[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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