By Keith Mansur,
Oregon Cannabis Connection
After nearly two years of inadequate testing rules and poorly operated laboratories across the state, Oregon Health Authority adopted new temporary rules in hopes of combating what is a growing problem. After the passage of HB 3460 in 2013, no certification rules for testing labs were ever adopted in the state, as Oregon Cannabis Connection pointed out in “Problems with Oregon Cannabis Testing” (Aug/Sep issue in 2014).
A subsequent investigation by the Oregonian in June of this year discovered that major problems did indeed exist with contaminated cannabis at Oregon dispensaries, especially concentrates:
“A total of 14 chemicals were found in eight of the samples, including a half-dozen the federal government has classified as having possible or probable links to cancer.”
New Standards, Better Labs
The new standards hope to address this failure in the system with a variety of new rules and requirements. They include : mandatory laboratory certification to the NELAC/TNI Standards by the state’s own Environmental Laboratory Program (ORELAP), testing for 60 specific pesticides commonly used in cultivation of marijuana (see Figure 1), stricter sampling requirements (only lab personnel), destruction of cannabis products that fail the minimum standards (no longer returned to supplier), testing for residual solvents present in extracts and concentrates, and many more.
The rules are available online at OHA website, link here. The administrative rule that covers testing is OAR 333-007-0300.
Rowshan Reordan of Green Leaf Laboratories, one of Oregon’s oldest testing labs and one offering statewide services, explained to OCC, “It’s been the Wild West in Oregon’s cannabis laboratory industry for years now and we are looking forward to regulation and oversight.”
“At Green Leaf Labs we have had high standards from the beginning. Without oversight there is no accountability. This has diminished the credibility of analytical science and led to the distrust of laboratory testing in the cannabis industry,” Reordan explained further. “Having proper standards and oversight for laboratories will help assist with accountability and credibility.”
“A lot of these labs that are doing these so called ‘State compliance tests’… they’re charging ridiculously [low] prices that can’t be sustained, but they can’t really be doing these tests,” explained Mike Goldman, COO of Iron Laboratories in Eugene. “You can’t run a thorough pesticide test, a thorough potency test, a thorough microbial exam, test for yeasts and molds and water activity from a gram and a half [sample] that could possibly represent any large batch of cannabis product.”
Lab Accreditation Log Jam?
There are literally scores of testing labs in Oregon, and all of them will now be required to get licensed by June of next year to continue providing testing services. The Oregon Environmental Laboratory Accreditation Program currently accredits qualified laboratories for testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, and the Safe Drinking Water Act. Now required by administrative rule, ORELAP is in charge of Cannabis testing laboratories, too.
We asked ORELAP about the process and what they expect in total numbers of applicants. So far, they have received 13 applications, none of them complete. They expect to receive up to 20, in all, before June.
“When a complete application is submitted, it will take approximately a week to be reviewed for completeness,” explained Shannon Swantek one of OHA’s Lead Assessors. “The scheduling of the assessment date will depend on how many complete applications are received at once. Two to three weeks per month, starting in January, are being held open in ORELAP’s existing schedule for new cannabis lab applicants…. The quality and preparedness of the lab system and accuracy of their data will dictate how quickly an application is processed.”
According to Roger Brauninger, Program Manager for Bio-Safety at the American Association for Laboratory Accreditation (A2LA), Oregon’s ORELAP program is one of the best in the country at what they do… certifying to the NELAC/TNI standards for environmental labs. Questions remain about the volume of work they may receive and concerns over whether they can handle the workload.
“Oregon is one of the very best NELAC [certification] states; they do a very good job,” explained Brauninger. “But, the question is whether they have an adequate amount of resources to be able to cover the normal environmental work, plus California, plus the cannabis laboratories.”
Most California labs needing NELAC/TNI certification have contracted with ORELAP, lending credence to the assertion that they are very capable. However, the California situation has already added to their workload. Could adding a large number of cannabis testing labs to their duties prove difficult?
ORELAP seems to have a handle on it. A 30-day turnaround is required on ORELAP assessments, but they currently do it in a under two weeks. Also, the speed of the process is primarily determined by the lab and whether they are prepared and their procedures are complete.
“The limiting time factor when our report is complete is how many deficiencies or findings of non-compliance the lab has to address,” Swantek said. “They are required to respond to these deficiencies within 30 days but, if the findings are severe, the correction must be complete before accreditation is granted.”
What is required and what would be a typical fee for accreditation of a lab? There is a fee calculator available for labs that are interested at http://public.health.oregon.gov/LaboratoryServices/.
Another Standard for Testing
There is another standard that could be used to accredit labs. According to Brauninger, if they use the requirements set forth in ISO/IEC 17025:2005, the standard used by the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement, instead of NELAC/TNI standards, an independent accreditation programs could be a solution to any logjam.
“Other accreditation bodies that operate to just ILAC [the international accreditation standards], like A2LA and our competitors, have plenty of auditors and we have the skill set to be able to go in and analyze a cannabis laboratory.”
Beyond the accreditation requirement, ORELAP is also required to monitor the labs in order to check on their procedures and practices. This process will require surprise site visits and analysis of the labs’ work.
“They should probably allow for third party accreditation of labs so they can handle the oversight of the labs [that are] operating,” explained Joe Rutkowski, a head chemist with Iron Laboratories who helped with their laboratory setup in Oregon.
Iron Laboratories opened a testing lab in Eugene a few months ago, but they have been operating in Michigan for years and are already ISO 17025 accredited there. They believe a company like theirs might have a smoother process since they are already ISO-certified and know what to expect.
“It gives you an advantage because you have already gone through the ISO certification process so you are more familiar with what is necessary,” Rutkowski said.
That change would be a heavy lift, according to Swantek. “The decisions regarding third-party accreditation programs would have to be made and changed at the legislative level. The legislature determined the accreditation body in administrative rule and this was not solicited by ORELAP.”
Reordan, of Green Leaf Labs, thinks ORELAP’s oversight and NELAC/TNI’s standards are the best choice for Oregon and she fully supports the Rule requiring ORELAP accreditation.
“I believe ORELAP is the best organization for accreditation of Oregon Laboratories,” she explained. “They have the knowledge, experience and are extremely reputable.”
“They have experience accrediting other Oregon laboratories,” Reordan added. “They are headquartered in Oregon and are able to have local oversight and insight on Oregon’s cannabis testing industry.”
She believes an out-of-state third party accreditation company cannot have the same level of commitment or the same level of oversight.
“I understand the argument for ISO 17025 standards,” Reordan states. “However, NELAC/ TNI not only incorporate many of those standards, but go above and beyond, requiring more accountability and more responsibility. We have to work at building back Oregon’s cannabis industry’s trust in analytical testing. If we are going to be accredited, let’s be the leaders in accreditation and have the highest standards, which is what ORELAP and NELAC/TNI offer.”
Higher Testing Prices
Another requirement that could be a problem for many labs is the pesticide testing standards in the rules, which will require very expensive equipment in order to obtain the level of accuracy required. The type of equipment needed, like a HPLC system with triple quadrupole MS-MS detection, is hundreds of thousands of dollars, on sale! This requirement alone will put many labs out of business.
“A reasonable rate for the battery of tests required is $200 to $300 dollars, minimum,” explained Goldman, who has a unique view on the pricing. “That’s the going rate around the rest of the country. Iron Laboratories have performed over 50,000 separate tests on cannabis products…which sets us apart from other labs.”
The current prices as low as $100.00 for a “full state compliance test” under HB 3460 will become a thing of the past. The new rules will be in effect in June and prices will likely rise to sustainable levels for this type of industry.
Immediate Changes Proposed
Most recently, a suggestion was made to the OHA that 10–12 most common pesticides be immediately added to the rules to provide a stopgap measure to help curtail some pesticide-laden products from reaching the market.
Mowgli Holmes, an owner and scientist at Phylos Bioscience in Portland, submitted recommendations to the OHA committee for changes to the current standards, which only test for four very broad classes of pesticides.
“The problem is that these pesticide testing rules don’t make any sense and can’t be followed,” Holmes told the OHA. “Stuff is going onto the shelves and it looks like they have been testing for pesticides and it hasn’t been tested for pesticides.”
Whether these recently suggested changes to current standards are adopted is still up in the air, and with no oversight currently in place, it’s hard to say how the temporary standards proposed by Holmes would be enforced or monitored.
One thing is certain: Next June the landscape of cannabis testing in Oregon will change drastically. Growers should be preparing for the changes, too, and stop using pesticides not on the OHA pesticide list. OCC will cover that in our next issue!
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