Guidance for DOE User Application of 10 CFR 71.15, 71.22, and 71.23


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).

The DOE Packaging Certification Program (PCP) prepared this guidance in response to periodic questions from DOE Management & Operating (M&O) contractors that are registered with DOE for the Department’s use of packages certified by DOE or the Nuclear Regulatory Commission (NRC).  The primary benefit to DOE is the option to use less expensive packaging for shipment of low-risk fissile material.  

Introduction 
DOE nuclear facilities are not NRC licensees in terms used in 10 CFR Part 71, Packaging and Transportation of Radioactive Material.  However, the terms “licensee”, or “general license” used in Part 71 in this guidance are applicable to DOE as follows: a “licensee” or “general license” means a DOE element or M&O contractor that is registered with DOE PCP for the Department’s use of packages certified by DOE or NRC (see https://rampac.energy.gov/home/package-certification-information/guidance/registered-users for the list of registered users).  The prerequisite to registering with DOE PCP for the Department’s use of packages certified by DOE or NRC is the user must have a 10 CFR 71 Subpart H quality assurance program (QAP) that is approved by the DOE Headquarters Certifying Official (HCO) (see https://rampac.energy.gov/home/quality-assurance/qa-docket-status for users with QAPs approved by the HCO).  This prerequisite also meets the condition in §71.22(b) for “general licensees.”

This guidance was prepared by the DOE PCP to demonstrate the application of §§71.15, 71.22, and 71.23 to DOE elements and those under contract (i.e., M&O contractors) to DOE elements. 

The history, background, and technical basis for these regulations is documented in NUREG/CR-7239, Review of Exemptions and General Licenses for Fissile Material in 10 CFR 71.  This NUREG was used as a reference to prepare the guidance.  Please note, this guidance is not an official/formal interpretation by DOE PCP of 10 CFR Part 71, only the NRC can make official/formal interpretations, in writing, and in accordance with §71.2.

Sections 71.15, 71.22, and 71.23 include provisions that allow for shipment of fissile material in packages that do not require DOE or NRC certification.  These provisions include criteria for exemptions from classification as fissile material (§71.15) and shipments under the general license for limited quantities of fissile material and plutonium-beryllium special form sources (§§71.22 and 71.23, respectively).

Guidance
Section 71.15, Exemption from classification as fissile material, (also §173.453, Fissile materials—exceptions).
Safety Basis (from NUREG/CR7239): “The exemption criteria in 10 CFR 71.15 provide criteria for the fissile material type, quantity, form, moderation, and mass concentration deemed adequate to ensure that there are no credible means to achieve a critical condition for a package or accumulation of packages under normal conditions of transport or hypothetical accident conditions.”

DOE PCP Guidance: The criteria in these regulations are used to determine if fissile material or packages are exempt (NRC) or excepted (DOT).  The terms fissile exempt (NRC) and fissile excepted (DOT) are used synonymously in the regulations.  The radioactive material (RAM) in question could be a Type A or Type B quantity; however, if the fissile material or package meets the criteria, it is exempt from the fissile material package standards of §§71.55 and 71.59, but is subject to all other requirements of 10 CFR Part 71.  Likewise is it excepted from the requirements of 49 CFR 173 Subpart I for fissile materials, including the requirements of §§173.457 and 173.459, but is subject to all other requirements of 49 CFR 173 Subpart I, except as noted.

DOE User Application: If the RAM is a:
• Type A quantity and meets the fissile exempt/excepted criteria, then it may be shipped in DOT Type A packaging.
• Type A quantity and does not meet the fissile exempt/excepted criteria, then it still may meet the criteria of §71.22, otherwise it must be shipped in at least a Type AF packaging certified by DOE or NRC.
• Type B quantity and meets the fissile exempt/excepted criteria, then it must be shipped in Type B, Type B(U), or Type B(M) packaging certified by DOE or NRC.
• Type B quantity and does not meet the fissile exempt/excepted criteria, then it must be shipped in a Type B(U)F, or Type B(M)F packaging certified by DOE or NRC.
• Liquid solution of uranyl nitrate and meets the fissile exempt/excepted criteria, then it may be shipped in at least DOT Type A packaging.
• Liquid solution of uranyl nitrate and does not meet the fissile exempt/excepted criteria, then it must be shipped in Type AF, Type B(U)F, or Type B(M)F packaging certified by DOE or NRC, based on the A2 value of the mixture.   

Section 71.22, General license: Fissile material, and §71.23, General license: Plutonium-beryllium special form material.
Safety Basis (from NUREG/CR7239): “The general license criteria in 10 CFR 71.22 (fissile material) and 71.23 (Pu-Be special form material) are intended for the shipment of small quantities of fissile material per package with accumulation control provided by an assigned criticality safety index (CSI) for each package.  However, the general license provision requires that the fissile material be contained in a Type A package that meets U.S. Department of Transportation (DOT) requirements of 49 CFR 173.417(a) … to ensure the package withstands normal conditions of transport without dispersing fissile material.”

DOE PCP Guidance - The criteria in these regulations are used to determine the packaging and consignment requirements of Type A quantities of RAM with small quantities or low concentrations of fissile material.  However, these regulations include a prerequisite condition that the licensee “… has a quality assurance program approved by the Commission as satisfying the provisions of Subpart H of this part.” DOE elements or their M&O contractor meet this condition when their Subpart H QAP is approved by the DOE HCO.

DOE User Application: If the fissile material, package CSI, and shipment CSI:
• Meets the criteria of §71.22 or §71.23, then it may be shipped in DOT Type A packaging.
• Does not meet the criteria of §71.22 or §71.23, then it must be shipped in at least a Type AF packaging certified by DOE or NRC.

References 
References used to prepare this guidance: DOE Order 460.1D, 10 CFR Part 71, 49 CFR 173 Subpart I, and NUREG/CR-7239.


 
​Questions or comments? Contact the DOE Packaging Certification Program Manager, Dr. Shuler, (301) 903-5513, james.shuler@em.doe.gov

Added January 31, 2019



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