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l M 2 2 1984 MEMORANDUM FOR: James C. Malaro, Chief
- Regulatory Analysis and Materials ;
Risk Branch Division of Risk Analysis and Operations, RES ,
FROM:~ Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
SUBJECT:
RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING
! As requested by your June 8,1984 memorandum, the NMSS package, " Human Uses of Byproduct Material" Revision to 10 CFR 35, was assigned to the Health Effects Branch for review, r
{ The draft staff recomendation is that NRC should proceed with the specific ongoing rulemaking. One item, involving addition of materials not yet 4
approved for licensing, is suggested for further consideration.
Enclosed is our draft independent review package. The RES task leader is Judith D. Foulke, x74563.
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
! A. Rulemaking review package received from NMSS B. Draft staff recommendations C. Results of RES staff review cc: R. Cunningham, NMSS (Seeattachedlistfordistribution) 0FC: HEB
- HEB : DRPES: : DRPES:D -
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l NAME ,, '. dm : WAMN is : PC lla : KGoller : : :
DATEQ'6/j%84 :
6///84 : / /84 : 6/A2/84 : : :
1 8509230499 850906 .
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A ENCLOSURE B 1
Draft Staff Recomendations !
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DRAFT STAFF RECOMMENDATIONS Based on the staff review, DRPES finds that the proposed rulemaking should continue on the schedule adopted by NMSS.
One item was noted.that should be brought to NMSS' attention. Section 35.400, Use of Sources for Brachytherapy, of the proposed rule lists iridium-192 as wire in'(d) and tantalum-182 as wire in (g). The iridium-192 wire is currently the subject of a petition for rulemaking. We are not aware of any action regarding addition of tantalum-182 to the list. Therefore, it may be necessary to delete these before the NPRM is published.
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ENCLOSURE C Results of RES Staff Review D
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RESULTS OF RES STAFF REVIEW I. Introduction The subject rulemaking is a proposed revisinn of 10 CFR 35. "Huran Use of Byproduct Material." NMSS prepared an earlier proposal which was described in SECY-83-62 and presented to the Commission. The present version reflects guidance from the Commission to the staff on that earlier proposal, as well as additional coments from headquarters and regional staff and from the Agreenent States. Coments by the Division of Radiation Programs and Earth Sciences on the latest version were provided in a May 10, 1984 memorandum, t;o rma n tecn rnv .
the NMSS contact. has discussed our comments in detail and resolved them to our satisfactier.
II. Quality Control Review A check of.the package subnitted by NMSS against the documentation ~ requirements specified in II.C.I. of the " Procedures for Conducting RES Independent Pule of Rulemakings," revealed that several documents were missing. Norman McElroy provided the Periodic and Systematic Review (Enclosure 3), the Regulatory Analysis (Enclosure 4), the Environmental Impact Analysis (Enclosure 7), a sumary table of comments on content of SECY-83-62 regulation (Enclosure 6),
and a summary table of human use licensee citetions issued in 1982 (Enclosure 9); copies are attached for the RES Independent Review Board. At this stage of development it is not necessary to examine the draft public announcement or the draft congressional letter.
The Regulatory Analysis was reviewed using the criteria outlined in " Contents and Forr.at for the Regulatory Analysis" of NUREG/BR-0058. The reculatorv analysis was very well-written and addressed all six requirements in Section III.B. Brecially noteworthy was the table developed to estimate the. burden on
, six hypothetical licensees of complying with each individual section of the proposed regulation. This table with accompanying discussion contains the basic information collection burden estimates required by the Paperwork Reduction Act and the economic impacts on small entities required by the Regulatory Flexibility Act. A complete OMB Statement has been prepared in accordance with draft NRC appendix 0230; it was spot-checked and appeared comprehensive. The Cost Analysis Group (CAG) reviewed the cost analysis section of the Regulatory Analysis and. provided comments in their April 6,1954 menorandum; all comments have been resolved.
The Environmental Impact Analysis (Environmental Assessment - Finding of No Significant Impact) was reviewed using 10 CFR 51, " Licensing and Regulatory Policy and Procedures for Environmental Protection." The specific impacts discussed were exposure of the public resulting from release of patients containing radiopharmaceuticals or permanent implants, mobile service
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transportation, storage of volatiles and gases, and exposure of the ecosystem.
The <44cemetinn of Why none of these will result in any significant impact on
- the environment was technically sound and well-Dresented.
The RES Independent Review procedures state that CRGR guidelines apply only to requirements inposed on one or more classes of power reactors. NMSS rulemaking concerning medical licensees is therefore exempt from CRGR review.
III. Evaluation of Rulemaking Proposal a) Issue to be addressed.
NMSS is proposing a complete revision of the regulations for licensing the intentional irradiation of humans by medical practitioners. These regulations are codified in 10 CFR 35, " Human Use of Byproduct Materials."
b) Necessity and urgency for addressing the issue. <
At the present tine the requirements that apply to human use are dispersed throughout the existing Part 35, standard license conditions, branch policy positions, and regulatory guides. The proposed revision will 4
codify all the requirements in one place, thus reducing confusion on the part of the licensee and promoting unifonnity among the Regions in '
licensing and inspection. Also by codifying the requirements, it will not be necessary to tie the licensee to all statements made in his application including those not related to health and safety. This will. allow greater flexibility and reduce the number of requests for amendments.
, _The urgency for revising Part 35 results from the fact that an earlier
, version was presented to the Commission in SECY-83-62. The Commission directed the staff to revise it and resubmit it for their review.
c) Alternative to rulemaking.
There is really only one alternative, and that is to do nothing. The present system, while cumbersome, is workable.
d) How the issue will be addressed through rulenaking.
As noted in (b) above, the revision will codify all the requirements for medical use in the regulation itself.
e) How the public, industry, and NRC.will be affected.
Because no additional requirements will be imposed, no economic burden will be irrposed on the licensee (or be passed on to the public as increased costs for medical treatment). On the contrary, the resulting flexibility will reduce licensee costs and NRC staff time for amendments.
Regarding protection of the public and worker health and safety there will be no change since the requirements will be the same as those presently imposed, but dispersed throughout various sources, f) NRC resources and scheduling.
Most of the resources have already been expended in preparing the first '
version for the Comission, in incorporating the Comission's directives, 2
and in responding to comments from other NRC offices and licensees. NMSS hopes to issue a Notice of Proposed Rulemaking by the end of August 1984.
Analysis of public comments submitted during the comment period and preparation of the final rule will require substantial staff effort.
IV. Additional Discussion Item-Mobile Nuclear Medical Services Ref: Congressional Letter from MASI
Background:
Disgnostic radiopharmaceuticals are reconstituted in
. multi-dose vials from which the user can draw a single dosage. Current licensing policy allows mobile nuclear medicine services to transport both unit dosages and multi-dese vials for use at client facilities.
Events: In an earlier draft the drafting committee proposed to restict mobile services t'o transport of unit cosages because it was assumed that they were inherently safer in case of an accident. During the NRC and i Agreement State comment period that ended March 30, several individuals pointed out that both were safe, and there had been no problem with
. current policy. Also, one licensee who had obtained the draft called an NRC license reviewer and said: (1) if a client has an extra patient, there would be no pharmaceutical available; and (2) if the mobile service arrived early or late, the unit dosage may be outside the prescribed dosage range due to radioactive deca,t.
The markup draft was changed, in respcnse to these comments, to allow mobile services to transport multi-dose vials.
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