Guidance for DOE Use of NRC 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 hereexternal (link to DOE Directives website).

Offsite Safety Use and Quality Assurance Requirements for Type B ​or Fissile Packages ​certified by NRC
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 NRC, 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 (SAR).

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 NRC. Certificates are posted on the NRC Certificates page.  Users must obtain package or packaging documentation (e.g., SAR, drawings, etc.) from the certificate holder.  The Department is either a NRC certificate holder of a Type B or fissile RAM package, or lessee of a package from a commercial NRC 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 QA​P 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 NRC.  First, a User must meet the conditions specified in the NRC certificate of compliance (Note - any ​User questions concerning a condition specified in a NRC 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 with NRC).  Second, a User must be registered with the HCO prior to first use of the package.

The HCO will register ​DOE with NRC, for DOE's use of a Type B or fissile RAM package certified by NRC.  Users in turn will then 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 page.  The User will be added to the Registered User List for the applicable NRC certificate, of which DOE is a registered User or certificate holder, after the User's registration form is received, complete, and approved

Consignees of NR​C certified packages must also be registered ​Users, if the consignee is opening the package in accordance with the certificate and SAR (e.g., operating the package).

Summary of User Requirements
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 NRC ​Certificate of Compliance, the SAR 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 April ​1​8, 2017



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