ML20236R534
| ML20236R534 | |
| Person / Time | |
|---|---|
| Issue date: | 07/09/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20236R530 | List: |
| References | |
| SECY-98-128-C, NUDOCS 9807220102 | |
| Download: ML20236R534 (3) | |
Text
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- NOTATION VOTE RESPONSE SHEET TO: Jchn C. Hoyle, Secretary t-FROM: CHAIRMAN JACKSON
SUBJECT:
SECY-98-128 - PROPOSED RULE: REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MATERIAL Approved xx Disapproved Abstain Not Participating _. Request Discussion COMMENTS:
See attached comments, I
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' SIGN /ffURE July 9, 1998 Release Vote / xx /
DATE Withhold Vote / /
Entered on "AS" Yes xx No M 7"!a = = c"2 CORRESPONDENCE PDR
_-_hWh 3 DlDh- - - - - - - - - - -
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! Chairman Jackson's Comments on SECY 98-128 I approve the staff's request to publish the proposed revision to 10 CFR par 135 in the Federal Register; however, I request that the regulatory requirements regarding precursor events be deleted from the proposed rule text. As I stated in my vote on SECY 98-054, there are existing regulations that contain sufficient requirements for licensees to identify and report " precursor events." Instead I recommend that the staff use an Information Notice to alert licensees of the l current requirements and reinforce the need for compliance with these requirements in its l inspection and enforcement activities. Additionally, I have several concerns with the proposed rule text that I request that the staff address or seek specific comments on during the public comment period. These are:
. Decay in Storaae The staff proposes the deletion of the 10 half-lives holding period for DlS wastes and to require that only a radiaticn turvey be made at the surface of the container to ensure that dose rates are not detectable above background. A layer of plastic would effectively eliminate the possibility that many beta emitting and low energy photon emitting isotopes would be detected by the licensee's survey instrun, ants. This rulemaking would also affect other licensees, since currently Part 20 recognizes DlS as a disposal option for all licensees and license reviewers grant authorizations to these other licensees consistent with the Part 35 authorization in the regulations. Therefore, this revision may result in a deminimus waste policy for all licensees which would require an Environmental Assessment or Environmentalimpact Statement at a minimum. Therefore, the staff should consider whether it should seek specific comments on this proposed revision, or address this specific change as a separate rulemaking since na Environmental Assessment is planned as part of the Part 35 Rulemaking.
. Badiation Safety Committee (RSC). The revision would allow the licensee's management to meet the objectives of a Radiation Protection Program under alternative methods rather than require that a formal RSC be formed to meet the objectives.
Additionally, the rule would require that the Radiation Safety Officer (RSO) sign a statement indicating awareness of radiation safety responsibilities and willingness to accept them. This change will take away the RSC, which historically has been the mechanism for stating needs for funding for the radiation protection program, and on the other hand the revision also makes the RSO wholly responsible / liable for any failure of the program. As a result, these changes may have a negative impact on the licensees' abilities to fill the RSO positions. Therefore, the staff should seek specific comments on whether this combination of changes in the proposed revision may actually reduce the effectiveness of Radiation Protection Programs.
. Trainina and ExoeriencA Increases to the Training and Experience requirements for Endocrinologist do not appear to be justified based on the lack of a history of radiation safety problems. Therefore, the staff should provide a more thorough explanation of its l
l basis for raising the number of training hours for this modality.
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. Brachytheraov Source Output Measlement. Currently licensees have been authorized to use the output or activity measurement supplied by the manufacturer or distributor for their brachytherapy sources. The proposed revision would require that all licensees measure the output for their sources. This new requirement raises issues of
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6 ALARA and concerns over the possible complications which can be introduced by licensees attempting to calibrate sources for which they have no technical expertise or conversely, if long lived sources are more accurately measured, this may introduce complications when the clinician and physicist try to resolve dose rate changes with future and past treatment planning. Therefore, the staff should seek specific comments on the possible ramifications of such a revision.
I also note that currently the list of medical physics tasks in 35.51 of the proposed rule contains
! a reference to 35.634; however, the version of the proposed rule provided to the Commission contains no such section. The staff should either correct the typographical error, or provide the missing section if it was omitted.
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