[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60318-60319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24337]



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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket DOT-OST-2010-0026]
RIN 2105-AE14


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs: 6-acetylmorphine (6-AM) Testing

AGENCY: Office of the Secretary, U.S. Department of Transportation 
(DOT).

ACTION: Final rule.

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SUMMARY: This rule adopts as final, without change, a May 4, 2012, 
interim final rule (IFR) which no longer requires laboratories and 
Medical Review Officers (MRO) to consult with one another regarding the 
testing for the presence of morphine when the laboratory confirms the 
presence of 6-acetylmorphine (6-AM). Also, laboratories and MROs will 
no longer need to report 6-AM results to the Office of Drug and Alcohol 
Policy and Compliance (ODAPC). This rule also responds to comments on 
the IFR.

DATES: The rule is effective October 3, 2012.

FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, U.S. Department of 
Transportation, Office of Drug and Alcohol Policy and Compliance, 1200 
New Jersey Avenue SE., Washington, DC 20590; 202-366-3784 (voice), 202-
366-3897 (fax), or bohdan.baczara@dot.gov (email).

SUPPLEMENTARY INFORMATION:

Background and Purpose

    On August 16, 2010, [75 FR 49850] the Department published its 
final rule to harmonize with many aspects of the revised Department of 
Health and Human Services (HHS) Mandatory Guidelines [73 FR 71858]. One 
item with which the DOT harmonized was the laboratory testing for 6-
acetylmorphine (6-AM) without a morphine marker. 6-AM is a unique 
metabolite produced when a person uses the illicit drug heroin. Prior 
to the October 1, 2010, rulemaking, both the HHS and Department of 
Transportation (DOT) regulations required the laboratory to first test 
for morphine, and if it detected morphine at the HHS/DOT cutoff of 
2000ng/mL, the lab would then test for 6-AM.
    For the reasons discussed in the DOT final rule [75 FR 49850], we 
decided that, until more experience was gained with the new testing 
procedures for 6-AM, we would place additional requirements on 
laboratories and MROs. Specifically, when there was a 6-AM positive 
result and morphine was not detected by a laboratory at the 2000ng/mL 
cutoff, we added a requirement for the laboratory and MRO to determine 
whether morphine was detected at the laboratory's level of detection 
(LOD). If morphine was not detected at the laboratory's LOD, the 
laboratory and MRO were to report that result to DOT's Office of Drug 
and Alcohol Policy and Compliance (ODAPC). After consulting with ODAPC, 
the MRO would make a verified result determination, keeping in mind 
that there is no legitimate explanation for 6-AM in the employee's 
specimen [see Sec.  40.151(g)]. The Department would track these 
results and discuss them with HHS.
    On May 4, 2012, the Department issued an IFR [77 FR 26471] and 
effective July 3, 2012, related to 6-AM testing. For reasons stated in 
that IFR, we removed the requirement for laboratories and MROs to 
consult with one another regarding the testing for the presence of 6-
AM. The IFR also streamlined the laboratory analysis and MRO reporting 
of 6-AM results by not having either the laboratory or MRO report the 
6-AM information to ODAPC. The IFR also sought comments to the IFR 
which were to be submitted by June 4, 2012. There were two such 
comments.

Discussion of Comments to the Docket

    There were two comments to the docket representing three 
organizations. One comment was submitted by a large organization which 
represents physicians who are MROs. The other comment was submitted by 
a large medical review officer service and consortium which provide 
drug and alcohol testing services primarily to the pipeline industry.
    Each of the commentors fully supported the Department's position on 
amending the requirements for testing and reporting 6-AM test results. 
Their support of the IFR further reinforces that there are no 
legitimate medical explanations for the confirmation of 6-AM on a DOT 
drug test and that the MRO must make positive results determinations in 
these cases.
    One commenter asked whether we had noted a spike followed by a 
decline in the 6-AM results during the first year of testing, as they 
did. They wondered whether our commissioned study was designed to shed 
light on their observation.
    We would note that over time, the Department has indeed seen an 
increase of laboratory-reported 6-AM test results. However, we found 
that the largest semi-annual period rise of 6-AM results, by number and 
percentage increase, came even before the October 2010 effective date 
of the new rules. This larger rise was noted when we compared the July-
December 2009 period with the January-June 2010 period. Also, it is 
important to note that the number of total drug tests reported by 
laboratories has risen during each 6-month period, starting with the 
July-December 2009 period, and the number of 6-AM positive results has 
steadily risen each period since July-December 2008.
    The following table displays the laboratory data for 6-AM before, 
during transition, and after full implementation of the new testing 
protocols:

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                                                                                                       2010 \*\  July-
      Semi-Annual period        2008  July-Dec    2009  Jan-June    2009  July-Dec    2010  Jan-June         Dec         2011  Jan-June   2011  July-Dec
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Total Laboratory Test Results  2.85 million....  2.59 million....  2.57 million....  2.69 million....  2.77 million...  2.82 million...  2.87 million
6-AM Laboratory Positives....  121.............  158.............  173.............  281.............  298............  371............  429
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\*\ The new requirement for 6-AM testing was in effect for the last 3 months of the period.


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    Our commissioned study was not designed to evaluate the pattern of 
6-AM test results over time. Its scope was ``* * * to verify the 
atypical results obtained by the laboratories, to determine if other 
drug or metabolites present in the specimens could explain the absence 
of morphine, and to determine if something other than heroin use could 
explain the presence of 6-AM.'' [77 FR 26472] The study's findings were 
presented and discussed in the IFR. [77 FR 26472] We would note that 
the rise in 6-AM positives was predicted, and a rise seems to have 
become the trend over time.
    For the reasons discussed above and outlined in the IFR, we are 
adopting the rule text in the IFR as final.

Regulatory Analyses and Notices

Authority

    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 54101 et seq.) and the Department of 
Transportation Act (49 U.S.C. 322).

Executive Order 12866 and Regulatory Flexibility Act

    This Final Rule is not significant for purposes of Executive Order 
12866 or the DOT's regulatory policies and procedures. It finalizes 
modifications, already in effect, to our procedures that do not 
increase costs on regulated parties. The rule will impose no new 
burdens on any parties, and will actually decrease the burden upon the 
laboratories and the MROs. I hereby certify, under the Regulatory 
Flexibility Act, that this rule does not have a significant economic 
impact on a substantial number of small entities.

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.

    Accordingly, the Interim Final Rule amending 49 CFR Part 40 which 
was published at 77 FR 26471 on May 4, 2012 is adopted as a final rule 
without change.

    Issued on September 20th, 2012, at Washington DC
Ray LaHood,
Secretary of Transportation.
[FR Doc. 2012-24337 Filed 10-2-12; 8:45 am]
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