ML21250A120
| ML21250A120 | |
| Person / Time | |
|---|---|
| Issue date: | 09/08/2021 |
| From: | Rolland J NRC/NMSS/DMSST/MSLB |
| To: | Wallace S Valmet |
| J. Rolland | |
| References | |
| 21-22 | |
| Download: ML21250A120 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
September 8, 2021
Steve Wallace Radiation Safety Officer Valmet, Inc.
2425 Commerce Ave.
Suite 100 Duluth, GA 30096
SUBJECT:
VALMET, INCORPORATED R EQUEST FOR ADDITIONAL INFORMATIO N
Dear Mr. Wallace:
This letter is in response to your application dated July 20, 2 021, requesting an amendment to your Sealed Source and Device Registration Certificate NR-0596-D-113-G to authorize the use of the Kr85.T3 source.
We do not have sufficient information to complete the review of your application. In the enclosure to this letter you will find the list of questions an d items not addressed in your application.
Please be aware that upon your request, proprietary information submitted to the U.S. Nuclear Regulatory Commission (NRC) may be withheld from public disclos ure. To do this, you must follow the procedures in Title 10 of the Code of Federal Regulations (10 CFR) Paragraph 2.390(b) including requesting withholding at the time the infor mation is submitted and complying with the document marking and affidavit requirements set forth in 10 CFR 2.390(b)(1).
We will continue our review upon receipt of this information. If we do not receive your reply within 30 calendar days from the date of this letter, we will c onsider your application as having been abandoned by you. This action would be without prejudice to the resubmission of another application with the required information.
In accordance with 10 CFR Section 2.390 of the NRCs Agency Ru les of Practice and Procedure, a copy of this letter will be available electronica lly for public inspection in the NRC Public Document Room or from the Publicly Available Records com ponent of NRCs Agencywide Documents Access and Management System (ADAMS). ADA MS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
S. Wallace 2
If you have any questions, please contact me at (301) 415-4059, or by e-mail at Joseph.Rolland@nrc.gov.
Sincerely, 9/8/2021
X
Joseph Rolland Mechanical Engineer Signed by: NRC-PIV Joseph Rolland, Mechanical Engineer MaterialsSafetyTribal and Liaison Branch DivisionofMaterialsSafety,Security,State, and Tribal Programs OfficeofNuclearMaterialSafety and Safeguards
Enclosure:
Request for Additional Information S. Wallace 3
SUBJECT:
VALMET, INCORPORATED REQUEST FOR ADDITIONAL INFORMATION
DATED: September 8, 2021
ADAMS ACCESSION NO.: ML21201A388 *Concurrence Via email OFFICE MSST/MSTB MSST/MSTB MSST/MSTB MSST/MSTB NAME JRolland THerrera LSepulveda JRolland DATE 9/7/21 9/7/21 9/8/21 9/8/21 OFFICIAL RECORD COPY
Enclosure VALMET, INC.
APPLICATION DATED July 20, 2021 REQUEST FOR ADDITIONAL INFORMATION
The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed the Valmet, Inc. (Valmet) application dated July 20, 2021, and determined that additional information is needed. In order to continue with our review, please address the issues listed b elow. This information is required by Title 10 of the Code of Federal Regulations (10 CFR) Section 32.210 and described in the relevant guidance document NUREG -1556, Volume 3, Revision 2, titled Applications for Sealed Source and Device Evaluation and Registration.
Description/Construction
- 1. Please confirm that there have been no changes made to BWM, BWM-T, BWM2, or BWM4 devices or source holder to accommodate the Kr85.T3 sealed source, this includes how the sealed source is secured/installed into the de vice source holders.
Radiation Profiles
- 2. In the amendment request, it states that the activity tolera nce for model Kr85.T3 is
+/-26.5%, providing a maximum activity of 506 mCi. In addition, t he amendment request also identifies that the KR85.1 sealed source may potentially h ave an activity tolerance of +35%, providing a maximum activity of 540 mCi. The registra tion certificate NR-0596-D-113-G states a maximum activity for KR85.1 of 400 mCi.
Since the BWM, BWM2, and BWM4 may contain up to a potential max imum of 540 mCi, please provide radiation profiles which reflect the potential m aximum activity contained in devices.
- 3. As noted above, due to the load tolerance, we note that the BWM-T is authorized to contain up to two sources Kr-85 please provide updated radiatio n profiles which reflect the potential maximum activity contained in the devices of 1080 mCi.
- 4. Please provide the date when the change to the Kr85.T3 mode l will be made.
- 5. Please confirm that the dose requirements for generally lice nsed user are not affected based on the potential maximum activity of 1080 mCi.
Quality Assurance (QA)
- 6. Please discuss any changes that have been made to Valmets Q A program.
- 7. According to the registration certificate NR-0596-D-113-G, t he QA program is compliant with ISO 9001-2008. Please indicate whether the program retains its ISO certification and if applicable please provide an updated ISO 9001 certificat e.
Enclosure