Civic AI
HHS Proposes Revisions to Federal Workplace Urine Drug Testing Guidelines
The Department of Health and Human Services is seeking public comment on proposed changes to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine, touching specimen validity criteria, laboratory certification, and MRO authority.
What the proposal does
The Department of Health and Human Services (HHS) has issued a notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), originally published in the Federal Register on October 12, 2023. The proposal spans 48 Federal Register pages and encompasses several discrete technical and procedural changes to how federal agencies conduct urine-based workplace drug testing.
Among the core changes, the proposal would raise the invalid-specimen pH cutoff from 9.0 to 9.5, revising the threshold at which a specimen is flagged as invalid based on acidity. The Department also proposes to revise initial test batch quality control requirements for both laboratories and instrumented initial test facilities (IITFs).
Laboratory certification and specimen validity
The proposal would update the definition of "Laboratory" to clarify that HHS may certify laboratories beyond those conducting all required testing of primary (A) and split (B) specimens — specifically, it would allow certification of laboratories that test split (B) specimens only and/or conduct additional drug or specimen validity tests for primary and split specimens in accordance with the Guidelines. The definition of "Substituted Specimen" would also be revised to refer to a test for an HHS-authorized biomarker rather than specifically referencing the Biomarker Testing Panel, reflecting the Department's review and approval process for HHS-certified test facilities.
MRO authority and split testing
The proposal would expand Medical Review Officer (MRO) authority, allowing an MRO to authorize use of a biomarker test for a specimen with an invalid result based on creatinine and specific gravity. Additionally, a split testing laboratory would be permitted to test for any HHS-authorized biomarker to reconfirm substitution based on a biomarker test — meaning the split lab may test for a different biomarker than the one originally used.
Publication and collection procedure changes
HHS also proposes to change how it publishes the Authorized Drug Testing Panels, moving from an annual publication schedule to publishing only when revisions are made. The current authorized drug testing panel and report nomenclature table for urine and oral fluid were published on January 16, 2025 (90 FR 4662). The Department additionally deleted the term and definition of "Gender Identity" from Section 1.5 to, as the document states, enhance the clarity of direct observed collection procedures. Language in Section 2.2 was reviewed and revised to clarify that pre-employment tests are performed for all individuals applying for a testing designated position, including federal agency employees.
Background and regulatory context
HHS acts under the authority of Section 503 of Public Law 100-71, 5 U.S.C. 7301, and Executive Order No. 12564 to establish scientific and technical guidelines for Federal Workplace Drug Testing Programs and to set standards for certification of laboratories engaged in drug testing for federal agencies. HHS originally published the Mandatory Guidelines in the Federal Register on April 11, 1988, and the guidelines have been revised multiple times since, with the current UrMG published on October 12, 2023. Using data from Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by federal agencies. The Department notes it is concurrently publishing a separate Federal Register notice proposing similar revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), with the same or similar revisions proposed where appropriate.
What to watch
Public comments on the proposed revisions are due on or before December 28, 2026.
Related
- Civic AI hub
- Five Federal Agencies Seek Public Comment on Information Collection Renewals Across Agriculture, Environment, and Marine Science
- NCUA Bans Reputation Risk in Supervision; FDA Files Flour Irradiation Petition
- Education Dept. Extends Funding for 43 American Indian Vocational Rehabilitation Projects Through Sept. 2027
Sources
17 citedEvery hard fact above is grounded in and cited to a primary source record.
-
The proposal spans 48 Federal Register pages.
federalregister.gov -
The proposal would raise the invalid-specimen pH cutoff from 9.0 to 9.5.
federalregister.gov -
The proposal would revise initial test batch quality control requirements for laboratories and instrumented initial test facilities (IITFs).
federalregister.gov -
The proposal would update the definition of 'Laboratory' to clarify that HHS may certify laboratories that test split (B) specimens only and/or conduct additional drug or specimen validity tests for primary and split specimens.
federalregister.gov -
The definition of 'Substituted Specimen' would be revised to refer to a test for an HHS-authorized biomarker rather than specifically referencing the Biomarker Testing Panel.
federalregister.gov -
The proposal would allow an MRO to authorize use of a biomarker test for a specimen with an invalid result based on creatinine and specific gravity.
federalregister.gov -
A split testing laboratory would be permitted to test for any HHS-authorized biomarker to reconfirm substitution based on a biomarker test, meaning it may test for a different biomarker.
federalregister.gov -
HHS proposes to change publication of the Authorized Drug Testing Panels from an annual schedule to publishing only when revisions are made.
federalregister.gov -
The current authorized drug testing panel and report nomenclature table for urine and oral fluid were published on January 16, 2025 (90 FR 4662).
federalregister.gov -
The Department deleted the term and definition of 'Gender Identity' from Section 1.5 to enhance the clarity of direct observed collection procedures.
federalregister.gov -
Section 2.2 was revised to clarify that pre-employment tests are performed for all individuals applying for a testing designated position, including federal agency employees.
federalregister.gov -
HHS acts under the authority of Section 503 of Public Law 100-71, 5 U.S.C. 7301, and Executive Order No. 12564.
federalregister.gov -
HHS originally published the Mandatory Guidelines in the Federal Register on April 11, 1988.
federalregister.gov -
The Department estimates that 275,000 urine specimens are tested annually by federal agencies.
federalregister.gov -
The Department is concurrently publishing a separate Federal Register notice proposing similar revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG).
federalregister.gov -
Public comments on the proposed revisions are due on or before December 28, 2026.
federalregister.gov -
HHS issued a notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), originally published in the Federal Register on October 12, 2023.
federalregister.gov