Postgraduate Educational Course in radiation protection and the Safety of Radiation sources PGEC Part IV The International System of Radiation Protection and the Regulatory Framework Module IV.11 . Safety and Security of Radioactive Sources 11.2 Regulatory Authority Information System Transport of radioactive sources; Recovery of orphan sources

Overview of Module IV.11 This module will discuss the following aspects: Introduction & Basic Requirements, Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA. Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources Guidance on transport of radioactive sources; recovery of orphan sources;

Regulatory Authority Information System (RAIS) RAIS is software developed by the IAEA. Developed to assist Member States in managing their regulatory activities in accordance with IAEA Safety Standards and guidance, including the Code of Conduct on the Safety and Security of Radioactive Sources and supplementary Guidance. Operation of RAIS depends on: Notifications Categorization of Radiation Sources Inventory of Radiation Sources and Users/Locations

Notification - Form Contents of the form Name and Address of the Legal Person Name and Address of the Organization Nature of the Practice in which source is used (cont.)

Notification - Form Identification of each source Date (a) Radionuclide Activity Chemical Form Sealed Source (if yes, Manufacturer/Model) (b) Radiation Generating Equipment Manufacturer, Model Operating Potential Nature of Equipment in which source is installed Date Signature for Legal Person

Notification New regulatory authority should (1/3) prioritize the need for gaining regulatory control over practices in terms of likelihood and magnitude of potential exposures identify and list likely source users provide documented requests for notification to all likely source users and request replies follow up likely source users telephonically or by on-site visits, if there is no response to the request for notification

Notification New regulatory authority should (2/3) follow up on cases where a negative response was provided to the request for notification, but where the regulatory authority has contradictory information or other reasons to believe that the respondent may possess sources document and log into the inventory all cases where sources (either in use/storage/abandoned) or source users are identified

Notification New regulatory authority should (3/3) periodically update the source inventory with new information develop and implement a process to check on the accuracy of the notification/inventory system, with an emphasis on sources or practices with higher risks be able to identify and locate every source (either directly through its own inventory or through licensees/registrants inventories) subject to its regulatory control

Categorization of sources Categorization is relevant to decisions in bringing sources under control guide the application of a regulatory infrastructure prioritize a regulatory authority’s resources and training activities guide the degree of detail necessary for a safety assessment serve as a measure of the intensity of effort which should be applied to the safety and security of a particular type of source

Categorization of sources Categorization of Radioactive Sources, Safety Guide RS-G-1.9, IAEA, Vienna (2005) Safety Guide builds on IAEA-TECDOC 1191, Categorization of Radiation Sources (Dec 2000) The categorization is based on the concept of dangerous sources which are quantified in terms of D values. The D value is the radionuclide specific activity of a source which, if not under control, could cause severe deterministic effects. D values are used as normalizing factors to provide a reference for comparing risks.

Categorization of sources Five categories are introduced Category Activity ratio (A/D) 1 A/D ≥ 1000 2 1000 > A/D ≥ 10 3 10 > A/D ≥ 1 4 1 > A/D ≥ 0.01 5 0.01 > A/D and A > exempt

Category 1 Sources A/D ≥ 1000 Examples Radioisotope thermoelectric generators (RTGs) Irradiators Teletherapy sources Fixed, multi-beam teletherapy (gamma-knife) sources

Category 2 Sources 1000 > A/D ≥ 10 Examples Industrial gamma radiography sources High/medium dose rate brachytherapy sources

Category 3 Sources 10 > A/D ≥ 1 Examples Fixed industrial gauges that incorporate high activity sources Well logging gauges

Category 4 Sources 1 > A/D ≥ 0.01 Examples Low dose rate brachytherapy sources (except eye plagues and permanent implants) Industrial gauges that do not incorporate high activity sources Bone densitometers Static eliminators

0.01 >A/D and A > exempt Category 5 Sources 0.01 >A/D and A > exempt Examples Low dose rate brachytherapy eye plagues and permanent implant sources X-ray fluorescence (XRF) devices Electron capture devices Mossbauer spectrometry sources Positron emission tomography (PET) sources

Regulatory authority Information System (RAIS) Module 1: Inventory of Radiation Sources and Installations Lists all radiation sources within an installation, classified by practice Covers installations having a given type of equipment, for a given practice Covers multiple radiation sources Tracks history of a source until returned to the supplier or managed as radioactive waste

Regulatory authority Information System (RAIS) Module 2: Authorization Tracks the administrative status of an installation, from initial application to its authorization, including pre-operational inspections Covers authorization related to transfers of radiation sources between authorizations Allows the regulatory authority to issue authorization documents through RAIS

Regulatory authority Information System (RAIS) Module 3: Inspection and Enforcement Inspections carried out within specified time periods Inspections that should be done over a future time period Assists in monitoring follow-up actions and deadlines Allows the regulatory authority to issue inspection reports through RAIS

Regulatory authority Information System (RAIS) Module 4: Individual Dose Monitoring Calculates estimates of the effective dose to workers from measured individual dose records Lists doses to workers at each installation Computes total doses for workers employed at more than one installation Stores the dose histories of workers

Regulatory authority Information System (RAIS) Module 5: Performance Indicators REGULATORY AUTHORITY INDICATORS Lists authorizations processed Displays average time for processing an authorization, classified by practice Lists inspections, by practice, geographic area or inspector; enforcement actions; ongoing actions/deadlines LICENSEE INDICATORS Displays average occupational doses by practice, doses exceeding dose constraints or investigation levels Stores history of incidents and non-compliance Stores history of enforcement actions

Regulatory authority Information System (RAIS) Search and reporting capabilities (1/3) sources report by installation installation reports by practice installation report by authorization type frequency of inspection by category report report on inspections by practice inspections made, pending and outstanding list of inspections by inspector name

Regulatory authority Information System (RAIS) Search and reporting capabilities (2/3) number of sealed sources by nuclide total activity of sealed sources by nuclide number of accelerators by practice number of authorizations by practice number of pending authorizations average time for granting authorizations the number of enforcement letters by practice/period

Regulatory authority Information System (RAIS) Search and reporting capabilities (3/3) number of proposals for penalties by practice/period number of findings by practice number of monitored workers maximum accumulated dose by practice annual effective dose distribution number of workers

Overview of Module IV.11 This module will discuss the following aspects: Introduction & Basic Requirements, Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA. Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources Guidance on transport of radioactive sources; recovery of orphan sources;

Transport of radioactive sources The next section provides a broad outline of the framework within which radioactive materials must be transported: Types of transport package Marking and Labelling Documentation Vehicle requirements (road) Driver training Note: before undertaking transport operations a specialist should be consulted 7 RADIOACTIVE

Dangerous Goods Classification Class Description 1 Explosives 2 Gases 3 Flammable liquids 4 Flammable solids 5 Oxidising substances 6 Toxic & infectious substances 7 Radioactive materials 8 Corrosive substances 9 Miscellaneous Regulations allocate Classes to the different types of dangerous goods. In general safety ensured by: a. integrity and marking of packaging b. training of personnel c. strict rules relating to mixed loads but specific requirements apply to each class of goods.

When is transport required? Source change or repair Movement to another company Transfer of samples (leak tests, etc) Return of a source to manufacturer or disposal agent Contaminated objects Supply of radioactive material Mobile sources……. Stress transport is not only relevant when it is your primary job, but can impact on many radiation uses.

IAEA Regulations Regulations for the Safe Transport of Radioactive Material, 2009 Edition Safety Requirements Regularly updated Adopted worldwide for all modes of transport – national legislation based on IAEA Regulations

Modes of Transport Mention that each mode regulated by separate authorities, but basic requirements the same. Recap IAEA TS-R-1 as basis (this previously described in Introduction to Legislation)

International Legislation The International Maritime Dangerous Goods Code Safe Transport of Dangerous Goods by Air Council Regulation 1493/93/Euratom - transfrontier shipment of RAM Council Directive 92/3/Euratom - the supervision and control of shipments of radioactive waste between Member States ADR / RID “European Agreement Concerning the Transport of Dangerous Goods by Road / Rail” Mention the significance of ADR, introducing ‘Class7’ Show Maritime and IATA regulations Expand on briefly movement waste shipment regs and how they impact and are enforced in the UK.

Transport regulations define: Consignor Carrier Consignee Give examples of each category

Responsibilities Consignor Carrier Consignee Packing Marking and labelling Documentation Information Placarding QA RPP Carrier Safety in Carriage (radiation & fire/accident) QA RPP Consignee RPP Restriction of exposure following receipt of package Briefly describe purpose of RPP extent / responsibilities for QA checks

Arranging a consignment 1. Packaging 2. Marking and Labelling 3. Documentation 4. Vehicle requirements (road) 5. Training Briefly summarise notifications - RSA 93 compliance - ensure consignee is registered Notifications under Shipment of Radioactive Materials Between Member States

Package Types Excepted Type A Type B Type C Industrial Describe: Increasing level of protection offered by each package type (illustrate with slides / props) Information required to decide which package type is needed Who may undertake compliance tests on each Note: special form covered already in Basic Concepts, but recap if necessary Coverage of A1 / A2 values not require unless specifically asked

Excepted packages for the transport of limited activity/limited hazard materials activity limits individual items total consignment limits are fractions of the limits for Type A packages surface dose rate must be < 5 Sv/h

Excepted Packages Stout cardboard box often sufficient Pack item well to prevent movement and absorb liquid Radiation warning inside package

Industrial Packages Industrial Packages: IP-I IP-II IP-III basic requirements IP-II IP-I plus stacking and drop tests IP-III equivalent to Type-A package

Industrial Packages Tanks and freight containers may be used as Industrial Packages II or III provided Loss of radioactive material or loss of shielding would not occur during normal conditions of transport

Industrial package limits Activity limits for industrial packages depend on: exclusive use LSA/SCO category physical state (solid/liquid/gas)

Type A Package More robust than excepted package Smallest dimension at least 10 cm Must satisfy specified tests consignor to demonstrate compliance Transport of: Unsealed sources for medicine / research Nuclear Density Gauges Other portable gauges

Type A Packages Activity limits: Radionuclide specific Special form material: A1 Non special form material: A2 Radionuclide specific

Special Form vs. Other Form Special Form Radioactive Materials are sealed radioactive sources for which a ‘Special Form Certificate’ is held All other Radioactive Materials are ‘Other Form’

Type A Packages

Type B Package For the transport of large industrial sources / nuclear material all type A requirements further specified tests certificate issued by competent authority (CA) activity limited by certificate

Approval of Shipments For a type B container which: relies on intermittent venting; is not designed to withstand -40 to 70 degrees; contains >3000 A1 or A2, or 1000 TBq; or contains fissile material with Transport Index, TI >50 shipment requires multilateral approval Certificate issued by all relevant CAs Must demonstrate compliance with conditions of Type B certificate

Type C For transport of high activity sources by air specific tests under low pressure conditions Competent Authority tested

Packaging of fissile material Additional requirements: competent authority approval maintain subcriticality throughout journey consider: water seepage loss of efficiency of moderators re-arrangement within the package reduced spacing between packages temperature changes

Contamination Control Packages and vehicles should be checked for contamination if this is likely to arise Contamination must be below specified limits Frequency of monitoring depends on likelihood of contamination

Transport Index (TI) Dose rate (Sv/hour) at 1 metre from the surface divided by 10 Used to assess the relative hazard of type A and B packages

Vehicle Limits Limits on Transport Index: Dose rate limits 50 TI limit for normal transport no limit if under exclusive use Dose rate limits 2 mSv/hour at surface 100 Sv/hour at 2 metres Criticality Safety Index Limits 50 for normal transport 100 if under exclusive use

Exclusive Use The consignor or consignee has direction throughout the movement: initial loading transport / storage in transit final unloading

External marking Excepted packages Type A packages, as above plus: Details of consignor or consignee UN number of content Weight if > 50 kg Type A packages, as above plus: ‘Type A’ UN number plus Proper Shipping Name Appropriate label

External marking Industrial Packages -as excepted package plus: IP-I, IP-II or IP-III as appropriate Appropriate labels

External marking Type B package - as excepted package plus fire proof trefoil symbol id for package design package design serial number appropriate labels Type B(U) or Type B(M) Type C Package - as Type B

Category I - white < 5 Sv/hour at surface of package Module 4

Category II - yellow > 5 - 500 Sv/h at surface 10 Sv/h at 1 m TI between 0 and 1.0 Module 4

Category III - yellow > 500 - 2000 Sv/h at surface > 10 - 100 Sv/h at 1 m TI between 1.0 and 10 Module 4

Transport Document Provided by consignor Travels with the package Contains specified information Required for all package types Signed declaration Copy retained by consignor for 2 years Regular consignment certificates - incidences where same package and contents are transported on a regular basis by the same consignor

Documentation Transport document Emergency provisions Transport Consignor: Rad-tools Warrington Consignee: Rad-tools Exeter Class 7 Material: Am-241 Emergency contacts: Mr I Freely Transport document Emergency provisions Discuss when documentation is required and who is responsible for it. Expand on contents of transport document, and retention requirements Do not expand on the content of local rules, registration, contingency plans as these are covered elsewhere in the course.

Radiation Protection Programme A radiation protection programme must be established to restrict radiation exposures during transport & in the event of an accident

Quality & Compliance Assurance A Quality Assurance Programme should demonstrate that the design, manufacture, testing, documentation, carriage, use, maintenance and inspection: of all special form material, of all low dispersible radioactive material, of all packages and packaging, and for transport and in-transit operations, meet the requirements of the regulations

Vehicle Placards & Plates Radioactive 7

Placard

Orange Plates Not required for Excepted Packages Front & back Min 300 x 120 mm

Vehicle Placards & Plates

Carried in Vehicle Transport documents Statement for carrier Instructions for loading/unloading & stowage Emergency provisions Fire extinguishers may be required by national legislation

Driver Training All individuals involved in any aspect of the transport operation should receive training in radiation protection and the IAEA regulations, commensurate with their responsibilities Level of training often varies with type and number of packages being carried

Overview of Module IV.11 This module will discuss the following aspects: Introduction & Basic Requirements, Code of Conduct: Scope and objectives, Legislation and Regulations, Regulatory Body, Import and Export of Radioactive Sources, Role of the IAEA. Introduction to Regulatory Authority Information System (RAIS), including National inventory of radiation sources Guidance on transport of radioactive sources; recovery of orphan sources;

Orphan Sources An orphan source is a radioactive source which is not under regulatory control, either because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorization. A vulnerable source is a radioactive source for which the control is inadequate to provide assurance of long term safety and security, such that it could be relatively easily be acquired by unauthorized persons.

Code of Conduct Basic Principle 7 states that “Every State should, in order to protect individuals, society and the environment, take the appropriate measures necessary to ensure: …. (a) that the radioactive sources within its territory, or under its jurisdiction or control, are safely managed and securely protected during their useful lives and at the end of their useful lives”.

Code of Conduct Basic Principle 8 states that “Every State should have in place an effective national legislative and regulatory system of control over the management and protection of radioactive sources. Such a system should: ….(b) minimize the likelihood of a loss of control; (c) include national strategies for gaining or regaining control over orphan sources”.

Recovery of orphan sources In order to develop a national strategies for gaining or regaining control over orphan sources need to: Decide on the scope of the strategy; Gather specific information on all aspects of the past and current degree of regulatory control of radioactive sources; Identify problems and potential issues (gap analysis).

Scope of the strategy Scope should at least include those sources capable of causing severe deterministic human health effects if not under control. Such sources are in Categories 1, 2 and 3 according to the Safety Guide on Categorization of Radioactive Sources

Gathering specific information

Identifying problems Problems and potential issues should be identified while the data gathering is taking place. As questions are asked and answered, it will become clear where there are gaps in information or where there are problems If experts are not available within a State, a peer review mission should be requested in order to obtain assistance

Further information Home page for IAEA Nuclear Safety & Security: http://www-ns.iaea.org/default.asp IAEA Safety Requirements BSS GSR Part 3 (Interim) IAEA (2011) http://www-pub.iaea.org/MTCD/Publications/PDF/p1531_startpage.pdf IAEA Safety Requirements: Governmental, Legal and Regulatory Framework for Safety. GSR Part 1 IAEA (2010) Regulations for the Safe Transport of Radioactive Material, 2009 Edition Safety Requirements, IAEA (2009) Code of Conduct on the Safety and Security of Radioactive Sources, IAEA, Vienna (2004) Guidance on the Import and Export of Radioactive Sources IAEA, Vienna (2005) Security of Radioactive Sources, IAEA Nuclear Security Series No. 11, IAEA, Vienna (2009) Security in the Transport of Radioactive Material, IAEA Nuclear Security Series No. 9, IAEA, Vienna (2008). Other publications issued in the IAEA Nuclear Security Series National Strategy for Regaining Control over Orphan Sources and Improving Control over Vulnerable Sources SSG-19, IAEA (2011) Security of Radioactive Sources, TECDOC 1355, IAEA (2003) Categorization of Radioactive Sources, Safety Guide RS-G-1.9, IAEA, Vienna (2005)