[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Rules and Regulations]
[Pages 26471-26473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10665]
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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, DOT.
ACTION: Interim final rule.
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SUMMARY: The Department is amending certain provisions of its drug
testing procedures for 6-acetylmorphine (6-AM), a unique metabolite of
heroin. Laboratories and Medical Review Officers (MROs) will no longer
be required to consult with one another regarding the testing for the
presence of morphine when the laboratory confirms the presence of 6-AM.
This rule is intended to streamline the laboratory process for
analyzing and reporting 6-AM positive results and will facilitate MRO
verification of 6-AM positive results.
DATES: The rule is effective July 3, 2012. Comments to this interim
final rule should be submitted by June 4, 2012. Late-filed comments
will be considered to the extent practicable.
ADDRESSES: To ensure that you do not duplicate your docket submissions,
please submit them by only one of the following means:
Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting
comments.
Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE., West Building Ground Floor
Room W12-140, Washington, DC 20590-0001;
Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Ave. SE., between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The telephone number is 202-366-9329;
Instructions: You must include the agency name and docket number
DOT- OST-2010-0026 or the Regulatory Identification Number (2105-AE14)
for the rulemaking at the beginning of your comments. All comments
received will be posted without change to http://www.regulations.gov,
including any personal information provided.
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
For its drug testing regulation, the Department of Transportation
(DOT) is required by the Omnibus Transportation Employee Testing Act of
1991 (Omnibus Act) to incorporate the laboratory testing protocols and
standards established by the U.S. Department of Health and Human
Services (HHS). The Omnibus Act requires that we utilize HHS-certified
laboratories and that we follow the HHS Mandatory Guidelines for
identifying the specific drugs for which we test and the scientific
methodologies the laboratories must use for testing. Because of these
requirements and to create consistency with certain aspects of the new
HHS Mandatory Guidelines effective October 1, 2010 [73 FR 71858], the
DOT published its final rule on August 16, 2010 [75 FR 49850], also
effective October 1, 2010, to harmonize with many aspects of the
revised Mandatory Guidelines.
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 HHS and 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.
[[Page 26472]]
In our final rule, we discussed the concern some commentors had
about whether morphine needed to be present with a confirmed positive
6-AM result. We discussed the data and studies submitted to the docket
addressing the question of whether there was research or studies
showing that morphine must also be present and at what quantitations.
As stated at 75 FR 49856, based on the comments to the docket and
multiple scientific publications, the facts were:
6-AM confirmed positive tests do not need a morphine
marker;
Data showed 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.
We decided that, until more experience was gained with the new
testing procedures for 6-AM, we would place additional requirements on
the laboratories and the MROs. Specifically, when morphine was not
detected at the HHS/DOT cutoff of 2000ng/mL, we added a requirement for
the laboratory and MRO to determine whether morphine was detected at
the laboratory's 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)].
Policy Discussion
From the October 1, 2010 effective date of the final rule through
September 30, 2011, ODAPC has received, on average, 14 results per
month from the laboratories and MROs that a specimen was positive for
6-AM with no morphine at the laboratory's LOD. During this period, we
learned that the laboratory LODs ranged from 100ng/mL to 600ng/mL, and
were set in accordance with National Laboratory Certification Program
guidance to them.
As part of our monitoring process and with the varying LODs in
mind, DOT worked with HHS to have their contractor, RTI International
(RTI), conduct a study of those DOT specimens reported to ODAPC as
confirmed positive for 6-AM and negative for morphine. The scope of the
study was ``* * * to verify the atypical results obtained by the
laboratories, to determine if other drugs or metabolites present in the
specimen could explain the absence of morphine, and to determine if
something other than heroin use could explain the presence of 6-AM.''
\1\ The study consisted of aliquots (from the A bottles) of DOT
specimens received by the laboratories between October and December
2010 and reported by the laboratory to the MRO as confirmed positive
for 6-AM and negative for morphine.
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\1\ Anomalous Results of Morphine and 6-Acetylmorphine in Urine
Specimens, Abstract at the 2011 Joint Meeting of Society of Forensic
Toxicologists (SOFT) & The International Association of Forensic
Toxicologists (TIAFT), San Francisco, CA, September 25-30, 2011.
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The study reconfirmed the presence of 6-AM in all the specimens. By
reconfirming the 6-AM results, the study confirmed ``* * * that the
presence of 6-AM in these specimens was not due to laboratory
contamination or 6-AM production during analysis.'' Morphine levels of
>5ng/mL were also detected in all but 6 of the specimens. For these 6
specimens, the report went on to say that, ``While atypical for heroin
exposure and metabolism, the remaining 6 specimens' results are
consistent with literature reports of atypical 6-AM results after
heroin exposure.'' The authors determined that other drugs or
metabolites present in the specimen were not responsible for the
absence of morphine. Furthermore, the study concluded, ``There was no
evidence indicating that the 6-AM originated from a source other than
heroin.'' \2\
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\2\ Ibid.
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Based upon these facts and research-based conclusions, there is no
longer a need for laboratories to detect the present of morphine below
the HHS/DOT established morphine cutoff of 2000ng/mL and for MROs to
confer with ODAPC on verifying these 6-AM results. Based on the RTI
study, morphine may be present below the laboratory's LOD. As we
indicated in the preamble of the final rule [75 FR 49856], for those
specimens where morphine was not present we believe there is a
scientific explanation. Therefore, we will amend 49 CFR 40.87 and 40.97
to say that if the laboratory confirms a specimen as positive for 6-AM,
and morphine is not at or above the 2000ng/mL cutoff, the laboratory
will report the specimen results to the MRO without any additional
testing for morphine. We will also revise 49 CFR 40.139 and remove
section 40.140. Furthermore, the MRO will conduct the verification as
he or she would for any other laboratory confirmed positive test
result, with the understanding there is no legitimate explanation for
the presence of 6-AM in the employee's specimen regardless of the
morphine result.
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).
Administrative Procedure Act
The Department has determined this rule may be issued without a
prior opportunity for notice and comment because providing prior notice
and comment would be unnecessary, impracticable, or contrary to the
public interest since this rule was thoroughly discussed in a prior
final rule effective October 1, 2010 [75 FR 49850]. This rule will
reduce the burden on laboratories and MROs since it will remove certain
provisions of the drug testing regulation which currently require the
laboratories and MROs to confer with each other and ODAPC regarding
laboratory tests positive for 6-AM with no morphine at the laboratory's
LOD. It will also remove requirements for further laboratory testing
where 6-AM is detected without the presence of morphine.
Providing an opportunity for prior notice and comment before
publishing this interim final rule (IFR) would be unnecessary since it
is based upon a final rule [75 FR 49850, August 16, 2010] that followed
public notice and comment. In that rule we indicated we would determine
what our first year of testing would reveal regarding the screening and
confirmation testing of 6-AM and the presence of morphine. The first
year has passed and from the information provided by the laboratories
and MROs, and the collaborative scientific study with HHS, we learned
morphine may be present below the laboratory's LOD. In addition, for
those few specimens where morphine was not present the study stated
that such results were consistent with literature reports of atypical
6-AM results after heroin use.
Providing an opportunity for notice and comment before publishing
this IFR is also unnecessary since it makes only minor procedural and
burden-relieving amendments to the rule text. Specifically, the rule
will no longer require laboratories and MROs to consult with one
another regarding the testing for the presence of morphine when the
laboratory confirms the
[[Page 26473]]
presence of 6-AM. In addition, laboratories and MROs will no longer be
required to notify ODAPC of 6-AM only positive results.
Executive Order 12866 and Regulatory Flexibility Act
This Interim Final Rule is not significant for purposes of
Executive Order 12866 or the DOT's regulatory policies and procedures.
The rule makes minor procedural amendments to its rule text. The rule
will impose no new burdens on any parties, and will actually decrease
the burden upon the laboratories and the MROs. The Department
consequently certifies, 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.
Issued this 24th Day of April 2012, at Washington, DC.
Ray LaHood,
Secretary of Transportation.
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: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
54101 et seq.
Sec. 40.87 [Amended]
0
2. In Sec. 40.87 remove paragraph (e).
Sec. 40.97 [Amended]
0
3. In Sec. 40.97 remove paragraph (g).
0
4. Section 40.139 is revised to read as follows:
Sec. 40.139 On what basis does the MRO verify test results involving
opiates?
As the MRO, you must proceed as follows when you receive a
laboratory confirmed positive opiate result:
(a) If the laboratory confirms the presence of 6-acetylmorphine (6-
AM) in the specimen, you must verify the test result positive.
(b) In the absence of 6-AM, if the laboratory confirms 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.
(c) 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 judgement and discretion to determine whether
there is clinical evidence of unauthorized use of opiates. Examples of
information that you may consider in making this judgement 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 (c)(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 (c)(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 this
paragraph (c). 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.
Sec. 40.140 [Removed]
0
5. Remove Sec. 40.140.
[FR Doc. 2012-10665 Filed 5-3-12; 8:45 am]
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