ML20137R272
| ML20137R272 | |
| Person / Time | |
|---|---|
| Issue date: | 06/14/1985 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230456 | |
| Download: ML20137R272 (3) | |
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\++*,,/ June 14,1985 Stello GCunningham OFFICE OF THE Minogue SEC R ETA R Y Kerr, SP Taylor McElroy MENORANDUM FOR: William J. Dircks Felton Executive Direc for Operations Philips Besaw FROM: amuel J. Chilk,, retary Shelton
SUBJECT:
SECY-84-485, P POSED REVISION OF 10 CFR PART 35, " MEDICAL USE OF BYPRODUCT MATERIAL" This is to advise you that the Ccmnission (with all Ccmnissioners agreeing) has approved SECY 84-485 subject to the following.
- 1. Modify Enclosure 1, page 30 by deleting the second paragraph under the heading, "S35.36 Radiation Safety Program Changes," and adding the following paragraphs:
"The Ccmnission notes that this change in the current licensing process under which all radiation safety program changes must be approved by license amendment, recognizes that, in the end, public health and safety is based on three features: (1) NBC regulates who may use byproduct material for medical use by listing authorized users on the license; (2) NRC regulates the degree of hazard, balanced with medical needs, by only allowing certain chemical and physical forms for medical use; and (3) NBC regulates where by product material may be used to allow for unannounced inspections of licensee radiation safety programs.
This proposal would retain those regulatory features by requiring licensees to receive a license amendment before using material for new clinical methods of use not permitted by the license; before '
permitting new authorized users to use material; before receiving more material or different kinds of material than permitted by the license; and before using material at locations not listed on the license. These are major changes in a licensee's radiation safety program for which a license amendment would still be required (see S35.17). Under this proposal all other changes (such as selecting replacement equipment, re-arranging the nuclear medicine clinic, switching frcm one service contractor to another, or switching to an alternative equipnent quality assurance procedure) would be minor changes.
The Ccanission would appreciate cmunents on this major / minor dividing line or threshold. Is this dividing line clear and ccroplete? Are there other features that should be considered as 1 major changes, or are scrne of these major changes really not important to health and safety? Is there sm e other dividing line, either fixed or flexible, that would clarify which changes 85D9230456 850906 PDR PR 35 50FR30616 PDR
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i are really not inportant to health and safety and may therefore be made by the licensee? Alternatively, should the Ccmnission continue to require licensees to sutmit all radiation safety program changes for agency approval?
- 2. Modify Enclosure 1, page 30, by adding the following text after the heading and introductory paragraph "S35.37 Records and Reports of Minaministrations":
"Although the Ccmnission has not revised its misadministration reporting and recordkeeping requiresnents, it would like to take this oppnunity to ask for public cmment on these requiresnents based on the experience gained since the requirements were first published in final form five years ago. For both diagnostic and therapeutic misadministrations, are the current requirernents adequate to protect the public health and safety or should they be made more or less stringent? Should the regulations require prtxnpt notification of the patient who received the misadmini-stration? Do the regulations provide the public with a clear notice of the Cmmission's role when there is a misadministration?
Should the Ccmnission take enforcement action against licensees who misadminister byproduct material or radiation to patients? If so, what type of enforcenent action should be taken?"
- 3. Delete the last paragraph under the heading "S35.30 AIARA program" in Enclosure 1, page 26, and insert the following:
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, "In this proposed rulemaking the Ccmnission has not required non-institutional licensees, such as one or a few physicians in private practice, to have a formal AIARA program because, for those licensees, the physician authorized user is usually also the Radiation Safety Officer, management, and the line manager. Hence, any formal AIARA report requirenent would consist of the physician reporting to himself. However, the
, Ccanission would appreciate ccanents as to whether all medical licensees should have a fonnal AIARA program. If so, should small licensees conduct an internal annual review or should that review be conducted by scmeone who is not associated with the licensee's program on a day-to-day basis? Ccmnenters are q , '. raninded that the exhortation in 10 CFR 20.l(c) to make every reasonable effort to maintain radiation exposures and releases 4
of radioactive materials AIARA applies to medical licensees. "
- 4. Modify Enclosure 1, page 3, by inserting a new sub-heading and text as the first subdivision under the heading "NRC's REGUIA'IORY PROGRAM." (This modification was proposed in your mmorandum to
'<r Mr. Hoyle, dated April 15, 1985.)
" Policy Regarding the Medical Use of Byproduct Material In a policy staternent published in 1979 (44 FR 8242) , the NRC
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noted that it regulates the medical use of byproduct material as necessary to provide for the radiation safety of workers and the general public, regulates the radiation safety of patients where
- justified by the risk to patients, and minimizes its intrusion into medical judgements affecting patients, and into other areas
! ; traditionally considered to be the practice of medicine. The NRC does have the authority to regulate the medical use of byproduct material to protect the health and safety of patients, but also recognizes that physicians have the primary responsibility for the protection of their patients. NRC regulations are predicted on the assumption that properly trained and adequately informed physicians will make decisions in the best interest of their patients.
"This revision retains NBC's current balance between adequate controls and avoidance of undue interference in medical judgements. Too much regulation could result in poorer health care delivery to patients. Insufficient regulation could result in the urwarranted or unsafe use of radiation."
'Ihe proposed rule should be modified as noted above and returned for signature and publication in the Federal Register.
(EDO/NMSS SECY suspense 7/12/85) .
The staff is also requested to meet with the Advisory Ccmnittee on Medical
- Uses of Isotopes and determine what level of physician training is appropriate.
cc: Chairman Palladino ccmnissioner Roberts Ccmnissioner Asselstine Ccrrmissioner Bernthal Ccmnissioner Zech OGC OPE