ML20236E784

Responds to ,Expressing Reservation Re Possible Changes in NRC 10CFR35 Regulations on Medical Use of Byproduct Matl

ML20236E784
Person / Time
Issue date:	05/19/1998
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Grassley C SENATE
Shared Package
ML20236E787	List: ML20236E784 ML20236E789 ML20236E792
References
FRN-62FR40975, RULE-PR-35 NUDOCS 9806010223
Download: ML20236E784 (8)

Text

May 19, 1998

)

Tha Honorablo Chirlfs E. Gr:ssley United Stat:s Senits

's Washington, DC 20510-1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, in which you expressed reservations about l

possible changes in 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 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 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 fucus on 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, 1

namely, to develop a risk-informed, and where appropriate, a more performance-based rule.

The proposed rule also addresses an obja etion 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.

incerely, WW, W S.

gg L. Joseph Callan

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The Honorable Ch rl:s E. Gressley United Stat:s Senits Washington, DC 20510-1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, in which you expressed reservations about possible changes in 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 materia The NRC staff is scheduled to provide its recommendation on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule is bei developed using an increased public participation process that included public workshops; eetings with various medical professional societies (including the American College of Radiol y); and the posting of a "strawman" rule text on the Internet for comments. The staff is car fully considering the comments received during these interactions, in preparing the propo al. After Commission approval, a proposed rule will be published in the FederalRegister f r public comment. We expect to hold additional public meetings during the comment period ter this year.

The issue of training and experience has eceived the most comments during the development of the proposed rule. Viewpoints on thi issue have varied. The Commission has received comments both supporting reduction ' requirements affecting personnel in the diagnostic area, including those from the American llege of Cardiology and the American Society of Nuclear Cardiologists, and favoring keepi the presently existing requirements. The staff draft, while reducing the number of hours r ired for certain medical modalities, also specified a focus on

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

This proposal appears to be i keeping with the direction the Commission provided to the staff, namely, to develop a risk-inf rmed, and where appropriate, a more performance-based rule.

The proposed rule also ad esses an objection often expressed by some commenters that NRC

' requirements sometimes

• truded into the practice of medicine.

The Commission will efully consider the staff proposal in light of public comments such as yours when it is recei The results of that consideration will then be available for additional public comment an iscussion.

Sincerely, Shirley Ann Jackson 1

DISTRIBUTION: G980288 SECY-CRC-98-0404 NRC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF l

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ETha Honorabla Charl s E. Grassisy Unit:d Statss S2 nata j

Washington, DC 20510 1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, in which you expressed reservations out

_ possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 3 regulations on medical use of byproduct material. In particular, you were concerned out the training and experience requirements that would be applicable to personnel inv ed in diagnostic and therapeutic uses of unsealed byproduct material.

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

The issue of training and experience has received the most omments during the development of the proposed rule. Viewpoints on this issue have varie The Commission has received comments both supporting reduction in requirements aff cting personnelin the diagnostic area, including those from the American College of Cardiot and the American Society of Nuclear Cardiologists, and favoring keeping the presently exi ing requirements. The staff draft, while reducing the number of hours required for certain dical modalities, also specified a focus on radiation safety and proposed that personnel co tency be verified through an examination.

This proposal appears to be in keeping with the irection the Commission provided to the staff namely, to develop a risk-informed, and where ppropriate, a more performance-based rule and it addressed an objection often expressed by ome commenters, that NRC requirements sometimes intruded into the practice of me cine.

The Commission will carefully consider t staff proposalin light of public comments such as yours when it is received. The results that consideration will then be available for additional public comment and discussion.

Sincerely, Shirley Ann Jackson o

DISTRIBUTION: G980288 SECY-CRC-98-0404 NRC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR:_X_ Yes _, No DOCUMENT NAME:A:GRASSLEY *SEE REVIOUS CONCURRENCE op/pnoorso/anay 7, t one OFC RGB*

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Ths Honorable Charl s E. Grassley United States Senate Washington, DC 20510-1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, where you expressed reservations about possible changes in 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 in'volved in diagnostic and therapeutic uses of unsealed byproduct material.

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The NRC staff is scheduled to provide its recommendations on proposed r'evisions 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 v$rious medical professional societies (including the American College of Radiologd; and the posting of a "strawman" rule text on the Internet for comments. The staff is csrefully considering the e

comments received during these interactions, in preparing thehroposal. After Commission approval, a proposed rule will be published in the Federal scister for public comment. We expect to hold additional public meetings during the com ent 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 reductio 1 in requirem'ents affecting personnelin the diagnnstic area, including the American College of Cardiology 4nd the American Society of Nuclear Cardiologists, and favoring keeping the prpsently existing requirements. The suff drs ft, while reducing the number of hours required fpf certain medical modalities, also spec'ied a focus on radiation safety ard proposed that pe,rsonnel competency be verified through an examination.

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

The Commission will care Ily 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.

Sincerely, L. Joseph Callan Executive Director for Operations DISTRI. UTION: G980288 f

SECYfCRC-98-0404 NRC File Center NMSS R/F EDO r/f HTho'mpson LCallan PTressler CPoland NMSS Dir. Off, r/f IMNS RF PDR: X Yes No DOCUMENT NAME:A:GRASSLEY *SEE PREVIOUS CONCURRENCE CP/ PROOFED /MAY 7.1998 OFC RGB*

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l-The Honortble Chirles E. Grassisy United StIt:s Ssnita

. Washington, DC 20510-1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory 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 provide its recommendations on proposed revisions to Part 75 to the Commission in June 1998. The proposed rule is being develcped 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 I

approval, a proposed rule will be published in the Federal Register for public comment. We i

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 -

l 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, j

including the American College of Cardiology and the American Society of Nuclear i

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 i

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.

Sincerely, L. Joseph Callan Executive Director for Operations DISTRIBUTION: G980288 SECY-CRC-98-0404 NRC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland -

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May 19, 1998 The Honorable Charles E. Grassley United States Senate Washington, DC 20510-1501

Dear Senator Grassley:

I am responding to your letter dated April 21,1998, in which you expressed reservations about possible changes in the U.S. Nuclear Regulatory 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 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 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.

The proposed rule also addresses an objection often expressed by some commenters that NRC l

requirements sometimes intruded into the practice of medicine.

I The Commission will carefully consider the staff proposalin light of public comments such as l

yours when it is received. The results of that consideration will then be available for additional I

public comment and discussion.

I Sincerely, 1

f L. J ph Callan Exe tive Director for Operations i

y ACTION

~

EDO Principal Correspondence Control i

FROM:

DUE: 05/14/98 EDO CONTROL: G980288 DOC DT: 04/21/98 FINAL REPLY:

Senator Charles E. Grassley TO:

\\

Chairman Jackson FOR SIGNATURE OF :

• • GRN CRC NO: 98-0404

{Dl-len7-EDO bIa mM 6)h DESC:

ROUTING:

REVISION TO 10 'CFR PART 35 -- TRAINING AND Callan EXPERIENCE WITH MEDICAL USE OF RADIOISOTOPES Thadani (Dr. Richard L. Kundel)

Thompson Norry Blaha Burns DATE: 05/05/98 ASSIGNED TO:

CONTACT:

NMSS Paperiello

@PECIAL INSTRUCTIONS OR REMARKS:

RECEIVED DATE:

MN ASSKEEDTO:

IMNS DUE DATE:

6/8[9P tir;s5 ou d.tk.

5/t<j W

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OFFICE OF THE SECRETARY

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CORRESPONDENCE CONTROL TICKET PAPER NUMBER:

CRC-98-0404 LOGGING DATE: May 1 98

-ACTION OFFICE:

EDO AUTHOR:

SEN. CHARLES GRASSLEY AFFILIATION:

U.S.

SENATE

- ADDRESSEE:

CHAIRMAN JACKSON LETTER DATE:

Apr 21 98 FILE CODE:

SUBJECT:

NRC'S PROPOSED REGULATIONS TO BE MORE RISK-BASED AND PERFORMANCE - ORIENTED ACTION:

Signature of W h DISTRIBUTION:

CHAIRMAN SPECIAL HANDLING: OCA TO ACK

'CONSTi!UENT:

DR RICHARD KUNDEL NOTES:

DATE DUE:

May 98 SIGNATURE:

DATE SIGNED:

AFFILIATION:

EDO -- G980288