Guidance for Type B or Fissile Package Certificate Content Questions
This guidance applies only to DOE elements or persons working under contract to DOE elements
DOE elements means programs, operations offices, field/site offices, and other organizational units of the Department of Energy, excluding those of the National Nuclear Security Administration. The list of DOE elements is posted here. 
(link to DOE Directives website).
Only DOE elements or persons working under contract to DOE elements (i.e., contractors) shall consign a DOE certified package for shipment. NRC licensees or Agreement State licensees shall not consign a DOE certified package for shipment, but can transfer the material on-site to DOE elements or persons working under contract to DOE elements, for consignment of the package. See NRC legal interpretation: Transfer by an NRC Licensee of Radioactive Material or of Radioactive-Contaminated Facility Components to the Department of Energy 
(External link to NRC website)
The following guidance is intended to provide a process for DOE elements or contractors to request and receive clarification regarding questions about authorized contents for packages certified by DOE, and guidance for DOE Certificate Holder evaluations of user content clarification requests.
Clarification Regarding Authorized Contents and Loading Configurations for Type B or Fissile Package Designs certified by DOE
Periodically, DOE registered users need clarification to ensure their contents or content loading configurations are compliant with those authorized in a Certificate of Compliance (CoC) for a Type B or fissile package design. The following steps are recommended by the DOE Packaging Certification Program (PCP) to obtain clarification:
- Describe your proposed contents and its loading configuration with respect to the CoC and note any and all deviations. Refer to §71.33 (b) and NRC Regulatory Guide 7.9, Section 1.2.2, for a complete and thorough content description. Any deviation from the explicit authorized content definition(s) or loading configuration(s) in the CoC will require a CoC amendment.
- Contact the Certificate Holder point of contact (https://rampac.energy.gov/home/package-certification-information/points-of-contact#DOE) to evaluate your proposed contents and loading configuration, and request they document their evaluation in writing.
If your proposed contents or loading configuration are not explicitly compliant with the CoC, work through the Certificate Holder to submit a request to DOE PCP to amend the CoC, or find another candidate package.
If your proposed contents and loading configuration are explicitly compliant with the CoC per the Certificates Holder’s evaluation, provide a copy of the evaluation to the DOE PCP Manager and maintain a copy with your package operations records, prior to shipment.
Content Evaluations by the Certificate Holder for Package Users
Each certificate issued by the DOE Certifying Official is based on the Safety Evaluation Report (SER) prepared by the DOE PCP Manager from staff's independent review and confirmatory analysis of the Certificate Holder's Safety Analysis Report of the package design (SARP), as supplemented.
- The package is only authorized for shipment of contents and content configurations explicitly listed in the CoC.
If the proposed contents or its loading configuration are not explicitly listed in the CoC, then a CoC amendment is required.
If the proposed contents or its loading configuration are explicitly listed in the CoC, then the Certificate Holder should document their content evaluation and provide a courtesy copy to the DOE PCP Manager, prior to shipment.
If a calculation is required in addition to the applicable SARP calculations to demonstrate that the proposed contents or loading configurations are explicitly compliant with the CoC, then a CoC amendment is required (i.e., the calculation must be independently reviewed by DOE PCP staff).
- It is unacceptable for a Certificate Holder to self-determine (e.g., a bounding evaluation or argument) that a proposed content or loading configuration that is not explicitly listed in the CoC may be offered for shipment in the package. Any deviation to the authorized contents or loading configurations listed in the CoC must be independently reviewed by DOE PCP staff.
Questions or comments? Contact the DOE Packaging Certification Program Manager, Dr. Shuler, (301) 903-5513,
james.shuler@em.doe.gov
Added October 1, 2019, updated August 26, 2021