Tag Archives: accredited

ASI Global Launches Cannabis Safety & Quality Audit Standards

By Cannabis Industry Journal Staff
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According to a press release published July 1, ASI Global Standards announced the launch of their newest audit standard: the Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

With input from a number of stakeholders in the cannabis space, the CSQ scheme is designed for the cannabis industry and by the cannabis industry. Each standard was developed by industry professionals and stakeholders, like growers, manufacturers and processors, to meet market, consumer and regulatory requirements from seed-to-sale.

The CSQ scheme is built on four standards:

  • Growing and Cultivation of Cannabis Plants
  • Manufacturing and Extraction of Cannabis
  • Manufacturing and Infusion of Cannabis into Food & Beverage Products
  • Manufacturing of Cannabis Dietary Supplements

There is a public comment period in effect now, and those wishing to provide input have until July 31 to do so. If certification bodies or accreditation bodies want to find more information and get involved in the CSQ certification or accreditation process, they are encouraged to reach out via email at info@csqcertification.com.

Deibel Bioscience Rebrands, Achieves ISO 17025 Accreditation

By Cannabis Industry Journal Staff
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On June 19, Charles Deibel, president and CEO of Deibel Bioscience, announced two important changes to his cannabis testing laboratory: First, they changed their name from Deibel Laboratories to Deibel Bioscience. Secondly, they achieved ISO/IEC 17025:2017 accreditation.

Deibel Labs is an internationally recognized corporation of 15 testing labs in North America that’s been around for about 50 years, serving the food, beverage and personal care industries. Starting in 2018, Deibel has ventured into the cannabis and hemp markets, and recently rebranded these labs as “Deibel Bioscience.” Currently, Deibel Bioscience operates in California and Illinois, with plans underway to open labs in Florida and Pennsylvania.

Charles Deibel, President & CEO of Deibel Bioscience

Deibel’s brand is very well known in the food testing industry and has recently become a prominent voice and industry advocate in the cannabis testing community. Charles Deibel’s father, Dr. Robert Deibel, was a pioneer of the Hazard Analysis and Critical Control Point (HACCP) system. Charles Deibel has a long career in the laboratory testing space and even worked with the Department of Justice to help shape the legal case against Peanut Corporation of America and testified as an expert witness during the trial.

With respect to their accreditation, Deibel Bioscience of California (Santa Cruz) achieved it through the American Association for Laboratory Accreditation (A2LA). The lab’s scope currently holds seven chemical and microbiological test methods as well as their sampling method, with plans to expand their scope to include four more chemical testing methods in the next month.

“At our level of testing services, any lab should be able to offer accurate testing, at a fair price and a reasonable turn-around time,” says Deibel. “These three qualities are no longer defining features; rather it is our high level of service and exceptional Technical Services acumen that set us apart.”

According to Deibel, their company is drawing on decades of experience in other testing industries to provide a high caliber of technical expertise. “We are a family owned and operated corporation and are not constrained by quarterly investor demands. Our size offers economics of scale that is reflected in our service and pricing.”

ACS Laboratory Get Certified for Cannabis Testing in Florida

By Cannabis Industry Journal Staff
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According to a press release published earlier this week, ACS Laboratory announced the Florida Department of Health Office of Medical Marijuana Use (OMMU) has certified ACS to test products for medical dispensaries in the state.

This certification comes after the Florida Department of Health adopted an emergency rule, requiring dispensaries to only use a certified lab for product testing. Dispensaries (or medical marijuana treatment centers as the state calls them) in Florida have until December 24, 2020 to sell products tested before June 24, 2020.

ACS Laboratory was founded in 2008. They are DEA- and AHCA-licensed, ISO 17025-accredited and CLIA-accredited with the largest testing facility in the eastern United States, according to their press release. They are USDA-compliant and certified by Florida to test hemp in the state and are now also certified to test medical cannabis products.

As a certified cannabis testing lab in Florida, ACS has to meet a list of requirements, similar to rules one might find in other legal states. The Florida rules mandate that labs are ISO-accredited and qualified to accurately test for contaminants, moisture content and cannabinoid potency.

Earlier this year, ACS acquired Botanica Testing, Inc., which added about 500 new hemp and CBD clients to their portfolio. ACS Laboratory now has customers in 44 states.

A Dank Opportunity: Private Equity in the Cannabis Industry & Compliance with the Securities Act

By Kayla Kuri
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Under current federal law, financial institutions are extremely limited in the services and resources that they can offer to cannabis companies. Without access to traditional financing, cannabis companies have been forced to turn to outside investments to finance their operations. The private equity approach can be a “dank” opportunity for cannabis companies; however, these companies should be cognizant of the securities laws implications that are present with this type of business structure. The focus of most cannabis companies when forming their business is compliance with the regulatory scheme of their jurisdiction as it relates to the operation of a cannabis business. While compliance with these laws is important, it is also important that these companies ensure that they are compliant with the Securities Act of 1933 (the Securities Act) before accepting investments from outside sources.

Securities Act Application

Oftentimes, smaller companies don’t realize that they are subject to the Securities Act. However, the definition of a “security” under the Securities Act is very broad1 and under S.E.C. v. W.J. Howey Co., an investment in a common enterprise, such as a partnership or limited liability company, where the investor expects to earn profits from the efforts of others is considered a “security” and thus, subject to the rigorous requirements of the Securities Act.2 In general, all companies offering securities within the United States are required to register those securities with the Securities and Exchange Commission (SEC) unless a registration exemption is available.3 A company can register its securities (i.e., its ownership interests offered to investors) with the SEC by filing a Registration Statement. These statements generally offer investors certain information about the company in order to enable investors to be able to make an informed decision about their investment. Filing a Registration Statement can be both time-consuming and costly, and most companies want to avoid filing one if they can. Luckily, the Securities Act offers certain exemptions from registration requirements to companies who meet certain standards.4 While there are numerous exemptions from securities registration, the most common exemptions used are the Regulation D5 exemptions, which provides three different exemptions based on the size of the offering and the sophistication of the investors, and the Rule 1476 Intrastate exemption.

Regulation D Exemptions

Rule 504-Limited Offerings

Rule 504, often called the “Limited Offering” exemption, provides an exemption from securities registration for companies who limit the offer and sale of their securities to no more than $5,000,000 in a twelve-month period.7 Unlike the other Regulation D exemptions, which are discussed in further detail below, the Limited Offering exemption does not have any limitations on the level of sophistication or number of investors.8 This means that companies who rely on this exemption do not have to verify the net worth or income of their investors or limit the number of investors in the company. Like all Regulation D exemptions, companies relying on the Limited Offering exemption are required to file a “Form D” with the SEC within 15 days of the first securities sale.9 A Form D is a relatively simple form which provides basic information about a company to the SEC, including the registration exemption that is being relied upon. A copy of Form D can be found here.

Rule 506(b)

The “Private Offering” exemption can be found at Rule 506(b) of Regulation D.10 This exemption is commonly used for larger investment offerings with varying levels of investor sophistication. The Private Offering exemption can be used for investment offerings of any size so long as the company: (1) does not use general solicitation or advertising, such as newspaper articles or seminars, to attract investors; and (2) limits the number of “non-accredited investors” to no more than 35.11 “Accredited investors” are those investors whom the Securities Act deems sophisticated enough to properly weigh the risk of their investment in the company. In order to qualify as an accredited investor, the investor must:

  1. Have an individual income of more than $200,000 in the past two years
  2. Have a joint income with their spouse of more than $300,000 in the past two years
  3. Have an individual net worth, or joint net worth with their spouse, in excess of $1,000,000 or:
  4. Be a director, executive officer or manager of the Company.12

If the investor is a corporation, partnership, limited liability company or other non-trust entity, then to qualify as an accredited investor, it must either have assets in excess of $5,000,000 or each of its equity owners must meet one of the requirements for individuals listed above.13 If the investor is a trust, then the trust must: (1) have total assets in excess of $5,000,000 and the investment decision must be made by a “sophisticated person” (i.e., the person who is making the investment decision has such knowledge and experience in financial and business matters that he or she is capable of evaluating the merits and risks of an investment in the company); (2) have a trustee making the investment decision that is a bank or other financial institution; or (3) be revocable at any time and the grantor(s) of the trust must meet one of the requirements for individuals listed above.14

The Private Offering exemption allows a company to have an unlimited number of accredited investors, but only up to 35 non-accredited investors. However, companies should be very cautious of allowing non-accredited investors to invest in the company. The Securities Act requires that companies make extensive disclosures to non-accredited investors which are essentially the same requirements as the company would have to provide in a registered security offering. These requirements include providing investors with financial statements, operations plan, detailed descriptions of the company’s business, description of all property owned, discussion and analysis of the company’s financial condition and the results of operations, biographies of and descriptions of each officer and director, as well as other descriptions regarding the details of the company.15 Failure to provide the necessary information to non-accredited investors can disqualify companies from the benefits offered by the Private Offering Exemption. Companies should be very cautious when relying on the Private Offering exemption. If a company does choose to utilize the Private Offering exemption, they must file a Form D with the SEC within 15 days of the first securities sale.

Rule 506(c)

Rule 506(c), the “General Solicitation” exemption, is similar to the Private Offering Exemption. Unlike the Private Offering exemption, companies relying on the General Solicitation exemption are permitted to use general solicitation and advertising to advertise their securities to potential investors.16 However, investors relying on the General Solicitation exemption must only sell their securities to accredited investors.17 Under Rule 506(c), the company selling the securities must take steps to verify the accredited-investor status of their investors.18 These steps can include reviewing past tax returns, reviewing bank statements, or obtaining confirmation from the investor’s attorney or accountant that such person is an accredited investor.19 Like the other Regulation D exemptions, companies relying on the General Solicitation exemption should file a Form D with the SEC.Private equity can be a dank opportunity for cannabis companies, but it is critical that these companies ensure that they are in compliance with all applicable securities laws.

Intrastate Exemption

Rule 147, known as the “Intrastate” exemption, provides an exemption from securities registration for companies who limit the offer and sale of their securities to investors who are residents of, if they are an individual, or have its principal place of business in, if they are an entity, the state where the company is organized and has its principal place of business.20 The Intrastate exemption permits general solicitation to investors who are in-state residents, and there are no limitations on the size of the offering or the number of investors, whether accredited or unaccredited. In addition, companies relying on this exemption are not required to file a Form D with the SEC. The Intrastate exemption can be very desirable to companies who wish to obtain a small number of key investors within their communities.

State Requirements

In addition to complying with the Securities Act, companies are also required to comply with the securities laws of each state where their securities are sold. Each state has its own securities laws which may place additional requirements on companies in addition to the Securities Act. Most states (including California, Colorado, Oregon, and Oklahoma) require that a copy of the Form D filed with the SEC be filed with the state securities commission if securities are sold within that state. Before offering securities for sale in any state, companies should thoroughly review the applicable state securities laws to ensure that they are in compliance with all state requirements in addition to the requirements under the Securities Act.

Additional Considerations for Cannabis Companies

Despite the fact that the purchase and sale of cannabis is illegal under federal law, cannabis companies are still subject to the Securities Act in the same manner as every other company. However, the SEC has issued a warning to investors to be wary of making investments in cannabis companies due to the high fraud and market manipulation risks.21 The SEC has a history of issuing trading suspensions against cannabis companies who allegedly provided false information to their investors.22 Cannabis companies who wish to rely on any of the registration exemptions under the Securities Act should ensure that they fully disclose all details of the company and the risks involved in investing in it to all of their potential investors. While cannabis companies are permitted to rely on the registration exemptions under the Securities Act, the SEC appears to place additional scrutiny on cannabis companies who offer securities to outside investors. It is possible to fully comply with the onerous requirements of the Securities Act, but cannabis companies should engage legal counsel to assist with their securities offerings. Failure to comply with the Securities Act could result in sanctions and monetary penalties from the SEC, as well as potentially jeopardize a cannabis company’s license to sell cannabis. It is extremely important that companies seek advice from legal counsel who has experience in these types of offerings and the requirements of the Securities Act and applicable state securities laws. Private equity can be a dank opportunity for cannabis companies, but it is critical that these companies ensure that they are in compliance with all applicable securities laws.


References

  1. See 15 U.S.C § 77b(a)(1)
  2. 328 U.S. 293 (1946).
  3. 15 U.S.C § 77f.
  4. See 15 U.S.C § 77d.
  5. 17 CFR § 230.500.
  6. 17 CFR § 230.147.
  7. 17 CFR § 230.504.
  8. Id.
  9. Id.
  10. 17 CFR § 230.506(b).
  11. Id.
  12. 17 CFR § 230.501.
  13. Id.
  14. Id.
  15. 17 CFR § 230.502; 17 CFR § 239.90; 17 CFR § 210.8; 17 CFR § 239.10.
  16. 17 CFR § 230.506(c).
  17. Id.
  18. Id.
  19. Id.
  20. 17 CFR § 230.147.
  21. Investor Alert: Marijuana Investments and Fraud. (2018, September 5).
  22. Investor Alert: Marijuana-Related Investments. (2014, May 16).

Mission Mountain Laboratories: The First Accredited Cannabis Testing Lab in Montana

By Aaron G. Biros
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Last week, Mission Mountain Laboratories (MML), based in Arlee, Montana, received their ISO/IEC 17025:2005 accreditation from Perry Johnson Laboratory Accreditation (PJLA). This marks the first cannabis testing lab in Montana to get ISO 17025-accredited.

According to a PJLA client spotlight, MML is a female-owned business with two generations of family-run business experience. Before they took the plunge into medical cannabis testing, MML started out testing in public water systems in Montana. They have since expanded their regimen of testing services to offer a host of other services, but most recently adding compliance testing for medical cannabis and cannabis related products.

The Mission Mountain Labs team

According to Kimberly Nuccio, president of MML, this accreditation allows them to grow their business considerably. “Accreditation has opened greater opportunities for business growth by attracting larger companies that are looking for reassurance that a laboratory follows the highest testing standards,” says Nuccio. “Being an accredited lab gives them that added confidence necessary when deciding which lab to partner with for their testing needs. Mission Mountain Laboratories is the first Medical Marijuana Lab to achieve ISO accreditation in the state of Montana, and PJLA accreditation helped expand us into the new arena of Medical Marijuana compliance testing.”

MML has plans to expand their operations greatly, including opening a location in Florida by 2020. “We are aware of the increased and urgent demand for quality Cannabis compliance testing nationwide and are currently working on a 3-year plan to expand into Florida and several other states to fill this void,” says Nuccio. “These new locations will also be equipped to provide full service testing for Nutraceuticals, Food manufacturing, and Environmental businesses.”

Deibel Cannabis Laboratories Launches Cannabis-Specific HACCP Program

By Dr. Laurie Post
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Manufacturers of cannabis products need a program tailored to the cannabis industry that helps assure the safety of cannabis products with respect to known hazards such as pesticides, residual solvents, microbial impurities, heavy metals and mycotoxins. Deibel Cannabis Laboratories has developed a course that that will teach those manufacturing cannabis products how to manage known product safety hazards using a Hazard Analysis and Critical Control Point (HACCP) system.

HACCP has a long history of use in the food industry based on preventing potential hazards from occurring rather than reacting to issues when they arise. This program was started in the US but is globally recognized, used by food companies around the world to help produce safe products for consumers. Deibel Cannabis Laboratories applies the same prevention based system of HACCP to the creation of safe and wholesome cannabis goods whether they be edible, medicinal or topical. They also explore ways cultivators can use HACCP principles in their operation.12

Deibel Labs was founded by Dr. Robert Deibel in the 1970’s. Dr. Deibel is one of the original pioneers of HACCP, expanding the program from its original three HACCP principles to the seven principles we recognize today. Dr. Deibel developed the first “HACCP Short Course,” teaching this prevention-based program to food industry leaders in the 1970s.

According to Charles Deibel, president of Deibel Labs, this is an important step for the cannabis space. “Deibel Labs is proud to continue in our historic role as leaders in HACCP training by providing the cannabis industry with a training course developed by Deibel Labs associates who are International HACCP Alliance accredited lead instructors with years of experience in crafting and implementing HACCP plans for the food industry.”

They are launching a pilot two-day Cannabis HACCP Class to select clients at the end of January in Santa Cruz, CA. The full Cannabis HACCP course schedule for 2019 is currently in development. Accreditation by the HACCP Alliance is expected by early January, assuring that a standardized and internationally recognized training curriculum is provided by accredited instructors.

The course is forward-thinking, anticipating that sometime in the near future cannabis manufacturers will be required to control and document the safe production, handling and preparation of products according to state or even federal regulatory standards. Participants will be able to develop their own model HACCP program in an interactive group learning environment.

Attendees will:

  • Understand how Prerequisite Programs provide the foundation on which HACCP programs are built including GMPs, Sanitation and Pest Control Programs
  • Be able to identify where and how product safety problems can occur using a Hazard Analysis that considers Biological, Chemical and Physical Hazards
  • Gain the skills, knowledge, and tools necessary to develop effective Critical Controls, formulate corrective actions, conduct program verification and validation activities
  • Learn how to document activities and maintain records

Stay tuned for more information on when the 2019 course schedule is announced and how to register.

Steep Hill Expands Hawaii Operations

By Aaron G. Biros
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According to a press release published yesterday, Steep Hill Hawaii announced the opening of their second location on the Big Island. Their first location located on Oahu and operating for a little over a year, was the first cannabis-testing laboratory to be certified by the State of Hawaii Department of Health (HDOH). It’s also the first ISO/IEC 17025:2005 accredited cannabis testing lab in the state.

steep-hill-labs-logoOwner and CEO of Steep Hill Hawaii, Dana Ciccone announced the second location yesterday. “”We are thrilled to open up our new location in Kailua Kona, Hawaii,” says Ciccone. “We have been working closely with the Department of Health and we look forward to working together with the large patient population and the two new dispensaries opening very soon.” Ciccone says with the new location they are focusing on quick turnaround times, good service and competitive prices.

According to Dr. Andrew Rosenstein, CEO of Steep Hill, they want to help provide safe medicine and quality testing to the Hawaii medical cannabis community. “In extending its services, Steep Hill Hawaii is committed to providing safe medicine and high quality testing to Hawaii’s patient community,” says Rosenstien. “Dana and the Steep Hill Hawaii team have worked hard to open up this new location and will continue to support cultivators and dispensaries in this emerging market.”

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From The Lab

The Case for ISO/IEC 17025 Accreditation in Cannabis Testing Laboratories

By Amy Ankrum
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Government regulations keep millions of Americans safe every year by controlling what companies can put in their products and the standards those products must meet to be sold to consumers.

Enter the strange case of legal cannabis: In order for cannabis to be legally distributed by licensed medical professionals and businesses, it must be tested. But unlike other consumable goods, cannabis is not regulated by the FDA. Without an overarching federal policy requiring cannabis testing laboratory accreditation, the testing and laboratory requirements differ greatly across state lines.For medical cannabis specifically, accredited testing facilities are especially important. 

To be federally regulated, cannabis would first have to be federally legalized. It turns out that states and businesses alike are not willing to wait for a federal mandate. Many states have begun to adopt standards for cannabis testing and some, such as Ohio, have even announced mandatory ISO/IEC 17025 accreditation for all cannabis testing laboratories. As the industry evolves, increased compliance expectations are certain to evolve in tandem.

Some cannabis labs have even taken the initiative to seek ISO/IEC 17025 accreditation of their own volition. Seth Wong, President of TEQ Analytics Laboratories, shared in a press release:

“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with State required tests that are accredited by an international standard.”

Other laboratories, such as DB Labs in Las Vegas and EVIO Labs in Florida are also leading the accreditation charge in their respective states, ahead of any state mandates.

There are key reasons why accreditation in cannabis testing labs is important. First and foremost, cannabis is a consumable product. Like fruits and vegetables, cannabis is prone to pesticides, fungi and contaminants. The result of putting a potentially hazardous material on the market without proper and documented testing could lead to a public health crisis. An accredited testing lab, however, will ensure that the cannabis products they test are free from harmful contaminants.

By utilizing role-based trainings, labs can trust employees are receiving proper onboarding.

For medical cannabis specifically, accredited testing facilities are especially important. Because many consumers of medical cannabis are immuno-compromised (such as in the case of chemotherapy patients), ensuring that products are free from any and all contaminants is critical. Further, in order to accurately determine both short- and long-term effects of prescribed cannabis consumption, accredited and compliant laboratories are necessary.

Accreditation standards like ISO/IEC 17025 also provide confidence that testing is performed properly and to an internationally accepted standard. Rather than returning a “pass/fail” rating on products, the Cannabis Safety Institute reports that an ISO/IEC 17025 laboratory is required to produce numerical accuracy percentages in testing for “at a minimum, cannabinoids, pesticides, microbiology, residual solvents, and water activity.” Reliable data sets that can be reviewed by both accreditors and the public foster trust between producers and consumers.

Finally, ISO/IEC 17025 accreditation demonstrates that a laboratory is properly staffed and trained. The Cannabis Safety Institute’s “Standards for Cannabis Testing Laboratories” explains that conducting proper analytical chemistry on cannabinoids (the chemical compounds extracted from cannabis that alter the brain’s neurotransmitter release) requires personnel who have met specific academic and training credentials. A system to monitor, manage and demonstrate proficiency is necessary to achieve and maintain accreditation. With electronic systems in place, this management and documentation minimizes risk and also minimizes administrative time tracking and maintaining training records.

Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming yearsFor cannabis testing labs, utilizing a comprehensive software solution to achieve and maintain compliance to standards such as ISO/IEC 17025 is key. Absent of a software solution, the necessary compliance requirements can become a significant burden to the organization. Paper tracking systems and complex spreadsheets open up organizations to the likelihood of errors and ultimately risk.

Because ISO/IEC 17025 has clearly defined expectations for training, a software solution also streamlines the training process while simultaneously documenting proficiency. By utilizing role-based trainings, organizations can be confident employees are receiving proper onboarding and in-service training. Additionally, the effectiveness of training can be proven with reports, which results in smoother audits and assessments.

Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming years- which means utilizing technology tools such as electronic workflows to ensure proper process controls. Beyond adding critical visibility, workflows also create efficiencies that can eliminate the need to increase staffing as companies expand and grow.

For an industry that is changing at a rapid pace, ensuring traceability, efficient processes and visibility across organizations is paramount. Using a system that enables automation, process control, document management and documented training procedures is a step in the right direction. With the proper software tools in place, cannabis testing labs can achieve compliance goals, demonstrate reliable and relevant results and most importantly ensure consumer safety.

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Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 2

By Aaron G. Biros
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In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.

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Roger Brauninger, A2LA biosafety program manager

He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).

In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.

CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?

Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.

CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?

Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.

CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?

Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to   provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.

CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?

Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.

CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?

Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.

CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?

Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court.   It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.