Florida Regulators Fine Two Cannabis Labs For Using a PCR Method to Test For Mold
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Regulators in Florida have fined two cannabis testing companies, ACS Laboratory and Green Scientific Labs, $20,000 each.
Both labs are accused of using an “unapproved” polymerase chain reaction (PCR) method to test cannabis samples for yeast and mold.
The two $20,000 fines are the latest in a recent list of penalties to cannabis labs from the Florida Department of Health.
Two labs, two fines
Analytical Cannabis understands that the Florida Department of Health issued two penalty notices, one to ACS Laboratory (which has a lab in Sun City Center, Florida) and one to Green Scientific Labs (which has a lab in Davie, Florida) on August 30.
Both notices claimed that the labs had used a PCR test to assess cannabis samples for yeast and mold. While the PCR method may have been fit for the task, neither lab had provided sufficient “accreditation” to the state health regulator to use the method.
Total yeast and mold tests are standard procedures in cannabis labs and help determine whether a product is contaminated with microbes such as Aspergillus, a fungus that can cause respiratory damage to vulnerable cannabis consumers. The tests can be carried out via a PCR method or a plating method (whereby the microbes, if there are any present, are grown in a petri dish culture). Many cannabis lab analysts are divided over which method is more suitable.
Both labs were fined $20,000 and told to immediately stop using the PCR method for total yeast and mold tests.
Responding to Analytical Cannabis, a representative of ACS Laboratory said the following:
“ACS Laboratory follows strict standards and protocols for all of its testing and promptly corrects any inaccuracies. Per the recent occurrence, an ISO certificate was missing an SOP number for PCR testing for Total Yeast and Mold only. ACS has corrected this issue and has notified the state that it is running the necessary proficiency tests required.”
“The state is being more strict now because this month and next month are the renewals of laboratory licenses and therefore they are going through all documentation with a fine tooth comb. In the meantime, ACS is currently testing seven other tests performed by PCR for Microbiology Testing and performing Total Yeast and Mold Testing by Culture Plating Method.”
Speaking to Analytical Cannabis, Rafael Bombonato, chief compliance officer and interim CEO of Green Scientific Labs, made clear that he broadly supported Florida Health’s actions.
“We support public health and safety. So, I would like to start with that; we don’t have any problems with the Department of Health and how they enforce their rules.”
“In this particular case, in our opinion, it was due to a clerical error. We had our ISO certification renewed last year. And just because we have multiple methods to test for total yeast and mold, there was a confusion at the time that certificate was created, and that line item was not included into the certificate.”
“It’s something that was quickly resolved. The day after I personally got the letter, we reached out to the accreditation company, they went back, they did an investigation, they checked their notes, and […] provided us with an updated certificate. And we have already communicated that immediately to the Florida Department of Health, and also sent them some more supporting documentation.”
“They’re going to check on all documentation that we sent, and they hope to issue a letter, if everything adds up, to publicly say that we are allowed to perform those tests, as we believe we always were.”
While content with the actions of Florida Health, Bombonato did question the heft of Green Scientific’s fine.
“The amount that we were fined, I believe it’s a little bit excessive, when you compare to fines that were issued a couple of weeks ago, which included manipulation of data,” he told Analytical Cannabis.
“But then again, I’m not the person that’s making those decisions. Just, in my opinion, I think that may send the wrong message to the industry.”
“If we had a warning letter from the state saying, ‘Hey, we noticed there’s a gap on this particular document,’ […] that is something that we could have resolved within a day and avoided this.”
Regardless of the fine, Bombonato and his colleagues were keen to stress their commitment to the health and safety of cannabis consumers.
“The people who are working in the industry know that we have to do our best every day, to make sure that we’re able to continue to provide medication that a lot of people need,” he said. “In Florida, if I’m not mistaken, we have almost 100,000 patients. So it’s important that people do things the right way. And we believe that we are doing things the right way.”
Other Floridian fines
For ACS Laboratory, the recent $20,000 fine wasn’t their first. Last week, Analytical Cannabis reported on how ACS and Tampa-based Method Testing Labs came afoul of fines worth $5,000 and $6,000, respectively.
Both penalties were due to the labs reporting “false information” on their certificates of analysis (COAs).
“The COA error was corrected immediately and for all other COAs for clients. At no time were any medical patients in danger,” ACS told Analytical Cannabis at the time.
“ACS has earned its gold standard industry recognition through its continued unwavering ethical standards and commitment to rectify any issues, including this recent occurrence. Any fraudulent intent is simply unsubstantiated.”
Similarly, Method Testing Labs’ CEO, Keith Browning, told this publication that it takes, “regulatory violations very seriously and we have updated our Certificate of Analysis to bring it back into compliance with the requirements from the state of Florida.”
“It is important to note that after a full review of our data packages by the State, the accuracy of our data, processes and analytical methods were not called into question.”