ML20249C793

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Responds to Re Proposed Rev to NRC 10CFR35 Regulations on Medical Use of Byproduct Matl.Recommendations Provided to Commission in June 1998
ML20249C793
Person / Time
Issue date: 06/23/1998
From: Shirley Ann Jackson, The Chairman
NRC COMMISSION (OCM)
To: Nussle J
HOUSE OF REP.
Shared Package
ML20249C794 List:
References
NUDOCS 9807010207
Download: ML20249C793 (6)


Text

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Norry June 23, 1998 Blaha Knapp, NMSS CHAIRMAN Haney, NMSS Poland, NMSS EDO R/F G980367 The Honorable Jim Nussle United States House of Representatives Washington, D.C. 20515-1502

Dear Representative Nussle:

I am responding to your letter dated May 19,1998, regarding proposed revisions to the U.S.

Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byprocLct material.

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The NRC staff has provided its recommendations on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule was developed using an increased public j

participation process including public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a "strawman" rule i

text on the Internet for comments. The staff has carefully considered 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 and forwarded to your office for your awareness. 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 j

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 comments favoring continuance of the existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also specified a I

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 bg g 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 proposalin light of public comments. The results of that consideration will then be available for additional public comment and discussion.

l Sincerely,

~

Shirley Ann Jackson l

9807010207 980623 OREh DEN PDR E_______________

i The Honor:ble Jim Nus:le United St:t s House of R:pr:sent tiv;s j'.

Washington, DC 20515-1502 i

Dear R resentative Nussle:

I am respon 'ng to your letter dated May 19,1998, regarding proposed revisions to the U.S.

Nuclear Regu Atory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of i

byproduct materbl.

l The NRC staff is sc eduled to provide its recommendations on proposed revisions to Part 35 to the Commission in J ie 1998. The proposed rule was developed using an increased public participation process idqluding public workshops; meetings with various medical professional societies (including the A'merican College of Radiology); and the posting of a "strawman" rule text on the Internet for co ents. The staft ieas carefully considered the comments received during these interactions, in reparing the proposal. After Commission approval, a proposed rule will be published in the Fhderal Reaister for public comment and forwarded to your office i

for your awareness. We expe ' to hold additional public meetings during the comment period later this year.

The issue of training and experienc has received the most comments during the development of the proposed rule. Viewpoints on is issue have varied. The Commission has received e,

comments both supporting reduction i requirements affecting personnel in the diagnostic area, including those from the American Colle e of Cardiology and the American Society of Nuclear Cardiologists, and comments favoring corynuance of the existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also specified a s

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-i formed, and where appropriate, a more l

performance-based rule and it addressed an obj l

that NRC requirements sometimes intruded into t,ction often expressed by some comm e practice of medicine.

The Commission will carefully consider the staff pro osalin light of public comments. The l

results of that consideration will then be available for dditional public comment and discussion.

Sincerely, Shirley Ann Jackson I

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OFFICIAL RECORD COPY

3 Th3 Honortble Jim Nussis United Stat:s House of R:pr:s:ntativas Washington, DC 20515-1502

Dear Representative Nussle:

I am responding to your letter dated May 19,1998, regarding proposed revisions to the U.S.

Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct mat 1.

The NRC staffis s eduled to provide its recommendations on proposed revisions to Part 35 to the Commission in une 1998. The proposed rule was developed using an increased public participation process i'ncluding 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 has carefully considered 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 and forwarded to your office for your awareness. We expect to' old additional public meetings during the comment period later -

this year.

The issue of training and experience as received the most comments during the development of the proposed rule. Viewpoints on t 's issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnelin the diagnostic area, including those from the American Collegg of Cardiology and the American Society of Nuclear Cardiologists, and comments favoring continuance of the existing requirements. The staff draft, while reducing the number of hours required' or certain medical modalities, also specified a focus on radiation safety and proposed that sonnel 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-inf6(med, and where appropriate, a more performance-based rule and it addressed an oblection often expressed by some commenters, that NRC requirements sometimes intruded into the actice of medicine.

. The Commission will carefully consider the staff propos in light of public comments. The results of that consideration will then be available for addfonal public comment and discussion.

I Sincerely, Shirley Ann Jackson DISTRIBUTION: G980367 I

NRC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF

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J 1 Th3 Honor:bla ' im Nussle J

Unit:d St t:s House of R;pr:sentativss

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Washington, DC 20515-1502

Dear Representative Nussle:

I am responding to your letter dated May 19,1998, regarding proposed revi ns to the U.S.

Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on edical use of byproduct mater,al..

The NRC staff is scheduled to provide its recommendations on pro sed revisions to Part 35 to the Commission in June 1998. The proposed rule is being develo d using an increased public participation process that included public workshops; meetings ith various medical professional societies (including the American College of Radiology); and t e posting of a "ctrawman" rule text on the Internet for comments. The staff has carefully c sidered the comments received

- during these interactions, in preparing the proposal. After ommission approval, a proposed

' rule will be published in the Federal Register for public c mment and forwarded to your office for your information. We expect to hold additional public eetings during the comment period later this year.

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

. This proposal appears to be in keepi g 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 e ressed by some commenters, that NRC requirements

- sometimes intruded into the pra ice of medicine.

- The Commission will careful consider the staff proposal in light of public comments when it is received. The results of th t consideration will then be available for additional public comment and discussion.

Sincerely, i-Shirley Ann Jackson DISTRIBUTI

G980367 NRC File Center NMSS R/F EDO r/f l

. HThompson LCallan PTressler CPoland '

NMSS Dir. Off, r/f IMNS RF PDR:

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6/ /98 6/ /98 OFFMMAL5850000D OOPY 4

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OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET PAPER NUMBER:

CRC-98-0527 LOGGING DATE: Jun 4 98 ACTION OFFICE:

EDO AUTHOR:

JIM NUSSLE, REP AFFILIATION:

U.S. HOUSE OF REPRESENTATIVES ADDRESSEE:

CHAIRMAN JACKSON LETTER DATE:

May 19 98 FILE CODE: IDR 14 PT 35

SUBJECT:

PROPOSED CHANGES TO PART 35... MEDICAL USE OF RADIOISOTOPES ACTION:

Signature of Chairman DISTRIBUTION:

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

NOTES:

CHAIRMAN'S CORRESPONDENCE DATE DUE:

Jun 18 98

. SIGNATURE:

DATE SIGNED:

AFFILIATION:

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