Connecticut raises mold levels for medical marijuana at one lab, emails show – CT Insider

Connecticut approved an increased limit of mold and yeast allowed in medical marijuana at one of the state’s two cannabis testing labs through private emails last year, documents show.

At the request of AltaSci Labs, the state Department of Consumer Protection agreed to raise the total passing level of yeast and mold from 10,000 colony forming units per gram to 1 million per gram for the lab, according to August 2020 emails obtained via a Hearst Connecticut Media Group public records request.

The request, which also included the addition of testing for a specific genus of mold, was the result of a 2015 study and changes from other states, officials said. Meanwhile, at Northeast Laboratories, the state’s other cannabis testing facility, the passing limit remains 10,000 CFU per gram.

Connecticut, which is in the throes of launching its adult-use recreational program, has about 54,000 medical marijuana patients who were not notified about the change in mold and yeast levels.

State regulators argue that the looser restrictions paired with the addition of testing for the Aspergillus mold genus makes the product safer.

Not all states have set requirements for testing medical marijuana. The result: A patchwork set of regulations that varies widely from state to state, and in Connecticut’s case, from lab to lab.

The testing standards evolve often with new research. Without federal standards, it’s a learning process, said Rodrick Marriott, the department’s Drug Control Division director.

“This program, and especially the microbiology portions of it, evolves over time based on things that other states learn, and that we learn, going through all of this, and really, you know, I don’t think there’s any true perfect system for this and no kind of like magic bullet to say what’s exactly perfect,” Marriott said. “We continue to learn from our peers.”

In the same August email, AltaSci suggested adding testing for four variants of the Aspergillus mold genus, which the state approved.

The Aspergillus genus is most likely to be harmful to consumers, and the state doesn’t allow any detectable levels in the marijuana, Marriott said.

“While this is not in USP 2023, it has been stablished [sic] by the industry that this is quite important in terms of patient safety,” Jose Zavaleta, AltaSci’s lab director, wrote in a 2020 email to Jessie McGinn, the lab’s quality manager.

McGinn forwarded that email to Scott Stoppa, a drug control agent at the state Department of Consumer Protection, who gave the lab the approval a couple of weeks after the initial request.

‘Taking cues’

When setting standards, the state is “taking cues” from the industry, which includes labs, producers and dispensaries, Marriott said.

When a request for a change or new research is received, Marriott and his team usually consider it. The department doesn’t have a microbiologist on staff, so he sometimes consults with university professors, and never relies on just the recommendation of a cannabis business, he said.

For this decision, a team of six at AltaSci considered a 2015 study and moves in other states, including New York, California and Missouri, where testing is done for specific mold genuses, including Aspergillus rather than a total count, Zavaleta said.

The move has sparked concerns among some Connecticut medical marijuana patients about the safety of the substance and transparency within the program.

“Like anyone else, patients are busy people with limited time to spend thinking about whether their medication is safe,” said Lou Rinaldi, a Connecticut medical marijuana patient. “If DCP is going to make a significant change to testing standards, say something that loosens safety restrictions by multiple orders of magnitude, those changes need to be communicated to patients proactively.”

Zavaleta said he’s been surprised by negative reactions to the move — he expected it to be met with positive reactions because of the Aspergillus testing, which he believes makes the product safer, he said.

He and Marriott said the new standards protect patient safety.

“We kept the (1 million per gram) where other states didn’t put a cap on the total use for yeast and mold,” Marriott said. “They’ve actually removed the caps on total yeast and mold. So we felt like this was a reasonable change to still protect our patients and provide good product for our patients.”

‘Who do you trust?’

But the change and the lack of notification has left patients like Mallory O’Connor, a new New Haven resident, worried.

O’Connor has a sensitivity to the issue after an event years ago in which she got pleurisy from a batch of marijuana she bought before she had her Connecticut license. She was hospitalized with the lung infection and it took her six months of after-care appointments to recover.

“I feel like if I went to the store and my lettuce had mold on it, there would be like a big report letting us all know … meanwhile, this is medicine and people are already sick and we’re not even being warned,” she said.

O’Connor uses cannabis to treat her post traumatic stress disorder. She’s careful to check the lab reports the state posts online before she buys it, but worries about the increased levels of mold, especially because her lungs are still more sensitive since the infection.

“If one lab is saying, ‘This is safe,’ then another lab is saying ‘this is safe,’ then who do you trust?,” she said.

However, Marriott reiterated that not all mold is harmful and patient safety is a top priority.

‘Lack of consistency’

Dr. Kevin Sabet, president of Smart Approaches to Marijuana and critic of the industry who wrote the book, “Smokescreen,” said most labs in general have “very little real oversight.” Sabet wrote the book “Smokescreen,” about the marijuana industry.

Differing standards between labs as well as lack of a stringent certification process contribute to the issue, he said.

“The result is dangerously high levels of mold, bacteria, fungi, and other additives,” Sabet said in a statement in response to questions from Hearst Connecticut Media. “Marijuana gets a free pass by states, who don’t have the infrastructure to regulate it properly and to make sure the product is mold-free.

“We would never accept these standards in other things we consume, but marijuana is operating in a gray area that allows growers to take advantage for profit gain.”

AltaSci is certified by the International Organization for Standardization.

The differing standards are confusing for patients, according to Rinaldi, a Guilford resident who has been a medical marijuana patient since June 2019.

“The lack of consistency and transparency creates unnecessary confusion and further exacerbates already-unsafe conditions,” Rinaldi said.

The reports between the labs are not in a consistent format, either, and don’t display all the same information. For example, sometimes a report will give the number of CFUs per gram found, and in other instances, the reports will simply indicate that the sample passed.

The state doesn’t have standards for formatting or requirements for how labs report testing results, although the reports are available online, Marriott said.

Zavaleta agreed that setting uniform standards would be helpful. It’s easier to test other products, with federal standards, he said.

“Right now, because of the federal situation of where cannabis is, it’s kind of baked into the problems, baked into the situation,” Zavaleta said.

Transparency concerns

To patient concerns about transparency, Zavaleta said the lab doesn’t work with patients or have ways to contact them.

Kaitlyn Krasselt, a spokesperson for the Department of Consumer Protection, said although the state didn’t alert patients, the agency encourages them to talk to their doctors if they have questions about the standards.

But the state also didn’t alert doctors to the change, Marriott said.

O’Connor thinks something as simple as an email alert would have helped patients, herself included, feel better about the decision.

“It’s just really crazy to me and it’s so confusing and it almost makes you, as a patient, want to steer away from the medical cannabis industry because it seems so unsafe,” O’Connor said. “I don’t think that that’s good either because I think cannabis is lifesaving.”

The state has increased efforts to be more transparent with the program, including by posting the lab reports online, Marriott said.

When concerned patients contact the department, officials explain the decision on a case-by-case basis, Marriott added.

“We try to explain the rationale for the decision and explain that we think this standard is really there to protect public health and safety,” he said. “And it’s part of an evolution of this program that we try to really kind of stay on top of.”

Rinaldi is one of the patients who’s filed a formal complaint with the Attorney General, the Office of the Healthcare Advocate and with the Connecticut Freedom of Information Commission.

“DCP needs to either drastically improve their oversight function for the medical program, or request that our legislators reassign the program to another state agency or external entity,” he said.

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