ML20207A749
| ML20207A749 | |
| Person / Time | |
|---|---|
| Issue date: | 03/09/1988 |
| From: | Carrico J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Strietelmeier LOS ALAMOS DIAGNOSTICS |
| Shared Package | |
| ML20205J307 | List: |
| References | |
| 020364, 20364, NUDOCS 8803150042 | |
| Download: ML20207A749 (2) | |
Text
MAR 0 91933 Los Alamos Diagnostics ATTN: Betty A. Strietelmeier QA Panager 2470 East Road P.O. Box 1221 Los Alamos, New Mexico 87544
Dear Ms. Strietelmeier:
This refers to your letter dated November 13, 1987, requesting a license unda Section 32.18 of 10 CFR Part 32 to distribute certain quantities of radioactive materials to persons exempt from licensing pursuant to Section 30.18 of 10 CFR i
Part 30. We find that the following additional infomation f s needed in support of your request.
I
/ 1.
Your November 13th letter enclosed a prototype brochure entitled, "Calibra-tion Standard for Los Alamos Diagnostics' Luminometers." (We assume this is a copy of the brochure you intend to include with the standards when distributed as required by Section 37.19(d), please confirm.) This brochure contains instructions to the user concerning disposal of the standards.
You should note that paragraph 30.18(a) of 10 CFR Part 30 exempts persons (with certain exceptions) who possess these quantities from the require-ments for a license.
Section 20.2 of 10 CFR Part 20 specifies that the requirerents in that Part (20) only apply to persons who possess material licensed pursuant to the regulations.
Therefore, your customers are except from Part 20 requirements, including those concerning disposal. Any information in the brochure which implies that the users are subject to regulatory requirements is inappropriate and rust be deleted. Also, references to licensed waste disposal firms and effluent release require-ments must be deleted.
/ 2.
Paragraph 32.19(d)(3) requires that the brochure provide appropriate radiation safety precautions for handling, use, storage, and disposal of the radioactive material. As noted above, the instructions should not imply that re5ulatory requirements rust be met.
Instead, the instructions should only describe the general radiation safety precautions which should be observed.
For example, disposal instructions should inform users that labels and radiation caution symbols are to be removed or defaced prior to
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disposal; storage instructions should identify the need for proper security.
C 3.
The infomation you provided concerning the label appears to indicate that the storage container rather than the source itself will be labeled.
Note that paragraph 32.19(c) requires that the label be on the imediate container (e.g.,thesource)ofeachquantity.
It would not be inappropriate to also label the storage centainer, hcwever the source itself must be labeled. Also, the statement which appears at the bottom of page concerning a general license should be deleted.
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lAAR 0 91938 Betty A. Strietelmeier Paragraph 32.19(c) also specifies that the label must be durable and legible. The label should be designed to raintain these characteristics over the expected useful life of the product. Please describe the label you intend to use to ensure these requirements will be net.
/.
Please provide details concerning your manufacturing procedures, including 4
the materials used to construct the source.
You should also describe the method and materials used to seal the source.
( 5.
Please provide more details concerning your procedures for ensuring that the maximum source activity is not exceeded, especially the role Los Alamos Laboratory will play. You should also describe procedures for testing finished sources for excessive removable contamination. Will each source be tested or a sarple from each lot?
Our review of your application request will continue upon receipt of the above infornation. Please reply within 30 days, in duplicate, and reference Mail Control No. 020364.
If you have any questions, please feel free to contact me at (301) 492-0634.
Sincerely, 5
J. Bruce arrico Medical,, Academic and Comercial Use Safety Branch Division of Industrial and Vedical Nuclear Safety, NMSS
Enclosures:
10 CFR Port 30 10 CFR Part 32 DISTRIBUTION HEC File Center IMNS Central File NMSS r/f hMS$ Office IMAB r/f MLamastra YMiller DFC: IMAB -g g NAME:ECarrico/bc DATE:03/[/88 CFFICIAL RECORD COPY
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