ML20248F181

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Responds to Which Conveyed Reservations Expressed by Indiana Radiological Society,Inc Chapter of American College of Radiology Re Changes in 10CFR35 Regulations on Medical Use of Byproduct Matl
ML20248F181
Person / Time
Issue date: 05/26/1998
From: Callan L
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Lugar R
SENATE
Shared Package
ML20248F182 List:
References
NUDOCS 9806040141
Download: ML20248F181 (3)


Text

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May 26, 1998 g The Honor:ble Rich rd G. Lugar 4

e United States Senat)

- Washington, DC 20510-1401

Dear Senator Lugar:

I am responding to your letter dated May 8,1998, which conveyed reservations expressed by the Indiana Radiological Society, Inc., Chapter of the American College of Radiology about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 l

regulations on medical use of byproduct material.- Particular concerns were expressed 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 participatiori process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and o.e posting of a "strawmarf rule l

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 FederalRegister for public comment. We expect to hold additional public meetings during the comment period later this year.

l 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 the American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while j

reducing the number of hours required for certain medical modalities, also specified a focus on l

radiation safety and proposed that personnel competency be verified through an examination.

I This proposal appears to be in keeping with the direction the Commission provided to the staff l

namely, to develop a risk-informed, and where appropriate, a more performance-based rule and 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 proposalin light of public comments such as yours when it is received. The results of that consideration will then be available for additional public comment and discussion.

h^l i

6 Pao Sincerely.

OdginalSigned by

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L. Joseph Callan L.J. Callan kg Executive Director E* "

DISTRIBUTION: G980324 J

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DUE: 05/27/98-

.EDO CONTROL: G980324

. DOC DT: 05f08 98-

$/M 9f FINAL REPLY:

! S nctor Richard G. - Lugar TOs,

. Chairman Jackson FOR SIGNATURE OF :

    • GRN CRC NO: 98-0447 Callan, EDO~

-DESC ROUTING:

REVISION TO 10 CFR PART 35 -- TRAINING AND Callan l

EXPERIENCE WITH MEDICAL USE OF RADIOISOTOPES Thadani (James M. Zieba)

Thompson Norry Blaha Burns j

DATE: 05/14/98

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ASSIGNED TO:

CONTACT:

NMSS Paperiello SPECIAL INSTRUCTIONS OR REMARKS:

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OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET 4

PAPER NUMBER:

CRC-98-0447 LOGGING DATE: May 12 98 ACTION. OFFICE:

EDO AUTHOR:

RICHARD LUGAR

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AFFILIATION:

U.S.

SENATE ADDRESSEE:

CHAIRMAN JACKSON LETTER DATE:

May 8 98 FILE CODE: IDR 14 PT 35

SUBJECT:

MEDICAL USE OF RADIOISOTOPES...PART 35 ACTION:

Signature of EDO DISTRIBUTION:

CHAIRMAN SPECIAL HANDLING: OCA TO ACK CONSTITUENT:

JAMES ZIEBA NOTES:

DATE DUE:

May 98 SIGNATURE:

DATE SIGNED:

AFFILIATION:

EDO -- G980324 i

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