ML20303A306
| ML20303A306 | |
| Person / Time | |
|---|---|
| Issue date: | 10/27/2020 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML20303A269 | List: |
| References | |
| RATS 2015-3 | |
| Download: ML20303A306 (41) | |
Text
Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements; Including Corrections 10 CFR Part 71 (80 FR 33987, Published June 12, 2015 and 80 FR 48683, Published August 14, 2015)
RATS ID: 2015-3 Effective Date: July 13, 2015 Date Due for State Adoption: July 13, 2018 January 31, 2017 revised to add reviewer notes.
July 31, 2017, revised reviewer notes.
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated
§ 71.0(d)(1) Purpose and D In § 71.0, paragraph (d)(1), Not required for Revised Scope remove the reference §§ purposes of 71.20 through 71.23 and compatibility.
add, in its place, the reference §§ 71.21 through 71.23.
§ 71.4 Definition: 28 [B] In § 71.4, add the definition of Yes No. Separated New Contamination 135c, 28- contamination to read as between 35-135f follows: multiple and 28- Contamination means the definitions.
35-135n presence of a radioactive Inserted in 28-substance on a surface in 35-135f and quantities in excess of 0.4 28-35-135n.
Bq/cm2 (1x10-5 µCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1x10-6 µCi/cm2) for all other alpha emitters.
(1) Fixed contamination means contamination that cannot be 1
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated removed from a surface during normal conditions of transport.
(2) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport.
§ 71.4 Definition: 28 [B] In § 71.4, revise the definition No No Add definition Revised Criticality 135c (iii) of Criticality Safety Index under Safety Index (CSI) to read as follows: 28-35-135c (ff).
(CSI) Criticality Safety Index (CSI) means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in §§ 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 2
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated container, consignment or conveyance.
§ 71.4 Definition: 28 [B] In § 71.4, revise the definition No No Add definition Revised Low Specific 135l(p) of Low Specific Activity under Activity (LSA) (LSA) material to read as 28-35-135l (p) material follows:
Low Specific Activity (LSA) material means radioactive material with limited specific activity which is nonfissile or is excepted under § 71.15, and which satisfies the descriptions and limits set forth in the following section. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. The LSA material must be in one of three groups:
(1) LSA-I.
(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides that are intended to be processed for the use of these radionuclides; (ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, 3
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated 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 in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined in accordance with appendix A.
(2) LSA-II.
(i) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/liter); or (ii) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 104 A2/g for solids and gases, and 105 A2/g for liquids.
(3) LSA-III. Solids (e.g.,
consolidated wastes, activated materials), excluding powders, that satisfy the requirements of
§ 71.77, in which:
(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly 4
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated 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 under loss of packaging, the loss of radioactive material per package by leaching when placed in water for 7 days will not exceed 0.1 A2; and (iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed 2 x 103 A2/g.
§ 71.4 Definition: 28 [B] In § 71.4, revise the definition Yes No Definition under Revised Special form 135s(z) of Special form radioactive 28-35-135s (z).
radioactive material to read as follows: Last sentence material Special form radioactive removed (Any material means radioactive other shall material that satisfies the meet the following conditions: specifications)
(1) It is either a single solid due to piece or is contained in a repetitive sealed capsule that can be nature not opened only by destroying the being allowed capsule; in Kansas 5
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated (2) The piece or capsule has at regulatory style least one dimension not less guide.
than 5 mm (0.2 in); and (3) It satisfies the requirements of §71.75. A special form encapsulation designed in accordance with the requirements of § 71.4 in effect on June 30, 1983 (see 10 CFR part 71, revised as of January 1, 1983), and constructed before July 1, 1985; a special form encapsulation designed in accordance with the requirements of § 71.4 in effect on March 31, 1996 (see 10 CFR part 71, revised as of January 1, 1996), and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of § 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.
§ 71.4 Definition: 28 [B] In § 71.4, revise the definition No No Added Revised Uranium - 135u (f) of Uraniumnatural, definition under 6
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated natural, depleted, enriched to read 28-35-135u (f) depleted, as follows:
enriched Uranium - natural, depleted, enriched.
(1) Natural uranium means uranium (which 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).
(2) Depleted uranium means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.
(3) Enriched uranium means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.
§ 71.6 Information D In § 71.6, revise paragraph (b) Not required for Revised Collection to read as follows: purposes of Requirements: (b) The approved information compatibility.
OMB Approval collection requirements contained in this part appear in
§§ 71.5, 71.7, 71.9, 71.12, 71.17, 71.19, 71.22, 71.23, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.47, 7
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated 71.85, 71.87, 71.89, 71.91, 71.93, 71.95, 71.97, 71.101, 71.103, 71.105, 71.106, 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, 71.125, 71.127, 71.129, 71.131, 71.133, 71.135, 71.137, and appendix A, paragraph II.
§ Exemption for 28 [B] In § 71.14, revise paragraphs No No Covered under 71.14(a)(1) low-level 196a(a)(1) (a)(1) and (2), and add K.A.R. 28 - (a)(3) materials paragraph (a)(3) to read as 196a(a)(1): (1)
Revised, follows: The licensee New (a) * *
- complies with (1) Natural material and ores the applicable containing naturally occurring requirements of radionuclides that are either in the regulations their natural state, or have only been processed for purposes of the U.S.
other than for the extraction of department of the radionuclides, and which transportation are not intended to be and processed for the use of these incorporated radionuclides, provided the sections of 10 activity concentration of the CFR Part 71 material does not exceed 10 (relating to times the applicable packaging and radionuclide activity transportation concentration values specified of radioactive in appendix A, Table A-2, or Table A-3 of this part. material) of the (2) Materials for which the U.S. nuclear activity concentration is not regulatory 8
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated greater than the activity commission concentration values specified that are in appendix A, Table A-2, or appropriate to Table A-3 of this part, or for the mode of which the consignment activity transport and is not greater than the limit for that are related an exempt consignment found in appendix A, Table A-2, or to the packing Table A-3 of this part. of radioactive (3) Non-radioactive solid material, and to objects with radioactive the monitoring, substances present on any marking, and surfaces in quantities not in labeling of excess of the levels cited in the those packages; definition of contamination in § 71.4.
§ 71.15(d) Exemption 28 [B] In § 71.15, revise paragraph No No Covered Revised from 196a(a)(1) (d) to read as follows: under K.A.R.
classification (d) Uranium enriched in 28 as fissile uranium-235 to a maximum of 1 196a(a)(1): (1) material percent by weight, and with The licensee total plutonium and uranium- complies with 233 content of up to 1 percent the applicable of the mass of uranium-235, requirements of provided that the mass of any the regulations beryllium, graphite, and hydrogenous material enriched of the U.S.
in deuterium constitutes less department of than 5 percent of the uranium transportation mass, and that the fissile and material is distributed incorporated homogeneously and does not 9
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated form a lattice arrangement sections of 10 within the package. CFR Part 71 (relating to packaging and transportation of radioactive material) of the U.S. nuclear regulatory commission that are appropriate to the mode of transport and that are related to the packing of radioactive material, and to the monitoring, marking, and labeling of those packages;
§ 71.17 General 28-35-500 B The Compatibility Category Yes No Changes have Revised, license: NRC for all of § 71.17 has changed been made to Removal of approved Note: The Compatibility from [B] to B signifying that reference Brackets on package Category for §71.17 has Agreement States should quality Compatibility changed from [B] to B. ensure that they have assurance (QA)
Category. regulations compatible with approvals this section that are made by the collocated with their department as 10
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated transportation regulations. In well as the
§ 71.17, revise paragraph (c) NRC. Some to read as follows: textual changes
- Reviewer note: exist between Agreement States (a) A general license is issued NRC text and should replace the noted to any licensee of the Kansas text are reference(s) to the Commission** to transport, or to in existing NRC/Commission with deliver to a carrier for transport, language that their corresponding licensed material in a package do not Agency information as it for which a license, certificate of significantly is directed to the States compliance (CoC), or other alter the general licensees. approval has been issued by essence of the the NRC. regulation.
(b) This general license applies only to a licensee who has a quality assurance program approved by the Commission**
as satisfying the provisions of subpart H of this part.
(c) Each licensee issued a general license under paragraph (a) of this section shall (1) Maintain a copy of the 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; 11
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated (2) Comply with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of subparts A, G, and H of this part; and (3) 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 § 71.1(a), 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 under 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 § 71.19.
12
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated
§ 71.19 Previously N/A NRC In § 71.19, redesignate NRC Only.
Revised approved paragraphs (b) through (e) as package paragraphs (a) through (d),
and revise newly redesignated paragraph (b)(2) to read as follows:
(b) * * *
(2) A package used for a shipment to a location outside the United States is subject to multilateral approval as defined in the DOTs regulations at 49 CFR 173.403.
§ 71.21 General 28 B The Compatibility Category Yes No Some textual Revised, license: Use 500a. for all of § 71.21 has changed changes made Removal of of foreign Note: The Compatibility from [B] to B signifying that to match Brackets on approved Category for §71.21 has Agreement States should language used Compatibility package changed from [B] to B. ensure that they have in 28-35-500 Category regulations compatible with without altering this section that are the meaning collocated with their significantly.
- Reviewer note: transportation regulations. In Agreement States § 71.21, revise paragraphs (a) should replace the noted and (d) to read as follows:
reference(s) to the NRC/Commission with (a) A general license is issued their corresponding to any licensee of the Agency information. Commission** to transport, or to deliver to a carrier for transport, licensed material in a package, 13
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated the design of which has been approved in a foreign national competent authority certificate, that has been revalidated by the DOT as meeting the applicable requirements of 49 CFR 171.23.
(b) Except as otherwise provided in this section, the general license applies only to a licensee who has a quality assurance program approved by the Commission** as satisfying the applicable provisions of subpart H of this part.
(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 paragraph (a) of this section 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; and 14
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated (2) Comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of subparts A, G, and H of this part.
§ 71.31(b) Contents of N/A NRC In § 71.31, paragraph (b), NRC Only.
Revised application remove the reference § 71.13 and add, in its place, the reference § 71.19.
§ 71.38 Renewal of a N/A NRC Revise § 71.38 to read as NRC Only.
Retitled, certificate of follows:
Revised compliance § 71.38 Renewal of a certificate of compliance.
(a) Except as provided in paragraph (b) of this section, each Certificate of Compliance expires at the end of the day, in the month and year stated in the approval.
(b) In any case in which a person, not less than 30 days before the expiration of an existing Certificate of Compliance issued pursuant to the part, has filed an application in proper form for renewal, the existing Certificate of Compliance for which the renewal application was filed 15
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated shall not be deemed to have expired until final action on the application for renewal has been taken by the Commission.
(c) In applying for renewal of an existing Certificate of Compliance, an applicant may be required to submit a consolidated application that is comprised of as few documents as possible. The consolidated application should incorporate all changes to its certificate, including changes that are incorporated by reference in the existing certificate.
§ 71.70 Incorporations N/A NRC Add § 71.70 to subpart F to NRC Only.
New by reference read as follows:
§ 71.70 Incorporations by reference.
(a) The materials listed in this section are incorporated by reference in the corresponding sections noted and made a part of the regulations in part 71.
These incorporations by reference were approved by the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. These materials are incorporated as they exist on the date of the approval. A 16
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated notice of any changes made to the material incorporated by reference will be published in the Federal Register, and the material must be available to the public. The materials can be examined, by appointment, at the NRCs Technical Library, which is located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301-415-7000; email:
Library.Resource@nrc.gov. The materials are also available from the sources listed below.
All approved material is available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 1-202-741-6030 or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) International Organization for Standardization, ISO Central Secretariat, Chemin de Blandonnet 8 CP 401, 1214 Vernier, Geneva, Switzerland; email: central@iso.org; phone:
+41 22 749 01 11; Web site:
17
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated (1) ISO 9978:1992(E),
Radiation protectionSealed radioactive sourcesLeakage test methods, First Edition (February 15, 1992),
incorporation by reference approved for § 71.75(a), is available for purchase from the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, 212-642-4900, http://www.ansi.org, or info@ansi.org.
(2) ISO 2919:1999(E),
Radiation protectionSealed radioactive sourcesGeneral requirements and classification, Second Edition (February 15, 1999),
incorporation by reference approved for § 71.75(d), is available on http://www.amazon.com.
§ 71.75 Qualification of N/A NRC In § 71.75, revise paragraphs NRC Only.
Revised special form (a)(5), (b)(2)(ii), (b)(2)(iii),
radioactive (d)(1), and (d)(2) to read as material follows:
(a) * * *
(5) A specimen that comprises or simulates radioactive 18
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated material contained in a sealed capsule need not be subjected to the leaktightness procedure specified in this section, provided it is alternatively subjected to any of the tests prescribed in ISO 9978:1992(E), Radiation protectionSealed radioactive sourcesLeakage test methods (incorporated by reference, see § 71.70).
(b) * * *
(2) * * *
(ii) The flat face of the billet must be 25 millimeters (mm) (1 inch) in diameter with the edge rounded off to a radius of 3 mm
+/- 0.3 mm (0.12 in +/- 0.012 in);
(iii) The lead must be hardness number 3.5 to 4.5 on the Vickers scale and not more than 25 mm (1 inch) thick, and must cover an area greater than that covered by the specimen; (d) * * *
(1) The impact test and the percussion test of this section, provided that the specimen is:
(i) Less than 200 grams and alternatively subjected to the Class 4 impact test prescribed 19
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated in ISO 2919:1999(E), Radiation protectionSealed radioactive sourcesGeneral requirements and classification (incorporated by reference, see § 71.70); or (ii) Less than 500 grams and alternatively subjected to the Class 5 impact test prescribed in ISO 2919:1999(E),
Radioactive protection Sealed radioactive sources General requirements and classification (incorporated by reference, see § 71.70); and (2) The heat test of this section, provided the specimen is alternatively subjected to the Class 6 temperature test specified in ISO 2919:1999(E),
Radioactive protection Sealed radioactive sources General requirements and classification (incorporated by reference, see § 71.70).
§71.85(a) - Preliminary N/A NRC In § 71.85, revise paragraphs NRC Only.
(c) determinations (a), (b), and (c) to read as Revised, Note: The Compatibility follows:
Compatibility Category for §71.85(a) - (a) The certificate holder shall Change (c) has changed from [B] ascertain that there are no to NRC. cracks, pinholes, uncontrolled voids, or other defects that 20
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated could significantly reduce the effectiveness of the packaging; (b) Where the maximum normal operating pressure will exceed 35 kPa (5 lbf/in2) gauge, the certificate holder shall test the containment system at an internal pressure at least 50 percent higher than the maximum normal operating pressure, to verify the capability of that system to maintain its structural integrity at that pressure; (c) The certificate holder shall conspicuously and durably mark the packaging with its model number, serial number, gross weight, and a package identification number assigned by the NRC. Before applying the model number, the certificate holder shall determine that the packaging has been fabricated in accordance with the design approved by the Commission; and
§ 71.85(d) Preliminary 28 B In § 71.85, add paragraph (d) No No Adopted by New determinations 504a(c) to read as follows: reference.
- Reviewer note: (d) The licensee shall ascertain paragraphs (a) through that the determinations in 21
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated (c) of this section refers paragraphs (a) through (c) of to 71.85(a) through (c), this section** have been made.
which are assigned Compatibility Category NRC and must not be adopted by the Agreement States.
Consequently, in 71.85(d), Agreement States should reference 10 CFR 71.85(a) through (c) and not their own regulations.
§ 71.91(a) Records 28 C In § 71.91, in paragraph (a) No No Adopted by Revised, 504a introductory text, remove the reference.
Compatibility Note: The Compatibility reference § 71.10 and add, Change Category for § 71.91(a) in its place, the reference § has changed from D to 71.14.
C.
§ 71.91(b) Records N/A NRC The Compatibility Category NRC Only.
Compatibility has changed.
Change Note: The Compatibility Category for § 71.91(b) b) Each certificate holder shall has changed from D to maintain, for a period of 3 years NRC. after the life of the packaging to which they apply, records identifying the packaging by model number, serial number, and date of manufacture.
22
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated
§ 71.91(c) Records 28 C The Compatibility Category No No Adopted by and (d) 504a has changed. reference.
Compatibility Note: The Compatibility Change Category for § 71.91(c) (c) The licensee, certificate and (d) has changed holder, and an applicant for a from D to C. CoC**, shall make available to the Commission** for
- Reviewer notes: inspection, upon reasonable
- 1) the phrase notice, all records required by certificate this part. Records are only valid holder, and if stamped, initialed, or signed applicant for a and dated by authorized CoC should be personnel, or otherwise deleted by the authenticated.
Agreement (d) The licensee, certificate States, or the holder, and an applicant for a State should CoC** shall maintain sufficient clearly indicate written records to furnish that these terms evidence of the quality of apply to the NRC, packaging. The records to be as the NRC has maintained include results of sole authority for the determinations required by issuing a § 71.85; design, fabrication, Certificate of and assembly records; results Compliance; of reviews, inspections, tests,
- 2) Agreement and audits; results of monitoring States should work performance and replace the noted materials analyses; and results reference(s) to of maintenance, modification, the and repair activities. Inspection, NRC/Commission test, and audit records must with their identify the inspector or data corresponding recorder, the type of 23
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated Agency observation, the results, the information. acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for 3 years after the life of the packaging to which they apply.
§ 71.101(a) Quality 28-35-505 C** In § 71.101, revise paragraph Yes No Adopted by Revised, assurance (a) to read as follows: reference in a Compatibility requirements Note: The Compatibility (a) Purpose. This subpart slightly altered Change Category for § 71.101(a) describes quality assurance 28-35-505.
has changed from D or C requirements applying to Refrences to to only C. design, purchase, fabrication, the NRC have handling, shipping, storing, been changed
- See last page for cleaning, assembly, inspection, to the additional note. testing, operation, maintenance, department, repair, and modification of save for CoC components of packaging that requirements.
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 24
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated predetermined requirements.
- Reviewer note: the Each certificate holder and highlighted section applicant for a package should be omitted by the approval is responsible for Agreement states as the satisfying the quality assurance NRC has sole authority requirements that apply to for issuing a CoC. design, fabrication, testing, and modification of packaging subject to this subpart.** 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.
§ 71.101(b) Quality 28-35-505 C** The Compatibility Category Yes No Adopted by and (c)(1) assurance has changed. reference in a Compatibility requirements Note: The Compatibility (b) Establishment of program. slightly altered Change Category for § 71.101(b) Each licensee, certificate 28-35-505.
and (c)(1) has changed holder, and applicant for a Refrences to from D or C to only C. CoC** shall establish, maintain, the NRC have and execute a quality been changed
- See last page for assurance program satisfying to the additional note. each of the applicable criteria of department,
§§ 71.101 through 71.137 and save for CoC
- Reviewer notes: satisfying any specific requirements.
- 1) the phrase provisions that are applicable to certificate the licensee's activities holder, and including procurement of applicant for a packaging. The licensee, CoC should be certificate holder, and applicant for a CoC** shall execute the 25
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated deleted by the applicable criteria in a graded Agreement approach to an extent that is States, or the commensurate with the quality State should assurance requirement's clearly indicate importance to safety.
that these terms (c) Approval of program. (1) apply to the NRC Before the use of any package as the NRC has for the shipment of licensed sole authority for material subject to this subpart, issuing a each licensee shall obtain Certificate of Commission** approval of its Compliance; quality assurance program.
- 2) in (c) the Using an appropriate method Agreement listed in § 71.1(a), each States should licensee shall file a description insert their of its quality assurance Agency where program, including a discussion noted and of which requirements of this provide their subpart are applicable and how Agency they will be satisfied, by information for submitting the description to:
notification. ATTN: Document Control Desk, Director, Division of Spent Fuel Management, Office of Nuclear Material Safety and Safeguards**.
§ Quality N/A NRC In § 71.101, revise NRC Only.
71.101(c)(2) assurance paragraphs (c)(2) to read Revised requirements as follows:
(c) * * *
(2) Before the fabrication, 26
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated testing, or modification of any package for the shipment of licensed material subject to this subpart, each certificate holder, or applicant for a Certificate of Compliance shall obtain Commission approval of its quality assurance program.
Each certificate holder or applicant for a CoC shall, in accordance with § 71.1, 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.
§ 71.101(g) Quality 28 C** The Compatibility Category Adopted by Compatibility assurance 505(d)(3) note has been revised. reference in a Note requirements ** See last page for note. (g) Radiography containers. A slightly altered Revised program for transport container 28-35-505.
inspection and maintenance Refrences to limited to radiographic exposure the NRC have devices, source changers, or been changed packages transporting these to the devices and meeting the department, requirements of § 34.31(b) of save for CoC this chapter or equivalent requirements.
Agreement State requirement, is deemed to satisfy the requirements of §§ 71.17(b) and 71.101(b).
27
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated
§ 71.103(a) Quality 28-35-505 C** In § 71.103, revise paragraph Yes No Adopted by Revised, assurance (a) to read as follows: reference in a Compatibility organization Note: The Compatibility (a) The licensee, certificate slightly altered Change Category for § 71.103(a) holder, and applicant for a 28-35-505.
has changed from D or Certificate of Compliance** Refrences to
[C] to only C. shall be responsible for the the NRC have establishment and execution of been changed
- See last page for the quality assurance program. to the additional note. The licensee, certificate holder, department, and applicant for a Certificate of save for CoC
- Reviewer note: the Compliance** may delegate to requirements.
phrase certificate others, such as contractors, holder, and applicant for agents, or consultants, the work a Certificate of of establishing and executing Compliance should be the quality assurance program, deleted by the or any part of the quality Agreement States, or the assurance program, but shall State should clearly retain responsibility for the indicate that these terms program. These activities apply to the NRC as the include performing the functions NRC has sole authority associated with attaining quality for issuing a Certificate objectives and the quality of Compliance. assurance functions.
§ 71.103(b) Quality 28-35-505 C** The Compatibility Category No No Adopted by Compatibility assurance note has been revised. reference in a Note organization ** See last page for note. (b) The quality assurance slightly altered Revised functions are-- 28-35-505.
(1) Assuring that an appropriate Refrences to quality assurance program is the NRC have been changed 28
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated established and effectively to the executed; and department, (2) Verifying, by procedures save for CoC such as checking, auditing, and requirements.
inspection, that activities affecting the functions that are important to safety have been correctly performed.
§ 71.106 Changes to 28-35-505 C Add § 71.106 to subpart H to No No Adopted by New quality read as follows: reference in a assurance § 71.106 Changes to quality slightly altered program **Reviewer note: the assurance program. 28-35-505.
Agreement states should (a) Each quality assurance Refrences to insert their Agency program approval holder shall the NRC have where noted submit, in accordance with § been changed 71.1(a), a description of a to the proposed change to its NRC**- department, approved quality assurance save for CoC program that will reduce requirements.
commitments in the program description as approved by the NRC**. The quality assurance program approval holder shall not implement the change before receiving NRC**
approval.
(1) The description of a proposed change to the NRC**-
approved quality assurance program must identify the change, the reason for the change, and the basis for 29
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated concluding that the revised program incorporating the change continues to satisfy the applicable requirements of subpart H of this part.
(2) [Reserved]
(b) Each quality assurance program approval holder may change a previously approved quality assurance program without prior NRC** approval, if the change does not reduce the commitments in the quality assurance program previously approved by the NRC**.
Changes to the quality assurance program that do not reduce the commitments shall be submitted to the NRC**
every 24 months, in accordance with § 71.1(a). 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:
(1) The use of a quality assurance standard approved 30
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated by the NRC** that is more recent than the quality assurance standard in the certificate holders or applicants current quality assurance program at the time of the change; (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; (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; (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 31
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated holder has committed to on record; and (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.
(c) Each quality assurance program approval holder shall maintain records of quality assurance program changes.
§ 71.135 Quality 28-35-505 C** Revise § 71.135 to read as No No Adopted by Revised, assurance follows: reference in a Compatibility records Note: The Compatibility The licensee, certificate holder, slightly altered Change Category for § 71.135 and applicant for a Certificate of 28-35-505.
has changed from D or C Compliance** shall maintain Refrences to to only C. sufficient written records to the NRC have describe the activities affecting been changed
- See last page for quality. These records must to the additional note. include changes to the quality department, assurance program as required save for CoC
- Reviewer note: the by § 71.106, the instructions, requirements.
phrase certificate procedures, and drawings holder, and applicant for required by § 71.111 to a Certificate of prescribe quality assurance Compliance should be activities, and closely related specifications such as required 32
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated deleted by the qualifications of personnel, Agreement States, or the procedures, and equipment.
State should clearly The records must include the indicate that these terms instructions or procedures that apply to the NRC as the establish a records retention NRC has sole authority program that is consistent with for issuing a Certificate applicable regulations and of Compliance. designates factors such as duration, location, and assigned responsibility. The licensee, certificate holder, and applicant for a Certificate of Compliance**
shall retain these records for 3 years beyond the date when the licensee, certificate holder, and applicant for a Certificate of Compliance** last engage 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, certificate holder, and applicant for a Certificate of Compliance** shall retain the superseded material for 3 years after it is superseded.
Appendix A Determination 28 [B] In appendix A to part 71, No No Adopted by Revised of A1 and A2 221b revise paragraphs IV.a. and reference.
IV.b., redesignate paragraphs IV.c. through IV.f. as 33
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated paragraphs IV.d. through IV.g., add new paragraph IV.c., revise newly redesignated paragraphs IV.d. through IV.g.,
redesignate paragraph V. as paragraph V.a., and add new paragraph V.b..
Revisions detailed below under Appendix A to Part 71 Determination of A1 and A2.
Appendix A, A1 and A2 28 [B] In Table A-1 of Appendix A, No No Adopted by Table A-1 Values for 221b add an entry for Kr-79 in reference.
Revised Radionuclides alphanumeric order; revise the entries for Cf 252, Ir-192, Kr-81, and Mo 99; revise footnotes a and c; remove footnote h; and redesignate footnote i as footnote h.
Revisions detailed below under Table A-1A1 and A2 VALUES FOR RADIONUCLIDES.
Appendix A, Exempt 28 [B] In Table A-2 of Appendix A, No No Adopted by Table A-2 Material 221b add the entry for Kr-79 in reference.
Revised Activity alphanumeric order, revise Concentrations the entries for Kr 81 and Te and Exempt 121m, and revise footnote b.
34
Change to Title State Compatibility Category Summary of Change to CFR Difference Significant If Difference, NRC Section Yes/No Yes/No Why or Why Section Not Was a Comment Generated Consignment Activity Limits Revisions detailed below under for Table A-2EXEMPT Radionuclides. MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES.
Appendix A, General 28 [B] In Table A-3 of Appendix A, No No Adopted by Table A-3 Values for A1 221b revise the second and third reference.
Revised and A2 entries and add a new footnote a.
Revisions detailed below under TABLE A-3GENERAL VALUES FOR A1 and A2.
- Note: §71.101(g) indicates that QA programs for industrial radiography Type B package users are covered by §34.31(b). It also indicated that this section satisfies §71.17(b) and therefore will satisfy those sections referenced in this provision (§§71.101 through 71.137).
35
Appendix A to Part 71 Determination of A1 and A2 IV. * * *
- a. For special form radioactive material, the maximum quantity transported in a Type A package is as follows:
B(i) i A1(i) 1 where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for radionuclide i.
- b. For normal form radioactive material, the maximum quantity transported in a Type A package is as follows:
B(i) i A2(i) 1 where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for radionuclide i.
- 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:
B(i ) C( j)
A (i) + A 1 i 1 j 2 (j) where B(i) is the activity of radionuclide i as special form radioactive material, A1(i) is the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form radioactive material, and A2(j) is the A2 value for radionuclide j.
- d. Alternatively, the A1 value for mixtures of special form material may be determined as follows:
A1 for mixture = 1 f (i )
A (i) i 1 where f(i) is the fraction of activity for radionuclide i in the mixture and A1(i) is the appropriate A1 value for radionuclide i.
- e. Alternatively, the A2 value for mixtures of normal form material may be determined as follows:
1 A2 for mixture =
f(i) i A2(i) where f(i) is the fraction of activity for radionuclide i in the mixture and A2(i) is the appropriate A2 value for radionuclide i.
36
- f. The exempt activity concentration for mixtures of nuclides may be determined as follows:
1 Exempt activity concentration for mixture =
f(i) i [A](i) where f(i) is the fraction of activity concentration of radionuclide i in the mixture and [A](i) is the activity concentration for exempt material containing radionuclide i.
- g. The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:
1 Exempt consignment activity limit for mixture =
f(i) i A(i) where f(i) is the fraction of activity of radionuclide i in the mixture and A(i) is the activity limit for exempt consignments for radionuclide i.
V. * * *
- 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 [A] (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 IV of this appendix. Groups may be based on the total alpha activity and the total beta/gamma activity when these are known, using the lowest [A] or A values for the alpha emitters and beta/gamma emitters, respectively.
37
Table A-1A1 and A2 VALUES FOR RADIONUCLIDES Element Specific activity Symbol of and atomic A1 (TBq) A1 (Ci)b A2 (TBq) A2 (Ci)b radionuclide (TBq/g) (Ci/g) number Cf-252 1.0x10-1 2.7 3.0x10-3 8.1x10-2 2.0x101 5.4x102 Ir-192 c1.0 c2.7x101 6.0x10-1 1.6x101 3.4x102 9.2x103 Kr-79 Krypton 4.0 1.1x102 2.0 5.4x101 4.2x104 1.1x106 (36)
Kr-81 4.0x101 1.1x103 4.0x101 1.1x103 7.8x10-4 2.1x10-2 Mo-99 a h 1.0 2.7x101 6.0x10-1 1.6x101 1.8x104 4.8x105 a A1 and/or A2 values include contributions from daughter nuclides with half-lives less than 10 days, as listed in the following:
Mg-28 Al-28 Ca-47 Sc-47 Ti-44 Sc-44 Fe-52 Mn-52m Fe-60 Co-60m Zn-69m Zn-69 Ge-68 Ga-68 Rb-83 Kr-83m Sr-82 Rb-82 Sr-90 Y-90 Sr-91 Y-91m Sr-92 Y-92 Y-87 Sr-87m Zr-95 Nb-95m Zr-97 Nb-97m, Nb-97 Mo-99 Tc-99m Tc-95m Tc-95 Tc-96m Tc-96 Ru-103 Rh-103m Ru-106 Rh-106 Pd-103 Rh-103m Ag-108m Ag-108 Ag-110m Ag-110 Cd-115 In-115m In-114m In-114 Sn-113 In-113m Sn-121m Sn-121 Sn-126 Sb-126m Te-127m Te-127 Te-129m Te-129 Te-131m Te-131 Te-132 I-132 I-135 Xe-135m 38
Xe-122 I-122 Cs-137 Ba-137m Ba-131 Cs-131 Ba-140 La-140 Ce-144 Pr-144m, Pr-144 Pm-148m Pm-148 Gd-146 Eu-146 Dy-166 Ho-166 Hf-172 Lu-172 W-178 Ta-178 W-188 Re-188 Re-189 Os-189m Os-194 Ir-194 Ir-189 Os-189m Pt-188 Ir-188 Hg-194 Au-194 Hg-195m Hg-195 Pb-210 Bi-210 Pb-212 Bi-212, Tl-208, Po-212 Bi-210m Tl-206 Bi-212 Tl-208, Po-212 At-211 Po-211 Rn-222 Po-218, Pb-214, At-218, Bi-214, Po-214 Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207 Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 Ra-225 Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209 Ra-226 Rn-222, Po-218, Pb-214, At-218, Bi-214, Po-214 Ra-228 Ac-228 Ac-225 Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209 Ac-227 Fr-223 Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212 Th-234 Pa-234m, Pa-234 Pa-230 Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214 U-230 Th-226, Ra-222, Rn-218, Po-214 U-235 Th-231 Pu-241 U-237 Pu-244 U-240, Np-240m Am-242m Am-242, Np-238 Am-243 Np-239 Cm-247 Pu-243 Bk-249 Am-245 Cf-253 Cm-249 c The activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement of the radiation level at a prescribed distance from the source.
h A2 = 0.74 TBq (20 Ci) for Mo-99 for domestic use.
39
Table A-2EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES Symbol of Element Activity Activity Activity limit Activity limit radionuclide and atomic concentration concentration for exempt for exempt number for exempt for exempt consignment consignment material (Bq/g) material (Ci/g) (Bq) (Ci)
Kr-79 Krypton 1.0x10 3 2.7x10-8 1.0x105 2.7x10-6 (36)
Kr-81 1.0x104 2.7x10-7 1.0x107 2.7x10-4 Te-121m 1.0x10 2 2.7x10-9 1.0x106 2.7x10-5 b Parent nuclides and their progeny included in secular equilibrium are listed as follows:
Sr-90 Y-90 Zr-93 Nb-93m Zr-97 Nb-97 Ru-106 Rh-106 Ag-108m Ag-108 Cs-137 Ba-137m Ce-144 Pr-144 Ba-140 La-140 Bi-212 Tl-208 (0.36), Po-212 (0.64)
Pb-210 Bi-210, Po-210 Pb-212 Bi-212, Tl-208 (0.36), Po-212 (0.64)
Rn-222 Po-218, Pb-214, Bi-214, Po-214 Ra-223 Rn-219, Po-215, Pb-211, Bi-211, Tl-207 Ra-224 Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Ra-226 Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 Ra-228 Ac-228 Th-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212(0.64)
Th-229 Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 Th-nat Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-234 Pa-234m U-230 Th-226, Ra-222, Rn-218, Po-214 U-232 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
U-235 Th-231 U-238 Th-234, Pa-234m U-nat Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 Np-237 Pa-233 Am-242m Am-242 Am-243 Np-239 40
TABLE A-3GENERAL VALUES FOR A1 and A2 Contents A1 A2 Activity Activity Activity Activity concen- concen- limits limits tration tration for for for for exempt exempt (TBq) (Ci) (TBq) (Ci) exempt exempt consign consign material material -ments -ments (Bq/g) (Ci/g) (Bq) (Ci)
Alpha emitting nuclides, but no neutron 2x10-1 5.4x100 9x10-5 2.4x10-3 1x10-1 2.7x10-12 1x103 2.7x10-8 emitters, are known to be present a Neutron emitting nuclides are known to be 1x10-3 2.7x10-2 9x10-5 2.4x10-3 1x10-1 2.7x10-12 1x103 2.7x10-8 present or no relevant data are available a If beta or gamma emitting nuclides are known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used.
41