
[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Rules and Regulations]               
[Page 49850-49864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au10-13]                         

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2010-0026]
RIN 2105-AD95

 
Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

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SUMMARY: The Department of Transportation (the Department or DOT) is 
amending certain provisions of its drug testing procedures dealing with 
laboratory testing of urine specimens. Some of the changes will also 
affect the training of and procedures used by Medical Review Officers. 
The changes are intended to create consistency with many, but not all, 
of the new requirements established by the U.S. Department of Health 
and Human Services.

DATES: This rule is effective October 1, 2010.

FOR FURTHER INFORMATION CONTACT: Mark Snider, Senior Policy Advisor (S-
1), Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey 
Avenue, SE., Washington, DC 20590; telephone number 202-366-3784 
(voice), 202-366-3897 (fax), or mark.snider@dot.gov (e-mail).

SUPPLEMENTARY INFORMATION: 

Background and Purpose

    On November 25, 2008 (73 FR 7185), the U.S. Department of Health 
and Human Services (HHS) Substance Abuse and Mental Health Services 
Administration (SAMHSA) issued a Final Notice of Revisions to the HHS 
Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS 
Mandatory Guidelines) that included changes to the procedures for 
collection and testing of urine specimens, creation of and requirements 
for the certification of Instrumented Initial Test Facilities (IITFs), 
collection site oversight requirements, and changes to the role of and 
standards for collectors and Medical Review Officers (MROs). The HHS 
Mandatory Guidelines were to become effective May 1, 2010, but on April 
30, 2010 (75 FR 22809), HHS postponed implementation until October 1, 
2010.
    On February 4, 2010, DOT published a Notice of Proposed Rulemaking 
(NPRM) (75 FR 5722) seeking comments about changing part 40 to be 
consistent with certain aspects of the HHS Mandatory Guidelines. The 
final rule responds to the comments and makes a number of changes to 
the existing rules governing the Department's drug testing program.

Principal Policy Issues

Requirements of the Omnibus Transportation Employee Testing Act of 1991

    Several commenters questioned whether and to what extent the 
Department must follow the HHS Mandatory Guidelines. Some commenters 
urged the Department to choose a different approach from the HHS 
regarding the drugs for which testing occurs, the initial testing of 
all specimens for 6-Acetylmorphine (6-AM), and the use of IITFs. 
Although since its passage, the Department has cited the Omnibus 
Transportation Employee Testing Act of 1991, 49 U.S.C. 31300, et seq., 
49 U.S.C. 20100, et seq., 49 U.S.C. 5330, et seq., and 49 U.S.C. 45100, 
et seq. (Omnibus Act), as the definitive authority for our reliance on 
the HHS Mandatory Guidelines for scientific testing issues, several of 
the commenters have challenged this or otherwise asked the Department 
to clarify what the Omnibus Act requires.
    Even before the Omnibus Act, the Department looked to the HHS 
Mandatory Guidelines for guidance on scientific matters. In a 1988 
Interim Final Rule (IFR) the Department relied upon the HHS for testing 
methodologies to determine the drugs for which testing would be done 
and which laboratories to use. Specifically, the Department noted that 
under ``the HHS Guidelines, a Federal agency may test a urine sample 
only for certain specified drugs. The Department's Procedures echo this 
requirement.'' (53 FR 47002, Nov. 21, 1988; emphasis in the original) 
In the same IFR, the Department required regulated transportation 
employers to use only laboratories certified under the HHS Mandatory 
Guidelines for Federal Workplace Drug Testing Programs. While deciding 
to utilize many aspects of the HHS Mandatory Guidelines, the Department 
acknowledged ``that the Guidelines, as written by HHS to apply to 
testing by Federal agencies, do not fit perfectly the circumstances of 
employers regulated by DOT * * *. Obviously, the circumstances of 
industries regulated by DOT are very different from those of Federal 
agencies.'' (53 FR 47002) Thus, the Department began to lay the 
foundation for using the technical expertise of the HHS for the 
scientific aspects of DOT's testing program while relying upon the 
Department's own authority and that of DOT agencies to tailor many 
procedural aspects of DOT testing to fit the transportation industries.
    In a 1989 final rule, we discussed the applicability of the Fourth 
Amendment of the United States Constitution to both the Federal agency 
programs covered by the HHS Mandatory Guidelines and the testing that 
transportation employers would conduct in response to the Department's 
requirements. The Department acknowledged that the HHS Mandatory 
Guidelines had passed Constitutional scrutiny by the Federal courts, 
all the way up to the Supreme Court of the United States. The Federal 
courts concluded that HHS had met the Fourth Amendment balancing of the 
Federal need to ensure safety by drug testing versus individuals' 
strong interests in their right to privacy. The HHS Mandatory 
Guidelines had set up a testing system with sound methodology that 
ensured privacy and accuracy. Given these considerations, the 
Department decided to rely on HHS for the science of DOT's testing 
program and for the drugs for which we test, the testing methodologies, 
and the integrity of the HHS certified laboratories. (54 FR 49854, Dec. 
1, 1989)
    Congress endorsed the Department's decision by explicitly 
directing, in the Omnibus Act, the Department to incorporate the HHS 
scientific and technical guidelines for laboratories and testing 
procedures for controlled substances. The Omnibus Act specifically 
requires that we incorporate the HHS scientific and technical 
guidelines that ``establish comprehensive standards for all aspects of 
laboratory controlled substances testing'' in order to ensure full 
reliability and accuracy in testing. [49 U.S.C. 31306(c)(2)(A), 49 
U.S.C. 20140(c)(2)(A), 49 U.S.C. 5331(d)(2)(A) and 49 U.S.C. 
45104(2)(A)] The legislative history for the Omnibus Act indicates the 
following intent: ``Incorporating the HHS

[[Page 49851]]

guidelines relating to laboratory standards and procedures for testing 
controlled substances, as proposed by the reported bill and as DOT has 
done in part 40 of title 49 CFR, as it exists at this writing, is an 
essential component of the procedural safeguard.'' Senate Report 102-
54, Omnibus Transportation Employee Testing Act of 1991, Report of the 
Senate Committee on Commerce, Science and Transportation on S.676, 
102nd Congress, 1st Session, May 2, 1991, page 26 (Senate Report 102-
54) (emphasis added). The Omnibus Act also requires the Department and 
DOT agencies to look to the HHS for laboratory certification, the 
procedures for reviewing laboratories for certification, and the 
procedures for the revocation of such certification. In addition, the 
Department must follow the HHS Mandatory Guidelines regarding 
establishing the list of drugs for which we test and the procedures for 
use of the Federal Drug Testing Custody and Control Form (CCF) to 
establish the chain of custody of specimens.
    The legislative history of the Omnibus Act indicates that Congress 
wanted the Department and DOT agencies to continue use of the HHS 
scientific and technical guidelines and the HHS certified laboratories 
to ensure accuracy, fairness, and the constitutionality of DOT's drug 
testing program. While the Omnibus Act was being drafted, opponents of 
drug testing warned that employees were in danger of ``false 
positives'' that would result from initial screening of urine that 
might indicate levels of illegal drugs. The Senate noted that it had 
addressed this concern: ``By incorporating laboratory certification and 
testing procedures developed by HHS and DOT and by providing for the 
subdivision of specimens and the opportunity for an independent test of 
positive samples, the Committee has taken affirmative steps to ensure 
accuracy.'' Senate Report 102-54, pages 6-7. The legislative history 
for the Omnibus Act makes numerous additional references to the 
understanding that the Department would work with HHS to ensure testing 
accuracy.
    There is also clear indication in the legislative history that 
Congress recognized that the HHS standards were likely to be modified 
over time. The Omnibus Act itself explicitly refers to incorporating 
the HHS ``scientific and technical guidelines dated April 11, 1988, and 
any subsequent amendments thereto * * *'' 49 U.S.C. 31306(c)(2), 49 
U.S.C. 20140(c)(2), 49 U.S.C. 5331(d)(2) and 49 U.S.C. 45104(2). 
Allowing for subsequent amendments, however, did not mean that Congress 
wanted to lower the standards for testing. ``Realizing that these 
guidelines possibly are subject to future modification, the Committee 
has acted to specify that the basic elements of certain provisions now 
in effect are mandated, including the need for comprehensive standards 
and procedures for all aspects of laboratory testing of drugs, the 
establishment of a minimum list of controlled substances for which 
employees may be tested, the establishment of standards and procedures 
for the periodic review of laboratories, and the development of 
criteria for laboratory certification.'' Senate Report 102-54, pages 
21-22, 26 and 32.
    When the Omnibus Act requires the Department to follow HHS on 
specified scientific matters, we adhere to the requirements. When the 
Omnibus Act allows the Department the option of following HHS, we have 
always and will continue to weigh the costs and benefits of following 
HHS in light of our mission. However, when the Omnibus Act specifically 
requires the Department to take a direction different from that which 
HHS takes, then the Department is prohibited from following HHS on such 
matters.
    In reviewing the Omnibus Act, its legislative history, and the 
regulatory history of the Department's testing program, it remains 
clear that, since the inception of our program, the Department has been 
tied to HHS for the scientific methodology, for identification of the 
drugs for which we will require testing; the certified laboratories we 
are to use; and the technical expertise for certifying and decertifying 
laboratories. These are the core scientific laboratory functions 
necessary for the Department's program.
    However, it is important to note that the Department has discretion 
concerning many other aspects of the regulations governing testing in 
the transportation industries' regulated programs.
    As far back as 1988, our regulations established the fundamental 
roles and concepts for the current DOT regulated industry testing 
program. Our early regulations established how collections were to be 
done, who could be an MRO or a Substance Abuse Professional (SAP), and 
the respective training for and responsibilities of these important 
gatekeepers. While relying on HHS for certain scientific efforts, we 
did not necessarily follow HHS regarding collection issues, laboratory 
reporting requirements, how MROs handle certain test results, the 
rehabilitation and the return-to-duty process, and other areas covered 
by the HHS Mandatory Guidelines. The Department's regulation and the 
regulations of DOT agencies set their own processes and procedures for 
all aspects leading up to and through specimen collection and then 
picking up from what processes and procedures would occur after a 
laboratory confirmed a drug test result, including the return-to-duty 
process for individuals who have non-negative test results. In shaping 
our program to fit the needs of the transportation industries, the 
Department and DOT agencies have made adaptations to meet the changing 
needs of the transportation industries. In some cases we have 
consequently chosen a different path from the one chosen by HHS on the 
same or similar non-scientific issues.
    The Omnibus Act acknowledged that such Departmental and DOT agency 
regulations were in place with respect to non-scientific issues. 
Congress explicitly allowed these regulations to continue in effect, 
with the option for the Department and DOT agencies to amend or further 
supplement their respective regulations in the future. 49 U.S.C. 
31306(i), 49 U.S.C. 20140(f), and 49 U.S.C. 45106(c).
    One example of the Department's divergence from HHS on non-
scientific matters covered in the HHS Mandatory Guidelines is the issue 
of how to conduct direct observation collections. On June 25, 2008, the 
Department issued a final rule (73 FR 35961) that, among other 
amendments, modified 49 CFR part 40 at section 40.67(b) and added a new 
paragraph 40.67(i) to improve direct observation procedures to better 
address known adulteration and substitution threats. Although HHS 
addresses direct observation collections in the HHS Mandatory 
Guidelines, the Department chose to use a different procedure because 
of evidence regarding cheating and our experience in regulating the 
transportation industries. In explaining our rationale, we noted that 
the use of direct observation collections is ``a very significant tool 
the Department employs to combat attempts by employees to cheat on 
their tests.'' (74 FR 37949, July 30, 2009) In addition, we stated in 
the final rule reinstating the direct observation provisions after the 
court victory, ``the Department remains convinced that conducting all 
return-to-duty and follow-up tests under direct observation is the most 
prudent course from the viewpoint of safety.'' (74 FR 37950, quoting 
the October 22, 2008 final rule preamble at 73 FR 62918)
    The Department's regulations concerning direct observation 
procedures were affirmed by a unanimous court. (BNSF Railway Company v. 
Department of

[[Page 49852]]

Transportation, 566 F.3d 200 (DC Cir. 2009) In upholding the rule, the 
U.S. Court of Appeals for the D.C. Circuit noted that the Department 
had experience, comments, and evidence to support the need to make the 
improvements to the direct observation procedures. BNSF Railway Company 
v. Department of Transportation, 566 F.3d at 204. The Court further 
found that the improved procedures were constitutional, stating, 
``[g]iven the combination of the vital importance of transportation 
safety, the employees' participation in a pervasively regulated 
industry, their prior violations of the drug regulations, and the ease 
of obtaining cheating devices capable of defeating standard testing 
procedures, we find the challenged regulations facially valid under the 
Fourth Amendment.'' Id. at 208. Hence, the Department chose a different 
approach from HHS on direct observation procedures, tailored them to 
the needs identified, and the Court upheld this approach as 
constitutional.
    Some of the commenters asked the Department to consider deviating 
from the HHS Mandatory Guidelines regarding the drugs for which testing 
is required. Some commenters want the Department to exclude 
Methylenedioxymethamphetamine (MDMA) from the list of drugs, while 
others want the Department to include synthetic opiates, and others 
want alternative testing methodologies to be employed.
    It is not unusual for the Department to receive requests from 
commenters to move away from the illegal drugs for which HHS has set 
the protocols; however, the Department has remained consistent in our 
responses and our reliance upon HHS as the scientific experts in these 
matters. What the Department stated in response to similar requests in 
the late 1990s to move beyond the HHS minimums still remains true: 
``This is a long-standing issue in the program, and DOT continues to 
take the position that we ought not to go beyond the testing that HHS 
has authorized and for which HHS has certified laboratories.'' (65 FR 
79484, Dec. 19, 2000) In response to those who have urged DOT to go 
beyond the drugs for which HHS tests, we have consistently stated: ``we 
believe the stability and reliability of the program are well served by 
limiting testing to the `HHS five.' HHS has established testing 
protocols and cutoffs for these drugs, and laboratories are subject to 
HHS certification for testing of these five drugs. This is not true for 
other drugs.'' (65 FR 79491, Dec. 19, 2000) Although the HHS has now 
expanded its panel to include an additional amphetamine, MDMA, the same 
reasoning holds true and the Department will continue to follow the HHS 
testing protocols for the reasons we explained in 2000.
    Also in 2000, the Department explained, ``With respect to 
alternative testing technologies such as hair testing, saliva testing, 
and on-site testing, which commenters recommended in context of several 
sections of the NPRM, the Department will wait upon the action of HHS 
before proposing to incorporate additional methods. Approval of these 
or other methods, and establishment of requirements and procedures for 
them, are matters primarily within the expertise of HHS.'' (65 FR 
79489, Dec. 19, 2000) Furthermore, in the preamble to our Specimen 
Validity Testing final rule in 2008 (SVT Final Rule), we stated that 
the Omnibus Act ``provides only one way to determine that an employee 
has tested positive for illicit drug use--a drug test confirmed by an 
HHS-certified laboratory using HHS scientific and testing protocols and 
verified by an MRO.'' (73 FR 35966, June 25, 2008)
    The Department, as required by the Omnibus Act, has consistently 
specifically followed HHS on laboratory certification matters, but we 
have also created responsibilities for laboratories under part 40 that 
do not impinge upon the scientific and technical aspects of drug 
testing. As the Department stated in 2000, ``laboratories have 
responsibilities under part 40 independent of their HHS 
responsibilities (e.g., with respect to relationships with MROs, 
release of information, and validity testing), and laboratories must be 
accountable to DOT in those matters.'' (65 FR 79484, Dec. 19, 2000)
    At times, we have had to adapt certain aspects of technical drug 
testing matters to fit the needs of the transportation industries. For 
example, in 2003, the Department issued an interim final rule (2003 
IFR) concerning laboratory substitution criteria. (68 FR 31624, May 28, 
2003) In the 2003 IFR, we did not, and could not, change the HHS-
established laboratory testing substitution criteria, but instead 
addressed how laboratories were to report out their findings to the 
MROs on the CCF, what subsequent actions would be required of the MROs 
with respect to the reported result, and whether to tell the employer 
to send the employee back in for a direct observation collection. In 
short, we said that specimens reported by laboratories as substituted 
with creatinine concentration in the 2-5 ng/mL range would not be 
considered by MROs to be refusals to test. Instead, transportation 
employees with such results would require immediate recollections under 
direct observation.
    In a July 2008 interpretation, which is being incorporated in this 
final rule at section 40.159, the Department instructed MROs on how to 
``handle laboratory results reported as invalid because of pH greater 
than or equal to 9.0 but less than or equal to 9.5.'' This is another 
example of how the Department has adapted the HHS scientific 
requirements established for laboratories to the needs of the 
transportation industries. In fact, the HHS Mandatory Guidelines have 
adopted our MRO provisions for invalids due to pH in the 9.0-9.5 range.
    We read the Omnibus Act to require the Department to follow the HHS 
on the drugs for which we test and the testing protocols, but the 
Omnibus Act allows us to, and we have chosen to, diverge from the HHS 
and the HHS Mandatory Guidelines on collections, MROs, and what 
laboratories can report. As we said in our 2008 SVT Final Rule 
preamble, ``Since Congress specifically limited the scientific testing 
methodology upon which DOT can rely in making its drug and alcohol 
testing regulations; we follow the HHS scientific and technical 
guidelines, including the amendments to their Mandatory Guidelines.'' 
(73 FR 35961, June 25, 2008) In the 2008 SVT Final Rule, we also 
explained that the ``Omnibus Act requires the DOT to incorporate the 
HHS scientific and technical guidelines, and we do not have the 
authority to impose additional scientific and technical requirements 
upon the laboratories.'' (73 FR 35963, June 25, 2008)
    In response to the commenters who would like us to consider 
alternative specimens such as hair testing and point of collection 
testing, we reiterate what we said in response to comments on our 
direct observation final rule in late 2008: ``The Department is not 
opposed to the use of alternative, less intrusive, testing methods as a 
means of accomplishing the safety purposes of the program while 
preventing individuals from cheating. Under the Omnibus Transportation 
Employee Testing Act of 1991, however, the Department is authorized to 
use only testing methods that have been approved by the Department of 
Health and Human Services (HHS). To date, HHS has not approved any 
specimen testing except urine.'' (73 FR 62917, Oct. 22, 2008) 
Therefore, we cannot consider alternative specimens at this particular 
point in time. In fact, DOT would not desire to do so without the HHS

[[Page 49853]]

scientific and laboratory certification processes being in place.
    Several commenters have asked us to explain how the Omnibus Act 
affects the Department's determination of whether it will and will not 
follow HHS. In response, as we explained above, where the Omnibus Act 
requires the Department to follow the HHS--for the laboratory and 
testing procedures, the Department will follow the scientific and 
technical aspects prescribed by the HHS. Where the Omnibus Act limits 
or otherwise prohibits the Department from following the HHS, the 
Department must decline to follow the lead of the HHS. For example, 
when HHS did not embrace a split specimen requirement, the Department 
departed from the HHS Mandatory Guidelines due to the Omnibus Act's 
requirements for split specimens. Where the HHS takes a position that 
we are neither required to follow nor prohibited from following, the 
Department will continue to view the HHS position as optional. We 
recognize that the HHS has expertise in the Federal employee testing 
program for these optional matters, but the Department has its own 
expertise as the regulator of the largest workplace drug and alcohol 
testing program in the world. As such, we will consider the optional 
matters in light of transportation safety, the costs and benefits to 
our regulated industries, and scientific and forensic considerations.

Use of Instrumented Initial Test Facilities

    In our NPRM, we proposed allowing DOT employers to choose between 
full service laboratories and IITFs. An IITF would be able to provide 
results to employers only for negative and certain negative dilute 
specimens, as well as specimens they reject for testing. All other 
specimens would be forwarded to an HHS certified, full service 
laboratory. We requested comments as to how this process would impact 
the industry, specifically employers. The majority of commenters felt 
that use of IITFs would be detrimental to the turnaround time for 
reporting of non-negative results and most did not favor use of IITFs. 
Other commenters believed IITFs would be very useful, accurate, and 
afford the ability for a rapid turnaround time for their negative 
results.

DOT Response

    The Omnibus Act actually prohibits the Department from following 
HHS on the issue of IITFs. The Omnibus Act requires ``that all 
laboratories involved in the controlled substances testing of any 
individual under this section shall have the capability and facility, 
at such laboratory, of performing screening and confirmation tests.'' 
(49 U.S.C. 31306(c)(3), 49 U.S.C. 20140(c)(3), 49 U.S.C. 5331(d)(3) and 
49 U.S.C. 45104(3)) An IITF can conduct the initial screening for drugs 
in a urine specimen, but is not certified to provide a confirmation 
test.
    Since IITFs do not have any confirmation testing capabilities, the 
Department must not use them in part 40. The Senate Report for S. 676, 
the bill that subsequently became the Omnibus Act, indicates the intent 
behind this requirement was to ensure that ``[a]ny testing program 
would be required to include procedures to protect individual privacy, 
incorporate laboratory certification and testing procedures developed 
by [HHS] * * * require that all laboratories involved in testing for 
drugs have the capability of performing screening and confirmation 
tests at such laboratory.'' Senate Report 102-54, pages 10-11. Because 
IITFs do not offer confirmation testing, the Department is prohibited 
by the Omnibus Act from using laboratory facilities that lack the 
capability to perform both screening and confirmation tests. Therefore, 
DOT employers do not have the option of using IITFs. For this reason 
there are no provisions in this final rule for IITFs, and they will not 
be authorized for use in DOT's program by our regulated employers.

MDMA Testing

    In the NPRM, we proposed to incorporate testing for MDMA into part 
40.
Comments
    A majority of commenters favored testing for MDMA. A few commenters 
indicated that their data showed that there would be relatively few 
positive test results, creating an unnecessary cost burden to 
employers. One laboratory group opposed the inclusion of MDMA and 
suggested the Department test instead for ``hydromorphone, hydrocodone, 
oxycodone, and oxymorphone.''
    Those who favored testing MDMA represented a wide range of 
interests--MRO groups, third-party administrators, a major employer 
association, a major service agent association, among them. Most who 
supported testing for MDMA said that many employers were already 
testing for MDMA in their non-DOT testing programs. They supported 
putting MDMA testing into the Federal testing arena.
    Some commenters presented information about the use of MDMA, saying 
that MDMA was no longer a threat; MDMA is strictly a drug for younger 
persons; MDMA is a ``club'' drug that is not being used by 
transportation employees.
    Others presented data showing that MDMA use is on the rise and the 
implication is that the threat of MDMA use will become greater as the 
current transportation population is replaced via attrition by a 
younger population.
DOT Response
    In this rulemaking, we are adopting the HHS laboratory testing 
requirements of conducting initial testing for MDMA, conducting 
confirmatory testing for MDMA, Methylenedioxyamphetamine (MDA), and 
Methylenedioxyethylamphetamine (MDEA). As we stated in our NPRM, 
regarding such matters, ``past experience has shown that DOT has never 
deviated from HHS on laboratory testing matters--the drugs for which we 
test, the specimens we test, specimen validity testing values, initial 
and confirmatory cutoff values, and laboratory testing processes and 
procedures, among others. The DOT is required by the Omnibus 
Transportation Employee Testing Act of 1991 to adhere with the HHS on 
these important laboratory testing matters.'' (75 FR 5722-5723, Feb. 4, 
2010) We can provide additional guidance to MROs, as appropriate, so 
that these changes fit the transportation industries. However, we do 
not read our authority as allowing us to depart from HHS on this 
subject.
    Aside from the fact that the Omnibus Act requires us to test the 
drugs for which HHS labs are certified to test, we note that, as some 
commenters said, MDMA is not just a ``club drug'' any more, it is being 
marketed to a much larger population in American communities.
    The Department of Justice National Drug Intelligence Center's 2010 
National Drug Threat Assessment (http://www.justice.gov/ndic/pubs38/
38661/38661p.pdf ) supports DOT's conclusion with regard to MDMA 
availability, finding:

    ``Asian DTOs [Drug Trafficking Organizations] are responsible 
for a resurgence in MDMA availability in the United States, 
particularly since 2005. These groups produce large quantities of 
the drug in Canada and smuggle it into the United States across the 
Northern Border. The smuggling of MDMA into the United States from 
Canada fueled an increase in the availability of the drug that began 
in 2005, although availability appears to be stabilizing. Data 
regarding MDMA availability are limited; nonetheless, analysis of 
National Forensic Laboratory Information System (NFLIS) data shows a 
76 percent increase in the number of MDMA submissions from 2005 to 
2008, although

[[Page 49854]]

MDMA submissions make up a much smaller percentage of submissions 
than other illicit drugs, including cannabis, cocaine, 
methamphetamine, and heroin. National Drug Threat Survey (NDTS) data 
also provide an indication of MDMA availability. The percentage of 
state and local law enforcement agencies that reported moderate or 
high availability of MDMA in their areas increased from 47.2 percent 
in 2005 to 51.5 percent in 2009.
    Seizure data show that the amount of MDMA seized along the 
U.S.[dash]Canada border increased 156 percent from 2007 to 2008 and 
that more MDMA was seized at the Northern Border in 2008 than in any 
year since 2005. MDMA seizure totals declined in 2009 but still 
exceeded 2007 totals. Although most Northern Border seizures occur 
at POEs (Points of Entry), the amount of MDMA seized between POEs 
appears to be increasing, likely because increased scrutiny at POEs 
has forced smugglers to develop new routes and smuggling methods in 
an attempt to circumvent law enforcement.
    For example, in 2008, more than 243,000 dosage units of MDMA 
were seized between POEs, compared with none the previous year; 
seizures between POEs in 2009 exceeded those in 2008.
    MDMA seizures along the Southwest Border and through commercial 
air have also increased, albeit on a much smaller scale. Seizures at 
or near the Southwest Border show an increase from 114,286 dosage 
units in 2006 to 387,143 dosage units in 2009. Furthermore, 
commercial air seizures spiked in 2008, with a 91.4 percent increase 
from 2007 to 2008 (433,571 dosage units to 829,857 dosage units); 
MDMA commercial air seizure totals for 2009 decreased, resulting in 
levels comparable to 2007 levels.
    Ready availability of MDMA has enabled distributors to expand 
their customer base to include new user groups, most notably African 
American and Hispanic users. Asian DTOs have begun distributing MDMA 
to African American and Hispanic street gangs, which distribute the 
drug along with other illicit drugs in markets throughout the United 
States, most notably in the Southeast, Southwest, and Great Lakes 
Regions. Moreover, MDMA is no longer exclusively viewed as a 
``rave'' or club drug, which also aids distributors in selling it to 
nontraditional abusers.''

    One laboratory group urged DOT to require testing prescription 
medications and synthetic drugs, rather than MDMA. While DOT shares the 
group's concern about unauthorized use of the prescription medications 
and the use of synthetic drugs, testing for prescription medications 
and synthetic drug and testing for MDMA are separate issues. As part of 
their non-DOT testing programs, regulated employers can test for 
prescription medications or synthetic drugs and in many instances it 
may be appropriate to do so.
    Some DOT agencies and the United States Coast Guard (USCG), for 
instance, have medical qualification standards--for Commercial Drivers 
License holders, certified pilots and aviation mechanics, and licensed 
mariners--that focus upon the underlying medical conditions that would 
require use of prescription medications. Evaluating medical 
professionals are trained to seek information that would shed light on 
an individual's use of medicines and their qualification to perform 
safety sensitive duties.
    It is also important to note that employers can expand upon the 
Department's regulatory requirements, as long as they do not represent 
the test as being required by DOT. Under their non-DOT testing 
programs, DOT-regulated companies may test for other drugs of their 
choosing. Therefore, companies are not prohibited by DOT from testing 
for additional drugs that may be of concern within their communities 
and companies.

Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines

    The Department proposed, in the NRPM, to adopt the HHS-lowered 
laboratory testing cutoffs for cocaine and amphetamines. Initial test 
cutoffs for cocaine metabolites would go from 300 to 150 ng/mL, while 
confirmation test cutoffs would go from 150 to 100 ng/mL.
    For amphetamines, initial test cutoffs would go from 1000 to 500 
ng/mL, while confirmation tests for amphetamines and methamphetamines 
would go from 500 to 250 ng/mL.
Comments
    Most commenters support the Department's conforming to the HHS 
Mandatory Guidelines in lowering the cutoffs for both cocaine and 
amphetamines. Most believe doing so will enhance the safety of the 
traveling public because more users of illicit drugs and more users of 
non-prescribed medications will be identified. There was no controversy 
about the new screening and confirmation test levels for cocaine.
    Some commenters believed that there could be ``false positive'' 
drug tests stemming from the new cutoffs for amphetamines. Some others 
believed the amphetamine cutoffs could even cause laboratories to 
report over-the-counter (OTC) medications as confirmed positive test 
results. Some others believed that lowering the screening cutoffs for 
amphetamines will provide little value in the confirmation process, 
serving only to increase the cost of the program.
    Some commenters cited the data from one of the laboratories--
Clinical Research Laboratory (CRL)--as reason to support the new 
cutoffs, while others cited the same data as reason to oppose the new 
cutoffs.
DOT Response
    As stated earlier in this document, the Department must follow the 
laboratory testing protocols and standards that are established by HHS. 
Therefore, we must and will adhere to the screening and confirmation 
drug testing cutoffs that HHS has established for the laboratories and 
for which the laboratories are certified. In addition, taken with the 
comment data from Quest Laboratories, we believe the laboratory data 
sets from both Quest and CRL lead likely to some, but not all, of the 
same conclusions.
    Regarding cocaine, based upon data provided by both Quest and CRL, 
we can expect a marked increase in cocaine users identified using the 
new screening and confirmation cutoffs that HHS has established. The 
Department, like the overwhelming number of commenters, considers this 
to be a beneficial change.
    In 2009, there were nearly 13,000 positive DOT drug test results 
reported by laboratories as having confirmed positives for cocaine. 
Quest and CRL data show that we can expect a significant number of 
confirmed positive test results for cocaine using the new cutoffs. 
These new lower cutoffs should result in the Department identifying 
more cocaine users, further assuring the traveling public that the 
transportation system is the safest it can be. Doing so will also 
permit us to continue to further deter drug use in the transportation 
industries and get those identified as using drugs referred for 
evaluation and treatment.
    Regarding amphetamine and methamphetamine, the Quest data report on 
68,000 regulated and 132,000 non-regulated specimens and indicate that 
a 40% increase in screening and a 30% increase in confirmation rates 
are expected; hence, a large number of currently non-detected users 
would be identified.
    A second submission of amphetamine and methamphetamine test data, 
this from CRL, includes the reanalysis of a much smaller number of 
regulated specimens. Several important facts about the CRL study 
protocols and results were not fully explained or clarified in their 
data submission. As a result, we are concerned that other commenters 
may have misinterpreted the CRL data as meaning that there will be 
``false positive'' tests results for amphetamines and that some OTC 
medications--ephedrine, pseudoephedrine, and phenylpropanolamine--will 
be confirmed and reported as positives by laboratories.

[[Page 49855]]

    We want to address these commenters' statements that testing at the 
new amphetamine screening cutoffs will yield ``false positive'' test 
results. Neither CRL nor Quest even alluded to there being a ``false 
positive'' testing issue with the new amphetamine cutoffs. Concerns 
about the risks of ``false positive'' test results are not supported by 
the available data. In fact, no reportable positive test results were 
identified in the CRL and Quest data on specimens that did not, in 
fact, screen and confirm positive for a drug for which DOT tests.
    In addition, we want to clarify that no OTC medication that CRL 
chose to test for--ephedrine, pseudoephedrine, and 
phenylpropanolamine--would confirm positive on a DOT test and would be 
reported on a DOT test. We are concerned that the CRL confirmation 
testing on these specimens may have proven misleading to the groups who 
read the data and believed that our tests for amphetamines would 
identify these particular OTC medications. It is our opinion that CRL's 
inclusion of this confirmation test data does not support CRL's 
conclusion. Laboratories simply will not conduct confirmation testing 
for or identify these OTC medications in DOT's program.
    It is also important to note that only confirmed positive drug 
tests are reported to the MRO as positive. No results screened positive 
are reported as positive until and unless they are also positive on a 
laboratory confirmation test and for the drugs for which we test. And, 
no test result is reported to the employer until the MRO properly 
verifies the result by determining if the employee has a legitimate 
medical explanation for the positive. If the employee has a legitimate 
medical explanation, the MRO will report the result to the employer as 
a negative test. These are ``due process'' steps that have always been 
an integral part of DOT's testing program.
    We realize that laboratories will certainly screen specimens for 
amphetamines at the new HHS cutoffs and will not realize the same 
return rate on confirmed positive testing as they observe now, as CRL 
points out effectively in their data. CRL is concerned that the cost of 
confirming the increased number of screened positive tests does not 
warrant the expense for such a small number of confirmed positives, as 
shown by their data.
    It is important to note that the confirmation rates for opiates and 
amphetamines is now generally less than that for THC, cocaine, and PCP. 
Therefore, it is not unusual to see a disparity between screening rates 
and subsequent confirmation rates, especially for opiates and 
amphetamines.
    However, we will urge HHS to closely monitor this screening issue 
for amphetamines during the first year the new cutoffs are in place. We 
believe that the issue will be properly evaluated by HHS with DOT, the 
Center for Substance Abuse Prevention Drug Testing Advisory Board (CSAP 
DTAB), and laboratories in determining if the screening cutoffs for 
amphetamine would need to be modified upward if the added cost largely 
outweighed the benefits. The CSAP DTAB provides advice to the 
Administrator, SAMHSA, regarding the drug testing laboratory 
certification program.

Laboratory Testing for 6-Acetylmorphine (6-AM)

    In the NPRM, we proposed to incorporate new HHS criteria for 
initial testing for 6-AM, a marker for heroin. We also asked if there 
were factual, evidence-based concerns about the need to show morphine 
with a 6-AM confirmed positive result. Also, if there were evidence-
based systematic research and studies showing that morphine must also 
be present and quantitations reported, we asked for solutions by 
laboratories and/or MROs to adequately address the issue.
Comments
    A slight majority of commenters expressed support for the new HHS 
screening and confirmation cutoffs for 6-AM. Some who support the tests 
for 6-AM do so because they believe transportation safety will be 
enhanced when more heroin users are identified and removed from their 
safety-sensitive duties. Several who do not support the provision 
express concern about the new cutoffs no longer requiring a test for 
morphine--something they say is imperative to ensure that the person is 
actually a heroin user. At least one commenter believes no additional 
heroin users will be identified and expresses concern about the cost of 
having only one supplier of laboratory reagent for 6-AM.
    Several laboratory entities and experts weighed in on the issue. 
RTI International (RTI) agreed with HHS for screening all specimens for 
6-AM and for dropping the requirement to ensure a presence of morphine 
above 2000 ng/mL. RTI indicated that the new testing will increase the 
positive rate by 8--29%, but failed to explain the basis for its 
concern. They also quote three studies as supporting the HHS decision.
    Clinical Research Laboratory (CRL) quoted their own study--for 
which we have no way to assess the adequacy of the study protocols--and 
stated that out of 820 tests for opiates and 6-AM, all screened at 3 
ng/mL, versus the HHS cutoff of 10 ng/mL, and all except one had opiate 
positive results above the 2,000ng/mL cutoff. CRL did not attempt to 
explain why this sample tested positive for 6-AM but did not test for 
morphine. They concluded that there is no published explanation for the 
detection of 6-AM without the presence of morphine. Therefore, CRL 
recommended that the Department provide guidance to MROs and 
laboratories about conferring with one another if there were ever 6-AM 
without the presence of morphine.
    Quest Laboratories reviewed 1.2 million test results. Of those 
specimen results, 112 tested positive for 6-AM (heroin). The Quest 
study data indicated that 7 of those 112 6-AM positives also tested 
positive for morphine in the 300-2000 ng/mL range. The remaining 105 6-
AM positives had morphine confirmed above 2000 ng/mL. Quest suggested 
that ``only'' six tests out of a million would test positive for 6-AM 
and not have morphine that was present reported to the MRO. Therefore, 
Quest recommended that DOT provide additional guidance to MROs to speak 
with laboratories related to morphine that may be present but not 
reported by the laboratory.
DOT Response
    As stated earlier in this document, the Department must follow the 
laboratory testing protocols and standards that are established by HHS. 
Therefore, we must adhere to the screening and confirmation drug 
testing cutoffs that HHS has established for the laboratories and for 
which the laboratories are certified.
    6-AM is a unique metabolite produced when a person uses the illicit 
drug heroin. 6-AM is both excreted in the urine and further metabolized 
to morphine. Morphine can also be excreted in the urine as a result of 
codeine or morphine use. Thus, morphine is a common metabolite of both 
heroin and codeine.
    It is well established that, in some instances, individuals who are 
positive for 6-AM are atypically low in the coincident morphine 
concentration found in urine. That is, their morphine concentrations 
are below the HHS/DOT cutoff of 2000 ng/mL and even below 300 ng/mL. 
Therefore, testing programs focused on the morphine concentration as 
the screening discriminator will fail to identify a number of heroin 
users

[[Page 49856]]

(estimated by some studies referenced in the docket to be about 10% of 
the opiate positives).
    While morphine positives in the absence of 6-AM require significant 
MRO intervention to differentiate legitimate morphine or codeine 
sources for morphine, 6-AM is a definitive marker for heroin use and 
thus requires no MRO intervention. There are simply no legitimate 
medical explanations for 6-AM positive tests. Although there has been 
from time to time some anecdotal suggestion that 6-AM can be produced 
from morphine, existing scientific evidence does not support such a 
claim.
    The atypical finding of a 6-AM positive in the absence of 
significant morphine findings by CRL may be the result of recent heroin 
use close to the time of sampling, a metabolic defect in the metabolism 
of 6-AM resulting in prolonged excretion, shunting of metabolic 
pathways away from morphine, or interaction with other substances not 
identified. Therefore, the 6-AM testing does not require confirmation 
by the simultaneous detection of a specified quantity of morphine.
    Multiple scientific publications have concluded that a portion of 
the population shows urinary concentrations of 6-AM above 10 ng/mL with 
morphine concentrations below 300 ng/mL, even though the Quest study 
showed that none of their 6-AM positive results had morphine below a 
300 ng/mL cutoff.
    Therefore, the salient facts are:
     6-AM confirmed positive tests do not need a morphine 
marker;
     Data show that when one looks for morphine as a marker, it 
most always exists above the morphine confirmation cutoffs or above 
Limit of Detection (LOD); and
     If the morphine marker does not exist on a 6-AM positive 
result, there is ample scientific reason to strongly suggest recent 
heroin use.
    Despite these facts and until more information is gathered from 
DOT's experience with 6-AM testing, when a 6-AM confirmed positive 
result is reported and morphine for that specimen is not reported at or 
above the 2000 ng/mL confirmed positive cutoff, the laboratory and MRO 
must confer to determine if there was confirmed morphine below the 2000 
ng/mL, and if not, whether further testing is needed to quantify the 
amount of morphine present. The laboratory must report the amount of 
morphine from the test to the MRO.
    If a laboratory finds no detectable morphine at its LOD upon 
further testing, the laboratory must report that fact to DOT's Office 
of Drug and Alcohol Policy and Compliance (ODAPC) immediately. Based 
upon the scientific evidence that exists today, we simply do not think 
that 6-AM with no morphine detected will occur. But we will determine 
what our first year of 6-AM screening and confirmation testing reveals 
in this matter. We would work directly with MROs on these cases, if 
there would be any. We would also work with HHS to determine if 
additional action is necessary. Ultimately, the MRO, with ODAPC's 
assistance, would make a verified result determination following these 
discussions.
    Last year, HHS-certified laboratories conducted approximately 5.2 
million DOT tests. Quest estimates that there will be 6 tests per one 
million that would be reported to MROs for 6-AM with morphine 
concentrations below the established confirmation cutoffs. 
Extrapolated, this would mean approximately 30 6-AM positive specimen 
tests a year will be reported to MROs with morphine below 2000 ng/mL. 
As with other 6-AM positives, the MRO must not accept an assertion that 
there is a legitimate explanation for the presence of 6-AM in the 
employee's specimen.

Approval of Medical Review Officer Training and Examination Groups

    The HHS Mandatory Guidelines will require that nationally-
recognized MRO certification entities or subspecialty boards for 
medical practitioners in the field of medical review must have their 
qualifications, training programs, and examinations approved by HHS on 
an annual basis. The Department requested comments on whether part 40 
should require these groups to be approved and if the Department should 
seek a shared approval process with HHS.
Comments
    Commenters were rather evenly divided about whether the Department 
should require or join the approval process of the nationally-
recognized MRO certification and subspecialty boards. Some who support 
DOT's involvement expressed concern that HHS would be the only 
approving authority if the Department does not share in that 
responsibility. Some who did not support the Department's involvement 
in the approval process also tended not to support HHS approval of 
these boards, either. Some commenters offered suggestions about basic 
standards for national certification groups.
DOT Response
    While we believe the current MRO training and examination boards 
have very strong standards, we want to be certain that these groups 
continue to present well and accurately the Department's part 40 and 
DOT agency, including the USCG, drug rules. After all, no MRO wants to 
be in violation of the Department's regulations because of erroneous 
information presented during training or on a certification 
examination. Consequently, it makes sense to consider the benefits of 
additional oversight of MRO certification groups.
    Some of the basic standards suggested by one commenter were very 
similar to our Subpart O requirements for national drug and alcohol 
counselor certification organizations. Our experience with these 
counselor certification organizations taught us that having standard 
requirements rules out up-front substandard counseling organizations. 
Our SAP experience also taught us that, from the beginning, the major 
MRO organizations had established highly reputable training and 
examination modalities. In fact, we used some of the MRO testing 
standards in laying out the examination requirements that SAP testing 
organizations now follow.
    We liked the idea submitted by one of the commenters for basic 
standards for the MRO certification organizations and will pass these 
ideas to HHS. However, we see no pressing need for the Department to 
use our limited staff time and personnel to participate in or require 
approval for these established organizations. Again, our experience has 
been that these national organizations effectively train, test, and 
certify MROs. As long as they continue to do so, and as long as there 
are no new MRO certification organizations on the horizon, we see no 
reason to expend additional resources approving those who have already 
demonstrated their competence.
    We will continue our practice of helping MRO training and 
examination groups to accurately update DOT's portions of their course 
materials, manuals, and examination content. We believe our assistance 
will enable us to make sure that content is DOT-specific and accurate.
    We anticipate that HHS approval standards would include all Federal 
testing programs. However, we do not intend to become involved in this 
approval process, unless HHS identifies significant deficits with any 
of the training and examination efforts by any of these boards that 
affect DOT's

[[Page 49857]]

program. For now, DOT will not require these MRO training and 
examination organizations to obtain HHS approval. Furthermore, MROs in 
the DOT program will not be required to be trained by an HHS-approved 
group, as long as the MROs meet DOT's qualification training and 
requalification training requirements.
    Some of the commenters noted that one MRO certification 
organization reportedly provides an on-line examination. These 
commenters ask the Department to put a stop to this practice by 
requiring only proctored testing. One commenter indicated that at least 
the examination for the initial MRO certification should be proctored. 
We will defer action on the issue of proctored versus on-line 
examinations until we know more about the HHS approval process. We 
would note, however, that the entire issue of proctored versus on-line 
examinations remains largely unresolved--with supporters in both 
corners and with studies and literature supporting both camps.\1\
---------------------------------------------------------------------------

    \1\ ``Proctored Versus Unproctored Online Exams: Studying the 
Impact of Exam Environment on Student Performance,'' Kimberly K. 
Hollister and Mark L. Berenson Decision Sciences Journal of 
Innovative Education Volume 7 Issue 1, Pages 271-294 Published 
Online: 16 Jan 2009 (copyright) 2010 Decision Sciences Institute.
    ``On-line instruction: Are the outcomes the same?'' Warren, L., 
& Holloman, Jr., H. (2005). Journal of Instructional Psychology, 
32(2), 148-151.
    ``Questioning the hybrid model: Student outcomes in different 
course formats'' Reasons, S., Valadares, K., & Slavkin, M., Journal 
of Asynchronous Learning Networks, (2005) 9(1).
    ``Comparison of outcomes on like exams administered to in-
residence and asynchronous distance-based Pharm. D. students.'' 
Ragan, R. & Kleoppel, J. (2004). Journal of Asynchronous Learning 
Networks, 8(4).
    ``The Relationship Between Performance Levels and Test Delivery 
Methods,'' Patricia Royal, Paul Bell; International Journal of 
Instructional Technology and Distance Learning, July 2008 Vol. 5. 
No. 7.
    ``Traditional versus Online Content Delivery and Assessment,'' 
Margaret D. Anderson and Mark Connell, International Journal of 
Instructional Technology and Distance Learning, February 2009, Vol. 
6. No. 2.
---------------------------------------------------------------------------

Medical Review Officer Recurrent Requalification Training and 
Examination

    In our NPRM we sought comments on whether part 40, at 49 CFR 
40.121(d), should be amended by removing the requirement that MROs must 
complete 12 Continuing Education Units (CEUs) pertaining to DOT and MRO 
practices every three years, and instead require MROs to be requalified 
every five years by an MRO certification board or subspecialty board 
for medical practitioners.
Comments
    Most commenters supported the idea that the Department require MROs 
to be requalified by being certified on a regular basis. Most also 
wanted DOT to continue to require MROs to have continuing education 
(or, Continuing Medical Education) related to their MRO work. Several 
commenters indicated that they did not see any benefit to changing the 
requirements, believing that initial qualification training and the 
continuing education requirement the Department established in 2000 has 
proven adequate.
DOT Response
    Medical review of drug test results is more complex today than when 
we established the continuing education requirement in 2000. Therefore, 
we have decided to side with the overwhelming majority of commenters 
supporting MRO requalification training and reexamination on a regular 
basis. We will require MRO requalification every five years. However, 
to offset the associated costs, we will not maintain the requirement 
for continuing education.
    Over the years, it has been somewhat difficult for us to know 
whether the 12 CEU hours obtained by many MROs every three years were 
indeed related to DOT's testing program, as required. However, based on 
our experience to date, we believe that a requalification requirement 
every five years will assure DOT agency auditors and inspectors and 
regulated employers that MROs are appropriately qualified.
    We anticipate that MROs will continue to obtain CEUs by virtue of 
their MD and DO licensure requirements. In addition, the MRO 
certification boards provide their members with MRO manuals and 
periodic newsletters in an effort to keep everyone up-to-date on the 
Department's program requirements.
    The MRO plays a key role in our important Federal safety program 
and maintains the Constitutionally mandated balance between the safety 
and privacy objectives of the program. The MRO's role in gathering and 
evaluating the medical evidence and providing due process is 
imperative. These are duties that must be carried out by the MRO and 
cannot be delegated to anyone.
    The MRO is charged with certain important medical and 
administrative duties. The MRO must have detailed knowledge of the 
effects of medications and other potential alternative medical 
explanations for laboratory reported drug test results. He or she is 
responsible for determining whether legitimate medical explanations are 
available to explain an employee's drug test result. This medical 
review process has become far more complex as a result of specimen 
validity testing and the myriad of medical explanations for 
adulterated, substituted, and invalid laboratory test results. These 
complexities have made MRO knowledge of the effects of drugs and 
medications even more important than it was in 2000.
    Part 40 also requires the MRO to confer with prescribing physicians 
in making decisions about prescription changes so that alternative 
medications can be used that will not impact public safety. Similarly, 
the MRO is required to report to employers the employees' prescription 
and over-the-counter medication use (or dangerous combinations of use) 
that the MRO believes will negatively affect duty performance. In 
addition, the MRO is required to medically assess referral physician 
examinations and evaluations in certain positive and refusal-to-test 
situations. These, too, have become more complex over time.
    For these reasons, we think qualification training and examination 
followed by requalification and an examination every five years will be 
much more effective than the current one-time training and examination 
requirement with periodic CEUs. To ensure that MROs are well qualified, 
the requalification process must be very similar to the original 
qualification training (i.e., a full training program addressing all 
issues required by part 40) and an examination administered by a 
nationally recognized MRO certification board or subspecialty board for 
medical practitioners in the field of medical review of DOT-mandated 
drug tests. A mere ``update'' type of training will be considered a 
violation of part 40.
    This regulation text lays out the requirements for when this new 
requalification training is to take place. MROs must maintain 
documentation about their qualification training and any subsequent 
continuing education. MROs would simply be required to complete the new 
requalification training and examination no later than five years from 
the date of having last met either their qualification training or 
continuing education requirements. Following the completion of the new 
requalification requirements, MROs will be required to complete 
requalification training and examination every five years thereafter.
    DOT will continue to use the term ``qualification training'' rather 
than ``certification training'' and will use

[[Page 49858]]

``requalification training'' rather than ``recertification training'' 
in part 40.

Medical Review Officer Records Maintenance

    In the NPRM we asked for discussion related to MRO records; 
primarily we asked what documentation of consultation and deliberation 
should be in MRO records. In the NPRM, we stated that our current 
recordkeeping requirements for negative and non-negative test results 
would not change based upon the new HHS MRO recordkeeping requirements.
Comments
    Six commenters addressed the issue of MRO records. All supported 
the idea that MROs should keep records and that the time frame should 
be the same as that required for employers.
    One association said that DOT inspectors are not qualified to 
question MRO judgments regarding medical information and its relevance. 
Another commenter indicated that personal information, which was not 
defined, should be confidential and not part of the MRO file. This same 
commenter provided a long list of items that should be part of the 
record, including various dates and times of MRO contacts and 
conversations with various Designated Employer Representatives (DERs), 
collectors, and employers. In addition, this commenter believed that 
information should be included related to contacts with other 
physicians, laboratories, and pharmacies, although without specific 
detail.
DOT Response
    The DOT agrees with commenters that MRO records are very important 
and integral to the MRO review process. We believe that records and 
notes generated by the review process need to be maintained. The 
purpose of any record is to ensure that proper procedures and results 
were achieved under part 40 requirements. MRO records must show why a 
particular specimen is negative or non-negative. At times, the test 
result must withstand legal challenges.
    DOT regulations already require MROs to follow the employer's 
record retention requirements--five years for non-negatives and one 
year for negatives. Those will not change.
    The notes recorded by the MRO are considered by the Department to 
be part of the record. These notes generally contain all the 
information that was discussed by the MRO with the employee and any 
supplemental information the MRO uses to support the various reasons 
the employee provides as legitimate medical explanation for a non-
negative result. The MRO records may include copies of prescriptions, 
letters from other physicians, and consultations by the MRO with 
physicians, pharmacy personnel, laboratory personnel, and other 
appropriate individuals.
    However, a listing of these contacts without specific references as 
to what was discussed would not be effective. There must be a specific 
comment or rationale to which the MRO can subsequently refer for 
support and reasoning about the outcome of the verification process. 
This is especially true if a decision is challenged in a court or an 
administrative hearing proceeding.
    During the verification interview, the employee may share personal 
information. Unless a specific issue, such as the use of psychotropic 
medication, is used as a medical explanation for a drug positive, the 
MRO should not include the other sensitive, unrelated personal 
information in the record. From a practical point of view, MROs will 
primarily record information that is specific to the issue at hand or 
may have an impact upon safety. The Department is comfortable that MROs 
are trained, both in their role as physicians and as MROs, to maintain 
a clear balance between recording of pertinent information versus not 
recording sensitive information which is not relevant to the 
verification process or transportation safety.
    In reference to inspectors' qualifications to question MROs medical 
decisions, we want to point out that the purpose of an inspection is 
not to challenge a physician's medical expertise, but rather to ensure 
that the MRO is abiding by regulations and current requirements. In 
most cases, the issue would be whether there is adequate documentation 
for whatever action the MRO took. For example, if the MRO had his or 
her staff confer with the pharmacist or a prescribing physician--
instead of doing so himself or herself, as the regulations require--the 
MRO's procedures would be contrary to part 40.
    When a positive result is downgraded to a negative result, the 
inspector would look at the reason for this downgrade. If there is a 
legitimate medical explanation, the inspector would expect to see this 
clearly spelled out in the record. For example, if a THC positive 
confirmed laboratory result were downgraded to negative because of an 
explanation of ``medical marijuana'' use, the inspector would 
rightfully view that as a serious matter, because it remains 
unacceptable for any safety-sensitive employee subject to DOT drug 
testing rules to use marijuana.
    Additional areas of concern by DOT inspectors and auditors focus 
upon the person(s) who actually talk(s) with the employee following a 
non-negative result (e.g., the MRO vs. the MRO staff), how requests for 
split specimen testing are handled and whether requests are handled in 
timely manner, and how DERs are notified about non-negative results. 
The Department also knows that inspectors and auditors are trained to 
address all of these issues, and they are sensitive to the fact that 
these MRO records contain medical information and that they must be 
handled appropriately. We want to reaffirm that inspecting and auditing 
MRO records has been, and will continue to be, one of the mechanisms 
that inspectors and auditors use to ensure compliance with DOT 
regulations.

Section-by-Section Discussion

    The following part of the preamble discusses each of the final 
rule's sections, including responses to comments on each section.

Table of Contents

    The Department proposed, in the NPRM, to modify some existing 
section headings in order to reflect regulation text changes. In all, 
three section headings have been modified and one has been added. Sec.  
40.3, Sec.  40.87, and Sec.  40.139 have been revised, and Sec.  40.140 
has been added.

Section 40.3 What do the terms in this part mean?

    In order to align more closely the definitions in Sec.  40.3 with 
definitions contained in the HHS Mandatory Guidelines, in the NPRM, the 
Department proposed modifying some existing definitions and adding 
several new ones.
    Five commenters supported this proposal and responded by making 
suggested additions or changes to this section. Several commenters did 
not support the changes, contending that the Department should not 
allow DOT-regulated employers to use IITFs. Because the Department is 
not allowing IITFs, no definitions related to IITFs will be added. A 
few commenters did not want the Department to change its definition of 
``cancelled test'' because the proposed definition was confusing. After 
reviewing the comments the Department agrees with the commenters and 
will keep the current definition of ``cancelled test.'' Other 
commenters did not want the Department to add definitions that were 
only applied to the HHS program and not to the DOT

[[Page 49859]]

program. We have reviewed those definitions and decided that most will 
be in the regulation. It is necessary to harmonize our terms with HHS 
definitions, in order that laboratories and others in the drug testing 
industry have consistent terms with which to operate.
    In all, 13 definitions will be modified or added to harmonize with 
HHS definitions, and one will be removed. The new or modified 
definitions are ``Adulterated specimen,'' ``Confirmatory drug test,'' 
``Initial drug test (also known as a Screening drug test),'' ``Initial 
specimen validity test,'' ``Invalid drug test,'' ``Laboratory,'' 
``Limit of Detection (LOD),'' ``Limit of Quantitation,'' ``Negative 
result,'' ``Positive result,'' ``Reconfirmed,'' ``Rejected for 
testing,'' and ``Split specimen collection.'' The term ``Initial 
validity test'' was removed.

Section 40.87 What are the cutoff concentrations for drug tests?

    The Department will require conducting initial and confirmation 
testing for MDMA, MDA, and MDEA, conducting initial testing for 6-AM, 
lowering the initial and confirmation cutoff concentrations for 
amphetamines, and lowering the initial and confirmation cutoff 
concentrations for cocaine. We include certain instructions for 
laboratories (and MROs) related to 6-AM testing. Specific discussions 
of these issues are included under ``Principal Policy Issues'' in this 
preamble.

Section 40.97 What do laboratories report and how do they report it?

    The Department added a paragraph to this section instructing the 
laboratory to contact ODAPC if it ever confirms 6-AM with no detectable 
morphine at its LOD, upon further testing. A fuller discussion of this 
matter is in ``Principal Policy Issues.''

Section 40.121 Who is qualified to act as an MRO?

    Commenters had a number of suggestions related to ongoing training 
for MROs. The DOT reviewed the comments and, as discussed in the 
``Principal Policy Issues,'' will require MRO requalification, 
including training and examination, every five years.

Section 40.139 On what basis does the MRO verify test results for 
codeine and morphine?

    The Department has revised this section by limiting the section to 
how MROs are to verify laboratory-confirmed codeine and morphine test 
results. We removed 6-AM verification from this section and moved it to 
a new section. We also revised the section's heading.

Section 40.140 On what basis does the MRO verify test results for 6-
acetylmorphine (6-AM)?

    This new section provides instructions to MROs on how they are to 
verify confirmed positive 6-AM results from laboratories. Instructions 
include how MROs are to handle 6-AM confirmed positive results when 
morphine is above the confirmation cutoff, when morphine is confirmed 
below the confirmation cutoff, when morphine is confirmed above LOD, 
and if ever morphine is not detected at LOD upon further testing. A 
fuller discussion of this matter is in ``Principal Policy Issues.''

Section 40.151 What are MROs prohibited from doing as part of the 
verification process?

    The Department has revised this section by adding MDMA, MDA, and 
MDEA as being among the drugs for the presence of which there exist no 
legitimate medical explanations. This instruction is consistent with 
what the Department has said about PCP and 6-AM.

Section 40.159 What does the MRO do when a drug test is invalid?

    In response to the commenters' concerns related to pH, this section 
is based on a July 2008 guidance authorizing MROs to consider time and 
temperature in making their verification decisions if pH is in the 9.0-
9.5 range. A fuller discussion of this matter is in ``Principal Policy 
Issues.''

Section 40.163 How does the MRO report drug test results?

    The majority of the commenters wanted DOT to be clear about the 
records MROs should keep and how long MROs should keep them. Based upon 
the comments, we have decided to put more specificity about this issue 
into the MRO rule text section. MROs keep negative and cancelled drug 
test reports and records for one year, and all positive and refusal 
drug test reports and records for five years. A fuller discussion of 
this matter is in ``Principal Policy Issues.''

Appendix B to Part 40--DOT Drug Testing Semi-Annual Laboratory Report 
to Employers

    The Department has modified the requirements for the semi-annual 
laboratory reports to employers. The changes require laboratories to 
also report the total number of MDMA, MDA, and MDEA positive drug test 
results.

Appendix C to Part 40--DOT Drug Testing Semi-Annual Laboratory Report 
to DOT

    The Department has modified the requirements for the semi-annual 
laboratory reports to DOT. The changes require laboratories to also 
delineate the positives for the newly added MDMA, MDA, and MDEA. We are 
also breaking out the other drugs for which we test in order to make it 
simpler for laboratories to report and for our staff to tally the 
reports.

Other Issues

    There were several comments that addressed editorial changes and 
included typographical errors. We appreciate these comments and 
incorporated a good many of the suggestions and edits.
    The Department also received several comments that we consider to 
be outside of the scope for this rulemaking. However, in order to try 
to bring closure to these issues, we will provide some explanation and 
clarification.
    One commenter said that section 40.25 stated that the employer was 
required to obtain consent from the applicant, but the commenter 
believed that section 40.27 prohibited the employer from obtaining 
consent for release of the 40.25 information. We would like to point 
out that section 40.25 requires the employee to sign this written 
consent in order to perform safety-sensitive duties and is very 
specific as to the purpose of this consent. Section 40.27 prohibits an 
employer from requiring the employee to sign a form consenting to 
participation in the program, a blanket release form for all drug and 
alcohol testing information, or any type of waiver of indemnification 
or liability. There is no contradiction between these two requirements.
    Another commenter believed that the HHS employer option for a 
second collection, if the first test result was ``negative dilute,'' 
was not adopted by DOT. We would point out that this authorization has 
already been part of our rule for some time and is clearly spelled out 
in section 40.197.
    One commenter wanted the Department to establish a time limit on 
how long an employee had to wait at a collection site before providing 
a urine specimen. This commenter thought that two hours should be the 
maximum timeframe an employee had to wait to provide a specimen. This 
same commenter also wanted clarification about what constituted a 
``drug failure''

[[Page 49860]]

and that leaving the collection site for a short time should not be 
considered a refusal, unless the employee left the collection area 
where the urine sample is actually taken. Additionally, this commenter 
wanted some grievance procedures to be established should there be 
problems at a collection site.
    Although this commenter was concerned about how long an employee 
may have to wait to provide a specimen, we would like to emphasize that 
section 40.61(b) clearly directs the collection site to ``begin the 
testing process without undue delay.'' The Department's position has 
always been that testing should start as soon as possible after the 
employee's arrival at the site. The Department's position has always 
been that the employee cannot leave the collection site, i.e., the 
waiting area, even for a short time. Leaving the site provides 
employees the opportunity to adulterate or substitute their specimens. 
And finally, collection site problems encountered by employees should 
be raised to the employer following the collection. The employer is 
ultimately responsible for the proper operation of its drug testing 
program.
    One association asked for clarification as to what the Department 
intended by the term ``same business day'' as it applies under section 
40.205. This section directs that if a problem is identified in the 
testing process, anyone involved in it should make an attempt to 
correct the problem on the same business day that notification is 
received about the problem. This commenter provided several scenarios 
where the employer, the collection site, or the service agent offices 
are closed, but the information is transmitted to them. The question is 
how these entities can meet the requirement of responding on the same 
day that they are notified about a problem.
    If an office is closed when information is received, common sense 
dictates that the next day the office is open is the business day it is 
received.
    Several commenters asked about other HHS Mandatory Guidelines 
procedures and whether the Department would adopt them. As discussed in 
the NPRM, the Department identified those HHS Mandatory Guidelines we 
proposed to adopt and which ones we did not. In this final rule, we 
have again highlighted those we have adopted.
    For example, the Department will not require observers to receive 
advanced, formalized training to learn about the steps necessary to 
directly observe a collection. The current process of having a 
qualified and trained collector provide immediate, precise, and 
relevant instructions to an observer at the time of a directly observed 
collection is very appropriate and effective and has been for years. 
That way, the Department can be assured that the requisite instructions 
are provided each time that direct observation is required, no matter 
how many, or few, an observer has already accomplished.
    In addition, the costs associated with formally training observers 
(and the resulting limitation on available observers) does not outweigh 
any minimal benefits to arguably be obtained by training observers in 
advance instead of providing timely and relevant instructions on site 
at the time direct observation is required. The Department is not aware 
of any cases where it was not effective to have the qualified and 
trained collector instruct the observer at the time a direct 
observation must occur, and to do so each and every time, no matter 
whether the observer has already been trained and properly informed.
    Also, DOT will not change our longstanding regulatory position that 
a collector need not obtain prior approval from a collection site 
supervisor before performing a directly observed collection. Requiring 
collectors to get approval from collection site supervisors would 
create difficult logistical issues that would complicate the process. 
There are numerous instances where the collector is alone or does not 
have immediate access to a collection site supervisor. In fact, the 
collector may be the site supervisor. Many collections occur off-site 
or in the middle of the night, where and when supervisors would not be 
available, and requiring consultation with an unavailable supervisor 
would prove onerous and serve only to delay the process unnecessarily. 
We believe qualified collectors should continue to make these direct 
observation collection decisions and to continue basing those decisions 
upon the clear requirements set forth in part 40.
    Also, we will not change the duration of the paperwork retention 
requirement for collectors. HHS will require collectors to keep Copy 3 
for two years. The Department believes the current 30 days is 
sufficient in DOT's program. Retention for 30 days has proven a 
sufficient amount of time in which to ensure that a CCF copy with the 
employee's signature would be available to the MRO when the MRO's CCF 
copy was not available. Requiring document retention for two years 
would greatly increase the paperwork burden without any added safety or 
efficiency benefit.
    Under the revised HHS Mandatory Guidelines, Federal agencies will 
be required to audit five percent or a maximum of 50 of their 
collection sites annually. The Department believes that creating a 
parallel requirement for transportation industry employers would be 
very expensive to employers in DOT's program in terms of time and 
resources, with few efficiency and/or safety benefits. The Department 
would anticipate seeing more effective monitoring by the collection 
site parent organizations in an effort to ensure for employers that 
sites under their organization umbrellas, with which employers are 
contracting, are properly conducting collections. The DOT agencies and 
the U.S. Coast Guard also provide on-site audits and inspections of 
collection sites. They have also increased their mock collection 
inspections and their clandestine inspections. All of these provide 
added oversight to determine whether collection site personnel are 
properly performing collections and whether collection sites adhere to 
DOT's strong security and integrity requirements.
    The revised HHS Mandatory Guidelines will require at least three 
percent blind specimen testing, compared to DOT's current one percent. 
We believe our current requirements represent a good balance between 
considerations of reducing burdens and maintaining an effective check 
upon laboratory performance. We have had few, if any, laboratory 
accuracy problems over the history of the program, and we believe that 
we can continue to ensure that this pattern continues while reducing 
burdens and costs on participants. Coupled with the HHS requirements 
and the additional proficiency testing required for laboratory 
certification, the blinds submitted to laboratories for quality control 
testing purposes via DOT requirements are quite ample.
    In the NPRM, the Department estimated the total annual cost of 
testing for MDMA and 6-AM to be $1,361,063. One commenter believed that 
estimate to be too low, but did not offer any recommended cost figure. 
We believe there will be approximately 5 million DOT tests per year, 
and an MDMA test will cost on average $ 0.09 per test, and 6-AM will 
cost on average $.26 per test. MDMA will cost approximately $450 
thousand per year, and 6-AM will cost approximately $1.3 million per 
year, for a total of $1.75 million per year.

Regulatory Analyses and Notices

    The statutory authority for this rule derives from the Omnibus 
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 
5331, 20140, 31306, and 45101 et seq.) and the

[[Page 49861]]

Department of Transportation Act (49 U.S.C. 322).
    The Department estimates there will be approximately 5 million DOT 
tests per year. An MDMA test will cost on average $0.09 per test, and 
6-AM will cost on average $.26 per test. MDMA will cost approximately 
$450 thousand per year, and 6-AM will cost approximately $1.3 million 
per year, for a total of $1.75 million per year. Based upon the data 
discussed in the ``Principal Policy Issues,'' the increased detection 
of amphetamine, methamphetamine, and cocaine use through drug testing 
is estimated to be approximately 30% more for amphetamines/
methamphetamines, and 30% more for cocaine. In 2009, HHS-certified 
laboratories reported to DOT that there were 14,195 confirmed DOT 
positive results for amphetamines/methamphetamines. So, we estimate an 
increase of over 4,000 confirmed positive amphetamine/methamphetamine 
test results. Also in 2009, laboratories reported 12,918 DOT cocaine 
confirmed positive results. Therefore, we estimate an increase of 
nearly 4,000 confirmed cocaine results. We estimate the cost associated 
with this increase of 8,000 positive test results for cocaine and 
amphetamines/methamphetamines to be $500 thousand. The total program 
cost of the new regulation will be $2.25 million.
    It stands to reason that it will be cost beneficial to identify the 
illegal drug use of an additional 8,000 safety-sensitive transportation 
employees annually, across all modes--on roads, rails, water, or in the 
air, over land and underground. Furthermore, if identifying the illicit 
drug use by these employees prevents a single serious accident, then 
the economic benefits of the rule will outweigh its costs. As we have 
stated throughout this preamble, the Omnibus Act requires us to follow 
HHS on these specific drug testing matters.
    We have concluded that this rule is not significant for purposes of 
Executive Order 12866 or DOT's regulatory policies and procedures. In 
addition to its low costs, it modifies our overall part 40 procedures 
and is intended to further align our laboratory procedures and 
processes, as well as some collection and MRO procedures, in order to 
harmonize DOT procedures with requirements that are being directed by 
HHS Mandatory Guidelines, which were themselves deemed to be non-
significant rules. The DOT also certifies, under the Regulatory 
Flexibility Act, that this rule will not have a significant economic 
impact on a substantial number of small entities. Given the small net 
change in regulatory costs compared to the present rule, spread over 
the many thousands of small entities in the transportation industries, 
the cost impact per entity is expected to be negligible.
    There are no new information collection requirements that would be 
subject to the Paperwork Reduction Act.
    This rule has been analyzed in accordance with the principles and 
criteria contained in Executive Order 13132 (``Federalism''). This rule 
does not include requirements that (1) have substantial direct effects 
on the States, the relationship between the national government and the 
States, or the distribution of power and responsibilities among the 
various levels of government, (2) impose substantial direct compliance 
costs on State and local governments, or (3) preempt State law. 
Therefore, the consultation and funding requirements of Executive Order 
13132 do not apply.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedures, Alcohol abuse, Alcohol 
testing, Drug abuse, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.
    49 CFR subtitle A, Authority and Issuance.

    Issued August 10, 2010, at Washington DC.
Ray LaHood,
Secretary of Transportation.

0
For reasons discussed in the preamble, the Department of Transportation 
amends Title 49 of the Code of Federal Regulations, part 40, as 
follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

0
1. The authority citation for 49 CFR part 40 continues to read as 
follows:

    Authority:  40 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.
* * * * *

0
2. Sec.  40.3 is amended as follows:
0
A. Revise the section heading.
0
B. Revise the definitions of Adulterated specimen, Confirmatory drug 
test, Initial drug test (also known as a Screening drug test), Invalid 
drug test, Laboratory, and Limit of detection (LOD).
0
C. Add in alphabetical order definitions of Initial specimen validity 
test, Limit of Quantitation, Negative result, Positive result, 
Reconfirmed, Rejected for testing, and Split specimen collection.
0
D. Remove the definition of Initial validity test.
    The revisions and additions read as follows:


Sec.  40.3  What do the terms used in this part mean?

* * * * *
    Adulterated specimen. A specimen that has been altered, as 
evidenced by test results showing either a substance that is not a 
normal constituent for that type of specimen or showing an abnormal 
concentration of an endogenous substance.
* * * * *
    Confirmatory drug test. A second analytical procedure performed on 
a different aliquot of the original specimen to identify and quantify 
the presence of a specific drug or drug metabolite.
* * * * *
    Initial drug test (also known as a ``Screening drug test''). The 
test used to differentiate a negative specimen from one that requires 
further testing for drugs or drug metabolites.
    Initial specimen validity test. The first test used to determine if 
a urine specimen is adulterated, diluted, substituted, or invalid.
    Invalid drug test. The result reported by an HHS-certified 
laboratory in accordance with the criteria established by HHS Mandatory 
Guidelines when a positive, negative, adulterated, or substituted 
result cannot be established for a specific drug or specimen validity 
test.
* * * * *
    Laboratory. Any U.S. laboratory certified by HHS under the National 
Laboratory Certification Program as meeting the minimum standards of 
Subpart C of the HHS Mandatory Guidelines for Federal Workplace Drug 
Testing Programs; or, in the case of foreign laboratories, a laboratory 
approved for participation by DOT under this part.
* * * * *
    Limit of Detection (LOD). The lowest concentration at which a 
measurand can be identified, but (for quantitative assays) the 
concentration cannot be accurately calculated.
    Limit of Quantitation. For quantitative assays, the lowest 
concentration at which the identity and concentration of the measurand 
can be accurately established.
* * * * *
    Negative result. The result reported by an HHS-certified laboratory 
to an MRO when a specimen contains no drug or the concentration of the 
drug is less than the cutoff concentration for the

[[Page 49862]]

drug or drug class and the specimen is a valid specimen.
* * * * *
    Positive result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the cutoff concentrations.
* * * * *
    Reconfirmed. The result reported for a split specimen when the 
second laboratory is able to corroborate the original result reported 
for the primary specimen.
* * * * *
    Rejected for testing. The result reported by an HHS-certified 
laboratory when no tests are performed for a specimen because of a 
fatal flaw or a correctable flaw that is not corrected.
* * * * *
    Split specimen collection. A collection in which the urine 
collected is divided into two separate specimen bottles, the primary 
specimen (Bottle A) and the split specimen (Bottle B).
* * * * *

0
3. In Sec.  40. 87, the section heading and paragraph (a) are revised, 
and paragraph (e) is added, to read as follows:


Sec.  40.87  What are the cutoff concentrations for drug tests?

    (a) As a laboratory, you must use the cutoff concentrations 
displayed in the following table for initial and confirmatory drug 
tests. All cutoff concentrations are expressed in nanograms per 
milliliter (ng/mL). The table follows:

----------------------------------------------------------------------------------------------------------------
                                         Initial test cutoff       Confirmatory test        Confirmatory test
         Initial test analyte               concentration               analyte            cutoff concentration
----------------------------------------------------------------------------------------------------------------
Marijuana metabolites................  50 ng/mL...............  THCA \1\...............  15 ng/mL.
Cocaine metabolites..................  150 ng/mL..............  Benzoylecgonine........  100 ng/mL.
Opiate metabolites
Codeine/Morphine\2\..................  2000 ng/mL.............  Codeine................  2000 ng/mL.
                                                                Morphine...............  2000 ng/mL.
6-Acetylmorphine.....................  10 ng/mL...............  6-Acetylmorphine.......  10 ng/mL.
Phencyclidine........................  25 ng/mL...............  Phencyclidine..........  25 ng/mL.
Amphetamines\3\
    AMP/MAMP \4\.....................  500 ng/mL..............  Amphetamine............  250 ng/mL.
                                                                Methamphetamine\5\.....  250 ng/mL.
MDMA \6\.............................  500 ng/mL..............  MDMA...................  250 ng/mL.
                                                                MDA\7\.................  250 ng/mL.
                                                                MDEA\8\................  250 ng/mL
----------------------------------------------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
\2\ Morphine is the target analyte for codeine/morphine testing.
\3\ Either a single initial test kit or multiple initial test kits may be used provided the single test kit
  detects each target analyte independently at the specified cutoff.
\4\ Methamphetamine is the target analyte for amphetamine/methamphetamine testing.
\5\ To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration
  equal to or greater than 100 ng/mL.
\6\ Methylenedioxymethamphetamine (MDMA).
\7\ Methylenedioxyamphetamine (MDA).
\8\ Methylenedioxyethylamphetamine (MDEA).

* * * * *
    (e) On a 6-AM confirmed positive result:
    (1) When a 6-AM confirmed positive result is reported and morphine 
for that specimen is not reported at or above the 2000 per ng/mL 
confirmed positive cutoff, you must confer with the MRO to determine if 
there was confirmed morphine below 2000 ng/mL.
    (2) If morphine was not confirmed below 2000 ng/mL, you and the MRO 
must determine whether further testing is needed to quantify the amount 
of morphine concentration present.
    (3) If you find no detectable morphine at LOD upon further testing, 
you must report that fact to ODAPC immediately.

0
4. In Sec.  40.97, paragraph (g) is added to read as follows:


Sec.  40.97  What do laboratories report and how do they report it?

* * * * *
    (g) If you confirm 6-AM and find no detectable morphine at LOD upon 
further testing, you must report that fact to ODAPC immediately.

0
5. In Sec.  40.121, paragraph (d) is revised to read as follows:


Sec.  40.121  Who is qualified to act as an MRO?

* * * * *
    (d) Requalification Training. During each five-year period from the 
date on which you satisfactorily completed the examination under 
paragraph (c)(2) of this section or have successfully completed the 
required continuing education requirements which were mandatory prior 
to October 1, 2010, you must complete requalification training.
    (1) This requalification training must meet the requirements of the 
qualification training under paragraph (c)(1) of this section.
    (2) Following your completion of requalification training, you must 
satisfactorily complete an examination administered by a nationally-
recognized MRO certification board or subspecialty board for medical 
practitioners in the field of medical review of DOT-mandated drug 
tests. The examination must comprehensively cover all the elements of 
qualification training listed in paragraph (c)(1) of this section.
* * * * *

0
6. Sec.  40.139 is revised to read as follows:


Sec.  40.139  On what basis does the MRO verify test results for 
codeine and morphine?

    As the MRO, you must proceed as follows when you receive a 
laboratory confirmed positive morphine or codeine test result:
    (a) In the absence of 6-AM, if the laboratory detects the presence 
of either morphine or codeine at 15,000 ng/mL or above, you must verify 
the test result positive unless the employee presents a legitimate 
medical explanation for the presence of the drug or drug metabolite in 
his or her system, as in the case of other drugs (see Sec.  40.137). 
Consumption of food products (e.g., poppy seeds) must not be considered 
a legitimate medical explanation for the employee having morphine or 
codeine at these concentrations.

[[Page 49863]]

    (b) For all other opiate positive results, you must verify a 
confirmed positive test result for opiates only if you determine that 
there is clinical evidence, in addition to the urine test, of 
unauthorized use of any opium, opiate, or opium derivative (i.e., 
morphine, heroin, or codeine).
    (1) As an MRO, it is your responsibility to use your best 
professional and ethical judgment and discretion to determine whether 
there is clinical evidence of unauthorized use of opiates. Examples of 
information that you may consider in making this judgment include, but 
are not limited to, the following:
    (i) Recent needle tracks;
    (ii) Behavioral and psychological signs of acute opiate 
intoxication or withdrawal;
    (iii) Clinical history of unauthorized use recent enough to have 
produced the laboratory test result;
    (iv) Use of a medication from a foreign country. See Sec.  
40.137(e) for guidance on how to make this determination.
    (2) In order to establish the clinical evidence referenced in 
paragraphs (b)(1)(i) and (ii) of this section, personal observation of 
the employee is essential.
    (i) Therefore, you, as the MRO, must conduct, or cause another 
physician to conduct, a face-to-face examination of the employee.
    (ii) No face-to-face examination is needed in establishing the 
clinical evidence referenced in paragraph (b)(1)(iii) or (iv) of this 
section.
    (3) To be the basis of a verified positive result for opiates, the 
clinical evidence you find must concern a drug that the laboratory 
found in the specimen. (For example, if the test confirmed the presence 
of codeine, and the employee admits to unauthorized use of hydrocodone, 
you do not have grounds for verifying the test positive. The admission 
must be for the substance that was found).
    (4) As the MRO, you have the burden of establishing that there is 
clinical evidence of unauthorized use of opiates referenced in 
paragraph (b) of this section. If you cannot make this determination 
(e.g., there is not sufficient clinical evidence or history), you must 
verify the test as negative. The employee does not need to show you 
that a legitimate medical explanation exists if no clinical evidence is 
established.

0
7. A new Sec.  40.140 is added to read as follows:


Sec.  40.140  On what basis does the MRO verify test results for 6-
acetylmorphine (6-AM)?

    As the MRO, you must proceed as follows when you receive a 
laboratory confirmed 6-AM test result:
    (a) If the laboratory confirms the presence of 6-AM in the specimen 
and there is also any level of quantitation of morphine, you must 
verify the test result positive.
    (b) When a laboratory 6-AM confirmed positive result is reported 
and morphine for that specimen is not reported at or above the 2000 per 
ng/mL confirmed positive cutoff, you must confer with the laboratory to 
determine if there was confirmed morphine below 2000 ng/mL.
    (1) If there was confirmed morphine below 2000 ng/mL, you must 
verify the test result positive.
    (2) If morphine was not confirmed below 2000 ng/mL, you and the 
laboratory must determine whether further testing is needed to quantify 
the amount of morphine present.
    (c) If a laboratory finds detectable morphine at its LOD upon 
further testing, you must verify the test result positive.
    (d) If a laboratory finds no detectable morphine at its LOD upon 
further testing, you and the laboratory must report that fact to the 
ODAPC immediately. Following your discussion with ODAPC, you will make 
a verified result determination.

0
8. In Sec.  40.151, paragraph (g) is revised to read as follows:


Sec.  40.151  What are MROs prohibited from doing as part of the 
verification process?

* * * * *
    (g) You must not accept an assertion that there is a legitimate 
medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA 
in a specimen.
* * * * *

0
9. In Sec.  40.159, paragraph (a)(6) is added to read as follows:


Sec.  40.159  What does the MRO do when a drug test is invalid?

    (a) * * *
    (6) When the test result is invalid because pH is greater than or 
equal to 9.0 but less than or equal to 9.5 and the employee has no 
other medical explanation for the pH, you should consider whether there 
is evidence of elapsed time and increased temperature that could 
account for the pH value.
    (i) You are authorized to consider the temperature conditions that 
were likely to have existed between the time of collection and 
transportation of the specimen to the laboratory, and the length of 
time between the specimen collection and arrival at the laboratory.
    (ii) You may talk with the collection site and laboratory to 
discuss time and temperature issues, including any pertinent 
information regarding specimen storage.
    (iii) If you determine that time and temperature account for the pH 
value, you must cancel the test and take no further action, as provided 
at paragraph (a)(4) of this section.
    (iv) If you determine that time and temperature fail to account for 
the pH value, you must cancel the test and direct another collection 
under direct observation, as provided at paragraph (a)(5) of this 
section.
* * * * *

0
10. In Sec.  40.163, paragraph (h) is added to read as follows:


Sec.  40.163  How does the MRO report drug test results?

* * * * *
    (h) You must maintain reports and records related to negatives and 
cancelled results for one year; you must maintain reports and records 
related to positives and refusals for five years, unless otherwise 
specified by applicable DOT agency regulations.

0
11. Appendix B to part 40 is revised to read as follows:

Appendix B to Part 40--DOT Drug Testing Semi-Annual Laboratory Report 
to Employers

    The following items are required on each laboratory report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include Billing Code or ID code)
C/TPA Identification: (where applicable; name and address)
1. Specimen Results Reported (total number)
By Test Reason
    (a) Pre-employment (number)
    (b) Post-Accident (number)
    (c) Random (number)
    (d) Reasonable Suspicion/Cause (number)
    (e) Return-to-Duty (number)
    (f) Follow-up (number)
    (g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
    (a) Negative (number)
    (b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Specimens Reported as Positive (total number) By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opiates (number)
    (1) Codeine (number)
    (2) Morphine (number)

[[Page 49864]]

    (3) 6-AM (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
    (5) MDEA (number)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)


0
12. Appendix C to part 40 is revised to read as follows:

Appendix C to Part 40--DOT Drug Testing Semi-Annual Laboratory Report 
to DOT

    Mail, fax, or e-mail to: U.S. Department of Transportation, 
Office of Drug and Alcohol Policy and Compliance, W62-300, 1200 New 
Jersey Avenue, SE., Washington, DC 20590. Fax: (202) 366-3897. E-
mail: ODAPCWebMail@dot.gov.
    The following items are required on each report:

Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. DOT Specimen Results Reported (total number)
2. Negative Results Reported (total number)
    Negative (number)
    Negative-Dilute (number)
3. Rejected for Testing Results Reported (total number)
    By Reason
    (a) Fatal flaw (number)
    (b) Uncorrected Flaw (number)
4. Positive Results Reported (total number)
    By Drug
    (a) Marijuana Metabolite (number)
    (b) Cocaine Metabolite (number)
    (c) Opiates (number)
    (1) Codeine (number)
    (2) Morphine (number)
    (3) 6-AM (number)
    (d) Phencyclidine (number)
    (e) Amphetamines (number)
    (1) Amphetamine (number)
    (2) Methamphetamine (number)
    (3) MDMA (number)
    (4) MDA (number)
    (5) MDEA (number)
5. Adulterated Results Reported (total number)
    By Reason (number)
6. Substituted Results Reported (total number)
7. Invalid Results Reported (total number)
    By Reason (number)

[FR Doc. 2010-20095 Filed 8-13-10; 8:45 am]
BILLING CODE 4910-9X-P

