic Lacks FDA
Anhydrase approval.
Inhibitor.
BANNED........................ S0 ................... Clomethiazole Sedative/ Lacks FDA
(Chlormethiazol Hypnotic. approval.
e).
BANNED........................ S4 ................... Clomifene....... Induce ovulation Generic..........
BANNED........................ S0 ................... Clomipramine.... Antidepressant.. Clomicalm........
BANNED........................ S0 ................... Clonazepam...... Anxiolytic...... Klonopin. DEA
Schedule IV.
CONTROLLED.................... S7 A Clonidine....... Antihypertensive/ Catapres-TTS.....
Analgesic.
BANNED........................ S0 ................... Clonixin........ NSAID........... Lacks FDA
approval.
BANNED........................ S5 ................... Clopamide....... Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Cloranolol...... Antihypertensive Lacks FDA
approval.
BANNED........................ S0 ................... Clorazepate..... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Clormecaine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Clorprenaline... Bronchodilator.. Lacks FDA
approval.
BANNED........................ S1 ................... Clostebol....... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Clotiapine...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Clotiazepam..... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Cloxazolam...... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Clozapine....... Antipsychotic... Clozaril,
Versacloz.
BANNED........................ S2 ................... CNTO 530........ Erythropoiesis.. Lacks FDA
approval.
BANNED........................ S2 ................... Cobalt Salts Erythropoiesi... ................. ................ Threshold: 0.1
(e.g., CoCl2). mcg/mL total
Cobalt in urine
OR 0.025 mcg/mL
total (free and
protein bound)/
mL in serum or
plasma.
BANNED........................ S6 ................... Cobratoxin, Neurotoxin...... Lacks FDA
alpha. approval.
BANNED........................ S0 ................... Cocaine Stimulant....... Goprelto,
(metabolite: Numbrino. DEA
benzoylecgonine Schedule II.
).
BANNED........................ S0 ................... Codeine......... Opioid Analgesic Generic (DEA
Schedule II or
in combination
with NSAIDs,
caffeine and
other drugs (DEA
Schedule III).
CONTROLLED.................... S7 B (x) Colchicine...... Anti-gout....... Colcrys, Mitigare
BANNED........................ S0 ................... Conorphone...... Opioid Analgesic Lacks FDA
approval.
BANNED........................ S2 ................... Corticorelin.... Corticosteroid Approved Oprhan
stimulation. Drug.
CONTROLLED.................... S7 B Corticotrophin.. Corticosteroid ACTH-80, Acthar
stimulation. Gel.
BANNED........................ S0 ................... Cortivazol...... Glucocorticoid.. Lacks FDA
approval.
BANNED........................ S0 ................... Cotinine Psychoactive/ Lacks FDA
(Cotinine is a Anxiolytic. approval.
metabolite of
nicotine. If
there is
credible
evidence that
the presence of
cotinine in a
horse's sample
is a
consequence of
nicotine
exposure, the
classification
of cotinine may
be revised to
S7(A).).
CONTROLLED.................... S7 C Cromolyn Mast Cell Gastrocrom.......
(Cromoglycate). Stabilizer.
BANNED........................ S0 ................... Cropropamide.... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S0 ................... Crotethamide.... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S0 ................... Cyamemazine..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Cyclandelate.... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Cyclizine....... Antihistamine... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Cyclobarbital... Barbiturate..... Lacks FDA
approval.
CONTROLLED.................... S7 B Cyclobenzaprine. Muscle relaxant. Flexeril, Amrix..
BANNED........................ S4 ................... Cyclofenil...... Selective Lacks FDA
Estrogen approval.
Receptor
Modulator
(SERM).
BANNED........................ S0 ................... Cycloguanil..... Antimalarial.... Lacks FDA
approval.
BANNED........................ S0 ................... Cyclomethycaine. Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Cyclopentamine.. Vasoconstrictor. Lacks FDA
approval.
[[Page 5134]]
CONTROLLED.................... S7 ................... Cyclopentolate.. Mydriatic....... Akpentolate,
Cyclogyl,
Pentolair,
Cyclomydril.
BANNED........................ S0 ................... Cyclophenil..... Selective Lacks FDA
Estrogen approval.
Receptor
Modulator
(SERM).
BANNED........................ S0 ................... Cyclothiazide... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Cycrimine....... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Cyproheptadine.. Antihistamine... Periactin........
BANNED........................ S4 ................... Dalantercept Anti-neoplastic. Lacks FDA
(ACE-041). approval.
BANNED........................ S1 ................... Danazol......... Anabolic........ Generic..........
CONTROLLED.................... S7 C Dantrolene...... Muscle relaxant. Dantrium......... Detection Time: 3 ng/mL of 5-
48 hrs. 500 mg hydroxydantrole
orally once ne in urine;
daily for 3 0.1 ng/mL in
days. (12 serum or plasma
horses). as 3'-
hydroxydantrole
ne.
BANNED........................ S2 ................... Darbepoetin Erythropoiesis.. Aranesp..........
(dEPO).
BANNED........................ S0 ................... Decamethonium... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Dehydrochloromet Anabolic........ Turinabol. DEA
hyltestos- Schedule III.
terone..........
BANNED........................ S0 ................... Delmadinone Reproductive Lacks FDA
acetate. hormone. approval.
BANNED........................ S0 ................... Delorazepam..... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Dembroxol Mucolytic....... Lacks FDA
(Dembrexine). approval.
BANNED........................ S0 (x) Demecolcine..... Anti-neoplastic/ Lacks FDA
Immunomodulator. approval.
BANNED........................ S0 ................... Demoxepam....... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Deoxycorticoster Minerlocorticoid Lacks FDA
one. approval.
BANNED........................ S0 ................... Deptropine...... Antihistamine... Lacks FDA
approval.
CONTROLLED.................... S7 B Deracoxib....... NSAID........... Deramaxx.........
BANNED........................ S6 ................... Dermorphin...... Opioid Receptor Lacks FDA
Agonist. approval.
BANNED........................ S0 ................... Deserpidine..... Antihypertensive Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Desipramine..... Antidepressant.. Norpramin........
CONTROLLED--fillies and Mares. S7 B Deslorelin...... Induce ovulation Ovuplant,
SucroMate,
Suprelorin.
BANNED--intact males and S4 ................... Deslorelin...... Reproductive Ovuplant,
geldings. hormone. SucroMate,
Suprelorin.
BANNED........................ S5 ................... Desmopressin.... Anti-diuretic... DDAVP, Nocdurna..
CONTROLLED.................... S7 C Desonide........ Corticosteroid.. Verdeso, Desowen.
CONTROLLED.................... S7 C Desoximethasone Corticosteroid.. Topicor..........
(desoxymethason
e,
desoximetasone).
BANNED........................ S1 ................... Desoxymethyltest Anabolic........ Lacks FDA
osterone. approval. DEA
Schedule III.
BANNED........................ S1 ................... Desoxyvinyl- Anabolic........ Lacks FDA
testosterone. approval.
CONTROLLED.................... S7 B Detomidine...... Sedative/ Dormosedan....... Detection Time: 2 ng/mL 3-
Analgesic. 48 hrs. 0.02 mg/ carboxydetomidi
kg single IV ne in urine;
dose (10 0.02 ng/mL in
horses). serum or
plasma.
CONTROLLED.................... S7 C Dexamethasone... Corticosteroid.. Azium, Dexasone.. Detection Time: 0.2 ng/mL in
72 hours. urine.
Single 20 mg
oral dose (20
horses).
CONTROLLED.................... S7 C Dexamethasone Corticosteroid.. Generic.......... Detection Time:
Sodium 72 hours. 0.06
phosphate. mg/kg single IV
dose (6 horses).
CONTROLLED.................... S7 B Dextromethorphan Antitussive..... Delsym,
Robitussin.
[[Page 5135]]
BANNED........................ S0 ................... Dextromoramide.. Opioid Analgesic Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S0 ................... Dextropropoxyphe Opioid Analgesic Discontinued, no
ne. FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Dextrorphan Psychoactive/ Lacks FDA
(Dextrorphan Antitussive. approval.
may be present
as a metabolite
of
dextromethorpha
n. If there is
credible
evidence that
the presence of
dextrorphan in
the horse's
sample is the
consequence of
dextromethorpha
n
administration,
the
classification
of dextrorphan
may be revised
to S7(A).).
BANNED........................ S0 ................... Dezocine........ Opioid Analgesic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Diacerein....... Anti- Lacks FDA
osteoarthritic. approval.
BANNED........................ S0 ................... Diamorphine Opioid Analgesic Lacks FDA
(diacetylmorphi approval. DEA
ne). Schedule I.
CONTROLLED.................... S7 B Diazepam........ Anxiolytic...... Valium. DEA
Schedule IV.
BANNED........................ S0 ................... Diazoxide....... Antihypertensive/ Proglycem........
Hyperglycemic.
BANNED........................ S0 ................... Dibenzepin...... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Dibucaine....... Local anesthetic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Dichlorisone.... Corticosteroid.. Lacks FDA
approval.
BANNED........................ S0 ................... Dichloroacetate. Anti-neoplastic. Lacks FDA
approval.
CONTROLLED.................... S7 C Dichlorphenamide Carbonic Keveyis..........
Anhydrase
Inhibitor.
CONTROLLED.................... S7 C Diclofenac...... NSAID........... Surpass, Voltaren ................ 50 ng/mL in
urine.
BANNED........................ S0 ................... Dicumarol....... Anticoagulant... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Diethylpropion.. Stimulant....... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Diethylthiambute Opioid Analgesic Lacks FDA
ne. approval. DEA
Schedule I.
BANNED........................ S0 ................... Diethyltryptamin Hallucinogen.... Lacks FDA
e (DET). approval.
CONTROLLED.................... S7 C Diflorasone..... Corticosteroid.. Florone..........
BANNED........................ S0 ................... Diflucortolone.. Corticosteroid.. Lacks FDA
approval.
BANNED........................ S0 ................... Diflunisal...... NSAID........... Generic..........
BANNED........................ S0 ................... Digitoxin....... Antiarrhythmic.. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Digoxin......... Antiarrhythmic.. Lanoxin..........
BANNED........................ S0 ................... Dihydrocodeine.. Opioid Analgesic Trezix (with
acetaminophen
and caffeine)
DEA Schedule III.
BANNED........................ S0 ................... Dihydrocodeinone Opioid Analgesic Lacks FDA
approval.
CONTROLLED.................... S7 B Dihydroergotamin Ergot alkaloid.. Migranal,
e mesylate. Trudhesa.
BANNED........................ S0 ................... Dihydromorphine. Opioid Analgesic Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S1 ................... Dihydrotestoster Anabolic........ Anabolex,
one (17[beta]- Andractimm,
hydroxy-5a Pesomax,
androstan-3- Stanolone. DEA
one, Schedule III.
Androstanolone).
BANNED........................ S0 ................... Diisopropylamine Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Diltiazem....... Antihypertensive Cardizem CD,
Taztia XT,
Tiazac.
BANNED........................ S0 ................... Dimefline....... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S0 ................... Dimethindene.... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Dimethisoquin Local anesthetic Lacks FDA
(quinocaine). approval.
BANNED........................ S0 ................... Dimethylamphetam Stimulant....... Lacks FDA
ine. approval.
BANNED........................ S0 ................... Dimethylphenidat Stimulant....... Lacks FDA
e. approval.
[[Page 5136]]
CONTROLLED.................... S7 C Dimethylsulfoxid NSAID........... Domoso........... Detection Time: 15 mcg/mL in
e (DMSO). 48 hrs. 70 mL urine or 1,000
90% DMSO in 500 ng/mL in serum
mL LRS IV or plasma.
single Note: The
administration detection of
(30 horses). more than one
NSAID in a
horse's post-
Race or Post-
Official
Workout blood
sample
constitutes a
Stacking
Violation.
BANNED........................ S0 (x) Dimethyltryptami Hallucinogen.... Lacks FDA ................ 10 mcg/mL total
ne (DMT). approval. DEA (free and
Schedule I. conjugated) in
urine.
BANNED........................ S0 ................... Diphenadione.... Anticoagulant... No FDA-approved
product.
Rodenticide.
CONTROLLED.................... S7 B Diphenhydramine. Antihistamine... Benadryl.........
CONTROLLED.................... S7 B Diphenoxylate... Anti-diarrheal.. DEA Schedule II.
Lomotil (with
atropine), DEA
Schedule II.
BANNED........................ S0 ................... Diphenylpyraline Antihistamine... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Dipipanone...... Opioid Analgesic Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S0 ................... Diprenorphine... Narcotic M50-50...........
antagonist.
BANNED........................ S0 ................... Diprophylline... Bronchodilator.. Lacks FDA
approval.
CONTROLLED.................... S7 B Dipyridamole.... Platelet Persantine.......
inhibitor.
CONTROLLED.................... S7 C Dipyrone........ NSAID/Anti- Zimeta........... Detection Time: 1,000 ng/mL of 4-
pyretic. 72 hrs. 30 mg/ methylaminoanti
kg single IV pyrine in
dose (10 urine. Note:
horses). The detection
of more than
one NSAID in a
horse's post-
Race or Post-
Official
Workout blood
sample
constitutes a
Stacking
Violation.
CONTROLLED.................... S7 B Disopyramide.... Antiarrhythmic.. Norpace,
Rythmodan.
BANNED........................ S0 ................... Disulfiram...... Alcohol Generic..........
antagonist.
BANNED........................ S0 ................... Divalproex...... Anticonvulsant.. Depakote.........
BANNED........................ S0 ................... Dixyrazine...... Antipsychotic... Lacks FDA
approval.
CONTROLLED.................... S7 B Dobutamine...... Beta-1 agonist.. Generic..........
BANNED........................ S4 ................... Domagrozumab.... Anabolic........ Lacks FDA
approval.
BANNED........................ S0 ................... Donepezil....... Behavior and Adilarity, Aricep
Cognitive
Modifier.
CONTROLLED.................... S7 A Dopamine........ Neurotransmitter Generic..........
BANNED........................ S0 ................... Dopexamine...... Vasodilator..... Lacks FDA
approval.
CONTROLLED.................... S7 B Dorzolamide..... Carbonic Cosop............
Anhydrase
Inhibitor.
BANNED........................ S0 ................... Dothiepin....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Doxacurium...... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Doxapram........ Respiratory Dopram, Respiram.
Stimulant.
BANNED........................ S0 ................... Doxazosin....... Antihypertensive Cardura..........
BANNED........................ S0 ................... Doxefazepam..... Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 A Doxepin......... Antidepressant.. Generic..........
CONTROLLED.................... S7 B Doxylamine...... Antihistamine... Unisom...........
BANNED........................ S1 ................... Dromostanolone Anabolic........ Lacks FDA
(drostanolone). approval.
BANNED........................ S0 ................... Droperidol...... Antipsychotic... Inapsine.........
BANNED........................ S0 ................... Drospirenone.... Reproductive Slynd,
hormone. Nextstellis,
Angeliq, Lo-
Zumandimine,
Loryna, elamisa,
Nikki, Yaz.
BANNED........................ S0 ................... Duloxetine...... Antidepressant.. Cymbalta,
Drizalma.
CONTROLLED.................... S7 C Dyclonine....... Topical Dyclopro.........
anesthetic.
BANNED........................ S0 ................... Dyphylline Antipsychotic/ Discontinued, no
(Diphylline). Anti-emetic. FDA-approved
product
commercially
available.
[[Page 5137]]
BANNED........................ S0 ................... Edrophonium..... Muscle Discontinued, no
strengthener. FDA-approved
product
commercially
available.
BANNED........................ S2 ................... Efaproxiral Hemoglobin FDA orphan drug..
(RSR13). modifier.
BANNED........................ S0 ................... Eletriptan...... Selective Relpax...........
Serotonin
Receptor
Agonist.
BANNED........................ S0 ................... Eltenac......... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Embramine....... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Embutramide..... Opioid Analgesic Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Emepronium...... Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Emidonol........ Anti- Lacks FDA
inflammatory. approval.
BANNED........................ S0 ................... Enalapril Angiotensin- Vasotec..........
(metabolite converting
enaloprilat). enzyme
inhibitor.
BANNED........................ S0 ................... Enciprazine..... Anxiolytic/ Lacks FDA
Antipsychotic. approval.
CONTROLLED.................... S7 A Ephedrine....... Stimulant....... Akovaz,
Corphedra,
Emerphed.
BANNED........................ S6 ................... Epibatidine..... Analgesic....... Lacks FDA
approval.
BANNED........................ S1 ................... Epi- Anabolic........ Lacks FDA
dihydrotestoste approval. DEA
rone. Schedule III.
CONTROLLED.................... S7 A Epinephrine..... Stimulant....... Adrenalin,
Epipen,
Adrenaclick,
Auvi-Q, Symjepi,
Primatene Mist.
BANNED........................ S1 ................... Epitestosterone. Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Eplerenone...... Antihypertensive Inspra...........
BANNED........................ S2 ................... EPO-based Erythropoiesis.. Lacks FDA
constructs approval.
(e.g. EPO-Fc).
BANNED........................ S2 ................... EPO-mimetic Erythropoiesis.. .................
agents (e.g.
CNTO-530,
peginesatide).
BANNED........................ S0 ................... Ergonovine...... Ergot alkaloid.. Lacks FDA
approval.
BANNED........................ S0 (x) Ergotamine...... Ergot alkaloid.. Ergomar, Migergot
(with caffeine).
BANNED........................ S0 ................... Erythritol Vasodilator..... Lacks FDA
tetranitrate. approval.
BANNED........................ S2 ................... Erythropoietin Erythropoiesis..
(EPO).
BANNED........................ S0 ................... Esmolol......... Antihypertensive Brevibloc........
CONTROLLED.................... S7 C Esomeprazole.... Anti-ulcer...... Nexium...........
BANNED........................ S0 ................... Estazolam....... Sedative/ Prosom. DE
Anticonvulsant. Schedule IV.
CONTROLLED--in male horses S7 B Estranediol..... Estroge......... ................. ................ Threshold: 0.045
(other than geldings). mcg/mL total
(free and
conjugated)
5[alpha]-
estrane-
3[beta],
17[alpha]-diol
per millilitre
in urine when,
at screening,
the total
5[alpha]-
estrane-
3[beta],
17[alpha]-diol
exceeds the
total 5,10
estrene-
3[beta],17[alph
a]-diol in
urine.
BANNED........................ S0 ................... Eszopiclone..... Hypnotic........ Lunesta..........
BANNED........................ S0 ................... Etafedrine...... Bronchodilator.. Lacks FDA
approval.
BANNED........................ S0 ................... Etamiphylline... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S0 ................... Etamivan Respiratory Lacks FDA
(Ethamivan). Stimulant. approval.
CONTROLLED.................... S7 B Etanercept...... NSAID........... Enbrel...........
BANNED........................ S5 ................... Ethacrynic acid Diuretic........ Edecrin..........
(Etacrynic
acid).
BANNED........................ S0 ................... Ethamivan....... Respiratory Lacks FDA
Stimulant. approval.
BANNED........................ S0 ................... Ethamsylate..... Antihemorrhagic. Lacks FDA
approval.
BANNED........................ S0 ................... Ethanol......... Depressant...... Grain alcohol,
Everclear.
BANNED........................ S0 ................... Ethaverine...... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Ethchlorvynol... Sedative/ Discontinued, no
Hypnotic. FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Ethiazide....... Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Ethinamate...... Sedative/ Discontinued, no
Hypnotic. FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Ethinylestradiol Reproductive Lacks FDA
hormone. approval.
BANNED........................ S0 ................... Ethoheptazine... Analgesic....... Lacks FDA
approval.
BANNED........................ S0 ................... Ethopropazine... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Ethosuximide.... Anticonvulsant.. Zarontin.........
[[Page 5138]]
BANNED........................ S0 ................... Ethotoin........ Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Ethoxzolamide... Carbonic Discontinued, no
Anhydrase FDA-approved
Inhibitor. product
commercially
available.
BANNED........................ S0 ................... Ethyl Sedative........ Lacks FDA
isobutrazine. approval.
BANNED........................ S0 ................... Ethyl Sedative Discontinued, no
Loflazepate. Anxiolytic. FDA-approved
product
commercially
available. DEA
Schedule IV.
CONTROLLED.................... S7 C Ethylaminobenzoa Local anesthetic Orajel...........
te (Benzocaine).
BANNED........................ S0 ................... Ethylamphetamine Stimulant....... Lacks FDA
approval.
BANNED........................ S1 ................... Ethylestrenol... Anabolic........ Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule III.
BANNED........................ S0 ................... Ethylmorphine... Opioid Analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Ethylnorepinephr Stimulant....... Lacks FDA
ine. approval.
BANNED........................ S0 ................... Ethylphenidate.. Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Etidocaine...... Local anesthetic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Etifoxine Anticonvulsant.. Lacks FDA
(etafenoxine). approval.
BANNED........................ S0 ................... Etilefrine...... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Etiocholanolone. Anabolic........ Lacks FDA
approval.
BANNED........................ S0 ................... Etizolam........ Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 B Etodolac........ NSAID........... Generic..........
BANNED........................ S0 ................... Etodroxizine.... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Etofenamate..... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Etomidate....... Anesthetic...... Amidate..........
BANNED........................ S0 ................... Etoricoxib...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Etorphine HCl... Opioid analgesic M99. DEA Schedule
I.
BANNED........................ S2 ................... Examorelin Growth Hormone.. Lacks FDA
(hexarelin). approval.
BANNED........................ S4 ................... Exemestane...... Aromatase Aromasin.........
inhibitor.
CONTROLLED.................... S7 C Famotidine...... Anti-ulcer...... Duexis, Pepcid...
BANNED........................ S0 ................... Famprofazone.... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Febarbamate..... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Felbamate....... Anticonvulsant.. Trezix, Tuxari,
Triacin-C.
BANNED........................ S0 ................... Felbinac........ NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Felodipine...... Antihypertensive Generic..........
BANNED........................ S0 ................... Fenbufen........ NSAID........... Felbatol.........
BANNED........................ S0 ................... Fenbutrazate.... Psychostimulant. Lacks FDA
approval.
BANNED........................ S0 ................... Fencamfamine.... Stimulant....... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Fencamine....... Psychostimulant. Lacks FDA
approval.
BANNED........................ S0 ................... Fenclofenac..... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Fenclozic acid.. NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Fenetylline Psychostimulant. Lacks FDA
(fenetylline, approval.
phenethylline,
phenetylline).
BANNED........................ S0 ................... Fenfluramine.... Stimulant....... Fintepla. DEA
Schedule IV.
CONTROLLED.................... S7 B Fenoldopam...... Vasodilator..... Corlopam.........
CONTROLLED.................... S7 B Fenoprofen...... NSAID........... Nalfon...........
BANNED........................ S3 ................... Fenoterol....... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S0 ................... Fenozolone...... Psychostimulant. Lacks FDA
approval.
BANNED........................ S0 ................... Fenpiprane...... Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Fenproporex..... Stimulant....... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Fenspiride...... Bronchodilator.. Lacks FDA
approval.
CONTROLLED.................... S7 A Fentanyl Opioid Analgesic Actiq, Fentora,
(fentanil). Lazanda,
Sublimaze,
Subsys. DEA
Schedule II.
[[Page 5139]]
BANNED........................ S0 ................... Fentiazac....... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Feprazone....... NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 C Fexofenadine.... Antihistamine... Allegra..........
BANNED........................ S2 ................... Fibroblast Growth Hormone.. .................
Growth Factors
(FGFs).
CONTROLLED.................... S7 C Firocoxib....... NSAID........... Equioxx, Previcox Detection Time: 2 ng/mL in serum
360 hrs. 100 or plasma.
mcg/kg orally
once daily for
total of 7
doses. (20
horses).
BANNED........................ S0 ................... Flavoxate....... Anticholinergic. Generic..........
CONTROLLED.................... S7 B Flecainide...... Antiarrhythmic.. Generic..........
BANNED........................ S0 ................... Floctafenine.... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Fluanisone...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Fludiazepam..... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Fludrocortisone. Corticosteroid.. Generic..........
BANNED........................ S0 ................... Flufenamic acid. NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 C Flumethasone Corticosteroid.. Flucort, Anaprime
(flumetasone).
BANNED........................ S5 ................... Flumethiazide... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Flunarizine..... Calcium channel Lacks FDA
blocker. approval.
BANNED........................ S0 ................... Flunisolide..... Corticosteroid.. Generic..........
BANNED........................ S0 ................... Flunitrazepam... Sedative/ Lacks FDA
Anxiolytic. approval. DEA
Schedule IV.
CONTROLLED.................... S7 C Flunixin........ NSAID (3 NSAIDs Banamine, Detection Time: 4 ng/mL in serum
(Flunixin, Flunixamine, 48 hrs. 1.1 mg/ or plasma.
Ketoprofen, Equileve, kg single IV Note: The
Phenylbutazone) Meflosyl. dose (16 detection of
are associated horses); 500 mg more than one
with a single IV dose NSAID in a
Detection Time (12 horses). horse's post-
of 48 hours. Race or Post-
Only one of the Official
three may be Workout blood
administered sample
using a constitutes a
Withdrawal Stacking
Interval based Violation.
on the 48 hour
Detection Time.
To avoid a
stacking
violation
(detection of
more than 1
NSAID in a
blood sample)
the following
secondary
Detection Times
should be
applied for the
following 3
NSAIDs:
Flunixin: 144
hours;
Ketoprofen 96
hours;
Phenylbutazone:
168 hours.).
CONTROLLED.................... S7 C Fluocinolone Corticosteroid.. Flucort-N........
acetonide.
CONTROLLED.................... S7 C Fluocinonide.... Corticosteroid.. Fluonex, Lidex,
Lonide, Lyderm.
BANNED........................ S0 ................... Fluocortolone... Corticosteroid.. Lacks FDA
approval.
BANNED........................ S0 ................... Fluopromazine Antipsychotic... Lacks FDA
(Triflupromazin approval.
e).
BANNED........................ S0 ................... Fluoresone...... Anticonvulsant.. Lacks FDA
approval.
BANNED........................ S0 ................... Fluorocortisone. Corticosteroid.. Lacks FDA
approval.
CONTROLLED.................... S7 C Fluorometholone. Corticosteroid.. FML Forte........
BANNED........................ S0 ................... Fluorophenethyla Stimulant....... Lacks FDA
mine. approval.
BANNED........................ S0 ................... Fluoroprednisolo Corticosteroid.. Discontinued, no
ne. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Fluoxetine...... Antidepressant.. Prozac...........
BANNED........................ S1 ................... Fluoxymesterone. Anabolic........ Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule III.
BANNED........................ S0 ................... Flupenthixol Antipsychotic... Lacks FDA
(flupentixol). approval.
CONTROLLED.................... S7 B Fluphenazine.... Antipsychotic... Generic..........
BANNED........................ S0 ................... Flupirtine...... Analgesic....... Lacks FDA
approval.
BANNED........................ S0 ................... Fluprednisolone. Corticosteroid.. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 C Flurandrenolide Corticosteroid.. Cordran..........
(Flurandrenolon
e,
Fludroxycortide
).
BANNED........................ S0 ................... Flurazepam...... Sedative/ Generic. DEA
Anxiolytic. Schedule IV.
CONTROLLED.................... S7 B Flurbiprofen.... NSAID........... Ansaid, Ocufen,
Strepfen.
BANNED........................ S0 ................... Fluspirilene.... Antipsychotic... Lacks FDA
approval.
[[Page 5140]]
CONTROLLED.................... S7 C Fluticasone..... Corticosteroid.. Flovent, Flonase.
BANNED........................ S0 ................... Flutoprazepam... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Fluvoxamine..... Antidepressant.. Luvox............
BANNED........................ S4 ................... Follistatin..... Myostatin
inhibitor.
BANNED........................ S1 ................... Formebolone..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S4 ................... Formestane...... Aromatase Lacks FDA
inhibitor. approval.
BANNED........................ S3 ................... Formoterol Beta-2 agonist- Brovana; Breyna
(Aformoterol). bronchodilator. (with
budesonide);
Duaklir Pressair
(with
aclidinium).
BANNED........................ S0 ................... Fosinopril...... Antihypertensive Generic..........
BANNED........................ S0 ................... Fosphenytoin.... Anticonvulsant.. Cerebyx..........
BANNED........................ S4 ................... Fulvestrant..... Estrogen Falsodex.........
antagonist.
BANNED........................ S1 ................... Furazabol....... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Furazadrol...... Anabolic........ Lacks FDA
approval.
BANNED........................ S0 ................... Furfenorex...... Stimulant....... Lacks FDA
approval.
CONTROLLED-(Permitted at all S7 C Furosemide...... Diuretic........ Lasix, Salix..... Restricted 50 ng/mL in
times during Workouts, Administration: urine or 0.1 ng/
Official Workouts, and other 48 hrs. 1 mg/kg mL in serum or
training exercise). single IV dose plasma.
(6 horses).
CONTROLLED-where permitted on S7 C Furosemide Diuretic........ Lasix, Salix..... Shall not be 100 ng/mL in
race day. (where administered serum or plasma
permitted by within 4 hours AND urine S.G.
exemption). prior to Post- < 1.010.
Time.
CONTROLLED.................... S7 B Gabapentin...... Anticonvulsant.. Horizant,
Gralise,
Neurontin.
BANNED........................ S0 ................... Galantamine..... Acetylcholineste Razadyne.........
rase inhibitor.
BANNED........................ S0 ................... Gallamine....... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Gamma Neurotransmitter Endogenous
Aminobutyric substance.
Acid (GABA).
BANNED........................ S0 ................... Gamma- Neurohormone.... Lacks FDA
butyrolactone approval.
(GBL).
BANNED........................ S0 ................... Gamma- CNS depressant.. Lacks FDA
hydroxybutyrate approval.
(GHB).
BANNED........................ S0 ................... Gepirone........ Antidepressant.. Lacks FDA
approval.
BANNED........................ S1 ................... Gestrinone...... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... GH-Releasing Growth Hormone..
Peptides
(ghrps), e.g.,
alexamorelin,
GHRP-6,
hexarelin and
pralmorelin
(GHRP-2).
BANNED........................ S0 (x) Glaucine........ Antitussive..... Lacks FDA ................ 0.5 ng/mL in
approval.. serum or
plasma.
BANNED........................ S0 ................... Glutethimide Sedative........ Discontinued, no
(chlorhexidol). FDA-approved
product
commercially
available. DEA
Schedule II.
CONTROLLED.................... S7 C Glycopyrrolate.. Anticholinergic. Robinul.......... Detection Time: 0.003 ng/mL in
48 hours. 1 mg serum or
single dose IV. plasma.
(20 horses).
CONTROLLED--fillies and mares. S7 B Gonadorelin..... Induce ovulation Cystorelin,
Factrel,
Fertelin,
OvaCyst,
Fertagyl,
Gonabree.
BANNED--intact males and S4 ................... Gonadorelin..... Reproductive Cystorelin,
geldings. hormone Factrel,
modulator. Fertelin,
OvaCyst,
Fertagyl,
Gonabreed.
BANNED........................ S2 ................... Goserelin....... Reproductive Zoladex..........
hormone
modulator.
BANNED........................ S1 ................... Growth Hormone Anabolic........
Releasing
Hormone (GHRH).
[[Page 5141]]
CONTROLLED.................... S7 C Guaifenesin Expectorant..... Mucinex.......... Detection Time: 1 ng/mL in serum
(glycerol 48 hrs. 2 grams or plasma.
guiacolate). total body
dose, orally
twice daily for
5 doses. (9
horses).
BANNED........................ S ................... ................ Antihypertensive Generic..........
BANNED........................ S0 ................... Guanadrel....... Antihypertensive Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Guanethidine.... Antihypertensive Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Guanoclor....... Antihypertensive Lacks FDA
approval.
BANNED........................ S0 ................... Halazepam....... Sedative/ Discontinued, no
Anxiolytic. FDA-approved
product
commercially
available. DEA
Schedule IV.
CONTROLLED.................... S7 C Halcinonide..... Corticosteroid.. Halog............
BANNED........................ S0 ................... Haldrol......... Anabolic........ Lacks FDA
approval.
CONTROLLED.................... S7 C Halobetasol..... Corticosteroid.. Lexette, Bryhali,
Ultravate.
BANNED........................ S0 ................... Haloperidol..... Antipsychotic... Haldol...........
BANNED........................ S0 ................... Haloxazolam..... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Harmaline....... Psychoactive.... Lacks FDA
approval.
CONTROLLED.................... S7 B Harpagoside Anti- Glycoside of
(Devil's Claw). inflammatory. plangt origin.
No FDA-approved
products
commercially
available.
Constituent of
multiple,
unregulated OTC
herbal remedies.
BANNED........................ S2 ................... Hepatocyte Growth Hormone..
Growth Factor
(HGF).
BANNED........................ S0 ................... Heptaminol...... Cardiac
stimulant.
BANNED........................ S0 ................... Hexafluorenium.. Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Hexobarbital.... Sedative........ Lacks FDA
approval.
BANNED........................ S0 ................... Hexocyclium..... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Hexylcaine...... Local anesthetic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S3 ................... Higenamine Bronchodilator.. Constituent of
(norclaurine, numerous OTC
demethylcoclaur dietary
ine). supplements
marketed for
weight loss or
as sports/energy
supplements.
Lacks FDA
approval.
BANNED........................ S0 ................... Histapyrrodine.. Antihistamine... Lacks FDA
approval.
BANNED........................ S4 ................... Histrelin....... GnRH agonist.... Supprelin LA,
Vantas.
CONTROLLED.................... S7 B Homatropine..... Anticholinergic. Hycodan [with
hydrocodone].
BANNED........................ S0 ................... Homophenazine... Antipsychotic... Lacks FDA
approval.
CONTROLLED.................... S7 A (x) Hordenine....... Stimulant....... Plant alkaloid ................ 80 mcg/mL total
(e.g. barley). (free and
Constituent of conjugated) in
numerous OTC urine.
dietary
supplements
marketed for
weight loss.
Lacks FDA
approval..
CONTROLLED.................... S7 B Hydralazine..... Vasodilator..... Hydra-Zide, Bidi.
BANNED........................ S5 ................... Hydrochlorthiazi Diuretic........ Lotensin (with
de. bisoprolol);
Vaseretic (with
enalapril);
Avilide (with
irbesartan);
Zestoretic (with
lisinopril);
Lopressor (with
metoprolol);
Micardis (with
telmisartan);
and other.
BANNED........................ S0 ................... Hydrocodone Opioid Analgesic Hysingla; Apadaz,
(dihydrocodieno Anexsia (with
ne). acetaminophen);
Hycodan (with
homatropine) DEA
Schedule II.
CONTROLLED.................... S7 C Hydrocortisone.. Corticosteroid.. Cortef. Note: ................ Threshold: 1 mcg/
hydrocortisone mL in urine.
is a component
of numerous
products,
particularly
those for
topical,
ophthalmic, and
otic
applications.
The Responsible
Person is
advised to read
all medication
labels prior to
authorizing
administration.
[[Page 5142]]
BANNED........................ S5 ................... Hydroflumethiazi Diuretic........ Discontinued, no
de. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Hydromorphinol.. Opioid Analgesic Lacks FDA
approval.
BANNED........................ S0 ................... Hydromorphone... Opioid Analgesic Dilaudid. DEA
Schedule II.
BANNED........................ S0 ................... Hydroxyamphetami Stimulant....... Paremyd (with
ne. tropicamide).
BANNED........................ S0 ................... Hydroxy-gamma Neurohormone.... Lacks FDA
amino butyric approval.
acid.
BANNED........................ S0 ................... Hydroxytestoster Anabolic........ Lacks FDA
one. approval.
CONTROLLED.................... S7 C Hydroxyzine..... Antihistamine... Atarax........... Detection time: ................
96 hours.
Hydroxyzine:
190 mg twice
daily for a
total of 9
doses (2
horses)..
BANNED........................ S6 ................... Ibandronate..... Bisphosphonate.. Generic..........
BANNED........................ S0 ................... Ibogaine........ Psychoactive.... Lacks FDA
approval. DEA
Schedule I.
CONTROLLED.................... S7 C Ibuprofen....... NSAID........... Advil, Motrin....
BANNED........................ S2 ................... Ibutamoren...... Growth Hormone.. Investigational
New Drug (in
clinical trials).
CONTROLLED.................... S7 B Ibutilide....... Antiarrhythmic.. Corvert..........
BANNED........................ S0 ................... Iloprost........ Vasodilator..... Ventavis.........
CONTROLLED.................... S7 A Imipramine...... Antidepressant.. Tofranil.........
BANNED........................ S3 ................... Indacaterol..... Beta-2 agonist- Discontinued, no
bronchodilator. FDA-approved
product
commercially
available.
BANNED........................ S5 ................... Indapamide...... Diuretic........ Generic..........
CONTROLLED.................... S7 B Indomethacin.... NSAID........... Indocin..........
BANNED........................ S0 ................... Indoprofen...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Indoramin....... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 B Infliximab...... Immunosuppressor Remicade.........
BANNED........................ S2 ................... Insulin- like Peptide hormone.
Growth Factor-1
(IGF-1) and its
analogues.
BANNED........................ S2 ................... Insulins........ Anti-
hyperglycemics.
BANNED........................ S2 ................... IOX-2........... Erythropoiesis.. Lacks FDA
approval.
BANNED........................ S2 ................... Ipamorelin...... Growth Hormone.. Lacks FDA
approval.
CONTROLLED.................... S7 B Ipratropium..... Bronchodilator.. Atrovent......... Detection Time: 0.25 ng/mL in
120 hrs. 5.5 urine.
mcg/kg once
daily via
nebulization
for 3 total
doses (6
horses).
CONTROLLED.................... S7 B Ipratropium Bronchodilator.. Atrovent;
bromide. Combivent (with
albuterol).
BANNED........................ S0 ................... Iprindole....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Iproniazid...... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Ipsapirone...... Antidepressant.. Lacks FDA
approval.
BANNED........................ S5 ................... Irbesartan...... Antihypertensive Avalide, Avapro..
BANNED........................ S0 ................... Isoaminile...... Antitussive..... Lacks FDA
approval.
BANNED........................ S0 ................... Isocarboxazid... Antidepressant.. Marplan..........
BANNED........................ S0 ................... Isoetharine..... Bronchodilator.. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 C Isoflupredone... Corticosteroid.. Predef 2x........ 14 day stand ................
down for all
intra-articular
injections.
Serum
concentrations
associated with
an experimental
dose of 8 mg IA
single joint (6
horses) were
all below Limit
of Detection by
14 days..
BANNED........................ S0 ................... Isomethadone Synthetic opioid Lacks FDA
(isoamidone). analgesic. approval. DEA
Schedule I.
BANNED........................ S0 ................... Isometheptene... Sympathomimetic. Lacks FDA
approval.
[[Page 5143]]
BANNED........................ S0 ................... Isopropamide.... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S3 ................... Isoproterenol... Beta-2 agonist.. Generic..........
BANNED........................ S0 ................... Isopyrin NSAID........... Lacks FDA
(Raminfenazone). approval.
CONTROLLED.................... S7 B Isosorbide Vasodilator..... Isordil..........
dinitrate.
BANNED........................ S0 ................... Isothipendyl.... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Isoxicam........ NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Isradipine...... Antihypertensive Generic..........
BANNED........................ S0 ................... Isoxsuprine..... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Kebuzone........ NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 B Ketamine/ Anesthetic...... Ketaset, Vetalar.
norketamine. DEA Schedule III.
BANNED........................ S0 ................... Ketazolam....... Sedative/ Lacks FDA
Anxiolytic. approval. DEA
Schedule IV.
CONTROLLED.................... S7 C Ketoprofen...... NSAID........... Ketofen.......... Detection Time: 2 ng/mL in serum
48 hrs. 2.2 mg/ or plasma.
kg single IV Note: The
dose. (24 detection of
horses). more than one
NSAID in a
horse's post-
Race or Post-
Official
Workout blood
sample
constitutes a
Stacking
Violation. 3
NSAIDs
(Flunixin,
Ketoprofen,
Phenylbutazone)
are associated
with a
Detection Time
of 48 hours.
Only one of the
three may be
administered
using a
Withdrawal
Interval based
on the 48 hour
Detection Time.
To avoid a
stacking
violation
(detection of
more than 1
NSAID in a
blood sample)
the following
secondary
Detection Times
should be
applied for the
following
NSAIDs:
Flunixin: 144
hours;
Ketoprofen 96
hours;
Phenylbutazone:
168 hours.
CONTROLLED.................... S7 A Ketorolac....... NSAID........... Acular, Acuvail,
Sprix, Omidria.
CONTROLLED.................... S7 B Ketotifen....... Antihistamine... Alaway, Zaditor..
BANNED........................ S2 ................... Krypton......... Hypoxia .................
Inducible
Factor
activating.
BANNED........................ S0 ................... Labetalol....... Antihypertensive Trandate.........
CONTROLLED.................... S7 A Lamotrigine..... Anticonvulsant.. Lamictal.........
BANNED........................ S4 ................... Landogrozumab... Myostatin Lacks FDA
inhibitor. approval.
CONTROLLED.................... S7 C Lansoprazole.... Anti-ulcer...... Prevacid.........
BANNED........................ S2 ................... Lenomorelin Growth Hormone.. Lacks FDA
(ghrelin). approval.
BANNED........................ S0 ................... Lenperone....... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Leptazole Stimulant....... Lacks FDA
(Pentylenetetra approval.
zole).
BANNED........................ S0 ................... Letosteine...... Mucolytic....... Lacks FDA
approval.
BANNED........................ S2 ................... Letrozole....... Aromatase Femara...........
inhibitor.
BANNED........................ S2 ................... Leuprorelin Reproductive Eligard Kit,
(leuprolide). hormone Fensolvi Kit,
modulator. Camcevi Kit.
BANNED........................ S0 ................... Levallorphan.... Opioid Discontinued, no
Antagonist. FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Levamisole...... Anthelmintic/ Ripercol,
Immunostimulant. Tramisol,
Levasole,
Prohibit,
LevaMed.
BANNED........................ S0 ................... Levobunolol..... Antihypertensive Betagan..........
BANNED........................ S0 ................... Levocabastine... Antihistamine... Discontinued, no
FDA-approved
product
commercially
available.
[[Page 5144]]
BANNED........................ S0 ................... Levodopa........ Decarboxylase Inbrija; Stalevo,
Inhibitor. Rytary, Duopa,
Dhivy, Sinemet
(all with
carbidopa).
BANNED........................ S0 ................... Levomethadone... Opioid Analgesic Lacks FDA
approval.
BANNED........................ S0 ................... Levomethorphan.. Opioid Analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Levophacetoperan Psychostimulant. Lacks FDA
e. approval.
BANNED........................ S0 ................... Levorphanol..... Opioid Analgesic Generic. DEA
Schedule I.
BANNED........................ S3 ................... Levosalbutamol Beta-2 agonist- Xopenex..........
(levalbuterol). bronchodilator.
BANNED........................ S4 ................... Levothyroxine... Metabolic Thyro-Tabs,
hormone. ThyroKare,
Tirosint,
Ermeza,
Euthyrox,
Levolet,
Synthroid,
Levoxyl,
Unithroid.
CONTROLLED.................... S7 B Lidocaine....... Local anesthetic Xylocaine [with Detection Time: 10 ng/mL as 3-
epinephrine], 48 hours. 200 hydroxylidocain
Lignospan, mg of lidocaine e in urine;
Ztlido, Akten. as its 0.02 ng/mL as 3-
hydrochloride hydroxylidocain
salt e in serum or
administered plasma.
subcutaneously
(6 horses).
BANNED........................ S0 ................... Lidoflazine..... Vasodilator..... Lacks FDA
approval.
BANNED........................ S4 ................... Ligandrol (LGD- Selective Lacks FDA
4033). Androgen approval.
Receptor
Modulator
(SARM).
BANNED........................ S0 ................... Lisinopril...... Antihypertensive Zestoretic,
Qbrelis.
BANNED........................ S0 ................... Lithium......... Mood Stabilizer. Lithobid.........
BANNED........................ S0 (x) Lobeline........ Respiratory Plant alkaloid ................ 2 ng/mL in serum
Stimulant. (Lobelia, Indian or plasma.
Tobacco)
Environmental
substance. Lacks
FDA approval..
BANNED........................ S0 ................... Lofentanil...... Opioid Analgesic Lacks FDA
approval.
BANNED........................ S0 ................... Lofepramine..... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Loflazepate, Anxiolytic...... Lacks FDA
Ethyl. approval.
BANNED........................ S2 ................... Lonapegsomatropi Growth Hormone.. FDA Orphan Drug..
n.
CONTROLLED.................... S7 B Loperamide...... Anti-diarrheal.. Imodium..........
BANNED........................ S0 ................... Loprazolam...... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
CONTROLLED.................... S7 C Loratidine...... Antihistamine... Claritin.........
BANNED........................ S0 ................... Lorazepam....... Anxiolytic...... Ativan. DEA
Schedule IV.
BANNED........................ S0 ................... Lormetazepam.... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Lornoxicam...... NSAID........... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Losartan........ Antihypertensive Cozaar, Hyzaar
[with
hydrochlorothiaz
ide].
BANNED........................ S0 ................... Loxapine........ Antipsychotic... Adasuve..........
BANNED........................ S3 ................... Lubabegron...... Beta adrenergic Experior.........
modulator.
BANNED........................ S0 ................... Lumiracoxib..... NSAID........... Lacks FDA
approval.
BANNED........................ S2 ................... Luspatercept.... Erythropoiesis.. FDA Orphan Drug..
CONTROLLED--fillies and mares. S7 B Luteinizing Reproductive
Hormone (LH). hormone
modulator.
BANNED--intact males and S2 ................... Luteinizing Reproductive
geldings. Hormone (LH). hormone
modulator.
BANNED........................ S3 ................... Mabuterol....... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S2 ................... Macimorelin..... Growth Hormone.. Macrilen.........
CONTROLLED.................... S7 B Magnesium Sedative/ Generic..........
sulfate. Laxative.
BANNED........................ S0 ................... Maprotiline..... Antidepressant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Mazindol........ Stimulant....... Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Mebanazine...... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Mebeverine...... Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Mebhyroline Antihistamine... Lacks FDA
(Mebhydrolin). approval.
[[Page 5145]]
BANNED........................ S0 ................... Mebutamate...... Sedative/ Discontinued, no
Anxiolytic. FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Mecamylamine.... Vasodilator..... Generic..........
BANNED........................ S2 ................... Mechano Growth Growth Hormone..
Factors (MGFs).
BANNED........................ S0 ................... Meclizine....... Antihistamine... Antivert.........
CONTROLLED.................... S7 B Meclofenamic NSAID........... Discontinued, no
acid. FDA-approved
product
commercially
available.
Routinely
compounded.
BANNED........................ S1 ................... Meclofenoxate... Cholinergic Lacks FDA
nootropic. approval.
BANNED........................ S0 (x) Meconine........ Opioid.......... Lacks FDA
approval.
BANNED........................ S0 ................... Medazepam....... Sedative/ Lacks FDA
Anxiolytic. approval. DEA
Schedule IV.
CONTROLLED.................... S7 B Medetomidine.... Sedative/ Domitor, ................ 5 ng/mL as 3-
Analgesic. Placadine. hydroxymedetomi
dine in urine.
CONTROLLED.................... S7 B Medroxyprogester Reproductive Depo-Provera.....
one. hormone.
BANNED........................ S0 ................... Medrylamine..... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Medrysone....... Corticosteroid.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Mefenamic acid.. NSAID........... Ponstel..........
BANNED........................ S0 ................... Mefenorex....... Stimulant....... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Mefexamide...... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Mefruside....... Diuretic........ Lacks FDA
approval.
BANNED........................ S2 ................... Meldonium....... Anti-ischemic... Lacks FDA
approval.
CONTROLLED.................... S7 B Meloxicam....... NSAID........... Metacam..........
BANNED........................ S0 ................... Melperone....... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Memantine....... Alzheimer's Namenda; Namzaric
treatment. (with donepezil).
BANNED........................ S0 ................... Meparfynol Sedative........ Lacks FDA
(methylpentynol approval.
).
BANNED........................ S0 ................... Mepazine........ Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Mepednisone..... Corticosteroid.. Lacks FDA
approval.
BANNED........................ S0 ................... Mepenzolate..... Anti-ulcer...... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Meperidine...... Opioid analgesic Demerol. DEA
Schedule II.
BANNED........................ S0 ................... Mephenesin...... Muscle relaxant. Lacks FDA
approval.
BANNED........................ S0 ................... Mephenoxalone... Muscle relaxant. Lacks FDA
approval.
BANNED........................ S0 ................... Mephentermine... Cardiac Discontinued, no
stimulant. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Mephenytoin..... Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Mephobarbital Sedative/ Lacks FDA
(Methylphenobar Anxiolytic. approval.
bital).
BANNED........................ S0 ................... Mepindolol...... Beta blocker.... Lacks FDA
approval.
CONTROLLED.................... S7 B Mepivacaine..... Local anesthetic Carbocaine, Detection Time: 10 ng/mL as 3-
Polocaine, 72 hrs. 40 mg hydroxymepivaca
Scandonest. (2 ml) single ine in urine;
dose SQ distal 0.05 ng/mL in
limb (6 horses). serum or
plasma.
BANNED........................ S0 ................... Meprobamate Anxiolytic...... Generic. DEA
(Meprobamate is Schedule IV.
a metabolite of
carisoprodol.
If there is
credible
evidence that
the presence of
meprobamate in
a horse's
sample is the
consequence of
carisoprodol
administration,
the
classification
of meprobamate
may be revised
to S7(A).).
BANNED........................ S0 ................... Meprylcaine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Meptazinol...... Narcotic........ Lacks FDA
approval.
BANNED........................ S5 ................... Meralluride..... Diuretic........ Lacks FDA
approval.
BANNED........................ S5 ................... Merbaphen....... Diuretic........ Lacks FDA
approval.
BANNED........................ S5 ................... Mercaptomerin... Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Mersalyl........ Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
[[Page 5146]]
CONTROLLED.................... S7 C Mesalamine Anti- Delzicol,
(mesalazine). inflammatory. Pentasa,
Sfrowasa,
Canasa, Lialda.
BANNED........................ S0 ................... Mesocarb........ Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Mesoridazine.... Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Mestanolone..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... Mesterolone..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Metaclazepam.... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S1 ................... Metandienone.... Anabolic........ Lacks FDA
approval.
BANNED........................ S3 ................... Metaproterenol Beta-2 agonist- Generic..........
(Orciprenaline). bronchodilator.
BANNED........................ S0 ................... Metaraminol..... Antihypotensive. Generic..........
BANNED........................ S0 ................... Metaxalone...... Muscle relaxant. Skelaxin.........
BANNED........................ S0 ................... Metazocine...... Opioid analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S1 ................... Metenolone...... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Metformin....... Anti- Fortamet,
hyperglycemic. Glumetza,
Glucophage.
BANNED........................ S0 ................... Methacholine.... Bronchoconstrict Provocholine.....
or.
BANNED........................ S0 ................... Methadone....... Synthetic opioid Methadose. DEA
agonist. Schedule II.
BANNED........................ S0 ................... Methallenestril. Synthetic Lacks FDA
estrogen. approval.
BANNED........................ S0 ................... Methamphetamine. Stimulant....... Desoxyn. DEA
Schedule II.
BANNED........................ S1 ................... Methandienone... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... Methandriol Anabolic........ Lacks FDA
(Methylandroste approval. DEA
nediol). Schedule III.
BANNED........................ S1 ................... Methandrostenolo Anabolic........ Lacks FDA
ne. approval.
BANNED........................ S0 ................... Methantheline... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Methapyrilene... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Methaqualone.... Sedative........ Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S0 ................... Metharbital..... Sedative........ Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Methasterone.... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Methazolamide... Carbonic Generic..........
Anhydrase
Inhibitor.
BANNED........................ S0 ................... Methcathinone... Stimulant....... Lacks FDA
approval. DEA
Schedule I.
BANNED........................ S0 ................... Methdilazine.... Antihistamine... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Methenolone..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Methimazole..... Anti-thyroid.... Generic..........
BANNED........................ S0 ................... Methixene....... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 C Methocarbamol... Muscle relaxant. Robaxin.......... Detection Time: 1 ng/mL in serum
48 hours. 15 mg/ or plasma.
kg single IV
dose. (20
horses).
BANNED........................ S0 ................... Methohexital.... Sedative........ Brevital.........
CONTROLLED.................... S7 B Methotrexate.... Immunomodulator. Otrexup, Rasuvo,
Reditrex,
Trexall.
BANNED........................ S0 ................... Methotrimeprazin Antipsychotic... Lacks FDA
e. approval.
BANNED........................ S0 ................... Methoxamine..... Stimulant....... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S3 ................... Methoxyphenamine Bronchodilator.. Lacks FDA
approval.
BANNED........................ S2 ................... Methoxypolyethyl Erythropoiesis.. Micera...........
ene glycol-
epoetin beta
(CERA).
[[Page 5147]]
BANNED........................ S0 ................... Methoxytyramine Neuromodulator.. Endogenous ................ Threshold: 4 mcg/
(3-). substance. mL total (free
and conjugated)
3-
methoxytyramine
per mL in
urine.
BANNED........................ S0 ................... Methscopolamine Anticholinergic. Generic..........
(Methyl
scopolamine).
BANNED........................ S0 ................... Methsuximide.... Anticonvulsant.. Celontin.........
BANNED........................ S1 ................... Methyl-1- Anabolic........ Android 25. DEA
testosterone. Schedule III.
BANNED........................ S0 ................... Methylaminorex.. Stimulant....... Lacks FDA
approval. DEA
schedule I.
BANNED........................ S0 ................... Methylatropine.. Anticholinergic. Lacks FDA
approval.
BANNED........................ S0 ................... Methylchlorthiaz Diuretic........ Lacks FDA
ide approval.
(Methylclothiaz
ide).
BANNED........................ S1 ................... Methylclostebol. Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S5 ................... Methylclothiazid Diuretic........ Discontinued, no
e. FDA-approved
product
commercially
available.
BANNED........................ S1 ................... Methyldienolone. Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Methyldopa...... Antihypertensive Generic..........
BANNED........................ S0 ................... Methylenedioxyam Stimulant....... Lacks FDA
phetamine (MDA). approval. DEA
Schedule I.
BANNED........................ S0 ................... Methylenedioxyet Stimulant....... Lacks FDA
hylamphetamine approval. DEA
(MDEA). Schedule I.
BANNED........................ S0 ................... Methylenedioxyme Stimulant....... Lacks FDA
thamphetamine approval. DEA
(MDMA). Schedule I.
BANNED........................ S0 ................... Methylephedrine. Stimulant....... Lacks FDA
approval.
CONTROLLED.................... S7 C Methylergonovine Ergot alkaloid.. Methergine.......
BANNED........................ S0 ................... Methylhexanamine Stimulant....... Lacks FDA
(Methylhexaneam approval.
ine).
BANNED........................ S0 ................... Methylmethcathin Stimulant....... Lacks FDA
one. approval.
BANNED........................ S1 ................... Methylnortestost Anabolic........ Lacks FDA
erone approval. DEA
(Trestolone). Schedule III.
BANNED........................ S0 ................... Methylphenidate. Stimulant....... Ritalin. DEA
Schedule II.
CONTROLLED.................... S7 C Methylprednisolo Corticosteroid.. Depo-Medrol......
ne.
BANNED........................ S0 ................... Methylprylone Sedative........ Lacks FDA
(methprylon). approval.
BANNED........................ S0 ................... Methylpseudoephe Stimulant....... Lacks FDA
drine. approval.
CONTROLLED.................... S7 C Methylsalicylate NSAID........... Salonpas (with
menthol).
CONTROLLED.................... S7 C Methylsulfonylme Anti- Feed contaminant ................ 1200 mcg/mL in
thane (MSM). inflammatory. per IFHA. urine.
BANNED........................ S1 ................... Methyltestostero Anabolic........ Android 25. DEA
ne. Schedule III.
BANNED........................ S1 ................... Methyltrienolone Anabolic........ Lacks FDA
(metribolone). approval. DEA
Schedule III.F89.
BANNED........................ S0 ................... Methyprylon..... Sedative........ Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule III.
BANNED........................ S0 ................... Methysergide.... Ergot alkaloid.. Discontinued, no
FDA-approved
product
commercially
availabl.
BANNED........................ S0 ................... Metiamide....... Antihistamine... Lacks FDA
approval.
BANNED........................ S5 ................... Meticrane....... Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Metipranolol.... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 C Metoclopramide.. Anti-emetic/ Gimoti, Reglan...
Prokinetic.
BANNED........................ S0 ................... Metocurine...... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S5 ................... Metolazone...... Diuretic........ Generic..........
BANNED........................ S0 ................... Metomidate...... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Metopon Opioid analgesic Lacks FDA
(methydihydromo approval. DEA
rphinone). Schedule II.
BANNED........................ S0 ................... Metoprolol...... Antihypertensive Lopressor........
BANNED........................ S0 ................... Metrenperone.... Myositis Lacks FDA
preventative. approval.
BANNED........................ S1 ................... Metribolone..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Metyrapone...... Hydrocortisone Metopirone.......
synthesis
inhibitor.
BANNED........................ S0 ................... Mexazolam....... Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 B Mexiletine...... Antiarrhythmic.. Generic..........
BANNED........................ S0 ................... Mianserin....... Antidepressant.. Lacks FDA
approval.
[[Page 5148]]
BANNED........................ S0 ................... Mibefradil...... Antihypertensive Lacks FDA
approval.
BANNED........................ S1 ................... Mibolerone...... Anabolic........ Cheque Drops. DEA
Schedule III.
CONTROLLED.................... S7 B Midazolam....... Anticonvulsant.. Seizalam. DEA
Schedule IV.
BANNED........................ S0 ................... Midodrine....... Antihypotensive. Orvaten..........
CONTROLLED.................... S7 B Milrinone....... Vasodilator..... Generic..........
BANNED........................ S0 ................... Minoxidil....... Antihypertensive Rogaine..........
BANNED........................ S0 ................... Mirtazapine..... Antidepressant.. Remeron..........
CONTROLLED.................... S7 C Misoprostol..... Prostaglandin Cytotec.......... Detection Time: ................
analog. 48 hrs. 5 mcg/
kg orally twice
daily for 14
days. (6
horses).
BANNED........................ S0 ................... Mitragynine..... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Mivacurium...... Muscle relaxant. Generic..........
BANNED........................ S0 ................... Modafinil....... Stimulant....... Provigil. DEA
Schedule IV.
BANNED........................ S0 ................... Moexipril Antihypertensive Generic..........
(metabolite,
moexiprilat).
BANNED........................ S0 ................... Mofebutazone.... NSAID........... Lacks FDA
approval.
BANNED........................ S2 ................... Molidustat (BAY Erythropoiesis.. Lacks FDA
85-3934). approval.
BANNED........................ S0 ................... Molindone....... Antipsychotic... Generic..........
CONTROLLED.................... S7 C Mometasone...... Corticosteroid.. Asmanex, Sinuva,
Elocon,
Ryaltris,
Nasonex.
CONTROLLED.................... S7 C Montelukast..... Leukotriene Singulair........
receptor
antagonist.
BANNED........................ S0 ................... Moperone........ Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Moprolol........ Antihypertensive Lacks FDA
approval.
BANNED........................ S0 ................... Morpheridine.... Analgesic....... Lacks FDA
approval.
CONTROLLED.................... S7 A (x) Morphine........ Opioid Analgesic Duramorph, ................ 30 ng/mL total
Infumorph, (free and
Mitigo, MS conjugated) in
Contin. DEA urine.
Schedule II;
Dietary
substance per
IFHA.
BANNED........................ S0 ................... Mosapramine..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Moxaverine...... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 (x) Muscarine....... Cholinergic..... Plant alkaloid...
BANNED........................ S0 ................... Myo-inositol Oxygen transfer. Lacks FDA
trispyrophospha approval.
te (ITPP,
OXY111A).
CONTROLLED.................... S7 B Nabumetone...... NSAID........... Generic..........
BANNED........................ S0 ................... Nadolol......... Antihypertensive Corgard..........
BANNED........................ S0 ................... Nadoxolol....... Antihypertensive Lacks FDA
approval.
BANNED........................ S0 ................... Naepaine........ Local anesthetic Lacks FDA
approval.
BANNED........................ S2 ................... Nafarelin....... Reproductive Synarel..........
hormone
modulator.
BANNED........................ S0 ................... Naftidrofuryl... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Nalbuphine...... Opioid receptor Generic..........
agonist and
antagonist.
CONTROLLED.................... S7 A Nalmefene....... Opioid Revex............
antagonist.
BANNED........................ S0 ................... Nalorphine...... Opioid receptor Nalline. DEA
agonist and Schedule III.F94.
antagonist.
CONTROLLED.................... S7 B Naloxone........ Opioid Narcan, Zimhi,
antagonist. Suboxone (with
buprenorphine
hydrochloride),
Zubsolv (with
buprenorphine
hydrochloride).
CONTROLLED.................... S7 A Naltrexone...... Opioid Trexonil.........
antagonist.
BANNED--fillies, mares and S1 ................... Nandrolone (19- Anabolic........ Discontinued, no
geldings. nortestosterone FDA-approved
). product
commercially
available. DEA
schedule III.
CONTROLLED.................... S7 B Naphazoline..... Sympathomimetic. Naphcon-A (with
pheniramine
maleate), Opcon-
A (with
pheniramine
maleate), Visine
(with
pheniramine
maleate).
CONTROLLED.................... S7 C Naproxen........ NSAID........... Aleve, Naprosyn,
Anaprox.
[[Page 5149]]
BANNED........................ S0 ................... Naratriptan..... Selective Amerge...........
Serotonin
Receptor
Agonist.
CONTROLLED.................... S7 C N- Anticholinergic. Buscopan......... Detection Time: 25 ng/mL in
Butylscopolammo 48 hrs. 0.3 mg/ urine.
nium. kg single IV
dose (6 horses).
BANNED........................ S0 ................... Nebivolol....... Antihypertensive Bystolic.........
CONTROLLED.................... S7 C Nedocromil...... Mast Cell Alocril..........
Stabilizer.
BANNED........................ S0 ................... Nefazodone...... Antidepressant.. Generic..........
BANNED........................ S0 ................... Nefopam......... Analgesic....... Lacks FDA
approval.
CONTROLLED.................... S7 B Neostigmine..... Anticholinestera Bloxiverz........
se.
BANNED........................ S6 ................... Neridronate..... Bisphosphonate.. Lacks FDA
approval.
BANNED........................ S0 ................... Nialamide....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Nicardipine..... Antihypertensive Generic..........
BANNED........................ S0 ................... Nicoumalone..... Anticoagulant... Lacks FDA
approval.
BANNED........................ S0 ................... Nifedipine...... Antihypertensive Procardia........
BANNED........................ S0 ................... Nifenalol....... Antihypertensive/ Lacks FDA
Antiarrhythmic. approval.
BANNED........................ S0 ................... Niflumic acid... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Nikethamide..... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Nimesulide...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Nimetazepam..... Hypnotic........ Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Nimodipine...... Calcium channel Generic..........
blocker.
BANNED........................ S0 ................... Nitrazepam...... Sedative/ Lacks FDA
Anxiolytic. approval. DEA
Schedule IV.
BANNED........................ S0 ................... Nitroglycerin... Vasodilator..... Nitromist, Nitro-
Dur, Nitrostat.
CONTROLLED.................... S7 C Nizatidine...... Anti-ulcer...... Axid.............
BANNED........................ S0 ................... Nomifensine..... Antidepressant.. Lacks FDA
approval.
BANNED........................ S1 ................... Norandrostenedio Anabolic........ Lacks FDA
l. approval.
BANNED........................ S1 ................... Norandrostenedio Anabolic........ Lacks FDA
ne. approval.
BANNED........................ S1 ................... Norandrosterone. Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... Norbolethone/ Anabolic........ Lacks FDA
Norboletone. approval. DEA
Schedule III.
BANNED........................ S1 ................... Norclostebol.... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Nordiazepam/ Sedative/ Lacks FDA
Nordazepam Anxiolytic. approval. DEA
(Nordiazepam is Schedule IV.
a metabolite of
diazepam. If
there is
credible
evidence that
the presence of
nordiazepam in
a horse's
sample is the
consequence of
exposure to
diazepam, the
classification
of nordiazepam
may be revised
to S7(A).).
CONTROLLED.................... S7 A Norepinephrine.. Stimulant....... Levophed.........
BANNED........................ S1 ................... Norethandrolone. Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... Norethisterone Anabolic........ Combipatch,
(norethindrone). Activella,
Amabelz,
Nortrel,
Alyacen,
Aranelle and
multiple others
(with estradiol).
BANNED........................ S0 ................... Norfenefrine.... Antihypotensive. Lacks FDA
approval.
BANNED........................ S0 ................... Norfenfluramine. Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Norfluoxetine Antidepressant.. Lacks FDA
(Seproxetine). approval.
BANNED........................ S0 ................... Norpseudoephedri Stimulant....... Lacks FDA
ne (cathine). approval. DEA
Schedule IV.
BANNED........................ S0 ................... Nortriptyline... Antidepressant.. Pamelor..........
BANNED........................ S0 ................... Noscapine....... Antitussive..... Lacks FDA
approval.
BANNED........................ S0 ................... Nylidrin Vasodilator..... Lacks FDA
(buphenine). approval.
[[Page 5150]]
BANNED........................ S0 ................... Octopamine Stimulant....... Lacks FDC
(Octopamine is approval.
a metabolite of
ephedrine. If
there is
credible
evidence that
the presence of
octopamine is a
consequence of
exposure to
ephedrine, the
classification
of octopamine
may be revised
to S7(A).).
BANNED........................ S0 ................... Olanzapine...... Antipsychotic... Zyprexa..........
BANNED........................ S0 ................... Oliceridine..... Opioid agonist.. Olinvk. DEA
Schedule I.
BANNED........................ S0 ................... Olmesartan...... Antihypertensive Benicar (with
medoxomil).
BANNED........................ S3 ................... Olodaterol...... Beta-2 agonist- Striverdi
bronchodilator. Respimat,
Stiolto Respimat
(with tiotropium
bromide).
BANNED........................ S6 ................... Olpadronate..... Bisphosphonate.. Lacks FDA
approval.
CONTROLLED.................... S7 C Olsalazine...... Anti- Diipentum........
inflammatory.
CONTROLLED.................... S7 C Omeprazole...... Anti-ulcer...... Gastrogard....... Restricted 10 ng/mL in
administration serum or plasma
time: 24 hours. as omeprazole
2.2 g orally sulfide.
once daily for
4 doses (9
horses).
BANNED........................ S0 ................... Opipramol....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S3 ................... Orciprenaline Beta-2 agonist- Generic..........
(Metaproterenol bronchodilator.
).
BANNED........................ S0 (x) Oripavine....... Opioid.......... Plant alkaloid.
DEA schedule I.
BANNED........................ S0 ................... Orphenadrine.... Muscle relaxant. Generic..........
BANNED........................ S4 ................... Ospemifene...... Selective Osphena..........
Estrogen
Receptor
Modulator
(SERM).
BANNED........................ S1 ................... Ostarine Selective Lacks FDA
(enobosarm). Androgen approval.
Receptor
Modulator
(SARM).
BANNED........................ S1 ................... Oxabolone....... Anabolic........ Lacks FDA
approval.
BANNED........................ S0 ................... Oxaflumazine.... Psychosedative.. Lacks FDA
approval.
BANNED........................ S1 ................... Oxandrolone..... Anabolic........ Generic. DEA
Schedule III.
BANNED........................ S0 ................... Oxaprozin....... NSAID........... Daypro...........
BANNED........................ S0 ................... Oxazepam Anxiolytic...... Generic. DEA
(Oxazepam is a Schedule IV.
metabolite of
diazepam. If
there is
credible
evidence that
the presence of
oxazepam in a
horse's sample
is the
consequence of
exposure to
diazepam, the
classification
of oxazepam may
be revised to
S7(A).).
BANNED........................ S0 ................... Oxazolam........ Sedative/ Lacks FDA
Anxiolytic. approval. DEA
Schedule IV.
BANNED........................ S0 ................... Oxcarbazepine... Anticonvulsant.. Generic..........
BANNED........................ S0 ................... Oxethazaine Local anesthetic Lacks FDA
(Oxetacaine). approval.
BANNED........................ S0 ................... Oxilofrine Stimulant....... Lacks FDA
(hydroxyephedri approval.
ne).
BANNED........................ S0 ................... Oxolamine....... Antitussive..... Lacks FDA
approval.
BANNED........................ S0 ................... Oxprenolol...... Antihypertensive Lacks FDA
approval.
CONTROLLED.................... S7 C Oxybuprocaine Local anesthetic Atafluor Benox...
(Benoxinate,
oxybucaine).
BANNED........................ S0 ................... Oxycodone....... Opioid Analgesic Oxycontin,
Roxybond,
Roxicodone,
Oxaydo, Xtampza;
Percocet,
Percodan, Oxycet
(with NSAID).
DEA Schedule II.
BANNED........................ S1 ................... Oxyguno......... Anabolic........ Lacks FDA
approval.
BANNED........................ S1 ................... Oxymesterone.... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
CONTROLLED.................... S7 B Oxymetazoline... Nasal Rhofade, Upneq,
decongestant. Visine.
[[Page 5151]]
BANNED........................ S1 ................... Oxymetholone.... Anabolic........ Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule III.
BANNED........................ S0 ................... Oxymorphone..... Opioid analgesic Generic. DEA
Schedule II.
BANNED........................ S0 ................... Oxypertine...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Oxyphencyclimine Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Oxyphenonium.... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Oxytocin........ Uterine Pitocin..........
contraction.
BANNED........................ S0 ................... Paliperidone.... Antipsychotic... Invega...........
BANNED........................ S0 ................... Palmitoylethanol Anti- Lacks FDA
amid. inflammatory. approval.
BANNED........................ S6 ................... Pamidronate..... Bisphosphonate.. Generic..........
CONTROLLED.................... S7 A Pancuronium..... Muscle relaxant. Generic..........
CONTROLLED.................... S7 C Pantoprazole.... Anti-ulcer...... Protonix.........
BANNED........................ S0 (x) Papaverine...... Vasodilator..... Plant alkaloid...
BANNED........................ S0 ................... Paraldehyde..... Anticonvulsant.. Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S0 ................... Paramethadione.. Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Paramethasone... Corticosteroid.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 (x) Paraxanthine Stimulant....... Lacks FDA
(Paraxanthine approval.
is a metabolite
of caffeine. If
there is
credible
evidence that
the presence of
paraxanthine in
a horse's
sample is the
consequence of
exposure to
caffeine, the
classification
of paraxanthine
may be revised
to S7(B).).
BANNED........................ S0 ................... Parecoxib....... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Pargyline....... Antihypertensive Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Paroxetine...... Antidepressant.. Paxil............
BANNED........................ S2 ................... Pegepoietin..... Erythropoiesis.. Micera...........
BANNED........................ S2 ................... Peginesatide.... Erythropoiesis.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Pemoline Stimulant....... Discontinued, no
(Pemoline is a FDA-approved
metabolite of product
aminorex, which commercially
is a metabolite available. DEA
of levamisole. Schedule IV.
If there is
credible
evidence that
the detection
of pemoline in
a horse's
sample is the
consequence of
exposure to
levamisole, the
classification
of pemoline may
be revised to
S7(B).).
BANNED........................ S0 ................... Pempidine....... Ganglion blocker/ Lacks FDA
antihypertensiv approval.
e.
BANNED........................ S0 ................... Penbutolol...... Antihypertensive Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Penfluridol..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Pentaerythritol Vasodilator..... Lacks FDA
tetranitrate. approval.
CONTROLLED.................... S7 B Pentazocine..... Opioid analgesic Generic (with
naloxone
hydrochloride).
DEA Schedule IV.
BANNED........................ S0 ................... Pentetrazol..... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Pentifylline.... Vasodilator..... Lacks FDA
approval.
CONTROLLED.................... S7 A Pentobarbital... Barbiturate..... Nembutal. DEA
Schedule II.
CONTROLLED.................... S7 C Pentoxyfylline.. Vasodilator..... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Pentylenetetrazo Stimulant....... Lacks FDA
l. approval.
BANNED........................ S2 ................... Perfluorodecahyd Oxygen transfer. Lacks FDA
ronophthalene. approval.
BANNED........................ S0 ................... Perfluorodecalin Oxygen transport Lacks FDA
(Octadecafluoro approval.
naphthalene).
[[Page 5152]]
BANNED........................ S2 ................... Perfluorooctyl Oxygen transfer. Discontinued, no
bromide. FDA-approved
product
commercially
available.
BANNED........................ S2 ................... Perfluorotriprop Oxygen transfer. Discontinued, no
ylamine. FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Pergolide....... Dopamine agonist Prascend.........
BANNED........................ S0 ................... Periciazine..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Perindopril..... Antihypertensive Generic,
Prestalia (with
amlodipine
besylate).
BANNED........................ S0 ................... Perlapine....... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Perphenazine.... Antipsychotic... Generic..........
BANNED........................ S0 ................... Phenacemide..... Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Phenaglycodol... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Phenazocine..... Opioid analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Phenazone....... NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 A Phenazopyridine. Local anesthetic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Phencyclidine Dissociative Lacks FDA
(PCP). hallucinogen. approval. DEA
Schedule I.
BANNED........................ S0 ................... Phendimetrazine. Stimulant....... Bontril. DEA
Schedule II.
BANNED........................ S0 ................... Phenelzine...... Antidepressant.. Nardil...........
BANNED........................ S0 ................... Phenibut........ Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Phenindamine.... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Phenindione..... Anticoagulant... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Pheniramine..... Antihistamine... Bromfed-DM (with
dextromethorphan
and
pseudoephedrine).
BANNED........................ S0 ................... Phenmetrazine... Stimulant....... Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Phenobarbital... Barbiturate..... predates FDA,
grandfathered.
DEA schedule IV.
BANNED........................ S0 ................... Phenoxybenzamine Antihypertensive Dibenzyline......
BANNED........................ S0 ................... Phenprocoumon... Anticoagulant... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Phenpromethamine Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Phensuximide.... Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Phentermine..... Stimulant....... Adipex-P,
Lomaira, Qsymia.
DEA Schedule IV.
CONTROLLED.................... S7 B Phentolamine.... Vasodilator..... Oraverse.........
CONTROLLED.................... S7 C Phenylbutazone.. NSAID (3 NSAIDs Butazolidin, Detection Time: 0.2 mcg/mL in
(Flunixin, Butatron, 48 hours. 4.4 serum or
Ketoprofen, EquiBute, Phen mg/kg single IV plasma. Note:
Phenylbutazone) Buta Vet, dose. (17 The detection
are associated Bizolin, horses). of more than
with a Butequine, one NSAID in a
Detection Time Superiorbute, horse's post-
of 48 hours. Pributazone. Race or post-
Only one of the Official
three may be Workout blood
administered and sample
using a constitutes a
Withdrawal Stacking
Interval based Violation.
on the 48 hour
Detection Time.
To avoid a
stacking
violation
(detection of
more than 1
NSAID in a
blood sample)
the following
secondary
Detection Times
should be
applied for the
following
NSAIDs:
Flunixin: 144
hours;
Ketoprofen: 96
hours;
Phenylbutazone:
168 hours.).
CONTROLLED.................... S7 B Phenylephrine... Stimulant....... Biorphen.........
[[Page 5153]]
BANNED........................ S0 ................... Phenylpiracetam Stimulant....... Lacks FDA
(Carphedon). approval.
BANNED........................ S0 ................... Phenylpropanolam Stimulant....... Proin............
ine.
BANNED........................ S0 ................... Phenyltoloxamine Antihistamine... Lacks FDA
approval.
CONTROLLED.................... S7 B Phenytoin....... Anticonvulsant.. Dilantin,
Phenytek.
BANNED........................ S0 ................... Pholcodine...... Opioid Lacks FDA
antitussive. approval; DEA
Schedule I.
BANNED........................ S0 ................... Pholedrine...... Stimulant....... Lacks FDA
approval.
CONTROLLED.................... S7 A Physostigmine... Acetylcholineste Antilirium.......
rase inhibitor.
BANNED........................ S0 ................... Picrotoxin...... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Piminodine...... Opioid analgesic Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S1 ................... Pimobendan...... Cardiac Vetmedin.........
stimulant.
BANNED........................ S0 ................... Pimozide........ Antipsychotic... Generic..........
BANNED........................ S0 ................... Pinazepam....... Anxiolytic...... Lacks FDA
approval.DEA
Schedule IV.
BANNED........................ S0 ................... Pinazepam....... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Pindolol........ Antihypertensive Generic..........
BANNED........................ S0 ................... Pipamazine...... Anti-emetic..... Lacks FDA
approval.
BANNED........................ S0 ................... Pipamperone..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Pipecuronium.... Muscle relaxant. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Pipequaline..... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Piper Anxiolytic/Anti- Lacks FDA
Methysticum inflammatory. approval.
(kava).
BANNED........................ S0 ................... Piperacetazine.. Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Piperidione..... Sedative........ Lacks FDA
approval.
BANNED........................ S0 ................... Piperidolate.... Antispasmodic... Lacks FDA
approval.
BANNED........................ S0 ................... Piperocaine..... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Piperoxan....... Antihistamine/ Lacks FDA
Antihypertensiv approval.
e.
BANNED........................ S0 ................... Pipotiazine..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Pipradrol....... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Piquindone...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Piracetam....... Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Pirbuterol...... Beta-2 agonist- Discontinued, no
bronchodilator. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Pirenzepine..... Anticholinergic. Lacks FDA
approval.
BANNED........................ S5 ................... Piretanide...... Diuretic........ Lacks FDA
approval.
BANNED........................ S0 ................... Piritramide..... Synthetic opioid Lacks FDA
analgesic. approval.
CONTROLLED.................... S7 B Piroxicam....... NSAID........... Feldene..........
BANNED........................ S0 ................... Pirprofen....... NSAID........... Lacks FDA
approval.
BANNED........................ S6 ................... Pitcher Plant Analgesic....... Sarapin..........
Extract.
BANNED........................ S0 ................... Pizotifen Antimigraine.... Lacks FDA
(Pizotylline). approval.
BANNED........................ S2 ................... Platelet-Derived Growth Hormone.. .................
Growth Factor
(PDGF).
BANNED........................ S5 ................... Polythiazide.... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Potassium Anticonvulsant/ KBroVet-CA1......
Bromide. anxiolytic.
BANNED........................ S0 ................... Practolol....... Antiarrhythmic.. Lacks FDA
approval.
BANNED........................ S2 ................... Pralmorelin..... Growth Hormone.. Lacks FDA
approval.
CONTROLLED.................... S7 C Pramoxine....... Topical Epifoam (with
anesthetic. hydrocortisone
acetate),
Pramosone (with
hydrocortisone
acetate).
BANNED........................ S1 ................... Prasterone Anabolic........ Intrarosa........
(dehydroepiandr
osterone, DHEA,
3[beta]hydroxya
ndrost-5-en17-
one).
BANNED........................ S0 ................... Prazepam........ Sedative/ Discontinued, no
Anxiolytic. FDA-approved
product
commercially
available. DEA
Schedule IV.
BANNED........................ S0 ................... Prazosin........ Antihypertensive Minipress........
CONTROLLED.................... S7 C Prednisolone.... Corticosteroid.. Endogenous ................ Threshold: 0.01
subtance (urine mcg/mL free
only) per IFHA. prednisolone in
urine.
CONTROLLED.................... S7 C Prednisone...... Corticosteroid.. Rayos............
CONTROLLED.................... S7 A Pregabalin...... Anticonvulsant/ Lyrica. DEA
Analgesic. Schedule V.
BANNED........................ S0 ................... Prenylamine..... Vasodilator..... Lacks FDA
approval.
BANNED........................ S0 ................... Pridinol........ Anticholinergic. Lacks FDA
approval.
[[Page 5154]]
BANNED........................ S0 ................... Prifinium Antispasmodic... Lacks FDA
Bromide. approval.
CONTROLLED.................... S7 B Prilocaine...... Local anesthetic Emla (with
lidocaine),
Oraqix (with
lidocaine),
Citanest (with
epinephrine).
CONTROLLED.................... S7 B Primidone....... Anticonvulsant.. Mysoline.........
BANNED........................ S5 ................... Probenecid...... Anti-gout....... Probalan.........
CONTROLLED.................... S7 B Procainamide.... Antiarrhythmic.. Generic..........
CONTROLLED.................... S7 B Procaine........ Local anesthetic (with Penicillin 17 mg (~17,000 25 ng/mL in
G). IU) per kg IM. serum or
plasma.
BANNED........................ S0 ................... Procarbazine.... Anti-neoplastic. Matulane.........
BANNED........................ S3 ................... Procaterol...... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S0 ................... Prochlorperazine Anti-nausea..... Compro, Procomp,
Compazine.
BANNED........................ S0 ................... Procyclidine.... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Proglumide...... Anti-ulcer...... Lacks FDA
approval.
CONTROLLED.................... S7 B Promazine....... Sedative/ Promazine
Antipsychotic. Granules.
CONTROLLED.................... S7 B Promethazine.... Antihistamine... Promethegan.
Note: Component
of multiple OTC
cough/cold
formulations.
BANNED........................ S0 ................... Pronethalol..... Antiarrhythmic.. Lacks FDA
approval.
CONTROLLED.................... S7 B Propafenone..... Antiarrhythmic.. Rythmol..........
BANNED........................ S0 ................... Propallylonal... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Propanidid...... Anesthetic...... Lacks FDA
approval.
BANNED........................ S0 ................... Propantheline... Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 C Proparacaine Local anesthetic Alcane...........
(Proxymetacaine
).
BANNED........................ S0 ................... Propentophylline Phosphodiesteras Lacks FDA
(propentofyllin e inhibitor. approval.
e).
BANNED........................ S0 ................... Propiomazine.... Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Propionylpromazi Sedative........ Lacks FDA
ne. approval.
BANNED........................ S0 ................... Propiram........ Opioid analgesic Lacks FDA
approval. DEA
Schedule I.
CONTROLLED.................... S7 A Propofol........ Anesthetic...... PropoFlo,
Rapanofal.
BANNED........................ S0 ................... Propoxycaine.... Local anesthetic Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Propoxyphene.... Opioid analgesic Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Propranolol..... Antiarrhythmic/ Inderal,
Antihypertensiv Hemangeol.
e.
BANNED........................ S0 ................... Propylhexedrine. Stimulant....... Benzedrex........
BANNED........................ S0 ................... Propyphenazone.. NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Proquazone...... NSAID........... Lacks FDA
approval.
BANNED........................ S1 ................... Prostanazol..... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Prothipendyl.... Anxiolytic/ Lacks FDA
Antihistamine. approval.
BANNED........................ S0 ................... Protokylol...... Bronchodilator.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Protriptyline... Antidepressant.. Generic..........
BANNED........................ S0 ................... Proxibarbital... Sedative/ Lacks FDA
Anxiolytic. approval.
BANNED........................ S0 ................... Proxyphylline... Bronchodilator.. Lacks FDA
approval.
CONTROLLED.................... S7 B Pseudoephedrine. Stimulant....... Sudafed..........
BANNED........................ S0 ................... Psilocin Hallucinogen.... Lacks FDA
(Psilocyn). approval; DEA
Schedule.
CONTROLLED.................... S7 B Pyridostigmine.. Cholinesterase Mestinon, Regonol
Inhibitor.
CONTROLLED.................... S7 B Pyrilamine...... Antihistamine... Histavet-P.......
BANNED........................ S0 ................... Pyrithyldione... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Pyrrobutamine... Antihistamine... Lacks FDA
approval.
BANNED........................ S0 ................... Quazepam........ Sedative........ Doral. DEA
Schedule IV.
BANNED........................ S0 ................... Quetiapine...... Antipsychotic... Lacks FDA
approval.
[[Page 5155]]
BANNED........................ S0 ................... Quinapril, Antihypertensive Accuretic........
Quinaprilat.
BANNED........................ S1 ................... Quinbolone...... Anabolic........ Lacks FDA
approval.
BANNED........................ S5 ................... Quinethazone.... Diuretic........ Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Quinidine....... Antiarrhythmic.. Generic..........
BANNED........................ S0 ................... Quinisocaine.... Local anesthetic Lacks FDA
approval.
CONTROLLED.................... S7 C Rabeprazole..... Anti-ulcer...... Aciphex..........
BANNED........................ S0 ................... Racemethorphan.. Anti-Alzheimer's Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Racemorphan..... Opioid agonist.. Lacks FDA
approval. DEA
Schedule II.
BANNED........................ S0 ................... Raclopride...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S1 (x) Ractopamine..... Anabolic........ Paylean,
Optaflexx,
Topmax.
BANNED........................ S4 ................... Raloxifene...... Selective Evista...........
Estrogen
Receptor
Modulator
(SERM).
BANNED........................ S4 ................... Ramatercept (ACE- Myostatin Lacks FDA
031). inhibitor. approval.
BANNED........................ S0 ................... Ramifenazone NSAID........... Lacks FDA
(Isopyrin). approval.
BANNED........................ S0 ................... Ramipril, Antihypertensive Altace...........
metabolite
Ramiprilat.
CONTROLLED.................... S7 C Ranitidine...... Anti-ulcer...... Generic.......... Restricted 40 ng/mL in
administration serum or
time: 24 hours. plasma.
8 mg/kg orally
twice daily for
7 doses. (9
horses).
BANNED........................ S0 ................... Regadenoson..... Cardiac Lexiscan.........
stimulant.
BANNED........................ S0 ................... Remifentanil.... Synthetic opioid Ultiva. DEA
analgesic. Schedule II.
BANNED........................ S0 ................... Remimazolam..... Anesthetic...... Byfavo. DEA
schedule IV.
BANNED........................ S0 ................... Remoxipride..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S3 ................... Reproterol...... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
CONTROLLED.................... S7 A Reserpine....... Antihypertensive/ Serpasil.........
Depressant.
BANNED........................ S0 ................... Rilmazafone..... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S3 ................... Rimiterol....... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S6 ................... Risedronate..... Bisphosphonate.. Actonel..........
BANNED........................ S0 ................... Risperidone..... Antipsychotic... Perseris Kit,
Risperdal
Consta,
Risperdal.
BANNED........................ S0 ................... Ritanserin...... Antidepressant.. Lacks FDA
approval.
BANNED........................ S3 ................... Ritodrine....... Beta-2 agonist.. Lacks FDA
approval.
BANNED........................ S0 ................... Rivastigmine.... Cholinesterase Exelon...........
Inhibitor.
BANNED........................ S0 ................... Rizatriptan..... Selective Maxalt...........
Serotonin
Receptor
Agonist.
CONTROLLED.................... S7 A Rocuronium...... Muscle relaxant. Generic..........
BANNED........................ S0 ................... Rofecoxib....... NSAID........... Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 B Romifidine...... Sedative........ Sedivet.......... Detection Time: 1 ng/mL in
60 hours. 80 urine.
mcg/kg single
IV dose (6
horses).
CONTROLLED.................... S7 A Ropivacaine..... Local anesthetic Naropin..........
BANNED........................ S2 ................... Roxadustat (FG- Erythropoiesis.. Lacks FDA
4592). approval.
BANNED........................ S0 ................... Salicylamide.... Analgesic....... Lacks FDA
approval.
CONTROLLED.................... S7 C Salicylic acid.. NSAID........... Paser............ ................ Threshold: 750
mcg/mL in urine
or 6.5 mcg/mL
in serum or
plasma.
CONTROLLED--when administered S7 B Salmeterol...... Beta-2 agonist- Serevent, Advair
via inhalation. bronchodilator. (with
fluticasone),
Airduo (with
fluticasone),
Wixela (with
fluticasone).
BANNED........................ S1 ................... SARM YK-11...... Anabolic........ Lacks FDA
approval.
CONTROLLED.................... S7 C (x) Scopolamine Anticholinergic. Transdermal Scop; ................ 60 ng/mL total
(Hyoscine). Dietary (free and
substance per conjugated) in
IFHA. urine.
CONTROLLED.................... S7 A Secobarbital Sedative/ Discontinued, no
(Quinalbarbiton Hypnotic. FDA-approved
e). product
commercially
available. DEA
Schedule II.
BANNED........................ S0 ................... Selegiline...... Antidepressant.. Emsam, Zelapar...
BANNED........................ S2 ................... Sermorelin...... Growth Hormone.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Sertraline...... Antidepressant.. Zoloft...........
BANNED........................ S0 ................... Sibutramine..... Stimulant....... Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule IV.
[[Page 5156]]
BANNED........................ S0 ................... Sildenafil...... Phosphodiesteras Viagra...........
e inhibitor.
BANNED........................ S6 ................... Snake Venoms.... Neurotoxin...... Lacks FDA
approval.
BANNED........................ S2 ................... Somatrem........ Growth Hormone.. Protropin........
BANNED........................ S2 ................... Somatrogon...... Growth Hormone.. Lacks FDA
approval.
BANNED........................ S2 ................... Somatropin...... Growth Hormone.. Lacks FDA
approval.
CONTROLLED.................... S7 B Sotalol......... Antiarrhythmic.. Betapace, Sorine,
Sotylize.
BANNED........................ S2 ................... Sotatercept..... Growth Hormone.. Lacks FDA
approval.
BANNED........................ S0 (x) Sparteine....... Antiarrhythmic.. Lacks FDA
approval.
BANNED........................ S0 ................... Spiperone....... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Spirapril, Antihypertensive Discontinued, no
metabolite FDA-approved
Spiraprilat. product
commercially
available.
BANNED........................ S5 ................... Spironalactone.. Diuretic........ Aldactazide,
Caarospir,
Aldactone.
BANNED........................ S4 ................... Stamulumab (Myo- Myostatin Lacks FDA
29). inhibitor. approval.
BANNED........................ S1 ................... Stanozolol...... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S1 ................... Stenbolone...... Anabolic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Strychnine...... CNS stimulant... Lacks FDA
approval. (Has
anetodal use as
contituent of
unregulated
appetite
stimulants and
leg paints.
Extreme caution
is advised when
using these
products.).
BANNED........................ S0 ................... Styramate....... Muscle relaxant. Lacks FDA
approval.
CONTROLLED.................... S7 A Succinylcholine. Muscle relaxant. Anectine,
Quelicin.
BANNED........................ S0 ................... Sufentanil...... Opioid analgesic Sufenta, Dsuvia.
DEA Schedule II.
CONTROLLED.................... S7 C Sulfasalazine... Disease- Azulfadine.......
modifying anti-
rheumatic.
BANNED........................ S0 ................... Sulfondiethylmet Sedative/ Lacks FDA
hane. Hypnotic. approval. DEA
Schedule III.
BANNED........................ S0 ................... Sulfonmethane... Sedative/ Lacks FDA
Hypnotic. approval. DEA
Schedule III.
BANNED........................ S0 ................... Sulforidazine... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Sulindac........ NSAID........... Generic..........
BANNED........................ S0 ................... Sulpiride....... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Sultopride...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Sumatriptan..... Selective Imitrex, Treximet
Serotonin [with naproxen].
Receptor
Agonist.
CONTROLLED.................... S7 C Suprofen........ NSAID........... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Suxibuzone...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 (x) Synephrine...... Stimulant....... Lacks FDA
approval.
BANNED........................ S4 ................... T3 Metabolic Lacks FDA
(triiodothyroni hormone. approval.
ne).
BANNED........................ S4 ................... T4 Metabolic Thyro-Tabs
(tetraiodothyro hormone. Canine,
nine/thy Thyrokare.
roxine).
BANNED........................ S2 ................... Tabimorelin..... Growth Hormone.. Lacks FDA
approval.
BANNED........................ S0 ................... Tadalafil....... Phosphodiesteras Cialis...........
e inhibitor.
BANNED........................ S0 ................... Talbutal........ CNS depressant.. Discontinued, no
FDA-approved
product
commercially
available. DEA
Schedule III.
BANNED........................ S4 ................... Tamoxifen....... Selective Soltamox.........
Estrogen
Receptor
Modulator
(SERM).
BANNED........................ S0 ................... Tandospirone.... Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Tapentadol...... Opioid analgesic Nucynta. DEA
Schedule II.
BANNED........................ S0 ................... Telmisartan..... Antihypertensive Micardis.........
[[Page 5157]]
CONTROLLED.................... S7 B Temazepam Anxiolytic...... Restoril. DEA
(Temazepam is a Schedule IV.
major
metabolite of
diazepam. If
there is
credible
evidence that
the presence of
temazepam in a
horse's sample
is the
consequence of
exposure to
diazepam, the
classification
of temazepam
may be revised
to S7(B).).
BANNED........................ S0 ................... Tenoxicam....... NSAID........... Lacks FDA
approval.
CONTROLLED.................... S7 B Tepoxalin....... NSAID........... Zubrin...........
BANNED........................ S0 ................... Terazosin....... Antihypertensive Generic..........
BANNED........................ S3 ................... Terbutaline..... Bronchodilator.. Brethine.........
BANNED........................ S0 ................... Terfenadine..... Antihistamine... Lacks FDA
approval.
BANNED........................ S2 ................... Tesamorelin..... Growth Hormone.. Egrifta..........
BANNED........................ S4 ................... Testolactone.... Aromatase Teslac. DEA
inhibitor. Schedule III.
BANNED........................ S2 ................... Testolone....... Selective Lacks FDA
Androgen approval.
Receptor
Modulator
(SARM).
BANNED--Fillies and Mares S1 ................... Testosterone.... Anabolic........ Androderm, Testm, ................ Threshold: 55 ng/
(unless in foal). Vogelxo, mL total (free
Testopel, Aveed, and conjugated)
Kyzatrex, testosterone in
Jatenzo, urine OR 0.1 n/
Xyosted. DEA mL free
Schedule III. testosterone in
serum or
plasma.
BANNED--Geldings.............. S1 ................... Testosterone.... Anabolic........ Androderm, Testm, ................ Threshold: 20 ng/
Vogelxo, mL total (free
Testopel, Aveed, and conjugated)
Kyzatrex, testosterone in
Jatenzo, urine OR 0.1 ng/
Xyosted. DEA mL free
Schedule III. testosterone in
serum or
plasma.
BANNED........................ S0 ................... Tetrabenazine Neurotransmitter Xenazine, Austedo
(deutetrabenazi modulator.
ne).
CONTROLLED.................... S7 B Tetracaine...... Local anesthetic Pliaglis [with
lidocaine],
Synera [with
lidocaine],
Kovanze [with
oxymetazoline].
BANNED........................ S1 ................... Tetrahydrogestri Anabolic........ Lacks FDA
none. approva. DEA
Schedule III.
CONTROLLED.................... S7 B Tetrahydrozoline Topical Visine...........
Decongestant.
BANNED........................ S0 ................... Tetrazepam...... Anxiolytic...... Lacks FDA
approval. DEA
Schedule IV.
BANNED........................ S1 ................... THC Psychoactive.... Lacks FDA
(tetrahydrocann approval. DEA
abinol). Schedule I.
BANNED........................ S0 (x) Thebaine........ Opioid analgesic Lacks FDA
approval. DEA
Schedule II.
CONTROLLED.................... S7 B (x) Theobromine..... Bronchodilator/ Lacks FDA ................ 2 mcg/mL (free
Vasodilator. approval; and conjugated)
Dietary in urine OR 0.3
substance per mcg/mL in serum
IFHA. or plasma.
CONTROLLED.................... S7 B (x) Theophylline.... Bronchodilator.. Generic; Dietary ................ 250 ng/mL (free
substance per and conjugated)
IFHA. in urine.
BANNED........................ S0 ................... Thialbarbital... Sedative/ Lacks FDA
Hypnotic. approval.
CONTROLLED.................... S7 A Thiamylal....... Sedative/ Surital, Biotal,
Hypnotic. Anestatal. DEA
Schedule III.
BANNED........................ S0 ................... Thiethylperazine Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Thiopental Anesthetic...... Combuthal Powder,
(pentothal). Xylamed. DEA
Schedule III.
BANNED........................ S0 ................... Thiopropazate... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Thioproperazine. Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Thioridazine.... Antipsychotic... Generc...........
BANNED........................ S0 ................... Thiothixene..... Antipsychotic... Generic..........
BANNED........................ S0 ................... Thiphenamil Antispasmodic/ Lacks FDA
(tifenamil). Local approval.
anesthetic.
BANNED........................ S0 ................... Thonzylamine.... Antihistamine/ Lacks FDA
anticholinergic. approval.
BANNED........................ S0 ................... Thozalinone..... Antidepressant.. Lacks FDA
approval.
BANNED........................ S2 ................... Thymosin........ Peptide hormone. Lacks FDA
approval.
BANNED........................ S0 ................... Tiapride........ Antipsychotic... Lacks FDA
approval.
[[Page 5158]]
BANNED........................ S0 ................... Tiaprofenic acid NSAID........... Lacks FDA
approval.
BANNED........................ S1 ................... Tibolone........ Anabolic........ Lacks FDA
approval.
BANNED........................ S6 ................... Tildronate Bisphosphonate.. Tildren..........
(Tiludronic
Acid).
CONTROLLED.................... S7 A Tiletamine...... Anesthetic...... Telazol [with
zolazepam]. DEA
Schedule III.
BANNED........................ S0 ................... Timiperone...... Antipsychotic... Lacks FDA
approval.
BANNED........................ S3 ................... Timolol......... Antihypertensive Istalol, Betimol,
Timoptic.
CONTROLLED.................... S7 B Tiotropium...... Bronchodilator.. Spiriva..........
BANNED........................ S0 ................... Tocainide....... Antiarrhythmic.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Tofenacin....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Tofisopam....... Anxiolytic...... Lacks FDA
approval.
CONTROLLED.................... S7 A Tolazoline...... Vasodilator..... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Tolfenamic Acid. NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Tolmetin........ NSAID........... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S5 ................... Tolvaptan....... Diuretic........ Jynarque, Samsca.
BANNED........................ S0 ................... Tolycaine....... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Topiramate...... Anticonvulsant.. Topamax, Qsymia
(with
phentermine
hydrochloride).
BANNED........................ S4 ................... Toremifene...... Selective Fareston.........
Estrogen
Receptor
Modulator
(SERM).
BANNED........................ S5 ................... Torsemide Diuretic........ Soaanz...........
(Torasemide).
CONTROLLED.................... S7 B Tramadol........ Opioid Analgesic Ultram. DEA
Schedule IV.
BANNED........................ S0 ................... Tramazoline..... Sympathomimetic. Lacks FDA
approval.
BANNED........................ S0 ................... Trandolapril Antihypertensive Generic..........
(and
metabolite,
trandolaprilat).
CONTROLLED.................... S7 C Tranexamic acid. Anti- Cykokapron.......
fibrinolytic.
BANNED........................ S0 ................... Tranylcypromine. Antidepressant.. Parnate..........
BANNED........................ S0 ................... Trazodone....... Antidepressant.. Generic..........
BANNED........................ S1 ................... Trenbolone Anabolic........ Finaplix;
(trendione). Revalor, Synovex
(with
Estradiol);
Component (with
estradiol and
tylosin). DEA
Schedule III.
BANNED........................ S1 ................... Trendione....... Anabolic........ Lacks FDA
approval.
BANNED........................ S0 ................... Trestolone...... Anabolic........ Lacks FDA
approval.
BANNED........................ S3 ................... Tretoquinol Beta-2 agonist- Lacks FDA
(trimetoquinol). bronchodilator. approval.
CONTROLLED.................... S7 C Triamcinolone... Corticosteroid.. Vetalog, Kenalog. ................ 0.5 ng/mL in
urine.
BANNED........................ S5 ................... Triamterene..... Diuretic........ Dyrenium.........
BANNED........................ S0 ................... Triazolam....... CNS depressant.. Halcion. DEA
Schedule IV.
BANNED........................ S0 ................... Tribromoethanol. Anesthetic...... Lacks FDA
approval.
BANNED........................ S0 ................... Tricaine Anesthetic...... Syncaine.........
methanesulfonat
e.
CONTROLLED.................... S7 C Trichlormethiazi Diuretic........ Discontinued, no
de. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Trichloroethanol Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Trichloroethylen Anesthetic...... Lacks FDA
e. approval.
BANNED........................ S0 ................... Triclofos....... Sedative........ Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Tridihexethyl... Anticholinergic. No FDA-approved
product.
BANNED........................ S0 ................... Triflumeprazine. Sedative........ Lacks FDA
approval.
BANNED........................ S0 ................... Trifluoperazine. Antipsychotic... Generic..........
BANNED........................ S0 ................... Trifluoromethylp Stimulant....... Lacks FDA
henyl approval.
piperazine.
BANNED........................ S0 ................... Trifluperidol... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Triflupromazine. Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Triflupromazine. Antipsychotic... Discontinued, no
FDA-approved
product
commercially
available.
[[Page 5159]]
BANNED........................ S0 ................... Trihexyphenidyl. Anticholinergic. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Trimecaine...... Local anesthetic Lacks FDA
approval.
BANNED........................ S0 ................... Trimeprazine Antihistamine... Temaril-P [with
(alimemazine). prednisolone].
BANNED........................ S4 ................... Trimetazidine... Angina treatment Lacks FDA
approval.
BANNED........................ S0 ................... Trimethadione... Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Trimethaphan.... Antihypertensive/ Discontinued, no
Anesthetic. FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Trimipramine.... Antidepressant.. Generic..........
CONTROLLED.................... S7 B Tripelennamine.. Antihistamine... Re-Covr..........
BANNED........................ S0 ................... Triprolidine.... Antihistamine... Triacin-C (with
codeine
phosphate and
pseudoephedrine
hydrochloride).
BANNED........................ S2 ................... Triptorelin..... Reproductive Triptodur,
hormone Trelstar.
modulator.
BANNED........................ S0 ................... Trometamol (Tris Alkalinizing Discontinued, no
hydroxymethylam agent. FDA-approved
inomethane product is
[THAM]). commercially
available.
CONTROLLED.................... S7 B Tropicamide..... Ophthalmic Mydriacyl........
Anticholinergic.
BANNED........................ S0 ................... Tuaminoheptane.. Stimulant....... Lacks FDA
approval.
BANNED........................ S0 ................... Tubocurarine Muscle relaxant. Plant alkaloid.
(Curare). Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S3 ................... Tulobuterol..... Beta-2 agonist- Lacks FDA
bronchodilator. approval.
BANNED........................ S0 ................... Tybamate........ Anxiolytic...... Lacks FDA
approval.
BANNED........................ S0 ................... Valdecoxib...... NSAID........... Discontinued, no
FDA-approved
product
commercially
available.
CONTROLLED.................... S7 A Valerenic acid.. Sedative........ Plant derived....
BANNED........................ S0 ................... Valnoctamide.... Sedative/ Lacks FDA
Hypnotic. approval.
BANNED........................ S0 ................... Valproate Sodium Anticonvulsant.. Discontinued, no
FDA-approved
product
commercially
available.
BANNED........................ S0 ................... Valsartan....... Antihypertensive Diovan, Entresto
(with
sacubitril).
BANNED........................ S0 ................... Vardenafil...... Phosphodiesteras Levitra..........
e inhibitor.
BANNED........................ S2 ................... Vascular- Growth Hormone.. .................
Endothelial
Growth Factor
(VEGF).
CONTROLLED.................... S7 A Vecuronium...... Muscle relaxant. Generic..........
BANNED........................ S0 ................... Vedaprofen...... NSAID........... Lacks FDA
approval.
BANNED........................ S0 ................... Venlafaxine..... Antidepressant.. Pristiq..........
BANNED........................ S0 ................... Veralipride..... Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Verapamil....... Antihypertensive Verelan, Calan...
BANNED........................ S3 ................... Vilanterol...... Beta-2 agonist- Trelegy, Ellipta.
bronchodilator.
BANNED........................ S0 ................... Viloxazine...... Antidepressant.. Qelbree..........
BANNED........................ S0 ................... Vinbarbital..... Hypnotic........ Lacks FDA
approval. DEA
Schedule III.
BANNED........................ S0 ................... Vinylbital...... Sedative/ Lacks FDA
Hypnotic. approval.
CONTROLLED.................... S7 C Warfarin........ Anticoagulant... Coumadin,
Jantoven.
BANNED........................ S2 ................... Xenon........... Hypoxia .................
Inducible
Factor
activating
agent.
BANNED........................ S5 ................... Xipamide........ Diuretic........ Lacks FDA
approval.
CONTROLLED.................... S7 B Xylazine........ Sedative/ Rompun, Anased... Detection Time: SL: 10 ng/mL U
Analgesic. 72 hours. 200 (as 4-OH
mg single IV xylazine); 0.05
dose.. ng/mL B.
BANNED........................ S0 ................... Xylometazoline.. Stimulant....... Afrin, Vicks
Sinex.
CONTROLLED.................... S7 B Yohimbine....... Stimulant....... Antagonil........
BANNED........................ S0 ................... Zafirlukast..... Asthma Accolate.........
prevention.
BANNED........................ S0 ................... Zaleplon........ CNS depressant.. Sonata. DEA
Schedule IV.
BANNED........................ S1 ................... Zeranol......... Anabolic........ Ralgro...........
BANNED........................ S6 ................... Ziconotide...... Neurotoxin...... Prialt...........
BANNED........................ S0 ................... Zileuton........ Asthma Zyflo............
prevention.
BANNED........................ S1 (x) Zilpaterol Anabolic........ Zilmax, Heifermax
hydrochloride.
BANNED........................ S0 ................... Zimeldine....... Antidepressant.. Lacks FDA
approval.
BANNED........................ S0 ................... Ziprasidone..... Antipsychotic... Geodon...........
CONTROLLED.................... S7 A Zolazepam....... Sedative/ Telazol [with
Anxiolytic. tiletamine].
BANNED........................ S6 ................... Zoledronic acid. Bisphosphonate.. Reclast..........
[[Page 5160]]
BANNED........................ S0 ................... Zolmitriptan.... Selective Zomig............
Serotonin
Receptor
Agonist.
BANNED........................ S0 ................... Zolpidem........ Sedative/ Ambien. DEA
Hypnotic. Schedule IV.
BANNED........................ S0 ................... Zomepirac....... Anticonvulsant.. Lacks FDA
approval.
BANNED........................ S0 ................... Zonisamide...... Anticonvulsant.. Zonegran.........
BANNED........................ S0 ................... Zopiclone....... Sedative/ Lunesta. DEA
Hypnotic. Schedule IV.
BANNED........................ S0 ................... Zotepine........ Antipsychotic... Lacks FDA
approval.
BANNED........................ S0 ................... Zuclopenthixol.. Antipsychotic... Lacks FDA
approval.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (Unless otherwise designated as a Threshold). Where no value is listed for serum or plasma the substance is controlled by Laboratory Limit of
Detection. Unless otherwise specified, urine values are in hydrolyzed urine.
[[Page 5161]]
5000. Equine Testing and Investigations Standards
5010. Purpose
(a) The Equine Testing and Investigations Standards have been
developed pursuant to the Act and the Protocol.
(b) The first purpose of the Testing and Investigations Standards
is to plan for intelligent and effective Testing, both in- and out-of-
competition, and to maintain the integrity and identity of the Samples
collected from the point of notification of a Covered Horse's selection
for Sample collection, to the point the Samples are delivered to a
Laboratory for analysis. To that end, these Testing and Investigations
Standards establish protocols for test planning, notification of a
Covered Horse's selection for Sample collection, preparing for and
conducting Sample collection, security/post-test administration of
Samples and documentation, and transport of Samples to Laboratories for
analysis.
(c) The second purpose of the Testing and Investigations Standards
is to establish rules for the efficient and effective gathering,
assessment, and use of anti-doping and medication control intelligence,
and for efficient and effective investigations into possible anti-
doping and medication control rule violations.
5020. Definitions
Unless specified otherwise, capitalized terms used in these Testing
and Investigations Standards have the meanings given to them in Rule
1020.
5100. Standards for Testing
5110. Planning Effective Testing
(a) The Agency is required to plan and implement intelligent and
effective Testing on Covered Horses over which it has authority, and
that is proportionate to the risk of doping and the misuse of
medication, and effective to detect and to deter such practices. The
objective of this Rule is to explain the steps that form part of a Risk
Assessment to inform Testing plans in a way that best ensures clean
competition and protects the health and welfare of Covered Horses.
(b) The Agency shall ensure that Covered Persons with a conflict of
interest in the outcome of the Testing being contemplated are not
involved in test planning or in the process of selection of Covered
Horses for Sample collection.
(c) The Agency should monitor, evaluate, and update its Risk
Assessment during the year or cycle in light of changing circumstances
and in implementing its Testing plans.
5120. Risk Assessment
The Risk Assessment shall be conducted in good faith, reviewed and
updated as required (at the discretion of the Agency), and should take
into account (if available) the following information:
(a) discipline and individual factors that may result in a higher
potential for adopting doping behavior or misuse of medication;
(b) available statistics and research on doping trends and misuse
of medication, practices, and methods;
(c) reliable information received and intelligence developed on
possible doping practices and misuse of medication;
(d) outcomes of previous test planning cycles, including past
testing strategies;
(e) optimal times to apply specific test types (including analysis)
to maximize opportunities for detecting and deterring doping;
(f) given the structure of the racing season (including generic
racing schedules and training patterns), the time during the year a
horse is most likely to be administered Banned Substances or be
subjected to Banned Methods (to enhance or impair performance or impact
welfare or soundness); and
(g) any Risk Assessment carried out by a State Racing Commission or
racing authority in another country and provided to the Agency for the
purposes of enhancing its Risk Assessment.
5130. Prioritizing Between Covered Horses, Types of Testing, and
Samples
(a) The Agency should consider various factors in prioritizing the
allocation of Testing resources. In addition, the Agency will use
Target Testing to focus Testing resources where they are most needed
within the overall pool of Covered Horses.
(b) Factors relevant to determining which Covered Horses should be
the subject of Target Testing may include, but are not limited to, the
following:
(1) Covered Horses serving a period of Ineligibility or a
Provisional Suspension;
(2) Covered Horses who were high priority for Testing before
retirement and are now returning from retirement to active
participation;
(3) Covered Horses' testing history, including any abnormal Sample
data (e.g., an Atypical Finding reported by a Laboratory);
(4) Covered Persons' prior anti-doping and medication control rule
violations and testing history, including any abnormal Sample data
(e.g., an Atypical Finding reported by a Laboratory);
(5) performance history, performance pattern, or high performance
(e.g., Trainer strike rate) without a commensurate testing record;
(6) repeated failure to meet whereabouts requirements;
(7) suspicious whereabouts filing patterns;
(8) moving to or training in a remote location;
(9) suspicious withdrawal or absence from expected Covered
Horserace(s);
(10) association with a third party (such as a Trainer,
Veterinarian, or Owner) with a history of involvement in doping or
misuse of medication;
(11) injury;
(12) age and stage of career;
(13) financial incentives for improved or degraded performance,
such as purse size, unusual betting patterns, or upcoming Claiming
Race; or
(14) reliable information from a third party, or intelligence
developed by or shared with the Agency.
(c) Target Testing is a priority because random Testing, or even
weighted random Testing, does not ensure that all of the appropriate
Covered Horses will be sufficiently tested. Covered Horses may be
tested at any time and at any place where they are located (e.g.,
Racetrack, Training Facility, private facility). The Protocol does not
impose any reasonable suspicion or probable cause requirement for
Target Testing or Testing.
(d) Testing that is not Target Testing should be determined based
on the Risk Assessment. Testing should be conducted using a documented
system for such selection, such as weighted testing (where Covered
Horses are ranked using pre-determined criteria to increase or decrease
the chances of selection) or random testing (where no pre-determined
criteria are considered, and Covered Horses are chosen arbitrarily from
a list or pool of names). Testing that is weighted should be
prioritized and conducted according to defined criteria which may take
into account the risk factors to ensure that a greater percentage of at
risk Covered Horses are selected.
(e) Based on the Risk Assessment and prioritization process
described above, the Agency should determine to what extent each of the
following types of Testing is required to effectively detect and deter
doping and misuse of medication within the sport:
(1) TCO2 and Post-Race Sample collection on Race Day;
(2) Post-Work Sample collection following Timed and Reported
Workouts;
[[Page 5162]]
(3) Out-of-competition Sample collection;
(4) Sample matrices to be considered:
(i) urine;
(ii) hair;
(iii) blood; or
(iv) other matrices or methodologies, as available.
5140. Sample Analysis, Retention Strategy, and Further Analysis
(a) Laboratories shall analyze Samples for an Analytical Testing
menu directed by the Agency. The Agency may also consider undertaking
more extensive Sample analysis for Prohibited Substances or Prohibited
Methods based on the assessed risk or any intelligence that the Agency
may receive (e.g., specific Prohibited Substances, gene doping).
(b) The Agency should develop a system for retention of Samples and
related documentation to enable the Further Analysis of such Samples at
a later date in accordance with Rule 3138. Such a system should comply
with the requirements of the Laboratory Standards and should take into
account the purposes of Sample analysis set out in Rule 3137, as well
as (without limitation) the following elements:
(1) Laboratory recommendations (when available);
(2) new relevant detection methods to be introduced in the future;
(3) collected Samples that meet some or all of the criteria set out
at Rule 5130; or
(4) the Agency determining based on available information or random
selection that long-term storage or Further Analysis of the Samples is
appropriate.
5150. Coordinating With State Racing Commissions and Other Entities
(a) In accordance with Rule 3132, the Agency may delegate Testing
(or aspects thereof) to State Racing Commissions, subject to the
applicable State Racing Commission electing to enter into an agreement
with the Agency. For example, the Agency may utilize Sample Collection
Personnel employed or designated by a State Racing Commission to
collect Samples. Any state rule, law, or regulation preventing sample
collection personnel employed or designated by a State Racing
Commission from contracting with the Agency to collect Samples is pre-
empted by this rule, which expressly permits such arrangements.
Regardless of who collects a Sample, only the Agency shall receive the
results of Sample analysis directly from the Laboratory.
(b) The Agency may delegate Testing (or aspects thereof) to
qualified third parties, e.g., by contracting a third-party sample
collection service provider to collect Samples on behalf of the Agency.
(c) State Racing Commissions, Racetracks, Race Organizers, and
other third parties may (at their own cost) contract with the Agency to
collect additional Samples on Covered Horses in a manner that is
consistent with the Act and the Protocol.
5200. Notification
5210. Requirements Prior to Notification
(a) Testing without advance notice should be the method for Sample
collection except in circumstances where advance notice is required to
facilitate the Testing. If the Responsible Person is with the Covered
Horse at the time of notification, the Responsible Person should be the
first Person notified that the Covered Horse has been selected for
Sample collection. In order to ensure that Testing is conducted on a
without advance notice basis, the Agency shall ensure Testing selection
decisions are only disclosed in advance of Testing to those who need to
know in order for such Testing to be conducted. Any notification to a
third party shall be conducted in a secure and confidential manner to
minimize the risk that the Responsible Person or other Covered Person
will receive any advance notice of a Covered Horse's selection for
Sample collection.
(b) The Agency shall appoint DCOs, BCOs, Chaperones, and other
Sample Collection Personnel sufficient to facilitate Testing without
advance notice and to ensure continuous observation of the Covered
Horse and confirmation that the Covered Horse is in a secure location
(a stall, for example) throughout the Sample collection process. Sample
Collection Personnel must be trained for their assigned
responsibilities, must not have a conflict of interest with respect to
the performance or outcome of the Sample collection, and must be 18 or
older. See Rule 5450 for more information on Sample Collection
Personnel requirements.
(c) Sample Collection Personnel shall have official documentation
provided by the Agency, evidencing their authority to collect a Sample
from the Covered Horse.
(d) Information provided in the Covered Horse's whereabouts filing
and registration with the Authority, or other equally reliable form of
identification, shall be used by Sample Collection Personnel to confirm
the identity of the Covered Horse. Confirmation of the Covered Horse's
identity by any other method or failure to confirm the identity of the
Covered Horse shall be documented, including through photographs, and
reported to the Agency.
(e) The DCO or BCO shall establish the location of the selected
Covered Horse and plan the approach and timing of notification, taking
into consideration the specific circumstances of the location,
schedule, and the situation in question (e.g., Covered Horserace, Timed
and Reported Workout, Vets' List Workout).
5220. Requirements for Notification
(a) Out-of-competition Sample collection.
(1) The Sample Collection Personnel will seek to locate the Covered
Horse based on available data regarding Racetracks and Training
Facilities or based on whereabouts information.
(2) If the Sample Collection Personnel are able to locate the
Covered Horse, notification of out-of-competition Sample collection
shall ordinarily take place in person, but may, if necessary, take
place by telephone, text message, or email using the contact details
provided by the Responsible Person upon registration with the
Authority.
(3) If the Sample Collection Personnel are not able to locate the
Covered Horse based on available data or whereabouts information,
notification of out-of-competition Sample collection shall take place
by telephone, text message, or email, using the contact details
provided by the Responsible Person upon registration with the
Authority.
(4) In accordance with Rule 3215, the Responsible Person shall
ensure that the Covered Horse is produced for Sample collection
immediately upon notification by a duly authorized person in accordance
with the Agency's procedures if the Covered Horse is present at the
location where notification is attempted. If the Covered Horse is not
present at the location where notification is attempted (including due
to a Whereabouts Failure), the Responsible Person shall ensure that the
Covered Horse is produced for Sample collection within 6 hours of
notification by a duly authorized Person in accordance with the
Agency's procedures, except that the Agency may extend the 6-hour
period if it considers that extenuating circumstances justify doing so.
(5) At the time of notification, the Sample Collection Personnel
shall inform the Responsible Person or Nominated Person:
(i) that the Covered Horse is required to undergo Sample
collection;
(ii) that immediate access to the Covered Horse shall be granted,
and (if
[[Page 5163]]
that is not possible because the Covered Horse is not present at the
location), the Responsible Person has 6 hours to produce the Covered
Horse for Sample collection, failing which significant Consequences may
apply in accordance with Rule 3215;
(iii) that the Sample collection process shall start immediately,
unless there are valid reasons for a delay (as determined by the DCO or
BCO);
(iv) that the Sample collection process shall take place in a
secure location determined suitable by the DCO or BCO (e.g., the
horse's stall);
(v) of the responsibilities of the Responsible Person or Nominated
Person with respect to the Covered Horse, including the requirement to:
(A) ensure that the Covered Horse remains under continuous
observation of Sample Collection Personnel at all times until the
completion of the Sample collection procedure;
(B) not leave the Covered Horse unattended once the Responsible
Person or Nominated Person is notified and contact is made with the
Covered Horse until the completion of the Sample collection procedure;
(C) produce on request identification for himself or herself and
the Covered Horse. Identification for the Responsible Person or
Nominated Person should include his or her Authority registration
number or (if not available) valid photo identification. The Sample
Collection Personnel may take photographs of the individual(s) and the
Covered Horse if identification is not provided;
(D) comply and cooperate with Sample collection procedures and
processes (the Responsible Person or Nominated Person should also be
advised of the possible Consequences of failure to comply, including
pursuant to Rule 3215 and 3510); and
(E) ensure that the Covered Horse is not administered any
medications or supplements from notification of Sample collection until
completion of Sample collection, unless there is a medical emergency,
as determined by a Regulatory Veterinarian or (if not available) a
Veterinarian.
(6) The Sample Collection Personnel shall have the Responsible
Person or Nominated Person sign an appropriate form to acknowledge and
accept the notification of Sample collection. If the Responsible Person
or Nominated Person refuses to sign the form, or evades notification,
the Sample Collection Personnel should, if possible, inform the
Responsible Person or Nominated Person of the Consequences of a failure
to comply, and the Sample Collection Personnel (if not the DCO) shall
immediately report all relevant facts to the DCO or BCO. When possible,
the Sample Collection Personnel shall continue the Sample collection.
The DCO shall document the facts in a detailed report and report the
circumstances to the Agency.
(7) A Nominated Person may be replaced by another Nominated Person
during the Sample collection process upon reasonable request to the
Sample Collection Personnel so long as the new Nominated Person (i)
falls within the scope of the definition of Nominated Person, (ii)
completes the relevant portions of the Sample collection paperwork, and
(iii) does not interfere with the Sample collection process. Any
changes of Nominated Person during the Sample collection process shall
be documented by the Sample Collection Personnel.
(b) Post-Race Sample collection.
(1) Pursuant to Rule 1020, a Post-Race Sample includes any Sample
collected by or on behalf of the Agency from a Covered Horse where
notification of such Sample collection takes place no more than 1 hour
after the end of a Covered Horserace in which a Covered Horse
participates or is entered, or the end of a Vet's List Workout in which
a Covered Horse participates.
(2) A member of the Sample Collection Personnel will tag or
otherwise identify a Covered Horse selected for Sample collection
(ordinarily in the unsaddling area) within 1 hour of the end of the
Covered Horserace or Vets' List Workout and chaperone the Covered
Horse, to the extent possible, from the point of tagging/notification
until the end of the Sample Collection Session. Such notification
should inform the Responsible Person or Nominated Person:
(i) that the Covered Horse is required to undergo Sample
collection;
(ii) that the Covered Horse must report to the Test Barn as soon as
practicable, unless there are valid reasons for a delay (as determined
by the DCO or BCO);
(iii) of the location of the Test Barn;
(iv) of the responsibilities of the Responsible Person or Nominated
Person with respect to the Covered Horse, including the requirement to:
(A) ensure that the Covered Horse remains under observation of
Sample Collection Personnel, to the extent possible, until the
completion of the Sample Collection Session;
(B) not leave the Covered Horse unattended to the extent possible
once the Responsible Person or Nominated Person is notified and contact
is made with the Covered Horse until the Sample Collection Session is
completed;
(C) produce on request identification for himself or herself (which
shall include his or her Authority registration number) and the Covered
Horse. The Sample Collection Personnel may take photographs of the
individual(s) and the Covered Horse if no identification is provided;
(D) comply and cooperate with Sample collection procedures and
processes (the Responsible Person or Nominated Person should be advised
of the possible Consequences of a failure to comply, including pursuant
to Rule 3215 and 3510);
(E) ensure that the Covered Horse is not administered any
medications or supplements (or similar items) from notification of
Sample collection until completion of the Sample Collection Session,
unless there is a medical emergency, as determined by the Test Barn
Veterinarian or a Regulatory Veterinarian; and
(F) confirm that the water bucket of the Covered Horse is clean and
acceptable and ensure that it is only used for that Covered Horse
during the Sample Collection Session.
(3) The Sample Collection Personnel shall notify the Responsible
Person or Nominated Person and document the time and the individual
notified (e.g., by taking a photograph or by having the Responsible
Person or Nominated Person sign an appropriate form or through such
other reasonable and appropriate measure under the circumstances), and
the Responsible Person or Nominated Person must sign an appropriate
form to acknowledge and accept the notification no later than once in
the Test Barn or other secure location. If the Responsible Person or
Nominated Person refuses to sign the form, or evades the notification,
the Sample Collection Personnel should, if possible, inform the
Responsible Person or Nominated Person of the Consequences of a failure
to comply, and the Sample Collection Personnel (if not the DCO or BCO)
shall immediately report all relevant facts to the DCO or BCO. When
possible, the Sample Collection Personnel shall continue the Sample
collection. The DCO or BCO shall document the facts in a detailed
report and report the circumstances to the Agency.
(4) From the time that a Covered Horse is tagged or identified for
Sample collection until the end of the Sample collection process, the
Sample Collection Personnel shall keep the Covered Horse under
observation or ensure the Covered Horse is in a secure location (a
stall, for example).
(5) A Nominated Person may be replaced by another Nominated Person
[[Page 5164]]
during the Sample collection process upon reasonable request to the
Sample Collection Personnel, so long as the new Nominated Person (i)
falls within the scope of the definition of Nominated Person, (ii)
completes the relevant portions of the Sample collection paperwork, and
(iii) does not interfere with the Sample collection process. Any
changes of Nominated Person during the Sample collection process shall
be documented by the Sample Collection Personnel.
(c) Pre-race Sample collection.
Blood samples may be collected before a Covered Horserace or Vets'
List Workout for purposes of TCO2 testing in accordance with Rule 5430.
Sample Collection Personnel shall provide notification of Sample
collection in accordance with paragraph (a) or (b) above depending on
the circumstances.
(d) Post-Work Sample collection.
Samples may be collected after a Timed and Reported Workout in
accordance with Rule 5400. All Banned Substances and any Controlled
Medication Substances specifically identified on the Prohibited List as
prohibited during Timed and Reported Workouts are prohibited from being
present in a Post-Work Sample. Sample Collection Personnel shall
provide notification of Sample collection in accordance with paragraph
(a) and (b) above depending on the circumstances.
5230. Requests for Delay
(a) The DCO or BCO may consider any reasonable request from the
Responsible Person or Nominated Person or third party for permission to
delay beginning the Sample collection process following acknowledgment
and acceptance of notification. The DCO or BCO may grant such
permission only if the Covered Horse can remain under continuous
observation of Sample Collection Personnel at all times until the
completion of the Sample collection procedure. The DCO or BCO shall
otherwise reject a request for delay, unless there is a medical
emergency (as determined by a Test Barn Veterinarian or Regulatory
Veterinarian or, if not available for an out-of-competition Sample
collection, a Veterinarian) or other circumstances so require it (as
determined by the DCO or BCO).
(b) For Race Day Sample collection, delayed reporting to the Test
Barn may be permitted in accordance with paragraph (a) on account of:
(1) participation in the winner's circle;
(2) obtaining necessary medical treatment if there is a medical
emergency, as determined by a Regulatory Veterinarian or Test Barn
Veterinarian; or
(3) any other reasonable circumstances, as determined by the DCO or
BCO, taking into account any instructions of the Agency.
(c) For out-of-competition Sample collection, delayed reporting for
Sample collection may be permitted in accordance with paragraph (a) on
account of:
(1) completing a training session or a cool down;
(2) receiving necessary medical treatment if there is a medical
emergency, as determined by a Regulatory Veterinarian or (if not
available) a Veterinarian; or
(3) any other reasonable circumstances, as determined by the DCO or
BCO, taking into account any instructions of the Agency.
(d) Sample Collection Personnel shall document any reasons for
delay in reporting for Sample collection.
(e) If immediate access to the Covered Horse is not granted, the
DCO or BCO shall report to the Agency a possible failure to comply. If
at all possible, the DCO or BCO shall proceed with collecting a Sample.
5300. Preparing for the Sample Collection Session
5310. General Requirements
(a) The Agency should establish a system for obtaining all of the
information necessary to ensure that the Sample Collection Session can
be conducted effectively.
(b) For Race Day Sample collection, a Test Barn should be used
that, where possible, is used solely as a Test Barn for the duration of
all Sample Collection Sessions. Unauthorized persons should not be
permitted access to the Test Barn. Should the DCO or BCO determine the
Test Barn is unsuitable, he or she shall seek an alternative location.
(1) Unless otherwise approved by the Agency, the Test Barn should
be equipped with:
(i) an enclosed area for Covered Horses to walk in or adjacent to
the Test Barn that is large enough to accommodate several horses and
allow for continuous observation of the Covered Horses;
(ii) sufficient enclosed stalls for the number of Sample
collections that permit observation of the collection process and
provide for the protection of Covered Horses undergoing Sample
collection and space for Sample Collection Personnel and up to 2
Covered Persons per Covered Horse;
(iii) facilities and equipment for the collection, identification,
and storage of Samples, including one refrigerator or cooler that can
be locked or otherwise secured, and one freezer that can be locked or
otherwise secured;
(iv) an area and appropriate facilities for a Covered Horse to be
bathed;
(v) a table or other suitable surface;
(vi) access to hot and cold running water;
(vii) clean water buckets for each Covered Horse; and
(viii) a security officer to ensure no unauthorized person is
permitted in the Test Barn.
(2) The Test Barn Veterinarian shall be responsible for managing
horse welfare in the Test Barn. For example, this includes determining
when and how to manage congestion in the Test Barn, when to release
Covered Horses from the Test Barn, and whether (if necessary) to permit
treatment of a Covered Horse. A Covered Horse in the Test Barn may
receive medical treatment only with the prior authorization of the Test
Barn Veterinarian or a Regulatory Veterinarian.
(c) For out-of-competition Sample collection, the DCO or BCO will
determine a suitable location to be used for the Sample Collection
Session. If at a stable, by default the Covered Horse's own stall
should be used.
5320. Sample Collection Equipment
(a) General. Sample Collection Personnel should ensure that they
have and use Sample Collection Equipment provided by or approved by the
Agency.
(b) Minimum requirements. Sample Collection Equipment should, at a
minimum:
(1) have a unique numbering system for all bottles, containers,
tubes, security bags, bar code labels, or other items used to seal and
transport the Samples;
(2) have a Tamper Evident sealing system;
(3) not reveal the identities of the Responsible Person and Covered
Horse on the equipment (i.e., only the unique numbering system shall be
used on the equipment);
(4) be clean and sealed prior to use;
(5) be constructed of a material and sealing system approved by the
Agency that should:
(i) be able to withstand the handling conditions and environment in
which the equipment will be used or subjected to, including, but not
limited to, transportation, Laboratory analysis, and long-term storage;
(ii) maintain the integrity (chemical and physical properties) of
the Sample for Laboratory analysis;
(iii) if the Sample will be transported or stored frozen, withstand
temperatures
[[Page 5165]]
of up to -20 [deg]C and a minimum of 3 freeze/thaw cycles;
(iv) be transparent or translucent so the Sample is visible;
(v) have a sealing system that allows verification by the
Responsible Person or Nominated Person and the DCO or BCO that the
Sample is correctly sealed in the bottles or containers;
(vi) be designed to prevent leakage during transportation
(including by air);
(vii) have been manufactured under the internationally recognized
ISO 9001 certified process which includes quality control management
systems; and
(viii) be able to be resealed after initial opening by a Laboratory
to maintain the integrity of the Sample and Chain of Custody in
accordance with the requirements for long-term storage and Further
Analysis; and
(6) include a transport device or packaging that is suitable to the
Sample at issue.
(c) Additional requirements applicable to urine Samples. In
addition to the requirements of paragraph (b) of this Rule 5320, Sample
Collection Equipment used in the collection of urine Samples shall
include:
(1) a collection vessel with the capacity to contain a minimum of
50 mL volume of urine;
(2) A and B bottles with the capacity to contain a minimum 25 mL
volume of urine; and
(3) visual markings on the A and B bottles and the collection
vessel, indicating the minimum volume of urine required and the maximum
volume levels that allow for expansion when frozen without compromising
the bottle, container, or sealing system.
(d) Specific requirements applicable to blood Samples. In addition
to the requirements of paragraph (b) of this Rule 5320, Sample
Collection Equipment used in the collection of blood Samples shall
include:
(1) a needle for blood sampling; and
(2) blood collection tubes, each with a capacity to contain a
minimum of 8 mL of blood, to ensure a minimum total of 30 mL of blood
is collected (except for TCO2 testing, where a lesser volume may be
collected at the discretion of the Agency).
(e) Specific requirements applicable to Hair Samples and other
Samples. Sample Collection Personnel should ensure that they have the
necessary equipment for hair Sample collection and any other approved
Testing matrices or methodologies, in accordance with any procedures or
guidance issued by the Agency.
5400. Conducting the Sample Collection Session
5410. Collection of Samples
(a) The Agency shall be responsible for the overall conduct of the
Sample Collection Session, with specific responsibilities delegated to
the DCO or BCO. Sample collection may be performed only by Sample
Collection Personnel approved by the Agency. The Agency may issue
supplemental procedures or guidance regarding Sample collection
procedures as it considers necessary.
(b) The following Persons may be authorized or required to be
present during the Sample Collection Session:
(1) Sample Collection Personnel sufficient to notify, chaperone,
and collect the required Samples must be present during the Sample
Collection Session;
(2) the Responsible Person or Nominated Person should be present
during the Sample Collection Session. If the Responsible Person or
Nominated Person is not present, this will be documented by the DCO or
BCO;
(3) no more than 2 Covered Persons (including the Responsible
Person or Nominated Person) may be present during the Sample collection
for a Covered Horse, except in exceptional circumstances, as determined
by the DCO or BCO; and
(4) any Person authorized by the Agency (e.g., a person who is
involved in the training or supervision of Sample Collection Personnel)
may be present during the Sample Collection Session.
(c) The Sample Collection Personnel will coordinate with the Test
Barn security officer to ensure that no unauthorized person is
permitted in the Test Barn.
(d) For Race Day Sample collection, the Covered Horse shall remain
in the Test Barn through to the end of the Sample collection when the
Covered Horse is released from the Test Barn by the DCO.
(e) Samples shall be collected in a manner that ensures:
(1) the Sample is of a quality and quantity that meets the relevant
Sample suitability and analytical requirements;
(2) the Sample has not been contaminated or otherwise tampered with
in any way at the time of collection;
(3) the Sample is clearly and accurately identified; and
(4) the Sample is securely sealed in a Tamper Evident kit.
(f) The Sample Collection Personnel shall collect the Sample from
the Covered Horse according to the following protocol(s) for the
specific type of Sample collection:
(1) Rule 5420: Collection of urine Samples;
(2) Rule 5430: Collection of blood Samples; and
(3) Rule 5440: Collection of hair Samples.
(g) Except for Samples collected for TCO2 testing (see Rule 5430(p)
below), each Sample collected shall be split into an A and a B Sample
at the time of collection.
(h) In general, the relevant Sample Collection Personnel should
wear a new pair of disposable gloves when handling the Sample
collection vessel/tubes and when sealing Samples.
(i) The following information shall be recorded at a minimum on the
Sample collection documentation for a Sample Collection Session:
(1) date and time of notification and name of notifying Sample
Collection Personnel;
(2) the arrival time of the Covered Horse to the Test Barn (for
Race Day Sample collection) or secure location (for out-of-competition
Sample collection);
(3) the name of the Responsible Person and Nominated Person;
(4) any changes in the Nominated Person during the Sample
Collection Session;
(5) the contact information of the Responsible Person or Nominated
Person(s), if requested;
(6) the name of the Covered Horse;
(7) the sex of the Covered Horse (intact male, mare, gelding);
(8) the color of the Covered Horse;
(9) the means by which the Covered Horse's identity is validated
(e.g., microchip number, or branding);
(10) the name and signature of the Sample Collection Personnel
involved in the Sample collection process for the Covered Horse;
(11) the name of additional Covered Persons (if any) present during
the Sample Collection Session;
(12) the Sample code number(s);
(13) the date and time of sealing of each Sample collected and date
and time of completion of entire Sample Collection Session;
(14) the location at which the Sample Collection Session took
place;
(15) the type of the Sample collected (e.g., urine, blood, hair);
(16) the type of test, e.g., Race Day (TCO2 or Post-Race Sample),
Post-Work, or out-of-competition;
(17) whether furosemide was administered to the Covered Horse
within 48 hours before Post-Time;
(18) any required Laboratory information on the Sample (e.g., for
[[Page 5166]]
urine or blood Sample, its volume; for hair Sample, mane/tail and
pulled/cut);
(19) for a blood Sample, the information to be recorded by the DCO
or BCO as outlined in Rule 5430;
(20) any irregularities in procedures (e.g., if advance notice was
provided, if there were any delays in arriving to the Test Barn or
secure location, or any anomalous behavior by those present at the
collection);
(21) any comments or concerns from the Responsible Person or
Nominated Person regarding the conduct of the Sample Collection
Session; and
(22) acknowledgement by the Responsible Person or Nominated Person
of the processing of Sample collection data and a description of such
processing.
(j) At the conclusion of the Sample Collection Session the
Responsible Person or Nominated Person and DCO or BCO shall sign
appropriate documentation to indicate their satisfaction (or otherwise)
that the documentation accurately reflects the details of the Covered
Horse's Sample Collection Session. The DCO (or BCO) shall also provide
the Responsible Person or Nominated Person the opportunity to document
any concerns he or she may have concerning the manner in which Sample
Collection Session was conducted.
(k) The Agency may require the Sample Collection Personnel to
complete supplemental documentation regarding the Sample Collection
Session. For example, any anomalous behavior by the Responsible Person,
Nominated Person, or other Covered Persons or Persons associated with
the Covered Horse or Responsible Person, or behavior with the potential
to compromise the Sample collection shall be recorded in detail by the
Sample Collection Personnel. If the Covered Horse requires any
emergency medical treatment, that shall be recorded in detail by the
Sample Collection Personnel.
(l) Only the DCO or BCO is authorized to end a Sample Collection
Session and so release a Covered Horse from the Test Barn or Sample
collection location. Only the DCO or BCO, in consultation with the Test
Barn Veterinarian for any Race Day Sample collection, is authorized to
temporarily release a Covered Horse from the Test Barn or Sample
collection location.
(m) Subject to Rule 5200, no photography or audio or video
recording of the Sample Collection Session is permitted. Instead, the
Sample collection documentation will be the definitive record of the
Sample Collection Session, and any comments regarding the Sample
Collection Session must be recorded on the Sample collection
documentation. If a Covered Person insists on photographing or
recording the Sample Collection Session (in whole or in part) in
violation of this Rule, the Sample Collection Session should continue,
but a case may be brought against the Covered Person under Rule 3510.
If the conduct of the Covered Person results in the Sample Collection
Session being discontinued, a case may be brought against the Covered
Person (on its own or in the alternative) for an Anti-Doping Rule
Violation under Rule 3215 or Rule 3216. For the avoidance of doubt, any
conduct by a Nominated Person or other Person or employee, agent, or
associate of the Responsible Person in relation to a Sample Collection
Session may in appropriate circumstances be imputed to the Responsible
Person for these purposes.
(n) If the Agency collects any Sample(s) from a deceased horse:
(1) Sample collection shall not interfere with any life-saving
treatment.
(2) Sample(s) should ordinarily be collected from the Covered Horse
before it is removed from the relevant venue where it suffered a fatal
condition, but otherwise may be collected at the location where the
Covered Horse is transported to (e.g., veterinary clinic).
(3) The Agency shall afford the Responsible Person and Nominated
Person the opportunity to waive attendance at the Sample collection if
such attendance would cause undue distress.
(4) The Sample collection shall proceed in accordance with the
applicable Sample collection procedures, amended as necessary to
account for the specific circumstances.
5420. Collection of Urine Samples
(a) Urine Samples may be collected and analyzed for any anti-doping
analytical matrix or methodology, as determined by the Agency, and in
accordance with the Prohibited List and related Technical Documents.
(b) The relevant Sample Collection Personnel will retain control of
the Sample collection vessel.
(c) The Responsible Person or Nominated Person will be instructed
to examine the Sample collection vessel to ensure that it will not
affect the integrity of the urine Sample.
(d) The relevant Sample Collection Personnel will then open and use
the selected Sample collection vessel to collect the urine Sample.
(e) The relevant Sample Collection Personnel shall ensure as
unobstructed a view as possible of the Sample leaving the Covered
Horse's body and shall continue to observe the Sample after provision
until the Sample is securely sealed.
(f) When the Covered Horse passes urine, the collection vessel
should be positioned to collect as much urine as possible.
(g) The volume of urine required for a full Sample is a minimum of
25 mL for each of the A Sample and B Sample (minimum of 50 mL in
total). If during the initial attempt less than 50 mL is obtained, the
relevant Sample Collection Personnel should try to collect additional
urine.
(h) The Test Barn Veterinarian (or a Regulatory Veterinarian), in
consultation with the DCO, shall determine if a Covered Horse is
intractable, and (if so) when the urine Sample Collection Session
should be terminated. If a urine Sample is not collected because the
Covered Horse is intractable, a blood Sample should be collected (in
addition to any other Sample, e.g., hair). The Sample Collection
Personnel should record the reasons for terminating any Sample
collection on the Sample collection documentation.
(i) Once the volume of urine provided by the Covered Horse is
deemed sufficient, the relevant Sample Collection Personnel will bring
the Sample to the designated processing area.
(j) The relevant Sample Collection Personnel will select the Sample
collection kit and will open, inspect, and confirm Sample codes numbers
match and ask the Responsible Person or Nominated Person to confirm the
same.
(k) If the Responsible Person or Nominated Person is not satisfied
with the chosen Sample Collection Equipment, this shall be recorded by
the DCO. If the DCO does not agree with the Responsible Person or
Nominated Person that the equipment is unsatisfactory, the DCO shall
inform the Responsible Person or Nominated Person that the Sample
Collection Session is proceeding. If the DCO agrees with the
Responsible Person or Nominated Person that the equipment is
unsatisfactory, the DCO shall use other available equipment that the
DCO determines is satisfactory. If no such equipment is available, the
DCO shall terminate the Sample Collection Session, and the termination
and its specific reason shall be recorded by the DCO.
(l) Once the Sample collection kit has been selected, the relevant
Sample Collection Personnel will pour and split the urine Sample into A
and B Sample
[[Page 5167]]
collection bottles within the view of the Responsible Person or
Nominated Person.
(m) The relevant Sample Collection Personnel will seal the A and B
bottles within the view of the Responsible Person or Nominated Person.
Once closed, the relevant Sample Collection Personnel will check that
the bottles have been properly sealed.
(n) The Sample Collection Personnel will complete all the required
Sample collection documentation, and the Responsible Person will
subsequently be provided a copy for his or her records.
(o) Urine should only be discarded when both the A and B bottles or
containers have been filled to the maximum amount they can hold and
have been sealed. Any excess urine should be disposed of into a drain
(ground drain or sink) or into a bin or waste pile, if necessary. The
Responsible Person or Nominated Person shall be given the option to
observe the disposal of any residual urine not sent to the Laboratory
for analysis.
5430. Collection of Blood Samples
(a) Blood collection shall be conducted by the BCO.
(b) Blood Samples may be collected and analyzed for any anti-doping
analytical matrix or methodology, as determined by the Agency, and in
accordance with the Prohibited List and related Technical Documents.
(c) The DCO or BCO will select a Sample collection kit containing a
sufficient number of blood collection tubes (two or three of which will
be paired together as the A Sample, and the third or fourth of which
will constitute the B Sample), and the other necessary equipment needed
to collect a blood Sample.
(d) If the Responsible Person or Nominated Person is not satisfied
with the chosen Sample Collection Equipment, this shall be recorded by
the DCO or BCO. If the DCO or BCO does not agree with the Responsible
Person or Nominated Person that the equipment is unsatisfactory, the
DCO or BCO shall inform the Responsible Person or Nominated Person that
the Sample Collection Session is proceeding. If the DCO or BCO agrees
with the Responsible Person or Nominated Person that the equipment is
unsatisfactory, the DCO or BCO shall use other available equipment that
the DCO or BCO determines is satisfactory. If no such equipment is
available, the DCO or BCO shall terminate the Sample Collection
Session, and this termination and its specific reason shall be recorded
by the DCO or BCO.
(e) Once the Sample collection kit has been selected, the relevant
Sample Collection Personnel will open, inspect, and confirm Sample
codes numbers within the kit match and ask the Responsible Person or
Nominated Person to confirm the same.
(f) The BCO will determine the most suitable location of
venipuncture;
(g) The BCO shall safely dispose of used blood sampling equipment
not required to complete the Sample Collection Session.
(h) Subject to paragraph (l) below, the BCO will collect the amount
of blood that will adequately satisfy the relevant analytical
requirements for the Sample analysis to be performed. The minimum total
volume requirement is 30 mL whole blood, plasma, or serum, with each
collection tube containing a minimum of 8 mL.
(i) If the amount of blood that can be removed from the Covered
Horse at the first attempt is insufficient, the BCO shall repeat as
necessary and appropriate (taking horse welfare into account) to try to
obtain the minimum total volume for a blood Sample. If the BCO is
unable to collect a sufficient amount of blood, the BCO or DCO may
terminate the blood Sample Collection Session and record the reasons
for such termination. Other matrices should be considered for
collection.
(j) Once a complete blood Sample is obtained, the Sample Collection
Personnel will properly seal the A and B tubes.
(k) The Sample Collection Personnel will complete all the required
Sample collection documentation, and the Responsible Person will
subsequently be provided a copy for his or her records.
(l) Total carbon dioxide (TCO2):
(1) In addition to the collection of a Post-Race Sample, blood
Sample(s) may also be collected from a Covered Horse prior to a Covered
Horserace or Vets' List Workout for the purpose of testing for TCO2.
The Prohibited List specifies the TCO2 levels that will be considered
prima facie evidence of alkalinization or administration of an
alkalinizing agent, i.e., a Controlled Medication Method.
(2) A blood Sample collected for TCO2 analysis may have a total
volume below 24 mL, at the Agency's discretion. Any volume of blood
collected for TCO2 analysis will be transported to the Laboratory.
(3) The Responsible Person or Owner of a Covered Horse selected for
TCO2 testing may request that a duplicate Sample be taken. Such request
must be made prior to the collection of the official Sample. The costs
related to obtaining, handling, shipping, and analyzing the duplicate
Sample shall be the responsibility of the Responsible Person or Owner
who requested such Sample.
(4) The duplicate sample shall not constitute a B Sample.
Accordingly:
(i) the provisions in the Protocol addressing the splitting of
Samples for analysis purposes shall not apply to blood samples
collected for TCO2 testing.
(ii) the provisions of Rule 5430 apply to blood Samples collected
for TCO2 testing, except that any references to A and B Samples or
tubes shall not apply, as there shall be only one official Sample.
(5) The official Sample and any duplicate Sample shall be analyzed
by the same Laboratory. If the Agency, in its discretion, determines
that the duplicate Sample cannot be analyzed within 5 days after the
Sample is collected, the findings of the official Sample shall be
final.
(6) Blood Samples collected for TCO2 testing may be subject to
Further Analysis if a Post-Race Sample collected from the same Covered
Horse returns an Atypical Finding or an Adverse Analytical Finding.
5440. Collection of Hair Samples
Sample Collection Personnel should collect hair Samples in
accordance with the following requirements:
(a) hair should (to the extent possible) be completely dry and free
of visible dirt, debris, or foreign substances;
(b) mane hair should be collected unless tail hair is specifically
requested. If, for a particular reason, a mane Sample cannot be
obtained (e.g., due to a hogged mane), tail hair may be collected;
(c) an adequate Sample of hair should be obtained for each of the A
and B Samples;
(d) if the mane is less than 10 cm, an additional Sample of hair
may be required to ensure a suitable volume is obtained for analysis;
(e) the Sample should be secured tightly with an elastic band, or
equivalent, and oriented to clearly mark the ends cut or pulled from
the Covered Horse; and
(f) hair shafts should remain aligned so that the hair does not
become knotted.
5450. Sample Collection Personnel Requirements
(a) Minimum requirements. The Agency shall establish the necessary
eligibility and qualification requirements for the positions of DCO,
BCO, and Chaperone. At a minimum:
[[Page 5168]]
(1) Sample Collection Personnel shall be 18 years or older;
(2) Sample Collection Personnel shall agree to undergo screening
required by the Agency (e.g., background checks, conflicts of
interest); and
(3) The BCO shall be a Veterinarian or veterinary technician with
the practical skills and knowledge to perform blood collection from a
vein on a horse.
(b) Conflicts.
(1) The Agency may require all Sample Collection Personnel to sign
an agreement regarding conflicts of interest, confidentiality, and an
appropriate code of conduct.
(2) The Agency shall not assign any Sample Collection Personnel to
a Sample Collection Session where they have an interest in the
performance or outcome of the Sample collection process. At a minimum,
Sample Collection Personnel are deemed to have such an interest if
they:
(i) are related to, employed or otherwise engaged by, or otherwise
affiliated with any Equine Constituencies, excluding State Racing
Commissions and Racetracks, if the Sample Collection Personnel have met
the other requirements set forth by the Agency;
(ii) have a financial interest in or are involved in any way with
the care or training or ownership of the Covered Horse at issue;
(iii) are engaged in business with, have a financial interest in,
or have a personal stake in a Covered Horserace; or
(iv) appear to have private or personal interests that detract from
their ability to perform their duties with integrity and in an
independent and purposeful manner.
(c) Training.
(1) The Agency shall establish or approve written training
materials for Sample Collection Personnel that outline their respective
responsibilities and that provide adequate training for their roles.
(2) The Agency shall ensure that DCOs and BCOs have completed the
necessary training program and are familiar with the requirements
before issuing them a credential or other authorization documentation.
(3) The training program for DCOs and BCOs should include, at a
minimum:
(i) comprehensive theoretical training in the activities relevant
to the DCO or BCO position (as applicable);
(ii) observation of the activities that are the responsibility of
the DCO or BCO as set out in these Testing and Investigations
Standards, preferably on-site; and
(iii) the satisfactory performance of one complete Sample
Collection Session on-site under observation by a qualified DCO, BCO,
or similar personnel.
(4) The training program for Sample Collection Personnel
responsible for the collection of blood Samples shall also include
standard precautions in veterinary settings.
(5) The Agency should ensure that Sample Collection Personnel are
adequately trained to carry out their responsibilities in a manner
respectful of any Covered Persons who are of a different race,
religion, sex, national origin, sexual orientation, age, citizenship,
disability, gender identity, or Veteran status.
(d) Credentialing.
(1) The Agency shall establish a system for credentialing and re-
credentialing DCOs and BCOs. DCOs and BCOs shall have either a
credential including their name, photograph, and date of expiration, or
a letter of authority from the Agency and a Federal- or State-issued
identification. The Agency may determine what information or
authorization documentation to require for other Sample Collection
Personnel.
(2) Only Sample Collection Personnel who have been authorized by
the Agency are permitted to conduct Doping Control and Medication
Control activities on behalf of the Agency.
(3) DCO and BCO credentials shall be valid for a maximum of 2
years. DCOs and BCOs should be subject to an assessment (theoretical or
practical) before being re-credentialed.
(4) The Agency will take steps to develop a system to monitor the
performance of DCOs and BCOs.
(5) The Agency will maintain records of conflicts of interest and
training of all Sample Collection Personnel.
5500. Storage and Transportation
5510. Storage and Custody of Samples Prior to Analysis
(a) After Sample collection, the DCO or BCO shall store Samples in
a manner that protects the integrity, identity, and security, prior to
transport to the Laboratory.
(b) If a urine or blood Sample is not transported to the Laboratory
on the day of collection:
(1) the relevant Sample Collection Personnel shall store the urine
Sample in a secure freezer or refigerator; and
(2) the relevant Sample Collection Personnel shall store the blood
Sample in a secure refrigerator;
(3) and, in each case, shall document in the Chain of Custody the
location and time in and time out of the urine or blood Sample.
(c) The DCO or BCO shall document who has custody of the Samples or
who is permitted access to the Samples.
(d) The Agency shall develop a system for recording the Chain of
Custody of Samples and receiving Sample Collection Session
documentation to ensure that each Sample is securely handled and the
documentation for each Sample is completed.
5520. Transport of Samples and Documentation
(a) Samples should be transported to the Laboratory as soon as
reasonably practicable after the conclusion of the Sample Collection
Session. Samples collected on a weekend or over consecutive days may be
stored and shipped together in batches (e.g., Samples collected on a
race weekend may be stored and sent to the Laboratory on the next
Monday), provided that the Samples are stored in accordance with the
requirements of these Testing and Investigations Standards.
(b) Samples shall be transported securely via a transportation or
shipping service authorized by the Agency. The Agency shall authorize a
transport system that ensures Samples and related documentation are
transported in a manner that protects their integrity, identity, and
security, and which minimizes the potential for Sample degradation due
to factors such as delays and extreme temperature variations. Blood
samples must be transported in a manner that maintains a cool and
constant environment.
(c) State Racing Commissions may select a Laboratory at which the A
Samples (or official TCO2 Samples) collected in its state shall be
analyzed. If specific analysis requested by the Agency cannot be
performed at the selected Laboratory, the Agency may have the Sample
sent to another Laboratory that can conduct the requested analysis.
Each year the State Racing Commissions must make their Laboratory
designation for all Samples collected within its state on or before
September 30th of the year prior to the designation taking effect. If a
State Racing Commission fails to select a Laboratory by this deadline,
the Agency shall select the Laboratory for that particular state. The
Agency may allow for a State Racing Commission to change its selection
of Laboratory outside of the time-period set forth above if a
reasonable request is made (as determined by the Agency).
(d) A and B Samples (and official and duplicate TCO2 Samples) will
be shipped together to the Laboratory conducting the A Sample analysis.
If the
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B sample analysis is requested, the B Sample will be shipped to the B
Sample Laboratory selected by the Agency.
(e) The Agency will have the ability to confirm, if necessary, that
Samples and related documentation arrived at the Laboratory. The
Laboratory shall report any irregularities to the Agency with respect
to the condition of Samples upon arrival in accordance with the
Laboratory Standards.
(f) The Agency shall develop a system to ensure that, where
required, instructions for the type of analysis to be conducted are
provided to the Laboratory that will be conducting the analysis. In
addition, the Agency shall provide the Laboratory with information as
required for result reporting and statistical purposes, including
whether long-term storage is required.
(g) Documentation identifying the Covered Horse and Responsible
Person or Nominated Person shall not be included with the Samples or
documentation sent to the Laboratory that will be analyzing the
Samples.
(h) If the Samples or related documentation are not received by the
Laboratory, or if a Sample's integrity or identity was compromised
during transport, the Agency will consider whether the Samples should
be voided. The decision to void a Sample is in the sole discretion of
the Agency.
5530. Ownership and Retention of Samples and Retention of Documentation
(a) Samples collected from a Covered Horse are owned by the
Authority. Samples shall be retained by Laboratories in accordance with
the requirements of Rule 6319.
(b) Documentation related to a Sample Collection Session or an
Anti-Doping Rule Violation or Controlled Medication Rule Violation
shall be stored by the Agency in accordance with the Agency's record
retention policy.
5600. Standards for Intelligence Gathering
5610. Purpose
The Agency shall ensure that it is able to: obtain, assess, and
process anti-doping and medication control intelligence from all
available sources to help deter and detect doping and misuse of
medication and inform effective, intelligent, and proportionate test
planning; plan Target Testing; and conduct investigations as required
by the Protocol. The objective of this Rule is to establish standards
for the efficient and effective gathering, assessment, and processing
of such intelligence for these purposes.
5620. Gathering Intelligence
(a) The Agency should make every reasonable effort to ensure that
it is able to obtain or receive anti-doping and medication control
intelligence from all available sources, including, but not limited to:
Covered Persons, including through Substantial Assistance; members of
the public (e.g., by means of a confidential whistleblower platform);
Sample Collection Personnel (whether via mission reports, incident
reports, or otherwise); Laboratories; pharmaceutical companies; the
Authority; law enforcement (authorized by any government, including
Federal, State, or international); State Racing Commissions;
Racetracks; Race Organizers; anti-doping organizations; equine
regulatory bodies; other relevant regulatory or disciplinary
authorities; and the media (in all its forms).
(b) The Agency shall ensure that anti-doping and medication control
intelligence obtained or received from a confidential source or in a
non-public fashion is handled securely and confidentially, that sources
of intelligence are protected, that the risk of leaks or inadvertent
disclosure is properly addressed, and that intelligence shared with the
Agency in a matter intended to be confidential is processed, used, and
disclosed only for any legitimate legal, law enforcement, regulatory,
anti-doping, medication control, integrity, disciplinary, horse
welfare, or safety purposes.
(c) The Agency shall facilitate, encourage, and seek to protect
whistleblowers.
(d) The Agency may consult or coordinate with the Authority, law
enforcement (authorized by any government, including Federal, State, or
international), State Racing Commissions, Racetracks, Race Organizers,
Training Facilities, Laboratories, anti-doping organizations, equine
regulatory bodies, or other relevant regulatory or disciplinary
authorities in obtaining, developing, or sharing information and
intelligence that may be useful for the implementation or enforcement
of the Protocol or the Act or for any legitimate legal, law
enforcement, regulatory, anti-doping, medication control, integrity,
disciplinary, horse welfare, or safety purposes (e.g., the Agency may
share information with other entities investigating the possible
commission of a crime, regulatory offense, or breach of other rules of
conduct; in particular, for example, the Agency may share the results
of Sample analyses with the Authority for purposes of enforcing the
Racetrack Safety Program).
5630. Assessment and Analysis of Intelligence
(a) The Agency should ensure that it is able to assess all anti-
doping and medication control intelligence upon receipt for relevance,
reliability, and accuracy, taking into account the nature of the source
and the circumstances in which the intelligence has been captured or
received.
(b) All relevant anti-doping and medication control intelligence
obtained or received by the Agency should be collated and analyzed to
establish patterns, trends, and relationships that may assist the
Agency in developing an effective anti-doping and medication control
strategy and in determining (where the intelligence relates to a
particular case) whether there is reasonable suspicion that an Anti-
Doping Rule Violation or Controlled Medication Rule Violation may have
been committed, such that further investigation is warranted.
5640. Intelligence Outcomes
Anti-doping and medication control intelligence may be used for the
following purposes (without limitation):
(a) developing, reviewing, and revising test distribution planning;
(b) determining when to conduct Target Testing; or
(c) creating targeted intelligence files to be referred for
investigation.
5700. Standards for Investigations
5710. Purpose
(a) The objective of this Rule is to establish standards for the
efficient and effective conduct of investigations under the Protocol,
including, but not limited to:
(1) the investigation of Sample abnormalities reported by
Laboratories;
(2) the investigation of any other analytical or non-analytical
information or intelligence where there is reasonable suspicion to
suspect that an Anti-Doping Rule Violation or Controlled Medication
Rule Violation may have been committed;
(3) the investigation of the circumstances surrounding or arising
from an Adverse Analytical Finding to gain further intelligence
concerning the Responsible Person or other Covered Persons associated
with the Covered Horse whose Sample is the subject of the Adverse
Analytical Finding, including to determine if any other methods are
involved in doping or medication abuse; and
(4) where a Covered Person is alleged to have committed an Anti-
Doping Rule Violation or Controlled Medication Rule Violation, the
investigation into whether
[[Page 5170]]
any other Covered Persons were complicit or otherwise involved in that
violation.
(b) In each case, the purpose of the investigation is to achieve
one of the following:
(1) to rule out a possible violation or involvement in an Anti-
Doping Rule Violation or Controlled Medication Rule Violation;
(2) to develop evidence that supports an Anti-Doping Rule Violation
or Controlled Medication Rule Violation proceeding or the initiation of
such a proceeding in accordance with the Protocol; or
(3) to provide evidence of a violation of any other provisions of
the Protocol or related Rule Series, or applicable law or regulation.
5720. Investigating Possible Violations
(a) The Agency shall conduct, direct, and manage all investigations
under the Protocol, unless it specifically delegates an investigation
(or aspects of an investigation) to a State Racing Commission (subject
to the applicable State Racing Commission electing to enter into an
agreement with the Agency).
(b) The Agency and any State Racing Commission to which the Agency
delegates investigatory tasks shall ensure that investigations are
conducted confidentially.
(c) The Agency will seek to investigate any analytical or non-
analytical information or intelligence that indicates that there is
reasonable suspicion that an Anti-Doping Rule Violation or Controlled
Medication Rule Violation may have been committed or that further
inquiry might lead to the discovery of admissible evidence of such
violation.
(d) The Agency should gather and record all relevant information
and documentation as soon as possible.
(e) The Agency shall ensure that investigations are conducted
fairly, objectively, and impartially at all times. The conduct of
investigations, the evaluation of information and evidence identified
in the course of that investigation, and the outcome of the
investigation, should be fully documented.
(f) Covered Persons are required under the Protocol to cooperate
with investigations conducted by the Agency (or a State Racing
Commission, if the investigation is delegated by the Agency). If they
fail to do so, the Agency may bring proceedings against them for
failure to cooperate (in accordance with Rule 3510(b)). If their
conduct amounts to subversion of the investigative process (e.g., by
providing false, misleading, or incomplete information, or by
destroying potential evidence), the Agency may also bring proceedings
against them for the Anti-Doping Rule Violation of Tampering or
Attempted Tampering.
(g) It shall not be a defense in a proceeding involving an Anti-
Doping Rule Violation or Controlled Medication Rule Violation that an
investigation should have been conducted more quickly or that any
aspect of the Testing and Investigations Standards was not followed by
the Agency or State Racing Commission, except as provided in Rule 3122.
5730. Obtaining Investigative Information
(a) General. The Agency should make use of all investigative
resources reasonably available to it to conduct its investigation.
These resources may include: obtaining information and assistance from
other entities pursuant to Rule 5620(d); investigative powers conferred
under applicable rules (including inspection, examination, and seizure,
production of documents, subpoenas, and interviews); and the power to
suspend a period of Ineligibility imposed on a Covered Person in return
for Substantial Assistance in accordance with the Protocol. Without
limitation, the Agency may utilize the investigative tools set forth in
paragraphs (b) through (f) of this Rule in relation to investigations
and inquiries of possible violations of the Protocol.
(b) Inspection, examination, and seizure.
(1) The Agency shall have access to the books, records, offices,
racetrack facilities, and other places of business of Covered Persons
that are used in the care, treatment, training, or racing of Covered
Horses.
(2) The Agency may seize any medication, drug, substance, or
paraphernalia in violation or suspected violation of any provision of
the Act or any rules approved by the Commission pursuant to the Act,
and any object or device reasonably believed to have been used in
furtherance of the violation or suspected violation.
(c) Return of seized property. Upon final resolution of a
violation, the Agency shall return seized property, including, but not
limited to, phones, computers and other repositories of electronic
data, the possession of which is not specifically prohibited by the Act
or the rules of the Authority.
(d) Production of documents and information.
(1) The Agency may require a Covered Person to provide any
information, documents, or records in such form as the Agency may
require, which are held by the Covered Person or are within his or her
power to obtain, and that are used in the care, treatment, training, or
racing of Covered Horses.
(2) The Agency may require production of any mobile phones,
computers, tablets, other electronic devices, books, documents and
records (including telephone or financial records whether currently in
the direct possession of a Covered Person or a third person who may be
directed by the Covered Person to provide the information) that may be
relevant to any investigation, inquiry, hearing, or proceeding, and
that are used in the care, treatment, training, or racing of Covered
Horses.
(e) Subpoenas. The Agency may request that the Authority issue a
subpoena to a Person to appear or to answer questions or produce
evidence related to anti-doping and medication control matters. A
subpoena may direct the witness to: appear at a specific time and place
to testify; produce designated evidence by a specific time; or permit
the Agency to inspect premises at a specific time. A subpoena must be
issued under the signature of a designated person from the Authority.
If the Covered Person fails to comply with a subpoena, the Agency or
Authority may seek enforcement of the subpoena in any of the district
courts of the United States within the jurisdiction of which such
inquiry is being conducted. Additionally, the arbitrator(s), IAP
member(s), administrative law judge, or Commission considering a case
arising under the Protocol may draw an adverse inference against a
Covered Person who fails to comply with a valid subpoena, regardless of
whether a court has been required to enforce the subpoena or has found
the Covered Person in contempt.
(1) This issuance of a subpoena and compliance therewith is
independent of the Agency's powers to inspect and obtain evidence
without a subpoena and a Covered Persons' duty to cooperate under the
Protocol. In addition to a rule violation for refusal to cooperate, a
refusal to cooperate can result in imposition of an adverse inference
against a Covered Person by the arbitrator(s), IAP member(s),
administrative law judge, or Commission.
(2) The following considerations should be taken into account by
the Agency in determining whether a subpoena should be requested to be
issued by the Authority:
(i) the availability of, and success in, using alternative methods
for obtaining the information in a timely manner;
[[Page 5171]]
(ii) the indispensability of the information to the success of the
investigation or establishing a violation; and
(iii) the need to protect against the destruction of records or
information that may be necessary to investigate and prosecute
violations of the Protocol.
(f) Interviews.
(1) Covered Persons shall comply with a request to be interviewed
by the Agency.
(2) If the Agency requires a Covered Person to submit to an
interview under oath, the Covered Person may request a delay of the
interview to seek legal advice. However, such delay shall only
encompass the time reasonably necessary to contact and retain legal
counsel and shall in no case exceed 7 days, unless agreed otherwise by
the Agency.
(3) An authorized Person may administer an oath or affirmation to a
Covered Person appearing for an interview under oath.
(4) The only basis for refusing to answer a question in an
interview is an assertion of the attorney-client privilege or the Fifth
Amendment privilege against self-incrimination.
5740. Investigation Outcomes
(a) The Agency shall determine without undue delay whether
proceedings should be initiated against a Covered Person for an Anti-
Doping Rule Violation or Controlled Medication Rule Violation.
(b) If the Agency concludes based on the results of its
investigation that proceedings should be initiated against a Covered
Person independently or in relation to a Covered Horse, asserting
commission of an Anti-Doping Rule Violation or Controlled Medication
Rule Violation, it shall give notice of that decision in the manner set
out in the Protocol.
(c) If the Agency concludes, based on the results of its
investigation, that proceedings asserting commission of an Anti-Doping
Rule Violation or Controlled Medication Rule Violation should not be
initiated against a Covered Person independently or in relation to a
Covered Horse, the Agency shall consider whether any of the
intelligence obtained or lessons learned during the investigation
should be used for test distribution planning, Target Testing, or
whether it should be shared with any other Person or included in any
report in accordance with these Testing and Investigations Standards.
(d) The Agency may include information from its investigations in
reports made to the Authority, Congress, State Racing Commissions, or
other appropriate bodies, regardless of whether the information relates
to one or more rule violations. The fact that information was included
in such a report shall not be a defense in any proceeding involving a
potential rule violation.
6000. Equine Standards for Laboratories and Accreditation
Rule 6010. Equine Standards for Laboratories and Accreditation
(a) The main purpose of these Laboratory Standards is to ensure
that Laboratories report valid test results based on reliable
evidentiary data and to facilitate harmonization in Analytical Testing
of Samples by Laboratories.
(b) The Laboratory Standards set out the requirements to be
followed by Laboratories that wish to demonstrate that they are
technically competent, operate within an effective Management System,
and can produce forensically valid results. The Laboratory Standards
include, inter alia, requirements for obtaining and maintaining HISA
Equine Analytical Laboratory (HEAL) accreditation, operating standards
for the performance of Laboratories, and a description of the
accreditation and approval processes. The Laboratory Standards also set
out requirements and guidance in relation to Sample custody and
storage, Analytical Testing, and some aspects of Results Management.
(c) Compliance with the Laboratory Standards in effect at the time
of Sample analysis (as opposed to another alternative standard,
practice, or procedure) shall be sufficient to conclude that the
procedures covered by the Laboratory Standards were performed properly.
A failure by a Laboratory to follow a requirement in effect at the time
of Analytical Testing, which has subsequently been eliminated from
these Laboratory Standards or applicable Technical Document(s) or
Technical Letter(s) at the time of a hearing, shall not serve as a
defense to an Anti-Doping Rule Violation.
(d) Otherwise undefined capitalized terms used in these Laboratory
Standards have the meanings given to them in Rule 1020.
Rule 6020. Technical Documents
(a) Technical Documents may be drafted by the Laboratory Expert
Group or Agency and circulated for stakeholder consultation before
being finalized. Technical Documents will be approved by the Agency,
and Authority (where appropriate), and published on the Agency website.
Once approved, a relevant Technical Document becomes an integral part
of the Laboratory Standards and supersedes any previous publication on
a similar topic, including Technical Letter(s) or the Laboratory
Standards.
(b) Implementation of the requirements detailed in a Technical
Document may occur prior to the effective date for implementation
specified in the Technical Document in accordance with this Rule 6020
and shall occur no later than the effective date.
(c) A failure by a Laboratory to implement a Technical Document or
Technical Letter by the effective date may result in the imposition of
an Analytical Testing Restriction against the Laboratory for that
Analytical Testing Procedure, or remediation requirements. In
exceptional circumstances, a suspension of the Laboratory's HEAL
accreditation may be warranted, as determined by the Agency.
(d) If a Laboratory is not able to implement a new Technical
Document by its effective date, it shall inform the Agency as soon as
possible. The Laboratory shall send a written request to the Agency for
an extension beyond the applicable effective date, providing the
reason(s) for the delayed implementation of the Technical Document, any
measures taken to ensure that Samples received in the Laboratory will
be subject to Analytical Testing in compliance with the new Technical
Document (for example, by subcontracting the analysis to another
Laboratory as applicable), as well as plans for the implementation of
the new Technical Document.
(e) The implementation of the Technical Documents' requirements
into the Laboratory's Management System is mandatory for obtaining and
maintaining HEAL accreditation or approval, respectively, and for the
application of the relevant Analytical Testing Procedure(s) to the
analysis of Samples.
(f) In cases when a newly approved version of a Technical Document
lowers a Threshold for a Threshold Substance, a Minimum Reporting Level
for a Non-Threshold Substance, or any other limit, as applicable, the
revised limits specified in the new Technical Document shall not be
applied to the reporting of analytical results for Samples collected
before the effective date of the Technical Document.
(g) Where the above revised limit specification does not apply,
Laboratories may implement a Technical Document as soon as it is
approved by the Agency, and Authority (where appropriate), provided
that the
[[Page 5172]]
requirements of the Technical Document have been implemented and
documented appropriately by the Laboratory.
(h) The most recently approved Technical Document shall be applied
to the Analytical Testing of Samples prior to the effective date if it
would lead to a result that benefits the Covered Person and Covered
Horse (e.g., increase of the Threshold for a Threshold Substance or of
the Minimum Reporting Level for a Non-Threshold Substance, or any other
limit, establishment of more stringent identification criteria for
chromatographic-mass spectrometric or other Confirmation Procedures).
Therefore, in the case where an analytical finding does not meet the
reporting criteria defined in the new Technical Document, it shall be
reported as a Negative Finding.
Rule 6030. Technical Letters
(a) Technical Letters may be issued in letter format on an ad-hoc
basis to provide direction to the Laboratories on particular issues on
the analysis, interpretation and reporting of results for specific
Prohibited Substance(s) or Prohibited Method(s) or on the application
of specific Laboratory procedures. Technical Letters are modified or
withdrawn by the Agency, as appropriate.
(b) Technical Letters will be drafted and approved by the Agency,
and Authority (where appropriate), in consultation with relevant
scientific experts, and published on the Agency's website. Technical
Letters become effective immediately, unless otherwise specified by the
Agency. Technical Letters may require actions (e.g., validation of new
Analytes or modifications to Analytical Testing Procedures, the
procurement of Reference Material(s) or Reference Collection(s)), which
may justify that its application cannot be immediate. In such cases,
the Agency shall make a time provision for implementation and specify
an effective date for the Technical Letter.
(c) Once approved, a relevant Technical Letter becomes an integral
part of the Laboratory Standards and supersedes any previous
publication on a similar topic, including Technical Document(s) or the
Laboratory Standards.
(d) The implementation of the requirements of relevant Technical
Letters into the Laboratory's Management System is mandatory for
obtaining and maintaining HEAL accreditation or approval, respectively,
and for the application of the relevant Analytical Testing Procedure(s)
to the analysis of Samples.
Rule 6040. Laboratory Guidelines
(a) Laboratory Guidelines may be issued to provide direction to the
Laboratories on new Analytical Methods or procedures approved by the
Agency. Laboratory Guidelines will be modified or deleted by the
Agency, as appropriate.
(b) Laboratory Guidelines will be approved by the Laboratory Expert
Group (LabEG). Laboratory Guidelines are provided to Laboratories only
and are not published on the Agency website.
(c) Implementation of Laboratory Guidelines is not mandatory.
However, Laboratories are encouraged to follow, to the fullest extent
possible, the recommendations of best practice included in relevant
Laboratory Guidelines.
Rule 6050. Technical Notes
(a) Technical Notes may be issued to Laboratories to provide
detailed technical guidance on the performance of specific Analytical
Methods or procedures.
(b) Technical Notes will be approved by the LabEG. Technical Notes
are provided to Laboratories only and are not published on the Agency
website.
(c) Implementation of the recommendations detailed in Technical
Notes is not mandatory. However, Laboratories are encouraged to follow,
to the fullest extent possible, the technical guidance included in
Technical Notes.
Rule 6060. Sample Analysis
(a) Sample analysis is part of the Analytical Testing process and
involves the detection, identification, and, in some cases,
demonstration of the presence above a Threshold of Prohibited
Substance(s) or their Metabolite(s), or Marker(s) of Use of Prohibited
Substances or Prohibited Methods in an equine Sample.
(b) Laboratories may accept samples for other forms of analysis,
subject to the provisions of the Code of Ethics, which are not under
the scope of HEAL accreditation. Any such analysis shall not be covered
by the Laboratory's HEAL accreditation and, therefore, shall not be
subject to the requirements of the Laboratory Standards, Technical
Documents, or Technical Letters. Test reports or other documentation or
correspondence from Laboratories shall not declare or represent that
any such analysis is covered under their HEAL accreditation status.
Rule 6070. Racing Medication and Testing Consortium Accredited
Laboratories
(a) These Laboratory Standards will replace current Racing
Medication and Testing Consortium (RMTC) accreditation, although a
transition phase which may include RMTC conducting the accreditation
program may be agreed between the Agency and RMTC.
(b) Where a laboratory has current RMTC accreditation, any
information required as part of the HEAL application process that has
already been provided as part of its RMTC accreditation, and that the
laboratory checks to confirm it is still current and valid may, with
the agreement of the parties, be provided to the Agency.
6100. Laboratory Accreditation and Operating Standards
Rule 6110. Process and Requirements for HEAL Laboratory Accreditation
(a) Applicant laboratory for HEAL accreditation. Only a laboratory
that satisfies the criteria in this Rule 6110 may apply to become a
candidate laboratory for HEAL accreditation.
(1) The applicant laboratory shall submit a completed application
form, provided by the Agency, duly signed by the laboratory Director
(or equivalent position) and, if relevant, by the Director (or
equivalent position) of the host organization (e.g., university or
public institution).
(2) Provision of business plan. The Agency shall request the
applicant laboratory to submit a business plan summary, which shall
include market considerations (clients, number of Samples, maintenance
costs, etc.), facility, instrumental, staffing and training needs, and
shall make a reasonable guarantee of the long-term provision of
adequate financial and human resources to the laboratory.
(b) Candidate laboratory for HEAL accreditation. The application
shall be evaluated by the Agency to determine whether the applicant
laboratory will be granted candidate laboratory status by the Agency
and thereby continue within the HEAL accreditation process. Additional
supporting documentation may be requested by, and at the discretion of,
the Agency.
(1) Description of the candidate laboratory. Once approved by the
Agency, the candidate laboratory shall complete a detailed
questionnaire and submit it to the Agency. The questionnaire will
include, but is not limited to, the following:
(i) Staff list and their qualifications, including description of
any relevant
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anti-doping experience and a list of relevant scientific publications
by laboratory staff;
(ii) Relevant memberships and engagement with professional
societies, such as the Association of Official Racing Chemists (AORC),
World Association of Anti-Doping Scientists (WAADS), Society of
Forensic Toxicologists (SOFT), and The International Association of
Forensic Toxicologists (TIAFT);
(iii) Description of the physical laboratory facilities, including
a description of the security considerations for Samples and records.
The laboratory facilities shall include ample analytical and
administrative space to allow separate, restricted and dedicated areas
for analytical and administrative operations;
(A) Physical security. Specific measures to maintain secure and
restricted access to the laboratory facility and a controlled internal
laboratory environment (e.g., dedicated and restricted Sample storage
areas, CCTV monitoring);
(B) IT security. Implementation of firewalls and other cyber
security measures consistent with best practice and any applicable
governmental regulations;
(C) Information Technology (IT) infrastructure. Implementation of a
data and information management system (e.g., LIMS) and a central
server/intranet which allows secure data handling.
(iv) List of actual and proposed instrumental resources and
equipment, including year of purchase and conditions for technical
support (e.g., contract/access to instrument manufacturer maintenance
services);
(v) List of validated Initial Testing Procedures and Confirmation
Procedures, including target Analytes and Limits of Detection (LODs),
Limits of Identification (LOIs) and, where applicable, Limits of
Quantification (LOQs) and estimates of Measurement Uncertainty (MU);
(vi) Status of method development and validation, including, at
minimum, all mandatory Analytical Methods and method validation reports
(if completed and currently in use);
(vii) List of available Reference Materials and Reference
Collections, or plans to acquire Reference Materials or obtain
Reference Collections;
(viii) Plans to ensure compliance with laboratory independence and
impartiality requirements before receiving HEAL accreditation (and if
this requirement is covered by other accreditation, such as ISO/IEC
17025, the laboratory may refer to it);
(ix) Status and scope of ISO/IEC 17025 accreditation; and
(x) A description of how the principles of the Code of Ethics is
integrated into the laboratory Management System. A letter of
compliance with the Code of Ethics signed by the laboratory Director
shall be provided.
(xi) The Agency may require an update of this documentation during
the process of accreditation.
(2) Payment of initial accreditation fee. Prior to entering the
probationary period, the candidate laboratory shall pay the Agency a
one-time non-refundable fee to cover the costs related to the initial
accreditation process. This fee shall be determined by the Agency and
disclosed to the laboratory prior to the accreditation process
commencing. The accreditation process will not commence until the fee
is agreed upon.
(3) Compliance with the Code of Ethics. The candidate laboratory
shall implement and comply with the provision(s) of the Code of Ethics.
Candidate laboratories shall not accept Samples directly from
individual Covered Persons or from individuals or organizations acting
on his or her behalf (unless approved in writing and in advance by the
Agency and on the condition that Samples will be treated as a Sample
under the Protocol, and proceedings may be brought against the relevant
Covered Person(s) if evidence of an Anti-Doping Rule Violation or a
Controlled Medication Rule Violation emerges).
(4) Pre-probationary testing and on-site assessment. If this is
covered by another accreditation, such as ISO/IEC 17025, the laboratory
may refer to this paragraph (4).
(i) Prior to entering the probationary accredited period, the
Agency shall conduct a pre-probationary testing (PPT) and on-site
assessment of the candidate laboratory at the candidate laboratory's
expense. The purpose of this assessment is to obtain information about
different aspects of the laboratory's competence and to clarify any
issues regarding the accreditation process, which are relevant for the
HEAL accreditation.
(ii) As part of the PPT, the candidate laboratory shall be required
to analyze at least 10 blind EQAS samples arranged by the Agency. The
general composition and content of the blind EQAS samples and the
evaluation of laboratory EQAS results are described in the Rule 6200
and 6400 Series, respectively.
(iii) The candidate laboratory shall report the results for the PPT
blind EQAS samples to, and in a form designated by, the Agency (in
compliance with paragraph (e) of Rule 6260) within 6 weeks, unless
otherwise requested by the candidate laboratory and agreed to by the
Agency.
(A) Upon request, the candidate laboratory shall provide the Agency
with a Laboratory Documentation Package for selected EQAS samples for
which there is an Adverse Analytical Finding. Additional data may be
required upon the Agency's request. This documentation shall be
submitted within 10 days of the request or as otherwise indicated by
the Agency.
(B) For selected EQAS samples with Negative Findings, the Agency
may request all, or a portion of, the Initial Testing Procedure data.
(iv) After receiving the PPT EQAS results, the Agency shall inform
the candidate laboratory of the evaluation of its performance and
provide guidance for improvement. Corrective actions, if any, shall be
conducted and reported by the candidate laboratory to the Agency within
30 days, or as otherwise indicated by the Agency.
(v) In addition, the Agency shall provide an assessment report
regarding the outcomes of the on-site assessment, including any
identified nonconformities, to allow the candidate laboratory to
implement the necessary improvements. Corrective actions, if requested,
shall be conducted, and reported by the candidate laboratory to the
Agency within 30 days, or as otherwise indicated by the Agency.
(vi) The nonconformities identified in the Agency assessment report
shall be satisfactorily addressed and the recommendations for
improvement shall be implemented before the candidate laboratory can be
accepted as an Agency probationary laboratory. The candidate
laboratory's performance in the PPT and on-site assessment will be
considered in the overall review of the candidate laboratory's
application and may affect the timeliness of the candidate laboratory's
entry into the probationary phase of accreditation.
(5) ISO/IEC 17025 accreditation.
(i) ISO/IEC 17025 accreditation is a critical and mandatory
precondition for HEAL accreditation.
(ii) The Agency will consider a candidate laboratory application
for HEAL accreditation only if the laboratory has obtained (or is in
the process of obtaining) ISO/IEC 17025 accreditation. ISO/IEC 17025
accreditation must be conferred prior to an applicant receiving full
HEAL accreditation.
(iii) The accreditation body, which may be specified by the Agency,
shall be an International Laboratory Accreditation Cooperation (ILAC)
full member that is a signatory to the ILAC
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Mutual Recognition Arrangement (ILAC MRA) for testing activities as
defined in ISO/IEC 17025.
(iv) The candidate laboratory shall (in a timely manner) send to
the Agency a summary of the assessment report and any corrective or
preventive action documentation addressing nonconformities.
(6) Analytical Testing Procedures. Before the Agency grants
accreditation, candidate laboratories shall provide documentation to
the Agency demonstrating that all mandatory Test Methods have been
validated and included in the Laboratory's scope of ISO/IEC 17025
accreditation.
(7) Laboratory independence and impartiality. Before the Agency
grants accreditation, probationary laboratories shall provide
documentation to the Agency demonstrating compliance with the
requirements of Laboratory independence and impartiality established in
paragraph (c) of Rule 6130.
(8) Professional liability insurance coverage. Before the Agency
grants accreditation, probationary laboratories shall provide
documentation to the Agency demonstrating that they have adequate
provisions for self-insuring, or professional liability risk insurance
coverage has been obtained to cover liability of no less than
$5,000,000 annually.
Rule 6120. The Agency Accredited Laboratory; Obtaining HEAL
Accreditation
(a) The Agency probationary HEAL accreditation.
(1) Upon satisfactory completion of the candidate laboratory
requirements (as per Rule 6110), as determined by the LabEG, a
candidate laboratory can be considered for entry to the probationary
phase of HEAL accreditation as an Agency probationary laboratory. Once
the Agency has determined that the laboratory has successfully
completed the requirements of a candidate laboratory, the Agency can
grant the laboratory probationary accreditation status.
(2) A probationary laboratory must comply with the requirements of
accredited laboratories, including the requirements for maintaining
accreditation.
(3) The probationary period is 2 years or following the analysis of
2,500 Samples, whichever comes later. In circumstances where the
laboratory was previously accredited by the RMTC, the Agency may
exercise its discretion to reduce or eliminate the probationary period.
(b) The Agency pre-final accreditation.
(1) Once the Agency has determined that the laboratory has
successfully completed the requirements of the probationary period, the
laboratory can be granted final accreditation status. At the Agency's
discretion, as part of the final accreditation process, a Final
Accreditation Test (FAT) or on-site assessment may be conducted by the
Agency. Costs associated with the Agency on-site assessment and FAT
shall be disclosed and agreed to with the probationary laboratory.
(2) As part of the FAT, the probationary laboratory shall analyze a
minimum of 15 blind EQAS samples selected from the routine EQAS
program. The general composition and content of the blind EQAS samples
and the evaluation of laboratory EQAS results are described in Rules
6200 and 6400, respectively.
(3) Compliance with the scope of ISO/IEC 17025 accreditation, the
Laboratory Standards, and other procedures required by the Agency
(e.g., Technical Documents, Technical Letters) will be assessed. The
FAT shall assess both the scientific competence and the capability of
the probationary laboratory to manage multiple Samples.
(4) The probationary laboratory shall successfully report the
results for the blind EQAS samples in the FAT to the Agency in
accordance with paragraph (e) of Rule 6260 within 6 weeks of receipt
the samples, unless otherwise specified by the Agency or otherwise
requested by the laboratory and agreed to by the Agency.
(5) Upon request, the probationary laboratory shall provide the
Agency with a Laboratory Documentation Package for selected EQAS
samples for which there is an Adverse Analytical Finding. Additional
data may be required upon the Agency's request. This documentation
shall be submitted within 10 days of the Agency request, or as
otherwise indicated by the Agency.
(6) For EQAS samples with Negative Findings, the Agency may request
all or a portion of the Initial Testing Procedure data.
(7) After receiving the FAT EQAS results, the Agency shall inform
the probationary laboratory of the evaluation of its performance.
Corrective actions, if any, shall be conducted and reported by the
probationary laboratory to the Agency within 30 days, or as otherwise
indicated by the Agency.
(8) The Agency shall provide an assessment report with the outcomes
of the accreditation assessment, including any identified
nonconformities, for the probationary laboratory to implement the
necessary improvements. Corrective actions, if any, shall be conducted
and reported by the probationary laboratory to the Agency within 30
days, or as otherwise indicated by the Agency. The nonconformities
identified in the FAT EQAS and the assessment report shall be
satisfactorily addressed by the laboratory and the recommendations for
improvement shall be implemented before accreditation will be granted.
(c) The Agency recommendation for accreditation.
(1) Based on the relevant documentation received from the
probationary laboratory, the assessment report(s) from the Agency and
from the relevant accreditation body, the Agency shall evaluate the
probationary laboratory's progress in meeting all the requirements
outlined in Rules 6110 and 6120.
(2) Once, as determined by the Agency (in the Agency's sole
discretion), all accreditation requirements have been satisfactorily
met by the probationary laboratory, the Agency will grant accreditation
to the laboratory.
(3) However, if following the FAT and on-site assessment, and the
review of any resulting Corrective Action Reports submitted by the
probationary laboratory, the Agency determines that the probationary
laboratory shall not be accredited, the laboratory will have a maximum
of 6 additional months to correct and improve any pending
nonconformities. The provision of documentation, the analysis of
additional EQAS samples, or an additional assessment (on-site,
remotely, or as a documentary audit, as determined by the Agency) may
be required and, if so, will be conducted at the probationary
laboratory's expense. A probationary laboratory that fails to provide
satisfactory improvements after 6 months, as determined by the Agency,
may be required to renew its candidacy as described in Rule 6110 or to
restart the probationary phase of accreditation in accordance with
paragraph (a) of this Rule 6120.
(d) Issuing and publishing of HEAL accreditation certificate. An
accreditation certificate signed by a duly authorized representative of
the Agency shall be issued in recognition of the HEAL accreditation. It
shall specify probationary or final accreditation status. Such
accreditation certificate shall specify the name of the Laboratory and
the period for which the accreditation certificate is valid.
Accreditation certificates may be issued after the effective date, with
retroactive effect. A list of HEAL accredited
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laboratories, together with internationally approved laboratories,
shall be published on the Agency's website.
Rule 6130. Maintaining HEAL Accreditation
(a) Maintain ISO/IEC 17025 accreditation. The Laboratory shall
maintain accreditation to ISO/IEC 17025, with primary reference to the
analysis of Samples, granted by an accreditation body, which may be
specified by the Agency, and which shall be an International Laboratory
Accreditation Cooperation (ILAC) full member that is a signatory to the
ILAC Mutual Recognition Arrangement (ILAC MRA) for testing activities
as defined in ISO/IEC 17025. Flexible scope of accreditation must be
included in the Laboratory's scope of accreditation.
(b) Participation in the Agency EQAS program. Laboratories are
required to participate in the Agency EQAS on a continuous basis and
meet the performance requirements of the EQAS as described in the Rule
6200 Series.
(c) Laboratory independence and impartiality.
(1) The Laboratory shall be administratively and operationally
independent from any organization or person(s) that could exert undue
pressure on the Laboratory and affect the impartial execution of its
tasks and operations. Laboratories shall comply with these requirements
of administrative and operational independence by the program effective
date, unless otherwise approved by the Agency.
(2) In order to be operationally independent, the Laboratory shall
manage its own affairs without hindrance, interference, or direction
from any Person, except in accordance with the Laboratory Standards.
The Laboratory shall, without limitation, control: the allocation of
its budget; the procurement of equipment and other resources;
Laboratory personnel decisions; the research conducted by the
Laboratory; and all Sample Analytical Testing and reporting of results.
The Laboratory shall not accept money from any Covered Person.
(3) The Laboratory shall have a dedicated budget allowing the
implementation of an efficient approval process for the timely
procurement of necessary Reference Materials, reagents, consumables and
essential equipment, as well as independent Laboratory management
decisions concerning the recruitment, retention and training of staff,
participation in scientific meetings and symposia, and other relevant
scientific decisions. This does not prevent the Laboratory from
receiving research grants or other financial support from its host
organization (e.g., university, public institution), anti-doping
organizations, sport organizations, governments, or other sponsors,
while following applicable accounting regulations in connection with
the receipt and management of those funds.
(d) Document compliance with the Code of Ethics.
(1) The Laboratory shall comply with the provisions of the Code of
Ethics.
(2) The Laboratory shall annually provide to the Agency a letter of
compliance with the provisions of the Code of Ethics, signed by the
Laboratory Director. All staff employed at the Laboratory, permanent or
temporary, shall also read, agree to, and sign documentation to
indicate their agreement to the Code of Ethics. The Laboratory may be
asked to provide documentation of compliance with the provisions of the
Code of Ethics.
(3) The Laboratory shall establish a system requiring Laboratory
staff to report any alleged breaches of the Code of Ethics to the
Laboratory Director, which the Laboratory Director shall promptly
report to the Agency. However, if Laboratory staff suspect that the
Laboratory Director may have breached the Code of Ethics, the
Laboratory staff shall promptly report the alleged breaches of the Code
of Ethics directly to the Agency. The Laboratory Director or the
Agency, as applicable, shall immediately and thoroughly investigate any
alleged breach of the Code of Ethics.
(4) If the Laboratory's investigation determines that a breach of
the Code of Ethics occurred, the Laboratory Director shall immediately
inform the Agency of the results of the investigation and the
disciplinary actions taken. The Agency may also impose penalties as a
result of its own investigations. Penalties may range from a personal
reprimand to the expulsion of the implicated Laboratory staff
member(s), the reporting of the breach to the pertinent authorities
(e.g., law enforcement), the suspension or revocation of the
Laboratory's HEAL accreditation, or any other follow-up measures the
Agency determines to be appropriate.
(e) Document implemented research and development activities.
(1) The Laboratory shall develop and maintain a plan for research
and development in the field of anti-doping science. The research
activities can either be conducted by the Laboratory alone or in
cooperation with other Laboratories or other research organizations.
(2) The Laboratory shall supply an annual progress report to the
Agency documenting research and development results in the field of
anti-doping science. The Laboratory shall also relate research and
development plans for the following year.
(3) The annual research summary will be evaluated and scored by the
LabEG. The Laboratory must, except where otherwise agreed by the
Agency, achieve the minimum requirement to meet accreditation research
requirements in Rule 6620.
(f) Document implemented sharing of knowledge.
(1) The Laboratory shall demonstrate its willingness and ability to
share knowledge with other Laboratories. The Laboratory shall
disseminate the results of its research and development activities to
other Laboratories. The Laboratory is encouraged to make at least one
annual contribution to an anti-doping symposium or conference.
Laboratories are encouraged to: participate in collaborative research
projects with other Laboratories; exchange experience and protocols
with other Laboratories; arrange for visits of specialists with other
Laboratories; and provide training to other Laboratories and
probationary laboratories in specific areas of Analytical Testing.
(2) The Laboratory shall supply a report on sharing of knowledge
with other Laboratories to the Agency, if requested. A description of
sharing of knowledge is provided in the Code of Ethics.
(g) Maintain professional liability insurance coverage.
Laboratories shall provide documentation to the Agency including
evidence that professional liability risk insurance coverage is
maintained of no less than $5,000,000 annually (for example, evidence
of timely payment of applicable fees and premiums).
(h) Maintain minimum number of Samples.
(1) To maintain proficiency in Analytical Testing, Laboratories are
required to analyze a minimum of 2,500 Samples provided annually by the
Agency. To determine the minimum number of Samples, each urine Sample
and blood Sample analyzed by the Laboratory (excluding Samples
submitted for TCO2 analysis only), regardless of whether they are
collected as a ``paired'' Sample, shall count as an individual Sample.
The Agency will monitor the number of Samples tested by the Laboratory.
Except where the Agency fails to send the minimum annual number of
Samples to the Laboratory, if the number of Samples falls below the
minimum, the
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Laboratory's HEAL accreditation may be suspended in accordance with
Rule 6510.
(2) It is recognized that specific circumstances may affect a
Laboratory's ability to analyze the minimum Samples annually, such as
when the Laboratory is not operational for the full calendar year. In
such cases, the Agency shall require that the Laboratory implement
measures to maintain proficiency in Analytical Testing, for example, by
strengthening its internal Quality Assurance Scheme (iQAS) and internal
audits program. The Agency may also provide additional EQAS samples,
conduct a documentary audit, or an on-site or remote (online)
assessment, at its discretion, to assess the status of the Laboratory's
operations.
(i) Laboratory Analytical Testing Procedures and services.
Laboratories shall provide to the Agency an up-to-date list of
Analytical Testing Procedures and services, to assist the Agency in
developing test distribution plans. Upon request, Laboratories shall
cooperate with the Agency by providing other relevant information
regarding Testing plans (e.g., Laboratory analytical capabilities).
(j) Participating in the Agency/accreditation body re-assessments
and continuous assessments during the accreditation cycle.
(1) The assessment team shall include at least one Laboratory
Standards-trained assessor selected by the accreditation body for the
assessment/re-assessment.
(2) The Laboratory shall (in a timely manner) send to the Agency a
summary of the assessment report and any corrective or preventive
action documentation addressing nonconformities.
(3) The Laboratory shall provide the Agency with an updated copy of
the ISO/IEC 17025 certificate and scope of ISO/IEC 17025 accreditation
as soon as it is obtained from the accreditation body.
(4) The Agency Laboratory assessment. The Agency reserves the right
to conduct documentary audits, as well as inspect and assess the
Laboratory, through on-site or remote (online) assessments at any time,
at the Agency's expense. The notice of the Agency assessment will be
made in writing to the Laboratory Director. In exceptional
circumstances, and at the Agency's discretion, the assessment may be
unannounced.
(5) As part of an announced or unannounced Laboratory assessment,
the Agency retains the right to request copies of Laboratory
documentation or request Further Analysis of selected A or B Samples,
either on-site or in any Laboratory selected by the Agency.
Rule 6140. The Agency Monitoring of Accreditation Status
(a) The Agency shall regularly review the compliance of
Laboratories with the requirements listed in the Laboratory Standards
and related Technical Documents and Technical Letters. In addition, the
Agency shall also conduct an annual review of EQAS results and of
relevant routine Analytical Testing issues to assess the overall
performance of each Laboratory and to decide its accreditation status.
(b) Maintenance of HEAL accreditation. Compliance with all the
requirements established in Rule 6130, including satisfactory
performance by a Laboratory in the EQAS and in routine Analytical
Testing, as determined by the Agency, is a critical requirement for the
maintenance of the Laboratory's HEAL accreditation.
(c) Issuing and publication of accreditation certificate. On an
annual basis, when maintenance of accreditation is approved by the
Agency, the Laboratory shall receive a HEAL accreditation certificate,
signed by a duly authorized representative of the Agency, which is
issued in recognition of such accreditation. The accreditation
certificate shall specify the name of the Laboratory and the period for
which the accreditation certificate is valid. HEAL accreditation
certificates may be issued after the effective date, with retroactive
effect. The list of the HEAL-accredited Laboratories is maintained on
the Agency's website.
6200. The Agency External Quality Assessment Scheme
Rule 6210. The Agency External Quality Assessment Scheme
The Agency regularly distributes External Quality Assessment Scheme
(EQAS) samples to Laboratories and, when applicable, to probationary
laboratories. The Agency EQAS is designed to continually monitor the
capabilities of the Laboratories and probationary laboratories, to
evaluate their proficiency, and to improve test result uniformity
between Laboratories. EQAS samples are used to assess Laboratory
routine analytical capacity and performance, reporting turn-around
times, and overall compliance with the Agency Laboratory standards
(e.g., Laboratory Standards, Technical Documents and Technical
Letters), as well as other, non-analytical performance criteria. At the
same time, the EQAS also represents, via its educational components, a
source of continuous improvement for the effectiveness of the
Analytical Testing Procedures.
Rule 6220. Types of EQAS
(a) Blind EQAS. The Laboratory will be aware that the sample is an
EQAS sample since it is delivered by the Agency's EQAS sample provider.
However, the Laboratory will not know the content of the sample.
(b) Double-blind EQAS. The Laboratory will not be aware that the
sample is an EQAS sample since it is delivered by the Agency and is
indistinguishable from routine Samples.
(c) Educational EQAS.
(1) Educational EQAS samples may be provided as open (in which case
the content of the EQAS sample is known), blind or double-blind
samples. This approach is used for educational purposes or for data
gathering.
(2) As part of the educational EQAS, the Agency may provide
Laboratories with new Reference Materials, Reference Collections, or
quality control (QC) samples for a prompt implementation of existing or
new Analytical Testing Procedures.
(3) The Agency may require the successful participation of
Laboratories in an educational EQAS for the Agency-specific Analytical
Testing Procedures for Laboratories to seek an extension of the
Laboratory's scope of ISO/IEC 17025 accreditation by an accreditation
body before the subsequent application of the Analytical Testing
Procedure to the routine analysis of Samples.
Rule 6230. Number of EQAS Samples
(a) The actual composition and number of EQAS samples supplied to
different Laboratories may vary; however, within any calendar year, all
Laboratories participating in the EQAS are expected to have analyzed
the minimum total number of EQAS samples.
(b) Each year, the EQAS program will consist of:
(1) At least 15 blind EQAS samples, distributed by the Agency in
multiple rounds;
(2) At least 5 double-blind EQAS samples, distributed by the Agency
in multiple rounds; and
(3) At least 3 of the above EQAS samples will contain Threshold
Substances.
(c) As part of the Agency's Laboratory monitoring activities, and
with the main purpose of assisting Laboratories in their continuous
improvement of performance, the Agency may increase the number of
annual EQAS samples (mainly for educational purposes) for
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certain Laboratories, according, but not limited, to the following
criteria:
(1) Monitoring the effectiveness of corrective action
implementation after questionable or unsatisfactory performance in the
Agency EQAS or in routine Analytical Testing;
(2) Substantiated intelligence information received by the Agency
indicating questionable or unsatisfactory Laboratory performance;
(3) Laboratories which do not receive enough Samples (<100 annual
Samples) for a specific Analytical Testing Procedure, which is not part
of the Laboratory's routine Analytical Testing menu; and
(4) As part of the Agency's Laboratory assessments.
Rule 6240. Composition of EQAS Samples
(a) EQAS samples may or may not contain Prohibited Substance(s) or
Metabolite(s) of Prohibited Substance(s) or Marker(s) of Prohibited
Substance(s) or Prohibited Method(s).
(b) Blank EQAS samples. Blank EQAS samples do not contain
Prohibited Substance(s) or Metabolite(s) of Prohibited Substance(s) or
Marker(s) of Prohibited Substance(s) or Prohibited Method(s).
(c) Adulterated EQAS samples. Adulterated EQAS samples are those
which have been deliberately adulterated by the spiking of non-
characteristic Metabolite(s) or by the addition of extraneous
substances designed to dilute or concentrate the sample, or to degrade
or mask the Analyte prior to or during the analytical determination.
Adulterated EQAS samples may also be obtained from the controlled
administration or the addition of non-prohibited substances, which
share common Metabolite(s) with Prohibited Substance(s).
(d) EQAS samples containing Prohibited Substance(s), their
Metabolite(s) or Marker(s), or the Marker(s) of Prohibited Method(s).
(1) The concentration(s) of selected Analyte(s) are those that may
be encountered in the urine or blood after Use of Prohibited
Substance(s) or Prohibited Method(s). For some Analytes, the EQAS
sample may contain the parent Prohibited Substance or its Metabolite(s)
or its Marker(s).
(2) EQAS samples may be spiked with Prohibited Substance(s) or
their Metabolite(s) or Marker(s) but, where appropriate, may be
prepared from controlled administration studies. The EQAS sample
composition shall reflect as closely as possible the expected target
Analyte Metabolite pattern and concentrations usually found in Samples.
(3) An EQAS sample may contain more than one Prohibited Substance,
Metabolite(s), or Marker(s) of a Prohibited Substance or Prohibited
Method. It may also contain multiple Metabolites or Markers of a single
Prohibited Substance or Markers of a Prohibited Method, which would
represent the presence of a single Prohibited Substance or the Use of a
single Prohibited Method.
(4) Double-blind EQAS samples shall be representative of Samples.
Therefore, to the extent possible (in consideration, for example, of
technical or ethical constraints, availability of the pharmaceutical
grade substance), double-blind EQAS samples containing Prohibited
Substance(s) or Metabolite(s) of Prohibited Substance(s) or Marker(s)
of Prohibited Substance(s) or Prohibited Method(s) shall be prepared
from controlled administration studies performed in equine subjects.
However, if this is not possible, then the double-blind EQAS sample(s)
may be prepared by spiking expected target Analyte(s) in the Sample
matrix in consideration of the representative metabolic profile(s).
(5) For Non-Threshold Substances, the concentration in the EQAS
sample will be guided by, but not limited to, one of the following
criteria: concentrations of the Prohibited Substance or its
Metabolite(s) or Marker(s) equal to or greater than (>=) the applicable
MRPL; concentrations of the Prohibited Substance or its Metabolite(s)
or Marker(s) between 50% of the MRPL and the MRPL (applicable only to
Non-Threshold Substances prohibited at all times and with no Minimum
Reporting Levels); Non-Threshold Substances with Minimum Reporting
Levels or other limits controlling them (e.g., substances prohibited in
a Post-Race Sample only), will normally be present in estimated
concentrations greater than (>) 120% of the applicable Minimum
Reporting Level; or concentrations of the Prohibited Substance or its
Metabolite(s) or Marker(s) below (<) 50% of the applicable MRPL (for
Non-Threshold Substances prohibited at all times with no Minimum
Reporting Levels, for educational purposes).
(6) For Threshold Substances, the concentration in the EQAS sample
will be guided by, but not limited to, one of the following criteria:
greater than (>) 10% of the Threshold as established in any relevant
Technical Document(s) or Laboratory Guidelines; or less than (<) 50% of
the Threshold for those Threshold Substances whose presence shall be
reported if detected in the presence of diuretics or masking agents.
Rule 6250. Laboratory Analytical Testing Procedures Used in EQAS
All procedures associated with the Analytical Testing of the EQAS
samples by the Laboratory are to be conducted in a manner substantially
similar to that applied to routine Samples, unless otherwise specified
by the Agency. No effort shall be made to optimize instrument (e.g.,
change multipliers or chromatographic columns) or method performance
prior to analyzing the EQAS samples, unless it is a scheduled
maintenance activity. Only validated, Fit-for-Purpose Analytical
Testing Procedures described in the Laboratory's Standard Operating
Procedures are to be employed in the analysis of EQAS samples (i.e.,
using the Initial Testing Procedures and Confirmation Procedures
applied in routine Analytical Testing).
Rule 6260. Reporting of EQAS Results
(a) The purpose of the EQAS program is to ensure that all
Laboratories maintain proficiency in the performance of their
Analytical Testing Procedures and report valid results to the Agency in
a timely manner.
(b) In the spirit of the EQAS program, a Laboratory shall not
communicate with other Laboratories regarding the identity or content
of substances present in or absent from blind EQAS samples prior to the
submission of EQAS results to the Agency. This prohibition also applies
to Laboratory requests for second opinions, which shall not be
requested for blind EQAS samples.
(c) Contact between Laboratories regarding any aspect of blind EQAS
analysis (including the results obtained) prior to reporting by all
Laboratories to the Agency will be considered an attempt to circumvent
the quality control assessment.
(d) For double-blind EQAS samples, which are indistinguishable from
routine Samples, consultation between Laboratories before reporting
such EQAS results to the Agency may occur. However, such consultation
shall not involve identifying the sample as an Agency double-blind EQAS
sample (in cases when, for any reason, the Laboratory identifies the
EQAS nature of the sample).
(e) Reporting blind EQAS results.
(1) The Laboratory shall report the results of blind EQAS samples
to the Agency in the same manner as specified for routine Samples (see
Rule 6316) unless otherwise notified by the Agency. For some blind EQAS
samples or sample sets, additional information may be requested from
the Laboratory (e.g., LODs, LOQs, MU estimations).
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(2) The results of the blind EQAS shall be submitted to the Agency
on or before the specified reporting date, unless an extension is
granted by the Agency. Failure to report results of blind EQAS samples
will be considered a false Negative Finding(s).
(f) Reporting double-blind EQAS results.
(1) The Laboratory shall report the results of double-blind EQAS
samples as per Rule 6316.
(2) Reporting of double-blind EQAS results shall occur within the
same timeframe as specified for routine Samples, unless an extension is
granted by the Agency.
(3) Failure to report double-blind EQAS results within this
timeframe or, subject to an extension of this deadline granted by the
Agency pursuant to subparagraph (2) above, within the agreed or the
Agency-approved deadline, will be considered a false Negative
Finding(s).
(g) Reporting educational EQAS results.
(1) The Laboratory shall report the results of open or blind
educational EQAS samples on or before the specified reporting deadline
and in a format specified by the Agency. Results received after the
deadline will not be included in the assessment of EQAS results or in
the subsequent educational EQAS report and will be considered a false
Negative Finding(s).
(2) For open educational and blind EQAS samples, the Laboratory
shall report the LODs of the identified Non-Threshold Substance(s) or
Metabolite(s) or Marker(s), or of the identified Marker(s) of
Prohibited Method(s), as estimated during method validation of the
Initial Testing Procedure.
(h) Reporting results for EQAS samples containing Non-Threshold
Substances. Unless otherwise specified by the Agency (for example, for
an educational EQAS), the report of EQAS results for Non-Threshold
Substances shall include all the Analytes whose presence in the EQAS
sample has been confirmed by the Laboratory, including the Prohibited
Substance(s) (e.g., parent compound(s), if applicable) and all
identified Metabolite(s) or Marker(s) of the Prohibited Substances or
Marker(s) of Prohibited Method(s). The Agency may also require that the
Laboratory report the estimated concentrations of the confirmed
Analyte(s).
(i) Reporting results for EQAS samples containing Threshold
Substances.
(1) For educational and blind EQAS samples, the report of EQAS
results for Threshold Substances shall include the values measured for
each aliquot analyzed, whenever the measured mean value of all
replicates is greater than or equal to (>=) 50% of the applicable
Threshold.
(2) For double-blind EQAS samples, the Laboratory shall report the
quantitative results to, and in a form designated by, the Agency for
routine Samples, in accordance with any relevant Technical Document(s),
Technical Letter(s) or Laboratory Guidelines.
6300. Analysis of Samples
Rule 6301. Application of ISO/IEC 17025 to the Analysis of Samples
(a) Introduction and scope. This section of the Laboratory
Standards is intended as an extension of the application of ISO/IEC
17025 and ILAC-G7 to the field of Doping Control. Any aspect of
Analytical Testing or management not specifically discussed in this
document or in any relevant Technical Documents, Technical Letters or
Laboratory Guidelines shall be governed by ISO/IEC 17025. The
application focuses on the specific parts of the processes that are
critical with regard to the quality of the laboratory's performance as
a Laboratory and are, therefore, significant in the evaluation and
accreditation process.
(b) This section introduces the specific performance standards for
a Laboratory, as applicable. The conduct of Laboratory Analytical
Testing is considered a process within the definitions of ISO 17000.
Performance standards are defined according to a process model where
the Laboratory practice is structured into 3 main categories of
processes:
(1) structural and resource requirements;
(2) process requirements; and
(3) management requirements.
Rule 6302. Subcontracting Analysis
(a) A Laboratory may subcontract an analysis to another Laboratory,
in consultation with, and following written approval from, the Agency.
The conditions that justify subcontracting include, for example:
(1) A specific technology or Analyte(s) that are not within the
Laboratory's scope of ISO/IEC 17025 accreditation;
(2) An Analytical Testing Restriction decision;
(3) Other valid explanations, such as a need for higher sensitivity
or specific equipment or expertise, temporary workload or technical
incapacity;
(4) In exceptional circumstances, the Agency may elect to grant
specific authorization to subcontract analyses using specific methods
to an ISO/IEC 17025-accredited laboratory approved by the Agency, which
has the necessary technique within its scope of ISO/IEC 17025
accreditation (for example, DNA analysis or genomic profiling);
(5) Other specific investigations, such as, without limitation,
forensic examinations which need to be performed in the course of the
Analytical Testing process may also be subcontracted by the Laboratory.
(b) In all such cases, the Laboratory subcontracting the analysis
is only responsible for the maintenance of the appropriate Chain of
Custody up to Sample reception by the subcontracted Laboratory. Such
arrangements shall be clearly recorded as part of the Sample's
documentation and included in the Laboratory Documentation Package, if
applicable.
Rule 6303. Samples With Irregularities
(a) The Laboratory shall observe and document conditions that exist
at the time of Sample reception or registration that may adversely
impact on the integrity of a Sample or on the performance of Analytical
Testing Procedures. Only unusual conditions shall be recorded.
(b) Irregularities to be noted by the Laboratory may include, but
are not limited to:
(1) Sample transport conditions (e.g., delivery time, temperature),
which may impact the integrity of the Sample for Analytical Testing, as
determined by the Laboratory;
(2) Sample collection information (including Sample identification
Protocol), which is necessary to conduct the Analytical Testing menu
requested by the Agency, is not provided (e.g., missing or incomplete
Sample collection documentation);
(3) Sample identification is questionable. For example, if the
number on the Sample container does not match the Sample identification
number on the Sample collection documentation;
(4) Covered Person or Covered Horse information is visible on the
Laboratory copy of the Sample collection documentation or any other
document transferred to the Laboratory;
(5) Sample identification numbers are different between the A and
the B Sample containers of the same Sample;
(6) Tampering or adulteration of the Sample is evident;
(7) Sample is not sealed with Tamper Evident device or not sealed
upon receipt;
(8) Sample volume does not meet the suitable volume for analysis or
is otherwise inadequate to perform the
[[Page 5179]]
Analytical Testing menu requested by the Agency;
(9) The Sample contains foreign objects, such as insects; or
(10) The Sample condition(s) is unusual (e.g., color, odor,
presence of turbidity or foam in a urine Sample, color, hemolysis,
freezing or clotting of a blood Sample, or unusual differences in
Sample appearance (such as color or turbidity) between the A and the B
Samples).
(c) When an analysis on a Sample with documented irregularities is
performed, the Laboratory shall record the irregularities in the test
report.
Rule 6304. Sample Splitting Procedure
(a) In cases when either the A or B Sample is not suitable for the
performance of the analyses (e.g., there is insufficient Sample volume,
the Sample container has not been properly sealed or has been broken,
the Sample's integrity has been compromised in any way, the Sample is
heavily contaminated, the A or B Sample is missing), the Laboratory
shall notify and consult with the Agency regarding whether it is
appropriate to split the other Sample container (A or B, as
applicable), provided that it is properly sealed. The Agency should
inform the Laboratory of its decision in writing within 3 days of
notification by the Laboratory. If the Agency decides not to proceed
with the Sample splitting procedure, then the Laboratory shall report
the Sample as ``not analyzed,'' including the noted Sample
irregularities and the documented reasons if provided by the Agency.
(b) The first fraction of the split Sample shall be considered as
the A Sample and shall be used for the Initial Testing Procedure(s),
unless the Initial Testing Procedure(s) have already been performed,
and the A Confirmation Procedure(s), if necessary. The second fraction,
considered as the B Sample, shall be resealed and stored frozen for the
B Confirmation Procedure(s), if necessary.
(c) The process of opening and splitting the Sample and resealing
of the remaining second fraction shall be conducted in accordance with
Rule 6312 for a customary B Sample opening.
(d) When the splitting procedure concerns blood Samples, which have
been collected for Analytical Testing on the blood serum/plasma
fraction, the sealed, intact (A or B) Sample shall be centrifuged as
soon as practicable after Laboratory reception to obtain the serum or
plasma fraction. The centrifuged Sample shall be stored frozen in the
sealed Sample collection tube according to established protocols until
the Sample opening/splitting procedure can be conducted. The opening of
the Sample for the splitting of the serum/plasma fraction and resealing
of the second fraction shall be carried out as described immediately
above.
Rule 6305. Initial Storage and Sample Aliquoting for Analysis
(a) The Aliquot preparation procedure for any Initial Testing
Procedure or Confirmation Procedure shall minimize the risk of
contamination of the Sample or Aliquot. The Laboratory shall use new
material(s) (e.g., new test tubes, disposable pipettes or pipettes with
disposable, non-reusable tips) to take Aliquots for Confirmation
Procedures.
(b) Urine Samples. In order to maintain the stability and integrity
of the urine Samples, the Laboratory shall implement Sample storage
procedures that minimize storage time at room and refrigerated
temperatures, as well as Sample freeze/thaw cycles.
(1) For urine Samples, the Laboratory shall obtain, following
proper homogenization of the Sample, an initial Aliquot containing
enough Sample volume for all analytical procedures (i.e., all Initial
Testing Procedures or all intended Confirmation Procedures, as
applicable), by decanting the Aliquot from the urine Sample container
into a secondary container (e.g., a Falcon tube). Procedure-specific
Aliquot(s) shall then be taken from the secondary container.
(2) The Laboratory shall measure the pH and specific gravity of
urine Samples once, using one Aliquot, during the Initial Testing
Procedure and the Confirmation Procedure(s) (A and B Samples). Other
tests that may assist in the evaluation of adulteration or manipulation
may be performed, if deemed necessary by the Laboratory.
(3) Urine A Samples shall be frozen after Aliquots are taken for
the Initial Testing Procedure(s) to minimize risks of Sample microbial
degradation. Urine B Samples shall be stored frozen after reception
until analysis, if applicable.
(c) Blood Samples. The Laboratory shall follow any applicable
Agency procedures, Technical Document(s), and Technical Letter(s) for
handling and storing blood Samples.
Rule 6306. Selection and Validation of Analytical Testing Procedures
(a) The Laboratory shall select, validate, and document Analytical
Testing Procedures, which are Fit-for-Purpose for the analysis of
representative target Analytes of Prohibited Substances and Prohibited
Methods.
(b) Validation results for Analytical Testing Procedures shall be
summarized in a validation report and supported by the necessary
documentation and analytical data. The validation report shall indicate
whether the Analytical Testing Procedure is Fit-for-Purpose and shall
be included in a Laboratory scope of accreditation.
(c) The Laboratory shall define and document the conditions that
would trigger the revalidation of an Analytical Testing Procedure
(e.g., change of internal standard, modified extraction procedure or
chromatographic methodology, change in detection technique) or a
partial re-assessment of the validation process (e.g., replacement or
upgrade of instrument, addition of new Analyte to the Analytical
Method).
(d) Validation of Analytical Testing Procedures for Non-Threshold
Substances. The Laboratory shall develop, as part of the method
validation process, appropriate standard solutions for detection or
identification and estimation of the concentration of Non-Threshold
Substances. In the absence of suitable Reference Materials, Reference
Collections may be used for detection and identification.
(1) Validation of Initial Testing Procedures for Non-Threshold
Substances.
(i) The Laboratory shall validate the Selectivity, carryover,
reliability of detection at the MRPL and Limit of Detection (LOD) for
the Initial Testing Procedure from the analysis of an adequate number
of representative samples prepared in the appropriate matrix of
analysis. For chromatographic-mass spectrometric Analytical Methods,
the Initial Testing Procedure shall allow the detection of each Non-
Threshold Substance or its representative Metabolite(s) or Marker(s) at
50% or less of the Minimum Required Performance Levels (MRPL).
(ii) For Non-Threshold Substances with Minimum Reporting Levels
(MRL), the Laboratory shall validate and document the estimated
concentration levels that will require a Confirmation Procedure.
(iii) If there is no available Reference Material, an estimate of
the detection capability of the Initial Testing Procedure (i.e., the
LOD) for the Non-Threshold Substance or its representative
Metabolite(s) or Marker(s) may be provided by assessing a
representative substance from the same class of Prohibited Substances
with a similar chemical structure.
(2) Validation of Confirmation Procedures for Non-Threshold
Substances. Factors to be investigated in the method validation
procedure to
[[Page 5180]]
demonstrate that a Confirmation Procedure for Non-Threshold Substances
is Fit-for-Purpose include, but are not limited to:
(i) Selectivity: The ability of the Confirmation Procedure to
detect and identify the Analyte of interest, taking into account
interference(s) from the matrix or from other substance(s) present in
the Sample. Selectivity shall be determined and documented from the
analysis of an adequate number of representative samples prepared in
the matrix of Sample analysis, in compliance with any applicable Agency
procedures, Technical Document, Technical Letter, or Laboratory
Guidelines. The Confirmation Procedure shall be able to discriminate
between Analytes of closely related structures;
(ii) Limit of Identification (LOI): When the analyses of Non-
Threshold Substances are based on chromatographic-mass spectrometric
techniques, the Laboratory shall determine the lowest concentration at
which each Non-Threshold Substance or its representative Metabolite(s)
or Marker(s), for which a Reference Material is available, is
identified at no more than 5% false negative rate (in compliance with
any applicable Agency procedures, Technical Document, Technical Letter,
or Laboratory Guidelines). The LOI shall be lower than the applicable
MRPL;
(iii) Robustness: The Confirmation Procedure shall be demonstrated
to produce similar results with respect to minor variations in
analytical conditions, which may affect the results of the analysis.
Those conditions that are critical to ensuring reproducible results
shall be considered; and
(iv) Carryover: The conditions required to eliminate carryover of
the substance of interest from Sample to Sample during processing or
instrumental analysis. Elimination of ``injection memory'' effect is
demonstrated by injecting a blank control sample for the Analyte in
question, prepared in the Sample matrix, immediately prior to the
Sample of interest.
(3) Validation of Analytical Testing Procedures for Threshold
Substances.
(i) As part of the validation process for chromatography-mass
spectrometric Analytical Methods applied to the analysis of Threshold
Substances, the Laboratory shall develop acceptable standard solutions
for identification of Threshold Substances. For Confirmation
Procedures, Certified Reference Materials shall be used for
quantification, if available.
(ii) For the application of affinity-binding assays, or other
methods as applicable, to the analysis of Threshold Substances, the
Laboratory shall follow any applicable Agency procedures and Technical
Document, and should follow any relevant Laboratory Guidelines.
(4) Validation of Initial Testing Procedures for Threshold
Substances.
(i) The Laboratory shall validate Initial Testing Procedures that
are Fit-for-Purpose, in accordance with any applicable Technical
Document(s), Technical Letter(s), or Laboratory Guidelines.
(ii) For chromatographic-mass spectrometric Initial Testing
Procedures, the Laboratory shall validate the Selectivity, LOD and
dynamic range from the analysis of an adequate number of representative
samples prepared in the appropriate matrix of analysis, unless
otherwise specified.
(iii) Unless otherwise specified, the Laboratory shall validate and
document the estimated concentration levels which will require
quantitative Confirmation Procedure(s).
(iv) In order to account for a possible underestimation of
concentrations of Threshold Substances during non-quantitative Initial
Testing Procedures, the Laboratory shall establish and document in the
Test Method's SOP criteria (e.g., concentration levels) determined,
during the Initial Testing Procedure method validation, to evaluate
initial results as Presumptive Adverse Analytical Findings and ensure
that all potentially positive Samples are subjected to quantitative
Confirmation Procedures.
(v) The estimation of Measurement Uncertainty (MU) is not required
during the validation of Initial Testing Procedures, unless otherwise
specified.
(5) Validation of Confirmation Procedures for Threshold Substances.
Factors to be investigated during the method validation to demonstrate
that a quantitative Confirmation Procedure for a Threshold Substance is
Fit-for-Purpose include, but are not limited to:
(i) Selectivity, LOI, robustness, and carryover;
(ii) Limit of Quantification (LOQ): The Laboratory shall
demonstrate that a quantitative Confirmation Procedure has an
established LOQ of no more than 50% of the Threshold value, in
accordance with the LOQ values required in relevant Technical
Document(s) or in consideration of Laboratory Guidelines;
(iii) Dynamic range: The range of the quantitative Confirmation
Procedure shall be documented from at least 50% to 200% of the
Threshold value;
(iv) Repeatability (sr): The quantitative Confirmation Procedure
shall allow for the reliable repetition of the results over a short
time, using a single operator and item of equipment. Repeatability at
levels close to the Threshold shall be determined;
(v) Intermediate Precision (sw): The quantitative Confirmation
Procedure shall allow for the reliable repetition of the results at
different times and with different operators and instruments, if
applicable, performing the assay. Intermediate Precision at levels
close to the Threshold shall be determined;
(vi) Bias (b): The Bias of the measurement procedure shall be
evaluated either using Certified Reference Materials or traceable
Reference Materials, if available, or from comparison with a reference
method or with the consensus values obtained from an inter-Laboratory
comparison study or EQAS participation. Bias at the levels close to the
Threshold shall be determined;
(vii) Measurement Uncertainty (MU): The MU associated with the
results obtained with the quantitative Confirmation Procedure shall be
estimated in accordance with any applicable Agency procedures,
Technical Document(s), Technical Letter(s), or Laboratory Guidelines.
At a minimum, MU at levels close to the Threshold shall be addressed
during the validation of the quantitative Confirmation Procedure.
(e) Confirmation Procedure method validation data (including the
estimation of MU) is evaluated during the assessment process for
inclusion of the quantitative Confirmation Procedure within the
Laboratory's scope of ISO/IEC 17025 accreditation. Therefore, for those
Confirmation Procedures that are included within the Laboratory's scope
of ISO/IEC 17025 accreditation, the Laboratory is not required to
produce method validation data, SOPs, or other evidence of method
validation in any legal proceeding.
Rule 6307. Sample Analysis
(a) Laboratories shall analyze Samples collected by or on behalf of
the Agency using any Analytical Testing menu directed by the Agency to
detect the presence of Prohibited Substances or Prohibited Methods only
(as defined in the Prohibited List).
(b) Covered Persons and their representatives are not permitted to
be present for any aspect of Sample analysis or processing described in
the Laboratory Standards, Technical Documents, Technical Letters,
Laboratory Guidelines, or Laboratory SOPs. In addition, Covered Persons
are not permitted to have a Sample transferred to be tested at a
laboratory.
[[Page 5181]]
(c) Laboratories may analyze Samples for the following, in which
case the results of the analysis shall not be reported as an Atypical
Finding or an Adverse Analytical Finding:
(1) Non-prohibited substances or methods that are included in the
Agency monitoring program;
(2) Non-prohibited substances for results interpretation purposes
(e.g., non-prohibited substances that share Metabolite(s) or
degradation products with Prohibited Substances), if applicable;
(3) Non-prohibited substances or methods requested as part of a
Results Management process by an adjudicatory body or the Agency;
(4) Non-prohibited substances or methods requested by the Agency as
part of its safety Protocol, Protocol of conduct or other regulations;
or
(5) Additional analyses for quality assurance/quality improvement/
method development or research purposes, in accordance with the
requirements indicated in Rule 6320.
(d) At minimum, all Laboratories are required to implement all
mandatory Analytical Testing Procedures, as determined by the Agency in
compliance with any relevant Technical Document(s) and Technical
Letter(s). Laboratories may implement additional methods for the
analysis of particular Prohibited Substances or Prohibited Methods.
(e) Analytical Testing Procedure(s) included in the Laboratory's
scope of ISO/IEC 17025 accreditation shall be considered as Fit-for-
Purpose, and, therefore, the Laboratory shall not be required to
provide method validation documentation, SOPs or EQAS performance data
in support of an Adverse Analytical Finding.
(f) However, if the Analytical Testing Procedure has not been
included yet in the Laboratory's scope of ISO/IEC 17025 accreditation,
the Laboratory shall validate the procedure in compliance with the
Laboratory Standards and any applicable Agency procedures, Technical
Document(s), Technical Letter(s), or Laboratory Guidelines prior to its
application to the analysis of Samples. In such cases, the Laboratory
may be required to provide method validation documentation or EQAS
performance data in support of an Adverse Analytical Finding.
(g) Laboratories may, on their own initiative and prior to
reporting a test result, apply additional Analytical Testing Procedures
to analyze Samples for Prohibited Substances or Prohibited Methods not
included in the standard Analytical Testing menu requested by the
Agency, provided that the additional work is authorized by the Agency,
conducted at the Laboratory's expense, and does not significantly
affect the possibility to submit the Sample to Further Analysis.
Results from any such analysis shall be reported to, and in a form
designated by, the Agency and have the same validity and Consequences
as any other analytical result.
Rule 6308. Application of Initial Testing Procedures
(a) The objective of the Initial Testing Procedure is to obtain
information about the potential presence of Prohibited Substance(s) or
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method. Results from Initial Testing
Procedure(s) can be included as part of longitudinal studies (e.g.,
endogenous steroid), provided that the method is Fit-for-Purpose.
(b) The Initial Testing Procedure(s) shall fulfill the following
requirements:
(1) The Initial Testing Procedure shall be Fit-for-Purpose;
(2) The Initial Testing Procedure shall be performed on Aliquot(s)
taken from the container identified as the A Sample (and if the A
Sample cannot be used for the Initial Testing Procedure(s), see Rule
6304);
(3) The Initial Testing Procedure shall be recorded, as part of the
Sample (or Sample batch) record, each time it is conducted;
(4) All batches undergoing an Initial Testing Procedure shall
include appropriate negative and positive quality controls prepared in
the matrix of analysis, unless otherwise specified by the Agency;
(5) The Initial Testing Procedures for Non-Threshold Substances
shall include appropriate controls of representative substance(s) at or
below the MRPL;
(6) The Initial Testing Procedures for Threshold Substances shall
include appropriate controls close to the Threshold, unless otherwise
specified by the Agency;
(7) Results from Initial Testing Procedures are not required to
consider the associated MU, unless otherwise specified by the Agency;
and
(8) The Laboratory shall establish criteria, based on its method
validation and in accordance with its SOP, to evaluate results from an
Initial Testing Procedure as a Presumptive Adverse Analytical Finding,
which would trigger confirmation analyses.
Rule 6309. Application of Confirmation Procedures
(a) The objective of the Confirmation Procedure is to obtain a
result, which supports or does not support the reporting of an Adverse
Analytical Finding or Atypical Finding.
(b) A Confirmation Procedure for a Non-Threshold Substance with a
Minimum Reporting Level or other control limit may also be performed if
the result estimated from the Initial Testing Procedure is lower than
the applicable Minimum Reporting Level, as determined by the Laboratory
in accordance with the method's validation results, or as specifically
required by the Agency.
(c) A result obtained in the Initial Testing Procedure for a
Threshold Substance higher than the Threshold requires a Confirmation
Procedure. A Confirmation Procedure may also be performed if the result
obtained in the Initial Testing Procedure is lower than the Threshold,
as determined by the Laboratory, or as specifically required by the
Agency.
(d) Irregularities in the Initial Testing Procedure(s) shall not
invalidate an Adverse Analytical Finding, which is adequately
established by a Confirmation Procedure.
(e) The Confirmation Procedure(s) shall fulfill the following
requirements:
(1) The Confirmation Procedure(s) shall be Fit-for-Purpose,
including the estimation of the MU associated with a quantitative
Confirmation Procedure;
(2) The Confirmation Procedure(s) shall be recorded, as part of the
Sample (or Sample batch) record, each time it is conducted;
(3) The Confirmation Procedure shall have equal or greater
Selectivity than the Initial Testing Procedure and shall provide
accurate quantification results (applicable to Threshold Substances).
The Confirmation Procedure shall incorporate, when possible and
adequate, a different Sample extraction protocol or a different
analytical methodology, unless otherwise specified by the Agency; and
(4) All batches undergoing a Confirmation Procedure shall include
appropriate negative and positive quality controls prepared in the
matrix of analysis.
Rule 6310. Confirmation Procedure Methods
Mass spectrometry (MS) coupled to chromatographic separation (e.g.,
gas or liquid chromatography) is the analytical technique of choice for
confirmation of most Prohibited Substances, Metabolite(s) of a
Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance
or Prohibited Method. These are acceptable methods for both the Initial
Testing Procedure and the Confirmation Procedure.
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Rule 6311. A Confirmation Procedure
(a) Aliquots. The A Confirmation Procedure shall be performed using
new Aliquot(s) taken from the container identified as the A Sample (and
if the A Sample cannot be used for the Initial Testing Procedure(s),
see Rule 6304). At this point, the link between the Sample external
code, as shown in the Sample container, and the Laboratory internal
Sample code shall be verified.
(b) Target Analyte(s). If the presence of more than one Prohibited
Substance, Metabolite(s) of a Prohibited Substance, or Marker(s) of the
Use of a Prohibited Substance or Prohibited Method is detected by the
Initial Testing Procedure(s), the Laboratory shall confirm as many of
the Presumptive Adverse Analytical Findings as reasonably possible (and
such decision should consider the volumes available in the A and B
Samples). The confirmation(s) shall prioritize the identification or
quantification of the Prohibited Substance(s) or Prohibited Method(s)
that carry the longest potential period of Ineligibility. The
prioritization decision shall be made in consultation with the Agency
and documented by the Laboratory.
(c) Repetition of the A Confirmation Procedure. The Laboratory may
repeat the Confirmation Procedure for an A Sample, if appropriate,
(e.g., quality control failure, chromatographic peak interferences,
inconclusive A confirmation results). In that case, the previous test
result shall be nullified. Each repeat confirmation shall be performed
using a new Aliquot(s) taken from the A Sample container and shall be
recorded.
(d) A Confirmation Procedure for Non-Threshold Substances.
(1) For Non-Threshold Substances without Minimum Reporting Levels,
Adverse Analytical Finding or Atypical Finding decisions for the A
Sample shall be based on the identification of the Non-Threshold
Substance or its characteristic Metabolite(s) or Marker(s), as
applicable, in compliance with any relevant Technical Document(s) or
Technical Letter(s) or in consideration of Laboratory Guidelines.
(2) For Non-Threshold Substances with Minimum Reporting Levels,
Adverse Analytical Finding decisions for the A Sample shall be based on
the identification of the Non-Threshold Substance or its characteristic
Metabolite(s) or Marker(s), in compliance with any applicable Agency
procedures or Technical Document, at an estimated concentration greater
than the Minimum Reporting Level, unless there is valid justification
for reporting the finding at levels below the Minimum Reporting Level
(e.g., if the analysis forms part of an ongoing investigation).
(e) A Confirmation Procedure for Threshold Substances.
(1) For Threshold Substances, Adverse Analytical Finding or
Atypical Finding decisions for the A Sample shall be based on the
confirmed identification (in accordance with any applicable Agency
Procedures or Technical Document) of the Threshold Substance or its
Metabolite(s) or Marker(s) and their quantitative determination in the
Sample at a level exceeding the value of the relevant Decision Limit.
(2) Quantitative Confirmation Procedures for Threshold Substances
shall be based on the determination of the mean of measured analytical
values (e.g., concentrations, chromatogram areas) or the ratio/score
calculated from the mean(s) of the measured analytical values of 2 A
Sample Aliquots, unless otherwise specified by the Agency. If there is
not enough Sample volume to analyze 2 Aliquots, the maximum number of
Aliquots that can be prepared shall be analyzed.
(3) By determining that the test result exceeds the Decision Limit,
the quantitative Confirmation Procedure establishes that the Threshold
Substance or its Metabolite(s) or Marker(s) is present in the Sample at
a level greater than the Threshold, with a statistical confidence of at
least 95%.
(4) For Threshold Substances, Markers of the ``biomarker profile'',
or any other Prohibited Substance that may be produced endogenously at
low levels, Adverse Analytical Finding decisions for the A Sample may
also be based on the application of any Fit-for-Purpose Confirmation
Procedure that establishes the exogenous origin of the Prohibited
Substance or its Metabolite(s) or Marker(s). Atypical Findings may
result from non-conclusive determinations of the origin (i.e.,
endogenous vs. exogenous) of the Prohibited Substance or its
Metabolite(s) or Marker(s).
Rule 6312. B Sample Procedure
(a) Testing Laboratory. If the B Sample procedure is to be
performed, it will be performed in a different Laboratory from the A
Sample analysis (with the choice of the Laboratory for the B Sample
analysis determined exclusively by the Agency), except where the Agency
considers it necessary for the same Laboratory to perform the B Sample
procedure:
(1) due to reasonable concerns over Sample integrity or unstable
analytes; or
(2) because no other Laboratory is available to perform the B
Sample procedure within a reasonable period of time.
(b) Notification and timing of B Sample procedure.
(1) The B Sample procedure shall only be performed by the
Laboratory upon request by the Agency.
(2) The Agency should inform the Laboratory, in writing, within 15
days following the reporting of an A Sample Adverse Analytical Finding
by the Laboratory, whether the B Sample procedure shall be conducted.
This includes situations when the Covered Person does not request the B
Sample analysis or expressly or implicitly waives his or her right to
the analysis of the B Sample, but the Agency decides that the B Sample
procedure shall still be performed.
(3) If the B Sample procedure is to be performed, whether upon the
request of the Covered Person in accordance with the Protocol or the
Agency:
(i) as soon as reasonably practicable after the Agency so decides
or the Covered Person so requests, the Agency should notify the
Laboratory that performed the A Sample analysis, and the Laboratory
that will perform the B Sample procedure, that the B Sample procedure
will be performed;
(ii) within 5 days of receipt of the notice at Rule 6312(b)(3)(i),
the Laboratory that performed the A Sample analysis should send the B
Sample to the Laboratory that will perform the B Sample procedure; and
(iii) the Laboratory that will perform the B Sample procedure
should perform the B Sample procedure as soon as reasonably practicable
after receipt of the B Sample.
(4) The timing of the B Sample procedure may be strictly fixed
within a very short period of time and without any possible
postponement, if circumstances so justify it. This can notably and
without limitation be the case when a postponement of the B Sample
analysis could significantly increase the risk of Sample degradation or
inadequately delay the decision-making process in the given
circumstances (e.g., and without limitation, during or in view of a
Covered Horserace requiring rapid completion of the Sample analysis).
(c) Opening, Aliquoting and Resealing of B Sample.
(1) The B Sample procedure shall be performed using Aliquot(s)
taken from the container defined as the B Sample (and if the B Sample
cannot be used, see Rule 6304).
(2) If the B Sample container was not properly sealed or showed
signs of
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Tampering, or if the identifying numbers did not match those on the
Sample collection documentation, the Laboratory shall not proceed with
the B Sample procedure and will inform the Agency immediately to obtain
instructions on how to proceed. In such cases, unless the entire case
is dismissed, the B Sample procedure may have to be re-scheduled.
(3) The Laboratory shall ensure that the B Sample container is
opened and Aliquots for the B Sample procedure are taken.
(4) The Laboratory shall also ensure that, after opening and taking
Aliquots for the B Sample procedure, the B Sample is properly resealed.
(5) At a minimum, the Laboratory Director or representative shall
sign another part of the Laboratory documentation attesting that the B
Sample opening and aliquoting procedures occurred and that the B Sample
was properly resealed.
(d) Target Analyte(s). If more than one Prohibited Substance,
Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method has been confirmed in the A
Sample procedure, the Laboratory shall confirm as many of the Adverse
Analytical Findings as possible given the B Sample volume available.
The decision on the prioritization for the confirmation(s) shall be
made to prioritize the analysis of the Prohibited Substance(s) or
Prohibited Method(s) that carry the longest potential period of
Ineligibility. The prioritization decision shall be made in
consultation with the Agency and documented.
(e) Repetition of the B Sample procedure. The Laboratory may repeat
the B Sample procedure, if appropriate, (e.g., quality control failure,
chromatographic peak interferences, inconclusive B confirmation
results). In that case, the previous test result shall be nullified.
The Laboratory may repeat the B Sample procedure using the remaining
volume of the same Aliquot initially taken from the B Sample container.
However, if there is not enough volume left of the initial Aliquot,
then the Laboratory shall use a new Aliquot(s) taken from the re-sealed
B Sample container. Each Aliquot used shall be documented.
(f) B confirmation with negative results. If the final B
confirmation results are negative, the Analytical Testing result shall
be considered a Negative Finding. The Laboratory shall notify the
Agency immediately. If requested by the Agency, one or more
Laboratories shall conduct an internal investigation of the causes of
the discrepancy between the A and B Sample results. Target Analytes
(e.g., parent compound, Metabolite(s), and Marker(s)) used to conclude
the presence of a given Prohibited Substance or Use of a Prohibited
Method may differ between the A and B Confirmation Procedures. This
does not mean that the B confirmation results are negative, as long as
the Analyte(s) targeted allows the unequivocal and conclusive
identification of the Prohibited Substance or Prohibited Method in the
B Sample.
(g) B Sample procedure for Non-Threshold Substances and exogenous
Threshold Substances. For Non-Threshold Substances (including those
with Minimum Reporting Levels) and exogenous Threshold Substances, the
B Sample results shall only confirm the presence of the Prohibited
Substance(s) or its Metabolite(s) or Marker(s) identified in the A
Sample (in compliance with any applicable Agency procedures or
Technical Document) for the Adverse Analytical Finding to be valid,
unless otherwise specified by the Agency. No quantification or
estimation of concentrations of such Prohibited Substance, or its
Metabolite(s) or Marker(s) is necessary.
(h) B Sample procedure for Threshold Substances.
(1) For Threshold Substances, Adverse Analytical Finding decisions
for the B Sample results shall be based on the confirmed identification
(in accordance with any applicable Agency procedures or Technical
Document, applicable to B Sample procedures based on chromatography-
mass spectrometry) of the Threshold Substance or its Metabolite(s) or
Marker(s) and their quantitative determination in the Sample at a level
exceeding the value of the relevant Threshold as specified in any
applicable Agency procedures, Technical Document(s), or Laboratory
Guidelines. Comparison of the measured value of the B Sample to the
measured value of the A Sample is not necessary to establish B Sample
confirmation. The B Sample value is only required to exceed the
applicable Threshold (plus any Measurement Uncertainty).
(2) Quantitative B Sample procedures for Threshold Substances shall
be based on the determination of the mean of measured analytical values
(e.g., concentrations, chromatogram areas) or the ratio/score
calculated from the mean(s) of the measured analytical values of 2 B
Sample Aliquots, unless otherwise specified by the Agency. If there is
not enough Sample volume to analyze 2 Aliquots, the maximum number of
Aliquots that can be prepared shall be analyzed.
(3) For Threshold Substances or any other Prohibited Substance that
may be produced endogenously at low levels, Adverse Analytical Finding
decisions for the B Sample results may also be based on the application
of any Fit-for-Purpose Analytical Testing Procedure that establishes
the exogenous origin of the Prohibited Substance or its Metabolite(s)
or Marker(s). Atypical Findings may result from non-conclusive
determinations of the origin (i.e., endogenous vs. exogenous) of the
Prohibited Substance or its Metabolite(s) or Marker(s).
Rule 6313. Further Analysis of Stored Samples
(a) Further Analysis of stored Samples shall, as a matter of
principle, be aimed at detecting all the Prohibited Substance(s) or
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method included in the Prohibited
List in force at the time of the collection of the Sample(s).
(b) Selection of Samples and Laboratories for Further Analysis.
(1) Stored Samples may be selected for Further Analysis at the
discretion of the Agency or the Authority.
(2) The choice of which Laboratory will conduct the Further
Analysis will be made by the Agency. Requests to the Laboratory for
Further Analysis shall be made in writing and be recorded as part of
the Sample's documentation.
(3) When a Sample has been reported as a Negative Finding or
Atypical Finding, there is no limitation on the Agency to conduct
Further Analysis on the Sample.
(4) Further Analysis may also be performed on stored Samples that
were previously reported as Adverse Analytical Findings. Any Prohibited
Substance or Prohibited Method detected, which was prohibited at the
time of Sample collection, shall be reported.
(5) Previously acquired Initial Testing Procedure data may also be
re-evaluated for the presence of Prohibited Substances or their
Metabolite(s) or Marker(s) of Prohibited Substances or Prohibited
Methods, at the initiative of the Agency or the Laboratory itself. The
results of such re-evaluation, if suspicious, shall be communicated to
the Agency, and may lead to Further Analysis.
(c) Analytical Testing Procedures for Further Analysis of stored
Samples.
(1) Further Analysis of stored Samples shall be performed under the
Laboratory Standards, Technical Documents, and Technical Letters in
effect at the time the Further Analysis is performed. Any
[[Page 5184]]
Laboratory Guidelines may also be referenced.
(2) Further Analysis of stored Samples includes, notably, but
without limitation, the application of newly developed or more
sensitive Analytical Testing Procedures or the analysis of new target
Analytes of Prohibited Substance(s) or Prohibited Method(s) (e.g.,
Metabolite(s) or Marker(s)), which were not known or not included in
the initial Analytical Testing of the Sample.
(3) Depending on the circumstances, and to ensure an effective and
targeted use of the available Sample volume, priorities may be set, or
the scope of the Further Analysis restricted to specific analyses (in
particular, but without limitation, to analyses based on new or
improved Analytical Testing Procedures).
(d) Further Analysis of stored Samples process.
(1) Use of the A Sample. The Agency may instruct the Laboratory to
use the A Sample for both the Initial Testing Procedure(s) and the A
Confirmation Procedure(s), to use it only for the Initial Testing
Procedure(s), or not to use the A Sample for Further Analysis at all.
(i) If the Laboratory has been instructed to perform only the
Initial Testing Procedure(s) on the A Sample, any suspicious analytical
result obtained from the A Sample shall be considered as a Presumptive
Adverse Analytical Finding, irrespective of the Analytical Testing
Procedure applied, and shall be confirmed using the split B Sample.
(ii) When a Confirmation Procedure is performed on the A Sample and
an Adverse Analytical Finding is reported on this basis, the B Sample
procedure shall be applicable (as per Rule 6316).
(2) Use of the split B Sample. When the A Sample is used only for
the Initial Testing Procedure(s) or is not used at all during Further
Analysis, the B Sample shall be split and used for analysis. The B
Sample shall be split into 2 fractions, in accordance with Rule 6304.
(i) In the event an Adverse Analytical Finding is notified based on
the results of a B Sample procedure of the first fraction of the B
Sample, the second split fraction of the B Sample shall be deemed as
the B Sample. Since the first split fraction of the B Sample is
considered as an A Sample, analysis of Aliquots taken from this Sample
may include the performance of Initial Testing Procedure(s) and A
Confirmation Procedures or A Confirmation Procedures only (if the
Initial Testing Procedure(s) was/were already performed using the A
Sample).
(ii) If applicable, a B confirmation shall be decided and performed
in accordance with Rule 6316.
(e) Alternative biological matrices. Any negative Analytical
Testing results obtained from hair, hoof, saliva or other biological
material shall not be used to counter Adverse Analytical Findings or
Atypical Findings from urine, blood (including whole blood, plasma or
serum), or hair.
Rule 6314. Ensuring the Validity of Analytical Results
(a) The Laboratory shall monitor its analytical performance and the
validity of test results by operating quality control schemes, which
are appropriate to the type and frequency of Analytical Testing
performed by the Laboratory. The resulting data shall be recorded in
such a way that trends are detectable and, where practicable,
statistical techniques shall be applied to review the results.
(b) All quality control procedures shall be documented by the
Laboratory. The range of quality control activities include, but are
not limited to:
(1) Use of appropriate quality control samples (QCs).
(i) Appropriate positive and negative QCs shall be included in
every analytical run both for the Initial Testing Procedure(s) and B
Sample procedure(s), unless otherwise specified by the Agency.
(ii) Appropriate internal standard(s) shall be used for
chromatographic methods.
(iii) For Threshold Substances, quality control charts (QC-charts)
referring to appropriate control limits depending on the Analytical
Testing Procedure employed (e.g., +/-2SD; +/-3SD; +/-MU95%), shall be
regularly used to monitor method performance and inter-batch
variability (when applicable).
(2) Implementation of an Internal Quality Assurance Scheme (iQAS).
(i) The Laboratory shall establish a functional and robust iQAS
program, in accordance with the requirements of ISO/IEC 17025, which
challenges the entire scope of the Analytical Testing process (i.e.,
from Sample accessioning through result reporting). The Laboratory
shall implement a procedure that prevents the submission of iQAS
results to the Agency.
(ii) The iQAS plan shall include and evaluate as many Laboratory
procedures as possible, including the submission of a sufficient number
of test samples on a regular basis (e.g., monthly) and shall
incorporate as many categories of Prohibited Substances and Prohibited
Methods as possible.
(iii) The Laboratory shall have a dedicated SOP for the iQAS
program which incorporates a detailed procedure for the planning,
preparation (blind or double-blind), introduction of the iQAS samples,
and management of the iQAS results (i.e., reviewing and follow-up of
nonconformities).
(3) Mandatory participation in the Agency EQAS.
(4) Implementation of internal audits.
(i) Internal audits shall be conducted in accordance with the
requirements of ISO/IEC 17025 and shall have a dedicated SOP
incorporating a detailed procedure for the planning and performance of
the audits, the training and selection of internal auditors, and
specification of their auditing activities, as well as for management
of the internal audit conclusions (i.e., reviewing and follow-up of
nonconformities).
(ii) Internal audit responsibilities may be shared amongst
personnel provided that any Laboratory staff member does not audit his
or her own area.
(iii) Internal audits shall be carried out by qualified Laboratory
staff members. In addition, qualified members of the Laboratory's host
organization (e.g., university, institute, company) may also be
included in the internal auditing teams.
(5) Implementation of external audits. Laboratories may also
consider having their procedures and systems audited by other
Laboratory Directors or external auditors. However, this shall not
replace the performance of internal audits by the Laboratory.
Rule 6315. Results Management
(a) Review of results. The Laboratory shall conduct a minimum of
one independent review of all Initial Testing Procedure raw data and
results. The review process shall be recorded.
(b) A minimum of 2 Certifying Scientists shall conduct an
independent review of all Adverse Analytical Findings and Atypical
Findings before a test result is reported. Evidence of the review and
approval of the analytical run/batch shall be recorded.
(c) Second opinion. The Laboratory may request a second opinion
from another Laboratory, selected by, and upon approval of, the Agency,
before reporting an Adverse Analytical Finding or Atypical Finding.
Such requests for second opinions may be required by specific Technical
Document(s) or Technical Letter(s), required by the Agency from certain
Laboratories for all or for specific Analytical Testing Procedures
under certain conditions (e.g., following the recent obtaining of HEAL
accreditation or after a period of
[[Page 5185]]
suspension or Analytical Testing Restriction), or requested at the
discretion of the Laboratory (e.g., for firstly detected Analytes or
for difficult to interpret findings). In any case, the request for a
second opinion shall be made in writing, and the second opinion
received shall be recorded as part of the Sample's documentation. Any
transfer of data and information necessary for the second opinion shall
be made securely and respecting the confidentiality of the analytical
data and any other information. The Laboratory that performed the
analysis is responsible for the result and for issuing the final test
report.
(d) Laboratory review of Adverse Analytical Findings and Atypical
Findings. At a minimum, the review of Adverse Analytical Findings and
Atypical Findings shall include:
(1) Documentation linking the Sample (as specified in the Sample
collection documentation) to the Laboratory Internal Chain of Custody
documentation;
(2) Laboratory Internal Chain of Custody documentation;
(3) Initial Testing Procedure(s) and Confirmation Procedure(s)
analytical data and calculations;
(4) Quality control data;
(5) Completeness of technical and analytical documentation
supporting the reported findings;
(6) Compliance of test data with the Analytical Testing Procedure's
validation results (e.g., MU); and
(7) Assessment of the existence of significant data or information
that would cast doubt on or refute the Laboratory findings.
(e) When the Confirmation Procedure result(s) are not determined to
be Adverse Analytical Finding(s) or Atypical Finding(s) based on the
results review, the reason(s) for the rejection shall be recorded in
the laboratory test report.
(f) Traceability of results and documentation. The Laboratory shall
have documented procedures to ensure that it maintains a record related
to each Sample analyzed. In the case of an Adverse Analytical Finding
or Atypical Finding, the record shall include the data necessary to
support the conclusions reported.
(1) Each step of Analytical Testing shall be traceable to the staff
member who performed that step;
(2) Significant deviation from a written SOP shall be recorded;
(3) Where instrumental analyses are conducted, the operating
parameters for each run shall be included as part of the record;
(4) Requests for information by the Agency to a Laboratory shall be
made in writing;
(5) Laboratories are not required to produce a Laboratory
Documentation Package for a Sample in which no Prohibited Substance or
Prohibited Method or their Metabolite(s) or Marker(s) was detected,
unless requested by an adjudication body as part of a Results
Management process or Laboratory disciplinary proceedings.
(g) Confidentiality of the Analytical Data and Covered Person or
Covered Horse's identity.
(1) The Laboratory shall not make any attempt to identify a Covered
Person linked to, or the Covered Horse that has provided, a Sample.
(2) Information sent by a facsimile is acceptable, provided that
the correct facsimile number is verified prior to transmission and the
receipt is verified after the facsimile has been transmitted.
(3) Secure emails or documents shall be used for reporting or
discussion of Adverse Analytical Findings or Atypical Findings if the
Covered Person or Covered Horse can be identified or if any information
regarding the identity of the Covered Person or Covered Horse is
included.
Rule 6316. Reporting Test Results
(a) Reporting times (including confirmatory analysis).
The Laboratory should report all A Sample results to the Agency in
a form designated by the Agency within 10 business days of receipt by
the Laboratory of the Sample. The reporting time may be altered by
agreement between the Laboratory and the Agency. The Agency shall be
promptly informed of any delay in the reporting of A Sample results.
(b) Reporting requirements.
(1) The Laboratory shall record the test result for each individual
Sample to, and in a form designated by, the Agency.
(2) The Laboratory shall report test results to the Agency in a
form designated by the Agency. When reporting test results, the
Laboratory shall include the following, in addition to the mandatory
information required by the Agency, in any relevant Technical
Document(s) or Technical Letter(s), and in the ISO/IEC 17025 standard:
(i) The specific gravity of the Sample, if applicable (Initial
Testing Procedure and A and B Confirmation Procedures);
(ii) Relevant comments, if necessary, for proper interpretation of
the test result or recommendations to the Agency (for example, for
Target Testing of the Covered Horse);
(iii) Specific tests performed, in addition to the Laboratory's
routine Analytical Testing menu (e.g., EPO, bisphosphonates, hGH); and
(iv) Any irregularities noted on Samples.
(c) The Laboratory is not required to provide any additional test
report, either in hard-copy or digital format, other than the
submission of test results to, and in a form designated by, the Agency.
Upon request by the Agency, the Laboratory shall report a summary of
the results of analyses performed in a format specified by the Agency.
In addition, the Laboratory shall provide any information requested by
the Agency in relation to the Monitoring Program (Protocol).
(d) The Laboratory shall qualify the result(s) of the analysis in
the Agency's test report as:
(1) Adverse Analytical Finding;
(2) Atypical Finding;
(3) Negative Finding; or
(4) Not Analyzed.
(e) Any Sample received at the Laboratory and not subject to
Analytical Testing for a valid, documented reason (as instructed or
agreed to by the Agency), such as Sample irregularities or intermediate
Samples of a Sample Collection Session, shall be dealt with in
accordance with ISO/IEC 17025.
(f) Test report for Non-Threshold Substances.
(1) A Sample test report.
(i) The Laboratory is not required to report concentrations for
Non-Threshold Substances. The Laboratory shall report the actual
Prohibited Substance(s) or its Metabolite(s), or Marker(s) of the Use
of Prohibited Substance(s) or Prohibited Method(s) present in the
Sample and in accordance with any reporting requirements established by
the Agency or in any applicable Technical Document.
(ii) However, the Laboratory shall provide estimated concentrations
when possible and for information purposes only, upon request by the
Agency, if the detected level of the Non-Threshold Substance(s), its
Metabolite(s), or Marker(s) may be relevant to the Results Management
of an anti-doping case. In such instances, the Laboratory shall
indicate the estimated concentration while making it clear to the
Agency that the concentration was obtained by an Analytical Testing
Procedure that has not been validated for quantitative purposes.
(2) B Sample test report. For Non-Threshold Substances,
irrespective of whether they have a Minimum Reporting Level, the
Laboratory result for the B Sample shall only establish the presence
(i.e., the identity) of the
[[Page 5186]]
Prohibited Substance(s) or its Metabolite(s) or Marker(s) in accordance
with any reporting requirements established by the Agency or in
relevant Technical Document(s). The Laboratory is not required to
quantify or estimate the concentration of such Prohibited Substance, or
its Metabolite(s) or Marker(s).
(g) Test report for Threshold Substances. For Threshold Substances,
the Laboratory test report for the A Sample shall establish that the
identified Prohibited Substance(s) or its Metabolite(s) or Marker(s) is
present at a concentration, ratio, or score of measured analytical
values greater than the Threshold, or that the Prohibited Substance(s)
or its Metabolite(s) or Marker(s) is of exogenous origin.
Rule 6317. Control of Nonconformities in Analytical Testing
(a) The Laboratory shall have policies and procedures that shall be
implemented when any aspect of its Analytical Testing does not comply
with then-current requirements.
(b) Any nonconformities in Analytical Testing shall be recorded and
kept as part of the documentation of the Sample(s) involved.
(c) When conducting a corrective action investigation, the
Laboratory shall perform and record a thorough Root Cause Analysis of
the nonconformity.
Rule 6318. Complaints
Complaints shall be handled in accordance with ISO/IEC 17025.
Rule 6319. Storage of Samples
(a) Storage of urine Samples. All urine Samples retained for
storage in the Laboratory shall be stored frozen in a secure location
under continuous Chain of Custody. The Laboratory shall keep all Chain
of Custody and other records (either as hard-copy or in digital format)
pertaining to those Samples unless and until notified in writing by the
Agency that such records may be destroyed.
(1) Urine Sample(s) without an Adverse Analytical Finding or
Atypical Finding: The Laboratory shall retain the A and B urine
Sample(s) without an Adverse Analytical Finding or Atypical Finding for
a minimum of 3 months after reporting the final analytical result to
the Agency, and they may be discarded after this time, unless the long-
term storage of the Sample(s) has been requested, in writing or
electronically, by the Agency and unless the Agency requests the
Laboratory retain the Sample for a longer period. The Laboratory may
charge storage costs to the Agency, as applicable, for the storage of
Samples for periods longer than the stated minimum storage times.
However, the Laboratory may store Samples beyond the applicable minimum
storage times at their own discretion and expense. In such cases, the
Laboratory shall inform the Agency in writing. Any Further Analysis on
these Samples will require the approval of the Agency. The maximum
storage period is 10 years after the Sample collection date.
(2) Urine Samples with irregularities: The Laboratory shall retain
the A and B urine Sample(s) with irregularities for a minimum of 3
months after reporting to the Agency, or for a longer period as
determined by the Agency.
(3) Urine Sample(s) with an Adverse Analytical Finding or Atypical
Finding: The Laboratory shall retain the A and B urine Sample(s) with
an Adverse Analytical Finding or Atypical Finding for a minimum of 6
months after reporting the final analytical result for the A or the B
Sample, as applicable to, the Agency and shall not dispose of any such
Samples without approval by the Agency.
(4) Urine Samples under challenge, dispute or investigation: If the
Laboratory has been informed by the Agency (in writing and within the
applicable storage period as defined in this Rule 6319) that the
analysis of a urine Sample is challenged, disputed or under
investigation, the Laboratory shall retain both the A and B Samples
until further notice by the Agency, as applicable.
(b) Storage of blood Samples.
(1) Samples for which Analytical Testing has been performed on
blood serum/plasma fraction only (not on cellular components):
(i) All serum or plasma Samples retained for storage in the
Laboratory shall be stored frozen according to established protocols in
a secure location under continuous Chain of Custody. The Laboratory
shall keep all Chain of Custody and other records (either as hard-copy
or in digital format) pertaining to those Samples.
(ii) Serum/plasma A and B Samples without an Adverse Analytical
Finding or Atypical Finding: The Laboratory shall retain the serum/
plasma A and B Samples without an Adverse Analytical Finding or
Atypical Finding for a minimum of 3 months after reporting the final
analytical result to the Agency, unless long-term storage of the
Sample(s) has been requested by the Agency or the Agency requests the
Laboratory retain the Sample for a longer period.
(iii) Unless otherwise requested by the Agency, serum/plasma
Samples analyzed only for TCO2 and without an Adverse Analytical
Finding or Atypical Finding, shall be retained unless and until the
corresponding Post-Race Sample is analyzed and no Adverse Analytical
Finding or Atypical Finding is reported (i.e., if the Post-Race Sample
is analyzed and an Adverse Analytical Finding or Atypical Finding is
reported, then the Agency may consider or conduct Further Analysis on
the TCO2 Sample).
(iv) Serum/plasma Samples with irregularities: The Laboratory shall
retain the serum/plasma Samples with irregularities for a minimum of 3
months after reporting the final analytical result to the Agency, or
for a longer period if directed by the Agency.
(v) Plasma/serum A and B Sample(s) with an Adverse Analytical
Finding or Atypical Finding: The Laboratory shall retain A and B
plasma/serum Sample(s) with an Adverse Analytical Finding or Atypical
Finding for a minimum of 6 months after reporting the final analytical
result (for the A or the B Sample, as applicable) to the Agency and
shall not dispose of any such Samples without approval by the Agency.
If the B Sample Confirmation Procedure is not performed, the Laboratory
may dispose of both the A and B whole blood Samples 3 months after
reporting the A Sample analytical result. However, if the B Sample
Confirmation Procedure is performed, then the Laboratory shall retain
both the A and B whole blood Sample(s) for a minimum of 3 months after
reporting the B Sample analytical result.
(vi) Plasma/serum A and B Sample(s) under challenge, dispute or
investigation: If the Laboratory has been informed by the Agency (in
writing and within the applicable storage period as defined in this
Rule 6319) that the analysis of a serum/plasma Sample is challenged,
disputed or under investigation, the Laboratory shall retain both the A
and B Samples until further notice by the Agency, as applicable.
(2) Samples for which Analytical Testing has been performed on
cellular fractions of whole blood.
(i) Whole blood A and B Samples without an Adverse Analytical
Finding or Atypical Finding: The Laboratory shall retain the whole
blood Samples without an Adverse Analytical Finding or Atypical Finding
for a minimum of 1 month after reporting the final analytical result to
the Agency, unless long-term storage of the Sample(s) has been
requested by the Agency or the Agency requests the Laboratory retain
the Sample for a longer period.
(ii) Whole blood Samples with irregularities: The Laboratory shall
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retain the whole blood Samples with irregularities for a minimum of 1
month after reporting the final analytical results to the Agency, or
for a longer period as requested by the Agency.
(iii) Whole blood A and B Sample(s) with an Adverse Analytical
Finding or Atypical Finding: The Laboratory shall retain A and B whole
blood Sample(s) with an Adverse Analytical Finding or Atypical Finding
for a minimum of 3 months after reporting the final analytical result
(for the A or the B Sample, as applicable) to the Agency and shall not
dispose of such Samples without approval by the Agency.
(iv) Whole blood A and B Sample(s) under challenge, dispute or
investigation: If the Laboratory has been informed by the Agency (in
writing and within the applicable storage period as defined in this
Rule 6319) that the analysis of a whole blood Sample is challenged,
disputed or under investigation, the Laboratory shall retain both the A
and B Samples until further notice by the Agency, as applicable, and
shall not dispose of such Samples without approval by the Agency.
(c) Storage of hair Samples. All hair Samples retained for storage
in the Laboratory shall be stored for as long as requested by the
Agency in a secure location under continuous chain of custody.
(d) Storage of other Samples. All other Samples shall be stored for
as long as requested by the Agency in optimal conditions based on the
available information applicable to the Sample type, and at the
direction of the Agency. They shall be stored in a secure location
under continuous Chain of Custody.
(e) Long-term storage of Samples.
(1) At the direction of the Agency, any urine, serum/plasma, hair
or other Sample may be stored in long-term storage after the Sample
collection date for the purpose of Further Analysis, subject to the
conditions set out in Rules 6313 and 6319.
(2) Sample(s) may be stored in long-term storage under the custody
of either a Laboratory or another Fit-for-Purpose facility under the
responsibility of the Agency. The Agency shall retain the Sample
collection records pertaining to all stored Samples for the duration of
Sample storage.
(3) Laboratories as Sample custodians:
(i) The Laboratory shall ensure that Samples are stored according
to established protocols in a secure location in the Laboratory's
permanent controlled zone and under continuous Chain of Custody. The
written request from the Agency for long-term storage of Samples shall
be properly documented.
(ii) Samples may also be transported for long-term storage to a
specialized, secure Sample storage facility, which is located outside
the Laboratory's permanent controlled zone and is under the
responsibility of the Laboratory, or may be transported to another
Laboratory. If the external Sample storage facility is not covered by
the Laboratory's ISO/IEC 17025 accreditation, then the subcontracted
external storage facility shall be Fit-for-Purpose and have its own ISO
accreditation or certification (e.g., 17025, 20387, 9001). The transfer
of the Samples to the external long-term storage facility or Laboratory
shall be recorded.
(iii) If Sample(s) are to be transported for storage at a location
outside the secured area of the Laboratory that first analyzed the
Sample(s), the Laboratory shall secure the A Sample(s) to be shipped
either by re-sealing individual A Sample container(s) with a Tamper
Evident sealing system, which has similar capabilities for security and
integrity as the original sealing system, or by sealing the box in
which the Sample(s) are shipped in a manner that maintains Sample
integrity and Chain of Custody. For example, Sample(s) may be resealed
with new resealing systems (e.g., new bottlecaps) produced by the
manufacturer of an appropriate Sample collection equipment that
replicates the security and Tamper Evident functionality of the
original seal. The resealing system of shipped A Sample(s) shall be
Tamper Evident.
(iv) B Sample(s) to be shipped shall be individually sealed, either
in the original, sealed B Sample container(s) or, if previously opened,
by re-sealing the individual B Sample container(s) with a Tamper
Evident sealing system, which has similar capabilities for security and
integrity as the original sealing system.
(v) During transport and long-term storage, Sample(s) shall be
stored at a temperature appropriate to maintain the integrity of the
Sample(s). In any Anti-Doping Rule Violation case, the issue of the
Sample's transportation or storage temperature shall be considered
where failure to maintain an appropriate temperature could have caused
the Adverse Analytical Finding or other result upon which the Anti-
Doping Rule Violation is based.
(vi) The Laboratory shall retain all Laboratory Internal Chain of
Custody and technical records (as per ISO/IEC 17025) pertaining to a
stored Sample for the duration of Sample storage, either as hard-copy
or in digital format. In addition, the Laboratory may retain Sample
analytical data which would allow retrospective analysis of such data,
for example, for the purpose of identifying signals for novel
Metabolite(s) of Prohibited Substance(s) or Marker(s) of Prohibited
Substance(s) or Prohibited Method(s) (e.g., full-scan mass spectrometry
data), as detailed in Rule 6313.
(vii) If Sample(s) are transported to another Laboratory for long-
term storage, the Sample's external Chain of Custody and other non-
analytical records (e.g., Sample collection documentation) available to
the transferring Laboratory shall also be transferred, immediately or
upon later request, to the Laboratory storing the Samples or to the
Agency, either as originals or copies.
(4) The Agency as Sample custodians:
(i) Sample(s) may also be transported for long-term storage to a
Fit-for-Purpose, secure Sample storage facility, which is under the
responsibility of the Agency. In such cases, the external storage
facility shall have its own ISO accreditation or certification (e.g.,
17025, 20387, 9001) and shall maintain security requirements comparable
to those applicable to a Laboratory. The Agency shall ensure that
Samples are stored according to established protocols in a secure
location under continuous Chain of Custody.
(ii) The written request from the Agency for the transfer of the
Sample(s) to long-term storage shall be properly documented. The
transfer of the Samples to the external long-term storage facility
shall also be recorded. The Laboratory shall secure the Sample(s) for
transportation to the long-term storage facility as described above.
(iii) The Laboratory shall retain all Laboratory Internal Chain of
Custody and technical records (as per ISO/IEC 17025) pertaining to all
Samples transferred for long-term storage for the duration of Sample
storage, either as hard-copy or in digital format. In addition, the
Laboratory may retain Sample analytical data which would allow
retrospective analysis of such data. The Laboratory shall transfer the
Sample's external Chain of Custody and other non-analytical records to
the Agency, either as originals or copies, immediately or upon request.
(f) For the purposes of this rule, ``storage'' refers to A and B
Samples stored in Sample collection containers (urine collection
bottles, blood collection tubes) and should not be confused with access
to Aliquots, which should be accessible to analysts for the performance
of Analytical Testing Procedures. However, minimum and maximum
retention times apply to any
[[Page 5188]]
Aliquot(s) of a Sample that remains after completion of the Analytical
Testing.
Rule 6320. Secondary Use or Disposal of Samples and Aliquots
(a) The Laboratory shall maintain SOP(s) pertaining to the
secondary use of Samples or Aliquots for research or quality assurance,
as well as for the disposal of Samples and Aliquots.
(b) If the Laboratory has discretion to dispose of a Sample, the
Laboratory shall do one of the following with the Sample(s) and
Aliquots as soon as practicable:
(1) Disposal of the Sample(s) and Aliquots. Disposal of Samples and
Aliquots shall be recorded under the Laboratory Internal Chain of
Custody.
(2) Secondary use of Samples and Aliquots for research and quality
assurance. Samples and Aliquots shall be anonymized to ensure that any
subsequent results cannot be traced back to a particular Covered Person
or Covered Horse. Only after anonymization, may a Sample or Aliquot be
used for:
(i) Anti-doping research. The Covered Person or their
representative's consent is not required for these purposes.
(ii) Quality assurance, quality improvement of existing Test
Methods, development or evaluation of Analytical Testing Procedures for
Prohibited Substances or Prohibited Methods included in the Prohibited
List at the time of Sample collection, or to establish reference
population ranges or Thresholds or other statistical purposes. The
Covered Person or their representative's consent is not required for
these purposes.
(c) The use of Samples and Aliquots for the purposes of this Rule
6320 is subject to the following conditions:
(1) The Laboratory must respect the Protocol and the Code of Ethics
requirements related to research, types of permitted research, and
respect of ethical standards for research or quality assurance studies
involving equine subjects;
(2) The Laboratory must not make any attempt to re-identify a
Covered Person or Covered Horse from Samples or Aliquots used for the
purposes of this Rule 6320 or data arising from any research or quality
assurance analysis;
(3) The Laboratory must consult the applicable State and Federal
regulations, guidance, or authorities to determine whether a study
shall be considered as falling under Rule 6320(c)(1) or (2) (if the
Laboratory is unsure whether a study can proceed without consent after
consulting the foregoing sources, the Laboratory shall consult with the
Agency to determine whether it can proceed); and
(4) In the event the Laboratory wishes to transfer Sample(s) or
Aliquots to be used for the purposes of this Rule 6320 to another
Laboratory or a third-party research institution or group, or wishes to
partner with another Laboratory or research institution or group for
the purpose of a study pursuant to Rule 6320(c)(1), the Laboratory
shall subject the receiving party to the conditions described in this
Rule 6320 by way of a written agreement and shall prohibit the
receiving party from further transferring any Sample(s) or Aliquots or
related data to another party.
6400. Evaluation of Laboratory EQAS
Rule 6410. Penalties
(a) The Agency shall inform a Laboratory in writing about the
imposition of penalties, corrective action, or other follow-up
measures.
(b) Technical or methodological error. If the Laboratory is able to
remedy the technical or methodological error through the implementation
of satisfactory corrective actions in a timely manner, as determined by
the Agency, the Laboratory will not face any additional penalty.
(c) Clerical/Administrative error. If the Laboratory is able to
remedy the clerical or administrative error through the implementation
of satisfactory corrective actions in a timely manner, as determined by
the Agency, the Laboratory will not face any additional penalty. For
the purposes of Laboratory performance evaluation, clerical/
administrative errors are defined as those incidental, non-systematic
errors of no technical or methodological origin, which have been
committed by the Laboratory during the performance of Analytical
Testing (e.g., a typographical error when manually recording an
analytical result). The Laboratory shall bear no responsibility for
clerical/administrative errors reflected in the Laboratory
documentation made by the Agency.
Rule 6420. Corrective Action Reports
(a) A Corrective Action Report may be requested by the Agency.
Where requested, it shall be submitted within the timeframe specified
by the Agency in written notification about the unsatisfactory result.
Failure to submit a satisfactory Corrective Action Report or the late
submission of the Corrective Action Report without prior approval by
the Agency may result in a penalty.
(b) A Corrective Action Report related, for example, to
nonconformities detected during the Agency Laboratory assessments, or
to procedural or reporting nonconformities with the Laboratory
Standards, Technical Documents or Technical Letters, or unsatisfactory
performance in the analysis of EQAS samples (not related to a false
Adverse Analytical Finding or false Negative Finding), shall be
submitted to the Agency within 30 days of the Agency's notification to
the Laboratory.
(c) Unless otherwise agreed with the Agency, the corrective and
preventive action(s) reported to and approved by the Agency shall be
implemented immediately in the routine operations of the Laboratory.
(d) The Corrective Action Report will be reviewed by the Agency as
soon as practicable. If applicable, it will establish the source of the
incorrect result as either a technical/methodological error or a
clerical/administrative error.
(e) Satisfactory Corrective Action Report. A Corrective Action
Report will be considered as satisfactory when it meets the following
criteria, as determined by the Agency:
(1) Properly and concisely identifies the root cause(s) of the
nonconformity, following an appropriate investigation into all the
factors that may have caused the problem (Root Cause Analysis);
(2) Leads to the documented implementation of effective corrective
action(s) to solve the problem; and
(3) Leads to the documented implementation of appropriate
preventive actions, if applicable, to minimize the risk of recurrence
of the problem.
(f) A satisfactory Corrective Action Report shall include only the
necessary supporting documentation (e.g., raw analytical data, data
review files, evidence of procurement of Reference Materials) which
demonstrates the implemented actions described in the Corrective Action
Report.
(g) Unsatisfactory Corrective Action Report. If the Laboratory's
Corrective Action Report is considered unsatisfactory by the Agency,
the Agency should provide feedback to the Laboratory and provide it
with the opportunity to resubmit a revised Corrective Action Report
within 7 days, or as otherwise agreed by the Agency.
(h) If the Laboratory is unable to submit a satisfactory revised
Corrective Action Report in a timely manner, as determined by the
Agency, the Agency may impose a penalty.
Rule 6430. Laboratory Self-Reporting
The Laboratory must identify and report all errors in Sample
analysis resulting in a false Adverse Analytical
[[Page 5189]]
Finding or a false Negative Finding. Self-reporting will be taken into
consideration by the Agency in determining whether or not to impose a
penalty (or what that penalty will be).
Rule 6440. Evaluation of EQAS Results
(a) Satisfactory EQAS performance in a single EQAS round and over a
consecutive 12-month period is necessary for maintaining HEAL
accreditation. An EQAS round is a distribution of EQAS sample(s) to the
Laboratories and the probationary laboratories for Analytical Testing
(as defined by the Agency). The 12-month period is defined as the most
recent consecutive 12-month interval starting either from the date that
the Laboratory or the probationary laboratory reported the
nonconforming result (EQAS or routine Analytical Testing, as
applicable) to, and in a form designated by, the Agency, or from the
date that the Laboratory or probationary laboratory is informed, in
writing, of nonconformity by the Agency, whichever is more favorable to
the Laboratory or the probationary laboratory.
(b) Unsatisfactory performance in an educational EQAS for a new or
the Agency-specific Analytical Testing Procedure may prevent the
Laboratory from seeking an extension of the Laboratory's scope of ISO/
IEC 17025 accreditation for the Analytical Testing Procedure and from
its application in routine Analytical Testing. In such circumstances,
the Laboratory may only apply the new Agency-approved method or
procedure for routine Sample analysis when it properly corrects the
deficiencies identified in the educational EQAS (as determined by the
Agency) and the method is included in the Laboratory's scope of ISO/IEC
17025 accreditation. Some Analytical Testing Procedures are not
eligible for a flexible scope of ISO/IEC 17025 accreditation and
require specific Agency approval before the Laboratory can apply the
procedure to the analysis of Samples. Agency approval will be based on
its assessment of the Fitness-for-Purpose of the Analytical Testing
Procedure, method validation by the Laboratory, and the successful
Laboratory participation in an inter-laboratory collaborative study or
the Agency EQAS round. The Agency will communicate which Analytical
Testing Procedures fall into this category to the Laboratories and to
the Accreditation Bodies.
Rule 6441. EQAS Samples Containing Non-Threshold Substances
(a) When a qualitative determination of a Non-Threshold Substance
has been reported, the Laboratory result will be evaluated on the basis
of the correct reporting of the finding (e.g., Adverse Analytical
Finding, Negative Finding) as intended in the preparation of the EQAS
sample.
(b) The results for any Non-Threshold Substance or its
Metabolite(s) or Marker(s) at concentrations greater than (>) the MRPL
(or exceeding 120% of the Minimum Reporting Level, when applicable)
shall be evaluated.
(c) The results for any Non-Threshold Substance or its
Metabolite(s) or Marker(s) at concentrations between 50% of the MRPL
and the MRPL (or less than 120% of the Minimum Reporting Level, when
applicable) may require an internal investigation and Corrective Action
Report from the Laboratory.
(d) If the results for any Non-Threshold Substance or its
Metabolite(s) or Marker(s) are at concentrations below (<) 50% of the
applicable MRPL in an EQAS sample, the Laboratory shall report its
finding(s) if the analyses are compliant with its validation data,
SOPs, the Laboratory Standards, and any applicable Technical Document.
Laboratories unable to report such substance(s) are encouraged, on
receipt of the EQAS report, to consider re-assessment of their
Analytical Testing Procedure.
Rule 6442. EQAS Samples Containing Threshold Substances
(a) For EQAS samples containing Threshold Substances at levels
greater than (>) 50% of the Threshold, the quantitative determination
will be statistically evaluated (e.g., z-score, degree of equivalence
analysis) to determine the compatibility of the reported result with
the assigned value (reference, nominal or consensus value, as
applicable).
(b) A Laboratory is to achieve a satisfactory statistical
evaluation of quantitative results reported based on the mean of 2
replicate determinations. The overall evaluation of the quantitative
performance is based on the criteria indicated in any relevant
Technical Document or Technical Letter, or the Laboratory Guidelines.
(c) The main criterion applied for the evaluation of EQAS results
for the quantification of Threshold Substances is the compatibility of
the reported Laboratory result with the assigned value. Therefore, the
incorrect reporting of an EQAS sample as a Negative Finding or as an
Adverse Analytical Finding, as applicable, when the assigned value of
the Threshold Substance in the EQAS sample is close to the Threshold,
is not considered as a false Negative Finding or false Adverse
Analytical Finding, respectively, if the absolute z-score (truncated to
one decimal place) for the Laboratory's quantitative result is <3.0.
(d) Unsatisfactory quantitative result for Threshold Substances
(absolute z-score >= 3.0). The Laboratory shall provide the Agency with
a Corrective Action Report for an unsatisfactory quantitative result.
The z-score is calculated according to the formula [z = (y-[ycirc])/
[delta]], where y is the mean value of the Laboratory's replicate
determinations; [ycirc] is the assigned value (reference, nominal or
consensus value, as applicable); [delta] is the target standard
deviation (e.g., uc_Max or robust Reproducibility sR of results from
all participant Laboratories). The z-score is truncated to one decimal
place.
(e) Questionable quantitative result (absolute z-score > 2.0 and <
3.0). The Laboratory shall perform an internal investigation to
determine the root cause(s) of the questionable result and implement
appropriate corrective measures to resolve them.
(f) EQAS evaluation of Laboratory performance. Where an EQAS result
is reported incorrectly, the Laboratory shall provide the Agency with a
Corrective Action Report.
(g) Double-blind, blind EQAS and educational EQAS samples. Failure
to report accurately, in accordance with criteria, 3 blind or double-
blind EQAS, or educational EQAS results within a continuous twelve 12-
month period may result in penalties imposed by the Agency, including,
but not limited to, potential suspension or revocation of HEAL
accreditation, or Analytical Testing Restrictions.
Rule 6443. False Adverse Analytical Finding or False Negative Finding
(a) If the Laboratory discovers that it reported a false Adverse
Analytical Finding or false Negative Finding, the Laboratory shall
inform the Agency immediately.
(b) When the false Adverse Analytical Finding or false Negative
Finding is identified by the Agency, through the Agency's own Results
Management activities or through any other means, the Agency shall
inform the Laboratory as soon as practicable.
(c) The Agency, considering the nature of the error that caused the
false Adverse Analytical Finding or false Negative Finding, may impose
a penalty, including, but not limited to, potential suspension or
revocation of HEAL accreditation, or Analytical Testing Restrictions
against the Laboratory for a particular Analytical Testing Procedure or
for the analysis of a particular class of Prohibited Substances or
Prohibited Methods, as
[[Page 5190]]
applicable, or other follow-up measures. For example, the Laboratory
may be required by the Agency to analyze EQAS samples or to review the
relevant analytical results and to re-analyze any relevant and
available Samples previously reported as Adverse Analytical Findings
during the preceding 12 months (or during a period otherwise determined
by the Agency) within 7 days (unless informed otherwise by the Agency).
Depending on the nature of the error that caused the false Adverse
Analytical Finding or false Negative Finding, this re-analysis may be
limited to one Analyte, a class of Prohibited Substances or Prohibited
Methods, or may include any Prohibited Substance or Prohibited Method.
A statement signed by the Laboratory Director shall record this re-
analysis. The retrospective review of the analytical results and re-
analysis of previous relevant Samples reported as Adverse Analytical
Finding(s) shall be performed with the objective of determining whether
any other related (i.e., produced by the same root cause(s)) false
Adverse Analytical Finding(s) have been reported by the Laboratory. The
discovery of additional false Adverse Analytical Finding(s) shall lead
to the implementation of corrective measures and shall be communicated
to the Agency.
(1) During the period of suspension, the Laboratory shall follow
the instructions provided in Rule 6561 in regard to Samples in the
Laboratory's possession at the time of suspension. Alternatively, if an
Analytical Testing Restriction has been imposed, the Laboratory shall
subcontract the affected analyses as provided in Rules 6560 and 6302.
(2) During the suspension or Analytical Testing Restriction period,
the Agency will conduct an assessment (preferably on-site) of the
Laboratory, including the analysis of further EQAS samples.
(3) The suspension or Analytical Testing Restriction of the
Laboratory shall be lifted only when the aforementioned conditions are
satisfactorily completed, and the Laboratory provides sufficient
evidence, as determined by the Agency and in the Agency's sole
discretion, that appropriate steps have been taken to remedy the
issue(s) that resulted in the suspension or Analytical Testing
Restriction.
Rule 6450. Further Procedural Evaluations
If the Agency considers that a Corrective Action Report is
unsatisfactory, and the Laboratory is not able to provide a
satisfactory revised Corrective Action Report within a reasonable time
frame after receiving feedback from the Agency, the Laboratory may
receive a penalty, at the Agency's discretion. Rule 6450 does not apply
to the evaluation of Corrective Action Reports for false Adverse
Analytical Findings or false Negative Findings, which are covered in
Rule 6443.
Rule 6460. Overall Laboratory Evaluation
(a) The Agency shall evaluate Laboratory EQAS performance for each
EQAS round, as well as Laboratory performance for routine Analytical
Testing, and assign penalties, including corrective actions or other
follow-up measures, in the Agency's sole discretion.
(b) If a Laboratory under suspension as a result of EQAS
performance is not capable of correcting the issue(s) before the end of
the suspension period, then the Agency may extend the Laboratory's
suspension for up to an additional 6 months or until such a time when
the Laboratory can satisfactorily correct all the issues identified (at
the Agency's discretion). If the Laboratory under suspension fails to
satisfy performance criteria during an extended period of suspension
(beyond the initial 6 months), then the Agency may Revoke the
Laboratory's accreditation.
(c) Laboratories under an Analytical Testing Restriction remain
operational (except for any activities under the Analytical Testing
Restriction) and, therefore, are evaluated during the Analytical
Testing Restriction as any other, fully operational Laboratory.
Rule 6470. Probationary Period and Probationary Laboratory Evaluation
(a) The probationary EQAS is a part of the initial evaluation of a
probationary laboratory seeking HEAL accreditation. Successful
participation in the Agency probationary EQAS is required before a
probationary laboratory is eligible to be considered for full HEAL
accreditation. The Agency may decide, based on its evaluation of the
overall performance of the probationary laboratory, to extend the
probationary period of accreditation.
(b) The Agency will evaluate probationary laboratory EQAS
performance.
(c) Serious and repeated issues in the probationary EQAS shall
result in the removal of the laboratory's status as a probationary
laboratory by the Agency.
(d) Any false Adverse Analytical Finding or false Negative Finding
of a technical or methodological nature reported automatically suspends
a probationary laboratory from further consideration for HEAL
accreditation.
(e) A suspended probationary laboratory wishing to re-enter the
probationary EQAS is required to provide documentation of corrective
and preventive action(s) no later than 30 days prior to the end of the
suspension period (unless otherwise indicated by the Agency). Failure
to do so will preclude the laboratory from participating in the
probationary EQAS.
(f) Lifting of the suspension occurs only when proper corrective
and preventive actions have been implemented and reported to the
Agency. The Agency may choose, at its sole discretion, to submit
additional EQAS samples to the laboratory or to require that the
laboratory be reassessed, at the expense of the laboratory.
Laboratories re-entering the probationary EQAS shall be considered
candidate laboratories and are required to provide the applicable
accreditation fee and documentation to the Agency.
Rule 6480. Removal of Samples by the Agency for Analysis or Further
Analysis
(a) Within the context of an investigation or Laboratory
performance monitoring activity (for example, during an on-site Agency
Laboratory assessment), the Agency, initially at its expense, may
remove Sample(s) from a Laboratory to conduct Further Analysis, or
analysis of the Sample if the analytical results for that Sample have
not yet been reported, for any purpose described in the Protocol. The
Agency shall retain the right to request analysis or Further Analysis,
at its expense, as permitted by the Protocol.
(b) The Agency may delegate an observer to monitor the removal of
the Samples, which shall be implemented in accordance with the Agency's
instructions. During the removal of Samples, the Agency shall be
responsible for maintaining proper Sample Chain of Custody
documentation and the safety and integrity of the Samples until receipt
by the other Laboratory(-ies).
(c) The Agency may also require that the Laboratory transfer the
Samples to other Laboratories selected by the Agency. In such
situations, the Laboratory shall be responsible for maintaining proper
Chain of Custody documentation for all transferred Samples and the
safety and integrity of the Samples until receipt by the receiving
Laboratory(-ies).
(d) Where for any reason (except where Rule 6312 applies), a
Laboratory transfers a Sample to another Laboratory, the first
Laboratory shall
[[Page 5191]]
send the Sample within 5 business days following receipt by the first
Laboratory of the request to transfer the Sample.
(e) In connection with its monitoring of Laboratory performance,
the Agency may direct Further Analysis of a Sample which has resulted
in an Anti-Doping Rule Violation without consent of the Covered Person
or approval from an adjudication body, as provided in the Protocol.
Rule 6490. Removal of Samples by the Agency for Laboratory Quality
Assessment
The Agency may also direct the re-analysis of anonymized Samples,
which have met the conditions described in Rule 6320, for purposes of
Laboratory quality assurance and education, including the
implementation of a system of transfer of Samples reported as Negative
Findings between Laboratories. In this regard, the number of Samples
directed by the Agency for re-analysis may vary.
6500. Withdrawal of HEAL Accreditation
Rule 6510. Withdrawal of HEAL Accreditation
(a) A Laboratory's HEAL accreditation may be suspended, Revoked, or
subject to an Analytical Testing Restriction, whenever the Laboratory
fails to comply with the Laboratory Standards, Technical Documents, or
Technical Letters, or where the suspension, Revocation or Analytical
Testing Restriction is otherwise required to protect the integrity of
the Samples, the Analytical Testing process or the interests of the
anti-doping community.
(b) The imposition of an Analytical Testing Restriction or the
suspension of a Laboratory's HEAL accreditation shall not imply the
automatic withdrawal of its ISO/IEC 17025 accreditation. The status of
the Laboratory's ISO/IEC 17025 accreditation is to be independently
assessed by the relevant accreditation body.
(c) The Agency may suspend a Laboratory's HEAL accreditation or
impose an Analytical Testing Restriction against a Laboratory if the
Agency identifies noncompliance with the Laboratory Standards,
Technical Documents, or Technical Letters based on the Laboratory's
performance during the EQAS or during routine Analytical Testing.
(d) The Laboratory may not challenge the penalty imposed by the
Agency.
Rule 6520. Noncompliance With the Laboratory Standards
(a) Noncompliance with the Laboratory Standards that may lead to an
Analytical Testing Restriction, suspension or Revocation of HEAL
accreditation, or other follow-up measures include, but are not limited
to:
(1) Suspension or withdrawal of ISO/IEC 17025 accreditation;
(2) Failure to establish or maintain administrative and operational
independence as described in paragraph (b)(7) of Rule 6110;
(3) Failure to analyze the minimum number of Samples indicated in
paragraph (i) of Rule 6130 (except where the Agency fails to send the
minimum annual number of Samples to the Laboratory);
(4) Reporting of false Adverse Analytical Findings or false
Negative Findings;
(5) Failure to implement a Technical Document or Technical Letter
by the effective date without prior approval of the Agency;
(6) Failure to comply with any of the requirements or standards
listed in the Laboratory Standards, Technical Documents or Technical
Letters;
(7) Noncompliance with results reporting timelines in Rule 6316;
(8) Failure to take appropriate corrective action after an
unsatisfactory performance during routine Analytical Testing or in a
blind EQAS or double-blind EQAS round;
(9) Failure to take appropriate corrective action for Laboratory
Standards, Technical Document(s), or Technical Letter(s)
noncompliance(s) identified from the Agency Laboratory assessment(s);
(10) Analysis of Samples from the Agency in violation of a
suspension or Analytical Testing Restriction decision;
(11) Failure to cooperate with the Agency in providing
documentation or other requested information;
(12) Noncompliance with the Code of Ethics; or
(13) Any other cause that materially affects the ability of the
Laboratory to ensure the full reliability and accuracy of Analytical
Testing and the accurate reporting of test results.
(b) Laboratory staff or management issues which may lead to an
Analytical Testing Restriction, suspension or Revocation of HEAL
accreditation, or other follow-up measures include, but are not limited
to:
(1) Major changes in senior Laboratory management positions (e.g.,
Laboratory Director, Quality Manager) without proper and timely
notification (usually within 30 days) to the Agency;
(2) Failure to appoint a permanent Laboratory Director or other
senior management positions (e.g., Quality Manager) within a reasonable
time period;
(3) Failure to guarantee the competence or proper training of
scientific staff including, for example, the qualification of analysts
as Certifying Scientists and Laboratory Supervisory Personnel;
(4) Significant loss or lack of experienced staff (e.g., Certifying
Scientists) that affects, as determined by the Agency, the Laboratory's
ability to ensure the full reliability and accuracy of Analytical
Testing and reporting of test results;
(5) Conviction of any key personnel for any criminal offence that
is determined by the Agency to impact the operations of the Laboratory;
(6) Loss of sufficient Laboratory support and resources that
affects, as determined by the Agency, the quality or viability of the
Laboratory; or
(7) Failure to cooperate in any Agency inquiry in relation to the
activities of the Laboratory.
Rule 6530. Notification of Penalty Decision
The Agency shall provide the Laboratory with written notice of its
decision regarding penalties. This notice shall state the following:
(a) That the Laboratory's HEAL accreditation has been maintained
(including warnings, if applicable); or
(b) That the Laboratory's HEAL accreditation has been suspended or
Revoked or that an Analytical Testing Restriction has been imposed
against the Laboratory. Such notice shall include:
(1) the reason(s) for suspension, Revocation, or the imposition of
an Analytical Testing Restriction;
(2) the terms of the suspension, Revocation, or Analytical Testing
Restriction;
(3) the period of suspension or Analytical Testing Restriction, if
applicable; and
(4) Any corrective actions or other follow-up requirements imposed
upon the Laboratory by the Agency.
Rule 6540. Effective Date and Appeals
(a) A Revocation, suspension, or Analytical Testing Restriction is
effective immediately upon receipt of notification of the Agency's
decision.
(b) The Agency's decision is not subject to appeal.
Rule 6550. Public Notice
(a) The Agency shall publicly announce a change in a Laboratory's
accreditation status (including, if appropriate, any Analytical Testing
Restriction) on its website as soon as practicable after the Laboratory
is notified by the Agency of its decision.
[[Page 5192]]
(b) The Agency's website shall be updated regarding a Laboratory's
accreditation status when:
(1) the Laboratory's HEAL accreditation is reinstated following a
suspension;
(2) an Analytical Testing Restriction is removed (if appropriate);
or
(3) a Laboratory whose accreditation has previously been Revoked is
re-accredited.
Rule 6560. Consequences of an Analytical Testing Restriction
(a) If the Agency determines that the noncompliance(s) are limited
to a class of Prohibited Substances or Prohibited Methods or to a
specific Analytical Testing Procedure, which are not included in the
standard Analytical Testing menu requested by the Agency for Samples
received by the Laboratory, the Agency may impose an Analytical Testing
Restriction for that class of Prohibited Substance(s) or Prohibited
Method(s) or for the specific Analytical Testing Procedure in which the
noncompliance(s) occurred.
(b) If the reason for the Analytical Testing Restriction was
related to the reporting of false Adverse Analytical Finding(s), all
analyses employing the affected Analytical Testing Procedure(s) shall
cease immediately.
(c) The Laboratory under an Analytical Testing Restriction shall
contact the Agency to arrange for the transfer of the relevant Samples
to subcontracted Laboratory(-ies), selected by the Agency, within 30
days of being notified of the Analytical Testing Restriction decision.
All associated costs shall be borne by the Laboratory under Analytical
Testing Restriction. The Laboratory shall transfer the following
Samples (A and B Samples) in the Laboratory's custody, which involve
the analysis of the same class of Prohibited Substances or Prohibited
Methods, or the application of the affected Analytical Testing
Procedure(s) subjected to the Analytical Testing Restriction, to
another Laboratory(-ies) for the performance of the A and, if needed,
the B Confirmation Procedures, unless otherwise instructed by the
Agency:
(1) Samples which had been previously reported as an Adverse
Analytical Finding (as requested by the Agency);
(2) Samples which had been opened and were undergoing analysis for
the Initial Testing Procedure(s) at the time of the Analytical Testing
Restriction decision;
(3) Samples for which, at the time of the Analytical Testing
Restriction decision, Initial Testing Procedure(s) had been completed
and had produced Presumptive Adverse Analytical Findings requiring
Confirmation Procedures, and Samples that are the subject of other
Confirmation Procedures;
(4) Samples for which the A or B Confirmation Procedures had been
completed, but results of the analysis had not been reported by the
Analytical Testing Restriction date, and Samples which were undergoing
A or B Confirmation Procedures at the time of the imposition of the
Analytical Testing Restriction;
(5) Samples which had been reported as Adverse Analytical Findings
based on the A Confirmation Procedure prior to the imposition of the
Analytical Testing Restriction. These Samples shall be kept in the
Laboratory under proper Laboratory Internal Chain of Custody and
appropriate storage conditions. Should a B Confirmation Procedure be
requested during the period of the Analytical Testing Restriction, both
A and B Samples shall be transferred to another Laboratory(-ies)
selected by the Agency for the A Confirmation Procedure to be performed
again and for the performance of the B Confirmation Procedure, if
applicable; and
(6) If the Analytical Testing Restriction was caused by the
reporting of false Negative Finding(s), and further investigation
reveals that other Negative Finding(s) had been reported for Samples
that are still stored in the Laboratory, the Laboratory shall inform
the Agency. In such cases, both the A and B containers of the relevant
Samples shall be transferred to another Laboratory(-ies) selected by
the Agency for Further Analysis, as determined by the Agency. These re-
analyses may be applied to the class of Prohibited Substances or
Prohibited Methods or to the Analytical Testing Procedure(s) that were
associated with the Negative Finding(s), as determined by the Agency.
Rule 6561. Consequences of Suspension
(a) A Laboratory whose HEAL accreditation has been suspended is
ineligible to perform Analytical Testing of Samples.
(b) Suspension for violation of the Code of Ethics. If the reason
for the suspension was related to a violation of the Code of Ethics,
all Analytical Testing in the suspended Laboratory shall cease
immediately and the Laboratory shall transfer all Samples (both the A
and B Samples) in the Laboratory's custody to other Laboratory(-ies)
selected by the Agency.
(c) Suspension for reporting of false Adverse Analytical
Finding(s). If the reason for the suspension was related to the
reporting of false Adverse Analytical Finding(s), all Analytical
Testing shall cease immediately. In addition, the Laboratory shall
transfer the following Samples (A and B Samples) in the Laboratory's
custody to another Laboratory(-ies) selected by the Agency for the
performance of the A and, if needed, the B Confirmation Procedures,
unless otherwise instructed by the Agency:
(1) Samples which had been previously reported as an Adverse
Analytical Finding for the same class of Prohibited Substances or
Prohibited Methods when applying the same Confirmation Procedure (as
requested by the Agency);
(2) Samples for which, at the time of the suspension decision,
Initial Testing Procedure(s) had been completed and had produced
Presumptive Adverse Analytical Findings requiring Confirmation
Procedures, and Samples that are the subject of other Confirmation
Procedures;
(3) Samples which had been opened and were undergoing analysis for
the Initial Testing Procedure(s) at the time of the suspension;
(4) Samples which had been received at the Laboratory but had not
been opened at the time of the suspension. (These Samples shall be kept
sealed in the Laboratory under proper Laboratory Internal Chain of
Custody and appropriate storage conditions until transfer to another
Laboratory(-ies) selected by the Agency);
(5) Samples for which A or B Confirmation Procedures had been
completed, but results of the analysis had not been reported by the
suspension date, and Samples which were undergoing A or B Confirmation
Procedures at the time of the suspension; and
(6) Samples which had been reported as Adverse Analytical Findings
based on the A Confirmation Procedure prior to the suspension.
(d) Suspension for other reasons. A Laboratory that has had its
HEAL accreditation suspended for reasons other than a violation of the
Code of Ethics or the reporting of false Adverse Analytical Findings(s)
shall take the following steps with respect to the Samples in the
Laboratory's custody, unless otherwise instructed by the Agency:
(1) Samples which had been analyzed and reported as a Negative
Finding, and which have either been stored in the Laboratory for a
period of less than 3 months or have been placed in long-term storage
upon request by the Agency shall be kept in the Laboratory
[[Page 5193]]
under proper Laboratory Chain of Custody and appropriate storage
conditions. The Laboratory shall inform the Agency of such actions,
including the provision of the Sample codes.
(2) If the suspension was caused by the reporting of false Negative
Finding(s), and further investigation reveals that other Negative
Finding(s) had been reported by the Laboratory, the Laboratory shall
inform the Agency. In such cases, both the A and B containers of the
relevant Samples shall be transferred to another Laboratory(-ies)
selected by the Agency for Further Analysis, as determined by the
Agency. These analyses may be applied for all the Prohibited Substances
and Prohibited Methods included in the Analytical Testing menu
requested by the Agency or be limited to the class of Prohibited
Substances or Prohibited Methods or to the Analytical Testing
Procedure(s) that were associated with the Negative Finding(s), as
determined by the Agency.
(3) Samples for which Initial Testing Procedures had been
completed, but results had not been reported at the time of the
suspension:
(i) If the Initial Testing Procedure(s) produced Presumptive
Adverse Analytical Finding(s) or other Confirmation Procedures were
required, both the A and B Samples shall be transferred to another
Laboratory(-ies) selected by the Agency for the performance of the A
and, if needed, the B Confirmation Procedures.
(ii) In addition, if the suspension was caused by the reporting of
false Negative Finding(s) and the Initial Testing Procedure(s) had
produced negative results, both the A and B Samples shall also be
transferred to another Laboratory(-ies) selected by the Agency for the
repetition of the Initial Testing Procedure(s) and, if needed, the
performance of Confirmation Procedures. These analyses may be applied
for all the Prohibited Substances and Prohibited Methods included in
the Analytical Testing menu requested by the Agency or be limited to
the class of Prohibited Substances or Prohibited Methods or to the
Analytical Testing Procedure(s) that were associated with the Negative
Finding, as determined by the Agency.
(iii) If the reason for the suspension was not related to the
reporting of false Negative Findings and the Initial Testing Procedures
had produced negative results, the Sample(s) shall be reported to the
Agency as Negative Finding(s). These Samples shall be kept in the
Laboratory under proper Laboratory Internal Chain of Custody and
appropriate storage conditions until further notice by the Agency. The
Laboratory shall inform the Agency of such actions including the
provision of the Sample codes.
(4) Samples which had been opened and were undergoing analysis for
the Initial Testing Procedure(s) at the time of the suspension:
(i) If the reason for suspension was not related to the reporting
of false Negative Finding(s), the Laboratory shall continue to analyze
the relevant Samples until all Initial Testing Procedures are
completed. If the Initial Testing Procedures produce Negative Findings,
the Laboratory shall report these findings to, and in a form designated
by, the Agency, and these Samples shall be kept in the Laboratory under
proper Laboratory Chain of Custody and appropriate storage conditions
until further notice by the Agency. The Laboratory shall inform the
Agency of such actions, including the provision of the Sample codes.
(ii) However, if the Initial Testing Procedure produced a
Presumptive Adverse Analytical Finding, both the A and B Samples shall
be transferred to another Laboratory(-ies) selected by the Agency for
the performance of the A and, if needed, the B Confirmation Procedures.
(iii) If the suspension was caused by the reporting of false
Negative Finding(s), then the Laboratory shall cease all Analytical
Testing and have the A and B Samples transferred to another
Laboratory(-ies) selected by the Agency for the performance of the A
and, if needed, the B Confirmation Procedures.
(5) Samples which had been received at the Laboratory but had not
been opened yet at the time of the suspension: these Samples shall be
kept sealed in the Laboratory under proper Laboratory Chain of Custody
and appropriate storage conditions until transfer to another
Laboratory(-ies) selected by the Agency for Analytical Testing.
(6) Samples for which A or B Confirmation Procedures had been
completed, but results of analysis had not been reported by the
suspension date, and Samples which were undergoing A or B Confirmation
Procedures at the time of the suspension: both the A and B Samples
shall be transferred to another Laboratory(-ies) selected by the Agency
for the repetition of the A and, if applicable, the B Confirmation
Procedures.
(7) Samples which had been reported as an Adverse Analytical
Finding based on the A Confirmation Procedure prior to the suspension:
(i) These Samples shall be kept in the Laboratory under proper
Laboratory Internal Chain of Custody and appropriate storage
conditions. Should a B Confirmation Procedure be requested during the
suspension, both A and B Samples shall be transferred to another
Laboratory(-ies) selected by the Agency for the A Confirmation
Procedure to be performed again and for the performance of the B
Confirmation Procedure, if applicable.
(ii) During a suspension or Analytical Testing Restriction period,
the Laboratory shall continue to participate in the Agency EQAS
program. The Agency may require the Laboratory to analyze additional
blind EQAS samples or perform a Laboratory assessment, at any time and
at the expense of the Laboratory, in order to evaluate the Laboratory's
status.
Rule 6562. Revocation
(a) A laboratory whose HEAL accreditation has been revoked is
ineligible to perform Analytical Testing of Samples. The Laboratory
Internal Chain of Custody maintained by a revoked laboratory for stored
Samples is valid until such time that arrangements can be made, in
consultation with the Agency, for the transfer of relevant Samples to a
Laboratory(-ies) selected by the Agency.
(b) A laboratory whose HEAL accreditation has been revoked shall
arrange the transfer of Samples in the laboratory's custody to a
Laboratory(-ies) selected by the Agency, respectively, within 30 days
of being notified of the decision revoking its HEAL accreditation. In
such circumstances, the Samples to be transferred shall be selected by
the Agency. The laboratory transferring the Samples shall inform the
Agency and provide the relevant Sample codes and the selected
Laboratory(-ies). In addition, the revoked laboratory shall assist with
the transfer of the relevant Sample data and records to the
Laboratory(-ies) that have been selected to receive the Samples.
(c) The revoked laboratory shall transfer all Samples in its
custody for which the Analytical Testing process has not been completed
at the time of the Revocation. The Agency may also choose to transfer
additional Samples retained in the laboratory in accordance with
paragraphs (a) through (d) of Rule 6319, or other Samples for which it
is the owner pursuant to the Testing and Investigations Standards and
that had been analyzed and were in long-term storage at the time of the
Revocation of the laboratory's HEAL accreditation. In addition, the
Agency may identify and
[[Page 5194]]
request that Samples be transferred to another Laboratory(-ies)
selected by the Agency.
Rule 6563. Reinstatement of Suspended Accreditation or Lifting of
Analytical Testing Restriction
The Agency shall lift the suspension of the Laboratory's HEAL
accreditation or lift the Analytical Testing Restriction only when the
Laboratory provides satisfactory evidence, as determined by the Agency
in its sole discretion, that appropriate steps have been taken to
remedy the noncompliance(s) that resulted in the suspension of the
Laboratory's HEAL accreditation or the imposition of the Analytical
Testing Restriction, and that proper measures have been implemented to
satisfactorily address the condition(s) specified, if any, for
reinstatement of HEAL accreditation.
Rule 6564. Extension of Suspension or Analytical Testing Restriction
(a) If a Laboratory whose HEAL accreditation has been suspended or
which has been the subject of an Analytical Testing Restriction has not
satisfactorily corrected the Laboratory Standards, Technical
Document(s), or Technical Letter(s) noncompliance(s) that resulted in
the suspension or Analytical Testing Restriction, or if the Agency
identifies any additional Laboratory Standards, Technical Document(s)
or Technical Letter(s) noncompliance(s) during an Agency Laboratory
assessment conducted during the initial suspension or Analytical
Testing Restriction period, either the suspension of the Laboratory's
HEAL accreditation or the Analytical Testing Restriction may be further
extended, or the Laboratory's accreditation shall be revoked, as
determined by the Agency. The suspension or Analytical Testing
Restriction period may be extended up to an additional 6 months, if the
Laboratory provides valid explanation(s) for the delay, as determined
by the Agency, in addressing the conditions to lift the suspension or
Analytical Testing Restriction (including the submission of
satisfactory corrective actions).
(b) If applicable, a delay in the delivery of the ISO/IEC 17025
accreditation to the Laboratory by the relevant accreditation body may
also constitute grounds to extend the suspension of the Laboratory's
HEAL accreditation.
(c) The decision to extend the suspension of a Laboratory's HEAL
accreditation or the period of the Analytical Testing Restriction shall
be made in the Agency's sole discretion.
(d) If, in accordance with the terms of the extension of the
suspension of the Laboratory's HEAL accreditation or the terms of the
extension of the Analytical Testing Restriction, the Laboratory
provides evidence determined to be satisfactory by the Agency that all
of the identified Laboratory Standards, Technical Document(s), or
Technical Letter(s) noncompliance(s) have been corrected, the
Laboratory's accreditation may be re-instated or the Analytical Testing
Restriction may be lifted by decision of the Agency in its sole
discretion.
(e) If the Laboratory has not provided evidence determined to be
satisfactory by the Agency at the end of the extended suspension or
extended Analytical Testing Restriction period, the Agency may Revoke
the Laboratory's accreditation.
(f) The Agency will notify the Laboratory of its decision to revoke
the Laboratory's HEAL accreditation in accordance with Rule 6530.
Rule 6565. Revoked Accreditation
(a) If a laboratory whose HEAL accreditation has been revoked
wishes to seek a new HEAL accreditation, it must apply for HEAL
accreditation as a new laboratory in accordance with Rule 6110.
(b) When seeking a new HEAL accreditation, the laboratory may
request that the Agency expedite the laboratory re-accreditation
procedure, which may be approved by the Agency. To do so the laboratory
shall provide the Agency, as part of its application for a new
accreditation, information that it considers constitutes ``exceptional
circumstances'' as justification for modifying the requirements of Rule
6110 to expedite the entry of the laboratory into, or shortening the
duration of, the probationary phase of accreditation. At its sole
discretion, the Agency may determine whether such modifications are
justified, and which steps must be followed prior to granting approval
to the laboratory to enter the probationary phase of accreditation.
Rule 6570. Voluntary Cessation of Laboratory Operations
(a) A Laboratory may decide to voluntarily cease its anti-doping
Analytical Testing operations on either a temporary or permanent basis,
despite not having been found to have committed any analytical failures
or other Laboratory Standards noncompliance(s) and not having been
subject to an Analytical Testing Restriction or suspension or
Revocation of its HEAL accreditation.
(b) In such circumstances, the Laboratory shall inform the Agency
and provide, in writing, the reason(s) for the cessation of anti-doping
Analytical Testing operations as soon as the decision is made to cease
its operations and, in any event, no later than 3 months prior to the
date on which its decision shall take effect. The Laboratory shall also
take all necessary measures to notify all its clients of the decision
to cease its operations and to arrange, in consultation with its
clients, to transfer Samples to another Laboratory(-ies) selected by
the Agency, in accordance with Rule 6561 (temporary closure) or Rule
6562 (permanent closure).
(c) If a Laboratory voluntarily ceases its anti-doping Analytical
Testing operations on a temporary basis, the Laboratory shall maintain
satisfactory performance in the analysis of EQAS samples during the
period of inactivity. The period of temporary cessation of Analytical
Testing activities shall not exceed 6 months, with one possible
extension of up to 6 months (as determined by the Agency). If the
Laboratory is unable to resume its Analytical Testing operations within
a 12-month period, the Agency shall revoke the Laboratory's
accreditation, unless otherwise approved by the Agency.
(d) If a Laboratory decides to cease its operations on a permanent
basis, the Laboratory shall assist the Agency with the transfer of
relevant Sample data and records to the Laboratory(-ies) that have been
selected by the Agency to receive the Samples.
6600. Code of Ethics for Laboratories and Research and Development
Activity Requirements
Rule 6610. Code of Ethics for Laboratories
(a) Compliance. Directors of Laboratories, their delegates and all
Laboratory staff shall respect and comply with the Laboratory Standards
and the Protocol. Laboratories and all of their staff shall maintain
the confidentiality of all of data, items and information received in
connection with Doping Control and Medication Control, including, but
not limited to, Samples, Testing documentation, and communications with
the Agency.
(b) Research in support of Doping Control.
(1) Laboratories shall participate in research programs, provided
that the Laboratory Director is satisfied with their bona fide nature
and the program(s) have received proper ethical approval, if
applicable. The Laboratory
[[Page 5195]]
shall not engage in any research activity that undermines or is
detrimental to the purposes of the Act.
(2) Laboratories are expected to develop a research and development
program to support and expand the scientific foundation of Doping
Control. This research may consist of the development of new methods or
technologies, the pharmacological characterization of a new doping
agent, the characterization of a masking agent or method, and other
topics relevant to the field of Doping Control.
(3) Laboratories are expected to conduct research on Equine (and
other animal species) subjects.
(4) Laboratories shall follow institutional animal care and use
guidelines and requirements regarding the use of animal subjects in
research.
(5) Covered Horses who may undergo Doping Control Testing shall not
be the subjects of drug administration studies that include Prohibited
Substances or Prohibited Methods.
(c) Controlled substances. Laboratories are expected to comply with
the relevant and applicable local, State, and Federal laws regarding
the handling, storage, and discarding of controlled or illegal
substances.
(d) Analysis. Laboratories shall not engage in any analysis or
activity that undermines or is detrimental to the purposes of the Act.
(e) Analytical Testing for other anti-doping organizations.
Laboratories shall accept Samples for Analytical Testing only if all
the following conditions have been met:
(1) The Sample matrix is of the proper type (e.g., blood, urine,
hair or other Samples) for the requested analyses;
(2) The Samples have been collected, sealed and transported to the
Laboratory in accordance with procedures equivalent to the Testing and
Investigations Standards; and
(3) The collection is a part of a legitimate anti-doping and
medication control program, as determined by the Agency, or satisfies
any of the conditions for Sample analysis indicated in Rule 6307.
(f) Analytical Testing for Covered Persons or those acting on their
behalf. Laboratories shall not accept Samples directly from individual
Covered Persons or from individuals or organizations acting on his or
her behalf (unless approved in writing and in advance by the Agency and
on the condition that Samples will be treated as Samples under the
Protocol). Proceedings may be brought against the relevant Covered
Person(s) if evidence of an Anti-Doping Rule Violation or a Controlled
Medication Rule Violation emerges from such Sample analysis.
(g) Other analytical activities.
(1) Laboratories shall not provide analytical services in a Doping
Control adjudication, unless specifically requested by the Agency or an
adjudication body as part of a Results Management process.
(2) Laboratories shall not engage in analyzing commercial material
or preparations (e.g., dietary or herbal supplements), unless:
(i) Specifically requested by the Agency or an adjudication body as
part of a Results Management process;
(ii) If done as part of a legitimate anti-doping research program,
as determined by the Agency; or
(iii) If a request is made by a Covered Person or his or her
representative, a Laboratory may conduct the analysis if agreed in
advance and in writing by the Agency, which may also specify conditions
that must be followed prior to or during the analysis (e.g.,
verification of original sealed packages, product batch number).
(3) Laboratories shall not provide results, documentation or advice
that, in any way, could be used as an endorsement of products or
services.
(4) Analytical activities performed outside the Act will not fall
under Agency-accredited status of the laboratory and shall not
negatively affect the Analytical Testing of Samples from the Agency.
Laboratory test reports or other documentation or correspondence
related to these other analytical activities shall not declare or
represent that any such testing is covered under the Laboratory's
Agency-accredited status.
(h) Sharing of knowledge.
(1) When information on new doping substance(s), method(s), or
practice(s) is known to a Laboratory, such information shall be shared
with the Agency within 60 days. When possible, Laboratories shall share
information with the Agency regarding the detection of potentially new
or rarely detected doping agents as soon as possible. Immediately after
having been notified of the Use of a new substance or method as a
doping agent, the Agency will inform all Laboratories.
(2) The Laboratory Director or staff shall participate in
developing standards for best practice and enhancing uniformity of
Analytical Testing in the HEAL-accredited laboratory system.
(i) Duty to preserve the integrity of the Program contemplated in
the Act and to avoid any detrimental conduct.
(1) Laboratory employees and consultants shall not engage in
conduct or activities that undermine or are detrimental to the anti-
doping and medication control program contemplated in the Act. Such
conduct includes, but is not limited to, fraud, embezzlement, perjury,
or any other conduct that might cast doubt on the integrity of the
anti-doping and medication control program.
(2) Laboratory employees and consultants shall maintain the
confidentiality of all of data, items and information received in
connection with Doping Control and Medication Control, including, but
not limited to, Samples, Testing documentation, and communications with
the Agency.
(3) No employee or consultant of any Laboratory may (directly or
indirectly) provide counsel, advice, or information to Covered Persons
or others regarding techniques or methods used to mask or avoid
detection of, alter metabolism of, or suppress excretion of a
Prohibited Substance or its Metabolite(s), or Marker(s) of a Prohibited
Substance or Prohibited Method in order to avoid an Adverse Analytical
Finding.
(4) No employee or consultant of any Laboratory may (directly or
indirectly) provide information about a Test Method to a Covered Person
(or to any individual or organization acting on his or her behalf) that
could be used to avoid the detection of doping. Instead, any such
Covered Person (or individual or organization) will be referred to the
Agency.
(5) No employee or consultant of any Laboratory may (directly or
indirectly) assist a Covered Person in avoiding collection of a Sample
(e.g., advice on masking strategies or detection windows). However,
this paragraph does not prohibit the publication or presentation of
scientific research results, general presentations to educate Covered
Persons, students, or others concerning anti-doping programs and
Prohibited Substances or Prohibited Methods.
(6) If an employee or consultant of a Laboratory is requested to
provide evidence in anti-doping proceedings, he or she is expected to
provide independent, scientifically valid expert testimony.
(7) Laboratories shall not issue any statements related to their
analytical processes or findings, unless otherwise provided in the
Protocol or as directed by the Agency or Authority. The responsibility
for evaluation of these findings with further action and publication,
if considered necessary, shall be the sole responsibility of the
Agency.
(j) Breach and enforceability.
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(1) A failure to respect any of the provisions of this Code of
Ethics may result in a Laboratory being subject to Disciplinary
Proceedings instituted by the Agency to either suspend or revoke its
HEAL accreditation or its Agency approval, as applicable.
(2) In addition, a failure to respect any of the provisions of this
Code of Ethics may result in staff of a Laboratory being subject to
disciplinary action by the Laboratory, resulting in consequences beyond
those stipulated under the Laboratory Standards, including potential
termination of employment or, where applicable, the imposition of
criminal charges.
Rule 6620. Research and Development Activity Requirements
(a) Laboratories must receive a minimum score of 10 points
annually:
(1) 5 points for each peer-reviewed manuscript;
(2) 5 points for the production of educational materials;
(3) 5 points for each funded research project;
(4) 5 points for hosting hands-on training workshop for all HEAL
Laboratories; and
(5) 2 points for each Laboratory (internal) method development.
(b) The validation or implementation of established anti-doping
methods with only minor adjustments, or the repetition of research
previously published or presented by others, is not sufficient to be
considered as a research and development activity.
7000. Arbitration Procedures
Rule 7010. Applicability
The Arbitration Procedures set forth in this Rule 7000 Series shall
apply to all adjudications arising out of the Rule 3000 Series.
Rule 7020. Delegation of Duties
(a) Subject to Rule 3249, Anti-Doping Rule Violations arising out
of the Rule 3000 Series and violations of Rule 3229 (together, ``EAD
Violations'') shall be adjudicated by an independent arbitral body (the
``Arbitral Body'') in accordance with the Rule 3000 Series and these
Arbitration Procedures. The Arbitral Body may also adjudicate any other
matter referred to it under the Protocol, and any other matter that
might arise from time to time under the Protocol that the Agency
considers should be determined by the Arbitral Body. The Arbitral Body
is selected by mutual agreement of the Authority and the Agency. The
Arbitral Body will ordinarily assign a sole arbitrator to hear a case
concerning an EAD Violation. However, the Arbitral Body may assign 3
arbitrators to hear a case involving an EAD Violation upon request by
the Agency, based on the nature or complexity of the case.
(b) Subject to Rule 3349, Controlled Medication Rule Violations
arising out of the Rule 3000 Series, violations of Rule 3329, and
violations of Rule 3510 (ECM or Other Violations) shall be adjudicated
by an adjudication panel (the Internal Adjudication Panel) in
accordance with the Rule 3000 Series and these Arbitration Procedures.
The Internal Adjudication Panel may also adjudicate any other matter
referred to it under the Protocol, and any other matter that might
arise from time to time under the Protocol that the Agency considers
should be determined by the Internal Adjudication Panel. The Internal
Adjudication panel is selected by mutual agreement of the Authority and
the Agency. The Internal Adjudication Panel will ordinarily assign a
single Internal Adjudication Panel member to adjudicate a case
involving an ECM or Other Violation; in exceptional circumstances only,
the Internal Adjudication Panel may assign 3 members to adjudicate a
case upon request by the Agency.
(c) Final decisions issued by the Arbitral Body or Internal
Adjudication Panel are subject to review as specified in section 3058
of the Act.
Rule 7030. Arbitral Body
(a) The Arbitral Body shall have a pool of arbitrators consisting
of a minimum of 5 members appointed by mutual agreement of the
Authority and the Agency.
(b) Arbitrators shall be appointed for 4-year terms. Candidate
arbitrators shall complete an application in a form designated by the
Authority.
(c) Candidates shall not be or have been in the previous 2 years an
officer, director, trustee, employee, consultant, or official, or be in
a policy making position for any Equine Constituencies or the Agency,
except that this requirement does not apply to former State Racing
Commission officials or employees.
(d) Candidate arbitrators shall be required to submit on request to
a background check before appointment and shall commit in writing to
accept appointment to all cases to which they are selected except:
(1) when they have been involved in the Provisional Hearing for the
matter;
(2) when they have an actual or perceived conflict of interest; or
(3) for personal hardship (candidates shall agree not to decline
appointment for personal hardship in more than 2 cases in any 12-month
period, except in exceptional circumstances).
(e) If an arbitrator dies, resigns, becomes incapacitated during
the arbitrator's term (legal incapacity is not required), or is removed
for an ethical breach or deficiency in carrying out his or her duties,
a new arbitrator shall be selected and appointed for a full 4-year
term, following the procedures set forth in this Rule 7030.
Rule 7040. Internal Adjudication Panel
(a) The Internal Adjudication Panel shall consist of impartial
members appointed by mutual agreement of the Authority and the Agency
to hear ECM and Other Violations (``IAP members''). The Internal
Adjudication Panel shall have a pool of IAP members. The Authority and
the Agency may appoint as many IAP members as they consider necessary
to the pool of IAP members in accordance with the Arbitration
Procedures.
(b) Candidate IAP members shall be required to submit on request to
a background check before appointment and shall commit in writing to
accept appointment to all cases to which they are selected except:
(1) when they have been involved in the Provisional Hearing for the
matter;
(2) when they have an actual or perceived conflict of interest; or
(3) for personal hardship (candidates shall agree to not decline
appointment for personal hardship in more than 2 cases in any 12-month
period, except in exceptional circumstances).
(c) IAP members are appointed for 4-year terms.
(d) Apart from appointment to the Internal Adjudication Panel, IAP
members shall not have any business or economic interest with a party
in a case.
(e) If an IAP member dies, resigns, becomes incapacitated during
the IAP member's term (legal incapacity is not required), or commits an
ethical breach or deficiency, the Authority or the Agency may remove
the IAP member from the Internal Adjudication Panel. The Agency will
publish a list of members of the Internal Adjudication Panel on its
website.
(f) A person is not precluded from serving as an IAP member
concomitantly with his or her service as an association or state
steward, provided that doing so does not put that him or her in a
position of actual or perceived conflict of interest.
Rule 7050. Training of Arbitrators and IAP Members
Arbitrators and IAP members shall receive at least 2 hours of
continuing education each year on issues related to
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proper and efficient handling of cases. The education must be approved
by the Authority. Failure to complete this required continuing
education is grounds for immediate dismissal.
Rule 7060. Initiation by the Agency
(a) EAD Violations. Unless Rule 3249 applies, if the Agency charges
a Covered Person with an EAD Violation, the Agency shall initiate
proceedings with the Arbitral Body. If a Covered Person is charged with
both an EAD Violation and an ECM or Other Violation, the procedures for
EAD Violations apply. The parties to the proceeding shall be the Agency
and the Covered Person(s) charged. The Owner and the Authority shall be
invited to join in the proceedings as observers and, if accepted as
such, receive copies of the filings in the case. In the context of EAD
Violation cases, the Owner may be permitted to intervene and make
written or oral submissions.
(b) ECM and Other Violations. Unless Rule 3349 applies, if the
Agency charges a Covered Person with an ECM or Other Violation, the
Agency shall initiate proceedings with the Internal Adjudication Panel.
The Covered Person may request a hearing before the Internal
Adjudication Panel. However, the Internal Adjudication Panel may decide
in its sole discretion to determine the matter based solely on the
written submissions without a hearing, if the Internal Adjudication
Panel considers itself sufficiently well-informed to render a decision
on the written submissions alone. The parties to the proceeding shall
be the Agency and the Covered Person(s) charged. The Owner and the
Authority shall be invited to join in the proceedings as observers and,
if accepted as such, receive copies of the filings in the case. In the
context of ECM and Other Violation cases, the Owner shall not be
permitted to intervene or make written or oral submissions.
(c) Only the following persons may attend hearings as the Owner of
the Covered Horse, unless otherwise agreed by the hearing panel:
(1) if the Covered Horse is owned by one individual, that
individual;
(2) if the Covered Horse is owned by more than one individual or by
a partnership, corporation, limited liability company, syndicate, or
other association or entity, either or both the Designated Owner or
Managing Owner.
Rule 7070. New or Additional Charges
If after charging a Covered Person with a violation, the Agency has
cause to bring any new or different charge(s) against the Covered
Person, the charge shall be made in writing and filed with the other
party or parties and (as applicable) the Internal Adjudication Panel or
Arbitral Body. The arbitrator(s) or IAP member(s) appointed to hear the
case shall decide whether the charges should be consolidated and heard
in the same proceedings or whether the new or additional charge(s)
should be heard separately.
Rule 7080. Expedited Procedures
(a) At the request of any party, any time period set forth in the
Arbitration Procedures may be shortened by the arbitrator(s) or IAP
member(s) if doing so is reasonably necessary to resolve any Covered
Person's or Covered Horse's eligibility before a Covered Horserace,
while continuing to protect the right of a Covered Person to a fair
process.
(b) Pursuant to Rule 3262 or Rule 3362, the Agency may, in its sole
discretion, shorten any deadlines within the Arbitration Procedures
proportionately to ensure resolution prior to a Covered Horserace.
(c) If the Agency does not agree to the process being expedited,
the arbitrator(s) or IAP member(s), as applicable, shall determine
whether the adjudication process shall be expedited and the schedule
pursuant to which the process shall proceed.
Rule 7090. Jurisdiction
(a) An arbitrator or IAP member shall have the authority to rule on
his or her own jurisdiction, including any objections with respect to
the existence, scope, or validity of the applicable rules.
(b) A party must object to the jurisdiction of the arbitrator(s) or
IAP member(s) or to the arbitrability of a charge by the Agency no
later than the filing of the answering statement to the charge that
gives rise to the objection. The arbitrator(s) or IAP member(s) may
rule on such objections as a preliminary matter or as part of the final
decision, in his or her sole discretion.
Rule 7100. Consolidation
Matters involving more than one Covered Person may, in the Agency's
discretion, be consolidated into a single matter. If an EAD Violation
is alleged by the Agency against any of the Covered Persons who are
parties in the consolidated matter, the process for EAD Violations will
be followed.
Rule 7110. Location and Means of Conducting Hearings
(a) Hearings regarding EAD Violations shall take place in person,
unless the arbitrator(s) order(s) the hearing (or parts thereof) to
take place by use of an audio-visual teleconferencing system.
(b) Hearings regarding ECM or Other Violations shall take place by
use of an audio-visual teleconferencing system, unless the IAP
member(s) order(s) the hearing to take place in person.
(c) In-person hearings shall be held in the United States at a
location determined by the arbitrator(s) or IAP member(s).
Rule 7120. Qualifications
Any arbitrator(s) or IAP member(s) appointed pursuant to Rule 7130
shall be subject to disqualification for the reasons specified in Rule
7140.
Rule 7130. Appointment of Hearing Panels To Adjudicate Cases
(a) The arbitrator(s) shall be appointed in the following manner:
immediately after the initiation of a proceeding by the Agency as set
forth in Rule 7060, the Arbitral Body shall appoint a single arbitrator
or 3 arbitrators from the pool of arbitrator(s) on a rotating basis,
after confirming that the arbitrator(s) will not decline the
appointment due to personal hardship. The arbitrator(s) adjudicating
the Provisional Hearing shall not serve as an arbitrator determining
the merits of the charge against the Covered Person. The Arbitral Body
shall communicate to the parties the name of the arbitrator(s)
appointed to hear the matter within 3 days of initiation by the Agency.
(b) The IAP member(s) shall be appointed in the following manner:
Immediately after the initiation of a proceeding by the Agency as set
forth in Rule 7060, the Internal Adjudication Panel shall appoint a
single IAP member (or in exceptional cases three IAP members) from the
pool of IAP members on a rotating basis, after confirming that the IAP
member(s) will not decline the appointment due to personal hardship.
The IAP member(s) adjudicating the Provisional Hearing shall not serve
as the IAP member(s) determining the merits of the charge against the
Covered Person. The Internal Adjudication Panel shall communicate to
the parties the name of the IAP member(s) appointed to hear the matter
within 3 days of initiation by the Agency.
(c) Once appointed, the arbitrator(s) and IAP member(s) shall
receive an electronic copy of the charge letter, Arbitration
Procedures, Rule 3000 Series and related rule series, and the Billing
Standards.
Rule 7140. Disclosure and Challenge Procedure
(a) Each arbitrator and IAP member appointed to hear a particular
case shall
[[Page 5198]]
disclose to the parties any circumstance likely to affect his or her
impartiality, including any bias or any financial or personal interest
in the result of the case, or any past or present relationship with the
parties or their representatives.
(b) Upon objection of a party to the continued service of an
arbitrator or IAP member, the Arbitral Body or Internal Adjudication
Panel (as applicable) shall determine whether the arbitrator or IAP
member is evidently partial, and (if so) the arbitrator or IAP member
shall be disqualified. The Arbitral Body or Internal Adjudication Panel
shall inform the parties of its decision, which shall be final and not
subject to review or any other challenge.
Rule 7150. Communication
Once appointed, no party and no Person acting on behalf of any
party shall communicate unilaterally concerning the case with any
arbitrator or IAP member appointed to hear the case. All communications
with the Arbitral Body or Internal Adjudication Panel or any arbitrator
or IAP member concerning the case shall include the other party or
parties.
Rule 7160. Vacancies
If for any reason following assignment to the case an arbitrator or
IAP member becomes unable to perform his or her duties in a particular
case, the Arbitral Body or Internal Adjudication Panel (as applicable)
may fill the vacancy on a rotating basis as described in these rules.
Rule 7170. Procedures for EAD Violations
(a) For matters involving an alleged EAD Violation arising from an
Adverse Analytical Finding, each Covered Person's pre-hearing
submission must be filed with the Arbitral Body on or before 14 days
after submitting a request for a hearing (or after the deadline to make
such request expires), and the Agency's pre-hearing submission must be
filed with the Arbitral Body on or before 14 days after the last
Covered Person's pre-hearing submission. There shall be no reply pre-
hearing submission unless ordered otherwise by the arbitrator(s), but
each party may present rebuttal evidence at the hearing.
(b) For matters involving an alleged EAD Violation involving a non-
analytical violation or a violation of Rule 3229, the Agency's initial
pre-hearing submission must be filed with the Arbitral Body on or
before 14 days after the last Covered Person requests a hearing (or
after the deadline to make such request expires). Each Covered Person's
pre-hearing submission must be filed with the Arbitral Body on or
before 14 days after the Agency's initial pre-hearing submission, and
the Agency's reply pre-hearing submission must be filed with the
Arbitral Body seven 7 days after the last Covered Person's pre-hearing
submission.
(c) A Covered Person's pre-hearing submission shall include a brief
not to exceed 30 double-spaced single-sided pages and shall include all
exhibits, schedules, witness statements, expert reports, and all other
evidence (except summaries and demonstrative aides) that the Covered
Person intends to rely upon at the hearing. The Covered Person's pre-
hearing submission shall include a designation of witnesses providing
the identity of witnesses, or name of the organization (in the case of
an organization representative) expected to be called to testify at the
hearing, along with signed statements for each of those witnesses. For
expert witnesses, the pre-hearing submission shall include a C.V. and
expert report, identifying all opinions to which they will testify and
the facts and scientific methods upon which those opinions are based,
as well as to identify all scientific treatises, studies, or articles
on which the expert relies in rendering their opinion(s), for each
expert included in the witness designations.
(d) The Agency's initial pre-hearing submission shall include a
brief not to exceed 30 single-sided double-spaced pages for each
Covered Person charged in the case and shall include all exhibits,
schedules, witness statements, expert reports, and all other evidence
(except impeachment evidence, summaries, and demonstrative aides) that
the Agency intends to rely upon at the hearing. The Agency's initial
pre-hearing submission shall include a designation of witnesses
providing the identity of witnesses, or name of the organization (in
the case of an organization representative) expected to be called to
testify at the hearing, along with signed statements for each of those
witnesses. For expert witnesses, the initial pre-hearing submission
shall include a C.V. and expert report, identifying all opinions to
which the expert will testify, and the facts and scientific methods
upon which those opinions are based. The submission shall identify all
scientific treatises, studies, or articles on which the expert relies
in rendering his or her opinion(s), for each expert included in the
witness designations. The Agency's reply pre-hearing submission shall
include all additional evidence upon which it intends to rely for
rebuttal (except impeachment evidence, summaries, and demonstrative
aides) and a reply brief not to exceed 15 single-sided double-spaced
pages for each Covered Person charged in the case.
(e) Each party is responsible for updating its disclosures as such
information becomes available. If a party should have submitted
evidence in the party's pre-hearing submission but did not submit such
evidence, the arbitrator(s) shall not admit such evidence absent a
showing of good cause.
(f) The hearing should take place no more than 60 days from the
date the last Covered Person requested a hearing in a particular case.
(g) At the request of any party, or at the discretion of the
arbitrator(s), the arbitrator(s) may schedule, as soon as practicable,
a preliminary hearing with the parties or their representatives. The
preliminary hearing shall be conducted by telephone or video
conference. During the preliminary hearing, the parties and the
arbitrator(s) shall discuss any preliminary matters to ensure
compliance with the procedures herein.
(h) Upon a showing of exceptional circumstances, the arbitrator(s)
may extend any of the deadlines set forth in Rule 7170 for the minimum
time necessary to address the circumstance. If all parties agree to an
alternative schedule in a particular case, the arbitrator(s) shall
alter dates accordingly.
(i) If any of the dates described in Rule 7170 fall on a weekend or
a Federal holiday, they shall be moved to the next business day.
Rule 7180. Procedures for ECM and Other Violations
(a) Subject to paragraph (b) below, the IAP member(s) may determine
to hold a hearing and require written submissions to be filed prior to
the hearing, or to require written submissions and determine the matter
based solely on the written submissions without a hearing. The IAP
member(s) shall have wide discretion to determine the conduct of the
proceedings in order to ensure that they are commensurate to the
violations at issue. The IAP member(s) may issue directions to the
parties as necessary. The IAP member(s) shall also have discretion to
amend any time limits as they see fit in the circumstances, but any
extension of deadlines shall be granted only for the minimum time
necessary to address the circumstance, as all matters before the IAP
member(s) shall proceed expeditiously.
(b) A person charged with a violation may request that the IAP
member waive the requirement that written submissions be filed by the
parties, and permit the person charged to make an
[[Page 5199]]
oral presentation at a hearing. The IAP member may grant the request in
the interest of justice, if the conduct of the hearing will not
prejudice any of the other parties. The IAP member(s) shall provide the
Agency the opportunity to respond to the oral presentation and shall
have wide discretion to determine the conduct and scope of the hearing.
The person charged may request that he or she be assisted by legal
counsel or other representative at the hearing.
(c) If the IAP member(s) order the parties to produce written
submissions, and the matter involves an alleged ECM or Other Violation
arising from an Adverse Analytical Finding, each Covered Person's
submission must be filed with the Internal Adjudication Panel on or
before 7 days after submitting a request for a hearing before the
Internal Adjudication Panel (or after the deadline to make such request
expires), and the Agency's submission must be filed with the Arbitral
Body on or before 7 days after the last Covered Person's submission.
There shall be no reply submissions unless ordered otherwise by the IAP
member(s).
(d) If the IAP member(s) order the parties to produce written
submissions, and the matter involves a non-analytical ECM Violation or
Other Violation, the Agency's initial submission must be filed with the
Internal Adjudication Panel on or before 7 days after the last Covered
Person requests a hearing before the Internal Adjudication Panel (or
after the deadline to make such request expires). Each Covered Person's
submission must be filed with the Arbitral Body on or before 7 days
after the Agency's initial submission. There shall be no reply
submissions unless ordered otherwise by the IAP member(s).
(e) If the IAP member(s) order the parties to produce written
submissions, the submissions of each party shall ordinarily not exceed
15 single-sided double-spaced pages and shall include all supporting
documentation on which the party relies. If any party intends to call a
witness or expert to testify at the hearing, a signed witness statement
and expert report (as applicable) shall be filed with the written
submission.
(f) If any of the dates described in Rule 7180 fall on a weekend or
a Federal holiday, the date shall be moved to the next business day.
Rule 7190. Exchange of Information
Information shall be exchanged electronically, unless otherwise
agreed by the parties. The arbitrator(s) and IAP member(s) are
authorized to resolve any disputes concerning the exchange of
information between the parties consistent with the expedited nature of
the proceedings.
Rule 7200. Participation
The Arbitral Body and Internal Adjudication Panel (and their
respective members) shall maintain the confidentiality of the
proceedings. The arbitrator(s) or IAP member(s) may proceed without the
participation of any party or representative who, after due notice,
fails to be present or make a submission. If a party defaults, the
arbitrator(s) or IAP member(s) may require the party who is present to
submit such evidence and documents as the arbitrator(s) or IAP
member(s) may require for the making of a final decision. Hearings are
not open to the media or the public. However, the arbitrator(s) or IAP
member(s) may permit one or more third parties to attend the hearing.
Rule 7210. Representation
Any party may be represented by legal counsel or other
representative. The legal counsel or other representative shall provide
a letter of representation notifying the other party and the Arbitral
Body or Internal Adjudication Panel (as applicable) of his or her name,
phone number, email, and mailing address. A party shall be bound by the
statements made and positions taken by its legal counsel or other
representative.
Rule 7220. Oaths
All testimony at hearings shall be taken under oath or affirmation.
Rule 7230. Stenographic Record
Any party desiring a stenographic record of all or a portion of the
hearing shall notify the other parties of the request at least 7 days
in advance of the start of the hearing, unless ordered otherwise by the
arbitrator(s) or IAP member(s). The Agency shall identify the court
reporter to be used for transcription services, and an electronic copy
of the transcript shall be provided to the arbitrator(s) or IAP
member(s) (as applicable) and to the parties. Parties are responsible
for the costs of any transcript they request.
Rule 7240. Interpreters
All proceedings shall take place in English. Any party wishing to
have an interpreter present during proceedings shall make all
arrangements directly with the interpreter. Interpreters shall have no
prior relationship with a party or have any interest in the proceeding,
and the arbitrator(s) or IAP member(s) (as applicable) must approve the
interpreter in advance. The costs of the interpreter shall be split
between the parties. Any document that is not in English shall be
officially translated by a certified translator paid for by the party
offering or relying upon the document.
Rule 7250. Conduct of Hearings
(a) The Agency shall present evidence to support its charge. The
Covered Person(s) charged shall then present evidence to support the
Covered Person(s) defense. The Agency is then entitled to present
rebuttal evidence. Witnesses for each party shall also submit to
questions from the arbitrator(s) or IAP member(s) and the adverse
party. The arbitrator(s) or IAP member(s) may vary this procedure,
provided that the parties are treated equally and that each party has
the right to be heard and is given a fair opportunity to present its
case.
(b) The arbitrator(s) or IAP member(s) shall have the power to
require the sequestration of any witness, other than a party or other
essential person, during the testimony of any other witness. It shall
be within the discretion of the arbitrator(s) or IAP member(s) to
determine the propriety of the attendance of any other person other
than a party and its representatives and the observers identified in
Rule 7060.
(c) The arbitrator(s) or IAP member(s) may direct the order of
proof, bifurcate proceedings, and direct the parties to focus their
presentations on issues the decision of which could dispose of all or
part of the case.
(d) The parties may agree to waive oral hearings.
Rule 7260. Evidence
(a) The parties may offer such evidence as is relevant and material
to the dispute and shall produce such evidence as the arbitrator(s) or
IAP member(s) may deem necessary to make a determination in a case.
(b) Prior to or during the hearing, a party may also request the
arbitrator(s) or IAP member(s) to order production of any document
which the party believes to be relevant and material to the dispute.
The arbitrator(s) or IAP member(s) shall have discretion to grant or
reject such a request as they see fit in the circumstances. However,
requests for discovery and wide-ranging or otherwise disproportionate
document requests shall not be permitted.
(c) The arbitrator(s) or IAP member(s) may retain an expert or seek
independent evidence only if (i) agreed to by all of the parties and
(ii) the parties or the Agency agree(s) to pay for the cost of such
expert or independent evidence. The parties shall have the right to
examine any expert retained by the
[[Page 5200]]
arbitrator(s) or IAP member(s) and shall have the right to respond to
any independent evidence obtained by the arbitrator(s) or IAP
member(s).
(d) The arbitrator(s) or IAP member(s) shall determine the
admissibility, relevance, and materiality of the evidence offered,
including hearsay evidence, and may exclude evidence deemed cumulative
or irrelevant. Conformity to legal rules of evidence shall not be
necessary, but the Federal Rules of Evidence may be used for guidance.
Evidentiary and other rules for proving violations of the Protocol are
also set out in Rule 3120.
(e) The arbitrator(s) or IAP member(s) shall apply relevant
principles of legal privilege, including those involving the
confidentiality of communications between an attorney and client and
the investigative privilege.
(f) The arbitrator(s) or IAP member(s) may issue subpoenas for
witnesses, documents, information, or other evidence upon the request
of any party, keeping in mind the expedited nature of the proceedings
and the procedures set forth in Rules 7170 and 7180. The arbitrator(s)
or IAP member(s) shall not issue a subpoena for a deposition, because
depositions (along with formal written discovery in civil litigation)
are not in keeping with the expedited nature of the Arbitration
Procedures.
Rule 7270. Inspection
If the arbitrator(s) or IAP member(s) consider it necessary to make
an inspection in connection with a proceeding, the arbitrator(s) or IAP
member(s) shall so advise the parties. The arbitrator(s) or IAP
member(s) shall set the date and time that shall not delay the
procedures in Rules 7170 and 7180 and shall notify the parties. Any
party who so desires may be present at such an inspection. If one or
all parties are not present at the inspection, the arbitrator(s) or IAP
member(s) shall make an oral or written report to the parties and
afford them an opportunity to comment.
Rule 7280. Interim Rulings and Measures
The arbitrator(s) or IAP member(s) may make interim rulings and
orders and may order whatever interim measures they deem necessary to
provide any party an immediate protection of rights.
Rule 7290. Provisional Hearings
Hearings to resolve challenges to Provisional Suspensions shall be
held in accordance with Rule 3247 or 3347, as applicable. Hearsay
evidence shall be admissible in a Provisional Hearing.
Rule 7300. Closing of Hearing
Subject to Rule 7310, the arbitrator(s) or IAP member(s) shall
declare the hearing closed after the conclusion of closing arguments.
Post-hearing briefs shall not be permitted, except as ordered by the
arbitrator(s) or IAP members(s) in complex or otherwise exceptional
cases. The time limit to issue the final decision shall commence upon
the closing of the hearing.
Rule 7310. Reopening of Hearing
To avoid manifest injustice, the hearing may be reopened on the
initiative of the arbitrator(s) or IAP member(s), or upon application
of a party, at any time before the final decision is made. At the
request of a party, the arbitrator(s) or IAP member(s) will determine
if the applicable standard has been met to reopen the hearing.
Rule 7320. Waiver of Rules
Any party who proceeds with the adjudication under these rules
after knowledge that any provision or requirement of these rules has
not been complied with and who fails to state an objection in writing
shall be deemed to have waived the right to object.
Rule 7330. Serving of Notice
(a) Any papers, notices, or process necessary or proper for the
initiation or continuation of a proceeding under these rules, and any
final decision made under these rules may be served by mail or email
addressed to the party or its representative at the last known address
or by personal service in or outside the state where the arbitration is
to be held.
(b) Unless otherwise instructed by the Arbitral Body or Internal
Adjudication Panel, any documents submitted by any party to the
Arbitral Body or Internal Adjudication Panel shall simultaneously be
provided to the other party or parties to the proceeding.
Rule 7340. Final Decision
A final decision shall be in writing and signed by the
arbitrator(s) or IAP member(s). The arbitrator(s) shall issue the final
decision on or before 14 days after the close of the hearing. The IAP
member(s) shall issue the final decision on or before 14 days after the
last written submission contemplated in Rule 7180 or after the close of
the hearing (as applicable). The 14-day time limit may be extended if
additional time is needed due to the complexity of the case or
exceptional circumstances.
Rule 7350. Scope of Final Decision
Arbitrators and IAP members may grant any remedy or relief
authorized by the Act or the Rules issued pursuant to the Act.
Rule 7360. Case Resolution During Proceedings
If the parties settle the case during the course of the proceedings
in accordance with Rule 3249 or 3349, the Arbitral Body or the Internal
Adjudication Panel shall issue an order terminating the proceedings.
Rule 7370. Notification of Final Decision
(a) The final decision shall be served on all parties by first
class mail, email, or personal service. Interested Parties shall also
be notified of the final decision.
(b) The final decision shall be Publicly Disclosed and shall not be
considered confidential, unless provided otherwise in the applicable
rules.
Rule 7380. Modification of Final Decision
Within 7 days of the issuance of a final decision, any party, upon
notice to the other parties, may request the Arbitral Body or Internal
Adjudication Panel to correct any clerical, typographical, or
computational errors in the final decision. The other parties shall
ordinarily be given 5 days to respond to the request.
Rule 7390. Release of Documents for Judicial Proceedings
The Arbitral Body and Internal Adjudication Panel (as applicable)
shall, upon the written request of a party, furnish to the party, at
the party's expense, certified copies of any papers in the Arbitral
Body's or Internal Adjudication Panel's possession that may be required
in judicial proceedings relating to the proceeding. If the matter is
subject to review by an administrative law judge in accordance with the
Act, the Arbitral Body and Internal Adjudication Panel (as applicable)
shall furnish copies of any documents requested by the administrative
law judge to such judge in connection with that proceeding.
Rule 7400. Right of Review
The final decision of the Arbitral Body or Internal Adjudication
Panel is subject to review in accordance with section 3058 of the Act.
Notwithstanding any provision set forth in these Arbitration
Procedures, nothing herein shall alter the standards of review set
forth in the Act.
[[Page 5201]]
Rule 7410. Applications to Court and Exclusion of Liability
(a) Arbitration is intended to be the exclusive remedy in all cases
arising under the Rule 3000 Series, subject to appeal as described in
the Rule 3000 Series and the Act.
(b) No civil action commenced by a party relating to the subject
matter of the proceeding under the Arbitration Procedures shall be
deemed a waiver of any party's right to adjudicate that party's case
under the Arbitration Procedures.
(c) Neither the Arbitral Body nor the Internal Adjudication Panel
(nor any arbitrator or IAP member) in a proceeding under these rules is
a necessary party in judicial proceedings relating to that proceeding.
(d) Parties to a proceeding under the Arbitration Procedures shall
be deemed to have consented that a final decision may be entered in any
Federal or State court having jurisdiction, unless the party seeks
review pursuant to section 3058 of the Act.
(e) None of the Authority, Agency, Arbitral Body, Internal
Adjudication Panel, arbitrators, or IAP members shall be liable to any
party for any act or omission in connection with any proceedings
conducted under these Arbitration Procedures.
Rule 7420. Costs
(a) The Arbitral Body shall prescribe filing and other
administrative fees and service charges to compensate it for the cost
of providing administrative services. The fees in effect when the fee
or charge is incurred shall be applicable. The Arbitral Body's filing
fee and any other administrative fee or charge shall be split equally
amongst the parties, and the Agency's portion shall be paid by the
Authority.
(b) The Arbitral Body shall split the costs of the proceeding
before an arbitrator (including arbitrator fees and expenses, but
excluding attorney, witness, and party expert fees) equally amongst the
parties with the Agency's portion being paid by the Authority. The
Arbitral Body, in its discretion, may require advanced costs be paid by
the parties to ensure payment is made.
(c) A party's failure to pay costs or advanced costs by the
deadlines imposed by the Arbitral Body will, if not rectified
immediately, result in a waiver of charges or defenses to charges (as
applicable) and result in imposition and publication of sanctions
requested by the Agency.
(d) The Authority shall be solely responsible for the
administrative costs stemming from IAP member-resolved cases as
described in the Arbitration Procedures.
Rule 7430. Expenses
The expenses of witnesses for any party shall be paid by the party
producing such witnesses. Each party shall bear its own attorneys' fees
and other expenses.
Rule 7440. Arbitrator's Compensation
(a) Arbitrators shall be compensated and reimbursed in a manner
consistent with the Billing Standards.
(b) If there is disagreement concerning the terms of compensation,
the disagreement shall be resolved as described in the Billing
Standards.
(c) Any arrangement for the compensation or reimbursement of an
arbitrator shall be made through the Arbitral Body and not directly
between the parties and the arbitrator.
(d) Arbitrator fees and IAP member fees shall be paid in accordance
with Rule 7420.
Rule 7450. Application of Rules
The Rule 1000-9000 Series shall be considered part of the agreement
to arbitrate and in all instances the arbitrators and IAP members are
required to apply the provisions of that arbitration agreement and
conform to its terms.
By direction of the Commission.
Joel Christie,
Acting Secretary.
[FR Doc. 2023-00957 Filed 1-25-23; 8:45 am]
BILLING CODE 6750-01-P