ML20141J162
| ML20141J162 | |
| Person / Time | |
|---|---|
| Issue date: | 05/03/1995 |
| From: | Bangart R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Morris B NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-032, AE41-2-32, NUDOCS 9708150116 | |
| Download: ML20141J162 (4) | |
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. UNITED STATES 3 E U NUCLEAR REGULATORY COMMISSION WA$HtNGTON, D.C. 30 2 4001 k . . . . . p. I .
Nay 3, 1995 MEMORANDUM TO: Bill M. Morris, Director Division of Regulatory Applications, RES FROH: Richard L. Bangart Director f '
Office of State Programs /( / b h 1.7
SUBJECT:
TECHNICAL REVIEW: ORAFT FINAL RULE - CRITERIA FOR THE RELEASE OF PATIENTS ADMINISTERED RADIOACT!YE MATERIALS This is in response to your April 12, 1995 memorandum on the subject document.
We have reviewed the draft final rule as it applies to the Agreement States through compatibility requirements. Attached are several suggested changes relating to staff's interaction with the Agreement States. .
We have no objection to proceeding with this rulemaking effort.
If you have any questions, please contact me or Lloyd Bolling of my staff.
Attachment:
As stated
1..- v,wu' ___ M
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Suggested Changes - Final Rule On Patient Release Criteria
.l. Page 24, Miscellaneous comments on the Rule We suggest the response to the first statement be revised as follows:
Response: The NRC does not agree. MP.C ::r. ducts an assessment of each proposed requirement or rule to determine what level of compatibility will be assigned to the rule. These case-by-case -
assessments are based, for_the most part, on protecting public health and safety.
- 2. Page, 34, IV. Coordination with NRC Agreement States We suggest the paragraph be revised as follows:
The staff discussed-the status of this-rulemaking effort at two public meetings; the Agreement State Managers Workshop held on July 12-14, 1994 and at the All Agreement States Meeting held on October 24-25, 1994. The Agreement States expressed no objections to the approach in this rule.
- 3. Page 39, Vlli. Issues of Compatibility for Agreement States 10 CFR 20.1002 Scope, Office of State Programs Internal Procedure B.7 entit'ed,
" Criteria for Compatibility Determinations", states that -
" Scope" in 10 CFR Part 20 is a Division til item of
_ compatibility. Therefore,-the wording regarding 20.1002
" scope" should be' designated as a Division 111 matter of compatibility rather than Division 11. Division 111 rules would be appropriate for Agreement States to adopt, but do not require any degree of uniformity between NRC and. State rules.
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PATIENT RELEASE FINAL RULEMAKING 10 CFR 35.75 _
OGC REQUESTED REVISIONS Nb 'A TO THE FEDERAL REGISTER NOTICE
- 1. Brad Jones asked if the Federal Register notice states that the revision to 10 CFR 35.75 is consistent with the current rule. Page 11, paragraph 2, specifically addresses this concern by stating that, "The NRC is establishing a dose limit of 5 millisieverts (0.5 rem) total effective dose equiva' ent to an individual from exposure to the released patient for each patient release. This dose limit is consistent with the underlying risk basis of the current 10 CFR 35.75 (50 FR 30627; July 26, 1995)...."
However, the response now contains additional clarifying information. On page 12, top paragraph, after the statement "The approached used in the regulatory guide is based on NCRP Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides,"' the following sentence has been added, "In the case of iodine-131, the most significant radionuclide, the release quantity based
, on the standard conservative assumptions is 1,221 megabecquerels (33 militcuries), which is essentially the same as the current release quantity."
- 2. Brad Jones asked that we revise the response on " contamination" on page 14 to specifically mention patient sweat. The response has been revised to read, "The concern over contamination is not justified by the radiation doses that are likely to be the caused by the removal of radionuclides from the patient's body by the pathways of exhaled air, feces, saliva, sweat, urine, and vomit."
In addition, this response has been revised to reference a British study on contamination. After the sentence, "These measurements show that even if the family members repeatedly touched household items touched by the patient, contamination does not cause unacceptably high doses," the following sentence has been added, "These findings were true even in the case of a British study where eleven patients volunteered to disregard special precautions against contamination and minimizing spousal and family exposure.
- 3. Brad Jones asked that the comment on using a value of $1,000 per person-rem be revised to include mention that the NRC is currently requesting public comment on using a value of $2,000.
The response at the top of page 38 now reads, "Use of a value of $1,000 per person-rem has been standard practice in conducting NRC cost-benefit analyses. The value of $1,000 was established in the early 1970s in the Appendix ! to 10 CFR 50 rulemaking for reactor effluents. The value of
$1,000 was selected because it bounded all the values of a person-rem estimated by a wide variety of different evaluation methods. The NRC has i
recently reevaluated the validity of the $1,000 value and is seeking public comments on a value of $2,000 per person-rem.
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