Proposed Generic Communications; Applicability of 10 CFR Part 21 Requirements to Applicants for Standard Design Certifications, 14212-14214 [2010-6500]
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Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Notices
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The timeline provides dates indicating
when (1) construction will begin on
various phases of the project, (2) outages
are scheduled for each unit, and (3)
critical equipment will be ordered,
installed, tested and become
operational.
Notwithstanding the schedule
exemptions for these limited
requirements, the licensee would
continue to be in compliance with all
other applicable physical security
requirements, as described in 10 CFR
73.55 and reflected in its current NRCapproved physical security program. By
January 31, 2011, SONGS would be in
full compliance with the regulatory
requirements of 10 CFR 73.55, as issued
on March 27, 2009.
4.0 Conclusion for Part 73 Schedule
Exemption Request
The staff has reviewed the licensee’s
submittal and concludes that the
licensee has provided adequate
justification for its request for an
extension of the compliance dates to
October 31, 2010, and to January 31,
2011, for two specified requirements.
Accordingly, the Commission has
determined that pursuant to 10 CFR
73.5, ‘‘Specific exemptions,’’ an
exemption from the March 31, 2010,
compliance date is authorized by law
and will not endanger life or property or
the common defense and security, and
is otherwise in the public interest.
Therefore, the Commission hereby
grants the requested exemption.
The NRC staff has determined that the
long-term benefits that will be realized
when the SONGS security modifications
are completed justifies exceeding the
full compliance date with regard to the
specified requirements of 10 CFR 73.55.
The significant security enhancements
SONGS needs additional time to
complete are new requirements imposed
by March 27, 2009, amendments to 10
CFR 73.55, and are in addition to those
required by the security orders issued in
response to the events of September 11,
2001. Therefore, the NRC concludes that
the licensee’s actions are in the best
interest of protecting the public health
and safety through the security changes
that will result from granting this
exemption.
As per the licensee’s request and the
NRC’s regulatory authority to grant an
exemption from the March 31, 2010,
deadline for the two items specified in
Enclosure 1 of SCE’s letter dated
December 17, 2009, the licensee is
required to be in full compliance by
January 31, 2011. In achieving
compliance, the licensee is reminded
that it is responsible for determining the
appropriate licensing mechanism (i.e.,
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10 CFR 50.54(p) or 10 CFR 50.90) for
incorporation of all necessary changes
to its security plans.
Pursuant to 10 CFR 51.32, ‘‘Finding of
no significant impact,’’ the Commission
has previously determined that the
granting of this exemption will not have
a significant effect on the quality of the
human environment (75 FR 12580;
dated March 16, 2010).
This exemption is effective upon
issuance.
Dated at Rockville, Maryland, this 16th day
of March 2010.
For the Nuclear Regulatory Commission.
Joseph G. Giitter,
Director, Division of Operating Reactor
Licensing, Office of Nuclear Reactor
Regulation.
[FR Doc. 2010–6492 Filed 3–23–10; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[NRC–2010–0122]
Proposed Generic Communications;
Applicability of 10 CFR Part 21
Requirements to Applicants for
Standard Design Certifications
AGENCY: Nuclear Regulatory
Commission.
ACTION: Notice of opportunity for public
comment.
SUMMARY: The U.S. Nuclear Regulatory
Commission (NRC) is issuing this
regulatory issue summary (RIS) to
clarify the agency’s regulatory position
regarding the applicability of 10 CFR
Part 21 requirements to standard design
certification or design certification rule
(DCR) applicants (hereafter referred to
as DCR applicants) before and after the
DCR is issued by the NRC. This RIS
requires no action or written response
on the part of addressees.
DATES: Comment period expires May 10,
2010. Comments submitted after this
date will be considered if it is practical
to do so, but assurance of consideration
cannot be given except for comments
received on or before this date.
ADDRESSES: Submit written comments
to the Chief, Rulemaking and Directives
Branch, Division of Administrative
Services, Office of Administration, U.S.
Nuclear Regulatory Commission, Mail
Stop TWB–05–B01M, Washington, DC
20555–0001, and cite the publication
date and page number of this Federal
Register notice.
FOR FURTHER INFORMATION, CONTACT:
Milton Concepcion, at 301–415–4054 or
by e-mail at
Milton.Concepcion@nrc.gov.
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SUPPLEMENTARY INFORMATION:
NRC Regulatory Issue Summary 2010–
XX
Applicability of 10 CFR Part 21
Requirements to Applicants for
Standard Design Certifications
Addressees
All holders of and applicants for an
early site permit, combined operating
license (COL), manufacturing license,
and standard design approval; and
applicants for a standard design
certification under the provisions of
Title 10 of the Code of Federal
Regulations (10 CFR) Part 52, ‘‘Licenses,
Certifications, and Approvals for
Nuclear Power Plants.’’
Intent
The U.S. Nuclear Regulatory
Commission (NRC) is issuing this
regulatory issue summary (RIS) to
clarify the agency’s regulatory position
regarding the applicability of 10 CFR
Part 21 requirements to standard design
certification or design certification rule
(DCR) applicants (hereafter referred to
as DCR applicants) before and after the
DCR is issued by the NRC. This RIS
requires no action or written response
on the part of addressees.
Background
The regulations in 10 CFR Part 21
establish procedures and requirements
for implementation of Section 206 of the
Energy Reorganization Act (ERA) of
1974, as amended. Section 206 applies
to any individual or responsible officer
of a firm ‘‘constructing, owning,
operating, or supplying the components
of any facility or activity which is
licensed or otherwise regulated’’ by the
NRC.
The statements of consideration that
accompanied the final rule for 10 CFR
Part 52 (3150–AG24), published in the
Federal Register on August 28, 2007 (72
FR 49352), clarified the applicability of
various requirements to each of the
licensing processes in 10 CFR Part 52,
including how Section 206 reporting
requirements and, therefore, the
provisions of 10 CFR Part 21, should be
extended to early site permits, standard
design certifications, and combined
licenses. As indicated in the statements
of consideration for the 2007
conforming changes to 10 CFR Part 52
Final Rule; the NRC’s reporting
requirements in 10 CFR Part 21, as
applicable to Part 52 licensing and
approval processes, are consistent with
three key principles as described below.
The first principle ensures that the
regulatory requirements of Section 206
of the ERA extend throughout the entire
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Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Notices
‘‘regulatory life’’ of a standard design
certification. The NRC considers
‘‘regulatory life’’ as the period of time in
which a standard design certification
needs to meet the regulations in effect.
This period begins when an application
is docketed and ends at the later of: (1)
The termination or expiration of the
standard design certification; or (2) the
termination or expiration of the last
license, directly or indirectly,
referencing the standard design
certification. Section 206 of the ERA
applies whenever necessary to support
effective NRC decision-making and
regulatory oversight of the referencing
licenses and regulatory approvals.
The second principle ensures that the
NRC, its licensees, and license
applicants receive information on
defects or failures to comply at the time
when the information would be most
useful to: (1) The NRC in carrying out
its regulatory responsibilities, and (2)
the licensee or applicant when engaging
in activities regulated by the NRC.
Under the 10 CFR Part 52 licensing
process, the NRC requires immediate
reporting throughout the period of
pendency of an application, be it for a
license or a standard design
certification. This reporting obligation
must be extended to contractors and
subcontractors supporting an
application with services that are basic
components (i.e., safety-related) and
could be relied upon in the siting,
design, and construction of a nuclear
power plant. However, the NRC
considers that DCR applicants may
delay the reporting of a defect or failure
to comply if there is no immediate
consequence or regulatory interest in
prompt reporting. For those Part 52
processes (e.g., early site permits, design
approvals, and design certifications)
which do not authorize continuing
activities required to be licensed under
the Atomic Energy Act or the ERA, but
are intended solely to provide early
identification and resolution of issues in
subsequent licensing or regulatory
approvals, the reporting of defects or
failures to comply associated with
substantial safety hazards may be
delayed until the time that the Part 52
process is first referenced. After
referencing, the DCR applicant must
make the necessary notifications to the
NRC as well as provide the necessary
corrections to the final design.
The third principle ensures that
entities conducting activities under 10
CFR Part 52 accurately fulfill their
reporting obligation in a timely manner
with the development and
implementation of procedures and
practices. This principle is consistent
with the current requirements in 10 CFR
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Part 21 in that licensees, license
applicants, and other entities seeking a
design certification must have
contractual provisions with their
contractors, subcontractors, consultants,
and other suppliers which notify them
that they are subject to the NRC’s
regulatory requirements on reporting
and the development and
implementation of reporting procedures.
Summary of Issues
Based on questions raised by
applicants for combined licenses and
design certifications, the NRC staff
developed this RIS to clarify the NRC’s
position on how and when a DCR
applicant notifies the NRC of a defect or
failure to comply in order to meet the
notification requirements established in
10 CFR Part 21.
Issue 1: Under 10 CFR Part 21, when
does a DCR applicant have to notify the
NRC of ‘‘Part 21 defects or failures to
comply’’ on information provided in a
COL application that referenced the
DCR applicant’s certified design?
The DCR applicant has a current
obligation under 10 CFR Part 21 to
report to the NRC any identified defect
or failure to comply within its scope of
supply that could create a substantial
safety hazard. This obligation exists
even if the COL applicant did not
actually contract with the DCR
applicant to provide further design and
engineering for the standard design
certification. As stated in the second key
principle of reporting under Section 206
of the ERA, the reporting obligation of
a DCR applicant under 10 CFR Part 21
continues until the termination or
expiration of the standard design
certification; or until the termination or
expiration of the last license referencing
the DCR applicant’s design certification.
Issue 2: If a DCR applicant states that
it addressed all potential 10 CFR Part 21
defects in a recent revision of the Design
Control Document (DCD) or in a COL
application that references the DCD,
does it also have to make a specific 10
CFR Part 21 notification to the NRC, or
can it assert that the NRC has been
adequately informed about the defects?
A DCD revision by itself does not
satisfy the reporting requirements of
Part 21. 10 CFR 21.21(d)(3) and 10 CFR
21.21(d)(4) set forth the form and
content of the required notification.
Consistent with the second principle of
reporting under Section 206 of the ERA,
if the referenced revision to the DCD or
COL application did not include the
information required by 10 CFR Part 21,
then the reporting requirement has not
been satisfied.
Issue 3: If issues identified in a
standard design certification rise to the
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14213
level of a 10 CFR Part 21 notification,
does the DCR applicant have to notify
a COL applicant or holder referencing
that design certification in addition to
the NRC, even though the DCR
applicant no longer has a contract with
the COL applicant?
The DCR applicant is required to
notify a COL applicant or holder only if
(1) the DCR applicant either has or had
a contract with the referencing COL
applicant/holder and (2) the DCR
applicant has identified a deviation or
failure to comply with its design
certification and it does not have the
capability to determine if it is a defect
or failure to comply as defined in 10
CFR Part 21. If the DCR applicant is
unable to determine whether the
deviation is a defect or failure to
comply, then it must inform the COL
applicant or holder referencing the
design certification of the identified
deviation or failure to comply in
accordance with § 21.21(b). This is
consistent with the third principle. The
notification must be provided within
five working days of this determination
so that the affected entities may evaluate
the deviation or failure to comply.
However, if the DCR applicant has
determined that the deviation
constitutes a defect or failure to comply,
then the applicant need only report the
defect or failure to comply to the NRC
under § 21.21(d). The DCR applicant
should consider whether notification to
purchasers (even if there is no longer a
contract in effect with the purchasers)
needs to be part of the corrective action
that the supplier is required to describe
in the notification to the NRC under 10
CFR 21.21(d)(4)(vii) and 10 CFR
21.21(d)(4)(viii).
Issue 4: Does the COL applicant or
holder have to notify the DCR applicant
of any deviation, defect, or failure to
comply that it finds even if there is no
contract between the COL applicant and
the DCR applicant?
No. The COL applicant does not have
a duty under 10 CFR Part 21 or 10 CFR
50.55(e) to notify the DCR applicant of
any deviation, defect, or failure to
comply that the COL applicant finds in
the certified or approved standard
design. In this circumstance, the COL
applicant is not supplying a basic
component to the DCR applicant.
Consistent with the third principle, the
COL applicant’s only duty under Part 21
or 10 CFR 50.55(e) is to notify the NRC
of the defect or failure to comply.
Backfit Discussion
This RIS provides regulatory
clarification on information collection
and reporting requirements in 10 CFR
Part 21. Information collection and
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Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Notices
reporting requirements are not subject to
the provisions of the Backfit Rule, 10
CFR Part 50.109 or comparable
backfitting requirements in 10 CFR Part
52. In addition, this RIS does not
present a new or different staff position
about the implementation of 10 CFR
Part 21, ‘‘Reporting of Defects and
Noncompliance,’’ within the definition
of ‘‘backfitting’’ in either the Backfit Rule
or comparable provisions in Part 52.
The staff positions for this RIS are either
taken from, or represent the logical
extension of, the discussion of Part 21
obligations for design certification
applicants presented in the statement of
considerations that accompanied the
final rule (3150–AG24) for Part 52 (72
FR 49352; August 28, 2007).
This RIS requires no action or written
response by addressees. Any action that
addressees take to implement changes to
their 10 CFR Part 21 programs in
accordance with the clarifications in
this RIS is strictly voluntary, and
therefore does not constitute backfitting.
For these reasons, the Backfit Rule does
not apply and a backfit analysis is not
required for issuance of this RIS.
Document Room at One White Flint
North, 11555 Rockville Pike (First
Floor), Rockville, Maryland. Publicly
available records will be accessible
electronically from the Agencywide
Documents Access and Management
System (ADAMS) Public Electronic
Reading Room on the Internet at the
NRC Web site, https://www.nrc.gov/NRC/
ADAMS/. If you do not have
access to ADAMS or if you have
problems accessing the documents in
ADAMS, contact the NRC Public
Document Room (PDR) reference staff at
1–800–397–4209 or 301–415–4737 or by
e-mail to pdr@nrc.gov.
• Gary L. Halbert, General Counsel,
National Transportation Safety Board;
• Debra A. Carr, Associate Deputy
Staff Director, U.S. Commission on Civil
Rights;
• Matthew T. Wallen, Director, Office
of Public Assistance, Governmental
Affairs and Compliance, Surface
Transportation Board, U.S. Department
of Transportation;
The following executive has been
selected to serve as an alternate member
of the PRB:
• Lola A. Ward, Director for the
Office of Administration, National
Transportation Safety Board.
Dated at Rockville, Maryland, this 18th day
of March 2010.
For the Nuclear Regulatory Commission.
Martin C. Murphy,
Chief, Generic Communications Branch,
Division of Policy and Rulemaking, Office
of Nuclear Reactor Regulation.
Dated: March 15, 2010.
Thomasina V. Rogers,
Chairman.
OFFICE OF PERSONNEL
MANAGEMENT
BILLING CODE 7590–01–P
Federal Register Notification
To be done after the public comment
period.
Senior Executive Service Performance
Review Board Membership
Congressional Review Act
Occupational Safety and Health
Review Commission.
ACTION: Annual notice.
AGENCY:
Paperwork Reduction Act Statement
This RIS does not contain new or
amended information collection
requirements subject to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). Existing information collection
requirements were approved by the
OMB, control numbers 3150–0035,
3150–0011 and 3150–0151.
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.
srobinson on DSKHWCL6B1PROD with NOTICES
Contact
Please direct any questions about this
matter to Milton Concepcion, at 301–
415–4054 or by e-mail at
Milton.Concepcion@nrc.gov.
End of Draft Regulatory Issue Summary
Documents may be examined, and/or
copied for a fee, at the NRC’s Public
VerDate Nov<24>2008
16:24 Mar 23, 2010
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BILLING CODE 7600–01–P
[FR Doc. 2010–6500 Filed 3–23–10; 8:45 am]
OCCUPATIONAL SAFETY AND
HEALTH REVIEW COMMISSION
This RIS is a rule as designated in the
Congressional Review Act (5 U.S.C.
801–808). The Office of Management
and Budget (OMB) has determined this
is not a major rule.
[FR Doc. 2010–6531 Filed 3–23–10; 8:45 am]
SUMMARY: Notice is given under 5 U.S.C.
4314(c)(4) of the appointment of
members to the Performance Review
Board (PRB) of the Occupational Safety
and Health Review Commission.
DATES: Membership is effective on June
22, 2010.
FOR FURTHER INFORMATION CONTACT:
Debra A. Hall, Deputy Executive
Director, U.S. Occupational Safety and
Health Review Commission, 1120 20th
Street, NW., Washington, DC 20036,
(202) 606–5397.
SUPPLEMENTARY INFORMATION: The
Review Commission, as required by 5
U.S.C. 4314(c)(1) through (5), has
established a Senior Executive Service
PRB. The PRB reviews and evaluates the
initial appraisal of a senior executive’s
performance by the supervisor, and
makes recommendations to the
Chairman of the Review Commission
regarding performance ratings,
performance awards, and pay-forperformance adjustments. In the case of
an appraisal of a career appointee, more
than half of the members shall consist
of career appointees, pursuant to 5
U.S.C. 4314(c)(5). The names and titles
of the PRB members are as follows:
PO 00000
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Excepted Service
AGENCY: U.S. Office of Personnel
Management (OPM).
ACTION: Notice.
SUMMARY: This gives notice of OPM
decisions granting authority to make
appointments under Schedules A, B,
and C in the excepted service as
required by 5 CFR 213.103.
FOR FURTHER INFORMATION CONTACT:
Roland Edwards, Senior Executive
Resource Services, Employee Services,
202–606–2246.
SUPPLEMENTARY INFORMATION: Appearing
in the listing below are the individual
authorities established under Schedules
A, B, and C between February 1, 2010,
and February 28, 2010.
These notices are published monthly
in the Federal Register at https://
www.gpoaccess.gov/fr/. A consolidated
listing of all authorities as of June 30 is
also published each year. The following
Schedules are not codified in the Code
of Federal Regulations. These are
agency-specific exceptions.
Schedule A
No Schedule A authorities to report
during February 2010.
Schedule B
No Schedule B authorities to report
during February 2010.
Schedule C
The following Schedule C
appointments were approved during
February 2010.
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]]>Agencies
[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14212-14214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6500]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[NRC-2010-0122]
Proposed Generic Communications; Applicability of 10 CFR Part 21
Requirements to Applicants for Standard Design Certifications
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of opportunity for public comment.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing this
regulatory issue summary (RIS) to clarify the agency's regulatory
position regarding the applicability of 10 CFR Part 21 requirements to
standard design certification or design certification rule (DCR)
applicants (hereafter referred to as DCR applicants) before and after
the DCR is issued by the NRC. This RIS requires no action or written
response on the part of addressees.
DATES: Comment period expires May 10, 2010. Comments submitted after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given except for comments received on or
before this date.
ADDRESSES: Submit written comments to the Chief, Rulemaking and
Directives Branch, Division of Administrative Services, Office of
Administration, U.S. Nuclear Regulatory Commission, Mail Stop TWB-05-
B01M, Washington, DC 20555-0001, and cite the publication date and page
number of this Federal Register notice.
FOR FURTHER INFORMATION, CONTACT: Milton Concepcion, at 301-415-4054 or
by e-mail at Milton.Concepcion@nrc.gov.
SUPPLEMENTARY INFORMATION:
NRC Regulatory Issue Summary 2010-XX
Applicability of 10 CFR Part 21 Requirements to Applicants for Standard
Design Certifications
Addressees
All holders of and applicants for an early site permit, combined
operating license (COL), manufacturing license, and standard design
approval; and applicants for a standard design certification under the
provisions of Title 10 of the Code of Federal Regulations (10 CFR) Part
52, ``Licenses, Certifications, and Approvals for Nuclear Power
Plants.''
Intent
The U.S. Nuclear Regulatory Commission (NRC) is issuing this
regulatory issue summary (RIS) to clarify the agency's regulatory
position regarding the applicability of 10 CFR Part 21 requirements to
standard design certification or design certification rule (DCR)
applicants (hereafter referred to as DCR applicants) before and after
the DCR is issued by the NRC. This RIS requires no action or written
response on the part of addressees.
Background
The regulations in 10 CFR Part 21 establish procedures and
requirements for implementation of Section 206 of the Energy
Reorganization Act (ERA) of 1974, as amended. Section 206 applies to
any individual or responsible officer of a firm ``constructing, owning,
operating, or supplying the components of any facility or activity
which is licensed or otherwise regulated'' by the NRC.
The statements of consideration that accompanied the final rule for
10 CFR Part 52 (3150-AG24), published in the Federal Register on August
28, 2007 (72 FR 49352), clarified the applicability of various
requirements to each of the licensing processes in 10 CFR Part 52,
including how Section 206 reporting requirements and, therefore, the
provisions of 10 CFR Part 21, should be extended to early site permits,
standard design certifications, and combined licenses. As indicated in
the statements of consideration for the 2007 conforming changes to 10
CFR Part 52 Final Rule; the NRC's reporting requirements in 10 CFR Part
21, as applicable to Part 52 licensing and approval processes, are
consistent with three key principles as described below.
The first principle ensures that the regulatory requirements of
Section 206 of the ERA extend throughout the entire
[[Page 14213]]
``regulatory life'' of a standard design certification. The NRC
considers ``regulatory life'' as the period of time in which a standard
design certification needs to meet the regulations in effect. This
period begins when an application is docketed and ends at the later of:
(1) The termination or expiration of the standard design certification;
or (2) the termination or expiration of the last license, directly or
indirectly, referencing the standard design certification. Section 206
of the ERA applies whenever necessary to support effective NRC
decision-making and regulatory oversight of the referencing licenses
and regulatory approvals.
The second principle ensures that the NRC, its licensees, and
license applicants receive information on defects or failures to comply
at the time when the information would be most useful to: (1) The NRC
in carrying out its regulatory responsibilities, and (2) the licensee
or applicant when engaging in activities regulated by the NRC. Under
the 10 CFR Part 52 licensing process, the NRC requires immediate
reporting throughout the period of pendency of an application, be it
for a license or a standard design certification. This reporting
obligation must be extended to contractors and subcontractors
supporting an application with services that are basic components
(i.e., safety-related) and could be relied upon in the siting, design,
and construction of a nuclear power plant. However, the NRC considers
that DCR applicants may delay the reporting of a defect or failure to
comply if there is no immediate consequence or regulatory interest in
prompt reporting. For those Part 52 processes (e.g., early site
permits, design approvals, and design certifications) which do not
authorize continuing activities required to be licensed under the
Atomic Energy Act or the ERA, but are intended solely to provide early
identification and resolution of issues in subsequent licensing or
regulatory approvals, the reporting of defects or failures to comply
associated with substantial safety hazards may be delayed until the
time that the Part 52 process is first referenced. After referencing,
the DCR applicant must make the necessary notifications to the NRC as
well as provide the necessary corrections to the final design.
The third principle ensures that entities conducting activities
under 10 CFR Part 52 accurately fulfill their reporting obligation in a
timely manner with the development and implementation of procedures and
practices. This principle is consistent with the current requirements
in 10 CFR Part 21 in that licensees, license applicants, and other
entities seeking a design certification must have contractual
provisions with their contractors, subcontractors, consultants, and
other suppliers which notify them that they are subject to the NRC's
regulatory requirements on reporting and the development and
implementation of reporting procedures.
Summary of Issues
Based on questions raised by applicants for combined licenses and
design certifications, the NRC staff developed this RIS to clarify the
NRC's position on how and when a DCR applicant notifies the NRC of a
defect or failure to comply in order to meet the notification
requirements established in 10 CFR Part 21.
Issue 1: Under 10 CFR Part 21, when does a DCR applicant have to
notify the NRC of ``Part 21 defects or failures to comply'' on
information provided in a COL application that referenced the DCR
applicant's certified design?
The DCR applicant has a current obligation under 10 CFR Part 21 to
report to the NRC any identified defect or failure to comply within its
scope of supply that could create a substantial safety hazard. This
obligation exists even if the COL applicant did not actually contract
with the DCR applicant to provide further design and engineering for
the standard design certification. As stated in the second key
principle of reporting under Section 206 of the ERA, the reporting
obligation of a DCR applicant under 10 CFR Part 21 continues until the
termination or expiration of the standard design certification; or
until the termination or expiration of the last license referencing the
DCR applicant's design certification.
Issue 2: If a DCR applicant states that it addressed all potential
10 CFR Part 21 defects in a recent revision of the Design Control
Document (DCD) or in a COL application that references the DCD, does it
also have to make a specific 10 CFR Part 21 notification to the NRC, or
can it assert that the NRC has been adequately informed about the
defects?
A DCD revision by itself does not satisfy the reporting
requirements of Part 21. 10 CFR 21.21(d)(3) and 10 CFR 21.21(d)(4) set
forth the form and content of the required notification. Consistent
with the second principle of reporting under Section 206 of the ERA, if
the referenced revision to the DCD or COL application did not include
the information required by 10 CFR Part 21, then the reporting
requirement has not been satisfied.
Issue 3: If issues identified in a standard design certification
rise to the level of a 10 CFR Part 21 notification, does the DCR
applicant have to notify a COL applicant or holder referencing that
design certification in addition to the NRC, even though the DCR
applicant no longer has a contract with the COL applicant?
The DCR applicant is required to notify a COL applicant or holder
only if (1) the DCR applicant either has or had a contract with the
referencing COL applicant/holder and (2) the DCR applicant has
identified a deviation or failure to comply with its design
certification and it does not have the capability to determine if it is
a defect or failure to comply as defined in 10 CFR Part 21. If the DCR
applicant is unable to determine whether the deviation is a defect or
failure to comply, then it must inform the COL applicant or holder
referencing the design certification of the identified deviation or
failure to comply in accordance with Sec. 21.21(b). This is consistent
with the third principle. The notification must be provided within five
working days of this determination so that the affected entities may
evaluate the deviation or failure to comply.
However, if the DCR applicant has determined that the deviation
constitutes a defect or failure to comply, then the applicant need only
report the defect or failure to comply to the NRC under Sec. 21.21(d).
The DCR applicant should consider whether notification to purchasers
(even if there is no longer a contract in effect with the purchasers)
needs to be part of the corrective action that the supplier is required
to describe in the notification to the NRC under 10 CFR
21.21(d)(4)(vii) and 10 CFR 21.21(d)(4)(viii).
Issue 4: Does the COL applicant or holder have to notify the DCR
applicant of any deviation, defect, or failure to comply that it finds
even if there is no contract between the COL applicant and the DCR
applicant?
No. The COL applicant does not have a duty under 10 CFR Part 21 or
10 CFR 50.55(e) to notify the DCR applicant of any deviation, defect,
or failure to comply that the COL applicant finds in the certified or
approved standard design. In this circumstance, the COL applicant is
not supplying a basic component to the DCR applicant. Consistent with
the third principle, the COL applicant's only duty under Part 21 or 10
CFR 50.55(e) is to notify the NRC of the defect or failure to comply.
Backfit Discussion
This RIS provides regulatory clarification on information
collection and reporting requirements in 10 CFR Part 21. Information
collection and
[[Page 14214]]
reporting requirements are not subject to the provisions of the Backfit
Rule, 10 CFR Part 50.109 or comparable backfitting requirements in 10
CFR Part 52. In addition, this RIS does not present a new or different
staff position about the implementation of 10 CFR Part 21, ``Reporting
of Defects and Noncompliance,'' within the definition of
``backfitting'' in either the Backfit Rule or comparable provisions in
Part 52. The staff positions for this RIS are either taken from, or
represent the logical extension of, the discussion of Part 21
obligations for design certification applicants presented in the
statement of considerations that accompanied the final rule (3150-AG24)
for Part 52 (72 FR 49352; August 28, 2007).
This RIS requires no action or written response by addressees. Any
action that addressees take to implement changes to their 10 CFR Part
21 programs in accordance with the clarifications in this RIS is
strictly voluntary, and therefore does not constitute backfitting. For
these reasons, the Backfit Rule does not apply and a backfit analysis
is not required for issuance of this RIS.
Federal Register Notification
To be done after the public comment period.
Congressional Review Act
This RIS is a rule as designated in the Congressional Review Act (5
U.S.C. 801-808). The Office of Management and Budget (OMB) has
determined this is not a major rule.
Paperwork Reduction Act Statement
This RIS does not contain new or amended information collection
requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.). Existing information collection requirements were
approved by the OMB, control numbers 3150-0035, 3150-0011 and 3150-
0151.
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.
Contact
Please direct any questions about this matter to Milton Concepcion,
at 301-415-4054 or by e-mail at Milton.Concepcion@nrc.gov.
End of Draft Regulatory Issue Summary
Documents may be examined, and/or copied for a fee, at the NRC's
Public Document Room at One White Flint North, 11555 Rockville Pike
(First Floor), Rockville, Maryland. Publicly available records will be
accessible electronically from the Agencywide Documents Access and
Management System (ADAMS) Public Electronic Reading Room on the
Internet at the NRC Web site, https://www.nrc.gov/NRC/ADAMS/.
If you do not have access to ADAMS or if you have problems accessing
the documents in ADAMS, contact the NRC Public Document Room (PDR)
reference staff at 1-800-397-4209 or 301-415-4737 or by e-mail to
pdr@nrc.gov.
Dated at Rockville, Maryland, this 18th day of March 2010.
For the Nuclear Regulatory Commission.
Martin C. Murphy,
Chief, Generic Communications Branch, Division of Policy and
Rulemaking, Office of Nuclear Reactor Regulation.
[FR Doc. 2010-6500 Filed 3-23-10; 8:45 am]
BILLING CODE 7590-01-P
