ML20247B963
| ML20247B963 | |
| Person / Time | |
|---|---|
| Issue date: | 05/06/1998 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Chapman J AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20247B968 | List: |
| References | |
| NUDOCS 9805110176 | |
| Download: ML20247B963 (5) | |
Text
1 Dr. Jam:s H. Chapman May 6, 1998 1100 Rockhurst Road Kansas City, MO 64110-2561 a
Dear Dr. Chapman:
I am responding to your letter dated March 31,1998, where you expressed reservations about possible changes in the U.S. Nucicar 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 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 usir g 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 Reaister fcr 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 Comrnission has received comments both supporting reduction in requirements affecting personnel in the diagnostic area, including the Ame.rican 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 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.
2 Sincerely,l signed by)
(Origina Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards qb 7j/
cc: Senator Ashcroft n
Senator C.S. Bond 2O DISTRIBUTION: G980265 SECY-CRC-98-0325 dC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF Release to the POR:l_ Yes _._ No DOCUMENT NAME:Achapman 5/1/9611 *SEE PREVIOUS CONCURRENCE To r:c c copy of this doc, indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE RGB" RGB*
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Dr. Jim:s H.- Ch pman 1100 Rockhurst Rord Kins:s City, MO 64110-2561
Dear Dr. Chapman:
J l am responding to your letter dated March 31,1999, where you expres sed 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 wer a concerned about the training and experience requirements that would be applicable to pe,sonnel involved in diagnostic uses of unsealed byproduct material.
/
The NRC staff is scheduled to provide its recommendations on proposed revisiori to Part 35 to the Commission in June 1998. The proposed rule is being developed using,an increased public i
participation process that included public workshops; meetings with various ' medical professional:,ocieties (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 I
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 cobments 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 Am'erican 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 venfied through ari 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 i
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, Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards DISTRIBUTION: G980265 SECY-CRC-98-0325 NRC File Cenwr NMSS R/F EDO r/f HThompson /
LCallan PTressler CPoland NMSS Cir. Off. r/f IMNS RF Release to the PDR: X Yes __ No DOCUMENT NAME:A: chapman 5/1/9811 *SEE PREVIOUS CONCURRENCE op/pssoomo/pany 4,1 see DOCUMENT hlAME:'H: CHAPMAN To receive a copy of this docuenent indicate in the bos: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE RGB*
IMNS*
l EDITOR
- l NMSS:DIR l
l NAME DFlack:ll DCool EKraus CPaperiello DATE 5/4/8 5/4/98 4/15/98 5/ /98 OFFICIAL RECORD COPY
I Dr. Jimts H. Chipmin 1100 Rockhurst Rold Kansas City, MO 64110-2561
=
t
Dear Dr. Chapman:
I am responding to your letter dated March 31,1998, 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 uses of unsealed byproduct material.
j
/
The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to j
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 st$ff 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 meetmgs during the comment period later this year.
l
?
The issue of training and experience has received the most comments during the development i
of the proposed rule. Viewpoints on this issue ha've varied. The Commission has received -
comments both supporting reduction in requirerfients affecting personnel in the diagnostic area, including the American College of Cardiologyjand the American Society of Nuclear i
Cardiologists, and favoring keeping the presently existing requirements. The stsff draft, while reducing the number of hours required for,certain medical modalities, also specified a focus on radiation safe +y and proposed that personnel competency be verified through an examination.
This proposal appears to be in keeping v'vith the direction the Cornmission 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 coi1 sider 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, Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards DISTRIBUTION: G980265 SECY-CRC-98-0325 NRC File Center NMSS R/F EDO r/f
- HThompson /
LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF Release to te PDR: X Yes _, No i
l
. DOCUMENT NAME:A:ct3,, nan 5/1/9811 To roc a copy of this doc, indicate in the box: "C"/ Copy without attachrnent/encfosure "E" = Copy with attachment / enclosure "N
' OFFICE RGB '
RGB EDITOR NMSS.DIR lNAME Delack/fl 4 W.M JPiccorj/
DCgdf A /
EKraus CPaperiello lDATE 5/ 4/-/98 5/ / /98 5/8//98 4/15/98 5/ /98
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ACTION l
I EDO Principal Correspondence Control FROM DUE: 05/11/98 EDO CONTROL: G980265
~
DOC DT: 04/18/98 FINAL REPLY:
Sanator John Ashcroft Stnntor Christopher S. Bond TO:
OCA FOR SIGNATURE OF :
ROUTING:
REVISION TO 10 CFR PART 35 -- TRAINING AND Callan EXPERIENCE WITH MEDICAL USE OF RADIOISOTOPES Thadani (Jnmes H. Chapman)
Thompson Norry Blaha Burns DATE: 04/27/98 ASSIGNED TO:
CONTACT:
jKMSS Paperiello 1
SPECIAL INSTRUCTIONS OR REMARKS:
I Raf. G980205, G980206, G980207, G980208, G980213, G980214, and G980235.
2G3
OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET PAPER NUMBER:
CRC-98-0379 LOGGING DATE: Apr 24 98 ACTION OFFICE:
EDO AUTHOR:
J. ASHCROFT & C.
BOND AFFILIATION:
U.S.
SENATE ADDRESSEE:
CONGRESSIONAL LIAISON LETTER DATE:
Apr 18 98 FILE CODE:
SUBJECT:
CONSTITUENT CONCERNS REGARDING THE NRC'S REVISING OF ITS REGULATIONS (PART 35)
I ACTION:
Signature of EDO DISTRIBUTION:
CHAIRMAN SPECIAL HANDLING:
CONSTITUENT:
NOTES:
OCA TO ACK.
Il DATE DUE:
May // 98 SIGNATURE:
DATE SIGNED:
AFFILIATION:
EDO -- G980265