CASP Meeting Book AOAC Annual Meeting 2023

AOAC INTERNATIONAL Cannabis Analytical Science Program AOAC INTERNATIONAL 2023 Annual Meeting Tuesday, August 29, 2023 1:00 – 3:00pm

Meeting Agenda I. WELCOME, INTRODUCTIONS AND ANNOUNCEMENTS (1:00PM – 1:05PM) Allison Baker, AOAC INTERNATIONAL, will provide an overview of recent CASP highlights and a summation of recent Advisory Panel meetings. II. AOAC LABORATORY PROFICIENCY TESTING PROGRAM (1:05PM– 1:35PM) Shane Flynn, Sr. Director, Laboratory Proficiency Testing Program, AOAC INTERNATIONAL will give an overview and update on the Cannabis and Hemp Proficiency Testing Program • UPDATES ON FIRST CANNABIS TESTING ROUND Danielle Lenoir, Signature Science, will provide updates on the first cannabis testing round results. • PROFICIENCY TESTING DEVELOPMENT – MICROBIOLOGICAL IMPURITIES Danielle Lenoir, Signature Science, will provide an overview of the microbiological impurities PT program currently in development. III. PESTICIDES IN CANNABIS MATRICES (1:35PM – 2:15PM)

• RECOMMENDED PESTICIDE LOQs FROM ACIL

Joe Konschnik (Plus One Consulting LLC) will highlight ACIL’s work and basis for the recommended LOQs for pesticides in the GUIDE TO HARMONIZING CANNABIS LABORATORY QUALITYAND TESTING PRACTICES Guidance Document. • COMMNUITY METHOD DEVELOPMENT ‘THINK TANK’

Julie Kowalski, Kowalski Science Support , will provide an overview of AOAC SMPR 2018.011, Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials, review challenges of the SMPR, and discuss the benefits of a community method development initiative.

IV. GUIDANCE FOR DETERMINING MOISTURE CONTENT (2:15PM - 2:35PM) Conner Jeffries (ADDIUM, Inc.) and Jini Glaros (ModernCanna) will present information on moisture content determinations in cannabis and provide a historical precedent for using dry weight basis. V. THE IMPORTANCE OF SAMPLING (2:35PM – 2:55PM) Polona K. Carson, Ph.D., MBA, (Neptune and Company, Inc.) will present on best practices for sampling of heterogeneous materials to the cannabis community.

VI. WRAP UP AND ADJOURN (2:55PM – 3:00PM)

This agenda can change without notice.

Allison Baker, AOAC INTERNATIONAL Allison works as a Coordinator of Standards and Official Methods, suppor�ng standards development ac�vi�es at AOAC INTERNATIONAL. She is the manager for the Cannabis Analy�cal Science Program (CASP), the Analy�cal Interna�onal Methods and Standards (AIMS) Program, and coordinates addi�onal working group ini�a�ves. Prior to joining AOAC, Allison worked at the Frederick Na�onal Laboratory for Cancer Research as a research associate for the Center for Molecular Microscopy, and at Leidos, serving as a scien�fic manager for the

Department of Defense’s Congressionally Directed Medical Research Programs. Allison graduated from Mount Saint Mary’s University in 2017 with a B.S in health sciences and again in 2019 with a M.Sc. in biotechnology and business management.

Shane Flynn, AOAC INTERNATIONAL Shane Flynn is the Senior Director of the AOAC Laboratory Proficiency Tes�ng (PT) Program. Shane helped start the first accredited Proficiency Tes�ng program for food labs in the United States 24 years ago at AOAC and has been developing new programs to address the needs of the analy�cal laboratory community since. He is currently working on Cannabis and Hemp PT programs. In addi�on to his Proficiency Tes�ng role, he also is the staff lead for the Analy�cal Laboratory Accredita�on Criteria Commitee (ALACC) and the Technical Division of Laboratory Management (TDLM). Danielle Lenoir, Signature Science Danielle Lenoir is a Senior Quality Assurance Chemist and Program Manager for the Hemp and Cannabis proficiency tes�ng program at Signature Science, in conjunc�on with AOAC INTERNATIONAL. Her focus is on developing and tailoring tools to help laboratories establish and maintain regulatory compliance, as well as developing solu�ons for complicated GC obstacles. She has over 10 years of experience in quality assurance, gas chromatography, and method development working with oil & gas, environmental, and government laboratories.

Joe Konschnik, Plus On e Consul�ng, LLC.

As Principal Consultant for Plus One Consul�ng LLC Joe applies his 40 years of analy�cal chemistry knowledge and experience to support his clients in the analy�cal tes�ng industry. Prior to re�ring from RESTEK in January, 2023 Joe was RESTEK’s Business Development Manager for the global Food & Agriculture market where he iden�fied market needs, new technologies, new product opportuni�es and coordinated technical content development for new workflow solu�ons. Prior to RESTEK Joe spent 19 years working for some of the na�on’s largest environmental tes�ng laboratory companies as a bench chemist and in

technical and laboratory opera�ons senior management roles. Joe has been an invited speaker on sampling and analy�cal chemistry topics globally. He serves as a volunteer in mul�ple AOAC working groups and communi�es and as a member of the TDRM Execu�ve Commitee. Joe has also previously served in volunteer leadership roles for the Independent Laboratories Ins�tute (ILI), the American Council of Independent Labs (ACIL)’s Food Sciences Sec�on and The North American Chemical Residue Workshop (NACRW). Direct correspondence at joe@plusone.llc, or joe.konschnik@restek.com.

Julie Kowalski, JA Kowalski Science Support LLC Julie Kowalski is a technical consultant serving primarily the cannabis, hemp and food tes�ng markets. She partners with clients offering technical exper�se and advise taking advantage of her over 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 analy�cal chemistry, training and the cannabis tes�ng industry, star�ng work on cannabis tes�ng in 2011. Julie is a sought - a�er speaker and trainer focusing on educa�onal presenta�ons on various aspects of analy�cal chemistry.

Julie earned her graduate degree in Analy�cal Chemistry from Pennsylvania State University. Her professional experience includes troubleshoo�ng, method development and valida�on for GC, GC - MS, LC, and LC - MS/MS with exper�se in pes�cide residue analysis and chromatography method development. She worked at a technology provider for over ten years developing methods and products including designing reference materials for specific applica�ons. Recently Julie served as Scien�fic Director and Chief Scien�fic Officer for a cannabis tes�ng lab. She has previously served as the President and Program chair of the North American Chemical Residue Workshop, served on AOAC Expert Review Panels, the Cannabis Scien�fic Task Force for Washington State and is currently co - chairing the AOAC CASP Chemistry Working Group. She is a member of the CASP PT and Training working groups. Julie is also a member of the AOAC CASP Proficiency Tes�ng Task Force. In addi�on to technical skills, Julie is an a uditor for an accredita�on body working primarily with laboratories seeking accredita�on to ISO 17025.

Conner Jeffries, ADDIUM Food R&D Lab Conner Jeffries is a scien�st in the ADDIUM Food R&D Lab. He earned his B.S. in chemistry from the University of Washington in 2008, and completed his M.S. in chemistry from the University of Idaho in 2013 researching synthe�c and materials chemistry. He pursued doctoral research in chemistry at the University of Idaho un�l 2017, at which point he le� academia for industry. His work in the Food R&D Lab helps ADDIUM understand the interac�ons between water molecules, food, and the AQUALAB instruments we develop. Jini Glaros, Modern Canna Labs Jini Glaros is the Chief Scientific Officer (CSO) at Modern Canna Labs in Lakeland, FL. She received her bachelor’s degree with honors in Biochemistry from the University of West Florida. In May of 2022, Jini earned a master’s degree in Medical Cannabis Science and Therapeutics from the University of Maryland, Baltimore. Before entering the cannabis industry, Jini gained valuable research experience at several well -

respected institutes, including Emory University, the National Institute of Aging, and the University of Florida. She became the laboratory director of Modern Canna in January of 2018 and was promoted to CSO in August of 2022. Jini is extremely involved in the cannabis industry and currently serves on the Scientific Advisory Board for Analytical Cannabis and CloudLIMS, is a member of the CASP Advisory Panel and the Proficiency Testing Advisory Task Force with AOAC International, is a member of the Cannabis Working Group (D37) with ASTM International, and was a member of the CannMed 2023 Advisory Board.

Polona Carson, Neptune and Company, Inc. Polona Carson, PhD, MBA has more than 30 years of experience working on multidisciplinary teams in the area of quality assurance, environmental science, analytical chemistry, materials science, and management. She started her career at Slovenian Forestry Institute where she managed the Laboratory for Forest Ecology and studied sampling of plant materials and soil. Her dissertation was on optimization of soil sampling designs in a long - term forest monitoring

program. She is currently working as a consultant and project manager at Neptune and Company, Inc., where she is utilizing her strong analytical skills, statistical knowledge, and her previous analytical laboratory management experience to provide support to laboratories and reference materials producers. She is an active member of ASTM Committee E11 Quality and Statistics.

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 | New Orleans, LA •

AOAC INTERNATIONAL CANNABIS ANALYTICAL SCIENCE PROGRAM

(CASP) MEETING Tuesday, August 29, 2023 1:00PM – 3:00PM CDT

Please scan to sign into the meeting and gain access to meeting materials!

Support for current scope in CASP is made possible by the following:

PIONEER Deibel BioScience PARTNER Modern Canna

Eurofins Scientific

MilliporeSigma AFFILIATE SPEX an Antylia Scientific Company Association of Food and Drug Officials

Medicinal Genomics

ADDIUM PSI Labs Restek

HORIBA Scientific

Hygiena

R-Biopharm Rhone GOVERNMENT MD Department of Agriculture

NV Cannabis Compliance Board IL Department of Agriculture

CO Department of Public Health & Environment

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA CASP Updates and Progress • Webinars, Speaking Opportunities, and Collaborations • CANNRA Standards Webinar with AOAC, USP, and ASTM • CANNRA External Stakeholder Panel (June 2023) • AOAC CASP/CANNRA Method Validation Training Course (August 2023) • AOAC Cannabis Analytical Science Program Session at Cannabis Science Conference Fall • General Working Group Updates • CASP Microbial Contaminants WG • Work on SMPR for Detection and Enumeration of Listeria monocytogenes in Cannabis Infused Edibles • Comment reconciliation for Micro Validation Guidelines • CASP Chemistry Working Group • CALL FOR METHODS: SMPR for the Determination of Heavy Metals in Cannabis Containing Beverages • CALL FOR METHODS: SMPR for the Determination of Pesticides in Cannabis Containing Beverages

CASP Deliverables

Completed Deliverables

AOAC CASP Priority Subtopics

Performance Tested Methods

Official Methods of Analysis

Proficiency Testing

CASP was formed to provide consensus-driven standards and methods to promote accuracy in label potency claims and to address public safety issues Standard Method Performance Requirements Detailed description of requirements and parameters for candidate methods CASP Consensus-Based Methods Aim to be accurate and repeatable

SMPRs

Aspergillus E. Coli (STEC) Salmonella

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Microbiology

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Listeria

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Yeast and Mold

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Pesticides

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Residual Solvents

Chemical Contaminants

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Mycotoxins Heavy Metals

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Cannabinoids

Hemp (Low THC) Cannabis > 0.3% THC

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Terpenes

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AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA

Applicable Matrices Covered in CASP-Deliverables

Applicable Matrices Covered in AOAC Completed Deliverables Microbiology Chemical Contaminants Cannabinoids/Terpenes

Cannabis and Cannabis Product

Cannabis Dried Plant Material

Concentrates

Dried Cannabis and Hemp Flower Cannabis Concentrates

Extracts

THC-Infused Chocolate

Cannabis and Cannabis Product

Dried Plant Material Edible Chocolates Infused Beverages Cannabis Flower

Infused Beverages

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA

AOAC Official Methods of Analysis (OMA)

Applicable SMPR(s)

Analyte(s)

OMA Number

Method Name

Matrix(es)

997.02 3M™ Petrifilm™ Yeast and Mold Count (YM) Plates Foods and dried cannabis flower

Yeast and Mold

2021.009

Enumeration of Yeast and Mold in Foods, Dried Cannabis Flower, and Selected Surfaces

2014.05

Foods and dried cannabis flower

2017.001 2017.002 2017.001 2017.002 2022.001

2018.10

Cannabinoids in Dried Flowers and Oil

Dried cannabis flowers and oils

Cannabinoids

Dried cannabis and hemp materials, concentrates, and oils

2018.11 Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils

Dried plant materials, concentrates, oils, extracts, tinctures of cannabis, and cannabis-related products.

Heavy metals

2021.03 Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products

2020.001

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA

CASP Guidance Documents:

Laboratory Guidance - Drying Field-Fresh Hemp Plant Samples in Preparation for Determination of Total THC on a Dry-Weight Basis Provides general guidance for laboratories to aid in the development of SOPs appropriate for processing hemp plant materials received fresh from the field.

Cannabis Appendix for the AOAC Accreditation Guidelines for Laboratories (ALACC) An Aid to Interpretation of ISO/IEC 17025:2017 created by the Analytical Laboratory Accreditation Criteria Committee (ALACC) to provide a section-by-section interpretation of requirements. (Revision coming soon!)

Guidelines for Validation of Microbiological Methods for Cannabis and Cannabis Products Provides comprehensive AOAC technical guidelines for conducting microbiological validation studies for analysis methods of cannabis and

cannabis products (Not yet finalized)

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA

Get involved in CASP

Learn more about the CASP Advisory Panel

Join a CASP Working Group!

AOAC INTERNATIONAL 137 th Annual Meeting & Exposition August 25 – 30, 2023 • New Orleans, LA