S.C. Code Regs. § § 61-63.II.RHA 2.22

Current through Register Vol. 48, 12, December 27, 2024

Section 61-63.II.RHA 2.22 - Transportation of Radioactive Materials

2.22.1 The transportation of radioactive material shall be in accordance with the requirements in 10 CFR Part 71 , which is incorporated by reference, with the exception of the following sections: 71.2, 71.6, 71.11, 71.14(b), 71.17, 71.19, 71.21, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, 71.51, 71.52, 71.53, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.70, 71.71, 71.73, 71.74, 71.75, 71.77, 71.85(a)-(c), 71.91(b), 71.91(c), 71.91(d), 71.99, 71.100, 71.101(a), 71.101(b), 71.101(c)(1), 71.101(c)(2), 71.101(d), 71.101,(e), 71.103(a), 71.106, 71.107, 71.109, 71.111, 71.113, 71.115, 71.117. 71.119, 71.121, 71.123, 71.125, and 71.135. The provisions of this section apply to the transportation of radioactive material, or delivery of radioactive material to a carrier for transportation, regardless of whether or not the carrier is also subject to the rules and regulations of the Nuclear Regulatory Commission contained in Title 10 CFR Part 71 and other agencies of the United States having jurisdiction.

2.22.1.1 No person shall deliver radioactive material to a carrier for transport or transport radioactive material except as authorized in a general or specific license issued by the Department or as exempted in 2.22.1.2.

2.22.1.2 Exemptions

2.22.1.2.1 Common and contract carriers, freight forwarders, and warehousemen, who are subject to the rules and regulations of the U.S. Department of Transportation or the U.S. Postal Service ( 39 CFR Parts 14 and 15), are exempt from RHA 2.22.1.1 to the extent that they transport or store radioactive material in the regular course of their carriage for another or storage incident thereto. Common and contract carriers who are not subject to the rules and regulations of the U.S. Department of Transportation or U.S. Postal Service are subject to RHA 2.22.1.1.

2.22.1.2.2 Physicians as defined in RHA 1.2.17 are exempt from the requirements of RHA 2.22.1.1 to the extent that they transport radioactive material for use in the practice of medicine.

2.22.1.2.3 Specific licensees are exempt from 2.22.1.1 to the extent that they deliver to a carrier for transport packages each of which contains no radioactive material having a specific activity in excess of .002 microcuries per gram.

2.22.1.2.4 Any licensee who delivers radioactive material to a carrier for transport where such transport is subject to the regulations of the U.S. Postal Service is exempt from the provisions of 2.22.1.1.

2.22.2 Preparation of Radioactive Material for Transport

2.22.2.1 A general license is hereby issued to deliver radioactive material to a carrier [FN9] for transport provided that:

2.22.2.2 The person complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the U.S. Department of Transportation and the U.S. Postal Service insofar as such regulations relate to the packaging of radioactive material, marking and labeling of packages, loading and storage of packages, placarding of the transporting vehicle, monitoring requirements and accident reporting; and

2.22.2.3 The person has established procedures for opening and closing packages in which radioactive material is transported to provide safety and to assure that, prior to delivery to a carrier for transport, each package is properly closed for transport; and

2.22.2.4 Prior to delivery of a package to a carrier for transport, the person shall assure that any special instruments needed to safely open the package are sent to, or have been made available to, the consignee.

2.22.3 Intrastate Transport

2.22.3.1 A general license is hereby issued to any common or contract carrier to transport and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. [FN10]

2.22.3.2 A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with regulations, appropriate to the mode of transport, of the U.S. Department of Transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting.

2.22.3.3 Persons who transport radioactive material pursuant to the general licenses in 2.22.3.1 and 2.22.3.2 are exempt from the requirements of Part III and Part VI of these regulations to the extent that they transport radioactive material.

2.22.4 Advance Notification of Nuclear Waste [FN11]

2.22.4.1 Prior to the transport of any nuclear waste outside of the confines of the licensee's facility or other place of use or storage, or prior to the delivery of any nuclear waste to a carrier for transport, each licensee shall provide advance notification of such transport to the governor (or governor's designee) of each State through which the waste will be transported.

2.22.4.2 Each advance notification required by 2.22.4.1 shall contain the following information:

2.22.4.2.1 The name, address, and telephone number of the shipper, carrier, and receiver of the shipment.

2.22.4.2.2 A description of the nuclear waste contained in the shipment as required by the regulations of the U.S. Department of Transportation in 49 CFR 172.202 and 172.203(d);

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

2.22.4.2.4 The seven-day period during which arrival of the shipment at State boundaries is estimated to occur;

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

2.22.4.2.6 A point of contact with a telephone number for current shipment information.

2.22.4.3 The notification required by 2.22.4.1 shall be made in writing to the office of each appropriate governor (or governor's designee) and to the Department. 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. A notification delivered by messenger must reach the office of the governor (or governor's designee) at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur. A copy of the notification shall be retained by the licensee for one year.

2.22.4.4 The licensee shall notify each appropriate governor (or governor's designee) and the Department of any changes to schedule information provided pursuant to 2.22.4.1. Such notification shall be by telephone to a responsible individual in the office of the governor (or governor's designee) of the appropriate State. The licensee shall maintain for one year a record of the name of the individual contacted.

2.22.4.5 Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the governor (or governor's designee) of each appropriate State and to the Department. A copy of the notice shall be retained by the licensee for one year.

[FN9] For the purposes of this regulation, a licensee who transports his own licensed material as a private carrier is considered to have delivered such material to a carrier for transport.

[FN10] Any notification of incidents referred to in the requirements shall be filed with, or made to, the Department.

[FN11] For the purpose of this section, "nuclear waste" means any large quantity of source, byproduct, or special nuclear material required to be in Type B packaging while transported to, through or across State boundaries to a disposal site, or to a collection point for transport to a disposal site.

2.22.5 Delete.

2.22.6 Delete.

2.22.7 Records.

2.22.7.1 The licensee shall make available to the Department for inspections, upon reasonable notice, all records required by this part. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

2.22.7.2 The licensee shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by 10 CFR 71.85; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for three (3) years after the life of the packaging to which they apply.

2.22.8 Quality assurance requirements.

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

2.22.8.2 Establishment of program. Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of 10 CFR 71.101 through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

2.22.8.3 Approval of program. Before the use of any package for the shipment of licensed material subject to this subpart, each licensee shall obtain Department approval of its quality assurance program. Each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, by submitting the description to: ATTN: South Carolina Department of Health and Environmental Control, Division of Waste Management, 2600 Bull Street, Columbia, South Carolina 29201.

2.22.9 Quality assurance organization.

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

2.22.10 Changes to quality assurance program.

2.22.10.1 Each quality assurance program approval holder shall submit a description of a proposed change to its Department-approved quality assurance program that will reduce commitments in the program description as approved by the Department. The quality assurance program approval holder shall not implement the change before receiving Department approval.

2.22.10.1.1 The description of a proposed change to the Department-approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of subpart H of 10 CFR 71.

2.22.10.1.2 Reserved.

2.22.10.2 Each quality assurance program approval holder may change a previously approved quality assurance program without prior Department approval, if the change does not reduce the commitments in the quality assurance program previously approved by the Department. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the Department every twenty-four (24) months. In addition to quality assurance 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:

2.22.10.2.1 The use of a quality assurance standard approved by the Department that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change;

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

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

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

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

2.22.10.3 Each quality assurance program approval holder shall maintain records of quality assurance program changes.

2.22.11 Quality assurance records.

2.22.11.1 The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by 2.22.10 of this part, the instructions, procedures, and drawings required by 10 CFR 71.111 to prescribe quality assurance activities, and closely related specifications such as required qualifications or personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three (3) years beyond the date when the licensee last engaged in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures, or instructions is superseded, the licensee shall retain the superseded material for three (3) years after it is superseded.

S.C. Code Regs. § 61-63.II.RHA 2.22

Amended by State Register Volume 42, Issue No. 02, eff. 2/23/2018; State Register Volume 44, Issue No. 09, eff. 9/25/2020; State Register Volume 47, Issue No. 10, eff. 10/27/2023.

Statutory Authority: Section 13-7-40 et seq., as amended, of the 1976 Code, namely the Atomic Energy and Radiation Control Act