CASP Meeting Book_MYM2023

AOAC INTERNATIONAL Cannabis Analytical Science Program AOAC INTERNATIONAL 2023 Midyear Meeting Wednesday, March 16, 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) 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.

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