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
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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
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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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