As an owner and operator of several healthcare diagnostic labs, we were always watched by a government agency. The Arizona Department of Health Services (AZDHS) in our case through the Clinical Laboratory Improvement Amendment (CLIA) that was established in 1988 and is United States federal regulatory standards that apply to all clinical laboratory testing on humans in the US. CLIA would come in and inspect our labs every two years to renew the lab operating license.
The AZDHS is the regulatory arm of all cannabis operations in Arizona this includes all cannabis testing labs in Arizona.
According to Senate bill 1494 “the testing bill”, the AZDHS will establish a required testing program, including safety testing and potency standards for medical marijuana. What will be the limits and types of tests that will be required? Most likely the AZDHS will not reinvent the wheel. The DHS will use the same testing list as other cannabis testing regulated states and the most important requirements are the safety testing. This includes microbiology, pesticides, and residual solvents.
As testing science advances with new technology, labs are now able to target cannabis-specific safety concerns. In our case qPCR/DNA testing for microbiology will look for Aspergillus contamination and it’s four dangerous strains that are specific to cannabis, in addition to E. Coli and Salmonella. Aspergillus is a strain of bacteria that, if inhaled, will cause severe illness for patients with weak immune systems, cystic fibrosis, or lung scarring. Companies like Medicinal Genomics (Beverly, MA) make microbiology testing kits that have been validated on cannabis. However, the testing labs need to have the correct analytical instrument to run these tests in house. qPCR for cannabis testing is a mandatory microbiology assay in California. Other cannabis microbiology testing includes Mycotoxins, which are strains of bacteria that are specific in cannabis. Mycotoxins have been implicated in a number of cases where people become ill or even died after using cannabis that was contaminated with this type of bacteria. Many known mycotoxin-pathogens can be missed using petri-dish or Petrifilm testing techniques, which indiscriminately look for about 40 strains of bacteria, including the plant’s natural bacteria. The Mycotoxins related to cannabis are Ochratoxin A and Aflatoxins (B1, B2, G1, G2). Two testing methodologies can be used to test Mycotoxins LC/MS and ELISA. Mycotoxins are mandatory testing in CA and CO.
Thus far we can assume that the Arizona DHS will adopt qPCR testing for Aspergillus, E. coli, Salmonella and Mycotoxins testing, as these tests will provide maximum safety to cannabis consumers.
The next important safety concern is pesticides that remain in the cannabis from the growing cycle. California and Colorado testing regulations require testing for 60 different pesticides, herbicides, fungicides, and growth regulators. In order to do this, the testing facility needs to have GC/MS and LC/MS (Cost $300,000) instruments in the laboratory. We can assume that AZDHS will require the same.
The regulated testing list will require all the testing labs in Arizona to make major investments in instrumentation. It is not likely that labs will make those investments until the testing regulations are clearer. But preparation needs to begin now from both sides, the testing labs and the cannabis industry.
Most of the tests that are ordered now are Potency, Residual Solvents and Terpenes. Those tests results are used by cannabis companies, mainly for marketing purposes. The safety testing is mostly ignored by Arizona cannabis companies. Safety testing is used to spot check new products but not on every batch. This is the place were Arizona cannabis companies will fail when full testing regulation is in place.
Potency testing will always produce a result high or low but potency will not make people ill; fungus, pesticides, harmful solvents and heavy metals will.
November 1st 2020 (D-Day) every cannabis product that does not have a Certificate of Analysis (COA) from an Arizona third party certified cannabis testing lab and showing full compliance with regulatory testing, is doomed. All untested flowers, cartridges, pre rolls, diamonds, shatters, crumbles, pre rolls and more will come off the shelves of every dispensary and then it will have to be destroyed by the wholesaler. The untested edibles will have to be thrown to the garbage bins of every cannabis kitchen in Arizona. Just imagine the economical impact on medium to small size cannabis companies in Arizona.
In California on January 1st 2019, the day cannabis testing regulations were enforced, $400 million worth of cannabis product was destroyed for non-compliance with testing regulations. This according to the United Cannabis Business Association of California. This amount of product loss would devastate the Arizona market. It would cost the growers and wholesalers dearly, create a bottleneck of product for consumers, and force a price spike in dispensaries. This can all be avoided and here is how:
Going back to the senate bill 1494, it is stated: “MEDICAL MARIJUANA DISPENSARIES SHALL TEST MARIJUANA AND MARIJUNA PRODUCTS TO DETERMINE UNSAFE LEVELS OF MICROBIAL CONTAMINATION, HEAVY METALS, PESTICIDES, HERBICIDES, FUNGICIDES,GROW REGULATORS AND RESIDUAL SOLVENTS AND CONFIRM THE POTENCY OF THE MARIJUANA TO BE DISPENSED” So, the list of regulated Arizona testing should look as follows:
Microbial Contamination – Yeast and Molds, E. Coli, Salmonella spp., Aspergillus, Mycotoxins.
Water activity – Measures the % Moisture Content.
Heavy Metals – Cadmium, Lead, Arsenic and Mercury.
Pesticides – to include 36 strains which are prevalent to Arizona and up to 90 pesticides including herbicides, fungicides, grow regulators.
Residual Solvents – processing chemicals, 20 chemicals at minimum.
Potency testing- testing the levels of cannabinoids, 10 cannabinoids at minimum.
I am a cannabis company, how do I prepare for D-day?
If you are already testing for potency you need to expand your testing to every batch coming out of your growing facility, extraction lab, and edible kitchen. At the same time you are ordering potency testing, you should order residual solvents testing, microbial contamination testing to include Yeast and Molds, Aspergillus, Mycotoxins E. Coli and Salmonella. Also order at least 35 analytes of pesticide testing. Now your sample is covered for safety and potency with a cost of pre-regulation testing for $250-$300 per sample. When regulation rolls around with the additional Heavy Metals and Water Activity testing, be ready to pay an additional 75% on this cost.
In California the average cost of full panel per sample in pre-regulation was at $350-$450. After January 1st 2019 the cost of regulation testing per sample in CA is $850-$1,200. Regulation testing will require cannabis companies to budget testing into the cannabis product cost. It will for sure change the final cost of all cannabis products. All cannabis companies in Arizona should be aware and prepare for D-Day.
A second issue will be Turn-Around-Time. Arizona labs with older instrumentation will need more time to produce reports on all regulation testing. Some of the testing will have to be sent out to a second lab that owns the required analytical instruments. Develop a working relationship with a testing lab now. Order more than just potency testing, this will benefit the cannabis company when regulation testing becomes mandatory (November 1st 2020). The company will be prepared for what to expect from regulation testing and will already have a workflow with a lab in place to make a seamless transition into a regulated cannabis market.
Thirteen months from now is not a long time if you consider the entire process of the cannabis grow cycle, curing time, manufacturing of product, packaging, and length of wholesale time. It takes a long time for product to hit the dispensary shelves. Skipping safety testing in the beginning of the growing cycle is taking a risk that your product will fail testing regulations before it even makes it to the dispensary shelf. Now is the time to take a serious look at your cannabis testing regime and to make a sure-fire plan that will prepare you for cannabis regulation testing.
Senate bill 1494 states: “BEGINNING NOVEMBER 1, 2020. NONPROFIT MEDICAL MARIJUANA DISPENSARIES SHALL: 2. DISPLAY IN CONSPICUOUS LOCATION A SIGN THAT NOTIFIES PATIENTS OF THEIR RIGHT TO RECEIVE THE CERTIFIED INDEPENDENT THIRD-PARTY LABORATORY TEST RESULTS FOR MARIJUANA AND MARIJUANA PRODUCTS FOR MEDICAL USE.”
By the time full regulations are in effect, the patients will be educated about the correct testing and know their rights and how to be safe. This why cannabis companies in Arizona need to get serious about testing their products now.
Mr. Boaz Lerer has been in the pharmaceutical and science business for the last 20 years owning and operating several diagnostics laboratories in healthcare to include cancer, fungus and nerve diagnostics labs. Mr. Lerer is the founder and owner of KB Labs, cannabis and Hemp scientific testing lab in Scottsdale, Arizona.