Section 8-3 - Regulatory Approach (a) The Department shall determine licensing inspection actions, enforcement, and other decisions by the Program based on the risk informed, performance based regulatory approach which is a combination of the following approaches: - (i) "A risk informed approach" to regulatory decision-making represents a philosophy whereby risk insights are considered together with other factors to establish requirements that better focus licensee and regulatory attention on design and operational issues, pertaining to licensed material safety, commensurate with their importance to employee health and safety, public health and safety, and environmental protection.
- (ii) "A performance based approach" to regulatory decision making represents a philosophy whereby performance standards are established that must be achieved by the licensee, but provides flexibility to the licensee as to the means of meeting those standards. This approach emphasizes results over process and methods and uses those results as the primary basis for regulatory decision-making. This approach incorporates the following attributes:
- (A) Measurable (or calculable) parameters (i.e., direct measurements of the physical parameter of interest or of related parameters that can be used to calculate the parameter of interest) that exist to monitor a system, including facility and licensee performance;
- (B) Objective criteria to assess performance are established based on risk insights, deterministic analysis, and performance history;
- (C) Flexibility for licensees to determine how to meet the established performance criteria in ways that will encourage and reward improved outcomes; and
- (D) Failure to meet a performance criterion, while undesirable, will not in and of itself constitute or result in an immediate safety concern.
(b) As part of the risk informed performance based regulatory approach, the Department shall utilize risk insight, engineering analysis and judgment, including the principle of defense-in-depth and incorporation of safety margins, and performance history to: - (i) Focus attention on the areas of greatest potential significance to human health, safety, and the environment;
- (ii) Establish objective criteria for evaluating performance;
- (iii) Develop measurable or calculable parameters for monitoring system and license performance;
- (iv) Provide flexibility to licensees to determine how to meet the established performance criteria in a way that will encourage and reward outcomes; and
- (v) Focus on the results as the primary basis for regulatory decisions.