AOAC CASP Meeting Minutes, September 7 2019

AOAC Cannabis Analytical Science Program Second Meeting: Denver, Colorado

September 7, 2019, 9:00 a.m. – 5:00 p.m. MT Meeting Minutes

I.

Welcome and Introductions

Coates welcomed all and explained the purpose of the meeting: to approve three new sets of AOAC Standard Method Performance Requirements ® for cannabis and to discuss other emerging issues in the industry. Coates congratulated all staff and volunteers for bringing the program to this point. AOAC invited participants to review the meeting book. 1 Program Overview – Scott Coates, AOAC Coates then reviewed the CASP program. He highlighted the four pre-existing AOAC Cannabis SMPRs (AOAC SMPRs 2017.001, 2017.002, 2017.019 and 2018.011) and the two AOAC Cannabis Official Methods of Analysis (AOAC 2018.10 & AOAC 2018.11) all of which were developed prior to the start of the CASP program. The interest in these projects led to AOAC’s development of a full- time, dedicated program for cannabis analytical science, CASP, in late 2018. CASP’s objectives are to facilitate a forum for discussions on cannabis analysis, facilitate the development and publication of cannabis and hemp-specific methods and standards, identify cannabis and hemp reference standards, establish a cannabis and hemp proficiency testing program in accord with international standards, provide analytical lab management training, to provide resources and education to regulators, and more as the community requires. He went on to review CASP’s current working groups – microbial contaminants, chemical contaminants, and cannabinoid content. He also reviewed the structure of the program, with an advisory panel of CASP members overseeing the program’s direction. He concluded with a summary of CASP’s next steps, including working group meetings, expert review panels and future CASP meetings. III. Consensus Building at AOAC INTERNATIONAL – Deborah McKenzie, AOAC McKenzie then gave a brief presentation on consensus building and standards development at AOAC INTERNATIONAL. She explained that the working group chairs will discuss their final draft standards and open the room to deliberation. Final revisions are captured in real time, on screen, and a motion will then be made to adopt the standard. For the first AOAC will conduct real time online voting, which will allow for wider participation and greater anonymity. This process was demonstrated for the group. McKenzie concluded by stating that the meeting and its outcomes will be carefully documented and reviewing the roles and responsibilities of the various groups. II.

IV. Report from the Microbial Contaminants Working Group – Pat Bird & Julia Bramante, Co-Chairs

1 September 7, 2019 AOAC CASP Meeting Book: https://griegler-aoac-org.cld.bz/AOAC-CASP-Meeting . All presentations referenced in this document are available in the meeting book.

AOAC CASP Meeting Minutes, September 7, 2019

Standard Method Performance Requirements

Bird and Bramante led a discussion on the activities of the CASP Microbial Contaminants Working Group. They reviewed the group’s membership, all work to date, and the SMPR. The SMPR’s applicability is for “candidate methods used to detect Aspergillus ( Apergillus niger, Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus ) in cannabis (plants/flowers) and/or cannabis products (concentrates, infused edibles and infused non-edibles). Candidate methods may be validated for specific matrices, categories or broader claims.” All comments submitted for this draft SMPR have been addressed.

MOTION to approve the Standard Method Performance Requirements ® (SMPRs) for Detection of Aspergillus in Cannabis and Cannabis Products (Bramante / Hom)

67 in favor, 1 opposed, 13 abstentions. The motion carried.

Bird and Bramante then led a discussion on their working groups’ recommendations for training and education. They stated that, aside from standards, education is one thing that is missing in this industry. They proposed a training module, “Microbiology and Cannabis Testing Facilities.” This module would include an overview of microbiology issues in the cannabis industry, a discussion of best practices in testing cannabis, validation and verification of testing methods, and general microbiology guidance for cannabis laboratories. Coates explained that this will be discussed with the AOAC CASP advisory panel and participants will be advised of next steps. Audino led a discussion on the activities of the CASP Chemical Contaminants Working Group. She reviewed the group’s membership, all work to date, and the SMPR. The SMPR’s applicability is for a “method or suite of methods to identify and quantify selected residual solvents in cannabis derivatives.” Audino reviewed and addressed all comments that had been submitted. MOTION to accept the Standard Method Performance Requirements ® (SMPR ® ) for Identification and Quantitation of Selected Residual Solvents in Dried Cannabis Materials as presented. (Audino / Krogull). Discussion followed this motion. A participant stated that the title should be changed to Identification and Quantitation of Selected Residual Solvents in Cannabis Derived Materials. There were no objections and this change was made. Another participant stated that the level for methanol should be 12,000 rather than 1200 and this was also corrected in real time. A participant asked if this could be applied to hemp and Audino responded that the intent was for this SMPR to be used on cannabis, but it could easily be adapted and referenced by the hemp industry. Report from the Chemical Contaminants Working Group – Susan Audino, Chair

V.

Audino then returned to the motion and called the question: 76 in favor, 6 opposed, 7 abstentions. The motion carried.

AOAC CASP Meeting Minutes, September 7, 2019

Audino stated she would like to take a few minutes to hear from the group where they think the working group should go with training and education, on the regulatory level, laboratory level and on an industry level? Educational pieces on solvents in vaporized products, pathogens in finished products and pesticide residues were all recommended. Audino encouraged anyone who did not have a chance to speak to email her at susan.audino@gmail.com

VI. Report from the Cannabinoids in Consumables Working Group – Holly Johnson, AHPA

Johnson led a discussion on the activities of the CASP Cannabinoids in Consumables Working Group. She reviewed the group’s membership, all work to date, and the SMPR. The SMPR’s applicability is for a “method will be able to identify and quantify individual cannabinoids (as listed in Table 1a and Table 1b) in plant materials expressed on a dry weight basis. The method must be able to report total THC regardless of how it is measured (total THC as defined in this SMPR).” Johnson then reviewed and addressed all comments that had been submitted.

MOTION to approve the Quantitation of cannabinoids in plant materials of hemp (low THC varieties Cannabis sp.) (Johnson / Brown)

76 in favor, 9 opposed, 3 abstentions. The motion carried.

Johnson followed up by stating her working group’s proposals for moving forward: an SMPR for moisture determination, as well as training on verification procedures, matrix extensions, and basic statistics (for reporting results, calculating confidence intervals, and measuring uncertainty).

VII. Challenges in Chemical Contaminant Testing and APHLs Cannabis Community of Practice- Heather Krug, Colorado Dept of Public Health & Environment

Krug provided a presentation on the challenges in chemical contaminant testing and on APHL’s “Cannabis Community of Practice.” She reviewed CDPHE lab roles, Colorado’s testing requirements, pesticide use on cannabis and Colorado’s pesticide list, and the implementation of pesticide testing. She explained that state cannabis regulatory bodies are using different approaches, but all face similar challenges: few standard methods, a lack of data, and varied legislative requirements. She then reviewed current cannabis activities at the Association of Public Health Laboratories (APHL). APHL has created an online community for discussing cannabis science. They have regular conference calls including guest speakers and provide an opportunity for callers to get state updates on their cannabis laboratory related activities. They also share announcements of meeting and provide a forum for communication among labs. She said APHL is always looking for new speakers for these calls and to contact her if interested.

VIII.

Testing CBD Products for Safety and Quality – Toby Astill, PerkinElmer

Astill gave a presentation on testing CBD projects. He started by addressing claims and misconceptions about CBD. Then, he discussed the lifecycle of CBD, from cultivation to final

AOAC CASP Meeting Minutes, September 7, 2019

product. He discussed laboratory challenges, the chemistry of hemp, different types of CBD products, testing CBD for THC, and testing CBD for pesticides and heavy metals. He summarized that there is an evolving regulatory landscape for hemp-based CBD, that it is a difficult matrix to test. He concluded that he and his organization are excited to work with AOAC to drive this science and methodology forward.

IX. Responsible Microbial Testing Policy in Cannabis: Challenges and Future Outlook – Ben Katchman, PathogenDx

Katchman provided a presentation on responsible microbial testing in cannabis. He reviewed the current regulatory challenges in with validation, rapid change, collaboration and evidence-based regulations. He went on to discuss challenges for assay designers and laboratories, including standardized testing materials, method verification, validation, education and training. He said there is a lack of agreement among states on what should be tested, and further collaboration and discussions will be needed to standardize the industry in the future.

X. The Present and Future of Cannabis, Hemp and CBD Market – Roy Bingham, BDS Analytics

Bingham gave a presentation on the state of the market. He reviewed the global cannabis market scale, the US cannabis market scale, product category development (flower, concentrates, edibles, pre-rolls, topicals, and others). He explained that concentrates have been the primary engine of growth in the major legal cannabis states, with vape products reaching approximately 50% of those sales. He then did a review of hemp-derived CBD and explained that consumer attitudes are changing with 15% of all US adults having now consumed hemp-derived products. Large gaps in consumer education exist, with the majority of people surveyed incorrectly believing that CBD and THC produce the same effects, although this number is shrinking as CBD becomes more mainstream. He concluded his presentation by explaining that CBD will continue to have significant sales across many categories.

XI. IFT’s Role Regarding Cannabis as a Food and Beverage Ingredient – Rosetta Newsome, Institute of Food Technologists

Newsome started by reviewing the mission of the Institute of Food Technologists (IFT), which is “to advance the science of food and its application across the global food system.” She reviewed IFT provided opportunities for the cannabis industry, including interest groups webcasts, courses and other events. She said the IFT’s objective is to ensure science is at the forefront of the safe production and legal consumption of foods and beverages containing cannabis. She concluded by discussing potential activities to continue this work, including reporting, meeting/convening, and engaging with partner organizations to advance the science.

XII.

2020 Work Plan Proposal

Coates thanked all speakers for their contributions and then presented the AOAC CASP 2020 Work Plan, in particular the scope of work, enrollment, performance tested methods, Official Methods of

AOAC CASP Meeting Minutes, September 7, 2019

Analysis , outreach, education, and training. Coates highlighted that now that there are approved SMPRs, AOAC will soon issue a call for methods. Submitted methods will be reviewed against the SMPR by a volunteer Expert Review Panel (ERP) and those that meet the requirements will be adopted as First Action OMAs. He also highlighted that AOAC is hoping to retain its existing sponsors and add at least ten new sponsors at the ‘pioneer’ level.

XIII.

Wrap Up

Coates summarized what had been accomplished at this session: three SMPRs were approved using a new voting format, recommendations for training on statistics, presentation of data, and other areas were put forward, and industry experts provided the community with updates in their respective areas. Coates thanked all for their attendance and the meeting adjourned at approximately 5:00pm MT. Attachments • All attachments available in the meeting book: https://griegler-aoac-org.cld.bz/AOAC-CASP-Meeting .

AOAC CASP Meeting Minutes, September 7, 2019

Addendum: Attendees (for all or part of the meeting):

Kristie Adams, Steelyard Analytics, Inc. Samantha Adams, Agilent Technologies Peter Alden, Waters Corporation Cristina Amarillas, Traditional Medicinals

Gabriel Giancaspro, USP Tetsu Goto, CSCJP Teresa Grant, NCDA Cathy Halverson, TTB

Toby Astill, Perkinelmer

Michael Halvorson, AGS Scientific Scott Hansen, Botanacor Laboratories

Gisele Atkinson, Council for Responsible Nutrition

Ryan Hayward, Supra Research and Development

Susan Audino, Audino & Associates

Dirk Hoegaerts, Agilent Technologies Inc.

Charles Barber, NIST

Sherman Hom, NJ Dept of Health Public Health and Environmental Laboratories

Carly Barone, Bia Diagnostics

Daniel Hughes, MCR Laboratories Rosemarie Ilic, Crossroad Ingredients Dorota Inerowicz, Purdue University Laurent Jain, Bio-Rad Laboratories Srinivas Jayanthi, Biotech Pharmacal Inc.

Brian Beck, Microbiologics DeAnn Benesh, 3M Food Safety

Claudia Bensley, Mondelēz International Patrick Bird, PMB BioTek Consulting Kirsten Blake, Emerald Scientific Joe Boison, Independent Consultant

Justyce Jedlicka, MilliporeSigma

Holly E Johnson, American Herbal Products Association Solomon Kariuki, University of Kentucky Division of Regulatory Services

David Bolliet, Kalsec

Julia Bramante, Colorado Dept. of Public Health and Environment Mark Britton, Illinois Department of Agriculture

Jason Kircos, Neogen

Vandana Kothari, CV Sciences Julie Kowalski, Trace Analytics Scott Krepich, Phenomenex

Paula Brown, BCIT Oscar Cabrices, SCIEX

Congmei Cao, Herbalife Nutrition

Mary Kay Krogull, Eurofins Scientific, Inc.

Candice Cashman, CEM Melissa Chandler, UCT

Kelsey Kropp, CDPHE

Heather Krug, Colorado Dept. of Public Health and Environment

Henry Chin

Adam Kuszak, NIH

France Cho, Bureau Veritas Laboratories

Quynh-Nhi Le, Neogen Corporation

Robert Clifford, Shimadzu Demeseh Cobb, USDA

John Lee, Agilent

Eva Lynch, Rock River Laboratory/Eva Lynch

Dan Denney, Ataraxis Biosciences

Steven Dentali, Dentali Botanical Sciences

Zahra Marin, Sorse Technology

Mary McBride McBride, Agilent technologies

Carrie Despotovich, USDA

Daniel McMillan, Sciex Josh Messerly, Eurofins

Jonathan DeVries, DeVries & Associates Luke Emerson-Mason, Bia Diagnostics Luis Fernandez, Toxicological Centre -CETOX Chris Fields, Applied Food Sciences inc.

Garegin Mikaelian, Wyckoff Farms, Inc.

Jesse Miller, NSF

Deepali Mohindra, Thermo

Kellan Finney, 8th Rev

Maria Monagas, USP

Evan Friedmann, Hellma USA INC Ruben Garnica, Agilent Technologies

Pranav Nagarnaik, Qualichem Laboratories

Eduardo Nascimento, Bruker Sidney Sudberg, Alkemist Labs Alan Sutton, GW Pharmaceuticals

Steven Gendel, FCC

Dipankar Ghosh, Thermo Fisher Scientific

Jeffrey Nauseda, bioMerieux, Inc

AOAC CASP Meeting Minutes, September 7, 2019

Hiroko Suzuki, Japan food research labolatory

Rosie Newsome, IFT

Lei Tang, FDA/ Center for Veterinary Medicine

Hong Nguyen, Transmed

Yijin Tang, Applied Food Science

Gary Niehaus, Crystal diagnostics

Matthew Noestheden, Supra Research and Development

Oliver Tasevski, CDPHE/LSD

Melissa Nutter, Titan Analytical

Mark Tess, Charm Sciences

Rob O’Brien, Supra Research and Development

Marina Torres, LATU

Judith Tran, Millipore Sigma

Sean Orlowicz, Phenomenex

Fiona Tymm, British Columbia Institute of Technology Jeffrey Vanderiet, Canadian Food Inspection Agency

Klaus Reif, PhytoLab GmbH & CO. KG

Wenhua Ren, CDPHE Catherine Rimmer, NIST

Eric Verdon, Anses

Ping W, OISC

Shauna Roman, Capstone Nutrition

Alison Wakeham, Mologic Matthew Ward, CDPHE

Yvonne Salfinger, AFDO

Jennifer Sanderson, Agilent Technologies

Nandakumara Sarma, USP Charles Schmidt, PerkinElmer Tom Seipelt, Abbott Nutrition Rachel Shegog, SōRSE Technology

Jennifer Watson, MilliporeSigma Landon Wiest, Restek Corporation

Walter Wilson, NIST Paul Winkler, SCIEX

Neil Shepherd, NATA Mei Shotts, Abbott Casey Simmons, Hygiena

Seth Wong, TEQ Analytical Labs

Curtis Wood, ERA Laura Wood, NIST

Jessica Wurtz, Midwest Laboratories Philip Wylie, Agilent technologies

Michelle Sipe, USDA AMS S&T LATD NSL

Jeremy Slade, Reckitt Benckiser Aniko Solyom, GAAS Analytical Randal Stahl, Stahl Analytics Brad Stawick, SGS North America Kathy Stenerson, Milliporesigma

Kenny Xie, USP

Hong You, Eurofins

Jessa Youngblood, Hardy Diagnostics

Ning Zhang, USP

Lei Zhang, Alta Scientific

Jose Suarez Martinez, Neogen Coporation Yacine Merabtine, Certified Laboratories

AOAC Staff:

Scott Coates, Christopher Dent, Arlene Fox, Dawn Frazier, Jonathan Goodwin, Deborah McKenzie, Marida Hines, Nora Marshall, Alicia Meiklejohn, Tien Milor, Maria Nelson, La’Kia Phillips, David Schmidt

AOAC CASP Meeting Minutes, September 7, 2019