ML20141J279
| ML20141J279 | |
| Person / Time | |
|---|---|
| Issue date: | 05/02/1996 |
| From: | Gagner S NRC |
| To: | Schlueter J NRC |
| Shared Package | |
| ML20007J296 | List:
|
| References | |
| FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-061, AE41-2-61, NUDOCS 9708150244 | |
| Download: ML20141J279 (3) | |
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From: Sue Gagner To: WNPl.JRS1
-Date: 5/2/96 4:43pm
Subject:
PA ON A FINAL RULE -Reply Janet:.
Per our discussion, OPA would like to leave this phrase in. While looking at the draft press release, we saw a couple of other. things we wanted to change.
I have checked these out with'RES.
- .The revised draft press release is attached.
Sue:-
I have a final-rulemaking package here on patient release (Parts 20 & 35).
Stewart Schneider indicated that you had written the attached public announcement. Do you have any objection to eliminating the phrase in parenthesis re: natural background radiation of 300 mrem? It could be unnecessarily alarming to some readers.
-Let me know your thoughts.
Thanks, Janet x 1736 CC: TWD2.TWP9.SXS4 l
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NRC REVISES REGULATIONS ON RELEASE OF PATIENTS ADMINISTERED BYPRODUCT MATERIAL The Nuclear Regulatory Commission is amending its regulations governing the release of patients from a hospital or other Itcensed medical facility after they have received radioactive material for treatment or diagnostic purposes. The revisions respond to three petitions received on this subject.
Radioactive pharmaceuticals or radioactive implants are administered to approximately 8 to 9 million patients in the United States each year for diagnosis or treatment of disease. These patients can expose other persons l around them to radiation until the radioactive material has been excreted from their bodies or has become less intense due to radioactive decay.
Under the final rule, licensees may not authorize the release of patients if the estimated dose, to anyone in contact with the patient, would be greater than 500 millirems. (Typical natural background radiation in the United States is 300 millirems per year.) The new criteria are consistent with recommendations of the International Commission on Radiological I Protection and the National Council on Radiation Protection and Measurements.
Under c.urrent NRC medical use regulations, licensees are not permitted to authorize the release of patients to whom nuclear material has been ,
administered until either (1) the measured dose rate from the patient is less than 5 millirems per hour at a distance of 1 meter or (2) the radiopharmaceutical content of the patient is less than 30 millicuries.
The final rule amends the NRC's general radiation protection regulations ,
to exclude doses to individuals exposed to released patients. Release of patients containing radioactivity is instead governed by the more explicit 1 Attachment 6
a requirements of revised medical use regulations, which include, in addition to the 500-millirem per year limit, a requirement that, if the annual dose to an individual exposed to the patient is likely to exceed 100 millirems, the J
licensee must provide the patient with written instructions on how to minimize exposures to others. If the released individual may be breast-feeding an infant or child, the instructions must also include guidance on the interruption or discontinuation of breast-feeding and information on the consequences of failure to follow the guidance.
The revisions partially grant three petitions for rulemaking on criteria for release of patients who have been administered radioactive material. On June 12, 1991, March 9, 1992, May 18, 1992, and July 26, 1994, the NRC published Federal Register notices concerning receipt of the petitions from i Dr. Carol S. Marcus, the American College of Nuclear Medicine and the American Medical Association.
A proposed rule on this subject was published in the Federal Register on June 15, 1994. The final rule reflects public comments received.
The rule will be effective (120 days after publication of a Federal Register notice on ),
m 2 Attachment 6