November 14 2019 OMB Meeting Materials

AOAC OMB MEETING MATERIALS

135

1

2

AOAC DUE PROCESS VOLUNTARY CONSENSUS STANDARDS DEVELOPMENT  Proposed Policy and Procedure for Due Process in the Development of Consensus Documents 4 5 AOAC INTERNATIONAL develops and publishes voluntary consensus standards in support of method development, 6 method modification, and method use or implementation. AOAC establishes voluntary consensus standards in 7 accordance to national and international principles for standards development. AOAC standards development activities 8 include participation from diverse perspectives across a given analytical industry or community area, discipline or issue. 9 Standards are developed upon consensus of stakeholders. Approval of standards is based upon confirmation that the 10 standard has been developed in accordance with AOAC’s processes and principles. 11 AOAC develops the following types of standards: voluntary consensus standards; performance standards; methods of 12 analysis; guidance documents; concepts of operation; best practice recommendation documents, and sampling 13 approaches. 14 I. POLICY STATEMENT 15 AOAC INTERNATIONAL develops national and international analytical consensus standards according to the national 1 16 and international principles 2 which includes basic principles to ensure due process in the development of standards: 17 openness, transparency, lack of dominance, balance, due consideration, coordination, consensus, and appeals. Rules 18 of engagement and parliamentary procedures for AOAC standards developing bodies follow Robert’s Rules of Order 19 (latest edition) in accordance with AOAC bylaws and policies, such as the AOAC Policy on Antitrust. 20 II. TERMINOLOGY 21 a. Analytical Communities  ‐ a group of individuals interested in a specific scientific or analytical area that 22 networks, engages the international, federal, and state governments, academia, industry, business, and 23 trade groups; identifies stakeholders and prioritizes issues of concern; and works to provide solutions to 24 method ‐ based needs and global problems (AOAC INTERNATIONAL, 2008). 25 b. AOAC Official Methods Board (OMB) – AOAC’s technical board stated in the AOAC bylaws to serve in an 26 advisory capacity and serves as oversight for implementation for AOAC policies and procedures, including 27 AOAC standards development and methods approvals. The AOAC OMB provides ensures that AOAC 28 standards are developed accordingly and renders final decision on approval of AOAC standards. 29 c. Appeals Process – Manner in which AOAC receives requests to reverse, revise, or reconsider consensus 30 decision and the mechanism by which AOAC review and reconcile such requests. 31 d. Balance – No one interest, or perspective should dominate or be the majority. Ideally, no single interest 32 category constitutes more than one ‐ third of those participating in development of safety related standards 33 and no single interest category constitutes a majority of those participating in the development of non ‐ 34 safety related standards (Breitenberg, 2009) (ANSI, 2019). 35 DRAFT 3

DO NOT DISTRIBUTE

1  US OMB Circular A‐119 (United States Executive Branch Office of Management and Budget Circular A‐119) and American National Standards  Institute (ANSI) Essential Requirements: Due process requirements for American National Standards 2 World Trade Organization Technical Barriers to Trade

Title revision, terminology addition, and streamlined proposed policy statement – v3 (November 2019) 

1

12/11/2019