ML19330F966
| ML19330F966 | |
| Person / Time | |
|---|---|
| Site: | 07109310 |
| Issue date: | 11/26/2019 |
| From: | Dan Doyle Storage and Transportation Licensing Branch |
| To: | Soleimani M Best Theratronics, Ltd |
| Garcia-Santos N | |
| Shared Package | |
| ML19330F819 | List: |
| References | |
| EPID L-2019-RNW-0010 | |
| Download: ML19330F966 (5) | |
Text
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION November 26, 2019 Ms. Mojgan Soleimani Best Theratronics 413 March Road Ottawa, Ontario Canada K2K 0E4
SUBJECT:
CERTIFICATE OF COMPLIANCE NO. 9310, REVISION NO. 7, FOR THE MODEL NUMBER F-431 TRANSPORT PACKAGE (EPID NUMBER L-2019-RNW-0010)
Dear Ms. Soleimani:
As requested by your application dated May 23, 2019 (Agencywide Documents Access and Management System [ADAMS] No. ML19150A567), as supplemented on June 25, 2019 (ADAMS Accession No. ML19177A354), July 29, 2019 (ADAMS Accession No. ML19329A531),
and November 5, 2019 (ADAMS Accession No. ML19312A446), enclosed is Certificate of Compliance No. 9310, Revision No. 7, for the Model No. F-431 transport package. Changes made to the enclosed certificate are indicated by vertical lines in the margin. The staffs safety evaluation report is also enclosed.
The approval constitutes authority to use the package for shipment of radioactive material and for the package to be shipped in accordance with the provisions of Title 49 of the Code of Federal Regulations (49 CFR) 173.471. Those on the attached list have been registered as users of the package under the general license provisions of 10 CFR 71.17 or 49 CFR 173.471.
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION Upon removal of Enclosure 3, this document is uncontrolled
M. Soleimani 2
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION If you have any questions regarding this certificate, please contact me or Norma García Santos of my staff at 301-415-6999.
Sincerely,
/RA/
Daniel Doyle, Acting Chief Storage and Transportation Licensing Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 71-9310 EPID No. L-2019-RNW-0010
Enclosures:
- 1. Certificate of Compliance No. 9310, Revision No. 7
- 2. Safety Evaluation Report
- 3. Registered Users cc w/encls 1 & 2:
R. Boyle, U.S. DOT J. Shuler, U.S. DOE, c/o L.F. Gelder
M. Soleimani 3
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION
SUBJECT:
CERTIFICATE OF COMPLIANCE NO. 9310, REVISION NO. 7, FOR THE MODEL NUMBER F-431 TRANSPORT PACKAGE (EPID NUMBER L-2019-RNW-0010)
DATE: November 26, 2019 DISTRIBUTION: SFST r/f ADAMS Package Accession No.: ML19330F819, Letter: ML19330F966 This closes EPID No. L-2019-RNW-0010.
OFFICE/DIV NMSS/DFM NMSS/DFM NMSS/DFM NAME N. García Santos S. Figueroa by email D. Doyle DATE 11/25/19 11/26/19 11/26/19 OFFICIAL RECORD COPY
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION SAFETY EVALUATION REPORT Docket No. 71-9310 Model No. F-431 Transport Package Certificate of Compliance No. 9310 Revision No. 7
SUMMARY
By application dated May 23, 2019 (Agencywide Documents Access and Management System
[ADAMS] No. ML19150A567), as supplemented on June 25, 2019 (ADAMS Accession No. ML19177A354), July 29, 2019 (ADAMS Accession No. ML19329A531), and November 5, 2019 (ADAMS Accession No. ML19312A446), Best Theratronics Ltd. (the applicant) requested the renewal of Certificate of Compliance (CoC) No. 9310, for the Model No. F-431 transport package. The applicant also requested to remove MDS Nordion in Gammacell-1000 and Gammacell-3000 from the Description section of the certificate, since the package can transport these types of gammacells from other manufacturers (ADAMS Accession No. ML19312A446).
The applicant did not request any changes to the package design or its authorized contents.
The certificate has been renewed for a five-year term.
EVALUATION The staff reviewed the applicants requests to renew the CoC the Model No. F-431 and to remove MDS Nordion from the Description section of the certificate related to Gammacell-1000 and Gammacell-3000. Per the applicants request dated November 5, 2019, these gammacells have been, through the years, manufactured at the same facility under the same name but different owners such as the following:
- 1)
AECL (Atomic Energy of Canada Limited),
- 2)
Nordion International,
- 3)
MDS Nordion, and
- 4)
Currently, Best Theratronics.
The Model No. F-431 package is used to transport all these gammacell units (ADAMS Accession No. ML19312A446). Therefore, the removal of the phrase MDS Nordion does not affect the performance of the package.
In terms of the renewal, the staff reviewed the documents referenced in the CoC and determined that the documentation was available and complete. Given the number of supplements in the certificate for the Model No. F-431, the staff requested a consolidated application for this renewal. The staff verified that the information in the supplements listed in
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION 2
OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION Revision 6 of CoC No. 9310 was incorporated into the consolidated application (ADAMS Accession Nos. ML19177A354 and ML19329A531).
Based on the application and its supplements, the staff finds that the information provided by the applicant is adequate and the package continues to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 71.
CONDITIONS The following conditions of the CoC were revised or added to the certificate:
- 1)
In Condition No. 1.b., the revision No. of the certificate was increased to 7.
- 2)
Condition 3.b. has been revised as follows:
Best Theratronics application dated July 29, 2019, as supplemented.
- 3)
Condition 5.(a)(2) has been revised to deleted the phrase MDS Nordion.
- 4)
Condition 5.(a)(3) has been revised as follows to reflect different revision Nos. of the drawings:
The packaging is constructed in accordance with the Best Theratronics drawing F643101-001, F-431/GC-1000/3000 Transportation Package Information Drawing, Sheet 1, Revision K, and Sheet 2, Revision F.
- 5)
Condition No. 9 has been added to allow using Revision 6 of the CoC until November 30, 2020.
- 6)
Condition No. 9 was renumbered as Condition No. 10 and revised to reflect the new certificate expiration date.
The REFERENCES section has been updated to include the date of the last consolidated application submitted by the applicant for the renewal request (i.e., July 29, 2019) and the supplement requesting the removal of MDS Nordion from the Description of the certificate.
CONCLUSION The certificate has been renewed for a five-year term, which expires on November 30, 2024.
Based on the statements contained in the application, and the conditions listed above, the staff concludes that the changes to the certificate indicated by the applicant do not affect the ability of the package to meet the requirements of 10 CFR Part 71.
Issued with Certificate of Compliance No. 9310, Revision No. 7, on 11/26/2019.