[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]
[[Page 60318]]
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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.
[[Page 60319]]
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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