ML20249B318
| ML20249B318 | |
| Person / Time | |
|---|---|
| Issue date: | 06/16/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Burr R HOUSE OF REP. |
| Shared Package | |
| ML20249B319 | List: |
| References | |
| NUDOCS 9806220313 | |
| Download: ML20249B318 (4) | |
Text
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The Honor:bla Rich;rd Burr United States House of Representatives l
Washington, DC 20515-3305
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Dear Congressman Burr:
I am responding to your letter dated April 10,1998, in w h you expressed concerns about possible changes in the U.S. Nuclear Regulatory Com ission's (NRC's) 10 CFR Part 35, l
" Medical Use of Byproduct Material." In particular, y posed specific questions:"Has the NRC conducted any risk assessment to determine whic procedures fall into low risk versus high risk categories prior to developing and publishing a oposed rule?" and " Why hasn't the Commission undertaken such activity prior to blishing a proposed ruleT The Commission did not perform a formal isk assessment as part of the 10 CFR Part 35 rulemaking effort. The Commission is rrently in the rulemaking process to restructure i
Part 35 into a risk-informed, more pe rmance-based regulation. In so doing, t,he Commission I
I has drawn on the extensive assess ents that have been conducted over the last few years, iricluding a 1093 internal senior nagement review; the external review conducted by the National Academy of Sciences nstitute of Medicine; and the C mmission Strategic Assessment and Rebaselining process.
the basis of these assessments the Commission directed the staff to proceed with rulem ing on an expedited basis, and to provide increased opportunities for public input in the dev opment process.
The program for revis' g Part 35 and the associated guidance has provided more opportunity for input from potentiall affected parties (the medical community and the public) through formal Federal Register n tices; facilitated public workshops; public meetings of the working and I
steerin0 groups; eetings with medical professional societies and boards; and the public release via the ternet of draft regulatory language as a "strawman" for public comment. Over 200 comment tiers have been received to date. The draft proposed rule, which the Commission ill be reviewing in June, has benefitted from all of these interactions, and reflects numerous anges from the existing requirements. However, given the extensive background already av ilable, and the enhanced public participation process used to develop the rule, the l
Commis 'on concluded that it would be better to move forward with proposals rather than conduct separate, additional risk assessment.
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l trust this responds to your concerns t
NRC MF C'mnrm ec-Shirley Ann Jackson DISTRIBUTION: G980313 980128 7 SECY-CRC-98-0438 r NRC File Centerz NMSS R/F EDO r/f HThompson LCallan PTressler CPolan i NMSS Dir. Off. r/f IMNS RF
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The Honorabb Rich rd Burr United States House of Representatives Washington, DC 20515-3305
Dear Congressman Burr:
I am responding to your letter dated April 10,1998, in which you expressed concems about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35,
" Medical Use of Byproduct Material." In particular, you posed specific questions: "Has the NRC conducted any risk assessment to determine which procedures fall into low ris categories prior to developing and publishing a proposed rule?" and " Why hasn't the Commission undertaken such activity prior to publishing a proposed rule?"
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The Commission did not perform a formal risk assessment as part of the 10 CFR P, art 35 rulemaking effort. The Commission is currently in the rulemaking process to restructure Part 35 into a risk-informed, more performance-based regulation. In so doing, the Commission has drawr' on the extensive assessments that have been conducted over the last few years, including a 1993 internal senior management review; the external review c'onducted by the National Academy of Sciences, institute of Medicine; and the Commission Strategic
' Assessment and Rebaselining process. On the basis of these assessments the Commission directed the staff to proceed with rulemaking on an expedited basis, and to provide increased opportunities for public input in the development process
/
,.e The program for revising Part 35 and the associated guidance has provided more opportunity for input from potentially affected parties (the medi, cal community and the public) through formal Federal Reaister notices; facilitated public workshops; public meetings of the working and steering groups; meetings with medical professional societies and boards; and the public release via the internet of draft regulatory language as a "strawman" for public comment. Over 200 comment letters have been received to date. The dra't p,roposed rule, which the Commission will be reviewing in June, has benefitted from all of these interactions, and reflects numerous changes from the existing' requirements. Howe'ver, given the extensive background already available, and the enhanced public participatiori process used to develop the rule, the Commission concluded that it would be better to move forward with proposals rather than conduct a separate, additional risk assessmerit.'
7 I trust this responds to your concerns /
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Sincerely,
,/
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DISTRIBUTION: G980313
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I AThadani June 16, 1998 HThompson FNorry-p riello, NM'SS DFlack, NMSS KCyr, 0GC G980313 EDO r/f The Honorable Richard Burr United States House of Representatives Washington, D.C. 20515-3305
Dear Congressman Burr:
I em responding to your letter dated April 10,1998, in which you expressed concems about possible changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35,
, " Medical Use of Byproduct Material." In particular, you posed specific questions: "Has the NRC
" conducted any risk assessment to determine which procedures fall into low risk versus high risk categories prior to developing and publishing a proposed rule?" and
- Why hasn't the Commission undertaken such activity prior to publishing a proposed rule?"
As a result of NRC's Strategic Assessment and Rebaselining efforts, the staff formed the Nuclear Byproduct Material Risk Review Group to develop a risk-informed, graded approach to regulating many material uses, including medical. The group's final recommendations are expected in the fall of 1998 and will be considered by the staff during the Part 35 rulemaking process. The Commission is currently in the rulemaking process to restructure Part 35 into a risk-informed, more performance-based regulation, in so doing, the Commission has drawn on the extensive assessments that have been conducted over the last few years, including a 1993 intamal senior management review; the extemal review conducted by the National Academy of Sciences, institute of Medicine; and the Commission's Strategic Assessment and Rebaselining process. On the basis of these assessments, the Commission directed the staff to proceed with rulemaking on an expedited basis and to provide increased opportunities for public input in the development process.
The program for revising Part 35 and the associated guidance has provided more opportunity-for input from potentially affected parties (the medical community and the public) through formal Federal Register notices; facilitated public workshops; public meetings of the working and cteering groups; meetings with medical professional societies and boards; and the public release via the internet of draft regulatory languap as a "strawman" for public comment. Over 200 comment letters have been received to date. The staff is reviewing information from all i
sources to become as informed on the risks of diagnostic and therapeutic procedures as -
possible. The draft proposed rule, which the Commission will be reviewing in June, has j
benefitted from these interactions' and reflects numerous changes from the existing require- -
1 montse Such changes include a regulatory burden reduction for diagnostic uses including -
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c requiring fewer license amendments and less prescriptive quality control requirements.' After the
. Commission approves the proposed rule for comment, the staff will conduct additional public -
- workshops to solicit input prior to finalizing the rule.
I trust this responds to your concems. If I can be of further assistance, phase do not hesitate to contact me.
l Sincerely, Shirley Ann Jackson
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