ML20236U743
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8 44 UNITED STATES
+ & NUCLEAR nEGULATORY COMMISSION h ., d WASHINGTON, D. C. 20555
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1 1986 g.
/ AUG j.
MEMORANDUM FOR: John G. Davis, ector l Office of Nuclear Material Safety and Safeguards FROM: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS i
SUBJECT:
NEW RULEMAKING: " QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" NMSS-860387 (PARTIAL RESPONSE)
On April 14, 1986, the Commission directed the staff to submit a rulemaking package to provide the authority to require independent verification of therapy doses and penalize medical licensees for negligence. The purpose of the enclosed paper is to request permission to initiate a rulemaking project entitled " Quality Assurance and Penalties for Negligence" to meet the Commission's requirement.
The objective of the rule is to reduce the chance of a therapy misadministration. The rule would require medical licensees to implement a quality assurance program, and would establish penalties for licensee acts of negligence. l The staff believes this rulemaking should be completed in a timely fashion because of the directive received from the Commission.
The staff has examined alternatives to rulemaking. A generic requirement for a quality assurance program could be placed by license condition, but this would run counter to the revision of 10 CFR Part 35, " Medical Use of Byproduct Material," which was drafted to include all generic requirements. The negli-gence penalty requirement must be placed by regulation because NRC regulations do not address negligence or amounts of administered radiation, but simply who may administer radiation and with what sources.
The enclosed rulemaking package follows the guidance developed in our meeting of May 8, 1986. The NRC will first publish an advance notice of proposed rule-making that asks for public comment on the proper content of a quality assurance program and its cost, and the proper scope of a negligence penalty rule. Then the staff will prepare a proposed rule for public comment. The staff will seek the assistance of the medical community to draf t a model quality assurance program. The final rule would require implementation of a quality assurance program with certain specified features, and would define and establish i penalties for negligence. l l
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I 8712030336 871201 PDR PR 35 52FR36942 PDR
AUG 1 1986 John G. Davis i I
The primary objective is to reduce the chance of a therapy misadministration.
Because of its policy implications, the staff expects the rule will affect l
patient care costs and licensee overhead, but the amount is not clear; the i costs are discussed in Enclosure 4, " Regulatory Analysis" of the draf t rule-making package. Other impacts are discussed in Enclosure 8, " Corollary Issues" of the draf t rulemaking package. There will be no effect on worker or public dose other than reducing the chance of a patient receiving a misadministration.
The staff anticipates the need for about one professional staff year and one secretarial staff year spread over FY86 and FY87, plus about $120,000 for consultant fees.
The staff has prepared an action plan that more fully describes the directive and corollary issues within the NRC and within the medical community. A copy is enclosed.
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/RXJE & J/-
Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
Enclosures:
- 1. Action Plan l
- 2. Request for Permission to Initiate Rulemaking 1
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