Background
Pursuant to its authority under section 503 of Public Law 100–71, 5 U.S.C. 7301, and Executive Order 12564, HHS establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies.
Using data obtained from the Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by Federal agencies. No Federal agencies are testing hair or oral fluid specimens at this time.
HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hereinafter referred to as Guidelines or Mandatory Guidelines) in the Federal Register (FR) on April 11, 1988 (53 FR 11979). The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 (59 FR 29908), September 30, 1997 (62 FR 51118), November 13, 1998 (63 FR 63483), April 13, 2004 (69 FR 19644), and November 25, 2008 (73 FR 71858). SAMHSA published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) on January 23, 2017 (82 FR 7920) and published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554). SAMHSA published proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Hair (HMG) on September 10, 2020 (85 FR 56108) and proposed revisions to the UrMG (87 FR 20560) and OFMG (87 FR 20522) on April 7, 2022.
There was a 60-day public comment period following publication of the proposed OFMG, during which 53 commenters submitted 204 comments on the OFMG. These commenters were comprised of individuals, organizations, and private sector companies. The comments are available for public view at https://www.regulations.gov/. All comments were reviewed and taken into consideration in the preparation of the Guidelines. The issues and concerns raised in the public comments for the OFMG are set forth below. Similar comments are considered together in the discussion.
Summary of Public Comments and HHS’s Response
The following comments were directed to the information and questions in the preamble.
Some submitted comments were specific to transportation industry drug testing which is regulated by the Department of Transportation (DOT). The Department has noted these comments below, but responded only to comments that are relevant to these Guidelines. DOT issued a notice of proposed rulemaking (NPRM) on February 28, 2022 (87 FR 11156). Subsequently, DOT extended the comment period to April 29, 2022 (87 FR 16160), and published the final rule on May 2, 2023 (88 FR 27596).
Authorized Drug Testing Panel
The Department requested comments on its proposal to publish the drug testing panel separately from the OFMG in a Federal Register\[[[[p Notification (FRN) each year. Fifteen commenters submitted a total of 40 comments on this topic for the OFMG.
Nine commenters disagreed with publishing a revised drug testing panel without a public comment period, expressing concerns that stakeholders including individuals subject to federally regulated drug testing would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden. Some of these commenters suggested alternate ways to permit public comment while enabling a quicker response to testing panel changes ( e.g., setting a shorter comment period, publishing the Guidelines as an interim final rule or issuing an advance notice of proposed rulemaking). The Department has reviewed these comments and suggestions and determined that no changes to the proposed Guidelines are needed. The Department has developed procedures which will allow review and comment before testing panel changes are published, as described below.
Consistent with current procedures, prior to making a change to the drug or biomarker testing panel, the Department will conduct a thorough review of the scientific and medical literature, and will solicit review and input from subject matter experts such as Responsible Persons (RPs) of HHS-certified laboratories, Medical Review Officers (MROs), research scientists, manufacturers of collection devices and/or immunoassay kits, as well as Federal partners such as DOT, the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA). Further, the Department plans to provide notice and opportunity for public comment regarding any proposed changes to the drug and biomarker testing panels as part of Drug Testing Advisory Board (DTAB) meetings and procedures.
Information regarding any proposed changes to the drug and biomarker testing panels and a request for public comment will be included in an advance notice of the DTAB meeting published in the Federal Register , along with the timeframe and method(s) for comment submission. During the meeting, the Department will present the basis for adding or removing analytes ( i.e., including technical and scientific support for the proposed changes), as well as a discussion of related costs and benefits. This information will be provided in advance to DTAB members. The Department will review all submitted public comments and will share information during a DTAB session prior to DTAB’s review of SAMHSA’s recommendation to the Secretary regarding each proposed change.
The Department will make the final decision on any panel changes and include the effective date(s) in the annual Notice, to allow time for drug testing service providers ( e.g., immunoassay kit manufacturers, oral fluid collection device manufacturers) to develop or revise their products, and for HHS-certified laboratories to develop or revise assays, complete validation studies, and revise procedures.
Three commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels, but expressed concern over the process for testing panel review and who would be involved. These commenters suggested involving other stakeholders ( e.g., HHS-certified laboratories, DTAB, FDA). As noted above, the Department will use multiple methods and involve subject matter experts from various stakeholder groups to determine testing panel changes, and will provide opportunity for public review and comment before changes are made. FDA, DOT, and other Federal partners will have opportunities to review and provide input.
