[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Rules and Regulations]
[Pages 33988-34018]
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 http://www.regulations.gov and search for Docket ID NRC-2008-0198. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. 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 http://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 [email protected]. 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: [email protected].

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: 
[email protected], or Renouf Publishing Company Ltd., 812 Proctor 
Ave., Ogdensburg, NY 13669-2205; telephone: 1-888-551-7470; email: 
[email protected]. An electronic copy of TS-R-1 may be found at 
the following IAEA Web site: http://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.
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    \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.
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    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.
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    \2\ http://pbadupws.nrc.gov/docs/ML0036/ML003686268.pdf.
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    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).
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    \3\ http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=10804.
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    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\ http://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 http://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, http://www.ansi.org, or [email protected]. Interested parties, including members 
of the general public can purchase the 1999 version of ISO 2919 on 
http://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: [email protected]. 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 [email protected]; 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 [email protected].

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 http://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, http://www.ansi.org, or [email protected]. 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 http://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: [email protected]. 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 http://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: [email protected], 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 http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) International Organization for Standardization, ISO Central 
Secretariat, Chemin de Blandonnet 8 CP 401, 1214 Vernier, Geneva, 
Switzerland; email: [email protected]; phone: +41 22 749 01 11; Web site: 
http://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, http://www.ansi.org, or [email protected].
    (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 http://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