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The following definitions apply to this chapter:

(1) "Act" means the Marijuana Regulation and Taxation Act, codified at 16-12-101, MCA, et. seq.

(2) "Authorized employee" means:

(a) an employee of the department who has received written authorization from the department director or the director's designee to obtain individual names and other identifying information from the marijuana registry;

(b) an employee of a state or local law enforcement agency who is authorized to obtain marijuana registry information through the Montana Criminal Justice Information Network (CJIN)/marijuana registry interface; or

(c) an employee of a state or local government agency, including a state or local law enforcement agency, who has received authorization to obtain marijuana registry information.

(3) "Batch" means:

(a) a quantity of usable marijuana from a harvest lot; or

(b) a quantity of cannabinoid concentrate or extract or cannabinoid product from a process lot.

(4) "CBD" means cannabidiol.

(5) "CBDA" means cannabidiolic acid.

(6) "Certificate of analysis" means the report prepared by a marijuana testing laboratory about the analytical testing performed and the results obtained by the laboratory.

(7) "Chemical manufacturing" means the use of chemical compounds such as, but not limited to, hydrocarbon solvents or food grade nonhydrocarbon solvents to separate cannabinoids or marijuana analytes of interest from marijuana.

(8) "Child resistant" means packaging designed or constructed to be significantly difficult for children under five years of age to open and not difficult for adults to use properly. The standard for child-resistant packaging is set by the federal consumer product safety commission (CPSC) and the testing procedures found in 16 CFR 1700.20 (2012).

(9) "Compliance audit" means a department review of aspects of a licensee's business without conducting a physical on-site inspection, including but not limited to website compliance checks, review of seed-to-sale tracking system records, permit compliance checks, and local ordinance compliance checks.

(10) "Cultivate" means to grow, propagate, clone, or harvest marijuana for use by registered cardholders or consumers.

(11) "Customer" means, collectively, adult use consumers and registered cardholders.

(12) "Edible marijuana-infused product" or "edible" means an ingestible marijuana-infused product that is intended to be taken by mouth, swallowed, and primarily absorbed through the gastrointestinal tract. Edible marijuana-infused products may be psychoactive when used as intended. Without limitation, edible marijuana-infused products may be in the form of a food, beverage, capsule, tablet, or tincture.

(13) "Employee" as defined in 16-12-102, MCA, includes an independent contractor that performs work for any aspect of a marijuana business.

(14) "Existing outdoor cultivation space" means outdoor space used to grow live marijuana plants in an area exposed to natural sunlight and environmental conditions including variable temperature, precipitation, and wind, licensed on or before November 3, 2020.

(15) "Exit package" means a sealed container or package provided at the retail point of sale, in which any marijuana item already within a container is placed.

(16) "Fee" means the mandatory fees required by the department.

(17) "Fingerprint card" means an FD-258 fingerprint card utilized to facilitate a Federal Bureau of Investigation (FBI) fingerprint and background check.

(18) "Food-Grade" means the processing and packaging has been done with clean equipment and can be safely eaten.

(19) "Green county" means a county where the majority of voters voted to approve Initiative Measure No. 190 in the November 3, 2020 general election or where the local government approval provisions of 16-12-301, MCA, have been satisfied. This definition does not include a municipality that has approved or disapproved a category or categories of marijuana businesses, as authorized in 16-12-301, MCA.

(20) "Ingestible marijuana-infused product" or "ingestible" means a product that contains marijuana and at least one other ingredient, is intended for consumption or use other than by smoking or vaporizing, is intended to be taken into the body, and is either categorized as an edible marijuana-infused product or a transmucosal marijuana-infused product.

(21) "Ingredient" means any substance that is added to marijuana items that changes its final form including but not limited to flavorings, aromatic oils, colorants, food items, spices, sweeteners, and preservatives.

(22) "Label" or "labeling" means the printed analytical information pertaining to the marijuana flower or marijuana product displayed on the packaging in which marijuana or a marijuana product is dispensed or displayed to a customer.

(23) "Licensee" means any person licensed by the department.

(24) "Limited access area" means a building, room, or other contiguous area upon the licensed premises where marijuana is grown, cultivated, stored, weighed, packaged, sold, or processed for sale, under the control of the licensee.

(25) "Major food allergen" or "allergen" means milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, sesame, soybeans, any additional ingredient identified by the United States Food and Drug Administration, and any ingredient containing a protein derived from these foods.

(26) "Manufacture" means the act of preparing and processing usable marijuana into a marijuana-infused product. A marijuana-infused product must be labeled as to indicate that it contains marijuana.

(27) "Marijuana" means the same as the definition in 16-12-102, MCA, and includes the biomass of the marijuana plant which contains greater than 0.3% total THC concentration and appreciable concentrations of other cannabinoids of interest including flower, bud, shake, trim, and manicure.

(28) "Marijuana concentrate and extract" or "concentrate and extract" means the same as the definition in 16-12-102, MCA, and includes a substance obtained by separating and/or concentrating naturally occurring chemical constituents of marijuana, such as, but not limited to, cannabinoids, from marijuana plant material by mechanical, physical, chemical, or other processes that may:

(a) contain solvents in allowable amounts and ingredients used to promote a desired physical state, texture, or flavor in the marijuana concentrate, but no other ingredients; or

(b) be intended for use in the production of marijuana-infused products; or

(29) "Marijuana-infused product" means the same as the definition in 16-12-102, MCA, and includes the infusion of cannabinoids of interest using marijuana or marijuana concentrate or extract into existing products, substances, or consumer goods, and as an ingredient in the production of consumer goods that would not naturally or ordinarily contain cannabinoids of interest.

(30) "Marijuana items" means:

(a) marijuana;

(b) usable marijuana;

(d) marijuana derivatives, concentrates, extracts, resins, infused products, edible products, ointments, tinctures, suppositories, topicals; and

(e) other marijuana-related products.

(31) "Marijuana laws" for the purposes of these rules, means any combination of regulatory authority pursuant to the Montana Marijuana Regulation and Taxation Act (Title 16, chapter 12, MCA), rules of the department, or local ordinances applicable to marijuana businesses.

(32) "Marijuana product category" means a defined group of marijuana products that are in the same form. Marijuana product categories are:

(a) marijuana flower;

(b) marijuana concentrates; and

(i) ingestible marijuana-infused products, including the following subcategories:

(A) edible; and

(B) transmucosal;

(ii) non-ingestible marijuana-infused products, including the following subcategories:

(A) topical; and

(B) transdermal.

(33) "Mechanical manufacturing" means the use of mechanical methods to produce or refine marijuana concentrates and extracts, such as but not limited to a press, centrifuge, or evaporation.

(34) "Mixed strain" means multiple strains of marijuana.

(35) "Monthly" means, for purposes of determining a registered cardholder's maximum monthly amount of usable marijuana, a period of 30 consecutive days.

(36) "Motor vehicle," for purposes of these rules, means a vehicle propelled by its own power and designed or used to transport persons or property on the highways of the state with an interior passenger compartment.

(37) "Non-ingestible marijuana-infused product" or "non-ingestible" means a product that contains marijuana and at least one other ingredient, is intended for consumption or use other than by smoking or vaporizing, is intended for external use only, and is either a topical marijuana-infused product or a transdermal marijuana-infused product.

(38) "Opaque" means packaging that does not allow the contents to be seen when unopened. Packaging may be opaque by virtue of the specific properties of the material of which it is composed, including any coating applied to it, or by means of a secondary opaque covering, such as a sticker.

(39) "Package" or "packaging" means the immediate container in which a finished marijuana product is placed for retail sale to consumers and any outer container or wrapping used in the retail display of the marijuana or marijuana product to customers, and includes graphics, logos, and design elements.

(40) "Performing work on behalf of any aspect of a marijuana business" means and includes:

(a) possessing, handling, producing, propagating, processing, securing, or selling marijuana or marijuana products at the licensed premises;

(b) recording of the possession, handling, production, propagation, processing, securing, or selling of marijuana or marijuana products at the licensed premises; and

(41) "Physician statement" means a written statement by a Montana licensed physician on department forms certifying the registered cardholder applicant's debilitating condition. Physician statement forms include:

(a) Physician Statement for Debilitating Condition; or

(b) Physician Statement for Minors.

(42) "Property owner permission form" means a completed, signed, and notarized form which gives an applicant or licensee who is renting or leasing the property where marijuana will be cultivated and manufactured permission to do so by the property owner. The form must be provided by the department.

(43) "Psychoactive" means capable of affecting mental processes or cognition when used as intended. A marijuana product is considered per se psychoactive if it is not a topical marijuana-infused product and the labeled potency is greater than .3% THC.

(44) "Reconcile" for purposes of seed-to-sale tracking means to ensure that what is recorded in the seed-to-sale tracking system is consistent with what is physically located at the licensed premises.

(45) "Red county" means a county where the majority of voters voted against approval of Initiative Measure No. 190 in the November 3, 2020 general election or where the local government has voted to prohibit all marijuana businesses pursuant to 16-12-301, MCA. This definition does not include a municipality that has approved or disapproved a category or categories of marijuana businesses, as authorized in 16-12-301, MCA.

(46) "Registered premises" has the same meaning as "licensed premises."

(47) "Registry" means the department's confidential record identifying registered cardholders.

(48) "Resident" means a person determined to be a resident of Montana for tax purposes, pursuant to ARM 42.15.109.

(49) "Safety data sheet (SDS)" means a summary document that provides information about the hazards of a product and advice about safety precautions written by the manufacturer or supplier of the product. An SDS must be provided by a supplier of a hazardous product at the time of sale.

(50) "Seed-to-sale tracking system" means the system provided in 16-12-105, MCA, for tracking inventory of marijuana, marijuana concentrate, and marijuana-infused products from either the seed or the seedling stage until the marijuana or marijuana product is sold to a consumer.

(51) "Standard operating procedure (SOP)" means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, or action.

(52) "Strain" means a pure breed or hybrid variety of cannabis reflecting similar or identical combinations of properties such as appearance, taste, color, smell, cannabinoid profile, and potency.

(53) "Test Batch" means a portion of a harvest or process lot that has been submitted for quality assurance testing.

(54) "THC" means delta-9 tetrahydrocannabinol.

(55) "THCA" means tetrahydrocannabinolic acid.

(56) "Topical marijuana-infused product" or "topical" means a non-ingestible marijuana-infused product that is not psychoactive when used as intended. Topicals include but are not limited to creams, salves, bath soaks, and lotions.

(57) "Total potential psychoactive THC" or "Total THC" means the highest theoretical concentration of psychoactive THC available in a marijuana item achievable only through the complete conversion of THCa to THC with the application of heat during administration/consumption. Total potential psychoactive THC is the sum of THC and THCa calculated using the following equation: Total potential psychoactive THC = (THCa x 0.877) + THC.

(58) "Transdermal marijuana-infused product" or "transdermal" means a non-ingestible marijuana-infused product that contains at least one skin-permeation-enhancing ingredient to facilitate absorption through the skin into the bloodstream, and may be psychoactive when used as intended. Transdermal products include but are not limited to adhesive patches applied to the skin.

(59) "Transmucosal marijuana-infused product" means an ingestible marijuana-infused product that is intended to be placed in a body cavity and absorbed through the mucosal lining of the cavity, and may be psychoactive when used as intended.

This rule has been repealed.

(1) Initial licensure and renewal fees for the following license types and endorsements are:

(a) Two-year marijuana transporter license: $10,000.

(b) Combined-use marijuana license: $7,500.

(d) Marijuana dispensary license: $5,000 per licensed premises.

(e) Cultivator license:

(i) $1,000 for a cultivator with a micro tier canopy license;

(ii) $2,500 for a cultivator with a tier 1 canopy license;

(iii) $5,000 for a cultivator with a tier 2 canopy license;

(iv) $7,500 for a cultivator with a tier 3 canopy license;

(v) $10,000 for a cultivator with a tier 4 canopy license;

(vi) $13,000 for a cultivator with a tier 5 canopy license;

(vii) $15,000 for a cultivator with a tier 6 canopy license;

(viii) $17,500 for a cultivator with a tier 7 canopy license;

(ix) $20,000 for a cultivator with a tier 8 canopy license;

(x) $23,000 for a cultivator with a tier 9 canopy license;

(xi) $27,000 for a cultivator with a tier 10 canopy license;

(xii) $32,000 for a cultivator with a tier 11 canopy license; and

(xiii) $37,000 for a cultivator with a tier 12 canopy license.

(f) Manufacturer license:

(i) $5,000 for each manufacturing facility that produces, on a monthly basis, less than ten pounds of concentrate;

(ii) $10,000 for each manufacturing facility that produces, on a monthly basis, between ten and 15 pounds of concentrate; and

(iii) $20,000 for each manufacturing facility that produces, on a monthly basis, 15 pounds or more of concentrate.

(g) Storage facility endorsement: $1,000 per licensed storage facility.

(h) The application fee to change location of a licensed premises: $2,500.

(2) At the time of the initial application and at renewal, an applicant shall pay the department a nonrefundable processing fee equal to 20 percent of the applicable license fee identified in (1). The department will not begin processing an application until it receives all processing fees. A licensee shall pay the department the remaining 80 percent of the license fee upon department notification of approval of its application or renewal.

(3) Initial worker permit and a renewal: $50. A replacement permit: $10.

(4) Initial registry identification card and a renewal card: $20. Replacement registry identification card: $10.

(5) Background checks: the department shall assess the applicant a fee of $30 per background check. This fee is separate from and in addition to the nonrefundable processing fee assessed in (2).

(6) Location changes: the fee for changing the location of any licensed premises is $2,500.

(1) A licensee must ensure that all employees wear a department-issued worker permit in a clearly visible manner on the outermost layer of clothing while working on behalf of the licensee. A licensee is responsible for the security of all marijuana and marijuana products on a licensed premises, during transit, and under the supervision of the licensee or its employee until the marijuana or marijuana product is sold.

(2) A licensee is responsible for ensuring the department has a current and working email address and a current and valid mailing address on file to receive department correspondence.

(3) A licensee is responsible for providing the department with its hours of operation for each licensed premises. A licensee or its employee must be on-site during hours of operation and must make the licensed premises available to department inspectors during those hours.

(4) A licensee must use a weighing device pursuant to 30-12-203, MCA, and ARM 24.351.101 whenever marijuana is:

(a) packaged for sale by weight;

(b) bought and sold by weight; and

(5) A licensee must establish and maintain and make available for department inspection at all licensed premises written emergency procedures to be followed in case of a fire, chemical spill, or other emergency.

(6) A licensee must maintain and make available for department inspection at all licensed premises the following documentation or information in a single binder, file, or other organized and readily accessible format:

(a) proof that any signage at the licensed premises complies with local jurisdiction sign ordinances and regulations;

(b) proof that licensees and employees of licensees are current on the required trainings;

(d) the written security plan required by ARM 42.39.121(1);

(e) for marijuana manufacturer licensees, the written standard operating procedures required by ARM 42.39.401(16);

(f) for marijuana cultivator licensees, the written standard operating procedures required by ARM 42.39.405(8); and

(g) for marijuana dispensary licensees, a written standard operating procedure for the destruction of returned marijuana or marijuana products.

(1) An applicant must be a resident of the State of Montana.

(2) All applications must be completed on forms provided by the department.

(3) A complete application must include the required fee, statements, and forms required in the application packet to be accepted and processed by the department. Any documents submitted electronically must be uploaded in a format that the department is able to access and view.

(4) The registry identification card expires one year from the date of issuance unless the physician statement provides a written certification for a shorter period of time.

(5) A physician statement must be dated within 60 days of the application date. The department shall deny an application submitted with a physician statement dated more than 60 days from the application date.

(6) Any denial under this part is subject to a contested case hearing before the department's Office of Dispute Resolution, as provided for under ARM 42.2.621.

(7) A registered cardholder who submits a renewal application less than 30 days prior to the registry identification card's expiration date assumes the risk and possibility of the card expiring until the department processes and approves the renewal application.

(8) A custodial parent or legal guardian may submit an application for a minor under 16-12-508, MCA.

(1) An applicant must be a resident of the State of Montana.

(2) All applications must be completed on forms provided by the department.

(3) Licenses expire one year from the date of issuance, except for marijuana transporter licenses which expire two years from the date of issuance.

(4) Renewal applications must be submitted at least 60 days prior to the expiration date of the license.

(5) The department will approve or deny a new application within 120 days of receiving a complete application and will approve or deny a renewal application within 60 days of receiving a complete application. An application is considered complete when the applicant or licensee, as applicable, has provided all statements, forms, diagrams, operation plans, and other applicable documents required in the application and has paid the nonrefundable processing fee pursuant to ARM 42.39.104(2) and has paid the remaining balance of the license fee upon notification by the department of its pending approval.

(6) If a renewal application is received less than 60 days prior to license expiration, the department will process the application, but the licensee assumes the risk and possibility of having to suspend operations until the department processes and approves the renewal application.

(7) Prior to approving an application, the department may contact any applicant or individual listed on the application and request additional supporting documentation or information.

(8) Prior to issuing a license or endorsement, the department will inspect the proposed premises to determine if the applicant complies with the marijuana laws.

(9) If a licensee fails to submit a renewal application prior to the license or endorsement expiration date, the licensee may not continue to operate.

(10) The department will not consider a renewal application received after the license or endorsement expiration date, in which case the license will lapse.

(11) The department will not amend or extend a license's expiration date unless the licensee can demonstrate that its failure to timely submit a renewal application was due to circumstances beyond its control.

(12) A licensee may not operate until on or after the effective date of the license.

(13) Any denial under these rules is subject to a contested case hearing before the department's Office of Dispute Resolution, as provided for under ARM 42.2.621.

This rule has been repealed.

(1) A fingerprint background check by the Montana Department of Justice and Federal Bureau of Investigation is required for the following:

(a) all individuals listed on the application; and

(b) a parent or guardian of a minor serving as the minor's provider.

(2) Two fingerprint cards must be completed by a trained individual within a certified fingerprinting agency and submitted to the department.

(3) Results of background checks must be received prior to approval of any application.

This rule has been repealed.

(1) A marijuana worker permit is required for any individual age 18 and over who performs work for or on behalf of any aspect of a marijuana business or testing laboratory.

(2) An applicant applying to work in a marijuana testing laboratory must undergo a criminal background check and pay the background check fee provided in ARM 42.39.104 before the department will begin processing the application.

(3) Applicants must pay the fee provided in ARM 42.39.104 within ten days of applying. Failure to pay the fee within the 10-day period will result in denial of the application.

(4) When an application is denied for any reason, an applicant must reapply and resubmit the fee provided in ARM 42.39.104.

(1) The department, after written notice to the applicant or registered cardholder, may deny or revoke an application or registry identification card if:

(a) the applicant did not provide the information required in the application;

(b) the department determines the information provided in the application was inaccurate, misleading, or falsified;

(d) the applicant or registered cardholder does not have or no longer has a debilitating medical condition as defined in 16-12-102, MCA;

(e) the applicant is not a resident of the State of Montana;

(f) the applicant is in the custody of or under supervision of the Department of Corrections or youth court

(g) the applicant or registered cardholder is found to be in violation of 16-12-523, MCA;

(h) the applicant or registered cardholder did not report changes to the department in accordance with ARM 42.39.311;

(i) the registry identification card has been found to be altered or manipulated in any way;

(j) the cardholder violates the daily or monthly purchase limitations contained in 16-12-515, MCA; or

(k) the registered cardholder is found to be in violation of any provision under Title 16, chapter 12, part 5, MCA.

(2) Any denial or revocation under this part is subject to a contested case hearing before the department's Office of Dispute Resolution, as provided under ARM 42.2.621.

(1) A registered cardholder may submit a petition for an increase in the monthly purchase limits defined in 16-12-515, MCA, on a form approved by the department and submitted through the licensing system.

(a) The department may take prior sales history and other factors deemed relevant into account when evaluating a petition for an increase in sales limits.

(b) The department may approve increases to the monthly purchase limits up to a maximum of 8 ounces of usable marijuana or the equivalent in marijuana products as described in (2).

(2) Usable marijuana may be in the form of flower or marijuana products. The following conversion shall be used to determine the allowable amounts of non-flower marijuana:

(a) 1 ounce of marijuana flower is equal to:

(i) 800 mg of THC in marijuana products including edibles; or

(ii) 8 grams or 8 mL of marijuana concentrate.

(b) A customer may purchase or possess any combination of marijuana flower or marijuana products if the total calculated conversion is equal to or less than the legal purchase or possession amount.

This rule has been repealed.

(1) All licensees must have a written, proactive security plan maintained on the licensed premises that safeguards against theft, diversion, or tampering of marijuana or marijuana products both on the licensed premises and during transit, if applicable. The security plan must, at a minimum, contain the following policies or procedures of how a licensee:

(a) restricts access to the areas of the licensed premises containing marijuana or marijuana products to authorized persons only;

(b) provides for identification of authorized persons to be in the areas of the marijuana business that contain marijuana or marijuana products; and

(2) A licensed premises must have only one single secure entrance to the building or licensed premises for public ingress and egress.

(3) A licensed premises must have a security alarm system on all perimeter entry points and perimeter windows, as applicable.

(4) A licensed premises must have a video monitoring system with cameras that:

(a) have a minimum digital resolution of 640 x 470 pixels or pixel equivalent for analog;

(b) record continuously twenty-four hours per day, or on a motion-sensor system, at a minimum of ten frames per second;

(d) are placed to record all entrances and exits to an indoor facility from both indoor and outdoor vantage points.

(5) The video monitoring system described in (4) must also:

(a) keep all recordings for a minimum of 60 days; and

(b) record images with clear and accurate date and time display.

(6) All monitoring system videos are subject to inspection by the department and must be copied and provided to the department upon request.

(7) Sections (3) through (6) will not be required until April 1, 2022.

(1) A marijuana business licensee must conspicuously display and make available its site identification certificate at each licensed premises.

(2) All marijuana business licensees, except for marijuana dispensaries, must conspicuously post a notice at each entry to a licensed premises that contains all of the following: "Persons under twenty-one years of age not permitted on these premises without a valid worker permit."

(3) All marijuana dispensaries must conspicuously post a notice or notices at each entry to the licensed premises that contains all of the following language:

(a) "Persons under twenty-one years of age not permitted on these premises without a valid registry identification card or valid worker permit. Registered cardholders under the age of 18 must be accompanied by a legal guardian."

(b) "No on-site consumption of marijuana or marijuana products." and

(4) A marijuana business licensee that is not permitted to sell marijuana or marijuana products to adult use consumers, or a marijuana business licensee that elects not to sell marijuana or marijuana products to adult use consumers, must conspicuously post a notice at the entry to the licensed premises visible from outside that contains all of the following language: "This dispensary is licensed for medical marijuana sales only. No sales will be permitted without a valid registry identification card."

(1) A licensee may promote its business and market its brand but may not advertise marijuana or marijuana products except in electronic advertising.

(2) "Advertise or advertising" means the publication, dissemination, solicitation, or circulation of visual, oral, or written communication to directly induce any person to purchase or consume marijuana or marijuana products. Advertising includes the promotion of special pricing, sales, or discounts on marijuana and marijuana products. Advertising does not include branding, marketing, or packaging and labeling of marijuana and marijuana products or information regarding special pricing, sales, or discounts on display within a licensed premises.

(3) "Billboard" means a sign that directs attention to a business, commodity, service, entertainment, or attraction sold, offered, or existing elsewhere than upon the same premises where such sign is displayed.

(4) "Brand" or "branding" means creating a unique identity for a business to target an audience or consumers. Branding does not include references to specific marijuana or marijuana products.

(5) "Market" or "marketing" means an action a business uses to promote their brand, location, or services. Marketing does not include references to specific marijuana or marijuana products.

(6) A licensee may use the phrase "marijuana" or "cannabis" in its signage or in its electronic advertising.

(7) A licensee's outdoor signage may not use colloquial terms for marijuana or marijuana products (e.g., pot, reefer, weed) and may not use an image or visual representation of useable marijuana, marijuana-infused products, marijuana concentrates, marijuana paraphernalia, or an image that indicates the presence of a product such as smoke, edibles, etc.

(8) A licensee's outdoor signage must comply with any applicable local jurisdiction sign ordinances and regulations.

(9) A marijuana business that maintains a webpage must utilize appropriate measures to verify that individuals visiting the webpage are 21 years of age or older.

(10) Marijuana business social media accounts that advertise marijuana or marijuana products must be private and must contain a clearly visible notice on the main page stating that only persons 21 years of age or older may follow the account. A marijuana business that uses a QR code in an electronic advertisement must utilize appropriate measures to verify that individuals visiting the QR code's webpage are 21 years of age or older.

(11) A marijuana business may not:

(a) engage in advertising via marketing directed towards location-based devices, including, but not limited to cellular phones, unless users affirmatively opt in to receiving push notifications related to marijuana or marijuana-related products;

(b) utilize unsolicited pop-up or push-to advertising on the internet;

(d) engage in advertising or utilize signage that asserts its products are safe;

(e) utilize a billboard;

(f) use objects such as toys or inflatables, movie or cartoon characters, or any other depiction or image likely to be appealing to youth, where the objects, images, or depictions indicate an intent to cause youth to become interested in the purchase or consumption of marijuana products; or

(g) use or employ a commercial mascot outside of, and in proximity to, a licensed marijuana business. A "commercial mascot" means a live human being, animal, or mechanical device used for attracting the attention of motorists and passersby so as to make them aware of marijuana products or the presence of a marijuana business. Commercial mascots include, but are not limited to, inflatable tube displays, persons in costume, or wearing, holding, or spinning a sign with a marijuana-related commercial message or image, where the intent is to draw attention to a marijuana business or its products.

(12) The prohibition in (11)(c) does not prohibit the use of informational pamphlets for dissemination at marijuana trade conferences or the use or distribution of business cards. Nothing in this rule shall be construed to allow the sale of marijuana or marijuana products outside of a licensed premises, including at tradeshows.

(13) The prohibition in (11)(d) does not prohibit a marijuana business from asserting that its products have been tested by a licensed marijuana testing laboratory.

(1) In order to apply the provisions of 16-12-207(3), MCA, to a cultivator licensee, manufacturer licensee, adult-use dispensary licensee, or medical marijuana dispensary licensee, the department must find:

(a) the entrance doors of the premises proposed for licensing and the entrance doors of the place of worship or school are situated on the same street; and

(b) the physical address of the premises proposed for licensing is designated as the same street as the physical address of the place of worship or school; and

(c) the distance, measured in a straight line from the entrance doors of the business proposed for licensing, and the entrance doors of the place of worship or school is 500 feet or less.

(2) If the three-part test in (1) is not met in its entirety, the provisions of 16-12-207, MCA, do not apply.

(3) The distance between entrance doors is measured by a geometric straight line, regardless of intervening property and buildings. An entrance is considered to be a means of ingress to the premises generally used by the public. This does not include egress-only doors, delivery, or service entrances.

(4) In the event that a county or city government should enact an ordinance or resolution supplanting the provisions of 16-12-207, MCA, the restriction shall not apply.

(5) A conformed copy of such supplanting ordinance or resolution must be submitted to the department by an applicant or a licensee, in the case where a local government adopts an ordinance or resolution regarding the premises location after the department approves the premises.

This rule has been repealed.

(1) A licensee must have a department seed-to-sale tracking system account activated and functional prior to operating or exercising any privileges of the license and must maintain an active account while licensed.

(2) Additional licensees or licensee employees may be authorized to obtain seed-to-sale tracking system user accounts.

(3) To obtain and maintain a seed-to-sale tracking system user account, a licensee or licensee employee must successfully complete all required department seed-to-sale tracking system training.

(4) An individual entering data into the seed-to-sale tracking system may only use that individual's seed-to-sale tracking system account.

(5) A licensee must ensure:

(a) all seed-to-sale tracking system users are up to date on seed-to-sale tracking system user training requirements; and

(b) any data that is entered into the seed-to-sale tracking system in error is corrected.

(6) A licensee and any designated seed-to-sale tracking system user must enter data into the seed-to-sale tracking system that accounts for all seed-to-sale tracking activities.

(7) A licensee is accountable for all actions seed-to-sale tracking system users take while logged into the seed-to-sale tracking system.

(8) A licensee is responsible for the accuracy of all information entered into the seed-to-sale tracking system.

(9) Nothing in this rule prohibits a licensee from using secondary separate software applications to collect information to be used by the business, including secondary inventory tracking or point-of-sale systems.

(10) If a licensee uses a separate software application that links to the seed-to-sale tracking system it must get approval from the seed-to-sale tracking system vendor contracting with the department and the software application must:

(a) accurately transfer all relevant inventory tracking system data to and from the seed-to-sale tracking system; and

(b) preserve original seed-to-sale tracking system data when transferred to and from a secondary application.

(11) If a licensee loses access to the seed-to-sale tracking system due to a power outage or other connectivity issue, the licensee must keep and maintain comprehensive records detailing all seed-to-sale inventory activities that were conducted during the loss of access.

(12) Once access is restored, all seed-to-sale tracking activities that occurred during the loss of access must be entered into the seed-to-sale tracking system.

(13) A licensee must document when access to the seed-to-sale tracking system was lost and when it was restored.

(14) All compliance notifications from the seed-to-sale tracking system must be resolved in a timely fashion.

(1) A licensee must use the department's seed-to-sale tracking system as the primary inventory and record keeping system.

(2) Each individual marijuana plant that reaches a height of twelve inches must be issued a unique identification number in the seed-to-sale tracking system, which follows the plant through all phases of production and final sale to a customer.

(3) All marijuana items, test batches, harvest lots, and process lots must be issued a unique identification number in the seed-to-sale tracking system.

(4) Unique identification numbers cannot be reused.

(5) Each marijuana plant, marijuana item, test batch, harvest lot, and process lot that has been issued a unique identification number must have a physical tag placed on it with the unique identification number.

(6) The tag must be legible and placed in a position that can be clearly read and must be kept free from dirt and debris.

(7) Licensees must use unique identification tags purchased from the seed-to-sale tracking system vendor.

(8) All on-premises and in-transit marijuana item inventories must be reconciled in the seed-to-sale tracking system at the close of business each day.

(9) For each marijuana sale or transfer to a registered cardholder, the licensee or its employee must verify the registered cardholder's eligibility and daily and monthly purchase limits and record in the seed-to-sale tracking system at the time of sale or transfer:

(a) the quantity of each item sold or transferred to a registered cardholder;

(b) the price before tax; and

(10) Licensees must record in the seed-to-sale tracking system:

(a) wet weight of all harvested marijuana plants immediately after harvest;

(b) information for marijuana items by unit count;

(d) weight and disposal of post-harvest waste materials, per the requirements described in ARM 42.39.310;

(e) theft or loss of marijuana items; and

(f) other information as may be required by the department.

(11) These requirements do not apply to marijuana items held by a laboratory licensee that are undergoing analytical testing, so long as the marijuana items do not leave the laboratory's licensed premises and are reconciled on the same day that the quality assurance testing concludes.

(12) All samples taken for quality assurance testing must be recorded in the seed-to-sale tracking system.

(13) Licensed testing laboratories must record all testing results in the seed-to-sale tracking system.

This rule has been repealed.

(1)�A licensee must store, manage, and dispose of solid and liquid waste generated during marijuana production and processing in accordance with applicable state and local laws and regulations.�

(2)�A licensee must store marijuana waste in a secured waste receptacle in the possession of and under the control of the licensee.

(3)�Waste that must be rendered unusable prior to disposal includes:

(a)�marijuana plant waste, including roots, stalks, leaves, and stems that have not been processed with solvent;

(b)�waste solvents used in the marijuana process;

(c)�spent solvents, laboratory waste, and excess marijuana from any quality assurance testing; and

(d)�marijuana items that ultimately fail to meet testing requirements.

(4)�The allowable method to render a marijuana item unusable is by grinding (for solids) and incorporating or absorbing (for liquids) the marijuana item with other ground materials so the resulting mixture is undesirable, unrecognizable, unfit for human use, and incapable of growth or germination.�For whole marijuana plants, the resulting mixture must be at least 50 percent nonmarijuana waste by volume.

(5)�For purposes of this rule, "use" includes, but is not limited to, ingestion, inhalation, topical application, processing, or remediation.

(6)�Nonhazardous marijuana waste shall be disposed of as follows:

�

Marijuana Item	Destruction Method	Disposal Method
Marijuana plants	Mix with yard debris, wood chips, sawdust, soil, manure, vegetable-based grease or oils, other wastes	Compost or anaerobic digester, if available, off site
Usable marijuana	Mix with yard debris, wood chips, sawdust, soil, manure, vegetable-based grease or oils, other wastes	Landfill, transfer station, or incinerator, if composing not available or feasible
Liquid concentrate, extracts, or infused products	Absorb in cat litter, slack lime, soil, or similar substance	Landfill, transfer station, or incinerator
Solid concentrate, extracts, or infused products	Mix with soil, slack lime, garbage, or similar substance	Landfill, transfer station, or incinerator

�

(7)�Marijuana testing laboratories, marijuana manufacturers, and other licensees that generate hazardous waste shall follow all applicable rules and regulations for the disposal of hazardous waste, including ARM 17.53.105 and 17.53.113.�Licensees need to contact the Department of Environmental Quality Hazardous Waste Program for assistance.

(8)�A licensee must maintain accurate and comprehensive records regarding waste material in the seed-to-sale tracking system that accounts for, reconciles, and evidences all waste activity related to the disposal of marijuana to include:

(a)�what was disposed;

(b)�quantity by weight or volume;

(c)�date disposed;

(d)�video evidence of disposal to be retained for 30 days; and

(e)�reason for the disposal.

(9)�A licensee must provide a minimum of 72 hours' notice in the seed-to-sale tracking system prior to rendering the marijuana item unusable and disposing of it.

(10) �After the expiration of the 72-hour period in (9), a licensee may dispose of marijuana waste other than usable marijuana as defined in 16-12-102, MCA,�without rendering�it unusable pursuant to (3) by releasing it to a third-party contractor to render it unusable.�A licensee must provide the department with a copy of the waste removal agreement with the third-party contractor before commencing services and must maintain the contract in the binder of documents required by ARM 42.39.105(6).�The third-party contractor may process marijuana stalks and stems into non-marijuana products or otherwise render the marijuana stalks and stems unusable.

�

(1) A registered cardholder must notify the department within ten days of any changes in the following:

(a) cardholder's name or address;

(b) referral physician; or

(2) A registered cardholder must report to the department within ten calendar days any lost or stolen registry identification card.

(3) A licensee must notify the department within ten days of any changes in the following:

(a) anyone identified as an applicant or controlling beneficial owner or anyone with a financial interest in the license;

(b) its standard operating hours;

(d) permanent closure of the business.

(4) A licensee who wishes to change the location of a licensed premises must submit a completed application for the new premises including all required forms, documents, and fees.

(5) A licensee who intends to make any material or substantial changes to the licensed premises must submit the changes to the department for approval prior to making any such changes. Material or substantial changes include:

(a) any increase or decrease in the total physical size or capacity of the licensed premises;

(b) alterations to public ingress or egress of limited access areas;

(6) A licensee must notify the department as soon as reasonably practical but in no case more than 24 hours following the theft of marijuana items or money from the licensed premises.

(1) For purposes of this rule, the following definitions apply:

(a) "affected licensee" means a licensee whose marijuana or marijuana products are subject to a recall. More than one licensee may be an affected licensee in a recall;

(b) "affected product" means marijuana or a marijuana product subject to a recall.

(2) A recall is required when marijuana or marijuana products pose a risk to public health and safety. A recall shall be based on evidence that marijuana or a marijuana product is contaminated or otherwise unfit for human use, consumption, or application.

(3) A licensee must develop a recall plan that establishes the procedures the licensee will follow in the event of a recall of its product or products. A recall plan must, at a minimum:

(a) designate a member of the licensee's staff who serves as the licensee's recall coordinator;

(b) establish procedures for identifying and isolating product to prevent or minimize its distribution to customers;

(d) establish a communications plan to notify those affected by the recall, including:

(i) how the affected licensee will notify registered cardholders and other licensees in possession of affected product; and

(ii) the use of a press release and other appropriate notifications to ensure customers are notified of the recall and affected product information.

(4) If the department or the Department of Public Health and Human Services determines that a recall is required, an affected licensee shall:

(a) immediately notify registered cardholders and other licensees that received the affected product;

(b) immediately issue a press release or other appropriate public notification to inform customers of the recall and identifying information about the affected product recalled;

(d) post on its website, if applicable, information about the recall and the affected product; and

(e) perform a causation analysis to determine the issue or issues leading to the recall and provide to the department a corrective action report and preventative action report, as both are defined by the Department of Public Health and Human Services, which details how the affected licensee plans to correct and prevent future recalls.

(5) An affected licensee must coordinate with the department for destruction of the affected product and allow the department to oversee the destruction.

(6) An affected licensee must track the total amount of affected product and the amount of affected product returned to the affected licensee as part of the recall effort. The affected licensee must periodically report to the department on the progress of the recall efforts.

(7) If an affected licensee determines that a recall is required, it must immediately notify the department. The affected licensee must then follow the procedures established in (4) through (6).

(8) If the department determines that a recall is successful, and the risk to public health and safety is no longer present, the department shall notify the affected licensee and close the recall.

(9) The department shall maintain a marijuana recall page on its website of all current recalls.

This rule has been repealed.

(1) Labeling requirements apply to marijuana and marijuana products sold from a dispensary to customers and wholesale products intended for final sale to customers from one licensee to another.

(2) All information required on the label of marijuana or a marijuana product shall be:

(a) unobstructed and conspicuous. A licensee may affix multiple labels to a package, or use a booklet, accordion, or other type of label, provided that no required information is completely and permanently obstructed;

(b) displayed in a legible font, such as Times New Roman, Arial, or Helvetica. The lowercase letter "o" must be at least one-sixteenth of an inch in height;

(d) displayed in English, although a licensee may choose to display required information in additional languages.

(3) All marijuana or marijuana products shall be labeled with the following information:

(a) the strain name, except when the marijuana or marijuana product contains a mixed strain, then indicate mixed strain;

(b) the common or usual name of the marijuana product (e.g., flower, inhaled extract, edible, cookie, or drinkable, topical, transdermal patch);

(c) the unique identification number generated from the seed-to-sale tracking system correlated to the marijuana or marijuana product's final form testing results;

(d) date of harvest for marijuana flower or date of manufacture for marijuana products;

(e) the net quantity of contents of the marijuana product. The statement of quantity shall be:

(i) stated in U.S. Customary Units and Metric (SI) Units, with the latter enclosed in parentheses;

(ii) if the product is a liquid:

(A) expressed in terms of fluid measure; and

(B) preceded by the phrase "Net Contents" or "Net"; or

(iii) if the product is a solid, semi-solid, or viscous:

(A) expressed in terms of weight; and

(B) preceded by the phrase "Net Weight," the abbreviation "Nt. Wt.," or "Net."

(iv) In addition to weight or fluid measure, a licensee shall include the number of servings in the net quantity of contents statement if the product is a multi-serving marijuana product (e.g., Net Weight: 2 oz. (56.7 g) (10 cookies), Net Contents: 2 fl. oz. (2 mL or milliliters));

(f) the following statement: "This product has been tested and meets the requirements of the state of Montana."

(g) a QR code that links to the product's certificate of analysis with a statement informing customers they can scan the code to see additional product information;

(h) the universal symbol, available from the department's website. The universal symbol may be a sticker if the sticker meets the requirements of this section. The universal symbol:

(i) shall be at least .33 inches wide and .33 inches high;

(ii) may be downloaded from the department's website;

(iii) may not be colored by hand and/or using a highlighter, marker, etc.; and

(iv) shall be in the following form:

A yellow triangle with a black background

Description automatically generated with low confidence

(4) All marijuana and marijuana products shall be labeled verbatim with the following warnings:

(a) "Keep out of reach of children and pets";

(b) "This product may be addictive"; and

(5) Marijuana or marijuana product labeling shall not contain any statement or information that is false or misleading.

(6) The label of manufactured marijuana products must identify the method of manufacturing (e.g., mechanical, chemical) and for chemical manufacturing must identify the solvent(s) used in the manufacturing process.

(7) Marijuana or marijuana products that, because of their size, do not have sufficient space for all of the information required for compliance with the Act and department rules may, if approved by the department pursuant to 16-12-208, MCA, display the information required in (3) in a legible font that does not meet the minimum size requirement established in (2)(b).

(8) Marijuana or marijuana products in excess of the THC limits in 16-12-224, MCA, may only be sold to registered cardholders and must contain the following additional information verbatim:

(a) "For medical use only"; and

(b) "This product is not approved by the U.S. Food and Drug Administration to treat, cure, or prevent any disease."

(9) Marijuana or marijuana products that do not require heat to administer or consume shall not have a total THC or total potential psychoactive THC value listed on the marijuana facts panel.

(1) For purposes of this rule and ARM 42.39.318, "flower" includes marijuana pre-rolls, but excludes infused marijuana pre-rolls.

(2) In addition to the general labeling requirements set forth in ARM 42.39.314, each package of marijuana flower sold to a customer shall be labeled with a marijuana facts panel.

(3) A marijuana facts panel shall include the percentage of concentration of:

(a) total potential psychoactive THC;

(b) THC;

(d) CBD; and

(e) CBDa.

(4) A marijuana facts panel may include the percentage concentration of each additional marketed cannabinoid or terpene, if applicable.

(1) In addition to the general labeling requirements set forth in ARM 42.39.314, each package of ingestible marijuana-infused product sold to a customer shall be labeled with the following information:

(a) an ingredients list that shall include all ingredients in the ingestible marijuana-infused product listed by common or usual name in descending order of predominance by weight and the word "marijuana" followed by the part of the plant (e.g., flower, trim) or form of concentrate (e.g., oil, infused butter) used as an ingredient in the manufacturing process. Any substance that is present in an ingestible marijuana-infused product in an insignificant amount and that does not have any technical or functional effect in the finished product may be excluded from the ingredients list;

(b) an allergen statement that must declare the presence of major food allergens in plain language;

(i) the actual milligrams per serving size or dose of:

(A) THC;

(B) THCa;

(D) CBDa;

(ii) the number of servings or doses per package; and

(iii) for multi-serving packages, the total actual milligrams per package of:

(A) THC;

(B) THCa;

(D) CBDa;

(d) in addition to the required warnings in ARM 42.39.314, each package of ingestible marijuana-infused product sold to a customer shall be labeled with the following information: "The intoxicating effects of this product may be delayed by two or more hours."

(2) A marijuana facts panel for ingestible marijuana-infused products may not contain information on the total potential psychoactive THC, total THC, or otherwise mislead customers into believing the product has higher THC levels than it does.

(3) A marijuana facts panel may include the milligrams of each additional marketed cannabinoid and terpene per serving size, dose, or package.

(1) In addition to the general labeling requirements set forth in ARM 42.39.314, each packaging of non-ingestible marijuana-infused products shall be labeled with the following information:

(a) an ingredients list that shall include all ingredients in the non-ingestible marijuana-infused product listed by common or usual name in descending order of predominance by weight and the word "marijuana" followed by the part of the plant (e.g., flower, trim) or form of concentrate (e.g., oil, infused butter) used as an ingredient in the manufacturing process. Any substance that is present in a non-ingestible marijuana-infused product in an insignificant amount and that does not have any technical or functional effect in the finished product may be excluded from the ingredients list;

(b) an allergen statement that must declare the presence of major food allergens in plain language; and

(i) the milligrams per application size or dose of:

(A) THC;

(B) THCa;

(D) CBDa;

(ii) the number of applications or doses per package; and

(iii) for multi-dose packages, the total milligrams per package of:

(A) THC;

(B) THCa;

(D) CBDa.

(2) A marijuana facts panel for non-ingestible marijuana-infused products may not contain information on the total potential psychoactive THC, total THC, or otherwise mislead customers into believing the product has higher THC levels than it does.

(3) A marijuana facts panel may include information about each additional marketed cannabinoid and terpene expressed in terms of milligrams per serving size, dose, or package.

(1) In addition to the general labeling requirements set forth in ARM 42.39.314, each package of marijuana concentrate, including infused marijuana pre-rolls, sold to a customer shall be labeled with the following information:

(a) an ingredients list that shall include all ingredients in the marijuana concentrate listed by common or usual name in descending order of predominance by weight and the word "marijuana" followed by the part of the plant (e.g., flower, trim) from which the marijuana concentrate is derived. Any substance that is present in a marijuana concentrate in an insignificant amount and that does not have any technical or functional effect in the finished product may be excluded from the ingredients list;

(b) an allergen statement that declares the presence of major food allergens in plain language unless the marijuana concentrate is not intended to be cooked with, eaten, or otherwise swallowed and digested;

(i) for marijuana concentrates that require the application of heat before they are administered or consumed:

(A) the percentage concentration of:

(I) total potential psychoactive THC;

(II) THC;

(III) THCa;

(IV) CBD; and

(V) CBDa;

(ii) for marijuana concentrates that do not require the application of heat before they are administered or consumed:

(A) the percentage concentration of:

(I) THC;

(II) THCa;

(III) CBD; and

(IV) CBDa; or

(B) the milligrams per serving size or dose of:

(I) THC;

(II) THCa;

(III) CBD; and

(IV) CBDa; and

(d) in addition to the required warnings in ARM 42.39.314, each package of activated concentrate that is intended to be cooked with, eaten, or otherwise swallowed and digested shall be labeled with the following: "The intoxicating effects of this product may be delayed by two or more hours."

(2) A marijuana facts panel for marijuana concentrates that do not require the application of heat to be administered or consumed may not contain information on the total potential psychoactive THC, total THC, or otherwise mislead customers into believing the product has higher THC levels than it does.

(3) A marijuana facts panel may include information about each additional marketed cannabinoid and terpene, expressed in percentage of concentration by weight or by volume or in milligrams.

(1) All packaging of marijuana and marijuana products shall:

(a) protect the product from contamination and shall not impart any toxic or deleterious substance to the marijuana or marijuana product;

(b) be capable of being resealed if the package contains more than one serving size;

(c) not primarily appeal to children. Packaging that primarily appeals to children includes but is not limited to packaging that:

(i) depicts a child;

(ii) portrays objects, images, celebrities, or cartoon figures that primarily appeal to children or are commonly used to market products to children; or

(iii) otherwise has special attractiveness for children beyond the general attractiveness for adults;

(d) not bear any reasonable resemblance to the trademarked or characteristic packaging of any commercially available product including but not limited to candy, snacks, baked goods, or beverages.

(2) All marijuana and marijuana products provided to customers at the point of sale shall be in exit packaging that:

(a) is child resistant as defined in ARM 42.39.102;

(b) is opaque; and

(3) Drinkable marijuana products that contain more than one serving per package must include a device or mechanism for measuring a single serving of the product.

(4) Exit packaging of marijuana and marijuana products provided to customers at the point of sale may not contain any other information or design elements than what is allowed under 16-12-208(6)(b)(ii), MCA.

(1) For purposes of this rule, "marijuana product categories" mean any of the marijuana and marijuana products described in ARM 42.39.315 through 42.39.318 that are subject to the packaging and labeling requirements of 16-12-208, MCA.

(2) For purposes of this rule, a "unique marijuana product package" means a custom package that contains variations in graphic or design elements including logos. For example, boxes used for pre-rolls with a graphic for "Grape Ape" and a different graphic for "Cherry Pie" are unique marijuana product packages.

(3) A unique marijuana product package does not mean a package with variations in language, such as product information or instructions, or a package that depicts flavor variation without an accompanying change in graphic or design, or a different size, shape, or color. For example, mylar bags used for marijuana flower with different colors for indica, sativa, or hybrid used in various sizes are not unique marijuana product packages.

(4) For purposes of this rule "generic package" or "generic packaging" means packaging without any graphic or design elements, including logo, whether preprinted on the package or affixed later with an adhesive, sticker, or by other means.

(5) All applicants, whether as an initial license applicant or existing licensee, must apply to the department for approval of the labeling of each marijuana product category intended for sale to customers.

(6) An applicant must submit a separate application for each label - up to a maximum of nine total label applications - based on the applicant's sale of some or all of the following marijuana or marijuana product categories:

(a) seeds/plants;

(b) adult-use flower;

(d) adult-use ingestible marijuana-infused products;

(e) medical ingestible marijuana-infused products;

(f) adult-use non-ingestible marijuana-infused products;

(g) medical non-ingestible marijuana-infused products;

(h) adult-use marijuana concentrates and extracts; and

(i) medical marijuana concentrates and extracts.

(7) An applicant will be given the following labeling options for the product categories listed in (6):

(a) selecting and affirming its use of a pre-approved template label available for download from the department, at no cost to the applicant, as provided in (16); or

(b) use of a custom label design and pay the custom label application fee, as provided in (16).

(8) An applicant that elects to use its custom (i.e., non-department template) label design must submit only one template label for each marijuana product category.

(9) Except as provided in (10), a new label application is not required when the marijuana facts panel information changes for disclosures such as levels of total potential psychoactive THC, THC, THCa, CBD, or CBDa, date of harvest, strain name, or ingredients.

(10) An applicant that sells marijuana products to registered cardholders with THC levels in excess of the limits set in 16-12-224, MCA, must submit a separate application and label template for each of the marijuana product categories sold.

(11) All applicants, whether as an initial license applicant or existing licensee, must submit an application to the department for approval for the packaging of each marijuana product category intended for sale to customers.

(12) An applicant will be given the following packaging options for the product categories listed in (6):

(a) selecting and affirming its use of generic packaging. The applicant shall identify on the application which marijuana or marijuana products will be placed in generic packaging; or

(b) use of custom packaging with graphic or design elements, including logo, whether preprinted on the package or affixed with an adhesive, a sticker, or by other means. In this case, the applicant must provide a picture or accurate, detailed rendering of the packaging. Further, the applicant shall identify on the application which marijuana or marijuana products will be placed in each unique marijuana product package.

(13) All applicants, whether as an initial license applicant or existing licensee, must submit an application to the department for approval for each exit package type it will use. If the applicant intends to use the same exit package type in multiple sizes, it may submit each size under one application.

(a) Exit packaging must comply with ARM 42.39.319(2).

(b) Exit packaging must comply with federal child-resistant packaging standards pursuant to 16-12-208(6), MCA.

(14) All applications and required attachments, such as photographs and renderings shall be submitted electronically to the department via its online portal.

(15) Licensees do not need to apply for package and label approvals for products purchased wholesale that have been previously approved by the department.

(16) Except as provided in (17), an applicant must submit the following fees to the department:

(a) no charge ($0.00) for label applications described in (7)(a) or packaging applications in (12)(a);

(b) $25 per label application described in (7)(b) for custom label design;

(d) $10 per exit package application.

(17) Wholesale label applicants must submit the following fees to the department:

(a) no charge ($0.00) for label applications described in (7)(a) or packaging applications in (12)(a);

(b) $25 per label application described in (7)(b) for custom label design; and

(18) The department shall review each application and shall notify an applicant, in writing, whether the packaging, label, or exit package has been approved or rejected.

(19) Whenever the department returns any application for correction, it shall notify an applicant, in writing, of the deficiencies or issues with the application or submitted materials.

(20) An applicant will receive an invoice for all application fees upon the department's approval of the application(s). The applicant shall pay all invoiced application fees to the department within ten days of receipt. An applicant's failure to pay all invoiced application fees may result in the reversal of application approval and denial of the application.

(21) An applicant whose application is denied under (5) or (11) must reapply.

(22) A licensee shall be subject to disciplinary proceedings when:

(a) it affirms to the department that it is using a pre-approved department template label but then uses any other label without submitting an application, applicable fees, and receiving department approval; or

(b) it affirms to the department that it is using generic packaging, but then uses any other product packaging, with graphic or design elements, including logo, whether preprinted on the package or affixed later with an adhesive, sticker, or by other means, without submitting an application, applicable fees, and receiving department approval.

(1) For purposes of this rule and ARM 42.39.320, "wholesale" means the act of a licensed cultivator, manufacturer, or dispensary engaged in selling marijuana or marijuana products in bulk or in quantities sufficient for resale, repackaging, or distribution by another licensee. The term does not include the sale of marijuana flower from licensed cultivator to licensed cultivator.

(2) Wholesalers of marijuana or marijuana products must comply with the package and label application requirements of ARM 42.39.320.

(3) All label and package applications for wholesale marijuana and marijuana products must contain photographs or accurate renderings of proposed labels and packages.

(4) A marijuana wholesaler must apply and receive department approval to use all wholesale packaging and labels before distributing any packaged and labeled wholesale products for final sale to customers. Package and label approval is not required for wholesale products that will receive additional processing or will be repackaged and relabeled by another licensee.

(1) Each package of marijuana seeds or plants shall be labeled with the following information:

(a) name of the dispensary selling the seeds or plants and the cultivator that produced the seeds or plants;

(b) net weight or number of individual seeds or number of plants, as applicable;

(d) the universal marijuana symbol as required in ARM 42.39.314.

(1) A marijuana manufacturer license allows a marijuana manufacturer to convert or to compound marijuana into marijuana products. A marijuana manufacturer licensee may buy marijuana and marijuana products from licensed marijuana cultivators and licensed marijuana manufacturers and may sell marijuana products to licensed marijuana dispensaries.

(2) The department shall begin accepting applications for marijuana manufacturers that are not former medical marijuana licensees, as defined in 16-12-102, MCA, on July 1, 2025.

(3) Licensees will elect their tier level at their next renewal date and pay the fee provided in ARM 42.39.104.

(4) A marijuana manufacturer licensee that manufactures above its licensure level may be subject to administrative proceedings. In determining whether a marijuana manufacturer licensee has manufactured above its licensure level, the department will determine the average amount of concentrate produced each month over the previous 12 months.

(5) The licensed premises of a former medical marijuana licensee that is located in a red county is not eligible to apply to increase its licensure level until the local government approval process in 16-12-301, MCA, allows for marijuana manufacturing.

(6) A marijuana manufacturer licensee must take all reasonable measures and precautions to ensure the following:

(a) that the placement of equipment and storage of materials allow for the maintenance of sanitary operations for the manufacture of marijuana products;

(b) that all surfaces, including utensils and equipment used for the preparation of marijuana products, shall be cleaned and sanitized as frequently as is necessary to protect against contamination; and

(c) that the storage and transport of finished marijuana products shall be under conditions that will protect products against physical, chemical, and microbial contamination.

(7) A marijuana manufacturer licensee must:

(a) use equipment, counters, and surfaces for manufacturing that are food grade, do not react adversely with any solvent being used, reduce the potential for development of microbials, molds, and fungi, and can be easily cleaned;

(b) maintain detailed instructions for making each infused product, concentrate, or extract, which shall be kept confidential by the department;

(d) use only potable water and ice made from potable water; and

(e) provide hand-washing facilities designed to ensure that employee hands are not a source of contamination of marijuana-infused products, contact surfaces, or packaging materials used for marijuana-infused products.

(8) A marijuana manufacturer licensee may not use:

(a) pressurized, canned fuel intended for use in camp stoves, handheld torch devices, refillable cigarette lighters, and similar products; or

(b) denatured alcohol.

(9) A marijuana manufacturer licensee may not manufacture, process, or offer for sale a synthetic marijuana product as defined in 16-12-102, MCA.

(10) A marijuana manufacturer licensee must have current, written SOPs at the licensed premises and available for inspection for the following:

(a) each category and type of marijuana product that it produces;

(b) how all equipment, counters, and surfaces are thoroughly cleaned;

(c) proper handling and storage of any solvent, gas, or other chemical used in processing or on the licensed premises; and

(d) proper disposal of any waste produced during processing in accordance with ARM 42.39.310.

(11) A marijuana manufacturer licensee and an employee of a marijuana manufacturer licensee may only transport marijuana and marijuana products that are in the licensee's seed-to-sale tracking system inventory in accordance with 16-12-222(4), MCA, and ARM 42.39.413(3) through (16) and may not transport the marijuana or marijuana products of other licensees without a marijuana transporter license.

(1) A marijuana manufacturer licensee that applies to engage in chemical manufacturing must indicate that type of manufacturing activity on its initial license or license renewal application. There is no additional cost for a marijuana manufacturer licensee who elects a chemical manufacturing designation on its initial license or license renewal application.

(2) A marijuana manufacturer licensee that engages in chemical manufacturing must:

(a) use only hydrocarbon-based solvents that are at least 99 percent pure, except when using solvents outlined in (3)(a);

(b) only use food grade nonhydrocarbon-based solvents, such as water, vegetable glycerin, vegetable oils, or animal fats;

(d) have processing equipment approved for use by the fire code official with jurisdiction over the licensed premises;

(e) have an emergency eye-wash station in any room in which chemical manufacturing is occurring;

(f) have all applicable safety data sheets readily available at the licensed premises; and

(g) have a current, written standard operating procedure available for inspection at the licensed premises that details employee training on closed-loop extraction system operation and proper handling of solvents and gasses used in processing or stored on the licensed premises.

(3) A marijuana manufacturer licensee that engages in chemical manufacturing may use:

(a) a chemical extraction process using a nonhydrocarbon-based or other solvent, such as water, vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol, or ethanol; or

(b) a chemical extraction process using the solvent carbon dioxide, provided that the process:

(i) does not involve the use of heat over 180 degrees Fahrenheit; and

(ii) uses a professional grade closed-loop carbon dioxide gas extraction system where every vessel is rated to a minimum of 600 pounds per square inch.

(4) A marijuana manufacturer licensee that engages in chemical manufacturing may not use class 1 solvents according to the Q3 Tables and List Guidance for Industry published by the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research.

(1) A marijuana manufacturer licensee that applies to engage in marijuana-infused product manufacturing must indicate that type of manufacturing activity on its initial license or license renewal application. There is no additional cost for a marijuana manufacturer licensee who elects an infused product manufacturing designation on its initial license or license renewal application.

(2) A marijuana manufacturer licensee that engages in marijuana-infused product manufacturing must store all products that require refrigeration or freezing in a refrigerator or freezer until the time of sale and affix these foods with a label that indicates the product must be kept refrigerated or frozen, as appropriate.

(3) A marijuana manufacturer licensee that engages in marijuana-infused product manufacturing may not:

(a) utilize a branded, commercially manufactured food product (e.g., Chex Mix, Nerds Ropes) as a marijuana-infused product except when commercially manufactured food products are used as ingredients in a marijuana-infused product in a way that renders them unrecognizable as the commercial food product in the final marijuana-infused product and the licensee does not state or advertise to the consumer that the final marijuana-infused product contains the commercially manufactured food product except on the product's ingredient;

(b) infuse any food with marijuana that requires heated, time-temperature control or a hot holding unit to keep it safe for human consumption and may not serve hot or heated foods that promote onsite consumption;

(d) infuse root vegetables, including but not limited to garlic and onion, in oil.

(1) A marijuana manufacturer licensee that applies to engage in mechanical manufacturing must indicate that type of manufacturing activity on its initial license or license renewal application. There is no additional cost for a marijuana manufacturer licensee who elects a mechanical manufacturing designation on its initial license or license renewal application.

(1) A marijuana cultivator license allows a marijuana cultivator to plant, cultivate, grow, dry, package, and label marijuana and sell marijuana to licensed marijuana manufacturers, licensed dispensaries, and to other licensed marijuana cultivators, and to sell marijuana products to licensed dispensaries. Marijuana cultivator licensees may not sell marijuana flower to other marijuana cultivator licensees.

(2) The department shall begin accepting applications for marijuana cultivators that are not former medical marijuana licensees, as defined in 16-12-102, MCA, on July 1, 2025.

(3) The licensed premises of a former medical marijuana licensee that is located in a red county is not eligible to apply to increase its licensure level until the local government approval process in 16-12-301, MCA, allows for marijuana cultivation.

(4) A former medical marijuana licensee who engaged in outdoor cultivation before November 3, 2020, may continue to engage in outdoor cultivation but may not expand their existing outdoor cultivation space.

(5) For purposes of determining the appropriate canopy license tier:

(a) an existing outdoor cultivation space counts as a cultivation facility as used in (4) and its square footage counts toward the total allowable square footage under each tier;

(b) a canopy is measured horizontally starting from the outermost point of a plant on the perimeter of a dedicated growing space and continuing around the outside of all plants located within the dedicated growing space;

(c) a marijuana cultivator licensee may designate multiple canopy areas at a cultivation facility, but each canopy area must be separated by a physical boundary such as an interior wall or by at least eight feet of open space.

(6) A marijuana cultivator licensee that cultivates above its licensure level may be subject to administrative proceedings.

(7) A marijuana cultivator licensee must create and maintain a manual of written SOPs to produce marijuana. The marijuana cultivator licensee must keep the manual at the licensed premises and make it available for department inspection at all times. The manual must include, at a minimum:

(a) when and how all pesticides or other chemicals are to be applied during the production process;

(b) water usage and wastewater disposal protocols; and

(8) If a marijuana cultivator licensee makes a material change to the SOPs, it must document the change and revise the written SOPs manual accordingly.

(9) A marijuana cultivator licensee must maintain on the licensed premises:

(a) the material safety data sheet for all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana at the licensed premises; and

(b) the original label, or a copy, for all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana at the licensed premises.

(10) A marijuana cultivator licensee must maintain a log of all pesticides, fertilizers, or other agricultural chemicals used in the production of marijuana in the seed-to-sale tracking system, which must be updated monthly. The log shall be kept confidential by the department.

(11) A marijuana cultivator licensee may not cultivate hemp at a licensed premises.

(12) A marijuana cultivator licensee and an employee of a marijuana cultivator licensee may transport marijuana and marijuana products that are in the licensee's seed-to-sale tracking system inventory in accordance with 16-12-222(4), MCA, and ARM 42.39.413(3) through (16) and may not transport the marijuana or marijuana products of other licensees without a marijuana transporter license.

(1) A marijuana dispensary license allows a marijuana dispensary to sell marijuana and marijuana products to registered cardholders and to consumers 21 years of age and older and to purchase marijuana and marijuana products from licensed cultivators, licensed manufacturers, and other licensed dispensaries.

(2) The department shall begin accepting applications for marijuana dispensaries from applicants that are not former medical marijuana licensees as defined in 16-12-102, MCA, on July 1, 2025.

(3) A former medical marijuana licensee with a dispensary located in a red county may only sell to registered cardholders under its existing license until the local government approval process in 16-12-301, MCA, allows for adult use dispensaries.

(4) The fee for a marijuana dispensary license is per licensed premises and is the same regardless of whether a marijuana dispensary licensee sells only to registered cardholders or to registered cardholders and consumers.

(5) A marijuana dispensary licensee and its employees must not sell marijuana or marijuana products to any person obviously or apparently under the influence of drugs or alcohol.

(6) A marijuana dispensary licensee and its employees may sell marijuana paraphernalia to registered cardholders 18 years of age and older and to consumers 21 years of age and older.

(7) A marijuana dispensary licensee may not sell a branded, commercially manufactured food product (e.g., Chex Mix, Nerds Ropes) as a marijuana-infused product except when commercially manufactured food products are used as ingredients in a marijuana-infused product in a way that renders them unrecognizable as the commercial food product in the final marijuana-infused product and the licensee does not state or advertise to the consumer that the final marijuana-infused product contains the commercially manufactured food product except on the product's ingredient list.

(8) Marijuana dispensary customers must not handle marijuana or marijuana products outside of its packaging prior to purchase. Customers may return marijuana or marijuana products but the dispensary must destroy those products. Nothing in this rule prevents a marijuana dispensary licensee from refusing product returns.

(9) A marijuana dispensary licensee and its employees are prohibited from engaging in the unlicensed practice of medicine. A marijuana dispensary licensee and its employees must not:

(a) offer or undertake to diagnose or cure any human or animal disease, ailment, injury, infirmity, deformity, pain, or other condition, physical or mental, by use of marijuana or marijuana products or any other means or instrumentality; or

(b) recommend or suggest modification or elimination of any course of treatment that does not involve the medical use of marijuana or marijuana products.

(10) All sales of marijuana and marijuana products must be recorded in real time in the seed-to-sale tracking system.

(11) A marijuana dispensary licensee and its employees must refuse to sell marijuana or marijuana products at the medical marijuana tax rate to registered cardholders who do not possess and present a valid registry identification card or temporary registry identification card at the time of sale.

(12) A marijuana dispensary licensee and its employees must refuse to sell marijuana or marijuana products to any consumer unless the consumer possesses and presents one of the following forms of valid and unexpired photo identification showing that the consumer is 21 years of age or older:

(a) a driver's license or temporary driver's permit issued by Montana or any other state or territory of the United States, including any state or territory that has authorized digital driver's licenses;

(b) an identification card issued by Montana or any other state or territory of the United States for the purpose of proof of age of the holder of the card;

(d) a Merchant Mariner Credential or other similar document issued by the United States Coast Guard;

(e) a passport or passport card issued by, or recognized by, the United States Government or a permanent resident card issued by the United States Citizenship and Immigration Services of the Department of Homeland Security; or

(f) a tribal identification card issued by a tribal government which requires proof of the age of the holder of the card for issuance.

(13) Any cards that require refrigeration or freezing to keep them safe for human consumption must be stored in a refrigerator or freezer until the time of sale and must be affixed with a label that indicates the product must be kept refrigerated or frozen, as appropriate.

(14) A marijuana dispensary licensee and its employees cannot sell marijuana or marijuana products in excess of the THC levels provided for in 16-12-224, MCA, except to registered cardholders.

(15) A marijuana dispensary licensee that offers retail deli-style sales must maintain and make available for inspection a SOP detailing sterile handling techniques to handle marijuana flower.

(16) A marijuana dispensary licensee and an employee of a marijuana dispensary licensee may only transport marijuana and marijuana products that are in the licensee's seed-to-sale tracking system inventory in accordance with 16-12-222(4), MCA, and ARM 42.39.413(3) through (16) and may not transport marijuana or marijuana products of other licensees without a marijuana transporter license.

(17) A marijuana dispensary licensee, its employees, or a commercial third party must not deliver marijuana or marijuana products to consumers.

(18) A marijuana dispensary must not maintain or make available for sale any marijuana product that has not received a "test passed" status from a licensed marijuana testing laboratory.

(1) A marijuana transporter license allows a marijuana transporter to physically distribute and deliver marijuana and marijuana products to a licensed premises and to registered cardholders within the state of Montana that present a valid registry identification card.

(2) Applicants for a marijuana transporter license must submit to the department proof of a valid Montana driver's license.

(3) All distribution and delivery of marijuana and marijuana products must:

(a) occur in a motor vehicle as defined by ARM 42.39.102;

(b) depart from a licensed premises and be delivered to a licensed premises or to a registered cardholder's address, in which case the registered cardholder must provide a valid registry identification card to the transporter prior to the transporter completing the transport;

(c) be accompanied by a transport manifest derived from the seed-to-sale tracking system that contains the following information:

(i) the physical address and license number of the departure location;

(ii) the physical address and license number or registered cardholder number of the arrival location;

(iii) actual date and estimated time of departure;

(iv) actual date and estimated time of arrival;

(v) transporter's driver's license number, vehicle make, model, and license plate number;

(vi) name and signature of each licensee or its employee accompanying the transport; and

(vii) a complete description of the marijuana or marijuana product being transported. The description must include:

(A) the name and type of product being transported;

(B) accurate amount of product being transported verified by count or with a weighing device pursuant to 30-12-203, MCA, and ARM 24.351.101; and

(d) be accomplished within seven days from the date and time of departure.

(4) If the transport requires an overnight stay during the planned direct route to complete the transfer, the transporting licensee must:

(a) identify the stay on the transport manifest prior to transport;

(b) accept the in-transit product into the storage facility's inventory or other licensed premises; and

(5) The transporter of the marijuana or marijuana product must record in the seed-to-sale tracking system:

(a) the actual time of departure from the originating license; and

(b) the actual time of arrival at the destination.

(6) The transport manifest may not be voided or changed after leaving the departure location.

(7) A copy of the transport manifest must be given to each licensed premises receiving the inventory described in the transport manifest.

(8) A receiving licensed premises is prohibited from receiving any marijuana or marijuana products without a valid transport manifest.

(9) Upon receipt, the receiving licensed premises shall ensure that the product received is as described in the transport manifest, verified by count or with a weighing device pursuant to 30-12-203, MCA, and ARM 24.351.101. A receiving licensed premises must immediately record receipt of the transported inventory.

(10) The receiving licensed premises must document any differences between the items described for transport in the transport manifest versus what was actually received and immediately report discrepancies to the department.

(11) While in transport, all marijuana and marijuana products must be shielded from public view and secured in a locked storage compartment inside the body of the transport vehicle.

(12) All vehicles used to transport marijuana or marijuana products:

(a) shall be considered a licensed premises for purposes of inspection by the department. Transport vehicles may be stopped and inspected by the department at any licensed premises or during transport;

(b) shall be lockable and equipped with a security alarm system;

(d) shall not have any external markings, words, or symbols that indicate the vehicle is used for the transport of marijuana or marijuana products or that it is owned or leased by a marijuana business.

(13) A marijuana transporter licensee or employee of a marijuana transporter licensee must not sell marijuana or marijuana products; or transport marijuana or marijuana products directly to consumers.

(14) A marijuana transport licensee must contact the department within 24 hours if a vehicle transporting marijuana items is involved in an accident that involves product loss.

(15) Copies of the transport manifest and delivery receipts must be presented to law enforcement officers or authorized department employees, if requested.

(16) If a marijuana transporter licensee maintains a licensed premises to temporarily store marijuana or marijuana products, the licensee must have a marijuana storage facility endorsement for each storage facility as provided in ARM 42.39.420.

(1) A combined use license allows a federally recognized tribe located in the state or a business entity that is majority-owned by a federally recognized tribe located in the state to maintain a marijuana cultivation license and one marijuana dispensary license.

(2) A combined use licensee is subject to the marijuana laws.

(1) A marijuana testing laboratory license allows a marijuana testing laboratory to provide testing of representative samples of marijuana and marijuana products and to provide information about the chemical composition and potency of a sample, as well as the presence of molds, pesticides, or other contaminants.

(2) A current marijuana testing laboratory licensee may continue to operate under its existing license and shall pay the annual license renewal fee provided for in ARM 42.39.104 at its next renewal date.

(3) The department shall begin accepting applications for new marijuana testing laboratories on January 1, 2022.

(4) Applicants for marijuana testing laboratories must receive an endorsement from the Department of Public Health and Human Services' state testing laboratory before applying for licensure with the department. The department will accept the state laboratory's standard form of approval or endorsement for the applicant of a marijuana testing laboratory license to meet this requirement.

(5) Marijuana testing laboratories may transport samples of marijuana and marijuana products for testing in accordance with 16-12-222(4), MCA, and ARM 42.39.413(4) through (15).

(6) A marijuana testing laboratory licensee must provide and maintain, at its own expense, analytical testing laboratory professional liability insurance with an aggregate limit of one million dollars prior to the issuance of a license.

(7) A marijuana testing laboratory licensee must obtain and maintain a $25,000 surety bond which names the department as loss payee in the event the laboratory licensee fails to adhere to the security plan approved by the department, or it otherwise operates the facility in a manner that allows for, or results in theft, loss, or diversion of marijuana items. A copy of the bond must be submitted to the department as a part of the license application process.

(1) A marijuana transporter or a marijuana testing laboratory shall obtain a marijuana storage facility endorsement for any overnight storage of marijuana or marijuana products. A marijuana storage facility endorsement allows a marijuana transporter or marijuana testing laboratory to maintain a separate, off-site storage facility.

(2) A marijuana storage facility may only be used for the temporary storage of marijuana or marijuana products, not to exceed 48 hours. A storage facility may not be used to grow, process, test, manufacture, consume, or sell marijuana or marijuana products.

(3) A marijuana transporter licensee or marijuana testing laboratory with a marijuana storage facility endorsement may not share its storage facility with any other marijuana business.

(4) A marijuana storage facility may only be located in a jurisdiction that allows for the operation of a marijuana business pursuant to 16-12-301, MCA.

(1) Subject to the authority and restrictions under 16-12-210, MCA, the department may conduct inspections to determine compliance with the marijuana laws.

(2) The department may conduct the following types of inspections:

(a) initial application;

(b) renewal application;

(d) complaint;

(e) deficiency follow-up; and

(f) suspension expiration.

(3) A licensee and its employees must cooperate with the department during an inspection. A licensee must allow inspectors full access to the licensed premises, provide requested copies of documents or videos, and allow inspectors to complete an inspection. Failure on the part of a licensee to cooperate could result in denial, reprimand, suspension, or revocation of a license.

(4) If a department inspection reveals that an applicant or licensee is not in compliance with the marijuana laws, the department shall:

(a) issue a deficiency report pursuant to ARM 42.39.502 to notify the applicant or licensee of the specific deficiencies or errors; or

(b) issue a notice of proposed department action.

(1) The department may issue a deficiency report to a licensee whenever a department inspection or compliance audit reveals a licensee is in violation of the marijuana laws. The purpose of the deficiency report is to afford licensees with an opportunity to cure deficiencies and avoid administrative proceedings before the department's Office of Dispute Resolution.

(2) A deficiency report shall, at a minimum:

(a) identify the date of the inspection;

(b) identify the name of the inspector;

(d) cite the specific statute, rule, or local ordinance that the deficiency violates.

(3) A licensee shall have ten days from the date of the deficiency report to cure any deficiencies.

(a) If a licensee can show proof of having cured the deficiencies through photographs, document submissions, or through other correspondence, the licensee shall submit the proof to the department.

(b) If an inspection is required to determine whether a licensee has cured deficiencies, the licensee shall contact the department to schedule a follow-up inspection within ten days from the date of the deficiency report.

(4) If a licensee cures the identified deficiencies, the department will send the licensee a deficiency resolution letter which informs the licensee that the department will close out the deficiency and take no further action on the deficiency report.

(5) If a licensee fails to respond to a deficiency report within ten days, the department may issue a notice of proposed department action. Failing to respond to a deficiency report within ten days may be cited as a separate violation subject to the imposition of a civil penalty.

(6) Nothing in this rule prevents the department from proceeding immediately to administrative proceedings without issuing a deficiency report.

(1) Evidence of violation by a licensee, a licensee's agent, or an employee of a licensee of any of the provisions of the marijuana laws is sufficient grounds for a warning, reprimand, suspension, revocation, and/or the assessment of a civil penalty in accordance with 16-12-109, MCA.

(2) Whenever the department seeks to impose a reprimand, suspension, revocation, and/or the assessment of a civil penalty in accordance with 16-12-109, MCA, the department shall serve a licensee with a notice of proposed department action. The notice of proposed department action shall, at a minimum:

(a) state the allegations;

(b) identify dates or approximate dates of the alleged incident;

(d) list each alleged violation as a separate count;

(e) identify the penalty that the department seeks to impose; and

(f) provide the licensee with appeal rights, including the right to request an administrative hearing before the department's Office of Dispute Resolution.

(3) Notwithstanding the provisions of (2)(f), whenever the department proposes revocation of a marijuana testing laboratory license, that proposed department action is subject to judicial review in accordance with 16-12-202(10), MCA.

(4) Aggravating circumstances may result in the imposition of maximum monetary penalties, maximum suspension time, or revocation. In addition to those identified in 16-12-109, MCA, aggravating circumstances include, but are not limited to:

(a) no effort on the part of a licensee to prevent a violation from occurring;

(b) a licensee's failure to report a violation at the time of renewal;

(d) repeated violations for sales to underage or intoxicated persons;

(e) providing marijuana or marijuana products to a person under 18 years of age that is not a registered cardholder;

(f) lack of cooperation by a licensee in an investigation;

(g) a violation's significant negative effect on the health and welfare of the community in which a licensee operates; and

(h) prior violations of the marijuana laws.

(5) Mitigating circumstances may result in the adjustment of monetary penalties, amount of suspension time, or in a determination not to revoke. In addition to those identified in 16-12-109, MCA, mitigating circumstances include, but are not limited to:

(a) the admissions of a licensee regarding violations of the marijuana laws prior to the department commencing investigation of the licensee;

(b) the existence of written policies that govern the conduct of a licensee's employees; or

(6) Ignorance of the law is not considered a mitigating circumstance.

(7) In the event a reprimand is issued:

(a) the incident shall be considered a prior violation; and

(b) the department shall assess a civil penalty, described in ARM 42.39.507.

(1) The department may suspend a license for any period of time not to exceed one year.

(2) The department shall revoke the license or licenses of a licensee that commits the offenses stated in 16-12-109(5), MCA, and for a marijuana testing laboratory, the offenses stated in 16-12-202(9), MCA. The department may revoke the license or licenses of a licensee that commits other violations of the marijuana laws.

(3) When determining the length of suspension or whether to revoke a license or licenses, the department shall consider aggravating and mitigating circumstances and the severity of the violation or violations as set forth in ARM 42.39.503.

(4) A license suspension shall be effective at each licensed premises that is the subject of the violation or violations resulting in the suspension.

(5) During a suspension, a licensee and its employees may not operate the licensed premises that is subject to the suspension. The suspended licensee may not sell, deliver, service, remove, transport, or receive marijuana or marijuana products or otherwise engage in business from the licensed premises. The department may negotiate terms with a licensee to prevent the potential loss of marijuana or marijuana products during a suspension.

(6) During a suspension, a licensee and its employees must obey the marijuana laws, including compliance with the tax and reporting laws provided in 15-64-102 through 15-64-106, MCA.

(7) A suspended licensed premises remains subject to inspection under 16-12-210, MCA.

(8) If a license is due for renewal during a suspension, a licensee must submit a renewal application including payment of applicable fees to avoid lapse of the license. The department shall not approve a renewal application with respect to the suspended licensed premises until the suspension has expired.

(9) If the department receives an application for renewal during a suspension, the time allowances in 16-12-104, MCA, will not begin with respect to the suspended licensed premises until the suspension expires.

(10) A suspension does not alter a license's renewal date.

(11) The department shall inspect all suspended licensed premises before a licensee can resume operations.

(12) When a license has been revoked, the department shall not accept an application from the person or persons qualified for licensure pursuant to 16-12-109(6), MCA, for three years from the date of revocation. After the three-year moratorium, an application will only be accepted if the applicant demonstrates to the department that sufficient steps have been taken to prevent future violations of the marijuana laws.

(1) A notice of proposed adverse action issued by the department pursuant to the marijuana laws shall be served upon the licensee by sending a copy of the notice to the licensee by electronic means to the email address on file with the department.

(2) Service shall be considered complete upon transmission but is not effective if the department learns that the notice did not reach the licensee, in which case the department will proceed with service of notice provided in (3).

(3) If a licensee has previously opted out of receiving department communications by electronic means, the notice shall be served by sending a copy of the notice to the licensee by certified mail to the mailing address on file with the department. Whenever the department serves a notice via certified mail:

(a) service shall be considered complete three days after mailing the notice;

(b) service shall not be considered incomplete because of refusal to accept delivery of the notice.

(4) A licensee must respond to the department in writing within 20 days of service of the notice of proposed adverse action. Failure to respond will result in enforcement of the administration action proposed in the notice.

(1) Whenever the department seeks to suspend or revoke the permit of any marijuana worker, the department shall serve the marijuana worker with a notice of proposed department action, as provided in ARM 42.39.503. The notice of proposed department action shall, at a minimum:

(a) identify dates or approximate dates of the alleged incident;

(b) cite the specific statute, rule, or local ordinance that the alleged incident violates;

(d) identify which penalty that the department seeks to impose; and

(e) provide the marijuana worker with appeal rights, including the right to request an administrative hearing before the department's Office of Dispute Resolution.

(2) The department shall revoke a marijuana worker permit if the worker knowingly sells, delivers, transfers, or makes available marijuana or a marijuana product to a person under 21 years of age. This section does not apply to sales, deliveries, or transfers to registered cardholders.

(1) When determining the amount of civil penalty imposed pursuant to 16-12-109, MCA, and rules of the department, the department shall consider aggravating and mitigating circumstances and the severity of the violation or violations as set forth in ARM 42.39.503.

(2) Upon reprimand or suspension of a license, the department shall also impose a civil penalty of not less than $100 and not more than $3,000 per violation.

(3) If a civil penalty is imposed in conjunction with a suspension, the licensee may not resume operations until it has paid the penalty in full.

(4) Failure to pay a civil penalty shall be considered a violation of department rule and could subject the licensee to further administrative proceedings.

(1) When any marijuana business license is suspended or revoked by the department, the department shall provide a written notice to the licensee and require the licensee to post the notice on the inside of the licensed premises so that it can be seen from the outside. The notice shall state, for the benefit of the public, that the license has been suspended or revoked. The notice must identify the name of the licensee, the reason for the suspension or revocation, and the period of suspension. The suspension or revocation notice must be dated and signed. In the case of a license suspension, the notice must be posted at all times during the suspension. In the case of a revocation, the notice must be posted on the licensed premises for ten days.

(2) If a notice is removed or caused to be removed by a licensee or its employee or agent during a suspension, the license shall be subject to revocation. A licensee or its employees may not place or permit the placement of any statement on the licensed premises indicating that the premises have been closed for any reason other than what is stated on the notice.

(3) The license or licenses suspended will be held by the department during the period of suspension.

As used in this subchapter, the following definitions apply:

(1) "Acceptance criteria" means the specified limits placed on the characteristics of an item or method that are used to determine data quality.

(2) "Accredited college or university" means a college or university accredited by a regional or national accrediting agency that is an accreditor recognized by the Secretary of the U.S. Department of Education.

(3) "Action level" means the threshold value that provides the criteria for determining whether a sample passes or fails an analytical test.

(4) "Adulteration" means intentionally modifying or altering a marijuana item from its original form to increase its monetary value, evade undesirable test results, or conceal the true composition of a marijuana item.

(5) "Analytical batch" means a set of matrix-specific laboratory test samples that are prepared together over a 24-hour time period using the same set of reagents for the same analysis and includes the required quality control samples.

(6) "Applicant" means a person seeking endorsement for testing laboratory licensure or renewal of licensure.

(7) "Batch" has the meaning provided for in ARM 42.39.102.

(8) "CBD" has the meaning provided for in ARM 42.39.102.

(9) "CBDA" has the meaning provided for in ARM 42.39.102.

(10) "Certificate of analysis (COA)" has the meaning provided for in ARM 42.39.102.

(11) "Coefficient of determination (r²)" means a statistical measure that determines how well the regression approximates the actual data points in the calibration curve, with a regression of 1 being a perfect fit.

(12) "Continuing calibration verification (CCV)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration to evaluate the validity of the instrument's calibration over the entire sample sequence.

(13) "Corrective action" means an action taken by a licensee to resolve, and prevent from recurrence, a problem with operations of the licensee.

(14) "Customer" has the meaning provided for in ARM 42.39.102.

(15) "Harvest lot" means a specifically identified quantity of marijuana that is cultivated utilizing the same growing practices, harvested within a 72-hour period at the same location, and cured under uniform conditions. A harvest lot may contain multiple strains.

(16) "Ingredient" has the meaning provided for in ARM 42.39.102.

(17) "Initial calibration verification (ICV)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration using secondary source standards to evaluate the validity of the calibration standards and calibration standards preparation.

(18) "ISO" means International Organization for Standardization.

(19) "ISO/IEC 17025" means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories.

(20) "ISO/IEC 17043" means the general requirements established by the ISO/IEC for proficiency testing.

(21) "Laboratory control sample (LCS)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration spiked into an analyte free matching matrix or a matrix that is as closely representative of the matrix being analyzed as possible, in order to evaluate the efficiency of the preparatory/extraction process. The LCS is prepared in the same manner as the rest of the laboratory test samples in the analytical batch. An LCS is required for contaminant testing only.

(22) "Laboratory quality assurance" means a set of operating principles that enable laboratories to produce defensible data of known accuracy and precision and includes employee training, equipment preventative maintenance procedures, calibration procedures, and quality control testing.

(23) "Laboratory test sample" means all sample increments collected from one test batch combined together into one sample container from which quality assurance compliance testing is conducted.

(24) "Limit of detection (LOD)" means the lowest quantity of a substance or analyte that can be distinguished from the absence of the substance within a stated confidence limit.

(25) "Limit of quantitation (LOQ)" means the lowest concentration of an analyte in the specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision.

(26) "Marijuana" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(27) "Marijuana concentrate and extract" or "concentrate and extract" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(28) "Marijuana infused products" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(29) "Marijuana items" has the meaning provided for under ARM 42.39.102.

(30) "Matrix" means the substances that are present in a sample except for the analytes of interest.

(31) "Matrix spike (MS)" means a quality control sample that is prepared by adding a known concentration of target analytes to a laboratory test sample spiked at a mid-range concentration of the calibration to evaluate matrix interference effects. The MS is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(32) "Method blank (MB)" means a quality control sample that is prepared using an analyte free matching matrix or a matrix that is as closely representative of the matrix being analyzed as possible to verify the absence of contamination in the preparatory/extraction process. The MB is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(33) "Method detection limit (MDL)" means a minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero as determined from analysis of a sample containing the analyte in a given matrix.

(34) "Method reporting limit (MRL)" means the lowest amount of an analyte in a sample that can be quantitatively determined with stated, acceptable precision and accuracy under stated analytical conditions.

(35) "Preventative action" means a proactive action implemented to eliminate the cause of a potential nonconformance or other quality problem before it occurs.

(36) "Process lot" means:

(a) any amount of marijuana concentrate or extract of the same type and processed in the same 48-hour period, using the same extraction methods, standard operating procedures, and test batches from the same or different harvest lots; or

(b) any amount of marijuana products of the same type and processed in the same 48-hour period, using the same ingredients, standard operating procedures, and test batches from the same or different harvest lots or process lots of marijuana concentrate or extract.

(37) "Proficiency test" means an evaluation of a testing laboratory's performance against pre-established criteria by means of interlaboratory comparisons of test measurements.

(38) "Property owner permission form" has the meaning provided for under ARM 42.39.102.

(39) "Quality control sample" means a sample that is produced and used by a testing laboratory for the purpose of ensuring the quality of the data and results. Quality control samples include initial calibration verifications, continuing calibration verifications, laboratory control samples, method blanks, replicates, and matrix spikes. When quality control samples fail it is assumed the preparatory/extraction process, instrumentation, procedures, equipment, etc., are out of statistical control.

(40) "Raw data" means any testing laboratory worksheet, records, memorandum, notes, or exact copies thereof, that are the result of original observations and activities of testing laboratory study and are necessary for the reconstruction and evaluation of the report of that study.

(41) "Replicate (REP)" means a quality control sample that is a sub-sample of a laboratory test sample used to evaluate the reproducibility of the preparatory/extraction process. The REP is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(42) "Sample increment" means an individual portion of material collected from a test batch.

(43) "Sample integrity" means maintaining marijuana items in a manner that prevents the degradation of testing laboratory results over time between the harvest/process lot, test batch, laboratory test sample, and customer product. Sample integrity factors include consistent storage, temperatures, humidity, and light exposure along with proper handling, transport, and tampering prevention.

(44) "Secondary source standard" means chemical standards sourced from a different supplier or from a different lot number of the same supplier.

(45) "Seed-to-sale tracking system" has the meaning provided for under ARM 42.39.102.

(46) "Standard operating procedure (SOP)" means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, or action.

(47) "Test batch" has the meaning provided for under ARM 42.39.102.

(48) "THC" has the meaning provided for under ARM 42.39.102.

(49) "THCA" has the meaning provided for under ARM 42.39.102.

(50) "Total potential psychoactive THC" has the meaning provided for under ARM 42.39.102.

(51) "Total THC" means the sum of THC and THCa calculated using the following equation:

(a) Total THC =(THCa x 0.877)+THC.

(52) "Validation" means the confirmation, by examination and objective evidence, that the requirements for an analytical method are fulfilled.

(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:

(a) the testing laboratory achieves and maintains ISO/IEC 17025:2017 accreditation for all testing methods/analytes required in ARM 37.107.316;

(b) the testing laboratory's processes and practices are compliant with ISO/IEC 17025:2017 standards;

(d) testing personnel have been appropriately trained and demonstrate competency prior to providing testing services;

(e) policies and procedures are in place for monitoring personnel competence;

(f) approved standard operating procedures are in place, have been reviewed, and are followed by all testing personnel;

(g) appropriate test methods are in place;

(h) test method validations have been performed initially and upon test method changes to determine the minimum following requirements as appropriate;

(i) accuracy;

(ii) precision;

(iii) linearity and working range;

(iv) coefficient of determination (r²) for calibration curves;

(v) LOD;

(vi) LOQ;

(vii) MDL; and

(viii) reproducibility.

(i) acceptable analytical test performance is established and maintained for each test system;

(j) quality assurance and quality control programs are established and maintained;

(k) 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;

(l) the testing laboratory successfully participates in an approved proficiency testing (PT) program(s), as described in this subchapter, for all methods/analytes required in ARM 37.107.316;

(m) the physical and environmental conditions of the testing laboratory are adequate and appropriate for the testing performed; and

(n) 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 ARM 37.107.316.

(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.

(1) A testing laboratory applicant must meet all applicable requirements under the Montana Marijuana Regulation and Taxation Act (Title 16, chapter 12, MCA) and this subchapter in order to qualify for endorsement of either licensure or renewal.

(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 ARM 42.39.417;

(b) business license;

(d) department-issued employee badge;

(e) laboratory security/storage plan;

(f) quality manual;

(g) standard operating procedures;

(h) validation studies/data and results;

(i) proficiency data/results;

(j) scientific director professional resume, college transcripts/degrees from an accredited college or university;

(k) scientific director references; and

(l) Certificate of ISO/IEC 17025:2017 accreditation and associated audit reports by an approved accreditation or credentialing body.

(3) An application for endorsement for a testing laboratory license or renewal of license will not be considered complete, and an on-site inspection will not be scheduled, until all of the required documentation is provided.

(4) An inspection of the testing laboratory will be scheduled with the applicant following receipt of all required documentation.

(5) An applicant must implement processes that are ISO/IEC 17025:2017 compliant.

(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.

(7) A testing laboratory must maintain ISO accreditation for all methods/analytes in ARM 37.107.316, at all times.

(8) If a testing laboratory's method/analyte ISO accreditation lapses or is revoked, the testing laboratory must not perform those methods until it is reinstated.

(9) For the purpose of this subchapter, the state laboratory adopts and incorporates by reference ISO/IEC 17025:2017, which sets forth general requirements for the competence of testing and calibration laboratories. 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.

(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 manual that addresses the following:

(a) quality control procedures;

(b) testing laboratory organization and employee training and responsibilities;

(d) traceability of data and analytical results;

(e) instrument maintenance, calibration procedures, and frequency;

(f) performance and system audits;

(g) corrective and preventative action procedures;

(h) steps to change processes when necessary;

(i) record retention and document control;

(j) laboratory test sample retention and disposal;

(k) test procedure standardization; and

(l) method validation.

(2) The scientific director shall annually review, amend if necessary, and approve the quality manual both when it is created and when there is a change in methods, laboratory equipment, or the scientific director.

(3) All testing laboratory personnel shall review the quality manual upon revision or at least annually.

(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):

(a) at least every six months for each analyte/method in ARM 37.107.316 that the laboratory performs on marijuana or marijuana-infused products;

(b) that are matrix specific or controlled when available; and

(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 state laboratory, 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 state laboratory 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 state laboratory upon request.

(10) When performing a proficiency test, a testing laboratory may not:

(a) perform multiple analyses (such as replicates or duplicates) that are not normally performed in the course of analysis of a routine laboratory test sample;

(b) average the results of multiple analyses for reporting when not specifically required to do so by the analytic method in question;

(c) 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;

(d) 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;

(e) 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;

(f) send proficiency testing samples or portions of samples to another testing laboratory to be tested; or

(g) knowingly receive a proficiency testing sample from another testing laboratory for analysis and fail to notify the state laboratory of the receipt of the other testing laboratory's sample within five business days of discovery.

(11) The state laboratory 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 state laboratory 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.

(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:

(a) the testing laboratory notifies the state laboratory of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;

(b) the testing laboratory has "successfully" participated in a proficiency program for the failed analyte(s) in the specific method in the previous six months;

(c) the testing laboratory submits to the state laboratory, 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

(d) within 30 days of plan approval by the state laboratory, 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 state laboratory 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:

(a) the testing laboratory notifies the state laboratory of the "unsuccessful" proficiency result in writing within three business days of receiving the report from the proficiency provider;

(b) the testing laboratory submits to the state laboratory, 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;

(c) within 30 days of plan approval by the state laboratory, 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

(d) "successfully" participate in a proficiency test for the failed analyte(s) by a proficiency testing provider that meets the requirements of this subchapter.

(1) The testing laboratory shall use quality control samples and adhere to ISO 17025:2017 in the performance of all quality assurance testing according to the following specifications:

(a) the testing laboratory shall analyze quality control samples in the same manner as the testing laboratory analyzes marijuana, marijuana concentrates and extracts, or marijuana-infused product laboratory test samples;

(b) the testing laboratory shall use at least one negative control and one positive control in each analytical batch for each target organism during microbial testing;

(c) if either of the controls produces unexpected results or fails, then the results for each sample in the analytical batch are invalid and the samples shall be re-prepped and reanalyzed with a new set of controls; and

(d) if the positive and negative controls produce the expected results then the laboratory test sample results in the analytical batch are valid and must be reported.

(2) The testing laboratory shall prepare and analyze at least one each of the following quality control samples for each analytical batch:

(a) method blank (MB);

(b) laboratory control sample (LCS);

(d) matrix spike (MS).

(3) The testing laboratory shall analyze an initial calibration verification (ICV) sample immediately following an instrument calibration.

(4) The testing laboratory shall analyze, at minimum, a continuing calibration verification (CCV) sample at the beginning of each analytical sequence and at least every 10 laboratory test samples thereafter.

(5) If any quality control sample result is outside the testing laboratory's specified acceptance criteria listed in the testing laboratory's quality manual, specific method SOP, or product instructions for use, the testing laboratory shall determine the cause and take corrective action steps to remedy the problem until the result is within the specified acceptance criteria.

(6) If any quality control sample produces a result outside the specified acceptance criteria, the testing laboratory cannot report the result and the entire analytical batch cannot be released for sale. The testing laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.

(7) The testing laboratory must calculate the method detection limit (MDL) and method reporting limit (MRL) for each chemical method analysis according to the United States Food and Drug Administration (USFDA) "Elemental Analysis Manual for Food and Related Products," the United States Environmental Protection Agency (USEPA) "Definition and Procedure for the Determination of the Method Detection Limit, Revision 2," or a substantially equivalent standard.

(1) Testing laboratories shall collect samples of marijuana items from licensees for the required quality assurance testing.

(2) Testing laboratories shall develop and implement a sampling protocol standard operating procedure that details at minimum:

(a) the testing laboratory's method for obtaining a random and representative sample for all matrices;

(b) sterile sampling technique for all matrices;

(d) appropriate sampling equipment;

(e) appropriate sample transportation and storage;

(f) maintenance of sample custody and integrity; and

(g) sampling documentation and records.

(3) Testing laboratories shall create a sampling plan for each sampling event that details at a minimum:

(a) the licensee's business/trade name and licensee ID number;

(b) the physical address from which the laboratory test samples are to be collected;

(d) the testing laboratory vehicle and license plate number; and

(e) the date and time the sampling route begins and ends.

(4) The testing laboratory shall ensure sample integrity is maintained during transport to and storage at the testing laboratory licensed facilities. If the marijuana item specifies on the label how the product shall be stored, the testing laboratory shall store the sample as indicated.

(5) An employee from the licensee requesting sample collection shall be present to observe sample collection but shall not assist the testing laboratory sampler while physically collecting the laboratory test samples.

(6) The 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.

(7) All sample increments from the same test batch shall be placed into one sample container that is free of the analytes of interest and appropriate for the analysis required.

(8) At least 50% of the laboratory test sample must be homogenized prior to its use for the appropriate analysis.

(9) Testing laboratories must refuse sample collection if sample adulteration is suspected and shall report incidents of suspected adulteration to the state laboratory within three business days. Adulteration may include:

(a) the application of kief to usable marijuana test batches;

(b) the application of solvents to usable marijuana test batches;

(d) the addition of any substance to increase any cannabinoid test result; or

(e) the addition of any substance to alter the weight of a marijuana item.

(10) A licensee shall only order tests for marijuana items that the licensee has grown, produced, processed, or legally purchased from another licensee.

(11) The licensee shall store and secure test batches in a manner that maintains sample integrity and security during laboratory testing.

(12) Failed or remediated marijuana items shall be re-tested at the same testing laboratory from which the original failed test results came unless explicit written permission from the state laboratory is granted prior to re-testing.

(13) The state laboratory may inspect marijuana sampling events to ensure sampling protocols are being followed.

(14) The state laboratory adopts and incorporates by reference the "Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, and Marijuana Infused Products" SOP-001 (Version 1.0), which describes the sampling protocol for marijuana, marijuana concentrates and extracts, and marijuana infused products. A copy of this publication is available electronically at https://dphhs.mt.gov/assets/MarijuanaLab/MarijuanaSamplingProtocolSOP.pdf and may also be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 E. Broadway, Helena MT, 59620.

(1) If the results of quality assurance testing for any analyte/method exceed the action levels defined in ARM 37.107.316, 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:

(a) standard curves;

(b) coefficient of determination (r²);

(i) ICV, CCV, LCS, MB, REP, and MS;

(d) positive and negative controls; and

(e) 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 ARM 37.107.316.

(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 state laboratory 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.

(1) Except as provided in (10), a licensee must submit for testing a sample of every test batch from a harvest lot of marijuana and process lots of marijuana-infused products, extracts, and concentrates intended for use by a customer prior to selling or transferring the marijuana item to a customer.

(2) All marijuana items intended for direct sale or transfer to customers shall be tested in its final form. The addition of any ingredient after final quality assurance compliance testing will require retesting.

(3) The cannabinoid profile/potency for each sample must include:

(a) THCA;

(b) THC;

(c) Total potential psychoactive THC for marijuana items that require the application of heat for administration/consumption only;

(d) CBDA; and

(e) CBD.

(4) The laboratory test sample and related lot or test batch fail quality assurance testing for moisture analysis if the results are greater than 12.0%.

(5) The laboratory test sample and related lot or test batch fail quality assurance testing for filth and foreign matter screening if the results are greater than the following action levels:

(a) 5.0% of stems 3mm or more in diameter; and

(b) 2.0% of seeds or other foreign matter.

(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 coli (STEC): non-detectable in 1.0 gram of material; and

(c) Pathogenic Aspergillus species A. flavus, A. fumigatus, A. niger, and A. terreus: Each non-detectable in 1.0 gram of material.

(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) The laboratory test sample and related lot fail quality assurance testing for mycotoxins if the results are greater than the following action level:

(a) Total of Aflatoxin B1, B2, G1, G2: 20 µg/kg; and

(b) Ochratoxin A: 20 µg/kg of substance.

(9) A laboratory test sample and related lot or test batch fail quality assurance testing for residual solvents if the results are greater than the action levels provided in table 1.0.

		Table 1.0
Residual Solvents	(CAS) Registry Number	Action Level ppm
Acetone	67-64-1	5,000
Benzene	71-43-2	2
Total Butanes	See¹	5,000
* n-butane	106-97-8
* iso-butane	75-28-5
Chloroform	67-66-3	2
Cyclohexane	110-82-7	3,880
Dichloromethane	75-09-2	600
Ethyl acetate	141-78-6	5,000
Heptane	142-82-5	5,000
Total Hexanes	See²	290
* n-hexane	110-54-3
* 2-methylpentane	107-83-5
* 3-methylpentane	96-14-0
* 2,2-dimethylbutane	75-83-2
* 2,3-dimethylbutane	79-29-8
Isopropanol (2-propanol)	67-63-0	5,000
Methanol	67-56-1	3,000
Total Pentanes	See³	5,000
* n-pentane	109-66-0
* iso-pentane	78-78-4
* neo-pentane	463-82-1
Propane	74-98-6	5,000
Toluene	108-88-3	890
Total Xylenes	See⁴	2,170
* 1,2-dimethylbenzene	95-47-6
* 1,3-dimethylbenzene	108-38-3
* 1,4-dimethylbenzene	106-42-3

1 Total butanes should be calculated as sum of n-butane and iso-butane.

2 Total hexanes should be calculated as sum of n-hexane, 2-methylpentane, 3-methylpentane, 2,2-dimethylbutane and 2,3-dimethylbutane.

3 Total pentanes should be calculated as sum of n-pentane, iso-pentane, and neo-pentane.

4 Total xylenes should be calculated as sum of 1,2-dimethylbenzene, 1,3-dimethylbenzene, and 1,4-dimethylbenzene.

(10) Heavy metals will be tested at random. A laboratory test sample and related lot or test batch fail quality assurance testing for heavy metals if the results are greater than the action levels provided in table 2.0.

Table 2.0

Heavy Metals	Action Level ppm; Inhalable Marijuana Items	Action Level ppm; Other Marijuana Items
Inorganic Arsenic	0.2	1.5
Cadmium	0.2	0.5
Lead	0.5	0.5
Mercury	0.1	3.0

(11) A laboratory test sample and related lot or test batch fail quality assurance testing for pesticides if the results are greater than the action levels provided in table 3.0.

Table 3.0

Pesticides	(CAS) Registry Number	Action Level ppm; Dry Flower	Action Level ppm; Concentrates and Extracts
Abamectin	71751-41-2	0.5	2.5
Acequinocyl	57960-19-7	2	10
Bifenazate	149877-41-8	0.2	1
Bifenthrin	82657-04-3	0.2	1
Chlormequat Chloride	999-81-5	1	5
Cyfluthrin	68359-37-5	1	5
Daminozide	1596-84-5	1	5
Etoxazole	153233-91-1	0.2	1
Fenoxycarb	72490-01-8	0.2	1
Imazalil	35554-44-0	0.2	1
Imidacloprid	138261-41-3	0.4	2
Myclobutanil	88671-89-0	0.2	0.6
Paclobutrazol	76738-62-0	0.4	2
Pyrethrins†	8003-34-7	1	5
Spinosad	168316-95-8	0.2	1
Spirotetramat	203313-25-1	0.2	1
Trifloxystrobin	141517-21-7	0.2	1

† Pyrethrins should be measured as the cumulative residues of pyrethrin 1, cinerin 1, and jasmolin 1 (CAS numbers 121-21-1, 25402-06-6, and 4466-14-2 respectively).

(12) Licensees must adhere to testing requirements for all marijuana and marijuana products intended for sale or transfer to customers.

(a) Usable marijuana, including trim and manicure must be tested for:

(i) pesticides;

(ii) moisture content;

(iii) cannabinoid profile/potency;

(iv) microbiological;

(v) mycotoxin;

(vi) filth and foreign matter; and

(vii) heavy metals (random testing).

(b) A licensee has the option to forgo testing of usable marijuana, including trim and manicure, if that usable marijuana is subject to further processing before sale or transfer to customers.

(i) pesticides;

(ii) cannabinoid profile/potency;

(iii) microbiological;

(iv) mycotoxin;

(v) heavy metals (random testing); and

(vi) residual solvents.

(d) Marijuana extract and concentrate that is intended for further processing before direct sale or transfer to customers must be tested for:

(i) pesticides;

(ii) residual solvents;

(iii) mycotoxin; and

(iv) heavy metals (random testing).

(e) Marijuana infused products intended for human consumption, ingestion, or used as suppositories, topicals, and transdermal patches must be tested for:

(i) cannabinoid profile/potency; and

(ii) microbiological.

(f) All marijuana products listed in (e) must use marijuana extract and concentrate that has passed quality assurance testing requirements as set forth in (d).