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- NUCLEAR REGULATORY COMMISSION
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- WASHINGTON, D.C. 20665-0001
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H, GENERAL CoVNSEL-MEMORANDUM FOR:- : Donald A. Cool, Director LM Division of-Industrial and Medical Nuclear Safety Office of Nuclear Material Safety Safeguards FROM:-
Stuart Treby '.
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Assistant General Counsel For
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Rulemaking and' Fuel Cycle.
OGC'REVI W OF[Id5DED? FINAL [RUUEM KING PACKA E ' PATIENT
SUBJECT:
-RELEASE,RULEJ-OGC has reviewed the final rulemaking package concerning the Patient Release Rule, which was modified in response to comments from the E00's office =and the Solicitor's office.
Subject to the following comment, 0GC continues to have
_no legal-objection to this final rulemaking package.
In response to one issue raised by the Solicitor concerning a commenter's criticism of procedural' aspects of the rulemaking process, we have drafted a footnote to be added to-the Commission paper addressing the_ issue of contacts allegedly concerning:the rulemaking that took place between one of the-petitioners in the rulemaking and former NRC Chairman Selin. The footnote should be? inserted on page 2 of the commission paper at the end of the first sentence in the first full paragraph which begins "Some licensees..." and ends
... received on the issue." The footnote should read:
e One commenter raised an issue about contacts allegedly relating-to this.rulemaking between one of the petitioners and former NRC Chairman Selin. The staff notes that the final rule is based on the public record associated with the rulemaking.and that the NRC-decision maker ~with whom contact was made, former Chairman Selin, is no longer with the Commission. -The staff has not included any further comment with respect to this issue in the final rulemaking package.
Subjeht to inclusion. of this footnote, 0GC has no legal abjection to the.
revised rulemaking package.
-CONTACT:
-Bradley-W. Jones, 0GC' 41E-1628
-0 9708150143 970007 PDR PR 4
20 62FR4120 PDR m~
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For example, if a licensee uses the default table of release quantities provided in the regulatory guide as the basis for release, the patient could be released l
with 1,221 megabecquerels (33 millicuries) or less of iodine-131 and no record l
of the release is required.
However, if the licensee chooses to release a l
patient with an activity that is greater than the value in the default table l
(e.g.,
3,700 to 5,550 megabecquerels (100 to 150 millicuries) of iodine-131),
the licensee must do a dose calculation using case-specific factors to I
demonstrate compliance with the release criteria. Regardless of the method used by the licensee to authorize release, the dose limit of 5 millisieverts (0.5 rem) in the revised 10 CFR 35.75 applies to all releases.
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FROM EDO 11.38.1995 12828-
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.; ( Y Response.
In commenting on the petitions, a number of States expressed,,,
- h concerns about releasing patients administered 14.8 gigabecquerals
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a (400 mill'icuries) of iodine-131, which one )f the petitioners roquested.
However, the Agreement States that commented on the proposed rule were generally favorable to the approach in the proposed rule limiting the dose to I
the most exposed individual to 5 millisieverts (0.'5 res). This limit would generally permit releases of only those patients containing much less than 14.8 gigabecquerels (400 mil 11 curies) of todine-131. For example, if a ?
. licensee uses the' default table provided in the regulatory guide as the basis for a patient's release; the patient'would~be released with 30 m1111 curies or less of iodine-131.
Inthiscase,nericordof.releaseisrequiredtobe
~ maintained.)-
es chooses noE to use the default table and.rele patient who was administered.a much larger dosage (e.g., 100-150 millicuries j
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of iodine-131), the licensee must use the criteria specified in the rule for J
calculating the total effective _ dose _oulvalent to ensure compliance _with the) so-based releaseph In this case, a record of the bahs for the patient e
release must be maintained for NRC review during-inspection.
Irregardless.of
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e the method useito calculate patient release?,the dose-based release limit of 5 mil 11sieverts-(.5res)appliestoanypatt.releashinaccordsneewithto
>d 4: CFR 35.75.3 None of the States that commented on the proposed rule indicated that the concerns of the Agreement States were misrepresented.
In fact, one Agreement State commented that it was pleased that the NRC had considered the cae:ments made by the Agreement States at various meetings with the NRC.
Comment. One commenter said that in some cases it should be permissible to authorize the release of a patient even if the dose to a family member O
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