Procedures for Transportation Workplace Drug and Alcohol Testing Programs: 6-acetylmorphine (6-AM) Testing, 60318-60319 [2012-24337]
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Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations
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
Office of the Secretary, U.S.
Department of Transportation (DOT).
ACTION: Final rule.
AGENCY:
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 6acetylmorphine (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:
SUMMARY:
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 6AM, 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 § 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 6AM 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 6month 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:
Semi-Annual period
2008
July–Dec
2009
Jan–June
2009
July–Dec
2010
Jan–June
2010 *
July–Dec
2011
Jan–June
Total Laboratory Test Results.
6-AM Laboratory Positives ..
2.85 million ...
2.59 million ...
2.57 million ...
2.69 million ...
2.77 million ...
2.82 million ...
2.87 million
121 ...............
158 ...............
173 ...............
281 ...............
298 ...............
371 ...............
429
erowe on DSK2VPTVN1PROD with
* The
new requirement for 6-AM testing was in effect for the last 3 months of the period.
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July–Dec
Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations
Our commissioned study was not
designed to evaluate the pattern of 6AM 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
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.
erowe on DSK2VPTVN1PROD with
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.
[FR Doc. 2012–24337 Filed 10–2–12; 8:45 am]
BILLING CODE 4910–9X–P
VerDate Mar<15>2010
14:51 Oct 02, 2012
Jkt 229001
National Oceanic and Atmospheric
Administration
50 CFR Part 229
RIN 0648–XC099
Harbor Porpoise Take Reduction Plan;
Coastal Gulf of Maine Closure Area
Established With a Temporary Shift of
Its Effective Date
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Establishment of the Coastal
Gulf of Maine Closure Area; temporary
shift of its effective date.
AGENCY:
Through this notice, NOAA’s
National Marine Fisheries Service
(NMFS) announces the establishment of
the Coastal Gulf of Maine Closure Area
under the Harbor Porpoise Take
Reduction Plan (Plan), and temporarily
shifts the effective date of year 1 of its
implementation from October 1, 2012,
to February 1, 2013. Recent information
suggests that harbor porpoise bycatch is
higher in February and March than in
October and November since the
implementation of sectors in May 2010,
warranting a temporary shift of the
closure in year 1 to a time period that
would provide greater conservation
benefit to harbor porpoises and allow
time for more complete consideration of
updated information on harbor porpoise
bycatch, harbor porpoise abundance,
and fishing effort by the Harbor
Porpoise Take Reduction Team (Team).
As such, this area will be closed to
gillnet fishing in February and March of
2013 rather than October and November
of 2012.
DATES: Year 1 effective February 1,
2013; Year 2 and beyond effective
October 1, 2013.
FOR FURTHER INFORMATION CONTACT: Kate
Swails, NMFS, Northeast Region, 978–
282–8481, kate.swails@noaa.gov; or
Kristy Long, NMFS, Office of Protected
Resources, 301–427–8402,
kristy.long@noaa.gov.
SUMMARY:
Authority
Issued on September 20th, 2012, at
Washington DC
Ray LaHood,
Secretary of Transportation.
DEPARTMENT OF COMMERCE
SUPPLEMENTARY INFORMATION:
Background
The Harbor Porpoise Take Reduction
Plan (Plan) was implemented in late
1998 pursuant to section 118(f) of the
Marine Mammal Protection Act
(MMPA) to reduce the level of serious
injury and mortality of the Gulf of
Maine/Bay of Fundy (GOM/BOF) stock
of harbor porpoises (63 FR 66464,
December 2, 1998). NMFS amended the
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
60319
Plan in 2010 (75 FR 7383, February 19,
2010) to address increased mortalities of
harbor porpoises in New England and
Mid-Atlantic commercial gillnet
fisheries due to non-compliance with
the Plan requirements and observed
interactions occurring outside of
existing management areas.
The 2010 amendments, based largely
on consensus recommendations from
the Team, included the expansion of
seasonal and temporal requirements
within the Plan’s management areas, the
incorporation of additional management
areas, and the creation of three closure
areas off the coast of New England that
would prohibit the use of gillnet gear if
certain levels of harbor porpoise bycatch
are exceeded (consequence closure area
strategy).
For New England, the 2010
amendments to the Plan implemented a
‘‘consequence’’ closure strategy, which
would close specific areas to gillnet gear
during certain times of the year if
observed average bycatch rates exceed
specified target bycatch rates over the
course of two consecutive management
seasons. If observed bycatch rates
exceeded the target rates, the following
three areas would become closed: the
Coastal Gulf of Maine, Eastern Cape
Cod, and Cape Cod South Expansion
Consequence Closure Areas. This
measure was intended to provide an
incentive for the gillnet industry to
comply with pinger requirements in
areas with historically high harbor
porpoise bycatch levels resulting from
relatively low levels of compliance. The
consequence closures, if implemented,
would further reduce harbor porpoise
mortalities due to the times and areas
chosen for their implementation.
The Coastal Gulf of Maine
Consequence Closure would be
triggered if the observed average bycatch
rates of harbor porpoises in the MidCoast, Stellwagen Bank, and
Massachusetts Bay Management Areas
(combined) exceed the target bycatch
rate of 0.031 harbor porpoise takes/
metric tons of fish landed (takes/mtons)
(1 harbor porpoise taken per 71,117
pounds of fish landed) after two
consecutive management seasons. If
triggered, the use of gillnet gear would
be prohibited during the months of
October and November, which
historically have been the months with
the highest amount of observed harbor
porpoise bycatch. When this area is not
closed, the seasonal requirements of the
three overlapping management areas,
including the March gillnet closure in
the Massachusetts Bay Management
Area, would remain in effect.
The Cape Cod South Expansion and
Eastern Cape Cod Consequence Closures
E:\FR\FM\03OCR1.SGM
03OCR1
]]>Agencies
[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.
-----------------------------------------------------------------------
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:
--------------------------------------------------------------------------------------------------------------------------------------------------------
2010 \*\ July-
Semi-Annual period 2008 July-Dec 2009 Jan-June 2009 July-Dec 2010 Jan-June Dec 2011 Jan-June 2011 July-Dec
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\*\ 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]
BILLING CODE 4910-9X-P
