NRC SENDS REPORT TO CONGRESS ON ON REGULATIONS FOR DIAGNOSTIC NUCLEAR MEDICINE

["Sandy Perle" <sandyfl@EARTHLINK.NET>]

Courtesy of the MEDHP-SEC Listserver



The Nuclear Regulatory Commission has sent a report to

the House and Senate Committees on Appropriations

regarding the regulatory burden associated with its

revised final regulations on 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



------------------------------------------------------------------------

Sandy Perle				Tel:(714) 545-0100 / (800) 548-5100   

Director, Technical			Extension 2306

ICN Worldwide Dosimetry Service	Fax:(714) 668-3149 	           

ICN Pharmaceuticals, Inc.		E-Mail: sandyfl@earthlink.net

ICN Plaza, 3300 Hyland Avenue  	E-Mail: sperle@icnpharm.com   

Costa Mesa, CA 92626                    



Personal Website: http://sandy-travels.com

ICN Worldwide Dosimetry Website: http://www.dosimetry.com





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