AOAC CASP Meeting Minutes, March 2020

AOAC Cannabis Analytical Science Program AOAC Mid-Year Meeting 2020

March 11, 2020, 8:00 a.m. – 2:00 p.m. ET Meeting Minutes

Attendees (for all or part of the meeting):

Susan Carly

Audino Barone

Audino & Associates

Jovan Elaine

Lubardic Marley McGuill Mendez Mindak Mirzoian Monagas Meinhardt

NSF International R-Biopharm Rhone

Bia Diagnostics

Julie

Blackwell Blakemore

Eurofins Soar labs

Charles Patricia Vanesa Armen Maria Maria Karau Bill

Hygiena

Tammy

R-Biopharm Inc.

Joe

Boison

EJ Consultancy

Randox Food Diagnostics

Julia

Bramante

CDPHE 1 Waters US FDA 3

Mindak Professional Services, LLC

Emily

Britton

US TTB 2

Jennifer Virginia Candice Melissa

Brzezinski

US Pharmacopoeia

Burkel

Independent

Monks Muriira Myoda Otten Pawar Phillips Phinney Oh

Caulder Chandler

CEM Corporation

Kenya Bureau of Standards

UCT

Sam

IEH Laboratories

Mike Nisha Pearl Sarah Devin

Clark

Bio-Rad Hygiena

Laura

USDA 4

Corrigan

Matthew

Oregon CBD

D’Cruz Dalton Darrell

PEARL Consulting LLC

Rahul

US FDA

EY

Melissa Curtis Cezary Schuyler

NIST 5

CEM Corporation

Curtis S. Phinney, CNS R-Biopharm Rhone

Catherine Dasenbrock

US FDA

Poplawski

Pearl

Dcruz

PEARL Consulting LLC Ataraxis Biosciences

Pruyn Quinn Reedy

US FDA

Dan

Denney

Dan

Thermo Fisher Scientific

Carrie

Despotovich

USDA

Savannah

Atlantic Test Labs

Arne Luke

Duebecke Emerson

Tcf2

Kate Scott

Rimmer

NIST

Bia Diagnostics

Robertson

ATL

Carlos Mark Tetsu

Galera

Hygiena Diagnóstica Sentient Technologies

Manuela

Rosenberger Tentamus

Goldschmidt

Alterra

Sanchez

University of Maryland

Goto Gray

CSC JP

Nandakumara Sarma

US Pharmacopoeia SōRSE Technology

Luke Chris Scott

Neogen

Rachel Victoria

Shegog

Gunning Hansen Haynes Helbert Helsius

A2LA

Siegel Smith

Eurofins CAL USDA, AMS

Botanacor Laboratories

Kerry

Ian

That Consulting

Angela

Smith Henry Agilent Technologies

Yvonne

Medicinal Genomics Neogen Corporation

Vanessa

Snyder Solyom Srigley

Eurofins

Jeremiah

Aniko

GAAS Analytical

Sunee

Himathongkham FDA

Cynthia

US FDA Eurofins

Shannon

Hoffman

Green Analytics

Jeff

Stassi

Predecisional Draft, Do Not Distribute 1 Colorado Department of Public Health and Environment 2 United States Tax and Trade Bureau 3 United States Food and Drug Administration 4 United States Department of Agriculture 5 National Institute for Standards and Technology

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Holly

Johnson Johnson Joseph

AHPA 6

Kathy

Stenerson

MilliporeSigma

Ron

bioMérieux

Benjamin

Strong Sullivan Szpylka Thomas Travis Tucker Watson Wilson Wong Zhang Waye Tang

Neogen Corporation

George James

AsureQuality New Zealand

Darryl

Eurofins

Jursich

Centera Bioscience

John Yijin

Consultant

Julie

Kowalski

Consultant

Applied Food Science Scientific Solutions

Mary Kay Krogull

Eurofins Scientific Inc.

Robert

Markus

Lacorn Lasater

R-Biopharm AG

John Larry

NSF International MetrohmUSA Caliper Foods Health Canada

Matt

Relief x laboratories

Neogen

Daniel

Quynh-Nhi Le

William Michael

Lipps

Shimadzu

Andrew

Loewenstein

Q Laboratories

Walter Brent

NIST

Seth Hao

TEQ Analytical Labs Canalyte Laboratories

AOAC Staff and Technical Consultants:

Patrick Bird (Technical Consultant), Scott Coates, Christopher Dent, Alicia Meiklejohn, Nora Marshall, David Schmidt

Meeting Minutes:

I.

Welcome and Introductions

Schmidt thanked all for attending the third meeting of AOAC’s Cannabis Analytical Science Program and invited all to sign into the meeting to access the meeting materials.

II.

Program Review – Scott Coates, AOAC

Coates begin by thanking the AOAC CASP members who make the program possible. He reviewed the current CASP structure, including all working groups and projects. He explained that the three active working groups, Cannabinoids, Chemical Contaminants, and Microbial Contaminants, have all been working on new SMPRs since the last CASP Meeting in Denver. The Cannabinoids in Consumables working group had an initial focus on cannabinoids in hemp plant materials, and that SMPR has been published. The chemical contaminants working group has developed and published an SMPR for residual solvents in cannabis and issued a call for methods. They have now developed a draft SMPR for heavy metals in cannabis. The Microbial Contaminants Working Group has developed an SMPR for detection of Aspergillus in cannabis and has now developed a draft SMPR for detection of Salmonella in cannabis. Coates further advised that the CASP training and education working group will launch soon, with Toby Astill of PerkinElmer set to chair that group. A proficiency testing working group will also start this spring.

III.

Consensus Building at AOAC INTERNATIONAL – Chris Dent, AOAC

6 American Herbal Products Association

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Dent provided a presentation on behalf of Deborah McKenzie who was unable to attend. He reviewed AOAC’s products and services, including Standards and Methods Development, Proficiency Testing Services, Publications, and Official Methods o Analysis and Performance Tested Methods. He explained that the basic principles of AOAC’s programs are transparency, openness, balanced interests, due process, consensus, and appeals. Examples include performance requirements, guidelines, sampling standards, methods of analysis, best practices, operational documents. AOAC achieves this through targeted communication, invitations to subject matter experts, email blasts, participation in meetings, association news, public comment periods and public hearings. He then reviewed the past year’s timeline of the CASP program’s standard development activity, which included development of three (3) new SMPRs by the three (3) working groups, which would be put forward to the group later during this meeting. Dent also advised that there were not enough CASP participants present at this meeting to constitute a quorum so the votes today will be simply to recommend SMPRs be moved forward to an e-ballot, which will be sent to the entire CASP community. Update on the USDA Domestic Hemp Program – Kerry Smith, USDA AMS Smith provided a presentation on the USDA Domestic Hemp Production Program. She described the mission of the USDA Agricultural Marketing Service – to facilitate the marketing of U.S. agriculture products while ensuring fair trading practices and promoting a competitive and efficient marketplace to the benefit of producers, traders and consumers of U.S. food. The U.S. Domestic Hemp Production Program is part of their Specialty Crops Program. She advised that the 2018 Farm Bill removed industrial hemp from the controlled substances act and directed USDA to develop a domestic production program and establish a federal plan for producers. She explained that the interim final rule (IFR) was published in 2019 and the comment period was extended to January 2020 to allow the USDA to get input on the rule. Key provisions of the IFR are procedures for tracking where hemp is grown, procedures for testing total THC, procedures for disposal of plants, and compliance provisions. The IFR also includes sampling provisions and testing provisions. Next steps will be for USDA to approve state and tribal plans, review applications from producers, develop a system to share information with law enforcement, and to process comments submitted to IFR. Further, the comment period will be reopened after the 1 st growing season to ask what has been learned and how things can be improved. Smith then reviewed the analytical challenges involved, such as calculation on a dry weight basis, standardization of sample processing, what other methods besides LC and GC may be useful, what constitutes a ‘representative’ sample and how to clearly define total THC. In conclusion she emphasized that the USDA AMS is eager to receive input from the community by way of expertise and general feedback. Attendees were advised to visit ams.usda.gov/rules-regulations/hemp or to email farmbill.hemp@usda.gov with questions. During a follow up discussion the following issues were addressed: the need for reference materials and/or proficiency testing materials, the need for resolution over the ‘conversion factor’ issue, guidance required regarding the use of proficiency testing programs, and a request on clarity of language regarding the definition of THC then talking about concentrations of THCA and Δ - 9 -THC versus total THC.

IV.

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V. Report from the Microbial Contaminants Working Group, Julie Bramante, CDPHE

Bramante provided a presentation on the work of the Microbial Contaminant Working Group. Since the last CASP meeting this group met ix times by teleconference and drafted one SMPR, Standard Method Performance Requirements for Detection of Salmonella in Cannabis and Cannabis Products. She gave an overview on Salmonella species, reviewed definitions used in the SMPR, the SMPR method performance requirements, and the comments that were received. Several questions were taken – one participant asked if the SMPR included guidance on sampling, Bramante replied that it did not but that may be another SMPR in the future. Another participant if this is measured in CFU per gram and Bramante replied that it is not quantitative, just presence or absence, and one other participant highlighted a minor error, that the SMPR says “mass spectroscopy” and that should be “mass spectrometry” and Bramante stated that will be fixed before publication. AOAC staff asked if there was anyone present who was opposed to moving this forward for balloting and there was not. Audino started by congratulating Julie Kowalski and Julia Bramante for recently being listed among the 20 most influential people in cannabis science. 7 She added that she is now the science advisor for the overall AOAC CASP program, and that Kowalski has now taken over as Chair of this working group. She then provided a presentation on the work of the Chemical Contaminant Working Group since the last CASP meeting. She thanked working group members and highlighted that this has been the largest working group in AOAC’s history and gave a special thank you to Mike Halvorson, Monica San Miguel, and AOAC Staff. There were five (5) teleconferences for this working group since the last CASP meeting and one SMPR has been developed, Determination of Heavy Metals in a Variety of Cannabis and Cannabis Derived Products. She then gave an overview of heavy metals, regulatory schemes, and the method performance requirements from the SMPR. The SMPR’s required analytes are arsenic, cadmium, mercury and lead, but other metals may be included optionally. After reviewing the comments Audino asked if there was any opposition to moving this SMPR to a ballot and there was none. Kowalski then provided an update on the work of this group since she assumed the Chair position, which has been focused on development of an SMPR for mycotoxins. The working group has already had one (1) call to discuss the topic of mycotoxins. On January 28 the group discussed analytes and matrices as well as a need for consolidated information. The group is considering development of two (2) SMPRs – a screening/’semi-quant’ SMPR as well as a quantitative SMPR. She explained that mycotoxins are toxic metabolites of fungi, and that the SMPRs will look at total aflatoxins and ochratoxin A at a minimum. The matrices will include flower, concentrate products and finished products. The group will next work to consolidate information per state for the USA, Canada and other countries on analytes, reporting individual or total aflatoxins, maximum residue limits and requested matrices. The next telecon of this group will be held in a few weeks and Kowalski encouraged members of the group to contact her (JAKScience@outlook.com) and AOAC staff member Dent (cdent@aoac.org) if they are interested in participating. VI. Report from the Chemical Contaminants Working Group – Susan Audino, Audino & Associates

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

Johnson joined remotely to provide a presentation on the work of the Cannabinoids in Consumables Working Group. She began by thanking the members of the working group, which is also one of AOAC’s largest, and reviewed the work competed by the group since the last CASP meeting. The group has held five (5) teleconferences and drafted one (1) SMPR, Determination of Moisture in Hemp and Cannabis Plant Materials. The applicability is determination of less than 15% moisture in dried, ground hemp and cannabis plant materials. She then reviewed parts of the 2018 Farm Bill, specifically the AMA definition of hemp: The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. She noted that the high-THC industry has no requirement for results on a dry weight basis and may report on an as-is basis, and that it is hypothesized that precision in total THC reporting may be influenced by moisture determination methods. She then reviewed the SMPR – the definitions, the performance requirements, validation guidance (which emphasized that precision data are critical to this SMPR), and the comments that have been submitted. The floor was then opened for discussion. Stakeholders suggested that this SMPR may only cover part of the problem, and a fully developed STOP starting with materials fresh from the field harvest all the way to reporting total THC on a dry weight basis is what is needed. In particular, instructions for dealing with the material before it gets to the 4-12% is what the community needs. The group discussed this and a vote on the SMPR was called, with only five (5) stakeholders in favor of moving this SMPR forward as it stands. The group agreed to send this SMPR back to the Cannabinoids in Consumables Working Group for further work before approval. Audino then gave a presentation on the new CASP Training & Education Working Group. She stated the objective of the working group: The Cannabis Analytical Science Program endeavors to provide opportunity and forum to share information within the scientific community, regulatory bodies, AOAC Stakeholders, and other general interested parties. Members of the working group will identify subject material, target audience(s), and delivery modality. General concepts would include consensus method development, basic analytical methodology, and operating a testing lab in a regulated environment. She reviewed target audiences, which will include AOAC stakeholders, regulators, and the broader cannabis scientific community; as well as training modalities, which may include webinars, short courses, classroom seminars, and hands on training. The next steps will be to continue to populate the working group with volunteers 8 , to solicit stakeholder feedback, and to have the working group prioritize subject matter that can VIII. Introduction to the Training & Education Working Group – Susan Audino, Audino & Associates

8 Working Group Sign Up Form - https://form.jotform.com/91005746932154

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reasonably be addressed in 2020 and 2021. Audino then opened the floor to discussion. Comments included:

• There are people with little experience doing analysis at the bench. They generate the data but do not necessarily understand what is going on. Basic instrumental technique training would help this. • There are chemists running microbiology tests who do not have the proper knowledge for that. Training on simple skills like pipetting and hands on training for wet chemistry and micro are needed. • To build confidence in the lab you need to look at the total solution, validation is not enough, proficiency and verification training are also needed. • The group could come up with white papers. • Soon there will be AOAC approved methods for this. A module on how to cross-validate and verify would be helpful so people do not have to start from the beginning. • Quality assurance people may not know what lab they should use, and that impacts the results. Demonstrate to QA people that this is a good lab. • Tools and knowledge: CASP could be a good resource for asking the lab the right questions – e.g., what does it mean to have a validated method? • Develop a quality manual, push more labs to have ISO 17025. • Mentorship program • Training and education for upper management so they can understand the value of having a good quality management system. • Quality Control best practices – independent data review is a problem. • More help with the manufactures and customers. They need more guidance to know what to look for if regulators conduct an audit. • Training on cannabis as a finished product – matrices include oils, edibles, flowers, all different applications of the same product. One lab may be trying to run all these tests and it is important for AOAC to start defining matrices for the community. • Even basic math and chemistry skills would be helpful – if people creating the data do not have these skills how can the community be confident in their data?

IX.

Discussion on Next Steps for CASP – Alicia Meiklejohn, AOAC

Meiklejohn thanked the speakers and reminded all attendees of the next steps for the CASP program. She said that the Microbial Contaminants Working Group will continue work on an SMPR for STEC, the Chemical Contaminants Working Group will continue work on an SMPR for mycotoxins, and the Cannabinoids in Consumables working group will revisit the moisture content SMPR before moving on to a discussion on an SMPR for hemp extracts. And the training and education working group will be formally launched within the next two months.

X.

Adjourn

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AOAC staff thanked all for their participation and the meeting adjourned at approximately 2:00pm ET.

Attachments:

All materials approved for release are available in the CASP Meeting Book: https://griegler-aoac- org.cld.bz/AOAC-CASP-Meeting-MYM-20201

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