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| Montana Administrative Register Notice 37-839 | No. 19 10/05/2018 | |
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BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA
TO: All Concerned Persons
1. On April 13, 2018, the Department of Public Health and Human Services published MAR Notice No. 37-839 pertaining to the public hearing on the proposed amendment of the above-stated rules at page 711 of the 2018 Montana Administrative Register, Issue Number 7.
2. The department has amended ARM 37.107.305 as proposed.
3. The department has amended the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
37.107.118 MARIJUANA AND MARIJUANA-INFUSED PRODUCTS PROVIDER LICENSEE REQUIREMENTS (1) through (5) remain as proposed. (6) A licensee may have up to 30 square feet of canopy space per registered cardholder.
(a) through (18) remain as proposed.
AUTH: 50-46-344, MCA IMP: 50-46-303, 50-46-308, 50-46-312, 50-46-319, 50-46-326, 50-46-328, 50-46-329, 50-46-330, MCA
4. The department has thoroughly considered the comments and testimony received. The following summary of comments received and the department′s responses is a concise statement of the principal reasons for and against adoption of the proposed changes to ARM 37.107.118 and 37.107.305.
COMMENT #1: Several comments were received stating that the proposed tiered canopy would be difficult and unworkable.
RESPONSE #1: Based on additional input, the department agrees that the tiered canopy may be difficult to implement, so the department has removed the proposed tiered canopy and changed the amount of canopy allowed per patient to 30 square feet for all providers. The department believes 30 square feet per patient is a prudent canopy size between the existing 50 square foot amount and other proposed size allocations.
COMMENT #2: Several comments were received stating the current canopy of 50 square feet per patient is too much and should be reduced.
RESPONSE #2: See Response #1.
COMMENT #3: Several comments were received stating that providers need the current 50 square foot of canopy to supply the needs of patients.
RESPONSE #3: See Response #1.
COMMENT #4: Several comments were received that organic and outdoor growers need 50 square foot of canopy to grow for patients.
RESPONSE #4: The department disagrees and has not inspected any organic or outdoor growers to date that were using 50 square feet of canopy per patient. Also see the department's Response #1.
COMMENT #5: Two comments from labs were received stating while they do not object to a $25,000 bond, they do not understand how the state would have standing under the direction of the bond, i.e., loss of materials. For example, the state would not be either liable for the loss, or be logically able to make a claim against a loss of test materials. Therefore, such a bond would not be paid out in the event of such a loss. They suggest that until this is clarified, the bond be set at $0 as a placeholder until the state's liability for licensed laboratories becomes clearer. This change would not contradict either the Montana Code Annotated or Administrative Rules of Montana, yet would ensure compliance with both.
RESPONSE #5: The department disagrees. A bond provides evidence of financial responsibility and is payable to the department if a laboratory operates the facility in a manner that allows for or results in theft, loss, or diversion of medical marijuana; or the testing laboratory has its license suspended or revoked due to prohibited activities.
COMMENT #6: One testing laboratory commented that in order to bring the METRC Tracking system software guide into scope of current statutory and administrative rule, they suggested the following actions:
1) Adopt the document "Medical Marijuana Quality Assurance Testing," 3/22/18 via reference in QA Testing Requirements (ARM 37.107.407), adding a section on sampling method derived from the proposed METRC manual. 2) Adopt the document "Laboratory Facility Checklist" from 4/15/18 via reference in lab licensee requirements (ARM 37.107.305). 3) Edit the proposed METRC Lab User Guide: a. Remove (i) the quality assurance testing section, (ii) the packaging and sampling methods section and (iii) the testing type, replacing these with references to MMJ QA Assurance Testing document and ISO/IEC 17025:2017.
The commenter further provided the department with documents supporting their position and their proposed edits to the METRC MT Testing Lab User Guide and the department's quality assurance and testing guidelines.
RESPONSE #6: The department agrees that a separate document for quality assurance and testing protocols is necessary and the department has separated "Quality Assurance Sampling Protocols" and "Quality Assurance" from the METRC MT Testing Lab User Guide into a document titled "Quality Assurance and Testing Protocols" that will be referenced in the METRC MT Testing Lab User Guide. The department does not agree that the laboratory facility checklist should be adopted and it will remain as a reference document for the program. The department does not agree that the packaging and sampling methods or testing types should be removed from the METRC MT Testing Lab User Guide.
COMMENT #7: The department received the following comment: METRC lab User guide: Test results per category: potency currently does not have a pass/fail: change "Select "XXX (%)" and select pass or fail as the status, then enter the percentage of THC" to "Select "XXX (%)" and enter the percentage of THC."
RESPONSE #7: While the department appreciates the commenter's comment, the department respectfully disagrees and will leave the potency test results entry in order to facilitate future planning for potency testing requirements.
COMMENT #8: The department received the following comment: while the required ISO accreditation will help address many of the above concerns, we are worried about the gap between now and a year from now when all labs are required to get ISO accreditation of their testing methods and protocols.
RESPONSE #8: The department agrees that laboratories should have to prove proficiency in all areas of testing in addition to ISO certification, which can take up to a year to complete, and has left the following requirement in the Quality Assurance Testing document. In addition to passing a review of the application and an on-site assessment, the laboratory must participate in a proficiency testing (PT) program and participate in two single-blind, single-concentration PT studies, where available, per year for each method it seeks accreditation. For all fields of testing, including those for which PT samples are not available, the laboratory shall ensure the reliability of its testing procedures by maintaining a total quality management system that meets all applicable requirements of V1:M1, Proficiency Testing, of the 2009 TNI Standards.
COMMENT #9: The department received the following comment: DPHHS should make sure, via inspections, that labs have taken the necessary precautions to ensure that their vehicles and containers will keep samples secure and safe from tampering and contamination throughout an entire day of couriering. Samples should always be under lock and key. Samples should always be stored under environmentally controlled conditions. Just like providers, a lab's samples must be stored at a registered premise at the end of the day.
RESPONSE #9: The department agrees and has added a section to the Quality Assurance Sampling Protocols specifying that: (i) Samples must be accompanied by a transfer manifest; (ii) Samples must be transferred in a locked, climate-controlled container; and (iii) Samples must be stored in a licensed, climate-controlled facility if the lab requires overnight travel to the document quality assurance and testing protocols.
COMMENT #10: The department received the following comment: METRC Lab User Guide: Delays in transportation including overnight stays are a feature of life when travelling in Montana, a reality not experienced often in other METRC states. We suggest that Franwell/METRC be specifically directed to not prohibit overnight stops and to accommodate reasonable traffic and weather delay to reflect uncertainty in Montana road conditions and distances.
RESPONSE #10: The department disagrees. The transfer manifest is good for a single day of travel. If an overnight stay is required, the lab representative needs to have a licensed facility listed in METRC to store the samples. Transfer manifests cannot be edited once the lab has left a licensed facility. Lab representatives are not allowed to keep samples in their vehicle overnight. This is an industry standard and verbiage has been added to Quality Assurance Sampling Protocols. The department will make available temporary "satellite" lab licenses until Complia, the Montana Medical Marijuana Program licensing system, can be configured to issue the licenses.
COMMENT #11: The department received the following comment: the term "Harvest Batches" is used through the document; however, it is not defined in the Terminology section.
RESPONSE #11: The department agrees and has added the description in the terminology section of the METRC MT Testing Lab User Guide.
COMMENT #12: The department received the following comment: wording in "Sampling Protocols" bullet should be improved for clarity. For example, bullet that reads "Licensee electronically creates test sample(s) in METRC from their batch packages" does mesh with previously established terminology for "Harvest Lot" and "Production Batch."
RESPONSE #12: The department agrees and has made the changes in the METRC MT Lab Testing User Guide.
COMMENT #13: The department received comments about errors on page 6 of the METRC MT Lab User Guide in the table that correlates a product type to its respective testing requirement. For instance: (i) for usable marijuana, water activity testing has been included when it should not have been added, and mycotoxins have been omitted; (ii) for concentrates, terpene testing has been included when they should not have been included, and mycotoxins have been omitted; and (iii) for edible Marijuana-infused product, mycotoxin testing has been omitted.
RESPONSE #13: The department agrees and has made the changes in the METRC MT Lab Testing User Guide, except for mycotoxin testing for edible marijuana-infused products. Mycotoxins are tested at the flower or concentrate level for edible marijuana-infused products.
COMMENT #14: The department received the following comment: on pages 13 and 14, there appear to be some errors. Random testing of heavy metals has also been omitted from the testing requirements listed for concentrates. Furthermore, we see no reason why usable marijuana that will be processed into a concentrate or extraction needs to be required to have moisture content, micro, and mycotoxin testing. In fact, for extraction products such as live resin, these tests would cause significant issues and likely prevent providers from making such products. We recommend removing these requirements.
RESPONSE #14: The department agrees and has made the changes in the Quality Assurance and Testing Protocols.
COMMENT #15: The department received the following comment: under "filth and foreign matter screening" on page 11 of the METRC guide, we are required to determine whether a gram of material has less than 10,000 CFU of culturable mold. This seems to us to require a general mold test. It is not a test that can be done visually. If our understanding of this is correct, then this requirement really belongs under microbiological screening rather than filth and foreign matter.
RESPONSE #15: The department agrees and has made the changes in the Quality Assurance and Testing Protocols.
COMMENT #16: The department received the following comment: under "Microbiological screening" we are required to test pathogenic E. coli, where a pass is 10 CFU/g or less. In our view, for pathogenic E. coli, the test should be "non-detectable in a gram of material." DPHHS should not allow any material found to possess pathogenic E. coli to pass.
RESPONSE #16: The department agrees and has made the changes in the Quality Assurance and Testing Protocols.
COMMENT #17: The department received the following comment: "pathogenic" should be removed from before E. coli. Traditional means of enumerating E. coli are selective for all E. coli strains, pathogenic or not.
RESPONSE #17: See Response #16.
COMMENT #18: The department received the following comment: heavy metals table – the column header unit has a typo "u/daily dose (5 grams)" header should be "ug/daily dose (5 grams)."
RESPONSE #18: The department agrees and has made the changes in the Quality Assurance and Testing Protocols.
COMMENT #19: The department received the following comment: the Guide also states that concentrates only require residual solvent and pesticide testing. The edible or topical, etc. batch requires cannabinoid, microbiological and mycotoxin tests for compliance. We request a change to make mycotoxin screening and pesticide screening occur on the same batches of material rather than different batches.
RESPONSE #19: The department agrees and has made the changes in the Quality Assurance and Testing Protocols and the METRC MT Testing Lab User Guide.
COMMENT #20: The department received several comments that are in favor of the reinstatement of the original pesticide panel and action limits. A representation of these comments is as follows:
Reinstating the full panel of over 60 pesticides will have zero impact on the cost we charge for the pesticide screening, and it will almost quadruple the number of pesticides for which we test. This is a situation in which DPHHS can ensure medicine will receive more thorough quality assurance testing, thereby increasing patient safety, with no additional cost added to the provider or the patient.
RESPONSE #20: The department agrees; however, since ARM 37.107.407 and the pesticide panel were not a part of this rulemaking, changes in the Quality Assurance and Testing Protocols, METRC MT Testing Lab User Guide, and ARM 37.107.407 pertaining to the pesticide panel will need to be pursued under a separate, future rulemaking.
COMMENT #21: The department received several comments requesting the department to set minimum sample sizes.
RESPONSE #21: The department agrees and has added the following to the Quality Assurance and Testing Protocols: Samples for products, including but not limited to, useable marijuana including trim and manicure, extracts (oils or shatters), tinctures, vape pens, kief, hash, edibles, capsules, salves, and ointments must be .5% of the batch size. Example: if the total batch weight is 3.31lbs, the lab would be required to collect 7.5 grams (3.31 lbs. = 1501 grams x .5% = 7.5 grams). For multiple strain batches, divided the minimum required sample sized by the number of strains. Example: If there are 5 strains that make up the 3.31lb batch, the lab is required to, at a minimum, collect 1.5 grams per strain (7.5g/5strains = 1.5 grams). A minimum of 1 gram per strain is required regardless of batch size and strain count.
COMMENT #22: The department received the following comment regarding collecting samples from providers: METRC MT Testing Lab User Guide, page 8, (2)(d) Labs cannot control construction or maintenance of providers.
RESPONSE #22: The department agrees and has made changes to the Quality Assurance and Testing Protocols.
COMMENT #23: METRC MT Testing Lab User Guide, page 9, Quality Assurance Sampling Protocols (9) . . ."directly" would preclude multiple pickups by a lab.
RESPONSE #23: The department agrees and has made changes to the Quality Assurance and Testing Protocols.
COMMENT #24: The department received the following comment: pages 7-8 – QA Sampling Protocols are not consistent with the current administrative rule. For example, ARM 37.107.405 does not specify explicitly who conducts the product sampling. However, the METRC guide explicitly states in section (2)(b) on page 8 that the person performing the sampling has to be trained and certified in the appropriate procedures by the laboratory they are employed by. This statement implies the sampling must be performed by a certified testing lab employee. (This is also in conflict with the Quality Sampling Protocol dated 3/22/2018.)
RESPONSE #24: The department disagrees with this conclusion. It has always been the intent of the department to have laboratory personnel collect samples. This is the only way the integrity of the sample can be preserved; and it is industry standard. Notwithstanding the department's disagreement with the commenter's conclusion, Quality Assurance Sampling Protocols (2)(b) has been revised to include "lab personnel" for clarification.
COMMENT #25: One commenter reported that the testing requirements table needs to be checked for consistency with administrative rules. In particular, the "Cannabinoid Products" row appears to have testing requirements not listed in the administrative rule for marijuana-infused products.
RESPONSE #25: The department agrees and has made changes to the Quality Assurance and Testing Protocols and the METRC MT Testing Lab User Guide where the testing requirements for marijuana-infused products and has removed mycotoxins.
COMMENT #26: One lab commented that they believe there are some inconsistencies in reporting potency values. Specifically, some labs in the state subtract moisture content from the potencies values while other labs do not. For example, if a flower sample measures 20% total THC and 10% moisture, a lab may "correct" the THC content by subtracting moisture which would result in a reported value of 22% THC content (i.e., 20% THC/90% dry weight = 22% THC). We feel that such calculations are accurate representations of the product which is sold and consumed by the patient. It also seems to go against the spirit of the METRC guidelines which, on page 8, state that "changing a sample in any way as to inflate the level of potency" is not allowed. We feel that this puts an unfair burden on patients as it forces them to calculate the actual THC in the product they are buying. We request that the department specifically require that all potency measurements be reported on an "as-is" basis or provide guidelines for making moisture corrections and require specific language to be included on the packaging stating that a moisture subtraction was made.
RESPONSE #26: The department disagrees. Potency and moisture content are to be tested separately. Combining potency and moisture content together is falsifying the testing and inflating the THC levels.
COMMENT #27: The department received a large number of comments that were not applicable to the rules being amended in this notice. A sample of the comments follows: "Tethering patients to providers and the card system that underlies that model has been a problem for almost 10 years." "Marijuana rules should be written along the same lines as alcohol rules." "MIPP licenses should be available to experts in the field and not only providers." "Our legislators proclaim, 'liberty for Montanans' from overreaching federal oppression, however, though marijuana is not as addictive as cigarettes, alcohol, or pharmaceutical pain medications, you, as a state entity, treat it as a class 1 drug with far more restrictions and requirements."
RESPONSE #27: The department appreciates the comments of the commenters, and always encourages public comment and input regarding any department program, policy, or proposed rulemaking. However, the department does not formally respond to comments that address matters outside the scope of the pending rulemaking.
5. The department will apply these rule amendments retroactively to April 10, 2018 in order to comply with the requirements of Senate Bill 333 (2017).
6. A small business impact statement has been prepared and may be obtained from the department by a request in writing to the Department of Public Health and Human Services, Montana Marijuana Program, P.O. Box 202953, Helena, MT 59620-2953 or at http://dphhs.mt.gov/marijuana.
/s/ Shannon L. McDonald______ /s/ Sheila Hogan ______ Shannon L. McDonald Sheila Hogan, Director Rule Reviewer Public Health and Human Services
Certified to the Secretary of State September 25, 2018.
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