Overview of the U.S. Standards and Conformity Assessment System

1. Overview of the U.S. Standards and Conformity Assessment System 2010

2. Table of Contents • Importance of Standards and Conformance • The U.S. Approach to Standards and Conformance • Overview of the ANSI Federation • Overview of Conformity Assessment

3. Importance of Standards and Conformance

4. Key Terms / Concepts StandardsMarket-drivenspecifications for a product, service, person, process or system, with which compliance is voluntary Technical RegulationsMandatoryspecifications, which may include (or reference) particular standards or conformity assessment procedures Conformity AssessmentProcesses used to verify the compliance of a product, service, person, process or system to either a standard or a regulation (e.g., testing, certification)

5. Statistics: Standards and Trade • According to the WTO, in 2007 global export trade in merchandise surpassed $13.5 trillion, and global export trade in commercial services surpassed $3.2 billion • The U.S. Commerce Department estimates that standards impact roughly 80% of all world commodity trade, and that number is growing every day • Those who understand how to effectively influence standardization and compliance programs will have the greatest success in the global marketplace

6. Importance of Standards and Conformance • When developed and used responsibly, standards facilitate a company’s ability to open and access markets • When overlooked, standards can negatively impact a company’s ability to do business in the U.S. and abroad Standards and conformance impact your bottom line Standards and conformance impact your ability to do business internationally

7. For example: Coke and Pepsi in India • Full or partial bans of Coke and Pepsi in seven Indian States • Allegations that Coke and Pepsi contain excessive pesticide residue – unsafe • Loss of market share and brand integrity for U.S. soft drink giants • Avoidable with globally acceptable food safety and hygiene standards and certification

8. The U.S. Approach to Standards and Conformance

9. Guiding Principles of the United StatesStandardization System Standards and their related compliance criteria should meet societal and market needs and should not be developed to act as barriers to trade

10. Guiding Principles of the United StatesStandardization System The U.S. endorses the globally accepted standardizationprinciples of the World Trade Organization Technical Barriers to Trade Agreement

11. The WTO Principles Transparency Openness Impartiality and Consensus Effectiveness and Relevance Coherence Development Dimension

12. The U.S. is supportive ofany international standard that: is technically suitable is used throughout a given market sector worldwide, and was developed in accordance with the WTO principles

13. U.S. Standards and Conformity Assessment SystemReliable - Flexible - Responsive • Market driven • Flexible and sector-based • Industry-led and government-supported As defined in the United States Standards Strategy, this system is designed to . . . • Support stakeholder engagement • Address emerging priorities • Allow stakeholders to find custom-fit solutions www.us-standards-strategy.org

14. United States Standards Strategy (USSS) • Reaffirms U.S. commitment to a sector-based approach to voluntary standardization activities, domestically and globally. • Built upon the traditional strengths of the U.S. system – such as consensus, openness, and transparency – while giving additional emphasis to speed, relevance, and meeting the needs of public interest constituencies. www.ansi.org/usss

15. U.S. Standards and Conformity Assessment SystemReliable - Flexible - Responsive • The National Conformity Assessment Principles for the United States document helps consumers, buyers, sellers, regulators and other interested parties understand key aspects of compliance verification. The NCAP is a guidance document that can be considered in conjunction with the United States Standards Strategy www.ansi.org/ncap

16. U.S. Standards and Conformity Assessment System comparison with many other economies • Emphasizes private-sector standards solutions • Relies on private-sector compliance verification for both regulatory and non-regulatory functions • Provides greater authority to standards users and stakeholders

17. U.S. Standards and Conformity Assessment Systemcomparison with many other economies (continued) Top Down Standards bodies drive standardization activities Standards users drive standardization activities Bottom Up

18. The U.S. System: A Toolbox • Rather than mandating a “one-size fits all” solution, the U.S. system allows users 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.”

19. U.S. Standards System Different tools for developing globally-relevant standards

20. ISO Participation in 620 TCs and SCs (roughly 79% of total) P Memberships: 570 O Memberships: 50 U.S. – held International Secretariats: 18% of total Summary of U.S. Participation in ISO and IEC IEC • Participation in 153 TCs and SCs (roughly 89% of total) • P Memberships: 153 • O Memberships: 0 • U.S. – held International Secretariats: 14% of total

21. U.S. Reps. to ISO Council / IEC CB ANSI staff on ISO Council -- 1 USNC President on IEC Council Board -- 1 U.S. Reps. to TMB/SMB ANSI Staff – 1 on TMB and 1 on SMB Volunteers – 1 (on SMB) ISO and IEC International Secretariats Most U.S. – held Secretariats are administered by volunteers ANSI staff administer U.S. – held Secretariats only at the request of ANSI constituents. 13 U.S. – held Secretariats are administered by ANSI staff. Leadership of U.S. mirror committees (TAGs) Leadership positions on U.S. TAGs are held by ANSI member volunteers. U.S. Technical Expert Participation U.S. technical contributions to ISO and IEC are provided by ANSI member volunteers. ANSI: Coordinator for U.S. Participation U.S. Contributions to ISO and IEC ANSI Staff ANSI delegates most ISO and IEC work to volunteers within the U.S. system (e.g. companies, trade associations, SDOs, etc)

22. U.S. Standards System Different tools for developing globally-relevant standards

23. 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.

24. Many American National Standards (ANS)are International Standards * Although the ANS process does not directly evaluate Effectiveness & Relevance, adherence to the other ANS criteria helps to assure the effectiveness and global relevance of ANS. ** Although the ANS process does not evaluate for this criteria, it is strongly encouraged in the U.S. Standards Strategy, and many SDOs engage in extensive international outreach and development activities

25. ASTM International American Society of MechanicalEngineers International Code Council American Dental Association NationalElectrical Manufacturers Association National Fire Protection Association Society of Automotive Engineers Institute of Electrical andElectronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations Examples of ANSI-Accredited SDOs

26. Getting Involved in U.S.-Based SDOs

27. Getting Involved in U.S.-Based SDOs (2)

28. U.S. Standards System Different tools for developing globally-relevant standards

29. 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 international 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.

30. U.S. Standards SystemMultiple Path Approach to Standard-Setting • Traditional SDOs and consortia each have a role to play • Consortia and other forums have become more clearly recognized – and embraced – as an integral part of the global standards system

31. The Role of Government in the U.S. Standards and Conformance Systems

32. U.S. Standards and Conformity Assessment SystemThe 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 each government agency to seek existing private sector standards that are appropriate for its purpose and mission

33. The Role of Government Agencies • OMB Circular A-119 • The National Technology Transfer and Advancement Act(NTTAA, Public Law 104-113) • Before regulating, each government agency is required to seek and consider using existing private sector standards that are appropriate for its needs • If so, the agency will use (i.e. reference) the private sector standard • If not, the agency is expected to work with the private sector to develop the needed standards, and to reference them in its regulations • Agencies creating their own standards must report to the Administration and Congress on an annual basis the justifications for doing so • NIST has the legal responsibility of implementing the NTTAA

34. The Role of Government Agencies • Significant elements of OMB Circular A-119 and The NTTAA: • U.S. regulators and procurement officials can use any standard from any source in the world which help them meet their Congressional mandates • These standards do not need to first be transposed into American National Standards by ANSI • These directly referenced standards include ISO, IEC, SDOs • These standards may also be consortia standards • Regulators and procurement officials may make reference to applicable parts of standards – i.e. are not limited to referencing only whole standards

35. Structure of the U.S. Standardization System • ANSI – Coordinator of the Private Sector led System • Responsible for coordinating U.S. private sector participation in the U.S. private sector ledStandards and Conformance systems • The National Standards Body for the United States – Represent the U.S. in intl. and regional standards fora • An Accreditation Body for private sector programs – Represent the U.S. in intl. and regional accreditation fora • Private sector, non-profit, membership organization • Supported by membership fees, sale of publications, funded programs, accreditation programs and periodic government grants • Standards Developing Organizations (SDOs) • Responsible for the development of standards for the specific technical sectors • Some, but not all, accredited by ANSI • When accredited, can administer U.S. mirror committees to ISO and IEC • Private trade and professional organizations, often non-profit • Business models vary by sector • Conformity Assessment Bodies (CABs) • Testing Laboratories, Certification Bodies, Inspection Bodies • Responsible for demonstrating compliance with standards (including those referenced by mandatory technical regulations) • Some, but not all, accredited by ANSI • Business models vary by sector (non-profit, for-profit, public sector, etc.) • NIST – National Institute of Standards & Technology – U.S. Department of Commerce • Coordinates the activities of Federal agencies in the U.S. private sector led Standards & Conformance Systems • National Metrology Institute for the U.S. – Represents the U.S. in international and regional metrology fora • Accreditation Body for public sector programs – Represent the U.S. in international and regional accreditation fora • U.S. government public sector body

36. U.S. Standards SystemExamples of roles and responsibilities *Documentary Standards, excluding “national participation models”

37. U.S. Standards System: policy development

38. 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

39. Summary of the U.S. System “The Drivers” Companies, Government Agencies and other Standards Users “The Vehicle” Standards Developers & Conformity Assessment Bodies “The Road” ANSI

40. The ANSI Federation

42. Represents U.S. globally Ensures integrity of the standards and conformity assessment system ANSI is the “Umbrella Organization” for the U.S. standards and conformance systems. • Offers neutral forum • Accredits standards developers and conformity assessment organizations

43. Academia Individuals Government Manufacturing Trade Associations Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more Members of the ANSI Federation include . . . The ANSI Federation represents more than125,000 companies and organizationsand3.5 million professionalsworldwide

44. Examples of ANSI-Accredited Standards Developers and U.S. TAGs ASTM International American Society of MechanicalEngineers International Code Council American Dental Association NationalElectrical Manufacturers Association National Fire Protection Association Society of Automotive Engineers Institute of Electrical andElectronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations

45. 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 Link to full list of ANSI accredited and non-ANSI accredited SDOs: www.nssn.org/sdoinfo.aspx

46. 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 5 • Total number of American National Standards published as of 12/31/05 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 6,000 • Number of company interests represented by ANSI 125,000 • Number of professionals represented by ANSI 3.5 million • Year ANSI was established 1918

47. WTO TBT Committee Third Triennial Review – Annex 4 ANSI Essential Requirements for the development of American National Standards ANSI promotes alignment with Internationally Recognized Principles for Standards Development openness transparency due process consensus Referenced in the United States Standards Strategy

48. ANSI Standards Panels

49. Coordination and Harmonization Activities • ANSI Standards Panels are cross-sector coordinating bodies established to promote the development and compatibility of voluntary consensus standards and conformity assessment programs necessary to support national and global priorities • Coordinate the efforts of the private and public sectors • Identify existing standards and compliance programs • Define where gaps exist • Recommend where additional work is needed • Identify organizations that can perform the needed work

50. Coordination and Harmonization ActivitiesANSI Standards Panels 2003 Homeland Security Standards Panel 2004 Nanotechnology Standards Panel 2005 Healthcare Information Technology Standards Panel 2006 ID Theft Prevention and ID Management Standards Panel 2007 Biofuels Standards Coordination Panel