Cannabis testing still problematic

Oklahoma’s medical cannabis program requires the testing of products before they hit dispensary shelves, but with a loose regulatory framework, patients still cannot be sure that the products that they are consuming are actually what is represented by provided results.

In fact, one of the state’s most prominent cannabis laboratories chose to surrender its license after the Oklahoma Medical Marijuana Authority moved to revoke it due to fabricating test results, court records show.

Kyle Felling, the former public face of F.A.S.T. Laboratories, claimed to be the owner and operator of the lab to the OMMA, but apparently has been an Arkansas resident during operations, according to the license revocation application filed by the state. F.A.S.T. stood for Felling Analytical Services and Technology.

“All toxicology testing data, which includes testing data for microbials, heavy metals, residual solvents, and pesticides, went through Mr. Felling on QBench even though Mr. Felling was typically in Arkansas and uninvolved with the actual testing of samples. In other words, Mr. Felling was the one who would complete and publish COAs in the system that would then be reported to FAST Labs' clients,” the application states.

On June 16, 2020, the Department received an anonymous complaint that Respondent, and specifically Mr. Felling, was falsifying cannabis test results. An investigation was initiated. On June 19, 2020, OSDH performed an onsite investigation of Respondent's medical marijuana laboratory to review records, system software, and samples. The purpose of this investigation was to investigate falsified laboratory reports produced by Respondent and other reporting inaccuracies and testing violations. During the June 19, 2020, onsite investigation of Respondent's medical marijuana business, OSDH learned of instances where Mr. Felling had entered a completed status on medical marijuana samples prior to conducting any testing on those samples in violation of [state statute]. Moreover, OSDH also found multiple instances where Mr. Felling had fraudulently changed raw testing data to ensure a passing testing result, and the passing result was reported on a [certificate of analysis] to FAST Labs clients without further testing being done. During the June 19, 2020, onsite investigation, Mr. Felling himself admitted to OSDH investigators that he had altered microbial and heavy metal results that were reported on COAs. Mr. Felling did not retest the samples that he altered. Upon information and belief, Mr. Felling would frequently report residual solvent results prior to testing ever being completed. This became more common when Respondent's instrument that tested residual solvents went down for a period of time in April or May 2020 and there was a backlog of testing for this analyte,” the application states.

It is unknown how long the lab had apparently been altering test results. They were one of the first to be operating in the state.

“Throughout the investigation, Petitioner has performed numerous onsite visits of Respondent's medical marijuana business. The investigation revealed widespread, flagrant, continuous and willful violations that place the public's health and safety at risk, including evidence that Respondent fraudulently manipulated testing data, completed and reported COAs that showed the test samples did ‘PASS’ without having supporting testing data, and failed to implement and/or adhere to basic standard operating procedures to ensure the integrity of the testing process. Medical marijuana patients rely on licensed medical marijuana testing laboratories to properly test the medical marijuana and medical marijuana product samples to ensure what is being consumed and/or inhaled is safe,” according to the application.

Samples that had received passing results from the lab were found to contain levels of lead, salmonella and staphylococcus, or staph, that exceeded legal thresholds for safe consumption, according to the OMMA’s application.

Fast Laboratories of Oklahoma City, LLC surrendered its license on Sept. 23. The owner on the surrender form is listed as Mary Roberts and the reason given was “disputes among members of closely held management company made continued operations undesirable,” the surrender of license form shows. Felling is not named on the surrender form.

OMMA spokeswoman Terri Watkins said the investigation into the laboratory is ongoing, though fines cannot be assessed since the company’s license was surrendered, she said.

But products failing product testing are still making their way onto dispensary shelves. On Nov. 4, the OMMA announced another recall, this time vape cartridges manufactured by Empire Strains, LLC and KushCandy 420, LLC.

“The products being recalled are vape cartridges labeled as Empire Strains or Ju·Ju that show Batch Number 153, Lot A on the labeling. Medical marijuana products labeled as Empire Strains or Ju·Ju that show Batch 153, Lot A have failed required testing and may not be safe for consumers,” the recall notice states.

No further information on what prompted the recall was immediately released by the OMMA.

However, the authority’s laboratory oversight manager said that upcoming changes to how the agency tracks cannabis plants and products as well as updated and strengthened inspection protocols should lead to more patient confidence in the certificates of analysis that will be available for their inspection before purchase.

“We have executed the contract with the quality assurance lab,” Lee Rhoades said.

“One of the first orders of business that we’ve undertaken with them, and it’s a process that’s underway as we speak, standard samples have been sent to each of our licensed laboratories in which they’re all testing for the same thing off of the same sample and we’re going to get their results back and see what the central tendency is, see who it is that’s perhaps aways out from the central results that we get and that will help guide us in making some decisions, certainly not to be punitive, but to try and figure out why we would have a dispersion of results around something that we have a target value for,” he said.

To do so, they have purchased hemp-based “certified reference materials” with a reconstitution process and are using manufacturer guidelines.

“As time goes by, we may look into using actual retained marijuana samples and do the same thing because sample preparation has a large effect, obviously, on the quality of your result. Right now, we're really trying to see, if we take that off the table, what kind of results are we seeing from each labs for just a simple analytical portion of what they're doing?” Rhoades said.

They plan to test the labs at a minimum of three times a year to make sure all of them are presenting results within the same range.

“We will kind of let the data guide us to see if we need to do that more often. And we always have the authority to do more along with interlaboratory comparisons as we see fit. Kind of the flip side of the coin on that is we will also be testing from various sources the same sample batches that the labs are on an individual basis and just kind of comparing results from that. Kind of going from dispensaries working our way back up upstream just so that we could see if the certificate of analysis that was produced correlates with the results that the QA lab gets,” Rhoades said.

In other words, there will be mystery shopping and result comparisons.

“When growers and processors have samples sent to the laboratory for testing, you're supposed to create what's called a primary sample and as well as a secondary sample, a reserve sample, that will be created out of the same homogenization process as the primary. And then you're required to store that reserve sample in a manner that keeps it from being contaminated or degraded. And we will also be testing those so we can compare head-to-head off of essentially the same sample that the laboratory got and what the QA lab got. Of course, we will rely heavily on the QA lab’s technical expertise but those with the lab program in the OMMA will be reviewing those results as well,” he said.

Demeter was chosen as the quality assurance laboratory through a competitive bidding process.

“We created a set of criteria of deliverables that we wanted and asked them to respond with how they would implement those things. Asked for a number of things such as years of experience from your director, your analytical staff, recommendations from other people that have used your services specifically in the Oklahoma marijuana industry. We had a number of technical specifications we requested such as throughput, whether or not you possessed ISO 17025 accreditation or not. Demeter has actually had their accreditation since early 2019 before it was even in any of the requirements for laboratories. They went ahead and got it on their own,” Rhoades said.

By the end of December, OMMA anticipates having a data-based operation plan in place that has everyone “singing from the same sheet music, so to speak,” he said.

Rhoades and the laboratories already operating have had an ongoing dialogue for over a year and has actively solicited opinions and feedback as to the direction that the industry should head. While 2020 should see more of a streamlined process as Demeter and the Metric seed-to-sale program are put into place, it is still an ongoing process and one that will never be flawless 100 percent of the time.

“I'm well aware that even the best of labs can have an issue from time to time. I've been in the lab world for 40 years and so anybody that says they never have a problem just hasn't been in the business very long at all. So we've opened it up and made it a little bit easier for growers and processors to understand how and when to retest and how to interpret those results. We've also opened the door a little bit more on what we call remediation but we're also calling some things decontamination. What you can do, for instance, when you fail a microbial test, and your repeat testing confirms it so we’ve not shut down those supply channels by opening other avenues of ways to still be able to transfer or sell that product,” Rhoades said.

Pesticide detection and heavy metal detection are not currently allowable for remediation, he said, but the next legislative session will hopefully result in more remediation guidelines. Microbials and residual solvents can now be remediated, but pesticides and heavy metals have not been clearly shown to be able to be successfully remediated, he said.

“We have to keep in mind that particularly for people that inhale marijuana, you basically bypass all of your body’s defense mechanisms and it’s different than ingesting it, so we have to keep that in mind with our stance on whether or not this stuff is in there,” Rhoades said.

While the process is still fallible, dispensaries are required to have certificates of analysis available for patients to request and inspect, Watkins said.

“We want patients to look at those certificates of analysis and know the product they’re getting and where it came from,” she said.

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