[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Rules and Regulations]
[Page 49850-49864]
[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<PHONE_NUMBER>
(voice),<PHONE_NUMBER> (fax), or<EMAIL_ADDRESS>(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

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

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

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

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.

    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

(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

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

``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

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''

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

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

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.

    (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)

    (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:<PHONE_NUMBER>. E-
mail<EMAIL_ADDRESS>    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