ML19177A354

E-Mail from E. Sacay (Best Theratronics) to N. Garcia-Santos/NRC Request for Information: Renewal of Model No. F431

ML19177A354
Person / Time
Site:	07109310
Issue date:	06/25/2019
From:	Sacay E Best Theratronics, Ltd
To:	Garcia-Santos N Spent Fuel Licensing Branch
Garcia-Santos N
Shared Package
ML19177A353	List: ML19177A354
References
Download: ML19177A354 (5)

Text

From:

Edna Sacay To:

Garcia Santos, Norma Cc:

McKirgan, John; Mojgan Soleimani; Victor Moga; Viktor Eichler

Subject:

[External_Sender] RE: Request for information: Renewal of Model No. F431 Date:

Tuesday, June 25, 2019 4:16:12 PM Attachments:

F643101-001_E, Sheet 2.pdf F643101-001_J, Sheet 1.pdf Importance:

High Good afternoon Norma,

This email is in response to your request for information dated June 14, 2019 regarding the clarification and missing information within the F431 consolidated renewal application. The planned revisions to the SAR document are stated below, which will be implemented and the SAR submitted to the USNRC upon satisfactory information acknowledgement. The response follows in the same format as your email below:

1. ML041970402 (April 16, 2004)

a. Consolidated application clarification:

i. Item 2.4 - Please see drawing F643101-001, Sheet 1 of 2 (left top). The warning statement is visibly painted on the top of the transport package.

ii. Item 2.6 - The ASTM A193, Gr. B8 bolts are referred to in Para 2.6.4.3. And again they are listed in the drawing F643101-001, Sheet 1 of 2 as item 19. Related hex.

nuts ASTM A194, Grade 8, Class 2 are listed in the drawing F643101-001, Sheet 1 of 2 as item 20.

iii. Drawing is to read F643101-001. The section 7.2 contains now the detailed listing for preparing GC100/3000 for shipment and the reference to IN/DS 1892 F431 was removed. On the drawing F643101-001, Rev K, the Note 8 is still relevant and not to be removed.

b. Justification between 2004 and 2019 versions of Table 4.2 - Added currently manufactured and used C3100 source model.

c. The total maximum activity of the gamma cell, source models C-3000 and C-3001 will be reverted back to 113 TBq in the SAR.

2. ML042040293 (July 16, 2004) - This letter was to advise the US NRC about change in fasteners and so to amend two certificates, for the F-430 and F-431 Transport Packages. The F-430 is not a part of this (F-431 transport package) application. Therefore there is no need to provide the F-430 drawing as part of the consolidated application.

3. ML042080284 (July 21, 2004) - The Assessment of the F-430 Tie-Down Collar Bolted Connection calculation will be added to the SAR as Section 2.4.6 and Appendix 2.10.8.

4. ML042180352 (July 23, 2004) - The Assessment of the F-430 Tie-Down Collar Bolted Connection calculation will be added to the SAR as Section 2.4.6 and Appendix 2.10.8.

5. ML11308A474 (October 21, 2011) - Page 8 (Fig. 1.1 Main Components) in IN/TR 1913 SAR will be replaced with pages 4 and 5 from IN/TR 6087 and will be named 1.1a and 1.1b. No affidavit is required.

6. ML16224A932 / ML16224A930 (Feb 15, 2012) - Page 8 (Fig. 1.1 Main Components) in IN/TR 1913 SAR will be replaced with pages 4 and 5 from IN/TR 6087 and will be named 1.1a and 1.1b. No affidavit is required.

7. ML120790138 (Mar 9, 2012) - The Supplementary SAR for the F430 Transport Package IN/TR 6088 F430 (C) will be added to the Appendix 2.10.3 under 2.10.3b. All references in IN/TR 1913 to Appendix 2.10.3 will be changed to Appendices 2.10.3a and 2.10.3b.

8. ML15198A208 / ML15181A090 (June 8, 2015) - Appendix 5.5.1 will be added to include our current Registry of Radioactive Sealed Sources and Devices No. NR-1307-D-102-S, dated May 15, 2015.

9. Condition 5.(a)(3), Drawings, Revision 6, of the CoC for the Model No. F-431 includes on Drawing No. F643101-001, Sheet 1, Revision J, and Sheet 2, Revision E - See attached. The changes are as follows:

a. F643101-001 sheet 1 of 2: From Rev. J to K - There was no design change from Rev J to K.

The change in revision is only to reflect change to revision of the sheet 2 of 2. Please see small table Revision Status on the bottom of the drawing.

b. F643101-001 sheet 2 of 2 : From Rev. E to F - Revision from E to F was to introduce improvement and standardization to the plywood bracing construction. The same bracing can be used for unit with or units without additional security feature.

If any additional information is required, please do not hesitate to contact me.

Kindest regards,

Edna Sacay, MASc.

Radiation Safety Specialist

Best Theratronics Ltd.

413 March Rd, Kanata, ON K2K 0E4 Office: (613)591-2100 ext 2029 Fax: (613)591-5680 edna.sacay@theratronics.ca

From: Garcia Santos, Norma [1]

Sent: Friday, June 14, 2019 3:16 PM To: Edna Sacay Cc: McKirgan, John

Subject:

Request for information: Renewal of Model No. F431 Importance: High

Good afternoon Edna,

As previously communicated to you, the review of the renewal would not be finalized on 6/17/19. I reviewed your renewal application and have the following questions and requests in order to finalize the review (Please feel free to contact me if any questions. I am working from home on Monday and you can call me through the NRCs operator (301-415-7000). The table that I am included at the end of this email is to facilitate the process of looking for information):

1. In the April 16, 2004 (ADAMS Accession No. ML041970402) submittal the applicant agreed to make changes in the application. Nevertheless, the staff could not find some of the proposed changes in the consolidated application for the renewal of the Model No. F-431.

Therefore, the staff requests the following from the applicant:

a. Revise the consolidated application to include the changes agreed upon on item Nos.

2.4, 2.6, and 7.2.

i. Item 2.4, the staff is not able to find a statement in the application that reflects this change in the consolidated application.

ii. Item 2.6, the staff is not able to find one of the new specifications (i.e., ASTM A194, Grade 8, Class 2) in the consolidated application.

iii. Item 7.2, DWG. No. F64331001-001, Revision K, Note No. 8, still references IN/DS 1892 F431. Revise the consolidated application as appropriate.

b. Provide justification about the differences between the 2004 and the 2019 versions of Table 4.2 of the SAR.

c. In Table 4.2 of the SAR (2004), the applicant included the total maximum activity of the gamma cell, source models C-3000 and C-3001, as 113TBq. In the consolidated application submitted in 2019 to renew the CoC, these values were changed to 112.5 TB. Explain if this change was previously approved.

2. In the July16, 2004 (ADAMS Accession No. ML042040293) submittal the applicant provided

DWG No. 643001-001 (Sheet 1, Revision K, and Sheet 2, Revision D) for Model No. F-430.

Nevertheless, the staff could not find a reference to DWG No. 643001-001 (Sheet 1, Revision K, and Sheet 2, Revision D) in the consolidated application. Since it seems that this drawing is part of the licensing basis of this package, the staff requests the applicant to provide a reference to this drawing in the appropriate section of the application.

3. In the July 21, 2004 (ADAMS Accession No. ML042080284) submittal the applicant included a qualitative analysis for the down collar joint and the bolt engagement. The staff could not find a similar discussion in the consolidated application. The staff requests the applicant the following:

a. include the discussion related to the tie down collar joint and the bolt engagement as well as references of the appropriate documents in the consolidated application.

b. provide the enclosure to the July 21, 2004 submittal. The staff was not able to locate this information in ADAMS.

4. In the July 23, 2004 (ADAMS Accession No. ML042180352) submittal the applicant included a stress analysis. Nevertheless, the staff could not find this analysis in the consolidated application submitted for the renewal of the CoC. Therefore, the staff requests this analysis to be included in the consolidated application, since it appears that it is part of the licensing basis of the CoC.

5. In the October 21, 2011 (ADAMS Accession No. ML042180352) submittal the applicant provided a supplementary SAR [IN/TR 6087 F431(A)]. The staff was not able to find the figures provided in IN/TR 6087 F431(A). If these figures are still applicable to the package, the staff requests the applicant to include these figures in the consolidated application.

Also, the staff noticed that even though the SAR supplement was not masked as proprietary, the cover page and the drawings included statements related to proprietary information. Since the October 21, 2011 did not include an affidavit, if you wish to withhold drawings from future public disclosure, please provide an affidavit requesting withholding such information on the October 21, 2011 submittal.

6. In the February 15, 2012 [ADAMS Accession Nos. ML16224A932 (Letter) and ML16224A930 (response)] submittal the applicant provided a supplementary information to the application. The staff was not able to find the figures provided in the supplement (similar figures to the ones submitted on October 21, 2011). If these figures are still applicable to the package, the staff requests the applicant to include these figures in the consolidated application. Also, the staff noticed that even though the SAR supplement was not masked as proprietary, the cover page and the drawings included statements related to proprietary information. Since the February 15, 2012 did not include an affidavit, if you wish to withhold drawings from future public disclosure, please provide an affidavit requesting withholding such information on the February 15, 2012 submittal.

7. In the March 9, 2012 (ADAMS Accession No. ML120790138) submittal the applicant provided a document related to Model No. 430. This document needs to be referenced in the application/SAR since it is part of the licensing basis for the package. Also, the staff noticed that even though the SAR supplement was not masked as proprietary, the cover page and the drawings included statements related to proprietary information. Since the

March 9, 2012 did not include an affidavit, if you wish to withhold drawings from future public disclosure, please provide an affidavit requesting withholding such information on March 9, 2012 submittal.

8. In the June 8, 2015 (ADAMS Accession Nos. ML15198A208 and ML15181A090) submittal the applicant provided information related to the new source to be added as authorized contents of the package and registry of radioactive sealed sources and devices safety evaluation of a device (No. NRR-1307-D-102-S). Information related to the new source was incorporated in the application but not information about the source registry. Clarify of the intent is seeking approval of the information submitted in 2015 later.

9. Condition 5.(a)(3), Drawings, Revision 6, of the CoC for the Model No. F-431 includes on Drawing No. F643101-001, Sheet 1, Revision J, and Sheet 2, Revision E. The staff is not able to locate these versions of the drawings in ADAMS. Therefore, the staff asks the applicant to provide the following:

a. Drawing No. F643101-001, Sheet 1, Revision J, and Sheet 2, Revision E

b. A description of changes to Sheets 1 and 2 of Drawing No. F643101-001 for the Model No. F-431 from the 2015 (i.e., version Sheet 1, RevisionJ, and Sheet 2, Revision E) to the 2019 version (current revision numbers). The consolidated application must include the most recent version of the drawings as previously approved.

FYI: Summary of supplements (P=Public, NP=Non-Public)

Supplement Date Availability Type of Document ADAMS Accession No.

Drawing No.

Sheet No.

Version 4/16/04 NP RAI Response ML041970402 No drawings in this document.

NA NA NP RAI Response ML15198A209 DWG No. 643101-001, F-431/GC-1000/3000, Transportation Package Information Drawing 1

A?

DWG No. 643101-001, F-431/GC-1000/3000, Transportation Package Information Drawing 2

B 7/16/04 P

Revision ML042040293 No drawings in this document.

NA NA NP Revision ML042040294 DWG No. 643001-001, F-430 GC-40, Transportation Package Information Drawing 1

K DWG No. 643001-001, F-430 GC-40, Transportation Package Information Drawing 2

D DWG No. 643101-001, F-431/GC-1000/3000, Transportation Package Information Drawing 1

F DWG No. 643101-001, F-431/GC-1000/3000, Transportation Package Information Drawing 2

B 7/21/04 P

RAI Response ML042080284 No drawings in this document.

NA NA 7/23/04 P

RAI Response ML042180352 No drawings in this document.

NA NA 2/27/09 P

Quality Assurance ML091470528 No drawings in this document.

NA NA

Registration (71-943) 3/31/09 P

Ownership Change ML091000670 No drawings in this document.

NA NA 5/29/09 P

Renewal ML091630052 No drawings in this document.

NA NA 10/21/11 P

Revision ML11308A474 (letter, no affidavit)

No drawings in this document.

NA NA NP Revision ML11308A475 DWG No. 643101-001, F-431/GC-1000/3000, Transportation Package Information Drawing 1

G 2

C 2/15/12 P

RAI Response ML16224A930 (response)

ML16224A932 (Letter)

No drawings in this document.

NA NA NP RAI Response ML16224A391 DWG No. 643101-001, F-431/GC-1000/3000 Transportation Package Information Drawing 1

H 2

D 3/9/12 P

RAI Response ML120790138 Drawings redacted from document.

NP RAI Response ML12073A131 F643001-001, F-430 GC-40 Transportation Package Information Drawing 1

P 2

H 3

B 3/5/14 P

Renewal ML14076A108 No drawings in this document.

NA NA 6/8/15 P

Revision ML15198A208 (7/14/15)

No drawings in this document.

NA NA P

Revision ML15181A090 Drawings Redacted (C3100)

NA NA NP Revision ML15170A2206 C3100 Source Capsule 1

A

Have a nice weekend, Norma Garcia Santos Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission

Telephone No.: 301-415-6999 Email: Norma.Garcia-Santos@nrc.gov