[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14212-14214]
From the Federal Register Online via the Government Publishing 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 [email protected].

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 [email protected].

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, http://www.nrc.gov/NRC/ADAMS/index.html. 
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 
[email protected].

    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