ML20236U483

Supports Need for Advance Notice of Proposed Rule Re Radiation Therapy QA & Penalties for Negligence.Development of Simple Prohibition of Therapy Misadministrations within 10CFR35 Coupled W/Enforcement Sanction Encouraged

ML20236U483
Person / Time
Issue date:	12/08/1986
From:	Grace J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:	Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20235F951	List: ML20235F945 ML20236T464 ML20236T476 ML20236T482 ML20236T485 ML20236T496 ML20236T511 ML20236T518 ML20236T519 ML20236T535 ML20236T550 ML20236T567 ML20236T646 ML20236T735 ML20236T744 ML20236T752 ML20236T756 ML20236T765 ML20236T777 ML20236T779 ML20236T783 ML20236T788 ML20236T794 ML20236T797 ML20236T800 ML20236T804 ML20236T823 ML20236T825 ML20236T826 ML20236T837 ML20236U166 ML20236U190 ML20236U206 ML20236U213 ML20236U224 ML20236U272 ML20236U288 ML20236U293 ML20236U303 ML20236U309 ML20236U317 ML20236U338 ML20236U366 ML20236U368 ML20236U382 ML20236U385 ML20236U483 ML20236U617 ML20236U620 ML20236U626 ... further results
References
FRN-52FR36942, RULE-PR-35 AC65-1-068, AC65-1-68, NUDOCS 8712030091
Download: ML20236U483 (1)

Text

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MEMORANDUM FOR: John Davis, Director y

Office of, Nuclear Materials Safety and Safeguards FROM:

J. Nelson Grace Regional Administrator, RII'

SUBJECT:

COMMENTARY ON ADVANCED NOTICE OF PROPOSED RULEMAXING

" RADIATION THERAPY QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" (MEMO, R. CUNNINGHAM TO J. GRACE, DATED 11/24/86)

We support the need for rulemaking in this area. We feel actions are needed in order to lessen the likelihood of therapeutic misadministration.

Instead of a quality. assurance approach as alluded to in the advance notice of rulemaking, we suggest consideration of rulemaking which prohibits therapeutic misadministration be developed.

Such rulemaking would be consistent with the approach taken in 10 CFR 20.101 and 20.103 which prohibit exposure to excessive levels of radiation and radioactive material.

The prohibition of therapy misadministration coupled with appropriate enforcement sanctions derived # rom an augmented enforcement policy should provide additional incentive for licensee improvement in this area.

This regulatory approach should be used without the need for a finding of negligence. We believe that making a finding of~ negligence would be difficult under our regulatory (administrative law) process.

Further, extensive inspection or investigative efforts in trying to establish a finding of negligence may be counterproductive to obtaining acknowledgement of the problem on the part of the l hensee and receiving prompt remedial actions.

In summary, we support an advanced notice of proposed rulemaking but encourage development of a simple " prohibition" of therapy misadministration within 10 CFR 35 coupled with an appropriate enforcement sanction, rather than tying the penalties to proof of negligence.

J. Nelson Grace 8712030091 871201 PDR PR

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