- Both applicants and licensee have a continuing duty to provide the department with up-to-date contact information. So, any changes to mailing addresses, phone numbers, electronic mail addresses, or other relevant contact information must be communicated to the department immediately.
- Similarly, changes to facility operations must be reported immediately.
- Typically, material changes must be reported to the department ahead of time. Examples of material changes include changes in owners, officers, members, managers and location. Some additional material changes include descriptions of violations of an ordinance or zoning violation, change in entity name, change in persons named in application, or an attempt to transfer, sell, or convey an interest in a license. Finally, any changes or modifications to the facility that were not yet inspected must be reported.
- Licensee must notify the department within 1 business day after becoming aware of or should have been aware of any of the following:
- Criminal convictions, charges or civil judgements against an applicant or licensee in any state.
- Adverse reactions to marijuana product sold or transferred by any licensee.
- Regulatory disciplinary action taken or determined against an applicant or licensee by any state.
- A licensee must notify the department, state police, and local law enforcement authorities within 24 hours of becoming aware of or should have been aware of the theft or loss of a marijuana product or criminal activity at the facility.
- The department may at any time, without a warrant and without notice, enter the facility, offices, or other places of business of a licensee if evidence of compliance or noncompliance is likely to be found in accordance with the act and these rules.
- The department may place an administrative hold on a marijuana product and order that no sales or transfers occur during an investigation for an alleged violation.
- Licensee's failure to cooperate with an investigation can result in the impoundment, seizure, assumption of control over, or the removal of records from the facility.
- The department may also eject or exclude an individual who is in violation of the act.
- Sanctions for the violation of these rules include license denial, restrictions on a license, fines, revocation, suspension, or nonrenewable of a license and orders to cease operations.
- Entity must only operate the type of facility allowed by the license.
- Licensee must comply with the following:
- Facility must be partitioned from another marijuana facility, activity, business or dwelling.
- Facility may not allow onsite sale, consumption, or serving or food (except for as provided in R 333.281).
- Facility may not allow onsite sale, consumption, or use of alcohol or tobacco products.
- Facility may not allow the consumption, use, or inhalation of a marijuana product.
- A marijuana facility shall have distinct and identifiable areas with designated structures that are contiguous and specific to the state operating license.
- Facility shall have separate entrances and exits, inventory, record keeping, and point of sale operations if applicable.
- Access to the facility shall be restricted to licensed employees, department agents, and patients and caregivers with valid registry cards. A visitors log must be current and available at all times for inspection.
- Licensee records must be maintained and be made available to the department upon request.
- All facilities must be at a fixed location. Put differently, they may not be mobile.
Operations at the same Location
- A licensee holding multiple licensee types can operate all of the separate facilities at the same location. A stacked license of this kind is considered one facility. Department authorization is necessary for this. The facility also must comply with local ordinances.
- A licensee operating multiple types of facility at one location must also:
- Apply for and obtain all licenses separately.
- Have distinct and identifiable areas with designated structures that are contiguous and specific to the state operating license.
- Have separate entrances, exits, inventory, record keeping, and point of sale operations where needed.
- Post the operating license on the wall.
- Obtain all necessary inspections and permits.
- If necessary, there should be a clearly marked retail entrance and exit separate from the other operations.
Marijuana Facilities; Requirements
- The facility must be housed in a building that meets security requirements and passes inspections.
- Operations must take place within a building, except cultivation that may occur outdoors if the outdoor area is continuous with the building and is full enclosed by fences or barriers that block outside visibility of the plants. Plants may not grow above fence-height. There must be security including locked entries.
- After the marijuana is harvested, the drying, trimming, curing, or packaging of the marijuana must occur inside the building and meet all of the requirements under these rules.
- The building must meet security requirements, passes the inspections, and has a building permit.
- A secure transporter shall have a primary place of business as its marijuana facility. The secure transporter must hold a separate license for every marijuana facility where a marijuana product will be stored. The transporter may travel through any municipality to transport a marijuana product. The transporter must comply with all of the following:
- Transporter may take physical custody of the marijuana or money, but legal custody belongs to transferor or transferee.
- Transporter may not purchase or sell the marijuana products.
- Transporter must transport the marijuana product in a locked secured, and sealed container, with a locked lid or closed door, that is not accessible while in transit. Marijuana from different facilities may not commingle. All marijuana products must be labeled and kept in separate compartments or containers. If the transporter is also transporting money, the money should be locked and kept separate from the marijuana product.
- Money associated with the purchase or sale of marijuana shall be logged and tracked by the secure transporter.
- Transporter must have a route plan and a manifest and carry it with them while transporting.
- The transporter shall follow the manifest. In cases of emergencies, the transporter shall notify the transferor and transferee, update the statewide monitoring system, and revise the manifest to reflect the change.
- The secure transporter may not maintain custody of the marijuana for more than 48 hours unless the transporter obtained permission by the department.
- Secure transporter shall identify and record all vehicles with the department and have the required vehicle registration with the secretary of state. The secure transporter's vehicles are subject to inspection at any time by the department.
A provisioning center shall have a separate room for the point of sale for the transfer or sale of marijuana product. Provisioning center shall keep marijuana products behind a counter or other barrier. Sales to qualifying patients who are under 18 must be made to a qualifying patient's parent or legal guardian, who serves as the registered qualifying patient's registered primary caregiver.
- A marijuana facility shall ensure that the handling of marijuana product is done in compliance with current good manufacturing practice in manufacturing, packing, or holding human food.
- A marijuana facility shall enter in the statewide monitoring system all transactions including, but not limited to, current inventory.
Building and Fire Safety
- Licensee must have a permanent certificate of occupancy has been issued by the appropriate enforcing agency in order to operate a marijuana facility.
- Licensee must have a building permit.
An applicant or licensee shall not operate a marijuana facility unless the proposed marijuana facility has passed the prelicensure fire safety inspection by the BFS. The state fire marshal, or his or her authorized designee, may conduct pre- licensure and post-licensure inspections of a marijuana facility. An applicant or licensee shall comply with the all of the following:
(a) A BFS inspection may be conducted at any reasonable time to ensure fire safety compliance. A BFS inspection may be annual or biannual and may result in the required installation of fire suppression devices or other means necessary for adequate fire safety pursuant to state standards.
(b) The BFS may require marijuana facilities to obtain any of the following operational permits:
(i) Carbon dioxide systems used in beverage dispensing applications, amended for cultivation use and extraction.
(ii) Compressed gases.
(iii) Combustible fibers.
(iv) Flammable and combustible liquids.
(v) Fumigation and insecticidal fogging.
(vi) Hazardous materials.
(vii) High piled storage (high rack system cultivation).
(viii) Liquefied petroleum (LP) gas.
(i) Building construction.
(ii) Electrical, mechanical, plumbing, boiler, and elevator.
(iii) Compressed gases.
(iv) Flammable and combustible liquids.
(v) Hazardous materials.
(vi) Liquified petroleum (LP) gas.
(vii) Automatic fire extinguishing/suppression systems.
(viii) Fire alarm and detections systems.
(ix) Related equipment found during fire safety inspections.
There are additional fire requirements as promulgated by the National Fire Protection Association (NFPA)
a) Ductwork must be installed with accordance with the Michigan mechanical code, R 408.30901 to R 408.30998.
(b) Suppression systems outlined in NFPA 1 and the Michigan mechanical code, R 408.30901 to R 408.30998, may be required to meet the suppression needs within a marijuana facility.
(c) Processors, growers, and safety compliance facilities shall implement appropriate exhaust ventilation systems to mitigate noxious gasses or other fumes used or created as part of any production process or operations. Exhaust and ventilation equipment must be appropriate for the hazard involved and must comply with NFPA 1 and Michigan mechanical code, R 408.30901 to R 408.30998.
- There must also be continuous fire safety checks in response modifications to the building.
- Applicants must submit a security plan.
- Licensees must insure that persons at the facility, other than employees, are escorted at all times.
- The facility must be locked at all times with commercial grade, nonresidential door locks. This includes interior rooms, windows points of entry/exit. Egress door locks must meet the requirements of NFPA 1, local fire codes, and the Michigan building code.
- There must be an alarm system.
- Licensee must have a video surveillance system, that consists of digital or network video recorders, cameras, video monitors, digital archiving devices, and a color printer.
- At a minimum, the video surveillance system must record areas where:
- The marijuana products are weighed, packed, stored, loaded, and unloaded for transport, prepared, or moved within the facility. It must also record in limited access areas and security rooms. Transfers between rooms must also be recorded.
- Areas storing a surveillance system device with not less than 1 camera recording the access points to the secured surveillance recording area.
- Entrances/exits to the building must be recorded from indoor and outdoor vantage points.
- Marijuana products are sold or displayed for sale.
- These recordings must have a minimum of 729p resolution.
- Each license must be installed in a fixed location. Camera placement must allow the camera to clearly record activity occurring within 20 feet of all points of entry and exit on the marijuana facility. The camera must allow for the clear recording of facial features.
- The camera must record continuously for 24 hours per day while accurately displaying the time and date.
- The physical media or storage device on which surveillance recordings are stored must be secure to protect against tampering or theft.
- At a minimum, the video surveillance system must record areas where:
- Generally, these surveillance videos must be kept for a minimum of 30 days. If there is an ongoing investigation, the tapes shall be kept until the department or law enforcement permits their destruction.
- Surveillance recordings may be inspected by the department, so they must be kept in a manner that allows the department to view and obtain copies of the recordings at the facility upon request immediately.
- This surveillance system must be equipped with a failure notification system.
- The facility shall keep a log of the recordings that includes:
- The identities of the employee(s) responsible for monitoring the video surveillance system
- The identity of the employee who removed the recording system from the storage device along with the data and time removed
- The identity of the employee who destroyed any recording
- Licensees may not sell or transfer marijuana products that are not identified in the statewide monitoring system pursuant to the act or these rules.
- Marijuana products without a batch number or identification tag or label pursuant to these rules must not be at the facility. Thus, a licensee must immediately tag, identify, or record any marijuana product.
- Violations can result of sanctions or fines.
Marijuana Product Destruction and Waste Management
- Marijuana products that are to be destroyed must be rendered unusable and unrecognizable. This can be accomplished through grinding and incorporating the marijuana product waste with non-consumable solid waste.
- This waste must be recorded into the statewide monitoring system.
- Licensees cannot sell the product that was destroyed as waste or is ordered to be destroyed as waste.
- Licensee must manage all hazardous waste pursuant to part 111 of the natural resources and environmental protection act.
- The licensee must dispose of marijuana product in a secure waste receptacle.
Storage of Marijuana Product
- All inventories of marijuana products must be stored at a marijuana facility in a secured limited access area or restricted access area and must be identified and tracked consistently in the statewide monitoring system under the act, the marijuana tracking act, or these rules.
- Containers for sales or transfers must be clearly marked and enclosed on all sides. Containers must be latched or locked to keep the contents secure. Containers must be identified and tracked consistently in the statewide monitoring system under the act, the marijuana tracking act, or these rules.
- Provisioning centers must store all marijuana products for sale or transfer separately from the stock rooms.
- Chemicals and solvents must be stored separately from marijuana products and kept in locked storage areas.
- Marijuana-infused products, edible marijuana products, or any products in direct contact with the aforementioned products must be stored separately from toxic or flammable materials.
- Marijuana products that are edible must be stored in compliance with current good manufacturing practice in manufacturing, packing, or holding human food. Also, editable marijuana products not in their final packaging must be stored separately from other marijuana products.
- Marijuana products for transfer or sale must be stored behind a counter or other barrier separated from the stock rooms.
- A safety compliance facility shall establish an adequate chain of custody and instructions for sample and storage requirements.
- Stock and storage rooms must meet the security requirements of these rules.
Because this is a heavily regulated industry, there are stringent testing procedures that marijuana facilities must undergo.
- Growers must identify each immature plant batch in the statewide monitoring system. Immature plant batches cannot consist of more than 100 immature plants.
- Plants greater than 8 inches must be tagged and recorded.
- Grower must separate plants as they go through different growth stages.
- After a tagged plant is harvested, it can be sampled as part of the harvest batch. Until it is tested, this batch must remain separate from all other batches.
- Before the product can leave the facility, a sample batch must be tested by a licensed safety compliance facility. Test results must be entered into the statewide system before the marijuana can be repackaged. Failure of the test due to pesticides cannot be remediated. If the facility cures a failure, the product still may not be sold until receiving approval from the department.
- After a batch is packaged, the grower must destroy the individual tags.
- Grower may not transfer or sell any marijuana product that has not been packaged with a tag and entered in the statewide monitoring system.
- A processor who received a batch then must give the product a new package tag each time the product changes form or is incorporated into something else.
- When the processor had the product in its final state, it must be tested. The processor may not sell or transfer the product until results indicate passage of the test.
- Then, once a provisioning center obtains the marijuana product, the center may only transfer the product to registered patients or registered primary caregivers. The center can make this transfer if the product is labeled, and the product has passed the test in the statewide monitoring system.
- A safety compliance facility may test or retest a sample to validate the results of a failed safety test.
- A failed safety test must pass 2 separate retests to be eligible to proceed to sale or transfer. If the sample failed one of the two retests, the batch must be destroyed.
- Marijuana products may not be retested when:
- The marijuana product is in a final package
- A final test for chemical residue failed pursuant to these rules.
- The product failed for microbial on a final test.
Safety Compliance Facilities and Testing
- Must use analytical testing methodologies, and this will be monitored by the department or a third party.
- Must conduct all of the tests below.
- Potency analysis that includes all of the following:
- (i) Tetrahydrocannabinol level.
- (ii) Tetrahydrocannabinol acid level.
- (iii) Cannabidiol level.
- (iv) Cannabidiol acid levels.
- Foreign matter inspection.
- Microbial screening.
- Chemical residue testing that includes all of the following:
- (i) Pesticides.
- (ii) Fungicides.
- (iii) Insecticides.
- Heavy metals testing as required in this rule.
- Residual solvent levels. The department may publish a list of required residual solvents and the action limits or levels.
- Water activity including moisture content.
- Mycotoxin screening if requested by the department.
- Failure to pass any of the tests will result in the entire batch being destroyed.
- For the purposes of the microbial screening and foreign matter inspection, a sample provided to a safety compliance facility pursuant to this rule is deemed to have passed if it satisfies the standards in the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph adopted by reference pursuant to R 333.203.
- The department may request mycotoxin testing. If the marijuana sample exceeds the published acceptable level, it is considered to be failed. A sample that is below the accepted value, then it is a passing sample.
- Heavy metal levels must fall below the department's published amount.
- The department also promulgated standards regarding acceptable levels for residual solvent, and chemical residue.
- The safety compliance facility must also:
- become professionally accredited.
- become fully accredited to the International Organization for Standardization (ISO) or by an International Laboratory Accreditation Cooperation (IEC).
- maintain internal standard operating procedures.
- Maintain quality control and quality assurance program that conforms to the ISO/IEC standards.
- A safety compliance facility must enter the information in the statewide monitoring system for a catch to be released for immediate processing, packaging, and labeling for transfer of sale.
- All results must be maintained so that they can be presented to the department upon request.
- Safety compliance facilities that fail to comply with the rules may be subject to sanctions, fines, or both.
- Safety compliance facilities are prohibited from:
- (a) Desiccate samples unless performing moisture analysis on the sample.
- (b) Dry label samples.
- (c) Pre-test samples.
- A safety compliance facility must comply with random quality assurance compliance checks.
- Safety compliance facilities may perform terpene analyses using an ISO accredited method.
- A safety compliance facility shall comply with the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia, which is adopted by reference in R 333.203, unless these rules provide otherwise.
Sampling and Safety Compliance Facilities
- Safety compliance facilities shall test samples.
- Safety compliance facilities shall physically collect the samples. Safety compliance facilities shall ensure that the samples of the marijuana product are places in secured, sealed, containers that have the proper labeling.
- The facility must collect a sample sufficient for testing, but this sample may not be less than 0.5% of the weight of the batch. The maximum batch size is 15 pounds.
- The sample must be entered into the statewide monitoring system along with the date and time that the product was collected, transferred, tested, and recorded.
- If a sample is collected for testing, it must be quarantined and not sold until the testing is passed.
- Sample may not be transferred after testing to anyone except for the licensee who submitted the sample.
- Safety compliance facilities may request additional sample material from the same licensee from which the sample was collected.
Marijuana- Infused Products and Edible Marijuana Product
Marijuana-infused products come with a separate set of requirements.
- A processor must prepackage and properly label marijuana- infused products before sale or transfer.
- Products must be homogenous. Permissible THC variation is to be no more than +/- 15%.
- The processor shall list and record THC levels of marijuana infused products.
- Marijuana-infused products must be stored and secured as prescribed under these rules.
- Processor must label any marijuana-infused product it produces or packages with the following:
- the name and address of the marijuana facility that processes or packages the product.
- the name of the product.
- the ingredients in the product, in descending order of predominance by weight.
- the net weight or volume of the product.
- for edible marijuana products, the processor must comply with the above requirements as well as:
- (i) Allergen labeling as specified by the Food and Drug Administration (FDA), Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), 21 USC 343;
- (ii) If any nutritional claim is made, appropriate labeling as specified by Code of Federal Regulations, Food Labeling, Title 21, Part 101, 21 CFR part 101 (2017); and
- (iii) The following statement printed in at least the equivalent of 11-point font size in a color that provides a clear contrast to the background: "Made in a marijuana facility.”
- Processors of edible marijuana must make sure:
- Potentially hazardous ingredients used to process shelf-stable edible marijuana products must be stored in 40 degrees Fahrenheit (4.4 degrees Celsius) or below.
- Provide employee training on safe food handling and demonstrate an employee's completion of this training program. A course taken pursuant to this program must be conducted for not less than two hours and cover:
- (i) Causes of foodborne illness, highly susceptible populations, and worker illness.
- (ii) Personal hygiene and food handling practices.
- (iii) Approved sources of food.
- (iv) Potentially hazardous foods and food temperatures.
- (v) Sanitization and chemical use.
- (vi) Emergency procedures, including, but not limited to, fire, flood, and sewer backup.
- Additionally, to ensure compliance with safe preparation standards, the licensee shall comply with at least one of the following:
- The FDA food safety modernization act
- The Safe Quality Food act
- The International Organization for Standardization.
- The department may request written documentation to verify certifications and compliance with these rules.
- Edible marijuana product package cannot be shaped or labeled in ways that would apply to minors. (No cartoons, caricatures, toys, designs, shapes, or packaging that is appealing to minors). Packaging cannot have designs that could be easily confused with commercially sold candy.
- They must be packaged in opaque, resealable, child resistant packages or containers.
- Edible marijuana products may not require time or temperature control for safety. Package must also have the following information:
- expiration or use-by date. Once this label has been affixed, the date on the package shall not be altered by the licensee.
Sale or Transfer
Plant Tracking Requirements
- Marijuana products that are sold or transported between facilities must have tracking numbers.
- The department may recall products.
- Before a marijuana plant is sold or transferred, a package tag must be affixed to the plant or plant container with the business name or trade name, license number, RFID package tag, name or strain, date of harvest, seed strain, and universal symbol.
Product Tracking Requirements
- Marijuana products that are sold or transported between facilities must have tracking numbers.
- The department may recall products.
- Before a marijuana plant is sold or transferred, a package tag must be affixed to the plant or plant container with the business name or trade name, license number, RFID package tag, name or strain, date of harvest, seed strain, and universal symbol, net weight, concentration of THC and CBD, name of compliance facility that performed any test, activation time, ad the following warnings:
(i) "For use by registered qualifying patients only. Keep out of reach of children."
(ii) "It is illegal to drive a motor vehicle while under the influence of marijuana."
(iii) “National Poison Control Center 1-800-222-1222.”
(2) An edible marijuana product sold by a provisioning center must comply with R 333.261(7).
- Provisioning centers can sell or transfer a marijuana product to a registered qualifying patient or visiting qualified patient if all of the following are met:
- Licensee confirms that patient has a valid registry identification card.
- Licensee confirms that patient has a valid government identification card.
- Licensee confirms that transfer or sale will not exceed permissible limits.
- The product was properly tested, labeled, and packaged.
Daily purchasing limits
- May not exceed 2.5 ounces/day for a qualifying patient.
- May not exceed 2.5 ounces/day for a registered primary caregiver.
- May not exceed 10 ounces/month purchasing limit through either the primary caregiver or the qualifying patient.
- A background check must be conducted on all prospective employees. Licensee must keep these records in case if the department requests to see them.
- Licensee must have a policy in place that requires all employees to report new or pending charges or convictions. Felony charges or convictions must be immediately reported to the department. Licensee must also enter new employee's information (ID number, level of access) into the statewide monitoring system within 7 business days of hiring the employee.
- Licensee must train employees and have a training manual.
- Licensee must establish point of sale or transfer procedures including training in dosage, marijuana product information, health or education materials, point of sale training, purchasing limits, CBD and THC information, serving size, and consumption information including any warnings.
- Licensees must screen prospective employees using the list of excluded employees created by the department.
- If a registered primary caregiver is hired at a marijuana facility, the individuals shall withdraw registration as a registered primary caregiver.
- Employees must handle the product in compliance with current good manufacturing, packing, or holding human food.
- No person is to be present in a marijuana facility or a transport vehicle who is not identified as a licensee or employee.
- Employee records are subject to examination.
- Employees may not consume food where marijuana is stored, processed, or packaged or where hazardous materials are used, handled, or stored, unless the facility has designated rooms to do so.
Provisioning Center Home Delivery Employees
- Online orders are only permissible in this circumstance and through a secure website.
- The delivery can only go to the home address of the qualifying patient.
- The delivery is limited by the daily and monthly dosage limits.
- These transactions must also be recorded in the statewide monitoring system.
- The delivery person must verify that the person accepting the delivery is the qualifying patient.
- The department can take away a provisioning center's ability to allow home deliveries.
- Records shall be kept that it was verified that the patient has a valid registry identification card; the patient presented his license or ID card at pick up; there was a verification of the home address; the qualifying patient consented in writing to home delivery; and maintenance of vehicle used in delivery.
- The driver for the home delivery must carry his employee ID number, provisioning center license number, contact information of the provisioning center licensee, a copy of the provisioning center's home delivery log, and a secure line of communication to the provisioning center.
- The home delivery employee (1) must maintain a physical or electronic copy of the home delivery request; (2) shall not leave a marijuana product in an unattended motor vehicle unless the motor vehicle is locked and equipped with an active vehicle alarm system; (3) vehicle must contain a global positioning system that the provisioning center can track; (4) cannot make more than 10 trips at a time; (5) must go from the center, to the delivery, and back; (6) may refuel the vehicle during a delivery.
- Delivery employee may not carry marijuana product valued in excess of the amount of the registered qualifying patient's delivery of the product at any time. Transactions must be completed within one business day. Money obtained must be brought back to the center.
- Home delivery employee cannot serve multiple provisioning centers.
- Home deliveries must occur during the hours of operation of the provisioning center.
- Product for home delivery must be individually packaged and may not be commingled during delivery. Product must be locked and secure.
For each delivery, the home delivery log must record all of the following:
(a) The date and time that the delivery began and ended.
(b) The name of the home delivery employee.
(c) The amount of marijuana product allowed to be possessed for delivery.
(d) The lot number of the marijuana product and the name of the strain of that marijuana product.
(e) The signature of the registered qualifying patient who accepted delivery.
A provisioning center shall notify the department, state police, or local law enforcement of any theft, loss of marijuana product, or criminal activity as provided in R 333.216. A provisioning center shall report to the department and law enforcement, if applicable, any other event occurring during home delivery that violates the home delivery procedure as provided in this rule, including delivery vehicle accidents and diversion of marijuana product.