AOAC CASP Meeting Book

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WEDNESDAY, MARCH 16, 2022 1:00PM – 5:00PM

at the

AOAC 2022 MID-YEAR MEETING Gaithersburg MarriottWashingtonian Center Gaithersburg, Maryland, USA

AOAC Mid-Year Meeting Wednesday, March 16, 2022 | 1:00pm – 5:00pm ET

MEETING AGENDA

I. WELCOME, INTRODUCTIONS AND ANNOUNCEMENTS (1:00PM – 1:05PM) David Schmidt, Executive Director, AOAC INTERNATIONAL

II. PROGRAM REVIEW & PROCESS OVERVIEW (1:05PM – 1:20PM) Christopher Dent, Sr. Manager, AOAC Science Programs, AOAC INTERNATIONAL

III. THE CHANGING REGULATORY LANDSCAPE (1:20PM – 1:45PM) Susan Audino, Audino & Associates / AOAC CASP Science Advisor

IV. GUEST SPEAKER: CANNABIS REGULATORS ASSOCIATION (CANNRA) (1:45PM – 2:15PM) Lori Dodson, Sr. Advisor, Maryland Medical Cannabis Commission

V. REPORT FROM THE CANNABIS CHEMISTRY WORKING GROUP: CANNABIS BEVERAGES (2:15PM – 3:15PM) • Heavy Metals, Pesticides: Julie Kowalski, Kowalski Science Support • Cannabinoids, Residual Solvents: Holly Johnson, Chief Science Officer, AHPA

VI. UPDATE ON AOAC PROFICIENCY TESTING PROGRAM (3:30PM – 3:45PM) Shane Flynn, Sr. Director, Laboratory Proficiency Testing Program, AOAC

VII. Update on ALACC Revision (3:45PM – 4:00PM) Susan Audino, Audino & Associates / AOAC CASP Science Advisor

VIII. CANNABIS DRYING GUIDANCE DOCUMENT *(4:00PM – 4:30PM) Holly Johnson, Chief Science Officer, AHPA • Discussion and Vote

IX. REPORT FROM THE MICROBIAL CONTAMINANTS WORKING GROUP (4:30PM – 5:00PM) Julia Bramante, Lead Scientist Cannabis Reference Laboratory, Colorado Department of Public Health & Environment • Discussion and vote on the proposed Cannabis Microbiology Validation Guidelines*

X. ADJOURN (5:00PM) Scott Coates, Sr. Director, AOAC Research Institute, AOAC INTERNATIONAL

02/14/22 Version 4 – Subject to Change Without Notice

Break at 3:15PM

*Item requires a live vote

AOAC INTERNATIONAL – Cannabis Analytical Science Program, March 16, 2022, Presenter Bios

PRESENTER BIOS

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. She is also a member of the AOAC Official Methods Board..

LORI DODSON, MARYLAND MEDICAL CANNABIS COMISSION / CANNRA

Lori Dodson currently serves as a Senior Advisor for the Maryland Medical Cannabis Commission and the Co ‐ Chair for the CANNRA Laboratory Testing Sub ‐ Committee. Over the years, Lori has been actively involved in developing cannabis policy and regulations, specifically in the area of cannabis testing. Prior to coming on board at the commission, Lori served the Maryland Department of Health and Mental Hygiene 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 a dog, and loves competing in endurance sports.

AOAC INTERNATIONAL – Cannabis Analytical Science Program, March 16, 2022, Presenter Bios

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

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

JULIE KOWALSKI, JKSS LLC Julie Kowalski is a technical consultant primarily serving the cannabis and hemp testing market. She earned her graduate degree in Analytical Chemistry from Pennsylvania State University. Her professional experience includes

troubleshooting, method development and validation for GC, GC ‐ MS, LC, and LC ‐ MS/MS in addition to pesticide residue analysis and chromatography method development. She has previously served as the President of the North American Chemical Residue Workshop, served on AOAC Expert Review Panels, the Cannabis Scientific Task Force for Washington State and is currently chairing the AOAC CASP Chemical Contaminants Working Group.

PROGRAM OVERVIEW AOAC MID-YEAR MEETING

MARCH 16, 2022

MARRIOTT GAITHERSBURG

WASHINGTONIAN CENTER

Overview & Updates

AOAC Standards Development

Cannabis Analytical Science Program Overview

• Documents a community’s

• Used to adopt AOAC Official

What are SMPRs?

analytical method needs.

Methods by Expert Review

Panels.

• Very detailed description of the

analytical requirements.

• Published as a standard in the

OMA and in the Journal of AOAC

• Includes method acceptance

International.

requirements.

On April 8, 2008, PCR Methods for Detection of Bacillus anthracis in Aerosol Collection Filters and/or Liquids, was approved by the Stakeholder Panel on Agent Detection Assays (SPADA). This would become AOAC’s first SMPR.

In 2009, AOAC replaced the terms “acceptance criteria” with “Standard Method Performance Requirements” (SMPR).

History of SMPRs at AOAC

Numerous SMPRs for the Stakeholder Panel on Agent Detection Assays (SPADA) were developed soon after and the format was duplicated for other efforts. Soon, AOAC was producing numerous SMPRs every year.

A standard format was developed and agreed in 2010.

SMPR is now a registered service mark of AOAC

Basis for method acceptance and approval.

Guidance to method developers for the development of new methods.

Advance the state-of-the-art in a particular direction.

How are SMPRs Used?

Address specific analytical needs.

Allow AOAC to reach a broader community of method developers and users.

Development time = 3 to 6 months.

Advisory panel explains their needs regarding methods in that specific area and assigns a working group to begin the standards development process.

Working group chair and members develop SMPR through a series of meetings.

SMPR

AOAC staff will post draft SMPRs to the AOAC website.

Development

Collect and compile comments.

Working group chair addresses comments.

Process

Approval process / voting

Staff works with working group chair to prepare SMPR for publication.

• Chemistry & microbiology • Quantitative & qualitative • Definitions • Evaluation recommendations • Expected results • Informative sections

Appendix F Covers:

Funding Policy

Objectives

• AOAC does not accept funding from any organization involved in the

• Facilitate a forum where the science of cannabis analysis is discussed with

cultivation, manufacture, distribution or possession of cannabis as

scientific experts.

long as it is federally illegal in the US.

• Facilitate the development and publication of cannabis and hemp-specific

methods and standards.

• AOAC does not advocate for or against the use or legalization of

•

Identify cannabis and hemp reference materials.

cannabis.

• Establish a cannabis and hemp proficiency testing program in accord with

• Our mission is consistent with ensuring public health and food safety

International Standards

by facilitating the development of methods for testing cannabis in

• Provide analytical and laboratory management training

food, feed or other substances of interest to determine the

best available science to promote public health.

• Provide resources and education to regulators responsible for establishing

rules and laws around cannabis and hemp.

• Fund provided by the analytical community consisting of testing

laboratories, technology providers, test kit companies, and other

associations.

SMPRs Developed: 2017 - 2022

SMPR 2018.011: Identification and

SMPR 2017.001: Quantitation of Cannabinoids in Cannabis Concentrates

SMPR 2017.002: Quantitation of Cannabinoids in Dried Plant Materials

SMPR 2017.019: Quantitation of Cannabinoids in Edible Chocolate

SMPR 2019.001: Detection of Aspergillus in Cannabis and Cannabis Products

Quantitation of Selected Pesticide Residues in Dried Cannabis Materials

SMPR 2019.002: Identification and Quantitation of Selected Residual Solvents in Cannabis Derived Materials

SMPR 2019.003: Quantitation of Cannabinoids in Plant Materials of Hemp (low THC varieties of Cannabis)

SMPR 2020.001: Determination of Heavy Metals in a Variety of Cannabis and Cannabis Derived Products

SMPR 2020.012: Detection of Shiga Toxin Producing Escherichia coli in Cannabis and Cannabis Products

SMPR 2020.013: Mycotoxin Screening Technique in Cannabis Plant Material and Derivatives

SMPR 2022.XXX Cannabinoids in Beverages

SMPR 2022.XXX Heavy Metals in Beverages

SMPR 2021.010: Quantitative Mycotoxins

SMPR 2021.009: Total Yeast and Mold

Find them all at: https://tinyurl.com/caspsmprs

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

• AOAC OMA 2018.10 Cannabinoids in Dried Flowers and Oil

• AOAC OMA: Method for the Quantification of Cannabinoids in Edible Chocolate by High-Pressure Liquid Chromatography: Single Laboratory Validation*

• AOAC OMA: Quantitating Cannabinoids in Edible Chocolates Liquid Chromatographic Separation with Photodiode Array Detection*

• AOAC OMA 2021.03: Determination of Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products

• Matrix Extensions of OMA 997.02, OMA 2002.11, and 2018.02* for Total Yeast and Mold in Cannabis

* Publication pending

CASP Methods Approved as of March 16, 2022

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)

Other Subgroups

•

Dr. Brent (Walter) Wilson

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

• Technical requirements for the following potential PT programs have been determined:

Cannabinoids

Pesticide Residues  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

•

 Terpenes  Heavy Metals  Mycotoxins  Residual Solvents

• The Microbial Contaminants Subgroup met on 4-30-21 o The meeting was well attended, and members provided excellent feedback on technical recommendations

Questions about the PT Working Group? Contact Shane Flynn, Director of PT at CASP_PT_WG@aoac.org

Ballot for Cannabinoids in Beverages

Ballot for Heavy Metals in Beverages

Coming Soon…

Comment Periods: Residual Solvents in Beverages , Micro Validation Guidelines

Mid-year meeting

• Live Vote on Cannabis Microbial Validation Guidelines • Live Vote on Cannabis Drying Guidance Document

New Calls for Method

• •

Cannabinoids in Cannabis Beverages Heavy Metals in Cannabis Beverages

CASP Advisory Panel

CASP

Microbial Working Group

Chemistry Working Group

Proficiency Testing

Training Development

Community

Conformity Assessment

{ AOAC Staff & CASP Science Advisor }

CASP Community • This is you!

• All are invited to semi-annual in person CASP meetings.

• Consists of all members of the working groups, advisory panel, expert review panels and anyone who has signed up for the CASP mailing list.

• How we communicate our offerings to the community AND where we source our experts for the various working groups, ERPs, training sessions, etc.

If you want to join ONLY the CASP Community, visit http://tinyurl.com/CASPAOAC and select “mailing list only” OR the working group(s) you would like to join.

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

• Staff contact is Alicia Meiklejohn, Director of Business Development, ameiklejohn@aoac.org.

Affiliate • Horiba • CEM Corporation • Hygiena • Canopy Growth • Q Laboratories • Medicinal Genomics • Antylia • PSI Labs • Meter Group

Pioneer • AFDO • SōRSE Technology • Millipore Sigma • Deibel Bioscience

Partner • Eurofins

CASP Advisory Panel Members

Government • MD Department of Agriculture • University of CA, San Diego

Want to join the Advisory Panel and set next year’s priorities? Contact Alicia Meiklejohn, Director, Governance and Business Development, ameiklejohn@aoac.org

2022 Survey Results

• Complete 2021 Projects (on or around MYM 2022)

•

Micro Validation Guidance

•

Drying Guidance Document

•

Beverages

Confirmed 2022 Workplan

• Standards Dev Groups Commence 2022 Workplan

•

Microbial Contamination of Edibles

•

Cannabis Containing

•

(a) Dietary Supplements

•

(b) Hempseed Oil

• Training Dev Group will develop training sessions around the following

themes:

•

Testing Cannabis Beverages

•

Validation of Cannabis Testing Methods

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.

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

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.

Working Groups: Training Development

• 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.

CASP Conformity Assessment • Three Expert Review Panels (ERPs) for CASP:

• Variety of Potential Method Submissions • Cannabinoids

• Cannabinoids ERP, Chair: Melissa Phillips, NIST

• Pesticides

• Chemical Contaminants ERP, Chair: Andrew Pham, Epic Labs • Microbial Contaminants ERP, Chair: Julia Bramante, Colorado Dept. of Public Health and Environment

• Residual Solvents

• Salmonella

• Aspergillus

• See them all at www.aoac.org

Recent Meetings:

Upcoming Meetings: March 30, 2022: Total Yeast and Mold Matrix Extension TBD June, 2022: Quantitative Mycotoxins (new method)

April 28, 2021: Cannabinoids ERP, two methods approved August 3, 2021: Chemical Contaminants ERP, one method approved August 5, 2021: Microbial Contaminants ERP, two matrix extensions approved December 14, 2021: Microbial Contaminants ERP, one method approved December 15, 2021: Cannabinoids ERP, reviewed but not approved

Open Calls for Methods

• Details at www.aoac.org

New Call for Methods!

Thank you, CASP Community!

Scott Coates Program Lead Effective March 16

Allison Baker Coordinator, Science Programs

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

AOAC CASP Staff

• Deborah McKenzie • Alicia Meiklejohn

• Katie Bergmann • Shane Flynn • Dawn Frazier • Jonathan Goodwin

• Palmer Orlandi • David Schmidt

So long!

www.linkedin.com/in/christopher-james-dent

www.facebook.com/christopher.j.dent

The Changing Regulatory Landscape

Susan Audino, PhD Science Advisor, AOAC CASP Susan.Audino@gmail.com

A Jump Back in Time

TEAM CANNABIS: Cynthia Ludwig

– AOCS

Holly Johnson Seth Wong John MacKay

– Alkemist Labs – TEQ Analytics – Waters Corp.

Roger Brauninger – A2LA

• Medical Patients ~ 1.5 to 2M • Adults • Muscle spasms caused by multiple sclerosis • Glaucoma • Anemia caused by chronic illness such as HIV • Crohn’s Disease • Psychiatric Disorders including PTSD

• Children

• Seizure Disorders • Attention Deficit Disorder • Autism

• Recreational Users

MAP OF MARIJUANA LEGALITY BY STATE | DISA Updated February 2022

• 2015

• Each state self ‐ regulated • A flurry of activities with non ‐ profit and other advocacy groups began to emerge • Accreditation Bodies began increased awareness and realized cannabis testing would become a staple • Major conferences for cannabis related businesses • CANNRA formed in November 2020 • Advocacy groups continue; some have merged • Accreditation Bodies have specialized “cannabis” assessors • Major conferences for cannabis related businesses, the scientific community , and international publications.

Progress

• 2022

Another Jump Back in Time

2017 • 5 states do not require independent testing • 4 states “may” include testing, but nothing strict • About 10 states ambitious require testing • 5 states require testing and require labs be ISO/IEC 17025 accredited • 1 state requires TNI accreditation • 1 state requires testing by DEA authorized/certified laboratory • At least 5 states currently require testing as outlined in the AHP Monograph … or better 2022 • 10 states do not require independent testing • 29 states have rigorous requirements for testing • Some states “recommend” but do not require testing

Requirements for Testing: Then and Now

• MYM: Stakeholder Panel for Strategic Food Analytical Methods • Starting Advisory Panel: • SPEX • SCIEX • SC Labs • GW Pharmaceuticals (now Jazz Pharmaceuticals) • Sigma Aldrich • CEM

2017: AOAC takes action

Develop 2 SMPRs

• Determine potency of defined cannabinoids in select food matrices • Determine residual pesticide residues in dry plant materials

GOAL in 2017

Launched in 2019 * Advisory Panel Growth

• Expand response to laboratory needs for sound scientific methods • Provide bridge between science & scientists and regulations & regulatory bodies

SMPRs Developed: 2017 ‐ 2021