CASP AOAC 2022 Annual Meeting

AOAC Annual Meeting Saturday, August 27, 2022 | 2:00PM – 5:00PM MT

MEETING AGENDA

I. WELCOME, INTRODUCTIONS AND ANNOUNCEMENTS (2:00PM – 2:05PM) David Schmidt, Executive Director, AOAC INTERNATIONAL

II. PROGRAM REVIEW & PROCESS OVERVIEW (2:05PM – 2:20PM) Scott Coates, Sr. Director, AOAC Research Institute & CASP Program Lead, AOAC INTERNATIONAL

III. SUMMARY OF ADVISORY PANEL SESSION (2:20PM – 2:30PM) Sherman Hom, Director of Regulatory Affairs, Medicinal Genomics

IV. GUEST SPEAKER: OVERVIEW OF THE CANNABIS REGULATORS ASSOCIATION (CANNRA) (2:30PM – 3:00PM) Gillian L. Schauer, Executive Director, The Cannabis Regulators Association (CANNRA)

V. REPORT FROM THE MICROBIAL CONTAMINANTS WORKING GROUP (3:00PM – 3:15PM) Julia Bramante, Lead Scientist Cannabis Reference Laboratory, Colorado Department of Public Health

VI. CASP CHEMISTRY WORKING GROUP UPDATE: (3:30PM – 3:55PM) Julie Kowalski, Kowalski Science Support Holly Johnson, Chief Science Officer, AHPA

VII. AOAC LABORATORY PROFICIENCY TESTING PROGRAM UPDATE (3:55PM – 4:10PM) Shane Flynn, Sr. Director, Laboratory Proficiency Testing Program, AOAC

VIII. GUEST SPEAKER: FUTURE OF CANNABIS SAMPLES (4:10PM – 4:25PM) Danielle M. Lenoir , Signature Science

IX. UPDATE ON ALACC REVISION (4:25PM – 4:50PM) Susan Audino, Audino & Associates / AOAC CASP Science Advisor

X. WRAP UP AND ADJOURN (4:50PM – 5:00PM) Scott Coates, Sr. Director, AOAC Research Institute, AOAC INTERNATIONAL A discussion on CASP future priorities

06/27/22 Version 1 – Subject to Change Without Notice

Break at 3:15PM

*Item requires a live vote

Scott G. Coates, Senior Director, AOAC 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 . Scott served as the Chief Science Officer from 2009 until June 2018. In this capacity, he served as the technical lead for many AOAC projects. Scott led the writing and development of Appendix F in the Official Methods of Analysis of AOAC INTERNATIONAL that describes validation requirements and the development of Standard Method Performance Requirements. Before joining AOAC, he worked for 10 years as the Operations Manager for an in-vitro diagnostic manufacturer making medical test kits such as Strep tests and specialized bacterial culture media. Scott holds a B.S. in Microbiology (1978) and a M.S. in Biotechnology Management (1994) from the University of Maryland.

Sherman Hom, Ph.D., Medicinal Genomics

Dr. Sherman Hom is the Director of Regulatory Affairs at Medicinal Genomics Corporation that markets genetics-based cannabis tests and breeding technologies. At MGC, Sherman provides recommendations to regulatory officials that are tasked with drafting or modifying cannabis, hemp, and psychedelic mushroom required microbial testing regulations to ensure safe products for patients and consumers. Previously, he was at the New Jersey Public Health & Environmental Laboratories, where he led teams that started the Cannabis Testing Laboratory, the Cannabis Microbial Testing Unit, and created the compendium of the all States Medical Cannabis Program required testing regulations database.

Sherman received his PhD in Microbiology at the University of California at Davis.

Gillian L. Schauer, PhD, MPH, Executive Director, CANNRA

Gillian Schauer, PhD, MPH is the Executive Director of the Cannabis Regulators Association (CANNRA), a nonpartisan, non-profit 501(c)(4)organization that convenes government officials involved in cannabis regulation from more than 40 U.S. states and territories to share best practices and lessons learned to protect public health and consumer safety, advance equity, and harmonize policy where feasible. Dr. Schauer has worked in public health and drug policy for nearly two decades and has a decade of experience working with federal and state agencies on cannabis policy, data monitoring, and research translation. Through work with the Centers for Disease Control and Prevention, she founded and led the Multi-State Collaborative for Cannabis and Public

Health from 2014-2021 to foster learnings and cultivate best practices for public health across states with legal cannabis. Prior to her work on cannabis issues, Dr. Schauer worked on tobacco prevention and control, with a focus on tobacco cessation and treatment. Dr. Schauer is also an affiliate Research Scientist with the Addictions, Drug & Alcohol Institute at the University of Washington. She has more than 70 peer-reviewed research publications on cannabis, tobacco, and other substances. She has a PhD in Behavioral Science from Emory University, a Master of Public Health from University of Washington, and a Bachelor of Science from Northwestern University.

Julia Bramante, Colorado Department of Public Health and Environment

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.

Julie Kowalski, Consultant at 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 E. Johnson, Ph.D., Chief Science Officer, AHPA

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.

Shane Flynn, Senior Director, AOAC 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 and has been developing new programs to address the needs of the analytical community since. He is currently working on Cannabis and Hemp PT programs. Shane accepted the position of Senior Director of Laboratory Proficiency Testing at AOAC in October of 2021. However, he has been with AOAC and specifically the proficiency testing department for 24 years where he was also a Director, Program Manager, and Program Coordinator. Through the years he has helped develop over 15 accredited proficiency

testing programs for Food Chemistry, Food Microbiology, Pesticides, Infant Formula, Swabs and is now working in Cannabis/Hemp. In addition to his Proficiency Testing role, he also is the staff lead for ALACC and the Technical Division of Laboratory Management (TDLM). ALACC is a multinational group of experts from varied scientific disciplines and industries that aids in the development and revisions of 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 was created by the Analytical Laboratory Accreditation Criteria Committee (ALACC) to provide a section-by-section interpretation of requirements. Shane Attended University of Maryland (College Park) for his B.S in Food Science and University of Maryland, University College (Now Global College) towards M.S. Biotechnology.

Dannielle Lenoir, Signature Science

Danielle Lenoir is a Quality Assurance Chemist and Project Manager for the Hemp and Cannabis proficiency testing program at Signature Science. Her focus is on developing and tailoring tools to help laboratories establish and maintain regulatory compliance, as well as developing solutions for complicated GC obstacles. She has 10 years of experience in laboratory quality assurance, gas chromatography, and method development. Prior to Signature Science, she worked on- and offshore in organic geochemical exploration for oil and gas companies.

Susan Audino, Ph.D., Audino & Associates

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.

August 27, 2022 AOAC INTERNATIONAL Annual Meeting

PROGRAM OVERVIEW

Program Objectives 1. Facilitate a forum where the science of cannabis analysis is discussed with scientific experts. 2. Facilitate the development and publication of cannabis and hemp-specific methods and standards. 3. Identify cannabis and hemp reference materials. 4. Establish a cannabis and hemp proficiency testing program in accord with International Standards 5. Provide analytical and laboratory management training 6. Provide resources and education to regulators responsible for establishing rules and laws around cannabis and hemp.

Funding Policy • Funds provided by the analytical community consisting of testing laboratories, technology providers, test kit companies, and other associations. • AOAC does not accept funding from any organization involved in the cultivation, manufacture, distribution or possession of cannabis as long as it is federally illegal in the US. • AOAC does not advocate for or against the use or legalization of cannabis. • Our mission is consistent with ensuring public health and food safety by facilitating the development of methods for testing cannabis in food, feed or other substances of interest to determine the best available science to promote public health.

CASP Advisory Panel

CASP Community

Microbial Working Group

Chemistry Working Group

Training Education

Proficiency Testing

Conformity Assessment

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Advisory Panel

• Determines the priorities and direction of the program. • Meet quarterly to review program progress and when needed discuss priorities. • Different levels of membership (Pioneer, partner, affiliate, and now government). • Members join at an organizational level.

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SUPPORT FOR CURRENT SCOPE OF WORK IN CASP IS MADE POSSIBLE BYTHE FOLLOWING:

PIONEER MEMBERS

PARTNER MEMBERS

AFFLIATE MEMBERS GOVERNMENT MEMBERS

Deibel BioScience Association of Food and Drug Officials (AFDO)

Antylia Scientific Medicinal Genomics

MD Department of Agriculture, State Chemist University of CA, San Diego

MilliporeSigma

Eurofins Scientific Canopy Growth Corporation

Meter Group

SōRSE Technology

CEM Corporation Perkin Elmer Nevada Cannabis Compliance Board

Supra Research and Development

HORIBA Scientific

PSI Labs

Hygiena

Q Laboratories

Forms the AOACCASP AdvisoryPanel which advises on program direction and priorities

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Cannabis Microbiology Working Group • Chair is Julia Bramante of the Colorado Department of Public Health and Environment • Most recent project was guidelines for cannabis microbiology, a new appendix for the AOAC Official Methods of Analysis. • Next, as per the Advisory Panel’s survey, they will start looking at microbial contamination of edibles, taking a product centric approach. • Most of this group’s work will lead to SMPRs, standards that methods need to meet to become OMAs via AOAC ERP review.

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8 Cannabis Chemistry Working 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.

• Chaired by Toby Astill, PerkinElmer. • Organized several educational sessions with input from working group members. • Will continue to develop training sessions as per the Advisory Panel’s priorities. • Survey feedback showed a high level of satisfaction with sessions so far. Working Groups: Training Development

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Training and Education Accomplishments Setting Up a Cannabis Lab (330 registrants) Microbial Contaminants in Cannabis (397 registrants) Heavy Metals in Cannabis (271 registrants) Chemical Contaminants in Cannabis (240 registrants) USDA Update on Final Hemp Rules (193 Registrants) Vape Science Panel (156 Registrants)

Working Groups: Proficiency Testing • 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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Questions about the PT Working Group? Contact Shane Flynn, Director of PT at CASP_PT_WG@aoac.org

Standard Method Performance Requirements (SMPRs)

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Standard Method Performance Requirements

2017.001

Cannabinoids in Cannabis Concentrates

2017.002 2017.019 2018.010

Cannabinoids in Dried Plant Materials

Cannabinoids in Chocolates

Cannabinoid in Dried Flowers and Oil

Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials Detection of Aspergillus in Cannabis and Cannabis Products Quantitation of Cannabinoids in Plant Materials of Hemp (Low THC Varieties Cannabis sp.)

2018.011

2019.001

2019.003

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Standard Method Performance Requirements

Determination of Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products Salmonella species in Cannabis and Cannabis Products Mycotoxin Screening Technique in Cannabis Plant Material and Derivatives Detection of Shiga Toxin-Producing Escherichia coli in Cannabis and Cannabis Products

2020.001

2020.002

2020.013

2020.012

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Standard Method Performance Requirements

Mycotoxin Screening Technique in Cannabis Plant Material and Derivatives Viable Yeast and Mold Count Enumeration in Cannabis and Cannabis Products Quantitative Analysis of Mycotoxins in Cannabis Biomass and Cannabis-Derived Product

2020.023

2021.009

2021.010

Heavy Metals in Beverages

2022.XXX

Cannabinoids in Beverages

2022.XXX

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Standard Method Performance Requirements

Hemp Drying Procedure (adopted in March 2022)

Draft Guidelines for Validation of Microbiological Methods for Cannabis and Cannabis Products (adopted in March 2022)

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Call for Methods

Open Calls for Methods

• Details at www.aoac.org

Open Calls for Methods

• Details at www.aoac.org

Open Calls for Methods

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Official Methods of Analysis (OMA)

1. AOAC OMA 2018.11 Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils 2. AOAC OMA 2018.10 Cannabinoids in Dried Flowers and Oil 3. AOAC OMA: Method for the Quantification of Cannabinoids in Edible Chocolate by High-Pressure Liquid Chromatography: Single Laboratory Validation* 4. AOAC OMA: Quantitating Cannabinoids in Edible Chocolates Liquid Chromatographic Separation with Photodiode Array Detection* 5. AOAC OMA 2021.03: Determination of Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products 6. Matrix Extensions of OMA 997.02, OMA 2002.11, and 2018.02* for Total Yeast and Mold in Cannabis

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Performance Tested Methods (PTM)

Performance Tested Methods

PTM Lisc. No. Test Kit Name Yeast & Molds – 6 kits

Company

021301 3M Petrifilm Rapid Yeast and Mold Count Plate 041001 TEMPO Yeast & Mold 092002 CompactDry "Nissui" YMR 072105 Quant X Fungal One Step 051301 Soleris Direct Yeast & Mold 012201 DetectX Combined

3M Food Safety

bioMeriéux

Nissui Pharmaceutical Co., Ltd.

PathogenDx

Neogen Corporation

PathogenDx

Performance Tested Methods

PTM Lisc. No. Test Kit Name Salmonella – 5 kits

Company

091501 3M Molecular Detection Assay 2 – Salmonella 121802 GENE-UP Salmonella 2 (SLM 2) 092101 GENE- UP PRO STEC / Salmonella Assay Invisible Sentinel 010803 iQ- Check Salmonella II Real - TIme PCR Test Bio- Rad Laboratories 3M Food Safety bioMeriéux

PathoSEEK Salmonella & STEC E. coli Multiplex Assay using SenSATIVAx Extraction

Medicinal Genomics Corp.

022202

Performance Tested Methods

Aspergillus – 4 kits

PTM Lisc. No. Test Kit Name

Company

032104 iQ-Check Aspergillus 022103 GENE- UP Aspergillus PRO 082102 PathoSEEK 5-Color Aspergillus Multiplex Assay using SenSATIVAx Extraction

Bio- Rad Laboratories

Invisible Sentinel

Medicinal Genomics Corp.

0102201 DetectX Combined

PathogenDX

Performance Tested Methods

E.Coli & Coliforms – 6 kits

PTM Lisc. No.

Test Kit Name

Company

121806 GENE-UP EHEC Series

bioMeriéux

102003 BAX System Real - Time PCR Assay for E. coli O157:H7 Exact 121901 Soleris Enterobacteriaceae Vial

Qualicon Diagnostics LLC, a Hygiena Company

Neogen Corporation

010302 Soleris Coliform Test

Neogen Corporation/FOSS A/S

071203 Soleris NF-TVC

Neogen Corporation

BAX System Real - Time PCR Assay Suite for Detecting non-O157:H7 STEC

Qualicon Diagnostics LLC, a Hygiena Company

091301

• Complete 2021 Projects (on or around MYM 2022) • Micro Validation Guidance • Drying Guidance Document • Beverages • Standards Dev Groups Commence 2022 Workplan • Microbial Contamination of Edibles • Cannabis Containing • Hempseed Oil • Training Dev Group will develop training sessions on ISO 17025

2022 Work Plan

2022 Survey Results

• Susan Audino, CASP Science Advisor (Audino & Associates)

AOAC CASP Staff

• Alicia

• Shane Flynn • Dawn Frazier

Allison Baker Coordinator, Science Programs

Scott Coates Program Lead

Meiklejohn • Palmer Orlandi • David Schmidt

• Jonathan Goodwin • Deborah McKenzie

Julia Bramante Chair, Microbial Contaminants Working Group Working Group Update

August 27 th , 2022 AOAC INTERNATIONAL Annual Meeting – Scottsdale, AZ | Virtual

Microbial Contaminants Working Group

Work Since Last AOAC CASP Annual Meeting:

• Working Group Teleconferences

• New initiative: Microbial Contaminants in Edibles

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Microbial Contaminants in Edibles • 3 Tiered Approach • Crosswalk of different microbial rules and regulations per product type • Compile pre-existing guidance documents or publications regarding microbial testing in cannabis products • Compile guidance documents and standards in analogous industries

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Crosswalk

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Sherman Hom, Medicinal Genomics Corporation

Next Steps • Definitions • In the final product, clearly define what is meant by “edibles” • “food ingredients that are orally ingested” • “orally ingested product” • Compile pre-existing edibles guidance documents and publications • E.g., Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes 4

• Compile guidance documents and publications in analogous industries • General and Listeria specific • E.g., FDA BAM

Many thanks to the Working Group and AOAC Team!

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Holly E. Johnson, Ph.D. Chief Science Officer American Herbal Products Association 27 August 2022

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Product Centric Working Group: Residual Solvents in Beverages SMPR

Questions?

Holly E. Johnson, Ph.D. Chief Science Officer American Herbal Products Association 16 March 2022

Julie Kowalski Co-chair Cannabis Chemistry Working Group

August 27, 2022 AOAC INTERNATIONAL Annual Meeting

ALL Working Group Members

Allison Baker (AOAC)

Kate Evans

Ben Strong

Heather Harris

Steve Crupi

Eric Petty

Emily Britton

Susan Audino

Cannabis Containing Beverages focus

• Teleconferences ~2/month

• One SMPR draft completed recently & soon to be out for public comment Determination of Pesticides in Cannabis Containing Beverages

DRAFT: Determination of Pesticides in Cannabis Containing Beverages

• Matrix Categories • Analyte list and target levels

Draft: Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

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Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

1 beverage = ### categories

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Determination of Pesticides in Cannabis Containing Beverages

Thank you Any questions?

Julie Kowalski julie@kowalskiscience.com

AOAC PROFICIENCY TESTING

Cannabis & Hemp Proficiency Testing Program

Shane Flynn, Senior Director of Proficiency Testing AOAC INTERNATIONAL

In Food & Agriculture, We Set the Standard

CANNABIS & HEMP PT

• Development • Why Develop the Program? • Pilot Round

• Future of the Cannabis & Hemp Matrices • Future Cannabis and Hemp PT Programs • Resources for Cannabis Labs • Enrollment

In Food & Agriculture, We Set the Standard

WHY DEVELOP THE PROGRAM

• AOAC Provides Ready to analyze samples in the actual matrix • Reduces opportunity for error

• Participating Labs must spike their own samples • Creates additional opportunity for errors to occur

• Cannabis labs must analyze Hemp

• AOAC’s Program provides actual >0.3% delta- 9-THC Cannabis (Low, Med, High) • Has pesticide sample in Cannabis

• Pesticide analyses much different for cannabis v hemp • Sample dilution not the same as regular samples: • Cannabinoids are lower and so the same dilution scheme may not be appropriate for hemp for labs doing only high THC material.

• Developing Micro Programs

• AOAC has Cannabis Matrix

In Food & Agriculture, We Set the Standard

DEVELOPMENT • Developed Through CASP PT WG • Technical Requirements Determined • Test Material Provider Selected • Website development • SAS Program Development • Pilot Round

In Food & Agriculture, We Set the Standard

PILOT ROUND

• Shipped May 2 • 20 labs were sent samples • 3 weeks to analyze and report • Results were computed and z-scores and other stats provided • Technical report and results were issued • Labs did well

In Food & Agriculture, We Set the Standard

RESULT SUBMISSION-CANNABINOIDS

In Food & Agriculture, We Set the Standard

RESULT SUBMISSION-PESTICIDES

In Food & Agriculture, We Set the Standard

RESULT SUBMISSION PESTICIDES

In Food & Agriculture, We Set the Standard

In Food & Agriculture, We Set the Standard

In Food & Agriculture, We Set the Standard

In Food & Agriculture, We Set the Standard

FUTURE OF CANNABIS & HEMP MATRICES

• Future of the Cannabis and Hemp PT Samples for Current Program

• Cannabis and Hemp plants grown specifically for AOAC PT Program

• Heavy Metals and Pesticides introduced during growing

Test Material Provider:

In Food & Agriculture, We Set the Standard

FUTURE CANNABIS & HEMP PT PROGRAMS

Microbiology • Aspergillus • Salmonella • E. coli (shiga toxin producing) • Yeast and Mold • More to be determined by advisory task force

• Product Centric • Gummies • Chocolate • Beverages

In Food & Agriculture, We Set the Standard

RESOURCES FOR CANNABIS LABS • New web page on AOAC Website • Resources • General info on programs • Benefits of programs • DEA License • DEA Form 222 • More

In Food & Agriculture, We Set the Standard

AOAC CANNABIS & HEMP PT

For More Information Contact AOAC PT Staff Cannabis_PT@AOAC.org

In Food & Agriculture, We Set the Standard

The Future of Cannabis Samples Cannabis & Hemp Proficiency Testing Program

Danielle M. Lenoir, PMP, CQA Signature Science, LLC

Who We Are

Signature Science is a scientific consulting and services firm, offering physical, life, forensic, and data science- related technical solutions and technologies through research and development, test and evaluation; laboratory operations; and systems design, integration and production.

https://www.signaturescience.com

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Quality Assurance and Proficiency Testing

SigSci has provided QA support to laboratory networks for more than 20 years.

 Testing and evaluation  QA program development  Risk assessments

 Proficiency testing  Laboratory auditing  ISO 17025 accreditation support

SigSci’s ISO/IEC 17043 accredited PT programs go beyond “check the box” exercises – they are operationally relevant and provide our customers with the information they need to understand the defensibility of analytical results.

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Hemp and Cannabis Matrix Preparation

 Texas Grown Hemp  Groff North America

Cultivation

 Receipt and Inspection  Quality Check

Homogenization

 Characterization  Homogeneity  Stability (including shipping and storage)

Testing

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Naturally Occurring Sample Type  Testing for: Cannabinoids Terpenes Heavy Metals Moisture Content  What is provided?  10 g sample  Natural vs. Spiked Sample 1 - Blue

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Naturally Occurring Sample Type  Testing for: Cannabinoids Terpenes Heavy Metals Moisture Content  What is provided?  10 g sample  Natural vs. Spiked Sample 1 - Blue

Cannabinoids & Terpenes  Different strains each round o Ensure cannabinoid and terpene coverage o Varied concentrations of analytes  Sample processing approach avoids increased temperatures o Minimize analyte loss

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Naturally Occurring Sample Type  Testing for: Cannabinoids Terpenes Heavy Metals Moisture Content  What is provided? o 10 g sample  Natural vs. Spiked Sample 1 - Blue

Heavy Metals  Real-world considerations o Metals of interest include both naturally-occurring and human- introduced metals o Tend to be heterogenous throughout the plant  Creating representative samples: o Grow plants that contain metals (rather than spiking) o Use customized/known grows when possible (e.g., metals added to soil or introduced via fertilizers and/or pesticides)  More metals coming after labs expand their scope

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Naturally Occurring Sample Type  Testing for: Cannabinoids Terpenes Heavy Metals Moisture Content  What is provided?  10 g sample  Natural vs. Spiked Sample 1 - Blue

Moisture  Minimal matrix processing performed to maintain naturally present moisture content

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Sample 2 – Red

Homogenize Bulk Matrix

Contaminant Sample Type  Testing for: Pesticide Residues Mycotoxins – coming soon  What is provided?  2.5 g sample (fortified)  1 g blank sample  Spiked vs. Natural

Prepare Spiking Solution and Apply to Bulk Matrix

Re-homogenize and Aliquot

Store and Ship Samples

Ready for Analysis

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Sample Shipment

Sample 1 = NDG Sample 2 = Excepted Quantities

 Shipping

 FedEx Overnight with ice packs in foam cooler  Licensing Requirements  Hemp  No Restrictions  Cannabis  DEA License for Schedule I Substances  DEA-222 Form  Export Control for International Labs  In process

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Questions?

Danielle M. Lenoir, PMP, CQA Signature Science, LLC dlenoir@signaturescience.com (512) 533-2063 www.sigscipt.com

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ALACC: Cannabis Appendix

Susan Audino, PhD Chemistry Consultant AOAC I, CASP Science Advisor

WHY?

• ALACC has brought clarity to many requirements • Food industry has benefited from enhanced guidance

• ISO/IEC 17025: Gold Standard, but “beautifully ambiguous” • ‘Risk’ is too often undervalued and over-looked • As need for scientific integrity improves, so does need for guidance

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8/26/2022

A Great Relationship!

AOAC Analytical Laboratory Accreditation Criteria Committee (ALACC)

CANNALAP  GUIDE TO A HARMONIZED NATIONAL CANNABIS

LABORATORY ACCREDITATION PROGRAM

Subcommittees

Harmonize the ACIL CANNALAP with ALACC Guidance.

Nomenclature/Glossary

Requirements that are within CANNALAP but not currently addressed by ALACC or ISO/IEC 17025:2017

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

ExperiencedSub-CommitteeTeam

17025:2017 Section 6

Glossary & Nomenclature

17025:2017 Sections 4 & 5

17025:2017 Section 7

17025:2017 Section 8

Special Considerations

Lead: Joe Konshnik

Lead: Shawn Kassner

Lead: Matt Sica

Lead: Brad Stawick

Lead: Jane Weitzel

Lead: Jane Weitzel

Chair: Susan Audino

Additional TeamMembers

Shane Flynn , AOAC

Chad Stephan , AOAC

Tracy Szerszen , PJLA

Keith Klemm , ANAB

Sarah Dorris , A2LA

Danny Noe , FDA

Aniko Solyom , Gass Analytical

Leeza Akimenko, PJLA

Heather Krug , CDPHE

Danielle Houston , PJLA

Erik Paulson , Infinite Cal

Josh Swider , Infinite Cal

AmazingWorkProducts inShort Time

Glossary & Nomenclature: LOD and LOQ, Cannabis, Marijuana, Hemp, etc. Not always straightforward yet critical to SMPR and Standards. 17025, sections 4 & 5: Specific risks do exist for cannabis laboratories, for example confidentiality is risked every time a lab uses state-required METRC to report test results, or when testing a sample into compliance. Special Considerations: Unique challenges exist for cannabis labs. This section is intended to identify some of the most significant risks. For example: Legal risks to labs and clients on basis of country, state, federal regulations; moisture correction requirements for hemp analysis; and ensuring proper scientific practices. Note: this is not a comprehensive list!

Timeline

ALACC currently undergoing 5-year internal review

Cannabis Appendix – Draft – to be prepared and introduced during the AOAC midyear meeting in March 2022 Final Cannabis Appendix Draft – in progress

Launch – Q4(this is somewhat dependent on the ALACC revision)

Expectations – Longer Range

 Nomenclature  Uniformity – Regulations, Test Methods, Technical Competence  Raise the (laboratory) bar  Regulator acknowledgement

8/26/2022

THANK YOU!

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8/26/2022

Join us on Monday, August 29 , from 1 :30PM – 3 :00PMMST for a CASP – related Technical Session!

A Higher Quality of Testing: Advancing Laboratory Analyses of Cannabis Chair: Evan Friedmann, Hellma USA

SUPPORT FOR CURRENT SCOPE OF WORK IN CASP IS MADE POSSIBLE BYTHE FOLLOWING:

PIONEER MEMBERS

PARTNER MEMBERS

AFFLIATE MEMBERS GOVERNMENT MEMBERS

Deibel BioScience Association of Food and Drug Officials (AFDO)

Antylia Scientific Medicinal Genomics

MD Department of Agriculture, State Chemist University of CA, San Diego

MilliporeSigma

Eurofins Scientific Canopy Growth Corporation

Meter Group

SōRSE Technology

CEM Corporation Perkin Elmer Nevada Cannabis Compliance Board

Supra Research and Development

HORIBA Scientific PSI Labs

Hygiena

Q Laboratories

Forms the AOACCASP AdvisoryPanel which advises on program direction and priorities

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