Each state has their own testing lab regulations, this week we will learn about the five states from Maryland to Montana.
Maryland
This state regulates the standards for hiring and firing testing lab employees. They also regulate the individual laboratory’s responsibilities for testing samples. Each testing lab employee in Maryland has to complete and execute an application as provided by the Commission. Each lab is also required to establish and follow written procedures to verify the education and experience of potential employees. This registration information must be submitted before 15 days of employment have elapsed. If any employees are fired the independent laboratory has some important procedures. They must collect the keys, ensure that the terminated employee cannot return, and notify the Commission within just one day of the employee being fired.
Each laboratory must also comply with accreditation for testing both for medical cannabis and products containing medical marijuana. If a laboratory fails accreditation (denied, suspended, or revoked) they must notify the Commission within one day of receiving the news. There are also some statutes set on any lab before they may ever touch medical cannabis. The cannabis must be registered by the Commission. A laboratory must also be completely independent in the industry, not connected to any dispensary. They must have been accredited and established a set of standard operating procedures that create a standard chain of custody for samples being transferred into labs.
Massachusetts
As far as state testing lab regulations go, Massachusetts has one of the most extensive sets of laws. First of all, to even touch a sample of cannabis, a laboratory must be ISO 17025 accredited by A2LA or ACLASS. The certification, accreditation, or registrar must be approved by Massachusetts. The Department of Health recognizes that various chemical compounds in cannabis are used for different medical benefits. At minimum, they require the dry-weight percentage of D 9 Tetrahydrocannabinol (D 9 – THC) and cannabidiol (CBD). Though there is no specified cannabinoid profile for samples, it is required that the cannabinoid profile be labelled clearly on the product. Analytical procedures for acquiring the cannabinoid profile can be found in AHP (2013). Before samples are distributed to patients they must be tested for four metals. Quantification of these metals must be achieved with a validated method provided by USP or FDA (2011).
Any product that has been evaluated should be labelled: “This product has been evaluated for environmental contamination (impurities) assuming that no more than 10 grams (0.35 ounces) of finished plant material (or the equivalent amount of concentrate) will be consumed per day.” In addition, any edible product should also be labelled with: “This product has been evaluated for impurities based on oral consumption only. DO NOT INHALE THIS PRODUCT.”
Massachusetts does allow non-organic pesticides to be used for marijuana cultivation in their state. At their final stage all products must be tested for residues of prohibited pesticides, this is at the very minimum. They recommend specific methods for all testing labs in the Department of Public Health document we’ve linked here. They also designate that a production batch of finished plant material may be dispensed to patients or used to make other medical marijuana products if no individual pesticide or plant growth regulator is detected above 10 ppb. If a testing lab can’t reach these levels with their current equipment they will be able to adhere to separate standards listed in the Department’s doctrine above.
As with all of the other testing lab procedures, MA provides analytical methods for testing mycotoxins and microbiological contaminants in their public health document. Requirements for total yeast and mold, total viable aerobic bacteria, total coliforms, and biletolerant gram-negative bacteria are listed in colony forming unit (CFU). Pathogenic E. coli and Salmonella spp. are based on detection in a one gram sample. Mycotoxins are based on concentration per kilogram of a sample.
All concentrates, resins, and other extractions must be tested for residual solvents. Basically residual solvents must be tested for if a solvent has been used in the production process. The extraction may be dispensed as a finished product or used to make other products if they meet certain standards for residual solvents. Testing labs must find that all residual solvents are below the amounts established by The Commonwealth of Massachusetts. The product must also pack all other applicable testing practices before being distributed. They also set which solvents can be used in production. Check out their extensive rules and lists in their state document Medical Use of Marijuana Program.
Michigan
This state does not currently require any specific testing on medical marijuana.
Minnesota
Minnesota is very hands on with quality control and requires that a medical cannabis manufacturer has to develop their own written quality assurance program. In this program, the manufacturer should assess the chemical and microbiological composition of the product. Appropriate storage times and conditions, as well as expiration dates should also be set in this program. In these protocols, manufacturers must conduct the sample in a manner that will provide accurate and analytically sound results. Every sampling event should be documented. The documents will describe teh sampling and testing plans, sampling methods, and the number of units per batch. Random samples from each batch should be labelled with a unique identifier, taken in the amount necessary to conduct the test, and then submitted for testing. These results must be retained for five years.
The state requires the manufacturer to develop an acceptance criteria for potential contaminants and metals based on their own cultivation practices. Test levels are always subject to approval by the commissioner. Patient health is first and foremost in setting testing criteria in MN. The set criteria should ensure that batches meet the allowable health risk for contaminants. They also force manufacturers to formulate an SOP in case a batch ever fails. The procedure must always end in the destruction of the contaminated cannabis. Documentation of this process should be retained by the manufacturer and lab for at least five years.
Each quality assurance program should include procedures for performing stability testing of each product to determine shelf life. These test should address sample size and test intervals based on statistical criteria for each attribute examined in relation to stability. They should also test the storage conditions necessary to retain stability and reliable and specific test methods. All stability studies should include medical cannabis testing at appropriate intervals. Testing labs should also test the medical cannabis product in the container that it is sold in. After these stability tests are concluded the manufacturer can use the time frames in the tests for the future labels. If the chemical compounds or manufacturing process changes the stability tests must be carried out once more.
Medical cannabis manufacturers should keep the uniquely labelled reserve sample and store it in compliance with the product label. The reserve sample should be double the amount needed to conduct the proper tests on the product. The sample must be reserved one year past the expiration date. If at any time the commissioner deems that the public’s health may be at risk they can request that the manufacturer retest that sample.
Montana
This state does not currently require any specific testing on medical marijuana.
What do you think of states that don’t have any testing lab regulations? Do you feel safer getting medical or recreational marijuana in a state that regulates their testing procedures? Let us know in the comments.
