AOAC SPSFAM March 16 2015 eBook
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Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM) Stakeholder Panel Meeting - March 16, 2015
Salon D/E Hilton Washington D.C. North Gaithersburg, Maryland 20877
contact: SPSFAM@aoac.org 301.924.7077 x 117 or 119
Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM) Stakeholder Panel Meeting - March 16, 2015
Salon A-B Hilton Washington D.C. North Gaithersburg, Maryland 20877
contact: SPSFAM@aoac.org 301.924.7077 x 117 or 119
Stakeholder Panel on Strategic Food Analytical Methods - Chair Biography
Co‐Chair, SPSFAM Erik Konings Nestle Research Center
Erik Konings has been an active member of AOAC since 1997. He is currently serving as a director on the Board of Directors and a member of the Advisory Panel membership on the Advisory Panel for the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN). Previous AOAC volunteer roles have included chairmanship of the SPIFAN Working Group on Folic Acid, membership on the AOAC Methods Committee on Food Nutrition, and service as a General Referee for Water Soluble Vitamins. Erik Konings started his professional career at the then called Food Inspection Service in Maastricht, the Netherlands. Konings was involved with the development of analytical methods for the analysis of vitamins in food and food products. In 1996 he started his PhD study “Dietary folates in human nutrition” in collaboration with the departments of Human Biology and Epidemiology of Maastricht University. During this study, which he completed in 2001, he obtained a MSc‐degree in epidemiology. Konings has worked as Senior Scientific Staff Officer in the department of Research & Development of the Food and Consumer Product Safety Authority (VWA) in the in the Netherlands, as Scientific Officer at the Data Collection and Exposure Unit for the European Food Safety Authority (EFSA) in Parma, Italy, and since June 2009, in a position in the Quality and Safety Department of the Nestlé Research Center in Lausanne, Switzerland. Konings is convenor of a working group on vitamins & carotenoids of the European Committee for Standardization (CEN), a member of the International Dairy Federation (IDF), Standing Committee Analytical Methods for Additives and Contaminants, and participates in Codex Committee for Methods of Analysis and Sampling (CCMAS). In 2012 he was appointed convenor for ISO TC 34 Working Group 14 on Vitamins, carotenoids, and other nutrients. He has (co)authored more than 30 scientific publications.
2015 AOAC MID YEAR MEETING MARCH 19, 2015 STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS– LIST OF REGISTERED ATTENDEES
Name
Affiliation
Country
MARTIN ALEWIJN
RIKILT
Netherlands
BRAD BARRETT
SCIEX
USA
ROBERT CLIFFORD
Shimadzu Scientific Instruments, Inc.
USA
Florida Department Of Agriculture And Consumer Services
JO MARIE COOK
USA
ERIN CROWLEY
Q Laboratories, Inc.
USA
JONATHAN DEVRIES
Medallion Laboratories / General Mills
USA
ROBERT DONOFRIO
NSF International
USA
KELLEY FREED
Kellogg Company
USA
QIAN GRAVES
FDA - CFSAN
USA
GREGORY HOSTETLER
Perrigo / PBM Nutritionals
USA
WJ HURST
Hershey Foods Corp
USA
GREG JAUDZEMS
Nestle USA, Inc
USA
BERT KLARENBEEK
FrieslandCampina Domo
Netherlands
JOSH MESSERLY
Eurofins Nutrition Analysis Center
USA
PAUL MILNE
Keurig Green Mountain, Inc.
USA
WILLIAM MINDAK
FDA/CFSAN
USA
JEFFREY MOORE
US Pharmacopeia (USP)
USA
JENNY NELSON
Agilent Technologies, Inc.
USA
LAWRENCE PACQUETTE
Abbott Nutrition
USA
MELISSA PHILLIPS
NIST
USA
TOM PHILLIPS
MD Department Of Agriculture
USA
RICK REBA
Nestle USA, Inc.
USA
SHAUNA ROMAN
RB (Reckitt Benckiser)
USA
JOE ROMANO
Waters Corporation
USA
YVONNE SALFINGER
Association Of Public Health Laboratories
USA
Name
Affiliation
Country
BRIAN SCHANEBERG
Starbucks Coffee Company
USA
BROOKE SCHWARTZ
Brooke Schwartz Consulting
USA
OLGA SHIMELIS
SUPELCO/Sigma-Aldrich
USA
NA SHU
Abbott Laboratories
Peoples Republic of China
CHRISTOPHER SMITH
The Coca-Cola Company
USA
DARRYL SULLIVAN
Covance Laboratories
USA
JOHN SZPYLKA
Silliker Laboratories
USA
JOSEPH THOMPSON
Abbott Laboratories
USA
WAYNE WARGO
Abbott Nutrition
USA
LAURA WOOD
NIST
USA
JASON WUBBEN
Archer Daniels Midland Company
USA
JUPITER YEUNG
Nestle Nutrition
USA
JOSEPH ZHOU
Sunshineville Health Products, Inc
USA
JOYCE ZHU
Jamieson Laboratories
MARTIN ALEWIJN
RIKILT
Netherlands
BRAD BARRETT
SCIEX
USA
ROBERT CLIFFORD
Shimadzu Scientific Instruments, Inc.
USA
Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM) Chair: Dr. Erik Konings, Nestlé
March 16, 2015 | 1:00PM – 5:00PM EST Registration Opens at 12:00 p.m.
Hilton Washington DC North | 620 Perry Parkway | Gaithersburg, Maryland, 20877
A G E N D A
I.
Welcome and Introductions (1:00pm-1:15pm) SPSFAM Chair Erik Konings will lead a review AOAC Policies & Procedures and Approval of September 7, 2014 Meeting Minutes. Working Group Update (1:15pm – 1:45pm) Erik Konings will provide an update on the meat species initiative and Jim Bradford will review brief the panel and lead a discussion on the new Working Group model. Heavy Metals Speciation SMPR Presentation* (1:45pm-2:45pm) Heavy Metals Speciation Working Group Chair Christopher Smith will present the draft Standard Method Performance Requirements ℠ (SMPRs) for review and adoption by SPSFAM. Heavy Metals ERP Update (2:45pm – 3:15pm) SPSFAM Heavy Metals ERP Chair Rick Reba will provide an update on the activities of the Heavy Metals Expert Review Panel. AOAC ISPAM Update / Micro Discussion (3:30pm – 4:30pm) AOAC ISPAM Chair Erin Crowley will update the panel on the activities of ISPAM, AOAC’s microbiology focused stakeholder panel. SPSFAM Chair Erik Konings will lead a discussion on where the needs of the two panels may overlap. Next Steps and Adjourn (4:30pm – 5:00pm) Accounting for the day’s discussions, SPSFAM Chair Erik Konings will review the next steps for SPSFAM and adjourn the meeting.
II.
III.
IV.
V.
VI.
*This item requires a vote
V 0.3 02/27/2015
Draft, Do Not Distribute
AOAC Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM)
Meeting Minutes Sunday, September 7, 2014, 1:00 p.m. – 6:00 p.m. EDT
Attendees (Present during all or part of the meeting) :
Stakeholder Panel Members:
Arti Arora, The Coca-Cola Company (Co-Chair) Erik Konings, Nestle (Co-Chair) Martin Alewijn, RIKILT Stan Bacler, Health Canada Brad Barrett, AB SCIEX Sneh Bhandari, Silliker Justin Bickford, ELISA Technologies Christopher Blake, Nestec Ltd. David Boaz, Caravan Ingredients Joe Boison, CFIA Michelle Briscoe, Brooks Rand Labs Michael Brodsky, Brodsky Consultants Amy Brown, FL. Dept. of Agriculture Nick Cellar, Abbott Marti Cenky, Abbott Robert Clifford, Shimadzu Mark Collison, Archer Daniels Midland Jeffery Cottenet, Nestle Jo Marie Cook, FL Dept. of Agriculture Jonathan DeVries, Medallion Labs/General Mills Aurelie Dubois, International Dairy Federation Milda Embuscado, McCormick John Finley, Louisiana State University
David Kennedy, Phenomenex Bert Klarenbeek, FrieslandCampina Domo Stephen Lock, AB SCIEX Katerina Mastovska, Covance Josh Messerly, Eurofins Deepali Mohindra, Thermo Scientific Cory Murphy, CFIA Maria Ofitserova, Pickering Labs Lawrence Paquette, Abbott Shang-Jing Pan, Abbott Melissa Phillips, NIST Shay Phillips, Mead Johnson Nutrition Tom Phillips, MD Dept of Agriculture Eric Poitevin, Nestle Joe Romano, Waters Steve Royce, Agilent Brian Schaneberg, Starbucks Charles Schneider, PerkinElmer Brooke Schwartz, Brooke Schwartz Consulting Tom Seipelt, Abbott Jeffery Shippar, Covance Olga Shimelis, SUPELCO Christopher Smith, The Coca-Cola Company Darryl Sullivan, Covance Laszlo Torma, Pickering Laboratories Wayne Wargo, Abbott Paul Wehling, General Mills Petra Wissenberg, Danone Asia / GFSI Laura Wood, NIST Joyce Zhu, Jamieson Laboratories Richard Zywicki, Covanca Lars Reimann, Eurofins John Reuther, Eurofins
Pamela Gilliland, Nestle USA, Inc. Jasmine Hagan, ELISA Technologies Michael Hauer, Thermo Scientific
Norma Hill, US Treasury Melissa Holskey, Abbott
Gregory Hostetler, Perrigo / PBM Nutritionals Harvey Indyk, Fonterra Cooperative Group Ltd. Greg Jaudzems, Nestle USA, Inc. George Joseph, AsureQuality
AOAC Staff:
Jim Bradford Christopher Dent Dawn Frazier Nora Marshall
Alicia Meiklejohn Anita Mishra Tien Milor Deborah McKenzie
1
AOAC Stakeholder Panel on Strategic Food Analytical Methods Meeting Minutes v0.3
Draft, Do Not Distribute
Meeting Minutes
I.
Welcome and Introductions
Arora opened the meeting and all attendees were introduced. Konings reviewed the AOAC Policies and Procedures in the meeting book and also the meeting minutes from the SPSFAM session on March 20, 2014. • MOTION to approve the meeting minutes from the March 20, 2014 SPSFAM Meeting. (Konings/Bhandari) o 21 in favor, 0 opposed, 1 abstain. The motion carried. Arora introduced guest speakers David Acheson, Robert Brackett and Samuel Godefroy. Acheson took the floor to begin the panel discussion on food safety. Acheson gave a presentation 1 on food safety challenges, the intersection of food and health, and approaches to managing risks. Brackett gave a presentation 2 on microbiological issues with food safety, including trends in regulatory philosophy, trends in views on food borne pathogens, and trends in analysis and testing. Godefroy concluded with a presentation 3 on the complexity of the food supply chain, globalization and its consequences, emerging food chemical safety challenges, allergen management and nutrition safety. Acheson moderated a discussion between Panel members and SPSFAM participants on the several areas presented. Panel Discussion on Food Safety
II.
III.
Global Food Safety Initiative
Wissenberg took the floor to provide a presentation 4 on the Global Food Safety Initiative and the efforts of its Food Fraud Think Tank in particular. A stakeholder asked if the guidelines being developed cover validation methods for the processes and Wissenberg noted that this would be the next step. Sullivan highlighted that the challenge will be how to validate these types of methods. Stakeholders agreed that this field presents opportunities and challenges.
Working Group Launch: Heavy Metals Speciation
IV.
Smith took the floor to give a presentation 5 on the launch of a new SPSFAM Heavy Metals Speciation Working Group as requested by the SPSFAM Advisory Panel. Smith updated the panel on the progress of the previous Heavy Metals Working Group and advised that an ERP will be held for the final methods in review before the end of 2014. Smith then proposed a fitness for purpose statement to support the development a Heavy Metals Speciation SMPR. During the discussion, Gilliland made the following motion:
1 Attachment 1 - Acheson Presentation 2 Attachment 2 – Brackett Presentation 3 Attachment 3 –Godefroy Presentation 4 Attachment 4 – Wissenberg Presentation 5 Attachment 5 – Smith Presentation
2
AOAC Stakeholder Panel on Strategic Food Analytical Methods Meeting Minutes v0.3
• MOTION to ensure that the Heavy Metals Working Group will start off with Arsenic as a target. (Gilliland/Murphy) 19 in favor, 3 against, 0 abstain. The motion carried. Discussion continued on the fitness for purpose statement. The fitness for purpose statement proposed read as follows: A method for the determination of the major chemical species present in selected food matrices of any of the following elements: Arsenic, Mercury, Cadmium or Lead.
After further discussion this was modified to the following:
Methods for the determination of the major toxic chemical species present in selected food and beverage matrices of any of the following elements: Arsenic, Mercury, or Chromium.
• MOTION to accept the Fitness for Purpose Statement for Heavy Metals Speciation as revised. (Smith/Briscoe) 21 in favor, 0 against, 0 abstain. The motion carried.
V.
Proposal for Working Group on Meat Species Authenticity
Konings introduced Delatour, who took the floor and gave a presentation 6 on the need for a working group on Meat Species Authenticity. Delatour reviewed the history of food fraud, the motivations for food fraud, its prevalence, and the challenges faced in preventing it. Konings asked for a straw poll to gauge interest in approaching this topic within SPSFAM and a significant number of attendees signaled support for this effort. Konings advised that the final decision will rest with the SPSFAM Advisory Panel. Konings led a discussion on SPSFAM priorities for recommendation to the SPSFAM Advisory Panel. Using the concepts developed at the March 2014 SPSFAM meeting as a starting point, the panel agreed to recommend the following topics to the Advisory Panel: • Food Fraud: Meat/Fish Species • Microbiology: Fast methods for pathogens; fast methods for quantification • General: Validation guidelines for non-targeted analysis; Guidelines for Laboratory Sample Preparation Schwartz, as Chair of the AOAC ISPAM/FP panel, recommended that a joint group be convened to discuss overlap between the two stakeholder panels, in particular with regards to rapid microbiological methods. Recommendation on Future Priorities
VI.
VII.
Adjourn
Konings announced that the next meeting of the SPSFAM will be during the week of March 16 in Gaithersburg, Maryland and that all presentations from this session will be made available online. The meeting was adjourned at approximately 6:00 p.m. EDT.
6 Attachment 6 – Delatour Presentation
September 7,2014 SPSFAM Meeting Meeting Minutes V0.2
Attachments:
Attachment 1: Acheson Presentation Attachment 2: Brackett Presentation Attachment 3: Godefroy Presentation Attachment 4: Wissenberg Presentation Attachment 5: Smith Presentation Attachment 6: Detalour Abstract and Presentation
September 7,2014 SPSFAM Meeting Meeting Minutes V0.2
Working Group (WG) Initiative • AOAC Board of Directors initiates WG Initiative on December 9, 2014 • Individual or entity who expresses a need for a method • WG may be funded and formed with assistance of AOAC • WG will develop SMPR to present to an existing stakeholder panels for review
Why the new WG Initiative? • Offers companies the opportunities to solve challenges without waiting on priorities of existing stakeholder panels • WG’s funded by current OA’s and new companies interested in solving problems
AOAC INTERNATIONAL STAKEHOLDER PANEL ON STRATEGIC FOOD ANALYTICAL METHODS
Christopher Smith Heavy Metals Speciation Working Group March 16, 2015
Hilton Washington DC North, Gaithersburg, Maryland, 20877
Fitness for Purpose
Methods for the determination of the major toxic chemical species present in selected food and beverage matrices of any of the following elements: Arsenic, Mercury, or Chromium.
Heavy Metals Speciation Working Group Members
•Christopher Smith, Coca-Cola •Sneh Bhandari, Silliker •Christopher Blake, Nestec Ltd. •Walter Brandl, Silliker •Michelle Briscoe, Brooks Rand Labs •France Cho, Maxxam Analytics •Robert Clifford, Shimadzu •Mark Collison, ADM •Patricia Faison, Kellen Company •Gergory Hostetler, Perrigo / PBM •Erik Konings, Nestle Research Center K i i L i k USP • r st e aurv c , •John Lupean, OMIC USA •Farzaneh Maniei, Coca-Cola
•Josh Messerly, Eurofins •William Mindak, FDA •Cory Murphy, CFIA •Jenny Nelson, Agilent •Rick Reba, Nestle •Steve Royce, Agilent •Brian Schaneberg, Starbucks •Kathryn Stanley, ADM •Laura Wood, NIST •Jason Wubben, ADM •Yang Zhou, Eurofins Ri h d Z i ki C • c ar yw c , ovance
Heavy Metals Speciation Working Group Work to Date
• 2 teleconferences (October 2014 – November 2014)
• 1 SMPR Drafted
• Public comment period (December 15, 2014 – January 30, 2015) • SMPRs made ready for SPDS review and approval
SMPR Key Points
SMPR Key Points
SMPR Key Points
Comments Submitted (if any)
Comments (Justification of Change(s))
Not sure if it is clear of not but the LOQ for total inorganic arsenic, either from the sum of AsIII + AsV or as Total Inorganic, should both be < 10 ppb.
Motion
• Move to accept the Standard Method Performance Requirements for Arsenic as presented.
DRAFT AOAC SMPR 2015.XXX; Version 6; February 27, 2015 1 2 Standard Method Performance Requirements for 3 Quantitation of Arsenic Species in Selected Foods and Beverages 4 5 Intended Use: Reference method for dispute resolution.
6 7
1 Purpose 8 9 AOAC Standard Method Performance Requirements SM SMPR’s describe the minimum 10 recommended performance characteristics to be used during the evaluation of a method. The 11 evaluation may be an on-site verification, a single-laboratory validation, or a multi-site 12 collaborative study. SMPRs are written and adopted by AOAC Stakeholder Panels composed of 13 representatives from the industry, regulatory organizations, contract laboratories, test kit 14 manufacturers, and academic institutions. AOAC SMPRs are used by AOAC Expert Review 15 Panels in their evaluation of validation study data for method being considered for Performance 16 Tested Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria for 17 verification at user laboratories. [Refer to Appendix F: Guidelines for Standard Method 18 Performance Requirements , Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th 19 Ed., AOAC INTERNATIONAL, Gaithersburg, MD, USA.] 22 23 Quantitation of arsenic (As) species and/or total inorganic arsenic in selected food and 24 beverage matrixes (see table I for a list of selected foods.) 27 28 Separation of species by either ion chromatography (IC or high-performance liquid 29 chromatography (HPLC and detection of separated species by inductively coupled plasma-mass 30 spectrometry (ICP-MS). 33 34 Arsenic Species .— For the purposes of this SMPR arsenic species includes the compounds listed 35 in table 2. 36 37 Limit of quantitation (LOQ) .—The minimum concentration or mass of analyte in a given matrix 38 that can be reported as a quantitative result. 39 40 Quantitative method. —Method of analysis which response is the amount of the analyte 41 measured either directly (enumeration in a mass or a volume), or indirectly (color, absorbance, 42 impedance, etc.) in a certain amount of sample. 43 44 Repeatability .—Variation arising when all efforts are made to keep conditions constant by using 45 the same instrument and operator and repeating during a short time period. Expressed as the 46 repeatability standard deviation (SDr); or % repeatability relative standard deviation (%RSDr). 20 21 2 Applicability 25 26 3 Preferred Analytical Technique 31 32 4 Definitions
47 48
1
Reproducibility .—The standard deviation or relative standard deviation calculated from 49 among-laboratory data. Expressed as the reproducibility standard deviation (SDR); or % 50 reproducibility relative standard deviation (%RSDR). 51 52 Recovery .—The fraction or percentage of spiked analyte that is recovered when the test 53 sample is analyzed using the entire method. 54 55 Total Inorganic Arsenic- The sum of arsenite and arsenate either reported as the sum of the 56 individual species or converted into one form and reported as the total.
57 58 59 60 61 62 63
5 Method Performance Requirement s
See table 3.
6 System suitability tests and/or analytical quality control 64 65 Suitable methods will include blank check samples, and check standards at the lowest point 66 and midrange point of the analytical range, and a protocol to demonstrate suitability.
67 68 69 70
7 Reference Material(s
Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F : 71 Guidelines for Standard Method Performance Requirements [19 th Edition of the AOAC 72 INTERNATIONAL Official Methods of Analysis (2012]. Available at: 73 http://www.eoma.aoac.org/app_f.pdf 76 77 Validation data must include at a minimum arsenite and arsenate, or total inorganic arsenic, in 78 the food types listed in table 1 that apply to the candidate method for First Action Official 79 Methods of Analysis approval. It is not required to represent every arsenic species or food type. 80 81 Appendix D : Guidelines for Collaborative Study Procedures To Validate Characteristics of a 82 Method of Analysis; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis 83 (2012. Available at: http://www.eoma.aoac.org/app_d.pdf 74 75 8 Validation Guidance
84 85 86 87 88 89 90 91 92 93 94
9 Maximum Time-To-Result
No maximum time to result.
2
95 96 97 98 99
Table 1: Selected Foods
rice
rice-based products
baby food –cereals
infant formula
100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120
cereal
fruit juice
apple juice grape juice
fish oil-based supplements
seafood
finfish
shellfish seaweed
Table 2: Arsenic Species
arsenite (As(III)) arsenate (As(V))
monomethylarsonic acid (MMA) dimethylarsinic acid (DMA)
arsenobetaine (AsB)
total inorganic arsenic (I-As)
3
121 122 123
Table 3: Method performance requirements
Minimum acceptance criteria
Parameter
Analytical range
10 ppb
1 ppm*
–
Limit of quantitation (LOQ)
< 10 ppb*
10 – 100 ppb
60 – 115 %
Recovery
≥ 100 ppb – 10 ppm
80 – 110 %
≤ 10 – 50 ppb
≤20 %
Repeatability (RSDr)
≥ 50 – 300 ppb
≤13 %
≥ 300ppb – 1 ppm
≤12 %
≤ 10 – 50 ppb
≤30 %
Reproducibility (RSDR)
≥ 50 – 300 ppb
≤20 %
≥ 300 ppb – 1 ppm
≤18 %
* Arsenic (As) species and/or total inorganic arsenic in selected food and beverage matrixes.
124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142
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Overview of International Stakeholder Panel on Alternative Methods (ISPAM)
March 16, 2015 1:00 PM – 5:00 PM EDT
Erin Crowley Chair, ISPAM Microbiology R&D Supervisor, Q Laboratories, Inc .
Overview
• Driven and supported by AOAC Organizational Affiliates and contributing members who participate in the AOAC Research Institute Program • Purpose and Scope • Develop harmonized internationally accepted standard validation , guidelines for alternative chemical and microbiological methods by leveraging global networks of experts to reach consensus on an analytical validation protocol
ISPAM Accomplishments: Microbiology
• Approved harmonized approaches for several testing parameters – Number of levels/samples/fractional positives – Results analysis/criteria/statistical analysis – Number of data sets for collaborative study/sample size • Approved Food Classification Table
ISPAM Current Work
• ISPAM approved new initiatives in M h 2013 arc
– Develop guidelines for method verification related to “All Foods Claim” Develop standards in the area of Fresh Produce –
ISPAM Sub‐Group on Validation and Verification of “All Foods Claim”
– ISPAM recommended that developers of analytical methods follow ISO 16140 2 Draft Annex A ‐ , Guidance on food matrices and food categories for method validation, as a guidance for choosing food categories to make a “broad range of foods” claim • ISPAM agreed to adopt the ISO 16140 1 Part 1: ‐ “Terminology of method validation” working definitions for “validation” and “verification ”
AOAC New Initiative on Fresh Produce
Fresh Produce Project Overview
• The produce industry was identified as a community that is underserved by AOAC • Project adopted by ISPAM in 2013 and funded by AOAC Research Institute • Project kicked off during 2013 AOAC Annual Meeting • Initial focus : Salmonella in leafy greens • Initial goals: – Develop best practices for sampling Salmonella in leafy greens fields – Develop an SMPR for Salmonella detection methods for leafy greens – Integrate SMPR and sampling best practices
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Stakeholder Participation
Chair, Fresh Produce Stakeholder Panel
David Acheson The Acheson Group LLC
Co-Chair, Fresh Produce Stakeholder Panel
Brooke Schwartz Brooke Schwartz Consulting
Chair, Working Group on Sampling Plan Chair, Working Group on SMPR
David Gombas United Fresh Produce Association
Erin Crowley Q Laboratories
for Salmonella
8
Progress Since 2013 Annual Mtg
• Identified and engaged subject matter experts and stakeholders
• Formed 2 Working Groups
Working Group on Sampling Plan Working Group on SMPR for Salmonella
• Prioritized first crops, targets and applications D t i d iti l t • e erm ne cr ca parame ers • Met with key produce stakeholder groups to solicit feedback on issues and process, including – United Fresh Members – FDA / CFSAN
7
Stakeholder Participation
ISPAM Fresh Produce by Broad Perspectives academia government industry laboratory
2%
5%
14%
79%
9
Stakeholder Participation
ISPAM Fresh Produce by Specific Perspective
consultant
FP producer
contract research organization
method developer academia/research
retailer
state laboratory state government
national government
2%
6% 8%
10%
2%
21%
18%
14%
19%
10
Salmonella SMPR Working Group
Drafted SMPR Document: Detection of Salmonella species in romaine lettuce and baby spinach Submitted for public comment Reviewed and addressed comments 66 comments received between Jun. 25 to Jul. 25, 2014 Prepared SMPRs for ISPAM/FP review and approval SMPR Key elements:
Applicability Definitions Method performance criteria Inclusivity / Exclusivity
Motion Approved • Motion to accept the SMPRs for Detection of Salmonella species in romaine lettuce and baby spinach as presented. • Unanimous approval on 9/6/14
Sampling Plan Working Group
• Evaluated existing sampling plans • Determined scope of first plan: Field sampling of Romaine lettuce for detection of Salmonella • Developed outline and draft white paper (in progress) : Considerations for Field Sampling Romaine Lettuce for Microbiological Testing Goals of white paper: – Provide recommendations and best practices regarding number, l i d ll i f l ocat on an co ect on o test samp es – Serve as a guideline for developing sampling plans – Have ability to be adapted and applied to additional products, organisms and stages in growing / distribution chain
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Sampling Plan White Paper
Outline • Objectives scope audience , , • Description of the challenge • Considerations in field sampling • Considerations in developing a sampling plan • Recommendations for a sampling plan – For routine sampling – For cause (suspected contamination) • Alternative sampling procedures • Research needs
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Working Group Field Trip
• Participants of Fresh Produce Sampling Plan Working Group toured Salinas Valley produce fields and processing facilities • Team observed in‐field sampling and harvesting activities, and processing / packaging of fresh and bagged products • Products included leafy greens and strawberries • Tour organized by David Gombas, United Fresh, and hosted by – Church Brothers – Naturipe Berry Growers – Earthbound Farm – Dole Fresh Vegetables
7
Next Steps‐ ISPAM
• Annual Meeting 2014 – Brainstorm Ideas on Future Initiatives
– 10 different topics proposed – Approved WG development of Harmonization of BAM and ISO Salmonella methods • Chaired by Tom Hammack‐ FDA‐CFSAN • 10 member group as of 9/6
• Review of validation guidelines for Rapid Confirmation and Identification Methods
Next Steps‐ ISPAM
Presentation at Mid‐Year Meeting
Overview of Standards for the Detection of Viruses Patrice Arbault, Nexidia; – Challenges to Testing for Foodborne Viruses in Food samples: Current Standard Methods and Future Directions – • Efi Papafragkou, FDA, CFSAN – ISO Technical Specifications for Viruses: How are they Relevant to Service Laboratories and Assay Manufacturers – • Fabienne Loisy, CEERAM (European Centre for Expertise and Research on Microbial Agents);
– SPADA and the Development of Standard Method Performance Requirements (SMPR) for Smallpox – • Scott Coates, AOAC Chief Scientific Officer
Next Steps‐ Fresh Produce • Identify next product for development of SMPR and expansion of Sampling Plan – Tomatoes? – Fresh herbs? – Peppers?
E L d i FP I d t • ngage ey p n on ea ers n n us ry to expand on ideas and collaborations K O i i
Collaborations with SPSFAM • Development of rapid methods – Unique client needs – Analyte/Target combination not currently approved – Advantages
‐ Method Developers in ISPAM ‐ Potential Customers in SPSFAM
High Priorities
• From Advisory Panel Call 2‐19‐15 1. Same Shift tests (< 8 hrs) a. Salmonella
b. Shiga‐toxin producing E. coli (STEC) c. Listeria monocytogenes 2. Rapid Confirmation Tests‐ < 24 hrs a. Maldi‐TOF b. Biochemical 3. Location of Analyses a. Pathogen testing on‐site
Next Steps • Engage Corporate Supporters • Form Working Groups • Develop SMPRs
AOAC Acronyms and Abbreviations
AMDL
acceptable minimum detection level
AOAC INTERNATIONAL (AOAC formerly stood for Association of Official Analytical Chemists , but long-name no longer used)
AOAC
CSO
chief scientific officer
ERP
expert review panel
ISO
International Organization for Standardization
LOD
limit of detection
LPOD
laboratory probability of detection
NGO
non-governmental organization
Official Methods of Analysis , frequently pronounced like “o maa”
OMA
OMB
Official Methods Board
POD
probability of detection
Performance Tested Methods
PTM
RI
AOAC Research Institute
RSDR
Relative Standard Deviation of Reproducibililty, sometimes referred to as “RSD big R”. The variation between laboratories. Relative Standard Deviation of Repeatability, sometimes referred to as “RSD little R”. The within laboratory variation, also called precision.
RSDr
SPSFAM
Stakeholder Panel on Strategic Food Analytical Methods
Standard Method Performance Requirement , frequently pronounced as in “smipper”.
SMPR
AOAC Stakeholder Panel Voting Members
with AOAC can provisionally approve an alternate from those in attendance to assure balance and lack of dominance. For stakeholder panels with scopes including diverse topics, the voting member representatives may be rotated to include other stakeholders for successive meetings to ensure a lack of dominance by any particular stakeholder. Approval Process AOAC works with the chair of the stakeholder panel and potentially other key stakeholders to develop a proposed representative voting member panel. Following AOAC policies and procedures, the proposed voting members and documentation are submitted to the AOAC Official Methods Board (OMB) for review and approval. The OMB’s review ensures that the proposed panel is balanced in interests and perspectives representing the stakeholder panel and a lack of dominance. Roles and Responsibilities Every stakeholder has a voice and every stakeholder is entitled to state his/her or organizational perspective(s). This is due process. In developing AOAC standards, stakeholder consensus is demonstrated by 2/3 vote (67%) in favor of a motion to adopt a standard. It is important to note: Individual voting members do not have any additional weight, voice or status in stakeholder deliberations than other stakeholders. The role of the voting members is to demonstrate the consensus of the stakeholder panel. Voting members may vote in favor or against any motion and/or they may abstain. Stakeholder panel chair will moderate voting process. AOAC carefully documents the vote. It is important for voting members to be in the room during the time for voting. It is also important for voting members to inform the chair of his/her inability to serve as a voting member.
AOAC INTERNATIONAL (AOAC) assembles stakeholder panels to develop voluntary consensus standards. While AOAC maintains transparency and openness in accordance with national and international guidance and regulations for standards development and its policies and procedures for assembling stakeholder panels, its policies and procedures also ensures that there is a balance of interests and perspectives in achieving consensus of the stakeholder panel. Due Process and Balance All AOAC stakeholder panels are diverse and can vary in size. Where a stakeholder panel is not balanced or if it is significantly large whereby consensus of the general assembly may be impractical, a balanced representative voting panel will be used to demonstrate consensus. AOAC encourages ALL stakeholders to participate in deliberations during stakeholder panel meetings and working group meetings, in addition to participating during any posted comment periods. To ensure that there is a balance of interests and perspectives, a representative subset of the stakeholder panel, the voting members, is selected to reach consensus for the development of AOAC voluntary consensus standards. Composition Voting members represent the perspectives of the larger stakeholder panel. The voting members consist of no more than ¼ to 1/3 of the total number of stakeholders in registered. Primary and secondary representative voting members are approved. Every attempt is made to approve a panel of voting members that represents all perspectives of the stakeholder panel. In the event of a primary voting member is not able to attend, and no alternate has been approved, the stakeholder panel chair, working
AOAC INTERNATIONAL STAKEHOLDER PANEL ON DIETARY SUPPLEMENTS (SPDS) WORKING GROUP CHAIR & MEMBERS
VOLUNTEER ROLE DESCRIPTION
POSITION TITLE:
Working Group Chair and Members, AOAC SPDS Working Group
POSITION CLASSIFICATION:
Volunteer SPDS Chair
REPORTS TO:
DATE PREPARED:
March 13, 2014
POSITION SUMMARY: In keeping with the mission of AOAC INTERNATIONAL and the goals of the Stakeholder Panel on Dietary Supplements (SPDS), working group chairs will lead their working group in the development of standards (or other tasks as assigned by the SPDS chair) for specific priority ingredients as defined by the SPDS Advisory Panel. Working group chair(s) will work with AOAC staff and stakeholders to meet the working group’s goals and disseminate recommendations to the stakeholder panel and community at-large. The working group may hold meetings in person and/or via teleconference (web and video) to complete its work. The chair of the working group will moderate the working group discussions, assist in scheduling the meetings, and report the working group’s recommendation back to SPDS. Working group chairs will work with AOAC to formulate the working group’s recommendations into motions for SPDS’s consideration. ELIGIBILITY CRITERIA FOR SPDS WORKING GROUP CHAIR: Must be a key expert and/or thought leader in dietary supplements and the technologies used for priority ingredients as assigned for the specific working group. Must have the recommendation of the SPDS Chair. WORKING GROUP CHAIR RESPONSIBILITIES: Chair meetings of the working group, moderate discussions of the working group and work with AOAC staff to facilitate working group’s work.
Work with AOAC staff and SPDS chair to identify working group members, any additional expertise/resources needed facilitate the work of the working group. Work as a team member and also independently. Present an overview on the specified priority ingredient under consideration including, but not limited to, regulatory implications, and public health and public safety challenges with methodology. Prepare a draft fitness for purpose statement for specified priority ingredient and technology to present to SPDS for consideration. Work with AOAC staff to reconcile actions and outcomes of working group deliberations. Using AOAC guidance to reconcile comments and address questions on SMPR. Present working group recommended SMPR to SPDS for review and approval. Work with AOAC staff and stakeholders to draft and review relevant methodology and working group documentation. Draft SMPR white paper for publication. Perform duties and reviews in timely fashion. Other tasks as agreed upon by working group chair, SPDS chair and AOAC staff. DUTIES AND RESPONSIBILITIES OF THE SPDS WORKING GROUP MEMBERS: The working group will meet either in person and via teleconference, web conferencing or by other means of communication. All communication and meetings of the working group must be facilitated through AOAC
Page 1 SPDS Volunteer Role Description – Working Groups Version 1
standard method performance requirements (SMPR), and additional work as tasked. 1) AOAC Fitness for Purpose Statement Guideline 2) Appendix F: Guidelines for Standard Method Performance Requirements 3) Appendix K: Guidelines for Dietary Supplements and Botanicals STAFF LIASON: AOAC will assign staff to facilitate the work of the working group. TERMS OF REVIEW: This document will be reviewed biannually by the SPDS Chair and AOAC staff.
staff. The working group’s tasks will include developing standard method performance requirements (SMPRs), review of methodology, identifying expertise and other as may be requested by the SPDS chair. Working groups are not required to vote, but to show general consensus for its recommendations. The groups should meet to discuss their objectives and complete their assigned tasks. Individuals on the working groups may be tasked with their own action items and responsibilities. More than one meeting and one round of communication may be required to complete the working group’s tasks. All working group participants are expected to contribute and are expected to have completed the SMPR Education Session. AOAC staff will document all working group decisions and actions. AOAC RESOURCES: Referencing AOAC guidance documentation to assist in drafting the fitness for purpose statement,
DATES REVISED:
Page 2 SPDS Volunteer Role Description – Working Groups Version 1
Voting Panel – A vetted, representative, and balanced subset of the assembled stakeholders. Ideally the number of voters represents 1 / 4 to 1 / 3 of the assembly. Voting Guidelines – A. motions to create a consensus based standard (ex: voting on fitness for purpose statements or Standard Method Performance Requirements) require a 2/3 vote for the motion to carry. B. Any other motion (ex: votes to clarify information for working groups, set priorities or direction, etc.) requires a majority vote to carry.
Expert Review P anel Working Group Stakeholder Panel
Voting Panel – 7 – 10 vetted experts YƵŽƌƵŵ Ͳ dŚĞ ƉƌĞƐĞŶĐĞ ŽĨ ϳ ŵĞŵďĞƌƐ Žƌ Ϯͬϯ ŽĨ ƚŽƚĂů ǀĞƚƚĞĚ ZW ŵĞŵďĞƌƐŚŝƉ͕ ǁŚŝĐŚĞǀĞƌ ŝƐ ŐƌĞĂƚĞƌ͘
Voting Guidelines – Motions to adopt a First Action Official Method SM of Analysis carry by unanimous vote on first ballot. If not unanimous, negative votes must delineate scientific reasons, and can be overridden by 2/3 of voting ERP members after due consideration. Dissenting opinions are recorded.
Voting Panel – There is no formal voting panel. Any interested and knowledgeable party may participate. Working groups sole purpose is to provide recommendations to stakeholder panels. Voting Guidelines – majority vote carries all motions, dissenting opinions considered by assembly and recorded.
Helpful Definitions & Terminology Ǥ ǡ Ǥ ȋ Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 151 ȌǤ Ǥ Ǥ Ǥ ȋ Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 237). ȋ ȌǤ Ǥ Ǥ ȋ Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 1) Ǥ Ǥ Ǥ (Fundamentals of Parliamentary Law and Procedure, 3 rd edition. pp. 1Ǧ2). ǡ ǡ ǡ ǡ ǯ Ǥ (Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 2). ǡ ǡ Ǥ (Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 2). Ǥ (Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 2). ǡ ǡ ǡ Ǥ Ǥ (Fundamentals of Parliamentary Law and Procedure, 3 rd edition. p. 2).
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Appendix W
POLICY AND PROCEDURES ON VOLUNTEER CONFLICT OF INTEREST
Statement of Policy
While it is not the intention of AOAC INTERNATIONAL (AOAC) to restrict the personal, professional, or proprietary activities of AOAC members nor to preclude or restrict participation in Association affairs solely by reason of such activities, it is the sense of AOAC that conflicts of interest or even the appearance of conflicts of interest on the part of AOAC volunteers should be avoided. Where this is not possible or practical under the circumstances, there shall be written disclosure by the volunteers of actual or potential conflicts of interest in order to ensure the credibility and integrity of AOAC. Such written disclosure shall be made to any individual or group within the Association which is reviewing a recommendation which the volunteer had a part in formulating and in which the volunteer has a material interest causing an actual or potential conflict of interest. AOAC requires disclosure of actual or potential conflicts of interest as a condition of active participation in the business of the Association. The burden of disclosure of conflicts of interest or the appearance of conflicts of interest falls upon the volunteer. A disclosed conflict of interest will not in itself bar an AOAC member from participation in Association activities, but a three-fourths majority of the AOAC group reviewing the issue presenting the conflict must concur by secret ballot that the volunteer's continued participation is necessary and will not unreasonably jeopardize the integrity of the decision-making process. Employees of AOAC are governed by the provision of the AOAC policy on conflict of interest by staff. If that policy is in disagreement with or mute on matters covered by this policy, the provisions of this policy shall prevail and apply to staff as well. 1. A volunteer who is serving as a committee member or referee engaged in the evaluation of a method or device; who is also an employee of or receiving a fee from the firm which is manufacturing or distributing the method or device or is an employee of or receiving a fee from a competing firm. 2. A volunteer who is requested to evaluate a proposed method or a related collaborative study in which data are presented that appear detrimental (or favorable) to a product distributed or a position supported by the volunteer's employer. 3. A referee who is conducting a study and evaluating the results of an instrument, a kit, or a piece of equipment which will be provided gratis by the manufacturer or distributor to one or more of the participating laboratories, including his or her own laboratory, at the conclusion of the study. 4. Sponsorship of a collaborative study by an interest (which may include the referee) which stands to profit from the results; such sponsorship usually involving the privilege granted by the investigator to permit the sponsor to review and comment upon the results prior to AOAC evaluation. Illustrations of Conflicts of Interest
5. A volunteer asked to review a manuscript submitted for publication when the manuscript contains information which is critical of a proprietary or other interest of the reviewer.
The foregoing are intended as illustrative and should not be interpreted to be all-inclusive examples of conflicts of interest AOAC volunteers may find themselves involved in.
Do's and Don't's
Do avoid the appearance as well as the fact of a conflict of interest.
Do make written disclosure of any material interest which may constitute a conflict of interest or the appearance of a conflict of interest.
Do not accept payment or gifts for services rendered as a volunteer of the Association without disclosing such payment or gifts.
Do not vote on any issue before an AOAC decision-making body where you have the appearance of or an actual conflict of interest regarding the recommendation or decision before that body.
Do not participate in an AOAC decision-making body without written disclosure of actual or potential conflicts of interest in the issues before that body.
Do not accept a position of responsibility as an AOAC volunteer, without disclosure, where the discharge of the accepted responsibility will be or may appear to be influenced by proprietary or other conflicting interests.
Procedures
Each volunteer elected or appointed to an AOAC position of responsibility shall be sent, at the time of election or appointment, a copy of this policy and shall be advised of the requirement to adhere to the provisions herein as a condition for active participation in the business of the Association. Each volunteer, at the time of his or her election or appointment, shall indicate, in writing, on a form provided for this purpose by AOAC, that he or she has read and accepts this policy. Each year, at the spring meeting of the AOAC Board of Directors, the Executive Director shall submit a report certifying the requirements of this policy have been met; including the names and positions of any elected or appointed volunteers who have not at that time indicated in writing that they have accepted the policy. Anyone with knowledge of specific instances in which the provisions of this policy have not been complied with shall report these instances to the Board of Directors, via the Office of the Executive Director, as soon as discovered.
* * * * * *
Adopted: March 2, 1989 Revised: March 28, 1990 Revised: October 1996 Reviewed by outside counsel March 2000 (Fran Dwornik) and found to be current and relevant
Appendix U
ANTITRUST POLICY STATEMENT AND GUIDELINES
Introduction
It is the policy of AOAC INTERNATIONAL (AOAC) and its members to comply strictly with all laws applicable to AOAC activities. Because AOAC activities frequently involve cooperative undertakings and meetings where competitors may be present, it is important to emphasize the on-going commitment of our members and the Association to full compliance with national and other antitrust laws. This statement is a reminder of that commitment and should be used as a general guide for AOAC and related individual activities and meetings.
Responsibility for Antitrust Compliance
The Association's structure is fashioned and its programs are carried out in conformance with antitrust standards. However, an equal responsibility for antitrust compliance -- which includes avoidance of even an appearance of improper activity -- belongs to the individual. Even the appearance of improper activity must be avoided because the courts have taken the position that actual proof of misconduct is not required under the law. All that is required is whether misconduct can be inferred from the individual's activities. Employers and AOAC depend on individual good judgment to avoid all discussions and activities which may involve improper subject matter and improper procedures. AOAC staff members work conscientiously to avoid subject matter or discussion which may have unintended implications, and counsel for the Association can provide guidance with regard to these matters. It is important for the individual to realize, however, that the competitive significance of a particular conduct or communication probably is evident only to the individual who is directly involved in such matters. In general, the U.S. antitrust laws seek to preserve a free, competitive economy and trade in the United States and in commerce with foreign countries. Laws in other countries have similar objectives. Competitors (including individuals) may not restrain competition among themselves with reference to the price, quality, or distribution of their products, and they may not act in concert to restrict the competitive capabilities or opportunities of competitors, suppliers, or customers. Although the Justice Department and Federal Trade Commission generally enforce the U.S. antitrust laws, private parties can bring their own lawsuits. Penalties for violating the U.S. and other antitrust laws are severe: corporations are subject to heavy fines and injunctive decrees, and may have to pay substantial damage judgments to injured competitors, suppliers, or customers. Individuals are subject to criminal prosecution, and will be punished by fines and imprisonment. Under current U.S. federal sentencing guidelines, individuals found guilty of bid rigging, price fixing, or market allocation must be sent to jail for at least 4 to 10 months and must pay substantial minimum fines. Antitrust Guidelines
Since the individual has an important responsibility in ensuring antitrust compliance in AOAC activities, everyone should read and heed the following guidelines.
1. Don't make any effort to bring about or prevent the standardization of any method or product for the purpose or intent of preventing the manufacture or sale of any method or product not conforming to a specified standard 2. Don't discuss with competitors your own or the competitors' prices, or anything that might
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