Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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OFFICIAL METHODS BOARD   TELECONFERENCE Thursday, April 11, 2019   2:00PM – 3:30PM ET 

DRAFT MEETING AGENDA 

Erin Crowley (Q Laboratories), Chair and Meeting Moderator 

I. PRELIMINARY ITEMS a. Welcome and Introductions  (Crowley)

Crowley will invite staff to conduct a roll call of OMB members to ensure a quorum of members are present.  Any proxies will be identified.  The status of the meeting will be determined base on a quorum of OMB members present at the roll call.

b. Call to Order/Announcements/Review of Policy Documents/Terms of Reference  (Crowley) Crowley will call the meeting to order and invite OMB members to review the OMB roster, the AOAC policies and bylaws, the OMB Terms of Reference, and the AOAC Strategic Plan. c. Review of OMB April 11, 2019 Teleconference Draft Agenda*  (Crowley) - p. 1 OMB members are expected to review the draft agenda and suggest any additions or deletions prior to reaching consensus on a final version of the agenda. d. Review of March 11 and 13, 2019 OMB Meeting Draft Minutes*  (Crowley) - p. 3 OMB members are expected to review the draft meeting minutes and suggest any edits or modifications prior and if possible, reaching consensus on a final version of the meeting minutes. II. AOAC MID‐YEAR MEETING OMB LIAISON UPDATES OMB liaisons to the various meeting will provide updates on the meetings they attended, making note of session outcomes, follow ups, and any current or potential technical and/or process issues, challenges, or opportunities for which OMB should be aware and may need to provide guidance, decisions, framework. OMB is expected to share the experience and take as action items as needed. a. ERP for Microbiology  (McMahon, Salfinger, Crowley)

b. Analytical Solutions Forum  (Crowley and any OMB member in attendance) c. Cannabis Analytical Science Program  (Mastovska, Campos Giménez, Salfinger) d. Working Group on Gluten in Oats  (Boison, Crowley) e. ERP for Gluten Assays  (Boison, Crowley) f. Dietary Supplements Roundtable/Town Hall  (Giancaspro) g. Food Authenticity Program  (Boison, Giancaspro, Masotovska, Campos Giménez) h. Quantitative Microbiology Method Validation Acceptance Criteria  (Crowley, McMahon) i. AOAC‐ISO/IDF Meeting  (McKenzie) j. Working Group on Food Allergens  (Crowley, Boison) k. Working Group on Furans  (Mastovska, Campos Giménez, Phillips, Giancaspro) l. Emerging Topics Breakout Session  (Gill, Phillips, Mastovska, Gilliland) m. SPIFAN Meeting  (Gilliland, Mastovska, Phillips, Gill, Campos Giménez) n. ERP for SPIFAN Nutrient Methods  (Gilliland, Mastovska, Phillips, Gill, Campos Giménez)

o. ERPs for Fertilizer Methods  (McKenzie) p. SPADA Working Groups  (McKenzie)

* Items that require or may require a vote during meeting or via e‐ballot

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III. OFFICIAL METHODS BOARD COMMITTEES AND WORKING GROUPS a. Update on Working Group on Certification of Application Notes*  (Coates, McKenzie) - p. 6 Coates and McKenzie to provide examples of application notes with draft technical parameters going through process for OMB’s discussion and decision on the draft policies and procedures. OMB is expected to discuss and reach consensus on the draft policies and procedures. OMB is also expected to consider the outline for technical requirements for endorsement. b. Update on New OMB Member Selection  (Crowley, Roman) Crowley to revisit the number of OMB membership and eligibility for new members for 2019‐2020 term with potential recommendations for path forward.  OMB is expected to discuss the options and endorse a plan forward. c. Committee on Safety  (Crowley, McKenzie) Crowley to continue the discussion on potential options for Committee on Safety.  McKenzie to present an idea for OMB’s consideration. OMB is expected to discuss plans and reach consensus on a plan of action. IV. AOAC EXPERT REVIEW PANELS a. Proposal to Revise the AOAC ERP for Flavanol Methods*  (McKenzie) - p. 43 McKenzie to present a proposal for the revising the ERP for Flavanol Methods.  OMB is expected to review the documentation and reach consensus on the proposal. b. ERP Recommendations for Final Action*  (McKenzie) - p. 159 McKenzie and OMB liaisons to present ERP recommendations for Final Action Status.  The methods are AOAC 2016.01, 2016.07, and 2016.08 (ERP for Microbiology Methods for Foods and Environmental Surfaces); and AOAC 2016.04 (ERP for Heavy Metals Methods) . OMB is being asked to review this information and reach consensus on each ERP’s recommendations. c. Proposal on AOAC Volunteer Experts and Expert Review Panels  (McKenzie) McKenzie is putting forward a proposal to engage volunteer expert reviewers at multiple levels to accommodate the PTM program and the ERPs.  OMB is expected to review and discuss further if needed, and if ready, endorse the proposal for further development.

V. EDITORIAL BOARD & PUBLICATIONS UPDATES a. Updates from the Editorial Board  (Boison, Gill, Phillips) OMB liaisons will provide any updates from the Editorial Board.

b. Updates on Publications  (Rathbone, McKenzie) AOAC staff will provide any relevant updates from the Publications department.

VI. ADJOURNMENT Crowley will entertain a motion to adjourn the meeting.  OMB members are expected to volunteer to move and second the motion. Upon consensus, Crowley will adjourn the meeting.

* Items that require or may require a vote during meeting or via e‐ballot

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OFFICIAL METHODS BOARD MEETING

AOAC MID‐YEAR MEETING – GAITHERSBURG MARRIOTT WASHINGTONIAN CENTER  Monday, March 11, 2019 – 6:00PM – 8:00PM ET – ROOM: Salon F/G  Wednesday, March 13, 2019 – 6:00PM – 8:00PM ET – ROOM: Salon C/D/E  D RAFT M EETING M INUTES

OMB MEMBERS  (present during all or part of the meeting)

Erin Crowley   Joe Boison  

Q Laboratories, Inc.  Independent Consultant  Nestlé Research Centre  US Pharmacopeia  Fonterra Cooperative  Abbott Nutrition 

Chair 

Vice Chair  Member  Member  Member  Member  Member  Member  Member  Member  Member 

Esther Campos Giménez  Gabriel Giancaspro 

Brendon Gill  Don Gilliland 

Katerina Mastovska   Wendy McMahon   Melissa Phillips  Yvonne Salfinger   Sidney Sudberg  (proxy)

Eurofins Food Integrity & Innovation 

Mérieux NutriSciences 

US NIST 

Independent Consultant 

Alkemist 

OMB Members Absent with Regrets  Eric Verdon 

ANSES – Laboratoire de Fougeres 

Member 

Shauna Roman 

Capstone Nutrition 

Past Chair‐Ex‐Officio 

AOAC STAFF  (present during all or part of the meeting) Delia Boyd  Scott Coates   Deborah McKenzie  Palmer Orlandi  David Schmidt  John Szpylka 

I.

PRELIMINARY ITEMS a.

Call to Order/Introductions/Announcements Crowley called the meeting to order at 6:05 pm ET on Monday, March 11, 2019.

b. Crowley welcomed members and called OMB’s attention to the AOAC policy documents, reminded all attendees to review the documents, and that the meeting will be held in accordance to these policies.

c.

Review and Approval of Draft Meeting Agenda MOTION:   For OMB to approve the agenda with items rearranged. McMahon moved, and Gilliland seconded.  Consensus: Unanimous.

d. Review and Approval of Draft OMB Meeting Minutes MOTION: For OMB to approve the February 28, 2019 OMB meeting minutes as presented. Salfinger moved, and Gilliland seconded.  Consensus: Unanimous. e. Update on the AOAC‐ISO/IDF Meeting  – McKenzie informed OMB of the meeting taking place on Wednesday, March 13, 2019.

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ACTION ITEM:  To brief OMB on the meeting during Wednesday.  Add this item to a future  OMB teleconference meeting agenda. 

II.

AOAC OMB AWARDS FOR 2019  a.

Recognition of Technical and Scientific Excellence MOTION:   For OMB to approve Bert Popping and Carmen Diaz‐Amigo for Food Allergens  guest editor section in the  Journal of AOAC INTERNATIONAL .    Gill moved, and Giancaspro seconded. Vote: 9 in favor; 1 opposed; 1 abstained.  Consensus: Motion passed.  Action Item:   Staff to contact recipients.  b. Expert Review Panel of the Year  MOTION:   For OMB to approve ERP for SPIFAN MCPD Methods as ERP of the Year.   Phillips moved, and Mastovska seconded.  Vote: 10 in favor; 1 abstained.  Consensus:  Motion passed.  Action Item:   Staff to contact recipients.    c. Technical Service Award of the Year  MOTION:   For OMB to approve Melissa Phillips, US NIST, for the Technical Service Award  of the Year   Boison moved, and Gilliland seconded.  Vote: 10 in favor; 1 abstained.    Consensus: Motion passed.  Action Item:   Staff to contact recipients.   Method of the Year  MOTION:   For OMB to approve AOAC 2016.15 (Whey Protein)   Boison moved, and Gill seconded.  Vote: 10 in favor; 1 abstained.    Consensus: Motion passed.  Action Item:   Staff to contact organizations to inform them of voting member status.  OFFICIAL METHODS BOARD COMMITTEES AND WORKING GROUPS a. Update on Working Group on Certification of Application Notes  – Coates and McKenzie  reviewed the concepts with OMB.   Action Items : McKenzie and Coates to provide an example and include examples of  technical criteria used to judge an application note.   b. Committee on Safety  – Salfinger and Crowley led a discussion on the role of the Safety  Committee and the need to recruit new members and the challenges that face the  committee in its current form.  Several options were discussed with respect to keeping the  committee, appoint ERP members as safety reviewers for methods, etc…  Action Item : For OMB to reconsider an approach to ensuring the inclusion of method  safety in adopted methods.  c. Update on Working Group on Stakeholder Panels & Working Group Process Revisions  –  Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda.  d. Update on Working Group on Vetting Experts for ISO TC 34  ‐ Agenda item not yet  discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda.  d.

III.

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IV. EXPERT REVIEW PANELS a. Proposal to Revise the AOAC ERP for Flavanol Methods  ‐ Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda. b. Proposal on AOAC Volunteer Experts and Expert Review Panels  ‐ Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda. c. ERP Recommendations for Final Action  ‐ Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda. V. AOAC OFFICIAL METHODS BOARD a. OMB Liaisons Midyear Meeting Updates  ‐ Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda. b. Schedule of OMB Work for 2019  ‐ Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda. c. Receipt of Premeeting OMB Meeting Materials  – OMB members discussed their suggestions for ensuring productive meetings that included high quality OMB review of documentation for making decisions and understanding of expectations. Action Items:  For items that will require OMB consensus, staff will send out pre‐read materials at least one weekend in advance of the scheduled Thursday meeting.  For staff to annotate the agenda, perhaps in lieu of memos, so that the purpose of the agenda item and the expected action or outcome is clear in advance. VI. EDITORIAL BOARD & PUBLICATIONS UPDATES a. Editorial Board Update – Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda.

Publications Updates – Agenda item not yet discussed at this meeting. Action Item: Move to a future OMB teleconference meeting agenda.

b.

VII.

ADJOURNMENT a.

Motion to adjourn MOTION: Phillips moved, and Gilliland seconded.  Consensus: Unanimous – Meeting adjourned at 8:10pm ET on Wednesday, March 13, 2019.

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Memo  Date: 

February 6, 2019 

To: 

OMB Working Group on Application Notes Certification 

From: 

Scott Coates, AOAC 

Re: 

Application Notes Certification Program (tentatively “Reviewed and Recognized”   certification) 

Thank you OMB Working Group members for agreeing to review this proposed program for the review  of Application Notes to be provisionally known as “Reviewed and Recognized” (R 2 ) certification program.   There are 3 parts to this memo:  1) the cover memo (which you are reading) to give some context to the  proposal; 2) a summary; and 3) draft policies and procedures.  Background  Last year, AOAC staff brain‐stormed on new potential products and services that might be useful for our  community and, also provide additional revenue streams for AOAC.  We started with 12 ideas, which  were widdled down to 8 ideas to explore.  AOAC staff organized a series of one‐on‐one calls with AOAC  members representing potential clients for the new potential products and services.  Based on these  conversations the list of potential products and services was further refined to four, one of which was  the Application Notes Certification mark.  During our conversations with potential clients it became clear that some form of recognition of  application notes could be very useful and valuable.  Currently, the primary avenue for recognition of  methods based on instruments / equipment is the Official Methods program.  This is great, but can  require a rather large investment in time and expense for the collaborative study.  Several of the  surveyed companies opined that an Application Notes Certification mark could serve a function for  much quicker recognition of methods with new platforms.  In fact, some clients became quite excited at  the possibility of incorporated the Application Notes Certification program into their development  process and be able to use the Application Notes Certification mark when a new product is rolled out.  The Application Notes Certification would also benefit method users in that AOAC will evaluate the  application note and its claims against real data, and thus have more confidence in selecting a new  platform based on application note claims.  We envision that the review process would be an analog of the Performance Tested Methods  (PTM)  program.  The PTM review evaluates the veracity of performance claims in a test kit package insert.  The  R 2  program would evaluate the veracity of performance claims in an application note.  It is also envisioned that R 2   program would lead to Official Methods application just as many approved  PTMs go on to Official Methods .  Pricing has not been settled yet.  We think the R 2  programwill have a similar role and value as PTM  certification, and plan to use the PTM pricing model once the program is established. 

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Attachment 1 

Summary: “Reviewed and Recognized” (R 2 ) certification program  Concept:

Review the procedures and claims application notes just like we would review a package  insert in the Performance Tested Methods  (PTM) program and license the use of a  “Reviewed and Recognized” (R 2 ) certification mark (shown below). 

Process:

This is essentially the PTM process.  1. Consulting (optional) 2.

Technology Provider (TP) submit R 2  application.

3.

AOACRI assigns a Technical Consultant (TC) to assist TP in process and development of internal data study report and proposed independent lab protocol.

4.

TC recruits two AOACRI reviewers plus an AOAC Voluntary Expert.

5.

AOACRI Reviewers and AOAC Voluntary Expert review: application note, internal data study report, and proposed independent lab protocol.

6.

Independent lab protocol approved.

7.

TC recruits independent lab using the Onsite Method Validation model. *

8.

Onsite Method Validation data collected.

9.

Onsite Method Validation data integrated into Validation Study Report by the TP with assistance of TC. AOACRI Reviewers and AOAC Voluntary Expert review the Validation Study Report and Application Notes. If Validation Study Report and Application Notes approved, then TP provider licensed to use R 2  certification mark.

10.

11.

* Onsite Method Validation model – AOACRI instituted the Onsite Method Validation model in 2018. This model allows a proprietary method to be evaluated onsite.  Samples are prepared and blind coded by an independent lab, and then shipped to the method developer, in this case the TP.  The independent lab also provides a technician who goes to the TP laboratory to carry out the independent study.  The independent study is monitored by an AOACRI TC to ensure the integrity of the study.  This process would eliminate a lot of potential liability and the need to ship, set up, and qualify expensive equipment from TP to an independent testing laboratory.

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Attachment 2 

AOAC Research Institute  A division of AOAC INTERNATIONAL 

Reviewed and Recognized SM  [R 2 ] PROGRAM  For Application Notes POLICIES and PROCEDURES 

Notice: 

AOAC Research Institute reserves   the right to modify the program at any   time.  Participants are required   to comply with the current program in   effect at time of initial application  or renewal. 

© 2019 - AOAC Research Institute

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Attachment 2 

TABLE OF CONTENTS

1. 

Purpose

2. 

Background 

3.  

Overview

4. 

Procedures 4.1 

Consulting  4.1.1 Consulting Application Package  4.1.2 Verification Plan  4.1.3 Payment, Delivery of the Verification Plan, and On‐Going Support 

Reviewed and Recognized SM  Application  4.2.1 Reviewed and Recognized SM  Application Review  4.2.2 Checklist  4.2.3 Certification of QA Program and QC Practices   4.2.4 Project Manager 

4.2

4.2.5 Invoicing  4.2.6 Refunds 

4.3

Independent Testing Site  4.3.1 Selection of Independent Testing Site  Validation Study Report and Review 

4.4 4.5 4.6 4.7 4.8 4.9

Selecting Reviewers 

Criteria for Granting Reviewed and Recognized SM  Status 

Certificate 

Certification Mark 

Certification Mark  License Agreement 

5. 

Re‐Certification (Annual Review) Process   5.1 Re‐Certification Review  5.2 Suspension and Late Fees  5.3 Re‐Instatement of Suspended Application notes  5.4 Revocation  5.5 Re‐Instatement of Revoked Application notes   

6. 

Program Administration  6.1 

AOAC Research Institute  

6.2 

AOAC Research Institute Staff and Reviewer and Duties  6.2.1 Senior Director Responsibilities 

6.2.2 Manager Responsibilities  6.2.3 Technical Project Managers 

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Attachment 2 

6.2.4 Expert Reviewers 6.2.5 AOAC Volunteer Expert  

6.3 

Confidentiality  6.3.1 Access to Confidential Information  6.3.2 Sanctions to Release Information  6.3.3 Expert Reviewers  6.3.4 Contractors and Consultants 6.3.5 In‐House Document Handling  6.3.6 Telephone Calls 

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AOAC   Reviewed and Recognized P rogram   Policies and Procedures 

POLICIES and PROCEDURES

1.  Purpose The AOAC Reviewed and Recognized program provides an independent third‐party review of  Application Notes for proprietary instruments and equipment.  Application Notes provided by  technology providers that contain procedures and claims that are verified for specific  analyte/matrix are granted AOAC Reviewed and Recognized  status.  Technology providers of  AOAC Reviewed and Recognized approved Application Notes are licensed to use the AOAC  Reviewed and Recognized  certification mark. The AOAC Reviewed and Recognized  certification  mark assures users that an independent assessment has found that the performance claims  contained in approved Application Notes meets an appropriate standard for the claimed  intended use.   2.  Background The AOAC Research Institute (AOAC RI) is a nonprofit division of the AOAC INTERNATIONAL.    The mission of the AOAC Research Institute is to promote and carry out activities related to the  development, improvement and verification of proprietary methods. A list of AOAC Reviewed  and Recognized Application Notes can be found at the AOAC Research Institute website at  [future URL].  The AOAC Reviewed and Recognized Application Notes program is designed to be  complementary to the Performance Tested Methods  SM  (PTM) and Official Methods of Analysis SM (OMA) programs.   3.   Overview

The AOAC Reviewed and Recognized Application Notes program has five distinct phases:   

1) 2) 3) 4) 5)

Consulting (optional) 

Reviewed and Recognized Application   Technology Provider Verification Plan 

Verification Study Report  Application Notes Review 

The Reviewed and Recognized evaluation begins with an optional Consulting phase in which the  Technology Provider and an AOAC RI Technical Consultant discuss and decide the aims of the  verification.   The technology, target analyte, matrices, market, and regulatory issues are all considered at this  stage.  The AOAC RI Technical Consultant works with the Technology Provider to prepare a 

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AOAC   Reviewed and Recognized P rogram   Policies and Procedures 

Verification Plan suitable to the claimed intended use of the Application Note.  The Verification  Plan is reviewed by the appropriate AOAC Volunteer Expert, and once approved the final outline  is provided to the Technology Provider.    After the Consulting phase is complete and an approved Verification Plan has been delivered,  the Technology Provider may choose to submit an AOAC Reviewed and Recognized Application.   Technology providers are under no obligation to submit an AOAC Reviewed and Recognized Application if they elect not to proceed.   The Technology Provider shall prepare a report per the Verification Plan that includes both the  results from the Technology Provider’s study.    A Technology Provider who decides to proceed must submit an AOAC Reviewed and Recognized application package as per section 4.2.  The application package is reviewed by the AOAC RI staff  to confirm that the package is complete.    After the preliminary review confirms that the Reviewed and Recognized application package is  complete, the AOAC RI staff will recruit two expert reviewers who will review the verification  report to determine the veracity of the Application Note.  The expert reviewers will provide  recommendations to the AOAC RI Senior Director for awarding or denying AOAC Reviewed and  Recognized  status.    Reviewed and Recognized  status will be granted if the performance claims contained in the  Application Notes are determined to: 1) be accurate;  2) meet or exceed the performance of an  appropriate standard (reference method when available); or 3) meet or exceed the minimum  performance requirements of a relevant  Standard Methods Performance Requirement sm . Once approved, the Technology Provider is awarded a unique AOAC Reviewed and Recognized certification number and is licensed to use the AOAC Reviewed and Recognized  certification  mark, and the verification study report is published with the certificate on the AOAC website.  AOAC Reviewed and Recognized  status must be re‐certified annually for as long as the  Licensee elects to maintain the AOAC Reviewed and Recognized  certification. AOAC Reviewed  and Recognized  status is extended in [periodic to be determined] increments.    4.  Program Administration  4.1 Senior Director Responsibilities:

 Financial oversight of the program as a whole and all decisions  pertaining to  product and services fees.   Maintenance of and revisions to the Program Policies and Procedures.   Enforcement of policies and procedures.   Strategic planning.   All personnel decisions and   Oversee the issuance of Reviewed and Recognized certificates as appropriate,  based on final review of the expert reviewer reports and recommendations. 

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AOAC   Reviewed and Recognized P rogram   Policies and Procedures 

4.2 

Manager Responsibilities:

 Provide application materials and assistance to potential Technology providers.   Conduct a preliminary review of the application materials for completeness of the  package.   Establish and maintain a log and tracking system for performance testing applications.   Assign projects to Technical Consultants/Project Managers.   Collect fees based on established fee structure.   Manage annual certificate renewal process.   Maintain a database of applications and Reviewed and Recognized certificates and  provide status reports as appropriate and   Establish and maintain an Expert Reviewers pool.  4.3  Technical Consultants/Project Managers:

 Develop Validation Study Protocols   Assign reviewers to specific performance testing applications 

 Resolve situations where the original reviewers do not agree on the recommendation.   Select independent testing laboratories, negotiate fees and contracts, and monitor their  work.   Coordinate and expedite the performance testing process with Technology providers, 

independent laboratories, and Expert Reviewers and,   Complete and issue required forms and reports.  4.4  Expert Reviewers:  

 Reviewing the Method Validation Study Report to determine adequacy and consistency  with AOAC RI technical requirements.   Reviewing package inserts and user manuals to confirm that the analytical intended use  claims in these documents are supported by the Technology Provider and independent  site data.  Expert Reviewers must:   Comply with AOAC RI policies and procedures on conflict of interest, including  signing a conflict of interest policy acknowledgment form .   Be willing to devote the time necessary to conduct the data reviews and design  testing protocols in a timely manner, as determined by the AOAC RI.   Have knowledge of method evaluation processes and have the ability to design and  evaluate method evaluation protocols and    Have a working knowledge of method evaluation statistics. 

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Experts selected for an R 2   review must not: 

 Not be employed by or have financial ties with the applicant, competitors, or closely  related entities   Not have a regulatory relationship with the applicant firm seeking Reviewed and  Recognized status.  Expert Reviewers may be entitled, but not required, to receive a fixed honorarium from  the AOAC Research Institute for services performed. Experts wishing to serve as  reviewers should make a written request to the AOAC RI Manager.  If the originally assigned Expert Reviewer cannot reach agreement on a  recommendation to grant or deny Reviewed and Recognized status, then the AOAC RI  Senior Director will direct the Project Manager to assign additional reviewer(s) to  provide a deciding recommendation.     4.5  AOAC Volunteer Expert Reviewed and Recognized reviews are coordinated with the appropriate AOAC  Volunteer Expert from the AOAC OMA program to ensure consistency between  programs.    AOAC Volunteer Expert duties include:   Replying to technical questions about the verification outline.   Reviewing the Validation Study Outline.   Reviewing the Methods Validation Study Report to determine adequacy and  consistency with AOAC technical requirements.   Reviewing package inserts and user manuals to confirm that the analytical  performance claims in these documents are supported by the Technology  Provider and independent site data and    Determining modification levels and data required, if any, to validate  modifications.  Consulting:  Technology Providers seeking AOAC Reviewed and Recognized  status for an Application  Note may use the AOAC Consulting Service program.   The AOAC Research Institute  maintains a pool of Technical Consultants with expertise in Reviewed and Recognized program procedures and technical requirements.   The AOAC RI Senior Director or  Manager will assign a Technical Consultant when a Consulting Application is submitted.  The Technology Provider may request a specific Technical Consultant for their  verification project, and the request will be honored whenever possible.  However, the  Senior Director shall have the ultimate decision as to which Technical Consultant is  assigned to a project.  Procedures 5.1 

 5. 

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Consulting Service fees vary.  See the AOAC Reviewed and Recognized  Fee Schedule in  Appendix 1 [to be added later] for details. AOAC Research Institute Contributing  Members are eligible for discounted consulting fees.    5.1.1 Consulting Application Package:  A Technology Provider requesting Consulting Services must submit: 

1) 2) 3)

Consulting Application (Appendix 2) [to be added later]  Consulting Agreement (Appendix 3) [to be added later] 

Copies of the Application Note or Notes. 

Electronic Consulting Applications are preferred.  Send electronic Consulting  Applications to aoacri@aoac.org .   

5.1.2 Verification Plan: 

The purpose of the consulting service is to clearly define the claims for which a  Technology Provider seeks AOAC Reviewed and Recognized  status, and to  deliver a Verification Plan that allows the Technology Provider to verify those  claims as efficiently as possible.  The Technical Consultant will meet with the  Technology Provider or by telephone to discuss the verification goals. The  Technical Consultant will produce a written Verification Plan after this initial  meeting.    Statement of principle of the method and intended use claim  Matrices to be tested to support intended use claim  *Technology Provider Verification Study Protocol  Appropriate reference method(s) with a standard method performance  summary (see form here) or a relevant SMPR.  *These items are reviewed and approved by the appropriate AOAC Volunteer  Expert.     Study Protocols approved by the AOAC Volunteer Expert are binding and may  not be altered or revised ex post facto by the Technology Provider.    AOAC Reviewed and Recognized Application:  Technology providers seeking AOAC Reviewed and Recognized  status for Application  Notes must submit an AOAC Reviewed and Recognized application package for each Application Note to be evaluated.  The AOAC Reviewed and Recognized Review  Application Form and the AOAC Reviewed and Recognized Review Agreement may be  Statistical analyses required  6)   Study Report Template   5.2 The Verification Plan includes:  1)   2)   3)  5)   5) 

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requested from the AOAC RI Manager or obtained online at  http://www.aoac.org/testkits/testkits.html . 

Reviewed and Recognized application packages for Application Note evaluations must  contain the following:  Completed AOAC Reviewed and Recognized Review Application Form (Appendix 5) [to be added later] Signed AOAC Reviewed and Recognized Review Agreement (Appendix 6) [to be added later] Manufacturing Quality Assurance program description or copy of International Organization for Standardization‐ ISO 17025 certificate. Technology providers are encouraged to recommend potential Expert Reviewers.   However, the AOAC RI is not obligated to accept the recommendations of the  Technology Provider.  The Expert Reviewers cannot relate to the Technology Provider or  related entities in any way, other than as a customer.    1) 2) 3) 4) Application Note(s)

Electronic applications are preferred. Send electronic applications to aoacri@aoac.org .   

5.2.1 AOAC Reviewed and Recognized Application Review: 

The AOAC Reviewed and Recognized Application package will be reviewed for  completeness by AOAC RI staff.  An acknowledgement letter, checklist review,  and an invoice will be sent to the Technology Provider within two business days  of receiving an application. 

5.2.2 Check List:   The Check List contained in the AOAC Reviewed and Recognized Application  package is intended for use by the Technology Provider and the AOAC RI staff to  determine if the basic submission requirements have been satisfied.  (Appendix  7) [to be added later] 5.2.2 Certification of QA Program and QC Practices:   Technology providers must submit a description of the quality assurance  program and quality control practices used in the manufacturing, production,  storage, and delivery of the Application Note components.   

5.2.3 Project Manager: 

A Project Manager is assigned by the AOAC RI Manager when an AOAC  Reviewed and Recognized application is submitted.  Typically, the Technical  Consultant who provided the Consulting Service is assigned as the Project 

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Manager for the AOAC Reviewed and Recognized  review.   A Technology  Provider may request a different Project Manager at any time. 

5.3 

Selection of Independent Testing:   The Method Developer may ask the Project Manager to request proposals from more  than one independent testing site.  Factors in the selection of an independent testing  site can include cost, timing, technical expertise, and ease of shipping method  components and equipment.  

5.3.1 Independent Evaluation 

The testing site must not have a financial, corporate, or regulatory relationship  with the applicant and must not be a competitor.   Preference will be given to qualified testing sites accredited to the ISO 17025  requirements for the appropriate field(s) of testing.  If evidence of appropriate  accreditation is not provided, on‐site visits by a representative of the AOAC‐ RI,  at the Technology Provider’s expense will be conducted to assess the testing  site's compliance with the General Criteria for Independent Laboratories  (Appendix 8). [to be added later] A method may be evaluated  in situ  at the “primary’ laboratory with the  following additional requirements:       Test samples must be prepared and blind‐coded by an independent  laboratory meeting the requirements specified in 5.3.1.   An analyst from the independent laboratory must analyze the blind‐ coded test samples.   An AOAC RI Project Manager must be present during the analysis.   Results must be reported back to the independent laboratory.   The independent laboratory will decode and analyze the results and  prepare a report.   If an On‐Site Method is commercialized, i.e., turned into and sold as a  test kit, the PTM mark does not apply to the test kit.  The test kit must  be evaluated at an independent laboratory meeting the requirements of  section 5.3.1.1. 

5.3.2 On‐Site Method Evaluation  

5.4 

Technology Provider Verification Study: 

Technology providers are responsible for collecting data for the Verification Study.  The  study should conform exactly to the Verification Study in the Verification Plan 

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developed during the consulting phase.  Any question(s) or proposed deviation(s) from  the Verfication Study must submitted to the Project Manager before data collection  begins.  The Project Manager will confer with the AOAC Volunteer Expert regarding the  question(s) or proposed deviation(s) and report back to the Technology Provider.  Technology providers may collect Verification Study data at their own facilities, or the  Technology Provider Verification Study may be contracted out to a contract vendor.   Results from Verification Study must be included in the Verification Study Report.   

5.5 Reviewer Selection:   For each application or group of similar applications for Reviewed and Recognized status, at least two Expert Reviewers and 1 AOAC Volunteer Expert will be assigned to  review the Verification Study Report.  The AOAC RI Project Manager is responsible for  recruiting two Expert Reviewers, and identifying the correct AOAC Volunteer Expert.     Technology providers are encouraged to recommend individuals as Expert Reviewers;  however, the final assignment will be at the sole discretion of the AOAC RI Project  Manager.  The experts selected to evaluate specific Application Notes must not have a  relationship (including as a financial investor, member of board of directors, or  consultant) with the applicant, competitors, or closely related parties and may have no  business relationship other than as a customer.    If there is no AOAC Volunteer Expert for a specific topic area every effort should be  made to recruit an AOAC RI method volunteer who is a member of a relevant expert  review panel to serve as an AOAC Volunteer Expert.  If a relevant, method committee  does not exist then the Official Methods Board (OMB) will be consulted for  recommendations for a reviewer.  5.6  Verification Study Report and Review:  Technology providers are required to prepare and submit a Verification Study Report  supporting the claims of the Application Note.  See Appendix 6 [to be added later] for  the Verification Study Report template.    The Verification Study Report and Application Note shall be submitted directly to the  Project Manager, who will forward the documents with the appropriate review form to  the AOAC Volunteer Expert and Expert Reviewers.  It is the responsibility of the Project  Manager to set deadlines during the review process and track progress of the reviews.   Generally, reviewers are asked to provide comments and questions within 2 weeks for  the first review and 1 week for each review thereafter.  Upon receipt, the Project Manager shall forward each reviewer's review form to the  Technology Provider.  The Technology Provider is responsible for responding to all 

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reviewer comments and questions in writing.  All responses and revised documents shall  be submitted to the Project Manager, who will forward them to the AOAC Volunteer  Expert and Expert Reviewers for additional comment or approval.  The process  continues until consensus is reached among the three reviewers for either approval or  rejection.     Criteria for Granting AOAC Reviewed and Recognized Status:  The AOAC Volunteer Expert and Expert Reviewers, acting as independent reviewers,  decide whether the results documented in the Verification Study Report merit awarding  AOAC Reviewed and Recognized  status.       The reviewers must be satisfied that results from the Technology Provider provide a  solid scientific case to for granting AOAC Reviewed and Recognized  status.  The criteria  for granting AOAC Reviewed and Recognized  status are based on:   Results from the Verification Study support and confirm all claims made in the  Application Note.  All results meet the acceptance criteria contained in the study protocols.  All results meet the minimum performance requirements of the application or  relevant SMPR (if one exists).  In some rare cases if an impasse develops between the Technology Provider and a  reviewer, it is the responsibility of the Senior Director of the AOAC RI to facilitate a  resolution.  If a resolution cannot be reached, then the Senior Director of the AOAC RI  may convene a special meeting to resolve all remaining questions.     1) 2)  5)  Certificate:   An AOAC Reviewed and Recognized  certificate is issued by the AOAC RI to the  Technology Provider for each Application Note granted AOAC Reviewed and Recognized status.  The certificate carries a unique certificate number and name of the approved  Application Note.  (See Appendix 13.) [to be added later]  5.8.1 Certificates Initially Granted Before October 1 st  of Any Given Year:  The initial AOAC Reviewed and Recognized  certificate is granted and effective  for a term expiring at the end of the current annual renewal cycle on December  31 st  of the same year.    5.8.2 Certificates Initially Granted On or After October 1 st  of Any Given Year:  The initial certificate is granted for a term expiring at the end of the next annual  renewal cycle on December 31 st  of the next  year. 

5.7 

5.8 

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AOAC Reviewed and Recognized  certificates are made available to the public  though the AOAC website.  Certification Mark:   Technology providers of approved Application Notes are licensed to use the AOAC  Reviewed and Recognized mark on their packaging and promotional materials.  (See  Figure 1.) Use of the certification mark is entirely optional but highly encouraged.    Technology providers will receive a copy of the certification mark with a unique  certification number as soon as the Application Note is AOAC Reviewed and Recognized approved. 

5.9 

Figure 1:  Certification Mark 

5.10  Certification Mark License Agreement:  A Certification Mark License Agreement between the AOAC RI and the Technology  Provider must be signed before the certification mark can be used.  The License  Agreement describes the rights, obligations, rules, and procedures in the use of the  Reviewed and Recognized mark.      A Technology Provider company officer must sign the License Agreement to use the  AOAC Reviewed and Recognized  certification mark.  Technology providers are not  required to sign the License Agreement until the AOAC Reviewed and Recognized  review  is complete and the candidate Application Note is granted AOAC Reviewed and  Recognized  status.    Technology providers are encouraged to review the License  Agreement before submitting an AOAC Reviewed and Recognized Review Application  to the AOAC Research Institute .   

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6. 

Re‐Certification (Annual Renewal) Process   The AOAC RI Manager is responsible for conducting the Annual Renewal.  The AOAC Reviewed  and Recognized  status is granted in periods of one year after the initial certification.  Each AOAC Reviewed and Recognized  certificate has an expiration date.   An Annual Renewal  Application (Appendix 15) [to be added later] and an Annual Renewal Fee (see Fee Schedule)  must be submitted to the AOAC‐ RI by the Licensee for each expiring AOAC Reviewed and  Recognized Application Note.    Annual Renewal Applications and Fees must be received by the  AOAC RI not less than 30 days prior to the expiration date on the certificate.    The AOAC RI will endeavor, to the best of its ability, to provide Licensees with timely notice of  the pending certificate expiration by registered mail and by email.   It is the responsibility of the  Licensee to provide the AOAC Research Institute with changes in contact information.    Ultimately, it is the responsibility of the Licensee to submit an Annual Renewal Application and  an Annual Renewal Fee.   The purpose of the Annual Renewal is to:  Affirm that no changes have been made to the  Application Note since originally receiving AOAC Reviewed and Recognized  status and to confirm  that the method and Application Note performs as originally evaluated; or for the review of any  modifications to the instrumentation or Application Note claims.  Modifications to any of these  parameters may require additional data.  The Application Note will be granted a one‐year certificate if: the Licensee certifies that no  changes have been made to the Application Note since originally receiving Reviewed and  Recognized status, and that the method performs as originally evaluated; or that sufficient data  is provided demonstrating that the method performs as well or better than the originally  reviewed method if any changes have been made to Application Note components,  instrumentation, intended use claims, or package insert.  A new or supplemental QA/QC package must be submitted with the Renewal Application if  changes have been made in the manufacturing or QC testing processes.  The AOAC RI reserves  the right to request and review QA/QC records to verify that the consistency of Application Note  performance is maintained throughout the life of the Application Note. 

 6.1 

Re‐Instatement of Suspended Application Notes: 

Licensees may seek reinstatement of a suspended Reviewed and Recognized  for a period  of up to six months after the renewal due date by submitting an Annual Review  Application with the Annual Review fee  including any late fees  (see Fee Schedule) plus  any additional data and/or information addressing serious adverse complaints or  undisclosed modifications. 

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6.2 Revocation: 

The AOAC RI, at its sole discretion, may revoke Reviewed and Recognized status and  cancel any license for the use of the certification mark at any time for any of the  following reasons:    The Reviewed and Recognized status of a method shall be revoked if the  Reviewed and Recognized status of a method has been suspended for more  than 6 months.  2) The Licensee has not complied with the original agreement relative to use of the  Research Institute's certification mark.  3)  The Licensee has not responded adequately or has not taken timely corrective  action relative to poor performance of the Application Note as reported by  Application Note users or others.  The Licensee modified the Application Note in a manner that could reasonably  be expected to affect its performance characteristics and failed to notify the  AOAC RI.  1)  4)  The Licensee failed to make an application for annual renewal.  The Licensee requested that Reviewed and Recognized status be discontinued.  The Reviewed and Recognized program requirements change and the Licensee  either will not or cannot ensure conformance to the new requirements  within a reasonable amount of time.  The Licensee will be allowed up to 60 days,  but not later than the expiration of the current certificate, to comply with any  new program requirements.  8)  The Licensee ceased to produce the Application Note and/or  9)  The Licensee failed to meet financial obligations to the AOAC RI.  When the Reviewed and Recognized status of an application note is revoked or  canceled, the Reviewed and Recognized certification mark must be removed from all  packaging and promotional literature.  The Technology Provider must cease any claims  as Reviewed and Recognized application note.   6.3  Re‐Instatement of Revoked Application notes:  Revoked Reviewed and Recognized may be submitted for Re‐Instatement if no changes  have been made to the Application Note and no  serious adverse comments have been  received.  See Appendix 16 [to be added later] for a Re‐Instatement Application.  The Technology Provider must collect data (at a new production location if applicable.)  that compares the performance of the lapsed application note to the appropriate  reference method(s) where applicable.  5)  6)  7) 

Comparison data for each reference method must be submitted if more than one 

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Attachment 2 

reference method was examined in the original verification study.  Copies of the original  verification study are available from the AOAC RI for a fee (see Fee Schedule).  The  Technology Provider must submit a formal report containing the results of the  comparison study.  The new data collected for re‐instatement must demonstrate that  the method performs as well or better than the original data.  If approved for re‐instatement, the method will be certified until the end of the calendar  year.  Renewal fees for the 1st year following re‐certification will be pro‐rated based on  the month the method is re‐certified.  For example, a method that is approved for re‐ certification on October 1, 2008 will be invoiced for 1/4 of the full annual renewal fee.  Thereafter, annual renewal fees will be assessed in full every year as long as the  Technology Provider desires to maintain the Reviewed and Recognized status for the  Application Note (assuming the Technology Provider and the method comply with all  AOAC RI policies and procedures.)  Confidentiality:  All documents generated by AOAC RI or received by the AOAC RI from applicant  Technology Provider and/or Licensee containing proprietary or confidential information  shall be clearly marked as "CONFIDENTIAL".  The AOAC RI considers the following items to be confidential information and therefore  subject to this policy:  The names of Application Notes and their manufacturers: with Application Notes under  review; who are discussing the possibility of submitting an Application Note for review;  or who have submitted application notes that the AOAC RI have declined to certify.  The contents of data submissions; the results of independent testing; the comments of  Expert Reviewers and/or independent testing laboratories; and the progress or status of  application notes under evaluation.  The progress of negotiations on license, indemnification, or other agreements with  specific test kit manufacturers; including the fact of, and progress of an appeal by a test  kit manufacturer.  If there is any doubt as to whether information in any form is confidential, it should be  handled as confidential information until the AOAC RI Senior Director determines  otherwise.    7.1  Access to Confidential Information:   AOAC RI employees, volunteers, and contractors are expressly forbidden to  discuss any confidential or proprietary information with: AOAC International 

7. 

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