2014 May 29, IAEA Headquarters, Vienna, Austria

1. ` 2014 May 29, IAEA Headquarters, Vienna, Austria IAEA International Working Group on Radioactive Source Security Manufactures’ Role in Sealed Source Security and Long Term Management of Disused Radioactive Sources Paul Gray ; Chairman, International Source Suppliers and Producers Association (ISSPA) www.ISSPA.com ; Vice President, External Relationships and Global Logistics, Nordion Inc.

2. Sealed Source Use : Overview

3. Medical treatment, diagnostics, therapeutics and palliation Sterilization of single-use medical devices Food safety and agricultural applications Process control Industrial, radiography and safety applications (NDT of welds, pipelines, castings and engines) 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

4. Importance of Radioisotopes & Sealed Sources U.N. declares that cancer is a “silent crisis” in the developing world and the need to treat cancer is rising Cancer takes more lives than HIV/AIDS, TB and malaria, combined Cobalt-60 is used for treating cancer (45,000 treatments/day in >50 countries) Caesium -137 is used in irradiation to prevent TA-GVHD following transfusions (Over 750 units installed in 50 countries) Brachytherapy techniques employ Iridium-192, Iodine-125, Palladium- 103, Strontium-90 for novel treatment applications Other applications of sources for level measurement, limit switches, oil well logging, density gauges, etc.

5. Cobalt - 60 Cobalt-60 is depended upon to sterilize some 45% of all single-use medical supplies and devices in the world : sutures, catheters, syringes, heart valves, artificial joints and an estimated 80% of all surgeons’ gloves Cobalt-60 is increasingly relied upon to enhance food safety and preservation ; destroying e-coli, food for the immuno-compromised; packaging treatment Cobalt-60 is used for treating cancer (45,000 treatments/day in >50 countries)

6. Sealed Sources vs. Alternative Technologies

7. Modality Comparison to Cobalt-60 Modality Advantages Disadvantages Trends Gamma • High penetration • Simple process • Immediate release • Radioactive material • Material compatibility • Initiative for SAL reduction • Legislation to replace isotope EO • Material compatibility • Complex process • Hazardous • Delayed release • Reduction in allowable residuals • Focus on material cost E-beam • Low cost • No isotope • Fast turnaround • Low penetration • Complex equipment • More adoption in Europe, Asia • Materials modification X-ray • High penetration • No isotope • Complex equipment • Very inefficient • Infrastructure requirements • 1st commercial x-ray

8. Process Control

9. Exposure Time

10. Efficiency

11. Equipment Maintenance

12. Penetration

13. Dose Uniformity

14. Blood Irradiation

15. Why Cobalt Therapy? Robust and reliable Easy to maintain Steady and predictable source output Intensity modulated arc therapy & Tomotherapy Technically less complex even after upgrades

16. Alternatives

17. Sealed Source Security

18. Cobalt - 60 Cobalt-60 pencils emit gamma radiation - this energy is harnessed to eliminate pathogens and microbes Cobalt-60: - A solid metal - Non-fissionable - Non-soluble - Non-dispersible - Non-flammable - Long half life - Large quantities per container - Sources and containers licensed - 5.25 year half-life

19. Sealed Source Testing • Sealed sources subject to: • Impact test • Bend test • High temperature test • After all tests, the source must maintain its full structural integrity

20. Sea Freight Container Handling Containers must be able to withstand worst-case potential accident conditions

21. F-168: A Type B(U) Package Large dimensions, weight and radioisotope holding capacity Cobalt-60 to sterilization facilities: - ports for export to overseas destinations - road/ocean/rail shipments

22. F-168 Package: Layers of Protection Steel-covered insulated fire shields for thermal protection Steel fins dissipate heat during normal conditions of transport and provide impact protection 11 inches (270 mm) of lead shielding, encased in steel for radiation protection Cage containing double-encapsulated sealed sources Weight: 5,445 kg (12,000 lbs)

23. F-168 Container Design – Shielding

24. F-168 Container Design - Plug

25. Regulatory Requirements • International • - International Atomic Energy Agency (IAEA) : • : SSR-6 (TS-R-1) – Regulations for the Safe Transport of • Radioactive Materials • : Code of Conduct – Import / Export Controls • Modal • - IMDG , IATA , ICAO • Country Specific • USA : DOT. PHMSA, CFR 49; NRC 10 CFR; FMCSA; SGI • Canada : TDG ; NSDSR ; PTNSR • China : Administrative Rules on Transportation Safety of Radioactive • Goods • : Nuclear Security Fa [2010] No. 43 • Country of import and export regulations

26. Other Regulatory Requirements • Regional / local specific : often where Port resides • Customs requirements (country – specific) • Port requirements • Carrier requirements • Significant communication and monitoring with international, national, and local authorities starts well before shipment is even produced, let alone shipped, and continues until safe and secure arrival at the customer’s site

27. Transport Considerations (eg. N. America) Road Carriers must be licensed and trained in transport regulations Carriers must have documented and approved Security Plan including qualified / security cleared drivers; communication plan, ER plan, etc.) Federal and local government regulatory approvals (for entire route) Real time communications (GPS, Cell phone) to regulators, shipper and home office Communicates routing information (time) to Federal & State Regulators Co-ordination of Escorts (police or alternate authority) Discussion and amendment of route plan with state authorities, pending special events and timing of shipment CVSA Level VI (or similar) Inspections (point of origin) of truck, trailer, containers and driver qualifications and shipping documentation Post arrival confirmation with Federal and local regulators

28. Transport Considerations Marine Capability and licenced to carry Class 7, including insurance and vessel construction restrictions Availability of seafreight containers Routing varies (weather, time of year, cargo volumes, extraordinary events (pirates, war and strife) verified prior to any shipment preliminary acceptance Co-sharing restrictions Vessel approvals by owners Port Approvals (Class 7) of all in-transit Ports prior to final carriage approval provision

29. 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 impinge 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

30. 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.

31. 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

32. 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

33. 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

34. Conclusions - Regulatory Industry works hard to maintain an exemplary safety and security record RAM sealed sources are very highly regulated from point of manufacture to point of use Government and industry controls in transport and Customs clearance are stringent; Code of Conduct critical and established Supply chain is highly trained and licenced to produce, ship and use Class 7 Industry compliance with regulatory standards is typically the minimum standard Integration, harmonization, and consistency of regulatory processes and practices critical to supply chain effectiveness Industry, working together and with regulators, with the IAEA/IMO/ICAO, and with the supply chain, is critical to safety, security and movement / use of sources

35. History of Safe Transport • “Over several decades of transport, there has neverbeen an in-transit accident with serious human health, economic or environmental consequences attributable to the radioactive nature of the goods.” • Source: IAEA International Conference ; Abu Dhabi, 2013 • Still applies today! An exemplary record over 60 years.

36. End – of – Life Source Management End of Life Management Options - Recycling - Long Term Storage - Disposal 2. Challenges - Source Pedigree - Container Availability - Transportation Costs and Logistics 3. Conclusions

37. General Challenges for Long Term Management of Used Sources Increased regulatory burden exacerbated by competing/conflicting regulatory agencies and regulations (international inconsistencies) Unified international regulations would ease international movements of disused sources Increased demand for disposal as sources approach the end of their working life and few national governments have a repository/disposal infrastructure in place. Manufacturers are reluctant to take on incalculable financial liabilities taking title to disused sources that they may not be able to recycle or dispose

38. General Challenges for Long Term Management of Used Sources Recycling in the context of regulatory constraints restricting the international shipment of materials that could be misconstrued as waste. Used sources should be regarded as “materials” easing international shipments Regulatory constraints and high cost of repackaging and shipping sources with expired regulatory documentation (Special Form, Type B etc) Expedient procedures for authorizing “special arrangements” would ease/encourage return shipments of sources with expired regulatory documentation - Risk / Benefit assessment of regaining control

39. Strategies - Long Term Management of DSRS Recycle Long Term Storage Disposal

40. Recycle – Reutilization of Resources Industry’s Preferred Option Reduces the amount of radioactive material that needs to be produced Must be cost effective and technically feasible for a commercial entity Various methods available

41. Recycle – Recover Material Source must be disassembled Specialized facilities, equipment & qualified technicians Recover material used as is or blended – Co60, AmBe

42. Recycle – “Re-Life” the Source Reutilize the source “as-is” • Inspection and Testing required for each source • Extends working-life Re-encapsulation and Over encapsulation • Remove and replace outer encapsulation, or • Over encapsulate entire source, use for new application

43. Recycle – “Re-life the Source” Original design parameters, weld integrity, environmental conditions of use and potential gas build up must be considered.

44. Long Term Storage of DSRS Less Preferred Option Source manufacturers have robust security controls so LTS at the source manufacturer facility is feasible. Must consider: Liability issues associated with quantities possessed Costs for return of sources to manufacturer Facility / site licence conditions and limits Financial responsibility of eventual disposal Ultimate disposal path must be available

45. Disposal Not a viable option through a source manufacturer Source manufacturers do not operate as waste brokers Licensing and regulatory restrictions would greatly limit this Disposal site availability may also be limited by legislatively imposed restrictions ( i.e. waste generator or country of origin restrictions)

46. Challenges Regardless of which end of life management option is selected the biggest challenge that we all face is simply getting a DSRS from Country A to Country B. Three issues : Source Pedigree Container Availability Transportation Costs and Logistics

47. Challenges – Source Pedigree Return to Original Manufacturer It is industry’s position that a sealed source could and should be returned to any willing source manufacturer capable of safely handling and managing it This position also addresses issues that arise when the original source manufacturer is no longer in business or authorized to possess the source • One-for-One Source exchange is a common industry practice that limits the number of disused sources that may otherwise be abandoned

48. Challenges – Container Availability Lack of containers does result in an increase in transportation costs but the limited availability has far reaching consequences that introduce additional barriers in the over all scheme of DSRS management.

49. Challenges – Container Availability Device Specific Containers: Many containers were built for a specific device or source. The Container may no longer be certified and/or the device is obsolete. The cost associated with developing a container to transport the specific device is not commercially viable.

50. Challenges – Container Availability Some work has been done, such as removing the source in the field and leaving the device behind. Requires a hot cell, expertise and a container authorized to transport the DSRS. GTRI has developed a Type B(U) overpack capable of transporting the source contained in the device.