NRC SENDS REPORT TO CONGRESS ON REGULATIONS
FOR DIAGNOSTIC NUCLEAR MEDICINE

The 2002 Energy and Water Appropriations Act prohibited the NRC from implementing or enforcing its revised regulations in Part 35 of Title 10 of the Code of Federal Regulations with regard to diagnostic nuclear medicine (except for certain parts that establish training and experience requirements) until the agency submitted its report.

The Commission had approved the final revised regulations for medical uses in October 2000, following consideration of public comments on the proposed regulations and subsequent public meetings and workshops. Because of the Congressional direction, the regulations have not yet been issued and the previously existing regulations have remained in effect.

As stated in letters to Congress transmitting the report, the NRC believes that the net reduction in regulatory burden reflected in the revised final regulations is commensurate with the low risk of adverse impact on health and safety from diagnostic nuclear medicine procedures. However, it believes that further reduction of the regulatory burden beyond that in the revised rule may have an adverse effect on public health and safety.

The NRC acknowledged that some interested stakeholders have expressed concerns related to the perceived burden associated with the implementation of the new rule. As a result, the NRC has committed to review the licensing and inspection guidance to identify any needed improvements and to train license reviewers and inspectors to implement the revised rule effectively and efficiently. The NRC stated that it will work with stakeholders to develop appropriate guidance.

In addition, the NRC may consider future rule changes through the agency's established rulemaking processes as experience with the rule is gained by NRC staff and licensees.

The report concludes that the revised Part 35 is necessary to authorize medical professionals who are trained and experienced in radiation safety to administer nuclear material for diagnostic purposes, while at the same time providing for radiation safety of the workers and of the general public.

The NRC told Congress that it plans to submit the revised final Part 35 to the Federal Register, for publication, in about 30 days. The rule would not become effective until 6 months thereafter.

Copies of the report and of the final revised rule will be available through the NRC's Electronic Reading Room at http://www.nrc.gov as an Agencywide Document Access and Management System (ADAMS) document. They will also be available for reproduction (for a fee) through the NRC Public Document Room, Washington, D.C. 20555, telephone: 301/415-4737 or 1/800/397-4209, e-mail: pdr@nrc.gov. The Public Document Room staff is available to provide help in accessing ADAMS.

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Last revised Wednesday, June 25, 2003