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Cannabis Testing Policy: Recommendations for More Thoughtful and Consistent Regulations Acknowledgements

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Cannabis Testing Policy: Recommendations for More Thoughtful and Consistent Regulations Acknowledgements JULY 2018 Learn more about NCIA’s Policy Council TheCannabisIndustry.org/PolicyCouncil National Cannabis Industry Association TheCannabisIndustry.org CANNABIS TESTING POLICY: RECOMMENDATIONS FOR MORE THOUGHTFUL AND CONSISTENT REGULATIONS ACKNOWLEDGEMENTS NCIA’S POLICY COUNCIL would like to thank the individuals who donated their time, energy, and ideas as members of our Testing Policy Working Group. In a process that was managed and facilitated by Andrew Livingston of VS Strategies on behalf of the Policy Council, Working Group members participated in 10 hours of conference calls and provided comments on numerous drafts of recommendations. We could not have produced the thoughtful recommendations in this document without their collective insight and expertise. We should note, however, that the involvement of these individuals in the process should not be considered an endorsement by them of any specific recommendation contained herein. NCIA POLICY COUNCIL TESTING POLICY WORKING GROUP MEMBERS Susan Audino, Ph.D. Grant D. Orvis, Ph.D. SAAudino and Associates, LLC. BoCo Famrs Sonia Erika Jeffrey C. Raber, Ph.D. Massachusetts Recreational Consumer Council The Werc Shop Douglas Fischer Alena Rodriguez, M.S. NACB Rm3 Labs Kevin M. George Dr. Markus Roggen Cannabis Testing Consultant OutCo Mowgli Holmes Dr. Mark Scialdone Phylos Bioscience Culta Processing Shawn Kassner Jordan Wellington Neptune and Company, Inc. VS Strategies/NCIA Policy Council Andrew Livingston Michael Wheeler VS Strategies/NCIA Policy Council Flow Kana Paul Muchowsk, Ph.D. Seth Wong Dr. Paul’s TEQ Analytical Laboratories WE WOULD ALSO LIKE TO THANK the following companies and firms for providing financial support or other resources to the Policy Council during the research and drafting phase of this project: Canndescent MedMen Eden Labs MJ Freeway Flow Kana Mr. Moxey’s Mints Greenbridge Corporate Counsel National Association of Cannabis Businesses The Grove Native Roots Harborside Husch Blackwell Privateer Holdings iAnthus Strainwise Manna Molecular W Vapes 2 TABLE OF CONTENTS 2 ACKNOWLEDGEMENTS 4 INTRODUCTION AND KEY TAKEAWAYS 5 DEFINITIONS 6-18 RECOMMENDATIONS 6 #1 ESTABLISH A CANNABIS LABORATORY ADVISORY COMMISSION (“CLAC”) 7 #2 EMPLOYING LAW, REGULATION, OR CLAC POLICY 8 #3 THIRD-PARTY FACILITY AUDITING AND ACCREDITATION BODIES 9 #4 OWNERSHIP LIMITATIONS 9 #5 MAXIMUM BATCH SIZE 11 #6 CERTIFIED THIRD-PARTY CANNABIS SAMPLERS 11 #7 INVESTIGATORS ABILITY TO SELECT PRODUCTS FOR TESTING 12 #8 REQUIRED PROFICIENCY TESTING 12 #9 REQUIRED CONTAMINANT TESTING 13 #10 REQUIRED POTENCY AND ACTIVE INGREDIENT TESTING 14 #11 WHERE TO TEST ALONG THE SUPPLY CHAIN 15 #12 CANNABIS LABORATORY ACCREDITATION 16 #13 LABORATORY DIRECTOR EDUCATIONAL AND EXPERIENCE REQUIREMENTS 16 #14 CANNABIS PRODUCT RETESTING AND REMEDIATION 17 #15 SAMPLE AND RECORDS RETENTION REQUIREMENTS 18 #16 TESTING OF CANNABIS FROM NON-LICENSED ENTITIES 19 PROVIDING FEEDBACK 3 INTRODUCTION AND KEY TAKEAWAYS SINCE CALIFORNIA first legalized medical cannabis in 1996 and the first state-licensed cannabis businesses emerged across the west more than a decade later, there has been a vast array of complex policy developments. The paradigm of state legalization occurring under federal illegality creates new responsibilities for state regulators in areas often governed by federal law. Cannabis testing and the creation of a parallel testing industry for state-licensed cannabis businesses is just one of these new regulatory responsibilities. As a result, states have implemented a variety of different approaches and have created a true public policy laboratory where dozens of experiments are running simultaneously. From these experiments, best practices – as well as cautionary tales for future regulators – have started to emerge. The goal of this paper is to convey, based on the insights and guidance from experts in the field, what we see as potential best practices for the future. This work is consistent with the mission of the National Cannabis Industry Association’s Policy Council, which is to develop and promote sensible policy for the cannabis industry. KEY TAKEAWAYS 1. Maximize flexibility and 4. Set high standards for testing responsiveness in the laboratories -- and give the In the following pages, we provide 16 system. Establish an ongoing laboratories time to reach that detailed recommendations for state Commission of policy makers, standard. Accredit cannabis and federal officials to consider when industry representatives, laboratories to ISO/IEC 17025 developing cannabis testing policy. and scientists to formulate for required analytical tests From those, here are six key takeaways: recommendations for regulations but allow for initial provisional and adopt official policies registration so labs can conduct covering certain aspects of the the testing necessary to receive testing program. accreditation. 2. Ensure sampling is independent, 5. Increase efficiency by reducing representative, and consistent duplicative testing along the with scientific best practices. supply chain. Only require Require trained laboratory testing on products in their final employees or third-party form because those products will contractors to collect all samples reach consumers and will more in accordance with regulations effectively protect public health for statistical representation or safety. established by the Commission. 3. Enable business growth while 6. Expand the reach, benefits, and accounting for the variation profitability of cannabis testing. within cannabis for testing. Allow Allow licensed laboratories to cultivators and manufacturers accept cannabis samples from to determine their own batch home cultivators, patients, size for testing but require that journalists, and other individuals additional sample increments are who are legally able to possess taken in proportion to the size of cannabis. the production batch. 4 DEFINITIONS Throughout this document, we employ some terms that may not be familiar to all readers. We have therefore included the following definitions to aid in the reader’s understanding: Accreditation body Certificate of analysis Laboratory Director An impartial non-profit organization The report prepared by the laboratory An individual of suitable education and that operates in conformance with about the analytical testing performed experience responsible for training the International Organization and results obtained by the laboratory. all employees, developing standard for Standardization/International operating procedures, and generally Electrotechnical Commission standard Certified reference material ensuring the scientific validity of all 17011 and is a signatory to the Reference material (RM) characterized testing analysis performed by the International Laboratory Accreditation by a metrologically valid procedure licensed laboratory. Cooperation Mutual Recognition for one or more specified properties, Arrangement for testing. accompanied by an RM certificate that Method validation provides the value of the specified The process used to confirm that an Action level property, its associated uncertainty, and analytical procedure employed for a The threshold value that provides the a statement of metrological traceability. specific test is suitable for its intended criterion for determining whether a use. Results from method validation can sample passes or fails an analytical test. CLAC official policy be used to judge the quality, reliability Memorandums created by the and consistency of analytical results. Active ingredient Cannabis Laboratory Advisory Any component that is intended to Commission governing the specific Proficiency test furnish pharmacological activity or processes of cannabis testing An assessment of the performance other direct effect in the diagnosis, and actions of licensed marijuana of a cannabis testing facility’s cure, mitigation, treatment, or establishments. methodology and processes. prevention of disease, or to affect the Proficiency testing is also known structure or any function of the body. as inter-laboratory comparison. Commercial release Cannabis, cannabis concentrates, and Batch Reference material cannabis products that pass mandated A specific quantity of material produced Material, sufficiently homogeneous testing performed by an accredited in a process or series of processes so and stable with respect to one or more laboratory and are permitted to be sold that it is expected to be homogeneous specified properties, which has been to consumers. within specified limits. In the case of established to be fit for its intended use continuous production, a batch may in a measurement process. correspond to a defined fraction of the Consensus method production. The batch size can be defined A method that has undergone an Remediation either by a fixed quantity or by the amount extensive peer-review process, The process by which cannabis or produced in a fixed time interval. through which participants have cannabis products, which have failed reached consensus on the utility and contaminant or other testing, are Cannabis Laboratory Advisory specification of a given method. processed, reformulated, refined, Commission other otherwise altered to remove A commission created in law and ISO/IEC or otherwise eliminate the source of comprised of government, public The International Organisation failure and then retested. health, and relevant industry experts for Standardization/International tasked with creating official policy and Electrochemical Commission (ISO/IEC).
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