Guidance for DOE Use of IAEA Certificates of Competent Authority for Special Form Radioactive Materials
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 here. 
(link to DOE Directives website).
Competent Authority
Each International Atomic Energy Agency (IAEA) member nation has a designated "Competent Authority." The United States Competent Authority is the Department of Transportation (DOT). Here is the complete list of IAEA National Competent Authorities. (link to pdf on IAEA website)
IAEA Certificate of Competent Authority for Special Form Radioactive Materials
Prior to the first export shipment of a Special Form Class 7 (radioactive) material from the United States, each offeror shall obtain, from the DOT, an IAEA Certificate of Competent Authority (CoCA) for the specific material. For special form materials manufactured outside the United States, an IAEA CoCA from the country of origin may be used to meet this requirement [ref §173.476(b) (link to the DOT regulation)].
Unlike a certificate for a Type B or fissile package, a CoCA issued by a foreign Competent Authority of an IAEA member nation does not need to be revalidated by DOT.
Although an IAEA CoCA itself meets the DOT documentation requirement (i.e., complete safety analysis, including documentation of any tests, demonstrating that the special form material meets the requirements of §173.469), a foreign IAEA CoCA may include references to other national documents that are required to use/ship the capsule, but these documents may not be easily obtained. DOT has seen other numerous issues with foreign CoCAs, including conditions that you ship in accordance with unobtainable foreign documents. Consequently, DOE PCP recommends if you’re purchasing a SF capsule (typically a RAM source) with a foreign IAEA CoCA, issued from an IAEA member state, make sure your purchase order includes the supplier providing the necessary documentation to use/ship the SF capsule, including all documents referenced as conditions of use in the IAEA CoCA, or to provide a complete safety analysis, including documentation of any tests, demonstrating that the special form material meets the requirements of §173.469.
A current listing of IAEA CoCAs issued by DOT is posted on the RAMPAC DOT-IAEA Certificates webpage, and are identified by the "/S" in the Package Identification Number (e.g., USA/0018/S-96).
Registration and Quality Assurance Requirements
There is no current requirement in the Hazardous Material Regulations, 10 CFR Part 71, or DOE Order 460.1D, to register with DOT as a consignor (i.e., user) of an IAEA CoCA for special form radioactive materials. However, the Quality Assurance (QA) requirement section in an IAEA CoCA typically states "... Consignors in the United States exporting shipments under this certificate shall satisfy the applicable requirements of Subpart H of 10 CFR 71." Furthermore, DOT does not require consignors to have an approved Subpart H QA Program (QAP), but only to satisfy the applicable requirements of Subpart H.
DOE Packaging Certification Program Recommended Process to Ensure Compliance
To ensure the applicable Subpart H QA requirements are satisfied, the DOE Packaging Certification Program (PCP) strongly recommends prospective CoCA consignors (i.e., only DOE elements or persons under contract to DOE elements) to follow the same process required for registering with DOE Headquarters Certifying Official (HCO) as a user of a Type B or fissile package certificate, that is, to register with the HCO as a CoCA user. This process independently ensures the CoCA user satisfies the the applicable requirements of Subpart H.
The steps and process to submit a QAP for DOE 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.
CoCA User Registration Process - Becoming a Registered User
The process and form to register with the HCO is posted on the Certificate User Instructions and Registration page. The User will be added to the Registered User List for the applicable CoCA, after the User's registration form is received, complete, and approved.
Guidance Summary
Users or consignors should -
- Have and maintain a 10 CFR 71 Subpart H compliant QAP approved by the HCO, prior to performing activities related to the Special Form source and
- Register in writing with HCO prior to consignment of the certified Special Form source.
Users or consignors must –
- Obtain the required documentation for use of the certified Special Form source, and
- Make shipments/consignments in accordance with the terms and conditions specified in the CoCA 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 May 25, 2021