(1) This chapter establishes requirements for packaging, preparation for shipment, and transportation of radioactive material.

(2) Licensees shall also comply with applicable requirements of NRC, DOT, the United States Postal Service1, and other requirements of Title 246 WAC.

(3) The regulations in this chapter apply to any licensee authorized by specific or general license issued by the department, NRC or an agreement state, to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the license, or transports that material on public highways. No provision of this chapter authorizes possession of licensed material.

No licensee shall deliver radioactive material to a carrier for transport, or transport radioactive material, except as authorized in a general or specific license issued by the department, NRC or an agreement state, or as exempted in this chapter.

The definitions, abbreviations, and acronyms in this section and in WAC 246-220-010 apply throughout this chapter unless the context clearly indicates otherwise. To ensure compatibility with international transportation standards, all limits in this chapter are given in terms of dual units: The International System of Units (SI) followed or preceded by U.S. standard or customary units. The U.S. customary units are not exact equivalents, but are rounded to a convenient value, providing a functionally equivalent unit. For the purpose of this chapter, either unit may be used.

(1) "A1" means the maximum activity of special form radioactive material permitted in a Type A package. This value is either listed in WAC 246-231-200, Table A-1 or may be derived in accordance with the procedures prescribed in WAC 246-231-200.

(2) "A2" means the maximum activity of radioactive material, other than special form material, LSA and SCO material, permitted in a Type A package. This value is either listed in WAC 246-231-200, Table A-1, or may be derived in accordance with the procedure prescribed in WAC 246-231-200.

(3) "Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

(4) "Certificate holder" means a person who has been issued a certificate of compliance or other package approval by NRC.

(5) "Certificate of compliance" means the certificate issued by NRC under 10 C.F.R. 71 Subpart D which approves the design of a package for the transportation of radioactive material.

(6) "Close reflection by water" means immediate contact by water of sufficient thickness for maximum reflection of neutrons.

(7) "Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

(8) "Containment system" means the assembly of components of the packaging intended to retain the radioactive material during transport.

(9) "Contamination" means the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2(1x10-5 µCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2(1x10-6 µCi/cm2) for all other alpha emitters.

(a) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.

(b) Nonfixed contamination means contamination that can be removed from a surface during normal conditions of transport.

(10) "Conveyance" means:

(a) For transport by public highway or rail any transport vehicle or large freight container;

(b) For transport by water any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

(c) For transport by any aircraft.

(11) "Criticality safety index (CSI)" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks, or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in WAC 246-231-094, 246-231-096, and 10 C.F.R. 71.22, 71.23, and 71.59. The criticality safety index for an overpack, freight container, consignment, or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack, freight container, consignment, or conveyance.

(12) "Deuterium" means, for the purposes of WAC 246-231-040 and 246-231-094, deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.

(13) "DOT" means the United States Department of Transportation. DOT regulations are found in Code of Federal Regulations Title 49 Transportation.

(14) "Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

(15) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium, and natural uranium or depleted uranium that has been irradiated in thermal reactors only are not included in this definition. Certain exclusions from fissile material controls are provided in WAC 246-231-040.

(16) "Graphite" means graphite with a boron equivalent content less than five parts per million and density greater than 1.5 grams per cubic centimeter.

(17) "Indian Tribe" means an Indian or Alaskan native Tribe, band, nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, 25 U.S.C. 479a. A current listing of officially recognized Indian Tribes may be found at: http://www.bia.gov/cs/groups/mywcsp/documents/text/idc-020733.pdf.

(18) "Low specific activity (LSA) material" means radioactive material with limited specific activity which is nonfissile or is excepted under WAC 246-231-040 or 10 C.F.R. 71.15 and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups:

(a) LSA-I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides which are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium, or their compounds or mixtures, provided they are unirradiated and in solid or liquid form; or

(iii) Radioactive material other than fissile material for which the A2 value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined in accordance with Appendix A.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/liter); or

(ii) Other radioactive material in which the activity is distributed throughout, and the estimated average specific activity does not exceed 1x10-4 A2/g for solids and gases, and 1x10-5 A2/g for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of the 10 C.F.R. 71.77, in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.); and

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed 0.1 A2; and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed 2x10-3 A2/g.

(19) "Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days.

(20) "Maximum normal operating pressure" means the maximum gauge pressure that would develop in the containment system in a period of one year under the heat condition specified in NRC regulations 10 C.F.R. 71.71 (c)(1), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.

(21) "Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232).

(22) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as "special form radioactive material."

(23) "Nuclear waste" as used in WAC 246-231-140 means any quantity of radioactive material (not including radiography sources being returned to the manufacturer) required to be in Type B packaging while transported to, through, or across state boundaries to a disposal site, or to a collection point for transport to a disposal site. Nuclear waste, as used in these regulations, is a special classification of radioactive waste.

(24) "Optimum interspersed hydrogenous moderation" means the presence of hydrogenous material between packages to such an extent that the maximum nuclear reactivity results.

(25) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) "Fissile material package" or Type AF package, Type BF package, Type B(U)F package or Type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) "Type A package" means a Type A packaging together with its radioactive contents. A Type A package is defined and must comply with the DOT regulations in 49 C.F.R. 173.

(c) "Type B package" means a Type B packaging together with its radioactive contents. Upon approval by NRC, a Type B package design is designated by NRC as B(U) unless the package has a maximum normal operating pressure of more than 700 kPa (100 lbs/in2) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in NRC regulations 10 C.F.R. 71.73 (hypothetical accident conditions), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see DOT regulations in 49 C.F.R. 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 10 C.F.R. 71.19.

(26) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of this chapter. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.

(27) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five mm (0.2 in); and

(c) It satisfies the requirements of 10 C.F.R. 71.75. A special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on June 30, 1983, (see 10 C.F.R. 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996 (see 10 C.F.R. 71, revised as of January 1, 1996), and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015, in accordance with the requirements of 10 C.F.R. 71.75(d) in effect before September 10, 2015, may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(28) "Specific activity of a radionuclide" means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

(29) "Spent nuclear fuel" or "spent fuel" means fuel that has been withdrawn from a nuclear reactor following irradiation, has undergone at least one year's decay since being used as a source of energy in a power reactor, and has not been chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, by-product material, source material, and other radioactive materials associated with fuel assemblies.

(30) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

(31) "Surface contaminated object (SCO)" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: A solid object on which:

(i) The nonfixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed four Bq/cm2 (1x10-4 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (1x10-5 microcurie/cm2) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4x104 Bq/cm2 (1.0 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 4x103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters; and

(iii) The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4x104 Bq/cm2 (one microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 4x103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters.

(b) SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:

(i) The nonfixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 400 Bq/cm2 (1x10-2 microcurie/cm2) for beta and gamma and low toxicity alpha emitters or 40 Bq/cm2 (1x10-3 microcurie/cm2) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8x105 Bq/cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or 8x104 Bq/cm2 (two microcuries/cm2) for all other alpha emitters; and

(iii) The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8x105 Bq/cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or 8x104 Bq/cm2 (two microcuries/cm2) for all other alpha emitters.

(32) "Transport index (TI)" means the dimensionless number (rounded up to the next tenth) placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one meter (3.3 ft) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 ft)).

(33) "Tribal official" means the highest ranking individual who represents Tribal leadership, such as the chief, president, or Tribal council leadership.

(34) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material, or A2 for normal form radioactive material, where A1 and A2 are given in Table A-1 of WAC 246-231-200, or may be determined by procedures described in WAC 246-231-200.

(35) "Type B quantity" means a quantity of radioactive material greater than a Type A quantity.

(36) "Unirradiated uranium" means uranium containing not more than 2x103 Bq of plutonium per gram of uranium-235, not more than 9x106 Bq of fission products per gram of uranium-235, and not more than 5x10-3 g of uranium-236 per gram of uranium-235.

(37) Uranium-natural, depleted, enriched.

(a) "Natural uranium" means uranium (which may be chemically separated) with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238).

(b) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(c) "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

(1) Each licensee who transports licensed material outside the site of usage, as specified in the license issued by the department, NRC or an agreement state, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 C.F.R. 107, 171 through 180, and 390 through 397, appropriate to the mode of transport.

(a) The licensee shall particularly note DOT regulations in the following areas:

(i) Packaging—49 C.F.R. 173: Subparts A, B, and I.

(ii) Marking and labeling—49 C.F.R. 172: Subpart D, 172.400 through 172.407; and Subpart E, 172.436 through 172.441.

(iii) Placarding—49 C.F.R. 172: Subpart F, especially 172.500 through 172.519 and 172.556, and appendices B and C.

(iv) Accident reporting—49 C.F.R. 171.15 and 171.16.

(v) Shipping papers and emergency information—49 C.F.R. 172: Subparts C and G.

(vi) Hazardous material employee training—49 C.F.R. 172: Subpart H.

(vii) Security plans—49 C.F.R. 172: Subpart I.

(viii) Hazardous material shipper/carrier registration—49 C.F.R. 107: Subpart G.

(b) The licensee shall also note DOT regulations pertaining to the following modes of transportation:

(i) Rail—49 C.F.R. 174: Subparts A through D and K.

(ii) Air—49 C.F.R. 175.

(iii) Vessel—49 C.F.R. 176: Subparts A through F and M.

(iv) Public Highway—49 C.F.R. 177 and 390 through 397.

(2) If DOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the DOT specified in subsection (1) of this section to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the Director, Office of Nuclear Material Safety and Safeguards, NRC, Washington, D.C. 20555-0001.

(1) For the purpose of this chapter, deliberate misconduct by a person means an intentional act or omission that the person knows:

(a) Would constitute a violation of a requirement, procedure, instruction, contract, purchase order, or policy; or

(b) Causes or would cause, if not detected, a violation of any rule, regulation, or order; or any term, condition, or limitation of any license or certificate issued by the department.

(2) This section applies to any:

(a) Licensee;

(b) Certificate holder;

(c) Quality assurance program approval holder;

(d) Applicant for a license, certificate, or quality assurance program approval;

(e) Contractor (including a supplier or consultant) or subcontractor, to any person identified in (d) of this subsection; or

(f) Employee of any person identified in (a) through (e) of this subsection.

(3) A person subject to this section who knowingly provides any components, materials, or other goods or services that relate to any activities subject to these regulations may not:

(a) Engage in deliberate misconduct; or

(b) Deliberately submit to the department or to a person subject to this section information that the person knows to be incomplete or inaccurate in some respect that matters to the department.

(4) A person who violates subsection (3)(a) or (b) of this section may be subject to enforcement action in accordance with the procedures in 10 C.F.R. 2 Subpart B.

(1) Common and contract carriers, freight forwarders, warehouse workers, and the U.S. Postal Service are exempt from this chapter and chapters 246-232, 246-233, 246-235, 246-237, 246-240, 246-243, and 246-244 WAC to the extent that they transport or store radioactive material in the regular course of their carriage for another or storage incident thereto.

(2) Any licensee who delivers radioactive material to a carrier for transport, where such transport is subject to the regulations of the United States Postal Service, is exempt from the provisions of WAC 246-231-005.

(3) Exemption of physicians. Any physician as defined in WAC 246-220-010 who is licensed by the department, NRC or an agreement state, to dispense drugs in the practice of medicine, is exempt from WAC 246-220-030 with respect to transport by the physician of licensed material for use in the practice of medicine. However, any physician operating under this exemption must be licensed under chapter 246-240 WAC, 10 C.F.R. 35, or the equivalent agreement state regulations.

(4) Exemption for low-level materials. A licensee is exempt from all requirements of this chapter with respect to shipment or carriage of the following low-level materials:

(a) Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have only been processed for purposes other than for the extraction of the radionuclides, and which are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the applicable radionuclide activity concentration values specified in WAC 246-231-200, Table A-2 or Table A-3.

(b) Materials for which the activity concentration is not greater than the activity concentration values specified in WAC 246-231-200, Table A-2 or Table A-3, or for which the consignment activity is not greater than the limit for an exempt consignment found in WAC 246-231-200, Table A-2 or Table A-3.

(c) Nonradioactive solid objects with radioactive substances present on any surfaces in quantities not in excess of the levels cited in the definition of contamination in WAC 246-231-010.

(5) A licensee is exempt from all the requirements of this chapter, other than 10 C.F.R. 71.5 and 71.88, with respect to shipment or carriage of the following packages, provided the packages do not contain any fissile material, or the material is exempt from classification as fissile material in this subsection;

(a) A package that contains no more than a Type A quantity of radioactive material;

(b) A package transported within the United States that contains no more than 0.74 TBq (20 Ci) of special form plutonium-244; or

(c) The package contains only LSA or SCO radioactive material, provided:

(i) That the LSA or SCO material has an external radiation dose of less than or equal to 10 mSv/h (one rem/h), at a distance of three meters from the unshielded material; or

(ii) That the package contains only LSA-I or SCO-I material.

(6) Exemption from classification as fissile material. Fissile material meeting at least one of the requirements in (a) through (f) of this subsection is exempt from classification as fissile material and from the fissile material package standards of 10 C.F.R. 71.55 and 71.59, but are subject to all other requirements of this chapter, except as noted.

(a) Individual package containing two grams or less fissile material.

(b) Individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

(c)(i) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:

(A) There are at least 2000 grams of solid nonfissile material for every gram of fissile material; and

(B) There are no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material.

(ii) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

(d) Uranium enriched in uranium-235 to a maximum of one percent by weight, and with total plutonium and uranium-233 content of up to one percent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five percent of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.

(e) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two percent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 percent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of two. The material must be contained in at least a DOT Type A package.

(f) Packages containing, individually, a total plutonium mass of not more than 1000 grams, of which not more than 20 percent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

(1) A general license is hereby issued to any common or contract carrier not exempted under WAC 246-231-040 to receive, possess, transport and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the United States Department of Transportation.

(2) A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the United States Department of Transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, shipping papers, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with, or made to, the department.

(3) Persons who transport radioactive material pursuant to the general licenses of subsection (1) or (2) of this section are exempt from the requirements of chapters 246-221 and 246-222 WAC to the extent that they transport radioactive material.

(4) A general license is hereby issued to deliver radioactive material to a carrier1 for transport provided that:

(a) The licensee complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the United States Department of Transportation insofar as such regulations relate to the packaging of radioactive material, to shipping papers, and to the monitoring, marking and labeling of those packages.

(b) The licensee has established procedures for opening and closing packages in which radioactive material is transported to provide safety and to assure that, prior to the delivery to a carrier for transport, each package is properly closed for transport.

(c) Prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to or have been made available to the consignee.

(d) In addition to the requirements of the United States Department of Transportation, each package of Type A or B quantity radioactive material prepared for shipment must have the innermost container labeled as to the isotope, chemical form, number of becquerels or subunits thereof, and date of determination of activity and each innermost container shall be tested to assure that the container is properly sealed and that contamination which would cause undue hazard to public health and safety or property is not present prior to transportation. This requirement does not apply to properly packaged shipments of radioactive waste consigned to a commercial low level radioactive waste disposal facility.

(1) A general license is hereby issued to any licensee of the department, NRC, or an agreement state, to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance, or other approval has been issued by the NRC.

(2) This general license applies only to a licensee who has a quality assurance program approved by NRC as satisfying the provisions of 10 C.F.R. 71 Subpart H.

(3) Each licensee issued a general license under this chapter shall:

(a) Maintain a copy of the certificate of compliance, or other approval of the package, and the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken before shipment;

(b) Comply with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of 10 C.F.R. 71 Subparts A, G, and H; and

(c) Before the licensee's first use of the package, submits in writing to: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in 10 C.F.R. 71.1(a), the licensee's name and license number and the package identification number specified in the package approval.

(4) This general license applies only when the package approval authorizes use of the package under this general license.

(5) For a Type B or fissile material package, the design of which was approved by NRC before April 1, 1996, the general license is subject to the additional restrictions of 10 C.F.R. 71.19.

(1) A general license is issued to any licensee of the department, NRC, or an agreement state, to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by DOT as meeting the applicable requirements of 49 C.F.R. 171.23.

(2) Except as otherwise provided in this chapter, the general license applies only to a licensee who has a quality assurance program approved by NRC as satisfying the applicable provisions of 10 C.F.R. 71 Subpart H.

(3) This general license applies only to shipments made to or from locations outside the United States.

(4) Each licensee issued a general license under this section shall:

(a) Maintain a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and

(b) Comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of 10 C.F.R. 71 Subparts A, G, and H.

(1) A general license is issued to any licensee of the department, NRC, or an agreement state, to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. The fissile material need not be contained in a package which meets the standards of 10 C.F.R. 71 Subparts E and F; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a).

(2) The general license applies only to a licensee who has a quality assurance program approved by NRC as satisfying the provisions of 10 C.F.R. 71 Subpart H.

(3) The general license applies only when a package's contents:

(a) Contain no more than a Type A quantity of radioactive material; and

(b) Contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

(4) The general license applies only to packages containing fissile material that are labeled with a CSI which:

(a) Has been determined in accordance with subsection (5) of this section;

(b) Has a value less than or equal to 10; and

(c) For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

(5)(a) The value for the CSI must be greater than or equal to the number calculated by the following equation:

(b) The calculated CSI must be rounded up to the first decimal place;

(c) The values of X, Y, and Z used in the CSI equation must be taken from WAC 246-231-200 Table-1 or Table-2, as appropriate;

(d) If Table-2 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

(e) Values from Table-1 for X, Y, and Z must be used to determine the CSI if:

(i) Uranium-233 is present in the package;

(ii) The mass of plutonium exceeds one percent of the mass of uranium-235;

(iii) The uranium is of unknown uranium-235 enrichment or greater than 24 weight percent enrichment; or

(iv) Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H2O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

(1) A general license is issued to any licensee of the department, NRC, or an agreement state, to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this section. This material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a).

(2) The general license applies only to a licensee who has a quality assurance program approved by NRC as satisfying the provisions of 10 C.F.R. 71 Subpart H.

(3) The general license applies only when a package's contents:

(a) Contain no more than a Type A quantity of radioactive material; and

(b) Contain less than 1000 g of plutonium, provided that: Plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 g of the total quantity of plutonium in the package.

(4) The general license applies only to packages labeled with a CSI which:

(a) Has been determined in accordance with subsection (5) of this section;

(b) Has a value less than or equal to 100; and

(c) For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or equal to 100 (for shipment on an exclusive use conveyance).

(5)(a) The value for the CSI must be greater than or equal to the number calculated by the following equation:

(b) The calculated CSI must be rounded up to the first decimal place.

(1) Except as provided in subsection (2) 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 two mSv/hour (200 mrem/hour) at any point on the external surface of the package, and the transport index does not exceed 10.

(2) A package that exceeds the radiation level limits specified in subsection (1) 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:

(a) Two mSv/hour (200 mrem/hour) on the external surface of the package, unless the following conditions are met, in which case the limit is 10 mSv/hour (1000 mrem/hour):

(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;

(b) Two mSv/hour (200 mrem/hour) 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

(c) 0.1 mSv/hour (10 mrem/hour) at any point two 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 two 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

(d) 0.02 mSv/hour (two mrem/hour) 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 WAC 246-221-090 and 246-221-100.

(3) For shipments made under the provisions of subsection (2) 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.

(4) 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.

A licensee subject to this chapter, who, under a general or specific license, transports licensed material or delivers licensed material to a carrier for transport, shall comply with the requirements of 10 C.F.R. 71 Subpart G, with the quality assurance requirements of 10 C.F.R. 71 Subpart H, and with the general provisions of 10 C.F.R. 71 Subpart A.

When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

Before the first use of any packaging for the shipment of licensed material:

(1) The licensee shall ascertain that there are no cracks, pinholes, uncontrolled voids, or other defects that could significantly reduce the effectiveness of the packaging;

(2) Where the maximum normal operating pressure will exceed 35 kPa (five lbs/in2) gauge, the licensee shall test the containment system at an internal pressure at least 50 percent higher than the maximum normal operating pressure, to verify the capability of that system to maintain its structural integrity at that pressure;

(3) The licensee shall conspicuously and durably mark the packaging with its model number, serial number, gross weight, and a package identification number assigned by NRC. Before applying the model number, the licensee shall determine that the packaging has been fabricated in accordance with the design approved by NRC; and

(4) The licensee shall ascertain that the determinations in subsections (1) through (3) of this section have been made.

Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this chapter and of the license. The licensee shall determine that:

(1) The package is proper for the contents to be shipped;

(2) The package is in unimpaired physical condition except for superficial defects such as marks or dents;

(3) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

(4) Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

(5) Any pressure relief device is operable and set in accordance with written procedures;

(6) The package has been loaded and closed in accordance with written procedures;

(7) For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

(8) Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 C.F.R. 71.45;

(9) The level of nonfixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable, and within the limits specified in DOT regulations in 49 C.F.R. 173.443;

(10) External radiation levels around the package and around the vehicle, if applicable, will not exceed the limits specified in WAC 246-231-098 at any time during transportation; and

(11) Accessible package surface temperatures will not exceed the limits specified in 10 C.F.R. 71.43(g) at any time during transportation.

(1) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this chapter or included indirectly by citation of 49 C.F.R. chapter I, as may be applicable, the licensee shall assure that plutonium in any form, whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:

(a) The plutonium is contained in a medical device designed for individual human application; or

(b) The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in WAC 246-231-200, Table A-2, and in which the radioactivity is essentially uniformly distributed; or

(c) The plutonium is shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form, and is shipped in accordance with WAC 246-231-030; or

(d) The plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the Certificate of Compliance for that package issued by NRC.

(2) Nothing in subsection (1) of this section is to be interpreted as removing or diminishing the requirements of NRC regulations 10 C.F.R. 73.24.

(3) For a shipment of plutonium by air which is subject to subsection (1)(d) of this section, the licensee shall, through special arrangement with the carrier, require compliance with 49 C.F.R. 175.704 DOT regulations applicable to the air transport of plutonium.

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with WAC 246-221-160.

Applications for approval of a package design under this chapter, which are submitted to NRC, may be made available for public inspection, in accordance with provisions of 10 C.F.R. 2 and 9. This includes an application to amend or revise an existing package design, any associated documents and drawings submitted with the application, and any responses to NRC requests for additional information.

(1) Each licensee shall maintain, for a period of three years after shipment, a record of each shipment of licensed material not exempt under WAC 246-231-040(4), showing where applicable:

(a) Identification of the packaging by model number and serial number;

(b) Verification that there are no significant defects in the packaging, as shipped;

(c) Volume and identification of coolant;

(d) Type and quantity of licensed material in each package, and the total quantity of each shipment;

(e) For each item of irradiated fissile material:

(i) Identification by model number and serial number;

(ii) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and

(iii) Any abnormal or unusual condition relevant to radiation safety;

(f) Date of the shipment;

(g) For fissile packages and for Type B packages, any special controls exercised;

(h) Name and address of the transferee;

(i) Address to which the shipment was made; and

(j) Results of the determinations required by WAC 246-231-110 and by the conditions of the package approval.

(2) The licensee, certificate holder, and an applicant for a certificate of compliance, shall make available to the department and NRC for inspection, upon reasonable notice, all records required by 10 C.F.R. 71.91. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

(3) The licensee, certificate holder, and an applicant for a certificate of compliance shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by WAC 246-231-106; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for three years after the life of the packaging to which they apply.

(1)(a) As specified in subsections (2), (3), and (4) of this section, each licensee shall provide advance notification to the governor of a state, or the governor's designee, of the shipment of licensed material, within or across the boundary of the state, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.

(b) As specified in subsections (2), (3), and (4) of this section, after June 11, 2013, each licensee shall provide advance notification to the Tribal official of participating tribes referenced in subsection (3)(c)(iii) of this section, or the official's designee, of the shipment of licensed material within or across the boundary of the Tribe's reservation before the transport, or delivery to a carrier for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage.

(2) Advance notification is required under this section for shipments of irradiated reactor fuel in quantities less than that subject to advance notification requirements of NRC regulations 10 C.F.R. 73.37(f). Advance notification is also required under this section for shipment of licensed material, other than irradiated fuel, meeting the following three conditions:

(a) The licensed material is required by this section to be in Type B packaging for transportation;

(b) The licensed material is being transported to or across a state boundary enroute to a disposal facility or to a collection point for transport to a disposal facility; and

(c) The quantity of licensed material in a single package exceeds the least of the following:

(i) Three thousand times the A1 value of the radionuclides as specified in WAC 246-231-200, Table A-1 for special form radioactive material;

(ii) Three thousand times the A2 value of the radionuclides as specified in WAC 246-231-200, Table A-1 for normal form radioactive material; or

(iii) One thousand TBq (27,000 Ci).

(3) Procedures for submitting advance notification.

(a) The notification must be made in writing to the office of each appropriate governor or governor's designee, to the office of each appropriate Tribal official or Tribal official's designee, and to the Director, Office of Nuclear Security and Incident Response.

(b) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(c) A notification delivered by any other means than mail must reach the office of the governor or the governor's designee, or of the Tribal official or the Tribal official's designee, at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(i) Reserved.

(ii) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating Tribes, including telephone and mailing addresses of Tribal officials and Tribal official's designees, is available on the NRC website at https://scp.nrc.gov/special/designee.pdf.

(iii) A list of the names and mailing addresses of the governors' designees and Tribal officials' designees of participating Tribes is available on request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001.

(d) The licensee shall retain a copy of the notification as a record for three years.

(4) Information to be furnished in advance notification of shipment. Each advance notification of shipment of irradiated reactor fuel or nuclear waste must contain the following information:

(a) The name, address, and telephone number of the shipper, carrier, and receiver of the irradiated reactor fuel or nuclear waste shipment;

(b) A description of the irradiated reactor fuel or nuclear waste contained in the shipment, as specified in the regulations of DOT in 49 C.F.R. 172.202 and 172.203(d);

(c) The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

(d) The seven-day period during which arrival of the shipment at state boundaries or Tribal reservation boundaries is estimated to occur;

(e) The destination of the shipment, and the seven-day period during which arrival of the shipment is estimated to occur; and

(f) A point of contact, with a telephone number, for current shipment information.

(5) Revision notice. A licensee who finds that schedule information previously furnished to a governor or governor's designee, or a Tribal official or Tribal official's designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the state or of the governor's designee or the Tribal official or the Tribal official's designee, and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for three years.

(6) Cancellation notice.

(a) Each licensee who cancels an irradiated reactor fuel or nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the governor of each state or to the governor's designee previously notified, to each Tribal official or to the Tribal official's designee previously notified, and to the Director, Office of Nuclear Security and Incident Response.

(b) The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for three years.

(1) Purpose. This section describes quality assurance requirements that apply to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this chapter, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each licensee and applicant for a package approval is responsible for satisfying the quality assurance requirements that apply to design, fabrication, testing, and modification of packaging subject to this chapter. Each licensee is responsible for satisfying the quality assurance requirements that apply to its use of packaging for the shipment of licensed material subject to this chapter.

(2) Establishment of program. Each licensee, certificate holder, and applicant for a certificate of compliance shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria in 10 C.F.R. 71.101 through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee, certificate holder, and applicant for a certificate of compliance shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

(3) Approval of program. Before the use of any package for the shipment of licensed material subject to this chapter, each licensee shall obtain the department's approval of its quality assurance program. Using an appropriate method listed in 10 C.F.R. 71.1(a), each licensee shall file a description of its quality assurance program, including a discussion of which requirements of 10 C.F.R. 71 Subpart H are applicable and how they will be satisfied, by submitting the description to the department.

(4) Radiography containers. A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of WAC 246-243-120(2), 10 C.F.R. 34.31(b), or equivalent agreement state requirements, is deemed to satisfy the requirements of WAC 246-231-060(2) and 246-231-150(2).

(1) The licensee, certificate holder, and applicant for a certificate of compliance shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a certificate of compliance may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

(2) The quality assurance functions are:

(a) Assuring that an appropriate quality assurance program is established and effectively executed; and

(b) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

(3) The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

(a) Identify quality problems;

(b) Initiate, recommend, or provide solutions; and

(c) Verify implementation of solutions.

(4) The persons and organizations performing quality assurance functions shall report to a management level that assures that the required authority and organizational freedom, including sufficient independence from cost and schedule, when opposed to safety considerations, are provided.

(5) Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.

(6) Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this chapter are being performed, must have direct access to the levels of management necessary to perform this function.

(1) The licensee, certificate holder, and applicant for a certificate of compliance shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of 10 C.F.R. 71.101 through 71.137. The licensee, certificate holder, and applicant for a certificate of compliance shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee, certificate holder, and applicant for a certificate of compliance shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

(2) The licensee, certificate holder, and applicant for a certificate of compliance, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee, certificate holder, and applicant for a certificate of compliance shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee, certificate holder, and applicant for a certificate of compliance shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

(3) The licensee, certificate holder, and applicant for a certificate of compliance shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components:

(a) The impact of malfunction or failure of the item to safety;

(b) The design and fabrication complexity or uniqueness of the item;

(c) The need for special controls and surveillance over processes and equipment;

(d) The degree to which functional compliance can be demonstrated by inspection or test; and

(e) The quality history and degree of standardization of the item.

(4) The licensee, certificate holder, and applicant for a certificate of compliance shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee, certificate holder, and applicant for a certificate of compliance shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.

(1) Each quality assurance program approval holder shall submit, in accordance with 10 C.F.R. 71.1(a), a description of a proposed change to its NRC-approved quality assurance program that will reduce commitments in the program description as approved by the NRC. The quality assurance program approval holder shall not implement the change before receiving NRC approval.

(a) The description of a proposed change to the NRC-approved quality assurance program must identify the change, the reason for the change, the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of 10 C.F.R. Subpart H.

(b) (Reserved.)

(2) Each quality assurance program approval holder may change a previously approved quality assurance program without prior NRC approval, if the change does not reduce the commitments in the quality assurance program previously approved by the NRC. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the NRC every 24 months, in accordance with 10 C.F.R. 71.1(a). In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and nonsubstantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

(a) The use of a quality assurance standard approved by the NRC that is more recent than the quality assurance standard in the certificate holder's or applicant's current quality assurance program at the time of the change;

(b) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities;

(c) The use of generic organization charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;

(d) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and

(e) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

(3) Each quality assurance program approval holder shall maintain records of quality assurance program changes.

The licensee, certificate holder, and applicant for a certificate of compliance shall establish measures to control, in accordance with instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided.

(1) The licensee, certificate holder, and applicant for a certificate of compliance shall establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures must provide for the identification of items that have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of the inspections and tests.

(2) The licensee shall establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.

The licensee, certificate holder, and applicant for a certificate of compliance shall establish measures to control materials, parts, or components that do not conform to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

The licensee, certificate holder, and applicant for a certificate of compliance shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformance, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures must assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management.

The licensee, certificate holder, and applicant for a certificate of compliance shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by 10 C.F.R. 71.106, the instructions, procedures, and drawings required by 10 C.F.R. 71.111 to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee, certificate holder, and applicant for a certificate of compliance shall retain these records for three years beyond the date when the licensee, certificate holder, and applicant for a certificate of compliance last engaged in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a certificate of compliance shall retain the superseded material for three years after it is superseded.

The licensee, certificate holder, and applicant for a certificate of compliance shall carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow-up action, including re-audit of deficient areas, must be taken where indicated.

(1) Values of A1 and A2 for individual radionuclides, which are the basis for many activity limits elsewhere in these regulations, are given in this section, Table A-1. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) value. The Terabecquerel values are the regulatory standard. The curie values are for information only and are not intended to be the regulatory standard. Where values of A1 or A2 are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material.

(2)(a) For individual radionuclides whose identities are known, but which are not listed in this section, Table A-1, the A1 and A2 values contained in this section, Table A-3 may be used. Otherwise, the licensee shall obtain prior NRC approval of the A1 and A2 values for radionuclides not listed in this section, Table A-1, before shipping the material.

(b) For individual radionuclides whose identities are known, but which are not listed in this section, Table A-2, the exempt material activity concentration and exempt consignment activity values contained in this section, Table A-3 may be used. Otherwise, the licensee shall obtain prior NRC approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in this section, Table A-2, before shipping the material.

(c) The licensee shall submit requests for prior approval, described under (a) and (b) of this subsection, to NRC in accordance with 10 C.F.R. 71.1.

(3) In the calculations of A1 and A2 for a radionuclide not in this section, Table A-1, a single radioactive decay chain, in which radionuclides are present in their naturally occurring proportions, and in which no daughter radionuclide has a half-life either longer than 10 days, or longer than that of the parent radionuclide, shall be considered as a single radionuclide, and the activity to be taken into account, and the A1 or A2 value to be applied shall be those corresponding to the parent radionuclide of that chain. In the case of radioactive decay chains in which any daughter radionuclide has a half-life either longer than 10 days, or greater than that of the parent radionuclide, the parent and those daughter radionuclides shall be considered as mixtures of different radionuclides.

(4) For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply:

(a) For special form radioactive material, the maximum quantity transported in a Type A package is as follows:

Where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for radionuclide i.

(b) For normal form radioactive material, the maximum quantity transported in a Type A package:

Where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for radionuclide i.

(c) If the package contains both special and normal form radioactive material, the activity that may be transported in a Type A package is as follows:

Where B(i) is the activity of radionuclide i as special form radioactive material, A1(i) is the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form radioactive material, and A2(j) is the A2 value for radionuclide j.

(d) Alternatively, the A1 value for mixtures of special form material may be determined as follows:

Where f(i) is the fraction of activity for radionuclide i in the mixture and A1(i) is the appropriate A1 value for radionuclide i.

(e) Alternatively, the A2 value for mixtures of normal form material may be determined as follows:

Where f(i) is the fraction of activity for radionuclide i in the mixture and A2(i) is the appropriate A2 value for radionuclide i.

(f) The exempt activity concentration for mixtures of nuclides may be determined as follows:

Where f(i) is the fraction of activity concentration of radionuclide i in the mixture, and [A](i) is the activity concentration for exempt material containing radionuclide i.

(g) The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:

Where f(i) is the fraction of activity of radionuclide i in the mixture and A(i) is the activity limit for exempt consignments for radionuclide i.

(5)(a) When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in subsection (4) of this section. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta/gamma emitters.

(b) When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest [A] (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV of this appendix. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest [A] or A values for the alpha emitters and beta/gamma emitters, respectively.

Table A-1.—A1 and A2 Values for Radionuclides