Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Enforcement

Slide 2 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 To provide understanding of the importance of enforcement as a key component of a regulatory program for ensuring that regulatory requirements are met Objective

Slide 3 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Legal basis and enforcement policy Procedure and detailed guidance to enforce regulatory requirements Graded enforcement action based on the nature of non- compliance and implication for safety; instructions, sanctions, fines, suspensions. Interaction between regulatory authority and other national bodies for enforcement action Contents

Slide 4 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Enforcement is action taken by the Regulatory Authority :- to require a registrant, licensee or other responsible party to correct matters of non-compliance with regulatory requirements; or, where appropriate, the application of penalties (prosecution, suspension or cancellation of the authorization, confiscation of the radiation sources, etc.)

Slide 5 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 The legislation should:- explain the powers of the Regulatory Authority; Legal Basis for Enforcement provide for the Authority to impose sanctions that will deter deliberate or careless deviations from regulatory requirements; give the Authority power to ban imports, exports or sales; explain the Authority’s role in legal actions i.e. subject to the accepted legal norms of the country, whether investigations and prosecutions are undertaken by the Authority, the police or other agency.

Slide 6 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 The Regulatory Authority should make its enforcement policy publicly available:- Enforcement Policy so that registrants and licensees are informed of sanctions and penalties for non-compliance; as guidance for Regulatory Authority staff.

Slide 7 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Reasons for enforcement actions can include:- matters of non-compliance noted during inspections; Enforcement Policy (cont) disregard of instructions or directions given by the Authority or its inspectors; RPO not appointed (or unacceptable to the Authority); failure to give required notifications the Authority; transfer of a source to a person who does not hold a relevant or valid authorization.

Slide 8 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Operations deemed unsafe Potential risk to health and safety exists No immediate threat to health and safety (perhaps a basic regulatory infraction) Threats to health and safety Graded Enforcement Actions

Slide 9 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Informal or formal instructions may be given to correct the infraction (however, written instructions should follow oral instructions or directions); Facility operations may continue while corrective measures are taken. Prosecution not necessarily appropriate. No immediate threat to health and safety (perhaps a basic regulatory infraction) Graded Enforcement Actions (cont) Possible actions based on the threat to health and safety

Slide 10 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 The Regulatory Authority may decide to suspend or restrict the facility’s operations until regulatory infractions or safety conditions are corrected. Prosecution may be appropriate. Graded Enforcement Actions (cont) Potential risk to health and safety exists Possible actions based on the threat to health and safety

Slide 11 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 The Regulatory Authority should consider suspending or restricting the facility’s operations and, where practicable, may consider confiscating the radiation sources. Prosecution should be considered. Graded Enforcement Actions (cont) Operations deemed unsafe Possible actions based on the threat to health and safety

Slide 12 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Communication between the Regulatory Authority and the licensee should be:- Enforcement Action timely (given as soon as practicable during or after the inspection); well documented with a stated time-frame for correcting deficiencies; confirmed in writing; clear and unambiguous;

Slide 13 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 On-the-spot enforcement procedures:- must be clearly documented and may be graded by the Regulatory Authority according to the inspector’s position and competence; Enforcement Action (cont) If an inspector does not have this authority, a system for timely referral of the relevant inspection findings to their supervisor must be established.

Slide 14 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 qualified and experienced scientists and/or managers bypass safety systems prescribed by the regulations; or Enforcement Action (cont) regulations have been violated but no apparent harm was caused. Uniform enforcement actions must also be applied in situations where, for example:-

Slide 15 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 In considering enforcement actions, the Regulatory Authority should anticipate the potential negative impact on:- Justification of Enforcement Action economic issues Suspending or cancelling an authorization might cause unemployment and unnecessarily penalise innocent workers. health issues Suspending or cancelling an authorization for a medical radiation source may jeopardise the health of the public, particularly if no alternative facilities are readily available.

Slide 16 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Exercise 1 Two workers are exposed to radiation during work in the vicinity of a level gauge (370 MBq 137 Cs source). The level gauge had been dismantled from the side of a silo and the shutter was left open so that the workers were in the radiation beam. Fortunately, the working times in the beam were small and the workers’ effective dose was estimated at less than 1 mSv. However, investigations showed that the owner of the device did not have a licence. The source is now stored at the premises of the operator. What is appropriate enforcement action?

Slide 17 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 A newspaper published an article about a rock musician including a radiograph of the musician’s head demonstrating his ear, lip and tongue jewellery. Exercise 2 The Regulatory Authority suspects violation of the justification principle. What might be appropriate enforcement action?

Slide 18 Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Module 3-9 Exercise 3 The conditions of a licence for a nuclear medicine practice require that a qualified nuclear medicine physician be present on the premises when radioactive substances are administered to patients. The regulatory authority learns that the sole physician has gone overseas for 3 months and no alternative arrangements for a responsible medial practitioner to be on site have been made. Discuss actions that the regulatory authority might take.