Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements, 33987-34018 [2015-14212]

Download as PDF Vol. 80 Friday, No. 113 June 12, 2015 Part V Nuclear Regulatory Commission mstockstill on DSK4VPTVN1PROD with RULES3 10 CFR Part 71 Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements; Final Rule VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\12JNR3.SGM 12JNR3 33988 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 71 [NRC–2008–0198] RIN 3150–AI11 Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements Nuclear Regulatory Commission. ACTION: Final rule. AGENCY: The U.S. Nuclear Regulatory Commission (NRC), in consultation with the U.S. Department of Transportation (DOT), is amending its regulations for the packaging and transportation of radioactive material. These amendments make conforming changes to the NRC’s regulations based on the International Atomic Energy Agency’s (IAEA) 2009 standards for the international transportation of radioactive material and maintain consistency with the DOT’s regulations. In addition, these amendments re-establish restrictions on materials that qualify for the fissile material exemption, clarify requirements, update administrative procedures, and make editorial changes. DATES: Effective date: This rule is effective July 13, 2015. Incorporation by reference: The incorporation by reference of certain publications listed in the regulation is approved by the Director of the Federal Register as of July 13, 2015. ADDRESSES: Please refer to Docket ID NRC–2008–0198 when contacting the NRC about the availability of information for this final rule. You may obtain publicly-available information related to this final rule by any of the following methods: • Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC–2008–0198. Address questions about NRC dockets to Carol Gallagher; telephone: 301–415–3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this final rule. • NRC Agencywide Documents Access and Management System (ADAMS): You may obtain publiclyavailable documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/ adams.html. To begin the search, select ‘‘ADAMS Public Documents’’ and then select ‘‘Begin Web-based ADAMS Search.’’ For problems with ADAMS, mstockstill on DSK4VPTVN1PROD with RULES3 SUMMARY: VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 please contact the NRC Public Document Room (PDR) reference staff at 1–800–397–4209, 301–415–4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section. • NRC PDR: You may examine and purchase copies of public documents at the NRC PDR, Room O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone: 301–415– 3781; email: Solomon.Sahle@nrc.gov. SUPPLEMENTARY INFORMATION: I. Background II. Discussion III. Opportunities for Public Participation IV. Public Comment Analysis V. Section-by-Section Analysis VI. Plain Writing VII. Finding of No Significant Environmental Impact: Availability VIII. Paperwork Reduction Act Statement IX. Congressional Review Act X. Regulatory Flexibility Certification XI. Regulatory Analysis XII. Backfitting and Issue Finality XIII. Criminal Penalties XIV. Compatibility of Agreement State Regulations XV. Voluntary Consensus Standards XVI. Availability of Guidance XVII. Incorporation by Reference Under 1 CFR Part 51—Reasonable Availability to Interested Parties I. Background The NRC regulates the transportation of radioactive material under part 71 of Title 10 of the Code of Federal Regulations (10 CFR). Periodically, the IAEA revises its regulations related to transportation of radioactive material. The NRC evaluated changes in the 2009 edition of the IAEA’s ‘‘Regulations for the Safe Transport of Radioactive Material’’ (TS–R–1) and identified a number of areas in 10 CFR part 71 that needed to be revised to maintain compatibility with the IAEA’s regulations. Accordingly, the NRC developed a proposed rule to amend 10 CFR part 71, and published it for comment in the Federal Register on May 16, 2013 (78 FR 28988). The NRC is now publishing its final rule. Together with a related DOT final rule amending Title 49 of the Code of Federal Regulations (49 CFR) [79 FR 40590, July 11, 2014], these actions bring United States regulations into general accord with TS–R–1, and PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 maintain consistency between NRC and DOT regulations. The NRC’s final rule also revises 10 CFR part 71 to: (1) Update administrative procedures for the quality assurance program requirements described in subpart H of 10 CFR part 71; (2) re-establish restrictions on material that qualifies for the fissile material exemption; (3) clarify the requirements for a general license; 4) clarify the responsibilities of certificate holders and licensees when making preliminary safety determinations on packaging to be used for transporting radioactive material; and 5) make editorial changes. Compatibility With IAEA and Consistency With DOT Transportation Regulations The IAEA was formed by member nations to promote safe, secure, and peaceful nuclear technologies. It establishes safety standards to protect public health and safety and to minimize the danger to life and property, and has developed safety standards for the safe transport of radioactive material in TS–R–1. Copies of TS–R–1 may be obtained from the United States distributors, Bernan, 15200 NBN Way, P.O. Box 191, Blue Ridge Summit, PA 17214; telephone: 1–800–865–3457; email: customercare@ bernan.com, or Renouf Publishing Company Ltd., 812 Proctor Ave., Ogdensburg, NY 13669–2205; telephone: 1–888–551–7470; email: orders@renoufbooks.com. An electronic copy of TS–R–1 may be found at the following IAEA Web site: https://wwwpub.iaea.org/MTCD/publications/PDF/ Pub1384_web.pdf. These IAEA safety standards and regulations were developed in consultation with IAEA Member States, and reflect an international consensus on what is needed to provide for a high level of safety. By providing a global framework for the consistent regulation of the transport of radioactive material, TS–R–1 facilitates international commerce and contributes to the safe conduct of international trade involving radioactive material. By periodically revising its regulations to be compatible with IAEA and DOT regulations, the NRC is able to remove inconsistencies that could impede international commerce and reflect knowledge gained in scientific and technical advances and accumulated expericence. This rulemaking harmonizes the NRC’s regulations with the IAEA’s transportation regulations in TS–R–1 and aligns with the DOT regulations. The regulations in TS–R–1 represent an accepted set of requirements that provide a high level of safety in the E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 packaging and transportation of radioactive materials and provides for a basis and framework that facilitates the development of internationallyconsistent regulations. Internationally consistent regulations for the transportation and packaging of radioactive material reduce impediments to trade; facilitate international cooperation; and, when the regulations provide a high level of safety, can reduce risks associated with the import and export of radioactive material. In November 2012, the IAEA issued revised standards for the safe transport of radioactive material and designated them as ‘‘Specific Safety Requirements Number SSR–6’’ (SSR–6). The present NRC rulemaking does not incorporate the SSR–6 requirements, because doing so would require significant changes to the NRC rule, and it would need to be re-published for further comment. The NRC will consider any necessary changes related to SSR–6 in a future rulemaking after consulting with the DOT, rather than further delay finalizing this rulemaking. Historically, the NRC has coordinated its revisions to 10 CFR part 71 with the DOT, because the DOT and the NRC coregulate transport of radioactive materials in the United States. The roles of the DOT and the NRC in the coregulation of the transportation of radioactive materials are documented in a memorandum of understanding (MOU) (44 FR 38690; July 2, 1979). Consistent with this MOU, the NRC has coordinated its efforts with the DOT during this rulemaking, and representatives from the NRC and DOT have advised and consulted with one another. This final rule has been coordinated with DOT to ensure that consistent regulatory standards are maintained between NRC and DOT radioactive material transportation regulations, and to ensure coordinated publication of the final rules by both agencies. On July 11, 2014, the DOT published its final rule titled, ‘‘Hazardous Materials: Compatibility with the Regulations of the International Atomic Energy Agency’’ in the Federal Register (79 FR 40590) with an effective date of October 1, 2014, and a mandatory compliance date of July 13, 2015. Fissile Material Exemption The NRC is re-establishing restrictions on material that will qualify for the 10 CFR 71.15 fissile material exemption. In 10 CFR 71.15 (‘‘Exemption from classification as fissile material’’), the exemption in paragraph (d) is being revised. The 10 CFR 71.15 exemptions VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 were formerly set forth in 10 CFR 71.53. In 1997, the NRC issued an emergency final rule (62 FR 5907; February 10, 1997) that revised the 10 CFR 71.53 regulations on fissile material exemptions and general license provisions that apply to fissile material. Based on the public comments on the 1997 emergency final rule, the NRC contracted with the Oak Ridge National Laboratory (ORNL) to review the fissile material exemptions and general license provisions, study the regulatory and technical bases associated with these regulations, and perform criticality model calculations for different mixtures of fissile materials and moderators. The results of the ORNL study were documented in NUREG/CR– 5342,1 and the NRC published a notice of the availability of this document in the Federal Register (63 FR 44477; August 19, 1998). The ORNL study confirmed that the emergency final rule was needed to provide safe transportation of packages with special moderators that are shipped under the general license and fissile material exemptions, but concluded that the revised regulations may have been excessive for shipments where water moderation is the only concern. The ORNL study also recommended that the NRC revise 10 CFR part 71 as it applied to the requirement specific to uranium enriched in uranium-235 (U–235) to a maximum of 1 percent by weight, and with a total plutonium and uranium-233 (U–233) content of up to 1 percent of the mass of U–235. Specifically, as discussed in NUREG/CR–5342, ORNL recommended that (1) a definition of ‘‘homogeneity’’ be developed that could be clearly understood for use with uranium enriched to a maximum of 1 percent and (2) the term ‘‘lattice arrangement’’ be clarified or not used. Alternatively, ORNL suggested that the moderator criteria restricting the mass of beryllium, carbon, or heavy water (deuterium oxide) to less than 0.1 percent of the fissile mass should be maintained, which would remove the need to provide definitions such as ‘‘homogeneous’’ and ‘‘lattice arrangement’’ that are difficult to define and to apply practically. The NRC chose to implement this ORNL suggestion, as reflected in a 2002 rulemaking regarding 10 CFR part 71 (67 FR 21390; April 30, 2002). Similar to the present rulemaking, the NRC in 2002 proposed to make the NRC’s regulations more consistent and compatible with 1 NUREG/CR–5342, ‘‘Assessment and Recommendations for Fissile-Material Packaging Exemptions and General Licenses within 10 CFR part 71,’’ July 1998, ADAMS Accession No. ML12139A419. PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 33989 IAEA’s standards. Additionally, the NRC proposed to make changes to the fissile material exemption requirements to address the unintended economic impact of the 1997 final rule. In a final rule dated January 26, 2004 (69 FR 3698), the NRC removed the restriction (then stated in 10 CFR 71.53(b)) that, to qualify for the fissile material exemption, uranium enriched in U–235 must be distributed homogeneously throughout the package and may not form a lattice arrangement within the package. In addition, the 2004 final rule re-designated the section for fissile material exemptions from § 71.53 to § 71.15. Although the NRC determined in 2004 that the limits on restricted moderators were sufficient to assure subcriticality for all moderators of concern, the NRC now believes that additional restrictions are needed to have a sufficient margin of criticality safety for shipments of material under the low-enriched fissile material exemption. Therefore, the NRC is revising 10 CFR 71.15(d) in this final rule by reinstating the requirement removed in 2004 that, for uranium enriched to a maximum of 1 percent to be exempted, the fissile material must be distributed homogeneously throughout the package contents and not form a lattice arrangement. Further technical details regarding the basis for now revising 10 CFR 71.15(d) are discussed in Section II.M of this document. Quality Assurance Program Approvals The regulations of 10 CFR part 71 require that licensees and certificate holders have quality assurance programs approved by the Commission as satisfying the applicable provisions of subpart H of 10 CFR part 71. Unlike 10 CFR part 50, there are no specific requirements in 10 CFR part 71 addressing changes to an NRC-approved quality assurance program. Once a 10 CFR part 71 quality assurance program is approved, no changes to the program may be made without further NRC approval, because a change would alter the program and make it an unapproved program. Consequently, the process has been overly burdensome and inefficient for both the licensee and the NRC. For example, under the existing 10 CFR part 71 requirements, a change in the quality assurance program to correct typographical errors or punctuation must be submitted to and approved by the NRC. In 2004, the NRC changed the renewal period for quality assurance program approvals issued under 10 CFR part 71 from 5 years to 10 years in order to E:\FR\FM\12JNR3.SGM 12JNR3 33990 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations reduce the unnecessary regulatory burden of some administrative actions. This change was announced in ‘‘NRC Regulatory Information Summary (RIS) 2004–18, Expiration Date for 10 CFR part 71 Quality Assurance Program Approvals,’’ dated December 1, 2004 (ADAMS Accession No. ML042160293). Under the new 10 CFR 71.106, the NRC will allow some changes to be made to quality assurance programs previously approved under 10 CFR part 71 without obtaining additional NRC approval. The process for making changes to approved quality assurance program descriptions will now be similar to the process that the NRC has used to approve changes that are made to the quality assurance program descriptions for nuclear power plants licensed under 10 CFR part 50 through the provisions at § 50.54(a), and will result in a more consistent approach for allowing changes to approved quality assurance programs. The NRC also will re-issue NRC Form 311 without an expiration date. The 24month period for reporting changes will begin on the date of the NRC approval of a quality assurance program issued with no expiration date, as specified by the date of signature at the bottom of NRC Form 311. The changes being made to the quality assurance program approval process are discussed further in Sections II .H, II.I, and II.J of this document. II. Discussion mstockstill on DSK4VPTVN1PROD with RULES3 A. What action is the NRC taking? The NRC is amending its regulations to make them more consistent and compatible with the IAEA’s international transportation regulations TS–R–1. These revisions are also consistent with the DOT’s hazardous materials regulations, and maintain a consistent framework for regulating the transportation and packaging of radioactive material. In addition, the NRC is revising 10 CFR part 71 to: (1) Update administrative procedures for the quality assurance program requirements described in subpart H of 10 CFR part 71; (2) re-establish criticality safety restrictions on certain material that qualifies for the fissile material exemption; (3) clarify the requirements for a general license; (4) clarify the responsibilities of certificate holders and licensees when making preliminary determinations; and (5) make editorial changes. B. Who is affected by this action? This action affects: (1) NRC licensees authorized by a specific or general NRC VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 license to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, or transports the material outside of the site of usage as specified in the NRC license, or transports that material on public highways; (2) holders of, and applicants for a Certificate of Compliance (CoC); and (3) holders of a 10 CFR part 71, subpart H quality assurance program approval. This action would also affect holders of quality assurance program approvals under appendix B of 10 CFR part 50 or subpart G of 10 CFR part 72 to the extent that those approvals apply to transport packaging as specified in 10 CFR 71.101(f), ‘‘Previously approved programs.’’ This action also changes requirements that are matters of compatibility with Agreement States. Agreement States will need to update their regulations, as appropriate, at which time those licensees in Agreement States will need to meet the revised Agreement State regulations. C. What changes are being made to increase the compatibility with the IAEA’s regulations, TS–R–1, and the consistency with the DOT’s regulations? The NRC is revising its regulations in 10 CFR part 71 to be more consistent or compatible with the international transportation regulations. These changes also improve or maintain consistency between 10 CFR part 71 and the DOT’s regulations to maintain a consistent framework for the transportation and packaging of radioactive material. To accomplish these goals, the NRC is revising 10 CFR part 71 as follows: 1. The concept of processing ores for purposes other than radioactive material content is added to the provisions that apply to natural materials and ores in the exemptions for low-level materials in § 71.14. 2. The NRC is adopting the scoping statement paragraph 107(f) of TS–R–1, which addresses non-radioactive solid objects with radioactive substances present on any surface in quantities not in excess of certain levels. In conjunction with this change, a definition of ‘‘contamination’’ corresponding to the definition in TS– R–1 is added to § 71.4. 3. The following definitions in 10 CFR 71.4 (‘‘Definitions’’) are amended to reflect the current definitions in TS–R– 1: ‘‘Criticality Safety Index (CSI)’’; ‘‘Low Specific Activity (LSA) material’’; and ‘‘Uranium—natural, depleted, enriched.’’ When the NRC last revised subsection (1)(i) of the definition for LSA material, the NRC added the modifier ‘‘not,’’ which resulted in this PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 component of the NRC definition being inconsistent with the DOT and IAEA definitions. The NRC is correcting this so that LSA material includes material intended to be processed for its radionuclides. 4. The NRC is adopting the use of the Class 5 impact test prescribed in the International Organization for Standardization’s (ISO) Document 2919, ‘‘Radiation protection—Sealed radioactive sources—General requirements and classification,’’ Second Edition (February 15, 1999), ISO 2919:1999(E),2 for special form radioactive material, provided the mass is less than 500 grams. 5. The NRC is incorporating by reference (A) ISO Document 2919, and (B) ISO Document 9978, ‘‘Radiation protection—Sealed radioactive sources—Leakage test methods,’’ First Edition (February 15, 1992), ISO 9978:1992(E). 6. The description of billet used in the percussion test in § 71.75(b)(2)(ii) is corrected by replacing ‘‘edges’’ with ‘‘edge.’’ 7. The definition of ‘‘Special form radioactive material’’ in § 71.4 is revised to allow special form radioactive material that is successfully tested in accordance with the current requirements to be transported as special form radioactive material, if the testing was completed before the effective date of the final rule. 8. In appendix A of 10 CFR part 71, footnote h to californium-252 (Cf-252) (alternate A1 and A2 values for domestic use of Cf-252) in Table A–1, ‘‘A1 and A2 Values for Radionuclides,’’ is eliminated. The A1 and A2 values in the table for Cf-252 are updated to be consistent with the IAEA values in TS– R–1. 9. Krypton-79 (Kr-79) values are added to Table A–1 and Table A–2, ‘‘Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides.’’ The A1 and A2 values in Table A–1, the activity concentration for exempt material, and the activity limit for exempt consignment are consistent with the IAEA’s values in TS–R–1. 10. Footnote a to Table A–1 is revised to include the list of parent radionuclides whose A1 and A2 values include contributions from daughter radionuclides with half-lives of less than 10 days. These additions conform to footnote a to Table 2, ‘‘Basic Radionuclide Values,’’ in TS–R–1 with the exception of argon-42 (Ar-42) and 2 https://pbadupws.nrc.gov/docs/ML0036/ ML003686268.pdf. E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 tellurium-118 (Te-118), which appear in footnote a to Table 2 in TS–R–1 but do not appear within Table A–1. 11. Footnote c to Table A–1 is moved to the A1 values and revised to clarify that only the activity for iridium-192 (Ir192) 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. 12. In Appendix A, Table A–2, the activity limit in Table A–2 for exempt consignment for tellurium-121m (Te121m) is revised to be consistent with the new IAEA value in TS–R–1. 13. The list of parent radionuclides and their progeny included in secular equilibrium in footnote b to Table A–2 is revised to be consistent with the list accompanying Table 2 in TS–R–1. 14. The descriptive language in Table A–3, ‘‘General Values for A1 and A2,’’ of appendix A under the heading ‘‘Contents’’ is revised to be consistent with the IAEA descriptions in Table 3, ‘‘Basic Radionuclide Values for Unknown Radionuclides or Mixtures,’’ in TS–R–1 (2009 edition). ‘‘Only alpha emitting nuclides are known to be present’’ is replaced with ‘‘Alpha emitting nuclides, but no neutron emitters, are known to be present.’’ The phrase ‘‘No relevant data are available’’ is replaced with the phrase ‘‘Neutron emitting nuclides are known to be present or no relevant data are available.’’ Additionally, footnote a is added to the new language ‘‘Alpha emitting nuclides, but no neutron emitters, are known to be present’’ stipulating that if beta or gamma emitting nuclides are known to be present, the A1 value of 0.1 terabecquerel (TBq) (2.7 Ci) should be used. D. How is the NRC changing the exemption for materials with low activity levels? The NRC is revising its 10 CFR 71.14(a)(1) exemption for natural materials and ores containing naturally occurring radionuclides to reflect changes in the scope of TS–R–1. The TS–R–1 includes statements that describe its activities included within the scope of this IAEA regulation. It also has a list of material to which TS–R–1 does not apply, hereafter referred to as ‘‘non-TS–R–1 material.’’ Included in the list of non-TS–R–1 materials are natural materials and ores containing naturally occurring radionuclides. These natural materials and ores are not intended to be processed for their radionuclides and are classified as non-TS–R–1 materials, provided that the activity concentration for the material does not exceed 10 times the activity concentration for VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 exempt material specified in Table A–2 of Appendix A. The NRC previously established its 10 CFR 71.14(a)(1) exemption from the requirements of 10 CFR part 71 for licensees who ship or carry certain natural materials and ores designated as low-level materials. The exemption allows the transport of certain qualifying natural material or ore without the material being regulated as a hazardous material during transportation. However, all applicable NRC regulations in other 10 CFR parts continue to apply to these natural materials and ores. The current exemption in § 71.14(a)(1) is consistent with the 1996 edition of TS–R–1 (as amended in 2000) and 49 CFR 173.401(b), as they apply to natural materials and ores containing naturally occurring radionuclides. The NRC is updating this exemption to include the shipment of natural materials and ores containing naturally occurring radionuclides that have been processed, which will retain consistency with the DOT’s regulations and harmonize the NRC’s regulations with the current TS– R–1. This exemption continues to be limited to those natural materials and ores containing naturally occurring radionuclides whose activity concentrations may be up to 10 times the activity concentration specified in Table A–2 of appendix A. The NRC is also revising the definition of LSA–I material in 10 CFR 71.4 (i.e., material intended to be processed for its radionuclides) so that it applies to uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides that are intended to be processed for their radionuclides. The low-level material exemption at § 71.14(b)(3), which includes packages containing only LSA material, will now apply to LSA–I material. With the revision of the definition of LSA–I material, uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radionuclides that are intended to be processed for these radionuclides may be able to qualify for the low-level material exemption in § 71.14(b)(3), provided that the other restrictions are satisfied. The restrictions include: (1) The package contains only LSA–I or Surface Contaminated Object (SCO)–I material or (2) the LSA or SCO material has an external radiation dose rate of less than 10 millisieverts per hour (mSv/h) (1 rem per hour (rem/h)) at a distance of 3 meters from the unshielded material. Section 71.14 provides an exemption PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 33991 from the requirements of 10 CFR part 71, with the exception of §§ 71.5 and 71.88. Section 71.5 references the DOT’s regulations in 49 CFR parts 107, 171 through 180, and 390 through 397. If the DOT’s regulations are not applicable to a shipment of licensed material, then § 71.5 requires licensees to conform to the referenced DOT standards and regulations to the same extent as if the shipment were subject to the DOT’s regulations. Section 71.88 will continue to apply to the material because its applicability is not limited by any of the exemptions in 10 CFR part 71. Natural material or ore that has been incorporated into a manufactured product, such as an article, instrument, component of a manufactured article or instrument, or consumer item, will not qualify for the low-level material exemption for natural materials and ores containing naturally occurring radionuclides. Slags, sludges, tailings, residues, bag house dust, oil scale, and washed sands that are the byproducts of processing or refining are examples that may contain natural material or ore that has been processed, are examples of material that may still qualify for the exemption, provided that the processed material has not been incorporated into a manufactured product. The NRC is adding a definition for ‘‘contamination’’ to § 71.4 in conjunction with the new exemption in 10 CFR 71.14(a)(3) to include nonradioactive solid objects with substances present on any surface not exceeding the levels used to define contamination. Contamination is defined as quantities in excess of 0.4 Bq/cm2 (1 × 10¥5 mCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1 × 10¥6 mCi/ cm2) for all other alpha emitters. The derived values used in the definition are conservative with respect to transportation. Quantities of radioactive substances below these values will result in small amounts of exposure during normal conditions of transportation and will contribute insignificant exposures under accident conditions. E. How is the qualification of special form radioactive material changing? The IAEA has incorporated in TS–R– 1 the Class 4 and Class 5 impact tests in ISO 2919:1999(E), the Class 6 temperature test in ISO 2919:1999(E), and the leaktightness tests in ISO 9978:1992(E). The NRC is updating the alternate tests in § 71.75 that may be used for the qualification of special form radioactive material by incorporating by reference the Class 4 and Class 5 impact tests and the Class 6 temperature test E:\FR\FM\12JNR3.SGM 12JNR3 mstockstill on DSK4VPTVN1PROD with RULES3 33992 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations prescribed in the ISO document ISO 2919:1999(E). The NRC is also incorporating by reference the leaktightness tests specified in ISO document 9978:1992(E). The Class 4 impact test in ISO 2919:1999(E) replaces the impact test in § 71.75(d) and will be available for use with specimens that have a mass that is less than 200 grams. The Class 5 impact test, which is being added, will allow use of an ISO impact test for specimens that have a mass that is less than 500 grams. The updated ISO impact tests maintain the requirement that the mass of the hammer used in the test is greater than 10 times the mass of the specimen. The Class 6 temperature test in ISO 2919:1999(E) replaces the temperature test in § 71.75(d). The Class 6 temperature test in ISO 2919:1999(E) is more stringent than the test that it replaces because it requires the same specimen to be used for both portions of the temperature test. The Class 6 temperature test will continue to be more stringent than the testing required by § 71.75(b). The leaktightness tests prescribed in ISO 9978:1992(E) replace the tests in ISO/TR 4826.3 The consensus standard ISO 9978:1992(E) has replaced ISO/TR 4826:1979(E), which has been withdrawn by ISO. The NRC has determined that the leaktightness tests prescribed in ISO 9978:1992(E) provide an equivalent level of radiological safety as the leaching assessment procedure in § 71.75(c). The NRC is revising the definition of ‘‘Special form radioactive material’’ in § 71.4 to allow material tested using the current requirements to continue to be treated as special form material, provided that the testing was completed before the effective date of the final rule. This will allow material tested using requirements in effect at the time of the testing to continue to be used. The NRC is revising the reference in § 71.4, which went into effect on March 31, 1996, by changing the date of the revision from January 1, 1983, to January 1, 1996. The NRC is replacing ‘‘edges’’ with ‘‘edge’’ to describe the billet used for the percussion test in § 71.75(b)(2). The edge corresponds to the circular edge at the face of the billet. This revision clarifies the description of the billet and maintains consistency with the language used by the DOT in 49 CFR 173.469. 3 https://www.iso.org/iso/iso_catalogue/catalogue_ tc/catalogue_detail.htm?csnumber=10804. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 F. What changes are being made to 10 CFR part 71, Appendix A, ‘‘Determination of A1 and A2 Values’’? The NRC is changing the following items in appendix A: 1. Determination of the quantity of radioactive material that can be shipped in a package that contains both special form and normal form radioactive material. The final rule specifically addresses how to calculate the limit of the activity that may be transported in a Type A package, if the package contains both special form and normal form radioactive material and the identities and activity limits for the radionuclides are known. 2. Table A–1, ‘‘A1 and A2 Values for Radionuclides.’’ The values in Table A–1 have been revised to make the values in 10 CFR part 71 consistent with the values in Table 2, ‘‘Basic Radionuclide Values,’’ in TS–R–1. Specifically, the final rule: (1) Adds an entry for Kr-79, which is now found in Table 2 in TS–R–1; (2) adopts the A1 and A2 values for Cf-252; (3) revises footnote a to include the list of parent radionuclides whose A1 and A2 values include contributions from daughter radionuclides with half-lives of less than 10 days; and (4) moves and revises footnote c, which formerly applied to all Ir-192, so that the footnote applies only to Ir-192 in special form material. The IAEA added an entry for Kr-79 in Table 2 of TS–R–1. The NRC is adopting the same radionuclide-specific values for Kr-79 in Table A–1 in 10 CFR part 71. The radionuclide-specific values replace the generic values in Table A– 3, which were previously used for Kr79. The radiological criteria underlying the A1 and A2 values for Kr-79 have not changed, but the radionuclide-specific values were derived using radionuclidespecific information and better reflect the radiological hazard of Kr-79 than the generic values that they are replacing. The IAEA revised the A1 value for Cf252 to the value that previously applied to domestic transportation. The NRC is adopting the A1 value for Cf-252, which will apply to both international and domestic transportation, and is adopting the IAEA value for A2. As a result, the final rule removes the A2 value that formerly applied only to domestic transportation. Making this change improves the harmonization of 10 CFR part 71 with TS–R–1. The final rule revises footnote a to Table A–1 that identifies the A1 and A2 values that include contributions from daughter radionuclides that have a halflife less than 10 days. The list PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 corresponds to the radionuclides listed in footnote a to Table 2 in TS–R–1, with the exception of argon-42 (Ar-42) and tellurium-118 (Te-118). Argon-42 and Te-118 are not included because they do not appear within Table A–1 in 10 CFR part 71. Footnote c to Table A–1 has been revised to clarify that the activity of Ir192 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. 3. Table A–2, ‘‘Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides.’’ The final rule revises Table A–2 to make the values in 10 CFR part 71 consistent with the values in TS–R–1 and adds an entry for Kr-79 adopted from Table 2 of TS–R–1. The final rule also updates the list of parent radionuclides and their progeny in footnote b to Table A–2 by removing the chains for the parent radionuclides cerium-134 (Ce-134), radon-220 (Rn220), thorium-226 (Th-226), and U-240 and by adding the chain for the parent radionuclide silver-108m (Ag-108m) to make the footnote consistent with footnote (b) in Table 2 of TS–R–1. The activity limit for exempt consignment for Te-121m has also been updated to match the values in TS–R–1. Materials that have an activity concentration that is less than the activity concentration for exempt material pose a very low radiological risk. The activity limit for exempt consignment has been established for the transportation of material in small quantities so that the total activity is unlikely to result in any significant radiological exposure. This is the case, even for material that exceeds the activity concentration for exempt material. Previously, Kr-79 was not listed in Table A–2 and instead values from Table A–3, ‘‘General Values for A1 and A2,’’ in appendix A were used to determine the activity concentration for exempt material and the activity limit for exempt consignment for Kr-79. Radionuclide-specific values for the activity concentration for exempt material and the activity limit for exempt consignment have been derived for Kr-79 and are now included in TS–R–1. The final rule adds an entry for Kr-79 to Table A–2 in 10 CFR part 71 to be consistent with TS–R–1. In TS–R–1, the IAEA revised the activity limit for exempt consignment for Te-121m. The change to the activity level for exempt consignment for Te-121m, which is based on new analyses and information, is consistent E:\FR\FM\12JNR3.SGM 12JNR3 mstockstill on DSK4VPTVN1PROD with RULES3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations with the objectives of the exemption values. To conform to International Commission on Radiological Protection (ICRP) and IAEA changes, the activity limit for exempt consignment for Te121m in Table A–2 of 10 CFR part 71 is changed from 1 × 105 Bq (2.7 × 10¥6 Ci) to 1 × 106 Bq (2.7 × 10¥5 Ci). The IAEA has revised the list of parent radionuclides and their progeny included in secular equilibrium in footnote (b) to Table 2 in TS–R–1. This revision arose from the adoption of the nuclide-specific basic radionuclide values from the Basic Safety Standards (IAEA Safety Series No. 115, ‘‘International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources’’ (1996)) for use in transportation. The list of parent radionuclides and their progeny was modified by adding the decay chain for Ag-108m and by removing the decay chains for Ce-134, Rn-220, Th-226, and U–240. The list of parent radionuclides and their progeny included in secular equilibrium presented in footnote b to Table A–2 is revised to be consistent with the changes to the list in TS–R–1. 4. Table A–3, ‘‘General Values for A1 and A2.’’ In the 2005 edition of TS–R–1, the IAEA revised Table 2, ‘‘Basic Radionuclide Values for unknown radionuclides or mixtures.’’ The values are now in Table 3 in the 2009 edition of TS–R–1. The table divides unknown radionuclides and mixtures into three groups, with a row for each group. The first column of each row provides a descriptive phrase for contents that are suitable for that group. The NRC is adopting the new descriptive phrases in Table A–3 of 10 CFR part 71. The descriptive phrase for the first group, ‘‘Only beta or gamma emitting radionuclides are known to be present,’’ is not being changed. The phrase for the second group, ‘‘Only alpha emitting nuclides are known to be present,’’ is being changed to ‘‘Alpha emitting nuclides, but no neutron emitters, are known to be present.’’ The phrase for the third group, ‘‘No relevant data are available,’’ is being changed to ‘‘Neutron emitting nuclides are known to be present or no relevant data are available.’’ Some users have assigned alphaemitting radionuclides that also emit beta particles or gamma rays to the third group, when it was intended that they be assigned to the second group. The change in the descriptive phrase for the second group is intended to reduce the confusion caused by the current phrase because all alpha emitting radionuclides also emit other particles and/or gamma VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 rays. The change in the descriptive phrase for the third group is intended to clarify that neutron-emitting radionuclides, or alpha emitters that also emit neutrons, such as Cf-252, Cf254 and curium-248 (Cm-248), should be assigned to the third group. It is intended that when groups of radionuclides are based on the total alpha activity and the total beta and gamma activity, the lowest radionuclide values (A1 or A2) for the alpha emitters or the beta or gamma emitters, respectively, are used. Consequently, an A1 value of 1 TBq (2.7 Ci) and an A2 value of 9 × 10¥5 TBq (2.4 × 10¥3 Ci) are used for a group containing both alpha emitting radionuclides and beta or gamma emitting radionuclides. 5. Other changes that correct formulas and their descriptions in section IV of appendix A. The NRC is making several corrections to the formulas and the descriptions of the formulas that address mixtures of radionuclides in section IV of appendix A in 10 CFR part 71. These changes involve formatting and typographical changes in the formulas and their descriptions. G. How will the responsibilities of certificate holders and licensees change with these amendments? The final rule revises § 71.85(a)–(c) to make certificate holders, not licensees, responsible for making the required preliminary determinations before the first use of any package for shipping radioactive material. The preliminary determinations involve evaluating, testing, and marking the packaging. The DOT’s requirements in 49 CFR 173.22 require that the person offering a hazardous material for shipping make determinations relating to the manufacturing, assembly, and marking of the packaging or container. New § 71.85(d) will require licensees to ascertain that the certificate holders have made the required preliminary determinations. Note that before each shipment, licensees must still make the findings required by the existing § 71.87(a)–(k) provisions, to ensure the continued safety of packages containing radioactive material. The NRC is revising § 71.85, because it is more appropriate to assign the responsibility to certificate holders for evaluating, testing, and marking the packaging. Only certificate holders are authorized to design and fabricate packages, and only certificate holders have a full scope quality assurance program approval. By assigning the responsibility for making the preliminary determinations to the certificate holder, the NRC streamlines PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 33993 the implementation of its regulations, and the revisions to § 71.85 also better reflect current practice. Reflecting the revisions to § 71.85(a)– (c) previously discussed, conforming changes are made to the § 71.101 Quality Assurande (QA) provisions, to clarify that only certificate holders and applicants for a CoC have QA responsibilities regarding the fabrication and testing of packages. In this regard, references to licensees §§ 71.101(a) and (c)(2) have been removed. H. Why is renewal of my quality assurance program description not necessary? The duration of quality assurance program approvals issued under 10 CFR part 71 is a matter of practice and is not specified in the regulations. The NRC has limited the duration of the quality assurance program approval by assigning an expiration date to NRC Form 311, ‘‘Quality Assurance Program Approval for Radioactive Material Packages.’’ The inclusion of an expiration date provided an opportunity for the NRC to periodically review the quality assurance programs and for the NRC to maintain periodic contact with the quality assurance program approval holders. The NRC is changing its practice regarding the duration of its quality assurance program approvals. The NRC will no longer limit the duration of its quality assurance program approvals issued under 10 CFR part 71. The NRC is amending 10 CFR part 71 to implement this change in order to make the periodic communication between the NRC and the quality assurance program approval holders more efficient. The NRC will reissue NRC Form 311 without an expiration date. The NRC is still requiring quality assurance program approval holders to periodically report changes in their quality assurance program description to the NRC. However, the NRC has determined that with the continuing contact between the NRC and the quality assurance program approval holders, requiring the renewal of quality assurance program approvals is no longer necessary. Every 24 months, each quality assurance program approval holder is required to report those changes that do not reduce commitments made to the NRC in a quality assurance program description. Regarding quality assurance program description changes that reduce commitments made to the NRC, such changes will continue to require NRC approval. The NRC expects that this new process will provide the NRC with E:\FR\FM\12JNR3.SGM 12JNR3 33994 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 adequate assurance that the quality assurance program approval holders will continue to maintain and implement their approved quality assurance programs, while reducing regulatory burden and the expenditure of NRC resources. I. What changes can be made to a quality assurance program description without seeking prior NRC approval? Previously, quality assurance program descriptions approved under 10 CFR part 71 could not be changed without NRC approval. Therefore, all changes to 10 CFR part 71 quality assurance programs, irrespective of their significance or importance to safety, were required to be submitted to the NRC for approval. Licensees with quality assurance programs approved under 10 CFR part 50, may make some changes to their quality assurance program without NRC approval, in accordance with 10 CFR 50.54. Under the final rule, the NRC will allow some changes to be made to quality assurance programs previously approved under 10 CFR part 71 without obtaining additional NRC approval. As indicated previously, the new process for making changes to approved quality assurance program descriptions under 10 CFR part 71 will be similar to the process that the NRC has used to approve changes that are made to the quality assurance program descriptions for nuclear power plants and will result in a more consistent NRC-wide approach. As stated previously in II.H, quality assurance program description changes that reduce commitments made to the NRC will continue to require NRC approval. For such changes, the following information will need to be provided for NRC review: A description of the proposed changes, the reason for the changes, and the basis for concluding that the revised program incorporating the changes will continue to satisfy the requirements of 10 CFR part 71, subpart H. Quality assurance program approval holders will no longer be required to submit for NRC approval changes to their quality assurance program descriptions under 10 CFR part 71, if those changes do not reduce the commitments that they have made to the NRC. For example, administrative changes (e.g., revisions to format, font size or style, paper size for drawings and graphics, or revised paper color) and clarifications, spelling corrections, and non-substantive editorial or punctuation changes will not require NRC approval. Five types of nonsubstantive changes that will no longer require NRC approval are being codified VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 in the new 10 CFR 71.106(b) provisions. Changes to reporting responsibilities, functional responsibilities, and functional relationships may be substantive and have the potential to reduce commitments made to the NRC. Such changes will therefore still require prior NRC approval before being implemented, and quality assurance program approval holders will still be required to maintain records of all quality assurance program changes. J. How frequently do I submit periodic updates on my quality assurance program description to the NRC? Under the revised requirements, every 24 months, quality assurance program approval holders will be required to report changes to their approved quality assurance program that do not reduce any commitments in their quality assurance program descriptions. Such changes will no longer require NRC approval before they can be implemented. If a quality assurance program approval holder has not made any changes to its approved quality assurance program description during the preceding 24-month period, the approval holder will be required to report this to the NRC. The NRC inspection program relies on having current information about the quality assurance program available to the NRC. By requiring that the most important changes be submitted to the NRC for approval before they are implemented, and with the periodic reporting of non-substantive changes every 24 months, the NRC will have current information for its inspection program. The NRC considers the 24month reporting period as providing an appropriate balance between the burden placed on the quality assurance program approval holders and the need to ensure that the NRC has current information for its oversight of these quality assurance programs. As previously stated in Section I, the NRC will re-issue NRC Form 311 without an expiration date. The 24month period for reporting of changes will begin on the date of the NRC approval of a quality assurance program issued with no expiration date, as specified by the date of signature at the bottom of NRC Form 311. By making these changes, the NRC is seeking to balance the regulatory burden for submitting and reviewing this information with the NRC’s need to ensure that the NRC has current information. PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 K. How do the requirements in Subpart H, ‘‘Quality Assurance,’’ change with the removal of footnote 2 in 10 CFR 71.103? The NRC is removing footnote 2 in § 71.103 regarding the use of the term ‘‘licensee’’ in subpart H because it is no longer necessary. The removal of the footnote does not change the quality assurance requirements in subpart H. The footnote regarding use of the term ‘‘licensee’’ was included to clarify that the quality assurance requirements in subpart H apply to whatever design, fabrication, assembly, and testing of a package is accomplished before a package approval is issued. The terms ‘‘certificate holder’’ and ‘‘applicant for a CoC’’ were added to the requirements in subpart H in a previous rulemaking to make explicit the application of those quality assurance requirements to certificate holders and applicants for a CoC. Although removing the footnote will not change the quality assurance requirements, other changes to subpart H in this rulemaking clarify which requirements apply to users of NRCcertified packaging and which apply to applicants for, or holders of CoCs, which are the entities that are performing design, fabrication, assembly, and testing of the package before a package approval is issued. L. What changes are being made to general licenses? The NRC is changing the requirements for general licenses on the use of an NRC-approved package (§ 71.17) and use of a foreign-approved package (§ 71.21). In § 71.17, the NRC is revising the general license requirements to clarify the conditions for obtaining a general license and the responsibilities of the general licensee. A quality assurance program approved by the NRC that satisfies the provisions of subpart H of 10 CFR part 71 is required in order to be granted the general license. The changes clarify that the licensee is responsible for maintaining copies of the appropriate documents, such as the CoC, or other approval of the package, the documents associated with the use and maintenance of the packaging, and the actions that are to be taken before shipment with the package. The changes also clarify that the notifications to the NRC, as required in § 71.17(c)(3), are a responsibility of the licensee, rather than a condition for obtaining the license. The changes to §§ 71.17 and 71.21 do not change the current notification process nor the required timing or content of the notification required by § 71.17(c)(3) or any other E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 reporting requirements relating to package use or, when required, the prior notification of shipments. The changes also update the reference in § 71.21(a) from 49 CFR 171.12 to 49 CFR 171.23 to reflect a DOT final rule published on May 3, 2007 (72 FR 25162), that previously moved the requirements. M. How is the exemption from classification as fissile material (10 CFR 71.15) changing? The NRC is revising § 71.15(d) criteria that, if satisfied, exempt certain material from being classified as fissile material. Material within the scope of § 71.15 is exempt from the fissile material package standards and criticality safety requirements stated in §§ 71.55 and 71.59. The objective of the fissile material exemptions in § 71.15 is to facilitate the safe transport of low-risk (e.g., small quantities or low concentrations) fissile material. This is done by exempting shipments of these materials from the packaging requirements and the criticality safety assessments required for fissile material transportation so that the shipments may take place without specific NRC approval. A lower amount of regulatory oversight is acceptable for these shipments because the exemptions were established to ensure safety under all credible transportation conditions. Provided that the exempt material is packaged consistent with the radioactive and hazardous properties of the material, there are no additional packaging or transport requirements for exempt fissile material beyond those noted in the specific exemption. In order to ensure criticality safety, the exemptions were evaluated using assumptions that, as part of the criticality safety assessment for package designs approved to transport fissile material, the fissile material can be released from the packaging during transport, may reconfigure into a worstcase geometric arrangement, may combine with material from other transport vehicles, and may be subject to the fire and water immersion. The reactivity of uranium enriched in U–235 depends on the level of enrichment, the presence of moderators, and heterogeneity effects. Hydrogen is the most efficient moderator and water is the most common material containing large quantities of hydrogen; therefore, water is the typical moderating material of interest in criticality safety. The maximum enrichment in U–235 allowed to qualify for the fissile material exemption in § 71.15(d) is 1 percent by weight, which is slightly less than the minimum critical enrichment for an VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 infinite, homogeneous mixture of enriched uranium and water.4 The minimum critical enrichment is the enrichment necessary for a system to have a neutron multiplication factor of one. Systems containing homogeneous mixtures of uranium enriched to less than the minimum critical enrichment (e.g., a homogenous mixture of uranium enriched to a maximum of 1 percent) are not capable of obtaining criticality, irrespective of the mass or size of the system. The fissile material exemption in § 71.15(d) also limits the quantity of some less common moderating materials (beryllium, graphite, and hydrogenous material enriched in deuterium), because the presence of these materials has the potential to reduce the minimum critical enrichment, thereby increasing the potential for criticality with uranium of lower enrichment. Therefore, homogeneous materials containing uranium enriched to no more than 1 percent by weight and subject to the noted restrictions on moderators are inherently safe from a potential criticality and do not need to be limited by mass or size to be subcritical during transport. However, uranium enriched to less than 5 percent by weight is most reactive when it is in a heterogeneous configuration; therefore, the minimum critical enrichment is lower for an optimized heterogeneous system than for an optimized homogeneous system of the same material. In consideration of this fact, requirements have been added to § 71.15(d) in order to clarify the need for homogeneity in the material. The exemption for uranium enriched to a maximum of 1 percent at § 71.15(d) includes a limit on moderators that increases the reactivity of the lowenriched fissile material, but it does not include limits on heterogeneity. In contrast, TS–R–1 allows the uranium enriched to a maximum of 1 percent by weight to be distributed essentially homogeneously throughout the material and requires that if the U–235 is in metallic, oxide, or carbide forms then it cannot form a lattice arrangement, but TS–R–1 does not limit the amount of beryllium, graphite, or hydrogenous material enriched in deuterium. In its supplemental guidance to TS–R–1, TS– G–1.1 ‘‘Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material,’’ 5 the IAEA indicated that ‘‘[t]here is agreement that homogeneous mixtures and slurries are those in which the particles in the 4 H.C. Paxton and N. L. Pruvost, Critical Dimensions of Systems Containing U–235, Pu-239, and U–233, LA–10860–MS, Los Alamos National Laboratory (1987). 5 https://www-pub.iaea.org/MTCD/publications/ PDF/Pub1109_scr.pdf. PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 33995 mixture are uniformly distributed and have a diameter no larger than 127 mm [(5 × 10¥3 in.)].’’ The homogeneity requirement in TS–R–1 is intended to prevent latticing of slightly enriched uranium in a moderating medium. An analysis performed by the DOE indicated that large arrays of uranium with enrichment of 1 percent by weight of U–235, which qualify for the fissile material exemption at § 71.15(d), could exceed an effective neutron multiplication factor (keff) of 0.95 when optimally moderated by water. The DOE analysis was performed assuming five shipments under normal conditions and two shipments under accident conditions. Shipping the material under the exemption would have resulted in a lower margin of safety with respect to criticality than is allowed for shipments using approved fissile material packages, because shipments using the fissile material packages, by design, will typically use a keff of 0.95 as an upper limit. Because such a shipment, as was analyzed by the DOE, could both qualify for the fissile material exemption for low-enriched fissile material and have a keff greater than 0.95, the NRC believes that additional restrictions on lowenriched fissile material shipped under the fissile material exemption in § 71.15(d) are warranted. As discussed in Section I of this document, the NRC in 2004 removed exemption provisions regarding homogeneous distribution and lattice arrangement. Although the NRC had determined that the limits on restricted moderators were sufficient to assure subcriticality for all moderators of concern, the NRC now believes that additional restrictions are needed to have a sufficient margin of safety for shipments of material under the lowenriched fissile material exemption. Therefore, the NRC is reinstating the requirement that, for uranium enriched to a maximum of 1 percent to be exempted, the fissile material must be distributed homogeneously throughout the package contents and not form a lattice arrangement. Some variability in the distribution and enrichment of the uranium enriched to a maximum of 1 percent is permissible, provided that the maximum enrichment does not exceed 1 percent. The total measured mass of U–233 and plutonium, plus two times the measurement uncertainty, must be less than 1.0 percent of the mass of U– 235 in the material. The total measured mass of beryllium, graphite, and hydrogenous material enriched in deuterium, plus two times the measurement uncertainty, must be less than 5.0 percent of the uranium mass. Although there are heterogeneity effects E:\FR\FM\12JNR3.SGM 12JNR3 33996 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations at very small scales, the NRC does not believe that it is necessary to require homogeneity with respect to particle size. Further, the NRC does not consider it to be credible to accumulate the volume and regularity of fissile material particles necessary for small-scale heterogeneity to introduce criticality concerns. Small volumes of heterogeneity may exist for material shipped under this exemption, provided that a significant fraction of the fissile material is homogeneous and mixed with non-fissile material, or the lumps of fissile material are spaced in a largely irregular arrangement. The homogeneity criterion, allowing some variability in the distribution of fissile material, is consistent with the IAEA’s regulations, which require that the fissile nuclides be essentially homogenously distributed. Restricting the variability in concentration is not sufficient for limiting the reactivity of the uranium enriched to a maximum of 1 percent; therefore, the NRC is reinstating the lattice prevention criterion. The contents of the package must not involve concentrations of fissile material separated by non-fissile material in a regular, lattice-like arrangement. Although the lattice prevention requirement in TS–R–1 is limited to uranium present in metallic, oxide, or carbide form, the NRC believes that this restriction is too narrow and should apply irrespective of the form of uranium. mstockstill on DSK4VPTVN1PROD with RULES3 N. What other changes is the NRC making to its regulations for the packaging and transportation of radioactive material? A requirement in § 71.19(a) that implemented transitional arrangements (‘‘grandfathering’’) expired on October 1, 2008, and § 71.19(a) was designated as ‘‘reserved.’’ Because this entry is no longer needed, paragraphs (b) through (e) have been redesignated as paragraphs (a) through (d). In the redesignated paragraph (b)(2), transitional language that is no longer needed has been removed because the transitional period has expired and the requirement now applies to all previously approved packages used for a shipment to a location outside of the United States. The reference to § 71.20 in § 71.0 has been removed, because § 71.20 has expired and is no longer included in the regulations. In § 71.31, the reference to § 71.13 has been changed to § 71.19. In § 71.91, the reference to § 71.10 has been changed to § 71.14. These changes will correct references that were not updated when VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 the requirements were redesignated in 2004. O. When do these proposed amendments become effective? This rule is effective July 13, 2015. Compliance with the amendments adopted in this final rule is required beginning July 13, 2015. Agreement States, under their formal agreements with the NRC, have 3 years after the effective date of the rule to adopt the changes. III. Opportunities for Public Participation The proposed rule was published on May 16, 2013 (78 FR 28988), for a 75day public comment period that ended on July 30, 2013. The NRC received eight comments from Federal agencies, States, licensees, industry organizations, and individuals. Copies of the public comments are available in the NRC Public Document Room, 11555 Rockville Pike, Rockville, MD 20852; or at https://www.regulations.gov under Docket ID NRC–2008–0198. IV. Public Comment Analysis In general, there was a range of stakeholder views concerning the proposed rule. Two commenters voiced general support of the NRC’s efforts to harmonize 10 CFR part 71 with the DOT’s and the IAEA’s regulations. Three other commenters indicated support for the proposed revisions to the definition of LSA group I, with two of those commenters stating their view that this proposed revision corrected a longstanding error in the NRC’s regulations that created an incompatibility with existing DOT regulations. Other commenters voiced general support for the proposed revisions to quality assurance requirements and for provisions related to exempted low-level material. The comments and responses have been grouped into five topical areas: New and Revised Definitions, Exemptions for Low-level Materials, Quality Assurance, Technical Requirements, and Other. To the extent possible, all of the comments on a particular subject are grouped together. The NRC specifically requested input on three subjects: (1) Frequency for reporting changes to an approved quality assurance program; (2) clarity of new restrictions on low-enriched fissile material in § 71.15(d); and (3) the cumulative effects of this rulemaking, including influence of other regulatory actions, unintended consequences, and reasonableness of the cost benefit estimates. These subjects are addressed within the appropriate area grouping. A PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 discussion summarizing the comments and providing the NRC’s comment responses follows. The NRC finds that the comments did not require any changes to the proposed rule’s provisions. A. New and Revised Definitions A.1 Contamination Comment: One commenter was concerned that DOT had stated in its parallel proposed rule Federal Register notice that the DOT did not have the regulatory authority to establish a radioactive material unrestricted transfer (free release) limit and was leaving it to the NRC as to whether the NRC would continue a longstanding provision of the DOT’s regulations that allowed conveyances that meet the return to service (RTS) standards to be released without applying NRC licensing requirements. The commenter stated that with the DOT and the NRC adopting the same definition of ‘‘contamination,’’ and excluding conveyances with contamination below the limits established by that definition, it was the commenter’s view that the transportation requirements of the DOT and the NRC are not applicable to such conveyances. It was also the commenter’s view that by adopting the DOT’s definition for contamination, the NRC is continuing the long-held position that, for materials below the level that meet the definition of contamination for conveyances in transportation or storage incidental to transportation, conveyances in transportation do not need to be licensed. Response: The NRC does not agree with the commenter’s views, because they are contrary to existing general provisions in 10 CFR part 71. Specifically, 10 CFR 71.0(b) states that the 10 CFR part 71 requirements ‘‘are in addition to, and not in substitution for,’’ NRC requirements in other 10 CFR parts. Additionally, existing 10 CFR 71.0(c) states that no provision in 10 CFR part 71 ‘‘authorizes possession of licensed material.’’ Therefore, the new definition of contamination in § 71.4, and the new exemption for contamination in § 71.14(a)(3) applicable to transport of material, are sufficiently clear, and should not be misconstrued as providing relief from the provisions of any other applicable parts of 10 CFR, in particular with respect to the licensing of on-site materials, (also see response to comment D.4.). Comment: One commenter stated that although the application of the definition of contamination provides a E:\FR\FM\12JNR3.SGM 12JNR3 mstockstill on DSK4VPTVN1PROD with RULES3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations regulatory path for the release of conveyances, the current language found in 49 CFR 173.443(c) and the associated table of contamination limits should be incorporated into the NRC’s regulations as an authorized method to remove conveyances from licensed control when the conveyances are limited to the transportation of contaminated or potentially contaminated material or storage for future such transportation. Response: The comment does not provide a sufficient basis to incorporate this DOT regulation into NRC’s regulations. The DOT and the NRC share regulatory responsibility for the safety of radioactive materials in transport. To avoid duplication of effort and imposing unnecessary burden, the respective roles of the two agencies are delineated in the DOT/NRC MOU. Under this MOU, the NRC recognizes the DOT’s authority to define and regulate the safety of Class 7 Hazardous Materials (radioactive materials) in transport. The NRC requires its licensees to comply with the DOT’s regulations when transporting radioactive materials. The DOT has issued regulations for safe transport of radioactive materials by all modes, including requirements addressing residual contamination on conveyances, and the NRC believes the DOT regulations regarding contaminated conveyances are adequate to protect public health and safety. Accordingly, the NRC sees no need to duplicate the DOT’s conveyance provisions in 10 CFR. Note also that the NRC issues licenses to persons to possess, use, and transfer radioactive materials; the NRC does not license conveyances. Comment: One commenter stated that the NRC, by defining contamination, is establishing a de minimis quantity. The commenter believed that this is a sensible view given the minimal potential for contamination in transportation or storage pending future transportation and that this approach constitutes a sound application of the NRC’s risk-informed, performance-based approach. The commenter indicated, however, that it would be helpful, given the many stakeholders and Agreement State regulators, that this position be clearly stated in the NRC’s regulations. Specifically, the commenter recommended that the proposed § 71.14(a)(3) exemption be modified (as indicated by the underlined text) to state: ‘‘(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 of this part. Such objects in the transportation VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 process, or in storage pending future transportation, need not be licensed under this chapter.’’ Response: The NRC finds that the wording of the new exemption provision in 10 CFR 71.14(a)(3), as proposed, is sufficiently clear, and therefore is not accepting the proposed modification. The scope of this new exemption is limited to the NRC’s transportation regulations in 10 CFR part 71. The NRC licensees are not being exempted from meeting the requirements stated in other applicable 10 CFR parts, (also see response to Comment A.1 and Comment D.4.). A.2 Special Form Radioactive Material Comment: Although one commenter voiced general support for the revised definition of special form radioactive material in § 71.4, another commenter was concerned that the new language being added to revised paragraph (3) of the definition, ‘‘. . . and special form material that was successfully tested before July 13, 2015 . . .,’’ is unclear. The commenter noted that the existing language contained within paragraph (3) uses the term ‘‘special form encapsulation’’ and that this term was consistent with the commenter’s understanding of the intent of these changes as discussed in the Federal Register notice. However, the commenter stated that using the term special form ‘‘material,’’ rather than ‘‘encapsulation’’ is ambiguous as to whether the revised language is meant to apply to a special form that is a single solid piece of material only, or whether the rule aims to grandfather special form designs including encapsulations that were designed and constructed after the earlier dates cited in the paragraph. For clarity and consistency, the commenter recommended replacing the proposed ‘‘special form material’’ term with the term ‘‘special form encapsulation’’ in paragraph (3) of the revised definition. Response: Special form radioactive material may be either encapsulated or a single solid piece; using the term ‘‘special form encapsulation’’ would not refer to a single solid piece. The NRC is choosing to use the broader ‘‘special form material’’ term so that the revised definition will: (1) Permit the continued use of encapsulations authorized under the existing definition, and (2) cover special form materials as authorized in the DOT’s regulation (see 49 CFR 173.469(e)). A.3 Other Comment: One commenter recommended adding a new definition to 10 CFR 71.4 to define ‘‘radiation level’’ as: ‘‘the radiation dose-equivalent PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 33997 rate expressed in millisieverts per hour or mSv/h (millirem per hour or mrem/ h). It consists of the sum of the dose equivalent rates from all types of ionizing radiation present including alpha, beta, gamma, and neutron radiation. Neutron flux densities may be used to determine neutron radiation levels according to Table 1.’’ Response: The NRC declines to add the requested definition of ‘‘radiation level’’ to 10 CFR 71.4 for the following reasons. ‘‘Radiation’’ is already defined in 10 CFR part 20 (‘‘Standards for Protection Against Radiation’’), and this term includes all the types of ionizing radiation that are referenced in the comment. Additionally, the term ‘‘radiation’’ applies to all types of NRC licensees, in accordance with the 10 CFR 20.1002 scoping provisions. B. Exemptions for Low-Level Materials Comment: One commenter stated that the discussion contained within the Federal Register notice appears to indicate that natural material that has been processed could qualify for the exemption if it is not included in a manufactured product, such as an article, instrument, component of a manufactured article or instrument, or consumer item. The commenter was concerned that there appears to be a discrepancy between this statement and the language in the proposed rule regarding intent to be processed for the use of radionuclides. Response: The comment does not specify the exemption provisions that are of concern, but as indicated in this response, the NRC assumes that those in 10 CFR 71.14 are at issue. The NRC does not find there is any discrepancy between the revised 71.14(a)(1) exemption, and the existing 71.14(b)(3)(ii) exemption that is not being revised. The NRC is revising the 10 CFR 71.14(a)(1) exemption to include natural material and ores containing naturally occurring radionuclides that: (1) Are either in their natural state, or have only been processed for purposes other than for the extraction of the radionuclides, and (2) are not intended to be processed for the use of these radionuclides, provided that they do not exceed 10 times the activity concentration values listed in Table A– 2 or Table A–3, as appropriate. Natural material or ore that has been processed but has not been incorporated into a manufactured product, such as an article, instrument, component of a manufactured article or instrument, or consumer item, would be within the scope of this revised exemption. A licensee is exempt from all the requirements of 10 CFR part 71 with E:\FR\FM\12JNR3.SGM 12JNR3 33998 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations respect to shipment or carriage of this material. The NRC is also revising the definition of LSA–I in 10 CFR 71.4 to include 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 radioactive materials. Under existing 71.14(b)(3)(ii), a licensee is exempt from all the requirements of 10 CFR part 71, other than §§ 71.5 and 71.88, with respect to shipment or carriage of packages containing LSA–I, provided the packages do not contain any fissile material, or the material is exempt from classification as fissile material under § 71.15. As revised, the NRC finds that the definition of LSA–I is adequate to ensure that material is properly characterized; therefore, it is clear to the user when the exemption provisions in 71.14(b)(3)(ii) would apply. Comment: One commenter noted that the IAEA’s 2012 edition of SSR–6 did not include the phrase ‘‘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.’’ The commenter was concerned that given the length of time it can take to promulgate a rulemaking, the NRC should consider revising its proposed 10 CFR 71.14(a)(1) text to be consistent with the current SSR–6. Specifically, Section 107 of SSR–6 states that regulations do not apply to any of the following: mstockstill on DSK4VPTVN1PROD with RULES3 (f) Natural material and ores containing naturally occurring radionuclides, which may have been processed, provided the activity concentration of the material does not exceed 10 times the values specified in Table 2, or calculated in accordance with paras 403(a) and 404–407. For natural materials and ores containing naturally occurring radionuclides that are not in secular equilibrium the calculation of the activity concentration shall be performed in accordance with para. 405. The commenter therefore recommended revising the proposed 10 CFR 71.14(a)(1) provisions to exempt ‘‘Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have been processed, 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.’’ Response: The NRC is choosing not to make the commenter’s recommended revisions. The DOT/NRC MOU recognizes the DOT as the Federal agency responsible for the definition of VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 radioactive material in transit. After careful consideration, the DOT chose not to remove the intended use-clause in its current proposed rule, in part because the rule is intended to achieve compatibility with the 2009 Edition of the IAEA regulations, not the 2012 Edition. Publication of the 2012 Edition in October 2012, did not allow adequate time for the NRC and DOT to effectively evaluate the changes as part of this rulemaking effort. There are other changes in the 2012 Edition that also are not reflected in either the proposed DOT or NRC rulemakings. The NRC will consider any necessary changes related to SSR–6 in a future rulemaking after consulting with DOT, rather than to further delay finalizing this rulemaking. The NRC is choosing not to make such changes unilaterally, since doing so would create a conflict between DOT and NRC regulatory requirements. Not only would conflicting requirements and definitions contradict long-standing policy to establish a uniform, national hazardous material transportation safety system, such conflicts could likely create uncertainty within the regulated community and prove to be unenforceable. C. Quality Assurance Program Comment: Three commenters voiced support of proposed changes to 10 CFR part 71 relating to the quality assurance program approvals. One of these commenters stated that the proposed changes would (1) streamline the process of maintaining an approved program, (2) contribute to implementation of continued improvement efforts by the approval holders, and (3) ensure the level of safety afforded shipments will not be diminished. Another of these commenters believed that the proposal would better risk inform U.S. regulations and harmonize the U.S. regulations with international rules. A different commenter disagreed with the proposed approach and recommended that 10 CFR 71.38(c) only extend the expiration dates to 10 years. The proposed rule would have removed the quality assurance expiration provision in order to minimize the impact on the applicants while still requiring a licensee to submit all documentation, including the quality assurance program, for review when renewing their license. Response: The NRC expects that parties who already have an approved QA program will receive an updated completed approval form identifying the removal of the expiration. Essentially, this is no different than what has been expected of the receipt of the previous PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 QA program approval, except that this will be the last and only receipt if no changes affecting QA commitments occur. For future applicants, the original QA program approval will be issued with no expiration date. But any changes affecting QA commitments must still be submitted to the NRC for approval, including any such changes that are part of a license renewal request. The NRC therefore finds that there is no need to adopt the commenter’s recommended 10-year expiration provision. Comment: One commenter stated that while it agreed with the philosophy of the proposed 10 CFR 71.106, which will allow a licensee to make changes to the quality assurance program, it recommended mirroring 10 CFR 35.26 by adding the following rule language: (1) The revision has been reviewed and approved by management. (2) Affected individuals are instructed on the revised program before the changes are implemented. (3) A record of this instruction be created and maintained.’’ Response: The NRC agrees with the commenter that management review and approval, appropriate instruction or training prior to implementation, and record keeping, are key attributes of effectively managing changes. The specific language referenced from 10 CFR 35.26 has not been added because these requirements are already embedded in the existing regulations. The NRC finds that the first two recommended additions to proposed 10 CFR 71.106 are not necessary, because they are adequately addressed by the existing general provisions of 10 CFR 71.105 (‘‘Quality assurance program’’). Regarding management review and approval of non-substantive revisions to a quality assurance program, existing § 71.105(d) states in relevant part that management of organizations involved in a licensee’s or CoC holder’s quality assurance program ‘‘shall review regularly the status and adequacy of that part of the quality assurance program they are executing.’’ The NRC finds that this existing requirement adequately ensures management oversight of quality assurance programs. Regarding the recommended need to have affected individuals instructed on the revised QA program before the changes are implemented, existing § 71.105(d) states in relevant part that a licensee or CoC holder ‘‘shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained.’’ The NRC finds that this existing requirement adequately ensures that affected E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations individuals will be properly instructed before any QA program changes are implemented. Regarding the third recommendation to have records of these instructions created and maintained, the NRC finds that this addition to proposed 10 CFR 71.106 is not necessary, because it is adequately addressed by the existing criteria stated in § 71.135 (‘‘Quality assurance records’’). Specifically, § 71.135 states in relevant part that a licensee or CoC holder must maintain written records, and that such records include instructions pertaining to the ‘‘required qualifications of personnel.’’ The NRC finds that this existing requirement adequately ensures that training records will be created and maintained. Comment: Regarding proposed 10 CFR 71.106, a commenter requested that corresponding changes be made to 10 CFR part 72, subpart G. The commenter recommended that the NRC initiate action to make similar and compatible changes to 10 CFR part 72, subpart G, so that all QA program changes that do not reduce commitments could be implemented without prior NRC approval. Response: The NRC agrees with the commenter’s recommendation, and will consider making the recommended changes to 10 CFR part 72 during a future rulemaking. However, changes to 10 CFR part 72 are outside the scope of this 10 CFR part 71 rulemaking. Note that existing sets of parallel QA provisions in 10 CFR 71.101(f) and 10 CFR 72.140(d) allow for a single QA program to meet both the requirements of 10 CFR part 71 and 10 CFR part 72. D. Technical Requirements mstockstill on DSK4VPTVN1PROD with RULES3 D.1 Latticing/Homogeneity Comment: One commenter recommended that clarifying language be provided relating to the prevention of latticing and also homogeneity as it relates to the exemption for uranium enriched up to 1 percent. The commenter noted that similar language to the proposed language existed in earlier versions of the regulations, and that NUREG/CR 5342 recommended that the terms ‘‘lattice arrangement’’ and ‘‘homogeneity’’ either be removed or defined. Response: The intent of the fissile material exemptions in 10 CFR 71.15 is to facilitate the safe transport of small quantities or low concentrations of fissile material. This is accomplished by exempting such fissile material from the criticality safety requirements in 10 CFR 71.55 and 71.59 that are generally applicable to fissile material VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 transportation packages. Since these packaging requirements are not applicable pursuant to the 10 CFR 71.15 exemptions, it is conservatively assumed that (a) small quantities or low concentrations of fissile material can be released from packaging during transport, (b) this material may configure into a worst-case geometric arrangement, and (c) the fissile material may be subject to the fire and water immersion conditions assumed for transportation criticality analyses performed for approved packages under 10 CFR 71.55. The 10 CFR 71.15 exemptions are intended to ensure that criticality safety is maintained under all credible transportation conditions, although it is recognized that unlikely scenarios may be conceived which can make almost any amount or concentration of material become a criticality safety concern. As indicated in the comment, the NRC is restoring former lattice arrangement and homogeneous distribution provisions, as discussed in the following section, regarding the revised 10 CFR 71.15(d) exemption requirement. Uranium enriched to less than 5.0 weight percent U–235 is generally more reactive in a heterogeneous configuration than when it is distributed homogeneously within a transportation package. The fissile exemption for uranium enriched to a maximum of 1.0 weight percent U–235 in 10 CFR 71.15(d) is based on the fact that this enrichment level is slightly less than the minimum critical U–235 enrichment for infinite homogeneous mixtures of uranium and water. Accordingly, 10 CFR 71.15(d) as revised requires that the fissile material be distributed homogeneously within its transportation package, and excludes from the exemption’s scope situations where fissile ‘‘lumps’’ or lattice arrangements of fissile material are present within the package. The 10 CFR 71.15(d) exemption language continues to exclude large quantities (less than 5 percent of the uranium mass) of lowabsorbing moderators (beryllium, graphite, or hydrogenous material enriched in deuterium). These requirements will preclude fissile material arrangements in packages that can potentially result in criticality at U–235 enrichments less than 1 weight percent. Homogeneity and lattice arrangement are well understood terms in the criticality safety community. Nuclear Criticality Safety—Theory and Practice (Knief, 1998), states that heterogeneous systems are generally defined as any mixtures of fissile and moderator materials with uniformly distributed PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 33999 fissile material particles larger than ∼0.1 mm. Additionally, the IAEA Safety Guide TS–G–1.1, Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material, contains a description of essentially homogeneous materials as ‘‘those in which the particles in the mixture are uniformly distributed and have a diameter no larger than 127 microns (0.127 mm).’’ Lattice arrangement means a fixed, repeating configuration of separate fissile material lumps. A nuclear fuel assembly is an example of a lattice arrangement. For the exemption in 10 CFR 71.15(d), small volumes of heterogeneity may exist, provided that a significant fraction of fissile material is homogeneous and mixed with non-fissile material, or lumps of fissile material are in a largely irregular arrangement. Further, heterogeneous effects in a package due to large fissile material lumps/particles or lattice arrangements of fissile material would only affect criticality safety in a regular or near-optimal configuration over a large volume. Large quantities of fissile material (kilograms of U–235) and regions of heterogeneity on the order of a cubic meter in size are necessary before a system could adversely affect the validity of the 1 weight percent U–235 enrichment limit for this fissile exemption. D.2 Container Closure Verification Comment: One commenter was concerned that requiring the closure of waste containers be verified by two independent inspectors prior to shipment in a licensed package was not risk-informed. The commenter believed that this new requirement was based on an incident with an iridium source. The commenter stated that the majority of low-level radioactive waste (LLRW) containers transported in licensed packages are LSA group II materials that exhibit a few areas of elevated dose rates that can exceed 1 R/hr at 3 meters and that this dose rate limit is the main reason licensed shipping packages are employed for transport of large containers of commercial LLRW in the United States. The commenter believes that the risk from LSA material does not warrant the dual container closure independent inspection requirement and that such requirements should be limited to concentrated radioactive sources similar to the one involved in the incident with an iridium source. Response: The NRC’s proposed rule did not address this topic. The NRC neither has at present, nor is it proposing, a requirement that ‘‘waste containers be verified by two independent inspectors prior to E:\FR\FM\12JNR3.SGM 12JNR3 34000 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 shipment in a licensed package.’’ Because this comment raises issues that are outside the scope of this rulemaking, it will not be further addressed here. Comment: A commenter stated that containers of activated metal loaded underwater cannot be sealed because the water must be allowed to drain from the containers prior to shipment. Since activated metal is not dispersible, sealing of the waste container should not be required. Response: The NRC’s proposed rule did not include such a requirement. Because this comment raises issues that are outside the scope of this rulemaking, it will not be further addressed here. D.3 Activity Limit for Type B Packages Comment: One commenter stated concerns that the new calculations to limit the activity that a licensed Type B package may contain are not risk informed for LSA group II low-level waste that commercial power plants routinely ship. The commenter believes that these new calculations were imposed because of an incident with an iridium source, and therefore, such calculation requirements should be limited to the shipment of concentrated radioactive sources similar to the one involved in the event. Response: The commenter misconstrues the proposed change in the calculations regarding iridium. The NRC is not proposing any changes regarding when Type B packages are required for LSA shipments. Under existing regulations, Type B packaging is required for LSA when the material has an external radiation dose greater than 10 mSv/h (1 rem/h), at a distance of 3 meters from the unshielded material. Therefore, the need for Type B packaging for LSA material is directly based on the dose rate from, not the activity of, the material. Further, iridium sources do not meet the existing 10 CFR 71.4 definition of LSA II (ii). The proposed change regarding iridium pertains only to the placement of an explanatory footnote in 10 CFR part 71, appendix A, Table A–1, to make clear that the activity of special form iridium sources may be determined through measurement at a prescribed distance from the source. Comment: A commenter stated that the NRC is now requiring registered users of licensed packages to conduct and provide radiolysis calculations on hydrogen gas generation. The commenter does not believe a requirement for such calculations is risk informed. Combustible Gas generation within a licensed transport package is a valid concern. According to the commenter, based on past history, the VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 source of combustible gas generation from commercial LLRW is not from radiolysis, but rather from biological sources (methane) or rusting of waste container internals (hydrogen) noted as bulging drums. The commenter is not aware of any calculation method for biological or rusting combustible gas generation. Response: This comment does not provide sufficient technical basis for evaluation. The NRC is not aware of any requirement that registered users of licensed packages conduct and provide radiolysis calculations on hydrogen gas generation. Nor is the NRC aware of any history showing that commercial LLRW is generating combustible gas from either biological sources (methane) or rusting of waste container internals. The topics discussed in this comment are outside the scope of this rulemaking. D.4 Storage of Radioactive Material Containers Comment: One commenter had concerns that the proposed revision to the DOT’s and the NRC’s regulations may have the unintended consequence of severely complicating the storage of radioactive material containers and conveyances when they are not in use. The DOT’s rule essentially defines ‘‘returned to service (RTS)’’ conveyances not in use for Class 7 material as radioactive material; therefore, it implies that a radioactive material license is necessary to store these RTS conveyances when they are not transporting Class 7 material. The commenter is concerned that this would impose a significant burden on industry processors as there are no licensed facilities that have sufficient capacity to store the inventory of gondola rail cars and other conveyances. The commenter does not believe that the DOT has demonstrated, nor that in fact there exists, a health and safety justification for imposing new restrictions on the storage of conveyances while not in use. The commenter recommends that the NRC should amend § 71.14(a) to add a paragraph 4 that would read as follows: ‘‘(4) Transport vehicles with radioactive substances meeting the return to service provisions of 49 CFR 173.443(c) in effect on September 13, 2004, when in transport of contaminated or potentially contaminated material or empty vehicles in storage pending future such transportation. Such vehicles need not be licensed under this chapter.’’ Response: The NRC disagrees with this comment, because adding the requested exemption to § 71.14(a) would be contrary to existing general provisions in 10 CFR part 71. Specifically, 10 CFR 71.0(b) states that PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 the 10 CFR part 71 requirements ‘‘are in addition to, and not in substitution for,’’ NRC requirements in other 10 CFR parts. Also, existing 10 CFR 71.0(c) states that no provision in 10 CFR part 71 ‘‘authorizes possession of licensed material.’’ The suggestion that NRC use its 10 CFR part 71 transport regulations to exempt certain transport vehicles from the need to have an NRC license is therefore not permissible. Furthermore, under the DOT/NRC MOU, the DOT is responsible for regulation of Class 7 (radioactive) material in transport. The DOT is responsible for all transport modes, including highway and railway conveyances. The DOT has established radiation dose rate and removable contamination levels for returning exclusive use vehicles to service. However, allowing exemption or release from licensing of radioactive material, including conveyances not in service, at these levels would not be compatible with current and generally accepted radiation protection practices, (also see response to comment A.1). E. Other E.1 Agreement State Compatibility Comment: One commenter recommended that the compatibility for the new proposed 10 CFR 71.85(d) be changed to ‘NRC’ since paragraphs (a) through (c) are being revised to compatibility ‘‘NRC.’’ Response: The NRC disagrees with this comment. As stated in the 2013 statement of considerations in the Federal Register notice of the proposed rule, paragraphs (a) through (c) of § 71.85 would be designated as Compatibility Category NRC because as revised they would apply exclusively to certificate holders, and granting package approvals to certificate holders is an action reserved to the NRC. New § 71.85(d) applies to NRC licensees and licensees in Agreement States that use the packages. This new requirement has been designated as Compatibility Category ‘‘B’’ because it applies to activities that have direct and significant effects in multiple jurisdictions, and Agreement States should adopt program elements essentially identical to those of NRC to achieve nationwide consistency. Comment: One commenter recommended that the Agreement States be offered 3 years to implement these changes when they are finalized by the NRC. Response: Agreement States, under their formal agreements with the NRC, have 3 years after the effective date of the rule to adopt the changes. E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations E.2 Cumulative Effect of Regulation Comment: Section III.P of the Federal Register notice for the proposed rule asked, ‘‘Do other regulatory actions influence the implementation of the proposed requirements?’’ One commenter answered ‘‘yes’’ to this question and stated that the creation of 10 CFR part 37 and the revisions of 10 CFR parts 35 and 61 should take precedence over this 10 CFR part 71 revision. The commenter indicated this revision would also add to the workload of Agreement State staff needing to revise their applicable regulations. Response: The NRC agrees with the commenter that implementation of this rulemaking will impact the Agreement States that are currently implementing changes related to the recent promulgation of other rule changes such as 10 CFR part 37. However, these 10 CFR part 71 amendments are necessary to make the NRC’s regulations conform to the IAEA’s regulations for the international transportation of radioactive material, and to maintain consistency with the DOT’s regulations. Agreement States may, and often do, combine the action of making their regulations compatible with multiple NRC rule changes in one State rulemaking action, which can somewhat reduce overall effort. Regarding the added burden that may result from future changes to 10 CFR parts 35 and 61, it is uncertain when the final rule changes for those parts may be approved by the Commission and promulgated. V. Section-by-Section Analysis mstockstill on DSK4VPTVN1PROD with RULES3 Section 71.0 Purpose and Scope Paragraph (d)(1) has been revised to delete § 71.20 from the list of sections in which a general license is issued without requiring the NRC to issue a package approval. The list of sections has been revised to add §§ 71.21 through 71.23. Section 71.4 Definitions The definition of ‘‘contamination’’ has been added and is now consistent with the definition of contamination in the DOT’s regulations in 49 CFR 173 and TS–R–1. The definition of ‘‘Criticality Safety Index (CSI)’’ has been revised to be more consistent with the definition in the DOT’s regulations in 49 CFR 173 and TS–R–1 by addressing overpacks and freight containers in the definition. The definition of ‘‘Low Specific Activity (LSA) material’’ has been revised so that it is more consistent with the definition in the DOT’s regulations in 49 CFR 173 and TS–R–1 by revising paragraphs (1)(i) and (1)(ii). In VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 paragraph (1)(i), the definition is changed to make the description of LSA–I material apply to material that is intended to be processed for the use of the uranium, thorium, and other naturally occurring radionuclides. In paragraph (1)(ii), the definition is changed to clarify consideration of compounds or mixtures regardless of the form (solid or liquid). The definition of ‘‘Special form radioactive material’’ has been revised to allow special form radioactive material that was successfully tested using the current requirements of § 71.75(d) to continue to qualify as special form material, if the testing was completed before September 10, 2015. The reference to the version of 10 CFR part 71 in effect on March 31, 1996, is corrected by changing 1983 to 1996. The definition of ‘‘Uranium—natural, depleted, enriched’’ has been revised by adding ‘‘(which may be chemically separated)’’ to paragraph (1), which applies to natural uranium. Section 71.6 Information Collection Requirements: OMB Approval Paragraph (b) is revised to add § 71.106 to the list of sections with information collections. Section 71.14 Exemption for Low-Level Materials Paragraph (a)(1) has been revised to allow natural material and ores that contain naturally occurring radionuclides and that have been processed for purposes other than the extraction of the radionuclides, to qualify for the exemption. Natural material or ore that has been processed but has not been incorporated into a manufactured product, such as an article, instrument, component of a manufactured article or instrument, or consumer item, could qualify for the exemption. Slags, sludges, tailings, residues, bag house dust, oil scale, and washed sands that are the byproducts of processing or refining are considered to be a natural material and could qualify for the exemption, provided that they were not incorporated into a manufactured product. To qualify for this exemption, the activity concentration of the natural material or ore cannot exceed 10 times the activity concentration values, and the material cannot be intended to be processed for the use of the radionuclides. A reference to Table A–3 in appendix A is added as a source of activity concentration values that may be used to determine whether natural material or ore will qualify for the exemption. Table A–3 provides activity concentration values for exempt material that are used for individual PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 34001 radionuclides whose identities are known but which are not listed in Table A–2. Paragraph (a)(2) has been revised to add a reference to Table A–3 in appendix A Table A–3 provides activity concentration values for exempt material that are used for individual radionuclides whose identities are known but which are not listed in Table A–2. Paragraph (a)(3) has been added to provide an exemption for nonradioactive solid objects that have radioactive substances present on the surfaces of the object, provided that the quantity of radioactive substances is below the quantity used to define contamination. The definition of ‘‘contamination’’ has been added to § 71.4. Section 71.15 Exemption From Classification as Fissile Material Paragraph (d), which applies to fissile material in the form of uranium enriched in U–235 to a maximum of 1 percent by weight, has been revised. To qualify under the revised exemption, the fissile material will need to be distributed homogeneously and not form a lattice arrangement within the package. The revision re-establishes restrictions on material that qualifies for the fissile material exemption. Section 71.17 General License: NRCApproved Package Paragraph (c) is revised to clarify that the general licensee must comply with the requirements in § 71.17(c)(1) through (c)(3). Section 71.19 Previously Approved Package Paragraphs (b) through (e) are redesignated as (a) through (d). In redesignated (b)(2), the phrase ‘‘After December 31, 2003’’ is deleted. This will not change the requirement that packages used for a shipment to a location outside the United States will continue to be subject to multilateral approval as defined in the DOT’s regulations in 49 CFR 173.403 because all such shipments will occur after December 31, 2003. Section 71.21 General License: Use of Foreign Approved Package Paragraph (a) is revised to update the reference to 49 CFR 171.12 to 49 CFR 171.23. Paragraph (d) is revised to clarify that the general licensee must comply with the requirements in § 71.21(d)(1) and (d)(2). Paragraph (d)(2) is revised by deleting its second sentence, which provided an exemption from quality E:\FR\FM\12JNR3.SGM 12JNR3 34002 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations assurance provisions in subpart H for design, construction, and fabrication activities. As revised, § 71.21(d)(2) will require general licensees to comply ‘‘with the terms and conditions of the certificate and revalidation, and with the applicable requirements of subparts A, G, and H’’ of 10 CFR part 71. Because the quality assurance provisions in subpart H for design, construction, and fabrication activities are not applicable to a general licensee, the exemption was not needed. Section 71.31 Contents of Application In paragraph (b), the reference to § 71.13 is changed to § 71.19. This change was inadvertently omitted during a previous rulemaking, when certain sections were renumbered. mstockstill on DSK4VPTVN1PROD with RULES3 Section 71.38 Renewal of a Certificate of Compliance The title of this section is revised to remove the reference to the renewal of quality assurance program approvals. The section is revised to be limited to the renewal of CoCs by removing all references to quality assurance program approvals. The NRC is changing its practice regarding the duration of quality assurance program approvals. Quality assurance program approvals will not have an expiration date and the NRC will revise the current quality assurance program approvals so that they will not have an expiration date. The renewal of a quality assurance program approval is unnecessary. Paragraphs (a), (b) and (c) have also been revised for clarity. Section 71.70 Incorporations by Reference This section is added to incorporate by reference the consensus standards referenced in § 71.75: ISO 9978:1992(E), ‘‘Radiation protection—Sealed radioactive sources—Leakage test methods’’; and ISO 2919:1999(E), ‘‘Radiation protection—Sealed radioactive sources—General requirements and classification.’’ Interested parties, including members of the general public, can purchase the 1992 version of ISO 9978 from the American National Standards Institute, 25 West 43rd Street, 4th floor, New York, NY 10036, 212–642–4900, https:// www.ansi.org, or info@ansi.org. Interested parties, including members of the general public can purchase the 1999 version of ISO 2919 on https:// www.amazon.com. The materials incorporated by reference can also be examined at the NRC’s Public Document Room, O1–F21, 11555 Rockville Pike, Rockville, Maryland 20852 or at the NRC Library located at Two White Flint VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301–415– 5610; email: Library.Resource@nrc.gov. The materials incorporated by reference are each available for under $126. Accordingly, the NRC has determined that materials incorporated by reference are reasonably available to all interested parties, including members of the general public. Section 71.75 Qualification of Special Form Radioactive Material In paragraph (a)(5), the 1992 edition of ISO 9978 has been incorporated by reference for the alternate leak test methods for the qualification of special form material. The ISO/TR 4826 has been withdrawn by ISO and replaced by ISO 9978:1992(E). This change makes 10 CFR part 71 consistent with the DOT’s requirements in 49 CFR 173, which incorporated ISO 9978:1992(E) in 2004. In paragraph (b)(2)(ii), the description of the billet used in the percussion test has been changed to provide better clarity and to maintain consistency with the language used by the DOT in 49 CFR 173.469 by replacing ‘‘edges’’ with ‘‘edge.’’ The edge corresponds to the circular edge at the face of the billet. In paragraph (b)(2)(iii), the description of the sheet of lead used in the percussion test is changed to correct the thickness of the sheet of lead used in the percussion test to indicate that the thickness must not be more than 25 mm (1 inch) thick to be consistent with the thickness in TS–R–1. In paragraph (d), subparagraphs (d)(1)(i) and (d)(1)(ii) have been added. Also, the 1999 edition of ISO 2919 has been incorporated by reference, replacing the reference to the 1980 edition of ISO 2919 for the alternate Class 4 impact test in paragraph (d)(1)(i) and the alternate Class 6 temperature test in paragraph (d)(2). The availability and other language incorporating this standard by reference is moved to new § 71.70. Paragraph (d)(1)(ii) allows the Class 5 impact tests prescribed in the 1999 edition of ISO 2919 to be used in place of the impact and percussion tests in paragraphs (b)(1) and (b)(2), if the specimen weighs less than 500 grams. Section 71.85 Preliminary Determinations In paragraphs (a), (b), and (c), ‘‘licensee’’ is replaced by ‘‘certificate holder.’’ The NRC experience is that these determinations are performed by the certificate holders who manufacture the package. This change will make the requirements consistent with current practice, because only certificate holders will have a quality assurance program approval that will allow them PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 to conduct the required tests under an approved quality assurance program. Paragraph (d) is added to address the responsibilities of licensees using a package for transportation. Although certificate holders are required to make the preliminary determinations under paragraphs (a), (b), and (c), licensees are responsible for ensuring that these determinations have been made before their first use of the packaging. Section 71.91 Records In paragraph (a), the reference to § 71.10 is changed to § 71.14. This reference was not updated when § 71.10 was redesignated as § 71.14. Section 71.101 Quality Assurance Requirements Paragraph (a) is revised by deleting its first reference to licensees in order to clarify that with respect to the design, fabrication, testing, and modification of packaging, only certificate holders and applicants for a CoC are subject to the quality assurance requirements. Note that consistent with the existing 71.101(c)(1) QA-program-approval requirements, under 71.101(a), as revised, licensees are still subject to quality assurance requirements with respect to their use of packages when shipping radioactive material. The provisions of 71.101(c)(2) are revised by removing the reference to licensees in the first sentence. This will remove the overlap between § 71.101(c)(1) and (c)(2) by making it clear that licensees must notify the NRC before their first use of any package as required under § 71.101(c)(1), and certificate holders and applicants for a CoC will notify the NRC before the fabrication, testing, or modification of a package as required under § 71.101(c)(2). Section 71.103 Quality Assurance Organization Footnote 2 is removed from paragraph (a). The activities described in the footnote are performed by certificate holders and applicants for a CoC. The footnote is unnecessary, because the requirements no longer rely on the use of the term ‘‘licensee’’ for those activities performed by certificate holders and applicants for a CoC. Section 71.106 Changes to a Quality Assurance Program This new section is added to establish requirements that will apply to changes to quality assurance programs. It allows some changes to a quality assurance program to be made without obtaining the prior approval of the NRC. Previously, all changes, no matter how E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations insignificant, had to be approved by the NRC before they could be implemented. These provisions will allow changes to quality assurance programs that do not reduce commitments, such as those that involve administrative improvements and clarifications and editorial changes, to be made and implemented without NRC approval. Quality assurance program approval holders will still be required to get NRC approval before making changes to their quality assurance programs that would reduce their commitments to the NRC. Paragraph (a) will establish the requirements that will apply when a holder of a quality assurance program approval intends to make a change in its quality assurance program that would reduce its commitments to the NRC. The holder of a quality assurance program approval will be required to identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change will continue to satisfy the requirements of subpart H of 10 CFR part 71 that apply. Paragraph (a)(2) will require that each holder of a quality assurance program approval maintain quality assurance program changes as records. These records will need to be maintained as required in § 71.135. Paragraph (b) will allow the holder of a quality assurance program approval to make changes to its quality assurance program that will not reduce its commitments to the NRC and identify the changes that will not be considered as reducing its commitments to the NRC. Paragraph (c) will require that records be maintained documenting any changes to the quality assurance program. Section 71.135 Records Quality Assurance This section is revised to include those quality assurance records that apply to changes that are made to previously approved quality assurance programs. The second sentence is revised to include in the list of the types of records to be maintained the changes to the quality assurance program as required by new § 71.106. mstockstill on DSK4VPTVN1PROD with RULES3 Appendix A Determination of A1 and A2 In paragraphs IV.a. through IV.f., the equations and accompanying text are revised to make minor corrections. In paragraphs IV.a. and IV.b., the description of the equations will make it explicit that B(i) is the activity of radionuclide i in special form and normal form in paragraphs IV.a. and IV.b., respectively. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 Current paragraphs IV.c. through IV.f. are redesignated as paragraphs IV.d. through IV.g. New paragraph IV.c. is added and provides an equation to be used for determining the quantity of radioactive material that can be shipped in a package that contains both special form and normal form radioactive material. This equation increases the consistency between appendix A and TS–R–1. In paragraph V., the existing text is redesignated as paragraph V.a. Paragraph V.b. is added to provide direction on calculating the exempt activity concentration for a mixture and the exempt consignment activity limit of a mixture when the identity of each radionuclide is known, but the individual activities of some radionuclides are not known. Table A–1 is revised to change the A1 value for Cf-252 from 5.0 × 10¥2 TBq to 1.0 × 10¥1 TBq, and from 1.4 Ci to 2.7 Ci. Footnote h is deleted, and the following corresponding changes are made: (1) The reference to footnote h is removed from Cf-252, (2) footnote i is redesignated as footnote h, and (3) the entry for molybdenum-99 (Mo-99) is revised to identify footnote h instead of footnote i. Footnote c in the entry for Ir192 is moved, so that it is clear that it applies only to iridium in special form. Footnote c is revised to specifically state that the activity of iridium in special form may be determined through measurement at a prescribed distance from the source. Table A–1 is revised to include values for Kr-79. The A1 and A2 values for Kr-79 correspond to the A1 and A2 values in TS–R–1 and the specific activity is 4.2 × 104 TBq/g (1.1 × 106 Ci/g). The entry for Kr-81 is revised to reflect that it is no longer the first entry for the isotopes of krypton. In addition, footnote a is revised to identify the A1 and/or A2 values that include contributions from daughter radionuclides with half-lives of less than 10 days. Table A–2 is revised to include values for Kr-79, reflect changes in TS–R–1 for the activity limit for exempt consignment for Te-121m and in the list of parent radionuclides and their progeny included in secular equilibrium in Table A–2 in footnote b. The value for the activity concentration for exempt material for Kr-79 is 1.0 × 03 Bq/g (2.7 × 10¥8 Ci/g) and the value for the activity limit for exempt consignment is 1.0 × 105 Bq (2.7 × 10¥6 Ci). The activity limit for exempt consignment for Te121m is revised from 1 × 105 Bq (2.7 × 10¥6 Ci) to 1 × 106 Bq (2.7 × 10¥5 Ci). In footnote b, the chains for the parent radionuclides Ce-134, Rn-220, Th-226, and U-240 are removed, and a chain for PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 34003 Ag-108m is added. This makes footnote b to Table A–2 consistent with footnote b to Table 2 in TS–R–1. Table A–3 is revised to reflect changes in TS–R–1. In the second entry, the descriptive phrase ‘‘only alpha emitting radionuclides are known to be present’’ is changed to ‘‘alpha emitting nuclides, but no neutron emitters, are known to be present’’ to reduce the confusion caused by the current phrase because all alpha emitting radionuclides also emit other particles and/or gamma rays. In the third entry, the descriptive phrase ‘‘no relevant data are available’’ is changed to ‘‘neutron emitting nuclides are known to be present or no relevant data are available’’ to clarify that neutron-emitting radionuclides, or alpha emitters that also emit neutrons, such as Cf-252, Cf-254, and Cm-248, should be assigned to the third group. Footnote a indicates the appropriate value of A1 for a group containing both alpha emitting radionuclides and beta or gamma emitting radionuclides when groups of radionuclides are based on the total alpha activity and the total beta and gamma activity. VI. Plain Writing The Plain Writing Act of 2010 (Pub. L. 111–274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. The NRC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act as well as the Presidential Memorandum, ‘‘Plain Language in Government Writing,’’ published June 10, 1998 (63 FR 31883). VII. Finding of No Significant Environmental Impact: Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission’s regulations in subpart A of 10 CFR part 51, not to prepare an environmental impact statement for this final rule. The Commission has concluded on the basis of an Environmental Assessment (ADAMS Accession No. ML15105A527) that this final rule is not a major Federal action significantly affecting the quality of the human environment. Many of the changes fall under a categorical exclusion for which the Commission has previously determined that such actions, neither individually nor cumulatively, will have significant impacts on the human environment. The categorical exclusions in 10 CFR 51.22(c)(2) and 10 CFR 51.22(c)(3) were used in the Environmental Assessment. E:\FR\FM\12JNR3.SGM 12JNR3 mstockstill on DSK4VPTVN1PROD with RULES3 34004 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations The categorical exclusion at 10 CFR 51.22(c)(2) applies to amendments to 10 CFR part 71 that are corrective or of a minor or non-policy nature and do not substantially modify the regulations. The categorical exclusion at 10 CFR 51.22(c)(3) applies to amendments to 10 CFR part 71 that relate to—(1) procedures for filing and reviewing applications for licenses or construction permits or early site permits or other forms of permission or for amendments to or renewals of licenses or construction permits or early site permits or other forms of permission; (2) recordkeeping requirements; (3) reporting requirements; (4) education, training, experience, qualification, or other employment suitability requirements; or (5) actions on petitions for rulemaking relating to these amendments. Those changes not qualifying for a categorical exclusion were evaluated for their environmental impacts and include changes to (1) definitions, (2) the exemption of low-level materials, (3) the fissile material exemption for lowenriched fissile material, (4) alternate tests that may be used for the qualification of special form material, (5) preliminary determinations; (6) the A1 and A2 values for radionuclides, and (7) the exempt material activity concentrations and exempt consignment activity limits for radionuclides. The effects of these changes are addressed in more detail in the Environmental Assessment. The changes to the fissile material exemption will further reduce the potential for criticality during the transport of low-enriched fissile material under the fissile material exemption. Other changes, such as those relating to the exemption of low-level material, the A1 and A2 values for radionuclides, and the exempt material activity concentrations and exempt consignment activity limits for radionuclides have been found to have small or very small impacts. Some natural material and ore may be shipped without being regulated as hazardous material. The low-level material exemption is changed to allow some additional material to be transported without being regulated as hazardous material. The amount of transported material affected by this change is a very small fraction of the material that already qualifies for the exemption and will allow no greater activity than is already allowed for material that may already be transported under the exemption. Although there are changes to A1 and A2 values used to determine the type of packaging, the exempt material activity concentrations, and the exempt consignment activity limits for VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 some radionuclides, the approach for determining the appropriate values has not changed, so there are very small impacts from these changes. VIII. Paperwork Reduction Act Statement This final rule contains new or amended information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget, approval number 3150–0008. The burden to the public for these information collections is estimated to be a reduction of 1,700 hours (an average reduction of 55 hours per response), including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments on any aspect of these information collections, including suggestions for reducing the burden, to the FOIA, Privacy, and Information Collections Branch (T–5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, or by email to INFOCOLLECTS.RESOURCE@ NRC.GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB–10202, (3150–0008), Office of Management and Budget, Washington, DC 20503 or by email to oira_submission@omb.eop.gov. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. IX. Congressional Review Act This action is a rule as defined in the Congressional Review Act (5 U.S.C. 801–808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act. X. Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule affects NRC licensees who transport or deliver to a carrier for transport, relatively large quantities of radioactive material in a single package; holders of a 10 CFR part 71, subpart H, quality assurance program description PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 issued under 10 CFR parts 50, 71, or 72; and holders of a CoC for a transportation package. These entities do not typically fall within the scope of the definition of ‘‘small entities’’ set forth in the Regulatory Flexibility Act or the size standards adopted by the NRC in 10 CFR 2.810. XI. Regulatory Analysis The NRC has prepared a regulatory analysis (ADAMS Accession No. ML14237A383) of this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available for inspection in the NRC Public Document Room, 11555 Rockville Pike, Rockville, MD 20852; or at https:// www.regulations.gov under Docket ID NRC–2008–0198. XII. Backfitting and Issue Finality The NRC has determined that the backfit rule (§§ 50.109, 70.76, 72.62, or 76.76) and the issue finality provisions in 10 CFR part 52 do not apply to this final rule, because this final rule does not establish any provisions that will impose backfits as defined in 10 CFR Chapter I. Therefore, a backfit analysis is not required for this final rule, and the NRC did not prepare a backfit analysis for this final rule. XIII. Criminal Penalties For the purpose of Section 223 of the Atomic Energy Act of 1954, as amended (AEA), the Commission is amending 10 CFR part 71 under one or more of Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule will be subject to criminal enforcement. XIV. Compatibility of Agreement State Regulations Under the ‘‘Policy Statement on Adequacy and Compatibility of Agreement State Programs’’ approved by the Commission on June 30, 1997, and published in the Federal Register (62 FR 46517; September 3, 1997), this rule is a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among the Agreement States’ and the NRC’s requirements. The NRC analyzed the rule in accordance with the procedure established within part III, ‘‘Categorization Process for NRC Program Elements,’’ of Handbook 5.9 to Management Directive 5.9, ‘‘Adequacy and Compatibility of Agreement State Programs’’ (ADAMS Accession No. ML041770094). The compatibility categories assigned to the affected sections of 10 CFR part 71 are presented E:\FR\FM\12JNR3.SGM 12JNR3 34005 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations in the Compatibility Table in this section. There are four compatibility categories (A, B, C, and D). In addition, the NRC program elements can also be identified as having particular health and safety significance or as being reserved solely to the NRC. Compatibility Category A is assigned to those program elements that are basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts. An Agreement State should adopt Compatibility Category A program elements in an essentially identical manner to provide uniformity in the regulation of agreement material on a nationwide basis. Compatibility Category B is assigned to those program elements that apply to activities that have direct and significant effects in multiple jurisdictions. An Agreement State should adopt Compatibility Category B program elements in an essentially identical manner. Compatibility Category C is assigned to those program elements that do not meet the criteria of Compatibility Category A or B, but the essential objectives of which an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. An Agreement State should adopt the essential objectives of the Compatibility Category C program elements. Compatibility Category D is assigned to those program elements that do not meet any of the criteria of Compatibility Category A, B, or C and, therefore, do not need to be adopted by Agreement States for purposes of compatibility. Health and Safety (H&S) are program elements that are not required for compatibility but are identified as having a particular health and safety role (i.e., adequacy) in the regulation of agreement material within the State. Although not required for compatibility, the State should adopt program elements in this H&S category based on those of the NRC that embody the essential objectives of the NRC program elements because of particular health and safety considerations. Compatibility Category NRC is assigned to those program elements that address areas of regulation that cannot be relinquished to Agreement States under the AEA or the provisions of 10 CFR. These program elements are not adopted by the Agreement States. The following table lists the parts and sections that are revised and their corresponding categorization under the ‘‘Policy Statement on Adequacy and Compatibility of Agreement State Programs.’’ A bracket around a category means that the section may have been adopted elsewhere, and it is not necessary to adopt it again. The presence or absence of a bracket does not affect the compatibility category or the degree of uniformity required when an Agreement State adopts the requirement. The Agreement States have 3 years from the effective date of the final rule to adopt compatible regulations. COMPATIBILITY TABLE Compatibility Section Change Subject New 1 Existing Revised ......................... New ............................... Revised ......................... 71.4 .................................................... Revised ......................... 71.4 .................................................... Revised ......................... 71.4 .................................................... Revised ......................... 71.6 .................................................... Revised ......................... 71.14(a)(1) ......................................... Revised ......................... 71.14(a)(2) ......................................... Revised ......................... 71.14(a)(3) ......................................... New ............................... 71.15(d) ............................................. Revised ......................... 71.17 .................................................. 71.17(c) .............................................. mstockstill on DSK4VPTVN1PROD with RULES3 71.0(d)(1) ........................................... 71.4 .................................................... 71.4 .................................................... Removal of brackets on Compatibility Category. Revised ......................... 71.19 .................................................. Revised ......................... 71.21 .................................................. Removal of brackets on Compatibility Category. Revised ......................... 71.21(a) ............................................. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00019 Purpose and Scope ...... Definition Contamination Definition Criticality Safety Index (CSI). Definition Low Specific Activity (LSA) material. Definition Special form radioactive material. Definition Uranium—natural, depleted, enriched. Information Collection Requirements: OMB Approval. Exemption for low-level materials. Exemption for low-level materials. Exemption for low-level materials. Exemption from classification as fissile material. General license: NRCapproved package. D ................................... ....................................... [B] .................................. D. [B]. [B]. [B] .................................. [B]. [B] .................................. [B]. [B] .................................. [B]. D ................................... D. [B] .................................. [B]. [B] .................................. [B]. ....................................... [B]. [B] .................................. [B]. [B] .................................. B. General license: NRCapproved package. Previously approved package. General license: Use of foreign approved package. General license: Use of foreign approved package. [B] .................................. B. NRC .............................. NRC. [B] .................................. B. [B] .................................. B. Fmt 4701 Sfmt 4700 E:\FR\FM\12JNR3.SGM 12JNR3 34006 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations COMPATIBILITY TABLE—Continued Compatibility Section Change Subject New 1 Existing 71.21(d) ............................................. Revised ......................... 71.31(b) ............................................. 71.38 .................................................. Revised ......................... Retitled and revised ...... 71.70 .................................................. New ............................... 71.75 .................................................. Revised ......................... 71.85(a) ............................................. Revised ......................... 71.85(b) ............................................. Revised ......................... 71.85(c) .............................................. Revised ......................... 71.85(d) ............................................. New ............................... 71.91(a) ............................................. 71.91(b) ............................................. Revised ......................... Revised Compatibility Category. Revised Compatibility Category. Revised Compatibility Category. Revised ......................... 71.91(c) .............................................. 71.91(d) ............................................. mstockstill on DSK4VPTVN1PROD with RULES3 71.101(a) ........................................... VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00020 General license: Use of foreign approved package. Contents of application Renewal of a certificate of compliance. Incorporations by reference. Qualification of special form radioactive material. Preliminary determinations. Preliminary determinations. Preliminary determinations. Preliminary determinations. Records ......................... Records ......................... [B] .................................. B. NRC .............................. NRC .............................. NRC. NRC. ....................................... NRC NRC .............................. NRC. [B] .................................. NRC. [B] .................................. NRC. [B] .................................. NRC. — .................................. B. D ................................... D ................................... C. NRC. Records ......................... D ................................... C. Records ......................... D ................................... C. Quality assurance requirements. D—For those States which have no users of Type B packages— other than industrial radiography**. C—Those States which have users of Type B packages—other than industrial radiography**. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). C. **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). Fmt 4701 Sfmt 4700 E:\FR\FM\12JNR3.SGM 12JNR3 34007 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations COMPATIBILITY TABLE—Continued Compatibility Section Change Subject Existing Revised Compatibility Category. Quality assurance requirements. 71.101(c)(1) ....................................... Revised Compatibility Category. Quality assurance requirements. 71.101(c)(2) ....................................... Revised ......................... 71.101(g) ........................................... mstockstill on DSK4VPTVN1PROD with RULES3 71.101(b) ........................................... Revised Compatibility Category Note. Quality assurance requirements. Quality assurance requirements. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 New 1 D—For those States which have no users of Type B packages— other than industrial radiography**. C—Those States which have users of Type B packages—other than industrial radiography**. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). D—For those States which have no users of Type B packages— other than industrial radiography**. C—Those States which have users of Type B packages—other than industrial radiography**. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). NRC .............................. C. **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). NRC. C. .................................. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). C. **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). E:\FR\FM\12JNR3.SGM 12JNR3 C. **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). 34008 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations COMPATIBILITY TABLE—Continued Compatibility Section Change Subject Existing Revised ......................... Quality assurance organization. 71.103(b) ........................................... Revised Compatibility Category Note. Quality assurance organization. 71.106 ................................................ New ............................... 71.135 ................................................ mstockstill on DSK4VPTVN1PROD with RULES3 71.103(a) ........................................... Revised ......................... Changes to quality assurance program. Quality assurance records. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 New 1 D—For those States which have no users of Type B packagesother than industrial radiography**. [C]—Those States which have users of Type B packagesother than industrial radiography**. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). C—Those States which have users of Type B packages-other than industrial radiography**. **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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137).. — .................................. C. **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). D—For those States which have no users of Type B packages— other than industrial radiography**. C—For those States which have users of Type B packages— other than industrial radiography**. **Note: 10 CFR 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 § 71.12(b) and therefore will satisfy those sections referenced in this provision (§§ 71.101 through 71.137). E:\FR\FM\12JNR3.SGM 12JNR3 C **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). C C. **Note: 10 CFR 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). 34009 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations COMPATIBILITY TABLE—Continued Compatibility Section Change Subject New 1 Existing Appendix A ........................................ Appendix A, Table A–1 ..................... Appendix A, Table A–2 ..................... Appendix A, Table A–3 ..................... Revise paragraphs IV.a.–IV.f.; redesignate paragraphs IV.c.–IV.f. as paragraphs IV.d.–IV.g.; add paragraph IV.c.; redesignate the text of paragraph V. as paragraph V.a.; and add paragraph V.b. Revise entries for Cf252, Ir-192, Kr-81, and Mo-99; revise footnote a; delete footnote h; and redesignate footnote i as footnote h.. Add entry for Kr-79 ....... Add entry for Kr-79; revise entries for Kr-81 and Te-121m; and revise footnote b. Revise entries for column 1, ‘‘Contents,’’ and add footnote a. Determination of A1 and A2. [B] .................................. [B] A1 and A2 Values for Radionuclides. [B] .................................. [B]. Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides. General Values for A1 and A2. [B] .................................. [B]. [B] .................................. [B]. mstockstill on DSK4VPTVN1PROD with RULES3 1 Where there is a change in the assigned compatibility category, a compatibility category is assigned. Where the content of the section has been significantly changed, a summary of the analysis is presented below. Changes in the assigned compatibility category have been made in §§ 71.4 (added for the definition of contamination), 71.70, 71.85, 71.91, 71.101, 71.103, 71.106, and 71.135. In § 71.4, the definition of contamination will be designated Compatibility Category B, because it applies to activities that have direct and significant effects in multiple jurisdictions and it is also defined in the corresponding DOT regulations. In §§ 71.17, 71.21, and 71.103 the compatibility category is unchanged, but the brackets were not retained because there are no corresponding DOT regulations. The new § 71.70, ‘‘Incorporations by reference,’’ will be designated Compatibility Category NRC, because the documents incorporated by reference are incorporated for use in § 71.75, which addresses activities under Federal jurisdiction. Section 71.85, ‘‘Preliminary determinations,’’ will be changed to make the requirements in § 71.85(a) through (c) apply to holders of a CoC. Paragraphs 71.85(a) through (c) are designated as Compatibility Category NRC, because they apply exclusively to certificate holders and the granting of the package approval is reserved to the NRC. Paragraph 71.85(d) will be added and applies to licensees and it is designated as Compatibility Category B, because it applies to activities that have direct and significant effects in multiple jurisdictions and there is no corresponding DOT requirement. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 The compatibility category for § 71.91, ‘‘Records,’’ will be changed from Compatibility Category D to Compatibility Category C. In reaching an agreement with the NRC, the States have a general provision relating to records and for incident reporting. The recordkeeping requirements in § 71.91 include requirements associated with transportation, which may involve multiple jurisdictions. With the exception of § 71.91(b), the NRC is designating the compatibility of the requirements in § 71.91 as Compatibility Category C to require that the essential objectives of the requirements be adopted to avoid conflict, duplication, gaps, or other conditions that would jeopardize the orderly pattern in the regulation of agreement material on a nationwide basis, including creating an undue burden on interstate commerce through additional recordkeeping requirements; § 71.91(b) only applies to CoC holders and applicants and are designated as compatibility category NRC. The States are not required to adopt them in an essentially identical manner, as might be necessary if the requirements had a more direct and significant impact on multiple jurisdictions. In § 71.101, the compatibility category will be simplified with the removal of PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 the separate compatibility category for States that do not have a user of a Type B package. If a State does not have a user of a Type B package, the State is able to seek an exemption from the requirement to make their requirement compatible. The State requirements only need to be essentially compatible with respect to the requirements as they apply to licensees, because the application of the requirements to CoC holders and applicants would be performed by the NRC. The note that references the quality assurance programs for industrial radiographers is updated by changing § 71.12(b) to § 71.17(b). In § 71.103, the compatibility category for some users of packages was not designated. The compatibility category will be simplified by removing the separate compatibility category for States that do not have a user of a Type B package and by removing the bracket around the compatibility category for § 71.103(a). If a State does not have a user of a Type B package, the State can seek an exemption from the requirement to make their requirement compatible. The State requirements only need to be essentially compatible with respect to the requirements as they apply to licensees, because the application of the requirements to CoC holders and E:\FR\FM\12JNR3.SGM 12JNR3 34010 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 applicants will be performed by the NRC. The note that references the quality assurance programs for industrial radiographers will be updated by changing § 71.12(b) to § 71.17(b). The new § 71.106, ‘‘Changes to quality assurance program,’’ will apply to licensees and holders of, or applicants for, a CoC. The assigned compatibility category is consistent with the other quality assurance requirements that apply to licensees. The State requirements only need to be essentially compatible with respect to the requirements as they apply to licensees, because the application of the requirements to CoC holders and applicants will be performed by the NRC. In § 71.135, the compatibility category will be simplified by removing the separate compatibility category for States that do not have a user of a Type B package. If a State does not have a user of a Type B package, the State can seek an exemption from the requirement to make their requirement compatible. The State requirements only need to be essentially compatible with respect to the requirements as they apply to licensees, because the application of the requirements to CoC holders and applicants will be performed by the NRC. The note that references the quality assurance programs for industrial radiographers is updated by changing § 71.12(b) to § 71.17(b). XV. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104–113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC uses the consensus standards identified as follows and will incorporate them by reference. The NRC is adopting ISO 2919:1999(E), ‘‘Radiation protection— Sealed radioactive sources—General requirements and classification,’’ Second Edition (February 15, 1999), for the Class 4 and Class 5 impact tests and the Class 6 temperature test; and ISO 9978:1992(E), ‘‘Radiation protection— Sealed radioactive sources—Leakage test methods,’’ First Edition (February 15, 1992), for the leaktightness tests. In other portions of this final rule, the NRC is revising requirements that do not constitute the establishment of a standard that establishes generally applicable requirements. These revisions to the NRC’s requirements include changes to: (1) The scope of material falling under an existing VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 exemption for natural materials and ores containing naturally occurring radionuclides at an activity concentration below a specified value, (2) conditions on general licenses, (3) the oversight of quality assurance programs, and (4) the removal of transitional arrangements for previously approved packages. XVI. Availability of Guidance In the Rules and Regulations section of this issue of the Federal Register, the NRC is issuing revised implementation guidance for this rule, RG 7.10, Revision 3, ‘‘Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material’’ (Docket ID NRC–2013–0082). The guidance is also available in ADAMS under Accession No. ML14064A505. Revised RG 7.10 is intended to describe a proposed method that the NRC staff considers acceptable for use in complying with the NRC’s proposed amendments to its regulations on quality assurance programs related to transport of radioactive materials. Because the regulatory analysis for the final rule provides sufficient explanation for the rule and its implementing guidance, a separate regulatory analysis was not prepared for RG 7.10. XVII. Incorporation by Reference Under 1 CFR Part 51—Reasonable Availability to Interested Parties The NRC is required by law to obtain approval for incorporation by reference from the Office of the Federal Register (OFR). The OFR’s requirements for incorporation by reference are set forth in 1 CFR part 51. On November 7, 2014, the OFR adopted changes to its regulations governing incorporation by reference (79 FR 66267). The OFR regulations require an agency to discuss, in the preamble of the final rule, the ways that the materials it incorporates by reference are reasonably available to interested parties and how interested parties can obtain the materials. The discussion in this section complies with the requirement for proposed rules as set forth in 1 CFR 51.5(b)(2). The NRC considers ‘‘interested parties’’ to include all potential NRC stakeholders, not just the individuals and entities regulated or otherwise subject to the NRC’s regulatory oversight. These NRC stakeholders are not a homogenous group but vary with respect to the considerations for determining reasonable availability. Therefore, the NRC distinguishes between different classes of interested parties for purposes of determining whether the material is ‘‘reasonably PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 available.’’ The NRC considers the following to be classes of interested parties in NRC rulemakings generally: • Individuals and small entities regulated or otherwise subject to the NRC’s regulatory oversight (this class also includes applicants and potential applicants for licenses and other NRC regulatory approvals). • Large entities otherwise subject to the NRC’s regulatory oversight (this class also includes applicants and potential applicants for licenses and other NRC regulatory approvals). In this context, ‘‘large entities’’ are those which do not qualify as a ‘‘small entity’’ under 10 CFR 2.810. • Non-governmental organizations with institutional interests in the matters regulated by the NRC. • Other Federal agencies, states, local governmental bodies (within the meaning of 10 CFR 2.315(c)). • Federally-recognized and Staterecognized Indian tribes. • Members of the general public (i.e., individual, unaffiliated members of the public who are not regulated or otherwise subject to the NRC’s regulatory oversight). International Organization for Standardization’s (ISO) 9978:1992(E), ‘‘Radiation protection—Sealed radioactive sources—Leakage test methods,’’ First Edition (February 15, 1992), is incorporated by reference for § 71.75(a). Interested parties, including the general public, can purchase the February 1992 version of ISO 9978 from the American National Standards Institute, 25 West 43rd Street, 4th floor, New York, NY 10036, 212–642–4900, https://www.ansi.org, or info@ansi.org. The cost is $88. ISO 2919:1999(E), ‘‘Radiation protection—Sealed radioactive sources—General requirements and classification,’’ Second Edition (February 15, 1999), is incorporated by reference for § 71.75(d). Interested parties, including the general public, can purchase the 1992 edition of ISO 2919 on https://www.amazon.com for approximately $125.00. The two ISO standards incorporated by reference into 10 CFR 71.75 may be examined at the NRC’s Public Document Room, O1–F21, 11555 Rockville Pike, Rockville, Maryland 20852 or at the NRC Library located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301–415– 5610; email: Library.Resource@nrc.gov. The two ISO standards are also 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– E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations 6030 or go to https://www.archives.gov/ federal-register/cfr/ibr-locations.html. The NRC believes that the two ISO standards are reasonably available to large entities subject to the NRC’s regulatory oversight pursuant to 10 CFR 71.75, non-governmental organizations with institutional interests in the matters regulated by the NRC, other Federal agencies, states, local governmental bodies (within the meaning of 10 CFR 2.315(c)), and Federally-recognized and Staterecognized Indian tribes. With respect to individuals and small entities regulated or otherwise subject to the NRC’s regulatory oversight pursuant to 10 CFR 71.75, the NRC believes that the approximately $213 cost of obtaining the two ISO standards is reasonable for such individuals and small entities, and therefore that the two standards are reasonably available to these individuals and small entities. With respect to the general public, the NRC has identified above the ways in which the two ISO standards may be obtained. Because individuals and small entities are not required to comply with these two ISO standards, the NRC believes that the two standards are reasonably available to general public in accordance with the ways described above for obtaining access. List of Subjects in 10 CFR Part 71 Criminal penalties, Hazardous materials transportation, Incorporation by reference, Nuclear materials, Packaging and containers, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 71. PART 71—PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL 1. The authority citation for part 71 continues to read as follows: mstockstill on DSK4VPTVN1PROD with RULES3 ■ Authority: Atomic Energy Act secs. 53, 57, 62, 63, 81, 161, 182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act sec. 180 (42 U.S.C. 10175); Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109–58, 119 Stat. 594 (2005). Section 71.97 also issued under sec. 301, Pub. L. 96–295, 94 Stat. 789–790. VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 § 71.0 [Amended] 2. In § 71.0, paragraph (d)(1), remove the reference ‘‘§§ 71.20 through 71.23’’ and add, in its place, the reference ‘‘§§ 71.21 through 71.23’’. ■ 3. In § 71.4, add in alphabetical order the definition of ‘‘contamination,’’ and revise the definitions of ‘‘Criticality Safety Index (CSI),’’ ‘‘Low Specific Activity (LSA) material,’’ ‘‘Special form radioactive material,’’ and ‘‘Uranium— natural, depleted, enriched’’ to read as follows: ■ § 71.4 Definitions. * * * * * Contamination means the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2 (1 × 10¥5 mCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1 × 10¥6 mCi/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 means contamination that can be removed from a surface during normal conditions of transport. * * * * * 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 container, consignment or conveyance. * * * * * 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 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 34011 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 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 10¥4 A2/g for solids and gases, and 10¥5 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, 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 × 10¥3 A2/g. * * * * * Special form radioactive material means radioactive material that 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 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 E:\FR\FM\12JNR3.SGM 12JNR3 34012 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations 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. * * * * * 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. ■ 4. In § 71.6, revise paragraph (b) to read as follows: § 71.6 Information collection requirements: OMB approval. * * * * * (b) The approved information 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. ■ 5. In § 71.14, revise paragraphs (a)(1) and (2), and add paragraph (a)(3) to read as follows: mstockstill on DSK4VPTVN1PROD with RULES3 § 71.14 Exemption for low-level materials. (a) * * * (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 VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 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. (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. * * * * * ■ 6. In § 71.15, revise paragraph (d) to read as follows: § 71.15 Exemption from classification as fissile material. * * * * * (d) Uranium enriched in uranium-235 to a maximum of 1 percent by weight, and with total plutonium and uranium233 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. * * * * * ■ 7. In § 71.17, revise paragraph (c) to read as follows: § 71.17 General license: NRC-approved package. * * * * * (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 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. * * * * * ■ 8. In § 71.19, redesignate paragraphs (b) through (e) as paragraphs (a) through (d), and revise newly redesignated paragraph (b)(2) to read as follows: PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 § 71.19 Previously approved package. * * * * * (b) * * * (2) A package used for a shipment to a location outside the United States is subject to multilateral approval as defined in the DOT’s regulations at 49 CFR 173.403. * * * * * ■ 9. In § 71.21, revise paragraphs (a) and (d) to read as follows: § 71.21 General license: Use of foreign approved package. (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 revalidated by the DOT as meeting the applicable requirements of 49 CFR 171.23. * * * * * (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. § 71.31 [Amended] 10. In § 71.31, paragraph (b), remove the reference ‘‘§ 71.13’’ and add, in its place, the reference ‘‘§ 71.19’’. ■ 11. Revise § 71.38 to read as follows: ■ § 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 submit a consolidated application that is E:\FR\FM\12JNR3.SGM 12JNR3 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations 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. 12. Add § 71.70 to subpart F to read as follows: ■ mstockstill on DSK4VPTVN1PROD with RULES3 § 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 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 at the NRC’s Public Document Room, O1–F21, 11555 Rockville Pike, Rockville, Maryland 20852 or at the NRC Library located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301–415–5610; email: Library.Resource@nrc.gov, and is 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 https://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: https://www.iso.org. (1) ISO 9978:1992(E), ‘‘Radiation protection—Sealed radioactive sources—Leakage 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, https://www.ansi.org, or info@ansi.org. (2) ISO 2919:1999(E), ‘‘Radiation protection—Sealed radioactive sources—General requirements and classification,’’ Second Edition (February 15, 1999), incorporation by reference approved for § 71.75(d), is available on https://www.amazon.com. ■ 13. In § 71.75, revise paragraphs (a)(5), (b)(2)(ii) and (iii), and (d)(1) and (2) to read as follows: VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 § 71.75 Qualification of special form radioactive 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 protection—Sealed radioactive sources—Leakage 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 in ISO 2919:1999(E), ‘‘Radiation protection— Sealed radioactive sources—General 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). ■ 14. In § 71.85, revise paragraphs (a), (b), and (c) and add paragraph (d) to read as follows: § 71.85 Preliminary determinations. * * * * * (a) The certificate holder shall ascertain that there are no cracks, pinholes, uncontrolled voids, or other defects that could significantly reduce the effectiveness of the packaging; (b) Where the maximum normal operating pressure will exceed 35 kPa (5 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 34013 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 (d) The licensee shall ascertain that the determinations in paragraphs (a) through (c) of this section have been made. § 71.91 [Amended] 15. In § 71.91, in paragraph (a) introductory text, remove the reference ‘‘§ 71.10’’ and add, in its place, the reference ‘‘§ 71.14’’. ■ 16. In § 71.101, revise paragraphs (a) and (c)(2) to read as follows: ■ § 71.101 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this subpart, ‘‘quality assurance’’ comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each 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. * * * * * (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 E:\FR\FM\12JNR3.SGM 12JNR3 34014 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES3 § 71.106 Changes to quality assurance program. (a) Each quality assurance program approval holder shall submit, in accordance with § 71.1(a), a description of a proposed change to its NRCapproved 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 commitments shall be submitted to the NRC every 24 months, in accordance with § 71.1(a). In addition to quality VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 § 71.135 Quality assurance records. The licensee, certificate holder, and applicant for a Certificate of Compliance shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by § 71.106, the instructions, procedures, and drawings required by § 71.111 to prescribe 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, PO 00000 Frm 00028 Fmt 4701 Sfmt 4725 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: 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: 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: E:\FR\FM\12JNR3.SGM 12JNR3 ER12JN15.096</GPH> Quality assurance organization. (a) The licensee, certificate holder, and applicant for a Certificate of Compliance shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a Certificate of Compliance may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions. * * * * * ■ 18. Add § 71.106 to subpart H to read as follows: 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. ■ 20. In appendix A to part 71: ■ a. Revise paragraphs IV.a. and IV.b., redesignate paragraphs IV.c. through IV.f. as 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.; ■ b. In Table A–1, add an entry for Kr79 in 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; ■ c. In Table A–2, add the entry for Kr79 in alphanumeric order, revise the entries for Kr-81 and Te-121m, and revise footnote b; and ■ d. In Table A–3, revise the second and third entries and add a new footnote a. The additions and revisions read as follows: ER12JN15.095</GPH> § 71.103 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 holder’s or applicant’s 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 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. ■ 19. Revise § 71.135 to read as follows: ER12JN15.094</GPH> 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. * * * * * ■ 17. In § 71.103, revise paragraph (a) to read as follows: 34015 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations 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: 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: 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. f. The exempt activity concentration for mixtures of nuclides may be determined as follows: 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: 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. * * * * * TABLE A–1—A1 AND A2 VALUES FOR RADIONUCLIDES Specific activity Element and atomic No. * Cf-252 .................... * ............................... * Ir-192 ..................... * ............................... * * Kr-79 ...................... Kr-81 ...................... * Krypton (36) .......... ............................... * * * ............................... ah ............... * * (TBq/g) * 1.0 × 10¥1 c 1.0 4.0 4.0 × 101 * 1.0 * 2.7 * 3.0 × 10¥3 8.1 × 10¥2 * × 101 * 6.0 × 10¥1 1.6 × 101 * 1.1 × 102 1.1 × 103 * 2.0 4.0 × 101 5.4 × 101 1.1 × 103 * 2.7 × 101 * 6.0 × 10¥1 1.6 × 101 c 2.7 * * * * * * * 2.0 × 101 3.4 × 102 4.2 × 104 7.8 × 10¥4 1.8 × 104 * and/or A2 values include contributions from daughter nuclides with half-lives less than 10 days, as listed in the following: VerDate Sep<11>2014 Al-28 Sc-47 Sc-44 Mn-52m Co-60m Zn-69 Ga-68 Kr-83m Rb-82 Y-90 Y-91m Y-92 Sr-87m 21:18 Jun 11, 2015 * * 5.4 × 102 9.2 × 103 * 1.1 × 106 2.1 × 10¥2 * * 4.8 × 105 ER12JN15.099</GPH> Mg-28 Ca-47 Ti-44 Fe-52 Fe-60 Zn-69m Ge-68 Rb-83 Sr-82 Sr-90 Sr-91 Sr-92 Y-87 (Ci/g) ER12JN15.098</GPH> mstockstill on DSK4VPTVN1PROD with RULES3 aA 1 A2 (Ci) b A2 (TBq) Jkt 235001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\12JNR3.SGM 12JNR3 ER12JN15.097</GPH> Mo-99 A1 (Ci) b A1 (TBq) ER12JN15.100</GPH> Symbol of radionuclide mstockstill on DSK4VPTVN1PROD with RULES3 34016 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations 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 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 A = 0.74 TBq (20 Ci) for Mo-99 for domestic use. 2 * * * * * * * VerDate Sep<11>2014 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 E:\FR\FM\12JNR3.SGM 12JNR3 34017 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations TABLE A–2—EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR RADIONUCLIDES Activity concentration for exempt material (Bq/g) Symbol of radionuclide Element and atomic No. * Kr-79 .......................... Kr-81 .......................... * * Krypton (36) ...................................... ........................................................... * * Te-121m .................... * * ........................................................... * * * b Parent * VerDate Sep<11>2014 Activity limit for exempt consignment (Bq) * 2.7 × 10¥8 2.7 × 10¥7 * 1.0 × 102 * 2.7 × 10¥9 * * * * * * * * 1.0 × 105 1.0 × 107 * 2.7 × 10¥6 2.7 × 10¥4 1.0 × 106 * 2.7 × 10¥5 Y-90 Nb-93m Nb-97 Rh-106 Ag-108 Ba-137m Pr-144 La-140 Tl-208 (0.36), Po-212 (0.64) Bi-210, Po-210 Bi-212, Tl-208 (0.36), Po-212 (0.64) Po-218, Pb-214, Bi-214, Po-214 Rn-219, Po-215, Pb-211, Bi-211, Tl-207 Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210 Ac-228 Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212(0.64) Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) Pa-234m Th-226, Ra-222, Rn-218, Po-214 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) Th-231 Th-234, Pa-234m 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 Pa-233 Am-242 Np-239 * * * * * 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4701 Activity limit for exempt consignment (Ci) 1.0 × 103 1.0 × 104 * * * nuclides and their progeny included in secular equilibrium are listed as follows: Sr-90 Zr-93 Zr-97 Ru-106 Ag-108m Cs-137 Ce-144 Ba-140 Bi-212 Pb-210 Pb-212 Rn-222 Ra-223 Ra-224 Ra-226 Ra-228 Th-228 Th-229 Th-nat Th-234 U-230 U-232 U-235 U-238 U-nat Np-237 Am-242m Am-243 * mstockstill on DSK4VPTVN1PROD with RULES3 * Activity concentration for exempt material (Ci/g) Sfmt 4700 E:\FR\FM\12JNR3.SGM 12JNR3 * 34018 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Rules and Regulations TABLE A–3—GENERAL VALUES FOR A1 AND A2 A2 A1 Contents (TBq) * Alpha emitting nuclides, but no neutron emitters, are known to be present (a) ..... Neutron emitting nuclides are known to be present or no relevant data are available .. a If (Ci) (TBq) * (Ci) * Activity concentration for exempt material (Bq/g) * Activity concentration for exempt material (Ci/g) * * * 5.4 × 100 9 × 10¥5 2.4 × 10¥3 1 × 10¥1 2.7 × 10¥12 1 × 103 2.7 × 10¥8 1 × 10¥3 2.7 × 10¥2 9 × 10¥5 2.4 × 10¥3 1 × 10¥1 2.7 × 10¥12 1 × 103 2.7 × 10¥8 beta or gamma emitting nuclides are known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used. * * * * * * For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. 2015–14212 Filed 6–11–15; 8:45 am] BILLING CODE 7590–01–P VerDate Sep<11>2014 Activity limits for exempt consignments (Ci) 2 × 10¥1 Dated at Rockville, Maryland, this 4th day of June, 2015. mstockstill on DSK4VPTVN1PROD with RULES3 Activity limits for exempt consignments (Ba) 21:18 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4701 Sfmt 9990 E:\FR\FM\12JNR3.SGM 12JNR3 *

Agencies

NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Rules and Regulations]
[Pages 33987-34018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14212]

[[Page 33987]]

Vol. 80

Friday,

No. 113

June 12, 2015

Part V

Nuclear Regulatory Commission

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10 CFR Part 71

Revisions to Transportation Safety Requirements and Harmonization With
International Atomic Energy Agency Transportation Requirements; Final
Rule

Federal Register / Vol. 80 , No. 113 / Friday, June 12, 2015 / Rules
and Regulations

[[Page 33988]]

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NUCLEAR REGULATORY COMMISSION

10 CFR Part 71

[NRC-2008-0198]
RIN 3150-AI11

Revisions to Transportation Safety Requirements and Harmonization
With International Atomic Energy Agency Transportation Requirements

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC), in consultation
with the U.S. Department of Transportation (DOT), is amending its
regulations for the packaging and transportation of radioactive
material. These amendments make conforming changes to the NRC's
regulations based on the International Atomic Energy Agency's (IAEA)
2009 standards for the international transportation of radioactive
material and maintain consistency with the DOT's regulations. In
addition, these amendments re-establish restrictions on materials that
qualify for the fissile material exemption, clarify requirements,
update administrative procedures, and make editorial changes.

DATES: Effective date: This rule is effective July 13, 2015.
Incorporation by reference: The incorporation by reference of certain
publications listed in the regulation is approved by the Director of
the Federal Register as of July 13, 2015.

ADDRESSES: Please refer to Docket ID NRC-2008-0198 when contacting the
NRC about the availability of information for this final rule. You may
obtain publicly-available information related to this final rule by any
of the following methods:
Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0198. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this final rule.
NRC Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC Public Document Room (PDR) reference staff at 1-
800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section.
NRC PDR: You may examine and purchase copies of public
documents at the NRC PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
3781; email: Solomon.Sahle@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background
II. Discussion
III. Opportunities for Public Participation
IV. Public Comment Analysis
V. Section-by-Section Analysis
VI. Plain Writing
VII. Finding of No Significant Environmental Impact: Availability
VIII. Paperwork Reduction Act Statement
IX. Congressional Review Act
X. Regulatory Flexibility Certification
XI. Regulatory Analysis
XII. Backfitting and Issue Finality
XIII. Criminal Penalties
XIV. Compatibility of Agreement State Regulations
XV. Voluntary Consensus Standards
XVI. Availability of Guidance
XVII. Incorporation by Reference Under 1 CFR Part 51--Reasonable
Availability to Interested Parties

I. Background

The NRC regulates the transportation of radioactive material under
part 71 of Title 10 of the Code of Federal Regulations (10 CFR).
Periodically, the IAEA revises its regulations related to
transportation of radioactive material. The NRC evaluated changes in
the 2009 edition of the IAEA's ``Regulations for the Safe Transport of
Radioactive Material'' (TS-R-1) and identified a number of areas in 10
CFR part 71 that needed to be revised to maintain compatibility with
the IAEA's regulations. Accordingly, the NRC developed a proposed rule
to amend 10 CFR part 71, and published it for comment in the Federal
Register on May 16, 2013 (78 FR 28988).
The NRC is now publishing its final rule. Together with a related
DOT final rule amending Title 49 of the Code of Federal Regulations (49
CFR) [79 FR 40590, July 11, 2014], these actions bring United States
regulations into general accord with TS-R-1, and maintain consistency
between NRC and DOT regulations. The NRC's final rule also revises 10
CFR part 71 to: (1) Update administrative procedures for the quality
assurance program requirements described in subpart H of 10 CFR part
71; (2) re-establish restrictions on material that qualifies for the
fissile material exemption; (3) clarify the requirements for a general
license; 4) clarify the responsibilities of certificate holders and
licensees when making preliminary safety determinations on packaging to
be used for transporting radioactive material; and 5) make editorial
changes.

Compatibility With IAEA and Consistency With DOT Transportation
Regulations

The IAEA was formed by member nations to promote safe, secure, and
peaceful nuclear technologies. It establishes safety standards to
protect public health and safety and to minimize the danger to life and
property, and has developed safety standards for the safe transport of
radioactive material in TS-R-1. Copies of TS-R-1 may be obtained from
the United States distributors, Bernan, 15200 NBN Way, P.O. Box 191,
Blue Ridge Summit, PA 17214; telephone: 1-800-865-3457; email:
customercare@bernan.com, or Renouf Publishing Company Ltd., 812 Proctor
Ave., Ogdensburg, NY 13669-2205; telephone: 1-888-551-7470; email:
orders@renoufbooks.com. An electronic copy of TS-R-1 may be found at
the following IAEA Web site: https://www-pub.iaea.org/MTCD/publications/PDF/Pub1384_web.pdf.
These IAEA safety standards and regulations were developed in
consultation with IAEA Member States, and reflect an international
consensus on what is needed to provide for a high level of safety. By
providing a global framework for the consistent regulation of the
transport of radioactive material, TS-R-1 facilitates international
commerce and contributes to the safe conduct of international trade
involving radioactive material. By periodically revising its
regulations to be compatible with IAEA and DOT regulations, the NRC is
able to remove inconsistencies that could impede international commerce
and reflect knowledge gained in scientific and technical advances and
accumulated expericence.
This rulemaking harmonizes the NRC's regulations with the IAEA's
transportation regulations in TS-R-1 and aligns with the DOT
regulations. The regulations in TS-R-1 represent an accepted set of
requirements that provide a high level of safety in the

[[Page 33989]]

packaging and transportation of radioactive materials and provides for
a basis and framework that facilitates the development of
internationally-consistent regulations. Internationally consistent
regulations for the transportation and packaging of radioactive
material reduce impediments to trade; facilitate international
cooperation; and, when the regulations provide a high level of safety,
can reduce risks associated with the import and export of radioactive
material.
In November 2012, the IAEA issued revised standards for the safe
transport of radioactive material and designated them as ``Specific
Safety Requirements Number SSR-6'' (SSR-6). The present NRC rulemaking
does not incorporate the SSR-6 requirements, because doing so would
require significant changes to the NRC rule, and it would need to be
re-published for further comment. The NRC will consider any necessary
changes related to SSR-6 in a future rulemaking after consulting with
the DOT, rather than further delay finalizing this rulemaking.
Historically, the NRC has coordinated its revisions to 10 CFR part
71 with the DOT, because the DOT and the NRC co-regulate transport of
radioactive materials in the United States. The roles of the DOT and
the NRC in the co-regulation of the transportation of radioactive
materials are documented in a memorandum of understanding (MOU) (44 FR
38690; July 2, 1979). Consistent with this MOU, the NRC has coordinated
its efforts with the DOT during this rulemaking, and representatives
from the NRC and DOT have advised and consulted with one another. This
final rule has been coordinated with DOT to ensure that consistent
regulatory standards are maintained between NRC and DOT radioactive
material transportation regulations, and to ensure coordinated
publication of the final rules by both agencies. On July 11, 2014, the
DOT published its final rule titled, ``Hazardous Materials:
Compatibility with the Regulations of the International Atomic Energy
Agency'' in the Federal Register (79 FR 40590) with an effective date
of October 1, 2014, and a mandatory compliance date of July 13, 2015.

Fissile Material Exemption

The NRC is re-establishing restrictions on material that will
qualify for the 10 CFR 71.15 fissile material exemption. In 10 CFR
71.15 (``Exemption from classification as fissile material''), the
exemption in paragraph (d) is being revised. The 10 CFR 71.15
exemptions were formerly set forth in 10 CFR 71.53. In 1997, the NRC
issued an emergency final rule (62 FR 5907; February 10, 1997) that
revised the 10 CFR 71.53 regulations on fissile material exemptions and
general license provisions that apply to fissile material.
Based on the public comments on the 1997 emergency final rule, the
NRC contracted with the Oak Ridge National Laboratory (ORNL) to review
the fissile material exemptions and general license provisions, study
the regulatory and technical bases associated with these regulations,
and perform criticality model calculations for different mixtures of
fissile materials and moderators. The results of the ORNL study were
documented in NUREG/CR-5342,\1\ and the NRC published a notice of the
availability of this document in the Federal Register (63 FR 44477;
August 19, 1998). The ORNL study confirmed that the emergency final
rule was needed to provide safe transportation of packages with special
moderators that are shipped under the general license and fissile
material exemptions, but concluded that the revised regulations may
have been excessive for shipments where water moderation is the only
concern. The ORNL study also recommended that the NRC revise 10 CFR
part 71 as it applied to the requirement specific to uranium enriched
in uranium-235 (U-235) to a maximum of 1 percent by weight, and with a
total plutonium and uranium-233 (U-233) content of up to 1 percent of
the mass of U-235. Specifically, as discussed in NUREG/CR-5342, ORNL
recommended that (1) a definition of ``homogeneity'' be developed that
could be clearly understood for use with uranium enriched to a maximum
of 1 percent and (2) the term ``lattice arrangement'' be clarified or
not used. Alternatively, ORNL suggested that the moderator criteria
restricting the mass of beryllium, carbon, or heavy water (deuterium
oxide) to less than 0.1 percent of the fissile mass should be
maintained, which would remove the need to provide definitions such as
``homogeneous'' and ``lattice arrangement'' that are difficult to
define and to apply practically.
---------------------------------------------------------------------------

\1\ NUREG/CR-5342, ``Assessment and Recommendations for Fissile-
Material Packaging Exemptions and General Licenses within 10 CFR
part 71,'' July 1998, ADAMS Accession No. ML12139A419.
---------------------------------------------------------------------------

The NRC chose to implement this ORNL suggestion, as reflected in a
2002 rulemaking regarding 10 CFR part 71 (67 FR 21390; April 30, 2002).
Similar to the present rulemaking, the NRC in 2002 proposed to make the
NRC's regulations more consistent and compatible with IAEA's standards.
Additionally, the NRC proposed to make changes to the fissile material
exemption requirements to address the unintended economic impact of the
1997 final rule. In a final rule dated January 26, 2004 (69 FR 3698),
the NRC removed the restriction (then stated in 10 CFR 71.53(b)) that,
to qualify for the fissile material exemption, uranium enriched in U-
235 must be distributed homogeneously throughout the package and may
not form a lattice arrangement within the package. In addition, the
2004 final rule re-designated the section for fissile material
exemptions from Sec. 71.53 to Sec. 71.15.
Although the NRC determined in 2004 that the limits on restricted
moderators were sufficient to assure subcriticality for all moderators
of concern, the NRC now believes that additional restrictions are
needed to have a sufficient margin of criticality safety for shipments
of material under the low-enriched fissile material exemption.
Therefore, the NRC is revising 10 CFR 71.15(d) in this final rule by
reinstating the requirement removed in 2004 that, for uranium enriched
to a maximum of 1 percent to be exempted, the fissile material must be
distributed homogeneously throughout the package contents and not form
a lattice arrangement. Further technical details regarding the basis
for now revising 10 CFR 71.15(d) are discussed in Section II.M of this
document.

Quality Assurance Program Approvals

The regulations of 10 CFR part 71 require that licensees and
certificate holders have quality assurance programs approved by the
Commission as satisfying the applicable provisions of subpart H of 10
CFR part 71. Unlike 10 CFR part 50, there are no specific requirements
in 10 CFR part 71 addressing changes to an NRC-approved quality
assurance program. Once a 10 CFR part 71 quality assurance program is
approved, no changes to the program may be made without further NRC
approval, because a change would alter the program and make it an
unapproved program. Consequently, the process has been overly
burdensome and inefficient for both the licensee and the NRC. For
example, under the existing 10 CFR part 71 requirements, a change in
the quality assurance program to correct typographical errors or
punctuation must be submitted to and approved by the NRC.
In 2004, the NRC changed the renewal period for quality assurance
program approvals issued under 10 CFR part 71 from 5 years to 10 years
in order to

[[Page 33990]]

reduce the unnecessary regulatory burden of some administrative
actions. This change was announced in ``NRC Regulatory Information
Summary (RIS) 2004-18, Expiration Date for 10 CFR part 71 Quality
Assurance Program Approvals,'' dated December 1, 2004 (ADAMS Accession
No. ML042160293).
Under the new 10 CFR 71.106, the NRC will allow some changes to be
made to quality assurance programs previously approved under 10 CFR
part 71 without obtaining additional NRC approval. The process for
making changes to approved quality assurance program descriptions will
now be similar to the process that the NRC has used to approve changes
that are made to the quality assurance program descriptions for nuclear
power plants licensed under 10 CFR part 50 through the provisions at
Sec. 50.54(a), and will result in a more consistent approach for
allowing changes to approved quality assurance programs.
The NRC also will re-issue NRC Form 311 without an expiration date.
The 24-month period for reporting changes will begin on the date of the
NRC approval of a quality assurance program issued with no expiration
date, as specified by the date of signature at the bottom of NRC Form
311. The changes being made to the quality assurance program approval
process are discussed further in Sections II .H, II.I, and II.J of this
document.

II. Discussion

A. What action is the NRC taking?

The NRC is amending its regulations to make them more consistent
and compatible with the IAEA's international transportation regulations
TS-R-1. These revisions are also consistent with the DOT's hazardous
materials regulations, and maintain a consistent framework for
regulating the transportation and packaging of radioactive material.
In addition, the NRC is revising 10 CFR part 71 to: (1) Update
administrative procedures for the quality assurance program
requirements described in subpart H of 10 CFR part 71; (2) re-establish
criticality safety restrictions on certain material that qualifies for
the fissile material exemption; (3) clarify the requirements for a
general license; (4) clarify the responsibilities of certificate
holders and licensees when making preliminary determinations; and (5)
make editorial changes.

B. Who is affected by this action?

This action affects: (1) NRC licensees authorized by a specific or
general NRC license to receive, possess, use, or transfer licensed
material, if the licensee delivers that material to a carrier for
transport, or transports the material outside of the site of usage as
specified in the NRC license, or transports that material on public
highways; (2) holders of, and applicants for a Certificate of
Compliance (CoC); and (3) holders of a 10 CFR part 71, subpart H
quality assurance program approval. This action would also affect
holders of quality assurance program approvals under appendix B of 10
CFR part 50 or subpart G of 10 CFR part 72 to the extent that those
approvals apply to transport packaging as specified in 10 CFR
71.101(f), ``Previously approved programs.'' This action also changes
requirements that are matters of compatibility with Agreement States.
Agreement States will need to update their regulations, as appropriate,
at which time those licensees in Agreement States will need to meet the
revised Agreement State regulations.

C. What changes are being made to increase the compatibility with the
IAEA's regulations, TS-R-1, and the consistency with the DOT's
regulations?

The NRC is revising its regulations in 10 CFR part 71 to be more
consistent or compatible with the international transportation
regulations. These changes also improve or maintain consistency between
10 CFR part 71 and the DOT's regulations to maintain a consistent
framework for the transportation and packaging of radioactive material.
To accomplish these goals, the NRC is revising 10 CFR part 71 as
follows:
1. The concept of processing ores for purposes other than
radioactive material content is added to the provisions that apply to
natural materials and ores in the exemptions for low-level materials in
Sec. 71.14.
2. The NRC is adopting the scoping statement paragraph 107(f) of
TS-R-1, which addresses non-radioactive solid objects with radioactive
substances present on any surface in quantities not in excess of
certain levels. In conjunction with this change, a definition of
``contamination'' corresponding to the definition in TS-R-1 is added to
Sec. 71.4.
3. The following definitions in 10 CFR 71.4 (``Definitions'') are
amended to reflect the current definitions in TS-R-1: ``Criticality
Safety Index (CSI)''; ``Low Specific Activity (LSA) material''; and
``Uranium--natural, depleted, enriched.'' When the NRC last revised
subsection (1)(i) of the definition for LSA material, the NRC added the
modifier ``not,'' which resulted in this component of the NRC
definition being inconsistent with the DOT and IAEA definitions. The
NRC is correcting this so that LSA material includes material intended
to be processed for its radionuclides.
4. The NRC is adopting the use of the Class 5 impact test
prescribed in the International Organization for Standardization's
(ISO) Document 2919, ``Radiation protection--Sealed radioactive
sources--General requirements and classification,'' Second Edition
(February 15, 1999), ISO 2919:1999(E),\2\ for special form radioactive
material, provided the mass is less than 500 grams.
---------------------------------------------------------------------------

\2\ https://pbadupws.nrc.gov/docs/ML0036/ML003686268.pdf.
---------------------------------------------------------------------------

5. The NRC is incorporating by reference (A) ISO Document 2919, and
(B) ISO Document 9978, ``Radiation protection--Sealed radioactive
sources--Leakage test methods,'' First Edition (February 15, 1992), ISO
9978:1992(E).
6. The description of billet used in the percussion test in Sec.
71.75(b)(2)(ii) is corrected by replacing ``edges'' with ``edge.''
7. The definition of ``Special form radioactive material'' in Sec.
71.4 is revised to allow special form radioactive material that is
successfully tested in accordance with the current requirements to be
transported as special form radioactive material, if the testing was
completed before the effective date of the final rule.
8. In appendix A of 10 CFR part 71, footnote h to californium-252
(Cf-252) (alternate A1 and A2 values for domestic
use of Cf-252) in Table A-1, ``A1 and A2 Values
for Radionuclides,'' is eliminated. The A1 and A2
values in the table for Cf-252 are updated to be consistent with the
IAEA values in TS-R-1.
9. Krypton-79 (Kr-79) values are added to Table A-1 and Table A-2,
``Exempt Material Activity Concentrations and Exempt Consignment
Activity Limits for Radionuclides.'' The A1 and
A2 values in Table A-1, the activity concentration for
exempt material, and the activity limit for exempt consignment are
consistent with the IAEA's values in TS-R-1.
10. Footnote a to Table A-1 is revised to include the list of
parent radionuclides whose A1 and A2 values
include contributions from daughter radionuclides with half-lives of
less than 10 days. These additions conform to footnote a to Table 2,
``Basic Radionuclide Values,'' in TS-R-1 with the exception of argon-42
(Ar-42) and

[[Page 33991]]

tellurium-118 (Te-118), which appear in footnote a to Table 2 in TS-R-1
but do not appear within Table A-1.
11. Footnote c to Table A-1 is moved to the A1 values
and revised to clarify that only the activity for iridium-192 (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.
12. In Appendix A, Table A-2, the activity limit in Table A-2 for
exempt consignment for tellurium-121m (Te-121m) is revised to be
consistent with the new IAEA value in TS-R-1.
13. The list of parent radionuclides and their progeny included in
secular equilibrium in footnote b to Table A-2 is revised to be
consistent with the list accompanying Table 2 in TS-R-1.
14. The descriptive language in Table A-3, ``General Values for
A1 and A2,'' of appendix A under the heading
``Contents'' is revised to be consistent with the IAEA descriptions in
Table 3, ``Basic Radionuclide Values for Unknown Radionuclides or
Mixtures,'' in TS-R-1 (2009 edition). ``Only alpha emitting nuclides
are known to be present'' is replaced with ``Alpha emitting nuclides,
but no neutron emitters, are known to be present.'' The phrase ``No
relevant data are available'' is replaced with the phrase ``Neutron
emitting nuclides are known to be present or no relevant data are
available.'' Additionally, footnote a is added to the new language
``Alpha emitting nuclides, but no neutron emitters, are known to be
present'' stipulating that if beta or gamma emitting nuclides are known
to be present, the A1 value of 0.1 terabecquerel (TBq) (2.7
Ci) should be used.

D. How is the NRC changing the exemption for materials with low
activity levels?

The NRC is revising its 10 CFR 71.14(a)(1) exemption for natural
materials and ores containing naturally occurring radionuclides to
reflect changes in the scope of TS-R-1.
The TS-R-1 includes statements that describe its activities
included within the scope of this IAEA regulation. It also has a list
of material to which TS-R-1 does not apply, hereafter referred to as
``non-TS-R-1 material.'' Included in the list of non-TS-R-1 materials
are natural materials and ores containing naturally occurring
radionuclides. These natural materials and ores are not intended to be
processed for their radionuclides and are classified as non-TS-R-1
materials, provided that the activity concentration for the material
does not exceed 10 times the activity concentration for exempt material
specified in Table A-2 of Appendix A.
The NRC previously established its 10 CFR 71.14(a)(1) exemption
from the requirements of 10 CFR part 71 for licensees who ship or carry
certain natural materials and ores designated as low-level materials.
The exemption allows the transport of certain qualifying natural
material or ore without the material being regulated as a hazardous
material during transportation. However, all applicable NRC regulations
in other 10 CFR parts continue to apply to these natural materials and
ores. The current exemption in Sec. 71.14(a)(1) is consistent with the
1996 edition of TS-R-1 (as amended in 2000) and 49 CFR 173.401(b), as
they apply to natural materials and ores containing naturally occurring
radionuclides. The NRC is updating this exemption to include the
shipment of natural materials and ores containing naturally occurring
radionuclides that have been processed, which will retain consistency
with the DOT's regulations and harmonize the NRC's regulations with the
current TS-R-1. This exemption continues to be limited to those natural
materials and ores containing naturally occurring radionuclides whose
activity concentrations may be up to 10 times the activity
concentration specified in Table A-2 of appendix A.
The NRC is also revising the definition of LSA-I material in 10 CFR
71.4 (i.e., material intended to be processed for its radionuclides) so
that it applies to uranium and thorium ores, concentrates of uranium
and thorium ores, and other ores containing naturally occurring
radionuclides that are intended to be processed for their
radionuclides. The low-level material exemption at Sec. 71.14(b)(3),
which includes packages containing only LSA material, will now apply to
LSA-I material.
With the revision of the definition of LSA-I material, uranium and
thorium ores, concentrates of uranium and thorium ores, and other ores
containing naturally occurring radionuclides that are intended to be
processed for these radionuclides may be able to qualify for the low-
level material exemption in Sec. 71.14(b)(3), provided that the other
restrictions are satisfied. The restrictions include: (1) The package
contains only LSA-I or Surface Contaminated Object (SCO)-I material or
(2) the LSA or SCO material has an external radiation dose rate of less
than 10 millisieverts per hour (mSv/h) (1 rem per hour (rem/h)) at a
distance of 3 meters from the unshielded material. Section 71.14
provides an exemption from the requirements of 10 CFR part 71, with the
exception of Sec. Sec. 71.5 and 71.88. Section 71.5 references the
DOT's regulations in 49 CFR parts 107, 171 through 180, and 390 through
397. If the DOT's regulations are not applicable to a shipment of
licensed material, then Sec. 71.5 requires licensees to conform to the
referenced DOT standards and regulations to the same extent as if the
shipment were subject to the DOT's regulations. Section 71.88 will
continue to apply to the material because its applicability is not
limited by any of the exemptions in 10 CFR part 71.
Natural material or ore that has been incorporated into a
manufactured product, such as an article, instrument, component of a
manufactured article or instrument, or consumer item, will not qualify
for the low-level material exemption for natural materials and ores
containing naturally occurring radionuclides. Slags, sludges, tailings,
residues, bag house dust, oil scale, and washed sands that are the
byproducts of processing or refining are examples that may contain
natural material or ore that has been processed, are examples of
material that may still qualify for the exemption, provided that the
processed material has not been incorporated into a manufactured
product.
The NRC is adding a definition for ``contamination'' to Sec. 71.4
in conjunction with the new exemption in 10 CFR 71.14(a)(3) to include
non-radioactive solid objects with substances present on any surface
not exceeding the levels used to define contamination. Contamination is
defined as quantities in excess of 0.4 Bq/cm\2\ (1 x 10^-\5\
[mu]Ci/cm\2\) for beta and gamma emitters and low toxicity alpha
emitters, or 0.04 Bq/cm\2\ (1 x 10^-\6\ [mu]Ci/cm\2\) for all
other alpha emitters. The derived values used in the definition are
conservative with respect to transportation. Quantities of radioactive
substances below these values will result in small amounts of exposure
during normal conditions of transportation and will contribute
insignificant exposures under accident conditions.

E. How is the qualification of special form radioactive material
changing?

The IAEA has incorporated in TS-R-1 the Class 4 and Class 5 impact
tests in ISO 2919:1999(E), the Class 6 temperature test in ISO
2919:1999(E), and the leaktightness tests in ISO 9978:1992(E). The NRC
is updating the alternate tests in Sec. 71.75 that may be used for the
qualification of special form radioactive material by incorporating by
reference the Class 4 and Class 5 impact tests and the Class 6
temperature test

[[Page 33992]]

prescribed in the ISO document ISO 2919:1999(E). The NRC is also
incorporating by reference the leaktightness tests specified in ISO
document 9978:1992(E).
The Class 4 impact test in ISO 2919:1999(E) replaces the impact
test in Sec. 71.75(d) and will be available for use with specimens
that have a mass that is less than 200 grams. The Class 5 impact test,
which is being added, will allow use of an ISO impact test for
specimens that have a mass that is less than 500 grams. The updated ISO
impact tests maintain the requirement that the mass of the hammer used
in the test is greater than 10 times the mass of the specimen.
The Class 6 temperature test in ISO 2919:1999(E) replaces the
temperature test in Sec. 71.75(d). The Class 6 temperature test in ISO
2919:1999(E) is more stringent than the test that it replaces because
it requires the same specimen to be used for both portions of the
temperature test. The Class 6 temperature test will continue to be more
stringent than the testing required by Sec. 71.75(b).
The leaktightness tests prescribed in ISO 9978:1992(E) replace the
tests in ISO/TR 4826.\3\ The consensus standard ISO 9978:1992(E) has
replaced ISO/TR 4826:1979(E), which has been withdrawn by ISO. The NRC
has determined that the leaktightness tests prescribed in ISO
9978:1992(E) provide an equivalent level of radiological safety as the
leaching assessment procedure in Sec. 71.75(c).
---------------------------------------------------------------------------

\3\ https://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=10804.
---------------------------------------------------------------------------

The NRC is revising the definition of ``Special form radioactive
material'' in Sec. 71.4 to allow material tested using the current
requirements to continue to be treated as special form material,
provided that the testing was completed before the effective date of
the final rule. This will allow material tested using requirements in
effect at the time of the testing to continue to be used. The NRC is
revising the reference in Sec. 71.4, which went into effect on March
31, 1996, by changing the date of the revision from January 1, 1983, to
January 1, 1996.
The NRC is replacing ``edges'' with ``edge'' to describe the billet
used for the percussion test in Sec. 71.75(b)(2). The edge corresponds
to the circular edge at the face of the billet. This revision clarifies
the description of the billet and maintains consistency with the
language used by the DOT in 49 CFR 173.469.

F. What changes are being made to 10 CFR part 71, Appendix A,
``Determination of A1 and A2 Values''?

The NRC is changing the following items in appendix A:
1. Determination of the quantity of radioactive material that can
be shipped in a package that contains both special form and normal form
radioactive material.
The final rule specifically addresses how to calculate the limit of
the activity that may be transported in a Type A package, if the
package contains both special form and normal form radioactive material
and the identities and activity limits for the radionuclides are known.
2. Table A-1, ``A1 and A2 Values for
Radionuclides.''
The values in Table A-1 have been revised to make the values in 10
CFR part 71 consistent with the values in Table 2, ``Basic Radionuclide
Values,'' in TS-R-1. Specifically, the final rule: (1) Adds an entry
for Kr-79, which is now found in Table 2 in TS-R-1; (2) adopts the
A1 and A2 values for Cf-252; (3) revises footnote
a to include the list of parent radionuclides whose A1 and
A2 values include contributions from daughter radionuclides
with half-lives of less than 10 days; and (4) moves and revises
footnote c, which formerly applied to all Ir-192, so that the footnote
applies only to Ir-192 in special form material.
The IAEA added an entry for Kr-79 in Table 2 of TS-R-1. The NRC is
adopting the same radionuclide-specific values for Kr-79 in Table A-1
in 10 CFR part 71. The radionuclide-specific values replace the generic
values in Table A-3, which were previously used for Kr-79. The
radiological criteria underlying the A1 and A2
values for Kr-79 have not changed, but the radionuclide-specific values
were derived using radionuclide-specific information and better reflect
the radiological hazard of Kr-79 than the generic values that they are
replacing.
The IAEA revised the A1 value for Cf-252 to the value
that previously applied to domestic transportation. The NRC is adopting
the A1 value for Cf-252, which will apply to both
international and domestic transportation, and is adopting the IAEA
value for A2. As a result, the final rule removes the
A2 value that formerly applied only to domestic
transportation. Making this change improves the harmonization of 10 CFR
part 71 with TS-R-1.
The final rule revises footnote a to Table A-1 that identifies the
A1 and A2 values that include contributions from
daughter radionuclides that have a half-life less than 10 days. The
list corresponds to the radionuclides listed in footnote a to Table 2
in TS-R-1, with the exception of argon-42 (Ar-42) and tellurium-118
(Te-118). Argon-42 and Te-118 are not included because they do not
appear within Table A-1 in 10 CFR part 71.
Footnote c to Table A-1 has been revised to clarify that 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.
3. Table A-2, ``Exempt Material Activity Concentrations and Exempt
Consignment Activity Limits for Radionuclides.''
The final rule revises Table A-2 to make the values in 10 CFR part
71 consistent with the values in TS-R-1 and adds an entry for Kr-79
adopted from Table 2 of TS-R-1. The final rule also updates the list of
parent radionuclides and their progeny in footnote b to Table A-2 by
removing the chains for the parent radionuclides cerium-134 (Ce-134),
radon-220 (Rn-220), thorium-226 (Th-226), and U-240 and by adding the
chain for the parent radionuclide silver-108m (Ag-108m) to make the
footnote consistent with footnote (b) in Table 2 of TS-R-1. The
activity limit for exempt consignment for Te-121m has also been updated
to match the values in TS-R-1.
Materials that have an activity concentration that is less than the
activity concentration for exempt material pose a very low radiological
risk. The activity limit for exempt consignment has been established
for the transportation of material in small quantities so that the
total activity is unlikely to result in any significant radiological
exposure. This is the case, even for material that exceeds the activity
concentration for exempt material.
Previously, Kr-79 was not listed in Table A-2 and instead values
from Table A-3, ``General Values for A1 and A2,''
in appendix A were used to determine the activity concentration for
exempt material and the activity limit for exempt consignment for Kr-
79. Radionuclide-specific values for the activity concentration for
exempt material and the activity limit for exempt consignment have been
derived for Kr-79 and are now included in TS-R-1. The final rule adds
an entry for Kr-79 to Table A-2 in 10 CFR part 71 to be consistent with
TS-R-1.
In TS-R-1, the IAEA revised the activity limit for exempt
consignment for Te-121m. The change to the activity level for exempt
consignment for Te-121m, which is based on new analyses and
information, is consistent

[[Page 33993]]

with the objectives of the exemption values. To conform to
International Commission on Radiological Protection (ICRP) and IAEA
changes, the activity limit for exempt consignment for Te-121m in Table
A-2 of 10 CFR part 71 is changed from 1 x 10\5\ Bq (2.7 x
10^-\6\ Ci) to 1 x 10\6\ Bq (2.7 x 10^-\5\ Ci).
The IAEA has revised the list of parent radionuclides and their
progeny included in secular equilibrium in footnote (b) to Table 2 in
TS-R-1. This revision arose from the adoption of the nuclide-specific
basic radionuclide values from the Basic Safety Standards (IAEA Safety
Series No. 115, ``International Basic Safety Standards for Protection
against Ionizing Radiation and for the Safety of Radiation Sources''
(1996)) for use in transportation. The list of parent radionuclides and
their progeny was modified by adding the decay chain for Ag-108m and by
removing the decay chains for Ce-134, Rn-220, Th-226, and U-240. The
list of parent radionuclides and their progeny included in secular
equilibrium presented in footnote b to Table A-2 is revised to be
consistent with the changes to the list in TS-R-1.
4. Table A-3, ``General Values for A1 and
A2.''
In the 2005 edition of TS-R-1, the IAEA revised Table 2, ``Basic
Radionuclide Values for unknown radionuclides or mixtures.'' The values
are now in Table 3 in the 2009 edition of TS-R-1. The table divides
unknown radionuclides and mixtures into three groups, with a row for
each group. The first column of each row provides a descriptive phrase
for contents that are suitable for that group. The NRC is adopting the
new descriptive phrases in Table A-3 of 10 CFR part 71.
The descriptive phrase for the first group, ``Only beta or gamma
emitting radionuclides are known to be present,'' is not being changed.
The phrase for the second group, ``Only alpha emitting nuclides are
known to be present,'' is being changed to ``Alpha emitting nuclides,
but no neutron emitters, are known to be present.'' The phrase for the
third group, ``No relevant data are available,'' is being changed to
``Neutron emitting nuclides are known to be present or no relevant data
are available.''
Some users have assigned alpha-emitting radionuclides that also
emit beta particles or gamma rays to the third group, when it was
intended that they be assigned to the second group. The change in the
descriptive phrase for the second group is intended to reduce the
confusion caused by the current phrase because all alpha emitting
radionuclides also emit other particles and/or gamma rays. The change
in the descriptive phrase for the third group is intended to clarify
that neutron-emitting radionuclides, or alpha emitters that also emit
neutrons, such as Cf-252, Cf-254 and curium-248 (Cm-248), should be
assigned to the third group.
It is intended that when groups of radionuclides are based on the
total alpha activity and the total beta and gamma activity, the lowest
radionuclide values (A1 or A2) for the alpha
emitters or the beta or gamma emitters, respectively, are used.
Consequently, an A1 value of 1 TBq (2.7 Ci) and an
A2 value of 9 x 10^-\5\ TBq (2.4 x
10^-\3\ Ci) are used for a group containing both alpha
emitting radionuclides and beta or gamma emitting radionuclides.
5. Other changes that correct formulas and their descriptions in
section IV of appendix A.
The NRC is making several corrections to the formulas and the
descriptions of the formulas that address mixtures of radionuclides in
section IV of appendix A in 10 CFR part 71. These changes involve
formatting and typographical changes in the formulas and their
descriptions.

G. How will the responsibilities of certificate holders and licensees
change with these amendments?

The final rule revises Sec. 71.85(a)-(c) to make certificate
holders, not licensees, responsible for making the required preliminary
determinations before the first use of any package for shipping
radioactive material. The preliminary determinations involve
evaluating, testing, and marking the packaging. The DOT's requirements
in 49 CFR 173.22 require that the person offering a hazardous material
for shipping make determinations relating to the manufacturing,
assembly, and marking of the packaging or container. New Sec. 71.85(d)
will require licensees to ascertain that the certificate holders have
made the required preliminary determinations. Note that before each
shipment, licensees must still make the findings required by the
existing Sec. 71.87(a)-(k) provisions, to ensure the continued safety
of packages containing radioactive material.
The NRC is revising Sec. 71.85, because it is more appropriate to
assign the responsibility to certificate holders for evaluating,
testing, and marking the packaging. Only certificate holders are
authorized to design and fabricate packages, and only certificate
holders have a full scope quality assurance program approval. By
assigning the responsibility for making the preliminary determinations
to the certificate holder, the NRC streamlines the implementation of
its regulations, and the revisions to Sec. 71.85 also better reflect
current practice.
Reflecting the revisions to Sec. 71.85(a)-(c) previously
discussed, conforming changes are made to the Sec. 71.101 Quality
Assurande (QA) provisions, to clarify that only certificate holders and
applicants for a CoC have QA responsibilities regarding the fabrication
and testing of packages. In this regard, references to licensees
Sec. Sec. 71.101(a) and (c)(2) have been removed.

H. Why is renewal of my quality assurance program description not
necessary?

The duration of quality assurance program approvals issued under 10
CFR part 71 is a matter of practice and is not specified in the
regulations. The NRC has limited the duration of the quality assurance
program approval by assigning an expiration date to NRC Form 311,
``Quality Assurance Program Approval for Radioactive Material
Packages.'' The inclusion of an expiration date provided an opportunity
for the NRC to periodically review the quality assurance programs and
for the NRC to maintain periodic contact with the quality assurance
program approval holders.
The NRC is changing its practice regarding the duration of its
quality assurance program approvals. The NRC will no longer limit the
duration of its quality assurance program approvals issued under 10 CFR
part 71. The NRC is amending 10 CFR part 71 to implement this change in
order to make the periodic communication between the NRC and the
quality assurance program approval holders more efficient. The NRC will
reissue NRC Form 311 without an expiration date.
The NRC is still requiring quality assurance program approval
holders to periodically report changes in their quality assurance
program description to the NRC. However, the NRC has determined that
with the continuing contact between the NRC and the quality assurance
program approval holders, requiring the renewal of quality assurance
program approvals is no longer necessary. Every 24 months, each quality
assurance program approval holder is required to report those changes
that do not reduce commitments made to the NRC in a quality assurance
program description. Regarding quality assurance program description
changes that reduce commitments made to the NRC, such changes will
continue to require NRC approval.
The NRC expects that this new process will provide the NRC with

[[Page 33994]]

adequate assurance that the quality assurance program approval holders
will continue to maintain and implement their approved quality
assurance programs, while reducing regulatory burden and the
expenditure of NRC resources.

I. What changes can be made to a quality assurance program description
without seeking prior NRC approval?

Previously, quality assurance program descriptions approved under
10 CFR part 71 could not be changed without NRC approval. Therefore,
all changes to 10 CFR part 71 quality assurance programs, irrespective
of their significance or importance to safety, were required to be
submitted to the NRC for approval. Licensees with quality assurance
programs approved under 10 CFR part 50, may make some changes to their
quality assurance program without NRC approval, in accordance with 10
CFR 50.54. Under the final rule, the NRC will allow some changes to be
made to quality assurance programs previously approved under 10 CFR
part 71 without obtaining additional NRC approval. As indicated
previously, the new process for making changes to approved quality
assurance program descriptions under 10 CFR part 71 will be similar to
the process that the NRC has used to approve changes that are made to
the quality assurance program descriptions for nuclear power plants and
will result in a more consistent NRC-wide approach. As stated
previously in II.H, quality assurance program description changes that
reduce commitments made to the NRC will continue to require NRC
approval. For such changes, the following information will need to be
provided for NRC review: A description of the proposed changes, the
reason for the changes, and the basis for concluding that the revised
program incorporating the changes will continue to satisfy the
requirements of 10 CFR part 71, subpart H.
Quality assurance program approval holders will no longer be
required to submit for NRC approval changes to their quality assurance
program descriptions under 10 CFR part 71, if those changes do not
reduce the commitments that they have made to the NRC. For example,
administrative changes (e.g., revisions to format, font size or style,
paper size for drawings and graphics, or revised paper color) and
clarifications, spelling corrections, and non-substantive editorial or
punctuation changes will not require NRC approval. Five types of non-
substantive changes that will no longer require NRC approval are being
codified in the new 10 CFR 71.106(b) provisions. Changes to reporting
responsibilities, functional responsibilities, and functional
relationships may be substantive and have the potential to reduce
commitments made to the NRC. Such changes will therefore still require
prior NRC approval before being implemented, and quality assurance
program approval holders will still be required to maintain records of
all quality assurance program changes.

J. How frequently do I submit periodic updates on my quality assurance
program description to the NRC?

Under the revised requirements, every 24 months, quality assurance
program approval holders will be required to report changes to their
approved quality assurance program that do not reduce any commitments
in their quality assurance program descriptions. Such changes will no
longer require NRC approval before they can be implemented. If a
quality assurance program approval holder has not made any changes to
its approved quality assurance program description during the preceding
24-month period, the approval holder will be required to report this to
the NRC.
The NRC inspection program relies on having current information
about the quality assurance program available to the NRC. By requiring
that the most important changes be submitted to the NRC for approval
before they are implemented, and with the periodic reporting of non-
substantive changes every 24 months, the NRC will have current
information for its inspection program. The NRC considers the 24-month
reporting period as providing an appropriate balance between the burden
placed on the quality assurance program approval holders and the need
to ensure that the NRC has current information for its oversight of
these quality assurance programs.
As previously stated in Section I, the NRC will re-issue NRC Form
311 without an expiration date. The 24-month period for reporting of
changes will begin on the date of the NRC approval of a quality
assurance program issued with no expiration date, as specified by the
date of signature at the bottom of NRC Form 311. By making these
changes, the NRC is seeking to balance the regulatory burden for
submitting and reviewing this information with the NRC's need to ensure
that the NRC has current information.

K. How do the requirements in Subpart H, ``Quality Assurance,'' change
with the removal of footnote 2 in 10 CFR 71.103?

The NRC is removing footnote 2 in Sec. 71.103 regarding the use of
the term ``licensee'' in subpart H because it is no longer necessary.
The removal of the footnote does not change the quality assurance
requirements in subpart H. The footnote regarding use of the term
``licensee'' was included to clarify that the quality assurance
requirements in subpart H apply to whatever design, fabrication,
assembly, and testing of a package is accomplished before a package
approval is issued. The terms ``certificate holder'' and ``applicant
for a CoC'' were added to the requirements in subpart H in a previous
rulemaking to make explicit the application of those quality assurance
requirements to certificate holders and applicants for a CoC. Although
removing the footnote will not change the quality assurance
requirements, other changes to subpart H in this rulemaking clarify
which requirements apply to users of NRC-certified packaging and which
apply to applicants for, or holders of CoCs, which are the entities
that are performing design, fabrication, assembly, and testing of the
package before a package approval is issued.

L. What changes are being made to general licenses?

The NRC is changing the requirements for general licenses on the
use of an NRC-approved package (Sec. 71.17) and use of a foreign-
approved package (Sec. 71.21). In Sec. 71.17, the NRC is revising the
general license requirements to clarify the conditions for obtaining a
general license and the responsibilities of the general licensee. A
quality assurance program approved by the NRC that satisfies the
provisions of subpart H of 10 CFR part 71 is required in order to be
granted the general license. The changes clarify that the licensee is
responsible for maintaining copies of the appropriate documents, such
as the CoC, or other approval of the package, the documents associated
with the use and maintenance of the packaging, and the actions that are
to be taken before shipment with the package. The changes also clarify
that the notifications to the NRC, as required in Sec. 71.17(c)(3),
are a responsibility of the licensee, rather than a condition for
obtaining the license. The changes to Sec. Sec. 71.17 and 71.21 do not
change the current notification process nor the required timing or
content of the notification required by Sec. 71.17(c)(3) or any other

[[Page 33995]]

reporting requirements relating to package use or, when required, the
prior notification of shipments.
The changes also update the reference in Sec. 71.21(a) from 49 CFR
171.12 to 49 CFR 171.23 to reflect a DOT final rule published on May 3,
2007 (72 FR 25162), that previously moved the requirements.

M. How is the exemption from classification as fissile material (10 CFR
71.15) changing?

The NRC is revising Sec. 71.15(d) criteria that, if satisfied,
exempt certain material from being classified as fissile material.
Material within the scope of Sec. 71.15 is exempt from the fissile
material package standards and criticality safety requirements stated
in Sec. Sec. 71.55 and 71.59.
The objective of the fissile material exemptions in Sec. 71.15 is
to facilitate the safe transport of low-risk (e.g., small quantities or
low concentrations) fissile material. This is done by exempting
shipments of these materials from the packaging requirements and the
criticality safety assessments required for fissile material
transportation so that the shipments may take place without specific
NRC approval. A lower amount of regulatory oversight is acceptable for
these shipments because the exemptions were established to ensure
safety under all credible transportation conditions. Provided that the
exempt material is packaged consistent with the radioactive and
hazardous properties of the material, there are no additional packaging
or transport requirements for exempt fissile material beyond those
noted in the specific exemption. In order to ensure criticality safety,
the exemptions were evaluated using assumptions that, as part of the
criticality safety assessment for package designs approved to transport
fissile material, the fissile material can be released from the
packaging during transport, may reconfigure into a worst-case geometric
arrangement, may combine with material from other transport vehicles,
and may be subject to the fire and water immersion.
The reactivity of uranium enriched in U-235 depends on the level of
enrichment, the presence of moderators, and heterogeneity effects.
Hydrogen is the most efficient moderator and water is the most common
material containing large quantities of hydrogen; therefore, water is
the typical moderating material of interest in criticality safety. The
maximum enrichment in U-235 allowed to qualify for the fissile material
exemption in Sec. 71.15(d) is 1 percent by weight, which is slightly
less than the minimum critical enrichment for an infinite, homogeneous
mixture of enriched uranium and water.\4\ The minimum critical
enrichment is the enrichment necessary for a system to have a neutron
multiplication factor of one. Systems containing homogeneous mixtures
of uranium enriched to less than the minimum critical enrichment (e.g.,
a homogenous mixture of uranium enriched to a maximum of 1 percent) are
not capable of obtaining criticality, irrespective of the mass or size
of the system. The fissile material exemption in Sec. 71.15(d) also
limits the quantity of some less common moderating materials
(beryllium, graphite, and hydrogenous material enriched in deuterium),
because the presence of these materials has the potential to reduce the
minimum critical enrichment, thereby increasing the potential for
criticality with uranium of lower enrichment. Therefore, homogeneous
materials containing uranium enriched to no more than 1 percent by
weight and subject to the noted restrictions on moderators are
inherently safe from a potential criticality and do not need to be
limited by mass or size to be subcritical during transport. However,
uranium enriched to less than 5 percent by weight is most reactive when
it is in a heterogeneous configuration; therefore, the minimum critical
enrichment is lower for an optimized heterogeneous system than for an
optimized homogeneous system of the same material. In consideration of
this fact, requirements have been added to Sec. 71.15(d) in order to
clarify the need for homogeneity in the material.
---------------------------------------------------------------------------

\4\ H.C. Paxton and N. L. Pruvost, Critical Dimensions of
Systems Containing U-235, Pu-239, and U-233, LA-10860-MS, Los Alamos
National Laboratory (1987).
---------------------------------------------------------------------------

The exemption for uranium enriched to a maximum of 1 percent at
Sec. 71.15(d) includes a limit on moderators that increases the
reactivity of the low-enriched fissile material, but it does not
include limits on heterogeneity. In contrast, TS-R-1 allows the uranium
enriched to a maximum of 1 percent by weight to be distributed
essentially homogeneously throughout the material and requires that if
the U-235 is in metallic, oxide, or carbide forms then it cannot form a
lattice arrangement, but TS-R-1 does not limit the amount of beryllium,
graphite, or hydrogenous material enriched in deuterium. In its
supplemental guidance to TS-R-1, TS-G-1.1 ``Advisory Material for the
IAEA Regulations for the Safe Transport of Radioactive Material,'' \5\
the IAEA indicated that ``[t]here is agreement that homogeneous
mixtures and slurries are those in which the particles in the mixture
are uniformly distributed and have a diameter no larger than 127 [mu]m
[(5 x 10^-3 in.)].'' The homogeneity requirement in TS-R-1 is
intended to prevent latticing of slightly enriched uranium in a
moderating medium.
---------------------------------------------------------------------------

\5\ https://www-pub.iaea.org/MTCD/publications/PDF/Pub1109_scr.pdf.
---------------------------------------------------------------------------

An analysis performed by the DOE indicated that large arrays of
uranium with enrichment of 1 percent by weight of U-235, which qualify
for the fissile material exemption at Sec. 71.15(d), could exceed an
effective neutron multiplication factor (keff) of 0.95 when
optimally moderated by water. The DOE analysis was performed assuming
five shipments under normal conditions and two shipments under accident
conditions. Shipping the material under the exemption would have
resulted in a lower margin of safety with respect to criticality than
is allowed for shipments using approved fissile material packages,
because shipments using the fissile material packages, by design, will
typically use a keff of 0.95 as an upper limit. Because such
a shipment, as was analyzed by the DOE, could both qualify for the
fissile material exemption for low-enriched fissile material and have a
keff greater than 0.95, the NRC believes that additional
restrictions on low-enriched fissile material shipped under the fissile
material exemption in Sec. 71.15(d) are warranted.
As discussed in Section I of this document, the NRC in 2004 removed
exemption provisions regarding homogeneous distribution and lattice
arrangement. Although the NRC had determined that the limits on
restricted moderators were sufficient to assure subcriticality for all
moderators of concern, the NRC now believes that additional
restrictions are needed to have a sufficient margin of safety for
shipments of material under the low-enriched fissile material
exemption. Therefore, the NRC is reinstating the requirement that, for
uranium enriched to a maximum of 1 percent to be exempted, the fissile
material must be distributed homogeneously throughout the package
contents and not form a lattice arrangement. Some variability in the
distribution and enrichment of the uranium enriched to a maximum of 1
percent is permissible, provided that the maximum enrichment does not
exceed 1 percent. The total measured mass of U-233 and plutonium, plus
two times the measurement uncertainty, must be less than 1.0 percent of
the mass of U-235 in the material. The total measured mass of
beryllium, graphite, and hydrogenous material enriched in deuterium,
plus two times the measurement uncertainty, must be less than 5.0
percent of the uranium mass. Although there are heterogeneity effects

[[Page 33996]]

at very small scales, the NRC does not believe that it is necessary to
require homogeneity with respect to particle size. Further, the NRC
does not consider it to be credible to accumulate the volume and
regularity of fissile material particles necessary for small-scale
heterogeneity to introduce criticality concerns. Small volumes of
heterogeneity may exist for material shipped under this exemption,
provided that a significant fraction of the fissile material is
homogeneous and mixed with non-fissile material, or the lumps of
fissile material are spaced in a largely irregular arrangement. The
homogeneity criterion, allowing some variability in the distribution of
fissile material, is consistent with the IAEA's regulations, which
require that the fissile nuclides be essentially homogenously
distributed. Restricting the variability in concentration is not
sufficient for limiting the reactivity of the uranium enriched to a
maximum of 1 percent; therefore, the NRC is reinstating the lattice
prevention criterion. The contents of the package must not involve
concentrations of fissile material separated by non-fissile material in
a regular, lattice-like arrangement. Although the lattice prevention
requirement in TS-R-1 is limited to uranium present in metallic, oxide,
or carbide form, the NRC believes that this restriction is too narrow
and should apply irrespective of the form of uranium.

N. What other changes is the NRC making to its regulations for the
packaging and transportation of radioactive material?

A requirement in Sec. 71.19(a) that implemented transitional
arrangements (``grandfathering'') expired on October 1, 2008, and Sec.
71.19(a) was designated as ``reserved.'' Because this entry is no
longer needed, paragraphs (b) through (e) have been redesignated as
paragraphs (a) through (d). In the redesignated paragraph (b)(2),
transitional language that is no longer needed has been removed because
the transitional period has expired and the requirement now applies to
all previously approved packages used for a shipment to a location
outside of the United States.
The reference to Sec. 71.20 in Sec. 71.0 has been removed,
because Sec. 71.20 has expired and is no longer included in the
regulations.
In Sec. 71.31, the reference to Sec. 71.13 has been changed to
Sec. 71.19. In Sec. 71.91, the reference to Sec. 71.10 has been
changed to Sec. 71.14. These changes will correct references that were
not updated when the requirements were redesignated in 2004.

O. When do these proposed amendments become effective?

This rule is effective July 13, 2015. Compliance with the
amendments adopted in this final rule is required beginning July 13,
2015. Agreement States, under their formal agreements with the NRC,
have 3 years after the effective date of the rule to adopt the changes.

III. Opportunities for Public Participation

The proposed rule was published on May 16, 2013 (78 FR 28988), for
a 75-day public comment period that ended on July 30, 2013. The NRC
received eight comments from Federal agencies, States, licensees,
industry organizations, and individuals. Copies of the public comments
are available in the NRC Public Document Room, 11555 Rockville Pike,
Rockville, MD 20852; or at https://www.regulations.gov under Docket ID
NRC-2008-0198.

IV. Public Comment Analysis

In general, there was a range of stakeholder views concerning the
proposed rule. Two commenters voiced general support of the NRC's
efforts to harmonize 10 CFR part 71 with the DOT's and the IAEA's
regulations. Three other commenters indicated support for the proposed
revisions to the definition of LSA group I, with two of those
commenters stating their view that this proposed revision corrected a
longstanding error in the NRC's regulations that created an
incompatibility with existing DOT regulations. Other commenters voiced
general support for the proposed revisions to quality assurance
requirements and for provisions related to exempted low-level material.
The comments and responses have been grouped into five topical areas:
New and Revised Definitions, Exemptions for Low-level Materials,
Quality Assurance, Technical Requirements, and Other. To the extent
possible, all of the comments on a particular subject are grouped
together.
The NRC specifically requested input on three subjects: (1)
Frequency for reporting changes to an approved quality assurance
program; (2) clarity of new restrictions on low-enriched fissile
material in Sec. 71.15(d); and (3) the cumulative effects of this
rulemaking, including influence of other regulatory actions, unintended
consequences, and reasonableness of the cost benefit estimates. These
subjects are addressed within the appropriate area grouping. A
discussion summarizing the comments and providing the NRC's comment
responses follows. The NRC finds that the comments did not require any
changes to the proposed rule's provisions.

A. New and Revised Definitions

A.1 Contamination
Comment: One commenter was concerned that DOT had stated in its
parallel proposed rule Federal Register notice that the DOT did not
have the regulatory authority to establish a radioactive material
unrestricted transfer (free release) limit and was leaving it to the
NRC as to whether the NRC would continue a longstanding provision of
the DOT's regulations that allowed conveyances that meet the return to
service (RTS) standards to be released without applying NRC licensing
requirements. The commenter stated that with the DOT and the NRC
adopting the same definition of ``contamination,'' and excluding
conveyances with contamination below the limits established by that
definition, it was the commenter's view that the transportation
requirements of the DOT and the NRC are not applicable to such
conveyances. It was also the commenter's view that by adopting the
DOT's definition for contamination, the NRC is continuing the long-held
position that, for materials below the level that meet the definition
of contamination for conveyances in transportation or storage
incidental to transportation, conveyances in transportation do not need
to be licensed.
Response: The NRC does not agree with the commenter's views,
because they are contrary to existing general provisions in 10 CFR part
71. Specifically, 10 CFR 71.0(b) states that the 10 CFR part 71
requirements ``are in addition to, and not in substitution for,'' NRC
requirements in other 10 CFR parts. Additionally, existing 10 CFR
71.0(c) states that no provision in 10 CFR part 71 ``authorizes
possession of licensed material.'' Therefore, the new definition of
contamination in Sec. 71.4, and the new exemption for contamination in
Sec. 71.14(a)(3) applicable to transport of material, are sufficiently
clear, and should not be misconstrued as providing relief from the
provisions of any other applicable parts of 10 CFR, in particular with
respect to the licensing of on-site materials, (also see response to
comment D.4.).
Comment: One commenter stated that although the application of the
definition of contamination provides a

[[Page 33997]]

regulatory path for the release of conveyances, the current language
found in 49 CFR 173.443(c) and the associated table of contamination
limits should be incorporated into the NRC's regulations as an
authorized method to remove conveyances from licensed control when the
conveyances are limited to the transportation of contaminated or
potentially contaminated material or storage for future such
transportation.
Response: The comment does not provide a sufficient basis to
incorporate this DOT regulation into NRC's regulations. The DOT and the
NRC share regulatory responsibility for the safety of radioactive
materials in transport. To avoid duplication of effort and imposing
unnecessary burden, the respective roles of the two agencies are
delineated in the DOT/NRC MOU. Under this MOU, the NRC recognizes the
DOT's authority to define and regulate the safety of Class 7 Hazardous
Materials (radioactive materials) in transport. The NRC requires its
licensees to comply with the DOT's regulations when transporting
radioactive materials. The DOT has issued regulations for safe
transport of radioactive materials by all modes, including requirements
addressing residual contamination on conveyances, and the NRC believes
the DOT regulations regarding contaminated conveyances are adequate to
protect public health and safety. Accordingly, the NRC sees no need to
duplicate the DOT's conveyance provisions in 10 CFR. Note also that the
NRC issues licenses to persons to possess, use, and transfer
radioactive materials; the NRC does not license conveyances.
Comment: One commenter stated that the NRC, by defining
contamination, is establishing a de minimis quantity. The commenter
believed that this is a sensible view given the minimal potential for
contamination in transportation or storage pending future
transportation and that this approach constitutes a sound application
of the NRC's risk-informed, performance-based approach. The commenter
indicated, however, that it would be helpful, given the many
stakeholders and Agreement State regulators, that this position be
clearly stated in the NRC's regulations. Specifically, the commenter
recommended that the proposed Sec. 71.14(a)(3) exemption be modified
(as indicated by the underlined text) to state: ``(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 Sec. 71.4 of this part. Such objects in the
transportation process, or in storage pending future transportation,
need not be licensed under this chapter.''
Response: The NRC finds that the wording of the new exemption
provision in 10 CFR 71.14(a)(3), as proposed, is sufficiently clear,
and therefore is not accepting the proposed modification. The scope of
this new exemption is limited to the NRC's transportation regulations
in 10 CFR part 71. The NRC licensees are not being exempted from
meeting the requirements stated in other applicable 10 CFR parts, (also
see response to Comment A.1 and Comment D.4.).
A.2 Special Form Radioactive Material
Comment: Although one commenter voiced general support for the
revised definition of special form radioactive material in Sec. 71.4,
another commenter was concerned that the new language being added to
revised paragraph (3) of the definition, ``. . . and special form
material that was successfully tested before July 13, 2015 . . .,'' is
unclear. The commenter noted that the existing language contained
within paragraph (3) uses the term ``special form encapsulation'' and
that this term was consistent with the commenter's understanding of the
intent of these changes as discussed in the Federal Register notice.
However, the commenter stated that using the term special form
``material,'' rather than ``encapsulation'' is ambiguous as to whether
the revised language is meant to apply to a special form that is a
single solid piece of material only, or whether the rule aims to
grandfather special form designs including encapsulations that were
designed and constructed after the earlier dates cited in the
paragraph. For clarity and consistency, the commenter recommended
replacing the proposed ``special form material'' term with the term
``special form encapsulation'' in paragraph (3) of the revised
definition.
Response: Special form radioactive material may be either
encapsulated or a single solid piece; using the term ``special form
encapsulation'' would not refer to a single solid piece. The NRC is
choosing to use the broader ``special form material'' term so that the
revised definition will: (1) Permit the continued use of encapsulations
authorized under the existing definition, and (2) cover special form
materials as authorized in the DOT's regulation (see 49 CFR
173.469(e)).
A.3 Other
Comment: One commenter recommended adding a new definition to 10
CFR 71.4 to define ``radiation level'' as: ``the radiation dose-
equivalent rate expressed in millisieverts per hour or mSv/h (millirem
per hour or mrem/h). It consists of the sum of the dose equivalent
rates from all types of ionizing radiation present including alpha,
beta, gamma, and neutron radiation. Neutron flux densities may be used
to determine neutron radiation levels according to Table 1.''
Response: The NRC declines to add the requested definition of
``radiation level'' to 10 CFR 71.4 for the following reasons.
``Radiation'' is already defined in 10 CFR part 20 (``Standards for
Protection Against Radiation''), and this term includes all the types
of ionizing radiation that are referenced in the comment. Additionally,
the term ``radiation'' applies to all types of NRC licensees, in
accordance with the 10 CFR 20.1002 scoping provisions.

B. Exemptions for Low-Level Materials

Comment: One commenter stated that the discussion contained within
the Federal Register notice appears to indicate that natural material
that has been processed could qualify for the exemption if it is not
included in a manufactured product, such as an article, instrument,
component of a manufactured article or instrument, or consumer item.
The commenter was concerned that there appears to be a discrepancy
between this statement and the language in the proposed rule regarding
intent to be processed for the use of radionuclides.
Response: The comment does not specify the exemption provisions
that are of concern, but as indicated in this response, the NRC assumes
that those in 10 CFR 71.14 are at issue. The NRC does not find there is
any discrepancy between the revised 71.14(a)(1) exemption, and the
existing 71.14(b)(3)(ii) exemption that is not being revised. The NRC
is revising the 10 CFR 71.14(a)(1) exemption to include natural
material and ores containing naturally occurring radionuclides that:
(1) Are either in their natural state, or have only been processed for
purposes other than for the extraction of the radionuclides, and (2)
are not intended to be processed for the use of these radionuclides,
provided that they do not exceed 10 times the activity concentration
values listed in Table A-2 or Table A-3, as appropriate. Natural
material or ore that has been processed but has not been incorporated
into a manufactured product, such as an article, instrument, component
of a manufactured article or instrument, or consumer item, would be
within the scope of this revised exemption. A licensee is exempt from
all the requirements of 10 CFR part 71 with

[[Page 33998]]

respect to shipment or carriage of this material.
The NRC is also revising the definition of LSA-I in 10 CFR 71.4 to
include 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 radioactive materials.
Under existing 71.14(b)(3)(ii), a licensee is exempt from all the
requirements of 10 CFR part 71, other than Sec. Sec. 71.5 and 71.88,
with respect to shipment or carriage of packages containing LSA-I,
provided the packages do not contain any fissile material, or the
material is exempt from classification as fissile material under Sec.
71.15. As revised, the NRC finds that the definition of LSA-I is
adequate to ensure that material is properly characterized; therefore,
it is clear to the user when the exemption provisions in
71.14(b)(3)(ii) would apply.
Comment: One commenter noted that the IAEA's 2012 edition of SSR-6
did not include the phrase ``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.'' The
commenter was concerned that given the length of time it can take to
promulgate a rulemaking, the NRC should consider revising its proposed
10 CFR 71.14(a)(1) text to be consistent with the current SSR-6.
Specifically, Section 107 of SSR-6 states that regulations do not apply
to any of the following:

(f) Natural material and ores containing naturally occurring
radionuclides, which may have been processed, provided the activity
concentration of the material does not exceed 10 times the values
specified in Table 2, or calculated in accordance with paras 403(a)
and 404-407. For natural materials and ores containing naturally
occurring radionuclides that are not in secular equilibrium the
calculation of the activity concentration shall be performed in
accordance with para. 405.

The commenter therefore recommended revising the proposed 10 CFR
71.14(a)(1) provisions to exempt ``Natural material and ores containing
naturally occurring radionuclides that are either in their natural
state, or have been processed, 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.''
Response: The NRC is choosing not to make the commenter's
recommended revisions. The DOT/NRC MOU recognizes the DOT as the
Federal agency responsible for the definition of radioactive material
in transit. After careful consideration, the DOT chose not to remove
the intended use-clause in its current proposed rule, in part because
the rule is intended to achieve compatibility with the 2009 Edition of
the IAEA regulations, not the 2012 Edition. Publication of the 2012
Edition in October 2012, did not allow adequate time for the NRC and
DOT to effectively evaluate the changes as part of this rulemaking
effort. There are other changes in the 2012 Edition that also are not
reflected in either the proposed DOT or NRC rulemakings. The NRC will
consider any necessary changes related to SSR-6 in a future rulemaking
after consulting with DOT, rather than to further delay finalizing this
rulemaking. The NRC is choosing not to make such changes unilaterally,
since doing so would create a conflict between DOT and NRC regulatory
requirements. Not only would conflicting requirements and definitions
contradict long-standing policy to establish a uniform, national
hazardous material transportation safety system, such conflicts could
likely create uncertainty within the regulated community and prove to
be unenforceable.

C. Quality Assurance Program

Comment: Three commenters voiced support of proposed changes to 10
CFR part 71 relating to the quality assurance program approvals. One of
these commenters stated that the proposed changes would (1) streamline
the process of maintaining an approved program, (2) contribute to
implementation of continued improvement efforts by the approval
holders, and (3) ensure the level of safety afforded shipments will not
be diminished. Another of these commenters believed that the proposal
would better risk inform U.S. regulations and harmonize the U.S.
regulations with international rules. A different commenter disagreed
with the proposed approach and recommended that 10 CFR 71.38(c) only
extend the expiration dates to 10 years. The proposed rule would have
removed the quality assurance expiration provision in order to minimize
the impact on the applicants while still requiring a licensee to submit
all documentation, including the quality assurance program, for review
when renewing their license.
Response: The NRC expects that parties who already have an approved
QA program will receive an updated completed approval form identifying
the removal of the expiration. Essentially, this is no different than
what has been expected of the receipt of the previous QA program
approval, except that this will be the last and only receipt if no
changes affecting QA commitments occur. For future applicants, the
original QA program approval will be issued with no expiration date.
But any changes affecting QA commitments must still be submitted to the
NRC for approval, including any such changes that are part of a license
renewal request. The NRC therefore finds that there is no need to adopt
the commenter's recommended 10-year expiration provision.
Comment: One commenter stated that while it agreed with the
philosophy of the proposed 10 CFR 71.106, which will allow a licensee
to make changes to the quality assurance program, it recommended
mirroring 10 CFR 35.26 by adding the following rule language:
(1) The revision has been reviewed and approved by management.
(2) Affected individuals are instructed on the revised program
before the changes are implemented.
(3) A record of this instruction be created and maintained.''
Response: The NRC agrees with the commenter that management review
and approval, appropriate instruction or training prior to
implementation, and record keeping, are key attributes of effectively
managing changes. The specific language referenced from 10 CFR 35.26
has not been added because these requirements are already embedded in
the existing regulations.
The NRC finds that the first two recommended additions to proposed
10 CFR 71.106 are not necessary, because they are adequately addressed
by the existing general provisions of 10 CFR 71.105 (``Quality
assurance program''). Regarding management review and approval of non-
substantive revisions to a quality assurance program, existing Sec.
71.105(d) states in relevant part that management of organizations
involved in a licensee's or CoC holder's quality assurance program
``shall review regularly the status and adequacy of that part of the
quality assurance program they are executing.'' The NRC finds that this
existing requirement adequately ensures management oversight of quality
assurance programs. Regarding the recommended need to have affected
individuals instructed on the revised QA program before the changes are
implemented, existing Sec. 71.105(d) states in relevant part that a
licensee or CoC holder ``shall provide for indoctrination and training
of personnel performing activities affecting quality, as necessary to
assure that suitable proficiency is achieved and maintained.'' The NRC
finds that this existing requirement adequately ensures that affected

[[Page 33999]]

individuals will be properly instructed before any QA program changes
are implemented.
Regarding the third recommendation to have records of these
instructions created and maintained, the NRC finds that this addition
to proposed 10 CFR 71.106 is not necessary, because it is adequately
addressed by the existing criteria stated in Sec. 71.135 (``Quality
assurance records''). Specifically, Sec. 71.135 states in relevant
part that a licensee or CoC holder must maintain written records, and
that such records include instructions pertaining to the ``required
qualifications of personnel.'' The NRC finds that this existing
requirement adequately ensures that training records will be created
and maintained.
Comment: Regarding proposed 10 CFR 71.106, a commenter requested
that corresponding changes be made to 10 CFR part 72, subpart G. The
commenter recommended that the NRC initiate action to make similar and
compatible changes to 10 CFR part 72, subpart G, so that all QA program
changes that do not reduce commitments could be implemented without
prior NRC approval.
Response: The NRC agrees with the commenter's recommendation, and
will consider making the recommended changes to 10 CFR part 72 during a
future rulemaking. However, changes to 10 CFR part 72 are outside the
scope of this 10 CFR part 71 rulemaking. Note that existing sets of
parallel QA provisions in 10 CFR 71.101(f) and 10 CFR 72.140(d) allow
for a single QA program to meet both the requirements of 10 CFR part 71
and 10 CFR part 72.

D. Technical Requirements

D.1 Latticing/Homogeneity
Comment: One commenter recommended that clarifying language be
provided relating to the prevention of latticing and also homogeneity
as it relates to the exemption for uranium enriched up to 1 percent.
The commenter noted that similar language to the proposed language
existed in earlier versions of the regulations, and that NUREG/CR 5342
recommended that the terms ``lattice arrangement'' and ``homogeneity''
either be removed or defined.
Response: The intent of the fissile material exemptions in 10 CFR
71.15 is to facilitate the safe transport of small quantities or low
concentrations of fissile material. This is accomplished by exempting
such fissile material from the criticality safety requirements in 10
CFR 71.55 and 71.59 that are generally applicable to fissile material
transportation packages. Since these packaging requirements are not
applicable pursuant to the 10 CFR 71.15 exemptions, it is
conservatively assumed that (a) small quantities or low concentrations
of fissile material can be released from packaging during transport,
(b) this material may configure into a worst-case geometric
arrangement, and (c) the fissile material may be subject to the fire
and water immersion conditions assumed for transportation criticality
analyses performed for approved packages under 10 CFR 71.55. The 10 CFR
71.15 exemptions are intended to ensure that criticality safety is
maintained under all credible transportation conditions, although it is
recognized that unlikely scenarios may be conceived which can make
almost any amount or concentration of material become a criticality
safety concern. As indicated in the comment, the NRC is restoring
former lattice arrangement and homogeneous distribution provisions, as
discussed in the following section, regarding the revised 10 CFR
71.15(d) exemption requirement.
Uranium enriched to less than 5.0 weight percent U-235 is generally
more reactive in a heterogeneous configuration than when it is
distributed homogeneously within a transportation package. The fissile
exemption for uranium enriched to a maximum of 1.0 weight percent U-235
in 10 CFR 71.15(d) is based on the fact that this enrichment level is
slightly less than the minimum critical U-235 enrichment for infinite
homogeneous mixtures of uranium and water. Accordingly, 10 CFR 71.15(d)
as revised requires that the fissile material be distributed
homogeneously within its transportation package, and excludes from the
exemption's scope situations where fissile ``lumps'' or lattice
arrangements of fissile material are present within the package. The 10
CFR 71.15(d) exemption language continues to exclude large quantities
(less than 5 percent of the uranium mass) of low-absorbing moderators
(beryllium, graphite, or hydrogenous material enriched in deuterium).
These requirements will preclude fissile material arrangements in
packages that can potentially result in criticality at U-235
enrichments less than 1 weight percent.
Homogeneity and lattice arrangement are well understood terms in
the criticality safety community. Nuclear Criticality Safety--Theory
and Practice (Knief, 1998), states that heterogeneous systems are
generally defined as any mixtures of fissile and moderator materials
with uniformly distributed fissile material particles larger than ~0.1
mm. Additionally, the IAEA Safety Guide TS-G-1.1, Advisory Material for
the IAEA Regulations for the Safe Transport of Radioactive Material,
contains a description of essentially homogeneous materials as ``those
in which the particles in the mixture are uniformly distributed and
have a diameter no larger than 127 microns (0.127 mm).'' Lattice
arrangement means a fixed, repeating configuration of separate fissile
material lumps. A nuclear fuel assembly is an example of a lattice
arrangement.
For the exemption in 10 CFR 71.15(d), small volumes of
heterogeneity may exist, provided that a significant fraction of
fissile material is homogeneous and mixed with non-fissile material, or
lumps of fissile material are in a largely irregular arrangement.
Further, heterogeneous effects in a package due to large fissile
material lumps/particles or lattice arrangements of fissile material
would only affect criticality safety in a regular or near-optimal
configuration over a large volume. Large quantities of fissile material
(kilograms of U-235) and regions of heterogeneity on the order of a
cubic meter in size are necessary before a system could adversely
affect the validity of the 1 weight percent U-235 enrichment limit for
this fissile exemption.

D.2 Container Closure Verification

Comment: One commenter was concerned that requiring the closure of
waste containers be verified by two independent inspectors prior to
shipment in a licensed package was not risk-informed. The commenter
believed that this new requirement was based on an incident with an
iridium source. The commenter stated that the majority of low-level
radioactive waste (LLRW) containers transported in licensed packages
are LSA group II materials that exhibit a few areas of elevated dose
rates that can exceed 1 R/hr at 3 meters and that this dose rate limit
is the main reason licensed shipping packages are employed for
transport of large containers of commercial LLRW in the United States.
The commenter believes that the risk from LSA material does not warrant
the dual container closure independent inspection requirement and that
such requirements should be limited to concentrated radioactive sources
similar to the one involved in the incident with an iridium source.
Response: The NRC's proposed rule did not address this topic. The
NRC neither has at present, nor is it proposing, a requirement that
``waste containers be verified by two independent inspectors prior to

[[Page 34000]]

shipment in a licensed package.'' Because this comment raises issues
that are outside the scope of this rulemaking, it will not be further
addressed here.
Comment: A commenter stated that containers of activated metal
loaded underwater cannot be sealed because the water must be allowed to
drain from the containers prior to shipment. Since activated metal is
not dispersible, sealing of the waste container should not be required.
Response: The NRC's proposed rule did not include such a
requirement. Because this comment raises issues that are outside the
scope of this rulemaking, it will not be further addressed here.

D.3 Activity Limit for Type B Packages

Comment: One commenter stated concerns that the new calculations to
limit the activity that a licensed Type B package may contain are not
risk informed for LSA group II low-level waste that commercial power
plants routinely ship. The commenter believes that these new
calculations were imposed because of an incident with an iridium
source, and therefore, such calculation requirements should be limited
to the shipment of concentrated radioactive sources similar to the one
involved in the event.
Response: The commenter misconstrues the proposed change in the
calculations regarding iridium. The NRC is not proposing any changes
regarding when Type B packages are required for LSA shipments. Under
existing regulations, Type B packaging is required for LSA when the
material has an external radiation dose greater than 10 mSv/h (1 rem/
h), at a distance of 3 meters from the unshielded material. Therefore,
the need for Type B packaging for LSA material is directly based on the
dose rate from, not the activity of, the material. Further, iridium
sources do not meet the existing 10 CFR 71.4 definition of LSA II (ii).
The proposed change regarding iridium pertains only to the placement of
an explanatory footnote in 10 CFR part 71, appendix A, Table A-1, to
make clear that the activity of special form iridium sources may be
determined through measurement at a prescribed distance from the
source.
Comment: A commenter stated that the NRC is now requiring
registered users of licensed packages to conduct and provide radiolysis
calculations on hydrogen gas generation. The commenter does not believe
a requirement for such calculations is risk informed. Combustible Gas
generation within a licensed transport package is a valid concern.
According to the commenter, based on past history, the source of
combustible gas generation from commercial LLRW is not from radiolysis,
but rather from biological sources (methane) or rusting of waste
container internals (hydrogen) noted as bulging drums. The commenter is
not aware of any calculation method for biological or rusting
combustible gas generation.
Response: This comment does not provide sufficient technical basis
for evaluation. The NRC is not aware of any requirement that registered
users of licensed packages conduct and provide radiolysis calculations
on hydrogen gas generation. Nor is the NRC aware of any history showing
that commercial LLRW is generating combustible gas from either
biological sources (methane) or rusting of waste container internals.
The topics discussed in this comment are outside the scope of this
rulemaking.

D.4 Storage of Radioactive Material Containers

Comment: One commenter had concerns that the proposed revision to
the DOT's and the NRC's regulations may have the unintended consequence
of severely complicating the storage of radioactive material containers
and conveyances when they are not in use. The DOT's rule essentially
defines ``returned to service (RTS)'' conveyances not in use for Class
7 material as radioactive material; therefore, it implies that a
radioactive material license is necessary to store these RTS
conveyances when they are not transporting Class 7 material. The
commenter is concerned that this would impose a significant burden on
industry processors as there are no licensed facilities that have
sufficient capacity to store the inventory of gondola rail cars and
other conveyances. The commenter does not believe that the DOT has
demonstrated, nor that in fact there exists, a health and safety
justification for imposing new restrictions on the storage of
conveyances while not in use. The commenter recommends that the NRC
should amend Sec. 71.14(a) to add a paragraph 4 that would read as
follows: ``(4) Transport vehicles with radioactive substances meeting
the return to service provisions of 49 CFR 173.443(c) in effect on
September 13, 2004, when in transport of contaminated or potentially
contaminated material or empty vehicles in storage pending future such
transportation. Such vehicles need not be licensed under this
chapter.''
Response: The NRC disagrees with this comment, because adding the
requested exemption to Sec. 71.14(a) would be contrary to existing
general provisions in 10 CFR part 71. Specifically, 10 CFR 71.0(b)
states that the 10 CFR part 71 requirements ``are in addition to, and
not in substitution for,'' NRC requirements in other 10 CFR parts.
Also, existing 10 CFR 71.0(c) states that no provision in 10 CFR part
71 ``authorizes possession of licensed material.'' The suggestion that
NRC use its 10 CFR part 71 transport regulations to exempt certain
transport vehicles from the need to have an NRC license is therefore
not permissible. Furthermore, under the DOT/NRC MOU, the DOT is
responsible for regulation of Class 7 (radioactive) material in
transport. The DOT is responsible for all transport modes, including
highway and railway conveyances. The DOT has established radiation dose
rate and removable contamination levels for returning exclusive use
vehicles to service. However, allowing exemption or release from
licensing of radioactive material, including conveyances not in
service, at these levels would not be compatible with current and
generally accepted radiation protection practices, (also see response
to comment A.1).

E. Other

E.1 Agreement State Compatibility
Comment: One commenter recommended that the compatibility for the
new proposed 10 CFR 71.85(d) be changed to `NRC' since paragraphs (a)
through (c) are being revised to compatibility ``NRC.''
Response: The NRC disagrees with this comment. As stated in the
2013 statement of considerations in the Federal Register notice of the
proposed rule, paragraphs (a) through (c) of Sec. 71.85 would be
designated as Compatibility Category NRC because as revised they would
apply exclusively to certificate holders, and granting package
approvals to certificate holders is an action reserved to the NRC. New
Sec. 71.85(d) applies to NRC licensees and licensees in Agreement
States that use the packages. This new requirement has been designated
as Compatibility Category ``B'' because it applies to activities that
have direct and significant effects in multiple jurisdictions, and
Agreement States should adopt program elements essentially identical to
those of NRC to achieve nationwide consistency.
Comment: One commenter recommended that the Agreement States be
offered 3 years to implement these changes when they are finalized by
the NRC.
Response: Agreement States, under their formal agreements with the
NRC, have 3 years after the effective date of the rule to adopt the
changes.

[[Page 34001]]

E.2 Cumulative Effect of Regulation
Comment: Section III.P of the Federal Register notice for the
proposed rule asked, ``Do other regulatory actions influence the
implementation of the proposed requirements?'' One commenter answered
``yes'' to this question and stated that the creation of 10 CFR part 37
and the revisions of 10 CFR parts 35 and 61 should take precedence over
this 10 CFR part 71 revision. The commenter indicated this revision
would also add to the workload of Agreement State staff needing to
revise their applicable regulations.
Response: The NRC agrees with the commenter that implementation of
this rulemaking will impact the Agreement States that are currently
implementing changes related to the recent promulgation of other rule
changes such as 10 CFR part 37. However, these 10 CFR part 71
amendments are necessary to make the NRC's regulations conform to the
IAEA's regulations for the international transportation of radioactive
material, and to maintain consistency with the DOT's regulations.
Agreement States may, and often do, combine the action of making their
regulations compatible with multiple NRC rule changes in one State
rulemaking action, which can somewhat reduce overall effort. Regarding
the added burden that may result from future changes to 10 CFR parts 35
and 61, it is uncertain when the final rule changes for those parts may
be approved by the Commission and promulgated.

V. Section-by-Section Analysis

Section 71.0 Purpose and Scope

Paragraph (d)(1) has been revised to delete Sec. 71.20 from the
list of sections in which a general license is issued without requiring
the NRC to issue a package approval. The list of sections has been
revised to add Sec. Sec. 71.21 through 71.23.

Section 71.4 Definitions

The definition of ``contamination'' has been added and is now
consistent with the definition of contamination in the DOT's
regulations in 49 CFR 173 and TS-R-1.
The definition of ``Criticality Safety Index (CSI)'' has been
revised to be more consistent with the definition in the DOT's
regulations in 49 CFR 173 and TS-R-1 by addressing overpacks and
freight containers in the definition.
The definition of ``Low Specific Activity (LSA) material'' has been
revised so that it is more consistent with the definition in the DOT's
regulations in 49 CFR 173 and TS-R-1 by revising paragraphs (1)(i) and
(1)(ii). In paragraph (1)(i), the definition is changed to make the
description of LSA-I material apply to material that is intended to be
processed for the use of the uranium, thorium, and other naturally
occurring radionuclides. In paragraph (1)(ii), the definition is
changed to clarify consideration of compounds or mixtures regardless of
the form (solid or liquid).
The definition of ``Special form radioactive material'' has been
revised to allow special form radioactive material that was
successfully tested using the current requirements of Sec. 71.75(d) to
continue to qualify as special form material, if the testing was
completed before September 10, 2015. The reference to the version of 10
CFR part 71 in effect on March 31, 1996, is corrected by changing 1983
to 1996.
The definition of ``Uranium--natural, depleted, enriched'' has been
revised by adding ``(which may be chemically separated)'' to paragraph
(1), which applies to natural uranium.

Section 71.6 Information Collection Requirements: OMB Approval

Paragraph (b) is revised to add Sec. 71.106 to the list of
sections with information collections.

Section 71.14 Exemption for Low-Level Materials

Paragraph (a)(1) has been revised to allow natural material and
ores that contain naturally occurring radionuclides and that have been
processed for purposes other than the extraction of the radionuclides,
to qualify for the exemption. Natural material or ore that has been
processed but has not been incorporated into a manufactured product,
such as an article, instrument, component of a manufactured article or
instrument, or consumer item, could qualify for the exemption. Slags,
sludges, tailings, residues, bag house dust, oil scale, and washed
sands that are the byproducts of processing or refining are considered
to be a natural material and could qualify for the exemption, provided
that they were not incorporated into a manufactured product. To qualify
for this exemption, the activity concentration of the natural material
or ore cannot exceed 10 times the activity concentration values, and
the material cannot be intended to be processed for the use of the
radionuclides. A reference to Table A-3 in appendix A is added as a
source of activity concentration values that may be used to determine
whether natural material or ore will qualify for the exemption. Table
A-3 provides activity concentration values for exempt material that are
used for individual radionuclides whose identities are known but which
are not listed in Table A-2.
Paragraph (a)(2) has been revised to add a reference to Table A-3
in appendix A Table A-3 provides activity concentration values for
exempt material that are used for individual radionuclides whose
identities are known but which are not listed in Table A-2.
Paragraph (a)(3) has been added to provide an exemption for non-
radioactive solid objects that have radioactive substances present on
the surfaces of the object, provided that the quantity of radioactive
substances is below the quantity used to define contamination. The
definition of ``contamination'' has been added to Sec. 71.4.

Section 71.15 Exemption From Classification as Fissile Material

Paragraph (d), which applies to fissile material in the form of
uranium enriched in U-235 to a maximum of 1 percent by weight, has been
revised. To qualify under the revised exemption, the fissile material
will need to be distributed homogeneously and not form a lattice
arrangement within the package. The revision re-establishes
restrictions on material that qualifies for the fissile material
exemption.

Section 71.17 General License: NRC-Approved Package

Paragraph (c) is revised to clarify that the general licensee must
comply with the requirements in Sec. 71.17(c)(1) through (c)(3).

Section 71.19 Previously Approved Package

Paragraphs (b) through (e) are redesignated as (a) through (d).
In redesignated (b)(2), the phrase ``After December 31, 2003'' is
deleted. This will not change the requirement that packages used for a
shipment to a location outside the United States will continue to be
subject to multilateral approval as defined in the DOT's regulations in
49 CFR 173.403 because all such shipments will occur after December 31,
2003.

Section 71.21 General License: Use of Foreign Approved Package

Paragraph (a) is revised to update the reference to 49 CFR 171.12
to 49 CFR 171.23.
Paragraph (d) is revised to clarify that the general licensee must
comply with the requirements in Sec. 71.21(d)(1) and (d)(2). Paragraph
(d)(2) is revised by deleting its second sentence, which provided an
exemption from quality

[[Page 34002]]

assurance provisions in subpart H for design, construction, and
fabrication activities. As revised, Sec. 71.21(d)(2) will require
general licensees to comply ``with the terms and conditions of the
certificate and revalidation, and with the applicable requirements of
subparts A, G, and H'' of 10 CFR part 71. Because the quality assurance
provisions in subpart H for design, construction, and fabrication
activities are not applicable to a general licensee, the exemption was
not needed.

Section 71.31 Contents of Application

In paragraph (b), the reference to Sec. 71.13 is changed to Sec.
71.19. This change was inadvertently omitted during a previous
rulemaking, when certain sections were renumbered.

Section 71.38 Renewal of a Certificate of Compliance

The title of this section is revised to remove the reference to the
renewal of quality assurance program approvals. The section is revised
to be limited to the renewal of CoCs by removing all references to
quality assurance program approvals. The NRC is changing its practice
regarding the duration of quality assurance program approvals. Quality
assurance program approvals will not have an expiration date and the
NRC will revise the current quality assurance program approvals so that
they will not have an expiration date. The renewal of a quality
assurance program approval is unnecessary. Paragraphs (a), (b) and (c)
have also been revised for clarity.

Section 71.70 Incorporations by Reference

This section is added to incorporate by reference the consensus
standards referenced in Sec. 71.75: ISO 9978:1992(E), ``Radiation
protection--Sealed radioactive sources--Leakage test methods''; and ISO
2919:1999(E), ``Radiation protection--Sealed radioactive sources--
General requirements and classification.'' Interested parties,
including members of the general public, can purchase the 1992 version
of ISO 9978 from the American National Standards Institute, 25 West
43rd Street, 4th floor, New York, NY 10036, 212-642-4900, https://www.ansi.org, or info@ansi.org. Interested parties, including members
of the general public can purchase the 1999 version of ISO 2919 on
https://www.amazon.com. The materials incorporated by reference can also
be examined at the NRC's Public Document Room, O1-F21, 11555 Rockville
Pike, Rockville, Maryland 20852 or at the NRC Library located at Two
White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852;
telephone: 301-415-5610; email: Library.Resource@nrc.gov. The materials
incorporated by reference are each available for under $126.
Accordingly, the NRC has determined that materials incorporated by
reference are reasonably available to all interested parties, including
members of the general public.

Section 71.75 Qualification of Special Form Radioactive Material

In paragraph (a)(5), the 1992 edition of ISO 9978 has been
incorporated by reference for the alternate leak test methods for the
qualification of special form material. The ISO/TR 4826 has been
withdrawn by ISO and replaced by ISO 9978:1992(E). This change makes 10
CFR part 71 consistent with the DOT's requirements in 49 CFR 173, which
incorporated ISO 9978:1992(E) in 2004.
In paragraph (b)(2)(ii), the description of the billet used in the
percussion test has been changed to provide better clarity and to
maintain consistency with the language used by the DOT in 49 CFR
173.469 by replacing ``edges'' with ``edge.'' The edge corresponds to
the circular edge at the face of the billet.
In paragraph (b)(2)(iii), the description of the sheet of lead used
in the percussion test is changed to correct the thickness of the sheet
of lead used in the percussion test to indicate that the thickness must
not be more than 25 mm (1 inch) thick to be consistent with the
thickness in TS-R-1.
In paragraph (d), subparagraphs (d)(1)(i) and (d)(1)(ii) have been
added. Also, the 1999 edition of ISO 2919 has been incorporated by
reference, replacing the reference to the 1980 edition of ISO 2919 for
the alternate Class 4 impact test in paragraph (d)(1)(i) and the
alternate Class 6 temperature test in paragraph (d)(2). The
availability and other language incorporating this standard by
reference is moved to new Sec. 71.70. Paragraph (d)(1)(ii) allows the
Class 5 impact tests prescribed in the 1999 edition of ISO 2919 to be
used in place of the impact and percussion tests in paragraphs (b)(1)
and (b)(2), if the specimen weighs less than 500 grams.

Section 71.85 Preliminary Determinations

In paragraphs (a), (b), and (c), ``licensee'' is replaced by
``certificate holder.'' The NRC experience is that these determinations
are performed by the certificate holders who manufacture the package.
This change will make the requirements consistent with current
practice, because only certificate holders will have a quality
assurance program approval that will allow them to conduct the required
tests under an approved quality assurance program. Paragraph (d) is
added to address the responsibilities of licensees using a package for
transportation. Although certificate holders are required to make the
preliminary determinations under paragraphs (a), (b), and (c),
licensees are responsible for ensuring that these determinations have
been made before their first use of the packaging.

Section 71.91 Records

In paragraph (a), the reference to Sec. 71.10 is changed to Sec.
71.14. This reference was not updated when Sec. 71.10 was redesignated
as Sec. 71.14.

Section 71.101 Quality Assurance Requirements

Paragraph (a) is revised by deleting its first reference to
licensees in order to clarify that with respect to the design,
fabrication, testing, and modification of packaging, only certificate
holders and applicants for a CoC are subject to the quality assurance
requirements. Note that consistent with the existing 71.101(c)(1) QA-
program-approval requirements, under 71.101(a), as revised, licensees
are still subject to quality assurance requirements with respect to
their use of packages when shipping radioactive material.
The provisions of 71.101(c)(2) are revised by removing the
reference to licensees in the first sentence. This will remove the
overlap between Sec. 71.101(c)(1) and (c)(2) by making it clear that
licensees must notify the NRC before their first use of any package as
required under Sec. 71.101(c)(1), and certificate holders and
applicants for a CoC will notify the NRC before the fabrication,
testing, or modification of a package as required under Sec.
71.101(c)(2).

Section 71.103 Quality Assurance Organization

Footnote 2 is removed from paragraph (a). The activities described
in the footnote are performed by certificate holders and applicants for
a CoC. The footnote is unnecessary, because the requirements no longer
rely on the use of the term ``licensee'' for those activities performed
by certificate holders and applicants for a CoC.

Section 71.106 Changes to a Quality Assurance Program

This new section is added to establish requirements that will apply
to changes to quality assurance programs. It allows some changes to a
quality assurance program to be made without obtaining the prior
approval of the NRC. Previously, all changes, no matter how

[[Page 34003]]

insignificant, had to be approved by the NRC before they could be
implemented. These provisions will allow changes to quality assurance
programs that do not reduce commitments, such as those that involve
administrative improvements and clarifications and editorial changes,
to be made and implemented without NRC approval. Quality assurance
program approval holders will still be required to get NRC approval
before making changes to their quality assurance programs that would
reduce their commitments to the NRC.
Paragraph (a) will establish the requirements that will apply when
a holder of a quality assurance program approval intends to make a
change in its quality assurance program that would reduce its
commitments to the NRC. The holder of a quality assurance program
approval will be required to identify the change, the reason for the
change, and the basis for concluding that the revised program
incorporating the change will continue to satisfy the requirements of
subpart H of 10 CFR part 71 that apply.
Paragraph (a)(2) will require that each holder of a quality
assurance program approval maintain quality assurance program changes
as records. These records will need to be maintained as required in
Sec. 71.135.
Paragraph (b) will allow the holder of a quality assurance program
approval to make changes to its quality assurance program that will not
reduce its commitments to the NRC and identify the changes that will
not be considered as reducing its commitments to the NRC.
Paragraph (c) will require that records be maintained documenting
any changes to the quality assurance program.

Section 71.135 Quality Assurance Records

This section is revised to include those quality assurance records
that apply to changes that are made to previously approved quality
assurance programs. The second sentence is revised to include in the
list of the types of records to be maintained the changes to the
quality assurance program as required by new Sec. 71.106.

Appendix A Determination of A1 and A2

In paragraphs IV.a. through IV.f., the equations and accompanying
text are revised to make minor corrections. In paragraphs IV.a. and
IV.b., the description of the equations will make it explicit that B(i)
is the activity of radionuclide i in special form and normal form in
paragraphs IV.a. and IV.b., respectively.
Current paragraphs IV.c. through IV.f. are redesignated as
paragraphs IV.d. through IV.g. New paragraph IV.c. is added and
provides an equation to be used for determining the quantity of
radioactive material that can be shipped in a package that contains
both special form and normal form radioactive material. This equation
increases the consistency between appendix A and TS-R-1.
In paragraph V., the existing text is redesignated as paragraph
V.a. Paragraph V.b. is added to provide direction on calculating the
exempt activity concentration for a mixture and the exempt consignment
activity limit of a mixture when the identity of each radionuclide is
known, but the individual activities of some radionuclides are not
known.
Table A-1 is revised to change the A1 value for Cf-252
from 5.0 x 10^-2 TBq to 1.0 x 10^-1 TBq, and from
1.4 Ci to 2.7 Ci. Footnote h is deleted, and the following
corresponding changes are made: (1) The reference to footnote h is
removed from Cf-252, (2) footnote i is redesignated as footnote h, and
(3) the entry for molybdenum-99 (Mo-99) is revised to identify footnote
h instead of footnote i. Footnote c in the entry for Ir-192 is moved,
so that it is clear that it applies only to iridium in special form.
Footnote c is revised to specifically state that the activity of
iridium in special form may be determined through measurement at a
prescribed distance from the source. Table A-1 is revised to include
values for Kr-79. The A1 and A2 values for Kr-79
correspond to the A1 and A2 values in TS-R-1 and
the specific activity is 4.2 x 10\4\ TBq/g (1.1 x 10\6\ Ci/g). The
entry for Kr-81 is revised to reflect that it is no longer the first
entry for the isotopes of krypton. In addition, footnote a is revised
to identify the A1 and/or A2 values that include
contributions from daughter radionuclides with half-lives of less than
10 days.
Table A-2 is revised to include values for Kr-79, reflect changes
in TS-R-1 for the activity limit for exempt consignment for Te-121m and
in the list of parent radionuclides and their progeny included in
secular equilibrium in Table A-2 in footnote b. The value for the
activity concentration for exempt material for Kr-79 is 1.0 x 0\3\ Bq/g
(2.7 x 10^-8 Ci/g) and the value for the activity limit for
exempt consignment is 1.0 x 10\5\ Bq (2.7 x 10^-6 Ci). The
activity limit for exempt consignment for Te-121m is revised from 1 x
10\5\ Bq (2.7 x 10^-6 Ci) to 1 x 10\6\ Bq (2.7 x
10^-5 Ci). In footnote b, the chains for the parent
radionuclides Ce-134, Rn-220, Th-226, and U-240 are removed, and a
chain for Ag-108m is added. This makes footnote b to Table A-2
consistent with footnote b to Table 2 in TS-R-1.
Table A-3 is revised to reflect changes in TS-R-1. In the second
entry, the descriptive phrase ``only alpha emitting radionuclides are
known to be present'' is changed to ``alpha emitting nuclides, but no
neutron emitters, are known to be present'' to reduce the confusion
caused by the current phrase because all alpha emitting radionuclides
also emit other particles and/or gamma rays. In the third entry, the
descriptive phrase ``no relevant data are available'' is changed to
``neutron emitting nuclides are known to be present or no relevant data
are available'' to clarify that neutron-emitting radionuclides, or
alpha emitters that also emit neutrons, such as Cf-252, Cf-254, and Cm-
248, should be assigned to the third group. Footnote a indicates the
appropriate value of A1 for a group containing both alpha
emitting radionuclides and beta or gamma emitting radionuclides when
groups of radionuclides are based on the total alpha activity and the
total beta and gamma activity.

VI. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, well-organized manner
that also follows other best practices appropriate to the subject or
field and the intended audience. The NRC has attempted to use plain
language in promulgating this rule consistent with the Federal Plain
Writing Act as well as the Presidential Memorandum, ``Plain Language in
Government Writing,'' published June 10, 1998 (63 FR 31883).

VII. Finding of No Significant Environmental Impact: Availability

The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, not to prepare an environmental impact
statement for this final rule. The Commission has concluded on the
basis of an Environmental Assessment (ADAMS Accession No. ML15105A527)
that this final rule is not a major Federal action significantly
affecting the quality of the human environment.
Many of the changes fall under a categorical exclusion for which
the Commission has previously determined that such actions, neither
individually nor cumulatively, will have significant impacts on the
human environment. The categorical exclusions in 10 CFR 51.22(c)(2) and
10 CFR 51.22(c)(3) were used in the Environmental Assessment.

[[Page 34004]]

The categorical exclusion at 10 CFR 51.22(c)(2) applies to amendments
to 10 CFR part 71 that are corrective or of a minor or non-policy
nature and do not substantially modify the regulations.
The categorical exclusion at 10 CFR 51.22(c)(3) applies to
amendments to 10 CFR part 71 that relate to--(1) procedures for filing
and reviewing applications for licenses or construction permits or
early site permits or other forms of permission or for amendments to or
renewals of licenses or construction permits or early site permits or
other forms of permission; (2) recordkeeping requirements; (3)
reporting requirements; (4) education, training, experience,
qualification, or other employment suitability requirements; or (5)
actions on petitions for rulemaking relating to these amendments.
Those changes not qualifying for a categorical exclusion were
evaluated for their environmental impacts and include changes to (1)
definitions, (2) the exemption of low-level materials, (3) the fissile
material exemption for low-enriched fissile material, (4) alternate
tests that may be used for the qualification of special form material,
(5) preliminary determinations; (6) the A1 and A2
values for radionuclides, and (7) the exempt material activity
concentrations and exempt consignment activity limits for
radionuclides. The effects of these changes are addressed in more
detail in the Environmental Assessment. The changes to the fissile
material exemption will further reduce the potential for criticality
during the transport of low-enriched fissile material under the fissile
material exemption. Other changes, such as those relating to the
exemption of low-level material, the A1 and A2
values for radionuclides, and the exempt material activity
concentrations and exempt consignment activity limits for radionuclides
have been found to have small or very small impacts. Some natural
material and ore may be shipped without being regulated as hazardous
material. The low-level material exemption is changed to allow some
additional material to be transported without being regulated as
hazardous material. The amount of transported material affected by this
change is a very small fraction of the material that already qualifies
for the exemption and will allow no greater activity than is already
allowed for material that may already be transported under the
exemption. Although there are changes to A1 and
A2 values used to determine the type of packaging, the
exempt material activity concentrations, and the exempt consignment
activity limits for some radionuclides, the approach for determining
the appropriate values has not changed, so there are very small impacts
from these changes.

VIII. Paperwork Reduction Act Statement

This final rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). These requirements were approved by the
Office of Management and Budget, approval number 3150-0008. The burden
to the public for these information collections is estimated to be a
reduction of 1,700 hours (an average reduction of 55 hours per
response), including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing the information collection. Send comments on
any aspect of these information collections, including suggestions for
reducing the burden, to the FOIA, Privacy, and Information Collections
Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, or by email to INFOCOLLECTS.RESOURCE@NRC.GOV; and to the
Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202,
(3150-0008), Office of Management and Budget, Washington, DC 20503 or
by email to oira_submission@omb.eop.gov.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.

IX. Congressional Review Act

This action is a rule as defined in the Congressional Review Act (5
U.S.C. 801-808). However, the Office of Management and Budget has not
found it to be a major rule as defined in the Congressional Review Act.

X. Regulatory Flexibility Certification

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule will not, if
promulgated, have a significant economic impact on a substantial number
of small entities. This rule affects NRC licensees who transport or
deliver to a carrier for transport, relatively large quantities of
radioactive material in a single package; holders of a 10 CFR part 71,
subpart H, quality assurance program description issued under 10 CFR
parts 50, 71, or 72; and holders of a CoC for a transportation package.
These entities do not typically fall within the scope of the definition
of ``small entities'' set forth in the Regulatory Flexibility Act or
the size standards adopted by the NRC in 10 CFR 2.810.

XI. Regulatory Analysis

The NRC has prepared a regulatory analysis (ADAMS Accession No.
ML14237A383) of this final rule. The analysis examines the costs and
benefits of the alternatives considered by the Commission.
The analysis is available for inspection in the NRC Public Document
Room, 11555 Rockville Pike, Rockville, MD 20852; or at https://www.regulations.gov under Docket ID NRC-2008-0198.

XII. Backfitting and Issue Finality

The NRC has determined that the backfit rule (Sec. Sec. 50.109,
70.76, 72.62, or 76.76) and the issue finality provisions in 10 CFR
part 52 do not apply to this final rule, because this final rule does
not establish any provisions that will impose backfits as defined in 10
CFR Chapter I. Therefore, a backfit analysis is not required for this
final rule, and the NRC did not prepare a backfit analysis for this
final rule.

XIII. Criminal Penalties

For the purpose of Section 223 of the Atomic Energy Act of 1954, as
amended (AEA), the Commission is amending 10 CFR part 71 under one or
more of Sections 161b, 161i, or 161o of the AEA. Willful violations of
the rule will be subject to criminal enforcement.

XIV. Compatibility of Agreement State Regulations

Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
this rule is a matter of compatibility between the NRC and the
Agreement States, thereby providing consistency among the Agreement
States' and the NRC's requirements. The NRC analyzed the rule in
accordance with the procedure established within part III,
``Categorization Process for NRC Program Elements,'' of Handbook 5.9 to
Management Directive 5.9, ``Adequacy and Compatibility of Agreement
State Programs'' (ADAMS Accession No. ML041770094). The compatibility
categories assigned to the affected sections of 10 CFR part 71 are
presented

[[Page 34005]]

in the Compatibility Table in this section.
There are four compatibility categories (A, B, C, and D). In
addition, the NRC program elements can also be identified as having
particular health and safety significance or as being reserved solely
to the NRC. Compatibility Category A is assigned to those program
elements that are basic radiation protection standards and scientific
terms and definitions that are necessary to understand radiation
protection concepts. An Agreement State should adopt Compatibility
Category A program elements in an essentially identical manner to
provide uniformity in the regulation of agreement material on a
nationwide basis. Compatibility Category B is assigned to those program
elements that apply to activities that have direct and significant
effects in multiple jurisdictions. An Agreement State should adopt
Compatibility Category B program elements in an essentially identical
manner. Compatibility Category C is assigned to those program elements
that do not meet the criteria of Compatibility Category A or B, but the
essential objectives of which an Agreement State should adopt to avoid
conflict, duplication, gaps, or other conditions that would jeopardize
an orderly pattern in the regulation of agreement material on a
nationwide basis. An Agreement State should adopt the essential
objectives of the Compatibility Category C program elements.
Compatibility Category D is assigned to those program elements that do
not meet any of the criteria of Compatibility Category A, B, or C and,
therefore, do not need to be adopted by Agreement States for purposes
of compatibility. Health and Safety (H&S) are program elements that are
not required for compatibility but are identified as having a
particular health and safety role (i.e., adequacy) in the regulation of
agreement material within the State. Although not required for
compatibility, the State should adopt program elements in this H&S
category based on those of the NRC that embody the essential objectives
of the NRC program elements because of particular health and safety
considerations. Compatibility Category NRC is assigned to those program
elements that address areas of regulation that cannot be relinquished
to Agreement States under the AEA or the provisions of 10 CFR. These
program elements are not adopted by the Agreement States.
The following table lists the parts and sections that are revised
and their corresponding categorization under the ``Policy Statement on
Adequacy and Compatibility of Agreement State Programs.'' A bracket
around a category means that the section may have been adopted
elsewhere, and it is not necessary to adopt it again. The presence or
absence of a bracket does not affect the compatibility category or the
degree of uniformity required when an Agreement State adopts the
requirement. The Agreement States have 3 years from the effective date
of the final rule to adopt compatible regulations.

Compatibility Table
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject ---------------------------------------
Existing New \1\
----------------------------------------------------------------------------------------------------------------
71.0(d)(1)...................... Revised........... Purpose and Scope. D................. D.
71.4............................ New............... Definition .................. [B].
Contamination.
71.4............................ Revised........... Definition [B]............... [B].
Criticality
Safety Index
(CSI).
71.4............................ Revised........... Definition Low [B]............... [B].
Specific Activity
(LSA) material.
71.4............................ Revised........... Definition Special [B]............... [B].
form radioactive
material.
71.4............................ Revised........... Definition [B]............... [B].
Uranium--natural,
depleted,
enriched.
71.6............................ Revised........... Information D................. D.
Collection
Requirements: OMB
Approval.
71.14(a)(1)..................... Revised........... Exemption for low- [B]............... [B].
level materials.
71.14(a)(2)..................... Revised........... Exemption for low- [B]............... [B].
level materials.
71.14(a)(3)..................... New............... Exemption for low- .................. [B].
level materials.
71.15(d)........................ Revised........... Exemption from [B]............... [B].
classification as
fissile material.
71.17........................... Removal of General license: [B]............... B.
brackets on NRC-approved
Compatibility package.
Category.
71.17(c)........................ Revised........... General license: [B]............... B.
NRC-approved
package.
71.19........................... Revised........... Previously NRC............... NRC.
approved package.
71.21........................... Removal of General license: [B]............... B.
brackets on Use of foreign
Compatibility approved package.
Category.
71.21(a)........................ Revised........... General license: [B]............... B.
Use of foreign
approved package.

[[Page 34006]]

71.21(d)........................ Revised........... General license: [B]............... B.
Use of foreign
approved package.
71.31(b)........................ Revised........... Contents of NRC............... NRC.
application.
71.38........................... Retitled and Renewal of a NRC............... NRC.
revised. certificate of
compliance.
71.70........................... New............... Incorporations by .................. NRC
reference.
71.75........................... Revised........... Qualification of NRC............... NRC.
special form
radioactive
material.
71.85(a)........................ Revised........... Preliminary [B]............... NRC.
determinations.
71.85(b)........................ Revised........... Preliminary [B]............... NRC.
determinations.
71.85(c)........................ Revised........... Preliminary [B]............... NRC.
determinations.
71.85(d)........................ New............... Preliminary --................ B.
determinations.
71.91(a)........................ Revised........... Records........... D................. C.
71.91(b)........................ Revised Records........... D................. NRC.
Compatibility
Category.
71.91(c)........................ Revised Records........... D................. C.
Compatibility
Category.
71.91(d)........................ Revised Records........... D................. C.
Compatibility
Category.
71.101(a)....................... Revised........... Quality assurance D--For those C.
requirements. States which have **Note: Sec.
no users of Type 71.101(g)
B packages--other indicates that QA
than industrial programs for
radiography**. industrial
C--Those States radiography Type
which have users B package users
of Type B are covered by
packages--other Sec. 34.31(b).
than industrial It also indicated
radiography**. that this section
**Note: Sec. satisfies Sec.
71.101(g) 71.17(b) and
indicates that QA therefore will
programs for satisfy those
industrial sections
radiography Type referenced in
B package users this provision
are covered by (Sec. Sec.
Sec. 34.31(b). 71.101 through
It also indicated 71.137).
that this section
satisfies Sec.
71.12(b) and
therefore will
satisfy those
sections
referenced in
this provision
(Sec. Sec.
71.101 through
71.137).

[[Page 34007]]

71.101(b)....................... Revised Quality assurance D--For those C.
Compatibility requirements. States which have **Note: Sec.
Category. no users of Type 71.101(g)
B packages--other indicates that QA
than industrial programs for
radiography**. industrial
C--Those States radiography Type
which have users B package users
of Type B are covered by
packages--other Sec. 34.31(b).
than industrial It also indicated
radiography**. that this section
**Note: Sec. satisfies Sec.
71.101(g) 71.17(b) and
indicates that QA therefore will
programs for satisfy those
industrial sections
radiography Type referenced in
B package users this provision
are covered by (Sec. Sec.
Sec. 34.31(b). 71.101 through
It also indicated 71.137).
that this section
satisfies Sec.
71.12(b) and
therefore will
satisfy those
sections
referenced in
this provision
(Sec. Sec.
71.101 through
71.137).
71.101(c)(1).................... Revised Quality assurance D--For those C.
Compatibility requirements. States which have **Note: Sec.
Category. no users of Type 71.101(g)
B packages--other indicates that QA
than industrial programs for
radiography**. industrial
C--Those States radiography Type
which have users B package users
of Type B are covered by
packages--other Sec. 34.31(b).
than industrial It also indicated
radiography**. that this section
**Note: Sec. satisfies Sec.
71.101(g) 71.17(b) and
indicates that QA therefore will
programs for satisfy those
industrial sections
radiography Type referenced in
B package users this provision
are covered by (Sec. Sec.
Sec. 34.31(b). 71.101 through
It also indicated 71.137).
that this section
satisfies Sec.
71.12(b) and
therefore will
satisfy those
sections
referenced in
this provision
(Sec. Sec.
71.101 through
71.137).
71.101(c)(2).................... Revised........... Quality assurance NRC............... NRC.
requirements.
71.101(g)....................... Revised Quality assurance C................. C.
Compatibility requirements. **Note: Sec. **Note: Sec.
Category Note. 71.101(g) 71.101(g)
indicates that QA indicates that QA
programs for programs for
industrial industrial
radiography Type radiography Type
B package users B package users
are covered by are covered by
Sec. 34.31(b). Sec. 34.31(b).
It also indicated It also indicated
that this section that this section
satisfies Sec. satisfies Sec.
71.12(b) and 71.17(b) and
therefore will therefore will
satisfy those satisfy those
sections sections
referenced in referenced in
this provision this provision
(Sec. Sec. (Sec. Sec.
71.101 through 71.101 through
71.137). 71.137).

[[Page 34008]]

71.103(a)....................... Revised........... Quality assurance D--For those C.
organization. States which have **Note: Sec.
no users of Type 71.101(g)
B packages-other indicates that QA
than industrial programs for
radiography**. industrial
[C]--Those States radiography Type
which have users B package users
of Type B are covered by
packages-other Sec. 34.31(b).
than industrial It also indicated
radiography**. that this section
**Note: Sec. satisfies Sec.
71.101(g) 71.17(b) and
indicates that QA therefore will
programs for satisfy those
industrial sections
radiography Type referenced in
B package users this provision
are covered by (Sec. Sec.
Sec. 34.31(b). 71.101 through
It also indicated 71.137).
that this section
satisfies Sec.
71.12(b) and
therefore will
satisfy those
sections
referenced in
this provision
(Sec. Sec.
71.101 through
71.137).
71.103(b)....................... Revised Quality assurance C--Those States C
Compatibility organization. which have users **Note: Sec.
Category Note. of Type B 71.101(g)
packages-other indicates that QA
than industrial programs for
radiography**. industrial
**Note: Sec. radiography Type
71.101(g) B package users
indicates that QA are covered by
programs for Sec. 34.31(b).
industrial It also indicated
radiography Type that this section
B package users satisfies Sec.
are covered by 71.17(b) and
Sec. 34.31(b). therefore will
It also indicated satisfy those
that this section sections
satisfies Sec. referenced in
71.12(b) and this provision
therefore will (Sec. Sec.
satisfy those 71.101 through
sections 71.137).
referenced in
this provision
(Sec. Sec.
71.101 through
71.137)..
71.106.......................... New............... Changes to quality --................ C
assurance program.
71.135.......................... Revised........... Quality assurance D--For those C.
records. States which have **Note: 10 CFR
no users of Type 71.101(g)
B packages--other indicates that QA
than industrial programs for
radiography**. industrial
C--For those radiography Type
States which have B package users
users of Type B are covered by
packages--other Sec. 34.31(b).
than industrial It also indicated
radiography**. that this section
**Note: 10 CFR satisfies Sec.
71.101(g) 71.17(b) and
indicates that QA therefore will
programs for satisfy those
industrial sections
radiography Type referenced in
B package users this provision
are covered by (Sec. Sec.
Sec. 34.31(b). 71.101 through
It also indicated 71.137).
that this section
satisfies Sec.
71.12(b) and
therefore will
satisfy those
sections
referenced in
this provision
(Sec. Sec.
71.101 through
71.137).

[[Page 34009]]

Appendix A...................... Revise paragraphs Determination of [B]............... [B]
IV.a.-IV.f.; A1 and A2.
redesignate
paragraphs IV.c.-
IV.f. as
paragraphs IV.d.-
IV.g.; add
paragraph IV.c.;
redesignate the
text of paragraph
V. as paragraph
V.a.; and add
paragraph V.b.
Appendix A, Table A-1........... Revise entries for A1 and A2 Values [B]............... [B].
Cf-252, Ir-192, for Radionuclides.
Kr-81, and Mo-99;
revise footnote
a; delete
footnote h; and
redesignate
footnote i as
footnote h..
Add entry for Kr-
79.
Appendix A, Table A-2........... Add entry for Kr- Exempt Material [B]............... [B].
79; revise Activity
entries for Kr-81 Concentrations
and Te-121m; and and Exempt
revise footnote b. Consignment
Activity Limits
for Radionuclides.
Appendix A, Table A-3........... Revise entries for General Values for [B]............... [B].
column 1, A1 and A2.
``Contents,'' and
add footnote a.
----------------------------------------------------------------------------------------------------------------
\1\ Where there is a change in the assigned compatibility category, a compatibility category is assigned. Where
the content of the section has been significantly changed, a summary of the analysis is presented below.
Changes in the assigned compatibility category have been made in Sec. Sec. 71.4 (added for the definition
of contamination), 71.70, 71.85, 71.91, 71.101, 71.103, 71.106, and 71.135.

In Sec. 71.4, the definition of contamination will be designated
Compatibility Category B, because it applies to activities that have
direct and significant effects in multiple jurisdictions and it is also
defined in the corresponding DOT regulations.
In Sec. Sec. 71.17, 71.21, and 71.103 the compatibility category
is unchanged, but the brackets were not retained because there are no
corresponding DOT regulations.
The new Sec. 71.70, ``Incorporations by reference,'' will be
designated Compatibility Category NRC, because the documents
incorporated by reference are incorporated for use in Sec. 71.75,
which addresses activities under Federal jurisdiction.
Section 71.85, ``Preliminary determinations,'' will be changed to
make the requirements in Sec. 71.85(a) through (c) apply to holders of
a CoC. Paragraphs 71.85(a) through (c) are designated as Compatibility
Category NRC, because they apply exclusively to certificate holders and
the granting of the package approval is reserved to the NRC. Paragraph
71.85(d) will be added and applies to licensees and it is designated as
Compatibility Category B, because it applies to activities that have
direct and significant effects in multiple jurisdictions and there is
no corresponding DOT requirement.
The compatibility category for Sec. 71.91, ``Records,'' will be
changed from Compatibility Category D to Compatibility Category C. In
reaching an agreement with the NRC, the States have a general provision
relating to records and for incident reporting. The recordkeeping
requirements in Sec. 71.91 include requirements associated with
transportation, which may involve multiple jurisdictions. With the
exception of Sec. 71.91(b), the NRC is designating the compatibility
of the requirements in Sec. 71.91 as Compatibility Category C to
require that the essential objectives of the requirements be adopted to
avoid conflict, duplication, gaps, or other conditions that would
jeopardize the orderly pattern in the regulation of agreement material
on a nationwide basis, including creating an undue burden on interstate
commerce through additional recordkeeping requirements; Sec. 71.91(b)
only applies to CoC holders and applicants and are designated as
compatibility category NRC. The States are not required to adopt them
in an essentially identical manner, as might be necessary if the
requirements had a more direct and significant impact on multiple
jurisdictions.
In Sec. 71.101, the compatibility category will be simplified with
the removal of the separate compatibility category for States that do
not have a user of a Type B package. If a State does not have a user of
a Type B package, the State is able to seek an exemption from the
requirement to make their requirement compatible. The State
requirements only need to be essentially compatible with respect to the
requirements as they apply to licensees, because the application of the
requirements to CoC holders and applicants would be performed by the
NRC. The note that references the quality assurance programs for
industrial radiographers is updated by changing Sec. 71.12(b) to Sec.
71.17(b).
In Sec. 71.103, the compatibility category for some users of
packages was not designated. The compatibility category will be
simplified by removing the separate compatibility category for States
that do not have a user of a Type B package and by removing the bracket
around the compatibility category for Sec. 71.103(a). If a State does
not have a user of a Type B package, the State can seek an exemption
from the requirement to make their requirement compatible. The State
requirements only need to be essentially compatible with respect to the
requirements as they apply to licensees, because the application of the
requirements to CoC holders and

[[Page 34010]]

applicants will be performed by the NRC. The note that references the
quality assurance programs for industrial radiographers will be updated
by changing Sec. 71.12(b) to Sec. 71.17(b).
The new Sec. 71.106, ``Changes to quality assurance program,''
will apply to licensees and holders of, or applicants for, a CoC. The
assigned compatibility category is consistent with the other quality
assurance requirements that apply to licensees. The State requirements
only need to be essentially compatible with respect to the requirements
as they apply to licensees, because the application of the requirements
to CoC holders and applicants will be performed by the NRC.
In Sec. 71.135, the compatibility category will be simplified by
removing the separate compatibility category for States that do not
have a user of a Type B package. If a State does not have a user of a
Type B package, the State can seek an exemption from the requirement to
make their requirement compatible. The State requirements only need to
be essentially compatible with respect to the requirements as they
apply to licensees, because the application of the requirements to CoC
holders and applicants will be performed by the NRC. The note that
references the quality assurance programs for industrial radiographers
is updated by changing Sec. 71.12(b) to Sec. 71.17(b).

XV. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113) requires that Federal agencies use technical standards that
are developed or adopted by voluntary consensus standards bodies unless
the use of such a standard is inconsistent with applicable law or
otherwise impractical. In this final rule, the NRC uses the consensus
standards identified as follows and will incorporate them by reference.
The NRC is adopting ISO 2919:1999(E), ``Radiation protection--Sealed
radioactive sources--General requirements and classification,'' Second
Edition (February 15, 1999), for the Class 4 and Class 5 impact tests
and the Class 6 temperature test; and ISO 9978:1992(E), ``Radiation
protection--Sealed radioactive sources--Leakage test methods,'' First
Edition (February 15, 1992), for the leaktightness tests.
In other portions of this final rule, the NRC is revising
requirements that do not constitute the establishment of a standard
that establishes generally applicable requirements. These revisions to
the NRC's requirements include changes to: (1) The scope of material
falling under an existing exemption for natural materials and ores
containing naturally occurring radionuclides at an activity
concentration below a specified value, (2) conditions on general
licenses, (3) the oversight of quality assurance programs, and (4) the
removal of transitional arrangements for previously approved packages.

XVI. Availability of Guidance

In the Rules and Regulations section of this issue of the Federal
Register, the NRC is issuing revised implementation guidance for this
rule, RG 7.10, Revision 3, ``Establishing Quality Assurance Programs
for Packaging Used in Transport of Radioactive Material'' (Docket ID
NRC-2013-0082). The guidance is also available in ADAMS under Accession
No. ML14064A505. Revised RG 7.10 is intended to describe a proposed
method that the NRC staff considers acceptable for use in complying
with the NRC's proposed amendments to its regulations on quality
assurance programs related to transport of radioactive materials.
Because the regulatory analysis for the final rule provides sufficient
explanation for the rule and its implementing guidance, a separate
regulatory analysis was not prepared for RG 7.10.

XVII. Incorporation by Reference Under 1 CFR Part 51--Reasonable
Availability to Interested Parties

The NRC is required by law to obtain approval for incorporation by
reference from the Office of the Federal Register (OFR). The OFR's
requirements for incorporation by reference are set forth in 1 CFR part
51. On November 7, 2014, the OFR adopted changes to its regulations
governing incorporation by reference (79 FR 66267). The OFR regulations
require an agency to discuss, in the preamble of the final rule, the
ways that the materials it incorporates by reference are reasonably
available to interested parties and how interested parties can obtain
the materials. The discussion in this section complies with the
requirement for proposed rules as set forth in 1 CFR 51.5(b)(2).
The NRC considers ``interested parties'' to include all potential
NRC stakeholders, not just the individuals and entities regulated or
otherwise subject to the NRC's regulatory oversight. These NRC
stakeholders are not a homogenous group but vary with respect to the
considerations for determining reasonable availability. Therefore, the
NRC distinguishes between different classes of interested parties for
purposes of determining whether the material is ``reasonably
available.'' The NRC considers the following to be classes of
interested parties in NRC rulemakings generally:
Individuals and small entities regulated or otherwise
subject to the NRC's regulatory oversight (this class also includes
applicants and potential applicants for licenses and other NRC
regulatory approvals).
Large entities otherwise subject to the NRC's regulatory
oversight (this class also includes applicants and potential applicants
for licenses and other NRC regulatory approvals). In this context,
``large entities'' are those which do not qualify as a ``small entity''
under 10 CFR 2.810.
Non-governmental organizations with institutional
interests in the matters regulated by the NRC.
Other Federal agencies, states, local governmental bodies
(within the meaning of 10 CFR 2.315(c)).
Federally-recognized and State-recognized Indian tribes.
Members of the general public (i.e., individual,
unaffiliated members of the public who are not regulated or otherwise
subject to the NRC's regulatory oversight).
International Organization for Standardization's (ISO)
9978:1992(E), ``Radiation protection--Sealed radioactive sources--
Leakage test methods,'' First Edition (February 15, 1992), is
incorporated by reference for Sec. 71.75(a). Interested parties,
including the general public, can purchase the February 1992 version of
ISO 9978 from the American National Standards Institute, 25 West 43rd
Street, 4th floor, New York, NY 10036, 212-642-4900, https://www.ansi.org, or info@ansi.org. The cost is $88.
ISO 2919:1999(E), ``Radiation protection--Sealed radioactive
sources--General requirements and classification,'' Second Edition
(February 15, 1999), is incorporated by reference for Sec. 71.75(d).
Interested parties, including the general public, can purchase the 1992
edition of ISO 2919 on https://www.amazon.com for approximately $125.00.
The two ISO standards incorporated by reference into 10 CFR 71.75
may be examined at the NRC's Public Document Room, O1-F21, 11555
Rockville Pike, Rockville, Maryland 20852 or at the NRC Library located
at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland
20852; telephone: 301-415-5610; email: Library.Resource@nrc.gov. The
two ISO standards are also 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-

[[Page 34011]]

6030 or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
The NRC believes that the two ISO standards are reasonably
available to large entities subject to the NRC's regulatory oversight
pursuant to 10 CFR 71.75, non-governmental organizations with
institutional interests in the matters regulated by the NRC, other
Federal agencies, states, local governmental bodies (within the meaning
of 10 CFR 2.315(c)), and Federally-recognized and State-recognized
Indian tribes. With respect to individuals and small entities regulated
or otherwise subject to the NRC's regulatory oversight pursuant to 10
CFR 71.75, the NRC believes that the approximately $213 cost of
obtaining the two ISO standards is reasonable for such individuals and
small entities, and therefore that the two standards are reasonably
available to these individuals and small entities. With respect to the
general public, the NRC has identified above the ways in which the two
ISO standards may be obtained. Because individuals and small entities
are not required to comply with these two ISO standards, the NRC
believes that the two standards are reasonably available to general
public in accordance with the ways described above for obtaining
access.

List of Subjects in 10 CFR Part 71

Criminal penalties, Hazardous materials transportation,
Incorporation by reference, Nuclear materials, Packaging and
containers, Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting
the following amendments to 10 CFR part 71.

PART 71--PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL

0
1. The authority citation for part 71 continues to read as follows:

Authority: Atomic Energy Act secs. 53, 57, 62, 63, 81, 161, 182,
183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201,
2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act secs. 201,
202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste
Policy Act sec. 180 (42 U.S.C. 10175); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, Pub. L. 109-58, 119 Stat. 594 (2005).
Section 71.97 also issued under sec. 301, Pub. L. 96-295, 94
Stat. 789-790.

Sec. 71.0 [Amended]

0
2. In Sec. 71.0, paragraph (d)(1), remove the reference ``Sec. Sec.
71.20 through 71.23'' and add, in its place, the reference ``Sec. Sec.
71.21 through 71.23''.

0
3. In Sec. 71.4, add in alphabetical order the definition of
``contamination,'' and revise the definitions of ``Criticality Safety
Index (CSI),'' ``Low Specific Activity (LSA) material,'' ``Special form
radioactive material,'' and ``Uranium--natural, depleted, enriched'' to
read as follows:

Sec. 71.4 Definitions.

* * * * *
Contamination means the presence of a radioactive substance on a
surface in quantities in excess of 0.4 Bq/cm2 (1 x 10^-5
[micro]Ci/cm\2\) for beta and gamma emitters and low toxicity alpha
emitters, or 0.04 Bq/cm2 (1 x 10^-6 [micro]Ci/cm\2\) 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 means contamination that can be removed
from a surface during normal conditions of transport.
* * * * *
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 Sec. Sec. 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.
* * * * *
Low Specific Activity (LSA) material means radioactive material
with limited specific activity which is nonfissile or is excepted under
Sec. 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 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 10^-4 A2/g for solids and gases, and
10^-5 A2/g for liquids.
(3) LSA-III. Solids (e.g., consolidated wastes, activated
materials), excluding powders, that satisfy the requirements of Sec.
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, 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 10^-3
A2/g.
* * * * *
Special form radioactive material means radioactive material that
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 Sec. 71.75. A special form
encapsulation designed in accordance with the requirements of Sec.
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 Sec.
71.4 in effect

[[Page 34012]]

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 Sec. 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.
* * * * *
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.

0
4. In Sec. 71.6, revise paragraph (b) to read as follows:

Sec. 71.6 Information collection requirements: OMB approval.

* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 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.

0
5. In Sec. 71.14, revise paragraphs (a)(1) and (2), and add paragraph
(a)(3) to read as follows:

Sec. 71.14 Exemption for low-level materials.

(a) * * *
(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.
(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 Sec. 71.4.
* * * * *

0
6. In Sec. 71.15, revise paragraph (d) to read as follows:

Sec. 71.15 Exemption from classification as fissile material.

* * * * *
(d) Uranium enriched in uranium-235 to a maximum of 1 percent by
weight, and with total plutonium and uranium-233 content of up to 1
percent of the mass of uranium-235, provided that the mass of any
beryllium, graphite, and hydrogenous material enriched in deuterium
constitutes less than 5 percent of the uranium mass, and that the
fissile material is distributed homogeneously and does not form a
lattice arrangement within the package.
* * * * *

0
7. In Sec. 71.17, revise paragraph (c) to read as follows:

Sec. 71.17 General license: NRC-approved package.

* * * * *
(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 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 Sec. 71.1(a), the licensee's name and
license number and the package identification number specified in the
package approval.
* * * * *

0
8. In Sec. 71.19, redesignate paragraphs (b) through (e) as paragraphs
(a) through (d), and revise newly redesignated paragraph (b)(2) to read
as follows:

Sec. 71.19 Previously approved package.

* * * * *
(b) * * *
(2) A package used for a shipment to a location outside the United
States is subject to multilateral approval as defined in the DOT's
regulations at 49 CFR 173.403.
* * * * *

0
9. In Sec. 71.21, revise paragraphs (a) and (d) to read as follows:

Sec. 71.21 General license: Use of foreign approved package.

(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
revalidated by the DOT as meeting the applicable requirements of 49 CFR
171.23.
* * * * *
(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.

Sec. 71.31 [Amended]

0
10. In Sec. 71.31, paragraph (b), remove the reference ``Sec. 71.13''
and add, in its place, the reference ``Sec. 71.19''.

0
11. Revise Sec. 71.38 to read as follows:

Sec. 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 submit a consolidated
application that is

[[Page 34013]]

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.

0
12. Add Sec. 71.70 to subpart F to read as follows:

Sec. 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 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
at the NRC's Public Document Room, O1-F21, 11555 Rockville Pike,
Rockville, Maryland 20852 or at the NRC Library located at Two White
Flint North, 11545 Rockville Pike, Rockville, Maryland 20852;
telephone: 301-415-5610; email: Library.Resource@nrc.gov, and is
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 https://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:
https://www.iso.org.
(1) ISO 9978:1992(E), ``Radiation protection--Sealed radioactive
sources--Leakage test methods,'' First Edition (February 15, 1992),
incorporation by reference approved for Sec. 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, https://www.ansi.org, or info@ansi.org.
(2) ISO 2919:1999(E), ``Radiation protection--Sealed radioactive
sources--General requirements and classification,'' Second Edition
(February 15, 1999), incorporation by reference approved for Sec.
71.75(d), is available on https://www.amazon.com.
0
13. In Sec. 71.75, revise paragraphs (a)(5), (b)(2)(ii) and (iii), and
(d)(1) and (2) to read as follows:

Sec. 71.75 Qualification of special form radioactive 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 protection--Sealed radioactive sources--
Leakage test methods'' (incorporated by reference, see Sec. 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 protection--
Sealed radioactive sources--General requirements and classification''
(incorporated by reference, see Sec. 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 Sec. 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 Sec. 71.70).

0
14. In Sec. 71.85, revise paragraphs (a), (b), and (c) and add
paragraph (d) to read as follows:

Sec. 71.85 Preliminary determinations.

* * * * *
(a) The certificate holder shall ascertain that there are no
cracks, pinholes, uncontrolled voids, or other defects that could
significantly reduce the effectiveness of the packaging;
(b) Where the maximum normal operating pressure will exceed 35 kPa
(5 lbf/in\2\) 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
(d) The licensee shall ascertain that the determinations in
paragraphs (a) through (c) of this section have been made.

Sec. 71.91 [Amended]

0
15. In Sec. 71.91, in paragraph (a) introductory text, remove the
reference ``Sec. 71.10'' and add, in its place, the reference ``Sec.
71.14''.

0
16. In Sec. 71.101, revise paragraphs (a) and (c)(2) to read as
follows:

Sec. 71.101 Quality assurance requirements.

(a) Purpose. This subpart describes quality assurance requirements
applying to design, purchase, fabrication, handling, shipping, storing,
cleaning, assembly, inspection, testing, operation, maintenance,
repair, and modification of components of packaging that are important
to safety. As used in this subpart, ``quality assurance'' comprises all
those planned and systematic actions necessary to provide adequate
confidence that a system or component will perform satisfactorily in
service. Quality assurance includes quality control, which comprises
those quality assurance actions related to control of the physical
characteristics and quality of the material or component to
predetermined requirements. Each 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.
* * * * *
(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

[[Page 34014]]

shall obtain Commission approval of its quality assurance program. Each
certificate holder or applicant for a CoC shall, in accordance with
Sec. 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.
* * * * *

0
17. In Sec. 71.103, revise paragraph (a) to read as follows:

Sec. 71.103 Quality assurance organization.

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

0
18. Add Sec. 71.106 to subpart H to read as follows:

Sec. 71.106 Changes to quality assurance program.

(a) Each quality assurance program approval holder shall submit, in
accordance with Sec. 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 commitments shall be
submitted to the NRC every 24 months, in accordance with Sec. 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 holder's or applicant's 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
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.

0
19. Revise Sec. 71.135 to read as follows:

Sec. 71.135 Quality assurance records.

The licensee, certificate holder, and applicant for a Certificate
of Compliance shall maintain sufficient written records to describe the
activities affecting quality. These records must include changes to the
quality assurance program as required by Sec. 71.106, the
instructions, procedures, and drawings required by Sec. 71.111 to
prescribe 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 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.

0
20. In appendix A to part 71:
0
a. Revise paragraphs IV.a. and IV.b., redesignate paragraphs IV.c.
through IV.f. as 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.;
0
b. In Table A-1, add an entry for Kr-79 in 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;
0
c. In Table A-2, add the entry for Kr-79 in alphanumeric order, revise
the entries for Kr-81 and Te-121m, and revise footnote b; and
0
d. In Table A-3, revise the second and third entries and add a new
footnote a.
The additions and revisions read as follows:

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.094

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.095

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.096

[[Page 34015]]

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.097

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.098

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.
f. The exempt activity concentration for mixtures of nuclides
may be determined as follows:
[GRAPHIC] [TIFF OMITTED] TR12JN15.099

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:
[GRAPHIC] [TIFF OMITTED] TR12JN15.100

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.
* * * * *

Table A-1--A1 and A2 Values for Radionuclides
--------------------------------------------------------------------------------------------------------------------------------------------------------
Specific activity
Symbol of radionuclide Element and atomic A1 (TBq) A1 (Ci) \b\ A2 (TBq) A2 (Ci) \b\ -------------------------------
No. (TBq/g) (Ci/g)
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * * * *
Cf-252............................ .................... 1.0 x 10-\1\ 2.7 3.0 x 10-\3\ 8.1 x 10-\2\ 2.0 x 10\1\ 5.4 x 10\2\

* * * * * * *
Ir-192............................ .................... \c\ 1.0 \c\ 2.7 x 6.0 x 10-\1\ 1.6 x 10\1\ 3.4 x 10\2\ 9.2 x 10\3\
10\1\

* * * * * * *
Kr-79............................. Krypton (36)........ 4.0 1.1 x 10\2\ 2.0 5.4 x 10\1\ 4.2 x 10\4\ 1.1 x 10\6\
Kr-81............................. .................... 4.0 x 10\1\ 1.1 x 10\3\ 4.0 x 10\1\ 1.1 x 10\3\ 7.8 x 10-\4\ 2.1 x 10-\2\

* * * * * * *
Mo-99 \a\ \h\..................... .................... 1.0 2.7 x 10\1\ 6.0 x 10-\1\ 1.6 x 10\1\ 1.8 x 10\4\ 4.8 x 10\5\

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

[[Page 34016]]

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
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.
* * * * * * *

[[Page 34017]]

Table A-2--Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activity Activity
concentration for concentration for Activity limit Activity limit
Symbol of radionuclide Element and atomic No. exempt material exempt material for exempt for exempt
(Bq/g) (Ci/g) consignment (Bq) consignment (Ci)
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * * * *
Kr-79....................................... Krypton (36).................. 1.0 x 10\3\ 2.7 x 10-8 1.0 x 10\5\ 2.7 x 10-6
Kr-81....................................... .............................. 1.0 x 10\4\ 2.7 x 10-7 1.0 x 10\7\ 2.7 x 10-4

* * * * * * *
Te-121m..................................... .............................. 1.0 x 10\2\ 2.7 x 10-9 1.0 x 10\6\ 2.7 x 10-5

* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
\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

* * * * * * *

[[Page 34018]]

Table A-3--General Values for a1 and A2
--------------------------------------------------------------------------------------------------------------------------------------------------------
A1 A2 Activity Activity
-------------------------------------------------------- concen- concen- Activity Activity
tration for tration for limits for limits for
Contents exempt exempt exempt exempt
(TBq) (Ci) (TBq) (Ci) material (Bq/ material (Ci/ consign- consign-
g) g) ments (Ba) ments (Ci)
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * * * *
Alpha emitting nuclides, but no neutron 2 x 10-\1\ 5.4 x 10\0\ 9 x 10-\5\ 2.4 x 10-\3\ 1 x 10-\1\ 2.7 x 10- 1 x 10\3\ 2.7 x 10-\8\
emitters, are known to be present (a).. \12\
Neutron emitting nuclides are known to 1 x 10-\3\ 2.7 x 10-\2\ 9 x 10-\5\ 2.4 x 10-\3\ 1 x 10-\1\ 2.7 x 10- 1 x 10\3\ 2.7 x 10-\8\
be present or no relevant data are \12\
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.
* * * * * * *

Dated at Rockville, Maryland, this 4th day of June, 2015.

For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015-14212 Filed 6-11-15; 8:45 am]
BILLING CODE 7590-01-P

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