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| Montana Administrative Register Notice 37-967 | No. 1 01/14/2022 | |
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BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA
TO: All Concerned Persons
1. On November 19, 2021, the Department of Public Health and Human Services published MAR Notice No. 37-967 pertaining to the public hearing on the proposed adoption and amendment of the above-stated rules at page 1629 of the 2021 Montana Administrative Register, Issue Number 22.
2. The department has adopted the following rule as proposed: New Rule II (37.107.304).
3. The department has amended the following rules as proposed: ARM 37.107.311 and 37.107.313.
4. The department has adopted the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
NEW RULE I (37.107.310) QUALITY ASSURANCE SAMPLING PROTOCOL (1) and (2) remain as proposed. (3) Testing laboratories shall create a sampling plan (a) and (b) remain as proposed. (e) and (f) remain as proposed but are renumbered (d) and (e). (4) through (7) remain as proposed. (8) At least 50% of the laboratory test sample must be homogenized prior to its use for the appropriate analysis. (10) remains as proposed but is renumbered (9). (12) through (15) remain as proposed but are renumbered (11) through (14).
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
5. The department has amended the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
37.107.301 TESTING LABORATORY ENDORSEMENT REQUIREMENTS (1) remains as proposed. (2) An applicant must provide, to the department's state laboratory, documentation to support fulfillment of these requirements, which includes the following: (a) certificates of insurance and bonding in accordance with (b) through (e) remain as proposed. (f) quality (g) through (5) remain as proposed. (6) An applicant that meets all of the requirements under the Montana Marijuana Regulation and Taxation Act (Title 16, chapter 12, MCA) and this subchapter and that is actively seeking ISO/IEC 17025:2017 accreditation may be approved for endorsement if written evidence of pending ISO accreditation and an inspection from the state laboratory indicate that accreditation will be achieved within 12 months from the date of endorsement. (6) through (8) remain as proposed but are renumbered (7) through (9).
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.302 TESTING LABORATORY GENERAL REQUIREMENTS (1) remains as proposed. (2) The scientific director must ensure that: (a) and (b) remain as proposed. (c) the testing laboratory maintains quality practices in accordance with their quality (d) through (g) remain as proposed. (h) test method validations have been performed initially and upon test method changes to determine the minimum following requirements as appropriate; (i) through (10) remain as proposed.
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.303 DEFINITIONS As used in this subchapter, the following definitions apply: (1) through (14) remain as proposed. (17) through (21) remain as proposed but are renumbered (16) through (20). (23) through (50) remain as proposed but are renumbered (22) through (49). (50) "Total potential psychoactive THC" has the meaning provided for under ARM 42.39.102. (a) Total THC (53) remains as proposed but is renumbered (52).
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.307 TESTING LABORATORY QUALITY ASSURANCE PROGRAM (1) The testing laboratory shall develop and implement a quality assurance program to assure the reliability and validity of the analytical data produced by the testing laboratory. The quality assurance program shall, at a minimum, include a written quality (a) remains as proposed. (b) testing laboratory organization and employee training and responsibilities (c) through (l) remain as proposed. (2) The scientific director shall annually review, amend if necessary, and approve the quality (3) All testing laboratory personnel shall review the quality
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.309 TESTING LABORATORY QUALITY CONTROL (1) The testing laboratory shall use quality control samples and adhere to (a) through (4) remain as proposed. (5) If any quality control sample result is outside the testing laboratory's specified acceptance criteria listed in the testing laboratory's quality (6) and (7) remain as proposed.
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.315 TESTING LABORATORY FAILED LABORATORY TEST SAMPLES (1) remains as proposed. (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 (a) through (3) remain as proposed. (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 (5) through (7) remain as proposed. (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 (10) through (13) remain as proposed. (14) With the exception of moisture analysis or residual solvent screening, a (15) The testing laboratory must document all sampling, resampling, testing, retesting,
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
37.107.316 TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS (1) and (2) remain as proposed. (3) The cannabinoid profile/potency for each sample must include: (a) and (b) remain as proposed. (c) Total potential psychoactive THC for marijuana items that require the application of heat for administration/consumption only; (d) CBDA; and (e) CBD. (4) and (5) remain as proposed. (6) The laboratory test sample and related lot or test batch fail quality assurance testing for microbiological screening if the results are greater than the following action levels: (a) Salmonella species: non-detectable in 1.0 gram of material; (b) Shiga-toxin producing Escherichia (c) remains as proposed. (7) Microbiological testing using molecular methods must include an enrichment step that follows the protocol provided by the manufacturer, molecular method used, or product instructions for use. Decreasing the enrichment time outside of the range provided above is strictly prohibited. (8) through (12) remain as proposed.
AUTH: 16-12-202, 16-12-209, MCA IMP: 16-12-202, 16-12-209, MCA
6. The department has thoroughly considered the comments and testimony received. A summary of the comments received, and the department's responses are as follows:
COMMENT #1: Numerous commenters expressed opposition to increasing the test batch size from 5 to 10 pounds and revising the definition of "harvest lot" to require a uniform strain rather than multiple strains. The primary reasons cited in opposition to these changes included the short implementation timeline, added expense of testing, changes being too burdensome to providers, disruption to the supply chain, creation of a bottleneck of strains, lack of necessity, and scaling up too fast.
RESPONSE #1: The department partially agrees with the commenters and has revised the Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, and Marijuana Infused Products (SOP-001) to maintain a 5-pound test batch. The definition of "harvest lot" has also been revised to remain multiple in strain at this time. The department intends to initiate a separate rulemaking in the near future to address strain compositing in harvest lots. See Response #2 for more information pertaining to strain compositing in test batches and the reason for addressing the issue through future rulemaking.
COMMENT #2: Multiple commenters expressed support for the increase in test batch size from 5 to 10 pounds and the change in the definition of "harvest lot" from being multiple in strain to uniform in strain. The primary reasons cited in support of these changes included that single strain test batches will provide safer and better-quality products, the changes reflect more valid scientific practices, and larger providers will appreciate the increase to 10-pound test batches. It was suggested that allowing a certain number of strains per harvest lot instead of moving directly to a single strain system could be a feasible option. Recommendations on the number of strains allowed ranged from 3 to 10.
RESPONSE #2: See Response #1 concerning the department's decision on test batch size. The department agrees that single strain harvest lots will increase product safety. Multi-strain harvest lots have become a serious problem. The compositing of a large number of strains into one test batch effectively dilutes the presence of any contaminant that may exist in any of the strains within the laboratory test sample. When too many strains are composited into one laboratory test sample, the detection of contaminants becomes impossible even with the most sophisticated instrumentation. The adage "dilution is the solution to pollution" is effectively what is occurring here. The practice, if unchecked, could provide Montana customers with misleading test results. The practice of compositing 20, 30, or even more strains into one 5-pound test batch is prevalent in the industry. This practice has the potential to negatively impact the industry if an illness related to strain compositing occurred or a product recall were issued.
The department agrees that determining a minimum number of strains that can be allowed into one harvest lot may be a feasible option. The number of strains must be attainable and scientifically supported by all licensed testing laboratories' methods. However, the department believes additional stakeholder input is needed before it can adopt such a requirement. The potential change represents a significant departure from what is proposed in the rules. Therefore, the department believes the best course of action is to address the issue through separate rulemaking in the near future.
COMMENT #3: Numerous commenters expressed opposition to delayed implementation of new testing requirements. The commenters indicated the new testing requirements should have been anticipated and that any delay in implementation will adversely impact access to safe and legal marijuana. Some of these commenters also suggested that existing rules accommodate the original implementation date, ISO accreditation is not strictly necessary, and administrative and reporting conflicts will arise.
RESPONSE #3: The department disagrees. These proposed rules did not become publicly available and known to stakeholders until after filing with the Secretary of State on November 9, 2021. The new testing requirements could not have been reasonably anticipated prior to that time. The department has also received numerous comments in support of delaying implementation of the new testing requirements, which are summarized in Comment #4. Having carefully considered the comments supporting and the comments opposing delayed implementation, the department has determined the best course of action to ensure orderly implementation of the rules is to partially delay implementation of the new testing requirements. Specifically, the department is delaying implementation of new requirements relating to STEC and speciated aspergillus testing proposed under ARM 37.107.316(6)(b), (6)(c), and (7). The proposed rules have been revised to make these testing requirements effective March 14, 2022, a period of three months from the date of adoption of the remainder of the rules. The delayed implementation provides a reasonable time period for laboratories to take measures necessary to meet the new testing requirements. During this time period, culturable mold and E. coli testing requirements in existence under current rule remain in effect. The department believes this brief period of delayed implementation will not impact access to safe and legal marijuana products because laboratories will be subject to all other testing requirements contained in the proposed rules as well as SOP-001.
COMMENT #4: Numerous commenters expressed support for delaying implementation of the new testing requirements. These commenters suggested adequate time is necessary for laboratories who are not currently using PCR. Additionally, the commenters suggested additional time is necessary to procure and set up instrumentation, validate methodology, adequately train employees, write new SOPs, pass proficiency testing, and begin adding new methods to laboratory ISO scopes of accreditation. Recommended timelines for implementation ranged from 3 to 12 months.
RESPONSE #4: The department partially agrees with these commenters. The partial delay in implementation described under the response to Comment #3 balances the need for ensuring new testing requirements are not rushed and that quality method validation is achieved prior to testing while also ensuring timely implementation of House Bill (HB) 701.
COMMENT #5: Several commenters suggested an estimated route driven is unnecessary for the sampling plan.
RESPONSE #5: The department agrees, and has revised New Rule I accordingly.
COMMENT #6: Several commenters expressed concerns about the mandatory enrichment step for molecular methods under ARM 37.107.316(7) and requested that specific requirements, reagents, and incubation times be listed in rule for clarification.
RESPONSE #6: The department partially agrees with the stated concerns. Clarification is needed, but the proposed changes offered by the commenters are too specific. The department has revised the rule for clarity. However, due to the continuing advancement of instrumental analysis, particularly in the molecular analysis of marijuana, the revisions do not provide specific instruction on reagents, methods, or incubation times.
COMMENT #7: Several commenters raised concerns about the difficulty to open and remove marijuana concentrates from vapor cartridges and suggested allowing sample collection prior to packaging into cartridges instead of directly from cartridges.
RESPONSE #7: The department understands that retrieving marijuana extract from cartridges can pose unique challenges. However, the department disagrees that these challenges outweigh the health and safety benefits of testing the concentrate directly from the cartridge. Testing the concentrate from the cartridge will ensure a truly safe vapor product for Montana customers.
COMMENT #8: Numerous comments were received concerning proficiency testing. Issues raised by these commenters included ISO/IEC 17043 requirements, inter/intra laboratory studies, random compliance checks, frequency of proficiency testing, rules which allow the state to determine which proficiency tests to conduct, and discrepancies between laboratory standard operating procedures and proficiency testing provider instructions.
RESPONSE #8: The changes suggested by the commenters represent a significant departure from what is proposed in the rules. The department will consider the concerns raised by the commenters as part of future rulemaking where additional public input can be considered.
COMMENT #9: Several commenters suggested removing language in ARM 37.107.315(3), (8), and (9) on the basis that ARM 37.107.315(5) and (6) adequately address failed laboratory test samples and quality control samples.
RESPONSE #9: The department disagrees. Each of the rules has a purpose and clearly defines different scenarios in which laboratory test samples, quality control samples, resamples, data, and corrective/preventative action plans shall be handled.
COMMENT #10: Several commenters suggested increasing the percent moisture action level under ARM 37.107.316 from 12.0% to 14.0%.
RESPONSE #10: The department will consider this suggestion as part of future rulemaking where additional public input can be considered.
COMMENT #11: Several comments were received that section 4.1.5 of SOP-001 should allow sampling scales capable of 0.1g measurements rather than 0.01g measurements because 0.01g measurements are exorbitant.
RESPONSE #11: The department agrees, and has revised SOP-001 accordingly.
COMMENT #12: Several commenters suggested that remediation language under ARM 37.107.315(15) be removed because laboratories do not have control over licensee strategy, action to remediate samples, or failed sample destruction.
RESPONSE #12: The department agrees with the commenters, and has revised the rule accordingly.
COMMENT #13: A commenter stated laboratories do not have access to the mass recorded by the seed-to-sale tracking system in order to confirm the entire test batch is available and that the test batch mass is currently provided verbally by the licensee.
RESPONSE #13: The department understands that the mass of the test batch is provided to the sampler by the licensee and the laboratories do not have access to this value in the seed-to-sale system. The department has revised SOP-001 accordingly to adjust for this step, given the laboratories' lack of access to such information.
COMMENT #14: A commenter requested clarification on final form testing as well as when and what items require testing. The commenter provided extensive suggested rule text to be made part of the rules.
RESPONSE #14: The changes suggested by the commenter represent a significant departure from what is proposed in the rules. The department will consider the concerns raised by the commenter as part of future rulemaking where additional public input can be considered.
COMMENT #15: A commenter suggested a start and end time under New Rule I is unnecessary for the sampling plan.
RESPONSE #15: The department partially disagrees. A start and end time provides a timeline to track the sampling event for that day. The start and end time does not need to be known ahead of time. It can simply be entered into the laboratory sampling plan when the sampler leaves and returns from the day(s) of sampling. The department has revised the rule for clarity to indicate the start and end times do not need to be recorded prior to the sampling
COMMENT #16: A commenter requested "total THC" be removed from ARM 37.107.316(3)(c) and "total CBD" removed from ARM 37.107.316(3)(f) to conform to Department of Revenue (DOR) labeling rules that include "total potential psychoactive THC." It was also suggested to include "total psychoactive CBD" in ARM 37.107.316(3)(f).
RESPONSE #16: The department partially agrees. Amending these rules to better conform to DOR labeling rules is necessary to ensure consistency and avoid confusion. The department has revised the rule to include "total potential psychoactive THC" for products that require heat for administration/consumption only. The department has also revised the rule to remove reporting "total CBD" and to remove the definition of "total CBD" since the term is no longer used within the rules. The department disagrees that adding "total psychoactive CBD" conforms to DOR labeling rules; this term does not exist in the DOR rules nor is "total CBD" considered psychoactive.
COMMENT #17: A commenter suggested clarifying when to calculate a method detection limit (MDL) in ARM 37.107.302(2)(h) and stated some types of contaminate analysis do not facilitate calculation of this value.
RESPONSE #17: The department agrees, and has clarified in rule when an MDL shall be calculated.
COMMENT #18: A commenter stated that ARM 37.107.315(2) and ARM 37.107.309 are redundant.
RESPONSE #18: The department disagrees with this comment. The quality control sample types are stated in both rules. However, ARM 37.107.309 also informs readers on how to address failed samples and quality controls; ARM 37.107.315(2) does not. Additionally, standard curves, coefficient of determination, positive and negative controls, and cycle thresholds are addressed in ARM 37.107.315(2), but not addressed in ARM 37.107.309.
COMMENT #19: A commenter requests removal of language under ARM 37.107.315(14) prohibiting remediation of test batches that fail pesticide analysis. The commenter states that certain pesticides degrade over time and simply require more time between harvest and analysis to degrade to safe levels that meet testing standards.
RESPONSE #19: The department agrees, and has revised the rule accordingly.
COMMENT #20: A commenter stated that the pesticide Spiromesifen was included in previous versions of the department's administrative rules and made part of action level tables. The commenter suggests including Spiromesifen in the current pesticide table under ARM 37.107.316.
RESPONSE #20: Spiromesifen was included in action level tables in a past version of the department's rules, but was removed in a prior rule amendment and is not part of current rule. The addition of the pesticide at this time is not advisable as it could have unintended consequences. Some laboratories may not currently have method validations that include this contaminant. The department will consider the issue raised by the commenter as part of future rulemaking that considers an adequate timeline for laboratories to come into compliance with analyzing this specific pesticide.
COMMENT #21: A commenter suggested tables 2.0, 3.0, 4.0, and 5.0 of SOP-001 do not provide adequate sample volume for analysis for the lowest tiers of each table.
RESPONSE #21: The department disagrees with this comment. Every laboratory has different validated methods and some laboratories may be able to perform sample analysis using smaller sample volumes. The required sample volume may also change over time as new advancements in instrumentation and preparatory methods emerge. New Rule (I)(6) states: "[t]he testing laboratory sampler shall collect a laboratory test sample that is random and representative of the test batch, meets the standards of the state laboratory's 'Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, and Marijuana Infused Products' SOP-001, and is sufficient to complete all required quality assurance testing including quality control samples and re-runs." (Emphasis added). This indicates that if the sample mass provided in the tables is insufficient for a laboratory to analyze then the laboratory sampler is permitted to collect more sample mass. Please also see the response to Comment #65.
COMMENT #22: A commenter requested the random designation of heavy metal testing be removed and officially included in quality assurance compliance testing as it increases the safety of marijuana products and multiple labs have the instrumentation available.
RESPONSE #22: The department disagrees that multiple labs are currently capable of immediately implementing heavy metal testing. The department plans to address this issue in future rulemaking where the fiscal impact of such testing and an appropriate implementation period can be considered.
COMMENT #23: A commenter suggested adding language to ARM 37.107.309 concerning LOD, LOQ, and propagated experimental error. It was suggested this data should be included in the certificate of analysis.
RESPONSE #23: The department will consider the suggested changes as part of future rulemaking where additional public input can be considered.
COMMENT #24: A commenter suggested adding new rules concerning what items should be required on the certificates of analysis.
RESPONSE #24: Implementation of the commenter's suggested changes would require new rules to address required information for a certificate of analysis. The commenter's suggested changes will be taken into consideration as part of future rulemaking.
COMMENT #25: A commenter requested clarification of ARM 37.107.302(4) concerning how 75% of the testing capability is determined and suggested the rule be revised to reference 75% of quality assurance testing panels.
RESPONSE #25: The department will consider the suggested change as part of future rulemaking where additional public input can be considered.
COMMENT #26: A commenter suggested the 30-day time period for resampling under ARM 37.107.315(4) is too long and should be changed to five days.
RESPONSE #26: The department agrees that the 30-day time period is unnecessarily long, but disagrees that five days affords enough time for resampling. The department believes 10 days represents a reasonable time period to complete resampling and has revised the rule accordingly.
COMMENT #27: A commenter suggested that ARM 37.107.315(8) is unclear and redundant to ARM 37.107.309.
RESPONSE #27: The department partially agrees with the comment, and has revised ARM 37.107.315 for clarity. If quality control samples fail on the initial run, the results of the associated laboratory test samples shall not be reported to the licensee. Those same initial results shall only be reported into the laboratory information management system and seed-to-sale tracking system. The department disagrees the rules are redundant because ARM 37.107.309 separately addresses corrective action steps.
COMMENT #28: A commenter suggested revising ARM 37.107.316 by increasing the percent seeds action level for filth and foreign matter analysis from 2.0% to 5.0%.
RESPONSE #28: The commenter's suggested change represents a significant departure from what is proposed in the rules. The department will consider the suggestion as part of future rulemaking where the public has an opportunity to comment on the suggested change.
COMMENT #29: A commenter remarked on the laboratory moratorium discussions that took place before the Economic Affairs Interim Committee and expressed opposition to a moratorium. The commenter indicated a moratorium is unnecessary, would decrease competition, and could result in an inability to meet testing demand.
RESPONSE #29: The comment is outside the scope of this rulemaking process. The department's proposed rules are unrelated to and do not implicate the issue of a moratorium.
COMMENT #30: A commenter suggested the department inspect laboratories when new contaminate testing methods are implemented.
RESPONSE #30: The department agrees that new methods will require the state laboratory to assess each laboratory to ensure the proper equipment, method validations, proficiency testing, and ISO accreditation are present. The rules as proposed allow for these assessments and inspections to take place.
COMMENT #31: A commenter requested clarification regarding New Rule I(8) specifying that the unhomogenized portion of the laboratory test sample shall not be used for analysis.
RESPONSE #31: Under the rule, a portion of the sample that is unhomogenized must be maintained to complete filth and foreign matter screening. The intent of the rule is for the majority of the testing to be completed using the homogenized portion of the laboratory test sample. The department has revised the rule for clarity.
COMMENT #32: A commenter expressed opposition to the proposed removal of existing rule language under ARM 37.107.301(6) allowing 12 months for new laboratories to attain ISO 17025:2017 accreditation after licensure. The commenter suggested the language should instead be amended to allow testing laboratories who applied for licensure prior to January 1, 2022, a period of six months to attain accreditation.
RESPONSE #32: The department agrees that a reasonable time period is needed to allow testing laboratories to operate while actively working toward completion of the process of obtaining ISO accreditation. Such a time period is necessary to allow for an orderly transition to these new rules and to ensure that the necessary testing capacity exists to meet the anticipated demands of the market as Montana transitions to recreational marijuana. The department disagrees that the time period should be limited in application only to testing laboratories who started the ISO accreditation process prior to January 1, 2022. Such a limitation would effectively create differing requirements for testing laboratories depending upon the date of application. The approach taken by the department in proposing these rules has been to provide for a uniform set of rules that apply equally to current and future testing laboratories. Consistent with this approach, the department is revising the rule to allow endorsement of a testing laboratory that meets all other requirements of rule if written evidence of pending ISO accreditation and the results of an audit indicate that accreditation will be achieved within 12 months from the date of endorsement. A period of 12 months, rather than six months, has been chosen because it is consistent with the time period in the past rule, and the department's experience with implementation of the past rule is that the process of obtaining ISO accreditation can take longer than six months even in cases where a testing laboratory is diligently working toward accreditation.
COMMENT #33: A commenter stated that rules requiring new test methods must be implemented at the same time for all laboratories and new laboratories should not perform different tests on the same products compared to existing laboratories.
RESPONSE #33: The department agrees. The rules as proposed do not allow for laboratories to test for different analytes.
COMMENT #34: A commenter expressed concerns about the transition process from existing law to HB 701 and the department's proposed rules once they take full effect. The commenter indicated that a single set of rules should apply equally to both new testing laboratories and laboratories in existence prior to January 1, 2022. The commenter stated that a delay in implementation of new testing requirements is necessary to achieve this goal.
RESPONSE #34: Please see the response to Comment #3 on delayed implementation of new testing requirements. These proposed rules, and the revisions made in response to comments received, apply both to testing laboratories in existence prior to January 1, 2022, and to future testing labs.
COMMENT #35: A commenter sought clarification on how new laboratory license fees will apply to testing laboratories who started the process of acquiring a laboratory license prior to January 1, 2022.
RESPONSE #35: The comment is outside the scope of this rulemaking process. Under HB 701, rulemaking authority relating to testing laboratory fees rests with the Department of Revenue. 16-12-112, MCA.
COMMENT #36: A commenter requested the department adopt confidentiality rules to protect the proprietary nature of laboratory methods.
RESPONSE #36: The change proposed by the commenter is outside the scope of this rulemaking.
COMMENT #37: A commenter suggested revising ARM 37.107.316(6)(a) to reference "Salmonella species" to indicate any type of salmonella rather than just referencing "Salmonella."
RESPONSE #37: The department agrees with the comment, and has revised the rule accordingly.
COMMENT #38: A commenter suggested making the reference to "Coli" under ARM 37.107.316(6)(b) lowercase.
RESPONSE #38: The department agrees, and has revised the rule accordingly.
COMMENT #39: A commenter suggested revising ARM 37.107.316(7) to require use of an enrichment step for any method of microbiological testing.
RESPONSE #39: The commenter's suggested change represents a significant departure from what is proposed in the rules. The department will consider the suggestion as part of future rulemaking where the public has an opportunity to comment on the suggested change.
COMMENT #40: A commenter suggested reorganizing New Rule I(4) through (15) to reflect the order of operations for which these provisions ordinarily occur.
RESPONSE #40: The department does not believe the suggested change is needed. Rearrangement of the order of these sections of the rule would not increase clarity or understanding of the rule.
COMMENT #41: A commenter suggested clarifying New Rule I(11) to better accommodate the horizontal market.
RESPONSE #41: The department agrees, and has revised the rule to include product that has been purchased from another licensee.
COMMENT #42: A commenter suggested allowing a certain amount of time to field test the SOP-001 sampling protocol before it takes effect so laboratories could provide additional comment and SOP-001 could be further revised.
RESPONSE #42: Implementation of a sampling protocol is statutorily required by HB 701 and cannot be delayed. Revisions to SOP-001 must occur through the rulemaking process. If testing laboratories come across major issues or concerns with respect to implementing or operationalizing the protocol, they should contact the department; rulemaking can be initiated if warranted.
COMMENT #43: A commenter suggested adding a rule to clarify laboratory inspections shall be performed solely by approved members of the Public Health Laboratory of the Montana Department of Public Health and Human Services.
RESPONSE #43: The department disagrees. Amending the rules to make the department the only entity allowed to conduct inspections of testing laboratories would conflict with DOR's authority to conduct inspections under the Montana Marijuana Regulation and Taxation Act. See, e.g., 16-12-210, MCA.
COMMENT #44: A commenter requested standardization of use of the term "quality assurance plan" to match that of ISO 17025:2017, which uses "quality management system" or "quality manual."
RESPONSE #44: The department agrees with the comment, and has revised the rules by removing references to "quality assurance plan" and replacing it with "quality manual."
COMMENT #45: Several commenters expressed the opinion that portions of the proposed rules are redundant and duplicative of the ISO 17025:2017 accreditation standards and should be removed. In particular, the commenters questioned the need for ARM 37.107.302(2)(d) though (n), (6), (7), and 37.107.307.
RESPONSE #45: The department disagrees with the comments. Removing these rules would drastically reduce the ability of the department to adequately conduct thorough and meaningful inspections and to provide adequate oversight of testing laboratories.
COMMENT #46: A commenter suggested that the definition "good laboratory practice" and all references to it be removed from rule and replaced with ISO 17025:2017.
RESPONSE #46: The department agrees with the comment, and has revised the rules accordingly.
COMMENT #47: A commenter suggested the definition of "laboratory control sample" under ARM 37.107.303 be revised to exclude potency testing. The commenter stated reference standards for cannabinoids are expensive and the concentration of those cannabinoids in reference standards is heavily regulated by the Drug Enforcement Administration making this quality control sample for potency testing unnecessarily burdensome.
RESPONSE #47: The department agrees with the comment, and has revised the definition of "laboratory control sample" to include language indicating this quality control sample is for contaminate testing only.
COMMENT #48: A commenter suggested the definition of "method blank" under ARM 37.107.303 be revised to allow for a reagent method blank as finding a clean method blank can be difficult.
RESPONSE #48: The department disagrees. The definition of "method blank" provides adequate flexibility for laboratories to use a closely matched clean matrix from which to prepare a method blank. Laboratories may exercise their reasonable discretion in deciding what is a closely matched matrix. Reagent method blanks can be used at the discretion of laboratories to confirm reagents are clean. However, reagent method blanks do not confirm that the extraction/preparatory method is free of contamination.
COMMENT #49: A commenter suggested further clarifying the definition of "process lot" under ARM 37.107.303 to narrow the classification to just the extraction step.
RESPONSE #49: The department disagrees with the comment, and believes the definition of "process lot" is sufficiently clear as written.
COMMENT #50: A commenter suggested removing units from the equations defining "total THC" and "total CBD" under ARM 37.107.303 to clarify that other units may be used so long as the units for each term remain the same.
RESPONSE #50: The department agrees, and has revised the rule to remove reference to units for "total THC." The definition of "total CBD" has been removed entirely in response to Comment #16.
COMMENT #51: A commenter expressed concern with the time period under ARM 37.107.313(3)(a) for notification of an unsuccessful proficiency result and suggests keeping five business days or increasing the time to 10 business days.
RESPONSE #51: The department disagrees, and believes the proposed time period of three business days is adequate and reasonable. The proposed change also aligns with existing rule language under ARM 37.107.311(8) providing three business days to report to the department.
COMMENT #52: A commenter suggested that test batches should be removed from remediation requirements under ARM 37.107.315(11) because inclusion of test batches implies testing laboratories are responsible for remediation.
RESPONSE #52: The department disagrees that the rule implies testing laboratories are responsible for product remediation. ARM 37.107.315(11) simply states the circumstances under which failed harvest lots, process lots, or test batches may be remediated.
COMMENT #53: A commenter suggested ARM 37.107.315(14) be revised to clarify the intent is for failed harvest lots, process lots, and test batches to be remediated and not the laboratory test sample.
RESPONSE #53: The department agrees and has revised the rule accordingly.
COMMENT #54: A commenter suggested to keep general E. coli testing as STEC narrows the field of testing too much and will eliminate other pathogenic forms of E. coli. The commenter requests that if STEC is to remain in rule that laboratories are provided adequate time to implement the change.
RESPONSE #54: The department disagrees with the comment. STEC narrows testing to include the most common sources of pathogenic E. coli contamination similar to the manner in which culturable mold testing was narrowed to include common pathogenic forms such as aspergillus. Please see the response to Comment #3 regarding delayed implementation of this testing requirement.
COMMENT #55: A commenter suggested the action level for chloroform be updated from 2ppm to 60ppm to match that of Q3C - Tables and List Guidance for Industry maintained by the Food and Drug Administration.
RESPONSE #55: The commenter's suggested change represents a significant departure from what is proposed in the rules. The department will consider the suggestion as part of future rulemaking where the public has an opportunity to comment on the suggested change.
COMMENT #56: A commenter suggested existing rule language under ARM 37.107.316(12)(b) is inadvertently leading to certain marijuana products, such as cannabis butter, being inadequately tested because the products in question are only subject to testing under ARM 37.107.316(12)(e).
RESPONSE #56: The intent of the rules is to ensure all marijuana products undergo testing prior to reaching the end consumer. With respect to the commenter's specific example, the department refers to ARM 37.107.316(12)(f), which indicates marijuana concentrate and extract must pass the required testing set forth in ARM 37.107.316(12)(d).
COMMENT #57: A commenter suggested the calibration weight check requirements under section 4.1.6 of SOP-001 are excessive and multiple weight checks would have to happen at one facility.
RESPONSE #57: The department believes that the commenter has misinterpreted the referenced provision. The language states a balance weight check shall occur at each licensed facility. One weight check, not multiple weight checks, is required at each licensed facility.
COMMENT #58: A commenter suggested that trademark names should be removed from SOP-001.
RESPONSE #58: The department agrees, and has revised SOP-001 accordingly.
COMMENT #59: A commenter noted a spelling error in section 4.1.10 of SOP-001.
RESPONSE #59: The department has corrected the spelling error.
COMMENT #60: A commenter requests that references to hair nets and beard nets be removed from section 4.1.10.1 of SOP-001 as these requirements are more appropriate for other licensee types rather than testing laboratories.
RESPONSE #60: The department agrees, and has revised SOP-001 accordingly.
COMMENT #61: A commenter suggested removing the requirement under section 6.2 of SOP-001 for an internal field audit and indicated ISO 17025:2017 is adequate for addressing laboratory training.
RESPONSE #61: The department disagrees. The requirement is necessary to ensure testing laboratory samplers are consistently trained throughout the state.
COMMENT #62: A commenter suggested SOP-001 will be more time consuming and suggested removing provisions that increase the time needed to collect samples. Specific recommendations were not provided.
RESPONSE #62: The department understands SOP-001 will require additional time for sampling. However, the benefits of SOP-001 in establishing a uniform standard for sampling outweigh the resulting extra time needed to acquire a quality representative sample.
COMMENT #63: A commenter suggested revising the proposed rules to require use of standardized storage containers and packaging for all licensees to make sample collection easier.
RESPONSE #63: This comment is outside the scope of the rulemaking. Rulemaking authority relating to packaging rests with DOR. 16-12-112, MCA.
COMMENT #64: A commenter suggests changing the percent difference in sections 7.1.4.3, 7.2.4.3, 7.3.4.3, and 7.4.4.3 of SOP-001 from ±10.0% to ±5.0%.
RESPONSE #64: The department disagrees. This value was established with the intent to provide for a somewhat lenient margin of error in order to allow for a smooth transition toward implementation of SOP-001. The department will re-evaluate this value as SOP-001 is implemented, and can modify it through future rulemaking if warranted.
COMMENT #65: A commenter suggested that 80 increments of flower will require 60 to 70 increments to be very small. The department believes the commenter meant 8 increments will require 6 to 7 increments to be very small. It was recommended that sample increment values be reduced by half and sample size weights be rounded to the nearest whole number.
RESPONSE #65: The rules do not require increments be the same size. The rules allow for more increments to be collected than what is listed in the sampling tables of SOP-001. The department has revised SOP-001 to clarify that additional mass may also be collected to help facilitate this process.
COMMENT #66: A commenter suggested removing the sample mixing requirement for flower in section 7.1.11 of SOP-001 and indicated that mixing will damage trichomes and subsequently change the potency results.
RESPONSE #66: The department disagrees with the comment. Mixing a sample is a necessary part of collecting a representative sample of any matrix. The amount of mixing required will not significantly affect potency results any more than the routine handling of the product for packaging, transport, etc.
COMMENT #67: A commenter suggested moving distillates from section 7.3 to section 7.2 of SOP-001 because they are considered semi-solids. The commenter also recommended including Rick Simpson Oil under section 7.3.
RESPONSE #67: The department agrees, and has revised SOP-001 accordingly. However, please note the list provided in headings of SOP-001 such as sections 7.2 and 7.3 are merely examples and are not complete or exhaustive lists. Exceptions to these headings will exist and it is at the reasonable discretion of the laboratory sampler to properly assign a product to the best sampling procedure.
COMMENT #68: A commenter suggested adding language to section 7.4.8 of SOP-001 to clarify the minimum number of vape cartridges for sampling and noted that not all the extract can be removed from one cartridge.
RESPONSE #68: The department disagrees. New Rule I(6) already specifies that the laboratory test sample collected shall be sufficient to allow for analysis and reruns. It is the responsibility of the laboratory to understand that removal of all extract vape from cartridges is impossible and that collection of additional cartridges may be necessary.
COMMENT #69: A commenter suggested adding a column to Table 5.0 of SOP-001 to clarify the minimum number of servings.
RESPONSE #69: The department believes this change is unnecessary because section 7.5.7 of SOP-001 explicitly states that one serving size is equal to one sample increment.
COMMENT #70: A commenter suggested providing an example of what an acceptable random number generator would be under section 7.6 of SOP-001.
RESPONSE #70: The department agrees, and has revised SOP-001 to include examples.
COMMENT #71: A commenter suggested revising section 7.6.7 of SOP-001 to allow custody seals on bulk bags or individual laboratory test samples, to save time and resources.
RESPONSE #71: The department agrees, and has revised SOP-001 accordingly.
COMMENT #72: A commenter suggested removing time requirements from section 7.6.8.6 and removing sections 7.6.8.8 and 7.6.8.9 from SOP-001. The commenter indicated these requirements are excessive.
RESPONSE #72: The department agrees the time requirement under section 7.6.8.6 should be removed, and has revised this section accordingly. The department disagrees that sections 7.6.8.8 and 7.6.8.9 should be removed because the designation of the laboratory test sample is considered relevant and existed in ARM 37.107.405 previously. ARM 37.107.405 has since been transferred to DOR (renumbered ARM 42.39.305) and is in the process of being repealed. The language is simply being retained and moved to SOP-001.
COMMENT #73: A commenter suggested removing the term "unique" from section 7.6.9.2 of SOP-001 as Metrc tag numbers are unique numbers.
RESPONSE #73: The department agrees, and has revised SOP-001 accordingly. This will allow laboratories that use the Metrc ID as the laboratory ID to be in compliance with this section.
COMMENT #74: A commenter suggested removing the time requirement from section 7.6.9.3 of SOP-001 as it is excessive.
RESPONSE #74: The department agrees, and has revised SOP-001 accordingly.
COMMENT #75: A commenter suggested revising section 7.6.9.4.1 of SOP-001 to clarify who is responsible for the labeling requirement.
RESPONSE #75: The department agrees, and has revised SOP-001 to clarify that the task is the responsibility of the licensee.
COMMENT #76: A commenter suggested providing examples of shipping providers under section 9.5 of SOP-001.
RESPONSE #76: The department considers the existing language to be sufficiently clear and declines to make this change.
COMMENT #77: A commenter suggested adding language under section 9.7 of SOP-001 to indicate the sample report form must be in paper form and not electronic form.
RESPONSE #77: The department disagrees with the suggested revision. The section is intended to provide discretion to the testing laboratory to use paper or electronic forms for record retention.
COMMENT #78: A commenter suggested adding language to section 10.1 of SOP-001 to refer to a sampling activity more generally rather than a test batch.
RESPONSE #78: The department disagrees with the suggested revision. The intent of this section is to track and record the sampling for individual test batches and not just the sampling event.
COMMENT #79: A commenter suggested revising section 10.1.2 of SOP-001 for clarity by using the language "Name of representative from licensee submitting product(s) for testing and badge ID number" and suggested adding language to require the licensee representative signature and date.
RESPONSE #79: The department agrees, and has revised SOP-001 accordingly.
COMMENT #80: A commenter suggested adding language under section 10.1.8 to direct the reader to the percent difference equation found in SOP-001.
RESPONSE #80: The department agrees, and has revised SOP-001 accordingly.
COMMENT #81: A commenter suggested standardizing language in section 10.1.16 of SOP-001 to include the badge ID number instead of license ID number.
RESPONSE #81: The department agrees, and has revised this section of SOP-001 accordingly.
COMMENT #82: A commenter requested the department not adopt the proposed rules and SOP-001 until a cost analysis can be performed and additional feedback is sought from stakeholders. The commenter suggests proposed rules could be implemented in the summer of 2022.
RESPONSE #82: The department disagrees. The statutory provisions of HB 701 relating to marijuana sampling and testing laboratories take full effect on January 1, 2022. These provisions require the department to have rules in place governing testing laboratory endorsement requirements, sampling protocols, and parameters under which the department may suspend the license of a testing laboratory. The department has followed the requirements of the Montana Administrative Procedure Act, conducted a public hearing, and received extensive written comment on the rules. In response to these comments, the department has made significant modifications to the proposed rules. Delaying this rulemaking until the summer of 2022 would leave testing laboratories largely unregulated and would contravene the rulemaking requirements of HB 701.
COMMENT #83: A commenter suggested removal of language under section 7.1.4 of SOP-001 requiring testing laboratories to weigh test batches. The commenter indicated the language puts laboratories in the position of regulating licensees and will substantially increase sampling time. The commenter suggests program inspectors be responsible for this task.
RESPONSE #83: The department disagrees. The use of program inspectors, rather than testing laboratories, would only allow for random weight confirmations of test batches rather than weight confirmations on every occasion. Without this requirement, licensees could add extra product in a test batch to avoid testing costs. The placement of extra product in a test batch would also decrease the representativeness of the laboratory test sample and decrease the validity of the test results. The associated time requirements are necessary to ensure a quality representative sample and quality results.
COMMENT #84: A commenter suggested collecting 0.25% of the test batch and homogenizing 100% of the laboratory test sample to reduce product waste and the subsequent monetary loss to providers.
RESPONSE #84: The department disagrees. To obtain a truly representative laboratory test sample, adequate sample mass/volume must be collected. This may mean that not all the laboratory test sample collected will be used in compliance testing. This is typical of many laboratory industries. Extra sample is also necessary for potential laboratory reruns and the necessary quality control samples required by the rule. The state of Montana has used the standard of 0.5% for many years as do many other states with marijuana programs. Additionally, the homogenization of 100% of the laboratory test sample would render filth and foreign matter screening meaningless as the seeds, stems, or other foreign material would be destroyed. Some amount of the sample must remain intact to complete this analysis.
COMMENT #85: A commenter suggested it is very difficult to manufacture edibles that are exactly 10mg and proposes that a variance such as 9 to 11mg be applicable to these products.
RESPONSE #85: This comment is outside the scope of this rulemaking on testing laboratory and sampling protocol requirements.
7. The department intends the following rules to be effective on the dates listed below:
ARM 37.107.316(6)(b), 37.107.316(6)(c), and 37.107.316(7), are effective March 14, 2022. The requirements under the existing rule for testing of culturable mold and E. coli remain in effect until this date.
8. All other referenced rules are effective the day after the date of publication.
/s/ Robert Lishman /s/ Adam Meier Robert Lishman Adam Meier, Director Rule Reviewer Public Health and Human Services
Certified to the Secretary of State January 4, 2022.
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A directory of state agencies is available online at http://www.mt.gov/govt/agencylisting.asp.
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