Revisions to Transportation Safety Requirements and Harmonization With International Atomic Energy Agency Transportation Requirements, 28987-29016 [2013-11552]
Download as PDF
<![CDATA[
Vol. 78
Thursday,
No. 95
May 16, 2013
Part III
Nuclear Regulatory Commission
tkelley on DSK3SPTVN1PROD with PROPOSALS2
10 CFR Part 71
Revisions to Transportation Safety Requirements and Harmonization With
International Atomic Energy Agency Transportation Requirements;
Establishing Quality Assurance Programs for Packaging Used in Transport
of Radioactive Material; Proposed Rules
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
PO 00000
Frm 00001
Fmt 4717
Sfmt 4717
E:\FR\FM\16MYP2.SGM
16MYP2
28988
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 71
[NRC–2008–0198; NRC–2013–0082]
RIN 3150–AI11
Revisions to Transportation Safety
Requirements and Harmonization With
International Atomic Energy Agency
Transportation Requirements
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC), in consultation with
the U.S. Department of Transportation
(DOT), is proposing to amend its
regulations for the packaging and
transportation of radioactive material.
These amendments would make NRC
regulations conform to revisions to the
International Atomic Energy Agency
(IAEA) regulations for the international
transportation of radioactive material
and maintain consistency with DOT
regulations. These changes are
necessary to maintain a consistent
regulatory framework for the
transportation and packaging of
radioactive material. These changes
would make the regulation of quality
assurance programs more efficient by
allowing changes that do not change
quality assurance approval holder
commitments to be made without prior
NRC approval, and extending the
duration of quality assurance program
approvals. These changes would clarify
the responsibilities of general licensees
and further limit the shipping of fissile
material under a general license. The
parallel DOT proposed rulemaking was
published in the Federal Register on
August 12, 2011.
DATES: Submit comments by July 30,
2013. Submit comments specific to the
information collections aspect of this
proposed rule by June 17, 2013.
Comments received after these dates
will be considered if it is practical to do
so, but the NRC is able to assure
consideration only for comments
received on or before these dates.
ADDRESSES: You may submit comments
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific topic):
• Federal rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2008–0198. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–492–3668;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
tkelley on DSK3SPTVN1PROD with PROPOSALS2
SUMMARY:
VerDate Mar<15>2010
17:58 May 15, 2013
individual listed in the FOR FURTHER
section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Fax comments to: Secretary, U.S.
Nuclear Regulatory Commission at 301–
415–1101.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
• Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
(Eastern Time) Federal workdays;
telephone: 301–415–1677.
For additional direction on accessing
information and submitting comments,
see ‘‘Accessing Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
James Firth, Office of Federal and State
Materials and Environmental
Management Programs, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555–0001, telephone: 301–415–
6628; email: James.Firth@nrc.gov.
SUPPLEMENTARY INFORMATION: The
parallel DOT proposed rulemaking was
published in the Federal Register on
August 12, 2011 (76 FR 50332).
INFORMATION CONTACT
Jkt 229001
I. Accessing Information and Submitting
Comments
II. Background
III. Discussion
A. What action is the NRC proposing to
take?
B. Who is affected by this proposed action?
C. Which changes are being proposed to
increase the compatibility with the
International Atomic Energy Agency
Regulations (TS–R–1) and consistency
with the DOT regulations?
D. How is the NRC proposing to change the
exemption for materials with low
activity levels?
E. How might the qualification of special
form radioactive material change?
F. What changes may be made to Appendix
A, ‘‘Determination of A1 and A2 Values,’’
to part 71 of title 10 of the Code of
Federal Regulations (10 CFR)?
G. How would the responsibilities of
certificate holders and licensees change
with these amendments?
H. Why would renewal of my quality
assurance program description not be
necessary?
I. What changes could be made to a quality
assurance program description without
seeking prior NRC approval?
J. How frequently would I submit periodic
updates on my quality assurance
program description to the NRC?
K. How would the requirements in subpart
H, ‘‘Quality Assurance,’’ change with the
PO 00000
Frm 00002
Fmt 4701
Sfmt 4702
removal of the footnote in 10 CFR
71.103?
L. What changes would be made to general
licenses?
M. How would the exemption from
classification as fissile material (10 CFR
71.15) change?
N. What other changes is the NRC
proposing to make to its regulations for
the packaging and transportation of
radioactive material?
O. When Would these proposed
amendments become effective?
P. What should I consider as I prepare my
comments to the NRC?
IV. Section-by-Section Analysis
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Availability of Documents
VIII. Plain Writing
IX. Voluntary Consensus Standards
X. Finding of No Significant Environmental
Impact: Availability
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfitting
I. Accessing Information and
Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC–2008–
0198 when contacting the NRC about
the availability of information for this
proposed rule. You may access
information related to this proposed
rulemaking, which the NRC possesses
and is publicly available, by any of the
following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2008–0198.
• NRC Agencywide Documents
Access and Management System
(ADAMS): You may access publicly
available documents online in the NRC
Library at https://www.nrc.gov/readingrm/adams.html. To begin the search,
select ‘‘ADAMS Public Documents’’ and
then select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced in this proposed
rule (if that document is available in
ADAMS) is provided the first time that
a document is referenced. In addition,
for the convenience of the reader, the
ADAMS accession numbers are
provided in a table in Section VI,
Availability of Documents, of this
document.
• 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.
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
B. Submitting Comments
Please include Docket ID NRC–2008–
0198 in the subject line of your
comment submission, in order to ensure
that the NRC is able to make your
comment submission available to the
public in this docket.
The NRC cautions you not to include
identifying or contact information that
you do not want publicly disclosed in
your comment submission. The NRC
will post all comment submissions at
https://www.regulations.gov as well as
enter the comment submissions into
ADAMS, and the NRC does not
routinely edit comment submissions to
remove identifying or contact
information.
If you are requesting or aggregating
comments from other persons for
submission to the NRC, then you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
Your request should state that the NRC
does not routinely edit comment
submissions to remove such information
before making the comment
submissions available to the public or
entering the comment submissions into
ADAMS.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
II. Background
The NRC is proposing to revise its
regulations for the safe transportation of
radioactive material to make them
compatible with those of the IAEA. The
proposed rule, in combination with a
corresponding amendment of Title 49 of
the Code of Federal Regulations (49
CFR), by the DOT (76 FR 50332; August
12, 2011), would bring United States
regulations into general accord with the
2009 edition of the IAEA’s ‘‘Regulations
for the Safe Transport of Radioactive
Material’’ (TS–R–1). The NRC is also
proposing to make revisions to maintain
consistency with revisions to DOT
regulations. In addition, the NRC is
making other revisions to its
transportation regulations in 10 CFR
part 71. These other revisions include
NRC-initiated changes that would affect
administrative procedures for the
quality assurance program requirements
described in 10 CFR part 71, subpart H;
re-establish restrictions on material that
qualifies for the fissile material
exemption; clarify the requirements for
a general license; clarify the
responsibilities of certificate holders
and licensees when making preliminary
determinations; and make other
editorial changes.
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
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. The IAEA has developed
international safety standards for the
safe transport of radioactive material,
TS–R–1. The IAEA safety standards and
regulations are developed in
consultation with the competent
authorities of Member States, so they
reflect an international consensus on
what is needed to provide for a highlevel 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
that 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 experience.
On January 26, 2004 (69 FR 3698), the
NRC published in the Federal Register
a final revision to 10 CFR part 71,
‘‘Compatibility with IAEA
Transportation Safety Standards (TS–R–
1) and Other Transportation Safety
Amendments.’’ That revision, in
combination with a parallel revision of
the DOT hazardous materials
transportation regulations, brought the
United States domestic transport
regulations into general accord with the
1996 edition of TS–R–1 (as amended in
2000). The DOT published its
corresponding revision to 49 CFR parts
171 through 178 on the same date (69
FR 3632; January 26, 2004).
The IAEA periodically reviews and
revises the IAEA international
transportation standards to reflect
knowledge gained in scientific and
technical advances and accumulated
experience. In 2002, the IAEA began
using a 2-year review cycle. In each
review cycle, the IAEA will invite
Member States—the United States is a
Member State and the DOT is the
United States competent authority
before the IAEA for radioactive material
transportation matters—to submit for
consideration issues or problems that
could result in changes to the IAEA
transportation regulations and the
associated guidance. These issues and
problems are then considered by the
IAEA Transportation Safety Standards
PO 00000
Frm 00003
Fmt 4701
Sfmt 4702
28989
Committee (TRANSSC) and, if approved
by TRANSSC, will be developed into
specific proposed changes to the
transportation regulations. The specific
proposed changes are then considered at
a second TRANSSC meeting. The IAEA
will then issue those approved changes
at the second TRANSSC meeting for
formal review and comment by Member
States.
The IAEA has invited Member States
to submit comments and suggest
changes to the regulations as part of
these periodic revisions. The NRC and
DOT have sought public input related to
the proposed revisions. On July 22,
2003, the DOT held a public meeting,
with the NRC participating, to obtain
public views on proposed changes to
the 1996 edition of TS–R–1 and
accepted written comments through
August 8, 2003. On November 5, 2003,
the DOT held a public meeting, with the
NRC participating, seeking public views
on the DOT positions on the proposed
changes to TS–R–1. The NRC published
Federal Register notices on June 26,
2003 (68 FR 37986); October 24, 2003
(68 FR 60886); April 23, 2004 (69 FR
21978); April 27, 2005 (70 FR 21684);
and November 21, 2007 (72 FR 65470),
soliciting public input on proposed
revisions to TS–R–1. Subsequent to the
1996 edition of TS–R–1 (as amended in
2000), the IAEA published revisions to
TS–R–1 in 2003, 2005, and 2009.
This rulemaking effort would involve
harmonizing the NRC regulations at 10
CFR part 71 with changes to the IAEA
transportation regulations through TS–
R–1. Copies of TS–R–1 may be obtained
from the United States distributors,
Bernan, 15200 NBN Way, P.O. Box 191,
Blue Ridge Summit, PA 17214;
telephone: 1–800–865–3457; email:
customercare@bernan.com, or Renouf
Publishing Company Ltd., 812 Proctor
Ave., Ogdensburg, NY 13669–2205;
telephone: 1–888–551–7470; email:
orders@renoufbooks.com. An electronic
copy may be found at the following
IAEA Web site: https://wwwpub.iaea.org/MTCD/publications/PDF/
Pub1384_web.pdf. The regulations in
TS–R–1 represent an accepted set of
requirements that provide a high level
of safety in the packaging and
transportation of radioactive materials
and provide 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
E:\FR\FM\16MYP2.SGM
16MYP2
28990
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
material. Harmonization represents the
effort to increase the consistency or
compatibility between national
regulations and the internationallyaccepted requirements, within the
constraints of an existing national legal
and regulatory framework.
In November 2012, the IAEA issued
new standards for the safe transport of
radioactive material and designated
them as ‘‘Specific Safety Requirements
Number SSR–6’’ (SSR–6). This proposed
rulemaking would not incorporate the
2012 changes, which will undergo a
comprehensive review by the NRC staff
to determine if additional changes to 10
CFR part 71 are warranted.
Historically, the NRC has coordinated
its revisions to 10 CFR part 71 with the
DOT, because the DOT is the United
States competent authority for
transportation of hazardous materials.
‘‘Radioactive Materials’’ is a subset of
‘‘Hazardous Materials’’ in Title 49
regulations under DOT authority. The
DOT hazardous materials regulations
are found in 49 CFR parts 171 through
177. Currently, 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 coregulation of the transportation of
radioactive materials are described in a
memorandum of understanding (MOU)
(44 FR 38690; July 2, 1979). Consistent
with this MOU, the NRC is continuing
to coordinate its efforts with the DOT in
this proposed rulemaking process. Refer
to the DOT corresponding rule for
additional background on the proposed
changes in this document.
Scope of 10 CFR Part 71 Proposed
Rulemaking
The NRC staff evaluated recent
changes in the IAEA’s transportation
standards through the 2009 edition of
TS–R–1 to identify changes to be made
in 10 CFR part 71. Based on this effort,
the NRC staff identified a number of
areas in 10 CFR part 71 that need to be
addressed in this proposed rulemaking
process as a result of the changes to the
IAEA regulations. These changes are
discussed in Section III of this
document, question C, ‘‘Which Changes
are Being Proposed to Increase the
Compatibility with the International
Atomic Energy Agency Regulations (TS–
R–1) and Consistency with DOT
Regulations?’’
The NRC is also proposing a number
of self-initiated changes to its
regulations that are not related to either
compatibility with IAEA regulations or
consistency with DOT regulations.
These NRC changes would affect
administrative procedures for the
quality assurance program requirements
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
described in 10 CFR part 71, subpart H,
re-establish restrictions on material that
qualifies for the fissile material
exemption, clarify the requirements for
a general license, clarify the
responsibilities of certificate holders
and licensees when making preliminary
determinations, and make other
editorial changes.
Fissile Material Exemption
In 1997, the NRC issued an emergency
final rule (62 FR 5907; February 10,
1997) that revised the regulations on
fissile material exemptions and the
general licenses that apply to fissile
material. The NRC determined that good
cause existed under Section 553(b)(3)(B)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)(3)(B)), to publish
this final rule without notice and
opportunity for public comment.
Further, the NRC also determined that
good cause existed, under Section
553(d)(3) of the APA (5 U.S.C.
553(d)(3)), to make the final rule
immediately effective. Notwithstanding
the final status of the rule, the NRC
provided for a 30-day public comment
period. The NRC subsequently
published in the Federal Register (64
FR 57769; October 27, 1999) a response
to the comments received on the
emergency final rule and a request for
information on any unintended
economic impacts caused by the final
rule. Based on the public comments on
the emergency final rule, the NRC staff
contracted with 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
regulations may be excessive for
shipments where water moderation is
the only concern. The ORNL study
recommended that the NRC revise 10
CFR part 71. The ORNL made a
recommendation that applied to the
1 NUREG/CR–5342, ‘‘Assessment and
Recommendations for Fissile-Material Packaging
Exemptions and General Licenses within 10 CFR
Part 71,’’ July 1998.
PO 00000
Frm 00004
Fmt 4701
Sfmt 4702
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, hereafter referred
to as uranium enriched to a maximum
of 1 percent. Specifically, ORNL
recommended: (1) That a definition of
‘‘homogeneity’’ be developed that could
be clearly understood for use with
uranium enriched to a maximum of 1
percent; (2) the term ‘‘lattice
arrangement’’ be clarified or not used;
and (3) if the definitions for
homogeneity and lattice arrangement
cannot be provided, a restriction on
beryllium (Be), deuterium oxide (e.g.,
D2O or heavy water), and carbon
(graphite) (C) should be maintained. The
ORNL recommended that the moderator
criteria restricting the mass of Be, C, or
D2O to less than 0.1 percent of the fissile
mass should be maintained, which
would remove the need to provide
definitions—such as ‘‘homogeneous’’
and ‘‘lattice arrangement’’—that are
difficult to define and to apply
practically. The NRC staff indicated that
it agreed with the ORNL
recommendations (67 FR 21390; April
30, 2002) and removed the homogeneity
and lattice prevention requirements
from the fissile material exemptions.
The ORNL recommendations were
considered when the NRC proposed
changes to 10 CFR part 71 (67 FR 21390;
April 30, 2002) to make NRC regulations
more consistent and compatible with
IAEA regulations and to make changes
to the fissile material exemption
requirements to address the unintended
economic impact of the NRC emergency
final rule entitled ‘‘Fissile Material
Shipments and Exemptions’’ (62 FR
5907; February 10, 1997). In its final
rule (69 FR 3698; January 26, 2004) to
make 10 CFR part 71 compatible with
the IAEA regulations and make other
transportation safety amendments, the
NRC removed the restriction that, to
qualify for the fissile material
exemption, uranium enriched in U–235
is distributed homogeneously
throughout the package and does not
form a lattice arrangement within the
package, and redesignated the section
for fissile material exemptions from
§ 71.53 to § 71.15. Based on a comment
that shippers would have difficulty
implementing the proposed rule
language, the NRC determined that it
would be impractical to implement a
restriction based on the proposed ratio
of the restricted moderators to the fissile
mass and changed the restriction to
require that the mass of beryllium,
graphite, and hydrogenous material
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
enriched in deuterium be less than 5
percent of the mass of uranium; the NRC
concluded that limiting the mass of
these moderators to less than 5 percent
of the uranium mass would assure
subcriticality for all moderators of
concern.
Subsequent to the 2004 rulemaking,
the U.S. Department of Energy (DOE)
was planning a shipment of large
quantities of low-enriched fissile
material that would qualify for the
exemption at 10 CFR 71.15(d). Analyses
performed by the DOE indicated that
large arrays of heterogeneous uranium
with enrichment of 1 percent by weight
of U–235 could exceed a keff of 0.95
when optimally moderated by water.
For the material to become critical,2 the
keff would need to be greater than or
equal to 1.0. However, the quantity and
geometric arrangement of this material
exceeded a keff of 0.95, which is
typically used as a limit in regulatory
assessments of package designs for the
transport of fissile material. The
sensitivity of keff to increases in the
quantity of fissile material and changes
in geometry will depend on the
properties of the material. For uranium
enriched to a maximum of 1 percent and
keff greater than 0.95, keff is very
insensitive to changes in geometry and
quantity; consequently, significantly
larger quantities of material would be
required to get keff close to 1.0.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Quality Assurance Program Approvals
Part 71 of 10 CFR does not include
provisions for making changes to an
approved quality assurance program
without obtaining prior NRC approval
before implementing the change. The
requirement to obtain prior NRC
approval currently applies to all
changes, no matter how insignificant in
importance they are to safety.
Consequently, the process can be overly
burdensome and inefficient for both the
licensee and the NRC. For example, a
change in the quality assurance program
to correct typographical errors or
punctuation would need to be
submitted and approved by the NRC.
In the past, the NRC observed several
instances in which holders of a 10 CFR
part 71 quality assurance program
approval had made changes to their
2 For transportation purposes, nuclear criticality
means a condition in which an uncontrolled, selfsustaining and neutron-multiplying fission chain
reaction occurs. Nuclear criticality is generally a
concern when sufficient concentrations and masses
of fissile material and neutron moderating material
exist together in a favorable configuration. The
neutron moderating material cannot achieve
criticality by itself in any concentration or
configuration. It can enhance the ability of fissile
material to achieve criticality by slowing down
neutrons or reflecting neutrons.
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
NRC-approved quality assurance
program before obtaining NRC approval.
Although many of the changes were
found acceptable by the NRC after they
were reviewed, some of the changes did
not satisfy the respective requirements
of 10 CFR part 71, subpart H. In
Information Notice 2002–35 (December
20, 2002; ADAMS Accession No.
ML023520339), the NRC indicated that
it was considering changes to 10 CFR
part 71 to provide a method similar to
10 CFR 50.54(a)(3) and (4) for making
changes to 10 CFR part 71 quality
assurance programs.
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. This change
was announced in ‘‘NRC Regulatory
Information Summary (RIS) 2004–18,
Expiration Date for 10 CFR Part 71
Quality Assurance Program Approvals’’
(December 1, 2004; ADAMS Accession
No. ML042160293). After making this
change, the NRC evaluated whether a
change should be made in the
regulations to codify the effective term
of the quality assurance program
approval or whether any expiration date
for the quality assurance program
approval was necessary.
In the proposed rule section of this
issue of the Federal Register, the NRC
is issuing for public comment Draft
Regulatory Guidance (DG) 7009,
‘‘Establishing Quality Assurance
Programs for Packaging Used in
Transport of Radioactive Material’’ (RIN
3150–AI11; NRC–2013–0082).
III. Discussion
A. What action is the NRC proposing to
take?
The NRC is proposing to amend its
regulations to make them more
consistent or compatible with the IAEA
international transportation regulations.
These changes are in response to
changes introduced in the 1996 (as
amended in 2003), 2005, and 2009
editions of TS–R–1. The NRC is
proposing to revise its regulations to be
consistent with DOT hazardous
materials regulations to maintain a
consistent framework for the
transportation and packaging of
radioactive material.
The NRC is proposing to make
changes that would clarify the
requirements to obtain a general license
and the responsibilities of general
licensees. The NRC is proposing to
make changes that would clarify the
roles of users of NRC-approved
packaging and certificate holders or
applicants for a certificate of
compliance (CoC). Also, the NRC is
PO 00000
Frm 00005
Fmt 4701
Sfmt 4702
28991
proposing to make changes that would
make the regulation of quality assurance
programs more efficient. The NRC is
proposing to issue quality assurance
program approvals that would not
expire, removing the need for the
approval to be renewed, and would
revise the current quality assurance
program approvals so that they would
not expire. The NRC is also proposing
to allow those changes that do not
reduce the commitments in an approved
quality assurance program to be made
without prior NRC approval.
The NRC is proposing to make
changes that would change the
responsibilities of licensees and
certificate holders for making the
preliminary determinations in § 71.85.
Other proposed changes would
correct errors and clarify the
regulations.
B. Who is affected by this proposed
action?
This action would affect NRC
licensees authorized by a specific or
general license issued by the
Commission 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; holders of,
and applicants for, a CoC; and 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 would change
requirements that are matters of
compatibility. Agreement States would
be required to update their regulations
and Agreement State licensees would be
affected by the changes to the
Agreement State regulations.
C. Which changes are being made to
increase the compatibility with the
International Atomic Energy Agency
Regulations (TS–R–1) and consistency
with DOT regulations?
The NRC has identified changes in 10
CFR part 71 that would make the NRC
regulations more consistent or
compatible with the international
transportation regulations. These
changes would also improve the
consistency with the current DOT
regulations or would maintain
consistency between 10 CFR part 71 and
DOT regulations by making changes that
correspond to those proposed by the
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
28992
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
DOT. The NRC is proposing the
following changes to 10 CFR part 71.
1. In the 2003 Edition of TS–R–1, the
IAEA changed the scope of TS–R–1 as
it applies to natural materials and ores
by adding language that addresses the
processing of these materials (paragraph
107(e) of the 2009 edition of TS–R–1).
The NRC is proposing to include the
concept of processing into the
provisions that apply to natural
materials and ores in the exemptions for
low-level materials at § 71.14.
2. The NRC is proposing to adopt the
scoping statement in paragraph 107(f) of
TS–R–1, which addresses nonradioactive solid objects with
radioactive substances present on any
surface in quantities not in excess of
certain levels. In conjunction with this
proposed change, a definition of
‘‘contamination’’ corresponding to the
definition in TS–R–1 would be added to
§ 71.4.
3. The NRC is proposing to amend the
following definitions in 10 CFR 71.4 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
the definition for LSA material, the NRC
added the modifier ‘‘not,’’ which
resulted in the NRC definition becoming
inconsistent with the DOT and IAEA
definitions. The NRC is proposing to
correct this, so that LSA material
includes material intended to be
processed for its radionuclides.
4. The NRC is proposing to adopt the
use of the Class 5 impact test prescribed
in the International Organization for
Standardization (ISO) document 2919,
‘‘Radiation protection—Sealed
radioactive sources—General
requirements and classification,’’
Second Edition (February 15, 1999), ISO
2919:1999(E), for special form
radioactive material, provided the mass
was less than 500 grams.
5. The NRC is proposing to
incorporate by reference ISO document
2919, ‘‘Radiation protection—Sealed
radioactive sources—General
requirements and classification,’’
Second Edition (February 15, 1999), ISO
2919:1999(E), and ISO document 9978,
‘‘Radiation protection—Sealed
radioactive sources—Leakage test
methods,’’ First Edition (February 15,
1992), ISO 9978:1992(E).
6. The NRC is proposing to change the
description of billet used in the
percussion test in § 71.75(b)(2)(ii) by
replacing ‘‘edges’’ with ‘‘edge.’’
7. The NRC is proposing to revise the
definition of ‘‘special form radioactive
material’’ in § 71.4 to allow special form
radioactive material that is successfully
VerDate Mar<15>2010
19:22 May 15, 2013
Jkt 229001
tested in accordance with the current
requirements to continue 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, Table A–1, the NRC
is proposing to eliminate the A1 and A2
values for californium-252 (Cf-252) for
domestic use. The A1 and A2 values for
Cf-252 would be consistent with the
IAEA values.
9. The NRC is proposing to include
krypton-79 (Kr-79) in Table A–1 and
Table A–2. The A1 and A2 values in
Table A–1 and the activity
concentration for exempt material and
the activity limit for exempt
consignment would be consistent with
the IAEA values in the 2009 edition of
TS–R–1.
10. The NRC is proposing to revise
footnote a to Table A–1, ‘‘A1 and A2
values for radionuclides,’’ to include the
list of parent radionuclides whose A1
and A2 values include contributions
from daughter radionuclides with halflives of less than 10 days in footnote a
to Table 2, ‘‘Basic Radionuclide
Values,’’ in TS–R–1 (2009 edition), with
the exception of argon-42 (Ar-42) and
tellurium-118 (Te-118), which appear in
footnote a to Table 2 in TS–R–1 (2009
edition), but do not appear within Table
2.
11. The NRC is proposing to move
and revise footnote c to Table A–1 to
make clear that only for iridium-192 (Ir192) in special form is it appropriate for
the activity of Ir-192 to 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
NRC is proposing to revise the activity
limit for exempt consignment for
tellurium-121m (Te-121m) to be
consistent with the new IAEA value.
13. The NRC is proposing to revise the
list of parent radionuclides and their
progeny included in secular equilibrium
in footnote b to Table A–2, ‘‘Exempt
material activity concentrations and
exempt consignment activity limits for
radionuclides,’’ to be consistent with
the list accompanying Table 2, ‘‘Basic
Radionuclide Values,’’ in TS–R–1 (2009
edition).
14. The NRC is proposing to revise the
descriptive phrases for different
categories of unknown radionuclides
and mixtures in Table A–3 to be
consistent with the IAEA descriptions
in Table 3, ‘‘Basic Radionuclide Values
for Unknown Radionuclides or
Mixtures,’’ in TS–R–1 (2009 edition).
The descriptive phrases for ‘‘Only alpha
emitting nuclides are known to be
present’’ and ‘‘No relevant data are
available’’ would be revised.
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
D. How is the NRC proposing to change
the exemption for materials with low
activity levels?
The NRC is proposing to revise its
exemption for natural materials and ores
containing naturally occurring
radionuclides to reflect changes in the
scope of TS–R–1. In its proposed rule
(76 FR 50332; August 12, 2011), the
DOT proposed adopting these changes.
The TS–R–1 includes statements that
describe its scope. First, there is a
description of activities included within
the scope of regulation. Second, TS–R–
1 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 material are natural
materials and ores containing naturally
occurring radionuclides. These natural
materials and ores are not intended to
be processed for their radionuclides,
provided that the activity concentration
for the material does not exceed 10
times the activity concentration for
exempt material. In the 2003 edition of
TS–R–1, the description of natural
materials and ores containing naturally
occurring radionuclides contained in
the list of non-TS–R–1 material was
revised to add natural materials and
ores that have been processed.
In the 2003 edition of TS–R–1, ‘‘nonradioactive solid objects with
radioactive substances on any surfaces’’
in quantities not exceeding certain
values were identified as being outside
of the scope of the transportation
regulations.
The NRC has established an
exemption at 10 CFR 71.14 that exempts
licensees from the requirements of 10
CFR part 71 for certain natural materials
and ores. The exemption for low-level
materials exempts licensees from the
requirements of 10 CFR part 71 with
respect to the shipment or carriage of
material that qualifies for the exemption
and they would be allowed to transport
natural material or ore that qualifies for
the exemption without the material
being regulated as a hazardous material
during transportation; however, all
other NRC regulations that apply to this
material would continue to apply. The
exemption at § 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
proposing to update this exemption to
include the shipment of natural
materials and ores containing naturally
occurring radionuclides that have been
processed, which would retain
consistency with DOT regulations and
harmonize the NRC regulations with the
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
2009 edition of TS–R–1. This exemption
would continue 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 to
10 CFR part 71.
The NRC is proposing to correct the
definition of LSA–I material, so that it
applies to uranium and thorium ores,
concentrates of uranium and thorium
ores, and other ores containing naturally
occurring radionuclides that are
intended to be processed for their
radionuclides. The low-level material
exemption at § 71.14(b)(3), which
includes packages containing only LSA
material, would now apply to LSA–I
material (i.e., material intended to be
processed for its radionuclides).
Natural material and ore containing
naturally occurring radionuclides that
are not intended to be processed for
these radionuclides could qualify for the
low-level material exemption at 10 CFR
71.14(a)(1). With the correction to 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 at § 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) that the LSA or SCO
material has an external radiation dose
rate of less than 10 mSv/h (1 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 §§ 71.5 and 71.88.
Section 71.5 references the DOT
regulations in 49 CFR parts 107, 171
through 180, and 390 through 397. If the
DOT regulations are not applicable to a
shipment of licensed material, § 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
regulations. Section 71.88 would
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, would
not be able to qualify for the low level
material exemption for natural materials
and ores containing naturally occurring
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
radionuclides. Slags, sludges, tailings,
residues, bag house dust, oil scale, and
washed sands that are the byproducts of
processing or refining are examples of
natural material or ore that has been
processed and that may still qualify for
the exemption, provided that the
processed material has not been
incorporated into a manufactured
product.
The NRC is proposing to add a
definition of contamination and to
expand the exemption at § 71.14 to
include non-radioactive solid objects
with substances present on any surface
not exceeding the levels used to define
contamination. The derived values used
in the definition of contamination are
conservative with respect to
transportation, and quantities of
radioactive substances below these
values would result in small amounts of
exposure during normal conditions of
transportation and would contribute to
insignificant exposures under accident
conditions. Contamination would be
defined as quantities in excess of 0.4
Bq/cm2 (1 × 10¥5 mCi/cm2) for beta and
gamma emitters and low toxicity alpha
emitters, or 0.04 Bq/cm2 (1 × 10¥6 mCi/
cm2) for all other alpha emitters.
E. How might the qualification of
special form radioactive material
change?
The NRC is proposing to update the
alternate tests in § 71.75 that may be
used for the qualification of special form
radioactive material to tests in more
recent editions of the consensus
standards. The NRC is proposing to
incorporate by reference the Class 4 and
Class 5 impact tests and the Class 6
temperature test prescribed in the ISO
document ISO 2919:1999(E). The NRC is
proposing to incorporate by reference
the leaktightness tests specified in ISO
document 9978:1992(E). The IAEA has
adopted, 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 Class 4 impact test in ISO
2919:1999(E) would replace the impact
test in § 71.75(d)—the Class 4 impact
test in ISO 2919, ‘‘Sealed Radioactive
Sources—Classification,’’ first edition
(1980)—and would 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, would 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.
PO 00000
Frm 00007
Fmt 4701
Sfmt 4702
28993
The Class 6 temperature test in ISO
2919:1999(E) would replace the
temperature test in § 71.75(d)—the Class
6 temperature test in ISO 2919, ‘‘Sealed
Radioactive Sources—Classification,’’
first edition (1980). 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 would continue to be
more stringent than the testing required
by § 71.75(b).
The leaktightness tests prescribed in
ISO 9978:1992(E) would replace the
tests in ISO/TR 4826, ‘‘Sealed
Radioactive Sources—Leak Test
Methods,’’ (1979). The consensus
standard ISO 9978:1992(E) has replaced
ISO/TR 4826:1979(E), which has been
withdrawn by ISO. The NRC has
determined that the leaktightness tests
prescribed in ISO 9978:1992(E) provide
an equivalent level of radiological safety
as the leaching assessment procedure in
§ 71.75(c).
The NRC is proposing to revise the
definition of special form radioactive
material 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 would allow material tested using
requirements in effect at the time of the
testing to continue to be used. The NRC
is proposing to correct the reference to
the version of § 71.4 in the CFR that was
in effect on March 31, 1996, by changing
the date of the revision from January 1,
1983, to January 1, 1996.
The NRC is proposing to replace
‘‘edges’’ with ‘‘edge’’ to describe the
billet used for the percussion test in
§ 71.75(b)(2). The edge corresponds to
the circular edge at the face of the billet.
This is intended to clarify the
description of the billet and to maintain
consistency with the language used by
the DOT in 49 CFR 173.469.
F. What changes may be made to
Appendix A, ‘‘Determination of A1 and
A2 Values,’’ part 71 of Title 10 of the
Code of Federal Regulations (CFR) ?
The NRC is proposing the following
changes to appendix A.
1. Determining the Quantity of
Radioactive Material That Can Be
Shipped in a Package That Contains
Both Special Form and Normal Form
Radioactive Material
The NRC is proposing to specifically
address 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
E:\FR\FM\16MYP2.SGM
16MYP2
28994
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
radioactive material and the identities
and activity limits for the radionuclides
are known. By including this equation,
the NRC would increase the consistency
between 10 CFR part 71 and TS–R–1
and would provide additional clarity on
how to address cases where a package
will contain both special form and
normal form material. The equation is
similar to those already used in 10 CFR
part 71 for mixtures of special form
material and mixtures of normal form
material.
2. Table A–1, ‘‘A1 and A2 Values for
Radionuclides’’
The NRC is proposing to revise Table
A–1 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 NRC is proposing
to—add an entry for Kr-79, which has
been added to Table 2 in the 2009
edition of TS–R–1; adopt the A1 and A2
values for Cf-252; revise 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 move and revise
footnote c, which applies to Ir-192, so
that the footnote applies only to Ir-192
in special form material.
The A1 and A2 values are used for
determining what type of package must
be used for the transportation of
radioactive material. The A1 values are
the maximum amount of special form
material allowed in a Type A package.
The A2 values are the maximum activity
of ‘‘other than special form’’ material
allowed in a Type A package. A1 and A2
values are also used for several other
packaging limits throughout TS–R–1,
such as specifying Type B package
activity leakage limits, low-specific
activity limits, and excepted package
contents limits. The values of A1 and A2
have been adopted in 10 CFR part 71
and are specified in appendix A.
The IAEA has added an entry for Kr79 in the Table 2 of the 2009 edition of
TS–R–1. The NRC is proposing to adopt
these radionuclide-specific values for
Kr-79 in Table A–1. The radionuclidespecific values would replace the
generic values in Table A–3, which are
currently 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 radionuclidespecific information and better reflect
the radiological hazard of Kr-79 than the
generic values that they would replace.
The IAEA has revised the A1 value for
Cf-252 to the value that currently
applies to domestic transportation. In
the 2004 final rule for 10 CFR part 71
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
(69 FR 3698; January 26, 2004), the NRC
did not adopt the A1 value for Cf-252 in
TS–R–1 for domestic transportation,
because the NRC was aware that the
IAEA was considering changing the
value back to the value that has been in
10 CFR part 71; the IAEA has
subsequently made this change. The
NRC is proposing to adopt the A1 value
for Cf-252, which would apply to both
international and domestic
transportation, and to adopt the IAEA
value for A2. The NRC is proposing to
delete the A2 value that applies only to
domestic transportation. Making this
change would improve the
harmonization of 10 CFR part 71 with
TS–R–1 by adopting the A2 value for Cf252 in TS–R–1. Because the A2 value for
Cf-252 was established by the IAEA
using the Q-system and current data for
Cf-252, the A2 value for Cf-252 would be
consistent with the other values derived
using the Q-system that has been
incorporated into 10 CFR part 71.
The NRC is proposing to revise
footnote a to Table A–1 to identify the
A1 and A2 values that include
contributions from daughter
radionuclides that have a half-life that is
less than 10 days. The proposed 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). Ar-42 and Te118 would not be included, because
they do not appear within Table A–1.
The NRC is proposing to revise
footnote c to Table A–1 to make clear
that the activity of Ir-192 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 is appropriate for Ir-192
in special form.
3. Table A–2, ‘‘Exempt Material Activity
Concentrations and Exempt
Consignment Activity Limits for
Radionuclides’’
The NRC is proposing to revise Table
A–2 to make the values in 10 CFR part
71 consistent with the values in TS–R–
1 and to add an entry for Kr-79, which
has been added to Table 2, ‘‘Basic
radionuclide values,’’ in the 2009
edition of TS–R–1. The NRC is also
proposing to update the list of parent
radionuclides and their progeny in
footnote b to Table A–2 by removing the
chains for the parent radionuclides
cerium-134 (Ce-134), radon-220 (Rn220), thorium-226 (Th-226), and U–240
and 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
NRC is proposing to update the activity
PO 00000
Frm 00008
Fmt 4701
Sfmt 4702
limit for exempt consignment for Te121m to match the values in TS–R–1.
Material that has an activity
concentration that is less than the
activity concentration for exempt
material would pose a very low
radiological risk. The activity limit for
exempt consignment has been
established for the transportation of
material in quantities small enough for
which the total activity is unlikely to
result in any significant radiological
exposure. This would be the case even
for material that exceeds the activity
concentration for exempt material.
Krypton-79 is not listed in Table A–
2, and the values from Table A–3,
‘‘General Values for A1 and A2,’’ in
appendix A are 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 included in the 2009
edition of TS–R–1.
In the 2005 edition of 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 with the objectives of the
exemption values. Also, to conform to
International Commission on
Radiological Assistance (ICRP) and
IAEA changes, the activity limit for
exempt consignment for Te-121m in
Table A–2 is being changed from 1 × 105
Bq (2.7 × 10¥6 Ci) to 1 × 106 Bq (2.7 ×
10¥5 Ci).
The IAEA has revised the list of
parent radionuclides and their progeny
included in secular equilibrium in
footnote (b) to Table 2, ‘‘Basic
radionuclide values’’ 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 removing
the decay chain for Ce-134, Rn-220, Th226, and U-240. The list of parent
radionuclides and their progeny
included in secular equilibrium
presented in footnote b to Table A–2
would be revised to be consistent with
the changes to the list in TS–R–1.
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
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’’ (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 current descriptive phrases are: (1)
‘‘only beta or gamma emitting
radionuclides are known to be present,’’
(2) ‘‘only alpha emitting nuclides are
known to be present,’’ and 3) ‘‘no
relevant data are available.’’ The NRC is
proposing to adopt the descriptive
phrases as revised by the IAEA in TS–
R–1 in Table A–3.
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, would be used.
Consequently, an A1 value of 1 TBq (2.7
Ci) and an A2 value of 9 × 10¥5 TBq (2.4
× 10¥3 Ci) would be used for a group
containing both alpha emitting
radionuclides and beta or gamma
emitting radionuclides.
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
5. Other changes that correct formulas
and their descriptions in Section IV,
Section-by-Section Analysis, of this
document
The NRC is proposing to make several
corrections to the formulas and the
descriptions of the formulas that
address mixtures of radionuclides in
Section IV of this document. These
changes involve formatting and
typographical changes in the formulas
and their descriptions.
G. How would the responsibilities of
certificate holders and licensees change
with these amendments?
In the 1950s, the Atomic Energy
Commission (AEC) issued package
approvals to AEC licensees as
amendments to their licenses and the
DOT issued package approvals to nonAEC licensees. On March 22, 1973 (38
FR 8466), the AEC and the DOT entered
into an MOU where the DOT agreed to
adopt a requirement for AEC approval of
designs of packages for the shipment of
fissile material and other radioactive
material exceeding Type A limits, with
the exception of LSA material, and the
AEC agreed to develop safety standards
for the design and performance of
packages and to impose these standards
on AEC licensees and license-exempt
contractors. Under the MOU, the AEC
would issue an AEC license, an AEC
CoC, or other AEC package approval
directly to the person requesting the
evaluation. Although the AEC, and
subsequently the NRC, certified that the
packages met the regulations, they did
not have regulatory authority over the
certificate holders under DOT
jurisdiction. On July 2, 1979 (44 FR
38690), this MOU was superseded by an
MOU between the DOT and the NRC. In
this MOU, it was agreed that the NRC,
in consultation with the DOT, would
develop safety standards for the design
and performance of the packages. As the
NRC developed its safety standards for
the packages, it gained regulatory
authority over the certificate holders.
The requirements for making the
preliminary determinations have
remained largely unchanged since the
1979 MOU. In discussing the routine
and preliminary determinations (48 FR
35600; August 5, 1983), the Commission
indicated that the user of a package
always had the regulatory responsibility
for preliminary and routine
determinations and recordkeeping, even
though the user may not own the
package. The Commission also
indicated that although the user could
contract with some other person,
perhaps the owner, to satisfy those
requirements for the user, the user’s
PO 00000
Frm 00009
Fmt 4701
Sfmt 4702
28995
records must demonstrate that the
requirements have been satisfied.
Although leaktightness tests related to
the package design are required as a
condition of the package design
approval, the Commission has indicated
that it considers that in the case of
radioactive material packages, integrity
of the containment (including closures,
valves, and other routes of escape)
should be demonstrated for each
fabricated package before first use.
The NRC experience is that licensees
have never made preliminary
determinations themselves, unless they
also happened to be certificate holders.
Based on the NRC extensive experience
inspecting the activities of certificate
holders and NRC licensees who use
packages, the NRC is not aware of any
NRC licensee that performs preliminary
determinations, unless they are also the
certificate holder for the package design.
The scope of user-only quality
assurance program approvals, which are
issued to licensees who are not also
holders of a CoC, do not include the
testing required to make the preliminary
determinations. Licensees lease or buy
these packages from the certificate
holder, or fabricator, and most packages
are already marked by the certificate
holder. The NRC has identified cases
where the durable marking of the
packaging required by § 71.85 was done
incorrectly by a certificate holder.
Because the licensee is responsible for
the preliminary determinations,
enforcement could not be taken against
the certificate holder for improperly
marking the packaging.
The Commission is proposing to make
changes to § 71.85 that would make
certificate holders, not licensees,
responsible for making the preliminary
determinations before the first use of
each package. The preliminary
determinations involve evaluating,
testing, and marking the packaging. The
DOT requirements at 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. The
Commission is proposing to require the
licensee to ascertain that the
preliminary determinations involving
evaluating, testing, and marking the
packaging have been made. The licensee
would still make the required routine
determinations at § 71.87. As required
by § 71.91(d), both licensees and
certificate holders would still be
required to maintain sufficient written
records to furnish evidence of the
quality of the packaging, which includes
the results of the determinations
required by § 71.85.
E:\FR\FM\16MYP2.SGM
16MYP2
28996
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
The Commission is proposing to make
these changes, because it is more
appropriate to assign the responsibility
to certificate holders for marking the
packaging. Only certificate holders are
authorized to design and fabricate
packagings, and only certificate holders
would have a full scope quality
assurance program approval, which
would allow them to perform the testing
required as part of the preliminary
determinations under an approved
quality assurance program. However,
licensees would need to retain their
responsibility to determine that the
packaging has been manufactured,
assembled, and marked appropriately
and that the packaging does not have
any defects that could significantly
reduce the effectiveness of the
packaging. By assigning the
responsibility for making the
determinations to the certificate holder,
the NRC would be able to streamline the
implementation of its regulations and
have the regulations better reflect
current practice.
H. Why would renewal of my quality
assurance program description not be
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 to provide
an opportunity for the NRC staff to
periodically review the quality
assurance programs and for the NRC to
maintain periodic contact with the
quality assurance program approval
holders. The limited duration of the
approval facilitated the NRC
recordkeeping relating to points of
contact, package fabrication, use
activities, and other administrative
activities.
In 2004, the NRC extended the
duration of its quality assurance
program approvals from 5 years to 10
years, because the NRC had determined
that the periodic contact associated with
the 5-year renewal period was less
important than it was previously, and
the duration of the approval could be
lengthened. The NRC announced this
change in RIS 2004–18, ‘‘Expiration
Date for 10 CFR Part 71 Quality
Assurance Program Approvals’’
(December 1, 2004).
The NRC is changing its practice
regarding the duration of its quality
assurance program approvals. The NRC
would no longer limit the duration of its
quality assurance program approvals
issued under 10 CFR part 71. The NRC
is proposing changes to 10 CFR part 71
to implement this change and to
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
enhance the periodic communication
between the NRC and the quality
assurance program approval holders.
The NRC would reissue its quality
assurance program approval for
Radioactive Material Packages (NRC
Form 311) without an expiration date.
As discussed in Section III, question I,
‘‘What Changes Could be Made to a
Quality Assurance Program Description
without Seeking Prior NRC Approval?,’’
and question J, ‘‘How Frequently Would
I Submit Periodic Updates on My
Quality Assurance Program Description
to the NRC?,’’ the NRC is proposing to
require quality assurance program
approval holders to periodically report
changes in their quality assurance
program description to the NRC. 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 not necessary to provide the NRC
with assurance that the quality
assurance program approval holders
would continue to be able to adequately
maintain and implement their approved
quality assurance program.
As discussed under question I, ‘‘What
changes could be made to a quality
assurance program description without
seeking prior NRC approval?,’’ the NRC
would continue to approve quality
assurance program description changes
that reduce commitments made to the
NRC in quality assurance program
descriptions that have been approved by
the NRC. Every 24 months, each quality
assurance program approval holder
would be required to report those
changes that do not reduce
commitments made to the NRC in a
quality assurance program description
approved by the NRC. Holders of a CoC
and applicants for a CoC are subject to
periodic inspection of their quality
assurance program (approximately every
3 years) by the NRC. Licensees who use
packages are inspected on an as-needed
basis.
As discussed under question P, ‘‘What
should I consider as I prepare my
comments to the NRC?,’’ the NRC is
specifically requesting comment on the
proposed approach to reporting changes
to approved quality assurance program
descriptions.
I. What changes could be made to a
quality assurance program description
without seeking prior NRC approval?
Currently, quality assurance program
descriptions approved under 10 CFR
part 71 cannot be changed without NRC
approval. Therefore, all changes to 10
CFR part 71 quality assurance programs,
irrespective of their significance or
PO 00000
Frm 00010
Fmt 4701
Sfmt 4702
importance to safety, must 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,
consistent with the requirements at
§ 50.54. The NRC is proposing to allow
some changes to be made to quality
assurance programs approved under 10
CFR part 71 without obtaining NRC
approval. The process for making
changes to approved quality assurance
program descriptions would be similar
to the process that the NRC has used to
approve changes that are made to the
quality assurance program descriptions
for nuclear power plants licensed under
10 CFR part 50 through the provisions
at § 50.54(a) and would result in a more
consistent approach to allowing changes
to approved quality assurance programs.
The NRC is proposing to establish a
process that would require NRC
approval to be obtained for those
changes that are most important to
safety but would allow other changes to
be implemented without obtaining NRC
approval.
Quality assurance program approval
holders would be required to obtain
NRC approval before making any change
to their quality assurance program
description that would reduce the
commitments that they have made to
the NRC. Quality assurance program
approval holders would not be required
to submit changes to their quality
assurance program descriptions, if those
changes do not reduce the commitments
that they have made to the NRC.
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 would
not require NRC approval. Changes to
reporting responsibilities, functional
responsibilities, functional
relationships, and some editorial or
punctuation changes may be substantive
and have the potential to reduce
commitments made to the NRC and, in
these instances, would require prior
NRC approval before being
implemented. The following includes
types of changes that the NRC would
not consider as reducing a commitment
made to the NRC:
1. The use of a quality assurance
standard approved by the NRC, which is
more recent than the quality assurance
standard in the current quality
assurance program at the time of the
change;
2. The use of generic organizational
position titles that clearly denote the
function of the position, supplemented
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
tkelley on DSK3SPTVN1PROD with PROPOSALS2
as necessary by descriptive text, rather
than specific titles, provided that there
are no substantive changes 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;
4. The elimination of quality
assurance program information that
duplicates language in quality assurance
regulatory guides and quality assurance
standards to which the holder of the
quality assurance program approval has
committed 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.
Quality assurance program approval
holders would also need to maintain
records of all quality assurance program
changes.
J. How frequently would I submit
periodic updates on my quality
assurance program description to the
NRC?
The NRC would continue to require
quality assurance program approval
holders to obtain NRC approval of any
change to their approved quality
assurance program description that
would reduce any commitment in the
quality assurance program description
approved by the NRC before they
implement the change. The NRC would
require the following information to be
provided for its review: a description of
the proposed changes to the approved
quality assurance program description,
the reason for the change, and the basis
for concluding that the revised program
incorporating the change continues to
satisfy the requirements of subpart H.
The NRC is proposing to require that
quality assurance program approval
holders would report changes to their
approved quality assurance program
that do not reduce any commitments in
the quality assurance program
description approved by the NRC every
24 months. These changes would not
require NRC approval before they can be
implemented. If the quality assurance
program approval holder has not made
any changes to its approved quality
assurance program description during
the preceding 24-month period, it
would report to the NRC that no
changes have been made.
The NRC inspection program relies on
having current information about the
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
quality assurance program available to
the NRC. By requiring that the most
important changes be submitted to the
NRC before they are implemented and
with the periodic reporting of the less
significant changes every 24 months, the
NRC would 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 discussed under question H, ‘‘Why
would renewal of my quality assurance
program description not necessary?,’’
the NRC would re-issue NRC Form 311
without an expiration date. The 24month period for reporting of changes is
proposed to 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, ‘‘Quality
Assurance Program Approval for
Radioactive Material Packages.’’
As discussed under question P, ‘‘What
should I consider as I prepare my
comments to the NRC?,’’ the NRC is
proposing to require quality assurance
program approval holders to submit a
report every 2 years that describes the
changes that were made to their quality
assurance program description that do
not reduce a commitment in the quality
assurance program description
approved by the NRC. The NRC is
seeking to balance the regulatory burden
for submitting this information with the
NRC need to ensure that the NRC has
current information for its regulatory
oversight of quality assurance program
approval holders, which would include
using the information for inspections.
The NRC is requesting comment on the
following issue: would a different
frequency be more appropriate for
reporting changes to approved quality
assurance programs that do not reduce
a commitment in a quality assurance
program description approved by the
NRC?
K. How would the requirements in
subpart H, ‘‘Quality Assurance,’’ change
with the removal of the footnote in 10
CFR 71.103?
The NRC is proposing to remove the
footnote in § 71.103 regarding the use of
the term ‘‘licensee’’ in subpart H,
because it is no longer necessary. The
removal of the footnote does not change
the quality assurance requirements in
subpart H. The footnote regarding use of
the term ‘‘licensee’’ was included to
clarify that the quality assurance
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
28997
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 later
rulemaking to make explicit the
application of those quality assurance
requirements to certificate holders and
applicants for a CoC. Although
removing the footnote would not change
the quality assurance requirements,
other proposed changes to subpart H in
this proposed rulemaking would further
clarify which requirements apply to
users of NRC certified packaging and
which apply to applicants for, or
holders of, CoCs—the entities that
would be performing design,
fabrication, assembly, and testing of the
package before a package approval is
issued.
L. What changes would be made to
general licenses?
The NRC is proposing to change the
requirements for general licenses for the
following: (1) use of an NRC-approved
package (§ 71.17) and 2) use of a foreignapproved package (§ 71.21). In § 71.17,
the NRC is revising the general license
requirements to clarify the conditions
for obtaining a general license and the
responsibilities of the general licensee.
A quality assurance program approved
by the Commission as satisfying the
provisions of subpart H of 10 CFR part
71 is required to be granted the general
license. The proposed changes would
clarify that the licensee is responsible
for maintaining copies of the
appropriate documents, such as the
CoC, or other approval of the package,
and 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 would also clarify that making
the notification in § 71.17(c)(3) to the
NRC is a responsibility of the licensee,
rather than a condition for obtaining the
license. The proposed changes to
§§ 71.17 and 71.21 would not change
the current notification process and
would not change the required timing or
content of the notification required by
§ 71.17(c)(3) or any other reporting
requirements relating to package use or,
where required, the prior notification of
shipments.
The proposed changes also include
updating the reference in § 71.21(a) from
49 CFR 171.12 to 49 CFR 171.23. On
May 3, 2007 (72 FR 25162), the DOT
published a final rule that moved the
requirements at 49 CFR 171.12 to
paragraph (b)(11) at 49 CFR 171.23,
‘‘Requirements for the specific materials
E:\FR\FM\16MYP2.SGM
16MYP2
28998
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
and packagings transported under the
[International Civil Aviation
Organization] ICAO Technical
Instructions, [International Maritime
Dangerous Goods] IMDG Code,
Transportation Canada [Transportation
of Dangerous Goods] TDG Regulations,
or the IAEA Regulations.’’
tkelley on DSK3SPTVN1PROD with PROPOSALS2
M. How would the exemption from
classification as fissile material (10 CFR
71.15) change?
The objective of the fissile material
exemptions at § 71.15 is to facilitate the
safe transport of low-risk (e.g., small
quantities or low concentrations) of
fissile material by exempting shipments
of these materials from the packaging
requirements and the criticality safety
assessments required for fissile material
transportation and to allow the
shipments to take place without specific
Commission approval. The lower
amount of regulatory oversight is
acceptable for these shipments, because
the exemptions are established so as 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 would not be any additional
packaging or transport requirements for
exempt fissile material beyond that
noted in the specific exemption.
However, exempt fissile material would
still have fewer restrictions imposed
than if it were to be shipped as fissile
material. Therefore, for purposes of
ensuring criticality safety, the
exemptions consider that the material
can be released from any 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
conditions assumed as part of the
criticality safety assessment for package
designs approved to transport fissile
material.
The reactivity of uranium enriched in
U-235 will depend 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 at § 71.15(d) is 1 percent by
weight, which is slightly less than the
minimum critical enrichment for an
infinite, homogeneous mixture of
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
enriched uranium and water.3 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 one percent)
will not be critical, irrespective of the
mass or size of the system. The fissile
material exemption at § 71.15(d) also
limits the quantity of some less common
moderating materials (beryllium,
graphite, hydrogenous material enriched
in deuterium), because the presence of
these materials has the potential to
reduce the minimum critical
enrichment, increasing the potential for
criticality with uranium of lower
enrichment. Thus, homogeneous
materials containing uranium enriched
to no more than 1 percent by weight and
subject to the noted restrictions on
moderators will be inherently safe from
a potential criticality, because they 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 would be lower for
an optimized heterogeneous system
than for an optimized homogeneous
system of the same material. In
consideration of this fact, the current
proposed change at § 71.15(d) is to add
requirements to clarify the need for
homogeneity in the material.
The exemption for uranium enriched
to a maximum of 1 percent at § 71.15(d)
includes a limit on moderators that
increase the reactivity of the lowenriched fissile material, but the
exemption 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; however, 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,
‘‘Advisory Material for the IAEA
Regulations for the Safe Transport of
Radioactive Material’’ (TS–G–1.1), the
IAEA indicated that ‘‘[t]here is
agreement that homogeneous mixtures
and slurries are those in which the
3 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).
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
particles in the mixture are uniformly
distributed and have a diameter no
larger than 127 mm [(5 × 10¥3 in.)].’’ The
homogeneity requirement in
TS–R–1 is intended to prevent latticing
of slightly enriched uranium in a
moderating medium.
As described in Section II,
Background, of this document, analyses
performed by the DOE indicated that
large arrays of uranium with enrichment
of 1 percent by weight of U-235, which
would qualify for the fissile material
exemption at § 71.15(d), could exceed
an effective neutron multiplication
factor (keff) of 0.95 when optimally
moderated by water. The DOE analyses
were 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,
would 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 Commission believes that
additional restrictions on low-enriched
fissile material shipped under the fissile
material exemption at § 71.15(d) are
warranted.
When the Commission last identified
a defect in its fissile exemption
regulations, which allowed shipments
to be made without prior Commission
approval, the Commission published an
emergency final rule to restrict the use
of beryllium and other special
moderators, such as graphite and
hydrogenous material enriched in
deuterium. In this instance, the
Commission chose to use normal noticeand-comment rulemaking procedures
and determined that the proposed
change did not need to be effective
immediately. Uranium enriched to a
maximum of 1 percent by weight is
rarely available in quantities that would
allow keff to exceed 0.95. In the case of
uranium enriched to a maximum of 1
percent by weight, keff is not sensitive to
changes in mass, so a significant amount
of additional mass would be required to
increase the keff from 0.95 to a value
very close to 1.0, even when geometry
and moderator conditions are optimal
with respect to criticality. In addition,
keff is very sensitive to moderator
conditions. If the moderator conditions
are not optimal, keff is less sensitive to
changes in mass. Therefore, it is very
unlikely that even in the case of large
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
quantities of uranium enriched to a
maximum of 1 percent by weight that
the moderator conditions would also be
close to optimal with respect to
criticality. The upper subcritical limit is
the maximum allowed value of keff and
includes a minimum margin of
subcriticality. At a keff equal to 1, the
system is considered critical.
As discussed in Section II of this
document, the NRC removed both the
requirement for uranium enriched to a
maximum of 1 percent to be
homogeneously distributed and the
lattice prevention requirement.
Although the NRC had determined that
the limits on restricted moderators was
sufficient to assure subcriticality for all
moderators of concern, the NRC believes
that additional restrictions are needed to
have a sufficient margin of safety for
shipments of material under the lowenriched fissile material exemption.
Therefore, the NRC is proposing to
reinstate 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 would be 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,
should 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, should be
less than 5.0 percent of the uranium
mass. Although there are heterogeneity
effects at very small scales, the
Commission does not believe that it is
necessary to require homogeneity with
respect to particle size. Further, the
Commission 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
regulations, which require that the
fissile nuclides be essentially
homogenously distributed. Restricting
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
the variability in concentration is not
sufficient for limiting the reactivity of
the uranium enriched to a maximum of
1 percent. Therefore, the Commission is
also proposing to reinstate the lattice
prevention criterion. The contents of the
package should 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 Commission believes
that this restriction is too narrow and
should apply irrespective of the form of
uranium. As discussed under question
P, ‘‘What should I consider as I prepare
my comments to the NRC?,’’ the NRC is
seeking comment on the homogeneity
and lattice prevention requirements for
the exemption for uranium enriched to
a maximum of 1 percent. The
Commission is requesting comment on
the clarity of the homogeneity and
lattice prevention criteria for
implementation.
N. What other changes is the NRC
proposing to make to its regulations for
the packaging and transportation of
radioactive material?
A requirement in § 71.19(a) that
implemented transitional arrangements
(‘‘grandfathering’’) expired on October
1, 2008, and has been deleted.
Paragraph 71.19(a) is currently reserved.
Other paragraphs in § 71.19 would be
redesignated. In redesignated paragraph
71.19(b)(2), transitional language that is
no longer needed would be 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.
References to § 71.20 in § 71.0 would
be removed, because § 71.20 has expired
and has been removed from the
regulations.
In § 71.31, the reference to § 71.13
would be changed to § 71.19. In § 71.91,
the reference to § 71.10 would be
changed to § 71.14. These changes
would correct references that were not
updated when the requirements were
redesignated in 2004.
In § 71.101, the NRC is proposing to
make changes that would make the
requirements more precise. Paragraphs
71.101(a) and 71.101(c)(2) would be
revised to clarify the responsibilities of
licensees and certificate holders and
applicants for a CoC. The quality
assurance requirements pertaining to
the design, fabrication, testing, and
modification of packaging apply to
certificate holders and applicants for a
CoC. Licensees are responsible for the
PO 00000
Frm 00013
Fmt 4701
Sfmt 4702
28999
quality assurance requirements that
apply to their use of the packaging for
the shipment of licensed material.
Paragraph 71.101(c) would be changed
to remove the overlap between
paragraphs (c)(1) and (c)(2), by removing
the reference to licensees in paragraph
(c)(2).
O. When would these proposed
amendments become effective?
The NRC will coordinate the effective
date for this rule with the DOT. As
described under question P, ‘‘What
Should I Consider as I Prepare My
Comments to the NRC?,’’ the NRC is
requesting comments on the cumulative
effects of regulation (CER), including
comments that would inform the
amount of time that would be sufficient
to implement the proposed
amendments. The NRC intends that the
new regulations would become effective
no sooner than 90 days after the final
rule is published in the Federal
Register.
P. What should I consider as I prepare
my comments to the NRC?
Tips for preparing your comments—
when submitting your comments,
remember to:
1. Identify the rulemaking (RIN 3150–
AI11; NRC–2008–0198).
2. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
3. Describe any assumptions and
provide any technical information and/
or data that you used.
4. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
5. Provide specific examples to
illustrate your concerns, and suggest
alternatives.
6. Explain your views as clearly as
possible.
7. Make sure to submit your
comments by the comment period
deadline identified.
8. See Section VIII for the request for
comments on the use of plain writing,
Section IX for the request for comments
on the adoption of voluntary consensus
standards, Section XI for the request on
the reporting and recordkeeping burden,
and Section XII for the request for
comments on the draft regulatory
analysis.
9. The NRC is specifically requesting
comments on the following items:
a. As discussed under question J,
‘‘How frequently would I submit
periodic updates on my quality
assurance program to the NRC,’’ the
NRC is proposing to require quality
assurance program approval holders to
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
29000
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
submit a report every 2 years that
describes the changes that were made to
their quality assurance program that do
not reduce a commitment in the quality
assurance program description
approved by the NRC. The NRC is
seeking to balance the regulatory burden
for submitting this information with the
NRC need to ensure that the NRC has
current information for its regulatory
oversight of quality assurance program
approval holders, which includes using
the information for inspections.
Inspections of certificate holders occur
approximately every 3 years and
inspections of licensees who use
packages occur on an as-needed basis.
The NRC is requesting comment on
whether a different frequency would be
more appropriate for reporting changes
to an approved quality assurance
program that do not reduce a
commitment in a quality assurance
program description approved by the
NRC.
b. In § 71.15(d), the NRC is proposing
to reintroduce restrictions on lowenriched fissile material—uranium
enriched in U-235 to a maximum of 1
percent by weight, and with a total
plutonium and U-233 content of up to
1 percent of the mass of uranium-235—
by requiring that it be distributed
homogeneously and not form a lattice
arrangement. The NRC is seeking
comment on the clarity of this
requirement for implementation.
c. The CER describe the challenges
that licensees, certificate holders, States,
or other entities may encounter when
implementing the new regulatory
requirements (e.g., rules, generic letters,
orders, backfits, inspections). The CER
is an organizational effectiveness
challenge that results from a licensee or
impacted entity implementing a
significant number of new or complex
regulatory actions, within a limited
implementation period and with
available resources (which may include
limited available expertise to address a
specific issue). The CER can potentially
distract licensee or other entity staff
from executing other primary duties that
ensure safety or security. The NRC is
specifically requesting comment on the
cumulative effects of this proposed
rulemaking. In developing comments on
the CER, consider the following
questions:
i. In light of any current or projected
CER challenges, would the proposed
rule’s effective date provide sufficient
time to implement the new proposed
requirements, including changes to
programs and procedures?
ii. If current or projected CER
challenges exist, what should be done to
address this situation (e.g., if more time
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
is required to implement the new
requirements, what period of time
would be sufficient)?
iii. Do other (NRC or other agency)
regulatory actions (e.g., orders, generic
communications, license amendments
requests, inspection findings of a
generic nature) influence the
implementation of the proposed
requirements?
iv. Are there unintended
consequences? Does the proposed rule
create conditions that would be contrary
to the proposed rule’s purpose and
objectives? If so, what are the
unintended consequences and how
should they be addressed?
v. Please comment on the NRC cost
and benefit estimates in the regulatory
analysis that supports the proposed
rule.
IV. Section-by-Section Analysis
Section 71.0 Purpose and Scope
Paragraph (d)(1) would be revised to
delete § 71.20 from the list of sections
that a general license is issued without
requiring the NRC to issue a package
approval, so the reference to ‘‘§§ 71.20
through 71.23’’ would be revised to
‘‘§§ 71.21 through 71.23.’’
Section 71.4 Definitions
The definition of ‘‘contamination’’
would be added and would be
consistent with the definition of
contamination in DOT regulations at 49
CFR 173 and TS–R–1.
The definition of ‘‘Criticality Safety
Index (CSI)’’ would be revised to be
more consistent with the definition in
DOT regulations at 49 CFR 173 and
TS–R–1 by addressing overpacks and
freight containers in the definition.
The definition of ‘‘Low Specific
Activity (LSA) material’’ would be
revised to be more consistent with the
definition in DOT regulations at 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.
The definition of ‘‘Special form
radioactive material’’ would be revised
to allow special form radioactive
material that was successfully tested
using the current requirements of
§ 71.75(d) to continue to qualify as
special form material, if the testing was
completed before the date of the final
rule. The reference to the version of 10
CFR part 71 in effect on March 31, 1996,
would be corrected by changing 1983 to
1996.
The definition of ‘‘Uranium—natural,
depleted, enriched’’ would be revised by
PO 00000
Frm 00014
Fmt 4701
Sfmt 4702
adding ‘‘(which may be chemically
separated)’’ to paragraph (1), which
applies to natural uranium.
Section 71.6 Information Collection
Requirements: OMB Approval
Paragraph (b) would be revised to add
§ 71.106 to the list of sections with
information collections.
Section 71.14 Exemption for Low-Level
Materials.
Paragraph 71.14(a)(1) would be
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 would be
considered as 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 could not exceed 10
times the activity concentration values
and the material is not intended to be
processed for the use of the
radionuclides.
A reference to Table A–3 in appendix
A would be added in paragraphs
71.14(a)(1) and (a)(2) as a source of
activity concentration values that may
be used to determine whether natural
material or ore would qualify for the
exemption. Table A–3 would provide
activity concentration values for exempt
material that would be used for
individual radionuclides whose
identities are known, but which are not
listed in Table A–2.
Paragraph 71.14(a)(3) would be added
to provide an exemption for nonradioactive solid objects that have
radioactive substances present on the
surfaces of the object, provided that the
quantity of radioactive substances is
below the quantity used to define
contamination. The definition of
‘‘contamination’’ would be added to
§ 71.4.
Section 71.15 Exemption From
Classification as Fissile Material
Paragraph 71.15(d), which applies to
fissile material in the form of uranium
enriched in U-235 to a maximum of 1
percent by weight, would be revised.
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
The fissile material would be required
to be distributed homogeneously and
not form a lattice arrangement, where
concentrated fissile material is
separated by non-fissile material in a
regular, repeating pattern.
Section 71.17 General License: NRCApproved Package
Paragraph 71.17(c) would be revised
to clarify that the general licensee must
comply with the requirements in
§ 71.17(c)(1) through (c)(3).
Section 71.19 Previously Approved
Package
Paragraphs 71.19(b) through (e) would
be redesignated as §§ 71.19(a) through
(d).
In redesignated § 71.19(b)(2), the
phrase ‘‘[a]fter December 31, 2003’’
would be deleted. This would not
change the requirement that packages
used for a shipment to a location
outside the United States would
continue to be subject to multilateral
approval as defined in the DOT
regulations at 49 CFR 173.403, because
all such shipments would occur after
December 31, 2003.
Section 71.21 General License: Use of
Foreign Approved Package
Paragraph 71.21(a) would be revised
to update the reference to 49 CFR 171.12
to 49 CFR 171.23.
Paragraph 71.21(d) would be revised
to clarify that the general licensee must
comply with the requirements in
§ 71.21(d)(1) and (d)(2). Paragraph
71.21(d)(2) would be revised to delete
the sentence regarding exemption from
quality assurance provisions in subpart
H for design, construction, and
fabrication activities, because these
requirements are not applicable to a
general licensee. The general licensee
would be required to comply with the
quality assurance requirements in
subpart H that do apply.
Section 71.31
Contents of Application
In paragraph 71.31(b), the reference to
‘‘§ 71.13’’ would be corrected to
‘‘§ 71.19.’’ This change was
inadvertently omitted during a previous
rulemaking, when certain sections were
renumbered.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Section 71.38 Renewal of a Certificate
of Compliance
The title of this section would be
revised to remove the reference to the
renewal of quality assurance program
approvals. The section would be 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
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
duration of quality assurance program
approvals. Quality assurance program
approvals would not have an expiration
date, and the NRC would revise the
current quality assurance program
approvals so that they would not have
an expiration date. The renewal of a
quality assurance program approval
would be unnecessary. Paragraph
71.38(c) would also be revised for
improved clarity.
Section 71.70 Incorporations by
Reference
This section would be added to
incorporate by reference the consensus
standards referenced in § 71.75—ISO
9978:1992(E), ‘‘Radiation protection—
Sealed radioactive sources—Leakage
test methods’’ and ISO 2919:1999(E),
‘‘Radiation protection—Sealed
radioactive sources—General
requirements and classification’’—and
would describe the availability of the
documents.
Section 71.75 Qualification of Special
Form Radioactive Material
In § 71.75(a)(5), the 1992 edition of
ISO 9978 would be 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. This change would make 10
CFR part 71 consistent with the DOT
requirements in 49 CFR 173, which
incorporated ISO 9978:1992(E) in 2004.
In § 71.75(b)(2)(ii), the description of
the billet used in the percussion test
would be 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 § 71.75(b)(2)(iii), the description of
the sheet of lead used in the percussion
test would be 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 § 71.75(d), §§ 71.75(d)(1)(i) and
(d)(1)(ii) would be added. In § 71.75(d),
the 1999 edition of ISO 2919 would be
incorporated by reference, replacing the
reference to the 1980 edition of ISO
2919 for the alternate Class 4 impact test
in § 71.75(d)(1)(i) and the alternate Class
6 temperature test in § 71.75(d)(2). The
availability and other language
incorporating this standard by reference
is moved to § 71.70. Paragraph
71.75(d)(1)(ii) would allow 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
PO 00000
Frm 00015
Fmt 4701
Sfmt 4702
29001
§§ 71.75(b)(1) and (b)(2), if the specimen
weighs less than 500 grams.
Section 71.85 Preliminary
Determinations
In § 71.75(a), (b), and (c), ‘‘licensee’’
would be replaced by ‘‘certificate
holder.’’ The NRC experience is that
these determinations are performed by
the certificate holders who manufacture
the package. This change would make
the requirements consistent with
current practice, because only certificate
holders would have a quality assurance
program approval that would allow
them to conduct the required tests
under an approved quality assurance
program. Paragraph 71.85(d) would be
added to address the responsibilities of
licensees using a package for
transportation. Although certificate
holders would be required to make the
preliminary determinations under
§ 71.85(a), (b), and (c), the licensee
would be responsible for ensuring that
these determinations have been made
before their first use of the packaging.
Section 71.91
Records
In § 71.91(a), the reference to
‘‘§ 71.10’’ would be corrected to
‘‘§ 71.14.’’ This reference was not
updated when § 71.10 was redesignated
as § 71.14.
Section 71.101
Requirements
Quality Assurance
Paragraph 71.101(a) would be
changed to clarify that certificate
holders and applicants for a package
approval are responsible for satisfying
the quality assurance requirements that
apply to design, fabrication, testing, and
modification of packaging. The last two
sentences would be revised to be more
precise and to provide clarity.
Paragraph 71.101(c)(2) would be
changed to remove the reference to
licensees in the first sentence. This
would remove the overlap between the
two paragraphs, by making it clear that
licensees would notify the NRC before
their first use of any package as required
under § 71.75(c)(1) and certificate
holders and applicants for a CoC would
notify the NRC before the fabrication,
testing, or modification of a package as
required under § 71.75(c)(2).
Section 71.103
Organization
Quality Assurance
In § 71.75(a), footnote 2 would be
removed. 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
E:\FR\FM\16MYP2.SGM
16MYP2
29002
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
§ 71.106 in the list of the types of
records to be maintained.
Section 71.106 Changes to a Quality
Assurance Program
This section would be added to
establish requirements that would apply
to changes to quality assurance
programs. It would allow some changes
to a quality assurance program to be
made without obtaining the prior
approval of the NRC. Currently, all
changes, no matter how insignificant,
must be approved by the NRC before
they can be implemented. These
provisions would 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 would be
required to get NRC approval before
making changes to their quality
assurance program that would reduce
their commitments to the NRC.
Paragraph 71.106(a) would establish
the requirements that would apply
when a holder of a quality assurance
program approval intends to make a
change in its quality assurance program
that would reduce their commitments to
the NRC. The holder of a quality
assurance program approval would be
required to identify the change, the
reason for the change, and the basis for
concluding that the revised program
incorporating the change would
continue to satisfy the requirements of
subpart H that apply.
Paragraph 71.106(a)(2) would require
that each holder of a quality assurance
program approval maintain quality
assurance program changes as records.
These records would need to be
maintained as required in § 71.135.
Paragraph 71.106(b) would allow the
holder of a quality assurance program
approval to make changes to its quality
assurance program that would not
reduce its commitments to the NRC and
identifies the changes that would not be
considered as reducing its commitments
to the NRC.
Paragraph 71.106(c) would require
that records are maintained for any
changes to the quality assurance
program.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
activities performed by certificate
holders and applicants for a CoC.
Appendix A—Determination of A1 and
A2.
Section 71.135 Quality Assurance
Records
This section would be revised to
include those quality assurance records
that apply to changes that are made to
approved quality assurance programs.
The second sentence is revised to
include the changes to the quality
assurance program as required by
VerDate Mar<15>2010
19:22 May 15, 2013
Jkt 229001
In paragraphs IV.a. through IV.f., the
equations and accompanying text would
be revised to make minor corrections. In
paragraphs IV.a. and IV.b., the
description of the equations would
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.
Paragraph IV.c. would be added and
paragraphs IV.c. through IV.f. would be
redesignated as paragraphs IV.d.
through IV.g., respectively. Paragraph
IV.c. would provide 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 would increase
the consistency between appendix A
and TS–R–1.
In paragraph V., the existing text
would be redesignated as paragraph V.a.
Paragraph V.b. would be 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 would be revised to change
the A1 value for Cf-252 from 5.0 × 10¥2
TBq to 1.0 × 10¥1 TBq, and from 1.4 Ci
to 2.7 Ci. Footnote h would be deleted
and the following corresponding
changes would be made: 1) the reference
to footnote h would be removed from
Cf-252, 2) the entry for molybdenum-99
(Mo-99) would be revised to identify
footnote h instead of footnote i, and 3)
footnote i would be redesignated as
footnote h. Footnote c in the entry for
Ir-192 would be moved, so that it is
clear that it applies only to iridium in
special form. Footnote c would also be
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 would be 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 (2009 edition) and the
specific activity would be 4.2 × 104 TBq/
g (1.1 × 106 Ci/g). The entry for Kr-81
would be revised to reflect that it is no
longer the first entry for the isotopes of
krypton. In addition, footnote a would
be revised to identify the A1 and/or A2
values that include contributions from
daughter radionuclides with half-lives
of less than 10 days.
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
Table A–2 would be 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 would be 1.0 × 03 Bq/
g (2.7 × 10¥8 Ci/g) and the value for the
activity limit for exempt consignment
would be 1.0 × 105 Bq (2.7 × 10¥6 Ci).
The activity limit for exempt
consignment for Te-121m would be
revised from 1 × 105 Bq (2.7 × 10¥6 Ci)
to 1 × 106 Bq (2.7 × 10¥5 Ci). In footnote
b, the chains for the parent
radionuclides cerium-134 (Ce-134), Rn220, Th-226, and U–240 are proposed to
be removed, and a chain for Ag-108m is
proposed to be added. This would make
footnote b to Table A–2 consistent with
footnote b to Table 2 in TS–R–1.
Changes in the list in footnote b were
not initially made to TS–R–1 when the
nuclide-specific basic radionuclide
values from the International Basic
Safety Standards (IAEA Safety Series
No. 115, International Basic Safety
Standards for Protection against
Ionizing Radiation and for the Safety of
Radiation Sources) were adopted for
transportation purposes but were made
in the 2005 edition of TS–R–1.
Table A–3 would be revised to reflect
changes in TS–R–1. In the second entry,
the descriptive phrase ‘‘only alpha
emitting radionuclides are known to be
present’’ would be 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’’ would be
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 would indicate 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.
V. Criminal Penalties
For the purpose of Section 223 of the
Atomic Energy Act (AEA), the
Commission is proposing to amend 10
CFR part 71 under one or more of
Sections 161b, 161i, or 161o of the AEA.
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
Willful violations of the rule would be
subject to criminal enforcement.
VI. Agreement State Compatibility
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
would be a matter of compatibility
between the NRC and the Agreement
States, thereby providing consistency
among the Agreement States’ and the
NRC requirements. The NRC staff
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 proposed
compatibility categories assigned to the
affected sections of 10 CFR part 71 are
presented 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 Categories A, B, or C, and,
thus, 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, as
amended, or provisions of 10 CFR.
These program elements are not adopted
by the Agreement States.
The following table lists the parts and
sections that would be 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.
COMPATIBILITY TABLE
Compatibility
Section
Change
Subject
New1
Existing
Revised ..................
New ........................
71.4 .............
Revised ..................
71.4 .............
Revised ..................
71.4 .............
Revised ..................
71.4 .............
Revised ..................
71.6 .............
tkelley on DSK3SPTVN1PROD with PROPOSALS2
71.0(d)(1) ....
71.4 .............
Revised ..................
71.14(a)(1) ..
Revised ..................
71.14(a)(2) ..
Revised ..................
71.14(a)(3) ..
New ........................
71.15(d) .......
Revised ..................
VerDate Mar<15>2010
17:58 May 15, 2013
Purpose and Scope
Definition Contamination.
Definition Criticality
Safety Index
(CSI).
Definition Low Specific Activity (LSA)
material.
Definition Special
Form Radioactive
Material.
Definition Uranium—natural,
depleted, enriched.
Information Collection Requirements: OMB Approval.
Exemption for lowlevel materials.
Exemption for lowlevel materials.
Exemption for lowlevel materials.
Exemption from
classification as
fissile material.
Jkt 229001
PO 00000
D ..............................................................
.................................................................
D.
[B].
[B] ............................................................
[B].
[B] ............................................................
[B].
[B] ............................................................
[B].
[B] ............................................................
[B].
D ..............................................................
D.
[B] ............................................................
[B].
[B] ............................................................
[B].
.................................................................
[B].
[B] ............................................................
[B].
Frm 00017
Fmt 4701
Sfmt 4702
29003
E:\FR\FM\16MYP2.SGM
16MYP2
29004
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
COMPATIBILITY TABLE—Continued
Compatibility
Section
Change
Subject
New1
Existing
71.17 ...........
71.17(c) .......
Removal of brackets on Compatibility Category.
Revised ..................
71.19 ...........
Revised ..................
71.21 ...........
71.21(a) .......
Removal of brackets on Compatibility Category.
Revised ..................
71.21(d) .......
Revised ..................
71.31(b) .......
Revised ..................
71.38 ...........
Retitled and revised
71.70 ...........
New ........................
71.75 ...........
Revised ..................
71.85(a) .......
Revised ..................
71.85(b) .......
Revised ..................
71.85(c) .......
Revised ..................
71.85(d) .......
New ........................
71.91(a) .......
71.91(b) .......
Revised ..................
Revised Compatibility Category.
Revised Compatibility Category.
Revised Compatibility Category.
Revised ..................
71.91(c) .......
71.91(d) .......
71.101(a) .....
tkelley on DSK3SPTVN1PROD with PROPOSALS2
71.101(b) .....
VerDate Mar<15>2010
Revised Compatibility Category.
19:32 May 15, 2013
General license:
NRC-approved
package.
General license:
NRC-approved
package.
Previously approved
package.
General license:
Use of foreign approved package.
General license:
Use of foreign approved package.
General license:
Use of foreign approved package.
Contents of application.
Renewal of a certificate of compliance.
Incorporations by
reference.
Qualification of special form radioactive material.
Preliminary determinations.
Preliminary determinations.
Preliminary determinations.
Preliminary determinations.
Records ..................
Records ..................
[B] ............................................................
B.
[B] ............................................................
B.
NRC ........................................................
NRC.
[B] ............................................................
B.
[B] ............................................................
B.
[B] ............................................................
B.
NRC ........................................................
NRC.
NRC ........................................................
NRC.
.................................................................
NRC.
NRC ........................................................
NRC.
[B] ............................................................
NRC.
[B] ............................................................
NRC.
[B] ............................................................
NRC.
.................................................................
B.
D ..............................................................
D ..............................................................
C.
NRC.
Records ..................
D ..............................................................
C.
Records ..................
D ..............................................................
C.
Quality assurance
requirements.
D—For those States which have no
users of Type B packages—other
than industrial radiography.**.
C—Those States which have users of
Type B packages—other than industrial radiography**.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.12(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137)..
D—For those States which have no
users of Type B packages—other
than industrial radiography.**.
C—Those States which have users of
Type B packages—other than industrial radiography.**.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.12(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
C.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.17(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137)
Quality assurance
requirements.
Jkt 229001
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
E:\FR\FM\16MYP2.SGM
C.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.17(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
29005
COMPATIBILITY TABLE—Continued
Compatibility
Section
Change
Subject
Existing
Revised Compatibility Category.
Quality assurance
requirements.
71.101(c)(2)
Revised ..................
71.101(g) .....
Revised Compatibility Category
Note.
Quality assurance
requirements.
Quality assurance
requirements.
71.103(a) .....
Revised ..................
Quality assurance
organization.
71.103(b) .....
Revised Compatibility Category
Note.
Quality assurance
organization.
71.106 .........
New ........................
71.135 .........
tkelley on DSK3SPTVN1PROD with PROPOSALS2
71.101(c)(1)
Revised ..................
Changes to quality
assurance program.
Quality assurance
records.
VerDate Mar<15>2010
19:32 May 15, 2013
Jkt 229001
PO 00000
New1
D—For those States which have no
users of Type B packages—other
than industrial radiography**.
C—Those States which have users of
Type B packages—other than industrial radiography.**.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.12(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
NRC ........................................................
C.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.17(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
C. .............................................................
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.12(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
D—For those States which have no
users of Type B packages—other
than industrial radiography.**.
[C]—Those States which have users of
Type B packages—other than industrial radiography.**.
**Note: § 71.101(g) indicates that QA
programs for industrial radiography
Type B package users are covered by
§ 34.31(b). It also indicated that this
section satisfies § 71.12(b) and thus
would satisfy those sections referenced in this provision (§§ 71.101
through 71.137).
C—Those States which have users of
Type B packages—other than industrial radiography.**.
**Note: § 71.101(g) indicates that QA
programs for industrial radiography
Type B package users are covered by
§ 34.31(b). It also indicated that this
section satisfies § 71.12(b) and thus
would satisfy those sections referenced in this provision (§§ 71.101
through 71.137).
.................................................................
D—For those States which have no
users of Type B packages—other
than industrial radiography.**.
C—For those States which have users
of Type B packages—other than industrial radiography**.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.12(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
Frm 00019
Fmt 4701
Sfmt 4702
E:\FR\FM\16MYP2.SGM
NRC.
C.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.17(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
C.
**Note: § 71.101(g) indicates that QA
programs for industrial radiography
Type B package users are covered by
§ 34.31(b). It also indicated that this
section satisfies § 71.17(b) and thus
would satisfy those sections referenced in this provision (§§ 71.101
through 71.137).
C.
**Note: § 71.101(g) indicates that QA
programs for industrial radiography
Type B package users are covered by
§ 34.31(b). It also indicated that this
section satisfies § 71.17(b) and thus
would satisfy those sections referenced in this provision (§§ 71.101
through 71.137).
C.
C.
**Note: 10 CFR 71.101(g) indicates that
QA programs for industrial radiography Type B package users are covered by § 34.31(b). It also indicated
that this section satisfies § 71.17(b)
and thus would satisfy those sections
referenced in this provision (§§ 71.101
through 71.137).
16MYP2
29006
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
COMPATIBILITY TABLE—Continued
Compatibility
Section
Change
Subject
New1
Existing
Appendix A ..
Appendix A,
Table A–1.
Appendix A,
Table A–2.
Appendix A,
Table A–3.
Revise paragraphs
IV.a.—IV.f.; redesignate paragraphs IV.c.—IV.f.
as paragraphs
IV.d.—IV.g.; add
paragraph IV.c.;
redesignate the
text of paragraph
V. as paragraph
V.a.; and add
paragraph V.b.
Revise entries for
Cf-252, Ir-192, Kr81, and Mo-99;
revise footnote a;
delete footnote h;
and redesignate
footnote i as footnote h.
Add entry for Kr-79.
Add entry for Kr-79;
revise entries for
Kr-81 and Te121m; and revise
footnote b.
Revise entries for
column 1, ‘‘Contents,’’ and add
footnote a.
Determination of A1
and A2.
[B] ............................................................
[B].
A1 and A2 Values
for Radionuclides.
[B] ............................................................
[B].
Exempt Material Activity Concentrations and Exempt
Consignment Activity Limits for
Radionuclides.
General Values for
A1 and A2.
[B] ............................................................
[B].
[B] ............................................................
[B].
tkelley on DSK3SPTVN1PROD with PROPOSALS2
1 Where there would be a change in the assigned compatibility category, a compatibility category is assigned, or the content of the section has
been significantly changed, a summary of the analysis is presented in the following paragraphs. Changes in the assigned compatibility category
are being made in §§ 71.4 (added for the definition of contamination), 71.70, 71.85, 71.91, 71.101, 71.103, 71.106, and 71.135.
In § 71.4, the definition of
contamination would be designated
Compatibility Category [B], because it
applies to activities that have direct and
significant effects in multiple
jurisdictions and it is also defined in the
corresponding DOT regulations.
In §§ 71.17, 71.21, and 71.103, the
compatibility category is unchanged,
but the brackets were not retained
because there are no corresponding DOT
regulations.
The new § 71.70, ‘‘Incorporations by
reference,’’ would be designated
Compatibility Category NRC, because
the documents incorporated by
reference are incorporated for use in
§ 71.75, which addresses activities
under Federal jurisdiction.
Section 71.85, ‘‘Preliminary
determinations,’’ would be changed to
make the requirements in § 71.85(a)
through (c) apply to holders of a CoC.
Paragraphs 71.85(a) through (c) would
be 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) would be
added and applies to licensees.
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
Paragraph 71.85(d) would be 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 § 71.91,
‘‘Records,’’ would be changed from
Compatibility Category D to
Compatibility Category C. In reaching an
agreement with the NRC, the States
would have a general provision relating
to records and for incident reporting.
The recordkeeping requirements in
§ 71.91 include requirements associated
with transportation, which may involve
multiple jurisdictions. With the
exception of § 71.91(b), the NRC is
proposing to designate the compatibility
of the requirements in § 71.91 as
Compatibility Category C to require that
the essential objectives of the
requirements be adopted to avoid
conflict, duplication, gaps, or other
conditions that would jeopardize the
orderly pattern in the regulation of
agreement material on a nationwide
basis, including creating an undue
burden on interstate commerce through
additional recordkeeping requirements;
PO 00000
Frm 00020
Fmt 4701
Sfmt 4702
§ 71.91(b) only applies to CoC holders
and applicants and would be designated
as compatibility category NRC. The
States would not be required to adopt
them in an essentially identical manner
as might be necessary if the
requirements had a more direct and
significant impact on multiple
jurisdictions.
In § 71.101, the compatibility category
would 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 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
would be updated by changing
§ 71.12(b) to § 71.17(b).
In § 71.103, the compatibility category
for some users of packages was not
E:\FR\FM\16MYP2.SGM
16MYP2
29007
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
designated. The compatibility category
would be simplified by removing the
separate compatibility category for
States that do not have a user of a Type
B package and by removing the bracket
around the compatibility category for
§ 71.103(a). If a State does not have a
user of a Type B package, the State
would be 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 would be
updated by changing § 71.12(b) to
§ 71.17(b).
The new § 71.106, ‘‘Changes to quality
assurance program,’’ would apply to
licensees and holders of, or applicants
for, a CoC. The assigned compatibility
category would be 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 would be performed by the
NRC.
In § 71.135, the compatibility category
would 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
would be 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 would be
updated by changing § 71.12(b) to
§ 71.17(b).
VII. Availability of Documents
The following documents referenced
in this proposed rulemaking are
available either through ADAMS or at
the NRC PDR:
ADAMS Accession No.
Document
PDR
ADAMS
Management Directive 5.9, ‘‘Adequacy and Compatibility of Agreement State Programs.’’ ................
NRC Information Notice 2002–035: ‘‘Changes to 10 CFR Parts 71 and 72 Quality Assurance Programs.’’
NRC Regulatory Issue Summary 2004–018: ‘‘Expiration Date for 10 CFR Part 71 Quality Assurance Program Plan Approvals.’’.
NUREG/CR–5342, ‘‘Assessment and Recommendations for Fissile-Material Packaging Exemptions
and General Licenses within 10 CFR Part 71,’’ July 1998.
Draft Environmental Assessment and Finding of No Significant Impact for the Proposed Rule
Amending 10 CFR Part 71.
Draft Regulatory Analysis for Proposed Rulemaking—Compatibility with IAEA Transportation Standards (10 CFR Part 71).
Yes ..........
Yes ..........
Yes ..........
Yes ..........
ML041770094
ML023520339
Yes ..........
Yes ..........
ML042160293
Yes ..........
Yes ..........
ML12139A419
Yes ..........
Yes ..........
ML12187A109
Yes ..........
Yes ..........
ML12187A110
VIII. 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). The NRC
requests comments on the proposed rule
with respect to the clarity and
effectiveness of the language used.
Comments should be sent to the NRC as
explained in the ADDRESSES section of
this document.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
IX. 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 proposed rule, the
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
NRC proposes to use and incorporate by
reference the following consensus
standards: International Organization
for Standardization, 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
International Organization for
Standardization, ISO 9978:1992(E),
‘‘Radiation protection—Sealed
radioactive sources—Leakage test
methods,’’ First Edition (February 15,
1992), for the leaktightness tests. The
NRC invites comment on the
applicability and use of other standards.
In other portions of this proposed
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 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)
PO 00000
Frm 00021
Fmt 4701
Sfmt 4702
the oversight of quality assurance
programs, and (4) the removal of
transitional arrangements for previously
approved packages.
X. 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
proposed rule because the Commission
has concluded on the basis of an
Environmental Assessment (ADAMS
Accession No. ML12187A109) that this
proposed rule, if adopted, would not be
a major federal action significantly
affecting the quality of the human
environment.
Many of the proposed changes fall
under a categorical exclusion for which
the Commission has previously
determined that such actions, neither
individually nor cumulatively, would
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. The
categorical exclusion at 10 CFR
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
29008
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
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: (i) Procedures
for filing and reviewing applications for
licenses or construction permit or early
site permit 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; (ii) recordkeeping
requirements; (iii) reporting
requirements; (iv) education, training,
experience, qualification, or other
employment suitability requirements; or
(v) actions on petitions for rulemaking
relating to these amendments.
Those changes not qualifying for a
categorical exclusion were evaluated for
their environmental impacts and
include changes to: (1) Definitions; (2)
the exemption of low-level materials; (3)
the fissile material exemption for lowenriched fissile material; (4) alternate
tests that may be used for the
qualification of special form material;
(5) preliminary determinations; (6) the
A1 and A2 values for radionuclides; and
(7) the exempt material activity
concentrations and exempt consignment
activity limits for radionuclides. The
effects of these changes are addressed in
more detail in the Environmental
Assessment. The changes to the fissile
material exemption would 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 would be 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 would be allowed 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
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
radionuclides, the approach for
determining the appropriate values has
not changed, so there would be very
small impacts from these changes.
The determination of this
Environmental Assessment is that there
will be no significant impact to the
public from this action. However, the
NRC is providing an opportunity to
comment on the Environmental
Assessment. Comments on any aspect of
the Environmental Assessment may be
submitted to the NRC as indicated
under the ADDRESSES section of this
document.
The NRC has sent a copy of the
Environmental Assessment and this
proposed rule to every State Liaison
Officer and requested their comments
on the Environmental Assessment.
XI. Paperwork Reduction Act
Statement
This proposed 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). This proposed rule
has been submitted to the Office of
Management and Budget (OMB) for
review and approval of the information
collection requirements.
Type of submission, new or revision:
Revision.
The title of the information collection:
10 CFR part 71, Revisions to
Transportation Safety Requirements and
Harmonization with International
Atomic Energy Agency Transportation
Requirements.
The form number if applicable: Not
applicable.
How often the collection is required:
On occasion, for reports of changes
reducing commitments to the NRC on
quality assurance plans. Every 24
months for all changes to quality
assurance plans.
Who will be required or asked to
report: General licensees or users of
packages, certificate holders and
certificate applicants.
An estimate of the number of annual
responses: 31.
The estimated number of annual
respondents: 250.
An estimate of the total number of
hours needed annually to complete the
requirement or request: ¥1,700 hours (a
decrease of 1,925 hours reporting + an
increase of 100 third party disclosure
hours and 125 hours recordkeeping).
Abstract: The NRC is proposing to
amend its regulations for the packaging
and transportation of radioactive
material, including changes to
information collections that would
affect persons with a quality assurance
program approved under 10 CFR part
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
71. Rather than submitting all quality
assurance program changes to the NRC
for approval, licensees, certificate
holders, and applicants would only
need to submit changes to their quality
assurance program that would reduce
their commitments to the NRC. They
would be required to keep records of all
quality assurance program changes and
submit a report of these changes to the
NRC every 24 months. Burden on
licensees would be reduced for
renewing quality assurance programs, as
future approvals of these programs
would not expire.
The NRC is seeking public comment
on the potential impact of the
information collections contained in
this proposed rule (or proposed policy
statement) and on the following issues:
1. Is the proposed information
collection necessary for the proper
performance of the functions of the
NRC, including whether the information
will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the
quality, utility, and clarity of the
information to be collected?
4. How can the burden of the
information collection be minimized,
including the use of automated
collection techniques?
A copy of the OMB clearance package
may be viewed free of charge at the NRC
PDR, Room O1–F21, One White Flint
North, 11555 Rockville Pike, Rockville,
MD 20852. The OMB clearance package
and rule are available at the NRC public
Web site: https://www.nrc.gov/publicinvolve/doc-comment/omb/,
for 60 days after the signature date of
this document.
Send comments on any aspect of
these proposed information collections,
including suggestions for reducing the
burden and on the previously stated
issues, by June 17, 2013 to the
Information Services Branch (T–5 F53),
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001, or by
email to
INFOCOLLECTS.RESOURCE@NRC.GOV
and to the Desk Officer, Chad
Whiteman, Office of Information and
Regulatory Affairs, NEOB–10202,
(3150–0008), Office of Management and
Budget, Washington, DC 20503.
Comments on the proposed information
collections may also be submitted via
the Federal rulemaking Web site
https://www.regulations.gov, docket #
NRC–2008–0198. Comments received
after this date will be considered if it is
practical to do so, but assurance of
consideration cannot be given to
comments received after this date.
Comments can also be emailed to
Chad_S_Whiteman@omb.eop.gov or
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
submitted by telephone at 202–395–
4718.
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.
XII. Regulatory Analysis
The Commission has prepared a draft
regulatory analysis (ADAMS Accession
No. ML12187A110) on this proposed
regulation. The analysis examines the
costs and benefits of the alternatives
considered by the Commission. The
Commission requests public comment
on the draft regulatory analysis.
Comments on the draft analysis may be
submitted to the NRC as indicated
under the ADDRESSES section of this
document.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
XIII. Regulatory Flexibility
Certification
In accordance with the Regulatory
Flexibility Act of 1980 (5 U.S.C. 605(b)),
the Commission certifies that this rule
would 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 quality assurance program
description issued under 10 CFR parts
50, 71, or 72; and holders of a certificate
of compliance for a transportation
package. These companies 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 at 10 CFR
2.810. Also, a draft regulatory analysis
was performed for this proposed rule.
The regulatory analysis included an
evaluation of the costs associated with
the proposed requirements. The
proposed rulemaking includes changes
that would reduce the regulatory burden
for licensees and certificate holders.
Based on the information developed in
the regulatory analysis, it is believed
that there will not be significant
economic impacts on a substantial
number of small entities.
XIV. Backfitting
The NRC has determined that the
backfit rule (50.109, 70.76, 72.62, or
76.76) and the issue finality provisions
in 10 CFR part 52 do not apply to this
proposed rule because this amendment
would not involve any provisions that
would impose backfits as defined in 10
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
CFR Chapter I. Therefore, a backfit
analysis is not required for this
proposed rule, and the NRC did not
prepare a backfit analysis for this
proposed rule.
List of Subjects in 10 CFR Part 71
Criminal penalties, Hazardous
materials transportation, Nuclear
materials, 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. 553; the NRC
is proposing to adopt the following
amendments to 10 CFR part 71:
PART 71—PACKAGING AND
TRANSPORTATION OF RADIOACTIVE
MATERIAL
1. The authority citation for part 71
continues to read as follows:
■
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. No. 109–58, 119 Stat. 594
(2005). Section 71.97 also issued under sec.
301, Pub. L. 96–295, 94 Stat. 789–790.
§ 71.0
[Amended]
2. In § 71.0, paragraph (d)(1), remove
the reference to ‘‘§§ 71.20 through
72.23’’ and add, in its place, the
reference ‘‘§§ 71.21 through 71.23’’.
■ 3. In § 71.4, add in alphabetical order
the definition of ‘‘contamination,’’ and
revise the definitions of ‘‘Criticality
Safety Index (CSI),’’ ‘‘Low Specific
Activity (LSA) material,’’ ‘‘Special form
radioactive material,’’ and ‘‘Uranium—
natural, depleted, enriched’’ to read as
follows:
■
§ 71.4
Definitions.
*
*
*
*
*
Contamination means the presence of
a radioactive substance on a surface in
quantities in excess of 0.4 Bq/cm2 for
beta and gamma emitters and low
toxicity alpha emitters, or 0.04 Bq/cm2
for all other alpha emitters.
(1) Fixed contamination means
contamination that cannot be removed
from a surface during normal conditions
of transport.
(2) Non-fixed contamination means
contamination that can be removed from
a surface during normal conditions of
transport.
*
*
*
*
*
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
29009
Criticality Safety Index (CSI) means
the dimensionless number (rounded up
to the next tenth) assigned to and placed
on the label of a fissile material package,
to designate the degree of control of
accumulation of packages, overpacks or
freight containers containing fissile
material during transportation.
Determination of the criticality safety
index is described in §§ 71.22, 71.23,
and 71.59 of this part. The criticality
safety index for an overpack, freight
container, consignment or conveyance
containing fissile material packages is
the arithmetic sum of the criticality
safety indices of all the fissile material
packages contained within the
overpack, freight container,
consignment or conveyance.
*
*
*
*
*
Low Specific Activity (LSA) material
means radioactive material with limited
specific activity which is nonfissile or is
excepted under § 71.15 of this part, and
which satisfies the descriptions and
limits set forth below. 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 material in which the
activity is distributed throughout and
the average specific activity does not
exceed 10¥4 A2/g for solids and gases,
and 10¥5 A2/g for liquids.
(3) LSA–III. Solids (e.g., consolidated
wastes, activated materials), excluding
powders, that satisfy the requirements
of § 71.77 of this part, in which:
(i) The radioactive material is
distributed throughout a solid or a
collection of solid objects, or is
E:\FR\FM\16MYP2.SGM
16MYP2
tkelley on DSK3SPTVN1PROD with PROPOSALS2
29010
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
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 would not
exceed 0.1 A2; and
(iii) The estimated average specific
activity of the solid, excluding any
shielding material, does not exceed 2 ×
10¥3 A2/g.
*
*
*
*
*
Special form radioactive material
means radioactive material that satisfies
the following conditions:
(1) It is either a single solid piece or
is contained in a sealed capsule that can
be opened only by destroying the
capsule;
(2) The piece or capsule has at least
one dimension not less than 5 mm (0.2
in); and
(3) It satisfies the requirements of
§ 71.75 of this part. A special form
encapsulation designed in accordance
with the requirements of § 71.4 of this
part in effect on June 30, 1983 (see 10
CFR part 71, revised as of January 1,
1983), and constructed before July 1,
1985; a special form encapsulation
designed in accordance with the
requirements of § 71.4 of this part in
effect on March 31, 1996 (see 10 CFR
part 71, revised as of January 1, 1996),
and constructed before April 1, 1998;
and special form material that was
successfully tested before [EFFECTIVE
DATE OF FINAL RULE] in accordance
with the requirements of § 71.75(d) of
this part in effect before [EFFECTIVE
DATE OF FINAL RULE] may continue
to be used. Any other special form
encapsulation must meet the
specifications of this definition.
*
*
*
*
*
Uranium—natural, depleted,
enriched:
(1) Natural uranium means uranium
(which may be chemically separated)
with the naturally occurring distribution
of uranium isotopes (approximately
0.711 weight percent uranium-235, and
the remainder by weight essentially
uranium-238).
(2) Depleted uranium means uranium
containing less uranium-235 than the
naturally occurring distribution of
uranium isotopes.
(3) Enriched uranium means uranium
containing more uranium-235 than the
naturally occurring distribution of
uranium isotopes.
■ 4. In § 71.6, paragraph (b) is revised to
read as follows:
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
§ 71.6 Information collection
requirements: OMB approval.
*
*
*
*
*
(b) The approved information
collection requirements contained in
this part appear in §§ 71.5, 71.7, 71.9,
71.12, 71.17, 71.19, 71.22, 71.23, 71.31,
71.33, 71.35, 71.37, 71.38, 71.39, 71.41,
71.47, 71.85, 71.87, 71.89, 71.91, 71.93,
71.95, 71.97, 71.101, 71.103, 71.105,
71.106, 71.107, 71.109, 71.111, 71.113,
71.115, 71.117, 71.119, 71.121, 71.123,
71.125, 71.127, 71.129, 71.131, 71.133,
71.135, 71.137, and appendix A,
paragraph II.
■ 5. In § 71.14, paragraphs (a)(1) and (2)
are revised,and paragraph (a)(3) is
added to read as follows:
§ 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 § 71.4 of this part.
*
*
*
*
*
■ 6. In § 71.15, paragraph (d) is revised
to read as follows:
§ 71.15 Exemption from classification as
fissile material.
*
*
*
*
*
(d) Uranium enriched in uranium-235
to a maximum of 1 percent by weight,
and with total plutonium and uranium233 content of up to 1 percent of the
mass of uranium-235, provided that the
mass of any beryllium, graphite, and
hydrogenous material enriched in
deuterium constitutes less than 5
percent of the uranium mass, and that
the fissile material is distributed
homogeneously and does not form a
lattice arrangement within the package.
*
*
*
*
*
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
7. In § 71.17, paragraph (c)
introductory text, (c)(1), and (c)(2) are
revised to read as follows:
■
§ 71.17 General license: NRC-approved
package.
*
*
*
*
*
(c) Each licensee issued a general
license under paragraph (a) of this
section shall—
(1) Maintain a copy of the CoC, 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
*
*
*
*
*
■ 8. In § 71.19, paragraphs (b) through
(e) are redesignated as paragraphs (a)
through (d), and redesignated paragraph
(b)(2) is revised to read as follows:
§ 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 regulations at 49
CFR 173.403.
*
*
*
*
*
■ 9. In § 71.21, paragraphs (a) and (d)
are revised to read as follows:
§ 71.21 General license: Use of foreign
approved package.
(a) A general license is issued to any
licensee of the Commission to transport,
or to deliver to a carrier for transport,
licensed material in a package, the
design of which has been approved in
a foreign national competent authority
certificate, that has been revalidated by
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.
E:\FR\FM\16MYP2.SGM
16MYP2
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
§ 71.31
[Amended]
1. In § 71.31, paragraph (b), remove
the reference to ‘‘§ 71.13’’ and add, in its
place, the reference to ‘‘§ 71.19’’.
■ 2. Section 71.38 is revised to read as
follows:
■
§ 71.38 Renewal of a certificate of
compliance.
(a) Except as provided in paragraph
(b) of this section, each Certificate of
Compliance expires at the end of the
day, in the month and year stated in the
approval.
(b) In any case in which a person, not
less than 30 days before the expiration
of an existing Certificate of Compliance
issued pursuant to the part, has filed an
application in proper form for renewal,
the existing Certificate of Compliance
for which the renewal application was
filed shall not be deemed to have
expired until final action on the
application for renewal has been taken
by the Commission.
(c) In applying for renewal of an
existing Certificate of Compliance, an
applicant may be required to submit a
consolidated application that is
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.
■ 3. Add § 71.70 to subpart F to read as
follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 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 10 CFR 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
are available for purchase at the
corresponding address noted in this
section. The materials can also be
examined at the NRC Public Document
Room, O1–F21, 11555 Rockville Pike,
Rockville, Maryland 20852 or at the
NRC Library, Two White Flint North,
11545 Rockville Pike, Rockville,
Maryland 20852; telephone: 301–415–
5610; email: Library.Resource@nrc.gov.
The materials are also available for
inspection at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
or go to https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(b) The following material is available
for purchase from the American
National Standards Institute, 25 West
43rd Street, 4th floor, New York, NY
10036, 212–642–4900, https://
www.ansi.org, or Info@ansi.org.
(1) International Organization for
Standardization, ISO 9978:1992(E),
‘‘Radiation protection—Sealed
radioactive sources—Leakage test
methods,’’ First Edition (February 15,
1992), incorporation by reference
approved for § 71.75(a) of this part.
(2) International Organization for
Standardization, ISO 2919:1999(E),
‘‘Radiation protection—Sealed
radioactive sources—General
requirements and classification,’’
Second Edition (February 15, 1999),
incorporation by reference approved for
§ 71.75(d) of this part.
■ 4. In § 71.75, paragraphs (a)(5),
(b)(2)(ii), (b)(2)(iii), (d)(1), and (d)(2) are
revised to read as follows:
§ 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 in
§ 71.70 of this part).
(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 (.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 in § 71.70 of
this part); or
(ii) Less than 500 grams and
alternatively subjected to the Class 5
impact test prescribed in ISO
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
29011
2919:1999(E), ‘‘Radioactive protection—
Sealed radioactive sources—General
requirements and classification’’
(incorporated by reference in § 71.70 of
this part); 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 in § 71.70 of
this part).
■ 5. In § 71.85, paragraphs (a), (b), and
(c) are revised and paragraph (d) is
added to read as follows:
§ 71.85
Preliminary determinations.
*
*
*
*
*
(a) The certificate holder shall
ascertain that there are no cracks,
pinholes, uncontrolled voids, or other
defects that could significantly reduce
the effectiveness of the packaging;
(b) Where the maximum normal
operating pressure will exceed 35 kPa (5
lbf/in2) gauge, the certificate holder
shall test the containment system at an
internal pressure at least 50 percent
higher than the maximum normal
operating pressure, to verify the
capability of that system to maintain its
structural integrity at that pressure;
(c) The certificate holder shall
conspicuously and durably mark the
packaging with its model number, serial
number, gross weight, and a package
identification number assigned by the
NRC. Before applying the model
number, the certificate holder shall
determine that the packaging has been
fabricated in accordance with the design
approved by the Commission; and
(d) The licensee shall ascertain that
the determinations in paragraphs (a)
through (c) of this section have been
made.
§ 71.91
[Amended]
1. In § 71.91, paragraph (a), remove
the reference to ‘‘§ 71.10’’ and add, in its
place, the reference to ‘‘§ 71.14’’.
■ 2. In § 71.101, paragraphs (a) and
(c)(2) are revised to read as follows:
■
§ 71.101
Quality assurance requirements.
(a) Purpose. This subpart describes
quality assurance requirements applying
to design, purchase, fabrication,
handling, shipping, storing, cleaning,
assembly, inspection, testing, operation,
maintenance, repair, and modification
of components of packaging that are
important to safety. As used in this
subpart, ‘‘quality assurance’’ comprises
all those planned and systematic actions
necessary to provide adequate
confidence that a system or component
E:\FR\FM\16MYP2.SGM
16MYP2
29012
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
§ 71.103
Quality assurance organization.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
(a) The licensee, certificate holder,
and applicant for a Certificate of
Compliance (CoC) shall be responsible
for the establishment and execution of
the quality assurance program. The
licensee, certificate holder, and
applicant for a CoC 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.
*
*
*
*
*
■ 4. Add § 71.106 to subpart H to read
as follows:
§ 71.106 Changes to quality assurance
program.
(a) Each quality assurance program
approval holder shall submit, in
accordance with § 71.1(a) of this part, a
description of a proposed change to its
NRC-approved quality assurance
program that would reduce
commitments in the program
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
description as approved by the NRC.
The quality assurance program approval
holder shall not implement the change
before receiving NRC approval.
(1) The description of a proposed
change to the NRC-approved quality
assurance program must identify the
change, the reason for the change, and
the basis for concluding that the revised
program incorporating the change
continues to satisfy the applicable
requirements of subpart H of this part.
(2) [Reserved]
(b) Each quality assurance program
approval holder may change a
previously approved quality assurance
program without prior NRC approval, if
the change does not reduce the
commitments in the quality assurance
program previously approved by the
NRC. Changes to the quality assurance
program that do not reduce the
commitments shall be submitted to the
NRC every 24 months, in accordance
with § 71.1(a) of this part. 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.
PO 00000
Frm 00026
Fmt 4701
Sfmt 4725
(c) Each quality assurance program
approval holder shall maintain records
of quality assurance program changes.
■ 5. Section 71.135 is revised to read as
follows:
§ 71.135
Quality assurance records.
The licensee, certificate holder, and
applicant for a Certificate of Compliance
(CoC) shall maintain sufficient written
records to describe the activities
affecting quality. These records must
include changes to the quality assurance
program as required by § 71.106 of this
part, the instructions, procedures, and
drawings required by § 71.111 of this
part 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
CoC shall retain these records for 3
years beyond the date when the
licensee, certificate holder, and
applicant for a CoC 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 CoC shall
retain the superseded material for 3
years after it is superseded.
■ 6. In appendix A to part 71, IV.a. and
IV.b. are revised, paragraphs IV.c.
through IV.f. are redesignated as
paragraphs IV.d. through IV.g. and are
revised, new paragraph IV.c. is added,
paragraph V. is redesignated as
paragraph V.a., and new paragraph V.b.
is added to 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:
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:
E:\FR\FM\16MYP2.SGM
16MYP2
EP16MY13.010</GPH> EP16MY13.011</GPH>
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
(CoC) shall obtain Commission approval
of its quality assurance program. Each
certificate holder or applicant for a CoC
shall, in accordance with § 71.1 of this
part, 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.
*
*
*
*
*
■ 3. In § 71.103, paragraph (a) is revised
to read as follows:
29013
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
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:
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:
e. Alternatively, the A2 value for mixtures
of normal form material may be determined
as follows:
Where f(i) is the fraction of activity for
radionuclide i in the mixture and A2(i) is the
appropriate A2 value for radionuclide i.
f. The exempt activity concentration for
mixtures of nuclides may be determined as
follows:
Where 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
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.
Where f(i) is the fraction of activity
concentration of radionuclide i in the
mixture and [A](i) is the activity
concentration for exempt material containing
radionuclide i.
g. The activity limit for an exempt
consignment for mixtures of radionuclides
may be determined as follows:
Where f(i) is the fraction of activity of
radionuclide i in the mixture and A(i) is the
activity limit for exempt consignments for
radionuclide i.
V.a. * * *
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.
■
1:
a. Add entry for Kr-79 in
alphanumeric order;
■
*
Krypton (36) .....
...........................
*
*
Mo-99 (a)(h) ...............
*
...........................
VerDate Mar<15>2010
*
*
A2 (Ci)b
A2 (TBq)
*
1.0 × 10¥1
c 1.0
4.0
4.0 × 101
*
1.0
*
*
2.7
*
3.0 × 10¥3
8.1 × 10¥2
*
× 10
*
6.0 × 10¥1
1.6 × 101
*
1.1 × 102
1.1 × 103
*
2.0
4.0 × 101
5.4 × 101
1.1 × 103
*
2.7 × 101
*
6.0 × 10¥1
1.6 × 101
c 2.7
*
*
*
*
*
*
2.0 × 101
3.4 × 102
4.2 × 104
7.8 × 10¥4
1.8 × 104
*
A2 values include contributions from daughter nuclides with half-lives less than 10 days, as listed in the following:
Al-28
Sc-47
Sc-44
Mn-52m
Co-60m
Zn-69
17:58 May 15, 2013
Jkt 229001
PO 00000
Frm 00027
Fmt 4701
Sfmt 4702
E:\FR\FM\16MYP2.SGM
16MYP2
(Ci/g)
*
*
5.4 × 102
9.2 × 103
*
1.1 × 106
2.1 × 10¥2
*
*
4.8 × 105
EP16MY13.016</GPH>
*
and/or
Mg-28
Ca-47
Ti-44
Fe-52
Fe-60
Zn-69m
*
EP16MY13.015</GPH>
*
...........................
*
Kr-79 ..........................
Kr-81 ..........................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
*
Ir-192 ..........................
*
*
(TBq/g)
*
...........................
*
*
Specific activity
A1 (Ci)b
A1 (TBq)
*
Cf-252 ........................
aA
1
Appendix A to Part 71—Determination
of A1 and A2
EP16MY13.014</GPH>
Element and
atomic No.
*
*
*
*
7. In appendix A to part 71, Table A–
■
EP16MY13.012</GPH> EP16MY13.013</GPH>
Symbol of radionuclide
*
b. Revise the entries for Cf-252, Ir-192,
Kr-81, and Mo-99;
■ c. Revise footnotes a and c; and
■ d. Remove footnote h; and
■ e. Redesignate footnote i as footnote h.
The revisions read as follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
29014
Ge-68
Rb-83
Sr-82
Sr-90
Sr-91
Sr-92
Y-87
Zr-95
Zr-97
Mo-99
Tc-95m
Tc-96m
Ru-103
Ru-106
Pd-103
Ag-108m
Ag-110m
Cd-115
In-114m
Sn-113
Sn-121m
Sn-126
Te-127m
Te-129m
Te-131m
Te-132
I-135
Xe-122
Cs-137
Ba-131
Ba-140
Ce-144
Pm-148m
Gd-146
Dy-166
Hf-172
W-178
W-188
Re-189
Os-194
Ir-189
Pt-188
Hg-194
Hg-195m
Pb-210
Pb-212
Bi-210m
Bi-212
At-211
Rn-222
Ra-223
Ra-224
Ra-225
Ra-226
Ra-228
Ac-225
Ac-227
Th-228
Th-234
Pa-230
U-230
U-235
Pu-241
Pu-244
Am-242m
Am-243
Cm-247
Bk-249
Cf-253
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
Ga-68
Kr-83m
Rb-82
Y-90
Y-91m
Y-92
Sr-87m
Nb-95m
Nb-97m, Nb-97
Tc-99m
Tc-95
Tc-96
Rh-103m
Rh-106
Rh-103m
Ag-108
Ag-110
In-115m
In-114
In-113m
Sn-121
Sb-126m
Te-127
Te-129
Te-131
I-132
Xe-135m
I-122
Ba-137m
Cs-131
La-140
Pr-144m, Pr-144
Pm-148
Eu-146
Ho-166
Lu-172
Ta-178
Re-188
Os-189m
Ir-194
Os-189m
Ir-188
Au-194
Hg-195
Bi-210
Bi-212, Tl-208, Po-212
Tl-206
Tl-208, Po-212
Po-211
Po-218, Pb-214, At-218, Bi-214, Po-214
Rn-219, Po-215, Pb-211, Bi-211, Po-211, Tl-207
Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212
Ac-225, Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209
Rn-222, Po-218, Pb-214, At-218, Bi-214, Po-214
Ac-228
Fr-221, At-217, Bi-213, Tl-209, Po-213, Pb-209
Fr-223
Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208, Po-212
Pa-234m, Pa-234
Ac-226, Th-226, Fr-222, Ra-222, Rn-218, Po-214
Th-226, Ra-222, Rn-218, Po-214
Th-231
U-237
U-240, Np-240m
Am-242, Np-238
Np-239
Pu-243
Am-245
Cm-249
*
*
*
*
*
*
*
activity of Ir-192 in special form may be determined from a measurement of the rate of decay or a measurement of the radiation level at
a prescribed distance from the source.
*
*
*
*
*
*
*
h A = 0.74 TBq (20 Ci) for Mo-99 for domestic use.
2
c The
VerDate Mar<15>2010
17:58 May 15, 2013
Jkt 229001
PO 00000
Frm 00028
Fmt 4701
Sfmt 4702
E:\FR\FM\16MYP2.SGM
16MYP2
29015
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
*
*
*
*
*
■ 8. In appendix A, Table A–2, the entry
for Kr-79 is added, in alphanumeric
order, the entries for Kr-81 and Te-121m
are revised, and footnote b is revised to
read as follows:
Appendix A to Part 71—Determination
of A1 and A2
*
*
*
*
*
TABLE A–2—EXEMPT MATERIAL ACTIVITY CONCENTRATIONS AND EXEMPT CONSIGNMENT ACTIVITY LIMITS FOR
RADIONUCLIDES
Activity
concentration
for exempt
material
(Bq/g)
Symbol of radionuclide
Element and
atomic No.
*
*
Kr-79 .......................................................
Kr-81 .......................................................
*
Krypton (36)
..............................
*
*
*
Te-121m .................................................
*
..............................
*
*
Activity
concentration
for exempt
material
(Ci/g)
*
*
*
*
b
Parent
Sr-90
Zr-93
Zr-97
Ru-106
Ag-108m
Cs-137
Ce-144
Ba-140
Bi-212
Pb-210
Pb-212
Rn-222
Ra-223
Ra-224
Ra-226
Ra-228
Th-228
Th-229
Th-nat
Th-234
U-230
U-232
U-235
U-238
U-nat
Np-237
Am-242m
Am-243
Activity limit for
exempt
consignment
(Bq)
1.0 × 103
1.0 × 104
*
2.7 × 10¥8
2.7 × 10¥7
*
1.0 × 102
*
2.7 × 10¥9
*
*
Activity limit for
exempt
consignment
(Ci)
1.0 × 105
1.0 × 107
*
2.7 × 10¥6
2.7 × 10¥4
1.0 × 106
*
2.7 × 10¥5
*
*
*
*
*
*
*
nuclides and their progeny included in secular equilibrium are listed as follows:
Y-90
Nb-93m
Nb-97
Rh-106
Ag-108
Ba-137m
Pr-144
La-140
Tl-208 (0.36), Po-212 (0.64)
Bi-210, Po-210
Bi-212, Tl-208 (0.36), Po-212 (0.64)
Po-218, Pb-214, Bi-214, Po-214
Rn-219, Po-215, Pb-211, Bi-211, Tl-207
Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Ac-228
Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209
Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Pa-234m
Th-226, Ra-222, Rn-218, Po-214
Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)
Th-231
Th-234, Pa-234m
Th-234, Pa-234m, U-234, Th-230, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210
Pa-233
Am-242
Np-239
*
*
*
*
*
9. In appendix A to part 71, Table A–
3 is revised to read as follows:
*
Appendix A to Part 71—Determination
of A1 and A2
■
*
*
*
*
*
TABLE A–3—GENERAL VALUES FOR A1 AND A2
A1
A2
Activity
concentration for
exempt
material
(Bq/g)
Contents
tkelley on DSK3SPTVN1PROD with PROPOSALS2
(TBq)
Only beta or gamma emitting
radionuclides are known to
be present ............................
Alpha emitting nuclides, but no
neutron emitters, are known
to be present a ......................
VerDate Mar<15>2010
17:58 May 15, 2013
(Ci)
(TBq)
(Ci)
Activity
concentration for
exempt
material
(Ci/g)
Activity
limits for
exempt
consignments
(Ba)
Activity
limits for
exempt
consignments
(Ci)
1 × 10¥1
2.7 × 100
2 × 10
¥2
5.4 × 10¥1
1 × 101
2.7 × 10¥10
1 × 104
2.7 × 10¥7
2 × 10¥1
5.4 × 100
9 × 10¥5
2.4 × 10¥3
1 × 10¥1
2.7 × 10¥12
1 × 103
2.7 × 10¥8
Jkt 229001
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
E:\FR\FM\16MYP2.SGM
16MYP2
29016
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Proposed Rules
TABLE A–3—GENERAL VALUES FOR A1 AND A2—Continued
A2
A1
Activity
concentration for
exempt
material
(Bq/g)
Contents
(TBq)
Neutron emitting nuclides are
known to be present or no
relevant data are available ...
a If
*
(Ci)
1 × 10¥3
9 × 10¥5
(Ci)
2.4 × 10¥3
1 × 10¥1
2.7 × 10¥12
Activity
limits for
exempt
consignments
(Ba)
1 × 103
Activity
limits for
exempt
consignments
(Ci)
2.7 × 10¥8
beta or gamma emitting nuclides are known to be present, the A1 value of 0.1 TBq (2.7 Ci) should be used.
*
*
*
*
[FR Doc. 2013–11552 Filed 5–15–13; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 71
[NRC–2013–0082; NRC–2008–0198]
RIN 3150–AI11
Establishing Quality Assurance
Programs for Packaging Used in
Transport of Radioactive Material
Nuclear Regulatory
Commission.
ACTION: Draft regulatory guide; request
for comment.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is proposing to
amend its regulations for the packaging
and transportation of radioactive
material. The NRC is issuing for public
comment draft regulatory guide (DG),
DG–7009, ‘‘Establishing Quality
Assurance Programs for Packaging Used
in Transport of Radioactive Material.’’
This draft regulatory guide describes 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.
DATES: Submit comments by July 30,
2013. Comments received after this date
will be considered if it is practical to do
so, but the NRC is able to ensure
consideration only for comments
received on or before this date.
Although a time limit is given,
comments and suggestions in
connection with items for inclusion in
guides currently being developed or
improvements in all published guides
are encouraged at any time.
SUMMARY:
VerDate Mar<15>2010
17:58 May 15, 2013
You may submit comments
by any of the following methods (unless
this document describes a different
method for submitting comments on a
specific subject):
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2013–0082. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–492–3668;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individuals listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Mail comments to: Cindy Bladey,
Chief, Rules, Announcements, and
Directives Branch (RADB), Office of
Administration, Mail Stop: TWB–05–
B01M, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
• Fax comments to: RADB at 301–
492–3446.
For additional direction on accessing
information and submitting comments,
see ‘‘Accessing Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Jessica Glenny, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001; telephone: 301–492–3285, email:
Jessica.Glenny@nrc.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Dated at Rockville, Maryland, this 10th day
of May, 2013.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
2.7 × 10¥2
(TBq)
Activity
concentration for
exempt
material
(Ci/g)
Jkt 229001
I. Accessing Information and
Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC–2013–
0082 when contacting the NRC about
the availability of information regarding
this document. You may access
information related to this document,
which the NRC possesses and is
publicly available, by the following
methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2013–0082.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may access publicly
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
available documents online in the NRC
Library at https://www.nrc.gov/readingrm/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’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource.gov@nrc.gov. The
draft regulatory guide is available in
ADAMS under Accession No.
ML13079A004. The draft regulatory
analysis for the proposed rule may be
found in ADAMS under Accession No.
ML13079A005. Because this draft
regulatory analysis explains the reasons
for revising the rule and its
implementing guidance, a separate
regulatory analysis was not prepared for
this draft regulatory guide.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
Regulatory guides are not
copyrighted, and NRC approval is not
required to reproduce them.
B. Submitting Comments
Please include Docket ID NRC–2013–
0082 in the subject line of your
comment submission, in order to ensure
that the NRC is able to make your
comment submission available to the
public in this docket.
The NRC cautions you not to include
identifying or contact information that
you do not want to be publicly
disclosed in you comment submission.
The NRC will post all comment
submissions at https://
www.regulations.gov as well as enter the
comment submissions into ADAMS.
The NRC does not routinely edit
comment submissions to remove
identifying or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the NRC, then you should
inform those persons not to include
identifying or contact information that
they do not want to be publicly
disclosed in their comment submission.
E:\FR\FM\16MYP2.SGM
16MYP2
]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Proposed Rules]
[Pages 28987-29016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11552]
[[Page 28987]]
Vol. 78
Thursday,
No. 95
May 16, 2013
Part III
Nuclear Regulatory Commission
-----------------------------------------------------------------------
10 CFR Part 71
Revisions to Transportation Safety Requirements and Harmonization With
International Atomic Energy Agency Transportation Requirements;
Establishing Quality Assurance Programs for Packaging Used in Transport
of Radioactive Material; Proposed Rules
Federal Register / Vol. 78 , No. 95 / Thursday, May 16, 2013 /
Proposed Rules
[[Page 28988]]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
10 CFR Part 71
[NRC-2008-0198; NRC-2013-0082]
RIN 3150-AI11
Revisions to Transportation Safety Requirements and Harmonization
With International Atomic Energy Agency Transportation Requirements
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC), in consultation
with the U.S. Department of Transportation (DOT), is proposing to amend
its regulations for the packaging and transportation of radioactive
material. These amendments would make NRC regulations conform to
revisions to the International Atomic Energy Agency (IAEA) regulations
for the international transportation of radioactive material and
maintain consistency with DOT regulations. These changes are necessary
to maintain a consistent regulatory framework for the transportation
and packaging of radioactive material. These changes would make the
regulation of quality assurance programs more efficient by allowing
changes that do not change quality assurance approval holder
commitments to be made without prior NRC approval, and extending the
duration of quality assurance program approvals. These changes would
clarify the responsibilities of general licensees and further limit the
shipping of fissile material under a general license. The parallel DOT
proposed rulemaking was published in the Federal Register on August 12,
2011.
DATES: Submit comments by July 30, 2013. Submit comments specific to
the information collections aspect of this proposed rule by June 17,
2013. Comments received after these dates will be considered if it is
practical to do so, but the NRC is able to assure consideration only
for comments received on or before these dates.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific topic):
Federal rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0198. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: Carol.Gallagher@nrc.gov. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: Rulemaking.Comments@nrc.gov. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on accessing information and submitting
comments, see ``Accessing Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: James Firth, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
6628; email: James.Firth@nrc.gov.
SUPPLEMENTARY INFORMATION: The parallel DOT proposed rulemaking was
published in the Federal Register on August 12, 2011 (76 FR 50332).
I. Accessing Information and Submitting Comments
II. Background
III. Discussion
A. What action is the NRC proposing to take?
B. Who is affected by this proposed action?
C. Which changes are being proposed to increase the
compatibility with the International Atomic Energy Agency
Regulations (TS-R-1) and consistency with the DOT regulations?
D. How is the NRC proposing to change the exemption for
materials with low activity levels?
E. How might the qualification of special form radioactive
material change?
F. What changes may be made to Appendix A, ``Determination of
A1 and A2 Values,'' to part 71 of title 10 of
the Code of Federal Regulations (10 CFR)?
G. How would the responsibilities of certificate holders and
licensees change with these amendments?
H. Why would renewal of my quality assurance program description
not be necessary?
I. What changes could be made to a quality assurance program
description without seeking prior NRC approval?
J. How frequently would I submit periodic updates on my quality
assurance program description to the NRC?
K. How would the requirements in subpart H, ``Quality
Assurance,'' change with the removal of the footnote in 10 CFR
71.103?
L. What changes would be made to general licenses?
M. How would the exemption from classification as fissile
material (10 CFR 71.15) change?
N. What other changes is the NRC proposing to make to its
regulations for the packaging and transportation of radioactive
material?
O. When Would these proposed amendments become effective?
P. What should I consider as I prepare my comments to the NRC?
IV. Section-by-Section Analysis
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Availability of Documents
VIII. Plain Writing
IX. Voluntary Consensus Standards
X. Finding of No Significant Environmental Impact: Availability
XI. Paperwork Reduction Act Statement
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfitting
I. Accessing Information and Submitting Comments
A. Accessing Information
Please refer to Docket ID NRC-2008-0198 when contacting the NRC
about the availability of information for this proposed rule. You may
access information related to this proposed rulemaking, which the NRC
possesses and is publicly available, by any of the following methods:
Federal Rulemaking Web site: Go to https://www.regulations.gov and search for Docket ID NRC-2008-0198.
NRC Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library at https://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number
for each document referenced in this proposed rule (if that document is
available in ADAMS) is provided the first time that a document is
referenced. In addition, for the convenience of the reader, the ADAMS
accession numbers are provided in a table in Section VI, Availability
of Documents, of this document.
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.
[[Page 28989]]
B. Submitting Comments
Please include Docket ID NRC-2008-0198 in the subject line of your
comment submission, in order to ensure that the NRC is able to make
your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information that you do not want publicly disclosed in your comment
submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into
ADAMS, and the NRC does not routinely edit comment submissions to
remove identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment submissions into ADAMS.
II. Background
The NRC is proposing to revise its regulations for the safe
transportation of radioactive material to make them compatible with
those of the IAEA. The proposed rule, in combination with a
corresponding amendment of Title 49 of the Code of Federal Regulations
(49 CFR), by the DOT (76 FR 50332; August 12, 2011), would bring United
States regulations into general accord with the 2009 edition of the
IAEA's ``Regulations for the Safe Transport of Radioactive Material''
(TS-R-1). The NRC is also proposing to make revisions to maintain
consistency with revisions to DOT regulations. In addition, the NRC is
making other revisions to its transportation regulations in 10 CFR part
71. These other revisions include NRC-initiated changes that would
affect administrative procedures for the quality assurance program
requirements described in 10 CFR part 71, subpart H; re-establish
restrictions on material that qualifies for the fissile material
exemption; clarify the requirements for a general license; clarify the
responsibilities of certificate holders and licensees when making
preliminary determinations; and make other 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. The IAEA has developed international safety standards for the
safe transport of radioactive material, TS-R-1. The IAEA safety
standards and regulations are developed in consultation with the
competent authorities of Member States, so they 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 that 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 experience.
On January 26, 2004 (69 FR 3698), the NRC published in the Federal
Register a final revision to 10 CFR part 71, ``Compatibility with IAEA
Transportation Safety Standards (TS-R-1) and Other Transportation
Safety Amendments.'' That revision, in combination with a parallel
revision of the DOT hazardous materials transportation regulations,
brought the United States domestic transport regulations into general
accord with the 1996 edition of TS-R-1 (as amended in 2000). The DOT
published its corresponding revision to 49 CFR parts 171 through 178 on
the same date (69 FR 3632; January 26, 2004).
The IAEA periodically reviews and revises the IAEA international
transportation standards to reflect knowledge gained in scientific and
technical advances and accumulated experience. In 2002, the IAEA began
using a 2-year review cycle. In each review cycle, the IAEA will invite
Member States--the United States is a Member State and the DOT is the
United States competent authority before the IAEA for radioactive
material transportation matters--to submit for consideration issues or
problems that could result in changes to the IAEA transportation
regulations and the associated guidance. These issues and problems are
then considered by the IAEA Transportation Safety Standards Committee
(TRANSSC) and, if approved by TRANSSC, will be developed into specific
proposed changes to the transportation regulations. The specific
proposed changes are then considered at a second TRANSSC meeting. The
IAEA will then issue those approved changes at the second TRANSSC
meeting for formal review and comment by Member States.
The IAEA has invited Member States to submit comments and suggest
changes to the regulations as part of these periodic revisions. The NRC
and DOT have sought public input related to the proposed revisions. On
July 22, 2003, the DOT held a public meeting, with the NRC
participating, to obtain public views on proposed changes to the 1996
edition of TS-R-1 and accepted written comments through August 8, 2003.
On November 5, 2003, the DOT held a public meeting, with the NRC
participating, seeking public views on the DOT positions on the
proposed changes to TS-R-1. The NRC published Federal Register notices
on June 26, 2003 (68 FR 37986); October 24, 2003 (68 FR 60886); April
23, 2004 (69 FR 21978); April 27, 2005 (70 FR 21684); and November 21,
2007 (72 FR 65470), soliciting public input on proposed revisions to
TS-R-1. Subsequent to the 1996 edition of TS-R-1 (as amended in 2000),
the IAEA published revisions to TS-R-1 in 2003, 2005, and 2009.
This rulemaking effort would involve harmonizing the NRC
regulations at 10 CFR part 71 with changes to the IAEA transportation
regulations through TS-R-1. Copies of TS-R-1 may be obtained from the
United States distributors, Bernan, 15200 NBN Way, P.O. Box 191, Blue
Ridge Summit, PA 17214; telephone: 1-800-865-3457; email:
customercare@bernan.com, or Renouf Publishing Company Ltd., 812 Proctor
Ave., Ogdensburg, NY 13669-2205; telephone: 1-888-551-7470; email:
orders@renoufbooks.com. An electronic copy may be found at the
following IAEA Web site: https://www-pub.iaea.org/MTCD/publications/PDF/Pub1384_web.pdf. The regulations in TS-R-1 represent an accepted set
of requirements that provide a high level of safety in the packaging
and transportation of radioactive materials and provide 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
[[Page 28990]]
material. Harmonization represents the effort to increase the
consistency or compatibility between national regulations and the
internationally-accepted requirements, within the constraints of an
existing national legal and regulatory framework.
In November 2012, the IAEA issued new standards for the safe
transport of radioactive material and designated them as ``Specific
Safety Requirements Number SSR-6'' (SSR-6). This proposed rulemaking
would not incorporate the 2012 changes, which will undergo a
comprehensive review by the NRC staff to determine if additional
changes to 10 CFR part 71 are warranted.
Historically, the NRC has coordinated its revisions to 10 CFR part
71 with the DOT, because the DOT is the United States competent
authority for transportation of hazardous materials. ``Radioactive
Materials'' is a subset of ``Hazardous Materials'' in Title 49
regulations under DOT authority. The DOT hazardous materials
regulations are found in 49 CFR parts 171 through 177. Currently, 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 described in a
memorandum of understanding (MOU) (44 FR 38690; July 2, 1979).
Consistent with this MOU, the NRC is continuing to coordinate its
efforts with the DOT in this proposed rulemaking process. Refer to the
DOT corresponding rule for additional background on the proposed
changes in this document.
Scope of 10 CFR Part 71 Proposed Rulemaking
The NRC staff evaluated recent changes in the IAEA's transportation
standards through the 2009 edition of TS-R-1 to identify changes to be
made in 10 CFR part 71. Based on this effort, the NRC staff identified
a number of areas in 10 CFR part 71 that need to be addressed in this
proposed rulemaking process as a result of the changes to the IAEA
regulations. These changes are discussed in Section III of this
document, question C, ``Which Changes are Being Proposed to Increase
the Compatibility with the International Atomic Energy Agency
Regulations (TS-R-1) and Consistency with DOT Regulations?''
The NRC is also proposing a number of self-initiated changes to its
regulations that are not related to either compatibility with IAEA
regulations or consistency with DOT regulations. These NRC changes
would affect administrative procedures for the quality assurance
program requirements described in 10 CFR part 71, subpart H, re-
establish restrictions on material that qualifies for the fissile
material exemption, clarify the requirements for a general license,
clarify the responsibilities of certificate holders and licensees when
making preliminary determinations, and make other editorial changes.
Fissile Material Exemption
In 1997, the NRC issued an emergency final rule (62 FR 5907;
February 10, 1997) that revised the regulations on fissile material
exemptions and the general licenses that apply to fissile material. The
NRC determined that good cause existed under Section 553(b)(3)(B) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)), to
publish this final rule without notice and opportunity for public
comment. Further, the NRC also determined that good cause existed,
under Section 553(d)(3) of the APA (5 U.S.C. 553(d)(3)), to make the
final rule immediately effective. Notwithstanding the final status of
the rule, the NRC provided for a 30-day public comment period. The NRC
subsequently published in the Federal Register (64 FR 57769; October
27, 1999) a response to the comments received on the emergency final
rule and a request for information on any unintended economic impacts
caused by the final rule. Based on the public comments on the emergency
final rule, the NRC staff contracted with 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
regulations may be excessive for shipments where water moderation is
the only concern. The ORNL study recommended that the NRC revise 10 CFR
part 71. The ORNL made a recommendation that 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, hereafter referred to
as uranium enriched to a maximum of 1 percent. Specifically, ORNL
recommended: (1) That a definition of ``homogeneity'' be developed that
could be clearly understood for use with uranium enriched to a maximum
of 1 percent; (2) the term ``lattice arrangement'' be clarified or not
used; and (3) if the definitions for homogeneity and lattice
arrangement cannot be provided, a restriction on beryllium (Be),
deuterium oxide (e.g., D2O or heavy water), and carbon
(graphite) (C) should be maintained. The ORNL recommended that the
moderator criteria restricting the mass of Be, C, or D2O to
less than 0.1 percent of the fissile mass should be maintained, which
would remove the need to provide definitions--such as ``homogeneous''
and ``lattice arrangement''--that are difficult to define and to apply
practically. The NRC staff indicated that it agreed with the ORNL
recommendations (67 FR 21390; April 30, 2002) and removed the
homogeneity and lattice prevention requirements from the fissile
material exemptions.
---------------------------------------------------------------------------
\1\ NUREG/CR-5342, ``Assessment and Recommendations for Fissile-
Material Packaging Exemptions and General Licenses within 10 CFR
Part 71,'' July 1998.
---------------------------------------------------------------------------
The ORNL recommendations were considered when the NRC proposed
changes to 10 CFR part 71 (67 FR 21390; April 30, 2002) to make NRC
regulations more consistent and compatible with IAEA regulations and to
make changes to the fissile material exemption requirements to address
the unintended economic impact of the NRC emergency final rule entitled
``Fissile Material Shipments and Exemptions'' (62 FR 5907; February 10,
1997). In its final rule (69 FR 3698; January 26, 2004) to make 10 CFR
part 71 compatible with the IAEA regulations and make other
transportation safety amendments, the NRC removed the restriction that,
to qualify for the fissile material exemption, uranium enriched in U-
235 is distributed homogeneously throughout the package and does not
form a lattice arrangement within the package, and redesignated the
section for fissile material exemptions from Sec. 71.53 to Sec.
71.15. Based on a comment that shippers would have difficulty
implementing the proposed rule language, the NRC determined that it
would be impractical to implement a restriction based on the proposed
ratio of the restricted moderators to the fissile mass and changed the
restriction to require that the mass of beryllium, graphite, and
hydrogenous material
[[Page 28991]]
enriched in deuterium be less than 5 percent of the mass of uranium;
the NRC concluded that limiting the mass of these moderators to less
than 5 percent of the uranium mass would assure subcriticality for all
moderators of concern.
Subsequent to the 2004 rulemaking, the U.S. Department of Energy
(DOE) was planning a shipment of large quantities of low-enriched
fissile material that would qualify for the exemption at 10 CFR
71.15(d). Analyses performed by the DOE indicated that large arrays of
heterogeneous uranium with enrichment of 1 percent by weight of U-235
could exceed a keff of 0.95 when optimally moderated by
water. For the material to become critical,\2\ the keff
would need to be greater than or equal to 1.0. However, the quantity
and geometric arrangement of this material exceeded a keff
of 0.95, which is typically used as a limit in regulatory assessments
of package designs for the transport of fissile material. The
sensitivity of keff to increases in the quantity of fissile
material and changes in geometry will depend on the properties of the
material. For uranium enriched to a maximum of 1 percent and
keff greater than 0.95, keff is very insensitive
to changes in geometry and quantity; consequently, significantly larger
quantities of material would be required to get keff close
to 1.0.
---------------------------------------------------------------------------
\2\ For transportation purposes, nuclear criticality means a
condition in which an uncontrolled, self-sustaining and neutron-
multiplying fission chain reaction occurs. Nuclear criticality is
generally a concern when sufficient concentrations and masses of
fissile material and neutron moderating material exist together in a
favorable configuration. The neutron moderating material cannot
achieve criticality by itself in any concentration or configuration.
It can enhance the ability of fissile material to achieve
criticality by slowing down neutrons or reflecting neutrons.
---------------------------------------------------------------------------
Quality Assurance Program Approvals
Part 71 of 10 CFR does not include provisions for making changes to
an approved quality assurance program without obtaining prior NRC
approval before implementing the change. The requirement to obtain
prior NRC approval currently applies to all changes, no matter how
insignificant in importance they are to safety. Consequently, the
process can be overly burdensome and inefficient for both the licensee
and the NRC. For example, a change in the quality assurance program to
correct typographical errors or punctuation would need to be submitted
and approved by the NRC.
In the past, the NRC observed several instances in which holders of
a 10 CFR part 71 quality assurance program approval had made changes to
their NRC-approved quality assurance program before obtaining NRC
approval. Although many of the changes were found acceptable by the NRC
after they were reviewed, some of the changes did not satisfy the
respective requirements of 10 CFR part 71, subpart H. In Information
Notice 2002-35 (December 20, 2002; ADAMS Accession No. ML023520339),
the NRC indicated that it was considering changes to 10 CFR part 71 to
provide a method similar to 10 CFR 50.54(a)(3) and (4) for making
changes to 10 CFR part 71 quality assurance programs.
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.
This change was announced in ``NRC Regulatory Information Summary (RIS)
2004-18, Expiration Date for 10 CFR Part 71 Quality Assurance Program
Approvals'' (December 1, 2004; ADAMS Accession No. ML042160293). After
making this change, the NRC evaluated whether a change should be made
in the regulations to codify the effective term of the quality
assurance program approval or whether any expiration date for the
quality assurance program approval was necessary.
In the proposed rule section of this issue of the Federal Register,
the NRC is issuing for public comment Draft Regulatory Guidance (DG)
7009, ``Establishing Quality Assurance Programs for Packaging Used in
Transport of Radioactive Material'' (RIN 3150-AI11; NRC-2013-0082).
III. Discussion
A. What action is the NRC proposing to take?
The NRC is proposing to amend its regulations to make them more
consistent or compatible with the IAEA international transportation
regulations. These changes are in response to changes introduced in the
1996 (as amended in 2003), 2005, and 2009 editions of TS-R-1. The NRC
is proposing to revise its regulations to be consistent with DOT
hazardous materials regulations to maintain a consistent framework for
the transportation and packaging of radioactive material.
The NRC is proposing to make changes that would clarify the
requirements to obtain a general license and the responsibilities of
general licensees. The NRC is proposing to make changes that would
clarify the roles of users of NRC-approved packaging and certificate
holders or applicants for a certificate of compliance (CoC). Also, the
NRC is proposing to make changes that would make the regulation of
quality assurance programs more efficient. The NRC is proposing to
issue quality assurance program approvals that would not expire,
removing the need for the approval to be renewed, and would revise the
current quality assurance program approvals so that they would not
expire. The NRC is also proposing to allow those changes that do not
reduce the commitments in an approved quality assurance program to be
made without prior NRC approval.
The NRC is proposing to make changes that would change the
responsibilities of licensees and certificate holders for making the
preliminary determinations in Sec. 71.85.
Other proposed changes would correct errors and clarify the
regulations.
B. Who is affected by this proposed action?
This action would affect NRC licensees authorized by a specific or
general license issued by the Commission 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; holders of, and applicants for, a CoC; and 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 would change requirements that are matters of
compatibility. Agreement States would be required to update their
regulations and Agreement State licensees would be affected by the
changes to the Agreement State regulations.
C. Which changes are being made to increase the compatibility with the
International Atomic Energy Agency Regulations (TS-R-1) and consistency
with DOT regulations?
The NRC has identified changes in 10 CFR part 71 that would make
the NRC regulations more consistent or compatible with the
international transportation regulations. These changes would also
improve the consistency with the current DOT regulations or would
maintain consistency between 10 CFR part 71 and DOT regulations by
making changes that correspond to those proposed by the
[[Page 28992]]
DOT. The NRC is proposing the following changes to 10 CFR part 71.
1. In the 2003 Edition of TS-R-1, the IAEA changed the scope of TS-
R-1 as it applies to natural materials and ores by adding language that
addresses the processing of these materials (paragraph 107(e) of the
2009 edition of TS-R-1). The NRC is proposing to include the concept of
processing into the provisions that apply to natural materials and ores
in the exemptions for low-level materials at Sec. 71.14.
2. The NRC is proposing to adopt the scoping statement in 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 proposed change, a
definition of ``contamination'' corresponding to the definition in TS-
R-1 would be added to Sec. 71.4.
3. The NRC is proposing to amend the following definitions in 10
CFR 71.4 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 the
definition for LSA material, the NRC added the modifier ``not,'' which
resulted in the NRC definition becoming inconsistent with the DOT and
IAEA definitions. The NRC is proposing to correct this, so that LSA
material includes material intended to be processed for its
radionuclides.
4. The NRC is proposing to adopt the use of the Class 5 impact test
prescribed in the International Organization for Standardization (ISO)
document 2919, ``Radiation protection--Sealed radioactive sources--
General requirements and classification,'' Second Edition (February 15,
1999), ISO 2919:1999(E), for special form radioactive material,
provided the mass was less than 500 grams.
5. The NRC is proposing to incorporate by reference ISO document
2919, ``Radiation protection--Sealed radioactive sources--General
requirements and classification,'' Second Edition (February 15, 1999),
ISO 2919:1999(E), and ISO document 9978, ``Radiation protection--Sealed
radioactive sources--Leakage test methods,'' First Edition (February
15, 1992), ISO 9978:1992(E).
6. The NRC is proposing to change the description of billet used in
the percussion test in Sec. 71.75(b)(2)(ii) by replacing ``edges''
with ``edge.''
7. The NRC is proposing to revise the definition of ``special form
radioactive material'' in Sec. 71.4 to allow special form radioactive
material that is successfully tested in accordance with the current
requirements to continue 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, Table A-1, the NRC is proposing to eliminate the
A1 and A2 values for californium-252 (Cf-252) for
domestic use. The A1 and A2 values for Cf-252
would be consistent with the IAEA values.
9. The NRC is proposing to include krypton-79 (Kr-79) in Table A-1
and Table A-2. The A1 and A2 values in Table A-1
and the activity concentration for exempt material and the activity
limit for exempt consignment would be consistent with the IAEA values
in the 2009 edition of TS-R-1.
10. The NRC is proposing to revise footnote a to Table A-1,
``A1 and A2 values for radionuclides,'' 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 in footnote a to Table 2, ``Basic
Radionuclide Values,'' in TS-R-1 (2009 edition), with the exception of
argon-42 (Ar-42) and tellurium-118 (Te-118), which appear in footnote a
to Table 2 in TS-R-1 (2009 edition), but do not appear within Table 2.
11. The NRC is proposing to move and revise footnote c to Table A-1
to make clear that only for iridium-192 (Ir-192) in special form is it
appropriate for the activity of Ir-192 to 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 NRC is proposing to revise the
activity limit for exempt consignment for tellurium-121m (Te-121m) to
be consistent with the new IAEA value.
13. The NRC is proposing to revise the list of parent radionuclides
and their progeny included in secular equilibrium in footnote b to
Table A-2, ``Exempt material activity concentrations and exempt
consignment activity limits for radionuclides,'' to be consistent with
the list accompanying Table 2, ``Basic Radionuclide Values,'' in TS-R-1
(2009 edition).
14. The NRC is proposing to revise the descriptive phrases for
different categories of unknown radionuclides and mixtures in Table A-3
to be consistent with the IAEA descriptions in Table 3, ``Basic
Radionuclide Values for Unknown Radionuclides or Mixtures,'' in TS-R-1
(2009 edition). The descriptive phrases for ``Only alpha emitting
nuclides are known to be present'' and ``No relevant data are
available'' would be revised.
D. How is the NRC proposing to change the exemption for materials with
low activity levels?
The NRC is proposing to revise its exemption for natural materials
and ores containing naturally occurring radionuclides to reflect
changes in the scope of TS-R-1. In its proposed rule (76 FR 50332;
August 12, 2011), the DOT proposed adopting these changes.
The TS-R-1 includes statements that describe its scope. First,
there is a description of activities included within the scope of
regulation. Second, TS-R-1 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 material are natural materials and ores
containing naturally occurring radionuclides. These natural materials
and ores are not intended to be processed for their radionuclides,
provided that the activity concentration for the material does not
exceed 10 times the activity concentration for exempt material. In the
2003 edition of TS-R-1, the description of natural materials and ores
containing naturally occurring radionuclides contained in the list of
non-TS-R-1 material was revised to add natural materials and ores that
have been processed.
In the 2003 edition of TS-R-1, ``non-radioactive solid objects with
radioactive substances on any surfaces'' in quantities not exceeding
certain values were identified as being outside of the scope of the
transportation regulations.
The NRC has established an exemption at 10 CFR 71.14 that exempts
licensees from the requirements of 10 CFR part 71 for certain natural
materials and ores. The exemption for low-level materials exempts
licensees from the requirements of 10 CFR part 71 with respect to the
shipment or carriage of material that qualifies for the exemption and
they would be allowed to transport natural material or ore that
qualifies for the exemption without the material being regulated as a
hazardous material during transportation; however, all other NRC
regulations that apply to this material would continue to apply. The
exemption at 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 proposing to update this exemption to include
the shipment of natural materials and ores containing naturally
occurring radionuclides that have been processed, which would retain
consistency with DOT regulations and harmonize the NRC regulations with
the
[[Page 28993]]
2009 edition of TS-R-1. This exemption would continue 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 to 10 CFR
part 71.
The NRC is proposing to correct the definition of LSA-I material,
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, would now apply
to LSA-I material (i.e., material intended to be processed for its
radionuclides).
Natural material and ore containing naturally occurring
radionuclides that are not intended to be processed for these
radionuclides could qualify for the low-level material exemption at 10
CFR 71.14(a)(1). With the correction to 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 at 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) that the LSA or SCO material has an
external radiation dose rate of less than 10 mSv/h (1 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
regulations in 49 CFR parts 107, 171 through 180, and 390 through 397.
If the DOT regulations are not applicable to a shipment of licensed
material, 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 regulations. Section 71.88 would 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, would not be able
to 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 of natural
material or ore that has been processed and that may still qualify for
the exemption, provided that the processed material has not been
incorporated into a manufactured product.
The NRC is proposing to add a definition of contamination and to
expand the exemption at Sec. 71.14 to include non-radioactive solid
objects with substances present on any surface not exceeding the levels
used to define contamination. The derived values used in the definition
of contamination are conservative with respect to transportation, and
quantities of radioactive substances below these values would result in
small amounts of exposure during normal conditions of transportation
and would contribute to insignificant exposures under accident
conditions. Contamination would be defined as quantities in excess of
0.4 Bq/cm\2\ (1 x 10-5 [micro]Ci/cm\2\) for beta and gamma
emitters and low toxicity alpha emitters, or 0.04 Bq/cm\2\ (1 x
10-6 [micro]Ci/cm\2\) for all other alpha emitters.
E. How might the qualification of special form radioactive material
change?
The NRC is proposing to update the alternate tests in Sec. 71.75
that may be used for the qualification of special form radioactive
material to tests in more recent editions of the consensus standards.
The NRC is proposing to incorporate by reference the Class 4 and Class
5 impact tests and the Class 6 temperature test prescribed in the ISO
document ISO 2919:1999(E). The NRC is proposing to incorporate by
reference the leaktightness tests specified in ISO document
9978:1992(E). The IAEA has adopted, 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 Class 4 impact test in ISO 2919:1999(E) would replace the
impact test in Sec. 71.75(d)--the Class 4 impact test in ISO 2919,
``Sealed Radioactive Sources--Classification,'' first edition (1980)--
and would 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,
would 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) would replace the
temperature test in Sec. 71.75(d)--the Class 6 temperature test in ISO
2919, ``Sealed Radioactive Sources--Classification,'' first edition
(1980). 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 would continue to be more stringent than the
testing required by Sec. 71.75(b).
The leaktightness tests prescribed in ISO 9978:1992(E) would
replace the tests in ISO/TR 4826, ``Sealed Radioactive Sources--Leak
Test Methods,'' (1979). 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).
The NRC is proposing to revise the definition of special form
radioactive material 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 would allow material tested using requirements in
effect at the time of the testing to continue to be used. The NRC is
proposing to correct the reference to the version of Sec. 71.4 in the
CFR that was in effect on March 31, 1996, by changing the date of the
revision from January 1, 1983, to January 1, 1996.
The NRC is proposing to replace ``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 is
intended to clarify the description of the billet and to maintain
consistency with the language used by the DOT in 49 CFR 173.469.
F. What changes may be made to Appendix A, ``Determination of
A1 and A2 Values,'' part 71 of Title 10 of the
Code of Federal Regulations (CFR) ?
The NRC is proposing the following changes to appendix A.
1. Determining the Quantity of Radioactive Material That Can Be Shipped
in a Package That Contains Both Special Form and Normal Form
Radioactive Material
The NRC is proposing to specifically address 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
[[Page 28994]]
radioactive material and the identities and activity limits for the
radionuclides are known. By including this equation, the NRC would
increase the consistency between 10 CFR part 71 and TS-R-1 and would
provide additional clarity on how to address cases where a package will
contain both special form and normal form material. The equation is
similar to those already used in 10 CFR part 71 for mixtures of special
form material and mixtures of normal form material.
2. Table A-1, ``A1 and A2 Values for
Radionuclides''
The NRC is proposing to revise Table A-1 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 NRC is proposing to--add an
entry for Kr-79, which has been added to Table 2 in the 2009 edition of
TS-R-1; adopt the A1 and A2 values for Cf-252;
revise 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 move
and revise footnote c, which applies to Ir-192, so that the footnote
applies only to Ir-192 in special form material.
The A1 and A2 values are used for determining
what type of package must be used for the transportation of radioactive
material. The A1 values are the maximum amount of special
form material allowed in a Type A package. The A2 values are
the maximum activity of ``other than special form'' material allowed in
a Type A package. A1 and A2 values are also used
for several other packaging limits throughout TS-R-1, such as
specifying Type B package activity leakage limits, low-specific
activity limits, and excepted package contents limits. The values of
A1 and A2 have been adopted in 10 CFR part 71 and
are specified in appendix A.
The IAEA has added an entry for Kr-79 in the Table 2 of the 2009
edition of TS-R-1. The NRC is proposing to adopt these radionuclide-
specific values for Kr-79 in Table A-1. The radionuclide-specific
values would replace the generic values in Table A-3, which are
currently 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 would replace.
The IAEA has revised the A1 value for Cf-252 to the
value that currently applies to domestic transportation. In the 2004
final rule for 10 CFR part 71 (69 FR 3698; January 26, 2004), the NRC
did not adopt the A1 value for Cf-252 in TS-R-1 for domestic
transportation, because the NRC was aware that the IAEA was considering
changing the value back to the value that has been in 10 CFR part 71;
the IAEA has subsequently made this change. The NRC is proposing to
adopt the A1 value for Cf-252, which would apply to both
international and domestic transportation, and to adopt the IAEA value
for A2. The NRC is proposing to delete the A2
value that applies only to domestic transportation. Making this change
would improve the harmonization of 10 CFR part 71 with TS-R-1 by
adopting the A2 value for Cf-252 in TS-R-1. Because the
A2 value for Cf-252 was established by the IAEA using the Q-
system and current data for Cf-252, the A2 value for Cf-252
would be consistent with the other values derived using the Q-system
that has been incorporated into 10 CFR part 71.
The NRC is proposing to revise footnote a to Table A-1 to identify
the A1 and A2 values that include contributions
from daughter radionuclides that have a half-life that is less than 10
days. The proposed 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). Ar-42 and Te-118 would not be included,
because they do not appear within Table A-1.
The NRC is proposing to revise footnote c to Table A-1 to make
clear that the activity of Ir-192 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 is appropriate for Ir-192 in
special form.
3. Table A-2, ``Exempt Material Activity Concentrations and Exempt
Consignment Activity Limits for Radionuclides''
The NRC is proposing to revise Table A-2 to make the values in 10
CFR part 71 consistent with the values in TS-R-1 and to add an entry
for Kr-79, which has been added to Table 2, ``Basic radionuclide
values,'' in the 2009 edition of TS-R-1. The NRC is also proposing to
update 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 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 NRC is proposing to update the activity limit for exempt
consignment for Te-121m to match the values in TS-R-1.
Material that has an activity concentration that is less than the
activity concentration for exempt material would pose a very low
radiological risk. The activity limit for exempt consignment has been
established for the transportation of material in quantities small
enough for which the total activity is unlikely to result in any
significant radiological exposure. This would be the case even for
material that exceeds the activity concentration for exempt material.
Krypton-79 is not listed in Table A-2, and the values from Table A-
3, ``General Values for A1 and A2,'' in appendix
A are 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 included in the 2009 edition of TS-R-1.
In the 2005 edition of 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 with the objectives of the exemption values.
Also, to conform to International Commission on Radiological Assistance
(ICRP) and IAEA changes, the activity limit for exempt consignment for
Te-121m in Table A-2 is being 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,
``Basic radionuclide values'' 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 removing the decay
chain 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 would be revised to be consistent
with the changes to the list in TS-R-1.
[[Page 28995]]
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'' (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 current descriptive phrases are: (1)
``only beta or gamma emitting radionuclides are known to be present,''
(2) ``only alpha emitting nuclides are known to be present,'' and 3)
``no relevant data are available.'' The NRC is proposing to adopt the
descriptive phrases as revised by the IAEA in TS-R-1 in Table A-3.
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, would be 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) would be 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, Section-by-Section Analysis, of this document
The NRC is proposing to make several corrections to the formulas
and the descriptions of the formulas that address mixtures of
radionuclides in Section IV of this document. These changes involve
formatting and typographical changes in the formulas and their
descriptions.
G. How would the responsibilities of certificate holders and licensees
change with these amendments?
In the 1950s, the Atomic Energy Commission (AEC) issued package
approvals to AEC licensees as amendments to their licenses and the DOT
issued package approvals to non-AEC licensees. On March 22, 1973 (38 FR
8466), the AEC and the DOT entered into an MOU where the DOT agreed to
adopt a requirement for AEC approval of designs of packages for the
shipment of fissile material and other radioactive material exceeding
Type A limits, with the exception of LSA material, and the AEC agreed
to develop safety standards for the design and performance of packages
and to impose these standards on AEC licensees and license-exempt
contractors. Under the MOU, the AEC would issue an AEC license, an AEC
CoC, or other AEC package approval directly to the person requesting
the evaluation. Although the AEC, and subsequently the NRC, certified
that the packages met the regulations, they did not have regulatory
authority over the certificate holders under DOT jurisdiction. On July
2, 1979 (44 FR 38690), this MOU was superseded by an MOU between the
DOT and the NRC. In this MOU, it was agreed that the NRC, in
consultation with the DOT, would develop safety standards for the
design and performance of the packages. As the NRC developed its safety
standards for the packages, it gained regulatory authority over the
certificate holders.
The requirements for making the preliminary determinations have
remained largely unchanged since the 1979 MOU. In discussing the
routine and preliminary determinations (48 FR 35600; August 5, 1983),
the Commission indicated that the user of a package always had the
regulatory responsibility for preliminary and routine determinations
and recordkeeping, even though the user may not own the package. The
Commission also indicated that although the user could contract with
some other person, perhaps the owner, to satisfy those requirements for
the user, the user's records must demonstrate that the requirements
have been satisfied. Although leaktightness tests related to the
package design are required as a condition of the package design
approval, the Commission has indicated that it considers that in the
case of radioactive material packages, integrity of the containment
(including closures, valves, and other routes of escape) should be
demonstrated for each fabricated package before first use.
The NRC experience is that licensees have never made preliminary
determinations themselves, unless they also happened to be certificate
holders. Based on the NRC extensive experience inspecting the
activities of certificate holders and NRC licensees who use packages,
the NRC is not aware of any NRC licensee that performs preliminary
determinations, unless they are also the certificate holder for the
package design. The scope of user-only quality assurance program
approvals, which are issued to licensees who are not also holders of a
CoC, do not include the testing required to make the preliminary
determinations. Licensees lease or buy these packages from the
certificate holder, or fabricator, and most packages are already marked
by the certificate holder. The NRC has identified cases where the
durable marking of the packaging required by Sec. 71.85 was done
incorrectly by a certificate holder. Because the licensee is
responsible for the preliminary determinations, enforcement could not
be taken against the certificate holder for improperly marking the
packaging.
The Commission is proposing to make changes to Sec. 71.85 that
would make certificate holders, not licensees, responsible for making
the preliminary determinations before the first use of each package.
The preliminary determinations involve evaluating, testing, and marking
the packaging. The DOT requirements at 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. The Commission is proposing to require the licensee to
ascertain that the preliminary determinations involving evaluating,
testing, and marking the packaging have been made. The licensee would
still make the required routine determinations at Sec. 71.87. As
required by Sec. 71.91(d), both licensees and certificate holders
would still be required to maintain sufficient written records to
furnish evidence of the quality of the packaging, which includes the
results of the determinations required by Sec. 71.85.
[[Page 28996]]
The Commission is proposing to make these changes, because it is
more appropriate to assign the responsibility to certificate holders
for marking the packaging. Only certificate holders are authorized to
design and fabricate packagings, and only certificate holders would
have a full scope quality assurance program approval, which would allow
them to perform the testing required as part of the preliminary
determinations under an approved quality assurance program. However,
licensees would need to retain their responsibility to determine that
the packaging has been manufactured, assembled, and marked
appropriately and that the packaging does not have any defects that
could significantly reduce the effectiveness of the packaging. By
assigning the responsibility for making the determinations to the
certificate holder, the NRC would be able to streamline the
implementation of its regulations and have the regulations better
reflect current practice.
H. Why would renewal of my quality assurance program description not be
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 to provide an opportunity for the NRC staff to
periodically review the quality assurance programs and for the NRC to
maintain periodic contact with the quality assurance program approval
holders. The limited duration of the approval facilitated the NRC
recordkeeping relating to points of contact, package fabrication, use
activities, and other administrative activities.
In 2004, the NRC extended the duration of its quality assurance
program approvals from 5 years to 10 years, because the NRC had
determined that the periodic contact associated with the 5-year renewal
period was less important than it was previously, and the duration of
the approval could be lengthened. The NRC announced this change in RIS
2004-18, ``Expiration Date for 10 CFR Part 71 Quality Assurance Program
Approvals'' (December 1, 2004).
The NRC is changing its practice regarding the duration of its
quality assurance program approvals. The NRC would no longer limit the
duration of its quality assurance program approvals issued under 10 CFR
part 71. The NRC is proposing changes to 10 CFR part 71 to implement
this change and to enhance the periodic communication between the NRC
and the quality assurance program approval holders. The NRC would
reissue its quality assurance program approval for Radioactive Material
Packages (NRC Form 311) without an expiration date. As discussed in
Section III, question I, ``What Changes Could be Made to a Quality
Assurance Program Description without Seeking Prior NRC Approval?,''
and question J, ``How Frequently Would I Submit Periodic Updates on My
Quality Assurance Program Description to the NRC?,'' the NRC is
proposing to require quality assurance program approval holders to
periodically report changes in their quality assurance program
description to the NRC. 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 not necessary to provide the NRC with assurance that the quality
assurance program approval holders would continue to be able to
adequately maintain and implement their approved quality assurance
program.
As discussed under question I, ``What changes could be made to a
quality assurance program description without seeking prior NRC
approval?,'' the NRC would continue to approve quality assurance
program description changes that reduce commitments made to the NRC in
quality assurance program descriptions that have been approved by the
NRC. Every 24 months, each quality assurance program approval holder
would be required to report those changes that do not reduce
commitments made to the NRC in a quality assurance program description
approved by the NRC. Holders of a CoC and applicants for a CoC are
subject to periodic inspection of their quality assurance program
(approximately every 3 years) by the NRC. Licensees who use packages
are inspected on an as-needed basis.
As discussed under question P, ``What should I consider as I
prepare my comments to the NRC?,'' the NRC is specifically requesting
comment on the proposed approach to reporting changes to approved
quality assurance program descriptions.
I. What changes could be made to a quality assurance program
description without seeking prior NRC approval?
Currently, quality assurance program descriptions approved under 10
CFR part 71 cannot be changed without NRC approval. Therefore, all
changes to 10 CFR part 71 quality assurance programs, irrespective of
their significance or importance to safety, must 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, consistent with the requirements at Sec.
50.54. The NRC is proposing to allow some changes to be made to quality
assurance programs approved under 10 CFR part 71 without obtaining NRC
approval. The process for making changes to approved quality assurance
program descriptions would 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 would result in a more
consistent approach to allowing changes to approved quality assurance
programs. The NRC is proposing to establish a process that would
require NRC approval to be obtained for those changes that are most
important to safety but would allow other changes to be implemented
without obtaining NRC approval.
Quality assurance program approval holders would be required to
obtain NRC approval before making any change to their quality assurance
program description that would reduce the commitments that they have
made to the NRC. Quality assurance program approval holders would not
be required to submit changes to their quality assurance program
descriptions, if those changes do not reduce the commitments that they
have made to the NRC. 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 would not require NRC
approval. Changes to reporting responsibilities, functional
responsibilities, functional relationships, and some editorial or
punctuation changes may be substantive and have the potential to reduce
commitments made to the NRC and, in these instances, would require
prior NRC approval before being implemented. The following includes
types of changes that the NRC would not consider as reducing a
commitment made to the NRC:
1. The use of a quality assurance standard approved by the NRC,
which is more recent than the quality assurance standard in the current
quality assurance program at the time of the change;
2. The use of generic organizational position titles that clearly
denote the function of the position, supplemented
[[Page 28997]]
as necessary by descriptive text, rather than specific titles, provided
that there are no substantive changes 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;
4. The elimination of quality assurance program information that
duplicates language in quality assurance regulatory guides and quality
assurance standards to which the holder of the quality assurance
program approval has committed 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.
Quality assurance program approval holders would also need to
maintain records of all quality assurance program changes.
J. How frequently would I submit periodic updates on my quality
assurance program description to the NRC?
The NRC would continue to require quality assurance program
approval holders to obtain NRC approval of any change to their approved
quality assurance program description that would reduce any commitment
in the quality assurance program description approved by the NRC before
they implement the change. The NRC would require the following
information to be provided for its review: a description of the
proposed changes to the approved quality assurance program description,
the reason for the change, and the basis for concluding that the
revised program incorporating the change continues to satisfy the
requirements of subpart H.
The NRC is proposing to require that quality assurance program
approval holders would report changes to their approved quality
assurance program that do not reduce any commitments in the quality
assurance program description approved by the NRC every 24 months.
These changes would not require NRC approval before they can be
implemented. If the quality assurance program approval holder has not
made any changes to its approved quality assurance program description
during the preceding 24-month period, it would report to the NRC that
no changes have been made.
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 before they are
implemented and with the periodic reporting of the less significant
changes every 24 months, the NRC would 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 discussed under question H, ``Why would renewal of my quality
assurance program description not necessary?,'' the NRC would re-issue
NRC Form 311 without an expiration date. The 24-month period for
reporting of changes is proposed to 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,
``Quality Assurance Program Approval for Radioactive Material
Packages.''
As discussed under question P, ``What should I consider as I
prepare my comments to the NRC?,'' the NRC is proposing to require
quality assurance program approval holders to submit a report every 2
years that describes the changes that were made to their quality
assurance program description that do not reduce a commitment in the
quality assurance program description approved by the NRC. The NRC is
seeking to balance the regulatory burden for submitting this
information with the NRC need to ensure that the NRC has current
information for its regulatory oversight of quality assurance program
approval holders, which would include using the information for
inspections. The NRC is requesting comment on the following issue:
would a different frequency be more appropriate for reporting changes
to approved quality assurance programs that do not reduce a commitment
in a quality assurance program description approved by the NRC?
K. How would the requirements in subpart H, ``Quality Assurance,''
change with the removal of the footnote in 10 CFR 71.103?
The NRC is proposing to remove the footnote 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 later rulemaking to make explicit the application of those quality
assurance requirements to certificate holders and applicants for a CoC.
Although removing the footnote would not change the quality assurance
requirements, other proposed changes to subpart H in this proposed
rulemaking would further clarify which requirements apply to users of
NRC certified packaging and which apply to applicants for, or holders
of, CoCs--the entities that would be performing design, fabrication,
assembly, and testing of the package before a package approval is
issued.
L. What changes would be made to general licenses?
The NRC is proposing to change the requirements for general
licenses for the following: (1) use of an NRC-approved package (Sec.
71.17) and 2) 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
Commission as satisfying the provisions of subpart H of 10 CFR part 71
is required to be granted the general license. The proposed changes
would clarify that the licensee is responsible for maintaining copies
of the appropriate documents, such as the CoC, or other approval of the
package, and 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 would also clarify that making the
notification in Sec. 71.17(c)(3) to the NRC is a responsibility of the
licensee, rather than a condition for obtaining the license. The
proposed changes to Sec. Sec. 71.17 and 71.21 would not change the
current notification process and would not change the required timing
or content of the notification required by Sec. 71.17(c)(3) or any
other reporting requirements relating to package use or, where
required, the prior notification of shipments.
The proposed changes also include updating the reference in Sec.
71.21(a) from 49 CFR 171.12 to 49 CFR 171.23. On May 3, 2007 (72 FR
25162), the DOT published a final rule that moved the requirements at
49 CFR 171.12 to paragraph (b)(11) at 49 CFR 171.23, ``Requirements for
the specific materials
[[Page 28998]]
and packagings transported under the [International Civil Aviation
Organization] ICAO Technical Instructions, [International Maritime
Dangerous Goods] IMDG Code, Transportation Canada [Transportation of
Dangerous Goods] TDG Regulations, or the IAEA Regulations.''
M. How would the exemption from classification as fissile material (10
CFR 71.15) change?
The objective of the fissile material exemptions at Sec. 71.15 is
to facilitate the safe transport of low-risk (e.g., small quantities or
low concentrations) of fissile material by exempting shipments of these
materials from the packaging requirements and the criticality safety
assessments required for fissile material transportation and to allow
the shipments to take place without specific Commission approval. The
lower amount of regulatory oversight is acceptable for these shipments,
because the exemptions are established so as 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 would not be any additional packaging or transport
requirements for exempt fissile material beyond that noted in the
specific exemption. However, exempt fissile material would still have
fewer restrictions imposed than if it were to be shipped as fissile
material. Therefore, for purposes of ensuring criticality safety, the
exemptions consider that the material can be released from any
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 conditions assumed
as part of the criticality safety assessment for package designs
approved to transport fissile material.
The reactivity of uranium enriched in U-235 will depend 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 at 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.\3\ 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 one percent) will not be critical, irrespective of the mass
or size of the system. The fissile material exemption at Sec. 71.15(d)
also limits the quantity of some less common moderating materials
(beryllium, graphite, hydrogenous material enriched in deuterium),
because the presence of these materials has the potential to reduce the
minimum critical enrichment, increasing the potential for criticality
with uranium of lower enrichment. Thus, homogeneous materials
containing uranium enriched to no more than 1 percent by weight and
subject to the noted restrictions on moderators will be inherently safe
from a potential criticality, because they 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 would be lower for an optimized heterogeneous system than
for an optimized homogeneous system of the same material. In
consideration of this fact, the current proposed change at Sec.
71.15(d) is to add requirements to clarify the need for homogeneity in
the material.
---------------------------------------------------------------------------
\3\ 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 increase the
reactivity of the low-enriched fissile material, but the exemption 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; however, 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, ``Advisory Material for the IAEA
Regulations for the Safe Transport of Radioactive Material'' (TS-G-
1.1), 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.
As described in Section II, Background, of this document, analyses
performed by the DOE indicated that large arrays of uranium with
enrichment of 1 percent by weight of U-235, which would 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 analyses were 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, would
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 Commission believes that
additional restrictions on low-enriched fissile material shipped under
the fissile material exemption at Sec. 71.15(d) are warranted.
When the Commission last identified a defect in its fissile
exemption regulations, which allowed shipments to be made without prior
Commission approval, the Commission published an emergency final rule
to restrict the use of beryllium and other special moderators, such as
graphite and hydrogenous material enriched in deuterium. In this
instance, the Commission chose to use normal notice-and-comment
rulemaking procedures and determined that the proposed change did not
need to be effective immediately. Uranium enriched to a maximum of 1
percent by weight is rarely available in quantities that would allow
keff to exceed 0.95. In the case of uranium enriched to a
maximum of 1 percent by weight, keff is not sensitive to
changes in mass, so a significant amount of additional mass would be
required to increase the keff from 0.95 to a value very
close to 1.0, even when geometry and moderator conditions are optimal
with respect to criticality. In addition, keff is very
sensitive to moderator conditions. If the moderator conditions are not
optimal, keff is less sensitive to changes in mass.
Therefore, it is very unlikely that even in the case of large
[[Page 28999]]
quantities of uranium enriched to a maximum of 1 percent by weight that
the moderator conditions would also be close to optimal with respect to
criticality. The upper subcritical limit is the maximum allowed value
of keff and includes a minimum margin of subcriticality. At
a keff equal to 1, the system is considered critical.
As discussed in Section II of this document, the NRC removed both
the requirement for uranium enriched to a maximum of 1 percent to be
homogeneously distributed and the lattice prevention requirement.
Although the NRC had determined that the limits on restricted
moderators was sufficient to assure subcriticality for all moderators
of concern, the NRC 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
proposing to reinstate 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 would be
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, should 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, should be less than 5.0 percent of
the uranium mass. Although there are heterogeneity effects at very
small scales, the Commission does not believe that it is necessary to
require homogeneity with respect to particle size. Further, the
Commission 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 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 Commission is also proposing to
reinstate the lattice prevention criterion. The contents of the package
should 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 Commission believes that this
restriction is too narrow and should apply irrespective of the form of
uranium. As discussed under question P, ``What should I consider as I
prepare my comments to the NRC?,'' the NRC is seeking comment on the
homogeneity and lattice prevention requirements for the exemption for
uranium enriched to a maximum of 1 percent. The Commission is
requesting comment on the clarity of the homogeneity and lattice
prevention criteria for implementation.
N. What other changes is the NRC proposing to make 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 has
been deleted. Paragraph 71.19(a) is currently reserved. Other
paragraphs in Sec. 71.19 would be redesignated. In redesignated
paragraph 71.19(b)(2), transitional language that is no longer needed
would be 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.
References to Sec. 71.20 in Sec. 71.0 would be removed, because
Sec. 71.20 has expired and has been removed from the regulations.
In Sec. 71.31, the reference to Sec. 71.13 would be changed to
Sec. 71.19. In Sec. 71.91, the reference to Sec. 71.10 would be
changed to Sec. 71.14. These changes would correct references that
were not updated when the requirements were redesignated in 2004.
In Sec. 71.101, the NRC is proposing to make changes that would
make the requirements more precise. Paragraphs 71.101(a) and
71.101(c)(2) would be revised to clarify the responsibilities of
licensees and certificate holders and applicants for a CoC. The quality
assurance requirements pertaining to the design, fabrication, testing,
and modification of packaging apply to certificate holders and
applicants for a CoC. Licensees are responsible for the quality
assurance requirements that apply to their use of the packaging for the
shipment of licensed material. Paragraph 71.101(c) would be changed to
remove the overlap between paragraphs (c)(1) and (c)(2), by removing
the reference to licensees in paragraph (c)(2).
O. When would these proposed amendments become effective?
The NRC will coordinate the effective date for this rule with the
DOT. As described under question P, ``What Should I Consider as I
Prepare My Comments to the NRC?,'' the NRC is requesting comments on
the cumulative effects of regulation (CER), including comments that
would inform the amount of time that would be sufficient to implement
the proposed amendments. The NRC intends that the new regulations would
become effective no sooner than 90 days after the final rule is
published in the Federal Register.
P. What should I consider as I prepare my comments to the NRC?
Tips for preparing your comments--when submitting your comments,
remember to:
1. Identify the rulemaking (RIN 3150-AI11; NRC-2008-0198).
2. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
3. Describe any assumptions and provide any technical information
and/or data that you used.
4. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
5. Provide specific examples to illustrate your concerns, and
suggest alternatives.
6. Explain your views as clearly as possible.
7. Make sure to submit your comments by the comment period deadline
identified.
8. See Section VIII for the request for comments on the use of
plain writing, Section IX for the request for comments on the adoption
of voluntary consensus standards, Section XI for the request on the
reporting and recordkeeping burden, and Section XII for the request for
comments on the draft regulatory analysis.
9. The NRC is specifically requesting comments on the following
items:
a. As discussed under question J, ``How frequently would I submit
periodic updates on my quality assurance program to the NRC,'' the NRC
is proposing to require quality assurance program approval holders to
[[Page 29000]]
submit a report every 2 years that describes the changes that were made
to their quality assurance program that do not reduce a commitment in
the quality assurance program description approved by the NRC. The NRC
is seeking to balance the regulatory burden for submitting this
information with the NRC need to ensure that the NRC has current
information for its regulatory oversight of quality assurance program
approval holders, which includes using the information for inspections.
Inspections of certificate holders occur approximately every 3 years
and inspections of licensees who use packages occur on an as-needed
basis. The NRC is requesting comment on whether a different frequency
would be more appropriate for reporting changes to an approved quality
assurance program that do not reduce a commitment in a quality
assurance program description approved by the NRC.
b. In Sec. 71.15(d), the NRC is proposing to reintroduce
restrictions on low-enriched fissile material--uranium enriched in U-
235 to a maximum of 1 percent by weight, and with a total plutonium and
U-233 content of up to 1 percent of the mass of uranium-235--by
requiring that it be distributed homogeneously and not form a lattice
arrangement. The NRC is seeking comment on the clarity of this
requirement for implementation.
c. The CER describe the challenges that licensees, certificate
holders, States, or other entities may encounter when implementing the
new regulatory requirements (e.g., rules, generic letters, orders,
backfits, inspections). The CER is an organizational effectiveness
challenge that results from a licensee or impacted entity implementing
a significant number of new or complex regulatory actions, within a
limited implementation period and with available resources (which may
include limited available expertise to address a specific issue). The
CER can potentially distract licensee or other entity staff from
executing other primary duties that ensure safety or security. The NRC
is specifically requesting comment on the cumulative effects of this
proposed rulemaking. In developing comments on the CER, consider the
following questions:
i. In light of any current or projected CER challenges, would the
proposed rule's effective date provide sufficient time to implement the
new proposed requirements, including changes to programs and
procedures?
ii. If current or projected CER challenges exist, what should be
done to address this situation (e.g., if more time is required to
implement the new requirements, what period of time would be
sufficient)?
iii. Do other (NRC or other agency) regulatory actions (e.g.,
orders, generic communications, license amendments requests, inspection
findings of a generic nature) influence the implementation of the
proposed requirements?
iv. Are there unintended consequences? Does the proposed rule
create conditions that would be contrary to the proposed rule's purpose
and objectives? If so, what are the unintended consequences and how
should they be addressed?
v. Please comment on the NRC cost and benefit estimates in the
regulatory analysis that supports the proposed rule.
IV. Section-by-Section Analysis
Section 71.0 Purpose and Scope
Paragraph (d)(1) would be revised to delete Sec. 71.20 from the
list of sections that a general license is issued without requiring the
NRC to issue a package approval, so the reference to ``Sec. Sec. 71.20
through 71.23'' would be revised to ``Sec. Sec. 71.21 through 71.23.''
Section 71.4 Definitions
The definition of ``contamination'' would be added and would be
consistent with the definition of contamination in DOT regulations at
49 CFR 173 and TS-R-1.
The definition of ``Criticality Safety Index (CSI)'' would be
revised to be more consistent with the definition in DOT regulations at
49 CFR 173 and TS-R-1 by addressing overpacks and freight containers in
the definition.
The definition of ``Low Specific Activity (LSA) material'' would be
revised to be more consistent with the definition in DOT regulations at
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.
The definition of ``Special form radioactive material'' would be
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 the date of the final rule. The reference to the
version of 10 CFR part 71 in effect on March 31, 1996, would be
corrected by changing 1983 to 1996.
The definition of ``Uranium--natural, depleted, enriched'' would be
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) would be revised to add Sec. 71.106 to the list of
sections with information collections.
Section 71.14 Exemption for Low-Level Materials.
Paragraph 71.14(a)(1) would be 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 would be considered as 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 could not exceed 10 times
the activity concentration values and the material is not intended to
be processed for the use of the radionuclides.
A reference to Table A-3 in appendix A would be added in paragraphs
71.14(a)(1) and (a)(2) as a source of activity concentration values
that may be used to determine whether natural material or ore would
qualify for the exemption. Table A-3 would provide activity
concentration values for exempt material that would be used for
individual radionuclides whose identities are known, but which are not
listed in Table A-2.
Paragraph 71.14(a)(3) would be 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'' would be added to
Sec. 71.4.
Section 71.15 Exemption From Classification as Fissile Material
Paragraph 71.15(d), which applies to fissile material in the form
of uranium enriched in U-235 to a maximum of 1 percent by weight, would
be revised.
[[Page 29001]]
The fissile material would be required to be distributed homogeneously
and not form a lattice arrangement, where concentrated fissile material
is separated by non-fissile material in a regular, repeating pattern.
Section 71.17 General License: NRC-Approved Package
Paragraph 71.17(c) would be 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 71.19(b) through (e) would be redesignated as Sec. Sec.
71.19(a) through (d).
In redesignated Sec. 71.19(b)(2), the phrase ``[a]fter December
31, 2003'' would be deleted. This would not change the requirement that
packages used for a shipment to a location outside the United States
would continue to be subject to multilateral approval as defined in the
DOT regulations at 49 CFR 173.403, because all such shipments would
occur after December 31, 2003.
Section 71.21 General License: Use of Foreign Approved Package
Paragraph 71.21(a) would be revised to update the reference to 49
CFR 171.12 to 49 CFR 171.23.
Paragraph 71.21(d) would be revised to clarify that the general
licensee must comply with the requirements in Sec. 71.21(d)(1) and
(d)(2). Paragraph 71.21(d)(2) would be revised to delete the sentence
regarding exemption from quality assurance provisions in subpart H for
design, construction, and fabrication activities, because these
requirements are not applicable to a general licensee. The general
licensee would be required to comply with the quality assurance
requirements in subpart H that do apply.
Section 71.31 Contents of Application
In paragraph 71.31(b), the reference to ``Sec. 71.13'' would be
corrected 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 would be revised to remove the reference
to the renewal of quality assurance program approvals. The section
would be 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 would not have an
expiration date, and the NRC would revise the current quality assurance
program approvals so that they would not have an expiration date. The
renewal of a quality assurance program approval would be unnecessary.
Paragraph 71.38(c) would also be revised for improved clarity.
Section 71.70 Incorporations by Reference
This section would be 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''--and
would describe the availability of the documents.
Section 71.75 Qualification of Special Form Radioactive Material
In Sec. 71.75(a)(5), the 1992 edition of ISO 9978 would be
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. This change would make 10
CFR part 71 consistent with the DOT requirements in 49 CFR 173, which
incorporated ISO 9978:1992(E) in 2004.
In Sec. 71.75(b)(2)(ii), the description of the billet used in the
percussion test would be 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 Sec. 71.75(b)(2)(iii), the description of the sheet of lead
used in the percussion test would be 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 Sec. 71.75(d), Sec. Sec. 71.75(d)(1)(i) and (d)(1)(ii) would
be added. In Sec. 71.75(d), the 1999 edition of ISO 2919 would be
incorporated by reference, replacing the reference to the 1980 edition
of ISO 2919 for the alternate Class 4 impact test in Sec.
71.75(d)(1)(i) and the alternate Class 6 temperature test in Sec.
71.75(d)(2). The availability and other language incorporating this
standard by reference is moved to Sec. 71.70. Paragraph
71.75(d)(1)(ii) would allow 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 Sec. Sec. 71.75(b)(1) and (b)(2), if the specimen
weighs less than 500 grams.
Section 71.85 Preliminary Determinations
In Sec. 71.75(a), (b), and (c), ``licensee'' would be replaced by
``certificate holder.'' The NRC experience is that these determinations
are performed by the certificate holders who manufacture the package.
This change would make the requirements consistent with current
practice, because only certificate holders would have a quality
assurance program approval that would allow them to conduct the
required tests under an approved quality assurance program. Paragraph
71.85(d) would be added to address the responsibilities of licensees
using a package for transportation. Although certificate holders would
be required to make the preliminary determinations under Sec.
71.85(a), (b), and (c), the licensee would be responsible for ensuring
that these determinations have been made before their first use of the
packaging.
Section 71.91 Records
In Sec. 71.91(a), the reference to ``Sec. 71.10'' would be
corrected 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 71.101(a) would be changed to clarify that certificate
holders and applicants for a package approval are responsible for
satisfying the quality assurance requirements that apply to design,
fabrication, testing, and modification of packaging. The last two
sentences would be revised to be more precise and to provide clarity.
Paragraph 71.101(c)(2) would be changed to remove the reference to
licensees in the first sentence. This would remove the overlap between
the two paragraphs, by making it clear that licensees would notify the
NRC before their first use of any package as required under Sec.
71.75(c)(1) and certificate holders and applicants for a CoC would
notify the NRC before the fabrication, testing, or modification of a
package as required under Sec. 71.75(c)(2).
Section 71.103 Quality Assurance Organization
In Sec. 71.75(a), footnote 2 would be removed. 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
[[Page 29002]]
activities performed by certificate holders and applicants for a CoC.
Section 71.106 Changes to a Quality Assurance Program
This section would be added to establish requirements that would
apply to changes to quality assurance programs. It would allow some
changes to a quality assurance program to be made without obtaining the
prior approval of the NRC. Currently, all changes, no matter how
insignificant, must be approved by the NRC before they can be
implemented. These provisions would 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 would be required to get NRC approval before
making changes to their quality assurance program that would reduce
their commitments to the NRC.
Paragraph 71.106(a) would establish the requirements that would
apply when a holder of a quality assurance program approval intends to
make a change in its quality assurance program that would reduce their
commitments to the NRC. The holder of a quality assurance program
approval would be required to identify the change, the reason for the
change, and the basis for concluding that the revised program
incorporating the change would continue to satisfy the requirements of
subpart H that apply.
Paragraph 71.106(a)(2) would require that each holder of a quality
assurance program approval maintain quality assurance program changes
as records. These records would need to be maintained as required in
Sec. 71.135.
Paragraph 71.106(b) would allow the holder of a quality assurance
program approval to make changes to its quality assurance program that
would not reduce its commitments to the NRC and identifies the changes
that would not be considered as reducing its commitments to the NRC.
Paragraph 71.106(c) would require that records are maintained for
any changes to the quality assurance program.
Section 71.135 Quality Assurance Records
This section would be revised to include those quality assurance
records that apply to changes that are made to approved quality
assurance programs. The second sentence is revised to include the
changes to the quality assurance program as required by Sec. 71.106 in
the list of the types of records to be maintained.
Appendix A--Determination of A1 and A2.
In paragraphs IV.a. through IV.f., the equations and accompanying
text would be revised to make minor corrections. In paragraphs IV.a.
and IV.b., the description of the equations would 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.
Paragraph IV.c. would be added and paragraphs IV.c. through IV.f.
would be redesignated as paragraphs IV.d. through IV.g., respectively.
Paragraph IV.c. would provide 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 would increase the consistency between appendix A and TS-
R-1.
In paragraph V., the existing text would be redesignated as
paragraph V.a. Paragraph V.b. would be 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 would be 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 would be deleted and the following
corresponding changes would be made: 1) the reference to footnote h
would be removed from Cf-252, 2) the entry for molybdenum-99 (Mo-99)
would be revised to identify footnote h instead of footnote i, and 3)
footnote i would be redesignated as footnote h. Footnote c in the entry
for Ir-192 would be moved, so that it is clear that it applies only to
iridium in special form. Footnote c would also be 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 would be 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 (2009 edition) and the
specific activity would be 4.2 x 10\4\ TBq/g (1.1 x 10\6\ Ci/g). The
entry for Kr-81 would be revised to reflect that it is no longer the
first entry for the isotopes of krypton. In addition, footnote a would
be 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 would be 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 would be 1.0 x
0\3\ Bq/g (2.7 x 10-8 Ci/g) and the value for the activity
limit for exempt consignment would be 1.0 x 10\5\ Bq (2.7 x
10-6 Ci). The activity limit for exempt consignment for Te-
121m would be 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 cerium-134 (Ce-134), Rn-220, Th-226, and U-240
are proposed to be removed, and a chain for Ag-108m is proposed to be
added. This would make footnote b to Table A-2 consistent with footnote
b to Table 2 in TS-R-1. Changes in the list in footnote b were not
initially made to TS-R-1 when the nuclide-specific basic radionuclide
values from the International Basic Safety Standards (IAEA Safety
Series No. 115, International Basic Safety Standards for Protection
against Ionizing Radiation and for the Safety of Radiation Sources)
were adopted for transportation purposes but were made in the 2005
edition of TS-R-1.
Table A-3 would be revised to reflect changes in TS-R-1. In the
second entry, the descriptive phrase ``only alpha emitting
radionuclides are known to be present'' would be 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'' would be 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 would indicate 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.
V. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 10 CFR part 71 under one or more of
Sections 161b, 161i, or 161o of the AEA.
[[Page 29003]]
Willful violations of the rule would be subject to criminal
enforcement.
VI. Agreement State Compatibility
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 would be a matter of compatibility between the NRC and the
Agreement States, thereby providing consistency among the Agreement
States' and the NRC requirements. The NRC staff 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 proposed
compatibility categories assigned to the affected sections of 10 CFR
part 71 are presented 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 Categories A, B, or C,
and, thus, 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, as amended, or provisions of 10 CFR. These
program elements are not adopted by the Agreement States.
The following table lists the parts and sections that would be
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.
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 Uranium-- [B].................... [B].
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.
[[Page 29004]]
71.17............... Removal of brackets General license: [B].................... B.
on Compatibility NRC-approved
Category. package.
71.17(c)............ Revised............ General license: [B].................... B.
NRC-approved
package.
71.19............... Revised............ Previously approved NRC.................... NRC.
package.
71.21............... Removal of brackets General license: [B].................... B.
on Compatibility Use of foreign
Category. approved package.
71.21(a)............ Revised............ General license: [B].................... B.
Use of foreign
approved package.
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 States C.
requirements. which have no users of **Note: 10 CFR
Type B packages--other 71.101(g) indicates
than industrial that QA programs for
radiography.**. industrial radiography
C--Those States which Type B package users
have users of Type B are covered by Sec.
packages--other than 34.31(b). It also
industrial indicated that this
radiography**. section satisfies Sec.
**Note: 10 CFR 71.17(b) and thus
71.101(g) indicates would satisfy those
that QA programs for sections referenced in
industrial radiography this provision (Sec.
Type B package users Sec. 71.101 through
are covered by Sec. 71.137)
34.31(b). It also
indicated that this
section satisfies Sec.
71.12(b) and thus
would satisfy those
sections referenced in
this provision (Sec.
Sec. 71.101 through
71.137)..
71.101(b)........... Revised Quality assurance D--For those States C.
Compatibility requirements. which have no users of **Note: 10 CFR
Category. Type B packages--other 71.101(g) indicates
than industrial that QA programs for
radiography.**. industrial radiography
C--Those States which Type B package users
have users of Type B are covered by Sec.
packages--other than 34.31(b). It also
industrial indicated that this
radiography.**. section satisfies Sec.
**Note: 10 CFR 71.17(b) and thus
71.101(g) indicates would satisfy those
that QA programs for sections referenced in
industrial radiography this provision (Sec.
Type B package users Sec. 71.101 through
are covered by Sec. 71.137).
34.31(b). It also
indicated that this
section satisfies Sec.
71.12(b) and thus
would satisfy those
sections referenced in
this provision (Sec.
Sec. 71.101 through
71.137).
[[Page 29005]]
71.101(c)(1)........ Revised Quality assurance D--For those States C.
Compatibility requirements. which have no users of **Note: 10 CFR
Category. Type B packages--other 71.101(g) indicates
than industrial that QA programs for
radiography**. industrial radiography
C--Those States which Type B package users
have users of Type B are covered by Sec.
packages--other than 34.31(b). It also
industrial indicated that this
radiography.**. section satisfies Sec.
**Note: 10 CFR 71.17(b) and thus
71.101(g) indicates would satisfy those
that QA programs for sections referenced in
industrial radiography this provision (Sec.
Type B package users Sec. 71.101 through
are covered by Sec. 71.137).
34.31(b). It also
indicated that this
section satisfies Sec.
71.12(b) and thus
would 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: 10 CFR **Note: 10 CFR
Category Note. 71.101(g) indicates 71.101(g) indicates
that QA programs for that QA programs for
industrial radiography industrial radiography
Type B package users Type B package users
are covered by Sec. are covered by Sec.
34.31(b). It also 34.31(b). It also
indicated that this indicated that this
section satisfies Sec. section satisfies Sec.
71.12(b) and thus 71.17(b) and thus
would satisfy those would satisfy those
sections referenced in sections referenced in
this provision (Sec. this provision (Sec.
Sec. 71.101 through Sec. 71.101 through
71.137). 71.137).
71.103(a)........... Revised............ Quality assurance D--For those States C.
organization. which have no users of **Note: Sec.
Type B packages--other 71.101(g) indicates
than industrial that QA programs for
radiography.**. industrial radiography
[C]--Those States which Type B package users
have users of Type B are covered by Sec.
packages--other than 34.31(b). It also
industrial indicated that this
radiography.**. section satisfies Sec.
**Note: Sec. 71.17(b) and thus
71.101(g) indicates would satisfy those
that QA programs for sections referenced in
industrial radiography this provision (Sec.
Type B package users Sec. 71.101 through
are covered by Sec. 71.137).
34.31(b). It also
indicated that this
section satisfies Sec.
71.12(b) and thus
would satisfy those
sections referenced in
this provision (Sec.
Sec. 71.101 through
71.137).
71.103(b)........... Revised Quality assurance C--Those States which C.
Compatibility organization. have users of Type B **Note: Sec.
Category Note. packages--other than 71.101(g) indicates
industrial that QA programs for
radiography.**. industrial radiography
**Note: Sec. Type B package users
71.101(g) indicates are covered by Sec.
that QA programs for 34.31(b). It also
industrial radiography indicated that this
Type B package users section satisfies Sec.
are covered by Sec. 71.17(b) and thus
34.31(b). It also would satisfy those
indicated that this sections referenced in
section satisfies Sec. this provision (Sec.
71.12(b) and thus Sec. 71.101 through
would satisfy those 71.137).
sections 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 States C.
records. which have no users of **Note: 10 CFR
Type B packages--other 71.101(g) indicates
than industrial that QA programs for
radiography.**. industrial radiography
C--For those States Type B package users
which have users of are covered by Sec.
Type B packages--other 34.31(b). It also
than industrial indicated that this
radiography**. section satisfies Sec.
**Note: 10 CFR 71.17(b) and thus
71.101(g) indicates would satisfy those
that QA programs for sections referenced in
industrial radiography this provision (Sec.
Type B package users Sec. 71.101 through
are covered by Sec. 71.137).
34.31(b). It also
indicated that this
section satisfies Sec.
71.12(b) and thus
would satisfy those
sections referenced in
this provision (Sec.
Sec. 71.101 through
71.137).
[[Page 29006]]
Appendix A.......... Revise paragraphs Determination of A1 [B].................... [B].
IV.a.--IV.f.; 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- Revise entries for A1 and A2 Values [B].................... [B].
1. Cf-252, Ir-192, Kr- for Radionuclides.
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- Add entry for Kr- Exempt Material [B].................... [B].
2. 79; revise entries Activity
for Kr-81 and Te- Concentrations and
121m; and revise Exempt Consignment
footnote b. Activity Limits
for Radionuclides.
Appendix A, Table A- Revise entries for General Values for [B].................... [B].
3. column 1, A1 and A2.
``Contents,'' and
add footnote a.
----------------------------------------------------------------------------------------------------------------
\1\ Where there would be a change in the assigned compatibility category, a compatibility category is assigned,
or the content of the section has been significantly changed, a summary of the analysis is presented in the
following paragraphs. Changes in the assigned compatibility category are being 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 would 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,'' would 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,'' would 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) would be 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) would be added and applies to
licensees. Paragraph 71.85(d) would be 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,'' would be
changed from Compatibility Category D to Compatibility Category C. In
reaching an agreement with the NRC, the States would 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
proposing to designate 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 would be designated as
compatibility category NRC. The States would not be 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 would 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 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 would be 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
[[Page 29007]]
designated. The compatibility category would 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 would be 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 would be updated by changing Sec. 71.12(b) to
Sec. 71.17(b).
The new Sec. 71.106, ``Changes to quality assurance program,''
would apply to licensees and holders of, or applicants for, a CoC. The
assigned compatibility category would be 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 would be performed by the
NRC.
In Sec. 71.135, the compatibility category would 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 would be 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 would be updated by changing Sec. 71.12(b) to
Sec. 71.17(b).
VII. Availability of Documents
The following documents referenced in this proposed rulemaking are
available either through ADAMS or at the NRC PDR:
----------------------------------------------------------------------------------------------------------------
Document PDR ADAMS ADAMS Accession No.
----------------------------------------------------------------------------------------------------------------
Management Directive 5.9, ``Adequacy Yes.................. Yes.................. ML041770094
and Compatibility of Agreement State
Programs.''.
NRC Information Notice 2002-035: Yes.................. Yes.................. ML023520339
``Changes to 10 CFR Parts 71 and 72
Quality Assurance Programs.''
NRC Regulatory Issue Summary 2004- Yes.................. Yes.................. ML042160293
018: ``Expiration Date for 10 CFR
Part 71 Quality Assurance Program
Plan Approvals.''.
NUREG/CR-5342, ``Assessment and Yes.................. Yes.................. ML12139A419
Recommendations for Fissile-Material
Packaging Exemptions and General
Licenses within 10 CFR Part 71,''
July 1998.
Draft Environmental Assessment and Yes.................. Yes.................. ML12187A109
Finding of No Significant Impact for
the Proposed Rule Amending 10 CFR
Part 71.
Draft Regulatory Analysis for Yes.................. Yes.................. ML12187A110
Proposed Rulemaking--Compatibility
with IAEA Transportation Standards
(10 CFR Part 71).
----------------------------------------------------------------------------------------------------------------
VIII. 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). The NRC
requests comments on the proposed rule with respect to the clarity and
effectiveness of the language used. Comments should be sent to the NRC
as explained in the ADDRESSES section of this document.
IX. 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 proposed rule, the NRC proposes to use
and incorporate by reference the following consensus standards:
International Organization for Standardization, 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 International Organization for Standardization, ISO
9978:1992(E), ``Radiation protection--Sealed radioactive sources--
Leakage test methods,'' First Edition (February 15, 1992), for the
leaktightness tests. The NRC invites comment on the applicability and
use of other standards.
In other portions of this proposed 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 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.
X. 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 proposed rule because the Commission has concluded
on the basis of an Environmental Assessment (ADAMS Accession No.
ML12187A109) that this proposed rule, if adopted, would not be a major
federal action significantly affecting the quality of the human
environment.
Many of the proposed changes fall under a categorical exclusion for
which the Commission has previously determined that such actions,
neither individually nor cumulatively, would 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. The categorical exclusion at 10 CFR
[[Page 29008]]
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: (i) Procedures for filing
and reviewing applications for licenses or construction permit or early
site permit 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; (ii) recordkeeping requirements; (iii)
reporting requirements; (iv) education, training, experience,
qualification, or other employment suitability requirements; or (v)
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 would 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 would be 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 would be allowed 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 would be very small
impacts from these changes.
The determination of this Environmental Assessment is that there
will be no significant impact to the public from this action. However,
the NRC is providing an opportunity to comment on the Environmental
Assessment. Comments on any aspect of the Environmental Assessment may
be submitted to the NRC as indicated under the ADDRESSES section of
this document.
The NRC has sent a copy of the Environmental Assessment and this
proposed rule to every State Liaison Officer and requested their
comments on the Environmental Assessment.
XI. Paperwork Reduction Act Statement
This proposed 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). This proposed rule has been submitted to the
Office of Management and Budget (OMB) for review and approval of the
information collection requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR part 71, Revisions
to Transportation Safety Requirements and Harmonization with
International Atomic Energy Agency Transportation Requirements.
The form number if applicable: Not applicable.
How often the collection is required: On occasion, for reports of
changes reducing commitments to the NRC on quality assurance plans.
Every 24 months for all changes to quality assurance plans.
Who will be required or asked to report: General licensees or users
of packages, certificate holders and certificate applicants.
An estimate of the number of annual responses: 31.
The estimated number of annual respondents: 250.
An estimate of the total number of hours needed annually to
complete the requirement or request: -1,700 hours (a decrease of 1,925
hours reporting + an increase of 100 third party disclosure hours and
125 hours recordkeeping).
Abstract: The NRC is proposing to amend its regulations for the
packaging and transportation of radioactive material, including changes
to information collections that would affect persons with a quality
assurance program approved under 10 CFR part 71. Rather than submitting
all quality assurance program changes to the NRC for approval,
licensees, certificate holders, and applicants would only need to
submit changes to their quality assurance program that would reduce
their commitments to the NRC. They would be required to keep records of
all quality assurance program changes and submit a report of these
changes to the NRC every 24 months. Burden on licensees would be
reduced for renewing quality assurance programs, as future approvals of
these programs would not expire.
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule (or proposed
policy statement) and on the following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike,
Rockville, MD 20852. The OMB clearance package and rule are available
at the NRC public Web site: https://www.nrc.gov/public-involve/doc-comment/omb/, for 60 days after the signature date of this
document.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
previously stated issues, by June 17, 2013 to the Information Services
Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, or by email to INFOCOLLECTS.RESOURCE@NRC.GOV and to the
Desk Officer, Chad Whiteman, Office of Information and Regulatory
Affairs, NEOB-10202, (3150-0008), Office of Management and Budget,
Washington, DC 20503. Comments on the proposed information collections
may also be submitted via the Federal rulemaking Web site https://www.regulations.gov, docket # NRC-2008-0198. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given to comments received after this date.
Comments can also be emailed to Chad_S_Whiteman@omb.eop.gov or
[[Page 29009]]
submitted by telephone at 202-395-4718.
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.
XII. Regulatory Analysis
The Commission has prepared a draft regulatory analysis (ADAMS
Accession No. ML12187A110) on this proposed regulation. The analysis
examines the costs and benefits of the alternatives considered by the
Commission. The Commission requests public comment on the draft
regulatory analysis. Comments on the draft analysis may be submitted to
the NRC as indicated under the ADDRESSES section of this document.
XIII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would 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 quality
assurance program description issued under 10 CFR parts 50, 71, or 72;
and holders of a certificate of compliance for a transportation
package. These companies 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 at 10 CFR
2.810. Also, a draft regulatory analysis was performed for this
proposed rule. The regulatory analysis included an evaluation of the
costs associated with the proposed requirements. The proposed
rulemaking includes changes that would reduce the regulatory burden for
licensees and certificate holders. Based on the information developed
in the regulatory analysis, it is believed that there will not be
significant economic impacts on a substantial number of small entities.
XIV. Backfitting
The NRC has determined that the backfit rule (50.109, 70.76, 72.62,
or 76.76) and the issue finality provisions in 10 CFR part 52 do not
apply to this proposed rule because this amendment would not involve
any provisions that would impose backfits as defined in 10 CFR Chapter
I. Therefore, a backfit analysis is not required for this proposed
rule, and the NRC did not prepare a backfit analysis for this proposed
rule.
List of Subjects in 10 CFR Part 71
Criminal penalties, Hazardous materials transportation, Nuclear
materials, 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. 553; the NRC is proposing to
adopt 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. No. 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 to
``Sec. Sec. 71.20 through 72.23'' 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/cm\2\ for beta and gamma
emitters and low toxicity alpha emitters, or 0.04 Bq/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 of this part. 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 of this part, and which satisfies the descriptions and
limits set forth below. 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 material in which the activity is distributed throughout
and the 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 of this part, in which:
(i) The radioactive material is distributed throughout a solid or a
collection of solid objects, or is
[[Page 29010]]
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 would 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 of this part. A
special form encapsulation designed in accordance with the requirements
of Sec. 71.4 of this part 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 of this part in effect on March 31, 1996
(see 10 CFR part 71, revised as of January 1, 1996), and constructed
before April 1, 1998; and special form material that was successfully
tested before [EFFECTIVE DATE OF FINAL RULE] in accordance with the
requirements of Sec. 71.75(d) of this part in effect before [EFFECTIVE
DATE OF FINAL RULE] 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, paragraph (b) is revised 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, paragraphs (a)(1) and (2) are revised,and paragraph
(a)(3) is added 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 of this part.
* * * * *
0
6. In Sec. 71.15, paragraph (d) is revised 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, paragraph (c) introductory text, (c)(1), and (c)(2)
are revised 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 CoC, 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
* * * * *
0
8. In Sec. 71.19, paragraphs (b) through (e) are redesignated as
paragraphs (a) through (d), and redesignated paragraph (b)(2) is
revised 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
regulations at 49 CFR 173.403.
* * * * *
0
9. In Sec. 71.21, paragraphs (a) and (d) are revised 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 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.
[[Page 29011]]
Sec. 71.31 [Amended]
0
1. In Sec. 71.31, paragraph (b), remove the reference to ``Sec.
71.13'' and add, in its place, the reference to ``Sec. 71.19''.
0
2. Section 71.38 is revised 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 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
3. 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 10 CFR 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 are
available for purchase at the corresponding address noted in this
section. The materials can also be examined at the NRC Public Document
Room, O1-F21, 11555 Rockville Pike, Rockville, Maryland 20852 or at the
NRC Library, Two White Flint North, 11545 Rockville Pike, Rockville,
Maryland 20852; telephone: 301-415-5610; email:
Library.Resource@nrc.gov. The materials are also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) The following material is available for purchase from the
American National Standards Institute, 25 West 43rd Street, 4th floor,
New York, NY 10036, 212-642-4900, https://www.ansi.org, or
Info@ansi.org.
(1) International Organization for Standardization, 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) of this part.
(2) International Organization for Standardization, 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) of this
part.
0
4. In Sec. 71.75, paragraphs (a)(5), (b)(2)(ii), (b)(2)(iii), (d)(1),
and (d)(2) are revised 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 in Sec. 71.70 of
this part).
(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 (.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 in Sec. 71.70 of this part); 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 in Sec. 71.70 of this part); 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 in Sec. 71.70 of this part).
0
5. In Sec. 71.85, paragraphs (a), (b), and (c) are revised and
paragraph (d) is added 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
1. In Sec. 71.91, paragraph (a), remove the reference to ``Sec.
71.10'' and add, in its place, the reference to ``Sec. 71.14''.
0
2. In Sec. 71.101, paragraphs (a) and (c)(2) are revised 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
[[Page 29012]]
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 (CoC)
shall obtain Commission approval of its quality assurance program. Each
certificate holder or applicant for a CoC shall, in accordance with
Sec. 71.1 of this part, 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
3. In Sec. 71.103, paragraph (a) is revised to read as follows:
Sec. 71.103 Quality assurance organization.
(a) The licensee, certificate holder, and applicant for a
Certificate of Compliance (CoC) shall be responsible for the
establishment and execution of the quality assurance program. The
licensee, certificate holder, and applicant for a CoC 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
4. 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) of this part, a description of a proposed
change to its NRC-approved quality assurance program that would 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)
of this part. 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
5. Section 71.135 is revised to read as follows:
Sec. 71.135 Quality assurance records.
The licensee, certificate holder, and applicant for a Certificate
of Compliance (CoC) 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 of
this part, the instructions, procedures, and drawings required by Sec.
71.111 of this part 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 CoC shall retain these records
for 3 years beyond the date when the licensee, certificate holder, and
applicant for a CoC 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 CoC shall retain
the superseded material for 3 years after it is superseded.
0
6. In appendix A to part 71, IV.a. and IV.b. are revised, paragraphs
IV.c. through IV.f. are redesignated as paragraphs IV.d. through IV.g.
and are revised, new paragraph IV.c. is added, paragraph V. is
redesignated as paragraph V.a., and new paragraph V.b. is added to 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] TP16MY13.010
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] TP16MY13.011
[[Page 29013]]
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] TP16MY13.012
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] TP16MY13.013
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] TP16MY13.014
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] TP16MY13.015
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] TP16MY13.016
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.a. * * *
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.
* * * * *
0
7. In appendix A to part 71, Table A-1:
0
a. Add entry for Kr-79 in alphanumeric order;
0
b. Revise the entries for Cf-252, Ir-192, Kr-81, and Mo-99;
0
c. Revise footnotes a and c; and
0
d. Remove footnote h; and
0
e. Redesignate footnote i as footnote h.
The revisions read as follows:
Appendix A to Part 71--Determination of A1 and A2
* * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Specific activity
Symbol of radionuclide Element and atomic No. A1 (TBq) A1 (Ci)\b\ A2 (TBq) A2 (Ci)\b\ -------------------------------
(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 10 6.0 x 10-\1\ 1.6 x 10\1\ 3.4 x 10\2\ 9.2 x 10\3\
* * * * * * *
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
[[Page 29014]]
Ge-68 Ga-68
Rb-83 Kr-83m
Sr-82 Rb-82
Sr-90 Y-90
Sr-91 Y-91m
Sr-92 Y-92
Y-87 Sr-87m
Zr-95 Nb-95m
Zr-97 Nb-97m, Nb-97
Mo-99 Tc-99m
Tc-95m Tc-95
Tc-96m Tc-96
Ru-103 Rh-103m
Ru-106 Rh-106
Pd-103 Rh-103m
Ag-108m Ag-108
Ag-110m Ag-110
Cd-115 In-115m
In-114m In-114
Sn-113 In-113m
Sn-121m Sn-121
Sn-126 Sb-126m
Te-127m Te-127
Te-129m Te-129
Te-131m Te-131
Te-132 I-132
I-135 Xe-135m
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 29015]]
* * * * *
0
8. In appendix A, Table A-2, the entry for Kr-79 is added, in
alphanumeric order, the entries for Kr-81 and Te-121m are revised, and
footnote b is revised to read as follows:
Appendix A to Part 71--Determination of A1 and A2
* * * * *
Table A-2--Exempt Material Activity Concentrations and Exempt Consignment Activity Limits for Radionuclides
--------------------------------------------------------------------------------------------------------------------------------------------------------
Activity Activity
Element and concentration for concentration for Activity limit Activity limit
Symbol of radionuclide 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
* * * * *
0
9. In appendix A to part 71, Table A-3 is revised to read as follows:
Appendix A to Part 71--Determination of A1 and A2
* * * * *
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 material consign- consign-
(Bq/g) (Ci/g) ments (Ba) ments (Ci)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Only beta or gamma emitting radionuclides are known 1 x 10-\1\ 2.7 x 2 x 10 - 5.4 x 10- 1 x 10\1\ 2.7 x 10- 1 x 10\4\ 2.7 x 10-
to be present...................................... 10\0\ \2\ \1\ \10\ \7\
Alpha emitting nuclides, but no neutron emitters, 2 x 10-\1\ 5.4 x 9 x 10-\5\ 2.4 x 10- 1 x 10-\1\ 2.7 x 10- 1 x 10\3\ 2.7 x 10-
are known to be present \a\........................ 10\0\ \3\ \12\ \8\
[[Page 29016]]
Neutron emitting nuclides are known to be present or 1 x 10-\3\ 2.7 x 10- 9 x 10-\5\ 2.4 x 10- 1 x 10-\1\ 2.7 x 10- 1 x 10\3\ 2.7 x 10-
no relevant data are available..................... \2\ \3\ \12\ \8\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 10th day of May, 2013.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 2013-11552 Filed 5-15-13; 8:45 am]
BILLING CODE 7590-01-P
