aoac cannabis analytical science program inaugural meeting · nisha corrigan, hygena liberty...

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AOAC Cannabis Analytical Science Program Inaugural Meeting March 12, 2019, 1:00 p.m. – 5:00 p.m. ET Meeting Minutes Attendees (for all or part of the meeting): Justin Amesbury, Lazarus Naturals JP Khail Pasion, SPNCR 3 Toby Astill, PerkinElmer Sean Peschisolido, Bio-Rad Susan Audino, Audino & Associates Melissa Phillips, US NIST 6 Carly Barone, Bia Diagnostics Curtis Phinney, Curtis S. Phinney, CNS Brad Barrett, LECO Corporation Ashley Pierce, Consolidated Laboratory Services 1 Ryland Bates, Galbraith Laboratories Cezary Poplawski, R-Biopharm Tammy Blakemore, SORA Labs Kyle Putnam, Charm Sciences Francis Boero, Gavenum Joe Romano, Waters Corporation Emily Britton, Waters Corporation Yvonne Salfinger, AFDO 2 Robert Brodnick, Titan Analytical Andre Santos, Agilent Technologies Julie Brunkhorst, Trilogy Analytical Laboratory Nandakumara Sarma, US Pharmacopeia Jennifer Burgess, Scientialis Consulting Timothy Schnupp, Atlantic Test Labs Yanxuan Cai, US FDA 3 Tom Seipelt, Abbott Nutrition Bob Clifford, Shimadzu Mei Shotts, Abbott Nutrition Nisha Corrigan, Hygena Liberty Sibanda, Randox Laboratories Mathieu Dobois, Nestlé Victoria Seigel, Eurofins CAL Marcel de Vreeze, NEN 4 and ISO Frank Sikora, University of Kentucky Jonathan Draher, Abbott Nutrition Kelli Simon, US TTB 5 Anne Duebecke, Tentamus David Singer, GERSTEL Lauren Fleury, AsureQuality Lanny Smith, Vicam a Waters Business Chris Gunning, A2LA Brad Stawick, SGS North America Cathy Halverson, US TTB 5 Darryl Sullivan, Eurofins Scientific Hugh Hayes, US NIST 6 Hiroko Suzuki, Japan Food Research Laboratories Leslie Hoo Fung, ICENS 7 Mark Tess, Charm Sciences Greg Jaudzems, Nestlé Jeanice Thomas, US NIST 6 Holly Johnson, AHPA 8 Robert Thomas, Scientific Solutions James Jursich, Centera Bioscience Marina Torres, LATU 9 Solomon Kariuki, University of Kentucky Walter Wilson, US NIST 6 Joseph Konschnik, RESTEK Corporation Paul Winkler, SCIEX Vandana Kothari, CV Sciences Seth Wong, TEQ Analytical Laboratories Scott Krepich, Phenomenex Laura Wood, US NIST 6 Mary Krogull, Eurofins Tyler Yoon, Steep Hill Maryland Brittany Leffler, CEM Yuichi Yotsuyanagi, Shimadzu Frederick Li, IonSense Hong You, Eurofins JP Khail Pasion, SPNCR 3 Garrett Zielinski, Eurofins AOAC Staff: Scott Coates, Christopher Dent, Jonathan Goodwin, Alicia Meiklejohn, Tien Milor, Palmer Orlandi, David Schmidt 1 Virginia Division of Consolidated Laboratory Services 2 Association of Food and Drug Officials 3 US Food and Drug Administration 4 Netherlands Standardization Institute 5 US Tax and Trade Bureau 6 US National Institute of Standards and Technology 7 International Centre for Environmental and Nuclear Sciences 8 American Herbal Products Association 9 Laboratorio Tecnológico del Uruguay

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Page 1: AOAC Cannabis Analytical Science Program Inaugural Meeting · Nisha Corrigan, Hygena Liberty Sibanda, Randox Laboratories ... Greg Jaudzems, Nestlé Jeanice Thomas, US NIST . 6. Holly

AOAC Cannabis Analytical Science Program Inaugural Meeting March 12, 2019, 1:00 p.m. – 5:00 p.m. ET Meeting Minutes

Attendees (for all or part of the meeting):

Justin Amesbury, Lazarus Naturals JP Khail Pasion, SPNCR 3 Toby Astill, PerkinElmer Sean Peschisolido, Bio-Rad Susan Audino, Audino & Associates Melissa Phillips, US NIST6 Carly Barone, Bia Diagnostics Curtis Phinney, Curtis S. Phinney, CNS Brad Barrett, LECO Corporation Ashley Pierce, Consolidated Laboratory Services1 Ryland Bates, Galbraith Laboratories Cezary Poplawski, R-Biopharm Tammy Blakemore, SORA Labs Kyle Putnam, Charm Sciences Francis Boero, Gavenum Joe Romano, Waters Corporation Emily Britton, Waters Corporation Yvonne Salfinger, AFDO2 Robert Brodnick, Titan Analytical Andre Santos, Agilent Technologies Julie Brunkhorst, Trilogy Analytical Laboratory Nandakumara Sarma, US Pharmacopeia Jennifer Burgess, Scientialis Consulting Timothy Schnupp, Atlantic Test Labs Yanxuan Cai, US FDA3 Tom Seipelt, Abbott Nutrition Bob Clifford, Shimadzu Mei Shotts, Abbott Nutrition Nisha Corrigan, Hygena Liberty Sibanda, Randox Laboratories Mathieu Dobois, Nestlé Victoria Seigel, Eurofins CAL Marcel de Vreeze, NEN4 and ISO Frank Sikora, University of Kentucky Jonathan Draher, Abbott Nutrition Kelli Simon, US TTB5 Anne Duebecke, Tentamus David Singer, GERSTEL Lauren Fleury, AsureQuality Lanny Smith, Vicam a Waters Business Chris Gunning, A2LA Brad Stawick, SGS North America Cathy Halverson, US TTB5 Darryl Sullivan, Eurofins Scientific Hugh Hayes, US NIST6 Hiroko Suzuki, Japan Food Research Laboratories Leslie Hoo Fung, ICENS7 Mark Tess, Charm Sciences Greg Jaudzems, Nestlé Jeanice Thomas, US NIST6 Holly Johnson, AHPA8 Robert Thomas, Scientific Solutions James Jursich, Centera Bioscience Marina Torres, LATU9 Solomon Kariuki, University of Kentucky Walter Wilson, US NIST6 Joseph Konschnik, RESTEK Corporation Paul Winkler, SCIEX Vandana Kothari, CV Sciences Seth Wong, TEQ Analytical Laboratories Scott Krepich, Phenomenex Laura Wood, US NIST6 Mary Krogull, Eurofins Tyler Yoon, Steep Hill Maryland Brittany Leffler, CEM Yuichi Yotsuyanagi, Shimadzu Frederick Li, IonSense Hong You, Eurofins JP Khail Pasion, SPNCR 3 Garrett Zielinski, Eurofins AOAC Staff:

Scott Coates, Christopher Dent, Jonathan Goodwin, Alicia Meiklejohn, Tien Milor, Palmer Orlandi, David Schmidt

1 Virginia Division of Consolidated Laboratory Services 2 Association of Food and Drug Officials 3 US Food and Drug Administration 4 Netherlands Standardization Institute 5 US Tax and Trade Bureau 6 US National Institute of Standards and Technology 7 International Centre for Environmental and Nuclear Sciences 8 American Herbal Products Association 9 Laboratorio Tecnológico del Uruguay

Page 2: AOAC Cannabis Analytical Science Program Inaugural Meeting · Nisha Corrigan, Hygena Liberty Sibanda, Randox Laboratories ... Greg Jaudzems, Nestlé Jeanice Thomas, US NIST . 6. Holly

Meeting Minutes:

I. Welcome and Introductions

Orlandi welcomed all and explained the purpose of the meeting. AOAC invited participants to review today’s meeting book at https://tinyurl.com/CASP2019.

II. About AOAC, Processes, and Previous Work with Cannabis – Scott Coates, AOAC

Coates presented10 on AOAC and the work that has already been done on Cannabis. To date AOAC has created four Standard Method Performance Requirements (SMPRs®) and approved two Official Methods of Analysis for cannabis.

Coates explained that the previous work on Cannabis was project driven, with each working group expected to develop SMPRs and for methods to be submitted against these standards. CASP however is a full program that can include SMPRs and OMAs but also Performance Tested MethodsSM, sampling plans, validation guidance, harmonization, consulting, and more.

III. Regulatory Landscape for Cannabis and Hemp – Holly Johnson, AHPA Johnson provided an overview11 on current regulations around cannabis and hemp. She reviewed challenges in quality testing, state versus federal policies and legal status, state to state regulations, terminology, hemp and the impact of the Farm Bill (which amended the controlled substances act), changing perceptions and some of the recent work done in the field. She summarized that cannabis is still messy from a regulatory perspective although hemp is now considered a commodity is no longer regulated by the DEA but the FDA instead.

IV. Organizational Landscape – Susan Audino, Audino and Associates Audino then presented12 on the current organizational landscape. She reviewed cannabis methods development, lab testing, patient advocacy, accreditation bodies, proficiency testing, and previous AOAC work. She also emphasized that the work done with CASP needs to go beyond the science and also ensure that this work is communicated throughout the community so other organizations know these resources, such as standards and methods, are available to them.

V. Initial Priorities for CASP – Palmer Orlandi, AOAC A. CASP Working Group #1 – Chemical Contaminants (Audino)

The top needs with regards to chemical contaminates were identified as follows:

Analyte Matrix Deliverables 10 Attachment 1: Coates Presentation 11 Attachment 2: Johnson Presentation 12 Attachment 3: Audino Presentation

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Pesticides Various Revisit SMPR, methods Residual solvents Various SMPRs & methods Elemental impurities Various SMPRs & methods

B. CASP Working Group #2 – Cannabinoids in Consumables (Johnson)

Determination of cannabinoids and terpenes in: hemp plant material, hemp extracts, softgels/supplements, foods, and beverages. Deliverables would be OMAs or method extensions, proficiency testing, and training workshops.

Analyte Matrix Deliverables Cannabinoids Hemp plant material OMA Cannabinoids Hemp extracts OMA Cannabinoids Foods/beverages Sample prep method

Guidance on matrix extension

The group also recommended a white paper on analytical issues, including:

• Clarification on “dry weight” • THC_THC-A: How to calculate a report • Matrix extension verification for foods and beverages.

C. CASP Working Group #3 – Microbial Organisms (Coates)

Analyte Matrix Deliverables Salmonella Plant material SMPRs / OMAs / PTMs Listeria Plant material SMPRs / OMAs / PTMs Aspergillus Plant material SMPRs / OMAs / PTMs

All three of groups identified reference materials as an area that needs work, so the group suggested that a fourth working group could focus on reference materials. Members of this working group will be encouraged to participate on the other groups to allow two-way communications. The group also agreed that outreach and education should be done on a per-working group basis. The working groups will also consider the issue of sample size.

Orlandi assured the group that once these top priorities are addressed, CASP will look into other areas.

D. Next Steps – Palmer Orlandi and Alicia Meiklejohn, AOAC

These recommendations will now be brought to the AOAC CASP Advisory Panel for review. The priorities will be matched up with the first year’s budget and the advisory panel will determine how these priorities will be organized. Meiklejohn added that the advisory panel will meet to discuss this soon, and AOAC is still accepting new members for the advisory panel. If interested

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in joining the advisory panel, stakeholders should contact her directly at [email protected] or 301-927-7077 x 101. After the advisory panel meets, AOAC staff will send out a link to sign up for specific working groups.

E. Adjourn

Orlandi thanked all and the meeting was adjourned at approximately 5:00 p.m. ET.

Attachments: Attachment 1: Coates Presentation About AOAC, Processes, and Previous Work with Cannabis Attachment 2: Johnson Presentation Regulatory Landscape for Cannabis and Hemp Attachment 3: Audino Presentation: Organizational Landscape

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Hemp: the Farm Bill and the AMA

Amends the Agricultural Marketing Act…“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.”Hemp as an agricultural commodity under the federal purview of USDADefines hemp “plans” to be submitted to USDA by States and Tribal governments

The Farm Bill and the CSAAmends the Controlled Substances Act“The term ‘marihuana’ means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. The term ‘marihuana’ does not include (i) hemp, as defined in section 297A of the Agricultural Marketing Act of 1946; or (ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”

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The Farm Bill and the CSAAmends the Controlled Substances Act“Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp…” [re: CSA Schedule I]

Hemp under the FDCA

As a food, beverage, or cosmetic/personal care ingredient:

Hemp seed oil and other derivatives have been freely usedMarketers need to comply with the FDA regulations applicable to these product categories

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Hemp under the FDCA

As a dietary supplement:201(ff)(1)(C): The herb itself (any part)201(ff)(1)(F): Any concentrate, constituent, or extract [or metabolite or combination]Marketers need to comply with the FDA regulations applicable to dietary supplements

FDA DS regulations: Basics

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Page 29: AOAC Cannabis Analytical Science Program Inaugural Meeting · Nisha Corrigan, Hygena Liberty Sibanda, Randox Laboratories ... Greg Jaudzems, Nestlé Jeanice Thomas, US NIST . 6. Holly

Thank You!

Holly E. Johnson, Ph.D.Chief Science Officer

American Herbal Products [email protected]

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AOAC MID -YEAR MEETING Susan Audino, PhDS.A.Audino & Associates, LLC [email protected]

CANNABIS: AN ORGANIZATIONAL LANDSCAPE

A sampling of organizations currently involved in the cannabis space with specific interest in laboratory testing.

Applications: Marijuana and Hemp; Adult Use and Medicinal Intentions

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CONSENSUS METHOD DEVELOPMENT

D37D37.01 Indoor and Outdoor Horticulture and AgricultureD37.02 Quality Management SystemsD37.03 LaboratoryD37.04 Processing and HandlingD37.05 Security and TransportationD37.06 Personnel Training, Assessment, CredentialingD37.07 Industrial HempD37.90 ExecutiveD37.91 Terminology

LABORATORY TESTING

National Cannabis Industry Association (NCIA)

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LABORATORY TESTING

Non-Profit Educational Organization under American Council of Independent Laboratories (ACIL)

Cannabis Working GroupCurrent Topic: Sampling

LABORATORY TESTING

National Association of Cannabis Business

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PATIENT ADVOCACY

Industry Training; CultivationManufacturingDistributionLaboratory

Cannabis Laboratory CommitteeThe FOCUS Laboratory Committee develops cannabis-specific standards for laboratories that process cannabis samples.

ACCREDITATION BODIES

Cannabis-Centric Curriculum ISO/IEC 17025 – stand alone

MOU with ASA for laboratories: ISO/IEC 17025 & PFC Cannabis Requirements

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PROFICIENCY

Seeking ISO/IEC 17043 Accreditation (2019)

National Research Council: Developing PT Program

Toxic Elements in Hemp

BUILDING ON AOAC EXPERTISE

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THANK YOU

QUESTIONS? Susan Audino, [email protected]

410.459.9208

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