Ensuring Ongoing Safety and Security in the Global ... Dhabi Conference... · • Oil well logging oAggressive environments in drilling operation preclude use of known alternative

2013 October IAEA Conference on the Safety and Security of Radioactive Sources: Maintaining the Continuous Global Control of Sources Throughout Their Lifecycle ; Abu Dhabi, United Arab Emirates

Ensuring Ongoing Safety and Security in the Global Transportation and Use of Radioactive Sealed Sources Paul Gray, Chairman; International Source Suppliers and Producers Association (ISSPA) Vice President; External Relationships and Logistics, Nordion, Inc. October, 2013

WHY ARE SEALED SOURCES SO IMPORTANT?

WHAT ARE THEY?

• Medical treatment, diagnostics, therapeutics and palliation • Sterilization of single-use medical devices • Food safety and agricultural applications • Process control • Industrial 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 and Population Health

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• U.N. declares that cancer is a “silent crisis” in the developing world and the need to treat cancer is rising o 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.

Importance of Radioisotopes & Equipment

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• 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 immunocompromised - packaging treatment

• Ir-192 is used in radiography equipment for non-destructive testing of infrastructures

- availability of critical infrastructure depends on effective quality management processes

Importance of Radioisotopes & Equipment

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• Radiography

• Oil well logging

• Gauges

•Process Control

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Industrial Applications

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• Well established NDT method o Welds, castings, engines, pipelines

• Fixed, portable and self propelled equipment for various applications

⇒ Equipment is rugged and designed for use in remote and hostile environments

Radiography

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Radiography Equipment

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• Oil well logging o Aggressive environments in drilling operation preclude

use of known alternative technologies • Gauges

o Tracer investigations (flow rates, by-pass streams, process mixing, leak detection, wear & corrosion)

o Metal coating, ore processing o Thickness, density, height requirements o Statistical measurement precision from sources greatly

exceeds other technologies enabling cost control and minimizing process waste

Radiography Equipment

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• Explosives detection at airports and other monitoring points • Drug and gas detection • Crime analysis • Finger printing, counterfeiting

Law Enforcement & Counterterrorism

WHO IS INVOLVED IN SEALED SOURCE PRODUCTION ?

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• Founded in 2005 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.

• 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

• Global impact of the individual companies and need for one voice

ISSPA Background (Website : www.isspa.com)

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Safe and Secure Sealed Sources for Beneficial Uses Globally • 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

• Estimated that ISSPA members collectively produce ~ 95% of all sealed sources globally

• 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

• Industry leaders ensuring the safe and secure design, manufacture, transport, supply and return of radioactive sources and equipment

• Sixteen members in 9 countries o Alpha Omega Services o Berthold Technologies GmbH & Co. KG o Best Theratronics Ltd. o Dioxitek S.A./CNEA o Eckert & Ziegler Nuclitec GmbH o Elekta Instrument AB o Endress + Hauser GmbH + Co. KG o Gamma-Service Recycling GmbH

o GE-Hitachi Nuclear Energy o Institute of Isotopes, Co. Ltd. o International Isotopes Inc. o Nordion Inc. o NTP Radioisotopes o QSA Global Inc o Varian Brachytherapy o MASEP Infini

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ISSPA Members

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HOW IS SAFETY AND SECURITY MAINTAINED?

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Safe and Secure Sealed Sources for Beneficial Uses Globally • 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.

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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

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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

ISSPA Code of Good Practice

1. Regulatory Compliance 2. Quality Management 3. Design of Sources and Devices 4. Manufacturing of Sources and Devices 5. Sales 6. Distribution 7. Tracking 8. User Support 9. Source life Cycle Management

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• 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

Safety and Security of Radioactive Sealed Sources

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Regulatory Requirements

International - International Atomic Energy Agency (IAEA) : : TS-R-1 – Regulations for the Safe Transport of Radioactive Materials : Code of Conduct – Import / Export Controls Modal - IMDG , IATA , ICAO Country Specific - Europe ADR - Country of import and export regulations - Canada : TDG ; NSDSR ; PTNSR - USA : DOT. PHMSA, CFR 49; NRC 10 CFR; FMCSA; SGI

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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

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IAEA Code of Conduct : Objectives

Through the development, harmonization and implementation of national policies, laws and regulations, and through the fostering of international co-operation, to:

o achieve and maintain a high level of safety and security; o prevent unauthorized access or damage to, and loss, theft or o unauthorized transfer of, radioactive sources; and o mitigate or minimize the radiological consequences of any accident or malicious act involving a radioactive source

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IAEA Code of Conduct: Import/Export Requirements • Submit an application for an Export Permit to the Competent

Authority of the Member State in which the Shipper (typically Supplier) resides

• Supplier requests a copy of the customer’s Import Permit • Provide a copy of the Import Permit to CNSC, the freight

forwarder and ocean carrier • A copy of the Government issued Export Permit accompanies

each shipment along with a copy of the Export Declaration issued by Nordion

• No permits / approvals = No shipment

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Importing

States

Exporting

States Shipper/ Exporter

Buyer/ Importer

Export Auth 4

Req Export Lic 1

Consent Auth Cat 1 Only

3

Req Consent Cat 1 Only

2

Notification 5

Purchase Order with Authorization

c

Req Import Lic a

Issued Import Lic b

Importing

States

Exporting

States Shipper/ Exporter

Buyer/ Importer

Code of Conduct: Import/Export Requirements

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Transport Considerations 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

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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 • Denial of Shipment – always a risk

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• Life cycle source management is a cornerstone to strengthen the long term control of radioactive sources

o 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

o 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

Strategic Approach to a Safety & Security Culture for Sources and Equipment

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• A risk-informed (graded) approach is fundamental to ensuring the effective security of sources and devices

o 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

Strategic Approach to a Safety & Security Culture for Sources and Equipment

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Guidelines, Code of Conduct

Safe & Secure Use of Radioactive Sources

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Source Life Cycle Management Model

History of Safe Transport

“Over several decades of transport, there has never been an in-transit accident with serious human health, economic or environmental consequences attributable to the radioactive nature of the goods.”

– IAEA International Conference on the Safety

of Transport of Radioactive Material, 2003

1) Nuclear Medical Applications for Diagnosis and treatment of disease (short T1/2 radioisotopes – Mo-99, Tc-99m, I-123, etc.)

- efficient, reliable and timely transportation critical for patient, health care system (costs, out-patient capability, hospital and medical professional time)

2) Other Medical Applications (e.g. cancer treatment; Co-60, Ir-192, I-125) - longer T1/2 than medical radioisotopes but timely transport is still critical

- Continuous transport critical to avoid lengthy delays incurred with reapplication processes for import permits, Port approvals, carrier approvals, etc mandated if original schedule not maintained

- Lengthy delays will adversely impact product availability and subsequent beneficial medical uses

3) Other Applications (e.g. Radiography (Ir-192) - Extended delays could render source useless, impacting people and structural safety

and security (density, thickness, integrity of materials and products): completion timelines; business success; etc.

⇒ secure, reliable supply of medical isotopes is paramount to meet healthcare, industry and QA integrity needs

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Timely and Reliable Shipping is Critical

• Distribution challenges throughout the world due to concerns about radiation and due to restrictions arising from the economic situation globally

• 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

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Key Issues Impacting the Radioactive Sealed Source Industry

• 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 an alternative to disposal

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Key Issues Impacting the Radioactive Sealed Source Industry

Supply Chain Challenges Limited number of Ports (air & sea) willing or authorized to handle

Class 7

Limited number of carriers willing or authorized to handle Class 7

Limited number of Type B packages and no Type C packages dictates transportation schedules, mode, drives up costs for new and replacement sources and makes it difficult to recover disused sources

Package tracking technologies under consideration would increase costs and may reduce number of transportation routes, carriers and Ports even further

Delay or denial of shipments increases the cost to industry and the consumer, reduces inventories of sterile products and increases the perception of risk associated with the use of radioactive sources

“Denials” Definition (IAEA ISC)

“a refusal to carry or allow a shipment of radioactive material though it conforms to all applicable regulations”

Note : non-compliance with regulations cannot constitute a denial

IAEA International Steering Committee IAEA International Steering Committee on Denial of Transport of

Radioactive Materials (ISC) Established 2006; 8th annual meeting held June 2013 New structure recommended at ISC 8 : Denials Working Group

created and managed under the Inter-Agency Group (IAEA, ICAO, IMO, UNECE); technically integrated with IAEA, with DWG / IAG recommendations managed and where accepted, budgeted by TRANSSC

Mandate To develop and coordinate a comprehensive Action Plan which will

facilitate the global transportation of radioactive materials

Membership ~ 40 members : > 20 countries represented, plus IAEA, IMO, ICAO,

governmental and non-governmental organizations, industry associations and some specific industries

IAEA; National Focal Points (NFP) / Regional Networks (RN)

NFP’s IAEA requested all Member States to nominate a single point of contact

(regulatory) to deal with denials – NFP Have > 80 countries now represented by a NFP, good growth over past year

RN’s Multiple countries assimilated by region (Latin America, Mediterranean, Asia

Pacific countries incl. Australia and some Middle East countries, French / English speaking countries in Africa)

Aim - facilitating communication on denials and ultimately facilitating radioactive material (RAM) transport globally

Benefits: Geographically similar countries working together to resolve “local” denial

issues Global representation at ISC meetings historically, with DWG in future Specific points of contact in the regions and Member States Involved for further communication and coordination of actions Broader application of this framework and contact base possible?

Structure : comprehensive and inclusive of all

potentially involved parties National Govt Reps:

•Energy & Resources

•Foreign Affairs & Trade

•Transport Authority

•Customs Authority

National Trade Orgs:

•Importers

•Exporters

National Focal Point:

•Assigned

• ~80 M.S. of 151

Regional Coordinator:

•Provide Training Assistance

•5 regions globally

Suppliers:

•Medical Industry

•Radiopharmaceutical Industry

•Isotope Industry

Transport:

•Road Freight Companies

•Rail Freight Companies

•Freight Forwarders

Air:

•National Airports

•National Airlines

•National CAA

Sea:

•National Ports

•National Shippers

Reasons for Denials

Negative perception about radiation. Lack of awareness and

information of the industry and the benefits of these products.

Concerns of cost and extent of training of those who handle radioactive materials (RAM)

Multiplicity and diversity of regulations governing handling, use and transport of radioactive material; lack of harmonization between Member States. Result: duplicative, overlapping and sometimes contradictory regulatory requirements ( i.e. lack of global harmonization to IAEA Code of Conduct)

Lack of outreach with resultant lack of public awareness about the need & applications of radioactive material, and the extremely stringent regulatory environment in which they are managed

Outcome from IAEA Technical Meeting to Produce a Follow-up Report to the 2011 Conference on the Safe transport of Radioactive Material (TM-43650); 2012 March 12 – 16

- 8 key areas of focus for which actions were identified, discussed and agreed upon. These included : • Harmonization • Denial of Shipments • The Basis for Provisions (i.e. the way regulations are developed) • Safety Requirements and Security Recommendations • National Implementation and industry Compliance • Emergency Response • Communication • Regional Consideration Actions that the IAEA will further consider in developing their working and budgetary plans going forward

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

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Conclusions - Industry • Time sensitive nature and end use of radioactive sealed sources requires

reliable, effective and efficient transportation and export / import processes

• Sealed source transport and use process is formal, specific & generally consistent

• Experience is exemplary – safety and security recommendations, industry Code of Good Practice, regulations and standards do work

• Effective and routine communication and integration between Member States, shipper and carrier ongoing and effective

• Ongoing integration and continuous improvement is required - one of the objectives of “The Next 50 Years – Creating a Safe, Secure and SUSTAINABLE Framework”

• Sustainable MUST consider current state; cost of additional requirement implementation (law of diminishing returns), need for global consistency and harmonization; and utilization of an integrated regulator / industry interface (use NFPs and RNs)

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• Harmonization of safety and security requirements on a global basis

• Where conflicts or inconsistencies exist now, move towards an agreed upon set of requirements amongst all MS

• IAEA prepares a master list of all security requirements existing on a global basis associated with RAM transport

• As per ISC, establish (with existing or new) National Focal Point (NFP) type contact in each MS and Regional Coordinators (RC) to whom issues with security are managed

• Recognition of experience and application of safety & security requirements existing for RAM transport – changes only where changes are required based on risk determination (i.e. no change simply for sake of change)

Suggested Next Steps

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• 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

• Integrate with industry to provide assessment of practicality of proposed regulatory requirements from a shippers’ and a shipping perspective

• Integration of other organizations (i.e. Customs) where their involvement ties into proposed security changes

• Provision for flexibility in securely handling disused / spent sources

• Recognition of RAM end use and activity shipped when considering any changes to existing security measures

Suggested Next Steps

Continue to Work Together

Communicate to manage relevant threat level changes

Work together to facilitate safe and secure Cobalt-60shipments

Identify process to address routine shipment issues

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Questions?

Thank you

Slide Number 1Slide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Slide Number 10Slide Number 11Slide Number 12Safe and Secure Sealed Sources for Beneficial Uses Globally�Slide Number 14Slide Number 15Safe and Secure Sealed Sources for Beneficial Uses Globally�ISSPA Objectives�ISSPA Objectives ISSPA Code of Good PracticeSlide Number 20Regulatory RequirementsOther Regulatory Requirements IAEA Code of Conduct : Objectives IAEA Code of Conduct: Import/Export RequirementsCode of Conduct: Import/Export Requirements Transport ConsiderationsTransport ConsiderationsStrategic Approach to a Safety & Security�Culture for Sources and EquipmentStrategic Approach to a Safety & Security�Culture for Sources and EquipmentSlide Number 30History of Safe TransportSlide Number 32Slide Number 33Slide Number 34Supply Chain Challenges “Denials” Definition (IAEA ISC)IAEA International Steering CommitteeIAEA; National Focal Points (NFP) / Regional �Networks (RN)�Structure : comprehensive and inclusive of all potentially involved parties Reasons for DenialsOutcome from IAEA Technical Meeting to Produce a Follow-up Report to the 2011 Conference on the Safe transport of Radioactive Material  (TM-43650); 2012 March 12 – 16� �Conclusions - RegulatoryConclusions - IndustrySlide Number 44Slide Number 45Continue to Work TogetherSlide Number 47