AOAC STANDARDS & METHODS ORIENTATION E-BOOK

STANDARDS & METHODS ORIENTATION E-BOOK

TUESDAY, SEPTEMBER 10, 2019

AGENDA

AOAC STANDARDS & METHODS ORIENTATION Tuesday, September 10, 2019 8:00AM – 12:00PM

Governor’s Square 16 Sheraton Denver Downtown 1550 Court Place Denver, CO 80202 USA

AOAC INTERNATIONAL ANNUAL MEETING REGISTRATION

7:30 am – 5:00 pm

AOAC Annual Meeting Registration (Plaza)

ORIENTATION OBJECTIVES

Attendees will learn:  How the Analytical Solutions Forum leads to AOAC Standards and Official Methods SM .  About the evolution AOAC processes for standards and methods.  How the process can lead to AOAC First Action Official Methods SM and Final Action Official Methods SM .  About AOAC’s Consulting Services.

 How to recognize uses for AOAC SMPR® and AOAC standards.  How to understand expectations for drafting and formatting a candidate method or manuscript for Official Methods SM .  How to participate in method related volunteer opportunities.  How to identify the various types of resources for AOAC standards and methods.

8:00 am – 8:30 am

WELCOME & INTRODUCTIONS  Background & History of AOAC INTERNATIONAL

8:30 am – 10:15 am

ANALYTICAL SOLUTIONS FORUM & STANDARDS PROCESSES  What is an AOAC “Standard”?  AOAC Analytical Solutions Forum  Does AOAC still engage the AOAC Stakeholder Panels and do they still exist?  Standards Processes & Consensus  What is an AOAC SMPR®?  SMPR® Process through Standards **10:15 am – 10:30 am /Break** AOAC OFFICIAL METHODS PROGRAM  How does one get from SMPR® to OMA?  Calls for Methods & Experts  How to submit methods to AOAC?  Expert Review Panel Composition and Process  AOAC First Action Official Methods SM to AOAC Final Action Official Methods SM

10:30 am – 11:30 am

11:30 am – 11:50 am

WHAT METHOD AUTHORS NEED TO KNOW…  AOAC Consulting Services  AOAC Resources and Technical Requirements

11:50 am – 12:00 pm

Q & A SESSION

Sign-In@ http://bit.ly/AOACStandardsOrientation Wi-Fi Network ID: Sheraton-Meeting Room Access Code: AOAC2019 (non-case sensitive) *Agenda is subject to change. V1

AOAC INTERNATIONAL ● 2275 RESEARCH BLVD, SUITE 300 ● ROCKVILLE, MARYLAND 20850 USA

9/10/2019

Understanding AOAC Standards Standard Method Performance Requirements, and AOAC Official Methods

AOAC Annual Meeting Denver, Colorado

Goals

• Attendees will learn: – Basics of Standards Development – Types of AOAC standards

– Process for developing an AOAC standard  – What is and the Purpose of an AOAC SMPR – AOAC Official Methods SM Program – AOAC Official Methods approval process – About AOAC Official Methods and the components  of an Official Method – What Method Authors Need to Know

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Objectives

Attendees will: – be able to understand AOAC processes to develop standards. – be able to understand how the process can lead to Official First Action status. – be able to identify the various types of AOAC standards – learn about the evolution of SMPRs. – be able to distinguish between a fitness-for-purpose statement and a SMPR. – be able to recognize uses for AOAC SMPRs and AOAC standards. – be able to understand expectations for drafting an candidate method for Official Methods

Attendees will be thankful that this session is over  .

AOAC Products, Programs, and Services

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International Harmonization Efforts

ALACC Changes: • Fulfills need to help labs interpret requirements. • More information on technical records

AOAC and ISO ‐ New Agreement  signed on18  October 2018       ISO TC 34 (Food  Products)and its  subcommittees &  workinggroups

IDF is engaged  through ISO TC 34  SC 5 Methods are  jointly submitted  to CODEXprocess  by AOAC, ISO,  and IDF for  dispute  resolution status

13 AOAC Final  Action Official  Methods

AOAC Laboratory  Accreditation  Committee  Criteria Guidance  on interpreting  ISO 17025

• LOTS OF NOTES INCLUDED AND ADDED!!! • Use of CRMs • Sampling and addition of online references • Technical records & Data Information Management • Method Uncertainty and validity of results • Proficiency testing

Engaged in  review of  methods  referenced in  Codex STAN 234  – Methodsof  Analysis and  Sampling

AOAC began in Washington, DC as the Association  of Official Agricultural Chemists (1884)

• Federal and state departments of  agriculture through the USDA  Bureau of Chemistry.   Initially to standardize  methodology to be used for  composition of fertilizers by state  laboratories  Directed by Harvey Washington  Wiley who wrote the 1906 law  that began the US Food and Drug  Administration (FDA) 

• By the 1980s AOAC’s membership  included microbiologist, food  science professionals • In 1991, Association of Official  Agricultural Chemists  legally  changed its name to AOAC  INTERNATIONAL  • Often referred to as Association of  Analytical Communities ‐ used to  encompass all of the scientific  disciplines involved in AOAC’s work.

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Title 21: Food and Drugs PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS Subpart A—General Provisions

§2.19 Methods of analysis. Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the AOAC INTERNATIONAL (AOAC) as published in the latest edition (13th Ed., 1980) of their publication “Official Methods of Analysis of the Association of Official Analytical Chemists,” and the supplements thereto (“Changes in Methods” as published in the March issues of the “Journal of the Association of Official Analytical Chemists”), which are incorporated by reference, when available and applicable. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202‐741‐6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. NOTES: • [42FR15559,Mar. 22,1977,as amended at47FR946, Jan. 8,1982;54FR9034,Mar.3,1989;70FR 40880, July 15,2005;70FR67651,Nov. 8,2005] • Title 21→Chapter I→ Subchapter A→ Part2 →Subpart A→§2.19 • Accessed on7‐27‐2018 https://www.ecfr.gov/cgi‐bin/text‐idx?SID=7a20040ac19ed218138aed8bacc33e2f&mc=true&node=se21.1.2_119&rgn=div8

e-CFR data is current as of September 6, 2019

AOAC INTERNATIONAL Founded in 1884

Vision 

Global confidence in consensus based analytical solutions  for food safety, food integrity, and public health.

Mission

As a leader of analytical excellence, AOAC INTERNATIONAL  advances food safety, food integrity, and public health, by  bringing together members, organizations, and experts  dedicated to developing and validating standards, methods and  technologies, of global relevance.

Strategic  Goals  Include

Address emerging issues and influence  standards development as a global leader in  analytical excellence.

Analytical  Excellence 

Build strategic partnerships to  advance food safety, food  integrity, and public health.

Relationships

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AOAC Leverages the Power of Many

AOAC Leverages Networks to Assemble Stakeholders & Experts

AOAC INTERNATIONAL Headquarters

• Develop international voluntary consensus standards method performance requirements

• Discuss & adopt methods that are published in the Official Methods of Analysis of AOAC INTERNATIONAL using judgment of the world’s leading experts. Providing fit for purpose methods through standards development

GeneralLocationsof AOAC stakeholderpanelparticipants GeneralLocationsof the16 AOAC INTERNATIONALcurrentSections

AOAC ® INTERNATIONAL (AOAC) is an independent third‐party international standards  developing organization and AOAC has no vested interest in the development of standards or in  the evaluation of methods of analysis.

ANALYTICAL AOAC Products, Services, and Analytical Excellence

Standards & Methods Development

A Complete &  Harmonized Quality  System Through 

Official Methods of Analysis SM (OMA) &  Performance Tested Methods SM (PTM)

Laboratory Proficiency Testing & Quality Systems

Analytical  Excellence 

Publications, Training, Educational Outreach & Horizon-scanning

© Copyright AOAC INTERNATIONAL 

9/10/2019 9/10/2019

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2019 

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Analytical Solutions  Forum (ASF) began  in March 2019

• Ongoing AOAC efforts • Emerging Topics

AOAC Analytical Solutions Forum

• Agricultural Materials • Botanical and Herbal Supplements • Biostimulants and Soil Amendments

ASF in September  2019

Developed a Terms  of Reference and  Terms of  Operations

• Opportunity for engagement

Why a “ FORUM” ?

“Forum”……

... A place , situation, or group in which people exchange ideas and viewpoints, discuss issues/current questions; … An assembly ; a public meeting or lecture involving audience discussion; ... A program involving discussions of issues by authorities; ... An opportunity for open discussion to stimulate broad interest and encourage participation from multiple perspectives.

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The Analytical Solutions Forum Concept

Federal, State & Global Regulators

Technology Sector

AOAC Section Leadership

AOAC Communities

ASF Steering Committee

AOAC Science  Leadership Science –based Initiatives

Method  Developer Community

Peer Standard‐Setting Organizations

Training and Education

Programs &Projects

Certifications

Consultation

Food, Feed, Agriculture & Environmental Industry Consortia

Laboratory Associations

Biannual  Analytical Forum  Meetings

The Analytical Solutions Forum

 Multi‐faceted “idea incubator”;   An evolution of the current stakeholder panel  model to expand services to the analytical, food,  feed and agricultural safety communities;  Broader Stakeholder input and engagement;  Biannual forums;  To provide updates from funded tracks;  A venue to focus on regulatory and emerging issues.  Horizon scanning;  Proactive; identify needs before public health  emergencies arise;   To develop new scientific programs and foster  technological advancements to meet arising challenges.  “To stimulate thought; to facilitate communication; to encourage partici

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The Analytical Solutions Forum provides…

 Multiple avenues to identify new programs or new deliverables; a  continuous stream of scientific ideas and potential funding  opportunities to accomplish the work;  A mechanism to integrate, prioritize and provide oversight to 

prospective and ongoing programs and projects;  Programs funded on an annual, renewable basis;  Multiple forms of deliverables;   Standard Method Performance Requirements  Method review  Sampling plans, validation guidelines   Harmonization, training/workshop development, proficiency testing  Consulting service  Method certification, publication projects, special meetings

Flexibility for the Future • Work within the parameters of the defined need? Project or Program? Project A short term effort to deliver a specific output(s) in line with a predefined time, cost, and quality constraints; based on an agreed-upon work plan. Program A portfolio comprised of multiple projects that are managed and coordinated as one unit to achieve the expected outcomes determined by the advisory panel members; considered a long-term (potentially permanent) activity overseen by an AOAC INTERNATIONAL-designated Program Lead and Scientific Advisory. • Individual stakeholder engagement or Advisory Panel “Scientific Crowd-sourcing”

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Flexibility for the Future Addressing opportunities and provide products and services  not defined or confined by existing stakeholder panels.

ERPReviewof  FirstActionOMA  Methods&any  recommendations  forFinalAction  Status/Repeal/etc. .

OMB review&  rendered  decisionsonFinal  Action  status/Repeal

WorkingGroups (Stakeholderswill  conveneas  needed)

Call forMethods Call  forExperts (if  needed)

ERPReviewof  MethodsandFirst  ActionOMA status 

Established  Standards/SMPRs

Advisory  Panel

Advisory  Panel

AlternativeMethods ISPAM

WorkingGroups (Stakeholderswill  convene asneeded)

The  Analytical  Solutions  Forum

TestKitCertifications

ERPReviewof First  ActionMethods&  any  recommendations  for FinalAction  Status/Repeal/etc..

StrategicFood  AnalyticalMethods SPSFAM aka “TheFOOD  PANEL”

AOAC   Standards  Developing  Communities

OMB review&  rendereddecisions  on FinalAction  status/Repeal

Call forMethods Call  for Experts (if  needed)

AgentDetection  Assays SPADA

ERPReviewof  MethodsandFirst  Action status 

Establish SMPRs

Advisory  Panel

WorkingGroups (Stakeholderswill convene as  needed)

Working  Groups

Training andEducation  ProgramDevelopment

InfantFormulaand  AdultNutritionals SPIFAN

DietarySupplements SPDS

Advisory  Panel

WorkingGroups (Stakeholderswill  convene asneeded)

Proficiency Testingor  QualityManagement  ProgramDevelopment 

Advisory  Panel

The Analytical Solutions Forum

Continuity Between Midyear and Annual Meetings

‐Midyear Meeting‐

Analytical  Solutions Forum ‐Annual Meeting‐

Analytical Solutions Forum • Overview of current  Programs • Issues  “ just above” the  horizon Emerging Issues  Roundtable

• Horizon scanning

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The 2019 Midyear Meeting & the Inaugural Analytical Solutions Forum… The Transition begins

Review of Ongoing Programs Introduced N Services Under Development Newly Launched Programs

FURANS

• Food allergens; • Quantitative microbiology method validation acceptance criteria; • Stakeholder Panel on Infant Formula and Nutrition; • Gluten in Oats; • Stakeholder Panel on Agent Detection Assays.  Emerg ng T pics and Opportunities • Fertilizers/Biostimulants; • Glycemic (available) carbohydrates; • Mycotoxins; • Bioengineered labeling. Keynote Address “Analytical Needs to Support Future Regulatory Food  Safety and Food Defense Programs” Frank Yiannas, Deputy Commissioner,  Food Policy & Response,  U.S. Food and Drug Administration Establishing strategic partnerships to advance food safety and food integrity through international proficiency testing services

• On-site validation program • Application note certification program • Analytical science consultation services

The Analytical Solutions Forum

Continuity Between Midyear and Annual Meetings

‐Midyear Meeting‐

Analytical  Solutions Forum ‐Annual Meeting‐

Analytical Solutions Forum • Overview of current  Programs • Issues  “ just above” the  horizon Emerging Issues  Roundtable

• Horizon scanning

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The Analytical Solutions Forum: The Annual Meeting

Opening Plenary Session

Breakout Session 2

Breakout Session 1

Closing Plenary Session

OUTPUTS/RECOMMENDATIONS

Analytical Solutions Forum Steering  Committee

The 2019 ASF @ The Annual Meeting

“Analytical Tools for Emerging Agricultural Products” Plenary 1 (0830-0945): Introduction to the Annual Meeting ASF  Inception of the forum topic

 Keynote Address 1: Botanicals and Herbal Supplements  Keynote Address 2: Biostimulants and Soil Amendments  Closing remarks: Objectives and expectations for breakout session Breakout Sessions (1000-1200) Informational lunch and learn session (1230-1300) “ASF Concept 101” Plenary 2 (1300-1430)  Review of breakout session presentations  Read-out of proposal(s)  Open discussion  Next steps

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Standards

What Are Standards

• Common and repeated use of rules, conditions, guidelines or  characteristics for products or related processes .  • The definition of terms; classification of components; delineation of  procedures; processes, products, systems, services, or practices;  test  methods and sampling procedures. • A Performance standard is a standard that states requirements in  terms of required results with criteria for verifying compliance but  without stating the methods for achieving required results. • Voluntary Consensus standards are standards developed or adopted  by voluntary consensus standards bodies , both domestic and  international.

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Standards Development and Stakeholders

• AOAC conforms to NTTAA* and therefore includes all  stakeholder perspectives.

National Technology Transfer Advancement Act (Public Law 104‐113) – coordination of federal standards and conformity assessment activities  with private sector standards and conformity assessment activities.

• AOAC and an Advisory Panel will recommend a finite  number of potential voters in the stakeholder panel  representing the various perspectives.

OMB A-119 and NTTAA

• National Technology Transfer and Advancement Act of  1995 – Directs federal agencies with respect to their use of private  sector standards and conformity assessment practices. – Directs federal agencies to adopt private sector standards,  wherever possible, in lieu of creating proprietary non‐ consensus standards. – Codified existing policies in A‐119, established reporting  requirements, and authorized the National Institute of  Standards and Technology (NIST) to coordinate conformity  assessment activities of federal agencies.

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OMB A-119 and NTTAA

• US OMB Circular A‐119 – Standards developed by voluntary consensus standards bodies are  often appropriate for use in achieving federal policy objectives and in  conducting federal activities, including procurement and regulation. – Encourages federal agencies to benefit from the expertise of the  private sector – Promotes federal agency participation in such bodies to ensure  creation of usable standards – Reduces reliance on government‐unique standards

Terminology

Term

Definition

Balance of Interests

No one interest or perspective should dominate or be the majority.  It can be  affected not only by the number of participants in particular categories but also by  the funding source.  The provider of the funding in standards development work can  sometimes dominate the process.  If funding is to be provided by a government  agency or other entity, care must be taken to avoid undue influence on the outcome  of the process by the sponsor. A position or exercise of dominant authority, leadership or influence by reason of  superior leverage, strength or representation to the exclusion of fair and equitable  consideration of other viewpoints.  The process shall have a lack of dominance of any  one interest, organization or perspective A person with a direct or material interest, impact, risk or investment in an issue or  concern and/or outcomes. Identified segment of community members from various perspectives and interests  who are assembled to share in and address issues and concerns of the group.  Their  product is but not limited to standard method performance requirements.  Specific group of stakeholders commissioned by the stakeholder panel and approved  by the stakeholder panel chair to apply expertise develop draft standard(s) for  recommendation to the stakeholder panel.

Dominance

Stakeholder

Stakeholder Panel

Working Group

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Terminology (con’t)

Term

Definition

Advisory Panel

Planning or ad hoc committee of key stakeholders to identify additional  stakeholders and experts, identify priorities and help to plan the first stakeholder  meeting.

Key Stakeholder

A stakeholder who may have a great material interest 

Consensus

General agreement, but not necessarily unanimity, and includes a process for  attempting to resolve objections by interested parties, as long as all comments have  been fairly considered, each objector is advised of the disposition of his or her  objection(s) and the reasons why, and the consensus body members are given an  opportunity to change their votes after reviewing the comments

Fitness for Purpose

Description of what the method needs to do

Standard Method  Performance Requirements

Voluntary consensus standard that details the fitness for purpose; including relevant  analyte(s), non‐relevant analytes, matrices, potential interferents, and performance  characteristics including analytical range, levels of confidence; recoveries, etc….   A vetted balanced representative subset of the stakeholder panel who vote on  motions presented to the stakeholder panel on behalf of the stakeholder panel  demonstrating consensus of the stakeholders

Voting Members

Basic Principles of Standards Development

As an international standard developing organization, AOAC standard  setting activities include:

Transparency Openness Balance of Interests Due Process Consensus Appeals

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Transparency

– Announces the proposed standard development  activity

– Invites all stakeholders to participate and  contribute their perspectives

– Invites comments prior to final approval and  adoption of standards.

Openness

– Make the standards development process available for  participation for all who are materially interested.  

– Leverage networks of key stakeholders, membership and  volunteers to ensure that all materially affected parties and  interests are invited to participate and provide input.  

– Ensures that meetings are open to the public and are  advertised.

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Balance of Interests • AOAC establishes a voting member panel that is representative  of the scope of perspectives of the entire stakeholder panel.  – Vetted by the AOAC Official Methods Board – Balance and dominance • The stakeholder chair moderates the meeting and will maintain  seek to maintain a lack of dominance by any one stakeholder;  and • Primary voters and alternate voters may be specified – to ensure that identified perspectives are represented.

Due Process

• AOAC stakeholder panel meetings are open and all  stakeholders are highly encouraged to participate in any of the  discussions and share their perspectives.  

• Meetings are conducted in accordance to parliamentary  procedure.  

• Draft AOAC standards method performance requirements are  open for comment.  Every effort will be made to ensure that all  perspectives have the opportunity to participate.

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Consensus

• AOAC considers two‐thirds majority of the representative  voting members of the stakeholders or of the assembly. 

• Evidence of consensus is the documented vote.  Voting takes  place during in person meetings or by email or facsimile  ballot.  

• Voting and changes in votes are conducted in accordance  with standard parliamentary procedures.

Appeals Process

• All formal complaints, appeals or comments  are sent to the AOAC Staff.

• All written concerns will be considered and  given a response.

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AOAC Standards Development Processes

Transparency, Openness,  Balance, Due Process,  Consensus, Appeals US National Technology  Transfer and  Advancement Act ( PL 104‐ 113) Standards Process

Defensibility

Acceptability

Consensus

AOAC Consensus & Products

Examples: AOAC  Consensus Products • Performance  Requirements • Guidelines • Sampling Standards • Methods of Analysis

Basic Principles

• Transparency • Openness • Balance of Interests • Due Process • Consensus • Appeals

• Best Practices • Operational  Documents

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OVERVIEW: Project Initiation to Adopted Method

•New and Emerging Topics • Horizon Scanning •New working group projects and new programs

Analytical  Solutions Forum

• Urgent or Emerging Analytically‐based Issues  • AOAC forms an Advisory Panel of key stakeholders

Initiation of  Projects

• AOAC forms and engages working groups to draft standards • Stakeholders participate in consensus building and approval – most common are standard method performance requirements.

Standards  Development

• AOAC forms Expert Review Panels (ERPs) to review &  approve methods • Adopted methods are published in the Official Methods  of Analysis of AOAC INTERNATIONAL

Conformity  Assessment

Basic AOAC Standards Development Activity Framework

WG chair(s) present final   draft standard along with  reconciled comments for  deliberation and  consensus. Approval has  multiple mechanisms. Community Consensus  / Approval of Standard

Advisory Panel Meeting

WG begin work and draft  consensus documents via  web conference and  reach general consensus  on draft standard  between AOAC meetings WG Meetings

Works with AOAC to  define scope of work to  be launched, including  development of new  programs and/or new  working groups (WGs)

Draft standard is posted  for public comments.   Comment period is ≥ 30  days Virtual public comment  session via webconference Draft Standard Public  Comment Period

At AOAC meetings, launch WG  effort by refining a preset  scope of work into a basic  applicability statement from  which the WG to began  drafting the standard (e.g.,  SMPR, guidelines, etc) Launching New WG  Activities

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AOAC Voluntary Consensus Standards Development

Emerging  Topics

•Analytical  Solutions  Forum •Sole Source

Assemble  Experts

•Develop Draft  Standard

•Reconcile  Comments

Appeals

Reach  Consensus

•Broad  Stakeholder Input •Final Standard  Published

Stakeholder Panels vs Programs vs Individual Working Groups

Use of Analytical  Solutions Forum to start  new programs and  individual working  groups

AOAC formed  stakeholder panels and  used them primarily to  develop standards

SPIFAN is considered to  be an AOAC Program

Evolved stakeholder  panels into programs

A few things happened:

Stakeholder panels  developed their own  identity and support  mechanism to continue  work

AOAC placed all other  efforts into the two  panels it was supporting  and the overall effort less  defined

Stakeholder panels have  greater needs than just  the standards  development activity

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New Volunteer Position

• Added a  Senior Advisor  role for more challenging WG  activities – New position for experienced volunteer SMEs  – Advise and assist staff and working group chairs to  meet the objectives of the scope of work – Serves in an advisory capacity; reporting to the  AOAC CSO

Advisory Panel

• Identifies key stakeholders and subject matter  experts • Frames the issues and set priorities for the  stakeholder panel • Provides financial support • Program Chair or Lead moderates discussion

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Program/Project Stakeholders Composition

• Reference Materials Developers • Ingredient Manufacturers • Method End Users • Academia • Non‐Governmental Organizations   (ISO, IDF, etc…) • Other…. as identified

• Product Manufacturers • Analyte/Method Subject Matter  Experts • Technology Providers • Method Developers • Government and Regulatory  Agencies • Contract Research Organizations

Anyone with a material interest can participate AOAC Official Methods Board will oversee mechanism used to determine approval of standard

Program or Project Stakeholders

• All stakeholders are entitled to due  process.   – All stakeholders can share their  perspectives – Anyone with a material interest  may participate – Standards are established by a  group that lacks dominance by any  one interest ‐ BALANCE • Draft standard must contain input  of stakeholders of varying  perspectives. • AOAC will confirm consensus  regardless of mechanism used to  demonstrates consensus of the  stakeholders. 

Stakeholder Panel Composition

Perspective 1

Perspective 2

Perspective 3

Perspective 6

Perspective 4

Perspective 5

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Program/Project Participants  ‐ Broad Perspectives

ngo 2%

academia 4%

government 14%

industry 80%

Program/Project Participants ‐ Specific Perspectives

vet drugs 2%

cro 14%

tech providers 14%

dietary supp 5%

state regulators 7%

research 5%

food/beverage 14%

regulators 12%

food/formula 9%

ref materials 5%

iso 2%

food/ingred 5%

indep 2%

food/cro 2%

formula 2%

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SPSFAM Participants ‐ Regional Perspectives

Australia 3%

Netherlands 2%

Argentina 3%

Canada

5% Italy 2%

New Zealand 2%

Singapore 2%

Sweden 2%

Switzerland 2%

UK 2%

USA 75%

SPSFAM Participants ‐ Regional and Specific Perspectives

ARGENTINA  research 2%

CANADA regulator 2%

AUSTRALIA cro

NETHERLANDS  food/formula 2%

2% CANADA cro 2%

USA vet drugs 2%

CHINA regulator 2% ITALY  research 2%

NEW ZEALAND iso 2%

USA tech provider 11%

SINGAPORE  food/formula 2% SWEDEN regulator 2% SWITZERLAND  food/formula 2%

USA state regulator 7%

USA regulator 4%

USA  reference  materials 4%

UK tech  provider 2%

USA cro 11%

USA  independen t 2%

USA food/formula 7%

USA food/beverage 13%

USA food/ingred 4%

USA dietary supplements 4%

USA food/cro 2%

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Representative Stakeholder Input on Standards

Industry ‐ Food

Government

Academia/Research

STANDARD

NGO

Industry ‐ CRO

Industry – Technology Provider

Industry – Dietary  Supplement

Enhanced Public Comment Period

• Public Comment Period for Standards or other  consensus documents – Minimum 30 day period – Added an online public comment webconference session • Anyone can participate • Includes moderator, WG chair(s) • WG chair reviews a summary of the document • Attendees state their comments • AOAC captures comments on screen in the  document • WG chairs reconcile both written and oral  comments

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Ways AOAC Approves Standards

• AOAC is expanding the way consensus on  standards can be demonstrated – For each meeting, AOAC vets and forms a  representative voting members – based on  registration – For each standard, AOAC confirms that draft  standard was developed including due process,  balance of perspectives, and consensus.  Final  draft can be approved via electronic ballot  during the meeting. – Continuing to investigate varying ways to  demonstrate consensus for a standard.

Initiating Standards Development to Final Action Status of Methods

Advisory  Panel

ERP Review of First  Action Methods &  any  recommendations  for Final Action  Status/Repeal/etc..

OMB review &  rendered decisions  on Final Action  status/Repeal

Call for Methods Call  for Experts (if  needed)

ERP Review of  Methods and First  Action status 

Established  SMPRs

Stakeholder Panel

Working  Groups

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Process for approval of standard is overseen  and approved by the AOAC Official Methods  Board.

Advisory Panel & Working Groups

• Funding

Advisory  Panel

Sponsors

• Community of experts and key stakeholders • Routine 100+ stakeholders • Demonstrate consensus

ProgramorProject  Stakeholders

• Consists of technical experts from Industry, Government, CRO’s, and Academia to develop method performance criteria required for needed methods • Present background and history on analytical method needs for stakeholders

Working  Groups

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Working Groups

• Program/project  participants

• Members are recruited • Can meet prior eting • Develops draft standard(s) • May participate in method  processes

• Develop draft standards • Online Comment Session • Reconcile public comments  received on draft standards • Recommend draft standard  to the stakeholder panel for  deliberation and consensus • Participate in Orientation  for approved standard

Stakeholder Panel Role and Output

• Defines specific analytical issue(s)

1 st

• Forms working groups to draft standard(s)  that address the issue(s)

2 nd

• Comments on draft standard(s)

3 rd

• Demonstrate  consensus on standard(s)

4 th

AOAC Voluntary Consensus Standards  • Published in Official Methods of Analysis of AOAC INTERNATIONAL • Manuscript published in  Journal of AOAC INTERNATIONAL

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Establish SMPR ® Standard Method Performance Requirements

Establish  SMPRs

• Documents a community’s analytical method needs • Very detailed description of the analytical requirements • Includes method acceptance requirements • Used to qualify methods for AOAC approval in the Official Methods SM program • Published as a standard

Standard Methods Performance  Requirements (SMPRs)

• Documents a community’s analytical  method needs. • Very detailed description of the  analytical requirements. • Includes method acceptance  requirements. • Used to adopt AOAC Official Methods  by Expert Review Panels. • Published as a standard in the OMA  and in the  Journal of AOAC  International.

Publication of  Standard  Method  Performance  Requirements

After2years, ERP  recommends to  AOACOfficial  MethodsBoard  regarding status of  method

ExpertReview  Panel

FirstAction, Official  Methods  status

AdvisoryPanel

Stakeholder Panel

WorkingGroups

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Example SMPR: Selected Food Allergens

Performance parameters and targets that method must meet

Specified intended method use

How the method is to be applied

Definitions used for this SMPR as it relates to the method

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Example SMPR: Selected Food Allergens (con’t)

Commodities from which the method should

be able to determine allergenic targets

SMPRs

An analytical  voluntary  consensus  standard

Logically  documents a  community’s  analytical  method needs

Very detailed  description of  the analytical  requirements.

SMPR

Includes  method 

Published as a  standard.

performance  requirements.

Used as  acceptance  criteria for 

method  approval

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Questions?

SMPRs

• Introduction • Background • Format • Process • Performance parameters • Guideline for Development of SMPRs

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Standard Methods Performance Requirements

• Commonly referred to  as: – SMPRs

SMPRs

• documents a community’s analytical method  needs. • very detailed description of the analytical  requirements. • includes method acceptance requirements. • used to qualify methods for AOAC approval under  the Official Methods program. • published as a standard.

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Uses of SMPRs

•

Basis for method acceptance and approval.

• Guidance to method developers for the development of  new methods. • Advance the state‐of‐the‐art in a particular direction. • Address specific analytical needs. • Allow AOAC to reach a broader community of method  developers and users. • Development time = 3 to 6 months.

Background

Most OMA methods have been validated without  formal acceptance criteria. Compared to a reference method. Certain reference documents existed (but hard to  find) for describing PRSD (R) , expected recovery, &  HorRat value.

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Background

• In 2004, AOAC was awarded a US Dept of Homeland  Security (DHS) project to evaluate hand held assays. • AOAC developed a common study protocol, and for  the first time, developed and published a separate  acceptance criteria statement. • AOAC began developing what are now called standard  method performance requirements in 2007.

Background

In 2009: AOAC replaced the term “acceptance criteria” with  “Standard Method Performance Requirements” (SMPR).

An SMPR was completed for antibiotic residues in  seafood.

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Background In 2010 AOAC completed development of  standard method performance  requirements were also developed for: – Ricin hand held assays – Bacillus anthracis hand held assays – Bacillus anthracis PCR assays  – Francisella tularensis PCR assays  – Yersinia pestis PCR assays 

Background

• By 2010, a variety of method performance  requirements and acceptance requirements from  different AOAC projects had been developed ‐ each  with its own format and style. • AOAC recognized that it needed a standard process  and format.  • A standard format was developed in 2010.

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SMPR Format

Each SMPR is identified by a unique SMPR‐ number consisting of the year followed by a  sequential identification number  (YYYY.XXX).  

SMPR Format

• Intended use • Applicability • Analytical technique • Definitions • System suitability

• Reference materials • Validation guidance • Maximum time‐to‐determination • Method performance requirements table

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Performance requirements parameters for  quantitative methods:

• Analytical range • Limit of detection • Limit of  Quantitation  • Repeatability • Recovery • Reproducibility

SMPRs can be developed for all types of methods:

Quantitative methods – Trace components – Main components Qualitative methods – Trace components – Main components Identification methods

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SMPRs are published in the OMA. SMPR ID numbers use the year and 3 numerals. OMA ID numbers use the year and 2 numerals.

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AOAC has adopted 110+ SMPRs since 2010

Appendix F:  Guideline to SMPRs

• Complete guidance designed to contain all of AOAC’s validation requirements. • Everything you need to develop an SMPR • Published in OMA

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SMPR Guideline

Contents covers • Chemistry & microbiology • Quantitative & qualitative • Definitions • Evaluation recommendations • Expected results • Informative sections

SMPR Guideline

Introduction SMPRs Annex A: SMPR Format

Table A1: Performance Requirements Table A2: Recommended Definitions

Table A3: Recommendations for Evaluation Table A4: Annex 5: Expected Precision Table A5: Expected Recovery Table A6: Predicted Relative Standard Deviation of Reproducibility Table A7: POD and Number of Test Portions

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SMPR Guideline

Annex B:  Classification of Methods Annex C:  Understanding the POD Model Annex D:  Definitions and Calculations of HorRat Values from  Intralaboratory Data Annex E:  AOAC Method Accuracy Review  Annex F:   Development and Use of In‐House Reference  Materials

Table 5: Expected Recovery as a Function of Analyte Concentration

Mean Recovery (%)

Analyte %

Analyte Ratio

Unit

100

1

100%

98-102 98-102 97-103 95-105 90-107 80-110 80-110 80-110 60-115 40-120

10

10 -1 10 -2 10 -3 10 -4 10 -5 10 -6 10 -7 10 -8 10 -9

10%

1

1%

0.01

0.1%

0.001

100 ppm

0.0001

10 ppm

0.00001

1 ppm

0.000001

100 ppb

0.0000001

10 ppb

0.00000001

1 ppb

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Precision

• The closeness of agreement between independent test results obtained under stipulated conditions. • Same lab, same samples, same analysts, same instrument.

• Expressed as:

– RSD(r) or RSD r

or as “RSD little r”

– RSDr estimated as 2/3 of RSDR

Table 4: Expected Precision (repeatability) as a Function of Analyte Concentration

Analyte % Analyte Ratio

Unit

RSD%

100

1

100%

1.3 1.9 2.7 3.7 5.3 7.3

10

10 -1 10 -2 10 -3 10 -4 10 -5 10 -6 10 -7 10 -8 10 -9

10%

1

1%

0.01

0.1%

0.001

100 ppm (mg/kg) 10 ppm (mg/kg) 1 ppm (mg/kg) 100 ppb (μg/kg) 10 ppb (μg/kg) 1 ppb (μg/kg)

0.0001 0.00001 0.000001 0.0000001 0.00000001

11 15 21 30

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Performance parameters

• All of the following information (plus a ton more) is in: Appendix F: Guidelines for Standard Method Performance Requirements in the 19 th edition of the Official Methods of Analysis

Performance parameters

• Reproducibility – Precision under reproducibility conditions.

– Conditions where independent test results are obtained with the same method on identical test items in different laboratories with different operators using different equipment.

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Reproducibility

• Also known as inter-laboratory variation or precision.

• Measured as: – Relative Standard Deviation Reproducibility – RSDR or RSD R or “RSD big R”

Predicted RSDR or PRSD(R)

• PRSD(R) = 2C -0.15 • where C is expressed as a mass fraction.

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Table 6: Predicted Relative Standard Deviation of Reproducibility (PRSD R )

Concentration, C

Mass fraction, C

PRSD(R) (%)

100 %

1.0

2

1 %

0.01

4

0.01%

0.0001

8

1 ppm

0.000001

16

10 ppb

0.00000001

32

1 ppb

0.000000001

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Table excerpted from: Definitions And Calculations Of Horrat Values From Intralaboratory Data, AOAC INTERNTIONAL, Horrat for SLV.doc, 2004-01-18.

Questions?

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After Standards Development

How does one get from SMPR to OMA?

Basic AOAC Official Methods SM Activity Framework

AOAC issues call for  methods and call for  experts Method author  orientation incl SMPR  overview is done Call for Methods or  Experts

ERP Assembly &  Review of Methods

Final versions of methods  along with supporting  documentation are  submitted to OMB for  their decision on the  recommendation Final Action Review  Status

ERPs are vetted,  approved, and appointed.   Methods are reviewed  and ERPs meet to review  and reach consensus on  methods

Approved methods are  published and are tracked by  ERP in partnership with the  method author.  Methods that  satisfy ERP requirements and  demonstrate reproducibility  are recommended for Final  Action First Action Method  Publication & Tracking

Method authors may submit  methods that may meet the  approved standard Method authors will want to  attend the SMPR or standard  orientation for method  authors. Submission of  Methods

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Call for Methods • Try to collect as many methods that  might be useful. • To provide information on the analytical  possibilities and claimed performance. • AOAC has added a Method Author Orientation • Open to all potential method authors and others • Includes WG chair(s) reviewing SMPR • AOAC tutorial on developing an ideal submission package

Call for Methods

• AOAC issues a Call for Methods based on a  generally accepted fitness for purpose or  standard method performance  requirements

• Candidate methods are selected that may  meet the SMPR

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AOAC Methods Programs

AOAC Performance Tested Methods SM (OMA) • Method certification program for sole  source commercial rapid methods • AKA: testkits, alternative methods,  proprietary methods • Technical Requirements: Single  laboratory validation + independent  laboratory study • Administered by AOAC Research  Institute

AOAC Official Methods of Analysis SM (PTM)  • Method approval and publication  program • Methods meeting standard method  performance requirements • Individually criteria based methods • Rapid methods, traditional methods,  emerging methods • Administered by Standards and Official  Methods SM

AOAC Performance Tested Methods SM (PTM)

• AOAC Research Institute administers  PTM certification program • Sole source and individual test kit and  rapid method submissions • Application fee required • Harmonized technical criteria with OMA  • Harmonized process for methods  submitted to OMA program • Certifications published on AOAC  website • Manuscripts published in the  Journal of  AOAC INTERNATIONAL • Single laboratory validation and  independent expert laboratory study • Method developers licensed to use  certification mark • Annual review & recertification

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AOAC Official Methods of Analysis SM (OMA)

• AOAC’s premiere methods program • published in the Official Methods of Analysis of  AOAC INTERNATIONAL  (print and online) • Manuscripts published in the  Journal of AOAC  INTERNATIONAL • First Action and Final Action status • PTM Methods can be submitted to the OMA  program • AOAC administers Official Methods SM (OMA)  program based on AOAC standards  development activity or on sole/individual  submissions • Adoption of methods as Official Methods  is  contingent upon  – Relevant standards development activities  and call for methods

– Sole source/ individual submissions  through demonstration of validated  performance claims 

About OMA Methods

Must include safety  precautions and  warnings for any step  or component used or  that results from  using the method

Should be written  such that it can be  used as written

Can be modified  and/or extended to  other applicabilities

Must be extremely  detailed

Supporting Validation  Data Required

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Status of Official Methods

Official Methods SM Program Process

Assemble Methods & Experts • Call for Methods • Call for Experts

Method Review & Consensus • Adopt Methods • Track

Adopted Methods • First Action status • Final Action status

Adopted Methods

~ 6 month process after standard is established

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Basic Components of an AOAC Method

Sampling & Sample  Preparation • Preparation of  sample set • apportioning test  portion(s) from  the sample set

Isolation of Target  Analyte(s) • Isolation of the  target analyte(s)  of interest from  the testing  portion matrix

Analysis of Target  Analyte • Determination or  Quantification • Detection and  Confirmation • Identification and  Confirmation

• Enrichment 

and/or Extraction

Guide to Method Format

• Title • Applicability (SMPR can guide) • Principle – scientific premise of  method  • Apparatus (SMPR can guide) – types of technologies used and  technology specifications • Reagents • Sample  Preparation/Analysis/Determinat ion/Preparation of Standard  Solutions (may have subsections) • Calculations • References cited – including  SMPR, guidance used, etc...

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Guide to Method Format

• Title • Applicability (SMPR can guide) • Principle • Apparatus (SMPR can guide) • Reagents • Sample 

Preparation/Analysis/Determination/Preparation  of Standard Solutions (may have subsections)

• Calculation • Reference

Preparing a Candidate Method

Publishing a technique  in a peer reviewed  journal can be a start,  but is not enough

Testing your method to  ensure that all method  parameters are  characterized, accuracy  determined and  precision are required Analytical working ranges,  recovery/accuracies, Forms of limits (LOD, LOQ,  MDL, AMDL, etc…) Commodity matrices for which  method applies Repeatability, robustness,  reproducibility*) •*Reproducibility is required  for Final Action consideration

Write the method into  AOAC format and see if  it can be followed as  written. 

Evaluate and Test the  Method !!!

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Method Applicability

• Method must be clearly written  in AOAC format – What are the all matrices and/or commodities for which the  method is used should be listed?   • There are times when categories of matrices or  commodities are claimed applicable.  Evidence of this  information should be clearly documented with specifics  commodities evaluated by the method stated in the  method manuscript – Are there specific analytes or limitations for any of the  matrices that an end user will need to know?   • This should be documented also.  Evidence of this  information should be clearly documented in the method  manuscript

Validation Studies for Methods of Analysis

Required  Information for  Method  Evaluation • There are several studies that should be done to characterize the  performance of the method and assess the method’s precision and  consistent capability across multiple laboratories (reproducibility). – Single laboratory validation • Characterizes method performance and assesses method  robustness and repeatability to meet SMPR and/or  guidelines & community expectations – Reproducibility validation  (required for Final Action status) • Characterizes method performance consistency across  multiple method users under reasonable variable  conditions ‐ to meet SMPR and/or guidelines & community  expectations • Multiple approaches to method reproducibility under  consideration

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