Guidance for DOE Use of DOE Certified Packages
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)
Offsite Safety Use and Quality Assurance Requirements for Type B or Fissile Packages certified by DOE
DOE Order 460.1D (link to pdf), Section 4.a., addresses the offsite safety requirements for use of Type B or fissile radioactive material (RAM) packages certified by DOE, by DOE elements or persons working under contract to DOE elements (i.e., DOE contractors). Use of a certified Type B or fissile RAM package includes all package operations, acceptance testing, and maintenance in accordance with the requirements of the certificate and Chapters 7 and 8 of the respective Safety Analysis Report for Packaging (SARP).
Section 4.a. of the Order also addresses the Quality Assurance (QA) requirements for Type B or fissile RAM package or packaging activities participated in by DOE elements or persons working under contract to DOE elements. Participants must have and maintain a QA program in accordance with 10 CFR Part 71, Subpart H that is approved by Headquarter Certifying Official (HCO), prior to the performance of the following activities: use, design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of Type B or fissile materials package or packaging.
Attachment 1 of the Order addresses these "use and QA requirements" as they apply to contractors and their subcontractors at any tier and to the extent necessary to ensure the contractor's compliance with the Order requirements. In other words, contractors are responsible to comply with and to flow down the use and QA requirements of the Order to their supply chain, as necessary.
This guidance webpage will hereafter refer to DOE elements or persons working under contract to DOE elements who participate in the aforementioned activities as a "User" of the package or packaging.
Certificate Holder Information
Certificate holder means a person who has been issued a certificate of compliance for a Type B or fissile RAM package design by DOE. Certificates are posted on
DOE Certificates page. Users must obtain package or packaging documentation (e.g., SARP, drawings, etc.) from the certificate holder. The Department is either a DOE certificate holder of a Type B or fissile RAM package, or lessee of a package from a commercial DOE certificate holder. The User must have written permission (letter, memorandum, or email) from the certificate holder to use the package. A list of certificate holder contacts is posted on the
Points Of Contact page. In either case, the following use and QA requirements of the Order are applicable to the User.
QA Program Approval - Prerequisite for Becoming a Registered User
The Order requires Type B or fissile RAM package Users to have a QA Program (QAP) approved by the HCO, in accordance with 10 CFR Part 71, Subpart H, prior to participating in the use, design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of Type B or fissile RAM package/packaging. The steps and process to submit a QAP for HCO approval is posted on
RAMPAC QA Frequently Asked Questions . The status of QAPs approved or under review by the HCO are posted on
RAMPAC QA Docket Status.
Therefore, HCO approval of the User's 10 CFR 71 Subpart H compliant QAP is a prerequisite for becoming a registered User of a package.
Requirements for Conditions of Use - Becoming a Registered User
The Order requires two conditions for use of a Type B or fissile RAM package certified by DOE. First, a User must meet the conditions specified in the DOE certificate of compliance (Note - any User questions concerning a condition specified in a DOE certificate should be referred immediately to the DOE Packaging Certification Program Manager, Dr. Shuler, (301) 903-5513,
james.shuler@em.doe.gov, for resolution or clarification). Second, a User must be registered with the HCO prior to first use of the package.
Users will register with the HCO, after they have a 10 CFR 71 Subpart H compliant QAP approved by the HCO.
The process and form to register with the HCO is posted on
Certificate User Instructions and Registration. The User will be added to the
Registered User List for the applicable DOE certificate, after the User's registration form is received, complete, and approved.
Consignees of DOE certified packages must also be registered Users, if the consignee is opening the package in accordance with the certificate and SARP (e.g., operating the package).
Guidance Summary
Users must –
- Have and maintain a 10 CFR 71 Subpart H QAP approved by the HCO, prior to performing activities related to the package or packaging.
- Register in writing with the HCO prior to first "use" of the package,
- Obtain permission and the required documentation from the certificate holder for use of the package, and
- Make shipments and perform package or packaging activities in accordance with the terms and conditions specified in the DOE Certificate of Compliance, the SARP of the package design, and the QAP approved by the HCO.
Questions or comments? Contact the DOE Packaging Certification Program Manager, Dr. Shuler, (301) 903-5513,
james.shuler@em.doe.gov
Updated July 9, 2018