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'0GT 151984 1
tiEHORAliOUM FOR: John G. Davis, Director Office of fluclear liaterial Safety and Safeguards i FR0a: Richard E. Cunningha:a, Director Division of Fuel Cycle and Haterial Safety i SU3 JECT: PROPOSED REVISI0li 0F 10 CFR PART 35 The staff has prepared a proposed revision of 10 CFR Part 33, "Hu: nan Uses l of Byproduct P.aterial," (retitled " Medical Use of Byproduct Material") for public coment. Written concurrences have been received from the Office of Inspection and Enforcement, the Office of fluclear Regulatory Research, the Office of Administration, Region I, Region II, Region IV, and Region V. The Office of the. Executive Legal Director has no legal objection.
The Office of State Programs and Region III do not concur with the proposal,
- and the Agreement States object, because contrary to current practice, it j would allow licensees to make minor radiation safety program changes without agency review and approval. They raise two principal objections
- 1. Radiation safety program changes.
Coment: Most licensees do not have the expertise to make an adequate nealth and safety review of changes.
Staff response: The essential elements of a medical radiation safety program are clearly stated in the proposed regulation. The agency would continue to review licensees' major changes listed in the regulation. Hinor elements that could be changed are not of significant health and safety concern.
! 2. Inspection burden.
Cos:ent: Under the proposal, inspectors would have to review procedure changes during field inspections. The inspector will be under pressure frou1 the licensee to finish, and will not have reference works or management guidance avdilable. A field review of written procedures is also more expensive than an office review.
Staff response: Field inspectors should not review written procedures; they should watch worxers working. What workers do is more relevant to radiation safety than reading about what they are supposed to do. If an unsafe practice is observed, a citation would be issued pursuant to the regulations.
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John G. Davis OCT 151984 The staff notes another possible criticism that has not yet been raised.
Concent: You have compared this internal review nechanism to that used for power reactors. Note what happened at TMI u: der that kind of regulatory regime.
Staff response: Tne proposed regulation and HMSS internal operating procedures include many of the licensee and agency administrative oversight procedures recomended in the Rogovin report.
In order to bring the differences of opinion to the attention.of the Comissioners, the staff has prepared Enclosure 8, " Analysis of Unresolved Coments," and Enclosure 10 " Analysis of Alternatives."
Because of tne controversial history of this proposed rule and the developments at the October 3,1984 EDO meeting, we will contact your secretary to set up a detailed briefing on this package.
Original Signed by Richard E. Cunningham Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
Enclosure:
Proposed Rule Paper for Part 35 1 DISTRIBUTION:
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