ML24275A095

Safety Evaluation Report - Certificate of Compliance No. 9310, Revision No. 8, for the Model No. F-431 Transport Package

ML24275A095
Person / Time
Site:	07109310
Issue date:	10/11/2024
From:	Storage and Transportation Licensing Branch
To:	Wassenaar R Best Theratronics, Ltd
Shared Package
ML24275A092	List: ML24275A093 ML24275A094 ML24275A095
References
EPID L-2024-RNW-0021, CAC 001029
Download: ML24275A095 (1)

Text

Enclosure 2 SAFETY EVALUATION REPORT Docket No. 71-9310 Model No. F-431 Transport Package Certificate of Compliance No. 9310 Revision No. 8

SUMMARY

By application dated September 16, 2024 (Agencywide Documents Access and Management System [ADAMS] No. ML24275A198), Best Theratronics Ltd. (the applicant) requested the renewal of Certificate of Compliance (CoC) No. 9310, for the Model No. F-431 transport package. The quality assurance program for this package is under Docket No. 71-00943.

The applicant did not request any changes to the package design or its authorized contents.

The certificate has been renewed for a 5-year term.

EVALUATION The staff reviewed the applicants requests to renew the CoC of the Model No. F-431. The Model No. F-431 package is used to transport gammacell units (ML19312A446).

In terms of the renewal, the staff reviewed the documents referenced in the CoC and determined that the documentation was available and complete. The staff verified that the consolidated application and the supplement listed in Revision 7 of CoC No. 9310 were available in ADAMS (ML19219A062 and ML19312A446).

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)

Condition 1.b, the revision No. of the certificate was increased to 8.

2)

Condition 3.b was revised to reflect the title of the application and submission date.

3)

Condition No. 9 was removed because the CoC would expire in November 2024.

4)

Condition No. 10 was renumbered as condition No. 9 revised to reflect the new certificate expiration date.

2 The REFERENCES section has been updated to include the date for this renewal request.

CONCLUSION The certificate has been renewed for a five-year term, which expires on November 30, 2029.

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. 8, on October 11, 2024.