Guidance for State Medical Cannabis Testing Programs
While more than half of the states currently permit cannabis for medical use, it remains illegal at the federal level. This regulatory contradiction has created a significant problem – inconsistent and disjointed cannabis regulations that severely increase the risk to public health and safety. The absence of federal guidance regarding cannabis has led states to develop their own approach to regulations, quality management, and testing.
As new state cannabis programs continue to develop throughout the United States, concerns about quality, consistency and safety continue to grow. Public health agencies, physicians, patients, and the public have real concerns about the quality, therapeutic benefit, and possible side effects of the products they are using.
In 2014, the Association of Public Health Laboratories (APHL) convened a monthly community-of-practice call so laboratories could share questions, advice, lessons learned and resources. During these calls, a theme emerged surrounding cannabis – every new participant asked the same questions. As a result, the APHL Board commissioned a Workgroup to collect the shared knowledge and develop guidance for laboratories and states to use when implementing cannabis programs. The project was 100% federally funded and is also supported by a cooperative agreement funded by the Centers for Disease Control and Prevention. The Foundation of Cannabis Unified Standards (FOCUS) is honored to have been included in this workgroup
In May 2016, the APHL Workgroup published Guidance for State Medical Cannabis Testing Programs. The report provides specific guidance on analytes and action levels, sampling, testing protocols, test analysis and lab accreditation. The report builds on the monograph established by the US Pharmacopeia (USP) and includes recent experience and data from cannabis programs in a variety of U.S. states with active cannabis programs.
The report serves as an excellent resource for cannabis testing specifications with extensive lists of solvents, pesticides, metals and other chemicals and their action levels. The introduction and supporting sections of the report offer valuable insights into the importance of testing, when testing is not required, and how to use the process to continually improve product quality and safety.
The APHL specifications align with the FOCUS international, voluntary-consensus cannabis standards being released this month. FOCUS, a non-profit standards development organization, has spent two+ years developing cannabis specific standards in the form of Good Manufacturing Guidelines for cultivation, retail, extraction, infused products, security, sustainability, packaging and labeling, and testing labs.
The APHL Guidance was created to facilitate the development of state labs for new cannabis programs, help existing labs assess their programs, and to assist public agencies, legislators and the industry by creating more uniformity and consistency in the industry. In combination with the FOCUS standards, cannabis testing laboratories, state and federal regulators, as well as business owners now have multiple, valid sources for accurate, unbiased, cannabis information.
The Association of Public Health Laboratories(APHL) represents state and local governmental health laboratories in the United States to protect the health and safety of Americans. APHL brings together multiple disciplines, including public health, environmental, agricultural and food safety to collaborate with laboratory and public health partners to assure effective surveillance, detection and response to health threats. APHL also works closely with federal agencies, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Food and Drug Administration and the Environmental Protection Agency, to develop and execute national health initiatives. To learn more visit www.aphl.org.
Foundation of Cannabis Unified Standards (FOCUS) is a non-profit, 501(c)(3) organization that develops international, cannabis-specific standards and third-party certification for the cannabis industry to protect public health, consumer safety, and safeguard the environment. FOCUS is the only organization to create voluntary-consensus standards suitable for accreditation and adoption into regulations by assuring impartiality, balance and transparency in the development process. Unlike most standards-setting organizations, FOCUS does not accept dues or fees for standards development. FOCUS is not a regulatory agency or industry trade association. This autonomy fosters a principled, objective environment in which comprehensive standards can be developed. FOCUS Standards provide current good manufacturing practice (cGMP) guidelines for all key areas of the cannabis industry including Cultivation, Retail, Extraction, Infused Products, Laboratory, Security, Sustainability, and Packaging & Labeling. To learn more visit www.focusstandards.org
Owner/Director of a trace metals testing laboratory in Phoenix, AZ. 20+scientific publications in Science, J. Amer. Chemical Soc., J. Organic Chemistry, Photochem.&Photobiol., Langmuir, Royal Society of Chemistry (UK)
7yI own a lab and also design and set up labs for others as well. I personally would not take technical "guidance" from someone who comes from the cannabis industry. Following the standards as Andy says is the way to go. Most of the "technical" folks in the cannabis industry are hacks. Just my opinion. Just look for their publications in a real scientific journal.
Manager; Cannabis Division at BMH Material Handling
7yInteresting report. I design analytical labs and design and build to existing standards, ANSI/ISO, FDA,UL,DPH,OSHA standards. My clients are extraction companies and vape manufactures. These companies want to get a jump on the upcoming rules and regulations. I was just finishing up the lab for Care by Design who a couple of days prior had taken city, county and state representatives on a tour of the lab and extraction facilitates. A week later they were raided because someone had mistakenly reported that they were using a butane extraction method. They were not. Care by Design makes consistent dosage products. A few days later another extractor was busted. These were longtime cottage industries trying to meet the new standards. Now I'm beginning to see articles about safety, consistency and the concerns of the medical community. It smacks of the same type campaign as went on when the medical community wanted to grab supplements. Fear articles and warnings sound a clarion call to the dangers without stringent controls enacted.Here is the rub as I see it. Here in California we have a awful initiative born of capitulation by a novice group of lobbyists. The Feds, we believe will reschedule to 2. If AUMA passes and the schedule drop happens the people who have carried this fight for decades will be screwed and hello big business. The pass from DEA to FDA means clinical trials, millions of dollars and years to bring products to market. My rule is follow the money and it is not hard to follow right now. If I read one piece that includes the line we are doing this to protect the children I will throw my bong at the author.
Retired at Self-employed
7yhttp://www.safeaccessnow.org/federal_marijuana_law cannabis is classified as a Schedule I drug, which means that the federal government views cannabis as highly addictive and having no medical value. The DEA has a vested interest in keeping marijuana illegal. They would have to terminate a large number of employees and it would preclude using the law to prosecute traffickers doing business with other illegal substances. It's a double-edged sword.
Marketing & Comms Specialist | SEO & Content Strategist | Startup Advisor | Medical Cannabis & Ketamine Therapy Author | Data Science Geek | Proficient in Python, R, SQL
7yThanks for posting Lezli Engelking. Interesting report. I hadn't really thought about the fact that the labs must be approved by the DEA, but that makes sense. Kind of ironic, though, given the conflict in laws between fed and state.