By David Heldreth
To recall or not to recall, that is the question—at least that’s the question the Washington I-502 system is asking following the recent closure of Peak Analytics.
Peak Analytics, a Bellingham-based cannabis testing facility, was forced to close its doors, at least temporarily, following a surprise inspection by Washington Liquor and Cannabis Board (WLCB) auditors on June 15, 2017. RJ Lee, the WLCB auditors, took a closer look at Peak Analytics after reviewing the microbial testing results from early 2017, according to the audit. Peak Analytics customers’ products only failed 1.69% percent of their microbial tests, compared to an 11 percent average in the state. RJ Lee recommended suspending Peak Analytics’ certification until the lab can correct all deficiencies and the lab processes meet the requirements of state law.
The microbial test results for microbes such as E. coli, salmonella and mold proved not only to be the key to getting Peak Analytics flagged for review, but were the main reason the lab was closed. Peak Analytics was found to have placed multiple samples into a machine typically reserved for one, which resulted in poor sample preparation.
“It is the auditor’s opinion that there a number of microbes that are not being accounted for and the test is biasing to less numbers and hence passing rather than presenting an accurate analysis,” according to an excerpt from the audit.
Peak Analytics passed three of the five microbial tests, failing only on enteric bacteria and total coliform. The total coliform test is an indicator test used on the entire family of coliform bacteria, however, few pose a danger and only e. coli can be deadly. Peak Analytics did pass their testing audit for E. coli in June.
Thomas Hubbell, General Manager of Peak Analytics, said they believe there were errors in the methods RJ Lee used to prepare the microbial samples in the audit. RJ Lee was contacted for response, but didn’t return calls or emails before deadline.
“The proficiency test is still under investigation with the provider,” Hubbell said in an emailed statement. “It is suspected that the strain of coliform that was being used on this round had been temperature-stressed and may not have grown as usual.”
However, Peak Analytics also failed for enteric bacteria, which can include Shigella, Staphylococcus aureus and Campylobacter jejuni and can cause food poisoning, sinus infections and skin infections.
Trevor Morones, of the food safety firm Control Point Consulting, said that in similar situations, the food and beverage industries would typically require a recall of all products involved.
“If a lab analyzing food products had practices presented in the audit report, food products would be recalled,” Morones said. “False negatives, most likely caused by human error, are not unheard of in a laboratory, but falsifying documents has severe penalties, as it should for endangering consumers’ lives. Based on the findings in the audit, the lab had very poor practices.”
Morones recommended that the WLCB and other state governments begin forcing labs to achieve ISO/IEC 17025 certification—the science and laboratory standard for outside of cannabis. He stressed the danger to the legal cannabis market if there is an outbreak from products that aren’t recalled.
Despite these risks the WLCB passed the buck on the recall to RJ Lee and declined to do a recall.
“At this time, the WSLCB is not planning to instruct Peak Analytics to initiate a recall,”WLCB Communications Director Brian Smith, said in an email. “As a non-science agency, we rely heavily on the input of our contracted laboratory certification vendor, RJ Lee Group. The deficiencies identified during their audit of Peak Analytics were not dire enough to warrant a recall recommendation to the Board.”
However, WAC 314-55-225 states that evidence that a product carries a risk to the health of consumers, such as possible microbial contaminants, is grounds for a recall. The law appears to say that in such situations a recall would be triggered. Questions posed to state representatives about this issue seem to show that the legislature, while claiming concern for cannabis consumers, doesn’t currently think the aforementioned dangers or law necessitate a recall either.
“I am very much interested in protecting consumers of cannabis at retailers in my district (43rd LD) and across the state,” State Representative Nicole Macri said in an emailed statement. “From what I’ve heard and read about the Peak Analytics lab suspension from the [W]LCB and the Chair of the House Commerce & Gaming Committee, I’m satisfied the [W]LCB’s approach to this situation is doing exactly that. That said, I will continue to monitor the situation, and appreciate any new information you think is relevant for me to explore.”
Only time will tell if there is ultimately a recall of Peak Analytics products.
In addition to the microbial testing discrepancies, the audit also cataloged individual errors in potency testing methods, such as incorrectly calibrated equipment and not flagging possibly spiked samples to the WLCB. The audit found that there were samples with 0% moisture or over 37% THCA, attributed to bad calibration of testing machinery at the lab during the audit.
Hubbell said Peak Analytics has been attempting to work within their understanding of the rules and laws, but will make improvements as the lab works to regain certification and have the suspension lifted.
“There are no rules or guidelines to inform labs about what is considered adulterated, who is responsible for determining if the samples are adulterated and what parameters classify as adulteration,” Hubbell said. “If low moisture or high D9THC in flower is considered adulteration of a sample we, as an industry, should define and create guidelines to flag samples appropriately. Peak Analytics has worked directly with its clients to try and clarify these issues in the past. Moving forward, we will work in conjunction with the WSLCB to address samples of questionable adulteration.”
With the recall in doubt and corrections being made, it’s likely Hubbell and the lab will have their doors open again soon. They’ve already begun the process to reopen, according to this statement from Smith and the WLCB, “Peak Analytics is actively pursuing reinstatement and has submitted documentation to RJ Lee Group to address their audit findings. RJ Lee Group has reviewed the documents, and is working with Peak. Once RJ Lee Group recommends reinstatement, we will lift the suspension and Peak will be able resume normal operations.”