ML21250A120

Valmet, Inc. Request for Additional Information, Ssd Case No. 21-22

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 REQUEST FOR ADDITIONAL INFORMATION

Dear Mr. Wallace:

This letter is in response to your application dated July 20, 2021, 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 and 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 disclosure. 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 information 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 consider 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 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.

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 Materials Safety Tribal and Liaison Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety 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 below. 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 device source holders.

Radiation Profiles

2. In the amendment request, it states that the activity tolerance for model Kr85.T3 is

+/-26.5%, providing a maximum activity of 506 mCi. In addition, the amendment request also identifies that the KR85.1 sealed source may potentially have an activity tolerance of +35%, providing a maximum activity of 540 mCi. The registration 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 maximum of 540 mCi, please provide radiation profiles which reflect the potential maximum 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 radiation 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 model will be made.

5. Please confirm that the dose requirements for generally licensed 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 QA program.

7. According to the registration certificate NR-0596-D-113-G, the 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 certificate.

Enclosure