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High Standards

Cannabis producers say new mold and bacteria testing rules are too stringent and ask court to halt implementation

February 1, 2016, 4:30 pm
A group of New Mexico medical cannabis producers are pushing back against the state's strict new testing requirements they say will force them to discard up to a quarter of their medication.

Growers claim that the new rules, which require private labs to test their dried flowers and any products derived from cannabis concentrates for mold and yeast, could cause “acute” shortages of the medication and a big jump in prices around the state.

Jason Marks, an attorney for the Cannabis Producers of New Mexico, who sued the New Mexico Department of Health after it imposed the testing rules last February, filed a motion for temporary relief in Santa Fe on Friday.

Marks wants 1st Judicial District Judge Raymond Ortiz to issue an injunction blocking regulators from enforcing the US Pharmacopeial Convention standards because he says it is between ten and one hundred times more stringent than rules adopted by other states. In microbiology parlance, bacteria are measured by colony-forming units per gram, or the number of viable bacteria or fungal cells in a sample. New Mexico's standard calls for no greater than 1,000 cfu/gram.  

Last month, during a public rule-making hearing, Kathleen O’Dea, the owner and laboratory director at Scepter Labs, a DOH-licensed testing laboratory, testified that she’s analyzed more than 1,000 samples of medical cannabis grown by licensed growers in New Mexico and found that 20 percent of the product failed to meet the state's tough standard. Marijuana grown outdoors failed at an even higher rate.

O’Dea and the producers claim the higher standard doesn’t provide patients a higher degree of product safety, since Harvard Medical School researchers have shown that contamination up to 100,000 cfu/gram are still considered safe for medical consumption by patients.

Marks also claims the Health Department has no scientific evidence to support its testing standard for yeasts and mold in medical cannabis; he says the agency has the burden to prove a lower standard would be detrimental to patients.

“There are no reported cases of cannabis users being harmed by yeasts and molds (other than Aspergillus) in commercially produced medical cannabis in New Mexico or elsewhere,” says Marks, adding that patients will be irreparably harmed by the steeper prices and be forced to buy on the black market, where marijuana is not tested at any level.

Zeke Shortes, the founder of Santa Fe dispensary Sacred Gardens and newly elected president of the Cannabis Producers of New Mexico group, agrees. Shortes contends the new standard, if it isn’t fixed, will drive up costs and make growing medication outdoors nearly impossible. He says he’s worried some of the 19,000 registered patients in New Mexico won’t have access to pot to treat their debilitating diseases. 

“Withholding safe medication from patients because of an unsuitable testing standard will cause real harm, with no suitable benefit,” Shortes swears in an affidavit attached to the motion. 

Not everyone is convinced the testing standards should be lowered. Larry Love, an industry analyst and patient, has advocated for the testing for several years.

“Patients want clean medicine. This is a medical program, but some of the licensed producers are treating it like it's a recreational program," says Love.

Currently, only three other states require testing for mold and yeast contamination. Colorado and Washington regulators set their limits at 10,000 cfu/gram (the same level adopted by the World Health Organization, the American Herbal Products Association and the American National Standards Institute), while Oregon capped theirs at 100,000 cfu/gram.

While the testing standard was imposed on Feb. 27, 2015, regulators didn’t start enforcing the rules until last Monday. First they had to screen and approve private labs like Steep Hill and Scepter Labs.

Marks tells SFR he hopes the judge will schedule a hearing within two weeks to resolve the dispute. A spokesman for the health department says they "don't comment on pending litigation." 

 

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