Regulatory Bodies

What do I need to Know?

Responsibilities of the Regulatory Body

The Fundamental Safety Principles (SF-1) of the IAEA’s Safety Standard Series lays forth the fundamental safety objective and ten associated safety principles. This document is further referenced in the General Safety Requirements No.1 (GSR Part 1) in which the requirements in respect to the governmental, legal, and regulatory framework for safety are established. GSR Part 1 establishes the governments role in establishing a regulatory body for safety. Furthermore, in the General Safety Requirements No. 3 (GSR Part 3) the requirements for the regulatory body are further expanded upon in relation to radiation protection and safety of radiation sources.

“The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation. “– GSR Part 3 Requirement 3

The regulatory body has many responsibilities, primarily revolving around establishing regulations for protection and safety of workers in radiation environments. This regulatory system for protection and safety should include:

1. Notification and authorization.
2. Review and assessment of facilities and activities.
3. Inspection of facilities and activities.
4. Enforcement of regulatory requirements.
5. The regulatory functions relevant to emergency exposure situations and existing exposure situations;
6. Provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties.

Responsibilities of the Regulatory Body Specific to Occupational Exposure

“The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized, and the regulatory body shall enforce compliance with dose limits for occupational exposure” – GSR Part 3 Requirement 19

The regulatory body is responsible for establishing the responsibilities of employers, registrants, and licensees with regard to application of the requirements for occupational exposure in planned exposure situations, establishing and enforcing requirements for ensuring protection and safety is optimized, ensuring that applicable dose limits are complied with, and monitoring and recording occupational exposures.

Before authorization of a new or modified practice, the regulatory body shall require, as appropriate, and review supporting documents from the responsible parties that state:

1. Design criteria and design features relating to the exposure and potential exposure of workers in all operational states and in accident conditions.
2. Design criteria and design features of the appropriate systems and programmes for monitoring of workers for occupational exposure in all operational states and in accident conditions.

Record Management

The regulatory body shall make provisions for establishing, maintaining, and retrieving adequate records relating to facilities and activities. These records shall include:

1. Registers of sealed sources and radiation generators^1/.
2. Records of doses from occupational exposure.
3. Records relating to the safety of facilities and activities.
4. Records that might be necessary for the shutdown and decommissioning or closure of facilities.
5. Records of events, including non-routine releases of radioactive material to the environment.
6. Inventories of radioactive waste and of spent fuel.

Graded Approach

The regulatory body should adopt a graded approach to the implementation of the system of protection and safety, such that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.

It is required as a general responsibility of the government to ensure that the overall application of the principles of radiation protection is in line with the graded approach (see para. 2.18 of GSR Part 3 [2]).

References

• Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, IAEA, Vienna (2006) 
• Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards, IAEA Safety Standards Series No. GSR Part 3, IAEA, Vienna (2014) 
• Occupational Radiation Protection, IAEA Safety Standards Series No. GSG-7, IAEA, Vienna (2018) 
• Organization, Management and Staffing of the Regulatory Body for Safety, IAEA Safety Standards Series No. GSG-12, IAEA, Vienna (2018)
• Establishing the Infrastructure for Radiation Safety, IAEA Safety Standards Series No. SSG-44, IAEA, Vienna (2018) 
• Effective Managment of Regulatory Experience for Safety, IAEA TECDOC Series-1899, IAEA, Vienna (2020) 

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^1/ The regulatory body specifies which sources are to be included in the registers and inventories, with due consideration given to the associated risks.