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..... AUG 0 3 E84 MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS FF.0M: J. A. Hind, Director Division of Radiation Safety and Safeguards
SUBJECT:
REQUEST FOR CONCURRENCE ON PROPOSED REVISION 0F 10 CFR PART 35 In response to your July 13, 1984 memorandum to Region Ill, we concur with recomending that the Comission publish for public coment a proposed revision of Part 35 as specified in Alternative 3 on page 5 of the Commission paper as submitted to us for review. We do not agree with recomending that the Comission consider publishing Alternative 2, which includes a new method for licensing the medical use of byproduct material. The basis for our decision is sumarized in the attached enclosure.
We recomend the staff consider three modifications to Part 35 as suggested in our March 30, 1984, memorandum to you, since the sumary account, Enclosure 8 to your memorandum, does not address our concerns. Based upon our experience with licensees in Region lil, these modifications are necessary to alleviate a potential for increased external and/or internal exposure to radiation to workers and the public, in view of recent events in Region III with " breakthrough" of molybdenum-99 into generator eluates, we recomend that Section 35.204 of Part 35 be modified to include a reporting requirement as outlined in the attached enclosure.
( . r J. . Hin ctor
- )* Division of Radiation Safety and Safeguards cc: P. G. Norry, ADM G. H. Cunningham, ELD R. B. Minogue, RES R. C. DeYoung, IE G. W. Kerr, SP Regional Administrators, R1, Ril, RIV, RV G509230530 050906 PDR PR 35 50FR30616 PDR
ENCLOSURE Basis for Not Selecting Alternative 2 Most escalated enforcement with medical licensees in Region Ill is the result of lack of management control and Alternat'.ve 2 places more control for radiation safety judgement in the hands of these managers.
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Alternative 2 will definitely change day-to-day operations within NRC, contrary j to lines 29-31, page evaluating licensee's(,8)of theprocedures Comission paper, by transferring operating from licensing to inspectionthe burden of staff.
An extensive training program would be necessary for all the inspectors.
The new method will eliminate NRC's ability to examine changes in facilities and procedures proposed by licensees for which criteria are not addressed in the proposed Part 35. Experience in Region III has shown that health and safety problems with a particular modification have been circumvented by a review prior to licensee initiation. This is one of the major benefits as a result of regionalization.
/ The new licensing method depends upon the Radiation Safety Officer (RS0) or Radiation Safety Comittee to review and approve modified procedures. This may cause health and safety prceram degradation in some medical institutions where past inspection history supp)rts the fact that authorized users functioning as RS0's or comittees do not have adequate expertise nor desire to review n.odi fications.
9 Alternative 2 will eliminate NRC's ability to review inspector concerns with a particular licensee during the next license amendment request. This has been an effective means of correcting potential health and safety problems in Region III.
Modifications To Part 35
- 1. Section 35.30, Page 70 of Enclosure 1 Modify to include minimum criteria for an ALARA program for all medical programs and not medical institutions, exclusively.
Justification:
g We understand that the ALARA program elements in Section 35.30 are written to ensure information flow between managers with overlapping responsibili-ties; however, they also include comitments to keep doses as low as reasonably achievable, a review of personnel exposures, and establishment of investigational levels. We believe these comitments are necessary for all medical programs.
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3 / 2. Section 35.19, Page 69 of Enclosure 1 i
Modify to include requirements to amend license for any room relocation, as well as, building location.
Justification:
i Part 35 does not include criteria for medical licensees to utilize for performir.g close-out surveys prior to release of rooms and/or areas for
] unrestricted use.
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/ 3. Section 35.31, Page 71, and Section 35.38, Page 77 of Enclosure 1 l
Modify Section 35.31 to include a statement of availability of the RSO for
, emergencies and routine day-to-day operations. Delete this same statement for 4
an authorized user in Section 35.38 Justification:
Since the radiation safety program and actions proposed by Part 35 revolve around the RSO and not the authorized user, it is more prudent to require l the RSO to be available than the user,
, 4. Section 25.204, Page 89-90 Enclosure 1 Modify to include a reporting requirement as follows:
(d) The licensee shall notify by telephone the appropriate NRC Regional Office listed in Appendix D, of Part 20 of this Chapter and any affected redical facilities of the results of any tests where the molybdenum-99 concentration exceeds that specified in (a) above.
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! These notifications must be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee discovers the result. ,
Justification:
Recent events in Region Ill where licensees were not required to report the results of "high breakthrough" of molybdenum-99 in generator eluates have led to unnecessary misadministrations. Notification may alleviate '
future problems by making licensees and the NRC aware prior to distribution of such eluates for medical use in humans.
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p# #84 9 UNITED STATES y' ,
( jog NUCLEAR REGULATORY COMMISSION h o REGION il E 101 M ARIETTA STREET. N.W.
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AUG 71984 r p /V MEMORANDUM FOR: Richard E. Cunningham, Director /)*
Division of Fuel Cycle and Material Safety FROM: J. Philip Stohr, Director l Division of Radiation Safety and Safeguards
SUBJECT:
CONCURRENCE ON PROPOSED REVISION OF.10 CFR PART 35 (YOUR MEM0, JULY 13,1984)
This office has completed its review of the Proposed Revision of 10 CFR Part 35, and along with our previous verbal and written comments, we concur subject to the following additional comment:
10 CFR 35.35(a) limits the availability of mobile nuclear medicine services to just unlicensed clients. We believe this is unnecessarily restrictive since licensed hospitals may have an equipment failure and need a e.obile service, rather than transfer an ill patient. This consideration should prevail over the unlikely problem of determining fault between two licensees.
In the past, where a service licensee performs for a facility licensee, the NRC has generally held the facility licensee responsible for the conduct of activities even though the service licensee may have been an independent con-tractor, rather than an agent. In some cases both parties have been held in violation. Also, a simple condition in the mobile service license could define the responsibilities of the parties involved (e.g.,the mobile service licensee is subject to the radiation safety procedures of the client licensee upon entry onto .
their premises), and similar language could be placed in the client license.
In summary, we believe the potential benefit of permitting mobile services at l licensed hospitals far outweighs the risks. Please advise me of any questions
} or problems.
I J. Philip / toh i
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