ML19141A200
| ML19141A200 | |
| Person / Time | |
|---|---|
| Issue date: | 05/23/2019 |
| From: | Hipolito Gonzalez NRC/NMSS/DMSST/MSLB |
| To: | Vanderpool C Hopewell Designs |
| Arribas-Colon M | |
| Shared Package | |
| ML19023A155 | List: |
| References | |
| SSD 19-14 | |
| Download: ML19141A200 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 23, 2019 Hopewell Designs, Inc.
ATTN: Christopher Vanderpool Radiation Safety Officer 5940 Gateway Drive Alpharetta, GA 30004
SUBJECT:
DISCONTINUATION HOPEWELL DESIGNS, INC. APPLICATION FOR A NEW SEALED SOURCE AND DEVICE REGISTRATION CERTIFICATE DATED JANUARY 16, 2019
Dear Mr. Vanderpool:
This letter is in response to your application dated January 16, 2019, requesting a new sealed source and device registration certificate for Model DI-10C dosimeter calibrator. In reviewing your application, we find that it is lacking significant amounts of the required information. In the enclosure to this letter, we have summarized the issues not addressed in your application.
With incomplete information and unavailability of adequate information, the U.S. Nuclear Regulatory Commissions (NRCs) staff is unable to complete a safety evaluation of your application. Therefore, we have discontinued the review of your application. This action is taken without prejudice to submission of the required information. A new action will be opened once the NRC receives a complete application per the requirements in Title 10 of the Code of Federal Regulations (10 CFR) Sections 32.210. If you resubmit the application within 12 months from the date of your original application, you do not need to pay an additional application fee.
Please be aware that upon your request, proprietary information submitted to the NRC may be withheld from public disclosure. To do this, you must follow the procedures in 10 CFR Paragraph 2.390(b) including requesting withholding at the time the information is submitted and complying with the document marking and affidavit requirements set forth in 10 CFR 2.390(b)(1).
In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records component of NRCs Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
If you have any questions, please contact me at 301-415-5637, or via e-mail at Hipolito.Gonzalez@nrc.gov.
Sincerely,
/RA/
Hipolito Gonzalez, Chief Materials Safety and Tribal Liaison Branch Division of Material Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated
ML19023A155(pkg) ML19141A200 *via email OFC MSST/MSTB MSST/MSTB MSST/MSTB MSST/MSTB NAME MArribas-Colon CValentin-Rodriguez*
THerrera HGonzalez DATE 5/22/2019 5/22/2019 5/22/2019 5/23/2019
Enclosure Hopewell Designs, Inc. Application Dated January 16, 2019 The following issues need to be addressed in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Section 32.210 and the information described in the relevant guidance document NUREG-1556, Volume 3, Revision 2, titled Applications for Sealed Source and Device Evaluation and Registration.
Prototype Testing/Historical Use
- 1. The information and attachments submitted in your response to Question No. 2 (prototype testing) of NRC request for additional information dated April 10, 2019, do not adequately demonstrate that the product will maintain its integrity during normal use and likely accident conditions, or address concerns about the integrity of the device in normal conditions of use. At a minimum the device should be submitted to a drop test, vibration, fire and post-tests radiation measurements in order to demonstrate that the device will maintain its integrity as predicted in your analysis in Appendix B. The NRC typically considers that an increase of radiation greater than 20 percent constitutes a compromise of the shielding integrity. The information provided in your response does not provide reasonable assurance that in the event of an accident your device will not disperse the material and that the source will remain in its protective housing.
Based on the statements above, please submit prototype testing that verifies that the product design will maintain its integrity when subjected to conditions of normal use and likely accident conditions. The NRC may accept one of the following methods: (1) testing a prototype of the product, (2) performing an engineering analysis, (3) operational history of the product, or (4) comparison to a similar or equivalent model previously reviewed and registered.
Radiation Profiles
- 2. In Appendix B of your letter dated April 10, 2019, Table 1 showed the maximum radiation levels with the lid and the shutters opened, and the sources exposed. Table 1 indicated that the levels for Am-241 are 411 mR/hr (at contact), 12.4 mR/hr (at 30 cm), and 2.6 mR/hr (at 100 cm) and for Cl-36 are 265 mR/hr (at contact), 5.6 mR/hr (at 30 cm), and 0.17 mR/hr (at 100 cm), respectively. The measured radiological surveys on Appendix H of your application dated January 16, 2019, indicated that the radiation levels with the sources exposed ranges from 0.01-0.05 mR/hr; 0.05 mR/hr being the highest reading. Please clarify this apparent discrepancy.