The Role of Standards in International Trade & Nuclear Safety IAEA International Atomic Energy Agency International Atomic Energy Agency Technical Meeting on Shared Experiences and Lessons Learned from the Application of Different Management System Standards in the Nuclear Industry Gustave (Bud) Danielson Chief of Nuclear Safety Staff Central Technical Authority for Environmental Management Office of the Under Secretary for Management & Performance U. S. Department of Energy Washington, D. C. December 15, 2014
Outline Meeting Objective What are Standards? Standards and World Trade The World Trade Organization World Trade and International Standards The American National Standards Institute Nuclear Safety Management Focused Standards 2
Meeting Objective International forum of specialists to exchange experiences, lessons learned, and challenges implementing GS-R-3 with different standards; Discuss practical solutions to overcome those challenges and leverage our collective experience. Understanding the role, context, and relevancy of technical standards is crucial to meet our objective. 3
What are Standards? The Agreement on Technical Barriers to Trade (TBT) defines a standard as follows: Document approved by a recognized body, 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." The TBT defines an international body or system as follows: "Body whose membership is open to the relevant bodies of at least all Members (of the World Trade Organization (WTO))." 4
Technical Consensus Standards Highly technical documents developed by subject matter experts that provide details on methods for performing activities such as development of design, analysis, testing and assessment of nuclear facilities. Benefits: Transfer engineering, scientific, design and management systems methods, knowledge and technology Standardize work processes for consistent, acceptable results Avoids costly duplication of work Quicken market acceptance of products and processes Clarify how to improve the safety and protect people. Two Basic Types National/International Voluntary Consensus Standards (VCS), "Private Sector" Government Standards, Public Sector 5
Standards for World Trade 6
The World Trade Organization (WTO) WTO is the only international organization dealing with the global rules of trade between nations Where governments go to try to sort out the trade problems they face with each other Tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles. 7
WTO (Continued) The United States has been a WTO member since January 1, 1995. The Office of the U.S. Trade Representative is responsible for such matters. The European Union (EU) has been a WTO member since 1 January 1995. The EU speaks for all EU members 8
WTO (Continued) The International Trade Centre (ITC) is the technical cooperation agency of the United Nations. Stays abreast of WTO activities. ITC s technical assistance concentrates on the three most critical issues: helping businesses understand WTO rules; strengthening enterprise competitiveness; and developing new trade promotion strategies. 9
World Trade and International Standards International Organization for Standardization (ISO) International Electrotechnical Commission (IEC) International Telecommunications Union (ITU) So, where does the IAEA fit in this scheme? 10
International Organization for Standardization (ISO) ISO is the world's largest developer of standards. Network of the national standards institutes of ~165 countries, one member per country Central Secretariat in Geneva, Switzerland, that coordinates the system. A bridging organization in which a consensus can be reached. Between 1947 and the present day, ISO published more than 19,500 international standards. Nuclear TC 85 11
The American National Standards Institute (ANSI) A private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. U.S. member to ISO. Represents the interests of 125,000 companies and 3.5 million professionals Accredits standards developing organizations (SDO) to issue American National Standards, >10,000 ASME is one, and NQA-1 is under that system Brings U.S. standards into ISO and ISO standards into the U.S. 12
ANSI (Continued) The hallmarks of the American National Standards process include: consensus on a proposed standard by a group or consensus body; broad-based public review and comment on draft standards; consideration of and response to comments submitted by voting members; incorporation of approved changes into a draft standard; and right to appeal by any participant. 13
How Are Standards Adopted? International agreements/treaties International bodies (IAEA) National laws regulations Contracts Voluntary Example: U.S. Implementation of Public Law 104-113, National Technology Transfer and Advancement Act of 1995 (requires agencies use national/international STDs) U.S. Department of Energy Regulation 10 CFR 830, Nuclear Safety Management (requires STDs for quality and safety basis programs) DOE Order O 414.1.D, Quality Assurance (requires ASME NQA-1) 14
Our Focus This Week Nuclear Safety & Quality A number of nuclear management/quality systems standards are being used globally in the nuclear industry such as: ASME NQA-1-2012 Quality Assurance (QA) Requirements for Nuclear Facility Applications. "Requirements for a Quality Assurance Programme at a Nuclear Plant" (NP-011-99) and other key regulatory documents in force in Russia, such as the quality assurance program for a nuclear plant (POKAS) Management system requirements in China conform to the national legislation HAF-003 Other generic standards, ISO 9001:2008 New nuclear standards are being proposed 15
Our Focus (Continued) Characteristics of Nuclear Safety and QA Standards Basic Premise: Nuclear projects and processes are different and fundamentally more complex than any other industrial project or activity Nuclear Safety related standards must recognize and effectively address this vital characteristic A few examples of critical attributes that standards must possess include: Promote technical excellence, rigor, and discipline Demonstrated applicability to the type and nature of the nuclear work Responsive to life-cycle specific needs of the project Tailored appropriately to project risks and hazards Inherent interfaces among people, organization, hardware, and software Validated benefits and outcomes enhanced safety and quality assurance Realistic incorporation of lessons learned and operating experience Balanced approach to advancing the safe execution of project 16
Participation Questions to consider while listening to our colleagues: What are critical attributes of nuclear safety standards? What nuclear or non-nuclear standards do we use now? How do we use them? How do they support GS-R-3 implementation? Do they expand on GS-R-3 in significant way? Are there gaps that should be addressed? How do we handle multiple standards from different customers/regulators? Enjoy the meeting! 17