(1)
This rule establishes requirements for packaging, preparation for shipment, and
transportation of radioactive material and applies to any licensee or
registrant authorized by specific or general license to receive, possess, use,
or transfer licensed material, if the person delivers that material to a
carrier for transport, transports the material outside the site of usage as
specified in the license, or transports that material on public highways. This
rule does not authorize possession of licensed material.
(2) Except as authorized in a general license
or a specific license issued by the Division, or as exempted in this rule, no
licensee may:
(a) Deliver licensed material
to a carrier for transport; or
(b)
Transport licensed material.
(3) Any physician as defined in Rule
0400-20-04-.04 is
exempt from paragraph (4) of this rule with respect to transport by the
physician of licensed material for use in the practice of medicine. However,
any physician operating under this exemption must be licensed under Chapter
0400-20-07 or 10 CFR Part
35.
(4) A
licensee who, under a general or specific license, transports licensed material
outside its site of authorized use or on public highways, or who delivers
licensed material to a carrier for transport, shall comply with the applicable
requirements of this rule and with the applicable requirements of the U.S. DOT
regulations in 49 CFR Parts
107,
171 through
180, and
390 through
397,
appropriate to the mode of transport.
(a) The
licensee shall particularly note U.S. DOT regulations in the following areas:
1. Packaging: 49 CFR part
173, subparts A and
B and I;
2. Marking and labeling:
49 CFR
172, subpart D, 172.400 through 172.407, and
172.436 through 172.441 of subpart E;
3. Placarding: 49 CFR part
172, subpart F,
especially 172.500 through 172.519, 172.556 and appendices B and C;
4. Accident reporting: 49 CFR part
171,
171.15 and 171.16;
5. Shipping
papers and emergency information: 49 CFR part
172, subparts C and G;
6. Hazardous material employee training: 49
CFR part
172, subpart H;
7.
Hazardous material shipper/carrier registration: 49 CFR part
107, subpart G;
and
8. Security plans: 49 CFR Part
172, Subpart I.
(b) The
licensee shall also note U.S. DOT regulations pertaining to the following modes
of transportation:
1. Rail: 49 CFR part
174,
subparts A through D and K;
3. Vessel: 49 CFR
part
176, subparts A through F and M; and
4. Public highway: 49 CFR part
177 and parts
390 through 397.
(5) If U.S. DOT regulations are not
applicable to a shipment of licensed material, the licensee shall conform to
the standards and requirements of the U.S. DOT specified in subparagraph (4)(a)
of this rule to the same extent as if the shipment or transportation were
subject to U.S. DOT regulations. A request for modification, waiver or
exemption from those requirements, and any notification referred to in those
requirements, shall be filed with, or made to, the Director of the Division of
Radiological Health at the address given in Rule
0400-20-04-.07.
(6) Exemptions.
(a) Carriers
Common and contract carriers, freight forwarders,
warehousemen, and the U.S. Postal Service are exempt from the rules in this
chapter and the requirements for a license set in this chapter to the extent
that they transport or store byproduct material in the regular course of
carriage for another or storage incident thereto.
(b) Exemption for low-level materials.
1. A licensee is exempt from all requirements
of this rule with respect to shipment or carriage of the following low-level
materials:
(i) Natural material and ores
containing naturally occurring radionuclides that are either in their natural
state, or have only been processed for purposes other than for the extraction
of the radionuclides, and which are not intended to be processed for use of
these radionuclides, provided the activity concentration of the material does
not exceed ten times the values specified in Table A-2 or Table A-3 of Schedule
10-6 in Rule 0400-20-10.38; and
(ii) Materials for which the activity
concentration is not greater than the activity concentration values specified
in Table A-2 or Table A-3 of Schedule 10-6 in Rule
0400-20-10-.38,
or for which the consignment activity is not greater than the limit for an
exempt consignment found in Table A-2 or Table A-3 of Schedule 10-6 in Rule
0400-20-10-.38.
(iii) Non-radioactive solid objects with
radioactive substances present on any surfaces in quantities not in excess of
the levels cited in the definition of contamination in Rule
0400-20-04-.04.
2. Reserved.
3. Reserved.
(c) Exemption from classification as fissile
material.
1. Fissile material meeting the
requirements of at least one of the subparts (i) through (vi) of this part are
exempt from classification as fissile material, but are subject to all other
requirements of this rule, except as noted;
(i) Individual package containing 2 grams or
less fissile material;
(ii)
Individual or bulk packaging containing 15 grams or less of fissile material
provided the package has at least 200 grams of solid nonfissile material for
every gram of fissile material. Lead, beryllium, graphite, and hydrogenous
material enriched in deuterium may be present in the package but must not be
included in determining the required mass for solid nonfissile
material;
(iii)
(I) Low concentrations of solid fissile
material commingled with solid nonfissile material, provided that:
I. There is at least 2000 grams of solid
nonfissile material for every gram of fissile material, and
II. There is no more than 180 grams of
fissile material distributed within 360 kg of contiguous nonfissile
material;
(II) Lead,
beryllium, graphite, and hydrogenous material enriched in deuterium may be
present in the package but must not be included in determining the required
mass of solid nonfissile material;
(iv) Uranium enriched in uranium-235 to a
maximum of 1 percent by weight, and with total plutonium and uranium-233
content of up to 1 percent of the mass of uranium-235, provided that the mass
of any beryllium, graphite, and hydrogenous material enriched in deuterium
constitutes less than 5 percent of the uranium mass, and that the fissile
material is distributed homogeneously and does not form a lattice arrangement
within the package;
(v) Liquid
solutions of uranyl nitrate enriched in uranium-235 to a maximum of 2 percent
by mass, with a total plutonium and uranium-233 content not exceeding 0.002
percent of the mass of uranium, and with a minimum nitrogen to uranium atomic
ratio (N/U) of 2. The material must be contained in at least a DOT Type A
package; and
(vi) Packages
containing, individually, a total plutonium mass of not more than 1000 grams,
of which not more than 20 percent by mass may consist of plutonium-239,
plutonium-241, or any combination of these radionuclides.
(7) General license:
U.S. NRC-approved package.
(a) A general
license is hereby issued to any licensee of the Division to transport, or to
deliver to a carrier for transport, licensed material in a package for which a
license, certificate of compliance or other approval has been issued by the
U.S. Nuclear Regulatory Commission.
(b)
1. This
general license applies only to a licensee who has a quality assurance program
approved by the Division as satisfying the provisions of this rule.
2. Each licensee issued a general license
under subparagraph (a) of this paragraph shall:
(i) Maintain a copy of the NRC-issued
certificate of compliance, or other approval of the package, and 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;
(ii) Comply with the
terms and conditions of the license, certificate, or other approval, as
applicable, and the applicable requirements of this rule; and
(iii) Submit in writing before the first use
of the package to: ATTN: Document Control Desk, Director, Division of Spent
Fuel Storage and Transportation, Office of Nuclear Material Safety and
Safeguards, using an appropriate method listed in
10 CFR
71.1(a), the licensee's name
and license number and the package identification number specified in the
package approval.
(c) This general license applies only when
the package approval authorizes use of the package under this general
license.
(d) For a Type B or
fissile material package, the design of which was approved by U.S. NRC before
April 1, 1996, the general license is subject to the additional restrictions in
10 CFR
71.19.
(8) Reserved.
(9) General license: Use of foreign approved
package.
(a) A general license is issued to
any licensee of the Division to transport, or to deliver to a carrier for
transport, licensed material in a package the design of which has been approved
in a foreign national competent authority certificate that has been revalidated
by U.S. DOT as meeting the applicable requirements of
49
CFR
171.23.
(b) Except as otherwise provided in this
paragraph, the general license applies only to a licensee who has a quality
assurance program approved by the Division as satisfying the applicable
provisions of this rule.
(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 shall:
1. Maintain a copy of the applicable
certificate, the revalidation and the drawings and other documents referenced
in the certificate, relating to the use and maintenance of the packaging and to
the actions to be taken before shipment;
2. Comply with the terms and conditions of
the certificate and revalidation and with the applicable requirements of this
rule.
(10)
General license: Fissile material
(a) A
general license is issued to any licensee of the Division or U.S. NRC to
transport fissile material, or to deliver fissile material to a carrier for
transport, if the material is shipped in accordance with this paragraph. The
fissile material need not be contained in a package which meets the standards
of 10 CFR Part
71 subparts E and F of U.S. NRC regulations; however, the
material must be contained in a Type A package. The Type A package must also
meet the DOT requirements of
49 CFR
173.417(a).
(b) The general license applies only to a
licensee who has submitted to the Division and received Division approval for a
quality assurance program that satisfies the provisions found in this
rule.
(c) The general license
applies only when a package's contents:
1.
Contain less than a Type A quantity of fissile material; and
2. 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 that are labeled with a CSI which:
1. Has been determined in accordance with
subparagraph (e) of this paragraph;
2. Has a value less than or equal to 10;
and
3. For a shipment of multiple
packages containing fissile material, the sum of the CSIs must be less than or
equal to 50 (for shipment on a nonexclusive use conveyance) and less than or
equal to 100 (for shipment on an exclusive use conveyance).
(e)
1. The value for the CSI must be greater than
or equal to the number calculated by the following equation:
Click
to view Image
2.
The calculated CSI must be rounded up to the first decimal place;
3. The values of X, Y, and Z used in the CSI
equation must be taken from Tables RHS 7-3 or 7-4, as appropriate;
4. If Table RHS 7-4 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
5. Table RHS 7-3 values for X, Y, and Z must
be used to determine the CSI if:
(i)
Uranium-233 is present in the package;
(ii) The mass of plutonium exceeds 1 percent
of the mass of uranium-235;
(iii)
The uranium is of unknown uranium-235 enrichment or greater than 24 weight
percent enrichment; or
(iv)
Substances having a moderating effectiveness (i.e., an average hydrogen density
greater than H
2O) (e.g., certain hydrocarbon oils or
plastics) are present in any form, except as polyethylene used for packing or
wrapping.
Table RHS 7-3. Mass Limits for General License Packages
Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown
Enrichment per subparagraph (10)(e) of Rule 0400-20-10-.30
|
Fissile material
|
Fissile material mass mixed with moderating
substances having an average hydrogen density less than or equal to
H2O (grams)
|
Fissile material mass mixed with moderating
substances having an average hydrogen density greater than
H2Oa(grams)
|
|
235U (X)
|
60
|
38
|
|
233U (Y)
|
43
|
27
|
|
239Pu
or241Pu (Z)
|
37
|
24
|
a When mixtures of moderating
substances are present, the lower mass limits shall be used if more than 15
percent of the moderating substance has an average hydrogen density greater
than H2O.
Table RHS 7-4 Mass Limits for General License Packages
Containing Uranium-235 of Known Enrichment per subparagraph (10)(e) of Rule
0400-20-10-.30
|
Uranium enrichment in weight percent
of235U not exceeding
|
Fissile material mass
of235U (X) (grams)
|
|
24
|
60
|
|
20
|
63
|
|
15
|
67
|
|
11
|
72
|
|
10
|
76
|
|
9.5
|
78
|
|
9
|
81
|
|
8.5
|
82
|
|
8
|
85
|
|
7.5
|
88
|
|
7
|
90
|
|
6.5
|
93
|
|
6
|
97
|
|
5.5
|
102
|
|
5
|
108
|
|
4.5
|
114
|
|
4
|
120
|
|
3.5
|
132
|
|
3
|
150
|
|
2.5
|
180
|
|
2
|
246
|
|
1.5
|
408
|
|
1.35
|
480
|
|
1
|
1,020
|
|
0.92
|
1,800
|
(11) General
license: Plutonium-beryllium special form material.
(a) A general license is issued to any
licensee of the Division or the U.S. NRC to transport fissile material in the
form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver
Pu-Be sealed sources to a carrier for transport, if the material is shipped in
accordance with this rule. This material need not be contained in a package
which meets the standards of 10 CFR Part
71 subparts E and F; however, the
material must be contained in a Type A package. The Type A package must also
meet the DOT requirements of
49 CFR
173.417(a).
(b) The general license applies only to a
licensee who has submitted to the Division and received Division approval for a
quality assurance program that satisfies the provisions found in this
rule.
(c) The general license
applies only when a package's contents:
1.
Contain no more than a Type A quantity of radioactive material; and
2. Contain less than 1000 g of plutonium,
provided that: plutonium-239, plutonium - 241, or any combination of these
radionuclides, constitutes less than 240 g of the total quantity of plutonium
in the package.
(d) The
general license applies only to packages labeled with a CSI which:
1. Has been determined in accordance with
subparagraph (e) of this paragraph;
2. Has a value less than or equal to 100;
and
3. For a shipment of multiple
packages containing Pu-Be sealed sources, the sum of the CSIs must be less than
or equal to 50 (for shipment on a nonexclusive use conveyance) and less than or
equal to 100 (for shipment on an exclusive use conveyance).
(e)
1. The value for the CSI must be greater than
or equal to the number calculated by the following equation:
Click
to view Image
2.
The calculated CSI must be rounded up to the first decimal place.
(12) Fissile Material:
Assumptions as to Unknown Properties of Fissile Material.
(a) 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 shall
package the fissile material as if the unknown properties have credible values
that will cause the maximum neutron multiplication.
(13) Before the first use of any packaging
for the shipment of licensed material, a licensee shall ascertain that the
determinations in
10 CFR
71.85(a)-(c) have been
made.
(14) Routine determinations.
(a) Before each shipment of licensed
material, the licensee shall ensure that the package with its contents
satisfies the applicable requirements of this rule and of the license. The
licensee shall determine that:
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 in accordance with
10 CFR
71, Subpart F;
5. Any pressure relief device is operable and
set in accordance with written procedures;
6. The package has been loaded and closed in
accordance with written procedures;
7. For fissile material, any moderator or
neutron absorber, if required, is present and in proper condition;
8. Any structural part of the package that
could be used to lift or tie down the package during transport is rendered
inoperable for that purpose, unless it satisfies the design requirements of
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 and within the limits specified in
U.S. DOT regulations in
49 CFR
173.443;
10. External radiation levels around the
package and around the vehicle, if applicable, will not exceed the limits
specified in
10 CFR
71.47 at any time during transportation;
and
11. Accessible package surface
temperatures will not exceed the limits specified in
10 CFR
71.43(g) at any time during
transportation.
(b)
Reserved.
(15) Air
transport of plutonium.
(a) Notwithstanding
the provisions of any general licenses and notwithstanding any exemptions
stated directly in this rule or included indirectly by citation of 49 CFR
Chapter I, as may be applicable, the licensee shall assure that 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:
1. The plutonium is contained in a medical
device designed for individual human application; or
2. 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 A-2 of Schedule 10-6 in
Rule
0400-20-10-.38
and in which the radioactivity is essentially uniformly distributed;
or
3. The plutonium is shipped in a
single package containing no more than an A2 quantity of
plutonium in any isotope or form and is shipped in accordance with paragraphs
(4) and (5) of this rule; or
4. The
plutonium is shipped in a package specifically authorized for the shipment of
plutonium by air in the Certificate of Compliance for that package issued by
the U.S. Nuclear Regulatory Commission.
(b) Nothing in subparagraph (a) of this
paragraph is to be interpreted as removing or diminishing the requirements of
10
CFR
73.24.
(c) For a shipment of plutonium by air that
is subject to part (a)4 of this paragraph, the licensee shall, through special
arrangement with the carrier, require compliance with
49 CFR
175.704, U.S. Department of Transportation
regulations applicable to the air transport of plutonium.
(16) Opening instructions.
Before delivery of a package to a carrier for transport, the
licensee shall ensure that any special instructions needed to safely open the
package have been sent to, or otherwise made available to, the consignee for
the consignee's use in accordance with subparagraphs (5)(a) and (b) of Rule
0400-20-05-.115.
(17) Records.
(a) Each licensee shall maintain, for a
period of 3 years after shipment, a record of each shipment of licensed
material not exempt under paragraph (6) of this rule, showing where applicable:
1. Identification of the packaging by model
number and serial number;
2.
Verification that there are no significant defects in the packaging, as
shipped;
3. Volume and
identification of coolant;
4. Type
and quantity of licensed material in each package and the total quantity of
each shipment;
5. For each item of
irradiated fissile material:
(i)
Identification by model number and serial number;
(ii) Irradiation and decay history to the
extent appropriate to demonstrate that its nuclear and thermal characteristics
comply with license conditions; and
(iii) Any abnormal or unusual condition
relevant to radiation safety;
6. Date of the shipment;
7. For fissile packages and for Type B
packages, any special controls exercised;
8. Name and address of the
transferee;
9. Address to which the
shipment was made; and
10. Results
of the determinations required by paragraph (14) of this rule and by the
conditions of the package approval.
(b) The licensee shall make available to the
Division for inspection, upon reasonable notice, all records required by this
rule. Records are only valid if stamped, initialed, or signed and dated by
authorized personnel or otherwise authenticated.
(c) 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 paragraph (13)
of this rule; 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. The records must be
retained for three years after the life of the packaging to which they
apply.
(18)
Reserved.
(19) Inspection and
tests.
In addition to the requirements in paragraph (1) of Rule
0400-20-10-.27 and
Rule 0400-2010-.28, the licensee shall notify the Director, Division of
Radiological Health, at the address given in Rule
0400-20-10-.07,
at least 45 days before fabrication of a package to be used for the shipment of
licensed material having a decay heat load in excess of 5 kW or with a maximum
normal operating pressure in excess of 103 kPa (15
lbf/in2) gauge.
(20) Reports.
The licensee shall report to the Director, Division of
Radiological Health, within 30 days:
(a) Any instance in which there is
significant reduction in the effectiveness of any approved Type B, or fissile,
packaging during use;
(b) Details
of any defects with safety significance in Type B, or fissile, packaging after
first use, with the means employed to repair the defects and prevent their
recurrence; or
(c) Instances in
which the conditions of approval in the certificate of compliance were not
observed in making a shipment.
(21) Advance notification of shipment of
nuclear waste.
(a)
1. As specified in subparagraphs (b), (c) and
(d) of this paragraph, each licensee shall provide advance notification to the
governor of a state, or the governor's designee, and to the Director, Division
of Radiological Health, of the shipment of licensed material, within or across
the boundary of the State, before the transport, or delivery to a carrier for
transport, of licensed material outside the confines of the licensee's plant or
other place of use or storage.
2.
As specified in subparagraphs (b), (c), and (d) of this paragraph, each
licensee shall provide advance notification to the Tribal official of
participating Tribes referenced in subpart (c)3(iii) of this paragraph, or the
official's designee, of the shipment of licensed material, within or across the
boundary of the Tribe's reservation, before the transport, or delivery to a
carrier, for transport, of licensed material outside the confines of the
licensee's plant or other place of use or storage.
(b) Advance notification is also required
under this paragraph for shipment of licensed material, other than irradiated
fuel, meeting the following three conditions:
1. The licensed material is required by
10 CFR
71 to be in Type B packaging for
transportation;
2. The licensed
material is being transported to or across the State boundary en route to a
disposal facility or to a collection point for transport to a disposal
facility; and
3. The quantity of
licensed material in a single package exceeds the least of the following:
(i) 3000 times the A 1 value of the
radionuclides as specified in Schedule 10-6 in Rule
0400-20-10-.38,
Table A-1 for special form radioactive material;
(ii) 3000 times the A 2 value of the
radionuclides as specified in Schedule 10-6 in Rule
0400-20-10-.38,
Table A-1 for normal form radioactive material; or
(iii) 1000 TBq (27,000 Ci).
(c) Procedures for
submitting advance notification.
1. The
notification shall be made in writing to the office of each appropriate
governor or governor's designee, the office of each appropriate Tribal official
or Tribal official's designee, and to the Director, Division of Radiological
Health.
2. A notification delivered
by mail shall be postmarked at least 7 days before the beginning of the 7-day
period during which departure of the shipment is estimated to occur.
3. A notification delivered by any other
means than mail shall reach the office of the governor, or of the governor's
designee, or the Tribal official or Tribal official's designee and of the
Director, Division of Radiological Health, at least 4 days before the beginning
of the 7-day period during which departure of the shipment is estimated to
occur.
(i) A list of the names and mailing
addresses of the governors' designees receiving advance notification of
transportation of nuclear waste was published in the Federal Register on June
30, 1995 (
60 FR 34306).
(ii)
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 officials'
designees, is available on the NRC Web site at:
https://scp.nrc.gov/special/designee.pdf.
(iii) A list of the names and mailing
addresses of the governors' designees and Tribal officials' designees of
participating Tribes is available on request from the Director, Division of
Intergovernmental Liaison and Rulemaking, Office of Federal and State Materials
and Environmental Management Programs, U.S. Nuclear Regulatory Commission,
Washington, DC 205550001.
(iv) The
licensee shall retain a copy of the notification as a record for 3
years.
(d)
Information to be furnished in advance notification of shipment. Each advance
notification of shipment nuclear waste shall contain the following information:
1. The name, address and telephone number of
the shipper, carrier and receiver of the nuclear waste shipment;
2. A description of the nuclear waste
contained in the shipment, as specified in the regulations of U.S. DOT in
49 CFR
172.202 and
172.203(d);
3. The point of origin of the shipment and
the 7-day period during which departure of the shipment is estimated to
occur;
4. The 7-day period during
which arrival of the shipment at the State boundaries or Tribal reservation
boundaries is estimated to occur;
5. The destination of the shipment and the
7-day period during which arrival of the shipment is estimated to occur;
and
6. A point of contact, with a
telephone number, for current shipment information.
(e) Revision notice.
A licensee who finds that schedule information previously
furnished to the governor, or governor's designee, or a Tribal official or
Tribal official's designee, and to the Director, Division of Radiological
Health, in accordance with this paragraph, will not be met, shall telephone a
responsible individual in the office of the governor of the State, or of the
governor's designee, or a Tribal official or Tribal official's designee, and of
the Division of Radiological Health and inform those individuals of the extent
of the delay beyond the schedule originally reported. The licensee shall
maintain a record of the name of the individual contacted for 3 years.
(f) Cancellation notice.
1. Each licensee who cancels a nuclear waste
shipment for which advance notification has been sent shall send a cancellation
notice to the governor of each State, or to the governor's designee, previously
notified, each Tribal official or to the Tribal official's designee previously
notified, and to the Director, Division of Radiological Health.
2. The licensee shall state in the notice
that it is a cancellation and identify the advance notification that is being
canceled. The licensee shall retain a copy of the notice as a record for 3
years.
(22)
Quality Assurance
(a) Quality Assurance
Requirements.
1. This subparagraph 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 paragraph, "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 the quality assurance requirements that apply to
its use of a packaging for the shipment of licensed material subject to this
paragraph.
2. Establishment of
program.
Each licensee shall establish, maintain, and execute a
quality assurance program satisfying each of the applicable criteria of this
rule 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.
3. Approval of
program.
Before the use of any package for the shipment of licensed
material subject to this paragraph, each licensee shall obtain Division
approval of its quality assurance program. Using an appropriate method listed
in Rule
0400-20-04-.07
each licensee shall file a description of its quality assurance program,
including a discussion of which requirements of this paragraph 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 subparagraph (8)(b)
of Rule 0400-2008-.04 or equivalent Nuclear Regulatory Commission, or Agreement
State requirement, is deemed to satisfy the requirements of part (7)(b)4 of
this rule and part 2 of this subparagraph.
(b) Quality assurance organization.
1. A licensee
15 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. The quality
assurance functions are:
(i) Assuring that an
appropriate quality assurance program is established and effectively executed;
and
(ii) Verifying, by procedures
such as checking, auditing, and inspection, that activities affecting the
functions that are important to safety have been correctly performed.
3. The persons and organizations
performing quality assurance functions must have sufficient authority and
organizational freedom to:
(i) Identify
quality problems;
(ii) Initiate,
recommend, or provide solutions; and
(iii) Verify implementation of
solutions.
(c) Quality assurance program.
1. A licensee shall establish, at the
earliest practicable time consistent with the schedule for accomplishing the
activities, a quality assurance program that complies with the requirements of
this rule. The licensee shall document the quality assurance program by written
procedures or instructions and shall carry out the program in accordance with
those procedures throughout the period during which the packaging is used. The
licensee shall identify the material and components to be covered by the
quality assurance program, the major organizations participating in the
program, and the designated functions of these organizations.
2. A licensee, through its quality assurance
program, shall provide control over activities affecting the quality of the
identified materials and components to an extent consistent with their
importance to safety, and as necessary to assure conformance to the approved
design of each individual package used for the shipment of radioactive
material. The licensee shall assure that activities affecting quality are
accomplished under suitably controlled conditions. Controlled conditions
include the use of appropriate equipment; suitable environmental conditions for
accomplishing the activity, such as adequate cleanliness; and assurance that
all prerequisites for the given activity have been satisfied. The licensee
shall take into account the need for special controls, processes, test
equipment, tools, and skills to attain the required quality, and the need for
verification of quality by inspection and test.
3. A licensee shall base the requirements and
procedures of its quality assurance program on the following considerations
concerning the complexity and proposed use of the package and its components:
(i) The impact of malfunction or failure of
the item to safety;
(ii) The design
and fabrication complexity or uniqueness of the item;
(iii) The need for special controls and
surveillance over processes and equipment;
(iv) The degree to which functional
compliance can be demonstrated by inspection or test; and
(v) The quality history and degree of
standardization of the item.
4. A licensee shall provide for
indoctrination and training of personnel performing activities affecting
quality, as necessary to assure that suitable proficiency is achieved and
maintained. The licensee shall review the status and adequacy of the quality
assurance program at established intervals. Management of other organizations
participating in the quality assurance program shall review regularly the
status and adequacy of that part of the quality assurance program they are
executing.
(d) Handling,
storage, and shipping control.
The licensee shall establish measures to control, in
accordance with instructions, the handling, storage, shipping, cleaning, and
preservation of materials and equipment to be used in packaging to prevent
damage or deterioration. When necessary for particular products, special
protective environments, such as inert gas atmosphere, and specific moisture
content and temperature levels must be specified and provided.
(e) Inspection, test, and
operating status.
1. A licensee shall
establish measures to indicate, by the use of markings such as stamps, tags,
labels, routing cards, or other suitable means, the status of inspections and
tests performed upon individual items of the packaging. These measures must
provide for the identification of items that have satisfactorily passed
required inspections and tests, where necessary to preclude inadvertent
bypassing of the inspections and tests.
2. A licensee shall establish measures to
identify the operating status of components of the packaging, such as tagging
valves and switches, to prevent inadvertent operation.
(f) Nonconforming materials, parts, or
components.
A licensee shall establish measures to control materials,
parts, or components that do not conform to the licensee's requirements to
prevent their inadvertent use or installation. These measures must include, as
appropriate, procedures for identification, documentation, segregation,
disposition, and notification to affected organizations. Nonconforming items
must be reviewed and accepted, rejected, repaired, or reworked in accordance
with documented procedures.
(g) Corrective action.
A licensee shall establish measures to assure that conditions
adverse to quality, such as deficiencies, deviations, defective material and
equipment, and nonconformances, are promptly identified and corrected. In the
case of a significant condition adverse to quality, the measures must assure
that the cause of the condition is determined and corrective action taken to
preclude repetition. The identification of the significant condition adverse to
quality, the cause of the condition, and the corrective action taken must be
documented and reported to appropriate levels of management.
(h) Quality assurance records.
A licensee shall maintain sufficient written records to
describe the activities affecting quality. The records must include changes to
the quality assurance program as required by this rule, the instructions,
procedures, and drawings required by
10 CFR
71.111 to prescribe quality assurance
activities and must include closely related specifications such as required
qualifications of personnel, procedures, and equipment. The records must
include the instructions or procedures which 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 years beyond the date when the licensee last
engages 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 years after it is superseded.
(i) Audits.
A licensee shall carry out a comprehensive system of planned
and periodic audits to verify compliance with all aspects of the quality
assurance program and to determine the effectiveness of the program. The audits
must be performed in accordance with written procedures or checklists by
appropriately trained personnel not having direct responsibilities in the areas
being audited. Audited results must be documented and reviewed by management
having responsibility in the area audited. Follow up action, including re-audit
of deficient areas, must be taken where indicated.
(j) Changes to quality assurance program
1. Each quality assurance program approval
holder shall submit, in accordance with Rule
0400-20-04-.07,
a description of a proposed change to its Division-approved quality assurance
program that will reduce commitments in the program description as approved by
the Division. The quality assurance program approval holder shall not implement
the change before receiving Division approval.
(i) The description of a proposed change to
the Division-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
this paragraph.
(ii)
Reserved.
2. Each
quality assurance program approval holder may change a previously approved
quality assurance program without prior approval, if the change does not reduce
the commitments in the quality assurance program previously approved by the
Division. Changes to the quality assurance program that do not reduce the
commitments shall be submitted to the Division every 24 months, in accordance
with this rule. 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:
(i) The use of a quality assurance standard
approved by the Division that is more recent than the quality assurance
standard in the program approval holder's current quality assurance program at
the time of the change;
(ii) 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;
(iii) 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;
(iv) 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
(v) Organizational revisions
that ensure that persons and organizations performing quality assurance
functions continue to have the requisite authority and organizational freedom,
including sufficient independence from cost and schedule when opposed to safety
considerations.
3. Each
quality assurance program approval holder shall maintain records of quality
assurance program changes.
