3/21/20161 EnforcementEnforcement

Enforcement Objectives To provide understanding of the importance of enforcement as a key component of a regulatory programme for ensuring that regulatory requirements are met

Enforcement Enforcement is Action taken by the Regulatory Authority to ensure that the responsible party corrects non-compliance with regulatory requirements

Legal basis for enforcement Authority to enforce Needs to be addressed in legislation Regulatory Authority must be empowered to impose sanctions that will deter deliberate or careless deviations from regulatory requirements Ban on import, export or sale Legal process (investigation by police, prosecution?)

Enforcement policy Written and published policy Prevents infractions as licensee knows that non-compliance causes sanctions and penalties Guidance for Regulatory Authority staff

Enforcement programme Identification of reasons for enforcement action, e.g. Non-compliance discovered during inspection Negligence of instructions or orders given No radiation safety officer Negligence of notifications to the RA Non-compliance in transfers and trade  Transfer to non-authorized person  No notification of transfer to the RA

Enforcement programme Identification of possible actions based on supervisory rights or specific enforcement provisions in legislation instructions of an inspector restrictions on or discontinuation of operations ban on sales and tranfer etc.

Enforcement programme Written internal guidance actions based on threat to health and safety clear written procedures how to manage different situations

Graded enforcement actions Operations likely not safe Potential threat of health and safety No immediate threat to health and safety (usually regulatory infraction) Based on threat to health and safety

No immediate threat to health and safety (usually regulatory infraction) Graded enforcement actions Informal or formal instructions to correct the infraction Operations may continue while corrective measures are taken Informal oral instruction should be followed in writing

Potential threat of health and safety Graded enforcement actions Suspension of or restrictions on operations until regulatory infraction or safety condition is corrected

Operations likely not safe Graded enforcement actions Licensee shows a record of poor performance or adverse safety conditions Suspension of or restrictions on operations

Enforcement action Communication between RA and licensee Clear and unambiguous Timely Well documented All enforcement action should be confirmed in writing

Enforcement action Request to remedy non-compliance Agreed time-scale (dead line) Prevention of reoccurrence Ensuring that remedial actions are implemented

On-the-spot enforcement Level of authority of the inspector determined by the Regulatory Authority If the inspector does not have the authority, system for timely transmission of information to the Regulatory Authority shall be established Enforcement action

Clear uniform enforcement actions need also be applied to well trained and highly experienced scientists and managers if actions to bypass safety systems take place regulations have been violated but no apparent harm was caused

Enforcement action Good documentation and records of Infractions found during inspection Enforcement actions Sanctions or other regulatory actions Licensees response to enforcement actions Licensees corrective actions RA’s analysis on the acceptability of licensees response and corrective actions

“Justification” of enforcement action Potential negative impact on Economic issues Health issues Safety issues Need to be anticipated and considered by the Regulatory Authority

“Justification” of enforcement action Examples Economic, social and health effects of the public if a heat production plant is closed due to enforcement action Detriment to patients whose therapy or diagnosis is interrupted

Decisions made by an inspector Decisions assessed and validated by the Regulatory Authority, if necessary Decisions of the Regulatory Authority possibility to appeal through a process in court (depends on the national legal system) Appealing regulatory enforcement decisions

Interaction with other regulatory authorities l Customs l Police l Occupational Safety Authorities l Environmental Protection Authorities l Consumer Agency l etc.

Exercise (1/3) Enforcement Case 1 Two workers are slightly exposed 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 working in the radiation beam. Fortunately the working times in the beam were small and the effective dose of the workers were estimated at less than 1 mSv. However, investigations showed that the owner of the device did not have a safety licence. The source is now stored at the premises of the operator. Appropriate enforcement action?

Exercise (2/3) Enforcement Case 2 A newspaper published an article of a rock musician together with an X-ray radiograph of the head of the musician demonstrating his ear, lip and tongue jewellery. The Regulatory Authority suspect violation of the justification principle. Appropriate enforcement action?

Exercise (3/3) Enforcement Case 3 A telephone dealer was selling covers of mobile phones with a radiation hazard marking on them. The variety of goods sold by the dealer involved many covers, specially meant to attract young people. Appropriate enforcement action?