Original Notice.

     Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

     Title of Rule and Other Identifying Information: Chapter 246-231 WAC, Packaging and transportation of radioactive material.

     Hearing Location(s): Department of Health, Town Center 2, 111 Israel Road, Room 530, Tumwater, WA 98504, on February 26, 2008, at 1:00 p.m.

     Date of Intended Adoption: February 27, 2008.

     Submit Written Comments to: Arden Scroggs, Department of Health, Office of Radiation Protection, P.O. Box 47827, Olympia, WA 98504-7827, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2255, by February 26, 2008.

     Assistance for Persons with Disabilities: Contact Joy Redman by February 19, 2008, TTY (800) 833-6388 or 711.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule revision will address recent federal rule changes pertaining to transportation of radioactive materials. The proposal revises transportation procedures that pose the highest risk of exposure to workers and the general public, and structures the regulations to be more risk-informed and performance-based.

     Reasons Supporting Proposal: The intent of the underlying statute is to provide protection to workers and the public from hazards associated with the use of ionizing radiation and to ensure state radiation protection regulations are compatible with federal regulations. The proposed rule meets the intent of the underlying statute by amending state regulations to be compatible with national radiation protection requirements for the safe transportation of radioactive materials.

     Statutory Authority for Adoption: RCW 70.98.050.

     Statute Being Implemented: RCW 70.98.050.

     Rule is necessary because of federal law, 10 C.F.R. 71 as amended in 69 F.R. 3697.

     Name of Proponent: Department of health, governmental.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Arden Scroggs, 111 Israel Road, Tumwater, (360) 236-3221.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. According to RCW 19.85.025(3) and 19.85.061, this proposed rule is exempt from the requirements of chapter 19.85 RCW because it adopts federal regulations without material change. Washington state has a formal agreement with the United States Nuclear Regulatory Commission (USNRC) to regulate nuclear materials. The agreement, reflected in RCW 70.98.050, requires the department to revise state rules to be consistent with federal rules that have been deemed "matter of compatibility" by the USNRC. This proposed revision makes state rules compatible with 10 C.F.R. 71 and is necessary to maintain agreement state status with the USNRC.

     A cost-benefit analysis is not required under RCW 34.05.328. According to RCW 34.05.328 (5)(b)(iii), this proposed rule is exempt from the requirements of RCW 34.05.328 because it adopts federal regulations without material change.

January 14, 2008

Mary C. Selecky

Secretary

OTS-1015.5

AMENDATORY SECTION(Amending WSR 99-15-105, filed 7/21/99, effective 8/21/99)

WAC 246-231-001   Purpose and scope.   (1) This chapter establishes requirements for packaging, preparation for shipment, and transportation of radioactive material.

     (2) ((These rules are in addition to)) Licensees shall also comply with applicable requirements of the United States Nuclear Regulatory Commission (USNRC), the United States Department of Transportation (USDOT), the ((U.S.)) United States Postal Service¹ (USPS), 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, USNRC 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.

1	((Postal Service Manual (Domestic Mail Manual), section 124.3, which is incorporated by reference at)) Mailing Standards of the United States Postal Service, Domestic Mail Manual, 39 CFR 111.1.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-001, filed 7/21/99, effective 8/21/99.]

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-005, filed 7/21/99, effective 8/21/99.]

     (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. ((These)) This value((s are)) 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) "Agreement state" means any state with which the United States Nuclear Regulatory Commission has entered into an effective agreement under section 274 b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

     (4) "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))) (5) "Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the U.S. Nuclear Regulatory Commission (USNRC).

     (((5))) (6) "Certificate of compliance (CoC)" means the certificate issued by the USNRC under 10 CFR 71 Subpart D which approves the design of a package for the transportation of radioactive material.

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

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

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

     (((7))) (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 ((aircraft)) any aircraft.

     (((8))) (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 containing fissile material during transportation. Determination of the criticality safety index is described in WAC 246-231-094, 246-231-096, and 10 CFR 71.59.

     (12) "Department" means the Washington state department of health, which has been designated as the state radiation control agency under chapter 70.98 RCW.

     (13) "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.

     (14) "DOT" and "USDOT" mean the United States Department of Transportation. USDOT regulations are found in Code of Federal Regulations Title 49 Transportation.

     (15) "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.

     (((9))) (16) "Fissile material" means ((plutonium-238, plutonium-239, plutonium-241, uranium-233, uranium-235,)) 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 ((USNRC regulations 10 CFR 71.53)) WAC 246-231-040.

     (((10) "Highway route controlled quantity" means a quantity within a single package which exceeds:

     (a) 3,000 times the A1 or A2 quantity specified in WAC 246-231-200; or

     (b) 1,000 TBq (27,000 Ci) whichever is least.)) (17) "Graphite" means graphite with a boron equivalent content less than 5 parts per million and density greater than 1.5 grams per cubic centimeter.

     (18) "License" means a license issued by the department.

     (((11))) (19) "Licensed material" means radioactive, by-product, source, or special nuclear material received, possessed, used, or transferred under a general or specific license issued by the department pursuant to the regulations in this chapter, or issued by the USNRC or an agreement state pursuant to equivalent regulations.

     (((12))) (20) "Licensee" means any person who is licensed by the department under these rules and the act.

     (21) "Low specific activity (LSA) material" means radioactive material with limited specific activity ((that)) which is nonfissile or is excepted under WAC 246-231-040 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) ((Ores containing only naturally occurring radionuclides (e.g., uranium, thorium) and uranium or thorium concentrates of such ores; or)) 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 solid or liquid compounds or mixtures; or

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

     (iv) ((Mill tailings, contaminated earth, concrete, rubble, other debris, and activated material in which the radioactive material is essentially uniformly distributed, and the average specific activity does not exceed 1E-6 A2/g.)) 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 material in which the ((radioactive material)) activity is distributed throughout, and the average specific activity does not exceed 1E-4 A2/g for solids and gases, and 1E-5 A2/g for liquids.

     (c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of the 10 CFR 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 does not exceed 2E-3 A2/g.

     (((13))) (22) "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.

     (((14))) (23) "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 USNRC regulations ((Title)) 10 CFR 71.71 (c)(1), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.

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

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

     (((17))) (26) "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.

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

     (((19))) (28) "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 USDOT regulations in 49 CFR 173.

     (c) "Type B package" means a Type B packaging together with its radioactive contents. On approval by the USNRC, a Type B package design is designated by the USNRC 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 USNRC regulations ((Title)) 10 CFR 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 USDOT regulations in 49 CFR ((Part)) 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in ((WAC 246-231-070)) 10 CFR 71.19.

     (((20))) (29) "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.

     (((21))) (30) "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 ((USNRC regulations)) 10 CFR 71.75. A special form encapsulation designed in accordance with the USNRC requirements 10 CFR 71.4 in effect on June 30, 1983, (see 10 CFR ((Part)) 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 the USNRC requirements in 10 CFR 71.4 in effect on March 31, 1996((,)) (see 10 CFR ((Part)) 71, revised as of January 1, 1983), and constructed before April 1, 1998, may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

     (((22))) (31) "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.

     (((23))) (32) "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.

     (33) "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.

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

     (((25))) (35) "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 ((as follows:

     (a) For nonfissile material packages, 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)); or

     (b) For fissile material packages, the number determined by multiplying the maximum radiation level in millisievert 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)), or, for criticality control purposes, the number obtained as described in USNRC regulations 10 CFR 71.59, whichever is larger)) 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)).

     (((26))) (36) "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.

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

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

     (39) Uranium--natural, depleted, enriched.

     (a) "Natural uranium" means uranium 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.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-010, filed 7/21/99, effective 8/21/99.]

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

     (i) Packaging--49 CFR ((Part)) 173: Subparts A ((and)), B, and I.

     (ii) Marking and labeling--49 CFR ((Part)) 172: Subpart D, ((Secs.)) 172.400 through 172.407((, Secs.)); and Subpart E, 172.436 through ((172.440, and subpart E)) 172.441.

     (iii) Placarding--49 CFR ((Part)) 172: Subpart F, especially ((Secs.)) 172.500 through 172.519((,)) and 172.556, and appendices B and C.

     (iv) Accident reporting--49 CFR ((Part 171: Secs.)) 171.15 and 171.16.

     (v) Shipping papers and emergency information--49 CFR ((Part)) 172: Subparts C and G.

     (vi) Hazardous material employee training--49 CFR ((Part)) 172: Subpart H.

     (vii) Security plans -- 49 CFR 172: Subpart I.

     (viii) Hazardous material shipper/carrier registration--49 CFR ((Part)) 107: Subpart G.

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

     (i) Rail--49 CFR ((Part)) 174: Subparts A through D and K.

     (ii) Air--49 CFR ((Part)) 175.

     (iii) Vessel--49 CFR ((Part)) 176: Subparts A through F and M.

     (iv) Public Highway--49 CFR ((Part)) 177 and ((Parts)) 390 through 397.

     (2) If USDOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the USDOT specified in paragraph (1) of this section to the same extent as if the shipment or transportation were subject to USDOT 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, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-030, filed 7/21/99, effective 8/21/99.]

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

     (b) Would, if not detected, cause 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 CFR 2 Subpart B.

[]

     (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) ((Physicians as defined in WAC 246-220-010, are exempt from the requirements of this chapter only to the extent that they transport radioactive material for emergency use in the practice of medicine.)) Exemption of physicians. Any physician as defined in WAC 246-220-010 who is licensed by the department, the USNRC 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 CFR 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 ((a package containing radioactive material having a specific activity not greater than 70 Bq/g (0.002 uCi/g))) the following low-level materials:

     (a) Natural material and ores containing naturally occurring radionuclides that are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed ten times the values specified in WAC 246-231-200, Table A-2.

     (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 for which the consignment activity is not greater than the limit for an exempt consignment found in WAC 246-231-200, Table A-2.

     (5) ((A licensee is exempt from all requirements of this chapter, other than WAC 246-231-030 and 246-231-120, with respect to shipment or carriage of the following packages, provided the packages contain no fissile material:

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

     (b) A package in which the only radioactive material is low specific activity (LSA) material or surface contaminated objects (SCO), provided the external radiation level at 3 m from the unshielded material or objects does not exceed 10 mSv/h (1 rem/h); or

     (c) A package transported within locations within the United States which contains only americium or plutonium in special form with an aggregate radioactivity not to exceed 20 curies.

     (6) A licensee is exempt from all requirements of this chapter, other than WAC 246-231-030 and 246-231-120, with respect to shipment or carriage of low-specific-activity (LSA) material in group LSA-I, or surface contaminated objects (SCOs) in group SCO-I.)) 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 CFR 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 is at least 2000 grams of solid nonfissile material for every gram of fissile material; and

     (B) There is 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.

     (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 USDOT 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.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-040, filed 7/21/99, effective 8/21/99.]

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

     (3) This general license applies only to a licensee who:

     (a) Has 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 with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of ((the USNRC)) 10 CFR 71 Subparts A, G, and H; and

     (c) Before the licensee's first use of the package, submits in writing to ((the)): ATTN: Document Control Desk, Director, Spent Fuel Project Office, Office of Nuclear Material Safety and Safeguards, ((U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, before the licensee's first use of the package,)) using an appropriate method listed in 10 CFR 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 the USNRC before April 1, 1996, the general license is subject to the additional restrictions of ((NRC regulations)) 10 CFR ((71.13)) 71.19.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-060, filed 7/21/99, effective 8/21/99.]

     (2) This general license applies only to a licensee who has a quality assurance program approved by the USNRC as satisfying the provisions of Subpart H of the USNRC regulations, 10 CFR 71.

     (3) This general license applies only to a licensee who:

     (a) Has a copy of the specification; and

     (b) Complies with the terms and conditions of the specification and the applicable requirements of Subparts A, G, and H of ((NRC regulations)) 10 CFR 71.

     (4) This general license is subject to the limitation that the specification container may not be used for a shipment to a location outside the United States, except by multilateral approval, as defined in DOT regulations at 49 CFR 173.403.

     (5) This section expires October 1, 2008.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-080, filed 7/21/99, effective 8/21/99.]

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

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

     (4) This general license applies only to a licensee who:

     (a) Has 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 with the terms and conditions of the certificate and revalidation, and with the applicable requirements of ((the USNRC)) 10 CFR 71 Subparts A, G, and H. With respect to the quality assurance provisions of Subpart H of 10 CFR 71, the licensee is exempt from design, construction, and fabrication considerations.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-090, filed 7/21/99, effective 8/21/99.]

     (2) The general license applies only to a licensee who has a quality assurance program approved by the USNRC as satisfying the provisions of 10 CFR 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 1 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.

Table-1.
Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment per WAC 246-231-094(5)

Fissile material	Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H2O (grams)	Fissile material mass mixed with moderating substances having an average hydrogen density greater than H2Oa (grams)
235U (X)	60	38
233U (Y)	43	27
239Pu or 241Pu (Z)	37	24

^aWhen mixtures of moderating substances are present, the lower mass limits shall be used if more than 15 percent of the moderating substance has an average hydrogen density greater than H₂O.

Table-2.
Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment per WAC 246-231-094(5)

Uranium enrichment in weight percent of 235U not exceeding		Fissile material mass of 235U (X) (grams)
	24	60
	20	63
	15	67
	11	72
	10	76
	9.5	78
	9	81
	8.5	82
	8	85
	7.5	88
	7	90
	6.5	93
	6	97
	5.5	102
	5	108
	4.5	114
	4	120
	3.5	132
	3	150
	2.5	180
	2	246
	1.5	408
	1.35	480
	1	1,020
	0.92	1,800

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     Reviser's note: The brackets and enclosed material in the text of the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 246-231-096   General license -- Plutonium-beryllium special form material.   (1) A general license is issued to any licensee of the department, USNRC 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 USDOT requirements of 49 CFR 173.417(a).

     (2) The general license applies only to a licensee who has a quality assurance program approved by the USNRC as satisfying the provisions of 10 CFR 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.

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     Reviser's note: The brackets and enclosed material in the text of the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.
NEW SECTION
WAC 246-231-098   External radiation standards for all packages.   (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 2 mSv/h (200 mrem/h) 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) 2 mSv/h (200 mrem/h) on the external surface of the package, unless the following conditions are met, in which case the limit is 10 mSv/h (1000 mrem/h):

     (i) The shipment is made in a closed transport vehicle;

     (ii) The package is secured within the vehicle so that its position remains fixed during transportation; and

     (iii) There are no loading or unloading operations between the beginning and end of the transportation;

     (b) 2 mSv/h (200 mrem/h) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and

     (c) 0.1 mSv/h (10 mrem/h) at any point 2 meters (80 in) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point 2 meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and

     (d) 0.02 mSv/h (2 mrem/h) in any normally occupied space, except that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with 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.

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

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

     (b) Where the maximum normal operating pressure will exceed 35 kPa (5 lbf/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

     (c) 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 the U.S. Nuclear Regulatory Commission.))

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-100, filed 7/21/99, effective 8/21/99.]

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     (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 the USNRC. Before applying the model number, the licensee shall determine that the packaging has been fabricated in accordance with the design approved by the U.S. Nuclear Regulatory Commission.

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     (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 ((NRC regulations)) 10 CFR 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 USDOT regulations in 49 CFR 173.443;

     (10) External radiation levels around the package and around the vehicle, if applicable, will not exceed the limits specified in ((NRC regulations 10 CFR 71.47)) WAC 246-231-098 at any time during transportation; and

     (11) Accessible package surface temperatures will not exceed the limits specified in ((NRC regulations)) 10 CFR 71.43(g) at any time during transportation.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-110, filed 7/21/99, effective 8/21/99.]

     (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 ((not greater than 0.002 uCi/g (70 Bq/g) of material)) 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 the U.S. Nuclear Regulatory Commission.

     (2) Nothing in subsection (1) of this section is to be interpreted as removing or diminishing the requirements of USNRC regulations 10 CFR 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 CFR 175.704((, U.S. Department of Transportation)) USDOT regulations applicable to the air transport of plutonium.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-120, filed 7/21/99, effective 8/21/99.]

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     (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 CoC, shall make available to the USNRC for inspection, upon reasonable notice, all records required by 10 CFR 71.91. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

     (4) The licensee, certificate holder, and an applicant for a CoC 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.

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     (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 USNRC regulations 10 CFR 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 and to the ((Administrator of the appropriate NRC Regional Office listed in Appendix A of NRC regulations 10 CFR Part 73)) Director, Division of Nuclear Security, 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 ((messenger)) any other means than mail must reach the office of the governor or of the governor'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 will be published annually in the Federal Register on or about June 30 to reflect any changes in information.

     (iii) A list of the names and mailing addresses of the governors' designees is available on request from the Director, Office of State Programs, U.S. Nuclear Regulatory Commission, Washington, DC 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 USDOT in 49 CFR 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 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, 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 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, and to the ((Administrator of the appropriate NRC Regional Office listed in Appendix A of USNRC regulations 10 CFR 73)) Director, Division of Nuclear Security, 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.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-231-140, filed 7/21/99, effective 8/21/99.]

     (2) Establishment of program. Each licensee, certificate holder, and applicant for a CoC shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria in 10 CFR 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 CoC 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 USNRC approval of its quality assurance program. Using an appropriate method listed in 10 CFR 71.1(a), each licensee shall file a description of its quality assurance program, including a discussion of which requirements of 10 CFR 71 Subpart H are applicable and how they will be satisfied, by submitting the description to: ATTN: Document Control Desk, Director, Spent Fuel Project Office, 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), is deemed to satisfy the requirements of WAC 246-231-060(2) and 246-231-150(2).

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2	While the term "licensee" is used in these criteria, the requirements are applicable to whatever design, fabrication, assembly, and testing of the package is accomplished with respect to a package before the time a package approval is issued.

     (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.

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     (2) The licensee, certificate holder, and applicant for a CoC, 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 CoC 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 CoC 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 CoC 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 CoC 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 CoC 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.

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     (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.

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     ((II.)) (2)(a) For individual radionuclides whose identities are known, but which are not listed in this section, Table A-1, the ((determination of the values of A1 and A2 requires NRC approval, except that the values of A1 and A2 in Table A-2 may be used without obtaining approval from the NRC.

     III.)) A1 and A2 values contained in this section, Table A-3 may be used. Otherwise, the licensee shall obtain prior USNRC 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 USNRC 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 the USNRC in accordance with 10 CFR 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 ((nuclide)) radionuclide has a half-life either longer than ten days, or longer than that of the parent ((nuclide)) 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 ((nuclide)) radionuclide of that chain. In the case of radioactive decay chains in which any daughter ((nuclide)) radionuclide has a half-life either longer than ten days, or greater than that of the parent ((nuclide)) radionuclide, the parent and those daughter ((nuclides)) radionuclides shall be considered as mixtures of different ((nuclides)) radionuclides.

     ((IV.)) (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:

Where B(i) is the activity of radionuclide I, 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 and ((A1(i) and)) A2(i) ((are)) is the ((A1 and)) A2 value((s)) for radionuclide I((, respectively)).

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

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

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

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

     ((V.)) (e) 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 is the activity concentration f material containing radionuclide I.

     (f) 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 is the activity limit for exempt consignments for radionuclide I.

     (5) 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 ((paragraph IV)) 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