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Revised Mandatory Guidelines and Department of Transportation Notice of Proposed Rulemaking (NPRM) >>>
This article is a follow – on to the previous article concerning the DOT NPRM. The was published January 23, 2017 by the Office of Drug and Alcohol Policy and Compliance (ODAPC).
The primary purpose was to harmonize with the recently revised Mandatory Guidelines which DOT/ODAPC is obligated to follow by Public Law published and signed into law September 1991. The major impact is the addition of four additional Schedule II prescription medications: Hydrocodone, hydromorphone, oxycodone, and Oxymorphone with the following cutoff levels:
Drug Name Screen Test Confirmatory Test
Cutoff Level Cutoff Level
Hydrocodone/Hydromorphone …………………………300 ng/mL …………100 ng/mL
Oxycodone/Oxymorphone ……………………………. 100 ng/mL …………100 ng/mL.
To respond to potential questions, the Public Law that established Federal Agency drug testing passed in 1987 prohibits the testing of drugs that are not listed as Schedule I or II listed on the Controlled Substances Act.
One other change to the testing panel was to remove methylenedioxyethylamphetamine, (MDEA) as a confirmatory test analyte from the existing drug-testing panel and add methylenedioxyamphetamine (MDA) as an initial test analyte. These changes were part of the recently published Mandatory Guidelines.
DOT qualified collectors will be required to subscribe the updates published by ODAPC the site is: https://www.transportation.gov/odapc/get-odapc-email-updates. In addition to collectors, all service agents should subscribe to the periodic updates.
Collectors have an additional responsibility that is to inform the employer when a specimen that should been collected directly observed and was not the collector shall inform the employer. The employer is then required to have a direct observation collection. If the employee refuses to go and have a direct observation collection, that is considered a refusal to test.
This is a list of what can be considered a Fatal Flaw where the laboratories can reject a specimen for testing. The Fatal Flaws are listed in 49 CFR Part 40,83 and are applicable to 49 CFR part 40.199 can cause the test to be cancelled:
(1) There is no CCF;
(2) There is no specimen submitted with the CCF;
(3) There is no printed collector’s name and no collector’s signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the specimen bottle and the CCF do not match;
(6) The specimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (h) of this section);
(7) There is an insufficient amount of urine in the primary bottle for analysis, unless the specimens can be redesignated (st also ee paragraph (h) of this section).
Even MROs are required to subscribe to DOT/ODAPC updates before they can begin to perform the duties of an MRO. DOT has amended the MRO role to include the new drugs are identified in a urine test. MROs will have their work cut out for them with the addition of these substances when found in a urine specimen. The MRO’s are not authorized to test for D, L stereoisomer testing or tetrahydrocannabivarin (THC–v) testing when verifying lab results. The D, L isomer is for the determination of Methamphetamine with the D isomer used to identify use. THV-v can be used when a donor claims that they are taking Marinol and the MRO suspects that the door is also using marijuana. THV-v is found in the plant Cannabis sativa.
ODAPC has also removed the requirement for the submission of blind performance specimens. This will result in lower costs for major employers and large C/TPAs.
The NPRM discusses Section 193 titled: “What happens when an employee does not provide a sufficient amount of urine for a drug test?” If the donor cannot provide a sufficient specimen within three hours of the first unsuccessful attempt, the following: The collection must be stopped and not that on the CCF and notify the DER. If there are any observable discrepancies in the specimen that may have been submitted, that should be noted in the remarks section of the CCF. The specimen is required to be discarded. It should be noted on the CCF that the donor did not provide a second sufficient specimen.
It is clearly noted that Point-of-Collection urine testing or instant tests are not authorized. It should be noted that these tests cannot be used for Pre-employment testing to be followed hy a regulated drug test.
There are new requirements for the STTS and BATs, mainly that they must be subscribed to ODAPC Updates to be qualified. SAPS must also be subscribers of the update.
A very important item that should be noted is that “for any service agent, representing falsely that the service agent or its activities is approved or certified by the Department or a DOT agency (such representation includes, but is not limited to, the use of a Department or DOT agency logo, title, or emblem).” This has been a long-standing issue with DOT and the Modal agencies going back more than 20 years.
The rest of the NPRM is concerned with various reporting forms:
Appendix B to Part 40—DOT Drug-Testing Semi-Annual Laboratory Report to Employers
Appendix C to Part 40—DOT Drug-Testing Semi-Annual Laboratory Report to DOT
Appendix D to Part 40—Report Format:Split Specimen Failure To Reconfirm
Appendix H to Part 40 [Removed]
It should be noted that Appendix H is the annual MIS reporting and how to do that.
These above items can be commented on and as follows:
Comments should be submitted by March 24, 2017. If submitting comments, they should be submitted by one of the following methods:
• 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 W–12–140, 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: To ensure proper docketing of your comment, please include the agency name and docket number DOT–OST–2016–0189 or the Regulatory Identification Number (RIN), 2105–AE58, 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.
If any readers have an issue or a recommendation to be made to the proposed changes, they are urged to make comment using one of the methods for submitting a comment.