ML041810537
| ML041810537 | |
| Person / Time | |
|---|---|
| Issue date: | 06/29/2004 |
| From: | Kirkwood A NRC/NMSS/IMNS/MSIB |
| To: | Slodowitz M CAMPCO |
| References | |
| Download: ML041810537 (3) | |
Text
June 29, 2004 CAMPCO, Inc.
Motti Slodowitz, President 4625 W. Jefferson Blvd.
Los Angeles, California 90016
SUBJECT:
INSUFFICIENT INFORMATION FOR REVIEW OF APPLICATION FOR NEW EXEMPT DISTRIBUTION LICENSE
Dear Mr. Slodowitz:
This refers to your application dated June 2, 2004, requesting a Nuclear Regulatory Commission (NRC) exempt distribution license. This also refers to my letters to Paula Petry, of your staff, dated February 5, 2004, and March 5, 2004, requesting additional information and to my letter to you dated April 12, 2004, advising of our discontinued review. In addition, this also refers to my telephone conversation with Ms. Petry on March 23, 2004, again indicating that the activity of the timepieces was still to high to meet the NRC regulatory requirements in 10 CFR 32.14 and that we still needed a copy of your State of California radioactive materials possession license. I indicated to Ms Petry, during the telephone call, as I did in the letters, that you would need to decrease the activity of the timepieces to 25 millicuries or less total activity and the dial to 15 millicuries or less total activity of tritium in order to license the watches pursuant to 10 CFR 32.14. I also indicated in the call and the April letter that the other option would be to reapply for an NRC exempt distribution license pursuant to 10 CFR 32.22, but this would also require an engineering safety review and registry of the timepieces, which would mean an additional fee and greater review time. The engineering safety review would also require you to submit more detailed information on construction and design of the watches.
We note that your Betaglow activity information still indicates tritium content in excess of 25 millicuries per watch which conflicts with the labeling on the watch case you submitted, which indicates MILLICURUIES-UNDER 25-3H. If you wish to apply for a license under the higher activity provisions of 10 CFR 32.22, please submit the additional information required for an engineering safety review as described in the enclosure to this letter.
Since we do not have sufficient information to complete the review of your application, we have discontinued our review. We now consider your request for a new exempt distribution license as having been abandoned by you. This is without prejudice to your re-submission of your application, with our previous questions adequately answered or the submittal of the additional information required for an engineering safety review, at a later date.
In accordance with 10 CFR 2.790 of NRCs Rules of Practice, a copy of this letter will be available electronically for public inspection in NRCs Public Document Room or from the Publicly Available Records (PARS) component of NRCs document system (ADAMS). ADAMS is accessible from the NRC web site at http://www.nrc.gov/NRC/ADAMS/index.html (the Public Electronic Reading Room).
M. Slodowitz If you have any questions, please feel free to contact me at (301) 415-6140 or electronic mail:
ask@nrc.gov.
Sincerely,
/RA/
Anthony S. Kirkwood Materials Safety and Inspection Section A Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
10 CFR 32.22 Application Information DISTRIBUTION:
KBrock BBrown/LFARB ML041810537 MMoriarty CMurnahan/RIV DOCUMENT NAME: H:\\EXEMPT\\32.14\\DISCONTINUE\\CAMPCO06-29-04.WPD To receive a copy of this document, indicate in the box: "C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy OFFICE NMSS:MSIB NAME ASKirkwood:ask DATE June 29, 2004 OFFICIAL RECORD COPY
ENCLOSURE A summary of the process for you to be able to distribute exempt products such as tritium watches is below. I have provided you with direct links below. However, note that these links can also be reached through the U.S. Nuclear Regulatory Commission's (NRC's) main website at www.nrc.gov.
In order to possess, use, and distribute byproduct material, you must first satisfy the general requirements of 10 CFR 30.33 (http://www.nrc.gov/reading-rm/doc-collections/cfr/part030/index.html). Therefore, you must apply for and obtain a specific license authorizing the possession and use of byproduct material.
Based on the state(s) from which a device will be manufactured and/or distributed, either submit an NRC Form 313 to the appropriate U.S. Nuclear Regulatory Commission (NRC) regional office or, since the NRC has no regulatory jurisdiction in an Agreement State, contact the appropriate Agreement State office(s) for application information. Please note that the State of California is an Agreement State. The following link contains information on Agreement State contacts: http://www.hsrd.ornl.gov/nrc/asframe.htm. If possession and use will occur within a non-Agreement State (state that is under NRC jurisdiction), submit an NRC Form 313 to the appropriate NRC regional office (addresses available on the application form).
An applicant wishing to distribute or initially transfer products containing byproduct material, such as tritium watches, to persons exempt from licensing, must also obtain an exempt distribution license.
However, prior to licensing tritium watches for distribution, it will be necessary for the NRC Sealed Source Safety Staff to perform an engineering device review pursuant to the issuance of a device registration sheet. The product information to be submitted for a distribution license and a device registration is outlined in 10 CFR Part 32, specifically in Sections 32.22, 32.23, and 32.25, and in Regulatory Guide 6.9 and NUREG-1556, Vol. 3, "Applications for Sealed Source and Device Evaluation and Registration," and NUREG-1556, Vol. 8, "Program-Specific Guidance About Exempt Distribution Licenses." You can find these documents at the NRC web-site under Electronic Reading Room or at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556. While it is not necessary that you provide a sample of the tritium watches, you should submit detailed drawings of the device and an example of the point-of-sale package.
Most of the necessary application information can be found at the NRC web site address:
http://www.nrc.gov/materials/miau/mat-toolkits.html An application for an exempt distribution license should not contain information concerning the possession and use of radioactive material as covered in a possession license. Therefore, you should only answer questions 1 through 6, 12 and 13 on the enclosed NRC Form 313, "Application for Material License."
Regarding the fees required for NRC, you should contact Ms. Rosalyn Jones, of the License Fee and Debt Collection Branch, at (301) 415-7300, or by electronic mail at: www.rcj1@nrc.gov, for fee information.
Payment of the fee should be mailed, along with the application package, to the U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Washington, DC 20555. Please note that this fee is only for an NRC exempt distribution license and/or a device review.