ML20140B175
| ML20140B175 | |
| Person / Time | |
|---|---|
| Issue date: | 06/05/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Cyr K, Stitt J NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI), NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| References | |
| REF-10CFR9.7 M970508, NACMUI, NUDOCS 9706060088 | |
| Download: ML20140B175 (3) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION o
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W ASHINGTON, D.C. 20555
- ,g IN RESPONSE, PLEASE June 5, 1997 REFER TO
M970508 OFFICE OF THE SECRETARY MEMORANDUM TO:
Judith A.
Stitt, Chairman Advisory Committee on Medical Uses of Isotopes Karen D.
Cyr Gene 1
un el.Y FROM:
Joh
. Hoyl Secretary
SUBJECT:
STAFF REQUIREMENTS - MEETING WITH ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI), 9:00 A.M.,
THURSDAY, MAY 8,
- 1997, COMMISSIONERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)
The Commission was briefed by the Advisory Committee on Medical Uses of Isotopes (ACMUI) on the Committees' discussions on DSI-7 and the revision of 10 CFR Part 35.
l The Commission requested the ACMUI to take a focused look at revisions to Part.35, including test cases, as the Commission
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moves toward a more risk-informed, performance-based regulatory program.
In providing recommendations, the' Committee should address the questions posed by the Commissioners during the l
l meeting, which include the following:
1.
How should the NRC determine which industry standarda including voluntary ones, are adequate to meet the 'U s
regulatory responsibility for patient, worker, and puulic safety?
To what extent should NRC allow the licensee j
flexibility in interpreting or selecting an industry standard?
How should the concept of " quality improvement" be incorporated into reliance on industry standards and an i
accreditation-type of approach to licensing and inspection?
2.
What are the necessary transition steps the NRC should take in order to implement a more positive enforcement program while addressing the outlyers.
What metrics should the NRC -hh{);3 that, in effect, encourages or rewards good performance 4
t use to decide whether the approach is v.rking?
3.
In considering various events (e.g., misadministrations, j-equipment failures, or procedural errors), what criteria j
should the.NRC use to determine t at particular event is O pp.1 IllE EHERIljiJEI 9706060008 970605 PDR 10CFR PT9.7 PDR i
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isolated, rather than having program implications for that licensee or generic implications for other medical licensees?
What is the best process for the reporting of events to ensure that the NRC is aware of potential generic issues?
4.
In evaluating errors, should a threshold be established beneath which corrective action is not required?
How would such a threshold be set, and how would it be implemented?
The Commission requested OGC to provide an analysis of whether the Atomic Energy Act supports ACMUI's proposal that NRC regulation should tolerate a level of risk in radiation medicine comparable to the level of risk associated with other practices of medicine.
(OGC)
(SECY Suspense:
8/22/97) cc:
Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan EDO CFO CIO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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