ISSPA: Enhancing Safety and Security of Radioactive Sources

1. 2014 May 27, IAEA Headquarters, Vienna, Austria IAEA International Working Group on Radioactive Source Security Update on ISSPA 2013 /2014 Activities Paul Gray ; Chairman, International Source Suppliers and Producers Association (ISSPA) www.ISSPA.com

2. Founded in 2006 to address many international and national initiatives needed to improve source safety and security Received acceptance by IAEA as an NGO and participates regularly in policy and guidance discussions, Working Groups, Technical and Consultancy Meetings, conferences, etc. Global impact of the individual companies and need for one voice Participation in international standard setting meetings, in other UN organization meetings (ICAO, IMO) and in multiple international and national forums involving regulators, industry and the public ISSPA Background

3. Safe and Secure Sealed Sources for Beneficial Use The International Source Suppliers and Producers Association (ISSPA) is an association that is comprised of companies who are international industry leaders in the manufacture, production and supply of sealed radioactive sources and/or equipment that contain sealed radioactive sources as an integral component of the radiation processing or treatment system, device, gauge or camera Radioisotope products are used in a wide range of applications that positively impact upon health, safety, and security. Effective source management practices are a cornerstone to strengthen the long term safety and security of radioactive sources throughout their life cycle. Radioactive sources are a safe, secure, viable technology for use in a variety of important medical, industrial, and research applications

4. Safe and Secure Sealed Sources for Beneficial Use ISSPA aims to ensure the ongoing and beneficial use of radioactive isotope sealed sources and promotes continuous improvements in the safe and secure use, transportation and end of life management of sealed sources ISSPA addresses a number of industry-critical concerns including safety, security, lifecycle management, denial of shipments, isotope supply and transportation.  Its mission is to ensure the use of radioactive sources continues to be regarded by the public, the media, legislators, and regulators as beneficial.

5. ISSPA Objectives To establish, implement, and maintain a Code of Good Practice for source manufacturers and suppliers that will contribute to enhancing safety and security of sources throughout their life cycle To represent and communicate the interests of the Members with the International Atomic Energy Agency, legislative authorities and national regulators, and other key stakeholders To provide industry leadership in the development, implementation, and application of international guidelines and national regulations with respect to the safe and secure design, manufacture, and supply of radioactive sources

6. ISSPA Objectives To build and enhance public, user, and media confidence in safe and secure life cycle management of radioactive sources to promote their beneficial use To educate legislators and other key stakeholders with respect to the safety, security, and beneficial use of radioactive sources To promote good, sustainable practices by Association Members to enhance perception of the industry and the Members with regulators, the public and the media To provide technical expertise to assist and facilitate the management of disused sources

7. ISSPA Members • Industry leaders ensuring the safe and secure design, manufacture, supply and return of radioactive sources and equipment • Collectively, in our estimation, represents more than 95% of sealed sources produced and distributed globally • Fifteen members in 9 countries • Alpha Omega Services • Berthold Technologies GmbH & Co. KG • Best Theratronics Ltd • Dioxitek S.A./CNEA • Eckert & Ziegler Nuclitec GmbH • Elekta Instrument AB • Endress + Hauser GmbH + Co. KG • Gamma-Service Recycling GmbH • General Electric Healthcare • Institute of Isotopes, Co. Ltd. • International Isotopes Inc. • Nordion Inc. • NTP Radioisotopes • QSA Global Inc • Varian Brachytherapy

8. Medical treatment, diagnostics, therapeutics and palliation Sterilization of single-use medical products Food safety and agricultural applications Process control Industrial and safety applications (NDT of welds, pipelines, castings, engines, bridges, infrastructure, etc.) Research and development Nuclear Energy Electronics components (tantalum/niobium) Law enforcement & counterterrorism The radioisotope sector is broad and diverse, long established, with a culture of safety and security Radioactive Materials – Critical to Global Economy & Health

9. Some distribution challenges throughout the world due to concerns about radiation and due to restrictions arising from the changing global economy Increased regulatory burden (tracking, security, financial surety) exacerbated by competing/conflicting regulatory agencies and regulations Denials of shipment due to carrier, route, Port and supply chain restrictions; due to reluctance to handle Class 7 Key Issues Impacting the Radioactive Sources Industry

10. Inability to move sources efficiently, and sometimes, at all, due to regulatory inconsistency and lack of harmonization between countries and sometimes, within the same country Recycling in the context of regulatory constraints restricting the international shipment of materials that could be construed as waste * Increased demand for disposal as sources approach the end of their working life and few national governments have a repository/disposal infrastructure in place * source manufacturers are continually increasing their activities to recycle sources as alternative to disposal Key Issues Impacting the Radioactive Sources Industry

11. Safety and Security of Radiation Sources • Continuous design development to improve source safety in the case of fire or explosion (e.g. dispersion resistant designs) • Code of Conduct which applies to all radioactive sources that may pose a significant risk to individuals, society and the environment. • Industry and industry association standards • Industry engages in life-cycle management activities to minimize the amount of unused material in circulation and avoid loss of control • Extensive monitoring and tracking is associated with movements of these materials to avoid the risk of them being diverted • Security measures meet IAEA guidelines and international Member State requirements

12. Strategic Approach to a Safety & SecurityCulture for Sources and Equipment Life cycle source management is a cornerstone to strengthen the long term control of radioactive sources • Manufacturers endorse the concept of life cycle source management, however lack of State repository/disposal infrastructure and regulatory inconsistencies create undue burdens and disincentives for manufacturers An integrated system concept to source/equipment security is necessary for effective management of disused sources and to mitigate event consequences • Manufacturers increasingly design in safety, security and recyclability into systems. Equipment manufacturers work with source suppliers and regulators to design in such features. They are already actively recycling where this is technically and commercially viable

13. Strategic Approach to a Safety & SecurityCulture for Sources and Equipment A risk-informed (graded) approach is fundamental to ensuring the effective security of sources and devices. Example : • Based on risk, benefit, cost-effectiveness and practicability, ISSPA supports the concept of physical tracking of category 1 packages and administrative tracking of category 2 packages, but sources themselves cannot be tracked Regulators, manufacturers, suppliers and users all have specific but complementary and overlapping rolls and responsibilities  A means to ensure effective collaboration between all stakeholders is necessary to promulgate effective strategies

14. ISSPA Role in WGRSS • Strong, broad sealed source industry representation • Practical and informed knowledge of current and proposed source security changes • Integrated knowledge arising from our active involvement as an IAEA NGO in IAEA meetings, conferences, consultancies, working groups over many years • Ability to outreach to sealed source industry globally for information, data and suggestions / impact

15. Expectations and Priorities Harmonization of security requirements on a global basis Where conflicts or inconsistencies exist now, move towards an agreed upon set of requirements amongst all MS IAEA prepared master list of all security requirements existing on a global basis associated with RAM transport Using transportation denials process, expand National Focal Point (NFP) network in each MS to whom issues with security can be managed Recognition of experience and application of security requirements existing for RAM transport – changes only where changes are required based on risk determination

16. Expectations and Priorities Recognition of source and source container integrity and positive safety and security experience Recognition of practical limitations of individual source tracking (i.e. RFID) and package tracking Agreement at outset that risk management practices are applied to any security changes – no change for change sake Practicality of security requirements from a shippers and a shipping perspective Provision for flexibility in securely handling disused / spent sources

17. Expectations and Priorities Recognition of RAM end use and activity shipped when considering any changes to existing security measures Integration of other organizations (i.e. Customs) where their involvement ties into proposed security changes Integration with broader range of industry before promulgation

18. Key Actions (WGRSS 2013 to Present) ISSPA website renewal : www.isspa.com many (14) IAEA TM, CM, conferences (Abu Dhabi & others), committees (NSGC, ISC, SSR-6) participation, many in leadership role multiple provision of comments to draft regulatory and guidance documents to UN, US, Canada, and EU regulators PATRAM and several other regulatory and quasi-regulatory meeting presentations & participation in US, EU, Asia Pacific (18) ISSPA Code of Good Practice updated jointly work with other industry associations (GIPA, iia, CORAR, AIPES, WNA, WNTI, etc.) on areas of mutual interest and concern administrative : 10 monthly EC calls and 4 All-member calls

19. 2014 Annual General Meeting ISSPA Annual General Meeting 2014 Workshop Presentation List Presenter Organization Title 1. Pat Donnachie U.S. Customs and Border Protection Laboratories and Scientific Services CBP Detection and - Adjudication of Radiation Alarms 2. Rick Boyle US Department of Transportation Update on US DOT Transportation Regulations 3. Annette Rolle Federal Institute for Materials Research and Testing (BAM) Important aspects in design approval of special form radioactive material 4. Frank Cocina US Department of Energy NNSA/Global Threat Reduction Initiative Type B Container Efforts 5. Steffen Komann Federal Institute for Materials Research and Testing (BAM) Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not requiring Competent Authority Design Approval 6. Christina George International Atomic Energy Agency The IAEA Programmes for the Security of Radioactive Material in Use and Transport 7. Bill Rhodes - US Department of Energy Security Categorization of Radioactive Materials 8. Sylvain Faille - Canadian Nuclear Safety Commission Updates on Canadian Regulatory Requirements for the Security of Sources during Storage and Transport 9. Adelaide Giantelli US Nuclear Regulatory Commission Increasing Security of Category 1 and 2 materials within the United States 10. Andrew Mauer Nuclear Energy Institute Part 37- Impact on Industry 11. Bernard Sevestre CEA (Commissariat à l'énergie atomique et aux énergies alternatives) Improvement of Category 1 and 2 DSRS Management 12 . Kate Roughan International Atomic Energy Agency IAEA Approach to Operations Solving Problems of Disused Sealed Radioactive Sources in Member States 13 . Todd Lovinger / Gary Robertson Low-Level Waste Forum LLW FORUM Disused Sources Working Group Progress Report

20. Thank you • Questions?