ML20136F109
| ML20136F109 | |
| Person / Time | |
|---|---|
| Issue date: | 08/03/1984 |
| From: | Grace J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8408090153 | |
| Download: ML20136F109 (2) | |
Text
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,f AUG0g gg4 P MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety & Safeguards FROM: J. Nelson Grace, Director Division of Quality Assurance, Safeguards, and Inspection Programs Office of Inspection and Enforcement
SUBJECT:
PROPOSED REVISION OF 10 CFR PART 35
" MEDICAL USE OF BYPRODUCT MATERIAL" We concur with the subject revision of 10 CFR Part 35 and offer the following coments for your consideration. These. coments were discussed during a tele-phone conversation between Norman McElroy of your staff and Harriet Karagiannis of this office on July 23, 1984.
/ 1. Comission Paper, p. 7, last paragraph. Add a statement which will indicate that the proposal will ensure uniformity although it will also increase the inspecticn time in the field for inspectors to review the modified procedures which are currently reviewed by the licensing reviewers. According to the NRC regional offices, there are currently instances where the licensing staff spends at least eight hours evaluating and approving a licensee's modified procedure. Further, this may be only one of the several modified procedures which the licensee may have changed since the last inspection.
The procedures will have to be evaluated in the field by the inspectors instead of the current practice of having the evaluation performed by the licensing staff in the NRC regional offices.
/ 2. Enclosure 1, p. 65, 935.1, last sentence. The requirements and provisions of 10 CFR Part 71 must also apply to applicants and licensees subject to 10 CFR Part 35.
- 3. Enclosure 1, p. 84, 035.60b. This appears to be an unnecessary requirement.
6ilf* It will likely increase the occurrence of misadministrations since the M, technologists will be dealing with more equipment for the preparation of p the radiopharmaceuticals in rush hours. The reduction of the employees' exposures using these syringe shields will be. insignificant since the doses used for the preparation are not high. On the average there are only three or four preparations per day. Also the exposures may possibly be increased since the preparations area is a comon contamination area 4yg [ and contaminated syringe shields may be used by employees who are not using gloves to inject patients. This requirement will also impose an g additional expense on the medical licensees. They will have to purchase the glass type syringe shields to. enable them to see the desired volume.
Currently, these licensees may be using non-glass types of syringe shields.
Contact:
H. Karagiannis, IE 492-9655 L
Richard E. Cunningham .
v' 4. Enclosure 1, p. 84, %35.63. Change the title to read, " Vial Shield Labels," since the content of this item is on vial sh? eld labels.
f s 5. Enclosure 1, p. 86, 535.80. Add item (g) to read as following: " Transport "9 licensed materia'l in accordance with the requirements of 10 CFR 71.5(a)."
cp We will be glad to answer any questions you may have regarding our comments.
- c7 #
J. Nelson Grace, Director
/ Division of Quality Assurance, Safeguards, and Inspection Programs Office of Inspection and Enforcement
.