1. Workshop on School for Drafting Regulations on Radiation Safety on Regulatory Infrastructure Development Project (RIRP) Module Responsibilities for Compliance with Transport Regulations
15 – 19 December 2014 Vienna
Bill Brach

2. OBJECTIVE
This module describes the regulatory compliance obligations of the individuals and institutions engaged in the transport of radioactive material, and the basic functions of the competent authority for assuring that those obligations are met.
At the end of the module the participants should know the responsibilities of the various parties concerned with transport of radioactive material and the consequences of non-compliance.

3. REGULATORY RESPONSIBILITIES
Primary responsibility for compliance lies with consignors.
Regulations also assign responsibilities to carriers.
Specific responsibilities of consignors and carriers may vary from country to country.
Other users of the regulations (e.g. designers; manufacturers; consignees; competent authorities etc.) also have responsibilities.

4. CONSIGNOR
Consignor:
Any person, organization or government which prepares a consignment;
May be operator of the facility from where the consignment originates; or
Person or organization identified as consignor in transport documents responsible for preparing consignment in accordance with regulatory requirements.

5. CONSIGNOR’S RESPONSIBILITIES
The consignor should ensure that –
An adequate quality assurance programme is established, implemented and reviewed,
A radiation protection programme is established, implemented and reviewed,
Workers are suitably trained commensurate with their duties,
Applicable approval certificates are obtained from Competent Authorities.

6. CONSIGNOR’S RESPONSIBILITIES (CONTINUED)
The consignor should also ensure that –
Notification of shipment, where applicable, has been provided to the competent authority,
The package used meets design criteria,
The content of the package is properly characterised,
The content of the package is consistent with its type and conforms to regulatory requirements.

7. CONSIGNOR’S RESPONSIBILITIES (CONTINUED)
The consignor should further ensure–
The radioactive material is properly packaged,
Containment is closed, fastened and where appropriate tested,
Surface radiation levels are compliant,
Transport index conforms to regulatory requirements,
Non fixed contamination levels conform to regulatory requirements,
The package is properly marked and labelled.

8. CONSIGNOR’S RESPONSIBILITIES (CONTINUED)
Finally, the consignor should ensure–
Transport documents conform to regulatory requirements,
Information to carrier is provided (e.g. contingency arrangements) as required by regulations,
That they consult with other users of the IAEA regulations, as necessary, in order to fully discharge their duties.

9. IS THE LABELLING PROPER?

10. ARE LABELLING REQUIREMENTS MET?
Other Dangerous Goods
Additional labels as required for other dangerous goods.
Non-applicable Labels
All labels not relating to the package content must be removed.

11. CARRIER’S RESPONSIBILITIES
The Carrier should:
ensure that an adequate quality assurance programme is established, implemented and reviewed,
ensure that a radiation protection programme is established, implemented and reviewed,
ensure that workers are suitably trained commensurate with their duties,
accept packages only if the transport documents are correct and complete,
maintain the records of shipments for such period of time as may be specified by the competent authority,
provide adequate facilities for the in transit storage of packages if applicable.

12. CARRIER’S RESPONSIBILITIES (CONTINUED)
The Carrier should:
Segregate packages from occupied areas and undeveloped films, etc,
Comply with the limits on accumulation of packages during in-transit storage and carriage,
Deliver packages to correct destination,
Implement special instructions, if any, provided by the consignor in respect of the package, and
Inform the consignor and initiate the appropriate response measures if a non compliance during carriage is observed.

13. CONSIGNEE’S RESPONSIBILITIES
Consignee should :
Inform consignor (and when needed the carrier and competent authority) and
Initiate appropriate response measures in case of non-compliance on receipt of a consignment

14. COMPETENT AUTHORITY’S RESPONSIBILITIES
The Competent Authority should—
Create and maintain the regulatory framework ,
Establish safety principles and criteria,
Operate an effective compliance assurance programme,
Ensure compliance with regulations by the consignor, carrier and consignee,
Develop, establish and maintain a system to discharge its duties.

15. COMPETENT AUTHORITY’S RESPONSIBILITIES
The Competent Authority should also—
Conduct periodic assessment of radiation dose in transport,
Issue appropriate approval certificates, when technically justified and
Assign Competent Authority identification marks.

16. RESPONSIBILITIES OF OTHER USERS
Other users must be responsible for –
Design of material / packaging
Manufacture material / packaging
Maintenance and servicing of reusable packagings
Repair of packagings

17. NON-COMPLIANCE In case of non-compliance
Consignor should be informed of the non- compliance by carrier or consignee.
Carrier, consignor or consignee, as appropriate, should:
Take steps to mitigate consequences of non- compliance,
Investigate the causes, circumstances and consequences,
Remedy causes and circumstances that led to non- compliance, and
Communicate to the relevant competent authority.

18. NON-COMPLIANCE (CONTINUED)
In case of non-compliance
Communication to the consignor and competent authority should be made as soon as practicable but immediately whenever an emergency exposure situation has developed or is developing.

19. INTROSPECTION
Is it required that in the event of non-compliance with any limit in these Regulations applicable to radiation level or contamination the carrier, consignor or consignee, as appropriate, shall investigate the non- compliance and its causes, circumstances and consequences?
Is it required that the consignor, carrier or the consignee communicate to the relevant Competent Authority(ies) on the causes of the non-compliance and on corrective or preventive actions taken or to be taken?
Does the CA or its authorized representatives investigate the reported instances of non-compliance?

20. INTROSPECTION
What is the mechanism for investigating and informing the authorities about an instance of non- compliance with the regulations for the safe transport of radioactive material?

21. CONSEQUENCES OF NON-COMPLIANCE
Potential consequences of non-compliance with the regulations are –
Radiological consequences
Other consequences

22. RADIOLOGICAL CONSEQUENCES
Non-compliance
Radiological consequence
Radiation levels exceed limits
Potential exposure to persons
Non-fixed contamination levels exceed limits
Potential internal exposure
Improper marking and labeling
Inappropriate package handling and potential exposure to persons
Improper segregation of consignments
Improper criticality safety evaluation
Unsafe condition / Potential exposure to persons

23. OTHER CONSEQUENCES Non-compliance Other consequence
Inadequate tie-down
Potential loss of package from conveyance
Improper segregation from films
Films unusable due to fogging
Incorrect documentation or package labeling
Delayed or denied shipments

24. INTROSPECTION
Is there a mechanism for maintaining consistency of enforcement actions?
Is the primary purpose of an enforcement programme to carry out punitive action rather than to foster compliance with the Transport Regulations?
Is the competent authority responsible for enforcement of the Transport Regulations?

25. IN EFFECT ...
Checking non-compliance is one effective method of compliance assurance.
A mechanism should be in place to identify and report non-compliance and track the implemented action plan for ensuring that compliance assurance is achieved and maintained.

26. IN EACH CASE..
...all the relevant requirements of SSR 6 must be complied with.

27. SUMMARY
Compliance is the responsibility of consignor, carrier consignee and other identified users.
Competent authority has to assure compliance.
Consequences of non-compliance may include damage to persons, property and the environment (radiological consequences, other consequences).
Hence compliance with regulations is essential.

28. Drafting Regulations for Your Country

29. Overview Options for Transport Regulations
Referencing Existing International Standards/Regulations
Incorporation of All Regulatory Provisions
Determination of Approach to Drafting of Regulations
Questions?

30. Options for Transport Regulations
There are two basic approaches to the introduction of regulations for safe transport of radioactive material
(A) Referencing out to other international regulatory vehicles (TS-R-1/SSR-6, ADR, ADN, etc.)
Example: (FANR-REG-13, Ver 0)
(B) Including all provisions explicitly in your regulations
Examples: United Kingdom (No from 2002)
United States (10CFR Part 71)

31. Referencing Existing International Standards/Regulations
May be the least complicated approach
May make for very succinct regulations
Citing of external regulations should be done in such a way that the revision of the cited regulations does not require the national regulations to be re-issued
In general, should include the following:
A statement that radioactive material may not be transported unless it is in accordance with the regulations

32. Referencing Existing International Standards/Regulations, cont.
Also should include:
Assignment of authority/responsibility
The IAEA regulations are not enforceable, and therefore an assignment of responsibility for the various provisions in the regulations is necessary.
Definition of the Competent Authority (CA) (or authorities, if more than one) and their responsibility/responsibilities
Clear defining of exceptions to the referenced standards/regulations
Clear defining of powers of enforcement and, if appropriate to the country legislation, the penalties that may be imposed for noncompliance

33. Referencing Existing International Standards/Regulations, cont.
Further to include:
A description of national emergency arrangements
Requirement to report incidents /accidents to the CA
Including timescales for notification
Includes a definition of what is a reportable incident or accident (or theft) [See 2002 UK Regulations No Part XII, definition of “notifiable event”]

34. Incorporation of All Regulatory Provisions
These regulations will:
Include all applicable provisions directly in the rule/regulation/legislation (elements discussed in previous slides)
provide definitions for all terms of importance (those that may need a “legal” definition)
clearly assign responsibility and/or authority for key provisions
May follow same general format of international regulatory provisions
May refer to other National legislation or national or international standards as needed

35. Determination of Approach to Regulations
National policy or practices of the national legislative body may dictate which approach will need to be pursued
Be mindful that not all provisions of the international regulations/standards will be applicable to the situation in a given country
The passage of a “general” law related to the regulation of transport could place implementation of the law into the hands of the competent authority (CA)
A CA could then decide whether to issue regulations and/or guidance on safe transport

36. Determination of Approach to Regulations, cont.
For some countries, a combination of the previously described approaches may be the best solution
Ultimately, a country must decide what approach is going to work the best for the circumstances in their country to institute a reasonable and enforceable version of regulations for transport.
The IAEA can provide guidance in the process of drafting your national regulations.

37. Questions?
Thank you