Earlier this week, SC Labs issued a press release announcing they achieved ISO/IEC 17025:2005 accreditation for the cannabinoids panel at their Santa Cruz location.
“We are thrilled to announce our ISO accreditation as this is one of our most important achievements over the past seven years of serving the cannabis industry and demonstrates our commitment to serving our clients with integrity,” says Jeff Gray, co-founder and chief executive officer of SC Labs. ISO 17025 accreditation represents an international standard for a laboratory’s technical competence in producing accurate test results.
“Being accredited to this International Standard demonstrates our robust quality system, technical competence, the calibration and suitability of our instrumentation and our ability to produce precise and accurate test data,” says Gray. “For clients, it enhances their confidence in our services and their choice in a business partner, provides them with additional legal defensibility in complying with upcoming regulations, and enhances the integrity of their products based on SC Labs results.”
SC Labs is currently expanding in California, growing their Southern California and Santa Cruz locations, and adding field offices throughout the state, according to the press release.
This complimentary, 1-hour webinar will delve into the details of laboratories, analytics and all things cannabis laboratory accreditation.
Juniper Labs is a fully accredited cannabis laboratory in Bend, Oregon, whose business model is to perform all cannabis testing in-house and control analytical quality to maximize profitability. Learn how they successfully navigated the certification process through expertise management, capital expenditures, designing a detailed plan for success and achieved accreditation under Oregon’s ORELAP requirements. PerkinElmer reviews some of the instruments, processes and procedures used to support accreditation in the cannabis lab testing market. In addition, explore the variety of cannabis products, legality in the US, taxonomy and much more.
This live webinar is divided into three sections and will conclude with a “Question and Answer” session that will help attendees better understand what lab managers face when going through the accreditation process.
According to a press release published earlier this week, DB Labs achieved accreditation, becoming the first ISO 17025-accredited cannabis laboratory in Las Vegas. DB Labs received their accreditation with the help of Perry Johnson Laboratory Accreditation, Inc., an organization that provides third-party assessments to ISO/IEC 17025:2005. DB Labs was also the very first cannabis-testing lab in the state of Nevada.
According to Susan Bunce, president of DB Labs, ISO accreditation is one way the cannabis lab space is being standardized. “As the first cannabis-testing laboratory in Nevada, DB Labs has always taken patient safety very seriously and has always tried to raise the bar,” says Bunce. “The world of cannabis testing is often compared to the Wild West: each lab uses state regulations to set their standards, but it leaves a lot of room for subjective interpretations. The ISO accreditation removes the ambiguity and guarantees a consistent level of testing to users. We are proud to be a part of that.”
According to Tracy Szerszen, president and operations manager at Perry Johnson, ISO/IEC 17025:2005 is an international standard utilized to accredit testing laboratories. “This accreditation provides confidence to end-users that the test results they receive are reliable,” says Szerszen. “Laboratories achieving this accreditation have demonstrated their ability to adequately perform tests using appropriate equipment, environmental conditions and technical staff.” She says another requirement for that accreditation is a quality management system, which essentially helps manage operations and client needs. “Achieving this type of accreditation is quite challenging for laboratories especially with all of the new up-and-coming regulations, technologies and methods in the cannabis industry,” says Szerszen. “Laboratory testing is such a critical part of this industry and becoming accredited provides assurance that they are performing to the highest standard.”
As Szerszen points out, laboratory accreditation can provide a consumer that sense of confidence and trust in the product’s lab testing. “PJLA would like to commend DB Labs for achieving their ISO/IEC 17025:2005 accreditation and their commitment towards meeting the standard,” says Szerszen.
The news of their accreditation comes at an opportune time: With surging consumer demand at the outset of recreational sales, the state has raked in millions of dollars in sales within the first weekend. Recreational cannabis sales in Nevada began on July 1st, and a statewide cannabis product shortage recently led to Governor Sandoval issuing a statement of emergency, allowing more applications for distribution licenses to be considered.
According to Todd Denkin, president of Digipath, that massive start hasn’t showed any signs of slowing. “I was in a dispensary yesterday and it was packed,” says Denkin. “There were 40 people in line and it was pouring rain outside.” He says the flow of customers to dispensaries hasn’t stopped since July 1st.
Because of that demand as well as the state’s testing requirements, Denkin is preparing to expand. “From a laboratory’s perspective, we expect a large increase in volume,” says Denkin. “Most of the medical cultivators we work with got their rec license as well so we’re working with a lot of the same clients and getting new clients on a regular basis.” Before the launch of recreational sales, DigiPath has been doing lab testing for medical cannabis for over two years.
Cindy Orser, PhD., chief science officer at Digipath, says they are on their way to receiving ISO 17025 accreditation via the American Association for Laboratory Accreditation (A2LA). According to Orser, labs in Nevada must go out and do the sampling themselves, then bring the samples back to the lab for testing. The testing regulations overall seem relatively similar to what we’ve seen develop in other states with required pesticide testing and microbial screening. “We have a list of 24 pesticides, (two of them are plant growth regulators) that we monitor for,” says Orser. “We have specific allowable limits for that set of chemicals.” For microbial testing, Orser says they enumerate total aerobic count (TAC), total yeast and mold (TYM), pathogenic E. coli and Salmonella spp., enterobacteriaceae and bile-tolerant gram-negative, a subset of enterobacteria, as well as screening for mycotoxins. All of the testing in the state goes through just eleven laboratories, including DigiPath.
In preparing for expansion, they are looking at California in addition to other states. California released a set of draft regulations for lab testing in the spring, which many say is an example of regulatory overreach. “We still don’t know exactly what’s going to happen in California,” says Orser. “The draft regulations that have come out are so restrictive.” As Digipath looks toward expanding more in Nevada, California and other states, all eyes are on regulators proposing requirements for laboratory testing. “The future looks promising,” says Denkin.
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Those rules cover everything from sampling standard operating procedures to detection limits for pesticide analytes, which some say are absurdly strict as is. According to Jeffrey Raber, Ph.D, chief executive officer of The Werc Shop, a cannabis consulting firm located in Monrovia, CA, these rules will immediately raise prices. “The regulations are quite extensive and will undoubtedly drive the costs of patient medicine upward,” says Raber. “Regulations are not intended to be so detailed in these fashions, but are supposed to provide the floor and specific framework upon which operators can build best practices and differentiate themselves from others in a competitive market that drives prices downward.”
“Comparable guidance from other states operating today, and even federal regulations, are not nearly as specific in certain aspects,” says Raber. “While there are some very good parts to the current draft, and the bureau has certainly aimed to provide strong consumer protections, as they should, the idea of benzene even being mentioned or possibly permitted, or a completely cold transportation chain being required, and pesticide levels so low it pushes the limits of the most sophisticated and modern analytical equipment while going far past sensible EPA limits, strongly suggests there is work to be done to dial back the current position and make for far more workable and fully balanced regulations before they are fully finalized.”
It is important to note that nothing is set in stone yet. The bureau will hold four public hearings throughout the month of June for the lab testing rules. In addition to that, concerned stakeholders can send written comments through June 20th.
Dave Egerton, vice president of technical operations at CW Analytical, a cannabis-testing lab based in Oakland, is pleased they are finally regulating the market, but definitely plans on providing some feedback to change the rules a bit. “CW Analytical applauds the state’s efforts to regulate laboratories and the cannabis industry in general,” says Egerton. “…Many aspects of the proposed regulations for labs will make for a marked shift in the way our businesses operate, but the motivation behind them is well-intended.” His sentiment is consistent with many who operate cannabis laboratories and other stakeholders who see these proposed rules as overreach.
“Unfortunately, some of the regulations as written will create undo burden upon the industry and carry a strong probability of limiting supply to medical patients,” says Egerton. “During the current review period, CA laboratories will be providing feedback on some of the details within the law in order to streamline their quality assurance goals into a more tenable document that still protects patients.” That public comment period is a crucial part of the rulemaking process, as the rules will most likely change after cannabis laboratories’ voices are heard.
Terpenes are a group of volatile, unsaturated hydrocarbons found in the essential oils of plants. They are responsible for the characteristic smells and flavors of most plants, such as conifers, citrus, as well as cannabis. Over 140 terpenes have been identified to date and these unique compounds may have medicinal properties. Caryophyllene, for example, emits a sweet, woody, clove taste and is believed to relieve inflammation and produce a neuroprotective effect through CB2 receptor activation. Limonene has a citrus scent and may possess anti-cancer, anti-bacterial, anti-fungal and anti-depression effects. Pinene is responsible for the pine aroma and acts as a bronchodilator. One theory involving terpenes is the Entourage Effect, a synergistic benefit from the combination of cannabinoids and terpenes.
Many customers ask technical service which instrumentation is best, GC or HPLC, for analysis of terpenes. Terpenes are most amenable to GC, due to their inherent volatility. HPLC is generally not recommended; since terpenes have very low UV or MS sensitivity; the cannabinoids (which are present in percent levels) will often interfere or coelute with many of the terpenes.
Headspace (HS), Solid Phase Microextraction of Headspace (HS-SPME) or Split/Splitless Injection (SSI) are viable techniques and have advantages and disadvantages. While SPME can be performed by either direct immersion with the sample or headspace sampling, HS-SPME is considered the most effective technique since this approach eliminates the complex oil matrix. Likewise, conventional HS also targets volatiles that include the terpenes, leaving the high molecular weight oils and cannabinoids behind (Figure 1). SSI eliminates the complexity of a HS or SPME concentrator/autosampler, however, sensitivity and column lifetime become limiting factors to high throughput, since the entire sample is introduced to the inlet and ultimately the column.
The GC capillary columns range from thicker film, mid-polarity (Rxi-624sil MS for instance) to thinner film, non-polar 100% polysiloxane-based phases, such as an Rxi-1ms. A thicker film provides the best resolution among the highly volatile, early eluting compounds, such as pinene. Heavier molecular weight compounds, such as the cannabinoids, are difficult to bake off of the mid-polarity phases. A thinner, non-polar film enables the heavier terpenes and cannabinoids to elute efficiently and produces sharp peaks. Conversely the early eluting terpenes will often coelute using a thin film column. Columns that do not contain cyano-functional groups (Rxi-624Sil MS), are more robust and have higher temperature limits and lower bleed.
For the GC detector, a Mass Spectrometer (MS) can be used, however, many of the terpenes are isobars, sharing the same ions used for identification and quantification. Selectivity is the best solution, regardless of the detector. The Flame Ionization Detector (FID) is less expensive to purchase and operate and has a greater dynamic range, though it is not as sensitive, nor selective for coeluting impurities.
By accurately and reproducibly quantifying terpenes, cannabis medicines can be better characterized and controlled. Strains, which may exhibit specific medical and psychological traits, can be identified and utilized to their potential. The lab objectives, customer expectations, state regulations, available instrumentation, and qualified lab personnel will ultimately determine how the terpenes will be analyzed.
Formerly named the Bureau of Medical Cannabis Regulation under the state’s Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation and enforcement of the regulations for the state’s cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon’s already implemented testing regulations.
The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids.
The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations.
The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA’s Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC’s Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology.
Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency-test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab’s license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program.
Last week, the American Society for Testing and Materials (ASTM International) approved the formation of a committee to develop standards for the cannabis industry. ASTM International is a standards development organization that develops voluntary consensus-based standards for industries. United States regulatory bodies and the World Trade Organization have recognized the organization’s standards in other industries.
On March 1st, the non-profit announced the formation of a committee for ““creating technical standards and guidance materials for cannabis and its products and processes.” So now that the vote has passed, what is the next step? They will begin the process of member training, appointment of leadership and writing the bylaws. ASTM will have two online briefings before their official meeting for the cannabis committee (D37) in June. Those meetings will discuss how the committee was formed and how it’ll be structured. The first official meeting of the cannabis committee will take place June 11th and 12th in Toronto.
Voluntary consensus-based standards means there is a balance of interests, an appeals process and an overall consensus has been reached. The areas of focus for the cannabis standards include indoor and outdoor horticulture and agriculture, quality management systems, laboratories, processing and handling, security and transportation, and personnel training, assessment and credentialing. Many standards will be developed under each of these broad categories. A large component of consensus-based standard development is openness…so anyone who wants to participate in the development of the standards is welcome and encouraged to do so. They are still looking for participants from the cannabis industry and those interested can register here.
Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), says this is terrific news for the cannabis industry. “To have a global organization like ASTM, that federal governments actually work with and respect, is a huge stride forward for the cannabis industry,” says Engelking. “FOCUS is thrilled to be working with ASTM.” FOCUS and ASTM International have a derivative work license agreement that provides ASTM the FOCUS standards to use as a baseline for developing their standards. “FOCUS will continue to certify cannabis businesses to the FOCUS standards, but we will be able to add in the ASTM standards to our certification platform,” says Engelking. “It helps us expand our depth and reach in tools for our clients.”
FOCUS standards and ASTM standards are both voluntary consensus-based, meaning it is the businesses and stakeholders participating that ultimately write the standards. The organizations’ staff does not actually contribute to and develop the standards; they are more like a vehicle for the industry and stakeholders to come to a consensus, according to Engelking. “ASTM does the same thing that we do for the cannabis industry, just on a much larger scale,” says Engelking. “Its role is to fulfill the development, not actually develop it.” Because of that, ASTM and FOCUS standards can work in harmony.
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.