Tag Archives: labs

February 17, 2016

Amanda Rigdon to Offer Guidance on Method Validation at Cannabis Labs Conference

By Aaron G. Biros

With multiple states now requiring third-party certification as part of licensing cannabis laboratories, there is a large role for laboratory accreditation in the cannabis industry. Using method validation can prove that your data is reproducible and that you have robust methods for sample preparation and calibration. All of these tools are instrumental in getting a laboratory accredited.

Amanda Rigdon, associate marketing manager for GC columns at Restek, Inc. — Amanda Rigdon, associate marketing manager for GC columns at Restek

Amanda Rigdon, associate marketing manager for gas chromatography columns at Restek, Inc., will deliver a presentation, Opportunities and Challenges for Method Validation in the Evolving Cannabis Industry, at the first annual Cannabis Labs Conference taking place this March 9^th in Atlanta, Georgia. The Cannabis Labs Conference will be co-located with the third annual Food Labs Conference and the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon) at the Georgia World Congress Center.

In her presentation, Rigdon will discuss established validation guidelines from a variety of regulatory bodies. “Method validation is absolutely critical to the cannabis industry,” she says. “Accurate test results not only help to protect consumers, but because of the high dollar value of cannabis products, accurate results can also protect producers from false positives, and laboratories in backing up their results.” She will also be sharing actual validation data from a number of cannabis analytical methods.

Scott Radcliffe, technical support scientist at Romer Labs, Inc., will share his validation methods of immunoassays for the detection of pathogens and mycotoxins in cannabis. He will include a discussion of specific rapid pathogen detection methods for Salmonella and E. coli O157 species. This will cover their small-scale validation studies with partner labs in Michigan and Washington for immunoassays.

stevegoldner — Stephen Goldner, Esq, founder of Pinnacle Laboratory and Regulatory Affairs Associates

Stephen Goldner, Esq, founder of Pinnacle Laboratories, will discuss how cannabis labs can apply FDA lab practices with recommendations for short and long term management implementation. Goldner’s presentation will include a discussion of preparation for FDA involvement in sate regulatory systems.

Beyond validation methods in laboratories, the Cannabis Labs Conference will feature several presentations on ISO/IEC 17025:2005 compliance, the need for standardization, seed-to-sale traceability, FDA best lab practices and cannabis quality. Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), will deliver the keynote presentation on the role of quality assurance in the cannabis industry.

February 11, 2016

Cannabis Coaching & Compliance

Avoiding Recalls: Preparing for the What-Ifs

By Maureen McNamara

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Recalls are a necessary part of our lives, and they occur quite often. There are hundreds of food recalls performed each year. Now we are experiencing recalls in the cannabis industry. It is important to keep in mind that the primary objective of performing a recall is to protect consumer safety.

Welcome to a whole new game!

The Scoop:

A recall occurs to remove defective or potentially harmful products from the marketplace.

Recalls can be expensive and stigmatizing. Companies involved are usually highly motivated to remedy the issue and recover as quickly as possible. It is in the producer’s best interest to do everything in their power to maintain and regain patient & customer confidence and brand trust as soon as possible.

In the United States, food recalls are typically generated by the U.S. Food and Drug Administration (FDA), or by the U.S. Department of Agriculture (USDA) through the Food Safety and Inspection Service (FSIS). Food manufacturers regularly perform mock recalls and, when needed, perform voluntary recalls of possibly contaminated product. Recently, listeria has become a major concern for contamination in the food industry and as a result, many companies are preparing themselves for prevention strategies.

As cannabis is still federally illegal, the FDA does not perform cannabis recalls. As a result, we are seeing local health departments and the state departments of agriculture getting involved in cannabis recalls. Recent recalls are voluntary and are related to potentially dangerous pesticide residue on flower, concentrates and infused products. Colorado has come into the spotlight recently for businesses performing a number of voluntary recalls, in the interest of protecting consumer safety. This January, a recall included “individual units of marijuana concentrates that are used for vaporizing” testing positive for Imidacloprid, Myclobutanil, Etoxazole and/or Avermectin, which are all pesticides determined by the Colorado Department of Agriculture as not usable on cannabis.

How do we know there is a problem?

A manufacturer discovers a problem
Inspectors reveal a potential issue
A product fails a test carried out by a licensed laboratory
A state health department may be alerted to an issue

Preparing for the “What- Ifs”

What is your crisis management strategy?
How will your team communicate the issue with regulators?
What is the protocol to recover or destroy recalled product?
What is the communication plan with purveyors & consumers?
What new structures will be in place to prevent future issues?

How do we avoid a Recall?

Manufacturers and cultivators endeavor to prevent issues in the first place. Good Manufacturing Practices (GMP), Good Agricultural Practices (GAP) and Hazard Analysis and Critical Control Points (HACCP) plans are used to ensure quality and safety during the production process. Mistakes can occur. It is ultimately the manufacturer’s responsibility to remove any possibly contaminated product from the market quickly and before potential damage is incurred.

As we pioneer the cannabis industry, it is important to be as proactive as possible at every step of the supply chain, from seed to the sale of cannabis: Cultivating, trimming, curing, extracting, infusing, producing, packaging, shipping, receiving, storing and selling are all points where safety measures should be in place.

Prevention Rules!

How is your team doing with the following?

GAP, GMP & HACCP plans to ensure quality product
Testing, TESTING, Testing- to confirm safety of your goods
Requiring strict & tested operating procedures from your suppliers
Internal quality reviews
Training and Accountability

Our desire is that you do not ever need to recover from a crisis, but mistakes happen. They create a learning opportunity for us to make a higher quality product, to strengthen our procedures and to show our consumers that we are committed to excellence.

February 9, 2016

Quality From Canada

The Great Green North: Canada vs. US in Cannabis Regulations

By Tegan Adams

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A lot has been changing quickly in the world of cannabis across North America. While international drug treaties sit back and watch in horror, cannabis and cannabis-infused products have been popping up in households across Canada, on retail shelves and in private delivery services across the US. How each jurisdiction in North America accepts and regulates (or draws a blind eye) to the sale of cannabis is different depending on where you are located. Here are a few key distinctions between the current Canadian and US regulatory approaches to marijuana.

In Canada, cannabis is regulated at the federal level by Health Canada through the Marihuana for Medical Purposes Regulations, (MMPR). The MMPR allows persons to obtain dried cannabis for their own personal medical purposes or for another person for whom they are responsible. To obtain dried cannabis, a person must obtain a medical document from a physician, or nurse practitioner to register as a client with a licensed producer of their choosing. After registering as a client, they are able to order dried cannabis and possess up to a maximum of 150 grams at any one time, depending on the recommendation of their physician. More recently, in 2015, regulations allow the distribution of not only the dried form of cannabis but also their extracted forms.

In the US, at the federal level, cannabis is still 100% illegal. Public statements from the federal administration dictate that they steadfastly oppose legalization of cannabis and other drugs. They are concerned that legalization would increase the availability and use of illicit drugs, and pose significant health and safety risks to all Americans, particularly young people. At the state level, legalization laws are rapidly changing. The office of National Drug Control Policy lists 23 states (a rising number) and Washington DC that have passed laws allowing cannabis to be smoked for a variety of medical conditions. The state laws do not change federal regulation. Many local governments are creating zoning and other restrictions that prohibit dispensaries from operating in their communities. That being said, voters in Alaska, Colorado, Oregon and Washington state support legalizing the sale and distribution of cannabis to adults over 21. There are many differences in the regulation of marijuana within each state, municipality and within the country itself.

Internationally, Canada has a platinum reputation for delivering and regulating quality consumer products. Within the Canadian cannabis industry, many feel Health Canada’s regulatory regime is inaccessible, restricts production to large corporations and limits distribution channels. The average start up cost of even a small licensed facility is around $4-5M CAD. On top of the financial costs, production companies have to compete with the other 2000 or so applicants who have been waiting, in some cases up to two years, to hear back from Health Canada if they will succeed in the licencing application process. In response, Canada has seen many tolerances made to allow dispensaries to distribute marijuana at the municipal level, even though not allowed as per regulation.

Many Canadian dispensaries operate with professional policies and procedures including providing customers with access ID cards and offering physician consults. Vancouver became the first city in Canada to license and regulate marijuana dispensaries. The number of licenses within the city exceeds both Tim Hortons and Starbucks Franchises combined. Many dispensaries provide bar and café settings for people to enjoy a “bong shot” or café au lait infused with cannabis. Licensing dispensaries has become a great financial resource for the city, charging $30,000 CAD per licence. Vancouver’s dispensaries have been a topic of debate across all levels of government. The Health Minister asked Vancouver to shut the dispensaries down, while other municipalities have started to expand the same concept. The Royal Canadian Mounted Police (RCMP), Canada’s federal police force, has started raiding various dispensary locations. Part of the new Prime Minister, Justin Trudeau’s, political platform and claim to fame is to legalize cannabis recreationally across Canada. How the framework will unfold is still in the works and subject not only to local jurisdictional reform but also to international negotiations.

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

January 27, 2016

From The Lab

Cannabis Research in Israel: Meeting with Dr. Raphael Mechoulam

By Seth Wong

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I had the pleasure of visiting the famous Dr. Raphael Mechoulam last month at his Hebrew University office just outside of Jerusalem, Israel. For those who may not have heard of him, Dr. Mechoulam is essentially the godfather of the endocannabinoid system. He is best known for his work in isolating and totally synthesizing delta-9 tetrahydrocannabinol (THC). Dr. Mechoulam is one of the leading recognized scientists in our field. Much of his work is focused on the nervous system, specifically how various acids, and particularly cannabinoids, bind to the nervous system and thus their effect on humans.

Dr. Mechoulam is a humble man whose energetic demeanor belies his age. He speaks six languages and continues working regularly even at the age of 86. His mind is as sharp as any 25 year old and, while our meeting was short, it lacked nothing in content.

Dr. Raphael Mechoulam (right) and Seth Wong (left) in the Dr.'s Hebrew university office. — Dr. Raphael Mechoulam (right) and Seth Wong (left) in the Dr.’s Hebrew university office.

His discoveries in cannabis have not been his only accolades and only represent about a third of his work in his accomplished life time. He has a vast number of papers and studies related to fatty and amino acids and their effect on the brain. The underlying principles of all of Dr. Mechoulam’s areas of study are similar and he has equally distinguished himself in these fields as he has in the realm of cannabis. Because of it’s taboo nature and the limited amount of sophisticated scientific research that cannabis has been subject to, Dr. Mechoulam is more widely recognized for this specific focus.

During our brief hour-long meeting, we discussed the impact of cannabinoids on cancer patients and bone marrow transplants, his cannabis research on schizophrenia as well as the role cannabis plays in diabetes patients – all topics on which he has volumes of published research but stressed the point that more research needs to be done; we have only scratched the surface.

Dr. Mechoulam is an inquisitive man who is always investigating, digging, and striving to understand more about the effects of cannabis, fatty, and amino acids on the brain. When asked what charge the cannabis and medical industries need to pursue, he stressed the need for more scientific studies to investigate the impact of cannabis not just on the brain but the entire human body, as well as the need for grants to help promote those studies. Dr. Mechoulam specifically stressed the importance that these studies employ scientific vigor in a responsible and legal manner.

He is man of high moral ground, inquisitive nature, and a thorough investigator. I am privileged and humbled to have met him and heed his call to bring sophisticated and responsible scientific studies to the forefront of the Cannabis Green Rush.

January 20, 2016

Ask the Expert Series: Straight Talk on Safety, Defense and Security with Bruce Lesniak

By Aaron G. Biros, Bruce E. Lesniak

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This is the first part of a series dedicated to understanding more about defense, security and safety as they relate to the cannabis industry, the importance of having standards and some tips for cannabis business plans. Over the next few weeks, we will hear from multiple industry pioneers discussing those topics and offering practical solutions for problems that many cannabis businesses face daily.

Inconsistent laws across multiple states created a fragmented network of regulations for cannabis. Some third parties are filling the gaps between the industry standards and state regulations. The Colorado Marijuana Enforcement Division (MED) and the Washington Liquor and Cannabis Board’s i-502 rule provide guidance on regulations surrounding packaging and labeling, advertising, pesticide use, retail and other areas.

Still there are many opportunities to fill the gaps. The Foundation of Cannabis Unified Standards (FOCUS), is an independent non-profit founded to develop some consistency in standards governing public health, consumer safety and the environment. In cultivation, the third party certification, Clean Green Certified, works to provide some guidance for growing cannabis organically based on USDA organic standards. For laboratories, Washington’s regulations provide some guidance, but organizations like FOCUS, the American Association for Laboratory Accreditation (A2LA) and the Cannabis Safety Institute seek to fill the gaps in laboratory standards along with the ISO 17025 requirements.

Security and defense is one particular area of the cannabis industry that still needs a benchmark for businesses to follow. In this series, we sit down to discuss security, defense and safety with Bruce Lesniak, president of the Food Safety and Defense Institute and member of the oversight committee for the establishment of standards in the cannabis industry in conjunction with FOCUS.

Cannabis Industry Journal: What changes do you see coming to the cannabis industry related to product safety, defense and security?

Bruce Lesniak: As in every industry that provides a public consumable product, the primary objective is to protect the consumer by providing products that are consistently safe. The largest change coming to the cannabis industry will be the implementation of enforceable, nationally uniform standards across all states and all product lines. I believe that the standards and regulations developed for the cannabis industry will mirror those of the food industry. Companies are already busy working to develop this uniform standard, one such group is FOCUS. Founded by Lezli Engelking, FOCUS works with diverse professionals from regulatory, quality assurance, medical, law enforcement, business, research, and the government officials, medical and research professionals along with subject matter experts from numerous business disciplines across the industry to develop impartial, comprehensive, cannabis specific standards that will be presented for adoption by state and federal governing bodies. Lezli summarizes the FOCUS Mission as “ To protect public health, consumer safety, and safeguard the environment by promoting integrity within the cannabis industry.” Look for more on this in our next Ask the Expert update, on CannabisIndustryJournal.com or you can contact Lezli Engelking at FOCUS here: 866-359-3557 x101.

This series will highlight important issues involving security, defense and safety in the cannabis industry. Next week, Bruce, along with cannabis security professional, Tony Gallo of Sapphire Protection, will provide some advice on what companies can do to improve their master business plan. Stay tuned for next week’s Part II of Ask the Expert: Straight Talk on Safety, Defense and Security with Bruce Lesniak.

December 11, 2015

Tech Startup Seeking Investors for Cannabis Data Research Tool

By Aaron G. Biros

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Innovations in technology used for cannabis research have the potential to lead to major breakthroughs and discoveries for the plant’s various applications. Software and information technologies are particularly useful for sorting through the tremendous amount of data required in medical research and the cannabis industry. Tímea Polgár, founder of CannaData, worked in the pharmaceutical and biotech industries previously as a molecular biologist and computational chemist.

Her background in informatics, pharmaceutical research, molecular biology and chemistry brings her to the cannabis industry to study the plant in an herbal medicine context using high-tech informatics. Polgár, originally from Hungary, received her PhD from Budapest University of Technology and Engineering in pharmaceutical drug discovery. She has worked as a senior research scientist at Gedeon Richter in Budapest and as a senior molecular modeler at Servier, Inc. in Paris, France. After leaving the pharmaceutical industry, she began working at a startup called Chemaxon, a chemistry informatics company working on scientific business development. Polgár has worked for years in scientific business development, leveraging technology and knowledge to businesses, which brought her to work across multiple disciplines.

CannaData is essentially a software tool used to gather information on strain genetics, chemical components of different strains, molecular mechanisms of different strains and the medicinal effects. According to Polgár, the company plans to build a continuously growing data repository in conjunction with computational modeling and research in determining entourage effects to pinpoint how active chemical agents in cannabis interact. The tool will help scientists find areas of the plant that need more studying and areas that are inert. In addition to the database, CannaData will provide scientific analysis of data from seed banks, laboratories, clinics and other businesses collecting data in the cannabis industry.

A flowchart of the scientific concept behind herbal medicine research

Polgár’s organization is currently seeking investors to launch the project in hopes of connecting the cannabis industry, herbal medicine and computational chemistry for more accurate scientific research and understanding of the plant. According to Polgár, research and development of disease-fighting drugs has long had a narrow-minded approach. “Herbal medicine is very complex with numerous active chemical components. Recent technological and computational advancements have made it possible to study these chemical network interactions,” says Polgár. “The cannabis industry could provide a pioneering route for the novel concept of combining herbal medicinal research with information technology, furthering our molecular understanding of the benefits of cannabis.”

A flowchart breaking down the chemical composition of cannabis

Polgár believes that this type of research has the ability to help support standardization and quality control in the cultivation of cannabis. “We are linking technologies to herbal medicine and cannabis where there is a huge need to manage, extract and analyze data,” says Polgár. “Today, there are computational technologies that can manage this quantity of information required to model and understand herbal molecular mechanisms and we will be the first ones to do so on a commercial level.”

A flowchart describing the technical concept of CannaData, depicting the utility of a data repository — The technical concept of CannaData, depicting the utility of a data repository

Polgár’s organization is seeking investors looking to innovate in the areas of life sciences, pharmaceutical research and software development. Through bringing broad information technological solutions from research to the cannabis industry, CannaData hopes to serve analytical laboratories with chemical informatics software services. Ultimately, this project will serve the cannabis industry by analyzing data on strain genetics and known chemical profiles of cannabis, furthering scientific research on cannabis.

November 2, 2015

From The Lab

What to Consider When Selecting a Laboratory

By Seth Wong

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There are many factors to consider when selecting a third party analytical laboratory:

Why are you testing?
Does a governing body require it?
Are you testing to meet compliance with industry trends?
Are you testing as supplemental protection to an in house laboratory operation?
Are your results being used to help you market your product?
Are the results being utilized for internal R&D?
What are you looking to get out of testing?

Perhaps it is a combination of all these things. Regardless, whomever you contract with for whatever reasons, it is important to understand what you are getting, know what you are entitled to, understand your results, and understand where you and your company remain vulnerable. You must also be prepared with a plan to handle adverse results. Testing at a third party analytical contract laboratory does not mean they assume all of your product’s or company’s liability, regardless of the lab’s reputation.

Ask your third party laboratory about any accreditations, certifications, and licenses that the lab should be accredited and/or certified for. Each state has different certifications and licensing requirements; make sure the entity you are using is licensed or certified for the services you need. Additionally, there is an accreditation called International Standards Organization (ISO) 17025 that is the pinnacle of third party laboratory accreditation. ISO 17025 is a set of protocols that your third party lab should follow to do everything it can to ensure your data is accurate and produced with reliable standards, control samples, matrix control samples and proficiency tests to verify the accuracy of the lab’s employees and methods, among a number of other criteria included in the standard. A number of different entities offer accreditation to ISO 17025 but it is important that the the accrediting body is also accredited to their ISO standard. Simply buying ISO 17025 compliant materials or standards does not mean that the vendor service or product is accredited to ISO 17025. Cannabis laboratories are just starting to implement and build systems around ISO 17025 but it has been prevalent in the third party lab business in many industries for decades and should be applied to the cannabis industry.

Visit your lab and understand their background and experience. Start by requesting a tour of the laboratory you choose; you want to know how things look behind the scenes. Is the lab orderly and doing its best to protect sample integrity? There may be a lot of things going on in the laboratory and it may look chaotic but it should be relatively clean. This prevents contamination and sample mix-ups. Further your relationship with your laboratory by understanding the laboratory’s experience and getting to know your laboratory staff. Consider the lab staff as part of your extended team, they are there to help you and help bring your product to market. The more they understand your goals, the more they can help.

Understand your lab’s history and background: Have they worked with products and/or analytes similar to yours? Have they worked with your sample matrix or one similar to it before? Their prior knowledge and laboratory experience, as it relates to your product, will help provide accurate data and navigate complex matrices.

Most importantly, a laboratory should be willing to release the data packet that is used to generate test results to the client. Releasing this data does not divulge any proprietary information of the lab. It is the laboratory’s job to provide you with the data upon request. It is important to note, looking at your raw data is not the same as looking at the laboratory method, also known as a work instruction or operating procedure. The lab most likely won’t give you the method as those are typically trade secrets, but there is no reason not to share with you the chromatography that the HPLC, GC, GC/MS, or LC/MS generated. This will demonstrate the lab’s sound analytical data and increase your confidence in the analysis you are receiving. When you pay for the results, you are also paying for your data and if your laboratory is not releasing that information to you at your request, you should be skeptical. This data needs to be able to stand up to audits and legal action.

Finally, confidentiality: your data is your data. Yes, you may have to report results to a governing body, but your laboratory should not be sharing your name and your data with anyone but your authorized list of contacts without your permission. They should not even disclose that you are their client without your prior authorization. Confidentiality is not just applicable to a few key employees at the laboratory, it is pertinent to everyone from the sample pickup driver, if you have one, to the chemists and upper level management.

Understanding your contract laboratory’s certifications, licenses, and accreditations, requesting and receiving raw data packages, and ensuring that you feel comfortable with the laboratory, its staff and their practices are key elements to ensuring a successful relationship with your laboratory.

October 23, 2015

Using LIMS in Cannabis Laboratories

By Aaron G. Biros

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LIMS (laboratory information management systems) is a software-based information management tool that can streamline laboratory workflows, data management, automate repetitive steps, and improve instrumentation efficiency. The cannabis industry’s rapid growth, coupled with fluctuating state regulations, gave rise to a number of cannabis testing laboratories nationwide. Cannabis labs test primarily for potency, but testing regulations for pathogens, pesticides, and other contaminants are on their way to approval in California and Colorado.

limsbud — A dried flower prior to sample-preparation to be used for testing

Founded in 2010, BGASoft developed LIMSABC last year. The cloud-based laboratory informatics system is a platform that can manage all of a cannabis testing laboratory’s operational needs, while providing the tracking and audit trails required by some state’s regulations.

“The recreational and medical cannabis industry is in its infancy and many cannabis laboratories are small operations that need to be very capital efficient as they navigate a rapidly changing regulatory environment,” says Tim Kutz, vice president of business development at BGASoft.

“LIMSABC provides a flexible, modern platform to handle all of a testing laboratory’s operational needs while providing the rigorous tracking and audit trail required by today’s regulations, with the ability adapt to future regulations.”

According to Kutz, LIMS can help cannabis laboratories with bi-directional instrument and automation integration, and automate client reporting to help improve efficiencies and reduce errors. Because the software is cloud-based, the system is accessible through a secure web browser connection from any device.

trichome close up — The fine outgrowths, referred to as trichomes, house the majority of the plant’s resin, which is particularly important for sample-preparation in potency testing

“As legalization efforts advance nationwide, many states are putting in place strict regulatory requirements for the testing and handling of cannabis,” says Kutz. “Many states require or will require testing for pesticide levels, terpenes, cannabinoid levels, moisture, heavy metal, fungi and molds.”

As a result of strict sampling requirements, laboratories must account for all the sample test results from a variety of instruments as well as for every gram of the sample, from receiving it to consumption in testing to disposal.

“These requirements can quickly overwhelm even the most efficient laboratory trying to maintain paper and excel based records,” says Kutz. “LIMS allows laboratory personnel to keep sample and requisition-centric records, track the sample quantity and location, integrate all the test data, provide client reports all while providing an audit trail of each and every step.”

As testing regulations continue to roll out, cannabis laboratories will be required to use information management systems for traceability in compliance with state and local laws.

October 23, 2015

Setting a Benchmark in Cannabis Testing: GOAT Labs

By Aaron G. Biros

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GOAT Labs, Inc. is a veteran-owned, i502-certified cannabis testing company with laboratories in Vancouver, Washington and Portland, Oregon. The laboratory launched in 2010 by Dana Luce, the owner, with a personal mission to provide safe and tested cannabis to patients in need.

Dana Luce’s daughter, Dani Luce, CEO of GOAT Labs, has previous experience working in dialysis and watched cancer patients lose their battle to the illness. Many years later, Dani’s oldest son was diagnosed with stage IV Hodgkin lymphoma. Cannabis proved instrumental in alleviating the side effects of chemotherapy. “With a severely compromised immune system, we had to find a place to test all the raw foods given to him, including cannabis,” says Dani Luce.

Dani Luce’s son was in remission nine months after starting chemotherapy in conjunction with cannabis and has now been in remission for five years. “We want to ensure patients are not ingesting something potentially toxic and that proper testing is done, which includes not only potency, but testing for microbials, pathogens, and pesticides.”

GOAT Labs is a member of the Cannabis Coalition for Standards and Ethics (CCSE) along with the American Oil Chemist Society (AOCS), where they participate in the Expert Committee for Cannabis Oil.

With pesticide use on cannabis recently entering the spotlight, there is a growing need for standards in cannabis testing. “We need better regulatory oversight so that all laboratories are standardized, including proficiency testing done by the state,” argues the Luce’s.

billlucesample — Bill Luce, lab technician at GOAT Labs, preparing samples for testing

Roger Brauninger, biosafety program manager of A2LA (American Association for Lab Accreditation), is working on an accreditation process for cannabis laboratories that would be accepted nationally. “We believe that an accreditation process would increase efficacy of lab results, reduce laboratory shopping, and create consistency with results across different laboratories,” says Brauninger.

GOAT Labs, among a number of other laboratories and organizations, is working toward putting cannabis in the lens of mainstream medicine. Not only are they looking to achieve a safe standard for medicine, they are advancing legalization efforts nationwide by setting the benchmark for getting patients access to safe, lab-tested cannabis.

August 19, 2015

Cannabis Labs: The Need For Standardized Analytics

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Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.

Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.

Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.

Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.

“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).

Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.

“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”

Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.

Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.

“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”

The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.

Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.

Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”

While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.

CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!