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Office of the Secretary of Transportation
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 [email protected] (email).
SUPPLEMENTARY INFORMATION: 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.
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.
FOOTNOTE 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. END FOOTNOTE
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/
FOOTNOTE 2 Ibid. END FOOTNOTE
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.
--This is a summary of a Federal Register article originally published on the page number listed below--
Interim final rule.
CFR Part: "49 CFR Part 40"
RIN Number: "RIN 2105-AE14"
Citation: "77 FR 26471"
Document Number: "Docket DOT-OST-2010-0026"
Federal Register Page Number: "26471"
"Rules and Regulations"
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