 EPA ICR No. 1139.09; OMB Control No. 2070-0033

ATTACHMENT 2

40 CFR 790

Procedures Governing Testing Consent Agreements and Test Rules

  SEQ CHAPTER \h \r 1 Title 40: Protection of Environment

PART 790—PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST
RULES

Subpart A—General Provisions

§ 790.1   Scope, purpose, and authority.

(a) This part establishes procedures for gathering information,
conducting negotiations, and developing and implementing test rules or
consent agreements on chemical substances and mixtures under section 4
of TSCA.

(b) Section 4 of the Act authorizes EPA to require manufacturers and
processors of chemical substances and mixtures to test these chemicals
to determine whether they have adverse health or environmental effects.
Section 4 (a) empowers the Agency to promulgate rules which require such
testing. In addition, EPA has implied authority to enter into
enforceable consent agreements requiring testing where they provide
procedural safeguards equivalent to those that apply where testing is
conducted by rule.

(c) EPA intends to use enforceable consent agreements to accomplish
testing where a consensus exists among EPA, affected manufacturers
and/or processors, and interested members of the public concerning the
need for and scope of testing. If such a consensus does not exist and
the Agency believes that it can make the findings specified in section
4(a), EPA will initiate proceedings to promulgate test rules which will
be codified in part 799 of this chapter.

(d) Appendix A to this part presents timetables for various steps in the
evaluation of chemicals under consideration for testing, the initiation
and completion of negotiations to develop consent agreements, and the
proposal and promulgation of test rules. All deadlines which are imposed
by the Act are binding on EPA and will be observed by the Agency. The
remaining deadlines represent target dates that EPA intends to meet.

[51 FR 23712, June 30, 1986]

§ 790.2   Applicability.

This part is applicable to manufacturers and processors of chemical
substances or mixtures who are subject to the testing requirements of a
consent agreement or a rule under section 4(a) of the Act. The
procedures for test rules are applicable to each test rule in part 799
or this chapter unless otherwise stated in specific test rules in part
799 of this chapter.

[51 FR 23712, June 30, 1986]

§ 790.3   Definitions.

Terms defined in the Act and not explicitly defined herein are used with
the meaning given in the Act. For the purpose of this part:

Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

Additive means a chemical substance that is intentionally added to
another chemical substance to improve its stability or impart some other
desirable quality.

Chemical means a chemical substance or mixture.

Consortium means an association of manufacturers and/or processors who
have made an agreement to jointly sponsor testing.

EPA means the U.S. Environmental Protection Agency.

Equivalence data means chemical data or biological test data intended to
show that two substances or mixtures are equivalent.

Equivalent means that a chemical substance or mixture is able to
represent or substitute for another in a test or series of tests, and
that the data from one substance can be used to make scientific and
regulatory decisions concerning the other substance.

Exemption means an exemption from a testing requirement of a test rule
promulgated under section 4 of the Act and part 799 of this chapter.

Impurity means a chemical substance which is uninitentionally present
with another chemical substance.

Joint sponsor means a person who sponsors testing pursuant to section
4(b)(3)(A) of the Act.

Joint sponsorship means the sponsorship of testing by two or more
persons in accordance with section 4(b)(3)(A) of the Act.

Person means an individual, partnership, corporation, association,
scientific or academic establishment, or organizational unit thereof,
and any other legal entity.

Principal sponsor means an individual sponsor or the joint sponsor who
assumes primary responsibility for the direction of a study and for oral
and written communication with EPA.

Protocol means the plan and procedures which are to be followed in
conducting a test.

Reimbursement period refers to a period that begins when the data from
the last non-duplicative test to be completed under a test rule are
submitted to EPA and ends after an amount of time equal to that which
had been required to develop data or after five years, whichever is
later.

Sponsor means the person or persons who design, direct and finance the
testing of a substance or mixture.

Test substance means the form of chemical substance or mixture that is
specified for use in testing.

[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23712, June 30, 1986]

§ 790.5   Submission of information.

(a) All submissions to EPA under this part must bear the Code of Federal
Regulations (CFR) section number of the subject chemical test rule, or
indicate the identity of the consent agreement. For all submissions
under this part, six copies must be provided to EPA.

(b) Submissions containing both confidential business information or
non-confidential business information must be addressed to the Document
Control Office (7407), Office of Pollution Prevention and Toxics, U.S.
Environmental Protection Agency, Room G–099, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460, ATTN: TSCA Section 4.

[50 FR 20656, May 17, 1985, as amended at 51 FR 23712, June 30, 1986; 58
FR 34205, June 23, 1993; 60 FR 31922, June 19, 1995; 60 FR 34466, July
3, 1995]

§ 790.7   Confidentiality.

(a) Any person subject to the requirements of a consent agreement or a
test rule under section 4 of the Act may assert a claim of
confidentiality for certain information submitted to EPA in response to
the consent agreement or the test rule. Any information claimed as
confidential will be treated in accordance with the procedures in part 2
of this title and section 14 of the Act. Failure to assert a claim of
confidentiality at the time the information is submitted will result in
the information being made available to the public without further
notice to the submitter.

(b) A claim of confidentiality must be asserted by circling or otherwise
marking the specific information claimed as confidential and designating
it with the words “confidential business information,” “trade
secret,” or another appropriate phrase indicating its confidential
character.

(c) If a person asserts a claim of confidentiality for study plan
information described in §§790.50(c)(1)(iii)(D), (iv), (v), and (vi)
and 790.62(b)(6), (7), (8), (9), and (10), the person must provide a
detailed written substantiation of the claim by answering the questions
in this paragraph. Failure to provide written substantiation at the time
the study plan information is submitted will be considered a waiver of
the claim of confidentiality, and the study plan information will be
disclosed to the public without further notice.

(1) Would disclosure of the study plan information disclose processes
used in the manufacture or processing of a chemical substance or
mixture? Describe how this would occur.

(2) Would disclosure of the study plan information disclose the portion
of a mixture comprised by any of the substances in the mixture? Describe
how this would occur.

(3) What harmful effects to your competitive position, if any, do you
think would result from disclosure of this information? How would a
competitor use such information? How substantial would the harmful
effects be? What is the causal relationship between disclosure and the
harmful effects?

(4) For what period of time should confidential treatment be given?
Until a specific date, the occurrence of a specific event, or
permanently? Why?

(5) What measures have you taken to guard against disclosure of this
information to others?

(6) To what extent has this information been disclosed to others? What
precautions have been taken in connection with such disclosures?

(7) Has this information been disclosed to the public in any forms?
Describe the circumstances.

(8) Has the information been disclosed in a patent?

(9) Has EPA, another Federal agency, or any Federal court made any
pertinent confidentiality determination regarding this information? If
so, copies of such determinations must be included in the
substantiation.

(d) If the substantiation provided under paragraph (c) of this section
contains information which the submitter considers confidential, the
submitter must assert a separate claim of confidentiality for that
information at the time of submission in accordance with paragraph (b)
of this section.

[49 FR 39782, Oct. 10, 1984, as amended at 51 FR 23713, June 30, 1986]

Subpart B—Procedures for Developing Consent Agreements and Test Rules

Source:   51 FR 23713, June 30, 1986, unless otherwise noted.

§ 790.20   Recommendation and designation of testing candidates by the
ITC.

(a) Recommendations with intent to designate. The ITC has advised EPA
that it will discharge its responsibilities under section 4(e) of the
Act in the following manner:

(1) When the ITC identifies a chemical substance or mixture that it
believes should receive expedited consideration by EPA for testing, the
ITC may add the substance or mixture to its list of chemicals
recommended for testing and include a statement that the ITC intends to
designate the substance or mixture for action by EPA in accordance with
section 4(e)(1)(B) of the Act.

(2) Chemical substances or mixtures selected for expedited review under
paragraph (a)(1) of this section may, at a later time, be designated for
EPA action within 12 months of such designation. The ITC's subsequent
decision would be based on the ITC's review of TSCA sections 8(a) and
8(d) data and other relevant information.

(3) Where the ITC concludes that a substance or mixture warrants testing
consideration but that expedited EPA review of testing needs is not
justified, the ITC will add the substance or mixture to its list of
testing recommendations without expressing an intent to designate the
substance or mixture for EPA action in accordance with section
4(e)(1)(B) of the Act.

(4) The ITC reserves its right to designate any chemical that it
determines the Agency should, within 12 months of the date first
designated, initiate a proceeding under section 4(a) of the Act.

(b) EPA consideration of ITC recommendations. (1) Where a substance or
mixture is designated for EPA action under section 4(e)(1)(B) of the
Act, the Agency will take either one of the following actions within 12
months after receiving the ITC designation:

(i) Initiate rulemaking proceedings under section 4(a) of the Act.

(ii) Publish a Federal Register notice explaining the Agency's reasons
for not initiating such rulemaking proceedings. EPA may conclude that
rulemaking proceedings under section 4(a) of the Act are unnecessary if
it determines that the findings specified in section 4(a) of the Act
cannot be made or if the Agency has entered into a consent agreement
requiring testing in accordance with the provisions of this subpart.

(2) Where a substance or mixture has been recommended for testing by the
ITC without an intent to designate, EPA will use its best efforts to act
on the ITC's recommendations as rapidly as possible consistent with its
other priorities and responsiblities. EPA may respond to the ITC's
recommendations either by:

(i) Initiating rulemaking proceedings under section 4(a) of the Act.

(ii) Publishing a Federal Register notice explaining the Agency's
reasons for concluding that testing is unnecessary.

(iii) Entering into a consent agreement in accordance with this subpart.

§ 790.22   Procedures for gathering information and negotiating consent
agreements on chemicals which the ITC has recommended for testing with
an intent to designate.

(a) Preliminary EPA evaluation. Following receipt of an ITC report
containing a recommendation with an intent to designate, EPA will use
the following procedure for completing a preliminary evaluation of
testing needs. Appendix A 1 to this part presents the schedule that EPA
intends to follow for this purpose.

(1) EPA will publish the ITC report in the Federal Register and announce
that interested persons have 30 days to submit comments on the ITC's
testing recommendations.

(2) EPA will publish a Federal Register notice adding all
ITC-recommended chemicals to the automatic reporting provisions of its
rules under sections 8(a) and 8(d) of the Act (40 CFR parts 712 and
716).

(3) EPA will hold a public “focus meeting” to discuss the ITC's
testing recommendations and obtain comments and information from
interested parties.

(4) EPA will evaluate submissions received under the sections 8(a) and
8(d) reporting requirements, comments filed on the ITC's
recommendations, and other information and data compiled by the Agency.

(5) EPA will make a preliminary staff determination of the need for
testing and, where testing appears warranted, will tentatively select
the studies to be performed.

(6) EPA will hold a public meeting to announce its preliminary testing
determinations.

(b) Negotiation procedures for consent agreements. Where EPA believes
that testing is necessary, the Agency will explore whether a consent
agreement can be negotiated that satisfies the testing needs identified
by the Agency. EPA will use the following procedures for negotiating,
formulating and accepting consent agreements. Appendix A 1 to this part
presents the schedule that EPA intends to follow for this purpose.

(1) In the Federal Register notice described in paragraph (a)(1) of this
section, EPA will explain its procedures and timetable for negotiating
consent agreements and invite persons interested in participating in or
monitoring negotiations to contact the Agency in writing.

(2) Persons who respond to EPA's notice by the announced date of the
Agency's course-setting meeting will be deemed “interested parties”
for purposes of any negotiations that EPA conducts.

(3) Following the course-setting meeting announcing EPA's preliminary
testing determinations, the Agency will meet with manufacturers,
processors and other interested parties for the purpose of attempting to
negotiate a consent agreement. To facilitate attendance at these
meetings, EPA will contact all interested parties who have expressed a
desire to participate in or monitor negotiations under paragraph (b)(2)
of this section and advise them of meeting dates.

(4) All negotiating meetings will be open to members of the public. The
minutes of each meeting will be prepared by EPA. Meeting minutes,
testing proposals, background documents and other materials exchanged at
or prepared for negotiating meetings will be included in the public file
established by EPA on each ITC-recommended chemical. Materials in this
file will be made available for inspection in the OPPTS Reading Room
during EPA working hours.

(5) While negotiations are underway, EPA will promptly circulate meeting
minutes, testing proposals, correspondence and other relevant materials
to interested parties who expressed a desire to participate in or
monitor negotiations pursuant to paragraph (b)(2) of this section.

(6) As negotiations progress, EPA will make a tentative decision either
to proceed with formulation of a consent agreement or to initiate
rulemaking. EPA will terminate negotiations after 10 weeks and proceed
with rulemaking unless negotiations are likely to result in a draft
consent agreement within 4 additional weeks. By the end of this 4-week
period, EPA either will have prepared a draft consent agreement
reflecting the apparent consensus of the parties or will terminate
negotiations and proceed with rulemaking. If EPA decides to proceed with
rulemaking, no further opportunity for negotiations will be provided.
EPA will promptly send written notice to all interested parties of the
termination of negotiations.

(7) Where EPA prepares a draft consent agreement, it will be circulated
for comment to all interested parties who expressed a desire to
participate in or monitor negotiations under paragraph (b)(2) of this
section. A period of 4 weeks will be provided for submitting comments or
written objections under §790.24(a).

(8) If necessary, EPA will hold a public meeting to discuss comments on
the draft consent agreement and to determine whether revisions in the
agreement are appropriate.

(9) Where a consensus exists concerning the contents of a draft consent
agreement, it will be circulated to EPA management and interested
parties for final approval and signature.

(10) Upon final approval of a consent agreement, EPA will publish a
Federal Register notice that summarizes the agreement, describes the ITC
recommendations for the test substance, outlines the chemical's use and
exposure characteristics, and explains the background, objectives and
rationale of the testing to be conducted, and codifies in subpart C of
part 799 the name of the substance(s) to be tested and the citation to
the Federal Register notice of the agreement.

§ 790.24   Criteria for determining whether a consensus exists
concerning the provisions of a draft consent agreement.

(a) EPA will enter into consent agreements only where there is a
consensus among the Agency, one or more manufacturers and/or processors
who agree to conduct or sponsor the testing, and all other interested
parties who identify themselves in accordance with §790.22(b)(2). EPA
will not enter into a consent agreement in either of the following
circumstances:

(1) EPA and affected manufacturers and/or processors cannot reach a
consensus on the testing requirements or other provisions to be included
in the consent agreement.

(2) A draft consent agreement is considered inadequate by other
interested parties who, pursuant to §790.22(b)(2), have asked to
participate in or monitor negotiations; and these parties have submitted
timely written objections to the draft consent agreement which provide a
specific explanation of the grounds on which the draft agreement is
objectionable.

(b) EPA may reject objections described in paragraph (a)(2) of this
section only where the Agency concludes the objections are either:

(1) Not made in good faith.

(2) Untimely.

(3) Do not involve the adequacy of the proposed testing program or other
features of the agreement that may affect EPA's ability to fulfill the
goals and purposes of the Act.

(4) Not accompanied by a specific explanation of the grounds on which
the draft agreement is considered objectionable.

(c) The unwillingness of some manufacturers and/or processors of a
prospective test chemical to sign the draft consent agreement does not,
in itself, establish a lack of consensus if EPA concludes that those
manufacturers and/or processors who are prepared to sign the agreement
are capable of accomplishing the testing to be required and that the
draft agreement will achieve the purposes of the Act in all other
respects.

§ 790.26   Initiation and completion of rulemaking proceedings on
ITC-designated chemicals.

(a) Where EPA concludes that a consensus does not exist concerning the
provisions of a draft consent agreement and that the findings specified
by section 4(a) can be made, the Agency will proceed with rulemaking
under section 4(a) of TSCA.

(b) When EPA decides to proceed with rulemaking under paragraph (a) of
this section, the Agency intends to publish a rulemaking proposal and a
final rule or a notice terminating the rulemaking proceeding in
accordance with the schedule specified in Appendix A 1 to this part.

1Editorial Note: Appendix A appears at the end of subpart E.

(c) Where the testing recommendations of the ITC raise unusually complex
and novel issues that require additional Agency review and opportunity
for public comment, the Agency may publish an Advance Notice of Proposed
Rulemaking (ANPR). The schedule that EPA intends to follow for
rulemaking proceedings initiated by publication of an ANPR is presented
in appendix A 1 to this part.

§ 790.28   Procedures for developing consent agreements and/or test
rules for chemicals that have not been designated or recommended with
intent to designate by the ITC.

(a) Where EPA believes that testing is needed, it may also develop
consent agreements and/or test rules on chemical substances or mixtures
that either:

(1) Have been recommended but not “recommended with intent to
designate” by the ITC.

(2) Have been selected for testing consideration by EPA on its own
initiative.

(b) When EPA wishes to initiate negotiations concerning chemicals
described in paragraph (a) of this section, it will publish a Federal
Register notice describing its tentative evaluation of testing needs,
announcing a date for a public course-setting meeting, and inviting
persons interested in participating in or monitoring negotiations to
contact the Agency in writing. Any negotiations that EPA conducts will
conform to the procedures specified in §790.22(b) and, to the extent
feasible, will follow the schedules presented in appendix A 1 to this
part.

(c) EPA will enter into consent agreements on chemicals described in
paragraph (a) of this section only if there is a consensus among EPA,
affected manufacturers and/or processors, and any other persons who have
asked to participate in or monitor negotiations. In determining whether
such a consensus exists, EPA will employ the criteria specified in
§790.24. In the absence of consensus, EPA will initiate rulemaking if
it concludes that the findings specified in section 4(a) of the Act can
be made. The schedule for initiating and completing such rulemaking
proceedings will, to the extent feasible, follow the schedule specified
in appendix A 1 to this part.

Subpart C—Implementation, Enforcement, and Modification of Test Rules

Source:   50 FR 20657, May 17, 1985, unless otherwise noted.
Redesignated at 51 FR 23713, June 30, 1986.

§ 790.40   Promulgation of test rules.

(a) If EPA determines that it is necessary to test a chemical substance
or mixture by rule under section 4 of the Act, it will promulgate a test
rule in part 799 of this chapter.

(b) EPA will promulgate specific test rules in part 799 of this chapter
either by a single-phase rulemaking procedure or by a two-phase
rulemaking procedure.

(1) Under single-phase test rule development, EPA will promulgate a test
rule in part 799 of this chapter through a notice and comment rulemaking
which specifies the following:

(i) Identification of the chemical for which testing is required under
the rule.

(ii) The health or environmental effect or effects or other
characteristics for which testing is being required.

(iii) Which test substance(s) must be tested.

(iv) Standards for the development of test data.

(v) The EPA Good Laboratory Practice requirements for the required
testing.

(vi) Schedule for submission of interim reports and/or final reports to
EPA.

(vii) Who must submit either letters of intent to conduct testing or
exemption applications.

(viii) What types of data EPA will examine in determining equivalence if
more than one test substance is to be tested.

(2) Under two-phase test rule development, EPA will promulgate a Phase I
test rule in part 799 of this chapter through a notice and comment
rulemaking which specifies the following:

(i) Identification of the chemical for which testing is required under
the rule.

(ii) The health or environmental effect or effects or other
characteristics for which testing is being required.

(iii) Which test substance(s) must be tested.

(iv) A reference to appropriate guidelines for the development of test
data.

(v) The EPA Good Laboratory Practice requirements for the required
testing.

(vi) Who must submit either letters of intent to conduct testing and
study plans, or exemption applications.

(vii) What types of data EPA will examine in determining equivalence if
more than one test substance is to be tested.

(3) Under two-phase test rule development, test standards and schedules
will be developed in a second phase of rulemaking as described in
§§790.50 and 790.52.

[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713,
June 30, 1986; 54 FR 36313, Sept. 1, 1989]

§ 790.42   Persons subject to a test rule.

(a) Each test rule described in §790.40 will specify whether
manufacturers, processors, or both are subject to the requirement for
testing of the subject chemical under section 4(b)(3)(B) of the Act and
will indicate who will be required to submit letters of intent to
conduct testing.

(1) If testing is being required to allow evaluation of risks:

(i) Primarily associated with manufacture of the chemical, or

(ii) Associated with both manufacturer and processing of the chemical,
or

(iii) Associated with distribution in commerce, use, and/or disposal
activities concerning the chemical, each manufacturer of the chemical
will be subject and must comply with the requirements of the test rule.

(2) While legally subject to the test rule in circumstances described in
paragraphs (a)(1) (ii) and (iii) of this section, processors of the
chemical must comply with the requirements of the test rule only if
processors are directed to do so in a subsequent notice as set forth in
§790.48(b).

(3) If testing is being required to allow evaluation of risks associated
solely with processing of the chemical, processors will be subject and
must comply with the requirements of the test rule.

(4) While legally subject to the test rule in circumstances described in
paragraph (a)(1) of this section, persons who manufacture less than 500
kg (1,100 lb) of the chemical annually during the period from the
effective date of the test rule to the end of the reimbursement period,
must comply with the requirements of the test rule only if such
manufacturers are directed to do so in a subsequent notice as set forth
in §790.48, or if directed to do so in a particular test rule.

(5) While legally subject to the test rule in circumstances described in
paragraph (a)(1) of this section, persons who manufacture small
quantities of the chemical solely for research and development (meaning
quantities that are not greater than those necessary for purposes of
scientific experimentation or analysis or chemical research on, or
analysis of, such chemical or another chemical, including such research
or analysis for development of a product) from the effective date of the
test rule to the end of the reimbursement period, must comply with the
requirements of the test rule only if such manufacturers are directed to
do so in subsequent notice set forth in §790.48, or if directed to do
so in a particular test rule.

(6) If testing is being required to allow evaluation of risks associated
primarily with manufacture of a chemical for research and development (R
& D) purposes, manufacturers of the chemical for R & D will be subject
and must comply with the requirements of the test rule.

(b) [Reserved]

[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 55 FR 18884, May 7, 1990]

§ 790.45   Submission of letter of intent to conduct testing or
exemption application.

(a) No later than 30 days after the effective date of a test rule
described in §790.40, each person subject to that rule and required to
comply with the requirements of that rule as provided in §790.42(a)
must, for each test required, either notify EPA by letter of his or her
intent to conduct testing or submit to EPA an application for an
exemption from testing requirements for the test.

(b) EPA will consider letters of intent to test as commitments to
sponsor the tests for which they are submitted unless EPA agrees to the
substitution of an exemption application in instances where more than
one person indicates an intent to sponsor equivalent tests.

(c) Each letter of intent to conduct testing must include:

(1) Identification of test rule.

(2) Name, address, and telephone number of the firm(s) which will be
sponsoring the tests.

(3) Name, address, and telephone number of the appropriate individual to
contact for further information.

(4) For sponsors participating in a testing consortium—a list of all
members of the consortium, the signature of an authorized representative
of each member, and a designation of who is to serve as principal
sponsor.

(5) A list of the testing requirements for which the sponsor(s) intends
to conduct tests.

(6) If EPA is requiring testing of more than one representative
substance—which test substance the sponsor(s) intends to use in each
of the tests.

(d)(1) Any person not manufacturing or processing the subject chemical
as of the effective date of the test rule describing in §790.40 or by
30 days after the effective date of the rule who, before the end of the
reimbursement period, manufacturers or processes the test chemical and
who is subject to and required to comply with the requirements of the
test rule must submit the letter of intent to test or an exemption
application required by paragraph (a) of this section by the date
manufacture or processing begins, or

(2) When both manufacturers and processors are subject to the rule, any
person not processing the subject chemical as of the effective date of
the test rule described in §790.40 or by 30 days after publication of
the Federal Register notice described in §790.48(b)(2) who, before the
end of the reimbursement period, processes the test chemical and who is
required to comply with the requirements of the rule must submit the
letter of intent to test or an exemption application required by
§790.48(b)(3) of the date processing begins.

(e) Manufacturers subject to a test rule described in §790.40 who do
not submit to EPA either a letter of their intent to conduct tests or a
request for an exemption from testing for each test for which testing is
required in the test rule will be considered in violation of that rule
beginning on the 31st day after the effective date of the test rule
described in §790.40 or on the date manufacture begins as described in
paragraph (d) of this section.

(f) Processors subject to a test rule described in §790.40 and required
to comply with the requirements of test rule pursuant to §790.42(a)(2)
or a Federal Register notice as described in §790.48(b)(2) who do not
submit to EPA either a letter of their intent to conduct tests or a
request for an exemption for each test for which testing is required in
the test rule will be considered in violation of that rule beginning on
the 31st day after the effective date of the test rule described in
§790.40 or 31 days after publication of the Federal Register notice
described in §790.48(b)(2) or on the date processing begins as
described in paragraph (d) of this section, as appropriate.

§ 790.48   Procedure if no one submits a letter of intent to conduct
testing.

(a) If only manufacturers are subject to the rule. (1) This paragraph
applies if testing is being required solely to allow evaluation of risks
associated with manufacturing and the test rule described in §790.40
states that manufacturers only are responsible for testing.

(2) If no manufacturer subject to the test rule has notified EPA of its
intent to conduct one or more of the required tests within 30 days after
the effective date of the test rule described in §790.40, EPA will
notify all manufacturers, including those described in §790.42(a)(4)
and (a)(5), by certified mail or by publishing a notice of this fact in
the Federal Register specifying the tests for which no letter of intent
has been submitted and will give such manufacturers an opportunity to
take corrective action.

(3) If no manufacturer submits a letter of intent to conduct one or more
of the required tests within 30 days after receipt of the certified
letter or publication of the Federal Register notice described in
paragraph (a)(2) of this section, all manufacturers subject to the rule
will be in violation of the test rule from the 31st day after receipt of
the certified letter or publication of the Federal Register notice
described in this paragraph.

(b) If manufacturers and processors are subject to the rule. (1) This
paragraph applies if testing is being required to allow evaluation of
risks associated with manufacturing and processing or with distribution
in commerce, use, or disposal of the chemical and the test rule
described in §790.40 states that manufacturers and processors are
responsible for testing.

(2) If no manufacturer subject to the rule has notified EPA of its
intent to conduct testing for one or more of the required tests within
30 days after the effective date of the test rule described in §790.40,
EPA will publish a notice in the Federal Register of this fact
specifying the tests for which no letter of intent has been submitted.

(3) No later than 30 days after the date of publication of the Federal
Register notice described in paragraph (b)(2) of this section, each
person described in §790.40(a)(4) and (5) and each person processing
the subject chemical as of the effective date of the test rule described
in §790.40 or by 30 days after the date of publication of the Federal
Register notice described in paragraph (b)(2) of this section must, for
each test specified in the Federal Register notice, either notify EPA by
letter of his or her intent to conduct testing or submit to EPA an
application for an exemption from testing requirements for the test.

(4) If no manufacturer or processor of the test chemical has submitted a
letter of intent to conduct one or more of the required tests within 30
days after the date of publication of the Federal Register notice
described in paragraph (b)(2) of this section, EPA will notify all
manufacturers and processors by certified letter or publish a Federal
Register notice of this fact specifying the tests for which no letter of
intent has been submitted. This letter or Federal Register notice will
give the manufacturers and processors an opportunity to take corrective
action.

(5) If no manufacturer or processor submits a letter of intent to
conduct one or more of the required tests within 30 days after receipt
of the certified letter or publication of the Federal Register notice
described in paragraph (b)(4) of this section, all manufacturers and
processors subject to the rule will be in violation of the test rule
from the 31st day after receipt of the certified letter or publication
of the Federal Register notice described in paragraph (b)(4) of this
section.

(c) Only processors are subject to the rule. (1) This paragraph applies
if testing is being required solely to allow evaluation of risks
associated with processing and the test rule described in §790.40
states that only processors are responsible for testing.

(2) If no processor subject to the rule has notified EPA of its intent
to conduct one or more of the required tests within 30 days after the
effective date of the test rule described in §790.40, EPA will notify
all the processors by certified mail or publish a notice in the Federal
Register of this fact, specifying the tests for which no letter of
intent has been submitted and give the processors an opportunity to take
corrective action.

(3) If no processor submits a letter of intent to conduct one or more of
the required tests within 30 days after receipt of the certified letter
or publication of the Federal Register notice described in paragraph
(c)(2) of this section, all processors subject to the rule will be in
violation of the test rule from the 31st day after receipt of the
certified letter or publication of the Federal Register notice described
in this paragraph.

[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 55 FR 18884, May 7, 1990]

§ 790.50   Submission of study plans.

(a) Who must submit study plans. (1) Persons who notify EPA of their
intent to conduct tests in compliance with the requirements of a single
phase test rule as described in §790.40(b)(1) must submit study plans
for those tests prior to the initiation of each of these tests, unless
directed by a particular test rule or consent agreement to submit study
plans at a specific time.

(2) Persons who notify EPA of their intent to conduct tests in
compliance with the requirements of a Phase I test rule as described in
§790.40(b)(2) must submit the proposed study plans for those tests on
or before 90 days after the effective date of the Phase I rule; or, for
processors complying with the notice described in §790.48(b)(2), 90
days after the publication date of that notice; or 60 days after the
date manufacture or processing begins as described in §790.45(d), as
appropriate, to the address in §790.5(b).

(3) Study plans must be prepared according to the requirements of this
subpart B and part 792 of this chapter. Only one set of study plans
should be prepared and submitted by persons who are jointly sponsoring
testing.

(4) Any person subject to a test rule may submit a study plan for any
test required by the rule at any time, regardless of whether the person
previously submitted an application for exemption from testing for that
test.

(5) Unless EPA has granted an extension of time for submission of
proposed study plans, manufacturers who notify EPA that they intend to
conduct testing in compliance with the requirements of a Phase I test
rule as described in §790.40(b)(2) and who do not submit proposed study
plans for those tests on or before 90 days after the effective date of
the Phase I test rule or 60 days after the date manufacture begins as
described in §790.45(d) will be considered in violation of the test
rule as if no letter of intent to test had been submitted.

(6) Unless EPA has granted an extension of time for submission of
proposed study plans, processors who notify EPA that they intend to
conduct testing in compliance with the requirements of a Phase I test
rule as described in §790.40(b)(2) and who do not submit proposed study
plans for those tests on or before 90 days after the effective date of
the Phase I test rule or 90 days after the publication date of the
notice described in §790.48(b)(2), or 60 days after the date processing
begins as described in §790.45(d), as appropriate, will be considered
in violation of the test rule as if no letter of intent to test had been
submitted.

(b) Extensions of time for submission of study plans. (1) EPA may grant
requests for additional time for the development of study plans on a
case-by-case basis. Requests for additional time for study plan
development must be made in writing to EPA at the address in §790.5(b).
Each extension request must state why EPA should grant the extension.

(2) Under two-phase rulemaking, extension requests must be submitted to
EPA within 60 days after the effective date of the Phase I test rule as
described in §790.40(b)(2); or for processors complying with the notice
described in §790.48(b)(2), 60 days after the publication date of that
notice; or 30 days after the date manufacture or processing begins as
described in §790.45(d), as appropriate.

(3) EPA will notify the submitter by certified mail of EPA's decision to
grant or deny an extension request.

(4) Persons who have been granted an extension of time for submission of
study plans as described in paragraph (b)(1) of this section and who do
not submit proposed study plans in compliance with the requirements of a
Phase I test rule in accordance with the new deadline granted by EPA
will be considered in violation of the test rule as if no letter of
intent to test had been submitted as described in §790.45(e) and (f).

(c) Content of study plans. (1) All study plans are required to contain
the following information:

(i) Identity of the test rule.

(ii) The specific test requirements of that rule to be covered by the
study plan.

(iii)(A) The names and addresses of the test sponsors.

(B) The names, addresses, and telephone numbers of the responsible
administrative officials and project manager(s) in the principal
sponsor's organization.

(C) The name, address, and telephone number of the appropriate
individual to contact for oral and written communications with EPA.

(D)(1) The names and addresses of the testing facilities and the names,
addresses, and telephone numbers of the testing facilities’
administrative officials and project manager(s) responsible for the
testing.

(2) Brief summaries of the training and experience of each professional
involved in the study, including study director, veterinarian(s),
toxicologist(s), pathologist(s), chemist(s), microbiologist(s), and
laboratory assistants.

(iv) Identity and data on the chemical substance(s) being tested,
including physical constants, spectral data, chemical analysis, and
stability under test and storage conditions, as appropriate.

(v) Study protocol, including the rationale for any combination of test
protocols; the rationale for species/strain selection; dose selection
(and supporting data); route(s) or method(s) of exposure; description of
diet to be used and its source; including nutrients and contaminants and
their concentrations; for in vitro test systems, a description of
culture medium and its source; and a summary of expected spontaneous
chronic diseases (including tumors), genealogy, and life span.

(vi) Schedule for initiation and completion of each short-term test and
of each major phase of long-term tests; dates for submission of interim
progress and final reports to EPA that are within the reporting
deadlines specified by EPA In the final test rule.

(2) Information required in paragraph (c)(1)(iii)(D) of this section is
not required in proposed study plans submitted in compliance with the
requirements of a Phase I test rule if the information is not available
at the time of study plan submission; however, the information must be
submitted before the initiation of testing.

(d) Incomplete study plans. (1) Upon receipt of a study plan, EPA will
review the study plan to determine whether it complies with paragraph
(c) of this section. If EPA determines that the study plan does not
comply with paragraph (c) of this section, EPA will notify the submitter
that the submission is incomplete and will identify the deficiencies and
the steps necessary to complete the submission.

(2) The submitter will have 15 days after the day it receives this
notice to submit appropriate information to make the study plan
complete.

(3) If the submitter fails to provide appropriate information to
complete a proposed study plan submitted in compliance with the
requirements of a Phase I test rule on or before 15 days after receipt
of the notice, the submitter will be considered in violation of the test
rule as if no letter of intent to conduct the test had been submitted as
described in §790.45(e) and (f).

(e) Amendments to study plans. Test sponsors shall submit all amendments
to study plans to the Director, Office of Compliance Monitoring at the
address in §790.5(d).

[50 FR 20657, May 17, 1985. Redesignated and amended at 51 FR 23713,
June 30, 1986; 52 FR 36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989;
55 FR 18884, May 7, 1990; 58 FR 34205, June 23, 1993; 60 FR 34466, July
3, 1995]

§ 790.52   Phase II test rule.

(a) If EPA determines that the proposed study plan described in
§790.50(a)(2) complies with §790.50(c), EPA will publish a proposed
Phase II test rule in the Federal Register requesting comments on the
ability of the proposed study plan to ensure that data from the test
will be reliable and adequate.

(b) EPA will provide a 45-day comment period and will provide an
opportunity for an oral presentation upon the request of any person. EPA
may extend the comment period if it appears from the nature of the
issues raised by EPA's review or from public comments that further
comment is warranted.

(c) After receiving and considering public comments on the study plan,
EPA will adopt, as proposed or as modified in response to EPA review and
public comments, the study protocol section of the study plan, as
defined by §790.50(c)(1)(v) of this chapter, as the test standard for
the required testing, and the schedule section of the study plan, as
defined by §790.50(c)(1)(vi) of this chapter, as the schedule for the
required testing in a final Phase II test rule.

[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 52 FR 36569, Sept. 30, 1987]

§ 790.55   Modification of test standards or schedules during conduct
of test.

(a) Application. Any test sponsor who wishes to modify the test schedule
for the mandatory testing conditions or requirements (i.e., “shall
statements”) in the test standard for any test required by a test rule
must submit an application in accordance with this paragraph.
Application for modification must be made in writing to EPA at the
address in §790.5(b), or by phone with written confirmation to follow
within 10 working days. Applications must include an appropriate
explanation and rationale for the modification. Where a test sponsor
requests EPA to provide guidance or to clarify a non-mandatory testing
requirement (i.e., “should statements”) in a test standard, the test
sponsor should submit these requests to EPA at the address in
§790.5(b).

(b) Adoption. (1) Where EPA concludes that the requested modification of
a test standard or schedule for a test required under a test rule is
appropriate, EPA will proceed in accordance with this paragraph (b).

(2) Where, in EPA's judgment, the requested modification of the test
standard or schedule would not alter the scope of the test or
significantly change the schedule for completing the test, EPA will not
ask for public comment before approving the modification. EPA will
notify the test sponsor by letter of EPA's approval. EPA will place
copies of each application and EPA approval letter in the rulemaking
record for the test rule in question. EPA will publish a notice annually
in the Federal Register indicating the test standards or schedules for
tests required in test rules which have been modified under this
paragraph (b)(2) and describing the nature of the modifications. Until
the Federal Register notice is published, any modification approved by
EPA under this paragraph (b)(2) shall apply only to the test sponsor who
applied for the modification under this paragraph (a) of this section.

(3) Where, in EPA's judgment, the requested modification of a test
standard or schedule would significantly alter the scope of the test or
significantly change the schedule for completing the test, EPA will
publish a notice in the Federal Register requesting comment on the
proposed modification. However, EPA will approve a requested
modification of a test standard under paragraph (b)(3) of this section
without first seeking public comment if EPA believes that an immediate
modification to the test standard is necessary to preserve the accuracy
or validity of an ongoing test. EPA may also modify a testing
requirement or test condition in a test standard if EPA determines that
the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a test schedule extension under
paragraph (b)(3) of this section without first seeking public comment if
EPA determines, on a case-by-case basis, that a delay of over 12 months
is not the fault of the test sponsor and is the result of unforeseen
circumstances such as a lack of laboratory availability, lack of
availability of suitable test substance (e.g., 14–C labelled test
substance), lack of availability of healthy test organisms, or the
unexpected failure of a long-term test. EPA will publish an annual
notice in the Federal Register announcing the approval of any test
standard modifications and test schedule extensions under paragraph
(b)(3) of this section and provide a brief rationale of why the
modification was granted.

(4) For purposes of this paragraph (b), a requested modification of a
test standard or schedule for a test required under a test rule would
alter the scope of the test or significantly change the schedule for
completing the test if the modification would:

(i) Change the test species.

(ii) Change the route of administration of the test chemical.

(iii) Change the period of time during which the test species is exposed
to the test chemical.

(iv) Except as provided in paragraph (b)(3) of this section, extend the
final reporting deadline more than 12 months from the date specified in
the final rule.

(c) Disapproval. Where EPA concludes that the requested modification of
a test standard or schedule for a test required under a test rule is not
appropriate, EPA will so notify the test sponsor in writing.

(d) Timing. (1) Test sponsors should submit all applications for test
schedule modifications at least 60 days before the reporting deadline
for the test in question.

(2) EPA will not normally approve any test schedule extensions submitted
less than 30 days before the reporting deadline for the test in
question.

(3) Except as provided in paragraph (b)(3) of this section, EPA may
grant extensions for up to 1 year but will normally limit extensions to
a period of time equal to the in-life portion of the test plus 60 days.

(4) EPA will normally approve only one deadline extension for each test.

(5) Test sponsors should submit requests for test standard modifications
as soon as they determine that the test cannot be successfully completed
according to the test standard specified in the rule.

[50 FR 20657, May 17, 1985. Redesignated at 51 FR 23713, June 30, 1986,
and amended at 52 FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989;
60 FR 34466, July 3, 1995]

§ 790.59   Failure to comply with a test rule.

(a) Persons who notified EPA of their intent to conduct a test required
in a test rule in part 799 of this chapter and who fail to conduct the
test in accordance with the test standards and schedules adopted in the
test rule, or as modified in accordance with §790.55, will be in
violation of the rule.

(b) Any person who fails or refuses to comply with any aspect of this
part or a test rule under part 799 of this chapter is in violation of
section 15 of the Act. EPA will treat violations of the Good Laboratory
Practice standards as indicated in §792.17 of this chapter.

Subpart D—Implementation, Enforcement and Modification of Consent
Agreements

Source:   51 FR 23715, June 30, 1986, unless otherwise noted.

§ 790.60   Contents of consent agreements.

(a) Standard provisions. All consent agreements will contain the
following provisions:

(1) Identification of the chemical(s) to be tested.

(2) The health effects, environmental effects and/or other
characteristics for which testing will be required.

(3) The names and addresses of each manufacturer and/or processor who
will sign the agreement.

(4) The name and address of the manufacturer, processor or other entity
who has agreed to act as the principal test sponsor.

(5) The technical or commercial grade, level of purity or other
characteristics of the test substances(s) or mixture(s).

(6) Standards for the development of test data.

(7) A requirement that testing will be conducted in accordance with the
EPA Good Laboratory Practice (GLP) regulations (40 CFR part 792).

(8) Schedules with reasonable deadlines for submitting interim progress
and/or final reports to EPA.

(9) A requirement that the principal sponsor will submit a study plan to
EPA in accordance with §790.62.

(10) A statement that the results of testing conducted pursuant to the
consent agreement will be announced to the public in accordance with the
procedures specified in section 4(d) of the Act and that the disclosure
of data generated by such testing will be governed by section 14(b) of
the Act.

(11) A requirement that the manufacturers and/or processors signing the
consent agreement will comply with the notification requirements of
section 12(b)(1) of the Act and part 707 of this chapter if they export
or intend to export the substance or mixture for which the submission of
data is required under the agreement and a statement that any other
person who exports or intends to export such substance or mixture is
subject to the above cited export notification requirements.

(12) A requirement that, in the event EPA promulgates a significant new
use rule applicable to the test chemical under section 5(a)(2), the
consent agreement will have the status of a test rule for purposes of
section 5(b)(1)(A) and manufacturers and/or processors signing the
agreement will comply with the data submission requirements imposed by
that provision.

(13) A statement that each manufacturer and/or processor signing the
agreement agrees that violation of its requirements will constitute a
“prohibited act” under section 15(1) of the Act and will trigger all
provisions of TSCA applicable to a violation of section 15.

(14) A statement that, in the event one or more provisions of the
agreement are determined to be unenforceable by a court, the remainder
of the agreement would not be presumed to be valid and EPA will then
either initiate a rulemaking proceeding or publish in the Federal
Register the Administrator's reason for not initiating such a
proceeding.

(15) A statement that the Agency may conduct laboratory inspections
and/or study audits of the testing being conducted pursuant to the
consent agreement in accordance with the authority and procedures
contained in section 11 of the Act.

(16) A statement that EPA acceptance of a consent agreement constitutes
“final agency action” for purposes of 5 U.S.C. 704.

(17) Any other requirements that the parties agree are necessary to
achieve the purposes of the Act.

(b) Contents of standards for the development of data. The standards for
the development of the data included in consent agreements will be based
on the TSCA test guidelines in 40 CFR parts 796, 797, and 798, the
Organization for Economic Cooperation and Development (OECD) test
guidelines, the EPA pesticide assessment guidelines published by The
National Technical Information Service (NTIS), or other suitable test
methodologies. During the negotiation of consent agreements, EPA will
initially propose suitable test guidelines as the required test
standards; manufacturers and processors or other interested parties may
then suggest alternative methodologies or modifications to the Agency's
proposed guidelines. These alternative methodologies or modifications
will be adopted only where, in the judgment of EPA, they will develop at
least equally reliable and adequate data on the chemical substance or
mixture subject to the agreement.

(c) Statement of rationale for consent agreement. EPA will prepare a
written explanation of the basis for each consent agreement. This
document will summarize the agreement, describe any ITC testing
recommendations for the chemical involved, outline the chemical's use
and exposure characteristics, and explain the objectives of the testing
to be conducted and the rationale for the specific studies selected.
This document will be published in the Federal Register and, for
ITC-designated chemicals, will constitute the statement of EPA's reasons
for not initiating rulemaking required by section 4(e)(1)(B) of the Act.

[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989]

§ 790.62   Submission of study plans and conduct of testing.

(a) Timing of submission. The principal sponsor of testing conducted
pursuant to a consent agreement shall submit a study plan no later than
45 days prior to the initiation of testing.

(b) Content of study plans. All study plans are required to contain the
following information:

(1) Identity of the consent agreement under which testing will be
performed.

(2) The specific test requirements to be covered by the study plan.

(3) The name and address of the principal test sponsor.

(4) The names, addresses, and telephone numbers of the responsible
administrative official[s] and project manager[s] in the principal
sponsor's organization.

(5) The names, addresses, and telephone numbers of the technical
contacts at each manufacturer and/or processor subject to the agreement.

(6) The names and addresses of the testing facilities responsible for
the testing and the names, addresses, and telephone numbers of the
administrative officials[s] and project manager[s] assigned to oversee
the testing program at these facilities.

(7) Brief summaries of the training and experience of each professional
involved in the study, including study director, veterinarian[s],
toxicologist[s], pathologist[s], chemist[s], microbiologist[s], and
laboratory assistants.

(8) Identity and supporting data on the chemical substance[s] being
tested, including physical constants, spectral data, chemical analysis,
and stability under test and storage conditions, as appropriate.

(9) Study protocol, including the rationale for any combination of test
protocols; the rationale for species/strain selection; dose selection
(and supporting data); route(s) or method(s) of exposure; description of
diet to be used and its source, including nutrients and contaminants and
their concentrations; for in vitro test systems, a description of
culture medium and its source; and a summary of expected spontaneous
chronic diseases (including tumors), genealogy, and life span.

(10) A schedule, with reasonable timeables and deadlines, for initiation
and completion of each short-term test and of each major phases of
long-term tests, and submission of interim progress and/or final reports
to EPA.

(c) Review and modification. (1) Upon receipt of a study plan, EPA will
review it to determine whether it complies with paragraph (b) of this
section. If EPA determines that the study plan does not comply with
paragraph (b) of this section, EPA will notify the submitter that the
plan is incomplete and will identify the deficiencies and the steps
necessary to complete the plan. It is the responsibility of the test
sponsor to review the study protocols to determine if they comply with
all the mandatory testing conditions and requirements in the test
standards (i.e., “shall statements”).

(2) The submitter will have 15 days after the day it receives a notice
under paragraph (c)(1) of this section to submit appropriate information
to make the study plan complete.

(3) If the submitter fails to provide appropriate information to
complete a study plan within 15 days after having received a notice
under paragraph (c)(1) of this section, the submitter will be considered
to be in violation of the consent agreement and subject to enforcement
proceedings pursuant to §790.65 (c) and (d).

(4) The test sponsor shall submit any amendments to study plans to EPA
at the address specified in §790.5(b).

(d) Functions of the principal test sponsor. When testing is being
conducted pursuant to a consent agreement, the principal test sponsor
will be responsible for submitting interim progress and final reports to
EPA, informing the Agency of any proposed changes in standards for the
development of data, study plans or testing schedules, and communicating
with the Agency about laboratory inspections and other matters affecting
the progress of testing.

[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989;
60 FR 34466, July 3, 1995]

§ 790.65   Failure to comply with a consent agreement.

(a) Manufacturers and/or processors who have signed a consent agreement
and who fail to comply with the test requirements, test standards, GLP
regulations, schedules, or other provisions contained in the consent
agreement, or in modifications to the agreement adopted pursuant to
§790.68, will be in violation of the consent agreement.

(b) The Agency considers failure to comply with any aspect of a consent
agreement to be a “prohibited act” under section 15 of TSCA, subject
to all of the provisions of the Act applicable to violations of section
15. Section 15(1) of TSCA makes it unlawful for any person to fail or
refuse to comply with any rule or order issued under section 4. Consent
agreements adopted pursuant to this part are “orders issued under
section 4” for purposes of section 15(1) of TSCA.

(c) Manufacturers and/or processors who violate consent agreements are
subject to criminal and/or civil liability. Under the penalty provisions
of section 16 of TSCA, such firms could be subject to a civil penalty of
up to $25,000 per violation with each day in violation constituting a
separate violation of section 15. Intentional violations could lead to
the imposition of criminal penalties of up to $25,000 for each day of
violation and imprisonment for up to one year. In addition, EPA could
invoke the remedies available under section 17 of TSCA, including
seeking an injunction to compel adherence to the requirements of the
consent agreement.

(d) Noncompliance with a consent agreement will constitute conduct “in
violation of this Act” under section 20(a)(1) of TSCA. Thus, failure
to comply with the requirements of a consent agreement could result in a
citizens’ civil action under section 20(a)(1) of TSCA.

§ 790.68   Modification of consent agreements.

(a) Changes in the scope of testing. (1) Manufacturers or processors
subject to a consent agreement, other persons or EPA may seek
modifications in the scope of testing performed under the consent
agreement. If, upon receiving a request for modification, EPA determines
that new issues have been raised that warrant reconsideration of the
scope of testing, or if EPA determines on its own that such
reconsideration is appropriate, EPA will publish a Federal Register
notice describing the proposed modification and soliciting public
comment. If, based on the comments received, EPA concludes that
differences of opinion may exist about the proposed modification, EPA
will establish a schedule for conducting negotiations and invite parties
who wish to participate in or monitor these negotiations to contact the
Agency in writing. Any negotiations that EPA conducts will conform to
the procedures specified in §790.22(b).

(2) The scope of testing required by a consent agreement will be
modified only where there is a consensus concerning the modified testing
requirements among EPA, affected manufacturers and/or processors, and
other persons who have asked to participate in or monitor negotiations
under paragraph (a)(1) of this section. In determining whether a
consensus exists, EPA will employ the criteria specified in §790.24. In
the absence of consensus, EPA may initiate rulemaking under section 4(a)
of the Act if it concludes that any testing beyond that required by the
consent agreement is necessary and that the other statutory findings
required by section 4(a) can be made. While such rulemaking proceedings
are underway, the consent agreement will remain in effect unless EPA
finds that the testing required by the agreement is or may be
unnecessary in view of the testing requirements included in EPA's
proposed rule.

(b) Changes in test standards or schedules. (1) Any test sponsor who
wishes to modify the test schedule for any test required under a consent
order must submit an application in accordance with this paragraph.
Application for modification must be made in writing to EPA at the
address in §790.5(b), or by phone with written confirmation to follow
within 10 working days. Applications must include an appropriate
explanation and rationale for the modification. EPA will consider only
those applications that request modifications to mandatory testing
conditions or requirements (“shall statements” in the consent
order). Where a test sponsor requests EPA to provide guidance or to
clarify a non-mandatory testing requirement (i.e., “should
statements”), the test sponsor should submit these requests to EPA at
the address in section 790.5(b).

(2)(i) Where EPA concludes that the requested modification of a test
standard or schedule for a test required under a consent agreement is
appropriate, EPA will proceed in accordance with this paragraph (b)(2).

(ii) Where, in EPA's judgment, the requested modification of a test
standard or schedule would not alter the scope of the test or
significantly change the schedule for completing the test, EPA will not
ask for public comment before approving the modification. EPA will
notify the test sponsor, and any other persons who have signed the
consent agreement, by letter of EPA's approval. EPA will place copies of
each application and EPA approval letter in the administrative record
maintained for the consent agreement in question. EPA will publish a
notice annually in the Federal Register indicating the test standards or
schedules for test required in consent agreements which have been
modified under this paragraph (b)(2)(ii) and describing the nature of
the modifications.

(iii) Where, in EPA's judgment, the requested modification of a test
standard or schedule would significantly alter the scope of the test or
significantly change the schedule for completing the test, EPA will
publish a notice in the Federal Register requesting comment on the
proposed modification. However, EPA will approve a requested
modification of a test standard under paragraph (b)(2)(iii) of this
section without first seeking public comment if EPA believes that an
immediate modification to the test standard is necessary to preserve the
accuracy or validity of an ongoing test. EPA also may modify a testing
requirement or test condition in a test standard if EPA determines that
the completion or achievement of this requirement or condition is not
technically feasible. EPA may approve a requested modification of a test
schedule under paragraph (b)(2)(iii) of this section without first
seeking public comment if EPA determines, on a case-by-case basis, that
a delay of over 12 months is not the fault of the test sponsor and is
due to unforeseen circumstances such as a lack of laboratory
availability, lack of availability of suitable test substance (e.g.,
14–C labelled test substance), lack of availability of healthy test
organisms, or the unexpected failure of a long-term test. EPA will
publish an annual notice in the Federal Register announcing the approval
of any test standard modifications and test scheduled extensions under
paragraph (b)(2)(iii) of this section, and provide a brief rationale of
why the modification was granted.

(iv) For purposes of this paragraph (b)(2), a requested modification of
a test standard of schedule for a test required under a consent
agreement would alter the scope of the test or significantly change the
schedule for completing the test if the modification would:

(A) Change the test species.

(B) Change the route of administration of the test chemical.

(C) Change the period of time during which the test species is exposed
to the test chemical.

(D) Except as provided in paragraph (b)(2)(iii) of this section, extend
the final reporting deadline more than 12 months from the date specified
in the consent order.

(3) Where EPA concludes that the requested modification of a test
standard or schedule for a test requirement under a consent agreement is
not appropriate, EPA will so notify the test sponsor in writing.

(c) Timing. (1) Test sponsors should submit all applications for test
schedule modifications at least 60 days before the reporting deadline
for the test in question.

(2) EPA will not normally approve any test schedule extensions submitted
less than 30 days before the reporting deadline for the test in
question.

(3) Except as provided in paragraph (b)(2)(iii) of this section, EPA may
grant extensions as shown necessary for up to 1 year but will normally
limit extensions to a period of time equal to the in-life portion of the
test plus 60 days.

(4) EPA will normally approve only one deadline extension for each test.

(5) Test sponsors should submit requests for test standard modifications
as soon as they determine that the test cannot be successfully completed
according to the test standard specified in the consent order.

[51 FR 23715, June 30, 1986, as amended at 52 FR 36571, Sept. 30, 1987;
54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]

Subpart E—Exemptions From Test Rules

Source:   50 FR 20660, May 17, 1985, unless otherwise noted.

§ 790.80   Submission of exemption applications.

(a) Who should file applications. (1) Any manufacturer or processor
subject to a test rule in part 799 of this chapter may submit an
application to EPA for an exemption from performing any or all of the
tests required under the test rule.

(2) Processors will not be required to apply for an exemption or conduct
testing unless EPA so specifies in a test rule or in a special Federal
Register notice as described in §790.48(b)(2) under the following
circumstances:

(i) If testing is being required to allow evaluation of risks associated
with manufacturing and processing or with distribution in commerce, use,
or disposal of the chemical and manufacturers do not submit notice(s) of
intent to conduct the required testing; or

(ii) If testing is being required solely to allow evaluation of risks
associated with processing of the chemical.

(b) When applications must be filed. (1) Exemption applications must be
filed within 30 days after the effective date of the test rule described
in §790.40 or, if being submitted in compliance with the Federal
Register notice described in §790.48(b)(2), within 30 days after the
publication of that notice.

(2) Exemption applications must be filed by the date manufacture or
processing begins by any person not manufacturing or processing the
subject chemical as of the effective date of the test rule described in
§790.40 or by 30 days after the effective date of the test rule
described in §790.40, who, before the end of the reimbursement period,
manufactures or processes the test substance and who is subject to the
requirement to submit either a letter of intent to test or an exemption
application.

(3) When both manufacturers and processors are subject to the rule,
exemption applications must be filed by the date processing begins by
any person not processing as of the effective date of the test rule
described in §790.40 or by 30 days after publication of the Federal
Register notice described in §790.48(b)(2) who, before the end of the
reimbursement period, processes the test substance and who is subject to
the requirement to submit either a letter of intent to test or an
exemption application.

(c) Scope of application. A person may apply for an exemption from all,
or one or more, specific testing requirements in a test rule in part 799
of this chapter.

[50 FR 20660, May 17, 1985, as amended at 58 FR 34205, June 23, 1993]

§ 790.82   Content of exemption application.

The exemption application must contain:

(a) The identity of the test rule, the chemical identity, and the CAS
No. of the test substance on which the application is based.

(b) The specific testing requirement(s) from which an exemption is
sought and the basis for the exemption request.

(c) Name, address, and telephone number of applicant.

(d) Name, address, and telephone number of appropriate individual to
contact for further information.

(e)(1) If required in the test rule to establish equivalence:

(i) The chemical identity of the test substance on which the application
is based.

(ii) Equivalence data specified in §790.85.

(2) If a test rule requires testing of a single representative
substance, EPA will consider all forms of the chemical subject to that
rule to be equivalent and will not require the submission of equivalence
data as described in §790.85.

[50 FR 20660, May 17, 1985, as amended at 54 FR 36315, Sept. 1, 1989]

§ 790.85   Submission of equivalence data.

If EPA requires in a test rule promulgated under section 4 of the Act
the testing of two or more test substances which are forms of the same
chemical, each exemption applicant must submit the following data:

(a) The chemical identity of each technical-grade chemical substance or
mixture manufactured and/or processed by the applicant for which the
exemption is sought. The exact type of identifying data required will be
specified in the test rule, but may include all characteristics and
properties of the applicant's substance or mixture, such as boiling
point, melting point, chemical analysis (including identification and
amount of impurities), additives, spectral data, and other physical or
chemical information that may be relevant in determining whether the
applicant's substance or mixture is equivalent to the specific test
substance.

(b) The basis for the applicant's belief that the substance or mixture
is equivalent to the test substance or mixture.

(c) Any other data which exemption applicants are directed to submit in
the test rule which may bear on a determination of equivalence. This may
include a description of the process by which each technical-grade
chemical substance or mixture for which an exemption is sought is
manufactured or processed prior to use or distribution in commerce by
the applicant.

§ 790.87   Approval of exemption applications.

(a) EPA will conditionally approve exemption applications if:

(1)(i) For single-phase test rules, EPA has received a letter of intent
to conduct the testing from which exemption is sought;

(ii) For two-phase test rules, EPA has received a complete proposed
study plan for the testing from which exemption is sought and has
adopted the study plan, as proposed or modified, as test standards and
schedules in a final Phase II test rule; and

(2) The chemical substance or mixture with respect to which the
application was submitted is equivalent to a test substance or mixture
for which the required data have been or are being submitted in
accordance with a test rule; and

(3) Submission of the required test data concerning that chemical
substance or mixture would be duplicative of data which have been or are
being submitted to EPA in accordance with a test rule.

(b)(1) If a single representative substance is to be tested under a test
rule, EPA will consider all forms of the chemical subject to that rule
to be equivalent and will contact the exemption applicant only if
information is missing or unclear.

(2) If two or more representative substances are to be tested under a
test rule, EPA will evaluate equivalence claims made in each exemption
application according to the criteria discussed in the test rule.

(i) If EPA finds an equivalence claim to be in error or inadequately
supported, the applicant will be notified by certified mail. The
applicant will be given 15 days to provide clarifying information.

(ii) Exemption applicants will be notified that equivalence has been
accepted or rejected.

(c) The final Phase II test rule which adopts the study plans in
two-phase rulemaking, a separate Federal Register notice in single-phase
rulemaking, or a letter by certified mail will give exemption applicants
final notice that they have received a conditional exemption. All
conditional exemptions thus granted are contingent upon the test
sponsors’ successful completion of testing according to the
specifications in the test rule.

§ 790.88   Denial of exemption application.

(a) EPA may deny any exemption application if:

(1) EPA determines that the applicant has failed to demonstrate that the
applicant's chemical is equivalent to the test substance; or

(2) The exemption applicant fails to submit any of the information
specified in §790.82; or

(3) The exemption applicant fails to submit any of the information
specified in §790.85 if required in the test rule; or

(4)(i) For single-phase test rules, EPA has not received a letter of
intent to conduct the test for which exemption is sought; or

(ii) For two-phase test rules, EPA has not received an adequate study
plan for the test for which exemption is sought; or

(5) The study sponsor(s) fails to initiate the required testing by the
deadlines adopted in the test rule; or

(6) The study sponsor(s) fails to submit data as required in the test
standard and deadlines for submission of test data as adopted in the
test rule or as modified in accordance with §790.55.

(b) EPA will notify the exemption applicant by certified mail or Federal
Register notice of EPA's determination that the exemption application is
denied.

§ 790.90   Appeal of denial of exemption application.

(a) Within 30 days after receipt of notification that EPA has denied an
application for exemption, the applicant may file an appeal with EPA.

(b) The appeal shall indicate the basis for the applicant's request for
reconsideration.

(c)(1) The applicant may also include a request for a hearing. Hearings
will be held according to the procedures described in §790.97.

(2) Hearing requests must be in writing and must be received by EPA
within 30 days of receipt of the letter or publication of the Federal
Register notice described in §790.88(b). Hearing requests must provide
reasons why a hearing is necessary.

(d) If EPA determines that there are material issues of fact, then the
request for a hearing will be granted. If EPA denies a hearing request,
EPA will base its decision on the written submission.

(e) EPA will notify the applicant of its decision within 60 days after
EPA receives the appeal described in paragraph (a) of this section or
within 60 days after completion of a hearing described in paragraph (c)
of this section.

(f) The filing of an appeal from the denial of an exemption shall not
act to stay the applicant's legal obligations under a test rule
promulgated under section 4 of the Act.

§ 790.93   Termination of conditional exemption.

(a) EPA shall terminate a conditional exemption if it determines that:

(1) The test which provided the basis for approval of the exemption
application has not been started by the deadlines for initiation of
testing adopted in the test rule or modified in accordance with
§790.55; or

(2) Data required by the test rule have not been generated in accordance
with the test standards or submitted in accordance with the deadlines
for submission of test data that were adopted in the test rule or
modified in accordance with §790.55; or

(3) The testing has not been conducted or the data have not been
generated in accordance with the Good Laboratory Practice requirements
in part 792 of this chapter.

(b) If EPA determines that one or more of the criteria listed in
paragraph (a) of this section has been met, EPA will notify each holder
of an affected conditional exemption by certified mail or Federal
Register notice of EPA's intent to terminate that conditional exemption.

(c) Within 30 days after receipt of a letter of notification or
publication of a notice in the Federal Register that EPA intends to
terminate a conditional exemption, the exemption holder may submit
information to rebut EPA's preliminary decision or notify EPA by letter
of its intent to conduct the required test pursuant to the test standard
established in the final test rule. Such a letter of intent shall
contain all of the information required by §790.45(c).

(d)(1) The exemption holder may also include a request for a hearing.
Hearings will be held in accordance with the procedures set forth in
§790.97.

(2) Hearing requests must be in writing and must be received by EPA
within 30 days after receipt of the letter or publication in the Federal
Register notice described in paragraph (b) of this section.

(e) EPA will notify the exemption holder by certified letter or by
Federal Register notice of EPA's final decision concerning termination
of conditional exemptions and will give instructions as to what actions
the former exemption holder must take to avoid being found in violation
of the test rule.

§ 790.97   Hearing procedures.

(a) Hearing requests must be in writing to EPA and must include the
applicant's basis for appealing EPA's decision.

(b) If more than one applicant has requested a hearing on similar
grounds, all of those appeals will be considered at the same hearing
unless confidentiality claims preclude a joint hearing.

(c) EPA will notify each applicant of EPA's decision within 60 days
after the hearing.

§ 790.99   Statement of financial responsibility.

Each applicant for an exemption shall submit the following sworn
statement with his or her application:

I understand that if this application is granted before the
reimbursement period described in section 4(c)(3)(B) of TSCA expires, I
must pay fair and equitable reimbursement to the person or persons who
incurred or shared in the costs of complying with the requirement to
submit data and upon whose data the granting of my application was
based.

Appendix A to Subpart E of Part 790—Schedule for Developing Consent
Agreements and Test Rules

EPA intends to follow the schedule set forth in this Appendix to
evaluate testing candidates, conduct negotiations, develop consent
agreements where appropriate, and propose and promulate test rules in
those instances where testing can be required under section 4(a) of TSCA
but agreement cannot be reached in timely manner on a consent agreement.
Where deadlines are imposed by the statute, they are binding on EPA and
will be observed by the Agency. The remaining dates represent targets
that EPA intends to meet.

This schedule is based on what EPA currently believes are reasonable
target dates. As EPA gains experience with the process and determines
the feasibility of these schedules, it may adjust the schedule
accordingly. EPA will solicit public comment before implementing any
changes in the schedule.

 

------------------------------------------------------------------------

           Week \1\                               Event

------------------------------------------------------------------------

0.............................  Receive ITC report, recommendation.

2.............................  Publish ITC report, 8(a) and 8(d)
notices, and invitation for public

                                 participation in negotiations.

3-6........................... Comment period on ITC report.

6.............................  Public focus meeting.

7-14..........................8(a) and 8(d) reporting period.

22............................ Public meeting on course-setting decision
and deadline for requests to

                                 participate in negotiations.

22-30........................Negotiations.

32............................ EPA decision point: consent agreement or
test rule.

------------------------------------------------------------------------

\1\ The dates contained in the left-hand column are calculated from the
date EPA receives the ITC report recommending a chemical for testing.

 

------------------------------------------------------------------------

  Week          Consent Agreement         Week          Test Rule

------------------------------------------------------------------------

36-40..........  Comment period on          32-60    Rule preparation,

                     consent agreement.                        agency
review and

                                                                        
 sign-off.

42.............    Comment resolution          62         Publish
proposed rule

                     meeting if necessary.                      in
Federal Register.\1\

48.............    Sign-off consent                70-106  Agency
reviews

                     agreement and Federal                   comments;

                     Register notice.                             
preparation of final

                                                                        
  rule or no-test

                                                                        
  decision, agency

                                                                        
  review and sign-

                                                                        
  off.\1\

50.............    Publish Federal                  108       Publish
final rule or

                     Register notice.                             
no-test decision in

                                                                        
  Federal Register.\1\

------------------------------------------------------------------------

\1\ As stated in § 790.26, EPA may publish an Advance Notice of
Proposed Rulemaking (ANPR) where the testing recommendations of the ITC
raise unusually novel and complex issues that require additional Agency
review and opportunity for public comment. EPA intends to publish such
ANPRs by Week 62 following receipt of the initial ITC report; to publish
a proposed rule or decision-not-to-test by Week 108; and to publish a
final rule or notice terminating the rulemaking process by Week 154.

[51 FR 23717, June 30, 1986]

 

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