NDASA recently submitted public comments on behalf of its members in the drug and alcohol testing industry to the Department of Health and Human Services regarding its proposed amendment to the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Fentanyl in the testing panels for urine and oral fluid specimen testing and remove Methylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA) from the panels.
In summary, NDASA requested:
- Explanation and clarification of the scientific basis for setting initial and confirmatory test cutoff levels, including the 1 ng/mL cutoff level for Fentanyl. The association reasoned, that employers and their service agents, who may have to litigate employment/business decisions in court based on drug test results, must be able to show that the science supports these decisions. The association further asked that scientific research and evidence regarding cutoff levels be made available to the public.
- Information on the decision-making process in selecting the 1 ng/mL cutoff level for Fentanyl: “Is this the most cost-efficient and programmatically effective cutoff level? Does this rule out therapeutic use? Are there other considerations supporting the 1 ng/mL cutoff?”
- The drug and alcohol testing industry be given sufficient time to implement changes in the drug testing panel and these changes not be made until the oral fluid reagents are cleared by the Food and Drug Administration (FDA). The association reasoned that it is critically important that the changes in the test panel happen at the same time for both oral fluid and urine drug testing.
- That test panel changes for HHS be made and implemented at the same time as the changes in the test panel are made and implemented for DOT. The association reasoned that it would be highly problematic if HHS-certified laboratories stopped testing for a drug (MDA and MDMA in this case) that was still included on the panel for DOT-mandated testing.
NDASA’s Full Comments
December 5, 2023
Re: Amendments to the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Fentanyl in the Analyte Table and remove Methylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA) from the Testing Panels for Urine and Oral Fluid Specimen Testing, as referenced in 88 Federal Register 80323 (Nov. 17, 2023)
Comments Submitted to:
Ron R. Flegel, B.S., MT(ASCP), MS.
Director
Division of Workplace Programs
Center for Substance Abuse Prevention
Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
DFWP@samhsa.hhs.gov
Cc: Lisa S. Davis, M.S
Social Science Analyst
Lisa.Davis@samhsa.hhs.gov
Dear Director Flegel, Ms. Davis, and the Federal Drug Testing Advisory Board,
The National Drug and Alcohol Screening Association (NDASA) is a non-profit professional association representing more than 5,000 private and public sector employers and service agents who administer and manage workplace drug and alcohol testing programs covered by the Mandatory Guidelines; the Omnibus Transportation Employee Testing Act (OTETA) and the Department of Transportation’s (DOT) Procedures for Transportation Drug and Alcohol Testing Programs, as well as the DOT agency regulations; the Nuclear Regulatory Commission’s regulations; and non-Federal/non-mandated drug free workplace programs.
NDASA’s membership includes laboratories, employers’ substance abuse program administrators, compliance auditors, consortia/third party administrators (C/TPA), specimen collection facilities, collectors, breath alcohol technicians, screening test technicians, laboratories, medical review officers (MRO) and substance abuse professionals (SAP) who support employers in their Drug-Free Workplace Program initiatives. NDASA is a member-owned organization that has led the way for industry education, training, and expertise in the drug free workplace arena through NDASA University professional training courses, industry-specific certifications, annual conferences, educational webinars and NDASA publications that keep our industry apprised of pertinent information. With the recent merger of the former Drug and Alcohol Testing Industry Association into NDASA, we are now the largest trade association representing employers and their drug and alcohol industry service agents in the United States. NDASA thanks the Division of Workplace Programs (DWP) of the Department of Health and Human Services (HHS) for this opportunity to provide public comment on its proposed changes to the Drug Testing Panels. NDASA respectfully submits the remarks contained in this letter in response to the DWP’s Federal Register Notice proposing to amend the Urine and Oral Fluid Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Fentanyl in the Analyte Table and remove Methylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA) from the Testing Panels for Urine and Oral Fluid Specimen Testing.
NDASA conceptually supports the addition of Fentanyl and removal of MDA and MDMA from the Testing Panels for both the Urine Mandatory Guidelines and the Oral Fluid Mandatory Guidelines, as long as the cutoff levels for Fentanyl are supportable, and the laboratories will implement on the same effective date as DOT’s amendments to include Fentanyl and remove both MDA and MDMA from its own regulation, 49 CFR Part 40. In addition, we applaud the decision of the Division of Workplace Programs to retain phencyclidine (PCP) in the Testing Panels because PCP remains a matter of considerable concern in DOT-regulated industries.
Under the new procedures for amending its urine and oral fluid drug testing panels, respectively, there is inherently a balancing that we strongly recommend DWP conduct. While DWP has a strong interest in developing a “nimble” panel that can respond to substance-related workplace threats, there also needs to be a well-established scientific basis for setting the initial and confirmatory test cutoffs and that basis needs to be clearly articulated by DWP in a Federal Register publication announcing the final decision of HHS on the Testing Panel changes.
In the past, DWP has changed cutoff levels for parent drugs and their metabolites in response to public comments. We encourage a continuation of such consideration of substantive public comments from those who are familiar with the effectiveness, efficiencies, and availability of research to support the final cutoffs. We are encouraged to hear from Director Flegel that there will be a longer consideration of public comments.
If there is scientific supportability articulated in the DWP’s Federal Register notice, then those employers and their service agents who will litigate around the testing (and the testing cutoffs) will have a firm footing to withstand those legal challenges. If there are no statements published by DWP regarding scientific sufficiency, the legal defensibility will be weak.
With this concern in mind, we respectfully ask whether there is research to support the 1 ng/mL cutoff proposed for Fentanyl and if so, that it be shared publicly. Is this the most cost-efficient and programmatically effective cutoff level? Does this rule out therapeutic use? Are there other considerations supporting the 1 ng/mL cutoff? We are requesting a clear delineation of what choices DWP faced in deciding on the proposed 1 ng/mL cutoff and why this level was chosen for screening and confirmation for Fentanyl and Norfentanyl.
When the DWP adds one or more drugs to the Testing Panels, it is extremely important to NDASA that our members and their laboratories have sufficient time to implement such changes. Since the Food and Drug Administration (FDA) has a complicated double-clearance process, we ask that HHS not implement changes to require testing for Fentanyl or another new drug until the oral fluid reagents are able to be cleared with the FDA.
If a urine drug test can be conducted by HHS-certified laboratories, but an oral fluid drug test cannot, that will cause significant problems for those who are required to test under the DOT’s regulation, 49 CFR Part 40. In circumstances where an employee who is subject to testing begins a urine collection, but then needs to have a direct observation collection, if the individual is transgender or nonbinary, they must have an oral fluid test and not a urine test per 49 CFR § 40.67(g)(3). This situation would become unnecessarily complicated if urine and oral fluid testing could not be available for the same drugs. Also, DOT allows employers to choose whether to use oral fluid or urine drug testing for each drug test type (pre-employment, random, post-accident, etc.). If a DOT-regulated employer has a standing order that requires oral fluid testing in some scenarios and urine testing in others, having a different panel of drugs for urine versus oral fluid could raise Constitutional Equal Protection concerns. Thus, the effective date and the laboratory implementation date for a changed Testing Panel for oral fluid testing must occur at exactly the same time as urine testing.
Respectfully, we would like to note for the record that the highly valued HHS certification process for laboratories and the proficiency testing that would need to be done before a drug could be added to the panel will add significant time to the actual effective date that should be determined. This is justifiable and should not be rushed. During the time the National Laboratory Certification Program (NLCP) will use to certify the laboratories and conduct proficiency testing, the DOT and the reagent manufacturers would have more time to prepare. However, we ask DWP to be mindful of the need for synchronous effective dates for HHS and DOT.
If effective dates are set too soon, there are likely to be shortages of reagents because suddenly a market of more than seven million tests annually would open. We don’t want to see reagent manufacturers monopolizing the market or running into shortages of the available supply reagents that will drive up costs.
When removing drugs from the panel, the NDASA membership is very concerned about what will happen if HHS and DOT have different effective dates. If HHS were to remove a drug from the drug testing panel months before DOT is able to undergo a full notice and comment rulemaking and publish a final rule under the Administrative Procedures Act, would the NLCP continue to grant HHS certification to laboratories to test for the removed drugs? If DOT still requires the testing and a transportation employee tests positive for that drug, how could that positive result be sustained if the laboratory was not HHS-certified to test for it? Such a gap between testing and HHS certification would create legal liability for the DOT-regulated employer and its laboratory.
Also, a gap between what HHS requires for its certified laboratories and what DOT requires of its regulated employers would certainly violate OTETA. DOT must follow HHS for the science and must utilize HHS-certified laboratories. It is highly unlikely that HHS would certify a laboratory and conduct proficiency testing for a drug that HHS has removed from its panel. There would be a similar problem if DWP changes the cutoffs for an existing drug in the Testing Panels. In other words, HHS would be certifying and proficiency testing laboratories at cutoffs different from the DOT regulation and thereby leaving the DOT program unsupported.
Consequently, we respectfully request extended effective dates for any changes to add or remove a drug from the Testing Panels and that the effective and implementation dates are fully synchronized with the DOT effective dates.
We anticipate filing a final version of these remarks as comments later this month.
Respectfully Submitted,
M. Jo McGuire
Executive Director
National Drug & Alcohol Screening Association
1629 K Street NW, Suite 300
Washington, D.C. 20006
888-316-3272