Overview of ANSI and the U.S. Standards System

1. Overview of ANSI and the U.S. Standards System

2. Greetings from ANSI President and CEO

3. Importance of Standards “The international language of commerce is Standards” Source: Donald L. Evans, Former U.S. Secretary of Commerce, From Standards & Competitiveness: Coordinating for Results

4. WTO/TBT Definitions* • Standard- Document that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. • Technical Regulations– Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. • Conformity Assessment (Conformance)– Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. (e.g., testing, certification) *World Trade Organization Technical Barriers to Trade Agreement, Annex 1 http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm

5. WTO/TBT Principles for the Development of International Standards* • Transparency • Openness • Impartiality and Consensus • Effectiveness • Coherence • Development Dimension *World Trade Organization Technical Barriers to Trade Agreement Second Triennial Review, Annex 4 http://docsonline.wto.org/DDFDocuments/t/G/TBT/9.doc

6. The ANSI Federation

7. What is ANSI? ANSI is the “Umbrella Organization” for and coordinator of the U.S. voluntary standards and conformity assessment systems. Duties and responsibilities include: • Develop and promote U.S. policies and positions • Accredit SDOs and approve American National Standards (ANS) • Accredit certifiers of products, personnel and management systems • Provide standards and compliance solutions domestically and internationally

8. What is ANSI? A Federation of members representing . . . • Academia • Individuals • Government • Manufacturing • Trade Associations • Professional Societies • Service Organizations • Standards Developers • Consumer and Labor Interests • and many more A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer

9. ANSI: A Private-Sector Organization ANSI is an independent not-for-profit (501(c)3) organization. ANSI does not receive government oversight or subsidization. Advantages: • Public and private sectorsare coequal partners • Impartiality • Market relevance

10. ANSI’s Member-Driven Policy Development Approach in the U.S. Approach in many other countries National Standards Body (e.g. ANSI, SAC) ANSI’s strength comes through effective representation of member interests Standards Developers (Including Consortia) Standards Users (e.g. regulators, companies, etc.) Other National Standards Bodies receive authority and funding through legal mandate

11. ANSI’s Member-Driven Policy Development

12. ANSI International Interaction • ANSI serves as the official U.S. member and sets policy for U.S. participation in several international and regional organizations, including: • International Organization for Standardization (ISO) • International Electrotechnical Commission (IEC) • Pacific Area Standards Congress (PASC) • ANSI communicates U.S. positions on standards and conformity assessment with its peer organizations around the world. (e.g. Standardization Administration of China, etc.) • ANSI members also engage with foreign counterparts, advocating for the positions of their individual organizations and engaging in sector and issue-specific cooperation. ANSI supports these efforts.

13. The U.S. Standards System

14. The U.S. System: Comparisons Compared with many other countries, the U.S. system… • Emphasizes private-sector solutions to ensure quality and protect Environment, Health and Safety (EHS) • Places a higher degree of confidence in private-sector conformity assessment activities for regulatory and non-regulatory functions • Provides a stronger voice and greater authority to standards users and individual stakeholders • Relies on a strong judicial system, brand-name recognition, open media and corporate social responsibility • Is highly decentralized

15. The U.S. System: Benefits • Speed and flexibility – solutions are delivered to market and implemented quickly • Participation – able to accommodate input from a wide spectrum of stakeholders • Efficiency – prevents unnecessary or costly regulation and allows multiple approaches to ensure health, safety, and quality The U.S. approach facilitates economic development and innovation

16. U.S. Regulatory Reliance on Voluntary Standards • U.S. regulators use voluntary standards to offset the need for additional regulations or to enhance existing regulations. • When regulations are necessary, U.S. regulators are required by law to use voluntary standards whenever possible. • When appropriate voluntary standards do not exist, regulators work in partnership with private-sector SDOs to develop suitable standards.

17. The U.S. System: A Toolbox • Rather than mandating a “one-size fits all” solution, the U.S. system allows players to find the tools and solutions that best fit their needs. • Approaches, philosophies and positions often vary across industry sectors. Such variations are seen as beneficial and are promoted in the “U.S. Standards Strategy.”

18. Standards Used in the U.S.: Different tools for different market needs • National Participation • Treaty Organizations • Non-Treaty Organizations • Direct Participation • Nationally Accepted • Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process One country, one vote Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

19. Standards Used in the U.S.: Different tools for different market needs • National Participation • Treaty Organizations • Non-Treaty Organizations • Direct Participation • Nationally Accepted • Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process One country, one vote Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

20. Standards Used in the U.S.:National Participation • Treaty Organizations: U.S. government agencies serve as national bodies. For example: • CODEX (U.S. Department of Agriculture) • ITU (U.S. Department of State) • OECD (U.S. Department of State) • Non-Treaty Organizations: ANSI Serves as national body and coordinates broad spectrum of private-sector input: • International Organization for Standardization (ISO) • International Electrotechnical Commission (IEC)

21. Standards Used in the U.S.: Different tools for different market needs • National Participation • Treaty Organizations • Non-Treaty Organizations • Direct Participation • Nationally Accepted • Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process through “one country, one vote” system Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples IGRS, SNIA, W3C, etc. Features Wide range of processes and procedures allows flexibility

22. Standards Used in the U.S.:Accredited/Approved Standards • ANSI is responsible for accrediting SDOs and approving standards as “American National Standards.” • National and international SDOs voluntarily choose to receive ANSI accreditation/approval (the U.S. has no legal requirement) • Accreditation and approval do not guarantee U.S. market acceptance; individual users have complete freedom to choose which standards best suit their needs. • ANSI accreditation and approval processes do not evaluate a standard’s technical merit, but only evaluate the process by which a standard was developed.

23. Accredited/Approved Standards:ANSI Essential Requirements • Openness • Transparency • Consensus • Due Process • Balance

24. ANSI Accredited Standards Developing Organizations (SDOs) 3-A ASC X9 ASA ACCA AMCA ARI ATIS AA AAMA AAMVA ABMA ABYC ABMA ACC ACI ADA AFPA AGA AGMA AH&LA AIHA AIAA AISC AITC AISI ALI ANS ANLA API ASNT ASQ ASAE ASB ASCE ASHRAE ASME ASSE AWWA AWS AWEA ATA ACMI ASIS AIIM AMT NPES AAMI ACDE AHAM ARMA ASTM AIM AGRSS ALI BHMA BICSI BOMA BIFMA CCPA CSAA CAPA CLSI CFPMI CAP CPA CAGI CGA CAM-I CEA CSPA CEMA CTI CSA DISA DASMA EIMA EASA EIA ESTA EIA EOS/ESD FCI FM GTEEMC GICC GEIA GEI HPVA HIBCC HL7 HPS HFES HI IESNA ITSDF IEEE IEST IIE INMM 12AMA IAF IAAMC IAPMO ICPA ICC ITI NETA I3A IIAR ISEA ISA ISANTA IWCA IPC ISA JCSEE KCMA LIA MSS MHI MBC NACE NAHBRC NAAMM NBBPVI NBFAA NCMA NCSL NCPDP NECA NEMA NFPA NGA NGCMA NISO NIMS NIST/ITL NPPC NSC NSAA NADCA NERC NAESB NALFA NASPO NSF NIRMA OLA OPCC OEOSC OPEI PMMI PSA PCA PWMA PMI RPTIA RSTC RVIA RESNA RIA RMA SIA SSFI SIA SMA SPRI SBS SAE SCTE SMPTE SVIA SAAMI SES SDI SJI SSCI TIA TCATA CI TMS SPI TCA TOY-TIA TAPS TCIA TPI USDA USPRO UL UAMA UAMA UCC VITA WQA WDMA WCMA WMMA

25. Standards Used in the U.S.: Different tools for different market needs • National Participation • Treaty Organizations • Non-Treaty Organizations • Direct Participation • Nationally Accepted • Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process through “one country, one vote” system Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

26. Standards Used in the U.S.:Consortia Standards • Consortia consist of groups of like-minded participants who place a priority on developing standards quickly enough to meet market demands or to harmonize or differentiate specifications within an industry. • Hundreds of consortia organizations operate in the global economy. Many have global membership, including both U.S. and Chinese companies. • Consortia usually have a narrow focus, with some only developing a single specification. However, some consortia are very broad and develop a large number of standards (examples: W3C, OASIS, etc.) • Companies often rely on consortia standards in areas where the technology changes rapidly.

27. The U.S. Standards System Government Private-Sector Regulators CPSC, EPA. FCC, USDA, etc. NGOs Academics Companies Standards Developers NIST coordinates Federal activities in voluntary standards Trade Associations Consumers Others Government NIST Procurement Agencies DOD, NASA, USDA, etc. Activities Carried out independent of the ANSI Structure Government Agencies are members of ANSI and of SDOs. Agencies participate directly in voluntary standards development and policy setting and use voluntary standards when it supports their missions U.S. Policies and Positions

28. The U.S. Standards System: Who’s Who *Documentary Standards, excluding “national participation models”

29. U.S. Standards System “The Drivers” Companies, Government Agencies and other Standards Users “The Vehicle” Standards Developers (Including Consortia) “The Road” ANSI

30. Questions or Comments?

31. Annex 1: Common Acronyms

32. Common Acronyms used in the U.S. • ANS- American National Standard • ANSI – American National Standards Institute • EHS – Environment, Health and Safety • IEC – International Electrotechnical Commission • ISO – International Standard Organization • ITU – International Telecommunications Union • NGO – Non-Governmental Organization • PASC – Pacific Area Standards Congress • S&C – Standards and Conformance • SAC – Standardization Administration of China • SCATR – Standards, Conformity Assessment, and Technical Regulations • SDO – Standards Developing Organization • TBT – Technical Barriers to Trade (Agreement under WTO) • WTO – World Trade Organization

33. Annex 2: Background Slides

34. ANSI in Numbers • Revenue • $25 million annual budget • Development of Standards 0% ($0.0m) • Sale of Publications 50% ($12.5m) • Membership Dues and Fees 20% ($5.0m) • Accreditation Services 19% ($4.8m) • Other 11% ($2.7m) • Est. total public sector portion of all of the above 10% ($2.5m) • ISO/IEC Annual Dues $2.1 million • Technical Committees of ANSI 0 • Number of Standard Developing Organizations (SDOs) accredited by ANSI 208 • Technical Committees of ANSI’s SDO members 565 • Number ANSI Standards Panels 4 • Total number of American National Standards published 9,915 • Estimated number of voluntary standards published in the U.S. 100,000 • Number of voluntary standards referenced in U.S. laws & regulations over 3,000 • Number of company interests represented by ANSI 125,000 • Number of professionals represented by ANSI 3.5 million • Year ANSI was established 1918

35. NSBs Others Members 200+ FCS Officers worldwide including 4 Regional Standards Attachés USNC IEC TAGs US ISO TAGs IEC TAGs IEC TAGs IEC TAGs IEC TAGs NHTSA ANSs (American National Standards) Laboratories / Metrology Certified Personnel QMS/EMS Certified Product/ Service Providers Accredited Laboratories Tested Products (Processes, Services) Certified Products(Processes, Services) Non-ANS Standards SSOs & Consortia without ANSI accreditation SDOs with ANSI accredited procedures ANSI accredited Personnel Certifiers ANSI accredited Product Certifiers ANAB accredited QMS/EMS Certifiers DOT (Accreditation of Laboratories) (Accreditation of Certifiers) Standards and Conformity Assessment Bodies of the U.S. Recognition (via ISO/IEC 17011) (Standardization) (Metrology) Other iSDOs PAC COPANT APLMF APMP ILAC (Accreditation of Laboratories) APLAC ISO JTC1 IEC IAAC PASC IAF OIML Standardization BIPM ESOs Accreditation SIM (Accreditation of Certifiers) ANSI Technical Policy DOC (Accreditation of SDOs) NACLA ITA TA ASQ CAPC IPC NPC IPRPC Standards Liaison NIST AIC USNC IAS PRI-Nadcap FQS-I AIHA L.A.B A2LA ACLASS Others * Institute policy committees& councils MAS Board MAC TS ISO/IEC 17025 ANSI Essential Requirements ISO/IEC Guides62 / 66 (17021) ISO/IEC Guide 65 ISO/IEC 17024 SSD US&FCS NVCASE NVLAP US Private & Government Sectors: Organizations, Government, Companies, Trade Associations, Consumers, Educational Institutions, Individuals, Others NCSCI (Standardization) (Testing) (Certification) US Private Sector Inquiry point ITAC16 WTO TBT (Standardization-SPS) (Standardization-Telecom) SPS FAO Inquiry point ICSP (Members) CODEX USDA APEC/ SCSC Other SDOs APEC-TEL IPPC FAS OIE CITEL ITU Sector Members FSIS USCO TPSC SC-S&TB Legend APHIS ITU PPQ ITAC ACICIP Cabinet Departments Executive Office Of the President Other Agencies Regional International FDA TSP FEMA OSHA ES&H DSP CIP EB Government DOC USDA DOD DOE DOEd HHS HUD DOI DOJ DOL State Treasury VA OMB USTR CPSC EPA FCC FTC GSA ITC NASA NRC NSF USPS DHS Non-Government Program / Body

36. The U.S. Conformity Assessment System International Activities Domestic Activities Testers, Inspectors & Certifiers Designating Authorities IEC (IECEE, IECx, IECQ) ISO (CASCO) Accreditors SDOC ANSI (ANAB) UL A2LA Intertek John Deere U.S. Positions developed through ANSI/USNC TUV FCC (Telecom) NIST (NVLAP) HP Other International Fora Includes accredited and non-accredited bodies USDA (Food) ANSI IAF EPA (ENLAP) ILAC ABs Generally manufacturers of high-tech and low-volume products Other Other No “official” U.S. representative