ML20137J229
| ML20137J229 | |
| Person / Time | |
|---|---|
| Issue date: | 01/27/1997 |
| From: | Dicus G NRC COMMISSION (OCM) |
| To: | Diaz N, Shirley Ann Jackson, Mcgaffigan E, Rogers K, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20137J180 | List: |
| References | |
| COMSECY-96-057, COMSECY-96-57, DSI-7, SECY-96-057-C, SECY-96-57-C, NUDOCS 9704030249 | |
| Download: ML20137J229 (2) | |
Text
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'o UNITED STATES RELEASED TO THE PDR S
NUCLEAR REGULATORY COMMISSION
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January 27, 1997 4
l MEMORANDUM TO:
Chairman Jackson Commissioner Rogers i
Commissioner Diaz i
Commissioner McGaffigan FROM:
Greta Joy Dicus
SUBJECT:
COMSECY-96-057 - MATERIALS / MEDICAL i
OVERSIGHT - DSI-7 i
1 Section 3.5 of the Phase ll " Stakeholder Interaction Report" discusses the i
public comments and Commission Preliminary Views on the subject of i
j NRC oversight of nuclear materials, and in particular, of the medical use of nuclear materials. I have reviewed the information provided and have concluded that the Commission should continue to support the Commission's preliminary views which were a combination of Options 2 l
(Continue the Ongoing Program with improvements) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities).
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I also believe that the Commission's final views should express support for revising Part 35 and for revising the Commission's 1979 Medical i
Policy Statement,if necessary. The Commission's final views should i
direct the staff to prepare a plan for Commission approval that will restructure 10 CFR Part 35 with the objective of making it a risk-informed, performance based regulation. To meet this objective, staff should consider the following:
s i
1.
Focusing Part 35 on those procedures having the highest risk of Injury to patients, e.g., therapeutic procedures and selected diagnostic procedures such as whole body *l tests.
2.
For other diagnostic procedures, staff should consider alternative regulatory schemes that retain regulatory oversight but in a cost effective manner consistent with the lower overall risk of these procedures.
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l 3.
To enhance NRC's regulations to protect patient safety, Part 35 l
should enlarge its efforts to prevent misadministrations. To this end, reporting requirements should be maintained but should focus on the causes of events and not on the events themselves.
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Nomenclature should be changed from misadministration reporting l
to medical event reporting.
Part 35 should be redesigned so that it is flexible enough to j
l 4.
j continue to provide the necessary regulatory requirements when new treatment modalities are developed.
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5.
The Quality Management Rule should be re-evaluated and revised to focus on those requirements that are essential to protect patient j
safety, e.g., confirming patient idendty, requiring written prescriptions and varifying dose. To the maximum extent possible, the requirements should be revised to be performance Lued.
Given the time elapsed since the issuance of the National Academy of Science, institute of Medicine report and Congressional interest, staff should develop this plan as expeditiously as possible. The plan should i
be developed in full partnership with the Agreement States and in a manner that allows the fullest participation of the other stakeholders.
Staff should consider the creation of a Joint Agreement State-NRC Working Group for this purpose whose meetings would be publicly j
announced including, as appropriate, public workshops.
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