19 CSR 30-95.040 Medical Marijuana Facilities Generally.
DHSS released new draft rules for all medical marijuana businesses. Key topic lines include:
1. Application Process
2. Application Requirements
3. Ownership & Employment
4. Facility Operation, Policies, and Procedures
5. Facility Inspections
1.2018-1.2019: data example of what is coming to Missouri. Plan wisely.
Title 19 – DEPARTMENT OF HEALTH AND SENIOR SERVICES Division 30 – Division of Regulation and Licensure Chapter 95 – Medical Marijuana 19 CSR 30-95.040 Medical Marijuana Facilities Generally
Purpose: Under Article XIV of the Missouri Constitution, the Department of Health and Senior Services is authorized to regulate and control the operations of Cultivation, Infused Product Manufacturing, Dispensary, Testing, and Transportation facilities, and to grant, refuse, suspend, fine, restrict, or revoke the licenses and certifications for such facilities.
This rule explains how this authority will be exercised.
(1) Application Processes.
The department will begin accepting applications for licensing and certification of cultivation, infused products manufacturing, dispensary, testing, and transportation facilities on August 3, 2019.
(A) The department will receive applications for facility licenses or certifications electronically through a department-provided, web-based application system. In the event of application system failure, the department will arrange to accept applications in an alternative, department-provided format and will notify the public of those arrangements through its website.
(B) The department will publish on its website time periods during which it will accept applications for review. All complete applications received by the department that are submitted during the application time periods will be approved or denied within one hundred fifty (150) days of that application’s submission.
1. Any application fees submitted before or during the first application time period and during any subsequent application period are nonrefundable.
2. After the first application time period, any application fees submitted outside of an application time period will not be accepted.
3. If licenses or certifications are available after a time period for accepting applications has passed, the department will determine when to publish on its website a new time period during which it will accept applications and will publish that new time period on its website at least six (6) months prior to the beginning of that time period.
4. Applications will be considered complete if they include all information required for applications by this rule and by 19 CSR 30-95.020(4). The department will notify an applicant if an application is incomplete and will specify in that notification what information is missing. Applicants will be given seven (7) days to provide missing information.
(C) The issuance of a facility license or certification does not authorize the facility to begin operations. A facility will be granted final approval to operate upon passing a commencement inspection.
(D) Licenses and certification for facilities may be suspended, denied, or revoked.
1. If a facility provides false or misleading information in an application, its application may be denied or, if the information is later discovered to have been false or misleading, its license or certification may be revoked. Plans, assurances, and projections offered in answers to 19 CSR 30-95.020(4) evaluation criteria questions may be considered false or misleading if, upon application for license renewal, the department determines the facility has not made a reasonable effort to implement or follow-through on those plans, assurances, or projections.
2. If a facility violates any provision in this chapter or fails to comply with a corrective action plan, its license or certification may be suspended or revoked.
3. If an applicant fails to provide a complete application within seven (7) days of being notified that an application is incomplete, the license or certification for which the applicant is applying will be denied.
4. If a facility is granted a license or certification but has not passed a commencement inspection within one (1) year of the department issuing the license or certification, the license or certification may be revoked.
5. If a facility fails to comply with a department order to immediately suspend all or a part of its operations, the license or certification shall be revoked.
(E) Cultivation, infused product manufacturing, and dispensary licenses and testing and transportation certifications are valid for three (3) years from the date the license or certification is issued and shall, except for good cause, be renewable by submitting, prior to expiration by at least one hundred fifty (150) days but no sooner than two hundred fifty (250) days, an updated application, which shall include any information required by Section (2) of this rule or Section (4) of 19 CSR 30-95.020 that has changed since the date of the previous application;
(F) The department shall charge an application or renewal fee for a facility license or certification and also an annual fee once a license or certification is granted. The first annual fee will be due thirty (30) days after a license or certification is issued and shall be due annually on that same date as long as the facility’s license or certification remains valid. The department shall publish the current fees, including any adjustments, on its website. The amount of fees due for each facility will be the amount that is effective as of that facility’s due date.
(2) Application Requirements.
Facilities must obtain a license or certification to cultivate, manufacture, dispense, test, and transport medical marijuana in Missouri. All applications for facility licenses or certifications and for renewals of licenses or certifications shall include at least the following information in a department-provided format:
(A) Name and address of the applicant;
(B) Legal name of the facility and a certificate of good standing from the Missouri Secretary of State;
(C) Names, addresses, and social security numbers of each known owner, principal officer, and manager;
(D) The percentage of ownership shares that each facility owner will possess and a copy of the facility’s operating agreement;
(E) Each owner’s residence address, and, in the case of a majority owner, a statement that the owner has primarily resided in Missouri for at least one (1) year, with the intention of permanently or indefinitely residing in Missouri, as well as proof of current Missouri residency, which shall be shown by—
1. A valid Missouri driver’s license number or Missouri Identification Card number;
2. A copy of a current Missouri motor vehicle registration and a recent Missouri utility bill; or 3. If none of these proofs are available, some other evidence of primary residence in Missouri, which shall be approved or denied at the discretion of the director of the medical marijuana program as sufficient proof of residency;
(F) For any owner, principal officer, or manager who is or was previously associated with an entity licensed in a jurisdiction outside the state of Missouri to cultivate, manufacture, test, or distribute marijuana:
1. A copy of a license or other documentation verifying licensure in that state;
2. If the license was ever denied, suspended, revoked, or otherwise sanctioned, a copy of documentation verifying that action and a written explanation for such action;
(G) For any owner, principal officer, or manager who was previously or currently is associated with an entity licensed or certified or applying for licensure or certification in Missouri to cultivate, manufacture, test, or dispense marijuana—
1. A list of those facilities, designating which of the owners, principal officers, or managers are associated with them;
2. A list of the facilities over which any owner has or will have substantially common control, ownership, or management; and
3. If the license was ever denied, suspended, revoked, or otherwise sanctioned, a copy of documentation verifying such action and a written explanation for such action;
(H) Proposed address of the facility and—
1. A map of the surrounding area that shows compliance with the facility location requirements of Section (4)(B) of this rule; or
2. Documentation showing a local government requirement different than the requirement in Section (4)(B) of this rule and a map of the surrounding area that shows compliance with the facility location requirements of the local government; and
3. An attestation that the proposed address of the facility complies with the facility location requirements of Section (4)(B);
(I) Descriptions, schematics, or blueprints for the facility;
(J) If the city, town, or county in which the facility will be located has enacted zoning restrictions applicable to the facility, the text of the restrictions and a description of how the facility plans to comply with those restrictions;
(K) Evidence that the facility complies with all requirements for transportation certification in 19 CSR 30-95.100;
(L) For all owners, principal officers, and managers identified in the application, results of a state and federal fingerprint-based criminal background check conducted by the Missouri State Highway Patrol within the previous six months, and—
1. A statement that the individual has no criminal record in any state not covered by this background check, or
2. If the individual has a criminal record in any state not covered by this background check, results of a fingerprint-based background check from the other state or states conducted within the previous six (6) months;
(M) All facility evaluation information required by 19 CSR 30-95.020(4); and
(N) All applicable fees or proof that all applicable fees have already been paid.
(3) Facility Ownership and Employment.
(A) Cultivation, infused products manufacturing, dispensary, testing, and transportation facilities shall not be owned by, in whole or in part, or have as an officer, director, board member, manager, or employee, any individual with a disqualifying felony offense.
(B) Cultivation, infused products manufacturing, dispensary, testing, and transportation facilities shall be held by entities that are majority owned by natural persons who have been citizens of the state of Missouri for at least one (1) year prior to applying for a facility license or certification.
(C) No more than three (3) cultivation or three (3) manufacturing licenses and no more than five (5) dispensary licenses shall be issued to any entity under substantially common control, ownership, or management. Any entity under substantially common control, ownership, or management that has applied for more than three (3) cultivation, three (3) manufacturing, or five (5) dispensary licenses shall contact the department at the time of application submission to identify for the department the applications associated with that entity. The department will use this information, once application scoring is complete pursuant to 19 CSR 30-95.020(4), solely for determining how many licenses the department may issue any particular entity.
(D) No testing facility shall be owned by an entity under substantially common control, ownership, or management as a cultivation, manufacturing, or dispensary facility.
(E) Facility Agent Identification Cards. Each owner, officer, manager, contractor, employee, and other support staff of licensed or certified entities shall obtain an agent identification card, which shall be assigned and display a unique, identifying number. For all such individuals associated with an entity at the time it is licensed or certified, application for an agent identification card must be made within thirty (30) days of a license or certification being granted. For all other such individuals, application for an agent identification card must be made before beginning employment with a licensed or certified entity. Applications for agent identification cards will be accepted beginning February 15, 2020, and will be received electronically through a department-provided, web-based application system.
1. All applications for agent identification cards and renewals of agent identification cards shall include at least the following information in a department-approved format:
A. Name, address, and Social Security number of the applicant;
B. Results of a state and federal fingerprint-based criminal background check conducted by the Missouri State Highway Patrol within the previous six months, and:
(I) A statement that the individual has no criminal record in any state not covered by this background check, or
(II) If the individual has a criminal record in any state not covered by this background check, results of a fingerprint-based background check from the other state or states conducted within the previous six (6) months; and
C. All applicable fees.
2. Agent identification cards shall be valid for three (3) years.
3. If arrested for a disqualifying felony offense, agent identification card holders must notify the department within thirty (30) days of the arrest.
4. For purposes of this section, a contractor is a person or company that undertakes a contract with a licensed or certified facility to perform work that would include access to medical marijuana or related equipment or supplies for a time period greater than fourteen (14) days.
5. Agent identification card holders must have their cards accessible to them at all times while performing work in or on behalf of a facility.
6. The department shall charge a fee for identification cards, which shall be one hundred and fifty (150) dollars, due at the time of application or renewal.
(4) Facility Operation, Policies, and Procedures.
(A) Each cultivation, infused product manufacturing, or dispensary facility in operation must obtain a separate license, but multiple licenses may be utilized in a single facility. All licenses shall be displayed at all times within twenty (20) feet of the main entrance to a facility.
(B) Unless allowed by the local government, no new cultivation, infused products manufacturing, dispensary, or testing facility shall be sited, at the time of application for license or for local zoning approval, whichever is earlier, within one thousand (1,000) feet of any then existing elementary or secondary school, daycare, or church.
1. In the case of a freestanding facility, the distance between the facility and the school, daycare, or church shall be measured from the property line of the facility to the closest point of the property line of the school, daycare, or church.
2. In the case of a facility that is part of a larger structure, such as an office building or strip mall, the distance between the facility and the school, daycare, or church shall be measured from the property line of the school, daycare, or church to the facility’s entrance or exit closest in proximity to the school, daycare, or church.
3. Measurements shall be made along the shortest path between the demarcation points that can be traveled by foot.
(C) A licensed or certified facility must seek and obtain the department’s approval through a department-provided format before it may—
1. Assign, sell, give, lease, sublicense, or otherwise transfer its license to any other entity, including a parent company or subsidiary;
2. Make any changes to the ownership interests, organizational structure, or financing arrangements of the facility;
3. Materially deviate from the proposed physical design or make material changes to the current physical design of the facility; or
4. Combine licensed facilities at a single location.
(D) All marijuana for medical use, including plants, flowers, and infused products, sold in Missouri shall be cultivated in a licensed cultivation facility located in Missouri.
(E) Any excess or unusable medical marijuana or medical marijuana byproduct of a cultivation, manufacturing, dispensary, or testing facility shall be disposed of in the following manner, as applicable:
1. Solid and liquid wastes generated during medical marijuana production and processing must be stored, managed, and disposed of in accordance with applicable state, tribal, local, and municipal laws and regulations. Facilities must keep records of the final disposal destinations of all such wastes for at least five (5) years.
2. Wastewater generated during medical marijuana production and processing must be disposed of in compliance with applicable state, tribal, local, and municipal laws and regulations.
3. Wastes from the production and processing of medical marijuana plants must be evaluated against state hazardous waste regulations to determine if those wastes qualify as hazardous waste. It is the responsibility of each waste generator to properly evaluate their waste to determine if it is a hazardous waste per 40 CFR 262.11. If a generator's waste does qualify as a hazardous waste, then that waste is subject to the applicable hazardous waste management standards.
A. All solid waste, as defined by 40 CFR 261.2, must be evaluated under the hazardous waste regulations, including:
(I) Waste from medical marijuana flowers, trim, and solid plant material used to create an extract;
(II) Waste solvents, pesticides, and other similar materials used in the cultivation, manufacturing, or testing process;
(III) Discarded plant waste, spent solvents, and laboratory wastes from any medical marijuana processing or quality assurance testing; and
(IV) Medical marijuana extract that fails to meet quality testing.
B. Medical marijuana flowers, trim, and solid plant material are not in themselves considered hazardous waste unless they have been treated or contaminated with a solvent, pesticide, or other hazardous waste constituent.
4. Medical marijuana waste that does not qualify as hazardous waste must be rendered unusable prior to leaving a facility, including plant waste, such as roots, stalks, leaves, and stems that have not been processed with solvent.
5. Medical marijuana plant waste that does not qualify as hazardous may be rendered unusable by grinding and incorporating the medical marijuana plant waste with other nonhazardous ground materials so the resulting mixture is at least fifty percent nonmarijuana waste by volume. Material used to grind with the medical marijuana may be either compostable waste or noncompostable waste. Other methods to render medical marijuana waste unusable must be approved by the department before implementation.
A. Compostable mixed waste: Medical marijuana waste to be disposed as compost feedstock or in another organic waste method (for example, anaerobic digester) may be mixed with the following types of waste materials:
(I) Food waste;
(II) Yard waste; or
(III) Vegetable based grease or oils.
B. Noncompostable mixed waste: Medical marijuana waste to be disposed in a landfill or another disposal method (for example, incinerator) may be mixed with the following types of waste materials:
(I) Paper waste;
(II) Cardboard waste;
(III) Plastic waste; or
6. Disposal of medical marijuana waste rendered unusable may be delivered to a permitted solid waste facility for final disposition. Examples of acceptable permitted solid waste facilities include:
A. For compostable mixed waste: Compost, anaerobic digester, or other facility with approval of the local health department.
B. For noncompostable mixed waste: Landfill, incinerator, or other facility with approval of the local health department.
7. All facility waste of any type must be stored securely before final disposition, which can be done within the facility in areas designated for disposal activities or, if necessary, outside the facility in a locked, tamper-resistant receptacle.
(F) All cultivation, manufacturing, dispensary, testing, and transportation facilities must establish and follow procedures to ensure medical marijuana remains free from contaminants. The procedures must address, at a minimum:
1. The flow through a facility of any equipment or supplies that will come in contact with medical marijuana including receipt and storage;
2. Employee health and sanitation;
3. Environmental factors, such as:
A. Floors, walls, and ceilings made of smooth, hard surfaces that are easily cleaned;
B. Temperature and humidity controls;
C. A system for monitoring environmental conditions;
D. A system for cleaning and sanitizing rooms and equipment;
E. A system for maintaining any equipment used to control sanitary conditions; and
F. For cultivation and manufacturing facilities, an air supply filtered through high-efficiency particulate air filters under positive pressure.
(G) All cultivation, infused products manufacturing, dispensary, testing, and transportation facilities shall use a department-certified seed-to-sale tracking system to track medical marijuana from seed or immature plant stage until the medical marijuana is purchased by a qualifying patient or primary caregiver or destroyed.
1. Each facility shall designate in writing a facility agent who is generally responsible for the inventory control system for that facility.
2. Each facility shall document each day’s beginning inventory, harvests, acquisitions, sales, disbursements, disposals, and ending inventory, which must indicate, at least:
A. For every quantity of medical marijuana in the form of plants, flowers, trim, or seeds--
(I) Number of plants, including cuttings;
(II) Weight of flowers, measured in grams;
(III) Weight of trim, measured in grams; and
(IV) Weight of seeds, measured in grams.
B. For each batch of medical marijuana cultivated or processed:
(I) The batch number, harvest lot number, and process lot number, as applicable;
(II) Whether the batch originated from medical marijuana seeds or cuttings;
(III) The strain of the medical marijuana seeds or cuttings planted;
(IV) The number of medical marijuana seeds or cuttings planted;
(V) The date on which the medical marijuana seeds or cuttings were planted;
(VI) A list of all chemical additives used in cultivation, including, without limitation, pesticides, fertilizers, and other agricultural chemicals;
(VII) The number of medical marijuana plants grown to maturity;
(VIII) Harvest information, including—
(a) The date of harvest;
(b) The final yield weight of medical marijuana, in grams; and
(c) The name and identifying number of the facility agent who was responsible for that harvest;
(VIX) The disposal of medical marijuana that is not usable medical marijuana, including:
(a) A description of and reason for the medical marijuana being disposed, including the weight in grams or ounces of the disposed medical marijuana and, if applicable, the number of failed or otherwise unusable medical marijuana plants;
(b) The date of disposal;
(c) The harvest lot number and/or process lot number of the disposed marijuana;
(d) Confirmation that the marijuana was rendered unusable before disposal, including the time and location of rendering that marijuana unusable;
(e) The method of rend