Tag Archives: laboratories

September 21, 2017

EVIO Labs Expands To Florida

By Aaron G. Biros

Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.

Chris Martinez, co-founder and president of EVIO Labs Florida

When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2^nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.

Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.

The EVIO team is using instruments from Shimadzu

EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.

According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.

Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.

Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.

When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.

In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.

September 21, 2017

Colorado Approves Emerald Scientific Proficiency Tests for Regulatory Compliance in Cannabis Testing

By Aaron G. Biros

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Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.

Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.

According to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.

Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.

Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”

As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25^th in the Fall 2017 Emerald Test ILC/PT.

August 30, 2017

JCanna Boot Camp Educates Portland Attendees

By Aaron G. Biros

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On Monday, August 28^th, attendees of the Cannabis Science Conference descended on Portland, Oregon for a week of educational talks, networking and studying the science of cannabis. On Monday, Chalice Farms, an extracts and infused products company, hosted the full-day JCanna Boot Camp focused on a deep dive behind the scenes of a cannabis production facility. The Cannabis Science Conference, hosted by Josh Crossney, founder of JCanna, takes place August 28^th to 30^th.

Attendees were split into five groups where they listened to a variety of educational sessions and toured the facility. A track focused on cultivation, led by Autumn Karcey, president of Cultivo, Inc., detailed all things facility design for cannabis cultivation, including an in-depth look at sanitation and safety. For example, Karcey discussed HVAC cleanliness, floor-to-ceiling sanitation and the hazards associated with negative pressure. These principles, while applicable to most cultivating facilities, applies particularly to commercial-scale grows in a pharmaceutical setting.

Sandy Mangan and Tristan DeBona demonstrating the grinding technique for sample prep

During one session, Sandy Mangan, accounts manager at SPEX Sample Prep and Tristan DeBona, sales specialist at SPEX Sample Prep, demonstrated the basics of sample preparation for detecting pesticides in infused products, such as gummies. That required using their GenoGrinder and FreezerMill, which uses liquid nitrogen to make gummies brittle, then pulverizing them to a powder-like substance that is more conducive for a QuEChERS preparation.

Joe Konschnik and Susan Steinike demonstrate the QuEChERS method

Joe Konschnik, business development manager at Restek, Susan Steinike, product-marketing manager at Restek and Justin Steimling, an analytical chemist at Restek, gave a demonstration of a full QuEChERS extraction of a cannabis sample for pesticide analysis, with attendees participating to learn the basics of sample preparation for these types of tests.

Following those were some other notable talks, including a tour of the extraction instruments and equipment at Chalice Farms, a look inside their commercial kitchen and a discussion of edibles and product formulation. Dr. Uma Dhanabalan, founder of Uplifting Health and Wellness, a physician with over 30 years of experience in research and patient care, led a discussion of physician participation, patient education and drug delivery mechanisms.

Amanda Rigdon, Emerald Scientific, showing some complex matrices in cannabis products

Amanda Rigdon, chief technical officer of Emerald Scientific, offered a demonstration of easy and adaptable sample preparation techniques for potency testing of infused product matrices. Rigdon showed attendees of the boot camp how wildly diverse cannabis products are and how challenging it can be for labs to test them.

The JCanna Canna Boot Camp is a good example of an educational event catered to the cannabis industry that offers real, hands-on experience and actionable advice. Before the two-day conference this week, the boot camp provided a bird’s eye view for attendees of the science of cannabis.

August 24, 2017

Ask the Expert: Q&A with Steve Stadlmann on Cannabis lab Accreditation

By Aaron G. Biros

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Steve Stadlmann has an extensive background as an analytical chemist working in laboratories since the early 90’s. He is now a sales specialist at PerkinElmer, an analytical instrument manufacturer that provides instruments for cannabis testing labs, in addition to a host of other industries. With over two decades of experience working in environmental testing labs, food and beverage labs and agricultural testing labs, Stadlmann is extremely familiar with the instruments used in cannabis labs.

Steve Stadlmann, sales specialist at Perkin Elmer

In 2014, he started working in the cannabis space with TriQ, Inc., a technology solutions provider for cannabis growers, where he worked in product development on a line of nutrients. In April of 2016, he started working at Juniper Analytics, a cannabis-testing laboratory in Bend, Oregon. As laboratory director there, he created their quality manual, quality assurance plan, SOP’s and all the technical documentation for ORELAP accreditation. He developed new methodologies for cannabis testing industry for residual solvents, terpene profiles and potency analysis. He worked with PerkinElmer on pesticide methodology for the QSight™ Triple Quadrupole LC/MS/MS system and implemented operational procedures and methods for LC-UV, GCMS and LC-MS/MS, including sample prep for cannabis products.

He left Juniper Analytics about two months ago to work with PerkinElmer as a sales specialist. With extensive experience in helping get Juniper’s lab accredited, he is a wealth of knowledge on all things cannabis laboratory accreditation. PerkinElmer will be hosting a free webinar on September 12^th that takes a deep dive into all things cannabis lab accreditation. Ahead of the upcoming webinar, Getting Accreditation in the Cannabis Industry, we sit down with Stadlmann to hear his observations on what instruments he recommends for accreditation, and processes and procedures to support that. Take a look at our conversation below to get a glimpse into what this webinar will discuss.

CannabisIndustryJournal: How can cannabis labs prepare for accreditation with selecting instrumentation?

Steve: Finding the appropriate instrumentation for the regulations is crucial. Ensuring the instrumentation not only has the capabilities of analyzing all the required compounds, but also able to achieve appropriate detection limit requirements. In addition, having an instrument manufacturer as a partner, that is willing and able to assist in method development, implementation and continued changes to the testing requirements at the state level (and potentially national level) is key.

Another consideration is robustness of the equipment. The instrumentation must be capable of high throughput for fast turnaround times of results. Unlike the environmental industry, the cannabis industry has consumer products with expiration dates. Clients demand quick turnaround of results to get product to market as quickly as possible and avoid sitting on inventory for any length of time.

To add to the robustness need, sample matrices in the cannabis industry can be quite challenging in relation to analytical instrumentation. Equipment that is able to handle these matrices with minimal downtime for routine service is becoming a requirement to maintain throughput needs of the industry.

CIJ: What are the most crucial procedures and practices for achieving ISO 17025 accreditation?

Steve: Development and documentation of processes and procedures following Good Laboratory Practices and procedures is essential to a successful accreditation process. Great attention must be paid to the quality objectives of the laboratory as well as associated documentation, including tracking of any errors, deviations, updates, complaints, etc.

Data integrity is a key component to any accrediting body and includes implementation and/or development of appropriate methods with support data proving acceptable results. In addition, documentation of all procedures and processes along with tracking of all steps in the process during routine laboratory work should be a priority. The ability to show a complete, documented trail of all procedures done to any sample is important in ensuring the results can be reproduced and ensuring no deviations occurred, in turn potentially causing questionable results.

Last but not least: training. Laboratory staff should be well versed in any procedures they are involved in to ensure high data quality and integrity. If any laboratory staff does not receive appropriate training in any operating procedures, the data quality becomes suspect.

CIJ: What are some of the biggest obstacles or pitfalls cannabis labs face when trying to get accredited?

Steve: Not fully preparing to meet any agency and testing regulations and requirements will cause delays in the accreditation process and potentially more work for the laboratory. From documentation to daily operations, if any aspect becomes a major finding for an auditor, additional data is usually required to prove the error has been fixed satisfactorily.

Taking the time early on to ensure all documentation, processes and procedures are adhering to any regulatory agency requirements is important for a smooth accreditation process. It is easy to overlook small details when building out the operating procedures that might be essential in the process. Again, going back to data quality, the laboratory must ensure all steps are outlined and documented to ensure high quality (reproducible) data and integrity.

A new employee should be able to come in and read a quality manual and standard operating procedure and produce equivalent data to any laboratory analyst doing the same job. With difficult or challenging operating procedures it becomes even more important that training and documentation are adhered to.

PerkinElmer’s free webinar will dive into these points and others in more detail. To learn more and sign up, click here.

July 26, 2017

SC Labs Santa Cruz Gets ISO 17025 Accreditation

By Aaron G. Biros

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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.

July 20, 2017

Las Vegas Gets First ISO 17025-Certified Cannabis Lab

By Aaron G. Biros

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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 1^st, 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.

July 13, 2017

DigiPath Gets Rec Testing License, Renews Medical License In Nevada

By Aaron G. Biros

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According to a press release, Digipath, Inc. (OTCQB: DIGP) was awarded a recreational cannabis-testing license and a renewal of their medical cannabis-testing license in Nevada.

The news came the week following Nevada’s opening day for recreational cannabis sales, which began July 1^st. Some estimates report up to $5 million in sales within the first weekend.

Todd Denkin, founder and president of Digipath

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 1^st.

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.

May 18, 2017

Regulatory Overreach: Are California’s Lab Rules Too Strict?

By Aaron G. Biros

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With California moving into a more regulated market, some are concerned the state may be overregulating the market with strict, unnecessary rules. The Bureau of Marijuana Control, California’s agency in charge of regulatory oversight for the cannabis industry, released a set of proposed draft regulations for lab testing recently.

Jeffrey Raber, Ph.D, Chief Executive Officer of The Werc Shop

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 20^th.

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.

May 17, 2017

The Practical Chemist

Instrumentation Used for Terpene Analysis

By Tim Herring

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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.

Figure 1: Terpene profile via headspace, courtesy of ProVerde Laboratories.

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.

May 10, 2017

California Releases Draft Lab Testing Regulations

By Aaron G. Biros

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Last Friday, the Bureau of Marijuana Control, the regulatory body overseeing California’s cannabis industry, released a set of proposed regulations for the lab testing market. The regulations are somewhat comprehensive, covering sampling, licensing, pesticide testing, microbiological contaminants, residual solvents, water activity and much more.

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.