Proposal for SPSFAM & SPDS December 2017 ERPs

PROPOSAL FOR THE FORMATION OR REVISION OF AOAC EXPERT REVIEW PANELS

Official Methods Board Review November 2017

ERP PROPOSALS Table of Contents

AOAC ERP PROPOSALS

3 4 9

Proposal for ERP for SPSFAM Proanthocyanidin (PAC) Methods Proposal for ERP for SPSFAM Cannabis Potency Methods Proposal for ERP for SPDS Free Amino Acid Methods Proposal for ERP for SPDS Protein Methods Proposal for ERP for SPDS Ginger Methods Proposal for ERP for SPDS Vitamin K Methods Proposal for Revising ERP for SPDS Folin C Methods Proposal for Revising ERP for SPDS Kratom Methods

17 23 31 39 44 49

ELECTRONIC BALLOT

To access the electronic ballot, you may click on the link above or copy and paste the following URL into your internet browser . https://form.jotform.com/51664856639975

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MEMORANDUM

Date:

November 13, 2017

To:

AOAC INTERNATIONAL Official Methods Board From: Deborah McKenzie, Staff Liaison – AOAC Official Methods Board Subject: Item II. - Expert Review Panel Proposals – Revised for Ballot BACKGROUND: The following pages contains proposals for Expert Review Panels for both SPSFAM and SPDS communities. For SPSFAM, AOAC has collected methods and is planning for the following ERP meetings in December: 1. AOAC ERP for SPSFAM Cannabis Potency Methods 2. AOAC ERP for SPSFAM Proanthocyanidins in Cranberries (PAC) Methods For SPDS, AOAC has collected methods and is planning for the following ERP meetings to be held in December: 1. AOAC ERP for SPDS Free Amino Acid Methods 2. AOAC ERP for SPDS Ginger Methods 3. AOAC ERP for SPDS Protein Methods 4. AOAC ERP for SPDS Vitamin K Methods 5. AOAC ERP for SPDS Folin C Methods 6. AOAC ERP for SPDS Kratom Methods Both the Folin C and Kratom ERPs have met before, but did not approve any methods. When AOAC issued a call for methods, methods for both ingredients were also submitted. Additionally, AOAC issued a call for experts for all of the analytes specified in the proposed ERPs. Please find attached proposals for all of the ERPs including revisions to the ERPs for Folin C and Kratom. These proposals were discussed during the OMB teleconference on November 9, 2017 during which it was determined that there were some revisions required and OMB would demonstrate consensus on each proposal via electronic ballot. RECOMMENDATION: To review each proposal and use the electronic ballot to vote on the formation of the ERPs.

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ERP PROPOSAL I: AOAC ERP for SPSFAM Proanthocyanidins in Cranberries (PAC) Methods I. METHODS SUBMITTED IN RESPONSE TO AOAC CALL FOR METHODS  PAC-001: Deconvolution of Matrix Assisted Laser Desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for identification of A-type proanthocyanins in cranberry based foods and dietary supplements o Method Author(s): Christian G. Krueger and Jess D. Reed - Organization: University of Wisconsin, Madison  PAC-002: 4-(dimethylamino) cinnamaldehyde assay using cranberry proanthocyanin standard for quantification of soluble proanthocyanidins in cranberry foods and dietary supplements o Method Author(s): Christian G. Krueger and Jess D. Reed - Organization: University of Wisconsin, Madison  PAC-003: Single Laboratory Validation for Determination of Total A-type Proanthocyanins in Cranberry Using 4-Dimethylaminocynnamaldehyde (DMAC) o Method Author(s): Marsha Sintara, Lin Li, David Cunningham, Ronald Prior, Xianli Wu, Tony Chang - Organization: International Chemistry Testing  PAC-004: Development of a New Thiolysis HPLC Method for the Analysis of Bioactive Procyanidins in Cranberry Products o Method Author(s): Liwei Gu, Chi Gao, David Cunningham, Christina Khoo, Haiyan Liu - Organization: University of Florida  PAC-005: Determination of Proanthocyanidins in Cranberry-Containing Products by Normal Phase High Performance Liquid Chormatography: SLV o Method Author(s): Marsha Sintara, Lin Li, David Cunningham, Ronald Prior, Xianli Wu, Tony Chang - Organization: International Chemistry Testing II. CANDIDATE ERP MEMBERS: Name Affiliiation 1. Es-Safi, Nour-Eddine Mohammed V University in Rabat 2. Jahromi, Ramin Eurofins 3. Johnson, Holly Alkemist Labs 4. Krueger, Christian Complete Phytochemical Solutions 5. Mudge, Elizabeth British Columbia Institute of Technology 6. Reed, Jess University of Wisconsin, Madison 7. Rimmer, Catherine US NIST 8. Tuzimski, Tomasz Medical University, Lublin Poland 9. Yadlapalli, Sudhakar First Source Laboratory Solutions 10. You, Hong Eurofins PROPOSED ERP CHAIR: HOLLY JOHNSON

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III. BALANCE AND ORGANIZATIONAL PERSPECTIVES OF THE CANDIDATES

45% 44% Broad Perspectives

11%

Academia Government Industry 40% Specific Perspectives 10%

40%

10%

Consultancy CRO Reference Standards Research

Regional Perspectives

10% 10%10% 10%

60%

Canada India Morocco Poland USA

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IV. CREDENTIALS, STATEMENTS OF EXPERTISE, AND CSO REVIEW & COMMENTS

Book of CVs/Resumes: https://griegler-aoac-org.cld.bz/PAC-App-CVs

Candidate Name Statement of Expertise

CSO Review and Comments A well-qualified analytical chemist with direct experience with the analyte of interest and well familiar with the AOAC process. I have been working food analysis since 1989 and fruit/fruit juice including authenticity since 2001. I have done research on cranberry polyphenols, anthocyanins, and organic acids. I have been interested in methods for A-type proanthocyanidin dimers. A well-qualified analytical chemist familiar with the AOAC process. I did not see direct experience with the analyte of interest in the submitted CV or statement of expertise.

Es-Safi

I am currently working as a full professor at Mohammed V University in Rabat. My research focuses on natural products, especially polyphenols, their caracterization, their antioxidant activity and their role in food technology, their organoleptic properties and their beneficial effects for human health. I have been working food analysis since 1989 and fruit/fruit juice including authenticity since 2001. I have done research on cranberry polyphenols, anthocyanins, and organic acids. I have been interested in methods for A-type proanthocyanidin dimers. Holly E. Johnson Ph.D., is the Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in identity and potency testing of botanicals in commerce. 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 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 also serves on AOAC 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 AOAC Cannabis Working Group, the American Herbal Products Association’s Cannabis Committee, the American Chemical Society’s Cannabis Chemistry Subdivision, the Editorial Board of the AOAC International Journal, and she serves on the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years’ experience in natural products chemistry with botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. Holly serves as a subject matter expert on Cannabis Quality and is active in efforts to establish broadly applicable standards for quality and safety testing that are relevant in the complex regulatory environment.

Jahromi

Johnson

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Krueger

I have spent the past 20 years in both the Public (University of Wisconsin-Madison) and Private (Complete Phytochemical Solutions, LLC) sector developing and applying analytic methods for the characterization and quantification of proanthocyanidins. I have been working in the plant and medicinal herb industry for over 5 years, focusing on development and validation of analytical methods. Specifically, I have been working closely with cannabis methods to quantify cannabinoids, in additional to many other different plants, fruits and herbs.

A well-qualified analytical chemist with direct experience with the analyte of interest and well familiar with the AOAC process. A well-qualified analytical chemist familiar with the AOAC process. I did not see specific experience with the analyte of interest (PAC) in the submitted CV or statement of expertise, but the candidate does have experience with polyphenols. A well-qualified analytical chemist familiar with the AOAC process. I did not see specific experience with the analyte of interest (PAC) in the submitted CV or statement of expertise, but the candidate does have experience with polyphenols. A well-qualified analytical chemist familiar with the AOAC process. I did not see specific experience with the analyte of interest (PAC) in the submitted CV or statement of expertise, but the candidate does have experience with polyphenols.

Mudge

Reed

Expertise in proanthocyanidin analytical methods (quantitative and qualitative techniques) and in the effects of proanthocyanidins on nutrition and health. A well-qualified analytical chemist with direct experience with the analyte of interest and well familiar with the AOAC process.

Rimmer

I have made measurements in food reference materials

Tuzimski

My scientific interest include the theory and application of liquid chromatography, taking into considerations optimisation of chromatographic systems for separation and quantitative analysis of analytes in multicomponent mixtures of xenobiotics and unknown compounds residue in food, environmental and biological samples. The main of research interest during last four years (2013-2017) was to develop analytical methods for xenobiotics analysis in food products of plant and animal origin by high performance liquid chromatography (HPLC-DAD, HPLC-MS and/or HPLC-MS/MS). In order to accomplish this goal, optimization experiments were conducted for, both, the chromatographic conditions of separation and quantitative analysis, as well as sample preparation approach for efficient isolation of the analytes (eg., pesticides, 5-nitroimidazoles (NDZs), sulfonated azo dyes, drugs, bisphenol A and its metabolites) form different food samples and subsequent extract clean-up. Sample preparation procedures for the analysis of various commodities, including sunflower seeds, edible oils, milk, soya milk, wines, different beverages, candies and caviar/fish roe, were developed by the optimization of the conditions of analytes isolation from complex matrices and extracts clean-up. For that purpose, different extraction and clean-up techniques were used, mainly QuEChERS (quick, easy, cheap, effective, rugged and safe), ultrasound assisted extraction (UAE), solid-phase extraction (SPE), dispersive-SPE (d-SPE) and matrix solid-phase dispersion (MSPD). Having knowledge and analytical experience in analysis of Bisphenol in water samples as per EPA. Contributed in collaborative study toward method to detect agricultural residues at sub – parts–per-billon levels in Soft drinks published as AOAC Official method 2007.08, First Action.

Yadlapalli

A well-qualified analytical chemist familiar with the AOAC process. I did not see specific experience with the analyte of interest (PAC) in the submitted CV or statement of

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expertise, but the candidate does have experience with polyphenols. A well-qualified analytical chemist familiar with the AOAC process. I did not see specific experience with the analyte of interest (PAC) in the submitted CV or statement of expertise, but the candidate does have experience with polyphenols.

You

I am currently a Principal Scientist at Eurofins Dietary Supplement Analysis Center. With a Ph.D. degree in Nutrition Sciences, I have more than 10 years experience in analytical method development and validation in various matrices, which include, but are not limited to carotenoids, xanthrophylls, isothiocyanates, flavonoids, and vitamins. I am very familiar with multiple analytical techniques including HPLC-DAD/ELSD/FLD/MSMS, GC-FID/MS, and UV/VIS/FL spectrophotometers. Moreover, I was one of the two reviewers of the AOAC ERP for evaluating Lutein official method of analysis in 2016. I have also reviewed 15 journal manuscripts for Food Chemistry, J of AOAC Int, and J Food Biochemistry, and 16 conference abstracts for Experimental Biology Annual Conference.

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ERP PROPOSAL II: AOAC ERP for SPSFAM Cannabis Potency Methods I. METHODS SUBMITTED IN RESPONSE TO AOAC CALL FOR METHODS  CAN-001: Quantitation of Cannabinoids in Cannabis Dried Plant Materials and Concentrations Using Liquid Chromatography – Diode Array Detection Technique with Optional Mass Spectrometric Detection o Method Author(s): Lukas Vaclavik, Frantisek Benes, Ales Krmela, Veronika Svobodova, Jana Hajslova and Katerina Mastovska - Organization: Covance Laboratories o Method Author(s): E Mudge, SJ Murch, PN Brown - Organization: British Colombia Institute of Technology  CAN-002: Leaner and Greener Analysis of Cannabinoids

II. CANDIDATE ERP MEMBERS: Name 1. An, Haejung US FDA 2. Arao, Yohei Shimadzu 3. Dhandapani, Ramkumar Phenomenex 4. Es-Safi, Nour-Eddine Mohammed V University in Rabat 5. Harris, Heather Arcadia University 6. Hudalla, Christopher ProVerde Laboratories 7. Indick, Pete Microbac Laboratories 8. Johnson, Holly Alkemist Labs 9. Marcu Jahan Americans for Safe Access 10. Mastovska, Katerina Covance 11. Mudge, Elizabeth British Columbia Institute of Technology 12. Phillips, Melissa US NIST 13. Phinney, Curtis Curtis S. Phinney, CNS 14. Reibach, Paul Smithers Viscient 15. Rimmer, Catherine US NIST 16. Roggen, Markus OutCo 17. Schaffer, Michael Psychemedics 18. Sweeney, Christian Cannabistry Labs 19. Tuzimski, Tomasz Medical University, Lublin, Poland 20. Voelker, Rodger OG Analytical 21. Yadlapalli, Sudhakar First Source Laboratory Solutions PROPOSED ERP CHAIR: MELISSA PHILLIPS Affiliiation

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III. BALANCE AND ORGANIZATIONAL PERSPECTIVES OF THE CANDIDATES

NGO 5% BROAD PERSPECTIVES

Academia 20%

Government 10%

Industry 65%

15% 10% 5% Specific Perspectives

25%

35%

10%

Consultancy CRO Federal Research Technology Trade

Regions

4%5%5% 5%

81%

Canada India Morocco Poland USA

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IV. CREDENTIALS, STATEMENTS OF EXPERTISE, AND CSO REVIEWS & COMMENTS

Book of CVs/Resumes: https://griegler-aoac-org.cld.bz/Cannabis-ERP-CVs

Candidate Name Statement of Expertise

CSO Review & Comments

An

Specialized in method development and validation of regulatory analyses of trace level veterinary drugs in foods A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience with measurement of vet drugs.

Arao

I developed Cannabis Analyzer as our company project. This Analyzer is operated by HPLC with UV detector for quantification of cannabinoids. I developed three methods in this product and they are selected according to the purpose of use. This experience would be helpful for the standardization of potency testing. My name is Ramkumar Dhandapani and I am GC Technical manager here at Phenomenex and I have 14 years of chromatography research experience pertaining to HPLC and GC. I have also earnt a PhD in Analytical chemistry from Seton Hall University and I am very passionate about chromatography. I have been actively involved in presenting my research at AOAC as oral presentation and posters. I am actively colloborating with cannabinoids labs to develop methods for potency by LC and for terpenes and residual solvents by GC and I would like to volunteer myself to be a part of peer reviewing working groups I am currently working as a full professor at Mohammed V University in Rabat Morocco. My research focuses on natural products, especially polyphenols, their qualitative and quantitative analysis, their isolation and characterization in addition to some of their biological activities. I have followed post-docs and have published many research papers. I am reviewer for various international scientific journals and Editorial Board Member of various scientific journals such as Journal of Food Composition and Analysis. I am Editor in Chief of the Green and Sustainable Chemistry journal.

A chemist with direct experience with the analyte of interest. A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

Dhandapani

Es-Safi

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have much experience in analytical science.

Harris

I have worked in marijuana/cannabis analysis for 17 years. I have tested thousands of seized drug samples over that time. Also, I have developed analytical methods for the A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

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identiication of cannabinoids by GC/MS. I am currently working on methods for analysis of solvents and terpenes by HS-GC/MS. Finally, I am participating in the AOAC working group for the development of the SMPRs. I am a Ph.D. analytical chemist with more than 25 years of research experience in analytical chemistry, spectroscopy and chromatographic method development, recognized worldwide as an expert in the field of traditional Reverse Phase Liquid and Supercritical Fluid Chromatography. I am the founder and Chief Scientific Officer of ProVerde Laboratories, a premier analytical testing, CO2 extraction and derivative product formulation consultancy for the regulated medical cannabis industry. ProVerde is one of few laboratories to receive an ISO 17025 accreditation that specifically governs medical cannabis testing. ProVerde Laboratories operates at the cutting edge of extraction, purification and product formulation, with expertise that will move cannabis research forward as the industry progresses. ProVerde plays an integral part in providing clients in the medical cannabis industry the ability to deliver new products and product formulations that meet the highest standards for quality, consistency, safety and labeling. I have delivered presentations world-wide in my areas of expertise, including analytical testing and formulation specific to medical cannabis. As Director of Organics for Microbac Labs I am involved with the evaluation and implementation of methodologies for cannabis testing within our network. I have over 25 years of experience working with organic methods and instrumentation including GC, GC/MS, LC, LC/MS and GC/MS/MS. After evaluation the current methodologies and state requirements I would welcome the opportunity to help develop a more cohesive and logical set of methods in this area. Holly E. Johnson Ph.D., is the Laboratory Director for Alkemist Labs, an ISO 17025 accredited natural products testing lab specializing in identity and potency testing of botanicals in commerce. 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 worked for Waters Corporation conducting technical training and regulatory consulting for

Hudalla

A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

Indick

A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

Johnson

A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

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pharmaceutical and supplements companies. She is currently a Research Associate with the National Tropical Botanical Garden and has served on AOAC 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 AOAC Cannabis Working Group, the American Herbal Products Association’s Cannabis Committee, and the American Chemical Society’s Cannabis Chemistry Subdivision. She also serves on the Editorial Board of the AOAC International Journal, and the Advisory Boards of the American Botanical Council and the American Herbal Pharmacoepia. Holly has over 20 years experience in natural products chemistry with botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii. Holly serves as a subject matter expert on Cannabis Quality and is active in efforts to establish broadly applicable standards for quality and safety testing that are relevant in the complex regulatory environment. Jahan Marcu, Ph.D., is currently the Chief Scientist at Americans for Safe Access and Chief Auditor for Patient Focused Certification (PFC). PFC is an international program, which audits cannabis operations for compliance with botanical safety standards and regulatory requirements. He is a founder and vice-chair of the Cannabis Chemistry Subdivision (CANN) in the Chemical Health and Safety Division of the American Chemical Society. He is also on the Board of Directors of the International Association for Cannabinoids as Medicine (Germany) and on the scientific board of the International Cannabis and Cannabinoid Institute (Czech Republic). Marcu is also on several review and editorial boards for scientific journals. He received his Ph.D. for significant contributions to the study of the structure and function of the cannabinoid receptors. Marcu’s published work includes studies on the anti-cancer effects of the active ingredients from cannabis, published in Molecular Cancer Therapeutics. Marcu is an author of the American Herbal Pharmacopeia's Cannabis Inflorescence Monograph, which has set the current US standards of identity, analysis and quality control for cannabis products. Marcu serves on multiple expert government, trade association committees, and scientific organizations including the American Herbal Products Association, American Oil Chemist Society, International Medical Cannabis Patients Coalition, International Cannabinoid Research Society, and is a court-qualified synthetic cannabinoid and cannabis expert. He also helped create medical cannabis educational training for clinicians in the US and has been invited to speak at many

Marcu

A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

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international conferences and universities, including the University of Leiden and Yale University. Dr. Marcu was a recipient of the Billy Martin research award from the International Cannabinoid Research Society. Advance knowledge and experience in the analysis of chemical residues and contaminants and various chromatographic and mass spectrometric techniques. I have been working in the plant and medicinal herb industry for over 5 years, focusing on development and validation of analytical methods. Specifically, I have been working closely with cannabis methods to quantify cannabinoids, in additional to many other different plants, fruits and herbs. I have been working in the plant and medicinal herb industry for over 5 years, focusing on development and validation of analytical methods. Specifically, I have been working closely with cannabis methods to quantify cannabinoids, in additional to many other different plants, fruits and herbs. Experienced chromatographer, standards expert, and board-certified nutritionist, Licensed Dietician-Nutritionist (LDN) in MD. Presenting Cannabis in Nutrition at Cannabis Science Conference, Portland OR, August 2017. Experienced WG, ERP member and JAOAC reviewer. I am an analytical chemist with a background in plant biochemistry. I have been involved with pesticide analyses for registration dossiers for over 30 years. Recently I have become involved with cannabis analytical methodologies and have conducted risk assessments related to pesticide exposures from cannabis. I have expertise in all forms of analytical instrumentation. I have made measurements in food reference materials

Mastovska

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have much experience in analytical science. A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids). A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids). A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids). A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids). A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have much experience in analytical science. A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

Mudge

Phillips

Phinney

Reibach

Rimmer

Roggen

Dr. Susan Audino asked me to apply for the ERP position to work on cannabis testing guidelines. I gladly comply and put my name forward. As you can see in my CV, I enjoyed my chemical education around the world at renown universities and research

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group, with a focus on organic and physical organic chemistry. After leaving academia, I set up a chemical analytical laboratory for cannabis in California. This is where I had my first experiences with the complicated world of cannabis references and sample testing. I also met Dr. Audino through that job. Since then I have moved on to oversee R&D and production at a medical marijuana collective in San Diego. As a stakeholder in the industry, I am a strong proponent on precise and dependable testing, both to support producers and to safeguard patients. measuring marijuana compounds in urine oral fluid and hair as well as some plant material, MS in Pharmacognsy helps. analytical chemistry helps I believe I am a strong candidate for the Cannabis Expert Review Panel for a number of reasons. My educational and professional background in Food Analysis has given me many years of experience in the development of analytical methods in unique food matrices. Even more applicable is my work in the flavor & fragrance industry developing methods for natural product extracts of tea, coffee, and hops, one of the most similar horticultural products to the cannabis plant. Lastly, my work over the last 2 years in the cannabis industry has given me direct experience with method development for cannabis plant material, extracts, and infused products. This work has given me the opportunity to speak at the AOCS annual meeting and the upcoming Cannabis Science Conference, as well as a position on the AOCS expert panel for cannabinoid analytics. It would be a true honor to be able to bring my skill set to the AOAC review panel. My scientific interest include the theory and application of liquid chromatography, taking into considerations optimisation of chromatographic systems for separation and quantitative analysis of analytes in multicomponent mixtures of xenobiotics and unknown compounds residue in food, environmental and biological samples. The main of research interest during last four years (2013-2017) was to develop analytical methods for xenobiotics analysis in food products of plant and animal origin by high performance liquid chromatography (HPLC-DAD, HPLC-MS and/or HPLC- MS/MS). In order to accomplish this goal, optimization experiments were conducted for, both, the chromatographic conditions of separation and quantitative analysis, as well as sample preparation approach for efficient isolation of the analytes (eg., pesticides, 5-nitroimidazoles (NDZs), sulfonated azo dyes, drugs, bisphenol A and its

Schaffer

A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids). A well-quailfied chemist with direct experience with the analyte of interest (cannabinoids).

Sweeney

Tuzimski

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have much experience in analytical science.

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metabolites) form different food samples and subsequent extract clean-up. Sample preparation procedures for the analysis of various commodities, including sunflower seeds, edible oils, milk, soya milk, wines, different beverages, candies and caviar/fish roe, were developed by the optimization of the conditions of analytes isolation from complex matrices and extracts clean-up. For that purpose, different extraction and clean-up techniques were used, mainly QuEChERS (quick, easy, cheap, effective, rugged and safe), ultrasound assisted extraction (UAE), solid-phase extraction (SPE), dispersive-SPE (d-SPE) and matrix solid-phase dispersion (MSPD). I have ~20 years of experience in various forms of analytical chemistry with a focus on botanical related analysis. I am one of the founders and lab director of OG Analytical which, for ~4 years, has been serving analytical needs of the cannabis industry. I have developed and validated numerous cannabis specific methods for analysis including analysis of cannabinoids from plant, extracts, and various food matrices. I have been heavily involved in helping craft rules regarding sale and testing of cannabis in Oregon. I have presented research and findings at multiple national conferences. I am a member of the Emerald Proficiency Testing Board and am on the board of the Oregon Technical Advisory Committee. Having knowledge and analytical experience in analysis of Bisphenol in water samples as per EPA. Contributed in collaborative study toward method to detect agricultural residues at sub –parts–per-billon levels in Soft drinks published as AOAC Official method 2007.08, First Action.

Voelker

A well-quailfied chemist with some direct experience with the analyte of interest (cannabinoids) in the statement of expertise although not mentioned in the CV.

Yadlapalli

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (cannabinoids) in the submitted CV or statement of expertise, but the candidate does have much experience in analytical science.

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ERP PROPOSAL III: AOAC ERP for SPDS Amino Acid Methods I. METHODS SUBMITTED IN RESPONSE TO AOAC CALL FOR METHODS  FAA-001 : Free Amino Acid Profile and Absence Verification Method by UPLC o Method Author(s): Philip Haselberger - Organization: Abbott Nutrition

II. CANDIDATE ERP MEMBERS: Name 1. Bhandari, Sneh 2. Gao, Quanyin 3. Ji, David 4. Johnson, Holly 5. Joseph, George 6. Koerner, Philip 7. Rimmer, Catherine 8. Schaneberg, Brian 9. Yang, Jinchuan 10. You, Hong 11. Young, Kurt 12. Zielinski, Garrett

Affiliiation Merieux NutriSciences Herbalife

Covance Alkemist Labs AsureQuality Phenomenex US NIST Starbucks

Waters Corporation Eurofins Scientific Nutra Manufacturing

Covance

PROPOSED ERP CHAIR: BRIAN SCHANEBERG

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III. BALANCE AND ORGANIZATIONAL PERSPECTIVES OF THE CANDIDATES

Broad Perspectives

0% 10%

90%

Academia Government Industry 18% Specific Perspectives

46%

18%

9%

9%

CRO Food & Beverage Reference Standards Supplements Technology

Regions

10%

90%

New Zealand USA

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IV. CREDENTIALS, STATEMENTS OF EXPERTISE, AND CSO REVIEW & COMMENTS

Book of CVs/Resumes: https://griegler-aoac-org.cld.bz/SPDS-Set-X-CVs

Candidate Name Statement of Expertise

CSO Review and Comments

Should be an ERP Member

Bhandari

I am involved in nutritional analysis particularly, vitamins, amino acids and protein for last 20 years. ERP member of SPIFAN, whey protein. A well-qualified chemist with direct experience with the analyte of interest. Submitted and get accepted by AOAC a validated Aloin method. Participated Protein test method discussion with USP. Submitted LC/MS method to USP for B12 test. Managed routine test for amino acid nutrients. A well-qualified chemist with direct experience with the analyte of interest.

X X X X

Gao

Ji

Twenty years experience in dietary supplement test

A well-qualified chemist with direct experience with the analyte of interest. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes.

Johnson

Holly E. Johnson Ph.D., is the 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 has served 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 in natural products chemistry with botanicals and spent many happy years conducting research on medicinal plants and giving courses at the University of Hawaii.

Joseph

I have ongoing working experience on these analyses over 20 years. I have developed and validated many methods over the last few years. A well-qualified analytical chemist. I did not see specific experience with the analyte of

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interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes.

Koerner

I am an analytical chemist with over 29 years of experience, particularly in HPLC, GC and SPE. I have extensive experience in the application of liquid chromatography in the fields of food safety and quality, clinical toxicology, pharmaceuticals, and environmental. I have served on two previous ERPs (Set 1 and Set 3) and believe I bring the skill set required for the critical evaluation of the suitability of analytical methods to meet the requirements outlined in the SMPRs. I am the coordinator for organic analytes in dietary supplement reference materials at NIST. Expertise in dietary supplement reference material design and certification. Analytical chemist with specialty in liquid chromatography.

X

Rimmer

X

Schaneberg

Brian Schaneberg, Ph.D., is the Global Scientific & Regulatory Affairs Director for Starbucks Corporation. Brian participates in the execution of company strategies while ensuring compliance and regulatory guidelines are met and followed by the company across all products: Starbucks, Teavana, Tazo, Evolution Fresh, La Boulange, and Ethos. Brian has over 15 years of natural products experience in the area of dietary supplements and herbals. Brian was also the Quality & Food Saftey and Scientific & Regulatory Affairs Director for Mars Botanical, a division of Mars, Inc. focusing on cocoa flavanol science and products. Before Mars Botanical, he was the Director of Technical Services at ChromaDex, Inc. in Irvine, California and was an Associate Research Scientist at the National Center for Natural Products Research at the University of Mississippi under the guidance of Dr. Ikhlas Khan, in a position

A well-qualified analytical chemist.

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funded by the US FDA for the development of methods to ensure the quality and safety of botanicals and dietary supplements. Over the years, Brian has worked closely with trade groups, industry, academia and government leaders. He has been a member of various review committees including NIH grants, analytical validation ERPs at AOAC and the Registry of Carcinogens. Brian also had the pleasure of holding an adjunct faculty position at the University of Colorado, Denver, advising a student that received his MS in Analytical Chemistry isolating phytochemicals and developing analytical testing procedures for Horse Chestnut. Brian has a Ph.D. in Organic Chemistry from Virginia Commonwealth University and a B.A. in Chemistry with a minor in Biology from Central College in Iowa. He has authored or co-authored more than 50 publications and presentations. I have worked on a number of compounds relevant to these compounds by LC/UV/FLU or LC/MS in food and dietary supplement matrices. I have intimate knowledge of LC and LC/MS technologies and have experience in the application of these tech. to complex sample matrices. I am currently a Principal Scientist at Eurofins Dietary Supplement Analysis Center. With a Ph.D. degree in Nutrition Sciences, I have more than 10 years experience in analytical method development and validation for various bioactive compounds, which include, but are not limited to carotenoids, xanthrophylls, isothiocyanates, flavonoids, amino acids and vitamins. I am familiar with multiple analytical techniques including HPLC-DAD/ELSD/FLD/MSMS, GC-FID/MS, and UV/VIS/FL spectrophotometers. Moreover, I was one of the two reviewers of the AOAC ERP for evaluating Lutein official method of analysis in 2016. I have also reviewed 16 journal manuscripts for Food Chemistry, Food Research International, J of AOAC Int, and J Food Biochemistry, and 16 conference abstracts for Experimental Biology Annual Conference. Eurofins has validated analytical methods and runs routine analysis for anthocyanins, cinnamon, collagen, kratom, lutein, proteins, polyphenols using Folin-C reagent, vitamin B12, vitamin K, ginger, and free amino acids in dietary supplements or/and food matrices. As a Eurofins representative, I look forward to the opportunity to serve AOAC ERPs again.

Yang

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes. A well-qualified chemist with direct experience with the analyte of interest.

You

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Young

Developed, and assisted in the implementation of, Quality testing methods for amino acid and ginger dietary supplement ingredients and finished products. A well-qualified chemist with direct experience with the analyte of interest. I routinely work with dietary supplement companies (brand owners, contract manufacturers, ingredient companies) regarding acceptable methodology for products depending on need (GMP compliance, meeting internal specs, etc). I also work with these companies to troubleshoot methods and develop method development/validation protocols.

X X

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (free amino acids) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes.

Zielinski

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ERP PROPOSAL IV: AOAC ERP for SPDS Protein Methods I. METHODS SUBMITTED IN RESPONSE TO AOAC CALL FOR METHODS  PRO-001 : Identification of Pea, Rice and Soy Proteins and Finished Goods using ESI- HPLC-MS/MS o Method Author(s) Organization: Genysis Labs  PRO-002: Identification of Milk Proteins in Raw Materials and Finished Goods using ESP HPLC-MS/MS o Method Author(s) Organization: Genysis Labs

II. CANDIDATE ERP MEMBERS: Name 1. Bhandari, Sneh 2. Carter, Spencer 3. Gao, Quanyin 4. Haselberger, Philip Abbott Nutrition 5. Lowenthal, Marcus NIST 6. Phinney, Curtis Curtis S. Phinney, CNS 7. Reimann, Lars Eurofins 8. Rimmer, Catherine US NIST 9. Schaneberg, Brian Starbucks 10. Szpylka, John Merieux NutriSciences 11. Tuzimski, Tomasz Medical University in Lublin 12. Yang, Jinchuan Waters Corporation 13. You, Hong Eurofins 14. Zielinski, Garrett Covance PROPOSED ERP CHAIR: BRIAN SCHANEBERG Affiliiation Merieux NutriSciences Genysis Herbalife

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III. BALANCE AND ORGANIZATIONAL PERSPECTIVES OF THE CANDIDATES

Broad

10%10%

80%

Academia Government Industry

Specific

9%

9% 9%

9%

37%

9%

9%

9%

Consultancy

CRO

Food & Beverage Supplements

Food & Formula Technology

Reference Standards Research

Regions

10%

90%

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IV. CREDENTIALS, STATEMENTS OF EXPERTISE, AND CSO REVIEW & COMMENTS

Book of CVs/Resumes: https://griegler-aoac-org.cld.bz/SPDS-Set-X-CVs

Candidate Name Statement of Expertise

CSO Review and Comments A well-qualified chemist with direct experience with the analyte of interest. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest in the submitted CV or statement of expertise, but the candidate does have experience with dietary supplements. A well-qualified chemist with direct experience with the analyte of interest. A well-qualified chemist with direct experience with the analyte of interest.

Should be an ERP Member

I am involved in nutritional analysis particularly, vitamins, amino acids and protein for last 20 years. ERP member of SPIFAN, whey protein. PhD in Analytical Chemistry. Currently serving as Sr VP of the lab. Have worked in this industry for 1.5 yrs. Previously spent 15 years in bioanalytical pharma research. My expertise is LC/MS/MS.

Bhandari

X

Carter

x

Submitted and get accepted by AOAC a validated Aloin method. Participated Protein test method discussion with USP. Submitted LC/MS method to USP for B12 test. Managed routine test for amino acid nutrients. - Method author on AOAC method 2012.07 as well as professional experience with the analysis of other proteins. Additional experience with free amino acid analysis as well as economic adulterants (i.e., Melamine). - Validated a method for free amino acid analysis that has been in use since 2010. The same methodology has subsequently been transferred to multiple sites successfully. I am an analytical biochemist with 17 years of experience in protein/small molecule analytical analysis and method development, and materials production. I have focused my research on developing approaches for quantitative proteomics analysis, and qualitative biomarker characterization. I am highly experienced in biomolecular analysis using a variety of techniques

X

Gao

Haselberger

X

A well-qualified analytical chemist with experience with the analyte of interest.

Lowenthal

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including mass spectrometry and HPLC. I have managed numerous undergraduate, graduate, and post-doctoral level scientists in my lab, and enjoy leading small groups. Experienced WG, ERP member and JAOAC reviewer

A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (protein) in the submitted CV or statement of expertise, but the candidate does have experience with dietary supplements. A well-qualified chemist with direct experience with the analyte of interest. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (gingers) in the submitted CV or statement of expertise, but the candidate does have a lot of experience dietary supplements and is familiar with AOAC processes. A well-qualified analytical chemist. I did not see specific experience with the analyte of interest (protein) in the submitted CV or statement of expertise, but the candidate does have experience with dietary supplements.

Phinney

X

I have been involved in protein and amino acid analysis in college and for more than 30 years in industry I am an analytical chemist with over 29 years of experience, particularly in HPLC, GC and SPE. I have extensive experience in the application of liquid chromatography in the fields of food safety and quality, clinical toxicology, pharmaceuticals, and environmental. I have served on two previous ERPs (Set 1 and Set 3) and believe I bring the skill set required for the critical evaluation of the suitability of analytical methods to meet the requirements outlined in the SMPRs. I am the coordinator for organic analytes in dietary supplement reference materials at NIST

Reimann

X

Koerner

X

Rimmer

X

rian Schaneberg, Ph.D., is the Global Scientific & Regulatory Affairs Director for Starbucks Corporation. Brian participates in the execution of company A well-qualified analytical chemist.

Schaneberg

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strategies while ensuring compliance and regulatory guidelines are met and followed by the company across all products: Starbucks, Teavana, Tazo, Evolution Fresh, La Boulange, and Ethos. Brian has over 15 years of natural products experience in the area of dietary supplements and herbals. Brian was also the Quality & Food Saftey and Scientific & Regulatory Affairs Director for Mars Botanical, a division of Mars, Inc. focusing on cocoa flavanol science and products. Before Mars Botanical, he was the Director of Technical Services at ChromaDex, Inc. in Irvine, California and was an Associate Research Scientist at the National Center for Natural Products Research at the University of Mississippi under the guidance of Dr. Ikhlas Khan, in a position funded by the US FDA for the development of methods to ensure the quality and safety of botanicals and dietary supplements. Over the years, Brian has worked closely with trade groups, industry, academia and government leaders. He has been a member of various review committees including NIH grants, analytical validation ERPs at AOAC and the Registry of Carcinogens. Brian also had the pleasure of holding an adjunct faculty position at the University of Colorado, Denver, advising a student that received his MS in Analytical Chemistry isolating phytochemicals and developing analytical testing procedures for Horse Chestnut. Brian has a Ph.D. in Organic Chemistry from Virginia Commonwealth University and a B.A. in Chemistry with a minor in Biology from Central College in Iowa. He has authored or co-authored more than 50 publications and presentations. I have been active for 25+ years in the development and in the management of analytical methods testing a range of food nutrients after receiving a Ph.D. in Analytical Chemistry. My method development focus areas include vitamins (2006 Study Director of the Year for Beta-Carotene Analysis; Acceptance of AOAC 2011.06 Folates in Infant Formula and Adult Nutritionals), antioxidants (AOAC 2012.04), and other nutrients used by food companies. Have served as chair of the AOAC Working Group on Antioxidant Activity which included Folin C assessments. Am currently in role of Dir. Scientific Affairs, Chemistry N.A. which includes overseeing new method development projects, and serving as technical resource for global Merieux NutriSciences.

Szpylka

A well-qualified analytical chemist.

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