80 FR 13794 - Requirement To Submit Complete and Accurate Information

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 51 (March 17, 2015)

The U.S. Nuclear Regulatory Commission (NRC) will consider in the rulemaking process the issues raised in a petition for rulemaking (PRM), PRM-50-107, submitted by James Lieberman (the petitioner). The petitioner requested that the NRC amend its regulations to require that all persons seeking NRC approvals provide the NRC with complete and accurate information. Current NRC regulations pertaining to completeness and accuracy of information apply only to NRC licensees and license applicants. The NRC has determined that the issues raised in the PRM have merit and are appropriate for consideration in the rulemaking process.

[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Proposed Rules]
[Pages 13794-13797]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06107]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 40, 50, 52, 60, 61, 63, 70, 71, and 72

[Docket Nos. PRM-50-107; NRC-2013-0077]


Requirement To Submit Complete and Accurate Information

AGENCY: Nuclear Regulatory Commission.

[[Page 13795]]


ACTION: Petition for rulemaking; consideration in the rulemaking 
process.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider in 
the rulemaking process the issues raised in a petition for rulemaking 
(PRM), PRM-50-107, submitted by James Lieberman (the petitioner). The 
petitioner requested that the NRC amend its regulations to require that 
all persons seeking NRC approvals provide the NRC with complete and 
accurate information. Current NRC regulations pertaining to 
completeness and accuracy of information apply only to NRC licensees 
and license applicants. The NRC has determined that the issues raised 
in the PRM have merit and are appropriate for consideration in the 
rulemaking process.

DATES: The docket for the petition for rulemaking, PRM-50-107, is 
closed on March 17, 2015.

ADDRESSES: Please refer to Docket ID NRC-2013-0077 when contacting the 
NRC about the availability of information for this petition. You can 
obtain publicly-available documents related to this petition by using 
any of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0077. Address 
questions about NRC dockets to Carol Gallagher, telephone: 301-415--
3463; email: [email protected]. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     The NRC's Agencywide Documents Access and Management 
System (ADAMS): You may obtain publicly-available documents online in 
the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS, 
please contact the NRC's Public Document Room (PDR) reference staff at 
1-800-397-4209, 301-415-4737, or by email to [email protected]. The 
ADAMS accession number for each document referenced in this document 
(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 
V of this document, Availability of Documents.
     The NRC's PDR: You may examine and purchase copies of 
public documents at the NRC's PDR, O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jenny Tobin, Office of Nuclear Reactor 
Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; telephone: 301-415-2328; email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background.
II. Requirement to Submit Complete and Accurate Information.
III. Analysis of Public Comments.
IV. Determination of Petition.
V. Availability of Documents.

I. Background

    On April 15, 2013, the NRC received a PRM (ADAMS Accession No. 
ML13113A443) requesting the NRC to revise its regulations relating to 
nuclear reactors at Sec. Sec.  50.1, 50.9, 52.0, and 52.6 of Title 10 
of the Code of Federal Regulations (10 CFR) to expand its ``regulatory 
framework to make it a legal obligation for those non-licensees who 
seek NRC regulatory approvals be held to the same legal standards for 
the submittal of complete and accurate information as would a licensee 
or an applicant for a license.'' James Lieberman, a regulatory and 
nuclear safety consultant, submitted the petition which was filed on 
April 15, 2013, and later amended on September 16, 2013. The petitioner 
originally requested that the NRC amend its regulations in 10 CFR parts 
50 and 52, to require all persons who seek NRC approvals to provide the 
NRC with complete and accurate information.
    The NRC assigned the petition Docket Number PRM-50-107 and 
published a notice of receipt of the petition in the Federal Register 
(FR) on June 10, 2013 (78 FR 34604). The NRC requested public comment 
on the petition and received two comments, both supporting the 
petition. On September 16, 2013 (ADAMS Accession No. ML13113A443), the 
petitioner amended the rulemaking petition to expand its scope to 
include not only 10 CFR parts 50 and 52 for reactors, but the 
regulatory framework for radioactive materials, waste disposal, 
transportation, and spent fuel storage as well (10 CFR parts 30, 40, 
60, 61, 63, 70, 71, and 72). The NRC published a notice regarding the 
amended petition (ADAMS Accession No. ML13261A190) in the Federal 
Register requesting comment (79 FR 3328; January 21, 2014). One 
additional comment in support of the amended petition was received.
    The petitioner asserts that non-licensees (including vendors and 
other contractors) used by NRC-regulated entities to meet regulatory 
requirements should be subject to the same requirements for complete 
and accurate submissions as NRC licensees and license applicants. When 
the Commission promulgated the 1987 ``Completeness and Accuracy of 
Information'' rule (52 FR 49362; December 31, 1987) (the 1987 rule), 
neither the rule language nor the Statement of Considerations (SOC) 
discussed non-licensees submitting information to the NRC for 
regulatory approvals. The 1987 rule included nearly identical 
``Completeness and Accuracy of Information'' requirements in 10 CFR 
parts 30, 40, 50, 60, 61, 70, 71, and 72. When the Commission added 10 
CFR parts 52 and 63 to its regulations, it added ``Completeness and 
Accuracy of Information'' requirements to these parts as well (72 FR 
49521, August 28, 2007; and 66 FR 55732, November 2, 2001; 
respectively). The petitioner asserts that the intent of this petition 
is to close the gap that exists in NRC requirements between licensees/
applicants and non-licensees regarding the submittal of complete and 
accurate information for NRC approval.
    The NRC assigned the petition Docket Number PRM-50-107 and 
published a notice of receipt of the petition in the Federal Register 
(FR) on June 10, 2013 (78 FR 34604). The NRC requested public comment 
on the petition and received two comments, both supporting the 
petition. On September 16, 2013 (ADAMS Accession No. ML13113A443), the 
petitioner amended the rulemaking petition to expand its request to 
include not only 10 CFR parts 50 and 52 for reactors, but the 
regulatory framework for radioactive materials, waste disposal, 
transportation, and spent fuel storage as well (10 CFR parts 30, 40, 
60, 61, 63, 70, 71, and 72). In the amended petition, the petitioner 
also requested that the ``scope'' section for each of the parts be 
revised to add language to highlight that any person seeking or 
obtaining an NRC approval for a regulated activity would be subject to 
enforcement action for violation of the completeness and accuracy 
provision of that part. The applicable sections are Sec. Sec.  30.1, 
40.2, 50.1, 52.0, 60.1, 61.1, 63.1, 70.2, 71.0, and 72.2.

II. Requirement To Submit Complete and Accurate Information

    The NRC's regulations at 10 CFR 30.9, 40.9, 50.9, 52.6, 60.10, 
61.9a, 63.10, 70.9, 71.7, and 72.11 implemented: (1) The longstanding 
policy that license applicants and licensees provide the Commission 
information that is complete and accurate in all material respects and 
maintain such information as required; and (2) the requirement that

[[Page 13796]]

license applicants and licensees notify the NRC of any information they 
identify as having, for the regulated activity, a significant 
implication for the public health and safety or common defense and 
security.
    The 1987 rule re-emphasized the NRC's need to receive complete and 
accurate information and timely notification of safety significant 
information from its licensees and license applicants if the NRC is to 
fulfill its statutory responsibilities under the Atomic Energy Act of 
1954, as amended (AEA). The SOC for the 1987 rule stated that ``the 
accuracy and forthrightness in communications to the NRC by licensees 
and applicants for licenses are essential if the NRC is to fulfill its 
responsibilities to ensure that utilization of radioactive material and 
the operation of nuclear facilities are consistent with the health and 
safety of the public and the common defense and security.'' The SOC 
relied on the general authority provision in AEA Section 161b. that 
permits the NRC to establish by rule, regulation, or order, such 
standards and instructions to govern the possession and use of special 
nuclear material, source material, and byproduct material. The SOC also 
specifically mentioned the importance of accurate information in AEA 
Section 186, which authorizes the NRC to revoke any license for 
material false statement in an application or statement of fact 
required under AEA Section 182.
    However, similar concerns also are raised when non-licensees seek 
the NRC's approval in other situations. For example, a non-licensee may 
submit a description of its Quality Assurance (QA) program to the NRC 
for approval in support of a Certificate of Compliance (CoC) for 
transportation and storage casks. The regulations at 10 CFR part 71 and 
part 72 set forth requirements for QA programs in subparts H and G, 
respectively. Non-licensees who intend to apply for a CoC establish, 
maintain, and execute programs satisfying the QA requirements for the 
control of quality-affecting activities such as design, procurement, 
special processes, inspection, and testing, among other activities. 
Implementing an effective QA program during transportation or storage 
cask design and testing pre-application phases provides adequate 
confidence that the systems or components will perform satisfactorily 
in service.
    On more than one occasion the NRC has received from a non-licensee 
a description of a QA program for NRC approval in accordance with 10 
CFR parts 71 and 72 requirements. After reviewing this information, the 
NRC staff approved the QA program, as documented. However, a subsequent 
on-site inspection of that NRC-approved QA program resulted in a 
finding of inadequate implementation of certain quality-related 
activities. Had this QA program implementation deficiency gone 
unidentified and uncorrected, it could have resulted in design issues 
or reduced confidence that systems or components would perform 
satisfactorily in service. Under current regulations, the NRC can only 
take an enforcement action against the applicant if the cause of a QA 
program deficiency is attributable to an applicant providing incomplete 
or inaccurate information. The NRC is unable to take enforcement action 
against the non-licensee for not providing complete and accurate 
information that was submitted for NRC's approval; the NRC is limited 
to issuing an administrative action, such as a notice of 
nonconformance.
    A topical report is another example of one type of information 
submitted to the NRC by non-licensees for regulatory approval. Once 
reviewed and approved, the NRC endorses the use of the topical report, 
and licensees implement the report accordingly. The petitioner cited 
reactor topical reports as an example of a single safety evaluation 
report, once approved by the NRC, that may be adopted by many 
licensees, and therefore greatly magnify the impact of any error beyond 
the non-licensee applicant for the topical report itself.
    The petition states that non-licensees who submit information to 
the NRC for approval should be held accountable for providing complete 
and accurate information. The petitioner's proposed rule change would 
provide the NRC staff with additional enforcement tools to encourage 
non-licensees to submit complete and accurate information to the NRC.

III. Analysis of Public Comments

    The NRC received a total of three comment submissions on the 
petition and amended petition from two private citizens. The NRC 
received two public comments in response to the June 10, 2013, Federal 
Register notice. Both were in support of the petition, one suggested 
the inclusion of additional licensees in the petition. In response to 
the January 21, 2014, Federal Register notice, the NRC received a 
second comment from a previous commenter reiterating his support on the 
amended petition.

Comment No. 1

Commenter: Hugh Thompson, Talisman International
    Comment: The commenter asserted that the NRC should consider for 
rulemaking Mr. Lieberman's petition to require vendors and suppliers to 
provide complete and accurate information. The commenter also stated 
that the NRC should consider expanding the original petition's request 
to include other parts of the regulations that have the same 
completeness and accuracy provisions, namely 10 CFR parts 30, 40, 61, 
70, 71, and 72. The commenter highlighted that it is important to have 
complete and accurate information in submittals by non-licensees who 
seek the following: (1) Exemption from NRC regulations; and (2) NRC 
approval that their activities do not need a license. The commenter 
pointed out that currently there is no legal obligation for a vendor to 
provide complete and accurate information either in the application for 
a topical report or in response to NRC questions on the topical report. 
The commenter noted that this oversight has been brought to light 
during litigation.
    NRC Response: The NRC agrees with this comment, and intends to 
consider this issue in the rulemaking process. In addition, the 
petitioner amended the petition to expand the request of proposed 
changes in the regulations.

Comment No. 2

Commenter: Charles Haughney
    Comment: The commenter stated that the NRC should consider Mr. 
Lieberman's petition for rulemaking.
    NRC Response: The NRC agrees with the comment and intends to 
consider this PRM in the rulemaking process.

Comment No. 3

Commenter: Hugh Thompson, Talisman International
    Comment: The commenter stated that the NRC should consider for 
rulemaking the revised petition that expands the original petition 
request.
    NRC Response: The NRC agrees with the comment and intends to 
consider the PRM in the rulemaking process.

IV. Determination of Petition

    Non-licensee applicants for NRC regulatory approvals (e.g. topical 
report, an exemption from licensing, or submission of a QA program) 
currently are not under the same regulatory obligation as licensees or 
license applicants to provide complete and accurate information. Non-
licensees that have received an NRC approval are also

[[Page 13797]]

not under the same regulatory obligation as licensees to notify the NRC 
of any information that may have a significant implication for public 
health and safety or the common defense and security. As a result, the 
lack of similar requirements for non-licensees could adversely affect 
public health and safety or the common defense and security. As with 
licensees and license applicants, the NRC staff relies on the 
information submitted by non-licensees as the primary basis for 
approving their requests; it is fundamental for good regulation that 
all applicants for NRC approvals meet the same requirement to submit 
complete and accurate information. It is also important that both 
licensees and non-licensees operating under an NRC approval be required 
to notify the NRC of information they have identified as having a 
significant implication for the public health and safety or common 
defense and security. In the case of reactor topical reports, as cited 
by the petitioner, a single safety evaluation report may be adopted by 
many licensees once it has been approved by the NRC, greatly magnifying 
the impact of any errors beyond the non-licensee applicant for the 
topical report itself.
    The NRC agrees with the petitioner that non-licensee applicants for 
NRC approvals in all subject areas (e.g. reactors, materials, 
transportation, and waste) should be required to submit complete and 
accurate information. Imposing the same requirement for completeness 
and accuracy of information to all non-licensee applicants for NRC 
approvals ensures a consistent and comprehensive set of regulatory 
expectations.
    Although not mentioned in the petition or the amended petition, the 
NRC staff identified other portions of the regulations that contain 
similar requirements for ``Completeness and Accuracy of Information.'' 
As a result, the NRC also considered the applicability of the issue to 
10 CFR parts 54, 76, and 110 in its evaluation.
    For these reasons, the NRC will consider the issues raised in the 
petition in the rulemaking process.

V. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 
indicated. For information on accessing ADAMS, see the ADDRESSES 
section of this document.

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                                                      ADAMS  Accession
            Date                    Document           number/ Federal
                                                      Register citation
------------------------------------------------------------------------
April 15, 2013..............  Original Petition              ML13113A443
                               (PRM-50-107).
June 10, 2013...............  Original FRN........           78 FR 34604
September 16, 2013..........  Amended Petition....           ML13261A190
January 21, 2014............  Amended FRN.........            79 FR 3328
August 29, 2013.............  Comment 1: Hugh                ML13241A222
                               Thompson.
August 26, 2013.............  Comment 2: Charles             ML13246A383
                               Haughney.
April 10, 2014..............  Comment 3: Hugh                ML14100A198
                               Thompson.
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    Dated at Rockville, Maryland, this 20th day of February, 2015.

    For the Nuclear Regulatory Commission.
Mark A. Satorius,
Executive Director for Operations.
[FR Doc. 2015-06107 Filed 3-16-15; 8:45 am]
 BILLING CODE 7590-01-P