ML20248L763

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Responds Re Concerns of Constituents About Possible Changes in NRC 10CFR35 Regulation on Medical Use of Byproduct Material
ML20248L763
Person / Time
Issue date: 06/04/1998
From: Shirley Ann Jackson, The Chairman
NRC COMMISSION (OCM)
To: Matthew Mcconnell
SENATE
References
FRN-62FR42219, RULE-PR-35 NUDOCS 9806110343
Download: ML20248L763 (1)


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The Honorable Mitch McConnell g

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United States Senate y

Washington, D.C. 20510-1702 i

Dear Senator McConnell:

I am responding to your letter dated April 27,1998, regarding the concems of your constitue about possib'e changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part regulations on medical use of byproduct material. In particular, you were concemed about the training and experience requirements that would be applicable to personnel involved in diagnostic and therapeutic uses of unsealed byproduct material.

The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule is being developed using an increased public participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a "strawman" rule text on the intemet for comments. The staff is carefully considering the comments received during these interactions, in preparing the proposal. After Commission approval, a proposed rule will be published in the Federal Reaister for public comment. We expect to hold additional public meetings during the comment period later this year.

The issue of training and experience has received the most comments during the development of the proposed rule. Viewpoints on this issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnel in the diagnostic area, including those from American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also specified a focus on radiation safety and proposed that personnel competency be verified through an examination.

This proposal appears to be in keeping with the direction the Commission provided to the staff namely, to develop a risk-informed, and where appropriate, a more perfomiance-based rule a it addressed an objection often expressed by some commenters, that NRC requirements sometimes intruded into the practice of medicine.

The Commission will carefully consider the staff proposal in light of public comments such as your constituents' when it is received. The results of that consideration will then be availabl additional public comment and discussion.

Sincerely, i.~u Shirley Ann Jackson

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