Notice of Proposed Rulemaking

MAR Notice No. 2026-444.1

Summary

Removal of Residual References to the Department of Public Health and Human Services State Laboratory From Cannabis Rules and Update Cross References From ARM Title 37 (DPHHS) to Title 42 (Revenue)

No Hearing Scheduled

If the agency receives requests for a public hearing on the proposed rulemaking from either 10 percent or 25, whichever is less, of the persons directly affected by the proposed rulemaking; from the appropriate administrative rule review committee of the Legislature; from a governmental subdivision or agency; or from an association having not less than 25 members who will be directly affected, a hearing will be held at a later date.  Notice of the hearing will be published in the Montana Administrative Register.

The estimated number of persons directly affected by the proposed rulemaking is two based on the total number of affected licensees active in Montana.  The number of hearing requests necessary for the department to conduct a public hearing shall be one.

Hearing Requests

If the persons directly affected by the proposed rulemaking wish to express their data, views, or arguments orally or in writing at a public hearing, they must make written request for a hearing and submit this request to the department using the contact information below.  Hearing requests must be received by Monday, August 24, 2026, at 5:00 p.m.

Comments

Comments may be submitted using the contact information below.  Comments must be received by Monday, August 24, 2026, at 5:00 p.m.

Accommodations

The agency will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. Requests must be made by Friday, July 31, 2026, at 5:00 p.m.

Contact

Todd Olson, Rule Reviewer - Department of Revenue, Legal Services Office

(406) 444-7905

todd.olson@mt.gov

General Reasonable Necessity Statement

The statutory duty for the oversight of cannabis testing and testing laboratory licensure was transferred from the Department of Public Health and Human Services (DPHHS) to the department under House Bill 128 (2023) (HB 128), which was effective July 1, 2023. While the department transferred the relevant rules under MAR Notice No. 42-1066, the department did not initiate all of the necessary internal revisions at that time. Accordingly, it is administratively necessary for the affected rules to have correct internal referencing.

The department proposes minor “housekeeping” amendments to ARM 42.39.602, 42.39.607, 42.39.608, 42.39.613, and 42.39.617 for the sole purpose of removing these residual references to the state laboratory at DPHHS from these rules and to update cross references from ARM 37.107.316 to ARM 42.39.614.

In ARM 42.39.617, the department also proposes to update referencing to the department’s Office of Dispute Resolution (ODR) and its procedural rules located at ARM 42.2.613 through 42.2.621.

Rulemaking Actions

Amend

The rules proposed to be amended are as follows, stricken matter interlined, new matter underlined:

42.39.602 Testing Laboratory General Requirements

1. A testing laboratory must employ a full-time scientific director that meets the minimum requirements described in 16-12-206, MCA.
2. The scientific director must ensure that:
   1. the testing laboratory achieves and maintains ISO/IEC 17025:2017 accreditation for all testing methods/analytes required in ARMdeleted: 37.107.316 , end deletedinserted:  42.39.614, end inserted;
   2. the testing laboratory's processes and practices are compliant with ISO/IEC 17025:2017 standards;
   3. the testing laboratory maintains quality practices in accordance with their quality manual;
   4. testing personnel have been appropriately trained and demonstrate competency prior to providing testing services;
   5. policies and procedures are in place for monitoring personnel competence;
   6. approved standard operating procedures are in place, have been reviewed, and are followed by all testing personnel;
   7. appropriate test methods are in place;
   8. test method validations have been performed initially and upon test method changes to determine the minimum following requirements as appropriate;
      1. accuracy;
      2. precision;
      3. linearity and working range;
      4. coefficient of determination (r 2) for calibration curves;
      5. LOD;
      6. LOQ;
      7. MDL; and
      8. reproducibility.
   9. acceptable analytical test performance is established and maintained for each test system;
   10. quality assurance and quality control programs are established and maintained;
   11. corrective and preventative actions are taken and documented when significant deviations from the testing laboratory's established performance characteristics are identified and test results are reported only when test systems are functioning properly;
   12. the testing laboratory successfully participates in an approved proficiency testing (PT) program(s), as described in this subchapter, for all methods/analytes required in ARMdeleted: 37.107.316, end deleted inserted: 42.39.614, end inserted;
   13. the physical and environmental conditions of the testing laboratory are adequate and appropriate for the testing performed; and
   14. the environment for employees is safe from physical, chemical, and biological hazards, and safety and biohazard requirements are met.
3. A scientific director must be physically present at the testing laboratory for the majority of time that testing is performed in order to adequately carry out his/her responsibilities.
4. A testing laboratory must be able to perform at least 75% of the quality assurance testing requirements defined in ARMdeleted: 37.107.316, end deleted inserted: 42.39.614, end inserted.
5. A testing laboratory can only refer quality assurance testing to another licensed testing laboratory in Montana which has met the requirements of this subchapter, and the referred testing laboratory must be identified in all testing reports, the certificates of analysis, and the seed-to-sale tracking system.
6. A testing laboratory must obtain written permission from the licensee prior to sending the laboratory test sample to another testing laboratory in Montana.
7. A testing laboratory must document certification of all testing performed and corresponding results in a certificate of analysis.
8. A testing laboratory must maintain for at least three years testing data and reports, including quality control data, standard curves, raw instrument data, calculations, spreadsheets, certificates of analysis, licensee reports, etc.
9. Records/data may be kept in either paper or electronic form on the premises and must be readily available for quality assurance and inspection purposes.
10. A testing laboratory must establish written emergency procedures to be followed in case of a fire, chemical spill, or other emergency at all premises.

Authorizing statute(s): 16-12-202, 16-12-209, MCA

Implementing statute(s): 16-12-202, 16-12-209, MCA

42.39.607 Testing Laboratory Required Proficiency Testing

1. For a testing laboratory to become endorsed to conduct quality assurance testing, the testing laboratory must, at its own expense, meet the proficiency testing requirements of this subchapter.
2. A testing laboratory shall successfully participate in a proficiency testing program(s):
   1. at least every six months for each analyte/method in ARMdeleted:  37.107.316, end deleted inserted: 42.39.614, end inserted that the laboratory performs on marijuana or marijuana-infused products;
   2. that are matrix specific or controlled when available; and
   3. that are provided by an organization operating in conformance with the requirements of ISO/IEC 17043:2010.
3. The testing laboratory shall report all analytes available by the proficiency testing program provider and for which the testing laboratory is required to test as required under this subchapter.
4. The testing laboratory shall participate in the proficiency testing program by following the testing laboratory's existing standard operating procedures for testing marijuana or marijuana-infused products.
5. The testing laboratory shall rotate the proficiency testing among all of the laboratory testing personnel who perform a specific test method(s) or have multiple analysts perform the same proficiency test, when sample quantity/volume permits.
6. Testing laboratory personnel who participate in a proficiency testing program shall sign the corresponding analytical reports and proficiency providers attestation forms, if provided, to certify that the proficiency testing program was conducted in the same manner as the laboratory tests marijuana or marijuana-infused products.
7. The scientific director shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed.
8. The testing laboratory shall request the proficiency testing program provider to send all proficiency data and results concurrently to the deleted: state laboratory, end deleted inserted: department, end inserted, when the data and results become available.  If the proficiency provider does not provide this service then it is the responsibility of the testing laboratory to provide the proficiency testing program data and results to the deleted: state laboratory, end deleted inserted: department, end inserted within three business days after the testing laboratory receives notification of their test results from the proficiency testing program provider.
9. The testing laboratory must maintain a paper and/or electronic copy of all proficiency testing records, including analytical data, quality control, standard curves, spreadsheets, calculations, and worksheets and a copy of the proficiency testing provider report forms for a period of three years.  The records must be easily and readily available to the deleted: state laboratory, end deleted inserted: department, end inserted upon request.
10. When performing a proficiency test, a testing laboratory may not:
    1. perform multiple analyses (such as replicates or duplicates) that are not normally performed in the course of analysis of a routine laboratory test sample;
    2. average the results of multiple analyses for reporting when not specifically required to do so by the analytic method in question;
    3. permit anyone other than bona fide testing personnel who perform the analyses on a day-to-day basis for the testing laboratory to participate in the generation of data or reporting of results;
    4. discuss the results of proficiency testing with any other testing laboratory until after the deadline set for receipt of results by the proficiency testing provider;
    5. discuss the results of a proficiency testing across sites or locations, if the testing laboratory has multiple testing sites, until after the deadline set for receipt of results by the proficiency testing provider;
    6. send proficiency testing samples or portions of samples to another testing laboratory to be tested; or
    7. knowingly receive a proficiency testing sample from another testing laboratory for analysis and fail to notify the deleted: state laboratory, end deleted inserted: department, end inserted of the receipt of the other testing laboratory's sample within five business days of discovery.
11. The deleted: state laboratory, end deleted inserted: department, end inserted may also provide inter-laboratory proficiency testing samples to testing laboratories in order to ensure that Montana testing laboratories are providing consistent and uniform results.
12. For the purposes of this subchapter, the deleted: state laboratory, end deleted inserted: department, end inserted adopts and incorporates by reference ISO/IEC 17043:2010, which specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.  A copy of the publication may be obtained from the American National Standards Institute (ANSI), 1899 L St. NW, 11th Floor, Washington, DC 20036; https://webstore.ansi.org/SDO/ISO.

Authorizing statute(s): 16-12-202, 16-12-209, MCA

Implementing statute(s): 16-12-202, 16-12-209, MCA

42.39.608 Testing Laboratory Satisfactory and Unsatisfactory Proficiency Test Performance

1. The testing laboratory shall be deemed to have "successfully" participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate a "satisfactory," "passed," or otherwise proficient performance determination by the proficiency testing program provider.
2. The testing laboratory shall be deemed to have "unsuccessfully" participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate an "unsatisfactory," "unacceptable," "questionable," or "failed or otherwise deficient" performance determination by the proficiency testing program provider.
3. If a testing laboratory is notified by a proficiency provider of an "unsuccessful" result for an analyte tested in a specific method, the testing laboratory may continue to report test results for the analyte(s) if all of the following conditions are met:
   1. the testing laboratory notifies the deleted: state laboratory, end deleted inserted: department, end inserted of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;
   2. the testing laboratory has "successfully" participated in a proficiency program for the failed analyte(s) in the specific method in the previous six months;
   3. the testing laboratory submits to the deleted: state laboratory, end deleted inserted: department, end inserted, for approval, a corrective and preventative action plan detailing how the testing laboratory will proceed to determine the cause of the failure within 10 business days of receiving the "unsuccessful" performance determination by the proficiency testing provider; and
   4. within 30 days of plan approval by the deleted: state laboratory, end deleted inserted: department, end inserted, submit a corrective and preventative action final report describing the cause of the failure, the corrective action, and processes that will ensure the effectiveness of the corrective action.
4. The deleted: state laboratory, end deleted inserted: department, end inserted will approve or reject a corrective action plan and/or final corrective action reports as soon as reasonably practicable.
5. If a testing laboratory is notified by a proficiency provider of an "unsuccessful" result for an analyte tested in a specific method and the testing laboratory has not "successfully" participated in a proficiency program for the failed analyte(s) in the previous six months, the testing laboratory may not continue to report test results for the analyte(s) until all of the following conditions are met:
   1. the testing laboratory notifies the deleted: state laboratory, end deleted inserted: department, end inserted of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;
   2. the testing laboratory submits to the deleted: state laboratory, end deleted inserted: department, end inserted, for its approval, a corrective and preventative action plan detailing how the testing laboratory will proceed to determine the cause of the failure within 10 business days of receiving the "unsuccessful" performance determination by the proficiency testing provider;
   3. within 30 days of plan approval by the deleted: state laboratory, end deleted inserted: department, end inserted, submit a corrective and preventative action final report demonstrating the cause of the failure, the corrective action, and processes that will ensure the effectiveness of the corrective action; and
   4. "successfully" participate in a proficiency test for the failed analyte(s) by a proficiency testing provider that meets the requirements of this subchapter.

Authorizing statute(s): 16-12-202, 16-12-209, MCA

Implementing statute(s): 16-12-202, 16-12-209, MCA

42.39.613 Testing Laboratory Failed Laboratory Test Samples

1. If the results of quality assurance testing for any analyte/method exceed the action levels defined in ARMdeleted: 37.107.316, end deleted inserted: 42.39.614, end inserted, then the laboratory test sample and related lot or test batch has "failed" quality assurance testing.
2. When a testing laboratory performs quality assurance testing, the testing laboratory must verify that the following quality control criteria are within acceptable limits based upon the testing laboratory's method specific standard operating procedures, the testing laboratory quality manual, and the manufacturer's instructions for use, if applicable:
   1. standard curves;
   2. coefficient of determination (r²);
   3. quality control samples:
      1. ICV, CCV, LCS, MB, REP, and MS;
   4. positive and negative controls; and
   5. cycle thresholds.
3. If the quality control criteria for initial quality assurance testing are within acceptable limits, then the results of all individual laboratory test samples within the analytical batch are considered valid, including "failed" laboratory test samples and must be reported.
4. A licensee may request that the testing laboratory resample the failed batch or lot for repeat testing within seven calendar days of receiving notice from the testing laboratory of any failed testing and resampled analyses must be completed by the testing laboratory within 10 days of receiving the request from the licensee.
5. Quality assurance testing on resampled batches or lots must include all of the analytes defined in ARMdeleted: 37.107.316, end deleted inserted: 42.39.614, end inserted.
6. The results of resample quality assurance tests are considered valid and must be reported if the quality control criteria are within the acceptable limits.
7. The licensee is responsible for the costs of resampling and retesting.
8. If the quality control criteria for initial quality assurance testing are not within acceptable limits, then the results of all laboratory test samples within an analytical batch are considered invalid (failed run) and the entire run must be repeated with new quality controls and not reported to the licensee.
9. The testing laboratory should document and investigate failed runs, as part of the testing laboratory's quality manual, to determine the root cause of the failure and whether corrective and preventative action measures are warranted.
10. A licensee is not permitted to sell or transfer to customers marijuana items that have a failed quality assurance test.
11. Failed harvest lots, process lots, or test batches may be remediated as long as the remediation method does not impart any substance or effect to the usable marijuana, marijuana concentrates and extracts, or marijuana-infused products that may have a toxic or deleterious effect on the health of the customer.
12. Remediation methods used on specific lots or batches of marijuana or marijuana-infused products that have failed initial quality assurance testing must be disclosed to the deleted: state laboratory, end deleted inserted: department, end inserted prior to remediation.
13. No remediated harvest lots, process lots, or test batches may be sold or transferred until the completion and successful passage of all quality assurance testing, and the results certified in a certificate of analysis, as required in these rules and Montana statute.
14. With the exception of moisture analysis or residual solvent screening, a laboratory test sample from a remediated harvest lot, process lot, or test batch that fails quality assurance testing cannot be remediated again and the harvest lot, process lot, or test batch must be destroyed.  Harvest lots, process lots, or test batches that fail initial quality assurance testing for moisture analysis or residual solvent screening may be remediated and retested a maximum of two times.
15. The testing laboratory must document all sampling, resampling, testing, retesting, and results under this subchapter.

Authorizing statute(s): 16-12-202, 16-12-209, MCA

Implementing statute(s): 16-12-202, 16-12-209, MCA

42.39.617 Suspension of Testing Laboratories

1. The deleted: state laboratory, end deleted inserted: department, end inserted may, after written notice to the testing laboratory, suspend the testing laboratory's license for a period of up to three months upon determining that a testing laboratory is providing inconsistent results in accordance with 16-12-202, MCA.
2. The deleted: state laboratory, end deleted inserted: department, end inserted will determine whether a testing laboratory is providing inconsistent results through evaluation of the testing laboratory's raw data.
3. A suspension of licensure under this rule is subject to a contested case hearing before the deleted: Department of Public Health and Human Services' Office of Administrative Hearings, end deleted inserted: department’s Office of Dispute Resolution, end inserted and shall be conducted pursuant to deleted: the following administrative procedures: ARM 37.5.101, 37.5.117, 37.5.131, 37.5.301, 37.5.304, 37.5.307, 37.5.313, 37.5.322, 37.5.325, 37.5.328, 37.5.331, 37.5.334, and 37.5.337, end deleted inserted: ARM 42.2.613 through 42.2.621, end inserted.
4. A testing laboratory may not conduct any testing or transporting of marijuana or marijuana products during a period of suspension. Operating during a period of suspension shall be considered a violation of the marijuana lawsinserted: ,, end inserted as defined in ARM 42.39.102inserted: ,, end inserted and could result indeleted: the Department of Revenue taking, end deleted further disciplinary action.

Authorizing statute(s): 16-12-202, MCA

Implementing statute(s): 16-12-202, MCA

Small Business Impact

With regard to the small business impact analysis requirements of 2-4-111, MCA, as amended by HB 592 (2025), the department has analyzed the proposed rule amendments and the group or class of businesses directly affected by this rulemaking, and concludes no small businesses will be impacted by the corrections described above.

Documentation of the small business impact analysis is available upon request.

Bill Sponsor Notification

The bill sponsor contact requirements do not apply.

Interested Persons

The Department of Revenue maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request, which includes the name and e-mail or mailing address of the person to receive notices and specifies that the person wishes to receive notice regarding particular subject matter or matters.  Notices will be sent by e-mail unless a mailing preference is noted in the request.  A written request may be mailed or delivered to the contact person in this notice or may be made by completing a request form at any rules hearing held by the Department of Revenue.

Rule Reviewer

Todd Olson

Approval

Brendan Beatty, Director of Revenue