AOAC CASP Meeting Book

SATURDAY, AUGUST 28, 2021 1:00PM – 5:00PM

at the

AOAC 2021 ANNUAL MEETING Sheraton Boston Hotel Boston, Massachusetts, USA

AOAC Annual Meeting Saturday, August 28, 2021 | 1:00pm – 5:00pm ET

Moderator: Christopher Dent, AOAC INTERNATIONAL

MEETING AGENDA

I. WELCOME, INTRODUCTIONS AND ANNOUNCEMENTS (1:00PM – 1:10PM) David Schmidt, AOAC INTERNATIONAL

II. PROGRAM REVIEW (1:10PM – 1:20PM) Christopher Dent, AOAC INTERNATIONAL

III. SMPR ORIENTATION (1:20PM – 1:30PM) Deborah McKenzie, AOAC INTERNATIONAL

IV. AOAC Research Institute: PTM, OMA, ERV and TME Programs (1:30PM– 1:45PM) Scott Coates, AOAC INTERNATIONAL

V. REPORT FROM THE PRODUCT CENTRIC WORKING GROUP (1:45PM – 2:45PM) Holly Johnson, AHPA & Julie Kowalski, Kowalski Science Support

VI. REPORT FROM THE PROFICIENCY TESTING WORKING GROUP (2:45PM – 3:00PM) Walter Brent Wilson, NIST

VII. REPORT FROM THE MICROBIAL CONTAMINANTS WORKING GROUP (3:15PM – 3:45PM) Julia Bramante, Colorado Department of Public Health & Environment

VIII. REPORT FROM THE TRAINING & EDUCATION WORKING GROUP (3:45PM – 4:00PM) Toby Astill, PerkinElmer

IX. PRESENTATION FROM NATIONAL SAFETY COUNCIL (4:00PM – 4:30PM) Katie Mueller, National Safety Council

X. DISCUSSION ON ADVISORY PANEL PRIORITIES (4:30PM – 5:00PM) Scott Coates will moderate a panel composed of experts in the field of Cannabis analytical science including CASP Science Advisor Susan Audino and CASP Advisory Panel Members . This will be an opportunity to provide input directly to the CASP Advisory Panel.

XI. ADJOURN (5:00PM)

06/15/2021 Version 2 – Subject to Change Without Notice

Break at 3:00PM

AOAC INTERNATIONAL – Cannabis Analytical Science Program, August 28, 2021, Chair Bios

SUSAN AUDINO, AUDINO & ASSOCIATES, LLC – AOAC CASP Science Advisor

Susan Audino obtained her PhD in Chemistry with an analytical chemistry major, physical and biochemistry minor areas. Susan was the recipient of NSF Chemometric Graduate Fellowship and was a visiting scientist at NIST where she completed her graduate research. She currently owns and operates a consulting firm to service chemical and biological laboratories, is an A2LA Lead Assessor and Instructor, and serves as a Board Member for the Center for Research on Environmental Medicine in Maryland. She is also serving as Quality Director for several laboratories and has worked with a variety of laboratories to establish

and/or improve their quality management systems. Susan has been studying the chemistry and applications of cannabinoids and provides scientific and technical guidance to medical marijuana dispensaries, testing laboratories, medical personnel, and regulatory agencies. Dr. Audino’s interest most directly involves marijuana/cannabis consumer safety and protection, and promotes active research towards the development of Official Test methods specifically for this industry. In addition to serving on Expert Review Panels, she has been working closely with AOAC to develop interest and movement toward the development of scientifically sound methodologies for the cannabis sector. Prior to her study of chemistry, Dr. Audino received advanced degrees and practiced psychology for more than a decade.

TOBY ASTILL, PERKINELMER – Chair, CASP Training and Education Working Group

Dr. Toby Astill is PerkinElmer’s Global Market Manager for Cannabis & Hemp. Dr. Astill has a Ph.D. in Chemistry and has spent the last 15 years working in Science, Technology and Business Roles for leading technology companies. For the last 11 years he has worked for PerkinElmer, based in locations across the West Coast of Canada & US. Dr. Astill is now focused on driving PerkinElmer's global cannabis and hemp initiatives; including but not limited to new product development, business strategy, market research, collaboration agreements

with customers, application development and marketing initiatives.

AOAC INTERNATIONAL – Cannabis Analytical Science Program, August 28, 2021, Chair Bios

JULIA BRAMANTE, COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT – Chair, CASP Microbiology Working Group

Julia Bramante is the Cannabis Reference Laboratory Manager and Lead Scientist at the Colorado Department of Public Health and Environment, in which the lab’s primary focus is conducting in depth method

development and validation studies for application to reference methods. Additionally, Julia is the Chair of the AOAC CASP Microbial Contaminants Working Group, Chair of the AOAC CASP Microbial Contaminants Expert Review Panel, and serves on the AOAC CASP Cannabinoids and Chemical Contaminants Expert Review Panels. She also serves as Chair of the Cannabis Chemistry Subdivision of the Division of Chemical Health and Safety of the American Chemical Society, a position she has held since January of 2019.

HOLLY E. JOHNSON, AMERICAN HERBAL PRODUCTS ASSOCIATION

Holly E. Johnson Ph.D., is the Chief Science Officer for the American Herbal Products Association (AHPA). She previously served for three years as Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in botanical dietary supplements. Dr. Johnson took her Ph.D. in Pharmacognosy at the College of Pharmacy, University of Illinois – Chicago (UIC), under renowned Pharmacognosist and

researcher Dr. Norman Farnsworth. Holly was awarded a National Institutes for Health (NIH) Fellowship and trained at the UIC/NIH Center for Botanical Dietary Supplements. She was a Postdoctoral Research Fellow at the Institute for EthnoMedicine studying the etiology of neurodegenerative disease, and also worked for Waters Corporation conducting technical training and regulatory consulting for pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and serves on AOAC working groups, stakeholders’ panels, and expert review panels for Foods and Dietary Supplements. She is a member of the United States Pharmacoepia’s (USP) Medical Cannabis Expert Panel, the Editorial Board of the Journal of AOAC International, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years’ experience working with natural products & botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii.

AOAC INTERNATIONAL – Cannabis Analytical Science Program, August 28, 2021, Chair Bios

JULIE KOWALSKI, JA KOWALSKI SCIENCE SUPPORT LLC Julie Kowalski is a technical consultant serving the cannabis and hemp testing markets. She partners with clients offering technical expertise and advise taking advantage of her nearly 20 years of laboratory experience. She specializes in developing fit ‐ for ‐ purpose technical programs and customized training for laboratory staff. Julie has a passion for analytical chemistry and the cannabis industry, starting work on cannabis testing in 2011. She brings a spirit of true collaboration and aptitude to her clients and to the developing cannabis science

community. Julie earned her graduate degree in Analytical Chemistry from Pennsylvania State University. Her professional experience includes troubleshooting, method development and validation for GC, GC ‐ MS, LC, and LC ‐ MS/MS in addition to pesticide residue analysis and chromatography method development. She worked at a technology provider for over ten years and recently served as Scientific Director and Chief Scientific Officer for a cannabis testing lab. She has previously served as the President of the North American Chemical Residue Workshop, served on AOAC Expert Review Panels, the Cannabis Scientific Task Force for Washington State and is currently chairing the AOAC CASP Chemical Contaminants Working Group.

WALTER BRENT WILSON, National Institute of Standards and Technology (NIST)

Dr. Wilson received his Ph. D. in Analytical Chemistry from the University of Central Florida (UCF) in August 2014, under the direction of Andres D. Campiglia. In February 2015, he was awarded a 2 ‐ year National Research Council post ‐ doctoral fellowship at the National Institute of Standards and Technology (NIST) under the direction of Stephen A. Wise and Lane C. Sander.

Dr. Wilson’s work currently focuses on the coordination the Cannabis research program at NIST with a focus on developing Cannabis reference materials, Cannabis Quality Assurance Program (CannaQAP), and development of new analytical methods including LC ‐ UV, LC ‐ MS/MS, and GC ‐ MS). He is an active member of multiple standards organizations including the Cannabis Analytical Science Program (CASP) of AOAC international. He serves as Chair of the AOAC CASP Proficiency Testing Working Group and a member of the Cannabinoids Expert Review Panel. He was recently recognized in the 50 th anniversary issue of Chromatographia as a Rising Star in Chromatography and completed a two ‐ year appointment as program coordinator/vice president for the Washington Chromatography Discussion Group.

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CASP 2021 and Beyond

Christopher Dent Manager, Standards and Methods CASP Program Lead AOAC INTERNATIONAL

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CASP as an Integrated Program

AOAC Research Institute / ERV

Training and Education

Marketing and Comms

Standards and OMA

Proficiency Testing

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CASP Advisory Panel

CASP Community

Microbial Contaminants Working Group Microbiology Working Group

Cannabinoids Working Group

Proficiency Testing Working Group

Product Centric Working Group

Training and Education Working Group

Chemical Contaminants Working Group

AOAC Staff & CASP Science Advisor

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CASP Community • This is YOU! • All are invited to semi ‐ annual in person CASP meetings. • Consists of all members of the working groups, advisory panel and anyone who has signed up for the CASP mailing list. • It’s how we communicate our offerings to the community AND where we source our experts for the various working groups, ERPs, training sessions, etc. If you want to join ONLY the CASP Community, visit http://tinyurl.com/CASPAOAC and select “mailing list only” OR the working group(s) you would like to join.

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CASP Advisory Panel • Determines the priorities and direction of the program • Members join at an organizational level • Meet generally quarterly to review program progress and when needed discuss topics • Different levels of membership (Pioneer, partner, affiliate)

If you would like to become a member of the AOAC CASP Advisory Panel, contact Alicia Meiklejohn by email at ameiklejohn@aoac.org or call (301) 924 ‐ 7077 x 101 to discuss.

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PIONEER:

6 ‐ CEM Corporation ‐ Institute of Food Technologies ‐ Bio ‐ Rad ‐ Canopy Growth Corporation ‐ ABC Testing ‐ Association of Food and Drug Officials ‐ Deibel Biosciene ‐ Industrial Labs PARTNER: ‐ Eurofins Scientific ‐ Horiba Scientific AFFILIATE:

‐ Ionization Labs ‐ Materia Medica ‐ Millipore Sigma ‐ PerkinElmer ‐ S ō RSE Technology ‐ TEQ Laboratories

‐ Medicinal Genomics ‐ Q Laboratories

!" # $ % ! " & ' ! % " !" &

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Interested in Being a CASP Advisory Panel Member?

• There are four levels of CASP annual membership: Pioneer , Partner, Affiliate, and now, Government • All levels offer participation on the CASP Advisory Panel, which meets quarterly to review progress and rank priorities for the overall program • Other member benefits will vary by tier and may include: name and logo in AOAC communications and outreach, discounts on AOAC services, and access to standing groups of technical experts • Pioneers receive discounts on AOAC Consulting Services and use of the CASP Logo in your related communication underscoring your leadership in the AOAC CASP Program

Government Tier • Created to allow state labs access to the Advisory Panel

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8 Product Centric Working Group • Brand new group! • Merger of the Chemical Contaminants Working Group and the Cannabinoids Working Group • Co ‐ Chairs are Holly Johnson, AHPA and Julie Kowalski, Kowalski Science Solutions • Will focus on cannabinoid content and chemical contamination of finished products. NOT Micro. • Most of their work will lead to SMPRs, standards that methods need to meet to become OMAs via AOAC ERP review. • Could also be developing guidelines, other standard documents, whatever the community needs. If you want to join any of our CASP working groups, visit http://tinyurl.com/CASPAOAC and select your desired groups.

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Microbiology Working Group • Chair is Julia Bramante of the Colorado Department of Public Health and Environment • Latest SMPR, Total Yeast and Mold , was recently approved and will soon be available in our OMA Online. • Currently at work on guidelines for cannabis microbiology, a new appendix for the AOAC Official Methods of Analysis. • Most of this group’s work will lead to SMPRs, standards that methods need to meet to become OMAs via AOAC ERP review.

If you want to join any of our CASP working groups, visit http://tinyurl.com/CASPAOAC and select your desired groups.

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SMPRs Developed SMPR 2017.001: Quantitation of Cannabinoids in Cannabis Concentrates SMPR 2017.002: Quantitation of Cannabinoids in Dried Plant Materials SMPR 2017.019: Quantitation of Cannabinoids in Edible Chocolate SMPR 2018.011: Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials SMPR 2019.001: Detection of Aspergillus in Cannabis and Cannabis Products SMPR 2019.002: Identification and Quantitation of Selected Residual Solvents in Cannabis Derived Materials SMPR 2019.003: Quantitation of Cannabinoids in Plant Materials of Hemp (low THC varieties of Cannabis) SMPR 2020.001: Determination of Heavy Metals in a Variety of Cannabis and Cannabis Derived Products SMPR 2020.012: Detection of Shiga Toxin Producing Escherichia coli in Cannabis and Cannabis Products SMPR 2020.013: Mycotoxin Screening Technique in Cannabis Plant Material and Derivatives

SMPR 2021.XXX: Total Yeast and Mold SMPR 2021.XXX: Quantitative Mycotoxins SMPR 2021.XXX: Cannabinoids in Cannabis Infused Beverages

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Proficiency Testing Working Group  Chair of PT Working Group (and Subgroups) o Dr. Brent (Walter) Wilson  Technical requirements for the following potential PT programs have been determined: o Cannabinoids o Pesticide Residues  Other Subgroups

o AOAC is determining a schedule for the remaining subgroups o Certain subgroups take priority based on WG feedback o Other Subgroups  Moisture/Aw ‐ this group has met once and will be scheduled to meet soon

 The technical recommendations will be provided to the Advisory Task Force for implementation

 Moisture/Aw (reporting would be a component of other PT program areas)

 Advisory Task Force has been formed  The Microbial Contaminants Subgroup met on 4 ‐ 30 ‐ 21 o The meeting was well attended, and members provided excellent feedback on technical recommendations

 Terpenes  Heavy Metals  Mycotoxins  Residual Solvents

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Would you like to join a subgroup? Contact Shane Flynn, Director of PT at CASP_PT_WG@aoac.org

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Training and Education Working Group • Chaired by Toby Astill, PerkinElmer. • Organized several educational sessions with input from working group members. • February 2021 Webinars included: • Setting up a Cannabis Lab (330 Registrants) • Microbial Contaminants in Cannabis (307 Registrants) • Heavy Metals in Cannabis • Pesticides in Cannabis • More recently the group has organized an update from USDA Domestic Hemp Production Final Rule, as well as a Vape Science Panel. • Survey feedback showed a high level of satisfaction with these sessions.

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CASP Expert Review Panels • AOAC Conformity Assessment Process • Three ERPs: • Cannabinoids ERP, Chair: Melissa Phillips, NIST • Chemical Contaminants ERP, Chair: Andrew Pham, Epic Labs • Microbial Contaminants ERP, Chair: Julia Bramante, CDPHE Recent Meetings: April 28, 2021: Cannabinoids ERP, two methods approved August 3, 2021: Chemical Contaminants ERP, one method approved August 5, 2021: Microbial Contaminants ERP, two matrix extensions approved

• Variety of Potential Method Submissions • Pesticides • Residual Solvents

• Salmonella • Aspergillus • See them all at www.aoac.org

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CASP Methods Approved as of August 28, 2021 • AOAC OMA 2018.11 Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils • AOAC OMA 2018.10 Cannabinoids in Dried Flowers and Oil • AOAC OMA: Method for the Quantification of Cannabinoids in Edible Chocolate by High-Pressure Liquid Chromatography: Single Laboratory Validation • AOAC OMA: Quantitating Cannabinoids in Edible Chocolates Liquid Chromatographic Separation with Photodiode Array Detection • AOAC OMA: Determination of Heavy Metals in a Variety of Cannabis and Cannabis ‐ Derived Products • Matrix Extensions of OMA 997.02 and OMA 2002.11 for Total Yeast and Mold in Cannabis

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Open Calls for Methods

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Importance of this Work

• 2018 Farm Bill directed USDA to establish a national regulatory framework for hemp production in the United States • Based on this, USDA published a final rule in January 2021, providing regulations for the production of hemp. AOAC is mentioned twice in final rule.

• State regulations for cannabis

• Not just important domestically – 3 out of 4 of our CASP OMAs are international

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2022 and Beyond New Working Groups?

• Adulteration Working Group? • Trade Issues Working Group? Training and Education • Continued integration with AOAC’s wider training and education efforts • Cannabis specific validation training courses • States needs Proficiency Testing • Continue to advise AOAC’s PT program • Possible new activities

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In Summary: CASP as an Integrated Program • CASP is an integrated program encapsulating much more than standards development and impacting many different parts of the Cannabis industry and leveraging several different departments within AOAC (e.g. proficiency testing, training, standards development) • As long as CASP persists it will continue to address multiple integrated needs of the cannabis analytical science community.

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Are you an AOAC INTERNATIONAL Member? Learn more about membership at www.aoac.org

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Appreciation Special thanks to: • Dr. Susan Audino who serves as our Scientific Advisor. • Working group chairs who lead our volunteers. • All our volunteers who selflessly share their expertise. • The CASP Team at AOAC: • Scott Coates

• Dawn Frazier • Palmer Orlandi • Marida Hines • Jonathan Goodwin

• Deborah McKenzie • Alicia Meiklejohn • Arlene Fox • Shane Flynn

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2021 Advisory Panel

Pioneer Members

Millipore Sigma

Association of Food and Drug Officials (AFDO)

TEQ & Industrial Labs

PerkinElmer

Ionization Labs

ABC Testing/Materia Medica

S ō RSE Technology

Deibel Bioscience

Partner Members Horiba

Eurofins Scientific

Affiliate Level

CEM Corporation Institute of Food Technologists

Canopy Growth Corporation

Bio ‐ Rad

Q Laboratories

Medicinal Genomics

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Christopher Dent Manager for Standards and OMA & CASP Program Lead (301) 924 ‐ 7077 x 119 cdent@aoac.org

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PTM, OMA, ERV and TME Programs

Scott Coates Senior Director AOAC Research Institute

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AOAC Programs • Official Methods of Analysis (OMA) • Performance Tested Methods (PTM) • Emergency Response Validation (ERV)

• Targeted Matrix Extension (TME) • Reviewed and Recognized (R 2 )

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Official Methods of Analysis (OMA) • AOAC INTERNATIONAL’s premiere method validation program. o More than 3,000 methods in the compendium. o Chemical, biochemical, biomolecular, and microbiology methods. o Hallmark is the collaborative study where common samples are analyzed by multiple laboratories determine both repeatability (RSD r ) and reproducibility (RSD R ).

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Official Methods of Analysis (OMA) • AOAC INTERNATIONAL’s premiere method validation program. o The Official Methods of Analysis is an international source of methods, with many countries and international organizations contributing their expertise to method validation. o The Official Methods of Analysis is the most comprehensive and reliable collection of chemical and microbiological methods available in the world and are contained in many of the Codex food standards.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Performance Tested Methods (PTM) • AOAC’s program for commercial test kits o Known as Performance Tested Methods (PTMs). o About 335 certified in the PTM database. o Chemical, biochemical, biomolecular, and microbiology methods. o Expert Reviewers review performance claims for accuracy. o Creates a level playing field for method developers.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Performance Tested Methods (PTM) • AOAC’s program for commercial test kits o PTM follows many of the requirements of the Official Methods of Analysis: – Repeatability. – LOD or LOQ or POD (probability of detection). – Selectivity (inclusivity/exclusivity).

– Matrix effects. – Ruggedness. – Lot-to-lot consistency. – Annual reviews.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Emergency Response Validation (ERV) Program for COVID-19 • 6 of 9 test kits designed to detect SARS-COV-2 reviewed and approved • 9 months from start to approval. • ERV was pertinent and timely. • Six-member expert review panel. • Used the AOAC Appendix Q on In-Silico analysis for the first time.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Emergency Response Validation (ERV) Program for COVID-19 •

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AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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PTM programs Targeted Matrix Extension (TME) • Designed to evaluate currently approved PTM kits for new matrixes of high importance. • Designed to review as many as 10 PTM kits at a time. • One study design, one independent laboratory, using common samples, by the same personnel, using the same basic lab equipment, and the same time [in batches]. • Evaluated by the same reviewers.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Targeted Matrix Extension (TME) • Total Yeast and Molds in Cannabis flower . o 9 test kits submitted; 7 test kits approved at this date. o Expert Review Panel including participants from 4 state regulatory agencies..

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Targeted Matrix Extension (TME)

• Total Yeast and Molds in Cannabis flower . o Held a Lessons Learn Session with participants to determine how to improve the program. o Official launched under the ERV. Developed TME in response to Lessons Learned.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Targeted Matrix Extension (TME)

• Salmonella and/or STEC in Cannabis flower. o 8 test kits submitted on or about August 1 st . o Expect first kits to be approved in December 2021.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Reviewed and Recognized (R 2 ) Program

Draft logo: do not copy or distribute.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Reviewed and Recognized (R 2 ) Program

• It is possible to certify methods in place as services using the R 2 program. • May serve as a lead-in to the Official Methods program. • The program will make use of the Onsite Method Validation model.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Reviewed and Recognized (R 2 ) Program

• Pilot program in process since June. • Creation of logo. • Review pilot program issues and finalize policies and procedures. • Program roll out (starting with 2021 annual meeting). • Creating a new revenue source for 2022.

Draft logo: do not copy or distribute.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Summary • The AOAC continues to develop products and services to serve our members and method developers. • Several new programs were successfully started in the last year. • We have more products and services coming. • Our aim is to provide a product or service for every member need.

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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QUESTIONS?

AOAC INTERNATIONAL 2021 Annual Meeting & Exposition August 27 – September 2, 2021 | Boston, MA

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Julie Kowalski Chair, CASP Chemical Contaminants Working Group (past) Co-chair Product Centric Working Group (current)

August 28, 2021 AOAC INTERNATIONAL Annual Meeting

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Chemical Contaminants (now PCWG) Working Group 2 Leaf Research Don Shelly Consulting, LLC Lourdes Matha Institute HMCT RM3 Labs 3M E4 Bioscience Maryland University of Integrative Health Robertet Flavors, Inc. 5202 Presidents coutrt epic Merieux NutriSciences Rock River Laboratory AccuScience labs Eurofins Food Integrity and Innovation Mettler Toledo Romer Labs, Inc. Acmic Inc Eurofins Forensics Belgium Microbióticos Uruguay Sartorius Corporation ACNGC consulting / ICCI FL Dept. of Agriculture MilliporeSigma SC Laboratories Advanced Analytical Laboratories Florida Department of Agriculture and Consumer Services Ministry of Health, Labour and Welfare, Japan Scientific Solutions Agilent Technologies, Inc Florida Department of Health MMCC SCIEX Agricultural Cooperatives' Union of Aeghion Fluresh NATA scs mda

116 organizations Academic institutions Testing labs US state government US federal government International government Technology providers Service providers

National Reference Laboratory, ICAR ‐ National Research Centre for Grapes, Pune, India

Agrolab Mexico

Food Safety Net Services

Shimadzu Scientific Instruments

AHPA

G2 Analytical

National Safety Council

Silver Bullet Water Treatment

National University of San Luis ‐ CONICET

Sonoma Lab Works

Applied Food Science Arcadia University Audino and Associates

GAAS Analytical Green Analytics

NEOGEN

SORA LABORATORIES, LLC.

GW Pharmaceuticals

Neogen Corporation

SoRSE Technology SoundScientific, LLC

Blunt Assessment Laboratories

Health Canada

NIST

Bold Growth Inc.

Herbalife Nutrition

Office of Indiana State Chemist

Southern Illinois University Carbondale

California cannabis industry association Hocking Technical College

PerkinElmer

SQRD LAB

Canadian Food Inspection Agency Canopy Growth Corporation

Horiba

PhytaTech dba Kaycha Labs PhytoLab GmbH & Co. KG PMB BioTek Consulting

State of Alaska EHL

IEC Thermo

State of Maine

cbdMD LLC

Independent Consultant

TagLeaf

CDPHE

Indo Laboratories Ionization Labs

Prati Donaduzzi Premium CBD Labs Quality Testing Lab Quantum Analytics PSI Labs

Unitech Laboratories University of Kentucky

CEM

Certainty Analytical Labs Certified Laboratories Charlotte's Web Inc.

JA Kowalski Science Support LLC

University of Wisconsin ‐ Parkside US FDA, Forensic Chemistry Center

JK Consulting Kaycha Labs

US Hemp Authority

Colorado Department of Agriculture

Labs ‐ Mart

Qure

Vertosa

CSC JP

Lake Superior State University

RADE LLC

VICAM ‐ Waters

Curtis S. Phinney, CNS

Latu

R ‐ Biopharm Rhone Ltd. Relief X Laboratories, Inc.

Viridis Laboratories Waters Corporation

DB Science, LLC

Longboard Scientific Consulting Corporation

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Chemical Contaminants Working Group: Work Since Last CASP Meeting

• Six teleconferences (Oct 2020 – March 2021) • One SMPR published AOAC SMPR® 2020.013 Standard Method Performance Requirements (SMPRs®) for Mycotoxin Screening Technique in Cannabis Plant Material and Cannabis Derivatives • One SMPR ready for publication Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

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DRAFT: Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

Analytes: mycotoxins are toxic metabolites of fungi aflatoxin B 1 aflatoxin B 2 aflatoxin G 1 aflatoxin G 2 (total aflatoxins) ochratoxin A Total Aflatoxins sum of B 1 , B 2 , G 1 , G 2

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Matrices Cannabis plant material.—Plant material from Cannabis spp. and its chemical varieties or chemotypes. Cannabis derivatives.— Products or extracts derived from cannabis plant material. Derivative products include but are not limited to: Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

a. Ingestibles / Edibles b. Inhalation products c. Concentrates and Extracts d. Personal care products

Method developers may choose one or more of the suggested matrices. Method developers must specify the matrix or matrices used.

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Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

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Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

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Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products

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Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis Derived Products • See draft document here: https://www.aoac.org/wp ‐ content/uploads/2021/06/Quant ‐ Cannabis_Mycotoxins_SMPRv9 ‐ for ‐ ballot.pdf • Unanimous vote to pass • Final version will be published soon

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Reorganize Working Groups – May 2021 • Advisory Panel = Product Focus Approach • Advisory Panel priorities Products

Cannabinoids Working Group

Chemical Contaminants Working Group

Product Centric Working Group

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From Advisory Panel

Product Priorities • Beverages • Personal Care Products • Hemp Seed Oil

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Product Centric Working Group

Define commodity group

Prioritize SMPRs

Work on SMPR documents

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Product Centric Working Group

Define commodity group

Beverages

Prioritize SMPRs

Work on SMPR documents

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Product Centric Working Group

Define commodity group

Beverages

Prioritize SMPRs

Work on SMPR documents

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Beverage commodity defined for use by Product Centric Working Group

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Product Centric Working Group

Define commodity group

Google Document

Beverages

Prioritize SMPRs

Work on SMPR documents

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Beverage testing requirements collected so methods can be prioritized

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Product Centric Working Group

Define commodity group

Google Document

Beverages

Prioritize SMPRs

Work on SMPR documents

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Product Centric Working Group

Define commodity group

Google Document

1. Cannabinoids 2. Residual Solvents 3. Heavy Metals 4. Others….

Beverages

Prioritize SMPRs

Work on SMPR documents

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Product Centric Working Group: June 2021 – August 2021 • Create workflow and combine groups

• Six teleconferences (June 2021 – August 2021) • Cannabinoids – SMPR out for public comment Draft: Quantitation of cannabinoids in beverages Open for public comment until September 17, 2021 • Metals – working on SMPR document • Residual solvents – working on SMPR document

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Holly E. Johnson, Ph.D. Chief Science Officer American Herbal Products Association 28 August 2021

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Objective To provide guidance for laboratories in developing standard operating procedures for processing hemp plant materials received fresh from the field (approximate moisture 70 ‐ 80%) to obtain a moisture content appropriate for grinding (generally <15%) when preparing samples for determining total THC on a dry weight basis, for example when using AOAC 2018.11 or other appropriate methods. Cannabinoids Working Group: Laboratory guidance for drying field ‐ fresh hemp plant samples in preparation for determination of total THC on a dry weight basis

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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Cannabinoids Working Group:

SMPR out for public comment (September 17): https://www.aoac.org/resources/draft ‐ smpr ‐ quantitation ‐ of ‐ cannabinoids ‐ in ‐ beverages/

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NEW ‐ Product Centric Working Group Product category: Beverages Evaluation of stakeholder needs Testing requirements by State

Priorities: pesticides, residual solvents, microbiology

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Product Centric Working Group: Residual Solvents in Beverages SMPR

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Product Centric Working Group: Residual Solvents in Beverages SMPR

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Product Centric Working Group: Residual Solvents in Beverages SMPR

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Product Centric Working Group: Residual Solvents in Beverages SMPR

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Questions?

Holly E. Johnson, Ph.D. Chief Science Officer American Herbal Products Association 28 August 2021

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Walter Brent Wilson Chair, CASP Proficiency Testing Working Group Update Presentation

August 28, 2020 AOAC INTERNATIONAL Virtual Mid ‐ Year Meeting

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AOAC Proficiency Testing Program • Shane Flynn – Director • Chad Stephan CASP Proficiency Testing Advisory Task Force • Nine members CASP Proficiency Testing Working Group • Walter Brent Wilson – Chair CASP Proficiency Testing Program

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Working with a test material provider lab on securing a hemp matrix and technical requirements that need to be met. • Current focuses: Cannabinoids, Moisture, and Pesticides in Hemp plant samples Working with a website developer and SAS statistical provider. • Building a secure PT website • Designing electronic reports specifically for the new CASP PT program. Design of the PT studies • SMPR and approved official methods needed. • Laboratories can submit data for in ‐ house and AOAC method. AOAC Proficiency Testing Program

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Members – 9 have been assembled • Domestic and international regions • Different areas of expertise to cannabis/hemp analysis. CASP PT Advisory Task Force

The advisory task works with AOAC staff to help implement the technical recommendations already determined/developed by the subgroup. • Provide expertise on specific analytes, matrices, organisms, and analytes. • Resolve analytical issues that occur during the development of the program.

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CASP PT Working Group

The role is to recommend the technical requirements needed to develop a PT program for Cannabis and hemp. Past Subgroup Meetings: cannabinoids, moisture, and pesticides Subgroup Meetings Since Mid ‐ year

• Microbials • Pesticides • Heavy metals

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SMPRs • Aspergillus • Salmonella • E. coli (Shiga Toxin) • Yeast & Mold Sample Requirements • 10 – 15 g • Dried hemp, moisture < 15 % might not be sufficient • Moisture < 6 % would be best • Require hydration after receiving samples CASP PT WG: Microbials Subgroup

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AOAC SMPR® 2018.011 for targeted analytes • AOAC would randomly select a set number of pesticides for each PT round. • Start with this list of pesticides and then narrow it down to a smaller list. Types of measurements • Qualitative and Quantitative Analysis Sample Requirements • 5 – 10 g • Dried hemp, moisture < 15 % CASP PT WG: Pesticides Subgroup

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AOAC SMPR® 2020.001 for targeted analytes • Required: total cadmium, total arsenic, total lead, and total mercury • Optional: antimony, barium, chromium, copper, nickel, silver, selenium, zinc • PT Studies would include all of these heavy metals AOAC method has been approved recently, Jenny Nelson. Sample Requirements • 5 g and dried hemp, moisture < 15 % • mg/kg instead of ppb • Non ‐ spiked samples preferred with normal levels • Control material included. CASP PT WG: Heavy Metals Subgroup

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Advisory Task Force needs to meet to discuss the information gathered for cannabinoids, moisture, pesticides, microbials, and heavy metals. Final target subgroups • Water Activity (included with moisture) • Mycotoxins • Terpenes CASP PT WG: Next Step

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Questions?

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Julia Bramante Chair, Microbial Contaminants Working Group Working Group Update

August 28 th , 2021 AOAC INTERNATIONAL Annual Meeting – Boston, MA | Virtual

Microbial Contaminants Working Group

Work Since Last AOAC CASP Annual Meeting:

• Working Group Teleconferences (April 2021-August 2021)

• SMPR completed voting period and accepted for publication (Yeast and Mold)

• Guidance for Validation of Microbiological Methods for Cannabis and Cannabis Products

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Microbiological Validation Guidance • Modeled similarly to Appendix J • Formed 6 Subgroups: • Matrices

• Decontamination of Matrix • Suitability of Testing Media • Quantitative versus Qualitative Validation Guidance • Requirements for Reference Methods • Requirements for In-Silico Data Analysis

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Matrices • Led by Steve Crupi • Matrix categorizations

• Considerations when conducting method validation on certain matrix categories, sub-categories, or matrices with certain physical properties

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Decontamination of Matrix • Led by Tess Eidem • Response to need for guidance on decontaminating matrices (for example: cannabis flower) to prepare them for use in microbiological method validation studies

• Key Focal Points: • Decontamination Approach

• E.g. Irradiation, Autoclaving, Microwaving • Methods to Confirm Integrity of Product Maintained following Decontamination

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Suitability of Testing Media • Led by Salvatore Parisi

• Guidance Sections: • Preparation of Test Strains • Suitability of the Method in the Presence of the Tested Product

• Scope: The suitability test should demonstrate that tested products have no inhibitory effects on the growth of selected control microorganisms under aerobic conditions

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Quantitative vs Qualitative Validations • Led by Susan Audino • Qualitative Method • Method of analysis whose response is either the presence or absence of the analyte detected either directly or indirectly in a specified test portion. • Quantitative Method • Method of analysis whose response is the amount (count or mass) of the analyte measured either directly (e.g., enumeration in a mass or a volume), or indirectly (e.g., color absorbance, impedance, etc.) in a specified test portion.

• New definition for consideration: threshold based microbiological methods • Pass/fail based on set threshold

Requirements for Reference Methods • Led by Shenaz Dave • Guidelines retrieved from entities such as: • AOAC • FDA BAM • ISO • Health Canada • USP • Dairy standard methods

• In conjunction with other subgroups, determinations for test portions per matrix category

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Requirements for In-Silico Data Analysis • Led by Maria Nelson • Based on AOAC Appendix Q: Recommendations for Developing Molecular Assays for Microbial Pathogen Detection Using Modern In Silico Approaches • Supplemental – not a replacement for laboratory testing

• By utilizing available databases combined with modern bioinformatics and physical modeling tools, in silico analysis can be used to predict the selectivity of a molecular assay (e.g, PCR, RT-PCR, LAMP, NASBA) against tens of thousands of known sequences • Inclusivity/Exclusivity • Physical Chemistry Modeling

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Yeast and Mold ERV Update

• Neogen Soleris® Direct Yeast and Mold • 3M™ Petrifilm™ Rapid Yeast and Mold Count Plate • 3M™ Petrifilm™ Yeast and Mold Count Plate • bioMerieux s.a. TEMPO Yeast and Mold • Nissui Pharmaceutical Company Ltd. CompactDry “Nissui” YMR • MilliporeSigma SimPlate® Yeast and Mold Color Indicator • PathogenDx Quant X Fungal One Step

• 7 Methods Granted Performance Tested Method (PTM) Status:

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Microbial Contaminants ERP Update

• The Expert Review Panel (ERP) reviewed two (2) existing Official Methods of Analysis SM for matrix extensions to apply to cannabis.

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Many thanks to the Working Group and AOAC Team!

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Toby Astill Chair, CASP Training and Education Working Group Working Group Update Presentation

August - September 2021 AOAC INTERNATIONAL Annual Meeting

Thanks to all those that have supported to date

• AOAC Team • Panel Presenters • Seminar Presenters • CASP WG Stakeholders

Recap for 2021 so far: • AOAC CASP Setting up a Cannabis Lab - 330 Registrants • AOAC CASP Microbial Contaminants in Cannabis - 307 Registrants • AOAC CASP Heavy Metals in Cannabis - 271 Registrants • AOAC CASP Chemical Contaminants in Cannabis - 340 Registrants • Navigating Laboratory Accreditation training • USDA Update on Final Hemp Rules – 193 Registrants • Vape Testing 2021: Overview of Today’s Vape Science Part 1

• National and International Audience from:

Cultivators

Extractors and Manufactures

Testing Labs

Govt Agencies

Upcoming events planned this year:

Webinars • Vape Testing 2021: Overview of Today’s Vape Heavy Metal Science - Part 2 • Understanding the Cannabis Vertical and its Science: Cultivation, Extraction, Product Manufacturing, and Testing

• *Validation of Cannabis Testing Methods – Call for speakers • *Testing Infused Cannabis Beverages – Call for speakers

What’s next?

• Longer training courses – 2-4 hours? • Expanding on Method Validation? What particulars?

• Method/Instrument Demos? Which ones? • Regionally Focused Training? Which regions? • International Overview of Cannabis/Hemp industry? Where and when?

Interested in supporting or have suggestions: toby.astill@perkinelmer.com Subject line: AOAC CASP Education

Cannabis Testing Regulations Research Project

AOAC Conference 2021 – CASP Meeting Katie Mueller, National Safety Council

CONFIDENTIAL

©2020 National Safety Council

National Safety Council

Our Mission Save lives, from the workplace to anyplace Our Vision The National Safety Council is a mission-based organization, focused on eliminating the leading causes of preventable death and injury. We focus our efforts and thought leadership on impacting safety through three strategic pillars: Workplace, Roadway and Impairment - until the data tells us otherwise. Every one of our employees, member organizations and strategic partners have one thing in common: a commitment to enable people to live their fullest lives.

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Problem: Lack of FDA regulation has led to inconsistencies in product testing and identification of substances in cannabinoid products, which may lead to a consumer being unwittingly impaired or harmed, placing the consumer and others at risk Goal: • Create a resource which reviews state medical and recreational cannabis testing regulations and oversight and develop a resource guide for “optimal” testing requirements, enabling NSC to weigh in on the need for federal and increased state oversight Strategy: • Gathering this research and compiling data into a single resource will accomplish: • Establishing a foot hold for NSC in marijuana space • Gathering research around what states are doing to generate awareness • Creating a resource that can be used to identify health and safety issues related to the content in cannabis products

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Unintended Consequences

Overdose Deaths According to the US Bureau of Labor Statistics Deaths from unintentional overdose in the workplace continue to rise Impaired Driving Impact of cannabis use in road traffic collisions and safety at work https://journals.lww.com/cja/Abstract/2019/03000/Impact_of_Cannabis_Use_on_Road_Traffic_Collisions.3.aspx Substance Misuse According to a study reported by the National Institute on Drug Abuse, employees who tested positive for cannabis had 55% more industrial incidents, 85% more injuries and 75% greater absenteeism compared to those who tested negative. https://jamanetwork.com/journals/jama/article-abstract/384067

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Testing Requirements

• Summary of current US-based testing requirements • Summary of available and publicly available testing related data from US regulatory bodies • Health and safety data relative to cannabis products (will identify information gaps) • Report on limitations and strengths of state reporting requirements • Will include specific analytical methodologies will be related to analyses such as: • Cannabinoids – major neutral and acid-precursor cannabinoids • Contaminants – such as (not limited to) heavy metals, residual solvents, pesticides & microbial • Excipients & Additives – such as vitamin E acetate, polyethylene glycol and medium chain triglycerides

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Project Deliverables

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©2020 National Safety Council

Project Deliverables White paper to discuss challenges and overview of current regulatory situation – opportunities

Cannabis laboratory testing industry current Technology utilization Quantitative results of research

Calls to action for public and regulators, public health advisors

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©2020 National Safety Council

NSC Cannabis Testing Project

Web Tool Scientific Advisory Board Assembled • Analytical chemist • Marijuana policy analyst • Program evaluator • Toxicologist

• Occupational Medicine Physician • Behavioral health/addiction clinician • Microbiologist • Cannabis industry representative • Public health professional

Data Collection Ongoing State Regulations Tracking Collaboration – AOAC CASP, CannRA

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Project Timeline 2021 May June July

August Sept

October Nov

Contracts

Advisory Board Data Collection Data Analysis Web tool creation

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Project Timeline 2022 Jan Feb March April

May

June July

Data Conversion Web tool Integration Data Analysis Technical Writing Report Creation Publishing

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AOAC Working Groups • Beverages • Residual solvents

Sharing of resources on state regulations, guidance, etc. leads to better understanding for all of us. NSC welcomes the opportunity for collaborating and sharing of information to move the needle on putting science in front of regulations for the health and safety of everyone.

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Questions? Katie Mueller, Sr. Program Manager

Impairment Practice Area National Safety Council Katie.mueller@nsc.org

Find us online www.nsc.org/workplace/safety-topics/drugs-at-work/cannabis

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