ML20236M814

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Responds to Expressing Reservations About Possible Changes in NRC 10CFR35 Regulations on Medical Use of Byproduct Matl.Staff Scheduled to Provide Recommendations on Proposed Rev to Part 35 in June 1998
ML20236M814
Person / Time
Issue date: 06/15/1998
From: Callan L
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Mccrery J
HOUSE OF REP.
Shared Package
ML20236M816 List:
References
NUDOCS 9807140272
Download: ML20236M814 (5)


Text

June 15, 1998 I'

The Honorable Jim McCrery United States House of Representatives Washington, DC 20515-1805 1

Dear Congressman McCrery:

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1 am responding to your letter dated May 28,1998, in which you expressed reservations about i

possible changes in the U.S. Nuclear Regulatory Commiission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material, in particular, youwere concerned about the training and experience requirements that would be applicable to personnel involved in diagnostic and therapeutic uses of unsealed byoroduct 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 FederalReaister 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 l'aa varied. The Commission has received comments both supporting reduction in requirements affecting personnelin the diagnostic area, including those from the 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 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 proposal in 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.

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June 15, 1998 l

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The Honorable Jim McCrery United States House of Representatives j

Washington, DC 20515-1805 j

Dear Congressman McCrery:

I am responding to your letter dated May 28,1998, in which you expressed reservations about possible changes in the U.S. Nuclear Regdatory Commission's (NRC's) 10 CFR Part 35 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 provble its recommendation.s 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 Internet 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 Register 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 the 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 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 prooosal in 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.

Sincerely, L J seph Callan cutive Director for Operations

1 Tha Honor:bla Jim McCr ry Unit:d Stat:s House of R pr:sent:tiv:s Washington, DC 20515-1805 1

Dear Congressman McCrery:

I am responding to your letter dated May 28,1998, where you expressed reservations abput possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35/

l regulations on medical use of byproduct material. In particular, you were concerned about l-the training and experience requirements that would be applicable to personnel involveli in l

diagnostic and therapeutic uses of unsealed byproduct material.

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The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to

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the Commission in June 1998. The proposed rule is being developed using an ip' creased public participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the hosting of a "strawman" rule text on the Internet for comments. The staff is carefully cop'sidering the comments received during these interactions, in. preparing the proposal. After Commission approval, a proposed rule will be published in the Federal Reaister for p6blic comment. We expect to hold additional public meetings during the comment period lat'er this year.

The issue of training and experience has received the most commen/

ts during the development of the proposed rule. Viewpoints on this issue have varied. The ommission has received comments both supporting reduction in requirements affecting rsonnelin the diagnostic area, including the American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing re 'uirements. The staff draft, while reducing the number of hours required for certain medical odalities, also specified a focus on radiation safety and proposed that personnel competene be verified through an examination.

This proposal appears to be in keeping with the directiori the Commission provided to the staff namely, to develop a risk-informed, and where appropriate, a more performance-based rule and it addressed an objection often expressed by some 4ommenters, that NRC requirements sometimes intruded into the practice of medicine. /

l The Commission will carefully consider the stg proposal in light of public comments such as l

yours when it is received. The results of that' consideration will then be available for additional public comment and discussion.

Sincerely, L. Joseph Callan Executive Director for Operations 1

DISTRIBUTION: G980362

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FROMt-DUE: 06/15/98 EDO CONTROL: G980362 DOC DT: 05/28/98 F

FINAL REPLY:

Rtp. Jim McCre

' Louisiana'..

l. TO s.

. Chairman Jackson

.FOR' SIGNATURE OF :

    • GRN CRC NO: 98-0512 Callan, EDO DESC8 ROUTING:

REVISION TO 10.CFR 35 -- TRAINING AND EXPERIENCE.

Callan WITH MEDICAL USE OF RADIOISOTOPES Thadani Thompson Norry Blaha Burns

~DATEt 06/02/98 ASSIGNED TO:

CONTACT:

NMSS Knapp

SPECIAL INSTRUCTIONS OR REMARKS:

j I-u-

OFFICE OF THE MECRETARY CORRESPONDENCE Cvi:1ROL TICKET PAPER NUMBER:

CRC-98-0512 LOGGING DATE: Jun 1 98 i

ACTION OFFICE:

EDO 1

AUTHOR:

JIM MCCRERY, REP AFFILIATION:

U.S.

HOUSE OF REPRESENTATIVES ADDRESSEE:

CHAIRMAN JACKSON LETTER DATE:

May 28 98 FILE CODE: IDR 14 PT 35

SUBJECT:

MEDICAL USE OF RADIO 1SOTOPES...PART 35 ACTION:

Signature of EDO DISTRIBUTION:

-CHAIRMAN, SECY/ RAS SPECIAL HANDLING: OCA TO ACK CONSTITUENT:

MARVIN KOGUTT NOTES:

DATE DUE:

Jun 15 98 SIGNATURE:

DATE SIGNED:

AFFILIATION:

l EDO -- G980362

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