ML18236A296

Alabama Cross Reference 2015-3

ML18236A296
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Issue date:	08/21/2018
From:	Office of Nuclear Material Safety and Safeguards
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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 Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.0(d)(1) Purpose and Rule D In § 71.0, paragraph (d)(1),

Revised Scope incorporated remove the reference §§ 71.20 by reference through 71.23 and add, in its

.02(21)(a)1.; place, the reference §§ 71.21 no changes through 71.23.

needed

§ 71.4 Definition: Rule [B] In § 71.4, add the definition of New Contamination incorporated contamination to read as by reference follows:

.02(21)(a)1.; Contamination means the no changes presence of a radioactive needed substance on a surface in quantities in excess of 0.4 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 removed from a surface during normal conditions of transport.

(2) Non-fixed contamination 1

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated means contamination that can be removed from a surface during normal conditions of transport.

§ 71.4 Definition: Rule [B] In § 71.4, revise the definition of Revised Criticality Safety incorporated Criticality Safety Index (CSI)

Index (CSI) by reference to read as follows:

.02(21)(a)1.; Criticality Safety Index (CSI) no changes means the dimensionless number needed (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 container, consignment or conveyance.

2

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.4 Definition: Rule [B] In § 71.4, revise the definition of Revised Low Specific incorporated Low Specific Activity (LSA)

Activity (LSA) by reference material to read as follows:

material .02(21)(a)1.; Low Specific Activity (LSA) no changes material means radioactive needed 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, provided they are unirradiated and in solid or liquid form; (iii) Radioactive material other 3

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 distributed in a solid compact binding agent (such as concrete, bitumen, 4

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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: Rule [B] In § 71.4, revise the definition of Revised Special form incorporated Special form radioactive radioactive by reference material to read as follows:

material .02(21)(a)1.; Special form radioactive material No changes means radioactive material that needed satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule; (2) The piece or capsule has at least one dimension not less than 5 mm (0.2 in); and (3) It satisfies the requirements of

§71.75. A special form encapsulation designed in 5

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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: Rule [B] In § 71.4, revise the definition of Revised Uranium - incorporated Uraniumnatural, depleted, natural, by reference enriched to read as follows:

depleted, .02(21)(a)1.; Uranium - natural, depleted, enriched No changes enriched.

needed. (1) Natural uranium means uranium (which may be chemically separated) with the naturally 6

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 N/A D In § 71.6, revise paragraph (b)

Revised Collection to read as follows:

Requirements: (b) The approved information 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, 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.

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Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.14(a)(1) Exemption for Rule [B] In § 71.14, revise paragraphs

- (a)(3) low-level incorporated (a)(1) and (2), and add Revised, New materials by reference paragraph (a)(3) to read as

.02(21)(a)1.; follows:

No changes (a) * *

• needed. (1) 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 the use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the applicable radionuclide activity concentration values specified in appendix A, Table A-2, or Table A-3 of this part.

(2) Materials for which the activity concentration is not greater than the activity concentration values specified in appendix A, Table A-2, or Table A-3 of this part, or for which the consignment activity is not greater than the limit for an exempt consignment found in appendix A, Table A-2, or Table A-3 of this part.

8

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated (3) 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 § 71.4.

§ 71.15(d) Exemption from Rule [B] In § 71.15, revise paragraph (d)

Revised classification as incorporated to read as follows:

fissile material by reference (d) Uranium enriched in uranium-

.02(21)(a)1.; 235 to a maximum of 1 percent by No changes weight, and with total plutonium needed. 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.

§ 71.17 General license: Rule B The Compatibility Category for Revised, NRC approved incorporated all of § 71.17 has changed from Removal of package by reference Note: The [B] to B signifying that Brackets on .02(21)(a)1.; Compatibility Agreement States should Compatibility No changes Category for ensure that they have Category. needed. §71.17 has regulations compatible with this 9

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated changed from section that are collocated with

[B] to B. their transportation regulations.

In § 71.17, revise paragraph (c) to read as follows:

(a) A general license is issued to any licensee of the Commission to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, certificate of compliance (CoC), or other approval has been issued by the NRC.

(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; (2) Comply with the terms and 10

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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.

§ 71.19 Previously N/A NRC In § 71.19, redesignate Revised approved paragraphs (b) through (e) as 11

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 license: Rule B The Compatibility Category for Revised, Use of foreign incorporated all of § 71.21 has changed from Removal of approved by reference Note: The [B] to B signifying that Brackets on package .02(21)(a)1.; Compatibility Agreement States should Compatibility No changes Category for ensure that they have Category needed. §71.21 has regulations compatible with this changed from section that are collocated with

[B] to B. their transportation regulations.

In § 71.21, revise paragraphs (a) and (d) to read as follows:

(a) A general license is issued to any licensee of the Commission 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 12

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 (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.

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Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.31(b) Contents of N/A NRC In § 71.31, paragraph (b),

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 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 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 14

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 Add 71.70 NRC Add § 71.70 to subpart F to read New by reference to the list of as follows:

rules not § 71.70 Incorporations by incorporated reference.

by reference (a) The materials listed in this in section are incorporated by

.02(21)(a)2. 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 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 15

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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:

http://www.iso.org.

(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 16

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 Revised special form (a)(5), (b)(2)(ii), (b)(2)(iii), (d)(1),

radioactive and (d)(2) to read as follows:

material (a) * * *

(5) A specimen that comprises or simulates radioactive 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 17

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated (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 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 18

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated ISO 2919:1999(E), Radioactive protectionSealed radioactive sourcesGeneral 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 protectionSealed radioactive sourcesGeneral requirements and classification (incorporated by reference, see § 71.70).

§71.85(a) - Preliminary Add NRC In § 71.85, revise paragraphs (c) determinations 71.85(a), (a), (b), and (c) to read as Revised, (b) and (c) Note: The follows:

Compatibility to the list of Compatibility (a) The certificate holder shall Change rules not Category for ascertain that there are no cracks, incorporated §71.85(a) - pinholes, uncontrolled voids, or by reference (c) has other defects that could in changed from significantly reduce the

.02(21)(a)2. [B] to NRC. 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 19

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 Rule B In § 71.85, add paragraph (d) to New determinations incorporated read as follows:

by reference (d) The licensee shall ascertain

.02(21)(a)1.; that the determinations in No changes paragraphs (a) through (c) of this needed. section have been made.

§ 71.91(a) Records Rule C In § 71.91, in paragraph (a)

Revised, incorporated introductory text, remove the Compatibility by reference Note: The reference § 71.10 and add, in Change .02(21)(a)1.; Compatibility its place, the reference § No changes Category for § 71.14.

needed. 71.91(a) has 20

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated changed from D to C.

§ 71.91(b) Records N/A NRC The Compatibility Category has Compatibility changed.

Change Note: The Compatibility b) Each certificate holder shall Category for § maintain, for a period of 3 years 71.91(b) has after the life of the packaging to changed from which they apply, records D to NRC. identifying the packaging by model number, serial number, and date of manufacture.

§ 71.91(c) Records Rule C The Compatibility Category has and (d) incorporated changed.

Compatibility by reference Note: The Change .02(21)(a)1.; Compatibility (c) The licensee, certificate holder, No changes Category for § and an applicant for a CoC, shall needed. 71.91(c) and make available to the Commission (d) has for inspection, upon reasonable changed from notice, all records required by this D to C. part. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

(d) The licensee, certificate holder, and an applicant for a CoC shall maintain sufficient written records to furnish evidence of the 21

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated quality of packaging. The records to be maintained include results of the determinations required by § 71.85; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for 3 years after the life of the packaging to which they apply.

§ 71.101(a) Quality Rule C** In § 71.101, revise paragraph (a)

Revised, assurance incorporated to read as follows:

Compatibility requirements by reference Note: The (a) Purpose. This subpart Change .02(21)(a)1.; Compatibility describes quality assurance No changes Category for § requirements applying to design, needed 71.101(a) has purchase, fabrication, handling, changed from shipping, storing, cleaning, D or C to only assembly, inspection, testing, C. operation, maintenance, repair, and modification of components of 22

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated packaging that are important to

• • See last safety. As used in this subpart, page for quality assurance comprises all additional those planned and systematic note. 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 certificate holder and applicant for a package approval is responsible for satisfying the quality assurance requirements that apply to 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.

23

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.101(b) Quality Rule C** The Compatibility Category has and (c)(1) assurance incorporated changed.

Compatibility requirements by reference Note: The (b) Establishment of program.

Change .02(21)(a)1.; Compatibility Each licensee, certificate holder, No changes Category for § and applicant for a CoC shall needed. 71.101(b) and establish, maintain, and execute a (c)(1) has quality assurance program changed from satisfying each of the applicable D or C to only criteria of §§ 71.101 through C. 71.137 and satisfying any specific provisions that are applicable to

• • See last the licensee's activities including page for procurement of packaging. The additional licensee, certificate holder, and note. applicant for a CoC shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

(c) Approval of program. (1)

Before the use of any package for the shipment of licensed material subject to this subpart, each licensee shall obtain Commission approval of its quality assurance program. Using an appropriate method listed in § 71.1(a), each licensee shall file a description of its quality assurance program, including a discussion of which 24

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated requirements of this subpart are applicable and how they will be satisfied, by submitting the description to: ATTN: Document Control Desk, Director, Division of Spent Fuel Management, Office of Nuclear Material Safety and Safeguards.

§ 71.101(c)(2) Quality N/A NRC In § 71.101, revise Revised assurance paragraphs (c)(2) to read as requirements follows:

(c) * * *

(2) Before the fabrication, 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.

25

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.101(g) Quality Rule C** The Compatibility Category Compatibility assurance incorporated note has been revised.

Note Revised requirements by reference ** See last (g) Radiography containers. A

.02(21)(a)1.; page for note. program for transport container No changes inspection and maintenance needed limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of § 34.31(b) of this chapter or equivalent Agreement State requirement, is deemed to satisfy the requirements of §§ 71.17(b) and 71.101(b).

§ 71.103(a) Quality Rule C** In § 71.103, revise paragraph (a)

Revised, assurance incorporated to read as follows:

Compatibility organization by reference Note: The (a) The licensee, certificate Change .02(21)(a)1.; Compatibility holder, and applicant for a No changes Category for § Certificate of Compliance shall be needed 71.103(a) has responsible for the establishment changed from and execution of the quality D or [C] to assurance program. The only C. licensee, certificate holder, and applicant for a Certificate of

• • See last Compliance may delegate to page for others, such as contractors, additional agents, or consultants, the work of note. establishing and executing the quality assurance program, or any part of the quality assurance 26

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated program, but shall retain responsibility for the program.

These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

§ 71.103(b) Quality Rule C** The Compatibility Category Compatibility assurance incorporated note has been revised.

Note Revised organization by reference ** See last (b) The quality assurance

.02(21)(a)1.; page for note. functions are--

No changes (1) Assuring that an appropriate needed quality assurance program is established and effectively executed; and (2) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

§ 71.106 Changes to Rule C Add § 71.106 to subpart H to New quality incorporated read as follows:

assurance by reference § 71.106 Changes to quality program .02(21)(a)1.; assurance program.

No changes (a) Each quality assurance needed program approval holder shall submit, in accordance with § 27

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 71.1(a), a description of a proposed change to its NRC-approved quality assurance program that will reduce 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 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 28

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 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 29

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 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.

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Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

§ 71.135 Quality Rule C** Revise § 71.135 to read as Revised, assurance incorporated follows:

Compatibility records by reference Note: The The licensee, certificate holder, Change .02(21)(a)1.; Compatibility and applicant for a Certificate of No changes Category for § Compliance shall maintain needed. 71.135 has sufficient written records to changed from describe the activities affecting D or C to only quality. These records must C. include changes to the quality assurance program as required by

• • See last § 71.106, the instructions, page for procedures, and drawings additional required by § 71.111 to prescribe note. quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee, 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 31

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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 of Rule [B] In appendix A to part 71, revise Revised A1 and A2 incorporated paragraphs IV.a. and IV.b.,

by reference redesignate paragraphs IV.c.

.02(21)(a)1.; through IV.f. as paragraphs No changes IV.d. through IV.g., add new needed. 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 Rule [B] In Table A-1 of Appendix A, add Table A-1 Values for incorporated an entry for Kr-79 in Revised Radionuclides by reference alphanumeric order; revise the 32

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated

.02(21)(a)1.; entries for Cf 252, Ir-192, Kr-81, No changes and Mo 99; revise footnotes a needed. 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 Material Rule [B] In Table A-2 of Appendix A, add Table A-2 Activity incorporated the entry for Kr-79 in Revised Concentrations by reference alphanumeric order, revise the and Exempt .02(21)(a)1.; entries for Kr 81 and Te 121m, Consignment No changes and revise footnote b.

Activity Limits for needed.

Radionuclides. Revisions detailed below under Table A-2EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES.

Appendix A, General Values Rule [B] In Table A-3 of Appendix A, Table A-3 for A1 and A2 incorporated revise the second and third Revised by reference entries and add a new footnote

.02(21)(a)1.; a.

No changes needed. Revisions detailed below under TABLE A-3GENERAL 33

Change to Title State Compatibility Summary of Change to CFR Difference Significant If NRC Section Section Category Yes/No Yes/No Difference, Why or Why Not Was a Comment Generated 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).

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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)

A (i) 1 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)

A (i) 1 i 2 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.

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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.

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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 37

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.

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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 (36) 1.0x10 3 2.7x10-8 1.0x10 5 2.7x10 -6 Kr-81 1.0x104 2.7x10-7 1.0x107 2.7x10-4 Te-121m 1.0x10 2 2.7x10-9 1.0x10 6 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 39

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.

40