Application for Package Approval

10 C.F.R. Part ..., Subpart D
in effectEffective: 2024-07-01

10 C.F.R. § 71.31 Contents of application.

(a) An application for an approval under this part must include, for each proposed packaging design, the following information: (1) A package description as required by § 71.33; (2) A package evaluation as required by § 71.35; and (3) A quality assurance program description, as required by § 71.37, or a reference to a previously approved quality assurance program. (b) Except as provided in § 71.19, an application for modification of a package design, whether for modification of the packaging or authorized contents, must include sufficient information to demonstrate that the proposed design satisfies the package standards in effect at the time the application is filed. (c) The applicant shall identify any established codes and standards proposed for use in package design, fabrication, assembly, testing, maintenance, and use. In the absence of any codes and standards, the applicant shall describe and justify the basis and rationale used to formulate the package quality assurance program.

10 C.F.R. § 71.33 Package description.

The application must include a description of the proposed package in sufficient detail to identify the package accurately and provide a sufficient basis for evaluation of the package. The description must include— (a) With respect to the packaging— (1) Classification as Type B(U), Type B(M), or fissile material packaging; (2) Gross weight; (3) Model number; (4) Identification of the containment system; (5) Specific materials of construction, weights, dimensions, and fabrication methods of— (i) Receptacles; (ii) Materials specifically used as nonfissile neutron absorbers or moderators; (iii) Internal and external structures supporting or protecting receptacles; (iv) Valves, sampling ports, lifting devices, and tie-down devices; and (v) Structural and mechanical means for the transfer and dissipation of heat; and (6) Identification and volumes of any receptacles containing coolant. (b) With respect to the contents of the package— (1) Identification and maximum radioactivity of radioactive constituents; (2) Identification and maximum quantities of fissile constituents; (3) Chemical and physical form; (4) Extent of reflection, the amount and identity of nonfissile materials used as neutron absorbers or moderators, and the atomic ratio of moderator to fissile constituents; (5) Maximum normal operating pressure; (6) Maximum weight; (7) Maximum amount of decay heat; and (8) Identification and volumes of any coolants.

10 C.F.R. § 71.35 Package evaluation.

The application must include the following: (a) A demonstration that the package satisfies the standards specified in subparts E and F of this part; (b) For a fissile material package, the allowable number of packages that may be transported in the same vehicle in accordance with § 71.59; and (c) For a fissile material shipment, any proposed special controls and precautions for transport, loading, unloading, and handling and any proposed special controls in case of an accident or delay.

10 C.F.R. § 71.37 Quality assurance.

(a) The applicant shall describe the quality assurance program (see Subpart H of this part) for the design, fabrication, assembly, testing, maintenance, repair, modification, and use of the proposed package. (b) The applicant shall identify any specific provisions of the quality assurance program that are applicable to the particular package design under consideration, including a description of the leak testing procedures.

10 C.F.R. § 71.38 Renewal of a certificate of compliance.

(a) Except as provided in paragraph (b) of this section, each Certificate of Compliance expires at the end of the day, in the month and year stated in the approval. (b) In any case in which a person, not less than 30 days before the expiration of an existing Certificate of Compliance issued pursuant to the part, has filed an application in proper form for renewal, the existing Certificate of Compliance for which the renewal application was filed shall not be deemed to have expired until final action on the application for renewal has been taken by the Commission. (c) In applying for renewal of an existing Certificate of Compliance, an applicant may be required to submit a consolidated application that is comprised of as few documents as possible. The consolidated application should incorporate all changes to its certificate, including changes that are incorporated by reference in the existing certificate.

10 C.F.R. § 71.39 Requirement for additional information.

The Commission may at any time require additional information in order to enable it to determine whether a license, certificate of compliance, or other approval should be granted, renewed, denied, modified, suspended, or revoked.

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