Panel Discussion-Adequacy and Compatibility-Safety and Source Security Considerations

In December 2010, the Commission disapproved the proposed final rule: Limiting the Quantity of Byproduct Material in a Generally Licensed Device,” but directed staff to update the Commission Policy Statement on Adequacy and Compatibility of Agreement State Programs and associated guidance documents to include both safety and source security considerations in the determination process. This presentation will discuss the status of staff’s efforts to revise the policy statement and associated guidance and discuss proposed changes to these documents.

David Walter abstract - The safe use of licensed radioactive material, and the security required for such safe use, has been the primary goal of Agreement State programs from the beginning. Over the nearly 50 years Agreement States have been around, as real and perceived viable threats to health and safety have occurred, states have constantly evolved their health and safety requirements to maintain a safe environment for the use of licensed radioactive material. Compatibility is a minor element in providing an effective and adequate radiation control program.

Abstract of the Association of Device Distributors and Manufacturers (ADDM)

The Association of Device Distributors and Manufacturers (ADDM) is a professional group consisting of most of the manufacturers and distributors of devices containing radioactive materials in the United States. We have come together to discuss the regulatory issues facing each of our companies and our customer bases, which are the end-users of the devices throughout the country. We appreciate the opportunity to openly discuss the questions and concerns of all involved in the many regulatory issues facing our industry today.

Specifically, ADDM would like to discuss the General License Rules of the Nuclear Regulatory Commission. We agree that it is worthwhile to discuss the current regulations and review any proposed changes that improve the safety and security of the devices used in the United States.

One of ADDM's most significant issues is the recent decisions of the NRC indicating a move away from Agreement State Compatibility with existing NRC regulations concerning Generally Licensed Devices. ADDM is in favor of Compatibility Level "B" to create the most uniformity in regulations between states. The NRC, working with all stakeholders (Agreement States, Manufacturers/Distributors, and end users), needs to identify the critical aspects of a General License program necessary to ensure the highest level of safety and security. Once this level is established, then this should be reflected in the NRC regulations. Because of the interstate impact of the General License Regulations, the regulations must be given a Level "B" Compatibility to ensure the regulations are consistently applied to all devices across all regulatory jurisdictions. Individual jurisdictional changes to the regulations would not improve safety or security, they would only complicate the process for those involved who are trying to maintain compliance. This should be the goal of the "Agreement State" program, that is to "be in agreement." A high level of Compatibility with the General License rules was also the presented as the position of NRC program staff (as relayed to ADDM members during the 2011 CRCPD meeting).

It is, and has been, the ADDM's position that Specific Licensing of certain Generally Licensed devices adds limited benefit to increasing the security and/or safety of these devices. Much greater benefit is attained by an alternative proposal to have all Generally Licensed devices be registered under the existing NRC and State General License Registration processes. This would allow State programs to continue with their exitsting registration programs, but not trigger the additional regulatory requirements associated with Specific Licenses. Requiring Specific Licenses for certain Generally Licensed devices is also likely to affect the sales of the these devices. End users will be required to invest additional costs and time in the procurement and maintenance of devices under a Specific License (i.e. RSO training, purchasing survey meters and calibrating them, audits, additional documentation, etc.). There has not been any additional increase in safety or security demonstrated in such a regulatory change. The devices can still be effectively regulated as Generally Licensed devices because the regulatory body will get reports on who the products were sold to and where they are located. Each regulatory body has the authority to require further registration, require annual updates, and inspect the devices. If there is a concern about devices the safety and security of the devices, there are many options available to the regulatory bodies under the existing NRC General License regulations to ensure proper handling, storage, and disposition of the devices.