ML19345H101
| ML19345H101 | |
| Person / Time | |
|---|---|
| Issue date: | 12/01/1980 |
| From: | Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML19345H095 | List: |
| References | |
| FOIA-81-105 NUDOCS 8104300494 | |
| Download: ML19345H101 (2) | |
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NUCLEAR REGULATORY COMMISSION g
WASHINGTON, D. C. 2C155 g.
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w r*"**j December 1,1980
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3 TO ALL MEDICAL LICENSEES DISPOSAL 0F BYPRODJCT MATERIAL USED FOR CERTAIN I.N-VITRO CLIt'ICAL OR LABORATORY TESTING This letter is written in response to many inquiries to the Comission from licensees in regards to disposal of wastes ger.erated by in-vitro testing.
If you are performing certain in-vitro tests using byproduct materials, including "Bactec", you may be authorized to dispose of the waste in the non-radicactive trash.
You should carefully read all of the information contained in this letter to deternine if you are eligible and what steps are necessary to gain this authorization.
Under the provisions of 10 CFR 31.11 (copy enclosed), a general license may be issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer or use certain byproduct materials in' prepackaged form for in-vitro tests.
The provisions of this paragraph exe :t most byproduct materials used pursuant to the general license frca the requirements of 10 CFR Parts 19, 20, and.21.
Because of the exemption from the provisions of 10 CFR Part 20, most radioactive wastes generated in the use of these in-vitro tests may be disposed of as ordinary waste.
Before these materials can be discarded in the trash, all radiation labels should be recoved and destroyed.
The general license covers most in-vitro test kits, including "Bactec".
HOW TO OBTAIN AUTHORIZATION FOR THE GENERAL LICENSE I.
Group Medical Licensees.
Under the provisions of 10 CFR 35.14(c) any licensee whc is licensed for ore or more cf the groups in 10 CFR Part 35.100 is also authorized to use bypr: duct material specified under the Seneral license in 10 CFR 31.11 witn:ut filing Form NRC-483 as otherwise required by 31.11.
However, licensees are subject to all of tne other provisions of 10 CFR 31.11 in ~their use of in-vitro test materials.
Some group tedical licensees have specific authorization on their licenses for in-vitro test materials in amounts greater than those specified in 10 CFR 31.11.
If you use the general license, you must not eiceed the :;uantities authorized in 10 CFR 31.11 and your operations under the general license must De physically and administratively separate from those conducted ur. der your specific license.
If the materiais are used under your specific iicense, you are subject te all the rovisions of 10 CFR Parts 19, 20 and 21, including reairements es;arding waste disposal.
P00R ORIGINAL w%q
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To *11 Medical Licensees.
Medical Institutions Possessinc l'icenses of Bread Scoce.
Broad s;cpe licensees may file for tne general itcense in accordance with 13 CFR 31.11.
They rust file a Form NRC *S3 and they nust maintain all operaticns carried out under the provisions of the general license separate fror, those operations carried out under the
- revisions of their bread license.
- II. :c er Medical Licensees.
Other medical licensees cust follow the
- recedures as outlinec in 10 CFR 31.11 and must file Form NRC-483 with the Cc mission.
Sincerely, f
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..aterial Licensing Branch Division of Fuel Cycle and Material Safety E. mci es.re:
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P00R ORIGINAL