Proposed Urine Drug Testing Guideline Changes for Collectors and MROs

On October 29, 2026, the Department of Health and Human Services (HHS) published proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG), Federal Register document 2026-22122 (91 FR 68398), RIN 0930-AA40, docket SAMHSA-2026-0002. Several of the proposed changes affect how collectors conduct observed and monitored collections and how Medical Review Officers (MROs) handle invalid and substituted results. Comments are due December 28, 2026.

This is a proposed rule. Nothing changes for collectors or MROs unless and until HHS finalizes the revisions. Until then, the current UrMG, published October 12, 2023 (88 FR 70768), are the guidelines in effect.

The official Federal Register PDF of the notice is available from GovInfo: FR Doc. 2026-22122 (PDF).

The UrMG apply to federal agency workplace drug testing programs. HHS states that the proposal may affect industries regulated by the Department of Transportation (DOT) and the Nuclear Regulatory Commission (NRC), depending on whether those agencies incorporate the final revisions. The notice does not itself change DOT or NRC drug testing rules.

Proposed Changes for Collectors

Observer and Monitor Selection

The current UrMG require the observer in a direct observed collection to be the same gender as the donor, as determined by the donor's gender identity. HHS proposes revising Sections 4.4, 8.1, 8.10 and 8.12 to refer to the sex of the observer and donor, and proposes deleting the "Gender Identity" definition. Under proposed Section 8.10:

• The observer's sex must be the same as the donor's sex, with no exception to this requirement.
• Before an observer is selected, the collector informs the donor that the sex of the observer will match the donor's sex.
• The collector asks the donor to identify the donor's sex on the federal Custody and Control Form (CCF) and initial it.
• The collector documents the observer's name and sex on the federal CCF.
• If no trained collector of the same sex as the donor is available, the collector or collection site supervisor selects an observer of the same sex as the donor who has been trained in direct observed collection. The observer does not need to be a trained collector.

Under proposed Section 8.1(b), the collector is not required to be the same sex as the donor. For a monitored collection under Section 8.12, the monitor would be a person of the same sex as the donor, unless the monitor is a medical professional such as a nurse, doctor, physician's assistant, technologist or technician licensed or certified to practice in the jurisdiction where the collection takes place.

Other Collection-Related Wording

• Section 8.9(a)(2). A direct observed collection is conducted when the laboratory reports an invalid specimen and the MRO reports there was not a legitimate explanation. HHS proposes removing the word "medical" from this item, because there may be a legitimate non-medical explanation for an invalid result.
• Section 1.7. HHS proposes adding examples of circumstances that constitute a refusal to test.
• Section 2.2(a). The revised wording would clarify that pre-employment tests are performed for all individuals applying for a testing designated position, including federal agency employees.

Proposed Changes for MROs

pH Results From 9.0 to 9.5

Under the current UrMG, a pH equal to or greater than 9.0 and less than 11 is an invalid result, and specimens with results from 9.0 to 9.5 undergo MRO review for possible explanations. HHS proposes raising the invalid cutoff from 9.0 to 9.5 and deleting the MRO action for invalid results based on a pH of 9.0 to 9.5 in Section 13.5(f). HHS states that the current review and recollections do not result in identifying additional adulterated specimens, and that a pH above 9.5 does not occur due to elevated temperature and increased shipping time.

Invalid Results and Reason for Test

HHS proposes editing Sections 13.5 and 13.6(b) to address different MRO actions for invalid specimens depending on the reason for the test. Under proposed Section 13.5(f), when the donor provides a legitimate explanation for an invalid result, the MRO reports a test cancelled result and:

• For a random, post-accident or reasonable suspicion/cause test, informs the agency that a recollection is not required.
• For a test that requires a negative result (pre-employment, return-to-duty or follow-up), directs the agency to immediately collect another specimen, either an unobserved urine collection or an oral fluid collection, depending on the reason for the invalid result.

When the donor cannot provide a legitimate explanation, the MRO reports a test cancelled result and directs the agency to immediately collect another urine specimen using a direct observed collection.

Biomarker Testing Authorization

Under proposed Section 11.19, a specimen with an invalid result based on inconsistent creatinine and specific gravity results may be tested for an HHS-authorized biomarker to determine substitution. The laboratory would contact the MRO for authorization before conducting the additional biomarker test or sending the specimen to another HHS-certified laboratory for that test.

Split (B) Specimen Reconfirmation

Under proposed Section 14.4(b), when a primary (A) specimen was reported substituted based on biomarker testing, the split testing laboratory may test for any HHS-authorized biomarker. It would not be necessary to test for the same biomarker used on the primary specimen. HHS states that these biomarker changes are expected to lead to definitive results and reduce the need for recollection. HHS also proposes revising Section 14.1(c) to clarify MRO action when a split specimen cannot be tested by a second laboratory, and editing and reorganizing Section 14.6, which describes MRO actions after receiving the split specimen result.

How to Comment

Collectors, MROs and other stakeholders may comment on or before December 28, 2026, at regulations.gov under docket SAMHSA-2026-0002, or by mail, express mail or hand delivery to SAMHSA, Center for Substance Abuse Prevention (CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room 16N02, Rockville, MD 20857. SAMHSA cannot accept comments by fax.

A companion proposal for oral fluid testing, Federal Register document 2026-22121, is open for comment under a separate docket, SAMHSA-2026-0001, with the same December 28, 2026 deadline.