Package Approval Standards

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

10 C.F.R. § 71.41 Demonstration of compliance.

(a) The effects on a package of the tests specified in § 71.71 (“Normal conditions of transport”), and the tests specified in § 71.73 (“Hypothetical accident conditions”), and § 71.61 (“Special requirements for Type B packages containing more than 10 5 A2”), must be evaluated by subjecting a specimen or scale model to a specific test, or by another method of demonstration acceptable to the Commission, as appropriate for the particular feature being considered. (b) Taking into account the type of vehicle, the method of securing or attaching the package, and the controls to be exercised by the shipper, the Commission may permit the shipment to be evaluated together with the transporting vehicle. (c) Environmental and test conditions different from those specified in §§ 71.71 and 71.73 may be approved by the Commission if the controls proposed to be exercised by the shipper are demonstrated to be adequate to provide equivalent safety of the shipment. (d) Packages for which compliance with the other provisions of these regulations is impracticable shall not be transported except under special package authorization. Provided the applicant demonstrates that compliance with the other provisions of the regulations is impracticable and that the requisite standards of safety established by these regulations have been demonstrated through means alternative to the other provisions, a special package authorization may be approved for one-time shipments. The applicant shall demonstrate that the overall level of safety in transport for these shipments is at least equivalent to that which would be provided if all the applicable requirements had been met.

10 C.F.R. § 71.43 General standards for all packages.

(a) The smallest overall dimension of a package may not be less than 10 cm (4 in). (b) The outside of a package must incorporate a feature, such as a seal, that is not readily breakable and that, while intact, would be evidence that the package has not been opened by unauthorized persons. (c) Each package must include a containment system securely closed by a positive fastening device that cannot be opened unintentionally or by a pressure that may arise within the package. (d) A package must be made of materials and construction that assure that there will be no significant chemical, galvanic, or other reaction among the packaging components, among package contents, or between the packaging components and the package contents, including possible reaction resulting from inleakage of water, to the maximum credible extent. Account must be taken of the behavior of materials under irradiation. (e) A package valve or other device, the failure of which would allow radioactive contents to escape, must be protected against unauthorized operation and, except for a pressure relief device, must be provided with an enclosure to retain any leakage. (f) A package must be designed, constructed, and prepared for shipment so that under the tests specified in § 71.71 (“Normal conditions of transport”) there would be no loss or dispersal of radioactive contents, no significant increase in external surface radiation levels, and no substantial reduction in the effectiveness of the packaging. (g) A package must be designed, constructed, and prepared for transport so that in still air at 38 °C (100 °F) and in the shade, no accessible surface of a package would have a temperature exceeding 50 °C (122 °F) in a nonexclusive use shipment, or 85 °C (185 °F) in an exclusive use shipment. (h) A package may not incorporate a feature intended to allow continuous venting during transport.

10 C.F.R. § 71.45 Lifting and tie-down standards for all packages.

(a) Any lifting attachment that is a structural part of a package must be designed with a minimum safety factor of three against yielding when used to lift the package in the intended manner, and it must be designed so that failure of any lifting device under excessive load would not impair the ability of the package to meet other requirements of this subpart. Any other structural part of the package that could be used to lift the package must be capable of being rendered inoperable for lifting the package during transport, or must be designed with strength equivalent to that required for lifting attachments. (b) Tie-down devices: (1) If there is a system of tie-down devices that is a structural part of the package, the system must be capable of withstanding, without generating stress in any material of the package in excess of its yield strength, a static force applied to the center of gravity of the package having a vertical component of 2 times the weight of the package with its contents, a horizontal component along the direction in which the vehicle travels of 10 times the weight of the package with its contents, and a horizontal component in the transverse direction of 5 times the weight of the package with its contents. (2) Any other structural part of the package that could be used to tie down the package must be capable of being rendered inoperable for tying down the package during transport, or must be designed with strength equivalent to that required for tie-down devices. (3) Each tie-down device that is a structural part of a package must be designed so that failure of the device under excessive load would not impair the ability of the package to meet other requirements of this part.

10 C.F.R. § 71.47 External radiation standards for all packages.

(a) Except as provided in paragraph (b) of this section, each package of radioactive materials offered for transportation must be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed 2 mSv/h (200 mrem/h) at any point on the external surface of the package, and the transport index does not exceed 10. (b) A package that exceeds the radiation level limits specified in paragraph (a) of this section must be transported by exclusive use shipment only, and the radiation levels for such shipment must not exceed the following during transportation: (1) 2 mSv/h (200 mrem/h) on the external surface of the package, unless the following conditions are met, in which case the limit is 10 mSv/h (1000 mrem/h): (i) The shipment is made in a closed transport vehicle; (ii) The package is secured within the vehicle so that its position remains fixed during transportation; and (iii) There are no loading or unloading operations between the beginning and end of the transportation; (2) 2 mSv/h (200 mrem/h) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and (3) 0.1 mSv/h (10 mrem/h) at any point 2 meters (80 in) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point 2 meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and (4) 0.02 mSv/h (2 mrem/h) in any normally occupied space, except that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with 10 CFR 20.1502. (c) For shipments made under the provisions of paragraph (b) of this section, the shipper shall provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information. (d) The written instructions required for exclusive use shipments must be sufficient so that, when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery or unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public.

10 C.F.R. § 71.51 Additional requirements for Type B packages.

(a) A Type B package, in addition to satisfying the requirements of §§ 71.41 through 71.47, must be designed, constructed, and prepared for shipment so that under the tests specified in: (1) Section 71.71 (“Normal conditions of transport”), there would be no loss or dispersal of radioactive contents—as demonstrated to a sensitivity of 10−6 A2 per hour, no significant increase in external surface radiation levels, and no substantial reduction in the effectiveness of the packaging; and (2) Section 71.73 (“Hypothetical accident conditions”), there would be no escape of krypton-85 exceeding 10 A2 in 1 week, no escape of other radioactive material exceeding a total amount A2 in 1 week, and no external radiation dose rate exceeding 10 mSv/h (1 rem/h) at 1 m (40 in) from the external surface of the package. (b) Where mixtures of different radionuclides are present, the provisions of appendix A, paragraph IV of this part shall apply, except that for Krypton-85, an effective A2 value equal to 10 A2 may be used. (c) Compliance with the permitted activity release limits of paragraph (a) of this section may not depend on filters or on a mechanical cooling system. (d) For packages which contain radioactive contents with activity greater than 10 5 A2, the requirements of § 71.61 must be met.

10 C.F.R. § 71.55 General requirements for fissile material packages.

(a) A package used for the shipment of fissile material must be designed and constructed in accordance with §§ 71.41 through 71.47. When required by the total amount of radioactive material, a package used for the shipment of fissile material must also be designed and constructed in accordance with § 71.51. (b) Except as provided in paragraph (c) or (g) of this section, a package used for the shipment of fissile material must be so designed and constructed and its contents so limited that it would be subcritical if water were to leak into the containment system, or liquid contents were to leak out of the containment system so that, under the following conditions, maximum reactivity of the fissile material would be attained: (1) The most reactive credible configuration consistent with the chemical and physical form of the material; (2) Moderation by water to the most reactive credible extent; and (3) Close full reflection of the containment system by water on all sides, or such greater reflection of the containment system as may additionally be provided by the surrounding material of the packaging. (c) The Commission may approve exceptions to the requirements of paragraph (b) of this section if the package incorporates special design features that ensure that no single packaging error would permit leakage, and if appropriate measures are taken before each shipment to ensure that the containment system does not leak. (d) A package used for the shipment of fissile material must be so designed and constructed and its contents so limited that under the tests specified in § 71.71 (“Normal conditions of transport”)— (1) The contents would be subcritical; (2) The geometric form of the package contents would not be substantially altered; (3) There would be no leakage of water into the containment system unless, in the evaluation of undamaged packages under § 71.59(a)(1), it has been assumed that moderation is present to such an extent as to cause maximum reactivity consistent with the chemical and physical form of the material; and (4) There will be no substantial reduction in the effectiveness of the packaging, including: (i) No more than 5 percent reduction in the total effective volume of the packaging on which nuclear safety is assessed; (ii) No more than 5 percent reduction in the effective spacing between the fissile contents and the outer surface of the packaging; and (iii) No occurrence of an aperture in the outer surface of the packaging large enough to permit the entry of a 10 cm (4 in) cube. (e) A package used for the shipment of fissile material must be so designed and constructed and its contents so limited that under the tests specified in § 71.73 (“Hypothetical accident conditions”), the package would be subcritical. For this determination, it must be assumed that: (1) The fissile material is in the most reactive credible configuration consistent with the damaged condition of the package and the chemical and physical form of the contents; (2) Water moderation occurs to the most reactive credible extent consistent with the damaged condition of the package and the chemical and physical form of the contents; and (3) There is full reflection by water on all sides, as close as is consistent with the damaged condition of the package. (f) For fissile material package designs to be transported by air: (1) The package must be designed and constructed, and its contents limited so that it would be subcritical, assuming reflection by 20 cm (7.9 in) of water but no water inleakage, when subjected to sequential application of: (i) The free drop test in § 71.73(c)(1); (ii) The crush test in § 71.73(c)(2); (iii) A puncture test, for packages of 250 kg or more, consisting of a free drop of the specimen through a distance of 3 m (120 in) in a position for which maximum damage is expected at the conclusion of the test sequence, onto the upper end of a solid, vertical, cylindrical, mild steel probe mounted on an essentially unyielding, horizontal surface. The probe must be 20 cm (7.9 in) in diameter, with the striking end forming the frustum of a right circular cone with the dimensions of 30 cm height, 2.5 cm top diameter, and a top edge rounded to a radius of not more than 6 mm (0.25 in). For packages less than 250 kg, the puncture test must be the same, except that a 250 kg probe must be dropped onto the specimen which must be placed on the surface; and (iv) The thermal test in § 71.73(c)(4), except that the duration of the test must be 60 minutes. (2) The package must be designed and constructed, and its contents limited, so that it would be subcritical, assuming reflection by 20 cm (7.9 in) of water but no water inleakage, when subjected to an impact on an unyielding surface at a velocity of 90 m/s normal to the surface, at such orientation so as to result in maximum damage. A separate, undamaged specimen can be used for this evaluation. (3) Allowance may not be made for the special design features in paragraph (c) of this section, unless water leakage into or out of void spaces is prevented following application of the tests in paragraphs (f)(1) and (f)(2) of this section, and subsequent application of the immersion test in § 71.73(c)(5). (g) Packages containing uranium hexafluoride only are excepted from the requirements of paragraph (b) of this section provided that: (1) Following the tests specified in § 71.73 (“Hypothetical accident conditions”), there is no physical contact between the valve body and any other component of the packaging, other than at its original point of attachment, and the valve remains leak tight; (2) There is an adequate quality control in the manufacture, maintenance, and repair of packagings; (3) Each package is tested to demonstrate closure before each shipment; and (4) The uranium is enriched to not more than 5 weight percent uranium-235.

10 C.F.R. § 71.59 Standards for arrays of fissile material packages.

(a) A fissile material package must be controlled by either the shipper or the carrier during transport to assure that an array of such packages remains subcritical. To enable this control, the designer of a fissile material package shall derive a number “N” based on all the following conditions being satisfied, assuming packages are stacked together in any arrangement and with close full reflection on all sides of the stack by water: (1) Five times “N” undamaged packages with nothing between the packages would be subcritical; (2) Two times “N” damaged packages, if each package were subjected to the tests specified in § 71.73 (“Hypothetical accident conditions”) would be subcritical with optimum interspersed hydrogenous moderation; and (3) The value of “N” cannot be less than 0.5. (b) The CSI must be determined by dividing the number 50 by the value of “N” derived using the procedures specified in paragraph (a) of this section. The value of the CSI may be zero provided that an unlimited number of packages are subcritical, such that the value of “N” is effectively equal to infinity under the procedures specified in paragraph (a) of this section. Any CSI greater than zero must be rounded up to the first decimal place. (c) For a fissile material package which is assigned a CSI value— (1) Less than or equal to 50, that package may be shipped by a carrier in a nonexclusive use conveyance, provided the sum of the CSIs is limited to less than or equal to 50. (2) Less than or equal to 50, that package may be shipped by a carrier in an exclusive use conveyance, provided the sum of the CSIs is limited to less than or equal to 100. (3) Greater than 50, that package must be shipped by a carrier in an exclusive use conveyance, provided the sum of the CSIs is limited to less than or equal to 100.

10 C.F.R. § 71.61 Special requirements for Type B packages containing more than 105A2.

A Type B package containing more than 10 5A2 must be designed so that its undamaged containment system can withstand an external water pressure of 2 MPa (290 psi) for a period of not less than 1 hour without collapse, buckling, or inleakage of water.

10 C.F.R. § 71.63 Special requirement for plutonium shipments.

Shipments containing plutonium must be made with the contents in solid form, if the contents contain greater than 0.74 TBq (20 Ci) of plutonium.

10 C.F.R. § 71.64 Special requirements for plutonium air shipments.

(a) A package for the shipment of plutonium by air subject to § 71.88(a)(4), in addition to satisfying the requirements of §§ 71.41 through 71.63, as applicable, must be designed, constructed, and prepared for shipment so that under the tests specified in— (1) Section 71.74 (“Accident conditions for air transport of plutonium”)— (i) The containment vessel would not be ruptured in its post-tested condition, and the package must provide a sufficient degree of containment to restrict accumulated loss of plutonium contents to not more than an A2 quantity in a period of 1 week; (ii) The external radiation level would not exceed 10 mSv/h (1 rem/h) at a distance of 1 m (40 in) from the surface of the package in its post-tested condition in air; and (iii) A single package and an array of packages are demonstrated to be subcritical in accordance with this part, except that the damaged condition of the package must be considered to be that which results from the plutonium accident tests in § 71.74, rather than the hypothetical accident tests in § 71.73; and (2) Section 71.74(c), there would be no detectable leakage of water into the containment vessel of the package. (b) With respect to the package requirements of paragraph (a), there must be a demonstration or analytical assessment showing that— (1) The results of the physical testing for package qualification would not be adversely affected to a significant extent by— (i) The presence, during the tests, of the actual contents that will be transported in the package; and (ii) Ambient water temperatures ranging from 0.6 °C ( + 33 °F) to 38 °C ( + 100 °F) for those qualification tests involving water, and ambient atmospheric temperatures ranging from −40 °C (−40 °F) to + 54 °C ( + 130°F) for the other qualification tests. (2) The ability of the package to meet the acceptance standards prescribed for the accident condition sequential tests would not be adversely affected if one or more tests in the sequence were deleted.

10 C.F.R. § 71.65 Additional requirements.

The Commission may, by rule, regulation, or order, impose requirements on any licensee, in addition to those established in this part, as it deems necessary or appropriate to protect public health or to minimize danger to life or property.

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