ML20141J272
| ML20141J272 | |
| Person / Time | |
|---|---|
| Issue date: | 05/02/1996 |
| From: | Schlueter J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stewart Schneider NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-060, AE41-2-60, NUDOCS 9708150219 | |
| Download: ML20141J272 (5) | |
Text
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. I The Commissioners 2 NRC's current patient release criteria are contained in 10 CFR 35.75, ' Release of patients or human research subjects containino radiopharmaceuticals or permanent-implants." That section states: "
release from confinement for medical care any(a) A licensee may not authorite subject administered a radiopharmaceutical until either: patient or human research dose rate from the patient or human research subject is les(1) The measured s than 5 millirens l per hour at a distance of 1 meter; or (2) The activity in the patient or human research subject is less than 30 mil 11 curies; b l release from confinement for medical care of an(y) patient or human researchA license subject administered a permanent implant until the measured dose rate from the patient or the human research subject is less than 5 milliress per hour at a distance of 1 meter."
Some licensees were uncertain about the effect that the revised 10 CFR Part 20 would have on patient releage criteria, and three petitions for rulemaking were received on the issue. To resolve this uncertainty, two steps were taken.
The short-term resolution was to inform licensees of the NRC's position that 10 CFR 35.75 governed patient release. The Commission was informed in SECY-94-01 release. of the staff's recommendation that 10 CFR 35.75 governs patient Information Notice No. 94-09.was issued on February 3, 1994, to inform licensees of this position in accordance with a Staff Requirements Memorandum (SRM) dated January 28, 1994.
The 1onser term resolution was to address this issue through rulemaking. A proposec rule was transmitted to the Commission in SECY-94-054 and responses to questions raised by the Office of the Inspector General are contained in SECY-94-054A.
to proceed withInthe anpro SRM dated May 11, 1994, the Commission directed the staff p
for comment on June 15,1994 posed rule. As a result, a draft rule was published rule for Commission approval,(59 FR 30724), and this paper transmits the final MAMi DIScOSSION:
The final ruleStates, the Agreement (Attachment as tel 1 takes into consideration the recommendations of rule and the petitions. as the comment letters received on the- proposed In all, 232 comment letters were received on the three petitions, and 63 comment letters were received on the proposed rule.
The rule was also discussed with the Advisory Committee on Medical Uses of
. 1995.
Isotopes (ACHUI) at several public meetings, the last on October 18 and 19, 3
One commenter raised an issue about contacts allegedly relating to this rulemaking between one of the petitioners and the Office of the Chairman. The staff notes that the final rule is based on the public record associated with the rulemaking and that the NRC decision maker w'th whom contact was made is no longer with the Commission. The staff has not included any further comment with respect to this issue in the final rulemaking package.
i i
FROM EDO e1.01.8000 18:00 P. 3 1
C. REGULATORY PDSITIDN i
). RELEASE CRITERIA '
1.1 Activitten for Relante of Pattants Licensees may demonstrate compliance with the dose limit in 10 CFR 35.75(a) for release of patients fron' licensee control if the activity administered is no greater than the activity in Column 1 of Table 1.In this case, no record of the release is required. If the activity administered exceeds the activity in Column 1 of Table 1, the licensee may hold the patient until the activity in the patient's body is no greater than Column 1 of Table 1 and then authorize release. In this case a record is required by 10 CFR 35.75(c) because the release is based on the retained activity rather 1
than the activity administered. - ,
1.2 Dose Ratan for Relente of Patients Licensees may also demonstrate compliance with the dose limit in 10 CFR 35.75(a) for release of patients from licensee control if the dose rate at 1 meter (from the patient centerline) is no greater than the value in Column 2 of Table 1 for that radionuclide. If the release is based on the dose rate at 1 meter, a record of the measured dose rate ic required by 10 CFR 35.75(c) because the measurement includes shielding by tissue. -
, i 1.3 Relentes Bated on Case-Snecific Factort' .
i Licensees may calculate the maximum likely dose to an individual exposed to the patient on a case-by-case basis to account for factors specific to a patient. ,
In such cases, licensees may be able to release a patient with radioactive material in excess of the activity listed in Table 1 and still demonstrate compliance with the annuti dose limit. Licensees may take into account the effective half-life of the radioactive material and other factors that may be relevant to the particular case.
DRAFT: October 13, 1995 5 i .
raon m et.ei.aase seine p. e Table 1.
Instructions AegivitiesandDeseRatesforAuthoriain9PatientReleaseand81ving i,
e t Column 1 Column t I
Column 3 Column 4 Dese Rate At Activity At or 1 meter At Requirina Below Which Or Below Requiring Patients May Instructlens if Instructions Be Released Which Activity Is If Dese Rates Patients May treater Than to Released at 1 meter is Radio- treater Than nuclido (mci) (Gle) teres /hr)
(act) (abe) (ares /hr) i An-111 500 to 4 100 4 2 Au-198 90 3 to to 0.7 4 Cr-51 100 4 t to 0.8 0.4 Cu-64 200 9 30 40 2 5 ,
Ga-67 200 9 20 40 2 4 I-123 160 6 20 '
30 1 4 I-125 8.7 0.32 (implant) 1 1.7 0.06 0.2 1-125 A 0.2 1 1.4 0.5 0.2 l I-131 [ 33 ) 1.t 7 6 0.24 I 1.4 In-111 Y Z to 10 0.4 4 !
Ir-192 1.6 0.06 0.8 0.3 0.01 0.1 '
P-32 100 4 NA 20 0.8 NA Pd-103 40 1.5 3
_ implants 7.9 0.29 0.7 i
Re-186 900 30 10 t00 7 2 '
Re-188 600 20 20 100 4 4 Sc-47 300 10 10 50 2 3 !
So-75 2 0.07 .5 .4 0.01 0.1 I Sm-153 700 30 30 100 5 '6 Sn-117m 30 1 4 6 _ 0. 2 0.8 Sr-89 l 100 4 NA 20 0.8 NA Tc-99m 700 30 50 100 6 10 T1-201 400 {
10 to 80 2 4 !
- Values rounded to one significant fi9ure, except in a few instances whereitwasconsideredappropriatetousetwosignificantfigures.The details of the calculations are shown in NUREG-14.2, Aegulatory Analysis on Criteria for the Release of Patients Administered Radioactive Material. .
DRAFT: October 13, 1995 7 ,
I i l
et.es.2ess 188e P. $
- 3. Ef&BQ1 3.1 Raened 'of Relanaa - i 4
There is no recordkeeping requirement for immediate release of patientsj based on Table 1. ;
However, if the release of the patient 12 based on factors :
other than the standard conservative assumptions on which Table 1 is based, i 10 CFR 35.75(c) requires that the licensee maintain, for 3 years, a record of I the basis for the release. For example, when the licensee releases a patient ;
with an activity that is greater than the value in the default table.'or the !
licensee maintains control of the patient until the retained activity is at or
'less than the value in the default table, a record of the basis for the-
~
Trelease must be maintained for NRC review during inspection.
Records should include (1) the patient's name, (2) the radioactive {
material, (3) the administered activity, (4) the date and time of administration, (5) the date and time of the patient's rslease, (6) the {
case-specific factors that were used in calculating the dose to the L i individual, and (7) the estimated dose to an individual exposed to the patient. Lin those instances for which a case-specific calculation applies to .
- - more than one patient release, the calculatio,n need not be performed again.
j
-The record for a particular patient's release could reference the calculation done for the class of patients.
3.2 Records of Instructions l
A record that instructions were provided is required by 10 CFR 35.75(d) if a woman is breast-feeding and failure to interrupt breast-feeding could j result (0.5 rem) in a dose to the beast-feeding child in excess of 6 mil 11siever,ts '
D. IMPLEMENTATION The purpose of this section is to provide information about the NRC staff's plans for using this regulatory guide.
. DRAFT: October 13, 1995 13 I
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