ML20236T859
| ML20236T859 | |
| Person / Time | |
|---|---|
| Issue date: | 07/14/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Allen T HOUSE OF REP. |
| References | |
| NUDOCS 9807290085 | |
| Download: ML20236T859 (2) | |
Text
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Tha Honor:ble Tom All:n Unit:d Stat:s House of R:prcstntativas Washington, DC 20515-1901
Dear Congressman Allen:
I am responding to your letter dated June 21,1998, regarding proposed revisions to the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned 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 provided its recommendations on proposed revisions to Part 35 to the l
Commission on May 29,1998. The proposed rule was developed using an increased public l
participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a l
"strawman" rule text on the Internet for comments. The Commission is currently reviewing the staff's proposed revision. After Commission approval, a proposed rule will be published in the Federal flegister for public comment. During the public comment period, public meetings will be held in San Francisco, California on August 19-20,1998; in Kansas City, IWssouri on September 16-17,1998; and in Washington, DC on September 23-24,1998. Additional details on the public meetings will be published in the Federal Reaister in July.
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 co. wents both supporting reduction in requirements affecting personnelin the diagnostic area, insuding those from the American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring continuance of the 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 rick-informed, and where appropriate, a more performance-based rule and l
it addressed an objection often expressed by some commenters, that NRC requirements somethes intruded into the practice of medicine.
The Commission is carefully considering the staff proposalin light of public comments. The results of that consideration will then be available for additional public comment and discussion.
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Sincerely, I
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av Shirley Ann Jackson DISTRIBUTION: G980406 94tC File Center NMSS R/F EDO r/f SECY-CRC-98-0594 HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR:_X_, Yes ___ No DOCUMENT NAME:A:G980406 *SEE PREVIOUS CONCURRENCE OP/PROOPED/ JUNE 30,19tMB a OFFICE RGB l
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- g HThompson PNorry CHAIRMAN JBlaha MKnapp, NMSS DFlack, NMSS The Honorable Tom Allen United States House of Representatives 40 Washington, D.C. 20515-1901 ED0 r/f
Dear Congressman Allen:
I am responding to your letter dated June 21,1998, regarding proposed revisions to the U.S. Nuclear Regulatory Comm:ssion's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particuiar, you were concerned about the training and experience requirements that would be applicable to personnelinvolved in diagnostic and therapeutic uses of unsealed byproduct material.
The NRC staff provided its recommendations on proposed revisions to Part 35 to the Commission on May 29,1998. The proposed rule was 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 Commission is currently reviewing the l
staff's proposed revision. After Commission approval, a proposed rule will be published in the Federal Benister_for public comment. During the pubN comment period, public meetings : vill be held in San Franciscc, California on August 19-20,1998; in Kansas City, Missouri on September 16-17,1998; and in Washington, DC on September 23-24,1998. Additional details on the public meetings will be published in the Federal Reaistr kly.
5 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 continuance of the existing requirements. The staff draft, while reducing the number o' 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 I
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 is carefully considering the staff proposalin light of public comments. The results of that consideration will then be available for additional public comment and discussion.
Sincerely,
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1Blastjington, DC 20515-1901 June 21, !998 Chairman Shirley Ann Jackson l.
Chairman U.S. Nuclear Regulatory Commission L
One White Flint Nonh 11555 Rockville Pike Rockville, Maryland 20852 2738
Dear Chairman Jackson:
I understand that the Nuclear Regulatory Commission (NRC) is revising its regulations to be more nsk-based and performance oriented. I am concerned about revision of 10 CFR Part 35, f
l which applies to the medical use of radioisotopes. While ! support the direction in which the Commission is moving, some of my constituents in the radiology community are concerned about the early drafts of the revisions of pan 35 relating to the training and experience necessary l
to become licensed to use radioisotopes diagnostically.
The ricord of safe usage of radioisotopes compiled over many years under NRC Licensure is a very good one. Like my constituents, I am concerned that, with the severe reductions in required training and experience under 10 CFR Pan 35.100,200 and 300 that are being considered, this record of safe usage will end and more incidents that jeopardize pati carc will occur. I urge you, as the Chair of the Commission, to considcr carefully the l
implications of the proposal that the NRC staffis preparing for your approval. We believe that patient care would best be served if the training and experience requirements were revis recommended in cornnsnts submitted to the NRC staff by the American College of Radiology.
It would be unfortunate to move too far in a direction that jeopardizes patients in the name of a l
more forward looking regulatory process.
l Thank you for your consideration of this matter.
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Sincerely, Tom Allen Member of Congress THNbb -
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i The Honor:bb Tom Allen United Stit s Housa of R pr:s:;ntitivas Washington, DC 20515-1901 l
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Dear Congressman Allen:
I am responding to your letter dated June 21,1998, regarding proposed revisions to the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned about the training and experience l
requirements that would be applicable to personnel involved in diagnostic and therapeutic uses 1
of unsealed byproduct material.
The NRC staff provided its recommendations on proposed revisions to Part 35 to the Commission on May 29,1998. The proposed rule was developed using an increased public participation process that included public workshops; meetings with variousjn'edical professional societies (including the American College of Radiology); and he posting of a "strawman" rule text on the Internet for comments.
staff's proposed revision. After Commission approval, a proposed ru will be published in the Federal Reaister for public comment. During the public comment period, public meetings will be held in San Francisco, California on August 19-20,1998; in K sas City, Missouri on September 16-17,1998; cnd in Washington, DC on Septembe 3-24,1998. Additional details on the public meetings will be published in the Federal Reais r in July.
i The issue of training and experience has received the m t comments during the development of the proposed rule. Viewpoints on this issue have var' d. The Commission has received comments both supporting reduction in requirements ffecting personnelin the diagnostic area, including the American College of Cardiology and t American Society of Nuclear Cardiologists, and favoring continuance of the exi ing requirements. The staff draft, while reducing the number of hours required for certai medical modalities, also specified a focus on radiation safety and proposed that personnel competency be verified through an examination.
This proposal appears to oe in keeping with the direction the Commission provided to the staff ne nely, 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.
1 The Commission is carefully considering the staff proposalin light of public comments. The results of that consideration will then be available for additional public comment and discussion.
Sincerely, l
/
Shirley Ann Jackson DISTRIBUTION: G980406 NRC File Center NMSS R/F EDO r/f CR-98-0594 HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR:_X._ Yes __ No E
DOCUMENT NAME:A:G980400 SEE PREVIOUS CONCURRENCE CP/ PROOFED / JUNE,1998 OFFICE RGB l
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