CASP Meeting Book_MYM2023

AOAC INTERNATIONAL Cannabis Analytical Science Program AOAC INTERNATIONAL 2023 Midyear Meeting Wednesday, March 15, 2023 1 :00pm – 5 :00pm ET Draft Agenda __________________________________________________________________________________________________

I. WELCOME, INTRODUCTIONS AND ANNOUNCEMENTS (1:00PM – 1:05PM) Scott Coates, AOAC INTERNATIONAL

II. CASP OVERVIEWS AND SUMMARY (1:05PM – 1:10PM) Allison Baker, AOAC INTERNATIONAL, will provide an overview of recent CASP highlights and a summation of recent Advisory Panel meetings.

New Solutions for Laboratories

III. UPDATE ON AOAC ACCREDITATION GUIDELINES FOR LABORATORIES (ALACC) REVISION (1:10PM – 1:30PM) Susan Audino, Audino & Associates/AOAC CASP Science Advisor, will provide an overview of the new Cannabis Appendix developed for The AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2017 IV. R 2 : THE IMPORTANCE OF VALIDATED METHODS (1:30PM – 1:50PM) Sharon Brunelle, Brunelle Biotech Consulting, AOAC Technical Consultant, will provide an overview and update on the R2 and discuss the importance of validated methods. V. AOAC LABORATORY PROFICIENCY TESTING PROGRAM (1:50PM – 2:10PM) Shane Flynn, Sr. Director, Laboratory Proficiency Testing Program, AOAC INTERNATIONAL FROM THE LABORATORY PERSPECTIVE (2:10PM – 2:25PM) Jini Curry, CSO, Modern Canna, will present on the issues and challenges laboratories face with current PTs. FROM THE REGULATOR’S PERSPECTIVE (2:25PM – 2:40PM) Julia Bramante, Colorado Department of Public Health, will present on the benefits that AOAC CASP and Proficiency Testing can provide to regulators and highlight the needs facing regulators in the cannabis industry. VI. OVERVIEW OF THE CANNABIS REGULATORS ASSOCIATION (CANNRA) (2:40PM – 3:00PM) Lori Dodson, Cannabis Regulators Association (CANNRA), will present an overview of CANNRA and discuss lab- specific progress and challenges facing laboratories.

*This agenda is subject to change at any time without notification Break from 3:00PM – 3:15PM

VII. OPEN FORUM (3:15PM – 5:00PM) AOAC CASP Science Advisor, Susan Audino, and CASP Working Group Chairs (Julie Kowalski, Kowalski Science Support; Julia Bramante, Colorado Department of Public Health; Holly Johnson, AHPA ; Brent Wilson, NIST ) will lead an open forum discussion.

*This agenda is subject to change at any time without notification Break from 3:00PM – 3:15PM

Allison Baker, AOAC INTERNATIONAL, Program Coordinator, CASP

Allison Baker is a Coordinator of Science Programs for Standards and Official Methods at AOAC International. She currently serves as the program coordinator for the Cannabis Analytical Science Program (CASP) and the Analytical International Methods and Standards (AIMS) Program, facilitating the development of voluntary consensus standard method performance requirements (SMPR®) and the adoption of methods as Official Methods of Analysis of AOAC. Prior to joining AOAC, Allison worked at the Frederick National Laboratory for Cancer Research as a research associate for the Center for Molecular Microscopy, and at Leidos, serving as a scientific 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.

Scott Coates, AOAC INTERNATIONAL, Senior Director, Research Institute

Scott was appointed as the Senior Director of the AOAC Research Institute on July 1, 2018. He is responsible for daily management of and business development for the AOAC Research Institute, a division of AOAC INTERNATIONAL. The AOAC Research Institute administers the Performance Tested Methods (PTM) and Reviewed and Recognized (R 2 ) programs. Scott was a founder of the Cannabis Analytical Science Program (CASP) that was established in 2019 by the AOAC INTERNATIONAL. CASP was founded to provide a scientific forum to: create standards for methods; discuss the performance of methods; and feed methods into the PTM, R 2 , and Official Methods programs. CASP also oversees the development of training programs, and identifies analytes for the AOAC Laboratory Proficiency Testing Program .

Susan Audino, Audino & Associates, CASP Science Advisor

Dr. Susan Audino is a chemist/chemometrician and independent consultant to chemical and biological laboratories. She is an analytical chemist and chemometrician. As a contractor for Accreditation Bodies, Dr. Audino assesses laboratories to and is an instructor for multiple ISO/IEC standards including ISO/IEC 17025. Susan is on the Board of Directors of the Center for Research on Environmental Medicine and Board of Associates of Hood College and serves as Science Advisor to the AOAC Cannabis Analytical Science Program. She has consulted to many testing laboratories, state regulatory bodies, scientific organizations, and has been an invited speaker at numerous domestic and international conferences. She has been on faculty at the Society for Cannabis Clinicians and at Teachable Medicine where she now serves as an advisor. Dr. Audino is principal of multiple independent companies, has several patents pending, is a contributing author to Cannabis Laboratory Fundamentals published by Springer-Nature in 2021, and contributes a monthly column to MJ Biz.

Sharon Brunelle, AOAC INTERNATIONAL, Technical Consultant

Sharon Brunelle has worked with the AOAC Research Institute and AOAC INTERNATIONAL since January 2003 as a technical consultant designing and coordinating microbiology and chemistry method validation studies in the Performance Tested Methods SM , Reviewed and Recognized SM and Official Methods of Analysis SM programs. Sharon also served as the technical lead for various contract and standard development projects within AOAC, including best practices for microbiology methods, biothreat agents, veterinary drug residues, low lactose, and glycerol esters of wood rosins. She played a major role in developing validation guidelines for biothreat agent and microbiology methods. In addition, Dr. Brunelle consults for industry in the areas of food microbiology and veterinary drugs in animal tissues and feeds. Prior to AOAC, Dr. Brunelle worked for 10 years in food microbiology and clinical oncology diagnostics development and validation. Sharon earned a B.S. in chemistry from the University of Delaware and a Ph. D. in biochemistry from Brandeis University. Her postdoctoral work was in medical biochemistry at Rockefeller University and the Picower Institute for Medical Research.

Shane Flynn, AOAC INTERNATIONAL, Senior Director, Laboratory Proficiency Testing Program

Shane Flynn is the Senior Director of the AOAC Laboratory Proficiency Testing (PT) Program. Shane helped start the first accredited Proficiency Testing 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 analytical laboratory community since. He is currently working on Cannabis and Hemp PT programs. In addition to his Proficiency Testing role, he also is the staff lead for the Analytical Laboratory Accreditation Criteria Committee (ALACC) and the Technical Division of Laboratory Management (TDLM).

Jini Curry, Modern Canna Labs

Jini Curry 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 CASP with AOAC International and sits on their Proficiency Testing Advisory Task Force, and is a member of the CannMed 2023 Advisory Board.

Julia Bramante, Colorado Department of Public Health

Julia Bramante serves as the Cannabis Reference Laboratory Manager 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 a board member of the AOAC Official Methods Board, Chair of the AOAC CASP Microbial Contaminants Working Group, Chair of the AOAC CASP Microbial Contaminants Expert Review Panel, serves on the AOAC CASP Cannabinoids and Chemical Contaminants Expert Review Panels, and is an active member of the Colorado Marijauna Science and Policy Working Group. She also serves as Chair of the Cannabis Chemistry Subdivision of the Division of Chemical Health and Safety of the American Chemical Society.

Lori Dodson, Maryland Medical Cannabis Commission, CANNRA

Lori Dodson currently serves as a senior advisor for the Maryland Medical Cannabis Commission and Co- Chair for the CANNRA Lab Testing and Product Safety subcommittee . During her public service in the cannabis space, Lori has been actively involved in developing policy, regulations and best practices for the medical cannabis industry, as well as working to pioneer standardized testing criteria for cannabis laboratories across the country. Prior to her work in cannabis, Lori was a Program Coordinator for the Maryland Department of Health and Mental Hygiene-Office of Health Care Quality where she was responsible for regulating and inspecting forensic and clinical laboratories in Maryland. Ms. Dodson has a Masters of Science in Biomedical Research from the University of Maryland-Baltimore and a Bachelors of Science in Medical Technology from Wichita State University. Lori is married with two very active children and two dogs, and loves competing in endurance sports.

Julie Kowalski, JA Kowalski Science Support LLC

Julie Kowalski is a technical consultant serving primarily the cannabis, hemp and food testing markets. She partners with clients offering technical expertise 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 analytical chemistry, training and the cannabis testing industry, starting work on cannabis testing in 2011. Julie is a sought-after speaker and trainer focusing on educational presentations on various aspects of analytical chemistry. 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 with expertise in pesticide 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 applications. Recently Julie served as Scientific Director and Chief Scientific Officer for a cannabis testing 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 Scientific 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 Testing Task Force. In addition to technical skills, Julie is an auditor for an accreditation body working primarily with laboratories seeking accreditation to ISO 17025.

Holly Johnson, American Herbal Products Association

Holly E. Johnson, Ph.D. is Chief Science Officer for the American Herbal Products Association, an alliance of over 400 member companies doing business in the natural products industry. Dr. Johnson took a B.S. in Botany and a Ph.D. in Pharmacognosy with specialization in Medical Ethnobotany, and was awarded an NIH Fellowship for doctoral training at the University of Illinois-Chicago NIH Center for Botanical Dietary Supplements. She previously served as Laboratory Director for Alkemist Labs, an ISO 17025 accredited third party contract testing lab specializing in botanicals. Dr. Johnson has been an AOAC volunteer for many years serving on working groups and expert review panels in standards setting work for foods, dietary supplements, and botanicals. Holly is a member of the United States Pharmacoepia (USP) Expert Committee for Botanical Dietary Supplements & Herbal Medicines and also the USP Cannabis Expert Panel, and serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia, among others. Holly has over 20 years experience in botanicals research and spent many happy years giving courses at the University of Hawaii.

Walter Wilson, NIST

Dr. Wilson work currently focuses on the coordination the Cannabis research program in the Chemical Sciences Division at NIST with a focus on developing Cannabis reference materials, development of new analytical methods, and administering the Cannabis Laboratory Quality Assurance Program. He is an active member of multiple standards organizations including the Cannabis Analytical Science Program (CASP) of AOAC international. He served as Chair of the AOAC CASP Proficiency Testing Working Group and a member of multiple Expert Review Panels.

Cannabis Analytical Science Program (CASP) Program Session Wednesday, March 15 | 1:00PM – 5:00PM ET

Scan to sign into the meeting and get access to meeting materials!

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL HOUSEKEEPING ITEMS

This meeting will be conducted in accordance with AOAC Policies & Procedures

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL HOUSEKEEPING ITEMS

This meeting is being recorded

Please mute your lines and unmute only when speaking

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Support for current scope in CASP is made possible by the following: Pioneer Members Partner Members Affiliate Members Government Members

SPEX an Antylia Scientific Company

MD Department of Agriculture

Deibel BioScience

Eurofins Scientific

Nevada Cannabis Compliance Board

MilliporeSigma

Modern Canna

HORIBA Scientific

The Colorado Department of Public Health and Environment

Hygiena

Medicinal Genomics ADDIUM PSI Labs Association of Food and Drug Officials

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Cannabis Analytical Science Program (CASP)

Allison Baker, Program Coordinator abaker@aoac.org

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CASP Deliverables:

Completed Deliverables

AOAC CASP Priority Subtopics

Performance Tested Methods

Official Methods of Analysis

Proficiency Testing

SMPRs

Aspergillus E. Coli (STEC) Salmonella













Microbiology







Listeria



Yeast and Mold









Pesticides





Residual Solvents

Chemical Contaminants



Mycotoxins Heavy Metals











Cannabinoids

Hemp (Low THC)







Cannabis > 0.3% THC







Terpenes



AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CASP SMPRs: SMPR Number Title

Analyte(s)

Matrices

Quantitation of Cannabinoids in Cannabis Concentrates

Cannabinoids

Cannabis concentrates

2017.001

Quantitation of Cannabinoids in Dried Plant Materials

2017.002

Cannabinoids

Cannabis dried plant materials

Quantitation of Cannabinoids in Edible Chocolate

2017.019

Cannabinoids

Cannabis infused chocolate

Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials Pesticide Residues

2018.011

Cannabis dried plant materials

Aspergillus spp., including Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, and Aspergillus terreus

Detection of Aspergillus in Cannabis and Cannabis Products

2019.001

Cannabis and Cannabis Products

Identification and Quantitation of Selected Residual Solvents in Cannabis-Derived Materials Quantitation of Cannabinoids in Plant Materials of Hemp (Low THC Varieties Cannabis spp.) Determination of Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products

2019.002

Residual Solvents

Cannabis concentrates

2019.003

Cannabinoids

Hemp plant materials

2020.001

Heavy Metals

Cannabis and Cannabis Products

Detection of Salmonella species in Cannabis and Cannabis Products

2020.002

Salmonella spp.

Cannabis and Cannabis Products

Detection of Shiga Toxin-Producing Escherichia coli in Cannabis and Cannabis Products Shiga Toxin-Producing Escherichia coli

2020.012

Cannabis and Cannabis Products

Mycotoxin Screening Technique in Cannabis Plant Material and Cannabis Derivatives

2020.013

Mycotoxins

Cannabis and Cannabis Products

Viable Yeast and Mold Count Enumeration in Cannabis and Cannabis Products

2021.009

Yeasts and molds

Cannabis and Cannabis Products

Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis-Derived Product

2021.010

Mycotoxins

Cannabis, Cannabis Products and Hemp

Quantitation of Cannabinoids in Beverages

2022.001

Cannabinoids

Beverages

Coming Soon! Determination of Heavy Metals in Beverages

Heavy Metals

Beverages

Coming Soon! Determination of Pesticide Residues in Beverages

Pesticide Residues

Beverages

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CASP Official Methods:

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

2020.001

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

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

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 Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Up next in CASP…

Coming SOON…

Advisory Panel Priorities…

Publication of SMPR and Call for Methods: • Determination of Heavy Metals in Beverages • Determination of Pesticide Residues in Beverages

Call for Comment:

• Detection and Enumeration of Listeria monocytogenes in Cannabis infused Edibles

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Contact Information

Allison Baker, Program Coordinator, Standards and Official Methods • abaker@aoac.org Scott Coates, Senior Director, Research Institute • scoates@aoac.org

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Susan Audino, Audino & Associates, CASP Science Advisor

Dr. Susan Audino is a chemist/chemometrician and independent consultant to chemical and biological laboratories. She is an analytical chemist and chemometrician. As a contractor for Accreditation Bodies, Dr. Audino assesses laboratories to and is an instructor for multiple ISO/IEC standards including ISO/IEC 17025. Susan is on the Board of Directors of the Center for Research on Environmental Medicine and Board of Associates of Hood College and serves as Science Advisor to the AOAC Cannabis Analytical Science Program. She has consulted to many testing laboratories, state regulatory bodies, scientific organizations, and has been an invited speaker at numerous domestic and international conferences. She has been on faculty at the Society for Cannabis Clinicians and at Teachable Medicine where she now serves as an advisor. Dr. Audino is principal of multiple independent companies, has several patents pending, is a contributing author to Cannabis Laboratory Fundamentals published by Springer-Nature in 2021, and contributes a monthly column to MJ Biz.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CANNABIS MEETS ALACC

Susan Audino Science Advisor, CASP

AMERICAN COUNCIL OF INDEPENDENT LABS (ACIL)

www.acil.org/page/About_ACIL • Trade Association representing independent, commercial scientific and testing laboratories. • Founded in 1937

• Vision: “Realizing a healthy safe environment for society through the application of unbiased, scientific testing.” • Mission: “Providing the independent testing community with advocacy, education, and alliances to enable members to better address environmental and product risks to the public.” • Values: “Ethical, Objective and Quality Business Practices”

INDEPENDENT LABORATORIES INSTITUTE (ILI)

2018: Guide to a Harmonized National Cannabis Laboratory Accreditation Program (CannaLAP)

Developed by:

o Industry-expert stakeholders o Laboratory personnel o Accreditation Bodies o Regulatory Bodies

“Developed to provide inputs into a consistent approach to each state’s accreditation process by developing the basic quality requirements for the accreditation of laboratory testing of cannabis plant material, cannabis-based products, or hemp across the nation.”

A GREAT RELATIONSHIP!

AOAC Analytical Laboratory Accreditation Criteria Committee (ALACC)

American Council of Independent Labs (ACIL) & Independent Laboratory Institute (ILI) CANNALAP Guide to a Harmonized National Cannabis Laboratory Accreditation Program

December 2021

EXPERIENCED SUB-COMMITTEE TEAM

17025:2017 Section 6

Glossary & Nomenclature

17025:2017 Sections 4 & 5

17025:2017 Section 7

17025:2017 Section 8

Special Considerations

Lead: Shawn Kassner

Lead: Brad Stawick

Lead: Jane Weitzel

Lead: Jane Weitzel

Lead: Matt Sica

Lead: Joe Konshnik

Chair: Susan Audino

ADDITIONAL TEAM MEMBERS Shane Flynn, AOAC Chad Stephan, AOAC Tracy Szerszen, PJLA Keith Klemm, ANAB Sarah Dorris, A2LA

Danny Noe, FDA

Aniko Solyom, Gass Analytical

Erik Paulson, Infinite Cal

Josh Swider, Infinite Cal

Heather Krug, CDPHE

Danielle Houston, PJLA

Leeza Akimenko

SUBCOMMITTEES

Harmonize the ACIL CANNALAP with ALACC Guidance.

Nomenclature/Glossary

CANNALAP recommendations not addressed by ALACC or ISO/IEC 17025:2017

Section by Section alignment with ISO/IEC 17025:2017 and ALACC

WORK PRODUCTS

Glossary & Nomenclature: LOD and LOQ, Cannabis, Marijuana, Hemp, etc. 17025, sections 4 & 5: • confidentiality is risked every time a lab uses state-required METRC to report test results • testing a sample into compliance. Special Considerations: • Legal risks to labs and clients on basis of country, state, federal regulations • moisture correction requirements for hemp analysis • proper scientific practices.

TIMELINE

ALACC Internal Review

Internal/ Publications

Cannabis Submission

Q1 2023 Subcommitte e Submission

Fall 2022

Q4 2023

GUIDANCE & LEADERSHIP

• Laboratories • Regulatory Bodies • Legislation?

THANK YOU

Sharon Brunelle, AOAC INTERNATIONAL, Technical Consultant

Sharon Brunelle has worked with the AOAC Research Institute and AOAC INTERNATIONAL since January 2003 as a technical consultant designing and coordinating microbiology and chemistry method validation studies in the Performance Tested Methods SM, Reviewed and Recognized SM and Official Methods of Analysis SM programs. Sharon also served as the technical lead for various contract and standard development projects within AOAC, including best practices for microbiology methods, biothreat agents, veterinary drug residues, low lactose, and glycerol esters of wood rosins. She played a major role in developing validation guidelines for biothreat agent and microbiology methods. In addition, Dr. Brunelle consults for industry in the areas of food microbiology and veterinary drugs in animal tissues and feeds.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 : The Importance of

Validated Methods CASP, March 15, 2023 Sharon L. Brunelle, PhD

Brunelle Biotech Consulting AOAC Technical Consultant sharon@brunellebiotech.com

Protecting the Consumer

Regulations

Sampling Plan

Stakeholder Standards

Consumer Protection

Proficiency Testing

Method Validation

Laboratory Accreditation

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Why should I validate my method?

• Ensure fitness for purpose • Ensure accuracy and repeatability of results • Increase customer confidence in results o actionable results • Expand my scope of ISO 17025 accreditation • Compliance with state regulations

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

lab

validate,

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CASP SMPRs and AOAC Methods

Analyte(s)

SMPRs

OMA Methods PTM Methods

R 2 Methods

Microbiology Cannabinoids Heavy Metals

4 5 2 2

2 2

28

1

1

Mycotoxins Pesticides

1 1

Solvents

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Why so few AOAC validated chemistry methods? • MLVs for cannabis and cannabis products are expensive • MLVs for cannabis and cannabis products are a logistical nightmare • State regulations vary – my method is specific for my state • No federal regulatory enforcement, so I don’t need OMA status • I don’t want to reveal the details of my method to my competitors

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

How should I validate my method?

• Do I need third-party validation? o Standardized study designs and acceptance criteria o Independent performance evaluation o Peer review process o Higher level of confidence • What level of validation do I need? o Regulatory enforcement o Product compliance • What kind of method am I validating?

o Instrument-based or test kit o Proprietary or non-proprietary

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC Method Validation

• Official Methods of Analysis SM (OMA) o Regulatory enforcement and trade dispute resolution o Reproducibility in 10-12 laboratories • Performance Tested Methods SM (PTM) o Test kit methods (PCR, ELISA, LFD) o Repeatability in 2 laboratories • Reviewed & Recognized SM (R 2 ) o Laboratory instrument-based methods o Repeatability in 2 laboratories Programs harmonized to Guidelines and SMPRs

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 Program

• Methods can be proprietary (commercial service methods) or non-proprietary (application notes) o publication of detailed method not required • Consulting Service available for protocol development o tailored to your method and its intended use • Independent Laboratories are qualified and trained o must have no conflict of interest • Successful methods receive R 2 Certificate and R 2 Certification Mark with unique certification number • Can be submitted as first step towards OMA status

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 Certificate

• Identifies method name and developer, Independent Laboratory, and peer reviewers • Documents method claim and compliance with guidelines and SMPR(s) • Provides key supporting data from validation studies • Documents all method modifications and supporting data o matrix extensions o method improvements • Searchable public database of certificates maintained by AOAC RI • Downloadable for ISO 17025 documentation • Methods reviewed and certificates renewed annually

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 Certification Mark

• Easily identifiable by customers • Can be displayed on customer analysis reports • Certification Mark License Agreement executed o rules for using the mark (reports, marketing, etc.) o can be used by all locations within a laboratory network o allows for sub-licensing of certified method and mark – sub-licensee signs addendum to license agreement

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 Methods

• Content requirements, but no specified format o intended user, environmental factors, applicability statement, limitations, system suitability, instructions, LOD/LOQ, precautions, technical assistance • Method details can be kept confidential o certificate includes principle of method only o publication of method and validation study is optional

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Independent Laboratory Study

• Traditional

o transfer method to IL o IL performs matrix study to verify method performance • On-site o IL prepares set of validation materials o IL analyst performs method on-site at MD laboratory o Technical Consultant present to ensure independence

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

R 2 Certification

• Supports ISO 17025 • Third-party validation and review • Intermediate between SLV and MLV • Maintains confidentiality of method details • Technical Consultant assigned to guide you through the process • Supports consumer protection o Accurate methods for safety and potency

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Thank you Questions?

Shane Flynn, AOAC Senior Director, Proficiency Testing

Shane Flynn is the Senior Director of the AOAC Laboratory Proficiency Testing (PT) Program. Shane helped start the first accredited Proficiency Testing 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 analytical laboratory community since. He is currently working on Cannabis and Hemp PT programs. In addition to his Proficiency Testing role, he also is the staff lead for the Analytical Laboratory Accreditation Criteria Committee (ALACC) and the Technical Division of Laboratory Management (TDLM).

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Cannabis & Hemp PROFICIENCY TESTING

Shane Flynn, Senior Director

Cannabis & Hemp Proficiency Testing •

•

•

•

•

•

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

•

Why Develop a Program

• Labs must spike their own samples o Creates opportunity for errors • Cannabis labs must analyze Hemp

• Ready to analyze, like routine, samples • Reduces opportunity for error

• > 0.3% ∆ -9-THC Cannabis

• Pesticide analyses much different for cannabis v hemp

• Has pesticide sample in Cannabis & Hemp

• Cannabinoids are lower in hemp so the same dilution scheme may not be appropriate for labs doing only high THC material.

• Developing Micro PT Cannabis & Hemp

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

In addition to Hemp, AOAC can ship >0.3% (low, med, and high) ∆ -9-THC Cannabis AOAC samples arrive homogeneous and ready to analyze, no spiking required Use of reference labs for statistics (most competitors use consensus)

What Sets Our Program Apart

Scientific Association with many SMEs

Developed through CASP based on feedback from over 500 stakeholders

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD Less expensive than top competitors

Round Information Sample Preparation information Instructions for analysis Results

Participant Reports

Z-score Plots Distribution

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

New Programs and Analytes

Concentration/Potency

Chemical Contaminants

Cannabinoids

Heavy Metals Pesticides Mycotoxins

Terpenes Moisture

Water Activity

More to come…….

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Programs in Development

Microbiological Impurities

Aspergillus niger Aspergillus flavus

E. coli (STEC) Salmonella Yeast & Mold

Aspergillus fumigatus Aspergillus terreus

More to come…….

Pilot Q3 2023

First Round Q4 2023

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Programs Being Assessed

Additional Programs being Assessed

Foreign Matter

Beverages Chocolate

Edibles

Oils

More to come…….

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

• International

o South Africa o Canada o Uruguay o Zimbabwe

Global Expansion

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Thank You

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

TDLM

• Technical Division for Lab Management o TDLM helps laboratory managers improve lab operations through professional development and peer networking o TDLM fosters harmonization of appropriate laboratory systems to improve understanding and transfer of information, data, and procedures. o TDLM plans and conducts educational and informational activities on laboratory management topics. • Thank you o Marco Garcia (Chair) TDLM@AOAC.org

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

ALACC

• Analytical Laboratory Accreditation Criteria Committee o ALACC was formed to help labs meet the challenges of accreditation. o “Helps take the grey out” of ISO 17025 o Revision of main guide and addition of Cannabis Appendix • Thank you o ACIL –Joe Konschnik, Zach Eisenberg, Shawn Kassner, and many more o Susan Audino , S.A. Audino and Associates-Cannabis Subcommittee Chair o Dawn Mettler , Rockbridge Lab Services-Microbiology Subcommittee Chair o Brad Stawick , Stawick Lab Management-Chemistry Subcommittee Chair

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

The Tools Your Lab Needs

Standard Method Performance Requirements (SMPR)

Performance Tested Methods (PTM)

Official Methods of Analysis (OMA)

R 2

Proficiency Testing • Resources for DEA forms

ALACC Guide to Interpreting ISO 17025

Training and Education

Q 2

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

March 20 th Round (Hemp) September 25 th (Cannabis/Hemp) Pilot Round Q3 Microbiological Impurities

To Enroll visit AOAC website or contact PT staff: Cannabis_PT@AOAC.org

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Jini Curry, Modern Canna

Jini Curry 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 CASP with AOAC International and sits on their Proficiency Testing Advisory Task Force, and is a member of the CannMed 2023 Advisory Board.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

AOAC Proficiency Testing Program Testimonial

Who is Modern Canna?

Proficiency Testing Requirements – Florida

Participate in two (2) Proficiency Testing rounds each calendar year.

Must complete PT’s for ALL analytes and matrices that the laboratory is accredited for.

Must have satisfactory results on two (2) of the three (3) most recent studies.

Available Programs

Current Issues with PT Programs

Current Issues with PT Programs

How AOAC has Corrected these Issues

Reading the Results and Understanding the Numbers

The Future – Moving all Proficiency Testing to this Type of Sample

Once there are PT samples for all analyses and matrices, there should be no reason for laboratories to not participate in the AOAC program.

Regulators should require laboratories to perform proficiency testing with pre-spiked samples.

Making AOAC PT’s Applicable to the Entire Industry

Julia Bramante, Colorado Department of Public Health and Environment

Julia Bramante serves as the Cannabis Reference Laboratory Manager 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 a board member of the AOAC Official Methods Board, Chair of the AOAC CASP Microbial Contaminants Working Group, Chair of the AOAC CASP Microbial Contaminants Expert Review Panel, serves on the AOAC CASP Cannabinoids and Chemical Contaminants Expert Review Panels, and is an active member of the Colorado Marijauna Science and Policy Working Group. She also serves as Chair of the Cannabis Chemistry Subdivision of the Division of Chemical Health and Safety of the American Chemical Society.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Standards and Proficiency Testing From a regulatory perspective

Julia Bramante Cannabis Reference Laboratory Manager

Proficiency Testing

● Quick development to meet the need ● Expansion: ○ Panels ○ Analytes ○ Sample types ○ Frequency ● Specificity to different regulations ○ Leads to some complications Key Points So Far…

● Applicability of PTs ○ Matrix Challenges

■ Is it representative? ■ What sample size is provided? ■ Is it realistic?

○ Analytes present

■ All? Some? None? ■ Rotation ○ Concentration of analytes ■ Realistic?

● Variability (or broadness) of acceptance criteria ○ Statistical models utilized ○ Small participant pools ○ Assigned values

● Details provided in instructions- too much or too little?

Path Forward

Collaboration!

● Development and evolution of PTs ○ Lessons learned ○ Alignment with other industries

Reference Materials

●

● Forums to voice concerns and collectively reach solutions ○ AOAC WGs, meetings, and AP ● Combine efforts between groups cohesively

Thank you! julia.bramante@state.co.us

Lori Dodson, Maryland Medical Cannabis Commission, CANNRA

Lori Dodson currently serves as a senior advisor for the Maryland Medical Cannabis Commission and Co-Chair for the CANNRA Lab Testing and Product Safety subcommittee . During her public service in the cannabis space, Lori has been actively involved in developing policy, regulations and best practices for the medical cannabis industry, as well as working to pioneer standardized testing criteria for cannabis laboratories across the country. Prior to her work in cannabis, Lori was a Program Coordinator for the Maryland Department of Health and Mental Hygiene-Office of Health Care Quality where she was responsible for regulating and inspecting forensic and clinical laboratories in Maryland. Ms. Dodson has a Masters of Science in Biomedical Research from the University of Maryland-Baltimore and a Bachelors of Science in Medical Technology from Wichita State University.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Presented by: Lori Dodson, MS, MT(ASCP) Senior Advisor, Maryland Medical Cannabis Commission Co-Chair-CANNRA Lab Testing Subcommittee

CANNRA EXECUTIVE LEADERSHIP FY2022-2023

Chris Tholkes, Treasurer

Tyler Klimas, President

Gillian Schauer Executive Director

Will Tilburg, Board Member

Michele Nakata, Board Member

Andrew Turnage, Board Member

Dominique Mendiola, Board Member

CANNRAMEMBERSHIP

• CANNRA was founded by the principal members of nineteen different cannabis regulatory agencies in Colorado, Delaware, Hawaii, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New York, North Dakota, Oregon, Rhode Island, Utah, and Washington. • CANNRA now includes members and associate members from more than 40 states and jurisdictions, including Guam and the Virgin Islands (not pictured on the map below).

CANNRA’s work is largely focused on supporting member jurisdictions through: • Policy tracking efforts to facilitate members understanding of policy approaches being implemented in other states and territories • Identification of emerging and best practices through topic-based committees that meet regularly and develop white papers and other resources • Education about key regulatory topics and on the ground regulatory challenges through factsheets and topic summaries https://www.cann-ra.org/white- papers-and-factsheets • Exploration of emerging and complex policy and regulatory topics as part of a monthly member-only webinar series • In-person convening of CANNRA members and national stakeholders to facilitate an exchange of ideas and information

CANNRA’S FOCUS

CANNRA’s Special Committees • Federal Policy • Social Equity • Lab Testing and Product Safety • Public Education

• Hemp • Licensing, Inspection, and Compliance • Banking, Finance, and Insurance • Market Structure & Taxation • Impaired Driving and Workplace Safety • Energy and Environmental Policy • Municipal and County Coordination

• Public Health and Data Monitoring • Packaging, Labeling, and Advertising • Medical Use and Research • Interstate Coordination

CANNRA Lab Testing and Product Safety

Currently 85 members rostered from all member states

Working groups based on member feedback

Proficiency Testing and Laboratory Compliance

Technical Resources/Repository

Method Standardization

Monthly Technical Calls

Emerging Trends

CANNRA website: https://www.cann-ra.org

For More Information Contact:

MicheleNakata:michele.nakata@doh.hawaii.gov

Lori Dodson: lori.dodson1@maryland.gov

CASP Open Forum

If in person, please come up to the mics on the floor to add to the discussion!

If virtual, please write in the chat or raise your hand to join the discussion!

Special thanks to our moderators: Susan Audino, Julie Kowalski, Holly Johnson, Julia Bramante & Brent Wilson

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

CASP Open Forum, Lead By…

Julia Bramante, Colorado

Holly Johnson, AHPA

Susan Audino, Audino & Associates

Brent Wilson, NIST,

Julie Kowalski, JA Kowalski Science Support LLC

Department of Public Health and Environment

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

With the ever-evolving testing and product formulation landscape in the cannabis space, it is increasingly difficult to address testing demands as they arise… • How can non-targeted screening methods can help fill some of these gaps? • Would it be helpful to invest some efforts into creating standards for non-targeted methods?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Missed and misunderstood factors related to “potency”, cannabinoids, inconsistent test results and inflated numbers • Possible inappropriate assumption that a batch of flower can be defined by a single cannabinoid concentration, sampling consideration • Measurement uncertainty

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Cannabinoids quantification: analytical methods at the crossroads of regulation, marketing, quality, and transparency • As cannabis and hemp markets evolve, a patchwork of widely varied regulations creates challenges in developing & implementing rigorous analytical standards. • How different analytical techniques to incorporate moisture in cannabinoids quantification has led to confusion among consumers and labs • The ongoing issues of measuring cannabinoids beyond delta-9THC, such as delta- 8THC.

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

What are the biggest technical challenges for cannabis labs?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

What are some of the biggest hurdles for lab resulting from regulations?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

Should the term “potency” be retired when referring to cannabinoid concentration analysis?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

What projects would you like to see CASP tackle?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD

How can labs get involved with CASP?

AOAC INTERNATIONAL Midyear Meeting March 13 –17, 2023 | Gaithersburg, MD