Current through Register Vol. 48, No. 9, September 27, 2024
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.
2.22.7 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.
Statutory Authority: Section
13-7-40
et seq., as amended, of the 1976 Code, namely the Atomic Energy and Radiation
Control Act