ML25155A035
| ML25155A035 | |
| Person / Time | |
|---|---|
| Site: | 07109405 |
| Issue date: | 06/02/2025 |
| From: | Podolak L QSA Global |
| To: | Stroud H Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| EPID L-204-NEW-0010 | |
| Download: ML25155A035 (1) | |
Text
OSAGLOBAL 2 June 2025 ATTN: Document Control Desk Mr. Heath Stroud, Project Manager Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852-2738 RE: Additional Information Supporting Type B(U) Application for the Model 1100 Transport Package Design (Docket: 71-9405; EPID No: L-204-NEW-0010)
Dear Mr. Stroud:
QSA Global, Inc. submits the enclosed information in response to your letter dated 29 May 2025. This response contains proprietary documentation for which we request withholding from public disclosure under the provisions of 10 CFR §2.390(a)(4). The attachments to this letter include Attachment 1 which is the Affidavit required for proprietary documentation under §2.390 and Attachment 2 which includes the responses to the RAI questions which includes information considered proprietary to Model 1100 design. Attachment 2 is requested to be withheld from public disclosure based on the affidavit in Attachment 1.
Should you have any additional questions or wish to discuss this submission after receipt please feel free to contact me.
Sincerely, E-SIGNED by Lori Podolak on 2025-06-02 15:04:34 GMT Lori Podolak Senior Regulatory Affairs Specialist Regulatory Affairs Department Ph: (781) 505-8241 Fax: (781) 359-9191 Email: Lori. Podolak@qsa-global.com
Enclosures:
- : Affidavit Pursuant to §2.390 E-SIGNED by Mary Flanigan on 2025-06-02 15:27:47 GMT RA/QA Approval E-SIGNED by Ryan Trulli on 2025-06-02 16:12:45 GMT Engineering Approval
- : RAI Response Information - Proprietary CC:
Document Control Desk Page 1
OSAGLOBAL
- : Affidavit Pursuant to 10 CFR §2.390 Page2
QSA GLOBAL AFFIDAVIT Pursuant to 10 CFR §2.390 I, Lori Podolak, Senior RA/QA Specialist of QSA Global, Inc. hereby affirm and state:
- 1. I have been specifically delegated the function of reviewing the information sought to be withheld and am authorized to apply for its withholding on behalf of QSA Global, Inc.
- 2. QSA Global, Inc. is providing NRC with a technical details, specifications and product related information as parts of the responses to questions raised by the NRC for the Model 1100 transport package. These responses contain proprietary commercial information related to the Model 1100 package design.
- 3. The information sought to be withheld pursuant to the provisions of 10 CFR §2.390(a)(4) are marked as follows in Attachment 2 of our application letter "Proprietary information submitted under 10 CFR §2.390 to be withheld from public disclosure under 10 CFR
§2.390."
- 4. These documents should be held in confidence by the NRC per 10 CFR §2.390(a)(4) based on the following justifications:
- a. This information is owned and been held in confidence by QSA Global, Inc.
- b. This information is of a type that QSA Global, Inc. has determined should be held in confidence since its release for public disclosure could result in a loss of an existing or potential competitive advantage as follows:
- i. The information reveals the distinguishing aspects of the design (including its design function in the package). The prevention of its use by QSA Global, Inc. competitors gives QSA Global, Inc. a competitive economic advantage.
ii. The information reviews testing, assessment or other evaluations (including calculations) that demonstrate and/or justify compliance of the design/design components to the transport requirements.
iii. The information, if used by a competitor, is likely to reduce the competitor's expenditure of resources or improve their advantage in design, quality and manufacture of a similar product.
- c. This information is being transmitted to the NRC voluntarily and in confidence for use in evaluation and approval of this package design for Type B(U) transport certification.
- d. This information is not available in public sources.
- e. Public disclosure of this information is likely to cause substantial harm to the competitive position of QSA Global, Inc. because of the reasons outlined below:
- i. Similar products are manufactured and sold by competitors of QSA Global, Inc.
Page 3
QSAGLOBAL ii. The development of this information by QSA Global, Inc., including test/evaluation documentation supporting this package design, is the result of significant expenditure of staff effort and a considerable amount of money. It is our belief that a competitor would have to undertake similar effort and expense to generate equivalent information.
iii. In order to generate such information, a competitor would also require considerable time (e.g., in excess of 1 year).
iv. If a competitor used this information and did not have to undertake the work required to generate this information, they are likely to. have lower overall costs and so are likely to have an unfair economic advantage over QSA Global, Inc. in offering a similar product to the market.
- 5. QSA Global has spent considerable commercial and technical resources to design and build this transport package design which incorporates improvements and design innovations over our other package designs. These design changes are unique to the package's ability to function as an industrial radiographic exposure device intended for worldwide distribution. Access to the technical information for this unique design would give a competitor an unfair advantage in expanding their domestic and international market without having to perform their own research and development of the market needs and the ideal configuration of the transport package to meet a wide variety of customer needs.
Accordingly, QSA Global, Inc. requests that the designated information be withheld from public disclosure pursuant to 10 CFR §2.390.
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Lori Podolak Senior RA/QA Specialist Subscribed and sworn to ( or affirmed) before me on this ate.I day of.:r;,\\12 d 03,~
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