The rules for the testing of cannabis, derivatives, concentrates and cannabis infused products have been long in coming. They were due to be written in 2017, per the constitutional amendment, and we now are in a new decade.
For the MMTC’s of Florida, this is a complex industry, coming from a dark and illegal world, not of their making. In this world of vertical integration, where each MMTC must be an expert at every aspect of cannabis production, from the choice of strain to cultivation, to production and growth, harvest and curing, product packaging, retail sales and distribution and finally delivery to product to patients. all licenses were initially given to horticultural nurseries, demanding that they cultivate a plant that was as alien to them as any plant they have ever seen, to make a medical-grade product to be sold to people with debilitating conditions.
REGULATION IS NECESSARY WHEN PRODUCING MEDICINE
The concept that, it grows like a weed in your backyard by just throwing seeds in the ground, and “boom”, you have medicine, is a fallacy. Anyone who has ever been inside a pharmaceutical manufacturing facility would understand that. Medicine, intended for patients, is made in “clean rooms”, and workers in clean suits, often called “Bunny suits” work in sterile conditions with every surface, container and tool sterilized.
Florida’s air and soil are full of contaminants. The humid air is filled with mold spores and the air and soil contains heavy metal, bacteria and residue of pesticides. Often growers, opting for simpler solutions add even more contaminants to combat insects and microbial threats.
The MMTC’s having been working as hard as they can to make medicinal products and have often spared no expense to deliver a product that is pure, potent and safe. But they are human, and the Florida ecosystem throws many curves, as do the workers who are hired and trusted by the MMTC’s to help them create a product that they would be confident and proud to sell.
CHALLENGED BY A BLACK MARKET PAST AND VERTICAL INTEGRATION TODAY
To add to all that they have to work within this vertically-integrated system, to be experts in laboratory analysis, a costly process requiring an entirely different skill set then cultivation, packaging and delivery, makes things even more complicated.
Plus, in this era where the industry is still emerging from a dark, illegal world, where no one can be fully trusted, since it was an unregulated industry, putting them in charge of testing their own product, for which its success is reliant on the results, is unfair. How can they build trust when they are testing their own product or directly paying someone to do so?
States like Nevada, where prices hinge on laboratory-reported THC potency, have found and prosecuted labs that have produced results for cannabis producers that are created or altered to fit the producer’s needs.
WE NOW KNOW EXACTLY WHAT’S REQUIRED OF MMTc’S and TESTING LABORATORIES
The rules are a welcome event from the Department of Health, in their constitutional and statutory duties, have stepped up to the plate to protect the patients of Florida and build a bond of trust between the MMTC’s and the public, and verify the purity, potency and safety that they have worked so hard to create.
There are many moving parts to these rules, including a plethora of definitions of all items involving ownership of the labs, and all the terms involving all aspects of competent testing of any kind of cannabis product, from flower to derivatives, concentrates to edibles, from operating procedures to contaminants, including quantizing residual amounts of solvents and agents used to create the completed product.
Unless you are truly a lab nerd, it’s enough to make your eyes glaze over.KEy points of the OMUU’s Requirements for certified marijuana testing laboratories
Here is the essence of the rules and their importance.
1. The rules, which were written using statutory Emergency Rulemaking, allowed them to write rules that could be active immediately, without waiting for approval and certification of the legislation.
2. They lay out the application process for an ISO17025 certified laboratory to become one of the State’s CMTLs, and charged with the testing of the MMTC’s products at an “arm’s length” manner, so there is no connection with the MMTCs and the labs, and the bond of confidence is set in place.
3. To apply for certification, an Applicant must submit a completed Form DH8022-OMMU-01/2020, “Application and Instructions for Certified Marijuana Testing Laboratory Certification,” incorporated by reference herein and available at Florida Administrative Register Volume 46, Number 15, January 23, 2020 354 https://knowthefactsmmj.com/
The application fee is set AT $62,945.25
5. It sets in place the requirements a lab must have to be a CMTL, from accreditation to the approval of Standard Operating Procedures (SOP). Even the contents and method of establishing the SOP is carefully constructed to leave no stone unturned to establish Quality Assurance and adherence to the rules. But there are more hurdles to clear.
6. CMTL’s must pass Proficiency testing. Even their employees, managers and directors must be beyond reproach, and be in established categories of identity and proficiency, including background, education and training.
7. The facility itself must meet standards, as noted in the rules, “A CMTL must have the ability to maintain adequate controls against the diversion, theft, or other loss of marijuana, the tampering or compromise of samples, and the tampering or compromise of testing equipment and materials.”
8. It maintains the standards of staffing and noting the security operations in place from identity badges to the number of staff on hand at any time during operating hours.
9. Accountability practices and standards must be in place, as noted, “A CMTL must have written Quality Assurance and Quality Control procedures. Quality controls must be contained within written Standard Operating Procedures and be in accordance with any accreditation required by this rule” That means constant and regular auditing of the staff and equipment, from calibration to verification of results for Quality Control. A “Chain of Custody” must be assured of samples, and background checks of staff must be ensured.
10. The CMTL must perform regular internal auditing of all procedures, staff, facility and equipment, and must still be subject to inspection of all aspects of the rules by the Office of Medical Marijuana Use (OMMU) of the DOH.
11. As noted, “The department may conduct random and unannounced inspections of any CMTL Testing Facility, vehicle utilized by a CMTL, or facility where CMTL records are kept. A CMTL’s refusal to allow entry or inspection is grounds for disciplinary action pursuant to CMTL rules”. It must also be noted that these inspections cannot be preempted by labs that prepare for their arrival.
The rules state, “A CMTL must allow department personnel complete, immediate, and unrestricted access to enter, inspect, monitor, and observe all areas and operations of a CMTL’s Testing Facility, vehicles, and all areas where CMTL records are kept. CMTLs must allow department personnel to examine records, view surveillance videos, interview Employees, and observe the CMTL’s testing facilities, procedures, and equipment. CMTL personnel must cooperate with the department’s inspection and provide responses to inquiries.”
12. Any violation or deficiency must have a process in place to correct the issue, and the rules specify the procedure for that, as well. Then, since rules are in place, and a process of inspection and audit are established, and rules to remediate issues are established, the next set of rules naturally follow this path and spell out the penalties for failure to adhere to all the rules mentioned, which are essentially the suspension and revocation of CMTL accreditation.
WHY SO MANY RULES, AND WHY SO MUCH CONCENTRATION ON THE DETAILS?
The answer is simple. Bonds of trust and confidence in results must be established, because the validity of those results will ensure that the bond of assurance of the MMTC’s products will be established through the verification of purity, potency and safety of the products.
The health and safety of Florida’s patients must be ensured, and any laboratory that can accomplish the goals of these rules will do just that.
It was long in coming, but it is finally here, and we applaud the OMMU and the DOH for completing this daunting task.
The stakes couldn’t be higher.
…….Up next, requirements for Testing.