ML20137J249
| ML20137J249 | |
| Person / Time | |
|---|---|
| Issue date: | 02/07/1997 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Diaz N, Dicus G, Shirley Ann Jackson, Rogers K, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20137J180 | List: |
| References | |
| COMSECY-96-057, COMSECY-96-57, DSI-7, FACA, SECY-96-057-C, SECY-96-57-C, NUDOCS 9704030253 | |
| Download: ML20137J249 (3) | |
Text
I
[ **%o
~
UNITED STATES 3*
[
NUCLEAR REGULATORY COMMISSION ;
RELEASED TO THE PDR
- l e I E
WASHIN GTON, D.C. 20555 e: sble Las
- l
\\% * * * * * #j date jDhials
- i
=
- .........,,,,,,,,,8 OFFICE OF THE commissioner february 7, 1997 i
MEMORANDUM T0:
Chairman Jackson Commissioner Rogers Commissioner Dicus 1
Commissioner Diaz FROM:
Edward McGaffigan, Jr.
h Commissioner
SUBJECT:
COMSECY-96-057 - DSI 7 - MATERIALS / MEDICAL OVERSIGHT i
Having reviewed this paper and stakeholder comments on it. I am generally supportive of the Commission's Preliminary Views but would also support pursuing Option 1 at a later date.
First. it strikes me that the key issue in this paper is the future of the NRC medical program, not the byproduct materials program as a whole.
Much of the discussion of non-medical byproduct materials 3rograms appears grafted on to the paper.
This paper is not the vehicle by w1ich the Commission is seriously dealing with matters such as the control of sealed sources and devices or with the Business Process Reengineering effort or other non-medical materials issues.
It is a good vehicle for decisions on the medical program.
I believe that we do need to continue the medical program (Option 2) and do so with a risk informed focus (0ption 3) and note that support for the Institute of Medicine (IOM) recommendations (Option 4) was very limited among stakeholder;.
I regret that the needed revisions to Part 35. which the staff has been prepared to undertake for several years and which stakeholders have been calling for, have had to be put on hold for so long as a result of the detour created,by the flawed IOM study.
It' is now critical to the credibility of the ' Commission that thd highest prioritybegiventorevisingPart35andassociatedregulatoryguidesassoon as possible.
I am concerned about encumbering that rulemaking process with The NRC staff has 3reviously identified possible revisions to Part 35 (most 2
recently in a note td tie Commission dated December 10, 1996 (attached)). This issue was identified as an action-item in the 5-year management plan for the medical use program approved by the Commission in September 1993.
'I do not see a need to revise the Commission's 1979 Medical Policy Statement at this time.
In particular. I see no need to insert the word "high" before the word " risk" as proposed by ACMUI.
Any revisions to the policy statement must be carefully considered and ultimately reflect a revised Part 35 i
and regulatory program.
{
l 9704030253 970401 PDR NRCSA I 7
I
\\
2 too many requirements, especially given the limited resources in the medical use regulatory program.
For example. I support using a risk-informed approach to determine which activities are low-risk, and then pursuing a rule (or rules) that would make appropriate use of performance measures or goals, but also would use prescriptive requirements revised to. reflect risk insights, where appropriate. Given the time and resource requirements.of full-blown risk-informed, performance-based rules and ACMUI's comments that DSI-12 is very difficult to understand, a mixed approach of performance-based and prescriptive rules, both risk-informed, would appear to make the most sense.
Similarly I am concerned about using an enhanced participatory rulemaking process to identify low-risk activities and to revise'Part 35 because of the time and resource implications of such a process. One way to enhance aarticipation without going to " enhanced p&rticipatory rulemaking" would be to
>e quite specific in any Advanced Notice of Proposed Rulemaking about changes being contemplated, up to including tentative draft rule language.
Alternatively, the Part 35 revision might be broken down into those elements likely to be non-controversial and those likely to spark controversy with the two tracks proceeding at different paces and with different levels of stakeholder interaction.
I agree with Commissioner Dicus that a rulemaking plan (for one or more rules) for Part 35 should be prepared as soon as possible.
I would propose that the staff be required to submit the plan for Commission ap)roval no later than July 31st of this year with a view toward completing tie revision of Part 35 no later than June 30. 1999.
The staff should plan to revise the associated regulatory guides along the same time line; however, this effort should not delay the rulemaking.
The staff should make additional resources available to
-the extent necessary to complete this rulemaking and guidance development on this schedule.
I would urge the staff to consider the specific recommendations of Commissioner Dicus in her vote on DSI 7. which appear to be in line with staff intentions, in developing the rulemaking plan.
I would propose to involve the Agreement States in drafting the plan to the extent time and resources permit, but have concerns about the delays inherent in setting up 3 formal working group for this purpose.
Finally. I am convinced that there would be benefits to broadening NRC's materials program to oversight of other sources of ionizing radiation (Option 1). But I believe that a prerequisite to pursuing this option is to get our house in order on the current medical program (and the byproduct materials program more broadly).
Thus. I would propose that the Commission make clear i
that it is willing, indeed eager, in principle to take on a broader function and work with stakeholders and other agencies over the next two years to develop an appropriate legislative package that might be considered in the
3 106th Congress after Part 35 revisions are complete.
Pursuit of this long-term goal should not divert resources from achieving the short-term Part 35 revisions, however.
Attachment:
As stated cc:
i 1