June 6, 2022
Center for Substance Abuse Prevention (CSAP)
Division of Workplace Programs (DWP)
5600 Fishers Lane, Room 16N02
Rockville, MD 20857.
Re: SAMHSA 2022–001
To Whom It May Concern:
The American College of Occupational and Environmental Medicine (ACOEM) appreciates the opportunity to comment on Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG).
ACOEM is a national medical society representing over 4,000 occupational medicine physicians and other health care professionals devoted to the prevention and management of occupational injuries.
In the following comments, we will focus on those which will have the greatest impact on medical review officers or those who administer a drug testing program.
- The proposal to publish an annual notification of changes to the authorized biomarkers, test analytes, and cutoffs, rather than providing for a comment period, will prevent those who will be most impacted by the changes to submit operational concerns. Frequent changes in any of the components will not provide sufficient time for labs to adjust processes, parties to make required IT/software changes, update reports, for MROs to be properly trained and for employers to ensure consistency with their Drug and Alcohol plans. We recommend that changes should not be made more frequently than every 4-5 years which will provide adequate time to implement such modifications, ensure that all involved understand new steps and have a reasonable amount of time before it will be changed again. More frequent modifications could have significant operational costs.
- We support revising the definition of a substituted specimen to include specimens with a biomarker concentration inconsistent with that established for a human specimen consistent with current science.
- ACOEM appreciates the modification to requiring MROs to determine if there is clinical evidence of illicit drug use for morphine and/or codeine results meeting specific criteria. As discussed in the document, MROs rarely perform in person assessment and have no choice but to default reporting the lack of clinical evidence of illicit drug use. With sufficient studies demonstrating that incidental use of poppy seeds would not lead to an inaccurate report of morphine and /codeine use, eliminating the clinical evaluation step will more accurate identify those illicitly using morphine and/or codeine. One likely outcome will be the increased identification of those who may have used a friend or family members morphine and /or codeine days earlier, leading to a lower level of the analyte.
- We are concerned about the requirement that MROs will be required to submit semiannual reports to the Secretary or designated HHS representative on federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative by the MRO. MROs performing services for FMCSA covered employees are already submitting positive results to the FMCSA Clearing house. Adding this requirement will essentially require tracking and reporting of all results sent to them by the lab for review. This additional step will likely add additional costs which will be passed along.
- We appreciate clarification that a medical examination is not required when an alternate specimen is collected and that the MRO only acts on a laboratory reported invalid result when the MRO has verified the other result(s) for the specimen (i.e., positive, adulterated, or substituted) as negative or when the split (B) specimen was tested and reported as a failure to reconfirm.
- We do have some concerns that the MRO must report a positive result when donor admits unauthorized use of drug(s) that caused the positive test result, since this may result in the donor later denying the allegation. However, we acknowledge the donor would also most likely be unable to provide documentation to substantiate authorized use. Our opinion is that this most often would occur with the tests positive for morphine or codeine below 15,000. This should, however, no longer be an issue with the revised confirmation cut-off and the elimination of the MRO requirements to determine if there was clinical evidence of use.
- We support the reinforcement that passive exposure or ingestion of food product or supplement containing the drug in question is not an acceptable medical explanation for a positive drug test, nor is a physician’s authorization or medical recommendation for a Schedule I substance. This would address THC (and CBD) as well as poppy seeds.
- Not specifically addressed in this rulemaking but is included in the DOT NRPM Addition of Oral Fluid Specimen Testing for Drugs. It was proposed to allow direct observation of a collection by any licensed or certified medical professional legally authorized to take part in a medical examination in the jurisdiction where the collection takes place. This would be very important in those areas where finding same gender observers, including for those that identify as non-binary.
Thank you for your consideration of our comments. If you should have any questions, please contact ACOEM’s Director of Government Affairs Patrick O’Connor at 703/351-6222 or by email at email@example.com
Douglas W. Martin, MD, FAADEP, FAAFP, FACOEM