ML20207T142

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RES Independent Review Board Voting Sheet Re Rulemaking, Rev to 10CFR30,32,40 & 70 Licensing of Sources & Devices. Author Not Participating in Vote Due to Insufficient Info Provided to Conduct Independent Review.Related Info Encl
ML20207T142
Person / Time
Issue date: 08/30/1985
From: Morrison W
NRC - RESEARCH INDEPENDENT REVIEW BOARD
To: Gillespie F
NRC - RESEARCH INDEPENDENT REVIEW BOARD
Shared Package
ML20205D544 List:
References
FRN-52FR2540, RULE-PR-30, RULE-PR-32 AB34-1-27, AB34-2-41, NUDOCS 8703230244
Download: ML20207T142 (5)


Text

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., 1 RES INDEPENDEt3 LEVIEW BOARD l l

VOTING SHEE1 T0: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: W. M. Morrison, Member, RIRB TITLE OF RULEMAKING: b h \0 CM 2o Mo MO -

5 w.w c__ seec.u REQUEST RIRB AGREE WITH RECOMMENDATIONS MEETING.

IN RES RULEMAKING REVIEW ~

PACKAGE MODIFY RECOMMENDATIONS IN NOT PARTICIPATING.

X RES RULEMAKING REVIEW

- PACKAGE AS INDICATED BELOW i COMMENTS AND SUGGESTIONS:

It is not possible to conduct an independent review of this rulemaking, as requested by the RAMRB Staff, because insufficient information is provided. Missing information, most of which is required to be included in the package by the May 1984 Procedures for Conducting RES Independent Review, includes the following:

(1)~ The NRC Regulatory Agenda entry; (2) The rulemaking as currently proposed; (3) The items listed in I.E.1.d. of the Procedures for Conducting RES Independent Review; l (4) The regulatory analysis;

!~ (5) The memorandum identified as " Attachment 1" in the draft Minogue to Dircks memorandum, subject " Draft Recommendations to EDO Concerning ...". (It is not clear why the " draft" is in the subject.)

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W. M. Morrison MEMBER, RIRB Tf30fW DATE 32 244 870304 30 52FR2540 PDR

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RIRB members are requested to conduct an independent review of the attached RES rulemaking review package and provide the Chairman, RIRB, with their voting sheets indicating their positions on the rulemaking..

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. . . . sheets to. assemble the complete RES review package for eventual transmittal to the OEDO and the Director of the user office. .

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1 RESEARCH 0FFICE REVIEW OF PROPOSED REVISIONS TO COMil5SION RULES GOVERNING THE LICENSING 0F SOURCES AND DEVICES (10 CFR 30, 32, 40 and 70)

The subject rulemaking package has been reviewed in accordance with the guid-ance provided in R. B. Minogue's memorandum to staff dated May 10 1984.

Basically, this rulemaking proposes that manufacturers and distributors of

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$. sealed sources or devices containing sealed sources be required, as a condi-V tion of licensing, to submit infomation on the characteristics and proposed I uses of their products. MRC and the Agreement states would, in procedures not

[ fully doctmented, review and " approve" such devices for the uses proposed f in the license application. Currently, product infomation of this type has been provided by manufacturers on a voluntary basis since it facilitates the subsequent licensing of the users (purchasers) of 'their products. Such product f

infomation is catalogued and published by MRC and distributed to the Agreement h

  1. States for their use in licensing reviews of applicants proposing to use a

$ given product. Where no prior product review has been made or where no product data is on hand, infomation is obtained from the user-applicant as part of his f[ licensing revi.!w.

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. In addition, this proposed rulemaking would establish a system which classifies sources and devices according to end-use and source characteristics. Further.

h-the rule would also permit licensee-users of such products to employ any one of 4 a number of sources or devices which have previously been " reviewed" by NRC or p the Agreement States without the need for a specific amendment to their license as is currently the case under existing regulations.

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After considering the information provided in this rulemaking package (State-ment of Considerations. Regulatory Analysis, etc) we are of the opinion that.

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2 This judge-in its present form, this rulemaking action should be terminated.

ment is based on the following:

(a) the health and safety of the public is not affected by the imposition of these proposed changes. Current regulatory requirements and procedures are adequate to ensure public and occupational safety in this activity.

No abuses of'the voluntary system having an impact on public safety have

[ (b) been cited to support the. need for improved regulatory control in this area . Q (c) The principal benefits cited in support of this rule are administrative in e nature. These benefits flow principally to the subsequent user of these devices rather than to the manufacturer or distributor upon whom these new licensing requirements are being imposed. The administrative burden

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appears to be a small reduction for the user and a small increase to the k

supplier.'

L 10 CFR 2.200) in (d) Legal redress is currently available to NRC (under

[ situations where it ca'n be shown that manufacturers or distributors have,

' through negligence, or fraud, adversely impacted on licensees' compliance I

with NRC regulations and, indirectly, on public health and tafety.

L (e) The net cost impact of these proposed changes is small; a slight increase Cost in manufacturers costs and reduction in users costs could occur.

and other impact estimates provided in the Regulatory Analysis are incon-clusive. It would seem that the manufacturers / distributors would be required to apply for a license amendment .for each new or unique product they produce. No assessment of.this impact is given.

These opinions are, we believe, consistent with those of ELD and ADMIN who provided extensive and substantive comments on the draft rulemaking package.

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