Section 289.257 - [Effective 10/23/2024] Packaging and Transportation of Radioactive Material(a) Purpose.(1) This section establishes requirements for packaging, preparation for shipment, and transportation of radioactive material including radioactive waste.(2) In addition to the requirements of this section, the packaging and transport of radioactive material are subject to the requirements of: (A) § 289.201 of this chapter (relating to General Provisions for Radioactive Material);(B) § 289.202 of this chapter (relating to Standards for Protection Against Radiation from Radioactive Materials);(C) § 289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections);(D) § 289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services) ;(E) § 289.205 of this chapter (relating to Hearing and Enforcement Procedures);(F) § 289.251 of this subchapter (relating to Exemptions, General Licenses, and General License Acknowledgements);(G) § 289.252 of this subchapter (relating to Licensing of Radioactive Material);(H) § 289.256 of this subchapter (relating to Medical and Veterinary Use of Radioactive Material); and(I) the regulations of other agencies (e.g., the United States Department of Transportation (DOT) and the United States Postal Service) having jurisdiction over means of transport.(b) Scope. (1) The requirements of this section apply to any licensee authorized by a specific or general license issued by the department to receive, possess, use, or transfer radioactive material, if the licensee delivers material to a carrier for transport, transports the material outside the site of usage, as specified in the department license, or transports material on public highways. No provision of this section authorizes possession of radioactive material.(2) Exemptions from the requirements for a license in subsection (c) of this section are specified in subsection (f) of this section. The general license in subsection (i)(2), (3), and (4) of this section requires that a United States Nuclear Regulatory Commission (NRC) certificate of compliance or other package approval be issued for the package used as specified in the general license. A licensee transporting radioactive material, or delivering radioactive material to a carrier for transport, must comply with the operating control requirements of subsections (l) - (q) of this section; the quality assurance (QA) requirements of subsections (s) - (u) and (w) - (bb) of this section; and the general provisions of subsections (a) - (e) of this section, including DOT regulations referenced in subsection (e) of this section.(c) Requirement for license. Except as authorized in a general or specific license issued by the department, or as exempted as specified in this section, no licensee may transport radioactive material or deliver radioactive material to a carrier for transport.(d) Definitions. The following words and terms when used in this section have the following meaning unless the context clearly indicates otherwise. To ensure compatibility with international transportation standards, all limits in this section are given in terms of dual units: The International System of Units (SI) followed or preceded by United States (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. In this section, SI units are used. (1) A1-- The maximum activity of special form radioactive material permitted in a Type A package. This value is either listed in Table 257-3 of subsection (ee)(6) of this section, or may be derived as specified in the procedure prescribed in subsection (ee) of this section.(2) A2--The maximum activity of radioactive material, other than special form, low specific activity (LSA), and surface contaminated object (SCO) material, permitted in a Type A package. This value is either listed in Table 257-3 of subsection (ee)(6) of this section, or may be derived as specified in the procedure prescribed in subsection (ee) of this section.(3) Carrier--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--A person who has been issued a certificate of compliance or other package approval by the department.(5) Certificate of compliance (CoC)--The certificate issued by the NRC that approves the design of a package for the transportation of radioactive materials.(6) Chelating agent--Amine polycarboxylic acids (e.g., ethylenediaminetetraacetic acid (EDTA) and diethylenetriaminepentaacetic acid (DTPA)), hydroxy-carboxylic acids, and polycarboxylic acids (e.g., citric acid, carbolic acid, and glucinic acid).(7) Chemical description--A description of the principal chemical characteristics of low-level radioactive waste (LLRW).(8) Consignee--The designated receiver of the shipment of low-level radioactive waste.(9) Consignment--Each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.(10) Containment system--The assembly of components of the packaging intended to retain the radioactive material during transport.(11) Contamination--The presence of a radioactive substance on a surface in quantities more than 0.4 becquerel per square centimeter (Bq/cm2) (10-5 microcurie per square centimeter (Ci/cm2)) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2(10-6 Ci/cm2) for all other alpha emitters. (A) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.(B) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport.(12) Conveyance--For transport on: (A) public highway or rail by transport vehicle or large freight container;(B) water by vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and(13) Criticality Safety Index (CSI)--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 subsection (i) of this section and 10 Code of Federal Regulations (CFR) §§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.(14) Decontamination facility--A facility operating under an NRC, agreement state, or department license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this section, is not considered to be a consignee for LLRW shipments.(15) Deuterium--In this section, this means deuterium and any deuterium compound, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms is greater than 1:5000.(16) Disposal container--A transport container principally used to confine LLRW during disposal operations at a land disposal facility (also see definition for high integrity container). Note that for some shipments, the disposal container may be the transport package.(17) Environmental Protection Agency (EPA) identification number--The number received by a transporter following application to the administrator of EPA as required by 40 CFR Part 263.(18) Exclusive use--The sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out as specified in the direction of the consignor or consignee. The consignor and the carrier must ensure any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor issues specific instructions, in writing, for maintenance of exclusive use shipment controls, and includes them with the shipping paper information provided to the carrier by the consignor.(19) Fissile material--The radionuclides plutonium-239, plutonium-241, uranium-233, uranium-235, 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 irradiated in thermal reactors only, are not included in this definition. The department's jurisdiction extends only to special nuclear material in quantities not sufficient to form a "critical mass" as defined in § 289.201(b) of this chapter. Certain exclusions from fissile material controls are provided in subsection (h) of this section.(20) Freight forwarder--A person or entity holding itself out to the general public to provide transportation of property for compensation and in the ordinary course of its business: (A) assembles and consolidates, or provides for assembling and consolidating, shipments and performs break-bulk and distribution operations of the shipments;(B) assumes responsibility for the transportation from the place of receipt to the place of destination; and(C) uses for any part of the transportation a rail, motor, or water carrier subject to the jurisdiction of either the Federal Motor Carrier Safety Administration or the Surface Transportation Board.(21) Generator--A licensee operating under a department, NRC, or agreement state license who: (A) is a waste generator as defined in this section; or(B) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985 (e.g., waste generated from decontamination or recycle activities).(22) Graphite--In this section, this means graphite with a boron equivalent content of less than 5 parts per million and density greater than 1.5 grams (g) per cubic centimeter.(23) High integrity container (HIC)--A container commonly designed to meet the structural stability requirements of 10 CFR § 61.56, and to meet DOT requirements for a Type A package.(24) Indian Tribe--An Indian or Alaska 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 United States Code (U.S.C.) §479a.(25) Low-level radioactive waste (LLRW)--Radioactive material that meets the following criteria: (A) LLRW is radioactive material: (i) discarded or unwanted and not exempt by rule adopted as specified in the Texas Radiation Control Act (Act), Texas Health and Safety Code § 401.106;(ii) waste, as that term is defined in 10 CFR § 61.2; and(iii) subject to: (I) concentration limits established in 10 CFR § 61.55, or compatible rules adopted by the department or the Texas Commission on Environmental Quality (TCEQ), as applicable; and(II) disposal criteria established in 10 CFR or established by the department or TCEQ, as applicable.(B) LLRW does not include: (i) high-level radioactive waste as defined in 10 CFR § 60.2;(ii) spent nuclear fuel as defined in 10 CFR § 72.3;(iii) byproduct material defined in the Act, Texas Health and Safety Code § 401.003(3)(B);(iv) naturally occurring radioactive material (NORM) waste that is not oil and gas NORM waste;(v) oil and gas NORM waste; or(vi) transuranics greater than 100 nanocuries (3.7 kilobecquerels) per gram (g).(26) Low specific activity (LSA) material--Radioactive material with limited specific activity that is non-fissile or is excepted as specified in subsection (h) of this section, and satisfies the following descriptions and limits set forth in this section. Shielding materials surrounding the LSA material is not considered in determining the estimated average specific activity of the package contents. LSA material is in one of the following three groups: (A) LSA-I. (i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides intended to be processed for the use of these radionuclides;(ii) Natural uranium, depleted uranium, natural thorium, or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;(iii) Radioactive material other than fissile material for which the A2 value is unlimited; or(iv) Other radioactive material (e.g., mill tailings, contaminated earth, concrete, rubble, other debris, and activated material) in which the radioactivity is distributed throughout, and the estimated average specific activity is not more than 30 times the value for exempt material activity concentration determined in accordance with subsection (ee) of this section.(B) LSA-II. (i) Water with tritium concentration up to 0.8 terabecquerel per liter (TBq/l) (20.0 curies per liter (Ci/l)); or(ii) Other material in which the radioactivity is distributed throughout, and the average specific activity is not greater than 10-4 A2/g for solids and gases and 10-5 A2/g for liquids.(C) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, satisfying the requirements of 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.);(ii) the radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even with a loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, is not greater than 0.1 A2; and(iii) the estimated average specific activity of the solid, excluding any shielding material, is not greater than 2 x 10-3A2/g.(27) Low toxicity alpha emitters--Natural uranium, depleted uranium, natural thorium; uranium-235, uranium-238, thorium-232, thorium-228, or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than 10 days.(28) Maximum normal operating pressure--The maximum gauge pressure that would develop in the containment system in a period of one year under the heat condition specified in 10 CFR § 71.71(c)(1), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.(29) Natural thorium--Thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232).(30) Normal form radioactive material--Radioactive material not demonstrated to qualify as special form radioactive material.(31) NRC Forms 540, 540A, 541, 541A, 542, and 542A--Official NRC forms referenced in subsection (ff) of this section that include the information required by DOT in 49 CFR Part 172. Licensees need not use originals of these forms if any substitute forms contain the equivalent information. Licensees may include additional information deemed relevant to the licensee's shipment of low-level radioactive waste. Upon agreement between the shipper and consignee, NRC Forms 541 (and 541A) and NRC Forms 542 (and 542A) or equivalent documents may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.(32) Package--The packaging together with its radioactive contents as presented for transport. (A) Fissile material package, Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package--A fissile material packaging together with its fissile material contents.(B) Type A package--A Type A packaging together with its radioactive contents. A Type A package is defined and complies with DOT regulations in 49 CFR Part 173.(C) Type B package--A Type B packaging together with its radioactive contents. On approval by the 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 kilopascals (kPa) (100 pounds per square inch (lbs/in2)) gauge or a pressure relief device allowing the release of radioactive material to the environment under the tests specified in 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 DOT 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 10 CFR § 71.19.(33) Packaging--The assembly of components necessary to ensure compliance with the packaging requirements of this section. 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.(34) Physical description--The items called for on NRC Form 541 to describe an LLRW.(35) Registered freight forwarder--A freight forwarder having an emergency plan approved as specified in subsection (r) of this section and issued a registration letter.(36) Registered shipper--A shipper having an emergency plan approved as specified in subsection (r) of this section and shipping containers approved as specified in subsection(cc)(8) of this section and issued a registration letter.(37) Registered transporter--A transporter having an emergency plan approved as specified in subsection (r) of this section and proof of financial responsibility submitted and approved as specified in subsection(e)(4) of this section and issued a registration letter.(38) Residual waste--LLRW resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.(39) Shipper--The licensed entity (i.e., the waste generator, waste collector, or waste processor) offering LLRW for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator. This definition applies only to shipments of LLRW shipped to a Texas LLRW disposal facility.(40) Site of usage--The licensee's facility, including all buildings and structures between which radioactive material is transported and all roadways not within the public domain on which radioactive material can be transported.(41) Special form radioactive material--Radioactive material satisfying the following conditions: (A) either a single solid piece or 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 millimeters (0.2 inches (in)); and(C) satisfies the requirements of 10 CFR § 71.75. A special form encapsulation designed as specified in the requirements of this subsection in effect on or after June 30, 1983 (see 10 CFR Part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed as specified in the requirements of this subsection in effect on or after March 31, 1996 (see 10 CFR Part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and(D) special form material successfully tested before September 10, 2015, as specified in the requirements of 10 CFR § 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.(42) Specific activity of a radionuclide--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.(43) Spent nuclear fuel or spent fuel--Fuel withdrawn from a nuclear reactor following irradiation, undergone at least one year's decay since being used as a source of energy in a power reactor, and not chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies.(44) Surface contaminated object (SCO)--A solid object not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. An SCO must be in one of the following two groups with surface activity not greater than the following limits: (A) SCO-I--A solid object on which: (i) the non-fixed contamination on the accessible surface averaged over 300 square centimeters (cm2) (or the area of the surface if less than 300 cm2) is not greater than 4 Bq/cm2 (10-4Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 4 x 10-1 Bq/cm2 (10-5Ci/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) is not greater than 4 x 104 Bq/cm2 (1 Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 4 x 103 Bq/cm2(10-1Ci/cm2) for all other alpha emitters; and(iii) the non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2(or the area of the surface if less than 300 cm2) is not greater than 4 x 104 Bq/cm2 (1 Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 4 x 103Bq/cm2 (10-1Ci/cm2) for all other alpha emitters.(B) SCO-II--A solid object on which the limits for SCO-I are exceeded and on which the following limits are not exceeded:(i) the non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) is not greater than 400 Bq/cm2 (10-2Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 40 Bq/cm2 (10-3 Ci/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) is not greater than 8 x 105 Bq/cm2 (20Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 Ci/cm2) for all other alpha emitters; and(iii) the non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) is not greater than 8 x 105 Bq/cm2 (20 Ci/cm2) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 Ci/cm2) for all other alpha emitters.(45) Transporter--A carrier who transports radioactive material.(46) Tribal official--The highest ranking individual representing Tribal leadership, such as the Chief, President, or Tribal Council leadership.(47) Uniform Low-Level Radioactive Waste Manifest or uniform manifest--The combination of NRC Forms 540, 541, and, if necessary, 542, and their respective continuation sheets as needed, or equivalent.(48) Unirradiated uranium--Uranium containing not more than 2 x 103 Bq (0.054 Ci) of plutonium per gram of uranium-235, not more than 9 x 106 Bq (243 Ci) of fission products per gram of uranium-235, and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235.(49) Uranium--Natural, depleted, enriched: (A) Natural uranium--Uranium that 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--Uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.(C) Enriched uranium--Uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.(50) Waste collector--An entity, operating under a department, NRC, or agreement state license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.(51) Waste description--The physical, chemical, and radiological description of an LLRW as called for on NRC Form 541.(52) Waste generator--An entity, operating under a department, NRC, or agreement state license, who: (A) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use; and(B) transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment before disposal. A licensee performing processing or decontamination services may be a waste generator if the transfer of LLRW from its facility is defined as residual waste.(53) Waste processor--An entity, operating under an NRC or agreement state license, whose principal purpose is to process, repackage, or otherwise treat LLRW or waste generated by others before eventual transfer of waste to a licensed LLRW land disposal facility.(54) Waste type--A waste within a disposal container having a unique physical description (i.e., a specific waste descriptor code or description; or a waste sorbed on or solidified in a specifically defined media).(e) Transportation of radioactive material. (1) Each licensee transporting radioactive material outside the site of usage as specified in the department license, transporting on public highways, or delivering radioactive material to a carrier for transport must comply with the applicable requirements of DOT regulations in 49 CFR Part 107, Parts 171 - 180, and Parts 390 - 397 appropriate to the mode of transport. The licensee must particularly note DOT regulations in the following areas:(A) Packaging - 49 CFR Part 173: Subparts A, B, and I.(B) Marking and labeling - 49 CFR Part 172: Subpart D, and §§172.400 - 172.407 and §§172.436 - 172.441 of Subpart E.(C) Placarding - 49 CFR Part 172: Subpart F, especially §§172.500 - 172.519 and §172.556, and Appendices B and C.(D) Accident reporting - 49 CFR Part 171: §171.15 and § 171.16.(E) Shipping papers and emergency information - 49 CFR Part 172: Subparts C and G.(F) Hazardous material employee training - 49 CFR Part 172: Subpart H.(G) Hazardous material shipper/carrier registration - 49 CFR Part 107: Subpart G.(H) Security Plans - 49 CFR Part 172: Subpart I.(2) The licensee must comply with DOT regulations pertaining to the following modes of transportation: (A) Rail: 49 CFR Part 174: Subparts A through D and K.(B) Air: 49 CFR Part 175.(C) Vessel: 49 CFR Part 176: Subparts A through F and M.(D) Public Highway: 49 CFR Part 177 and Parts 390 through 397.(3) If DOT regulations are not applicable to a shipment of radioactive material (i.e., DOT does not have jurisdiction), the licensee must conform to DOT standards and requirements specified in paragraph (1) of this subsection to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements must be filed and approved by the department. Any notification referred to in those requirements must be submitted to the department.(4) Transporter proof of financial responsibility. (A) Transporters of LLRW to a Texas LLRW disposal site must submit proof of financial responsibility required by 49 CFR § 387.7 and § 387.9 to the department and receive a registration letter from the department before initial shipment.(B) The transporter registration expires on the expiration date of the proof of financial responsibility or in 10 years if the proof of financial responsibility does not have an expiration date.(C) To renew a transporter's registration, the transporter must submit to the department new proof of financial responsibility.(D) The transporter must submit to the department new proof of financial responsibility any time the amount of liability coverage is reduced or a new policy is purchased.(5) The department must review and determine alternate routes for the transportation and routing of radioactive material as specified in 49 CFR § 397.103.(f) Exemption for low-level radioactive materials.(1) A licensee is exempt from all requirements of this section with respect to shipment or carriage of the following low-level materials: (A) Natural material and ores containing naturally occurring radionuclides either in their natural state, or only processed for purposes other than for the extraction of the radionuclides, and not intended to be processed for use of these radionuclides, provided the activity concentration of the material is not greater than 10 times the applicable radionuclide activity concentration values specified in subsection (ee), (ee)(7), and (ee)(8) of this section.(B) Materials for which the activity concentration is not greater than the activity concentration values specified in subsection (ee), (ee)(7), and (ee)(8) of this section, or for which the consignment activity is not greater than the limit for an exempt consignment found in subsection (ee), (ee)(7), and (ee)(8) of this section.(C) Non-radioactive solid objects with radioactive substances present on any surfaces in quantities not over the levels cited in the definition of contamination in subsection (d) of this section.(2) Common and contract carriers, freight forwarders, warehousemen, and the United States Postal Service are exempt from the regulations in this subchapter to the extent they transport or store radioactive material in the regular course of their carriage for another, or storage incident thereto.(3) Persons who discard licensed material as specified in § 289.202(fff) of this chapter are exempt from all requirements of this section.(g) Exemption of physicians and veterinarians. Any physician or veterinarian licensed by a state to dispense drugs in the practice of medicine or veterinary medicine is exempt from subsection (e) of this section with respect to transport by the physician or veterinarian of licensed material for use in the practice of medicine or veterinary medicine. However, any physician or veterinarian operating under this exemption must be licensed under § 289.256 of this subchapter or the equivalent NRC or agreement state regulations.(h) Exemption from classification as fissile material. Fissile materials meeting the requirements of at least one of paragraphs (1) through (6) of this subsection are 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 section, except as noted. (1) An individual package containing 2 g or less fissile material.(2) Individual or bulk packaging containing 15 g or less of fissile material provided the package has at least 200 g of solid non-fissile 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 non-fissile material.(3) Solid fissile material commingled with solid non-fissile material. (A) Low concentrations of solid fissile material commingled with solid non-fissile material provided:(i) there is at least 2000 g of solid non-fissile material for every gram of fissile material; and(ii) there is no more than 180 g of fissile material distributed within 360 kilograms (kg) of contiguous non-fissile material.(B) 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 non-fissile material.(4) Uranium enriched in uranium-235 to a maximum of one percent by weight, and with total plutonium and uranium-233 content of up to one percent of the mass of uranium-235, provided the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five percent of the uranium mass, and the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.(5) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two percent by mass, with a total plutonium and uranium-233 content not greater than 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.(6) Packages containing, individually, a total plutonium mass of not more than 1000 g, of which not more than 20 percent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.(i) General license. (1) NRC-approved package. (A) A general license is issued to any licensee of the department to transport, or to deliver to a carrier for transport, radioactive material in a package for which a license, CoC, or other approval has been issued by the NRC.(B) This general license applies only to a licensee who has a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71: Subpart H.(C) This general license applies only to a licensee who: (i) has a copy of the CoC or other approval by the NRC 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; and(ii) complies with the terms and conditions of the specific license, certificate, or other approval by the NRC, as applicable, and the applicable requirements in 10 CFR Part 71: Subparts A, G, and H; and(iii) before the licensee's first use of the package, submits in writing to: ATTN: Document Control Desk, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 using an appropriate method listed in 10 CFR Part 71, the licensee's name and license number and the package identification number specified in the package approval.(D) This general license applies only when the package approval authorizes use of the package as specified in this general license.(E) 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 paragraph (2) of this subsection.(F) For 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 § 289.255(m)(2)(B) of this chapter (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), is deemed to satisfy the requirements of subparagraph (B) of this paragraph.(2) Use of foreign approved package. (A) A general license is issued to any licensee 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 revalidated by the DOT as meeting the applicable requirements of 49 CFR § 171.23.(B) Except as otherwise provided by this section, the general license applies only to a licensee having a QA program approved by the department as satisfying the applicable provisions of subsection (s) - (u) and (w) - (bb) of this section.(C) This general license applies only to shipments made to or from locations outside the United States.(D) Each licensee issued a general license under subparagraph (A) of this paragraph must: (i) 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 the actions taken before shipment; and(ii) comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of § 289.205(j) and (k) of this chapter and subsections (a) - (e), (j) - (q), (s) - (u), and (w) - (bb) of this section.(3) Fissile material. (A) A general license is issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped as specified in this section. The fissile material need not be contained in a package meeting the standards of this section. The material must be contained in a Type A package. The Type A package must also meet DOT requirements in 49 CFR § 173.417(a).(B) The general license applies only to a licensee having a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71.(C) The general license applies only when a package's contents: (i) contain no more than a Type A quantity of radioactive material; and(ii) contain less than 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.(D) The general license applies only to packages containing fissile material labeled with a CSI: (i) determined as specified in paragraph (E) of this subsection;(ii) with a value less than or equal to 10.0; and(iii) for a shipment of multiple packages containing fissile material, with a sum of the CSIs less than or equal to 50.0 for shipment on a nonexclusive use conveyance and less than or equal to 100.0 for shipment on an exclusive use conveyance.(E) The CSI must be as follows: (i) the value for the CSI is greater than or equal to the number calculated by the following equation: Attached Graphic
(ii) the calculated CSI is rounded up to the first decimal place;(iii) the values of X, Y, and Z used in the CSI equation is taken from Tables 257-1 or 257-2 of this clause, as appropriate; Attached Graphic
(iv) if Table 257-2 of clause (iii) of this subparagraph 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(v) Table 257-1 values of clause (iii) of this subparagraph for X, Y, and Z are used to determine the CSI if: (I) uranium-233 is present in the package;(II) the mass of plutonium is greater than one percent of the mass of uranium-235;(III) the uranium is of unknown uranium-235 enrichment, or greater than 24 weight percent enrichment; or(IV) substances having a moderating effectiveness (i.e., an average hydrogen density greater than H2O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.(4) Plutonium-beryllium special form material. (A) A general license is issued to any licensee 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 as specified in this section. This material need not be contained in a package meeting the standards of 10 CFR Part 71; however, the material must be contained in a Type A package. The Type A package must also meet DOT requirements in 49 CFR § 173.417(a).(B) The general license applies only to a licensee having a QA program approved by the NRC as satisfying the provisions of 10 CFR Part 71.(C) The general license applies only when a package's contents: (i) contain no more than a Type A quantity of material; and(ii) contain less than 1000 g of plutonium, provided plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240 g of the total quantity of plutonium in the package.(D) The general license applies only to packages labeled with a CSI:(i) determined as specified in subparagraph (E) of this paragraph;(ii) with a value less than or equal to 100.0; and(iii) for a shipment of multiple packages containing Pu-Be sealed sources, with a sum of the CSIs less than or equal to 50.0 for shipment on a nonexclusive use conveyance and less than or equal to 100.0 for shipment on or exclusive use conveyance.(E) The value for the CSI must: (i) be greater than or equal to the number calculated by the following equation: Attached Graphic
(ii) be rounded up to the first decimal place once calculated.(j) Assumptions as to unknown properties. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee must package the fissile material as if the unknown properties have credible values causing the maximum neutron multiplication.(k) Preliminary determinations. Before the first use of any packaging for the shipment of licensed material, the licensee must ascertain the determinations were made as specified in 10 CFR § 71.85.(l) Routine determinations. Before each shipment of radioactive material, the licensee must ensure the package with its contents satisfies the applicable requirements of this section and of the license. The licensee must determine:(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, 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 as specified in written procedures;(6) the package has been loaded and closed as specified in 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 used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 CFR § 71.45;(9) the level of non-fixed (removable) radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable (ALARA), and within the limits specified in DOT regulations 49 CFR § 173.443;(10) external radiation levels around the package and around the vehicle, if applicable, are not greater than the following limits at any time during transportation: (A) Except as provided in subparagraph (B) of this paragraph, each package of radioactive materials offered for transportation must be designed and prepared for shipment so, under conditions normally incident to transportation, the radiation level is not greater than 2 millisieverts per hour (mSv/hr) (200 millirem per hour (mrem/hr)) at any point on the external surface of the package, and the transport index is not greater than 10.(B) A package that exceeds the radiation level limits specified in subparagraph (A) of this paragraph must be transported by exclusive use shipment only, and the radiation levels for such shipment must not be greater than the following during transportation: (i) 2 mSv/hr (200 mrem/hr) on the external surface of the package, unless the following conditions are met, in which case the limit is 10 mSv/hr (1000 mrem/hr): (I) the shipment is made in a closed transport vehicle;(II) the package is secured within the vehicle so its position remains fixed during transportation; and(III) there are no loading or unloading operations between the beginning and end of the transportation;(ii) 2 mSv/hr (200 mrem/hr) 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(iii) 0.1 mSv/hr (10 mrem/hr) at any point 2 meters (m) (6.6 feet (ft)) 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 m (6.6 ft) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and(iv) 0.02 mSv/hr (2 mrem/hr) in any normally occupied space, except this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with § 289.202(q) of this chapter.(C) For shipments made as specified in the provisions of subparagraph (B) of this paragraph, the shipper must provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information.(D) The written instructions required for exclusive use shipments must be sufficient so, when followed, they will cause the carrier to avoid actions unnecessarily delaying delivery or unnecessarily resulting in increased radiation levels or radiation exposures to transport workers or members of the general public.(m) Air transport of plutonium. (1) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this section or included in 49 CFR Chapter I, as may be applicable, the licensee must assure plutonium in any form, whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:(A) the plutonium is contained in a medical device designed for individual human application; or(B) the plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in Table 257-4 of subsection (ee)(7) of this section, 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 as specified in subsection (e) of this section; or(D) the plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the CoC for that package issued by the NRC.(2) Nothing in paragraph (1) of this subsection is interpreted as removing or diminishing the requirements of 10 CFR § 73.24.(3) For a shipment of plutonium by air subject to paragraph (1) of this subsection, the licensee must, through special arrangement with the carrier, require compliance with 49 CFR § 175.704, DOT regulations applicable to the air transport of plutonium.(n) Opening instructions. Before delivery of a package to a carrier for transport, the licensee must ensure any special instructions needed to safely open the package are sent to, or otherwise made available to, the consignee for the consignee's use as specified in § 289.202(ee)(5) of this chapter.(o) Records. (1) For a period of three years after shipment, each licensee must maintain, for inspection by the department, a record of each shipment of radioactive material not exempt under subsection (f) of this section, including, where applicable: (A) identification of the packaging by model number and serial number;(B) verification there are no significant defects in the packaging, as shipped;(C) volume and identification of coolant;(D) type and quantity of radioactive 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 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 subsection (l) of this section and by the conditions of the package approval.(2) The licensee, certificate holder, and an applicant for a CoC must make available to the department for inspection, upon reasonable notice, all records required by this section. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.(3) The licensee, certificate holder, and an applicant for a CoC must maintain sufficient written records to furnish evidence of the quality of packaging. (A) The records maintained include: (i) results of the determinations required by subsection (k) of this section;(ii) design, fabrication, and assembly records;(iii) results of reviews, inspections, tests, and audits;(iv) results of monitoring work performance and materials analyses; and(v) results of maintenance, modification, and repair activities.(B) Inspection, test, and audit records must identify the: (i) inspector or data recorder;(ii) type of observation;(v) action taken in connection with any deficiencies noted.(C) These records must be retained for three years after the life of the packaging to which they apply.(p) Reports. The transporter and shipper must immediately report by telephone all radioactive waste transportation accidents to the department, at (512) 458-7460, and the local emergency management officials in the county where the radioactive waste accident occurs. All other accidents involving radioactive material must be reported as specified in § 289.202(xx) and (yy) of this chapter.(q) Advance notification of transport of irradiated reactor fuel and certain radioactive waste. (1) As specified in paragraphs (3) - (5) of this subsection, each licensee must provide advance notification to the governor of a state or the governor's designee, of the shipment of radioactive waste within or across the boundary of the state before the transport or delivery to a carrier, for transport of radioactive waste outside the confines of the licensee's facility or other place of use or storage.(2) As specified in paragraphs (3) - (5) of this subsection, after June 11, 2013, each licensee must provide advance notification to the Tribal official of participating Tribes referenced in paragraph (4)(C)(iii) of this subsection or the official's designee, of the shipment of radioactive waste within or across the boundary of the Tribe's reservation before the transport or delivery to a carrier, for transport of radioactive waste outside the confines of the licensee's facility or other place of use or storage.(3) Advanced notification is also required under this subsection for the shipment of licensed radioactive material, other than irradiated fuel, meeting the following three conditions:(A) the radioactive waste is required by this section to be in Type B packaging for transportation;(B) the radioactive waste 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 radioactive waste in a single package is not greater than the least of: (i) 3000 times the A1 value of the radionuclides as specified in subsection (ee) of this section for special form radioactive material;(ii) 3000 times the A2 value of the radionuclides as specified in subsection (ee) of this section for normal form radioactive material; or(iii) 1000 terabecquerels (TBq) (27,000 curies (Ci)).(4) Procedures for submitting advance notification:(A) The notification must be made in writing, to: (i) the office of each appropriate governor or governor's designee and to the department;(ii) the office of each appropriate Tribal official or Tribal official's designee; and(iii) the Director, Office of Nuclear Security and Incident Response.(B) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.(C) A notification delivered by any means other than mail must reach the office of the governor or of the governor's designee or the Tribal official or 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) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating Tribes, including telephone and mailing addresses of Tribal officials and Tribal official's designees, is available on the NRC website at: https://scp.nrc.gov/special/designee.pdf.(ii) A list of the names and mailing addresses of the governors' designees and Tribal officials' designees of participating Tribes is available on request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.(D) The licensee must retain a copy of the notification for inspection by the department for three years.(5) Each advance notification of shipment of irradiated reactor fuel or radioactive waste must contain: (A) the name, address, and telephone number of the shipper, carrier, and receiver of the irradiated reactor fuel or radioactive waste shipment;(B) a description of the irradiated reactor fuel or radioactive waste contained in the shipment, as specified in the regulations of DOT 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 or Tribal reservation 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.(6) A licensee who finds schedule information previously furnished to a governor or governor's designee or a Tribal official or Tribal official's designee, as specified in this section, is not met, must 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 must maintain a record of the name of the individual contactedfor three years.(7) Procedures for a cancellation notice. (A) Each licensee canceling an irradiated reactor fuel or radioactive waste shipment for which advance notification was sent must 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, to the Director, Office of Nuclear Security and Incident Response, and to the department.(B) The licensee must state in the notice it is a cancellation and identify the advance notification being canceled. The licensee must retain a copy of the notice for inspection by the department for three years.(r) Emergency plan registration requirements. (1) Each shipper and transporter of radioactive waste must submit an emergency plan to the department and receive a registration letter from the department before initial shipment.(2) A freight forwarder must submit an emergency plan to become a registered freight forwarder.(3) Each shipper, transporter, or freight forwarder applying for registration must submit a Business Information Form (RC 252-1).(4) Shipper and freight forwarder registrations expire 10 years from the date of issuance. New documentation to renew the registration must be submitted at least 30 days before the expiration date.(s) QA requirements. (1) Purpose. This subsection describes QA requirements applying to the design, purchase, fabrication, handling, shipment, storage, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. (A) QA comprises all those planned and systematic actions necessary to provide adequate confidence a system or component performs satisfactorily in service.(B) QA includes quality control, which comprises those QA actions related to control of the physical characteristics and quality of the material or component to predetermined requirements.(C) The licensee, certificate holder, and applicant for a CoC are responsible for: (i) the QA requirements as they apply to the design, fabrication, testing, and modification of packaging; and(ii) the QA provision applicable to its use of a packaging for the shipment of licensed material under subsections (s) - (bb) and (ee) of this section.(2) Establishment of program. Each licensee, certificate holder, and applicant for a CoC must: (A) establish, maintain, and execute a QA program satisfying each of the applicable criteria of this subsection, subsections (s) and (t) of this section, and 10 CFR §§ 71.101 - 71.137 and satisfying any specific provisions applicable to the licensee's activities including procurement of packaging; and(B) execute the applicable criteria in a graded approach to an extent commensurate with the QA requirement's importance to safety.(3) Approval of program. Before the use of any package for the shipment of licensed material subject to this subsection, each licensee must: (A) obtain department approval of its QA program; and(B) file a description of its QA program, including a discussion of which requirements of this subsection and subsections (t) and (u) are applicable and how they will be satisfied.(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 § 289.255(m) of this subchapter, is deemed to satisfy the requirements of subsection (i)(1)(B) of this section and paragraph (2) of this subsection.(t) QA organization. The licensee, certificate holder, and applicant for a CoC must (while the term "licensee" is used in these criteria, the requirements are applicable to the design, fabrication, assembly, and testing of the package accomplished before the time a package approval is issued):(1) be responsible for establishing and executing the QA program. The licensee, certificate holder, and applicant for a CoC may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the QA program, or any part of the QA program, but must retain responsibility for the program;(2) clearly establish and delineate, in writing, the authority and duties of persons and organizations performing activities affecting the functions of structures, systems, and components important to safety. These activities include performing the functions associated with attaining quality objectives and the QA functions; and(3) establish QA functions as follows:(A) assuring an appropriate QA program is established and effectively executed; and(B) verifying, by procedures such as checking, auditing, and inspecting, activities affecting the functions important to safety are correctly performed; and(4) assure persons and organizations performing QA functions have sufficient authority and organizational freedom to: (A) identify quality problems;(B) initiate, recommend, or provide solutions; and(C) verify implementation of solutions.(u) QA program. A QA program must be maintained as follows: (1) The licensee, certificate holder, and applicant for a CoC must: (A) establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a QA program complying with the requirements of this section and 10 CFR §§ 71.101 - 71.137;(B) document the QA program by written procedures or instructions and carry out the program as specified in those procedures throughout the period during which the packaging is used; and(C) identify the material and components covered by the QA program, the major organizations participating in the program, and the designated functions of these organizations.(2) The licensee, certificate holder, and applicant for a CoC, through its QA program, must: (A) 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;(B) assure activities affecting quality are accomplished under suitable controlled conditions, including: (i) the use of appropriate equipment;(ii) suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and(iii) all prerequisites for the given activity are satisfied; and(C) consider 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 must base the requirements and procedures of its QA program on considerations concerning the complexity and proposed use of the package and its components, including: (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 must provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure suitable proficiency is achieved and maintained.(5) The licensee, certificate holder, and applicant for a CoC must review the status and adequacy of the QA program at established intervals. Management of other organizations participating in the QA program must review regularly the status and adequacy of that part of the QA program they are executing.(6) Changes to QA program. (A) Each QA program approval holder must submit, as specified in § 289.201(k) of this chapter, a description of a proposed change to its department-approved QA program reducing commitments in the program description as approved by the department. The QA program approval holder must not implement the change before receiving approval from the department. The description of a proposed change to the department-approved QA program must identify the change, the reason for the change, and the basis for concluding the revised program incorporating the change continues to satisfy the applicable requirements of subsections (s) - (bb) of this section.(B) Each QA program approval holder may change a previously approved QA program without prior approval from the department if the change does not reduce the commitments in the QA program previously approved by the department. Changes to the QA program that do not reduce the commitments must be submitted to the department every 24 months as specified in § 289.201(k) of this chapter. In addition to QA program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:(i) the use of a QA standard approved by the department more recent than the QA standard in the certificate holder's or applicant's current QA program at the time of the change;(ii) the use of generic organizational position titles clearly denoting the position function, supplemented as necessary by descriptive text, rather than specific titles, provided there is no substantive change to either the functions of the position or reporting responsibilities;(iii) the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided there is no substantive change to the functional relationships, authorities, or responsibilities;(iv) the elimination of QA program information duplicating language in QA regulatory guides and standards to which the QA program approval holder has committed on record; and(v) organizational revisions ensuring persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.(vi) Quality control program. Each shipper must adopt a quality control program ensuring shipping containers are suitable for shipments to a licensed disposal facility by verifying:(C) Each QA program approval holder must maintain records of QA program changes.(v) Quality control program. Each shipper shall adopt a quality control program to include verification of the following to ensure that shipping containers are suitable for shipments to a licensed disposal facility: (1) identification of appropriate containers;(2) container testing documentation is adequate;(3) appropriate container used;(4) container packaged appropriately;(5) container labeled appropriately;(6) manifest filled out appropriately; and(7) documentation maintained of each step.(w) Handling, storage, and shipping control. The licensee, certificate holder, and applicant for a CoC must establish measures to control, as specified in instructions, the handling, storing, shipping, cleaning, and preserving of materials and equipment 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.(x) Inspection, test, and operating status. Measures to track inspection, test, and operating status must be established.(1) The licensee, certificate holder, and applicant for a CoC must establish measures to indicate, using 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 having satisfactorily passed required inspections and tests where necessary to preclude inadvertent bypassing of the inspections and tests; and(2) The licensee must establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.(y) Non-conforming materials, parts, or components. The licensee, certificate holder, and applicant for a CoC must establish measures to control materials, parts, or components not conforming to the licensee's requirements to prevent their inadvertent use or installation. These measures must include, as appropriate: (1) procedures for identification, documentation, segregation, disposition, and notification to affected organizations; and(2) non-conforming items must be reviewed and accepted, rejected, repaired, or reworked as specified in documented procedures.(z) Corrective action. The licensee, certificate holder, and applicant for a CoC must establish measures to assure conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and non-conformances, are promptly identified and corrected.(1) In the case of a significant condition adverse to quality, the measures must assure the cause of the condition is determined and corrective action taken prevents repetition.(2) 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.(aa) QA records. The licensee, certificate holder, and applicant for a CoC must maintain written records sufficient to describe the activities affecting quality for inspection by the department for three years beyond the date when the licensee, certificate holder, and applicant for a CoC last engaged in the activity for which the QA program was developed. If any portion of the written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a CoC must retain the superseded material for three years after it is superseded. The records must include: (1) instructions, procedures, and drawings to prescribe QA activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment;(2) instructions or procedures establishing a records retention program consistent with applicable regulations and designating factors such as duration, location, and assigned responsibility; and(3) changes to the QA program as required by subsection (u)(6) of this section.(bb) Audits. The licensee, certificate holder, and applicant for a CoC must carry out a comprehensive system of planned and periodic audits, verifying compliance with all aspects of the QA program, and determining the effectiveness of the program. The audit program must include:(1) performance as specified in written procedures or checklists by appropriately trained personnel not having direct responsibilities in the area being audited;(2) documented results reviewed by management having responsibility in the area audited; and(3) follow-up action, including reaudit of deficient areas, taken where indicated.(cc) Transfer for disposal and manifests. (1) The requirements of this section and subsection (ff) of this section are designed to: (A) control transfers of LLRW by any waste generator, waste collector, or waste processor licensee, as defined in this section, shipping LLRW either directly or indirectly through a waste collector or waste processor to a licensed LLRW land disposal facility, as defined in § 289.201(b) of this chapter;(B) establish a manifest tracking system; and(C) supplement existing requirements concerning transfers and recordkeeping for those wastes.(2) Beginning March 1, 1998, all affected licensees must use subsection (ff) of this section.(3) Each shipment of LLRW intended for disposal at a licensed land disposal facility must be accompanied by a shipment manifest as specified in subsection (ff)(1) of this section.(4) Any licensee shipping LLRW intended for ultimate disposal at a licensed land disposal facility must document the information required on the uniform manifest and transfer this recorded manifest information to the intended consignee as specified in subsection (ff) of this section.(5) Each shipment manifest must include a certification by the waste generator as specified in subsection (ff)(10) of this section, as appropriate.(6) Each person involved in the transfer for disposal and disposal of LLRW, including the waste generator, waste collector, waste processor, and disposal facility operator, must comply with the requirements specified in subsection (ff) of this section, as appropriate.(7) Any licensee shipping LLRW to a licensed Texas LLRW disposal facility must comply with the waste acceptance criteria in 30 Texas Administrative Code Chapter 336.(8) Each shipper must submit a list for approval by the department of shipping containers they intend to use to ship LLRW to the Texas LLRW site. If the shipper is licensed in Texas and is the holder of a CoC, the shipper must also submit written documentation of its program for QA and control and handling, shipping, and control measures complying with the requirements of subsections (s), (t), and (v) - (bb) of this section.(dd) Fees. (1) Each shipper is assessed a fee for shipments of LLRW originating in Texas or originating out-of-state being shipped to a licensed Texas LLRW disposal facility and these fees are: (A) $10 per cubic foot of shipped LLRW;(B) collected by the department and deposited to the credit of the department's Radiation and Perpetual Care Account;(C) used by the department for emergency planning for and response to transportation accidents involving LLRW, including first responder training in counties through which transportation routes are designated as specified in this section; and(D) not collected on waste disposed of at a federal waste disposal facility.(2) Fee assessments are suspended from imposition against a party state compact waste generator when the amount in the department's Radiation and Perpetual Care Account attributable to those fees reaches $500,000. If the amount in that account attributable to those fees is reduced to $350,000 or less, the fee is reinstated until the amount reaches $500,000.(3) Money expended from the department's Radiation and Perpetual Care Account to respond to accidents involving LLRW are reimbursed to the department's Radiation and Perpetual Care Account by the responsible shipper or transporter according to this section.(4) For purposes of this subsection, "shipper" means a person who generates LLRW and ships, or arranges with others to ship, waste to a disposal site.(5) This subsection does not relieve a generator from liability for a transportation accident involving LLRW.(ee) Appendices for determination of A1 and A2. (1) Values of A1 and A2. Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits elsewhere in these rules, are given in Table 257-3 of paragraph (6) of this subsection. The Ci values specified are obtained by converting from the TBq value. The TBq values are the regulatory standard. The Ci 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) Values of radionuclides not listed.(A) For individual radionuclides whose identities are known but are not listed in Table 257-3 of paragraph (6) of this subsection, the A1 and A2 values contained in Table 257-5 of paragraph (8) of this subsection may be used. Otherwise, the licensee must obtain prior department or NRC approval of the A1 and A2 values for radionuclides not listed in Table 257-3 of paragraph (6) of this subsection before shipping the material.(B) For individual radionuclides whose identities are known but not listed in Table 257-4 of paragraph (7) of this subsection, the exempt material activity concentration and exempt consignment activity values contained in Table 257-5 of paragraph (8) of this subsection may be used. Otherwise, the licensee must obtain prior department or NRC approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table 257-4 of paragraph (7) of this subsection before shipping the material.(C) The licensee must submit requests for prior approval, described in subparagraphs (A) and (B) of this paragraph, to the department or the NRC.(3) Calculations of A1 and A2 for a radionuclide not in Table 257-3 of paragraph (6) of this subsection. In the calculations of A1 and A2 for a radionuclide not in Table 257-3 of paragraph (6) of this subsection, a single radioactive decay chain in which radionuclides are present in their naturally occurring proportions and in which no daughter radionuclide has a half-life either longer than 10 days or longer than the parent radionuclide, must be considered as a single radionuclide, and the activity to be taken into account and the A1 and A2 value to be applied must be those corresponding to the parent radionuclide of that chain. In the case of radioactive decay chains in which any daughter radionuclide has a half-life either longer than 10 days, or greater than the parent radionuclide, the parent and those daughter radionuclides must be considered as mixtures of different radionuclides.(4) Determination for mixtures of radionuclides whose identities and respective activities are known. 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: Attached Graphic
(B) For normal form radioactive material, the maximum quantity transported in a Type A package is as follows: Attached Graphic
(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: Attached Graphic
(D) Alternatively, an A1 value for mixtures of special form material may be determined as follows: Attached Graphic
(E) Alternatively, an A2 value for mixtures of normal form material may be determined as follows: Attached Graphic
(F) The exempt activity concentration for mixtures of nuclides may be determined as follows: Attached Graphic
(G) The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows: Attached Graphic
(5) Determination when individual activities of some of the radionuclides are not known. (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 paragraph (4) of this subsection. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta/gamma emitters.(B) When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph (4) of this subsection. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest or A values for the alpha emitters and beta/gamma emitters, respectively.(6) A1 and A2 values for radionuclides. Table 257-3 contains A1 and A2 values for radionuclides. Attached Graphic
(7) Exempt material activity concentrations and exempt consignment activity limits for radionuclides. Table 257-4 contains exempt material activity concentrations and exempt consignment activity limits for radionuclides: Attached Graphic
(8) General values for A1 and A2. Table 257-5 contains general values for A1 and A2: Attached Graphic
(9) Activity-mass relationships for uranium. Table 257-6 contains activity-mass relationships for uranium: Attached Graphic
(ff) Appendices for the requirements for transfers of LLRW intended for disposal at licensed land disposal facilities and manifests. (1) Manifest. A waste generator, collector, or processor who transports, or offers for transportation, LLRW intended for ultimate disposal at a licensed LLRW land disposal facility must prepare a manifest reflecting information requested on applicable NRC Forms 540 (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper)) and 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description)) and, if necessary, on an applicable NRC Form 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation)) or their equivalent. NRC Forms 540 and 540A must be completed and physically accompany the pertinent LLRW shipment. Upon agreement between shipper and consignee, NRC Forms 541, 541A, 542, and 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms. Licensees are not required by the department to comply with the manifesting requirements of this section when they ship: (A) LLRW for processing and expect its return (i.e., for storage under their license) before disposal at a licensed land disposal facility;(B) LLRW being returned to the licensee who is the waste generator or generator, as defined in this section; or(C) radioactively contaminated material to a waste processor that becomes the processor's residual waste.(2) Form instructions. For guidance in completing these forms, refer to the instructions accompanying the forms. Copies of manifests required by this subsection may be legible carbon copies, photocopies, or computer printouts reproducing the data in the format of the uniform manifest.(3) Forms. NRC Forms 540, 540A, 541, 541A, 542, and 542A, and the accompanying instructions, in hard copy, may be obtained by writing or calling the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone (301) 415-5877; or by visiting the NRC's website at http://www.nrc.gov and selecting forms from the index found on the NRC home page or at www.nrc.gov/reading-rm/doc-collections/forms/#NRC.(4) Information requirements of the DOT. This subsection includes information requirements of the DOT, in 49 CFR Part 172. Information on hazardous, medical, or other waste required to meet EPA regulations in 40 CFR Parts 259 and 261 or elsewhere, are not addressed in this section and must be provided on the required EPA forms. The required EPA forms must accompany the uniform manifest required by this section.(5) General information. The shipper of the LLRW must include on the uniform manifest:(A) the name, facility address, and telephone number of the licensee shipping the waste;(B) an explicit declaration indicating whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and(C) the name, address, and telephone number, or the name and EPA identification number, for the carrier transporting the waste.(6) Shipment information. The shipper of the LLRW must provide information regarding the waste shipment on the uniform manifest, including:(A) the date of the waste shipment;(B) the total number of packages/disposal containers;(C) the total disposal volume and disposal weight in the shipment;(D) the total radionuclide activity in the shipment;(E) the activity of each of the radionuclides hydrogen-3, carbon-14, technetium-99, and iodine-129 contained in the shipment; and(F) the total masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the total mass of uranium and thorium in source material.(7) Disposal container and waste information. The shipper of the LLRW must provide information on the uniform manifest regarding the waste and each disposal container of waste in the shipment, including: (A) an alphabetic or numeric identification uniquely identifying each disposal container in the shipment;(B) a physical description of the disposal container, including the manufacturer and model of any high integrity container;(C) the volume displaced by the disposal container;(D) the gross weight of the disposal container, including the waste;(E) for waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;(F) a physical and chemical description of the waste;(G) the total weight percentage of chelating agent for any waste containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;(H) the approximate volume of waste within a container;(I) the sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;(J) the identities and activities of individual radionuclides contained in each container, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material. For discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides associated with or contained on these waste types within a disposal container must be reported;(K) the total radioactivity within each container; and(L) for wastes consigned to a disposal facility, the classification of the waste as specified in § 289.202(ggg)(4)(A) of this chapter. Waste not meeting the structural stability requirements of § 289.202(ggg)(4)(B)(ii) of this chapter must be identified.(8) Uncontainerized waste information. The shipper of the LLRW must provide information on the uniform manifest regarding a waste shipment delivered without a disposal container including: (A) the approximate volume and weight of the waste;(B) a physical and chemical description of the waste;(C) the total weight percentage of chelating agent if the chelating agent is not greater than 0.1 percent by weight, plus the identity of the principal chelating agent;(D) for waste consigned to a disposal facility, the classification of the waste as specified in § 289.202(ggg)(4)(A) of this chapter. Waste not meeting the structural stability requirements of § 289.202(ggg)(4)(B)(ii) of this chapter must be identified;(E) the identities and activities of individual radionuclides contained in the waste, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material; and(F) for wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.(9) Multi-generator disposal container information. This paragraph applies to disposal containers enclosing mixtures of waste originating from different generators. (Note: The origin of the LLRW resulting from a processor's activities may be attributable to one or more generators (including waste generators) as defined in this section). It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators. (A) For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.(B) For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types (i.e., activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification/stabilization media), the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide: (i) the volume of waste within the disposal container;(ii) a physical and chemical description of the waste, including the solidification agent, if any;(iii) the total weight percentage of chelating agents for any disposal container containing more than 0.1 percent chelating agent by weight, plus the identity of the principal chelating agent;(iv) the sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in § 289.202(ggg)(4)(B)(ii) of this chapter; and(v) radionuclide identities and activities contained in the waste, the masses of uranium-233, uranium-235, and plutonium in special nuclear material, and the masses of uranium and thorium in source material if contained in the waste.(10) Certification. An authorized representative of the waste generator, processor, or collector must certify by signing and dating the shipment manifest the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the DOT and the department. A collector in signing the certification is certifying nothing has been done to the collected waste invalidating the waste generator's certification.(11) Control and tracking. (A) Any licensee transferring LLRW to a land disposal facility or a licensed waste collector must comply with the requirements in clauses (i) - (ix) of this subparagraph. Any licensee transferring waste to a licensed waste processor for waste treatment or repackaging must comply with the requirements of clauses (iv) - (ix) of this subparagraph. A licensee must: (i) prepare all wastes so the waste is classified according to § 289.202(ggg)(4)(A) of this chapter and meets the waste characteristic requirements in § 289.202(ggg)(4)(B) of this chapter;(ii) label each disposal container (or transport package if potential radiation hazards preclude labeling of the individual disposal container) of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater than Class C waste, as specified in § 289.202(ggg)(4)(A) of this chapter;(iii) conduct a QA program to assure compliance with § 289.202(ggg)(4)(A) and (B) of this chapter;(iv) prepare the uniform manifest as required by this subsection;(v) forward a copy or electronically transfer the uniform manifest to the intended consignee so that either: (I) receipt of the manifest precedes the LLRW shipment; and(II) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclauses (I) and (II) of this clause are also acceptable;(vi) include the uniform manifest with the shipment regardless of the option chosen in clause (v) of this subparagraph;(vii) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest;(viii) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by § 289.251 of this subchapter and § 289.252 of this subchapter; and(ix) for any shipments or any part of a shipment for which acknowledgement of receipt is not received within the times set forth in this subsection, conduct an investigation as specified in subparagraph (D) of this paragraph.(B) Any waste collector licensee handling only prepackaged waste must:(i) acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of the uniform manifest;(ii) prepare a new uniform manifest to reflect consolidated shipments meeting the requirements of this subsection. The waste collector must ensure, for each container of waste in the shipment, the uniform manifest identifies the generator of that container of waste;(iii) forward a copy or electronically transfer the uniform manifest to the intended consignee so either: (I) receipt of the uniform manifest precedes the LLRW shipment; or(II) the uniform manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclauses (I) and (II) of this clause are also acceptable;(iv) include the uniform manifest with the shipment regardless of the option chosen in clause (iii) of this subparagraph;(v) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest;(vi) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by § 289.251 of this subchapter and § 289.252 of this subchapter;(vii) conduct an investigation as specified in subparagraph (D) of this paragraph for any shipments or any part of a shipment for which acknowledgement of receipt is not received within the times set forth as specified in this clause; and(viii) notify the shipper and the department when any shipment, or part of a shipment, does not arrive within 60 days after receipt of an advance uniform manifest, unless notified by the shipper the shipment has been cancelled.(C) Any licensed waste processor treating or repackaging waste must:(i) acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of the uniform manifest;(ii) prepare a new uniform manifest meeting the requirements of this subsection. Preparation of the new uniform manifest reflects the processor's responsibility for meeting these requirements. For each container of waste in the shipment, the manifest must identify the waste generators, the preprocessed waste volume, and the other information as required in clause (i) of this subparagraph;(iii) prepare all wastes so the waste is classified according to § 289.202(ggg)(4)(A) of this chapter and meets the waste characteristics requirements in § 289.202(ggg)(4)(B) of this chapter;(iv) label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, as specified in § 289.202(ggg)(4)(A) and (C) of this chapter;(v) conduct a QA program to assure compliance with § 289.202(ggg)(4)(A) and (B) of this subchapter;(vi) forward a copy or electronically transfer the uniform manifest to the intended consignee so either: (I) receipt of the uniform manifest precedes the LLRW shipment; or(II) the uniform manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both subclause (I) of this clause and this subclause is also acceptable;(vii) include the uniform manifest with the shipment regardless of the option chosen in clause (vi) of this subparagraph;(viii) receive acknowledgement of the receipt of the shipment in the form of a signed copy of the uniform manifest;(ix) retain a copy of or electronically store the uniform manifest and documentation of acknowledgement of receipt as the record of transfer of radioactive material as required by § 289.251 of this subchapter and § 289.252 of this subchapter;(x) conduct an investigation as specified in clause (v) of this subparagraph for any shipment or any part of a shipment for which acknowledgement of receipt is not received within the times set forth as specified in this clause; and(xi) notify the shipper and the department when any shipment, or part of a shipment, does not arrive within 60 days after receipt of an advance uniform manifest, unless notified by the shipper the shipment has been cancelled.(D) Any shipment or part of a shipment for which acknowledgement is not received within the times set forth as specified in this section must be: (i) investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and(ii) traced and reported. The investigation must include tracing the shipment and filing a report with the department. Each licensee who conducts a trace investigation must file a written report with the department within two weeks of completion of the investigation.25 Tex. Admin. Code § 289.257
The provisions of this §289.257 adopted to be effective December 27, 2007, 32 TexReg 9633; amended to be effective October 1, 2011, 36 TexReg 5851; Amended by Texas Register, Volume 40, Number 11, March 13, 2015, TexReg 1423, eff. 3/22/2015; Amended by Texas Register, Volume 41, Number 09, February 26, 2016, TexReg 1449, eff. 3/1/2016; Amended by Texas Register, Volume 43, Number 38, September 21, 2018, TexReg 6289, eff. 9/24/2018; Amended by Texas Register, Volume 46, Number 53, December 31, 2021, TexReg 9309, eff. 1/5/2022; Amended by Texas Register, Volume 49, Number 40, October 4, 2024, TexReg 8100, eff. 10/23/2024