On March 18th, the Oregon Liquor Control Commission (OLCC) issued its first recall for recreational cannabis products. The recall, according to the press release, occurred because an unnamed wholesaler sent cannabis products to a retailer before the pesticide test results were entered into the OLCC Cannabis Tracking System (CTS).
The cannabis grown at Emerald Wave Estate, LLC is said to fail a test for pyrethrins exceeding the Oregon Health Authority (OHA) action level (the action level for pyrethrins is 1 ppm). Pyrethrins are a class of insecticides derived from the chrysanthemum flower. Their toxicity varies a lot depending on exactly what organic compound was used, but has an acute toxicity level that is cause for concern. When exposed to high levels of pyrethrins, people have reported symptoms similar to asthma. Generally, pyrethrins have a low chronic toxicity for humans.
The retailer, Buds 4 U LLC, located in Mapleton, OR, issued a voluntary recall for 82.5 grams of the strain Blue Magoo sold between March 8th and 10th. After finding the failed test results in the CTS, the retailer immediately contacted the OLCC. According to The Portland Tribune, OLCC spokesman Mark Pettinger says the retailer was very cooperative in immediately notifying the OLCC. “The retailer was great,” says Pettinger. “They get the gold star.” The Portland Tribune also says the wholesaler who shipped the cannabis prior to test results being entered is Cascade Cannabis Distributing of Eugene. That mistake could be a violation of Oregon’s regulations, leading to a 10-day closure and up to a $1,650 fine.
According to the press release, the rest of the nine pounds in the batch is on hold “pending the outcome of an additional pesticide retest.” The OLCC encourages consumers to check if their products have the license and product numbers detailed in the press release. They advise consumers who did purchase the affected cannabis to dispose of the product or return it to the retailer. The press release also mentions that they have not received any reports of illness related to the tainted cannabis.
Last week, the Oregon Health Authority (OHA) published a bulletin, outlining new temporary testing requirements effective immediately until May 30th of next year. The changes to the rules come in the wake of product shortages, higher prices and even some claims of cultivators reverting back to the black market to stay afloat.
According to the bulletin, these temporary regulations are meant to still protect public health and safety, but are “aimed at lowering the testing burden for producers and processors based on concerns and input from the marijuana industry.” The temporary rules, applying to both medical and retail products, are a Band-Aid fix while the OHA works on a permanent solution to the testing backlog.
Here are some key takeaways from the rule changes:
THC and CBD amounts on the label must be the value calculated by a laboratory, plus or minus 5%.
A harvest lot can include more than one strain.
Cannabis harvested within a 48-hour period, using the same growing and curing processes can be included in one harvest lot.
Edibles processors can include up to 1000 units of product in a batch for testing.
The size of a process lot submitted for testing for concentrates, extracts or other non-edible products will be the maximum size for future sampling and testing.
Different batches of the same strain can be combined for testing potency.
Samples can be combined from a number of batches in a harvest lot for pesticide testing if the weight of all the batches doesn’t exceed ten pounds. This also means that if that combined sample fails a pesticide test, all of the batches fail the test and need to be disposed.
Butanol, Propanol and Ethanol are no longer on the solvent list.
The maximum concentration limit for THC and CBD testing can have up to a 5% variance.
Process validation is replaced by one control study.
After OHA has certified a control study, it is valid for a year unless there is an SOP or ingredient change.
During the control study, sample increments are tested separately for homogeneity across batches, but when the control study is certified, sample increments can be combined.
Failing a test
Test reports must clearly show if a test fails or passes.
Producers can request a reanalysis after a failed test no later than a week after receiving failed test results and that reanalysis must happen within 30 days.
The office of Gov. Kate Brown along with the OHA, Oregon Department of Agriculture (ODA) and Oregon Liquor Control Commission (OLCC) issued a letter in late November, serving as a reminder of the regulations regarding pesticide use and testing. It says in bold that it is illegal to use any pesticide not on the ODA’s cannabis and pesticide guide list. The letter states that failed pesticide tests are referred to ODA for investigation, which means producers that fail those tests could face punitive measures such as fines.
The letter also clarifies a major part of the pesticide rules involving the action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous. “Despite cannabis producers receiving test results below OHA pesticide action levels for cannabis (set in OHA rule), producers may still be in violation of the Oregon Pesticide Control Act if any levels of illegal pesticides are detected.” This is crucial information for producers who might have phased out use of pesticides in the past or might have began operations in a facility where pesticides were used previously. A laboratory detecting even a trace amount in the parts-per-billion range of banned pesticides, like Myclobutanil, would mean the producer is in violation of the Pesticide Control Act and could face thousands of dollars in fines. The approved pesticides on the list are generally intended for food products, exempt from a tolerance and are considered low risk.
As regulators work to accredit more laboratories and flesh out issues with the industry, Oregon’s cannabis market enters a period of marked uncertainty.
Three health alerts were issued Thursday, November 4th for contaminated cannabis sold to consumers at North Bend, Salem and Eugene dispensaries. Green-Way Medicinal in Salem and Stonies in North Bend sold two strains of cannabis flower found to have high levels of piperonyl butoxide, an ingredient commonly found in pesticides that acts as a synergist to amplify the effects of certain compounds.
The two batches in question, including the strains Pleeze (batch number G6J0039-02) and Dryzl (batch number G6J0039-01), were found to contain the potentially dangerous chemical at levels of 15.39 ppm and 16.24 ppm, respectively. The Oregon Health Authority (OHA) action level for piperonyl butoxide is 2.0 ppm. To see the full health alert, click here.
The dispensary in Eugene, Flowr of Lyfe, sold one strain of cannabis that had levels of the insecticide spinosad over the 0.2-ppm action level. The very popular indica hybrid, Dutch Treat (batch number G6J0018-01), was found to contain 0.9-ppm of spinosad. Though it still tested above the 0.2-ppm action level for that insecticide, it pales in comparison to October’s health alert, where a batch of cannabis had over 200 times the acceptable level of that insecticide. Both spinosad and piperonyl butoxide are considered toxic to humans.
According to the health alert, “All tests were performed by an OHA-accredited and Oregon Liquor Control Commission-licensed laboratory.” It is unclear exactly how or why the cannabis was able to get transported and transferred from the grower to the dispensary and then sold to consumers after failing the pesticide test. According to Jonathan Modie, spokesman for the OHA, they are currently investigating the matter and following up with the dispensaries and growers to find out what happened. “We need to find out how this got transferred in the first place and then sold,” says Modie. “They had access to the test results and should have been able to determine for themselves that these products should not have been sold or transferred.”
“We don’t know, we are still gathering information, there is a risk of civil penalty as well as losing your registration for a dispensary or grower that illegally transferred products that have tested for analytes above the action levels,” says Modie, when asked if punitive measures would be taken. While there are no particular regulations for this scenario in performing a mandatory recall, the OHA is obligated under law to issue health alerts when there is a situation that might affect public health, according to Modie.
“We deal with this with infectious disease outbreaks or during a food borne illness outbreak; if they [the public] can avoid it by hearing from us then we want to get the word out and this is a very similar situation.” For medical patients that purchase potentially contaminated cannabis such as this, it is easy to contact them to have the patient dispose or return the cannabis. Dispensaries are not required to collect information from recreational customers, and most dispensaries do not, which is a major problem when this situation happens, as it has twice in the past two weeks.
“We can never do too much communication,” says Modie. “We will let the public know in any way possible that they should return this product or dispose of it responsibly.”
Oregon cannabis regulators began enforcing new rules over the weekend when the October 1st compliance deadline passed. Compared to the relatively cut-and-dried new Colorado regulations, the Oregon cannabis market faces more complex and changing regulatory compliance issues.
The new rules in Oregon address changes to testing, packaging and labeling regulations along with concentration and serving size limits, according to a bulletin published by the Oregon Health Authority (OHA) and the Oregon Medical Marijuana Program (OMMP) earlier this week. Most of the new rules are meant to add safeguards for public health and consumer safety, while putting an emphasis on keeping cannabis away from children.
Around the same time, the Oregon Liquor Control Commission (OLCC) published a bulletin with a new temporary rule that is meant to prevent marketing to children. The OLCC’s temporary rule clarifies “restrictions on product wording commonly associated with products marketed by or to children.” The OLCC reviewed around 500 strain names and found roughly 20 of them that could appeal to children. The OLCC will not approve labels that include strain names like Girl Scout Cookies, Candyland and Charlotte’s Web, among others. This means that breeders and growers have to change strain names on labels like Death Star, Skywalker and Jedi Kush because they contain a reference to the Star Wars franchise, which is marketed to children.
The new testing regulations establish requirements for testing cannabis products for THC and CBD concentrations, water activity, moisture content, pesticides and solvents in concentrates. They also stipulate that ORELAP-accredited laboratories must perform the testing. In the time leading up to the compliance deadline, many lacked confidence that ORELAP would accredit enough laboratories to meet the demand for testing. “We have heard from existing accredited labs that they can meet demand for cannabis product testing,” says Jonathan Modie, spokesman for the OHA. “We don’t yet know how much product requires testing, so we can’t speculate on whether labs will indeed be able to meet demand.” It is still unclear at this time if there are enough laboratories to perform all of the testing for cannabis products in the state.
At this time, 16 laboratories have been accredited for some form of testing, but only four labs have been accredited for pesticide testing. A list of the labs that ORELAP has accredited can be found here. Notably, only one lab is accredited for testing microbiological contaminants, such as E. coli. Testing for microbiological contaminants is not required for all cannabis products sold, rather it is only required upon written request by the OHA or OLCC.
The new labeling and packaging requirements concern testing, consumer education, childproofing and preventing marketing to minors. All cannabis products must contain a label that has been pre-approved by the OLCC. “Cannabis products have to be clearly labeled, showing that is has been tested, or if it has not been tested then it must display ‘does not meet new testing requirements’,” says Modie. “It [the label] must be clear, legible and readable, so they [the consumer] know exactly what it contains, including what cannabis product is inside the package, how much of it, how much THC, and where the product came from.”
According to Modie, it is particularly important that the packaging is not attractive to minors. Cartoons, designs and names that resemble non-cannabis products intended for, or marketed to children, should not be on the packaging or label. “Part of our education to the public and recreational cannabis users focuses on keeping these products out of reach of children in the first place, like storing cannabis in a locked area or an area where a child cannot reach or see,” says Modie. “Our goal is always to protect public health.”
Last week, news of problems facing Oregon’s cannabis laboratory accreditation program surfaced, leading some to speculate about possible delays for the recreational cannabis market. According to The Register-Guard, ORELAP administrator Gary Ward believed the program was “on the precipice of collapse.”
According to Jonathan Modie, spokesman for the Oregon Health Authority (OHA), the Oregon Environmental Laboratory Accreditation Program (ORELAP) was anticipating over 30 cannabis laboratories applying for accreditation and they doubled their staff from two to four to prepare for the uptick in applications.
In June, the agency had zero labs applying for accreditation but within two months, 37 labs applied. However, the Oregon Department of Environmental Quality (DEQ) just provided three additional staff members on Monday to help with the application process, says Modie.
Some believe the issues could mean the state may not have enough accredited labs by October 1st, when the recreational cannabis market is expected to go into full swing. “It is difficult to say exactly how many labs we can accredit by October 1,” says Modie. “We have seven labs today which would bring it to nine labs waiting for assessment, but our goal is to get as many labs assessed and hopefully accredited as soon as possible.”
With the additional staff members, Modie is hopeful this will jumpstart the program. “We really appreciate our collaboration with the DEQ and look forward to boosting our capacity a bit to help us get through this busy time,” says Modie.
Part of the reason some laboratories might have trouble meeting prerequisites is simply because the requirements are very strict. “The process involves submitting a quality manual, standard operating procedures, method validation, submitting proficiency testing data and finally undergoing an ORELAP assessment by our staff, so it is a very rigorous process,” says Modie. “This speaks to our concern for making sure they have the right systems in place so public health is protected.” Modie said there were at least three labs that did not pass the assessment.
Bethany Sherman, chief executive officer of OG Analytical, believes the hardest part of the process involves getting accredited for testing pesticides. OG Analytical, based in Eugene, Oregon, has already received their accreditation, one of the first to do so. “The pesticide testing requires our most expensive instrumentation and the sample preparation for testing pesticides is the most time consuming,” says Sherman. “Not only does it require very specific instrumentation, it also requires a real know-how and expertise to ensure we are cleaning samples appropriately, minimizing background noise and looking at the pesticides in trace quantities.” According to Sherman, laboratories are also left to their own devices to develop methodologies specifically for the cannabis matrix, adding to the difficulties.
Rodger Voelker, Ph.D., lab director at OG Analytical, seems confident that the state will be able to handle it. “It is a relief they were able to get some resources from the DEQ and I think the state will not allow a program with this kind of importance to fall apart,” says Voelker. He believes after this initial phase of putting the program in place, the workload will go down. “It is easier to maintain a program than it is to implement,“ adds Voelker. In his eyes, it is crucial for the program to require rigorous science. “People are forced to reconcile that there is a tremendous amount of controls to be considered to produce legally defensible data and I think it is great that the requirements are so strict.”
The OHA’s job is to essentially safeguard public health and they do not want to leave any stone unturned when it comes to potential contamination, says Modie. “This is not just about getting as many labs accredited as possible, this is about protecting public health.”
The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28th of this year with the goal to establish a set of regulations for cannabis testing by October 1st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.
The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.
ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.
Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”
Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”
The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1st.
Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”
One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.
Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.
Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.
The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”
According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.