ML20202F850
| ML20202F850 | |
| Person / Time | |
|---|---|
| Issue date: | 12/16/1976 |
| From: | Strauss P NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Gilinsky V, Kennedy R, Mason E, Rowden M, The Chairman NRC COMMISSION (OCM) |
| Shared Package | |
| ML20202F854 | List: |
| References | |
| SECY-76-574-C, NUDOCS 9902040190 | |
| Download: ML20202F850 (2) | |
Text
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MEMORANDUM FOR: Chairman Rowden -
Commissioner Mason Commissioner Gilinsky l Commissioner Kennedy p ,
FROM: Cb Peter L. Strauss, General Counsel ,e-f
SUBJECT:
SECY-76-574 (AMENDMENT TO 10 CFR PART 35: " HUMAN USES OF BYPRODUCT MATERIAL") l I have no objections, legal or otherwise, to the proposed amendment, as far as it goes, but this is not far enough. !
For example, I would feel more confident that miscalibra-tions would be brought promptly to the Commission's atten-tion if the proposed rule required licensees to make reports when a miscalibration exceeding a certain amount is detected, t rather than simply " maintain records", which may or may not '
come promptly to the attention of the Commission, depending on the frequency of inspections. .
Further, the rule is in no way responsive to the follow-up concerns expressed in the attached OGC memo of August 5 and noted by Commissioner Gilinsky. For example, there is no provision to guide (or compel) licensees in steps to remedy the consequences of past errors in dosages which calibration checks pursuant to the new rule may bring to light. Accord-ing to an earlier staff document (SECY-76-529, "The Issues g Concerning NRC Involvement in the Regulation of Nuclear Medicine" page 14) the staff is still considering amendments to 10 CFR Part 35, proposed by the AEC and published Septem-ber 9, 1973 (38 Fed. Reg. 6399), that would require reports to the Commission and to the patient of any "misadministra-tions of byproduct material," defined to include administra-tion of radiation "outside of the intended dose range l prescribed by the physician." This proposed rulemaking was
, based on a GAO recommendation "that was in turn based on GAO's review of the AEC's investigations of twelve instances of misadministrations of radioactive material (involving 20 l patients) between 1961 and 1972." The subsequent Riverside
Contact:
i E. Leo Slaggie 49-28155 i
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The Comm4 an 2 incident appears to point up strongly the need for something like what the GAO recommends.
I continue to regard Commission action in this direction as an immediate need and would hope to see a staff recommenda-tion shortly on the proposed AEC rule for dealing with the general problem of misadministration of byproduct materials.
With regard to the specific problem of misadministration in the teletherapy case and as a response to the concerns raised in this memorandum, I suggest replacing paragraph (b) (6) of the rule proposed in SECY-76-574 by the following two paragraphs:
Sec. 35.13(b)
(6) When measurements made pursuant to paragraphs (b) (1) and (b) (4) of this section indicate that patients treated by teletherapy units may have received a radiation dose differing from the prescribed dose by more than 10 per cent, the licensee shall notify the appropriate Regional Office of Inspection and Enforcement listed in Appendix D of 10 CFR Part 20, and, where practicable, the authorized physicians of affected patients. This notification shall be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee's discovery that such misadministration is likely to have occurred.
(7) The licensee shall maintain for inspection by the Commission records of the measurements made pursuant to paragraphs (b) (1) and (b) (4) of this section and of reports made to authorized physicians pursuant to paragraph (b) (6) of this section.
Attachment:
As stated cc/with attachment V. Gossick EDO K. Chapman, NMSS B. Huberman, OPE SECY (2) l l
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