The Code of Good Practice and ANSI’s Role in the U.S. Standards System Standards Alliance – East African Community Workshop on WTO SPS and TBT Agreements March 21-22, 2016

Presentation Objectives Overview of ANSI Overview of the U.S. system for standards and conformity assessment Recap on the Code of Good Practice for the Preparation, Adoption and Application of Standards Key ways in which ANSI implements the Code of Good Practice The Code of Good Practice and ANSI

The Code of Good Practice and ANSI The American National Standards Institute leads standards, conformity assessment, and related activities in the United States of America. Founded in 1918, ANSI is a private, non-profit organization. ANSI is not a government agency or a standards developer. The Code of Good Practice and ANSI

The Code of Good Practice and ANSI Represents U.S. globally Ensures integrity of the standards and conformity assessment system Offers neutral forum Accredits standards developers and conformity assessment organizations Bridge between U.S. public and private sectors The Code of Good Practice and ANSI

The Code of Good Practice and ANSI U.S. member of ISO U.S. member of the IEC, via ANSI’s U.S. National Committee a U.S. member of IAF and ILAC member of regional forums in the Pacific Rim and the Americas liaison with groups in Europe, Africa and the Middle East bilateral agreements with other national standards bodies The Code of Good Practice and ANSI

The Code of Good Practice and ANSI The ANSI Federation represents more than 125,000 companies and organizations and 3.5 million professionals worldwide Members of the ANSI Federation include . . . Academia Individuals Government Manufacturing Trade Associations Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more The Code of Good Practice and ANSI

Approach in many economies Approach in the United States The U.S. System for Standards and Conformity Assessment System: a comparison with many other economies Approach in many economies Many other economies Top Down Standards bodies drive standardization activities United States Bottom Up Standards users drive standardization activities ANSI and the government do not give direction as to what standards should be developed. It’s the standards users themselves that drive standardization activities. Approach in the United States The Code of Good Practice and ANSI

The U.S. System: a public-private partnership No single government agency has control over standards Each agency determines which standards meet its needs National Technology Transfer and Advancement Act (NTTAA) — Public Law 104-113 Encourages government agencies to: Use pre-existing voluntary consensus standards when regulating Participate in the development of voluntary consensus standards The Code of Good Practice and ANSI

The U.S. System: standards in the U.S. and American National Standards In the U.S. alone, there are more than 100,000 standards Documents developed mainly by SDOs and consortia Currently there are approximately 234 ANSI-accredited standards developers Not all standards developed by these organizations are submitted for consideration as ANS Over 11,000 approved American National Standards ANSI accredits SDOs and approves ANS according to requirements contained in the ANSI Essential Requirements: Due process requirements for American National Standards The Code of Good Practice and ANSI

Examples of ANSI-accredited SDOs ASTM International American Society of Mechanical Engineers International Code Council IAPMO Group National Electrical Manufacturers Association National Fire Protection Association Society of Automotive Engineers Institute of Electrical and Electronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations The Code of Good Practice and ANSI

ANSI, the U.S. Standards Sytem and the ANSI Essential Requirements Annex 3: Code of Good Practice for the Preparation, Adoption, and Application of Standards Key provisions: Standards should not act as technical barriers to trade Preference for international standards Avoid duplication and overlap, strive for consensus Publish a work program Allow for a 60-day comment period Take comments into account ANSI has accepted the CGP on behalf of its accredited SDOs ANSI, the U.S. Standards Sytem and the ANSI Essential Requirements

The Code of Good Practice and ANSI ANSI Essential Requirements The Code of Good Practice and ANSI Slide 12

Key facets of the ANSI Essential Requirements Overarching consideration of the ANS process is due process any person with a direct and material interest has a right to participate by expressing a position and its basis, having that position considered, appealing if adversely affected All ASDs are bound by the ANSI Essential Requirements and their ANSI-Accredited Procedures, but there is broad flexibility in consensus process models used by ASDs ANSI’s role in the ANS process is to: Accredit SDOs and approve ANS Audit ANS for procedural compliance Hear procedural appeals related to ANS Maintain and revise the procedures that govern the ANS process Approval DOES NOT reflect the technical quality of the standard Approval DOES reflect the process used to develop the standard The Code of Good Practice and ANSI

ANSI Essential Requirements The ANSI Essential Requirements include: Openness Lack of Dominance Balance Coordination and Harmonization Notification of Standards Development Coordination Consideration of Views and Objections Evidence of Consensus and Consensus Body Vote Standards Developer Appeal Process Written procedures Compliance with normative ANS policies and administrative procedures The ANSI Essential Requirements include the following requirements with respect to the PROCESS by which a standard is developed. Together, these requirements uphold the tenets of the requirements outlined in the Code of Good Practice, as well as the broader TBT Agreement. I’d like to use the last few slides to highlight how a few of these requirements implement certain requirements contained in the Code. The Code of Good Practice and ANSI

The Code of Good Practice and ANSI Implementing the Code of Good Practice: Avoiding duplication and overlap 2.4.2 Coordination/Harmonization A “good faith effort” must be made to resolve potential conflicts and coordinate activities 2.5.1.2 Assertions of conflict or duplication A deliberation between the relevant stakeholders must be convened if a standards developer receives comments asserting duplication or conflict with a project initiation notification (PINS) Comments must be received within 30 days of announcement and the deliberation must be held within 90 days of comment deadline Scope is limited to existing or candidate ANS With respect to the Code’s requirement that one standardizing body avoid the duplication or overlap with another standardizing bodies activities, the ANSI Essential Requirements have several provisions that apply. Conflict within the ANS process refers to a situation where, viewed from the perspective of a future implementer, the terms of one standard are inconsistent or incompatible with the terms of the other standard such that implementation of one standard under terms allowable under that standard would preclude proper implementation of the other standard in accordance with its terms. A “good faith” effort shall require substantial, thorough and comprehensive efforts to harmonize a candidate ANS and existing ANSs. Such efforts shall include, at minimum, compliance with other relevant sections of the procedures. Good faith effort applies to… 2.1 Openness 2.4 Coordination and harmonization 2.5 Notification of standards development and coordination 2.6 Consideration of views and objections 4.3 Planning, coordination and public notice “Good faith efforts” reflected in: Timely and clear communications Response to inquiries and proposals Genuine and appropriate efforts to discuss issues Documented efforts The Code of Good Practice and ANSI

The Code of Good Practice and ANSI Implementing the Code of Good Practice: Considering comments and achieving consensus 2.6 Consideration of Views and Objections Requires prompt consideration for the written views and objections of all participants Require effort to resolve all relevant objections expressed Unresolved objections, attempts at resolution, and substantive changes must all be reported to the consensus body so members have the opportunity to respond and/or change their vote 2.7 Evidence of consensus and consensus body vote Consensus defined as substantial agreement by directly and materially affected interests Consensus is determined in part by a vote Evidence of consensus must be documented This is the “recirculation”, “reconsideration” requirement All members of the ANS consensus body, not just those that voted on the main/first ballot to approve as an ANS Include unresolved objections, attempt at resolution and any substantive change If a voter does not respond to a recirculation opportunity, then his/her original vote stands, otherwise, the vote on recirculation trumps the original vote See recirculation interpretations (www.ansi.org/asd) Consensus means substantial agreement has been reached by directly and materially affected interests. This signifies the concurrence of more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that an effort be made toward their resolution. An example of the criteria for consensus includes a requirement that a majority of the consensus body cast a vote (counting abstentions) and at least two-thirds of those voting approve (not counting abstentions). The developer may submit for approval an alternative methodology for determining consensus. Every ANSI-Accredited Standards Developer’s procedures include a definition of consensus; the definitions vary but must be applied as written and must be consistent with ANSI’s definition More than a numerical determination – numbers + a fair process and compliance with ANSI’s requirements Evidence of consensus in accordance with these procedures and the accredited procedures of the standards developer shall be documented. The developer's procedures shall state specifically how consensus will be determined. The Code of Good Practice and ANSI

The Code of Good Practice and ANSI Implementing the Code of Good Practice: Work programs, public review and comments 2.5. Notification of standards development and coordination ASDs should consult regional and international activities that may be impacted or impact the ANS ASDs must coordinate with ANSI at two stages requiring public comment: Project proposal Draft document Notifications published in ANSI’s Standards Action Used in conjunction with ASDs’ own or additional platforms In general, the ANSI Essential Requirements require notification of standards activity in suitable media as appropriate to demonstrate an opportunity for participation by all directly and materially affected persons. Must advise relevant NMC if intent is to submit as ISO/IEC standard A statement shall be submitted and published as part of the PINS announcement that shall include: an explanation of the need for the project, including, if it is the case, a statement of intent to submit the standard for consideration as an ISO or ISO/IEC JTC-1 standard; and, identification of the stakeholders (e.g., telecom, consumer, medical, environmental, etc.) likely to be directly impacted by the standard. Proposals for new American National Standards and proposals to revise, reaffirm, or withdraw approval of existing American National Standards shall be transmitted to ANSI using the BSR-8 form for listing in Standards Action in order to provide an opportunity for public comment. Such listing may be requested at any stage in the development of the proposal, at the option of the standards developer, and may be concurrent with final balloting. However, any substantive change subsequently made in a proposed American National Standard requires listing of the change in Standards Action. ASDs can do more, but not less The Code of Good Practice and ANSI

The Code of Good Practice and ANSI Standards Action Weekly newsletter available online and free… Mission is to provide members and the public with timely, accurate information and enables effective participation in the standards development process - both in this country and internationally. In this way it also reflects the work programs of ASDs. The Code of Good Practice and ANSI

Madeleine McDougall Program Manager mmcdougall@ansi.org www.standardsportal.org