Does Minnesota Require Testing for Marijuana and Marijuana Products?
Yes, the State of Minnesota requires manufacturers of medical marijuana products to test all their products before making them available for public consumption. Section 9(b) of the Minnesota Session Laws-2014 requires manufacturers of medical marijuana to contract with marijuana testing laboratories to test products manufactured for public consumption. Medical marijuana products in Minnesota are required to be tested to:
- Ascertain what the product contains
- Ascertain that they do not contain contaminants
- Ascertain that they are consistent with the state’s requirement for medical cannabis. Subdivision 6 of the Minnesota Statutes 2020 defines medical marijuana as any of the species of the genus cannabis plant, their mixture, preparation, whole plant extract, or resins packaged for consumption in any of the following forms:
- As oil, or other forms of liquid
- As pill
- As a vaporized delivery product that can be used with oil or other forms of liquid, this excludes dried marijuana leaves or other plant forms.
- As any form or package of marijuana suitable for medical uses, excluding smoking, however, the forms must be approved by the Minnesota Commissioner of Health.
Section 4770.0550 of the draft rules regulating medical cannabis laboratory requirements in Minnesota require all medical marijuana products to undergo the following tests and for the following reasons:
General testing: The Minnesota Department of Health requires manufacturers of medical marijuana products to submit documents defining the content of each of their finished goods to the Commissioner for Health. This will be compiled in the registered finished goods list of the Minnesota Department of Health. The marijuana testing laboratory that took the test must complete a final test report after conducting the test on the samples. The testing facility must include a description of the tests they conducted, the methods used, and the results obtained from the tests. These must be included in the final report and forwarded to the Minnesota Commissioner for Health and the manufacturer.
Safety testing: The Minnesota Department of Health requires that a medical marijuana product formulation passes safety testing conducted by an approved third-party laboratory. A full spectrum safety testing must be conducted to determine all substances in the product. This must be done before a product formulation can be used to formulate a finished good.
Contaminant testing: Contaminant testing focuses on the presence of some specific analytes and their concentration. Here are the focus contaminants in medical marijuana products and the maximum acceptable concentration.
- Arsenic: 1.5 ppm (ppm is parts per million)
- Cadmium: 0.3 ppm
- Lead: 1 ppm
- Mercury: 0.5 ppm
- Aflatoxin B1: 5ppb (ppb is parts per billion)
- Aflatoxin B2, Aflatoxin G1, and Aflatoxin G2: There is no specific maximum limit for each of these three toxins, but the concentration summation of three must not exceed 15 ppm)
- Salmonella: must be absent
- E. coli: 7 CFU/g (CFU is Colony Forming Units)
- Mould and Yeast: 1000 CFU/g
- Aerobic Bacteria:100000 CFU/g
- Bile tolerant gram-negative bacteria: 150 CFU/g
- Pentane: 3000ppm
- N-hexane: 290ppm
- Pesticides: The manufacturer of a medical marijuana product must inform the marijuana testing laboratory if they used pesticides in the production process of the marijuana. The maximum concentration of pesticide in the product depends on the pesticide named by the manufacturer.
Potency testing: The Minnesota Department of Health requires that potency testing be conducted on all medical marijuana products in the state. The permissible potency variance for product contents measured by mg of cannabinoid/product weights are as follows:
- Primary cannabinoids: +/-10%
- Secondary cannabinoids: +/-25%
- Cannabinoids found in trace amounts do not have a potency limit except for tetrahydrocannabinol (THC) and tetrahydrocannabinolic acid (THCA). Cannabinoids found in trace amounts should be less than 1% of the total cannabinoid content, and they are required to be listed in the final testing report.
Stability testing: The Minnesota Department of Health requires that stability tests be conducted on every batch of medical marijuana products produced in the state. This is to ascertain that the product will be safe and effective until its expiration. The test must be conducted before the product is released to the market (the initial time). The test must also be conducted every three months for the first twelve months after the initial time and every six months after the first twelve months.
Does Minnesota License Independent Marijuana Testing Facilities?
Yes, the Minnesota Department of Health licenses independent marijuana testing facilities to ascertain the safety of medical marijuana products for human consumption. Medical marijuana testing laboratories can apply for licenses anytime as the license application is open all through the year. There are two independent medical marijuana laboratories approved in Minnesota. The state does not have a government agency conducting medical marijuana testing.
What Accreditations Do Marijuana Testing Facilities Need in Minnesota?
The Minnesota Department of Health requires all approved medical marijuana testing facilities in the state to have an ISO/IEC 17025 accreditation. In the Sales of Certain Cannabinoid Products Workgroup Report, medical marijuana manufacturers and growers must perform sampling and testing according to the ISO/IEC 17025 standard. The ISO/IEC accreditation is a formal recognition of the competence of a testing laboratory granted by the American National Standards Institute (ANSI) National Accreditation Board. The accreditation can be obtained when a testing laboratory meets the laboratory operation standards of the board. Laboratory test results obtained from an ISO/IEC accredited laboratory are deemed reliable.
The American National Standards Institute (ANSI) National Accreditation Board requires marijuana testing facilities to:
- Submit a document showing how the testing laboratory plans to perform representative sampling of all activities specified within the scope of the accreditation for a period not less than three years. The document submitted is expected to contain an evaluation of the possible risks associated with the processes of laboratory operations. Planned procedures to curtail these risks are also expected to be contained in the document.
- Prove to the ANSI National Accreditation Board their commitment to investigate any test results that fall outside of the predefined performance range. Actions expected of a marijuana testing facility in situations of unsatisfactory results include:
- The marijuana testing laboratory shall promptly notify the ANSI National Accreditation Board of any case of unsatisfactory results. The notification to the board can be done through email, using the ANAB FM 2830 Client Notification form.
- The testing facility shall have a documented time frame within which corrective actions will be taken in cases of unsatisfactory results.
- The testing facility shall have a record of the summary of all cases of unsatisfactory results. This shall consist of a briefing on the investigation and conclusion of all cases of bad results that occurred in the testing laboratory.
- Participate in proficiency testing (PT)/Inter-laboratory comparison(ILC), covering the processes defined in the scope of the accreditation. These include test technologies and other parameters. The term proficiency testing (PT) evaluates participants’ performance as they relate to established criteria.
How to Get a Marijuana Testing Laboratory License in Minnesota
The process of the application for a medical marijuana testing license in Minnesota is divided into three steps. These steps and the processes involved are stated below:
Step 1: The application and documentation stage:
This stage requires the applicant to submit the following documents:
A completed Medical Cannabis Laboratory Approval Program Application Form. This may also be collected from the Commissioner for Health.
A completed, signed, and notarized attestation form, which is obtainable from the office of the Commissioner for Health. This is to ascertain that the medical marijuana testing facility is independent of all medical marijuana facilities, both in operations and finances.
A quality assurance manual of the marijuana testing laboratory. This manual contains the management policies, company objectives, structure of the organization, and its chain of authority. It also contains the laboratory’s responsibilities and the implementation structures by which it ensures the quality of its services. The required sections in a quality assurance manual are:
* A title page, which should bear the name, address, and phone number of the contact person to the marijuana testing laboratory
- The effective date for revision.
- Signatures of approval authorities, such as those of the technical directors, quality assurance manager, and the laboratory director
- The organizational chart, showing the flow of authority, roles and responsibilities of individuals, and other important details
- The testing facility’s document control procedure. This procedure should state processes for the approval, issuance, and change of documents. Documents that are no longer in use should be suitably marked for identification as obsolete documents.
- List of jobs in the marijuana testing facility and the job descriptions
- A documented procedure of operation for every laboratory activity, processes involved in the determination of test results, and the production of analytical data
- A list of all accredited testing methods approved for the testing facility
- A document explaining the test processes to prospective clients and offering them an opportunity to review the testing contract. This document should state the methods to be used for each test and demonstrate that the testing laboratory has the resources to undertake the required tests.
- A list of the major equipment acquired for operations by the marijuana testing laboratory
- A document containing the reference standards adopted by the marijuana testing facility. This should include the company’s procedure for the calibration of all applicable reference standards. This includes weights, balances, thermometers, and other standards.
- A document containing the methods used in the maintenance of equipment
- A document containing the method employed by the testing laboratory to verify testing procedures such as the collection of performance testing samples, split samples, etc.
- A document containing the action procedures of the testing laboratory to investigate and resolve cases of non-conformance with organizational policy and acceptable standards
- A document explaining the organization's procedure for handling and resolving complaints from clients
- A document stating the testing laboratory’s commitment to the protection of confidentiality
- A document detailing the testing laboratory’s procedure and frequency of undertaking internal audits
Standard operating procedures of the testing laboratory. This includes details of the methods of operation, analysis, actions, and techniques used by the facility. The standard operating procedure should include the following for each of the testing methods:
Identification of the method or technology to be used for the testing, e.g., gas chromatography-mass spectrometry (GC/MS), a technique that can study gaseous, liquid, and solid samples
- The applicable testing matrix or matrices
- Acceptable limits of detection and quantitation
- The scope and application of the method specifying the parameters to be analyzed
- Summary of the testing method. This should include a list of preparation steps like sample volume, method of sample extraction, and digestion. It should also include the techniques used for quantitative determinations.
- The definition of terms used in the manual of standard operating procedures
- A list of all known possible interferences that could apply to each of the testing methods
- Safety procedures
- A material detailing the concentrations and the preparations of the reagents, including standards that will aid the duplication of works
- A detail of the approach of sample collection, preservation, shipment, and storage conditions
- Method of data analysis, assessment, and calculations
- Method of waste management
- Relevant images such as flowcharts, tables, validation data, and diagrams
- A demonstration of the testing laboratory’s capability and the acceptability of their test results by the supply of acquired certificates and approvals
- The name and educational qualification of at least one technical manager involved in the process of achieving and maintaining the quality and standards required of the facility
These documents are to be submitted physically to the Minnesota Department of Health using the address below:
Minnesota Department of Health
St. Paul, MN 55164-0882
Telephone: (651) 201-5598
Step 2: The Onsite Visit Stage:
The Minnesota Department of Health conducts an onsite visit to medical marijuana testing laboratories to review the following records and ascertain their competence to conduct laboratory testing.
- Laboratory procedure training records
- Detection limits for test results
- Activity logs in the testing laboratory, including temperature logs, balance logs, equipment maintenance logs, and records of calibrations used in the laboratory. Other logs necessary to be included are bench sheets or analytical logs and microbiology logs such as autoclave checks, culture media checks, and apparatus sterility checks.
- Calibration logs of glassware used for testing
- Reports of analytical tests done in the laboratory
Step 3: Testing license approval by the Minnesota Department of Health
The Minnesota Department of Health assesses the testing facility based on the documents submitted by the applicant and their observations from the onsite visit. If the Department finds the testing facility capable of testing with reliable procedures and test results, they will issue the facility a medical marijuana testing laboratory license. However, the license will indicate the analytes approved for the facility to test and the methods approved for testing in the facility.
How Much Does a Marijuana Testing Laboratory License Cost in Minnesota?
The Minnesota Department of Health does not make public the amount payable to obtain a marijuana testing laboratory license. Applicants may, however, contact the Minnesota Department of Health to request the amount payable for medical marijuana testing laboratory license using the address below:
Minnesota Department of Health
PO Box 64882
St. Paul, MN 55164-0882
Telephone: (651) 201-5598
Are there Local Regulations for Cannabis Testing Facilities in Minnesota?
Minnesota requires cities, counties, and municipalities to regulate the establishment and operations of medical marijuana testing laboratories in their localities. These regulations may include the procurement of local operational licenses, security standards, distance from schools and other facilities, etc. Medical marijuana testing facilities must abide by all the regulations stated by the city or county offices before they are permitted to operate in the locality.