Regulatory activities approach

EPA s previous efforts to expand its authority would have resulted in the submission of data of questionable quality, and the imposition of unnecessary burdens on industry. Industry has recommended a more focused approach under which EPA could still obtain more than enough sound information to support its regulatory activities under TSCA. The reporting provisions of Section 8 are sufficiently broad to allow EPA to accomplish its objectives without departing from the basic statutory framework established by Congress. 

In order to overcome this shortcoming, a program was instituted in 1980 to develop a leaching procedure suitable for use in expanding the Toxicity Characteristic to add additional organic constituents. In addition, in 1983 work began on development of a means to establish threshold concentrations. This paper will summarize the approach undertaken in both these areas and will discuss the status of EPA s regulatory activities to expand the Toxicity Characteristic. 

How to identify subjects with each AE of special interest. This includes specifying the medical definition of the AE of special interest (preferably, an established definition in the medical literature). Identification of subjects may include any of the following utilization of a search strategy in the Medical Dictionary for Regulatory Activities (MedDRA) or other dictionary utilization of a special case report form and/or adjudication. For example, it may be possible to utilize a standardized MedDRA query (SMQ) (see the MedDRA site). If a special case report form is developed, details of special collection may be included in the PSAP section on "Data Collection Plan and Standardization Approaches." If the AE of special interest definition will include event adjudication, detailed information on the adjudication process or a link to more detailed information should be included. It is recommended to have a common definition for an AE of special interest for the entire development program, in order to facilitate data integration, analysis, and interpretation. 

USNRC s policy for implementing risk-informed regulation was expressed in the 1995 policy statement on the use of probabilistic risk assessment (PRA) methods in nuclear regulatory activities. The policy statement says The use of PRA technology should be increased in all regulatory matters to the extent supported by the state-of-the-art in PRA methods and data and in a manner that complements the NRC s deterministic approach and supports the NRC s traditional defence-in-depth philosophy. 

The UK Safely Assessment Principles for Nuclear Power Plants [8J is another example of a consistent safety policy document which is applied to both modem existing and next generation NPPs. Other regulatory activities on the development of safety approaches for future NPPs have also been pursued in some other countries. 

The regulatory process should be routinely and systematically monitored in order to identify problems in the process and determine whether the activities actually carried out are consistent with the intended course of action. Several approaches may be employed for assessing the performance of dmg regulatory authorities self-review, supervisory body review and peer review. These approaches can complement one another in appraising the performance of the DRA, as well as assisting it to identify areas for improvement. 

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