DEPARTMENT OF HEALTH

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.

(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.

(((10))) (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. ((71.59)) 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.

(((11))) (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.

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

(((13))) (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.

(((14))) (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.

(((15))) (16) "Graphite" means graphite with a boron equivalent content less than 5 parts per million and density greater than 1.5 grams per cubic centimeter.

(((16))) (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.

(((17))) (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 ((not)) intended to be processed for the use of these radionuclides; ((or))

(ii) ((Solid unirradiated)) Natural uranium ((or)), depleted uranium ((or)), natural thorium, or their compounds or mixtures, provided they are unirradiated and in solid or liquid ((compounds or mixtures)) 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 ((1E-4)) 1x10-4 A2/g for solids and gases, and ((1E-5)) 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 ((2E-3)) 2x10-3 A2/g.

(((18))) (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 ten days.

(((19))) (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.

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

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

(((22))) (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.

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

(((24))) (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.

(((25))) (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.

(((26))) (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 5 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 ((NRC)) 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((, and)); a special form encapsulation designed in accordance with the requirements of ((NRC requirements in)) 10 C.F.R. 71.4 in effect on March 31, 1996 (see 10 C.F.R. 71, revised as of January 1, ((1983)) 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.

(((27))) (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.

(((28))) (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.

(((29))) (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.

(((30))) (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 4 Bq/cm2 (((1E-4)) 1x10-4 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (((1E-5)) 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 ((4E+4)) 4x104 Bq/cm2 (1.0 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or ((4E+3)) 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 ((4E+4)) 4x104 Bq/cm2 (1 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or ((4E+3)) 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 (((1E-2)) 1x10-2 microcurie/cm2) for beta and gamma and low toxicity alpha emitters or 40 Bq/cm2 (((1E-3)) 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 ((8E+5)) 8x105 Bq/cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or ((8E+4)) 8x104 Bq/cm2 (2 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 ((8E+5)) 8x105 Bq/cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or ((8E+4)) 8x104 Bq/cm2 (2 microcuries/cm2) for all other alpha emitters.

(((31))) (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 1 meter (3.3 ft) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at 1 meter (3.3 ft)).

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

(((33))) (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.

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

(((35))) (36) "Unirradiated uranium" means uranium containing not more than ((2E+3)) 2x103 Bq of plutonium per gram of uranium-235, not more than ((9E+6)) 9x106 Bq of fission products per gram of uranium-235, and not more than ((5E-3)) 5x10-3 g of uranium-236 per gram of uranium-235.

(((36))) (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) 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. ((Common and contract carriers who are not subject to the rules and regulations of the DOT or United States Postal Service are subject to WAC 246-231-005 and other applicable sections of these regulations.))

(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 ten 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.

(((5))) (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.

(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 2 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 1 percent by weight, and with total plutonium and uranium-233 content of up to 1 percent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than 5 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 2 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 2. 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 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) ((This)) Each licensee issued a general license ((applies only to a licensee who)) under this chapter shall:

(a) ((Has)) Maintain a copy of the certificate of compliance, or other approval of the package, and ((has)) 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) ((Complies)) 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 Spent Fuel ((Project Office)) Storage and Transportation, 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. ((171.12)) 171.23.

(2) Except as otherwise provided in this ((section)) 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) ((This)) Each licensee issued a general license ((applies only to a licensee who)) under this section shall:

(a) ((Has)) 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) ((Complies)) 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. ((With respect to the quality assurance provisions of Subpart H of 10 C.F.R. 71, the licensee is exempt from design, construction, and fabrication considerations.))

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 (5 lbs/in2) gauge, the licensee shall test the containment system at an internal pressure at least fifty percent higher than the maximum normal operating pressure, to verify the capability of that system to maintain its structural integrity at that pressure; ((and))

(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.

(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) ((Each certificate holder shall maintain, for a period of three years after the life of the packaging to which they apply, records identifying the packaging by model number, serial number, and date of manufacture.

(3))) 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.

(((4))) (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 en route 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) 3000 times the A1 value of the radionuclides as specified in WAC 246-231-200, Table A-1 for special form radioactive material;

(ii) 3000 times the A2 value of the radionuclides as specified in WAC 246-231-200, Table A-1 for normal form radioactive material; or

(iii) 1000 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, Division of Security Policy, 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) A list of the names and mailing addresses of the governors' designees receiving advance notification of transportation of nuclear waste was published in the Federal Register on June 30, 1995, (60 FR 34306).

(ii) ((The list of)) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and ((tribal officials' designees of)) participating ((tribes will be published annually in the Federal Register on or about June 30 to reflect any changes in information)) Tribes, including telephone and mailing addresses of Tribal officials and Tribal official's designees, is available on the NRC web site 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 Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials and Environmental Management Programs, NRC, 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, Division of Security Policy, 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. ((The)) Each licensee((, certificate holder,)) and applicant for a ((certificate of compliance are responsible for)) package approval is responsible for satisfying the quality assurance requirements ((as they)) that apply to design, fabrication, testing, and modification of packaging subject to this chapter. Each licensee is responsible for satisfying the quality assurance ((provision which applies)) 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 NRC 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: ATTN: Document Control Desk, Director, Division of Spent Fuel ((Project Office)) Management, Office of Nuclear Material Safety and Safeguards.

(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,((2)) certificate holder, and applicant for a ((CoC)) certificate of compliance shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a ((CoC)) 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) 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 twenty-four 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 ((CoC)) 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 ((CoC)) 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 ((CoC)) 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 ((CoC)) 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. ((The)) 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 ((must include)) closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures ((which)) 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 ((CoC)) 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 ((reaudit)) 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 ten 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 ten 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, and A1(i) is the A1)) i in special form, and A1(i) is the A1 value for radionuclide ((I)) 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 and A2(i) is the A2)) i in normal form, and A2(i) is the A2 value for radionuclide ((I)) 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:

(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)) i in the mixture and A1(i) is the appropriate A1 value for radionuclide ((I)) i.

(((d))) (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)) i in the mixture and A2(i) is the appropriate A2 value for radionuclide ((I)) i.

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

(((f))) (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)) i in the mixture((,)) and A(i) is the activity limit for exempt consignments for radionuclide ((I)) 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.

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