ML20141J225
| ML20141J225 | |
| Person / Time | |
|---|---|
| Issue date: | 06/08/1995 |
| From: | Treby S NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-043, AE41-2-43, NUDOCS 9708150184 | |
| Download: ML20141J225 (7) | |
Text
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UNITED STATES cc: McGuire
!cocePu l
o NUCLEAR REGULATORY COMMISSION Schneider 8*
wAsHiNOToN, o.c. osss-oooi Glenn l
Morris S
/
File e i June.8,.1995 '
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OF CE o HE GENE RAL CoVNsf L g /,,,,4 MEMORANDUM 10:
David L. Morrison, Director Office of Nuclear Reg /ulatdry Researpl-
/ 8 A M [' N J
FROM:
Stuart A. Treby Associate General Counsel for
/
Rulemaking and fuel Cycle
SUBJECT:
COMMENTS,0N' DRAFT FINAL RULE
. PATIENT RELEASE CRITERIA" In additional to several editorial comments and suggested clarifications contained in the attached marked copies of the draft final rule package, we have the following _ comments on the final rule. We are deferring our concurrence until we received and reviewed a Jackage revised in accordance with these comments and/or the comments of otler offices.
1.
On page 29 of Attachment 1, the second "Res)onse" appearing on the page needs to be expanded. A line or two descriaing to what extent the commenters' comments were incorporated into the final Regulatory Guide is needed.
For example, it's not clear that the first two comments, l
which raise specific numerical criteria, are consistent with the more general.last comment suggesting ICRP Pub. No. 53 values should be used.
l Thus, when the response says that the comments are valid, is is not evident what NRC is agreeing to change in the final Regalatory Guide.
2.
The provision at 6 35.75(c) of the draft regulation is unclear. It is our understanding that the intent of that provision is to assure that l
records are kept of calculations used to justify patient releases if the coicuedOons are bated on issumptions other than those usea in' generating the Regulatory Guide release values.
The current wording is l.
unclear and at first reading, appears to be implying that patients might be released that do not meet the release criteria of the new l
regulation. Accordingly, we recommend rewording 9 35.75(c) to read as j
follows:
35.75(c) - The licensee shall maintain, for 3 years, a record of the basis for authorizing the release of a patient or patients if the calculations on which the release is based uses other than the following conservative assumptions: the individual retains the initial administered activity, a point-source geometry, the physical half-life.of the radionuclide, an occupancy factor of 0.25 at one meter, and no attenuation of radiation in tissue.
CONTACT:
Bradley W. Jones, OGC 415-1628 9708150184 970807 PDR PR 20 62FR4120 PDR Aqo% tSb $C 043
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t 2
3.
Assuming comment 2 is adopted, the second paragraph of page 38 of the federal-register notice needs to be revised to track the new language, The same comment also applies to the last paragraph on the first page of Regulatory Guide 8.39,
Attachment:
As stated
The Commissioners 3
/
Specifying the release criterion in terms of dose requires th:1 ma NRC administered to that dose. provide an acceptable method to relate the quantity o l
That relationship will be provided in a l
regulatory guide.
A working draft of that guide is attached i
(Attachment 2); the guide is still under staff review published in active form before the final rule becomes, effective.but will be 4
ine guide provides two methods to relate dose to quantity of radioactivity administered. The first method is the use of a default table of release quantities and release dose rates based on conservative.
assumptions.
For the radioactive material of greatest significance, iodine-13), the default table is essinaally equivalent to the release 3
j criteria in the current regulations.
The second method is to perform a case-specific dose calculation using the method described in the guide.
The case-specific method can be less conservative than the default table because it permits a more realistic estimate of how quickly the radioactive material leaves the body.
containing several times more radioactive material than the
- Thus, regulations permit.
half-life and no biological excretion, the default table and theUnder c case-specific dose calculation may be more restrictive than the current release criteria.
Overall, a substantial majority of all comments supported a dose limit of 0.5 millisieverts (0.5 rem) for individuals exposed to patients released with radioactive material.
Agreement States sup)orted the criterion based on a dose limit.In addition, the commenters opposed tle new criterion because they thought that the-A few present criteria were-werking wdl and were ' adequate.
+
These commenters than permitted under the current regulations. opposed allowing releas 3.-
The. proposed rule prad ta require < licensees to maintain, for 3 years, a record of the basis for the patient's release and the total effective dose equivalent if any individual is likely to receive a dose in excess of 1 millistevert (0.1 rem) in a year from a single administration.
The purpose of this requirement was.so that records would be available to calculate the dose if there were multiple administrations in a year, This proposed requirement generated a great deal of opposition.
Commenters were especially concerned about having to retrieve records of
-previous administrations, sometimes from another hospital.
Upon reconsideration, it was decided to delete this requirement because a review of nuclear medicine procedures indicated that there was not DRAFT: May 31, 1995
guide is based on NCRP Report No. 37, " Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides."'
[
The supporting regulatory analysis contains a detailed examination of the benefits and impacts of the final rule that includes dose estimation, recordkeeping and radiation exposure.
Single copies of the final regulatory analysis and Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials," are available as indicated in the ADDRESSES heading.
Comment:
A commenter said that the calculational approach in the rule I
would require the physician to ask many personal questions of the patient.
t Response: The commenter is incorrect in believing that the dose-based approach will generally require personal information from the patient.
The NRC anticipates that nearly all patients will be released based on the default table of activities provided in Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials." The table of release quantities approach, based on standard conservative assumptions, does not require any personal informatioq from the patient.
Personal information mNt[only be, necessaryforeeYthn-patijnt-speificcases, w m G khe.cd ckC% ak W UfP/bUKM b G'b 6
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release patients based on the dose rate at 1 meter.
' National Council on Radiation Protection and Measurements (NCRP),
" Precautions in the Management of Patients Who Have Received Therapeutic Amounts of Radionuclides," NCRP Report No. 37 (October 1, 1970).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
DRAFT: May 31, 1995 12
t either decay away within the patient's body or will be excreteJ in the patient's urine and flushed down the toilet. The proportion that will be deposited as contamination on accessible surfacts will be small. Doses to
)
t individuals exposed to the patient from pathways other than direct external l
exposure (e.g., internal exposure due to intake of radionuclides from vomited matter, sweat, etc.) have been measured and have been found to be relatively low compared to direct external exposure.
(The intake from the milk in l
breast-feeding infants is dealt with in the regulations as a special case.)
These measurements are discussed in the supporting regulatory analysis and l
Regulatory Guide 8.39, " Release of Patients Administered Radioactive Materials."
In addition, the NCRP recently addressed the risk of intake of radionuclides from patients' secretions and excreta in NCRP Commentary No. 11,
" Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients,"andconcludedthat,"TNd,acontaminatior,incidentthatcouldlead s
to a significant intake of radioactive material is very unlikely."'
Comment: One commenter said that the Federal Register Notice for the proposedruiedidnotadeduatelyrepresenttheconcernsthattheAgr[ement
^
States expressed on the petitions for rulemaking concerning releasing patients with quantities of iodine-131 in excess of 30 millicuries.
Response
In commenting on the petitions, the States did express concerns about releasing patients administered relatively large quantities of
- National Council on Radiation Protection and Measurements. " Dose Limits for Individuals Who Receive Exposure from Radionuclide Therapy Patients," NCRP Commenta;y No. 11 (February 28,1995).
(Available for sale from the NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095.)
DRAFT:
May 31, 1995 14
4
/pis calculation could be done once and placed on file. A separate calculation would not have to be done for each patient.
With regard to the coments that the methodology is too conservative and that measured values are-lower than calculated by the methodology, the methodology in the table giving default release quantities is intended to be conservative. The NRC believes it is appropriate and prudent to be conservative when providing generally-applicable release quantities that may j
be used with little consideration of the specific details of a specific patient's release. A review of published information, as described in the regulatory analysis (NUREG-1492), finds that the measured doses were well below those predicted by the methodology used to calculate the table of default release quantities. Thus, the default release quantities are conservative as the NRC intended. However, the licensee is given the option to do case-specific calculations that may be less conservative.
)1%vMv
)e NRC agrees that the assumption used in the draft guide of 24-hour Jr.,c.w\\y' non-voiding in the thyroid cancer example 14-4ee ton w r~,ative. The revised C
example uses an excretion half-time of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> as-recommended by the ICRP in ICRP Publication _53,,," Radiation Dose to Patients from Radiopharmaceuticals.'.
Comment: One comenter said that the exposure factor (generally assumed
-to be 0.25 at 1 meter) should not be left to the discretion of the licensee because low exposure factors could easily be justified by providing strict-safety instructions without any verification that the instructions will be followed. Another comenter liked tha flexibility provided by being able to
' International Comission on Radiological Protection (ICRP), " Radiation Dose to Patients from Radiopharmaceuticals," ICRP Publication No. 53 (March 1987). Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.
DRAFT: May 31, 1995 28
Consent: One commenter said that the factor of 10 used in the draft guide to estimate internal dose is not well supported for nonoccupational exposures. Another commenter said that the calculation of dose to individuals exposed to the patient ignores the potential of radiation dose from the excretion of radioactive material from the patient and this could present a significant radiological hazard to family members.
Response
It is true that there is not a great deal of information on the use of-the factor in nonoccupational settings, but measurements (described in NUREG-1492) have been made in which iodine uptake was measured in people exposed to a patient. These data suggest that the fraction uptake of the administered activity will be on the order of 10.
Since iodine is among the most soluble and volatile radiopharmaceuticals, it can be expected that the transfer to others of less soluble and less volatile radiopharmaceuticals would less than that of iodine. Thus, the NRC considers use of the factor appropriate on a general basis.
In addition, the NCRP recently concluded that for individuals exposed to radionuclide therapy patients the riska of external-irradiation and potentfal contamination are minor from a public health viewpoint; therefore a AM C h
significant intake from a contamination incident is very unlikel Comment: A medical organization commented that the draft guide is not complete and does not provide sufficient comprehensive examples to assist licensees in complying with the rule.
DRAFT: May 31, 1995 31 l
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