Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants
Federal RegisterJul 3, 2003
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 2, 20, 21, 50, 51, 52, 72, 73, 140, and 170
RIN 3150-AG24
Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants
AGENCY:
Nuclear Regulatory Commission.
ACTION:
Proposed rule.
SUMMARY:
The Nuclear Regulatory Commission (NRC or Commission) is proposing to amend its requirements for early site permits, standard design certifications, combined licenses for nuclear power plants, and for other licensing processes. The amendments are based on the NRC staff's experience with the previous design certification reviews and on discussions with stakeholders about the early site permit (ESP), design certification, and combined license (COL) processes. This action is expected to improve the effectiveness of the licensing processes for future applicants.
DATES:
Submit comments by September 16, 2003. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
ADDRESSES:
You may submit comments by any one of the following methods. Please include the following number RIN 3150-AG24 in the subject line of your comments. Comments submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking Web site. Personal information will not be removed from your comments.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to:
SECY@nrc.gov
. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at (301) 415-1966. You may also submit comments via the NRC's rulemaking Web site at
http://ruleforum.llnl.gov
. Address questions about our rulemaking Web site to Carol Gallagher (301) 415-5905; email
cag@nrc.gov
.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone (301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415-1101.
Publicly available documents related to this rulemaking may be examined and copied for a fee at the NRC's Public Document Room (PDR), Public File Area O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. Selected documents, including comments, can be viewed and downloaded electronically via the NRC rulemaking Web site at
http://ruleforum.llnl.gov
.
Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at
http://www.nrc.gov/NRC/ADAMS/index.html
. From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR Reference staff at 1-800-397-4209, 301-415-4737 or by e-mail to
pdr@nrc.gov
.
FOR FURTHER INFORMATION CONTACT:
Jerry N. Wilson, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone (301) 415-3145, email
jnw@nrc.gov
; or Nanette V. Gilles, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-1180, e-mail
nvg@nrc.gov
.
SUPPLEMENTARY INFORMATION:
I. Background.
II. Reorganization of 10 CFR Part 52.
III. Discussion of Substantive Changes.
A. 10 CFR Part 52, Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants.
General Provisions.
Early Site Permits.
Early Site Reviews.
Standard Design Certifications.
Design Certification Backfit Requirement.
Standard Design Approvals.
Combined Licenses.
Referencing an Early Site Permit.
Testing Requirements for Advanced Reactors.
Probabilistic Risk Assessments.
Resolution of ITAAC.
Commission Finding on Acceptance Criteria.
Combined License Change Process.
Design Certifications for ABWR, System 80+, and AP600.
B. 10 CFR Part 2, Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders.
C. 10 CFR Part 20, Standards for Protection Against Radiation.
D. 10 CFR Part 21, Reporting of Defects and Noncompliance.
E. 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.
F. 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.
G. 10 CFR Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste.
H. 10 CFR Part 73, Physical Protection of Plants and Materials.
I. 10 CFR Part 140, Financial Protection Requirements and Indemnity Agreements.
J. 10 CFR Part 170, Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended.
IV. Specific Requests for Comments.
V. Availability of Documents.
VI. Plain Language.
VII. Voluntary Consensus Standards.
VIII.Environmental Impact'Categorical Exclusion.
IX. Paperwork Reduction Act Statement.
X. Regulatory Analysis.
XI. Regulatory Flexibility Certification.
XII. Backfit Analysis.
I. Background
The Commission promulgated 10 CFR part 52 on April 18, 1989 (54 FR 15386), to reform the licensing process for future nuclear power plant applicants. The rule added alternative licensing processes in 10 CFR part 52 for early site permits, standard design certifications, and combined licenses. These were additions to the two-step licensing process that already existed in 10 CFR part 50. The processes in 10 CFR part 52 resolve safety and environmental issues early in licensing proceedings and are intended to enhance the safety and reliability of nuclear power plants through standardization. The rule also moved the licensing processes in appendices M, N, O, and Q of 10 CFR part 50 to 10 CFR part 52. Subsequently, the NRC certified three nuclear plant designs under subpart B of 10 CFR part 52—the U.S. Advanced Boiling Water Reactor (ABWR) (62 FR 25827, May 12, 1997), System 80+ (62 FR 27867, May 21, 1997), and AP600 (64 FR 72015, December 23, 1999) designs—and codified these designs in Appendices A, B, and C of 10 CFR part 52, respectively.
The NRC had planned to update 10 CFR part 52 after using the design certification process for these three certified standard plant designs. In addition, discussions with stakeholders at public meetings and comments on SECY-00-0092, “Combined License Review Process,” dated April 20, 2000, identified licensing issues associated with subparts A and C of 10 CFR part 52. As a result, the NRC initiated this proposed rulemaking to (1) clarify and/
or correct 10 CFR parts 2, 20, 21, 50, 51, 52 (including appendices A, B, and C), 72, 73, 140, and 170; (2) update 10 CFR part 52; and (3) incorporate stakeholder comments.
This rulemaking action began with the issuance of SECY-98-282, “part 52 Rulemaking Plan,” on December 4, 1998. The Commission issued a staff requirements memorandum on January 14, 1999, approving the NRC staff's plan for revising 10 CFR part 52. A notice of the rulemaking plan was added to the NRC's rulemaking Web site on June 16, 1999. On September 3, 1999, letters were sent to 10 external stakeholders alerting them to this proposed rulemaking. In addition, the NRC staff held three public meetings with interested stakeholders on the 10 CFR part 52 rulemaking on December 14, 2000, February 16, 2001, and March 7, 2001. Following those meetings, on April 3, 2001, the Nuclear Energy Institute (NEI) submitted comments on issues discussed during the meetings.
On September 27, 2001, the NRC staff posted draft rule language for 10 CFR part 52 on the NRC's rulemaking Web site. The NRC received comments on the draft rule language in November 2001, from General Electric, Entergy, NEI, Westinghouse Electric, and Exelon Generation. The NRC staff has considered these comments in the development of this proposed rule and posted revised draft rule language for 10 CFR part 52 on the NRC's rulemaking Web site on February 28, 2002.
II. Reorganization of 10 CFR Part 52
The NRC is proposing to reorganize 10 CFR part 52 to establish a separate subpart for each of the seven licensing processes currently described in 10 CFR part 52 (early site permits, early site reviews, standard design certification, standard design approvals, combined licenses, manufacturing licenses, and duplicate design licenses). The purpose of this reorganization is to clarify that each licensing process has equal standing. In addition, several subparts would be reserved for future licensing processes. No substantive changes are intended by the incorporation of current appendices M, N, O, and Q into the new subparts in 10 CFR Part 52.
The NRC is also proposing to retitle 10 CFR part 52 as “Additional Licensing Processes for Nuclear Power Plants,” to clarify that the licensing processes in 10 CFR part 52 are in addition to and supplement the two-step licensing process in 10 CFR part 50 and the license renewal process in 10 CFR part 54, and are not limited to the early site permit, standard design certification, and combined license processes as the current title implies.
The proposed rule would amend § 52.1 to clarify that all seven licensing processes are within the scope of 10 CFR part 52. Paragraphs within current Appendices M, N, O, and Q would also become new sections of the revised part. In addition, the proposed rule would reserve subparts for future licensing processes. In doing so, the NRC hopes to convey that 10 CFR part 52 is the preferred location in 10 CFR for nuclear power plant licensing processes.
The proposed rule would amend § 52.19, the current § 52.49 (proposed § 52.111), and the current § 52.83 (proposed § 52.215) to provide a standard format in subparts A, D, and G. This standard format would set forth the standards for review of applications and the applicability of NRC requirements in a consistent manner in each of these subparts. The references to the part 170 fee requirements would be moved to be included in the sections on filing of applications. This reorganization of 10 CFR part 52 will make the subparts on early site permits and standard design certifications consistent with the existing arrangement in the subpart for combined licenses.
The proposed rule would also move the requirement on duration of a combined license that is currently located in § 52.83, “Applicability of part 50 provisions,” to paragraph (e) of proposed § 52.227, “Issuance of combined licenses.” Proposed § 52.227(e) is a more appropriate location for this requirement.
The Commission has prepared the following table that cross-references the new proposed provisions in 10 CFR part 52 to the superseded provisions of 10 CFR part 52.
Table 1.—Cross-References Between New and Old 10 CFR Part 52
New section
Old section
General Provisions:
52.1
52.1
52.3
52.3
52.5
52.5
52.8
52.8
None
52.9
Subpart A—Early Site Permits:
52.11
52.11
52.13
52.13
52.15
52.15
52.17
52.17
52.18
52.18
52.19
52.19
52.21
52.21
52.23
52.23
52.24
52.24
52.25
52.25
52.27
52.27
52.29
52.29
52.31
52.31
52.33
52.33
52.35
52.35
52.37
52.37
52.39
52.39
Subpart B—Early Site Reviews:
52.41
App. Q, Introduction
52.43(a)
App. Q, Paragraph 1
52.43(b)
App. Q, Paragraph 2
52.43(c)
App. Q, Paragraph 1
52.45
App. Q, Paragraph 3
52.46
N/A
52.47(a)
App. Q, Paragraph 4
52.47(b)
App. Q, Paragraph 5
52.47(c)
App. Q, Paragraph 6
52.49
App. Q, Paragraph 7
Subpart D—Standard Design Certification:
52.101
52.41
52.103
52.43
52.105
52.45
52.107
52.47
52.109
52.48
52.111
52.49
52.113
52.51
52.115
52.53
52.117
52.54
52.119
52.55
52.121
52.57
52.123
52.59
52.125
52.61
52.127
52.63
Subpart E—Standard Design Approvals:
52.131
App. O, Introduction
52.133(a)
App. O, Paragraph 1
52.133(b)
App. O, Paragraph 2
52.135
App. O, Paragraph 3
52.137
App. O, Paragraph 4
52.139(a)
App. O, Paragraph 5
52.139(b)
None
52.141(a)
App. O, Paragraph 5
52.141(b)
App. O, Paragraph 6
52.143
App. O, Paragraph 7
Subpart G—Combined Licenses:
52.201
52.71
52.203
52.73
52.205
52.75
52.207
52.77
52.209
52.78
52.211
52.79
52.213
52.81
52.215
52.83
52.217
52.85
52.219
52.87
52.221
52.89
52.223
52.91
52.225
52.93
52.227
52.97
52.229
52.99
52.231
52.103
Subpart H—Manufacturing Licenses:
52.241
App. M, Introduction
52.243(a)
N/A
52.243(b)
App. M, Paragraph 7
52.243(c)
App. M, Paragraph 9
52.243(d)
App. M, Paragraph 10
52.243(e)
App. M, Paragraph 11
52.243(f)
App. M, Paragraph 8
52.245(a)
App. M, Paragraph 2
52.245(b)
App. M, Paragraph 3
52.245(c)
App. M, Paragraph 4(b)
52.247
App. M, Paragraph 1
52.249
App. M, Paragraph 4(a)
52.251
N/A
52.253 (a) & (b)
App. M, Paragraph 5
52.253(c)
App. M, Paragraph 6
52.255
N/A
52.257
App. M, Paragraph 12
Subpart I—Duplicate Design Licenses:
52.261
App. N, Introduction
52.263
App. N, Paragraph 1
52.265
App. N, Paragraph 2
52.265(c)
App. N, Paragraph 3
Subpart M—Enforcement:
52.401
52.111
52.403
52.113
III. Discussion of Substantive Changes
A section-by-section analysis that explains the purpose and meaning of all sections in 10 CFR part 52 will be provided in the supplementary information for the final rule. The proposed rule makes the following substantive changes:
A. 10 CFR Part 52, Early Site Permits, Standard Design Certifications, and Combined Licenses for Nuclear Power Plants
General Provisions
The proposed rule would amend § 52.3 to add definitions for “modular design” and “prototype plant” to the current 10 CFR part 52. A definition of modular design is added to explain the type of modular reactor design to which the Commission intended to refer to in the second sentence of the current § 52.103(g) (proposed § 52.231(g)). This special provision for modular designs was added to 10 CFR part 52 to facilitate the licensing of nuclear plants, such as the Modular High Temperature Gas-Cooled Reactor (MHTGR) and Power Reactor Innovative Small Module (PRISM) designs, that consisted of 3 or 4 nuclear reactors in a single power block with a shared power conversion system. During the period that the power block is under construction, the Commission could separately authorize operation for each nuclear reactor when each reactor and all of its necessary support systems were completed. In a letter dated November 13, 2001 (comment A), NEI stated that “Part 1 of the definition would need to be revised for this purpose so that it does not describe typical multi-unit sites. The NRC staff should reconsider the need to define this term at all.” The Commission disagrees with NEI's recommendation because the term “modular design” needs to be defined to aid future use of the current § 52.103(g) (proposed § 52.231(g)) by distinguishing the intended definition from other definitions for “modular design.” Currently licensed multi-unit sites would not be affected by the proposed § 52.231(g). However, future applicants for a combined license for a multi-unit site similar in concept to current multi-unit sites (where each unit is similar in design but independent of all other units) could also use this provision.
A definition for prototype plant is added to explain the type of nuclear reactor that the Commission intended in the current § 52.47(b) (proposed § 52.107(b)) and intends in the proposed § 52.211(b)(3). A prototype plant is a licensed nuclear reactor test facility that is similar to and representative of either the first-of-a-kind or certified nuclear plant design in all features and size, but may have additional safety features. The purpose of the prototype plant is to perform testing of new or innovative design features for the first-of-a-kind or certified, advanced nuclear plant design, as well as being used as a commercial nuclear power facility.
The proposed rule would remove §§ 52.5 and 52.9 and replace them with a new § 52.5 listing all of the licensing provisions in 10 CFR part 50 that also apply to all of the licensing processes in 10 CFR part 52. The purpose of this amendment is to clarify that these 10 CFR part 50 provisions are applicable to the licensing processes that were formerly in 10 CFR part 50 (Appendices M, N, O, and Q) and are now in 10 CFR part 52, as well as to the new licensing processes for early site permits, standard design certifications, and combined licenses. Although these provisions in 10 CFR part 50 may not refer to the additional licensing processes in 10 CFR part 52, the new § 52.5 makes it clear that a holder of or applicant for an approval, certification, permit, site report, or license issued under 10 CFR part 52 must comply with all requirements in these provisions that are otherwise applicable to applicants or licensees under 10 CFR part 50.
In a letter dated November 13, 2001 (comment G), NEI stated:
The industry proposes that additional General Provisions be added to part 52 in addition to an appropriate provision on Written Communications. This approach is preferable to including cross-references in part 52 to part 50 general provisions because these provisions typically must be tailored to apply appropriately to the variety of licensing processes in part 52.
The Commission disagrees with the industry's proposal to create over 35 new general provisions that are tailored for 10 CFR part 52 because it would appear to be an inefficient and burdensome addition. Therefore, the Commission is proposing a new § 52.5 that would make the existing general provisions in 10 CFR part 50 applicable to the licensing processes in 10 CFR part 52.
Early Site Permits
The proposed rule would amend § 52.13 to state that an early site permit can also be referenced in an application for a combined license or a duplicate design license.
The proposed rule would amend § 52.17(a)(1) to state that the early site permit application should specify the range of facilities that the applicant is requesting the site to be qualified for (
e.g.
one, two, or three pressurized-water reactors). This new language is consistent with the language in Paragraph 2 of current Appendix Q. The Commission assumes that an applicant for an early site permit does not know what type of nuclear plant it will build at the site. Therefore, the application must specify the postulated design parameters for the range of reactor types, the numbers of reactors, etc., to increase the likelihood that the site will be qualified for the actual plant or plants that the applicant decides to build. In a letter dated November 13, 2001 (comment 27), NEI stated, “The proposed change is too limited. To address the required assessment of major SSCs [structures, systems, and components] that bear on radiological consequences and all items 52.17(a)(1)(i-viii), industry recommends a new § 52.17a.2.” The Commission disagrees with NEI's proposal to have a separate provision for applicants who have not determined the type of plant that they plan to build at the proposed site. The Commission expects that applicants for an early site permit will not have decided on a particular type of nuclear power plant and § 52.17(a)(1) was revised to address this situation.
The Commission proposes to amend § 52.17(a)(2) to clarify that an ESP applicant has the flexibility of either addressing the matter of alternative energy sources in the environmental
report supporting its ESP application, or deferring the consideration of alternative energy sources to the time that the ESP is referenced in a licensing proceeding. The Commission believes the current regulations already afford the ESP applicant such flexibility, inasmuch as § 52.17(a)(2) states that the environmental report submitted in support of an ESP application must “focus on the environmental effects of construction and operation of a reactor, or reactors * * *.” The environmental report's discussion of alternative energy sources does not, per se, address the “environmental effects of construction and operation of a reactor,” which is one of the matters which must be addressed in an environmental impact statement (EIS). See 10 CFR 51.71(d); National Environmental Policy Act of 1969 (NEPA), § 102(2)(C) (i), (ii) and (v). Rather, alternative energy sources constitutes part of the discussion of reasonable alternatives to the proposed action, which is required by § 102(2)(C)(iii) of NEPA. See 10 CFR 51.71(e) n.4; 46 FR 39440 (August 3, 1981) (proposed rule eliminating consideration of need for power and alternative energy sources at operating license stage), at 39441 (first column). Accordingly, it is the Commission's view that § 52.17(a)(2) already provides the ESP applicant the flexibility of choosing to defer consideration of alternative energy sources to the time (if ever) that the ESP is referenced in a combined license or a construction permit application. The proposed rule clarifies that the ESP applicant may either include a discussion of alternative energy sources in its environmental report, or defer consideration of the matter. The Commission proposes to make a conforming amendment to §§ 52.18 and 52.21 to make clear that the NRC's EIS need not address need for power, or alternative energy sources (and therefore such matters may not be litigated) if the ESP applicant chooses not to address either or both of these matters in its environmental report. The Commission notes that both the environmental report and EIS for an ESP must address the benefits associated with issuance of the ESP (
e.g.
, early resolution of siting issues, early resolution of issues on the environmental impacts of construction and operation of a reactor(s) that fall within the site parameters, and ability of potential nuclear power plant licensees to “bank” sites on which nuclear power plants could be located, without obtaining a full construction permit or combined license). The benefits (and impacts) of issuing an ESP must always be addressed in the environmental report and EIS for an ESP, regardless of whether the ESP applicant chooses to defer, pursuant to § 52.17(a)(2), consideration of the benefits associated with the construction and operation of a nuclear power plant that may be located at the ESP site. This is because the “benefits * * * of the proposed action” for which the discussion may be deferred under §§ 52.17(a)(2) are the benefits associated with the construction and operation of a nuclear power plant that may be located at the ESP site; the benefits which may be deferred under § 52.17(a)(2) are entirely separate from the benefits of issuing an ESP. To put it another way, the proposed action of issuing an ESP is not the same as the “proposed action” of constructing and operating a nuclear power plant for which the discussion of benefits (including need for power) may be deferred under § 52.17(a)(2)
1
. With this clarification, the Commission does not believe that further changes to the language of §§ 52.17 and 52.18 are necessary.
1
The Commission emphasizes that under § 52.17(a)(2), only the discussion of benefits (including need for power) of constructing and operating a nuclear power reactor (or reactors), and the discussion of alternative energy sources, may be deferred. The ER must always address the “environmental impacts of construction and operation of a reactor, or reactors, which have characteristics which fall within the postulated site parameters.”
The proposed rule would amend §§ 52.24 and 52.39 to clarify: (1) The information that the NRC must include in the early site permit when it is issued; (2) the matters accorded finality in any subsequent NRC review and proceeding for an application referencing the early site permit; and (3) the matters that may be challenged in a contention to be resolved in an adjudication, versus those matters that may be raised in a petition to be processed in accord with 10 CFR 2.206. Section 52.21 would be amended to clarify that an application referencing an early site permit must, in addition to showing that the design of the facility falls within the site parameters specified in the early site permit, demonstrate that all terms and conditions of the early site permit have been satisfied. Section 52.24 would also be amended to provide that the early site permit must state the site parameters, as well as the “terms and conditions,” of the early site permit, rather than the “conditions and limitations” as is currently provided. No substantive change in § 52.24 is intended by the proposed amendment; the change is proposed to provide consistency with § 52.39(a)(2) and paragraph (a)(2)(iii) of the current rule, which also refer to “site parameters” and “terms and conditions.”
The proposed rule would add § 52.28 to state that transfer of an early site permit from its existing holder to a new applicant will be processed under 10 CFR 50.80, which contains provisions for transfer of licenses. In a letter dated November 13, 2001 (comment 19), NEI recommended that a new section be added to part 52 to clarify the process for transfer of an early site permit. The Commission has determined that a new section is not necessary because an early site permit is a partial construction permit and, therefore, is considered to be a license under the AEA. The Commission believes that the procedures and criteria for transfer of utilization facility licenses in 10 CFR 50.80 (and the procedures in subpart M of 10 CFR part 2 for the conduct of any hearing) should apply to the transfer of an early site permit.
Section 52.39(a) would be amended to uniformly refer to “terms or conditions” of an early site permit. Section 52.39(a)(1) would also be amended to remove the term, “requirements,” and clarify that the Commission may not change or impose new site characteristics, terms, or conditions on the early site permit, including emergency planning requirements, unless the special backfitting criteria in § 52.39(a)(1) are satisfied. No substantive change is intended by this clarification; the Commission believes that “site characteristics, terms, or conditions” of an early site permit more accurately describe the existing scope of matters subject to the special backfitting criteria in § 52.39(a)(1).
Early Site Reviews
The proposed rule would amend certain paragraphs of the current Appendix Q to 10 CFR part 52 (proposed §§ 52.41, 52.43, and 52.47) to clarify that an early site review can also be used in an application for a combined license or a duplicate design license.
Standard Design Certifications
The proposed rule would amend the current §§ 52.41 and 52.45 (proposed § 52.101 and § 52.105) to clarify that a certified design may be referenced in an application for a duplicate design license, as well as a combined license application, filed under part 52.
The proposed rule would remove the requirements currently located in §§ 52.43(c), 52.45(c), and 52.47(b)(2)(ii) because the Commission has decided not to require a final design approval (FDA) as a prerequisite for certification
of a standard plant design under the new subpart D of 10 CFR part 52. This requirement was included in 10 CFR part 52 because, at the time of the original rulemaking, the NRC had no experience with design certification applications. By requiring an FDA as a prerequisite for certification, the NRC indicated that the licensing processes for design certifications and FDAs were similar, even though the requirements for and finality of design certifications differ from that of FDAs. The NRC has considerable experience with design certification applications and the requirement to apply for an FDA as part of an application for design certification is no longer needed.
In a letter dated April 3, 2001 (comment 2), NEI commented “Industry prefers to retain modified provisions. We agree that an FDA should be an option but not a prerequisite. Also, deletion recommended for 52.47(b)(2)(ii).” The Commission has decided not to retain these provisions. The proposed processes in subparts D and E allow future applicants for design certification the option to apply for an FDA for the same design information.
The proposed rule would also amend the current § 52.45(d) (proposed § 52.105(c)) to correct the reference to the filing requirements in § 50.30(a) and delete the reference to § 50.4. The applicability of the requirements in § 50.4 is set forth in the new § 52.5. No substantive change in the filing requirements is intended by this correction.
The proposed rule would amend the current § 52.47 (proposed § 52.107) to conform the statement of the requirements for acceptable inspections, tests, analyses, and acceptance criteria (ITAAC) in § 52.107 with the Atomic Energy Act (AEA) and the requirements in the current § 52.97(b) [proposed § 52.227(b)]. This clarification of the previous regulatory text, which condensed the language in § 52.79(c) and § 52.97(b), is intended to avoid any future misunderstandings.
Design Certification Backfit Requirement
The proposed rule would amend the special backfit requirement in the current § 52.63(a)(1) (proposed § 52.127(a)(1)) to provide the Commission with the ability to make changes to the design certification rules or the certification information in the generic design control documents that reduce unnecessary regulatory burdens. Section 52.63(a)(1) currently states that the Commission may not modify, rescind, or impose new requirements on the certification unless the change is: (1) Necessary for compliance with Commission regulations applicable and in effect at the time the certification was issued, or (2) necessary to provide adequate protection of the public health and safety or common defense and security. The regulation does not appear, on its face, to permit changes to the certification which reduce unnecessary regulatory burdens, in circumstances where the change continues to maintain protection to public health and safety and common defense and security. An example of a change which may not be able to be made under the current § 52.63(a)(1) is a proposed change to the three design certification rules in Appendices A, B and C of 10 CFR part 52, to incorporate into the Tier 2 change process the revised change criteria in 10 CFR 50.59. Section 50.59 was revised in 1999 to provide new criteria for,
inter alia,
making changes to a facility, as described in the final safety analysis report, without prior NRC approval, in order to reduce unnecessary regulatory burden (64 FR 53582, October 4, 1999).
To allow the Commission to modify the design certification rules in 10 CFR part 52 to incorporate the revised § 50.59 change criteria, and to allow the Commission to make future changes to reduce unnecessary regulatory burden, the Commission is proposing to amend § 52.127(a)(1) to include a new provision that explicitly allows the Commission to change the design certification rules or certification information if the change provides a reduction in regulatory burden and maintains protection to public health and safety and common defense and security. Maintaining protection generally embodies the same safety principles used by the NRC in applying risk-informed decision making,
e.g.
, ensuring that adequate protection is provided, applicable regulations are met, sufficient safety margins are maintained, defense-in-depth is maintained, and that any changes in risk are small and consistent with the Commission's Safety Goal Policy Statement (refer to NRC's Regulatory Guide 1.174). Changes to the design certification rules must be accomplished through rulemaking, with opportunity for public comment. Once a design certification rule is changed through rulemaking, under proposed § 52.127(a)(2) the provisions would apply to all future applications referencing the design certification rule as well as all current plans referencing the design certification, unless the change has been rendered “technically irrelevant” through other action taken under paragraphs (a)(3) or (b)(1) of § 52.127. Thus, standardization is maintained by ensuring that any changes to a design certification rule intended to reduce regulatory burden are imposed upon all nuclear power plants referencing the design certification rule.
In a letter dated November 13, 2001, NEI stated:
Furthermore, we do not think it is necessary to modify 10 CFR 52.63(a)(1) in order to make conforming, administrative or similar changes to the DCRs, such as those needed to conform the DCRs to the revised 10 CFR 50.59. Nor do we think the Commission intended the DCR backfit provisions to inhibit these types of changes. Rather, we believe 10 CFR 52.63(a)(1) is intended to apply to changes in the standard design approved via the DCR. We recommend the Commission clarify this intent and provide guidance to the NRC staff allowing certain changes to the DCRs (such as those needed to conform to the revised 10 CFR 50.59) within the existing DCR backfit provisions.
The Commission received similar comments from General Electric Company, Entergy, and Exelon in November 2001. The Commission disagrees with these comments and has concluded that it is necessary to amend § 52.63(a)(1) to allow changes to the design certification rules that reduce unnecessary regulatory burden, or do not constitute a backfit.
The current § 52.63(a)(1) (proposed § 52.127(a)(1)) was also modified to replace “a modification” with “the change,” in order to clarify that the three criteria for changes apply to modifications, rescissions or imposition of new requirements. Also, the Commission is clarifying the proposed § 52.127 to be consistent with its original intent (refer to 54 FR 15372; April 18, 1989) that the special backfit requirements apply to the certification information in the generic design control documents, not to the provisions in the design certification rules,
e.g.
, Section VI.E of Appendix A to 10 CFR part 52. Any proposed changes to these provisions that set forth how the design certification rules are to be used are controlled by the normal backfit requirements in 10 CFR 50.109.
The proposed rule would amend the current § 52.63(a)(2) (proposed § 52.127(a)(2)) to delete the reference to § 52.63(a)(4) (proposed § 52.127(a)(4)). The reference to § 52.63(a)(4) was in error because this paragraph discusses the finality of the findings required for issuance of a combined license or operating license, whereas § 52.63(a)(2) deals with modifications that the NRC may impose on a design certification rule under § 52.63(a)(3) or § 52.63(b)(1)
(proposed § 52.127(a)(3) or § 52.127(b)(1)). No substantive change is intended by the amendment which merely clarifies the original intent of the rule.
Standard Design Approvals
The proposed rule would amend the current Section 3 of Appendix O to 10 CFR part 52 (proposed § 52.135) to clarify that applications for standard design approvals should contain all of the applicable technical information required by § 50.34. The amendment would also require applications for standard design approvals to provide the same technical information required for applications for standard design certifications (
e.g.
, demonstration of compliance with any technically relevant Three Mile Island requirements, proposed technical resolutions of unresolved safety issues and medium- and high-priority generic safety issues, and a design-specific probabilistic risk assessment (PRA)). This clarification is consistent with past practice regarding applications for future designs and would implement the Commission's Policy Statements on Severe Reactor Accidents (50 FR 32138, August 8, 1985) and Nuclear Power Plant Standardization (52 FR 34884, September 15, 1987). This amendment would not require applicants to provide proposed ITAAC because standard design approvals are referenced in applications for construction permits and operating licenses under 10 CFR part 50, and the verification process used for 10 CFR Part 50 applications does not use ITAAC.
The proposed rule would amend the current Appendix O to 10 CFR Part 52 (proposed § 52.139) to specify that the duration of a standard design approval is for 15 years. In a letter dated November 13, 2001 (comment 18.a), NEI commented:
Industry recommends FDAs be valid for 15 years. This is consistent with Commission direction in COMSECY-94-025 to update the lead plant FDA to provide a 15 year duration instead of the five years initially provided. The ABWR and System 80+ FDAs were so revised in 1994; the designs were certified in 1997.
The Commission agrees with industry's recommendation. The final design approvals (FDAs) for the three certified designs were originally issued for a five year duration, in accordance with the Commission's Policy Statement on Standardization of Nuclear Power Plants (43 FR 38954, August 31, 1978). Only after design certifications were issued for the ABWR and the System 80+ designs did the Commission direct, for consistency, that the FDAs be revised to provide the same term as for the design certification. These actions did not change the Commission's policy for FDAs issued by themselves. The Commission has now decided that the duration of standard design approvals should correspond to the duration of design certifications. The Commission has not identified any compelling technical or policy considerations that would lead the Commission to maintain a shorter effective time period for an FDA as compared to a design certification.
Combined Licenses
The proposed rule would amend the current § 52.73 (proposed § 52.203(a)) to clarify that a site report issued under proposed subpart B of 10 CFR part 52 may also be referenced in an application for a combined license application filed under 10 CFR part 52. This amendment would also add the requirements in the current § 52.63(c) (proposed § 52.127(c)) to the new § 52.203(b) to clarify that this requirement applies to applicants for a combined license. This provision requires that, prior to granting a combined license which references a standard design certification, information normally contained in certain procurement specifications and construction and installation specifications be completed and available for audit if such information is necessary for the Commission to make its safety determinations, including the determination that the application is consistent with the certified design. No substantive change is intended by the restatement of this requirement. In a letter dated April 3, 2001 (comments 3 and 3.a), NEI agreed with the proposed change but recommended that the last sentence of § 52.63(c) be deleted and the remaining provision be added to the current § 52.79 rather than the current § 52.73. The Commission agrees with NEI that 10 CFR part 52 should be modified to clarify that the requirement in current § 52.63(c) applies to applicants for a combined license, and that the last sentence be deleted. However, the Commission is adding the remaining provision to what was § 52.73(b) (proposed § 52.203(b)) and not to § 52.79 (proposed § 52.211) as recommended by NEI.
The proposed rule would amend the current § 52.78 (proposed § 52.209) to clarify the requirements applicable to an applicant for, and holder of, a combined license with respect to the training program required by 10 CFR 50.120. As currently written, § 52.78 simply indicates that the application must demonstrate compliance with the training program requirements in § 50.120. There is no explicit requirement with respect to the applicant/licensee to implement the training program. Furthermore, proposed § 52.215(b) indicates that, after a combined license is issued but before the Commission has authorized operation under § 52.231, the combined license holder shall comply with all requirements in Title 10 of the Code of Federal Regulations applicable to holders of construction permits for nuclear power reactors. However, § 50.120 refers to a “nuclear power plant applicant;” therefore, § 50.120 would not apply to a combined license holder even under the language of proposed § 52.215(b).
To remove any ambiguity in this matter, the Commission is proposing to revise in its entirety the language in current § 52.78, which is being re-designated as § 52.209. The proposed rule provides that the application must “describe” the training program required by § 50.120. In addition, the proposed rule states that the training program described in the application must be “established, implemented, and maintained” no later than eighteen (18) months prior to the scheduled date for initial loading of fuel, as provided for in § 52.231(a). By “established [and] implemented”, the Commission intends to distinguish between the requirement to merely “describe” the training program in the application, versus the requirement for the combined license holder to establish (
e.g.
, establish a training organization, fill staff positions, write procedures, etc.) and implement (
i.e.
, perform training of applicable operating plant personnel in accordance with § 50.120) the training program. The proposed rule also clarifies that the eighteen (18) month period by which the training program must be established and implemented is measured from the combined licensee's scheduled date for fuel load under proposed § 52.231(a) (current § 52.103(a)).
Referencing an Early Site Permit
The proposed rule would amend current §§ 52.39 and 52.79 (proposed § 52.211) to require a license applicant referencing an early site permit to update and correct the emergency preparedness information provided under § 52.17(b). The issue of updating an early site permit was first raised by the Illinois Department of Nuclear Safety, who suggested in a September 28, 1994 letter that emergency plans and/or offsite certifications approved as part of an early site permit review be kept up-to-date throughout the duration of an early site permit and the
construction phase of a combined license. In SECY-95-090, “Emergency Planning Under 10 CFR part 52,” (April 11, 1995), the NRC staff stated that 10 CFR part 52 does not clearly require an applicant referencing an early site permit to submit updated information on changes in emergency preparedness information and any emergency plans that were approved as part of the early site permit in accordance with § 52.18. SECY-95-090 indicated (p. 4) that, in view of the lack of industry interest in pursuing an early site permit, resolution of this matter may be deferred until a “lessons learned” rulemaking updating 10 CFR part 52 is conducted after the first design certification rulemakings are issued. Following public release of a draft SECY paper setting forth the NRC staff's preliminary views on the licensing process for a combined license, the Nuclear Energy Institute (NEI) submitted a letter dated September 8, 1998 (comment 2.d), expressing NEI's opposition to a requirement for updating emergency preparedness information throughout the duration of an early site permit absent an application referencing the early site permit. As an alternative to updating throughout the duration of an early site permit, NEI proposed that emergency planning information be updated when an application for a license referencing the early site permit is filed; portions of the emergency plans that are unchanged would continue to have finality under 10 CFR 52.39. Thereafter, in a September 3, 1999 letter, the NRC staff identified updating of emergency preparedness information in early site permits as a possible subject for the part 52 rulemaking.
The Commission agrees with the Illinois Department of Nuclear Safety that the emergency preparedness information approved when the early site permit was issued must be updated if there is new information which may materially affect the Commission's earlier determination on emergency preparedness, or if the new information is needed to correct inaccuracies in the emergency preparedness information approved in the early site permit. In the absence of such an updating requirement, the NRC would bear the responsibility of identifying whether there is new information on emergency preparedness that necessitates a re-examination of the Commission's earlier emergency preparedness determinations for the early site permit, and the early site permit holder or applicant referencing the early site permit would be under no obligation to correct inaccurate emergency preparedness information in the early site permit or approved emergency plan. However, the Commission also agrees with NEI that a “continuous” early site permit update requirement would impose burdens upon the early site permit holder without any commensurate benefit if the early site permit is not subsequently referenced. Accordingly, the Commission has decided that § 52.39 and current § 52.79 (proposed § 52.211) should contain an updating requirement to be imposed upon the applicant referencing an early site permit.
The proposed rule redesignates paragraph (b) of current § 52.39 as paragraph (c), and adds a new paragraph (b) requiring an applicant for a construction permit, operating license, duplicate design license, or combined license whose application references an early site permit to update and correct the emergency preparedness information provided under § 52.17(b), and to discuss whether the new information may materially change the bases for compliance with the applicable NRC requirements. A parallel requirement is included in proposed § 52.211(d)(1) to ensure that applicants for combined licenses referencing an early site permit will submit the updated emergency preparedness information. New information which materially changes the bases for compliance includes: (1) Information which substantially alters the bases for a previous NRC conclusion with respect to the acceptability of a material aspect of emergency preparedness or an emergency preparedness plan, as well as (2) information which would constitute a sufficient basis for the Commission to modify or impose new terms and conditions related to emergency preparedness in accordance with § 52.39(a)(1). New information which materially changes the Commission's determination of the matters in § 52.17(b), or results in modifications of existing terms and conditions under § 52.39(a)(1) would be subject to litigation during the construction permit, operating license, duplicate design license, or combined license proceedings in accordance with § 52.39(a)(2)(ii).
Not all new information on emergency preparedness would be subject to challenge in a hearing under § 52.39(a)(2)(ii). For example, an emergency plan may have to be updated to reflect current telephone numbers, the names of governmental officials whose positions and responsibilities are defined in the plan (
e.g.
, the name of the current police chief for a municipality), or the current name of a hospital facility. Such corrections do not materially change the NRC's previously-stated bases for accepting the early site permit emergency plan; therefore, a hearing contention would not be admitted under § 52.39(a)(2)(ii) (or any other provision of § 52.39) in a proceeding for a license referencing the early site permit. By contrast, if an emergency plan submitted as part of an early site permit relies upon a bridge to provide the primary path of evacuation, and that bridge no longer exists, the change could materially affect the NRC's previous determination that the emergency plan complied with the Commission's emergency preparedness regulations in effect at the time of the issuance of the early site permit. Thus, such information may be the basis for a change in the early site permit's terms and conditions related to emergency preparedness under § 52.39(a)(1), as well as the basis for a hearing contention under § 52.39(a)(2)(ii)—assuming that the requirements in 10 CFR part 2 for admission of a contention are met.
An updating requirement for early site permit information other than emergency preparedness information does not appear to be necessary, inasmuch as it is unlikely that there would be changes to the information previously submitted on the site, such that a significant change to the site characteristics, terms, and conditions would be necessary if requested under the provisions of § 52.39(a)(2). If the site does not conform to the characteristics of the early site permit, an interested person may submit a petition under § 52.39(a)(2)(ii) alleging that the site does not conform to the early site permit. Accordingly, the proposed rule does not include an updating requirement for other early site permit information.
The proposed rule would amend § 52.79(a)(1) (proposed § 52.211(a)(1)), which currently requires a combined license application referencing an early site permit to contain information demonstrating that the design of the facility falls within the parameters specified in the early site permit, and information needed to resolve any other significant environmental issue not considered in the proceeding on the referenced early site permit. Currently, § 52.79(a)(1) requires a combined license application referencing an early site permit to contain information demonstrating that the design of the facility falls within the site parameters specified in the early site permit. However, § 52.79(a) does not explicitly require the application to address whether the terms and conditions specified in the early site permit under
§ 52.24 have been met by the combined license holder, although this is implicit by the inclusion of any terms and conditions in the early site permit. To remove any ambiguity in this matter, the Commission is proposing to include a proposed § 52.211(a)(1)(iii) by requiring the application to address whether the terms and conditions specified in the early site permit under § 52.24 have been met (the Commission also proposes to rearrange paragraph (a)(1) by dividing the criteria to be met by an application referencing an early site permit into separate subdivisions (i), (ii), and (iii)). The Commission's intent, as reflected in the words, “have been met,” is that all terms and conditions will be met prior to issuance of the combined license.
Testing Requirements for Advanced Reactors
The proposed rule would amend the current § 52.79(b) (proposed § 52.211(b)) to revise the requirements for combined license applications that do not reference a design certification rule by adding the current § 52.47(b)(2) (proposed § 52.107(b)(2)) to the list of requirements in the proposed § 52.211(b)(1) that a combined license applicant must comply with. This amendment will provide consistency between the current advanced reactor testing requirements in subpart B of part 52 (§ 52.47(b)(2)) and the proposed testing requirements in the proposed subpart G of part 52 (§ 52.211(b)). This amendment will require a combined license applicant that references a custom advanced reactor design to also perform the design qualification testing required by the current § 52.47(b)(2) for design certification applicants. If a combined license application references a certified advanced reactor design, the qualification testing required by § 52.47(b)(2) will have been performed. The amendment also requires (proposed § 52.211(b)(3)) that if a licensed prototype plant (see definition in proposed § 52.3) is used to meet the qualification testing requirements in the current § 52.47(b)(2), additional requirements on siting, safety features, or operational conditions may be required for licensing, in order to compensate for uncertainties associated with the performance of new or innovative safety features in the prototype plant.
The codification of testing requirements in the current § 52.47(b)(2) was a principal issue in the development of 10 CFR part 52 (see Section II of 54 FR 15372; April 18, 1989). The testing requirements in § 52.47(b)(2), to demonstrate the performance of safety features for nuclear power plants that differ significantly from evolutionary light-water reactors or utilize simplified, inherent, passive, or other innovative means to accomplish their safety functions (advanced reactors), were included in 10 CFR part 52 to ensure that these safety features will perform as predicted in the applicant's safety analysis report, that the effects of systems interactions are acceptable, and to provide sufficient data to validate analytical codes. The design qualification testing requirements may be met with either separate effects or integral system tests; prototype tests; or a combination of tests, analyses, and operating experience. These requirements implement the Commission's policy on proof-of-performance testing for all advanced reactors (see 51 FR 24643; July 8, 1986) and the Commission's goal of resolving all design issues before authorizing construction.
During the development of 10 CFR part 52, the focus of the nuclear industry and the NRC staff was on applications for design certification. That is why the testing requirements to qualify new or innovative safety features was only included in subpart B of 10 CFR part 52, “Standard Design Certifications.” The tests to qualify a design feature are different than verification tests, which are required by § 52.79(c) and performed in accordance with section XI, “Test Control,” of Appendix B to 10 CFR part 50. Verification tests are used to provide assurance that construction and installation of equipment (as-built) in the facility has been accomplished in accordance with the approved design.
Exelon Generation and NEI commented on the addition of testing requirements for combined license applications, in letters dated November 13, 2001. NEI stated:
COL application requirements in § 52.79(b)(1) have been modified to include a reference to the design certification application requirements of § 52.47(b)(2)(i). Under this proposal, an applicant seeking a COL for a non-certified design that differs significantly from typical light water reactors would have to demonstrate safety feature performance through either (A) analysis, testing, or experience, or (B) full-scale prototype testing. This requirement is entirely appropriate for design certification applicants. However, as discussed below, we believe it is unnecessary to apply these requirements to COL applicants, and that the potential requirement for full-scale prototype testing is particularly inappropriate.
First, part 52 should not be modified to open the door to requiring a COL applicant, who does not reference a certified design, to build and complete testing of a full-scale prototype before the granting of the license. The potential to require prototype testing to support issuance of a COL is contrary to Commission guidance in the part 52 Statements of Consideration. The Commission clearly recognized “licensing the prototype for commercial operation” as a path open to applicants under subpart C of part 52 that could lessen the burden of having to demonstrate innovative designs through full scale prototype testing. We agree with the further statement by the Commission that, “[i]t is well to remember also that, under the rule, prototype testing is required only for certification or an unconditional design approval, if at all.” * * * In sum, through its existing requirements and regulatory authority, the NRC is assured of (1) Adequate information to support required COL reviews and safety determinations, and (2) satisfactory demonstration of innovative design features during startup and power ascension testing. The proposed new COL application requirements are unnecessary and should not be carried forward into the part 52 NOPR (Notice of Proposed Rulemaking).
The Commission disagrees with NEI and Exelon regarding the need to perform qualification testing for new or innovative safety features in all advanced reactor designs. The Commission reformed the licensing process for new nuclear plants with the issuance of 10 CFR part 52 in 1989 and required applicants to demonstrate that safety features will perform as predicted in their final safety analysis report. Although the focus of the NRC staff in 1989 was on applications for design certification, the Commission intended that testing to qualify design features (proof-of-performance testing) would be required for all advanced reactors, including custom designs (see Question 6 at 51 FR 24646; July 8, 1986). Furthermore, it would make no sense for the Commission to require testing for design certification (paper designs) and not require testing for applications to build and operate an actual advanced nuclear reactor.
Although the Commission has stated that it favors the use of prototypical demonstration facilities and that prototype testing is likely to be required for certification of advanced non-light-water designs (see policy at 51 FR 24646; July 8, 1986 and Section II of 54 FR 15372 on 10 CFR part 52; April 18, 1989), the proposed rule does not mandate the use of a prototype plant. Rather, the proposed rule provides that if a prototype plant is used to qualify an advanced reactor design, then additional requirements may be required for licensing of the prototype to compensate for any uncertainties with the unproven safety features. Also, the prototype plant could be used for
commercial operation. Therefore, the Commission proposes to amend § 52.79(b) (proposed § 52.211(b)) to implement its original intent in adopting 10 CFR Part 52 and its policy on advanced reactors that it is necessary to demonstrate the performance of new or innovative safety features through design qualification testing for all advanced nuclear reactors.
Probabilistic Risk Assessments
The proposed rule would also amend the current § 52.79(b) (proposed § 52.211(b)) to adopt a requirement to submit a plant-specific PRA as part of an application for a combined license. The current § 52.79(b) references § 52.47(a)(1)(v), which requires a design-specific PRA within a design certification application. This amendment (§ 52.211(b)(2)) would require an application for a combined license to contain a plant-specific PRA that covers all of the nuclear plant design, including site-specific design features (
e.g.,
the ultimate heat sink). If the combined license application referenced a certified design, this amendment (§ 52.211(b)(5)) would require the design-specific PRA to be updated to include site-specific design features and to account for any design changes. In a letter dated April 3, 2001 (comment 11.1a), NEI stated “we agree on the NRC vision for a plant-specific PRA at COL that supplements the DC PRA with any changes that affect the DC PRA plus site-specific (interface) design information.”
The purpose of the requirement for a plant-specific PRA is to identify and address potential design and operational vulnerabilities, gain insights about the risk of the design, assess the balance between preventive and mitigative features in the design, to determine quantitatively whether the design represents a reduction in risk over current operating plants, and to determine how the risk associated with the new design relates to the Commission's safety goals. Accordingly, the Commission proposes to amend § 52.211(b) to require an application for a combined license to contain a plant-specific PRA.
Resolution of ITAAC
The proposed rule would amend the current § 52.79(c) (proposed § 52.211(c)), current § 52.97(a) (proposed § 52.227(a)), current § 52.99 (proposed § 52.229(e)), and current §§ 52.103(a) and (g) (proposed §§ 52.231(a) and (g)) to provide an applicant for a combined license with a process for resolving certain acceptance criteria in one or more of the ITAAC required by the proposed § 52.211(c) before issuance of the combined license. In a letter dated November 13, 2001 (comment 20), NEI recommended that Subpart C be revised to allow for completion of design acceptance criteria (DAC) at the COL application stage. NEI made this recommendation because applicants might want to complete certain DAC before construction. DAC are special design certification rule ITAAC. DAC set forth processes and criteria for completing certain design information, such as information about the digital instrumentation and control system. DAC were originally written to be verified as part of the normal, post-combined license, ITAAC verification process.
The Commission agrees with NEI's recommendation that combined license applicants be permitted to demonstrate DAC completion as part of the combined license application, for several reasons. First, completion of the design matters covered by DAC before the issuance of a combined license is consistent with the Commission's original concept for design certification and issuance of a combined license. When it adopted 10 CFR part 52, the Commission intended that a design certification contain final and complete design information. Allowing a finding of acceptable completion of DAC before issuance of a combined license is, therefore, consistent with the Commission's original intent. Second, completion of DAC before issuance of the combined license is consistent with the Commission's goal of resolving issues before construction. Determining whether DAC have been successfully completed before issuance of the combined license avoids the possibility that improperly completed DAC will result in the construction of improperly designed structures, systems, and components. Finally, the Commission believes that completion of DAC before issuance of the combined license will enhance public confidence in the overall licensing process because the public will have an opportunity to challenge whether the design has been properly completed before construction begins. Accordingly, the Commission proposes that a finding of successful completion of DAC may be made when a combined license is issued, if the combined license applicant demonstrates that the DAC have been successfully completed. This new process would also allow findings on successful completion of inspections or tests of components procured before the issuance of the combined license.
The proposed rule would also amend the current § 52.99 (proposed § 52.229 (b), (c) and (d)) and the current § 52.103 (proposed § 52.231(h)) to incorporate rule language from the design certification rules in 10 CFR part 52 regarding the completion of ITAAC (see paragraphs IX.A and IX.B.3 of Appendix A to part 52). During the preparation of the design certification rules for the ABWR and System 80+ designs, the NRC staff and nuclear industry representatives agreed on certain requirements for the performance and completion of the inspections, tests, or analyses in ITAAC. In the design certification rulemakings, the Commission codified these ITAAC requirements into Section IX of the rules. The purpose of the requirement in paragraph (b) of proposed § 52.229 is to make it clear that an applicant may proceed at its own risk with design and procurement activities subject to ITAAC, and that a licensee may proceed at its own risk with design, procurement, construction, and preoperational testing activities subject to an ITAAC, even though the NRC may not have found that any particular ITAAC has been successfully completed. Paragraph (c) of proposed § 52.229 requires the licensee to notify the NRC that the required inspections, tests, and analyses in the ITAAC have been completed and that the acceptance criteria have been met. Paragraph (d) simply states the options that a licensee will have in the event that it is determined that any of the acceptance criteria in the ITAAC have not been met. Finally, paragraph (h) of § 52.231 states that ITAAC do not, by virtue of their inclusion in the DCD, constitute regulatory requirements after the licensee has received authorization to load fuel or for renewal of the license. However, subsequent modifications must comply with the design descriptions in the design control document unless the applicable requirements in the current § 52.97 and Section VIII of the design certification rules have been complied with.
In a letter dated April 3, 2001 (comment 23), NEI stated “consider incorporating DCR general provisions into subpart C as appropriate.” The Commission has decided to add these ITAAC requirements to proposed § 52.229 because it believes that these provisions embody general principles that are applicable to all holders of combined licenses.
Commission Finding on Acceptance Criteria
The proposed rule would amend the current § 52.83 (proposed § 52.215) and the current § 52.99 (proposed § 52.229(e)) to clearly state the
Commission's determination that the NRC staff should be responsible for ensuring (through its inspection and audit activities) that the combined license holder performs and documents the completion of inspections, tests and analyses in the ITAAC. Currently, § 52.99 states that “the Commission shall ensure that the required inspections, tests, and analyses are performed and, prior to operation of the facility, shall find that the prescribed acceptance criteria are met.” When part 52 was first adopted by the Commission in 1989 (54 FR 15372, April 18, 1989), § 52.99 provided that the NRC staff shall ensure that the inspections, tests and analyses in the ITAAC are performed, and did not refer to the Commission finding on acceptance criteria being met. The requirement for a Commission finding on acceptance criteria was contained in § 52.103(g). The Commission adopted the current language of § 52.99 in 1992 (57 FR 60975, December 23, 1992) to reflect changes to Section 185 of the AEA made by Congress in the Energy Policy Act of 1992 (1992 EPA), which states:
Following issuance of the combined license, the Commission shall ensure that the prescribed inspections, tests, and analyses are performed and, prior to operation of the facility, shall find that the prescribed acceptance criteria are met.
Thus, the revisions to § 52.99 adopted by the Commission in 1992 simply reflect the language of the 1992 EPA. However, the Commission does not believe that Congress, by adopting language in section 185 stating that the Commission shall ensure that the ITAAC are performed, intended to alter the Commission's determination that the NRC staff is responsible for ensuring that “the required inspections, tests and analyses in the ITAAC are performed,” and by doing so alter the Commission's long-standing delegation of inspection and oversight activities to the NRC staff. For these reasons, the Commission proposes that § 52.99 (proposed § 52.229(e)) state that the NRC staff shall be responsible for ensuring that inspections, tests and analyses in the ITAAC have been performed. The requirement for a Commission finding on acceptance criteria will continue to be addressed separately in § 52.103(g) (proposed § 52.231(g)).
In a letter dated February 22, 1993, the Nuclear Management and Resources Council, Inc. (NUMARC) stated:
There is nothing in Title XXVIII or its legislative history which compels a change in the Staff responsibilities from that reflected in prior § 52.99. Indeed, any other implementation of § 52.99 would be wholly unworkable. Accordingly, it is our understanding that the reference to “the Commission” in amended § 52.99 is to be read as authorizing the Commission to delegate to the Staff the responsibility for overseeing ITAAC performance during the period of facility construction; and further that this is the Commission's intention. Responsibility for the pre-operational finding of acceptance criteria conformance would, of course, be the responsibility of the Commission, as reflected in both amended §§ 52.99 and 52.103(g).
The proposed rule is consistent with NUMARC's recommendation.
The requirements in the proposed § 52.229(e) will be limited to the responsibilities of the NRC staff. The staff will ensure that the inspections, tests, and analyses in the ITAAC have been performed and will publish notices in the
Federal Register
of the successful completion of inspections, tests, and analyses. The NRC staff will perform periodic inspections during construction of the facility and implementation of the licensee's operational programs,
e.g.
, emergency planning and training. The NRC staff will issue reports on these inspections and will make these reports publically available. At the conclusion of construction, the staff will make a recommendation to the Commission on its assessment of the licensee's completion of ITAAC. If the Commission determines that all of the acceptance criteria in the ITAAC for the combined license have been met, it will make the finding required under proposed § 52.231(g).
Consistent with the language in proposed § 52.229(e), the proposed rule would also amend the current § 52.83 (proposed § 52.215(c)) to state that the requirements in 10 CFR part 50 that are applicable to holders of operating licenses become applicable to holders of combined licenses after the Commission's finding of successful ITAAC completion under current § 52.103(g) (proposed § 52.231(g)), rather than referring to the Commission finding under the current § 52.99. As discussed above, the Commission's 1992 rulemaking amended § 52.99 to refer to the Commission's finding of ITAAC completion, and amended § 52.83 to refer to the Commission's finding under § 52.99. Inasmuch as the Commission finding and authorization of operation would be addressed in proposed § 52.231(g), it follows that proposed § 52.215(c) should refer to the Commission's authorization of operation under § 52.231(g) rather than the NRC staff's activities under proposed § 52.229(e).
Combined License Change Process
The proposed rule would amend the current § 52.97 (proposed § 52.227) to clarify the applicability of the change processes in 10 CFR part 50 and Section VIII of the design certification rules in 10 CFR part 52 to a combined license. This amendment will add § 52.227(c), which states that the change processes in 10 CFR part 50 apply to a combined license that does not reference a design certification rule. This amendment will also add § 52.227(d), which states that the change processes in Section VIII of the design certification rules apply to changes within the scope of the referenced certified design. However, if the proposed change affects the design information that is outside of the scope of the design certification rule, the part 50 change processes apply unless the change also affects the design certification information. For that situation, both change processes may apply.
In a letter dated November 13, 2001 (comment 21(a)(2)), NEI recommended that proposed §§ 52.227(c) and (d)(2) state that changes outside the scope of a certified design are subject to “the applicable change control requirements in 10 CFR part 50,
e.g.
, 10 CFR 50.59, 50.54 or 50.90.” The Commission has decided to propose this amendment to clarify which change processes are applicable to a combined license and this amendment is consistent with NEI's recommendation.
Design Certifications for ABWR, System 80+, and AP600
The proposed rule would amend paragraphs VI.B.4, 5, and 6 of the three design certification rules in 10 CFR part 52, Appendices A, B, and C (for U.S. ABWR, System 80+, and AP600 designs, respectively), by substituting the phrase “but only for that plant” for the erroneous phrase “but only for that proceeding” (emphasis added). The new phrase correctly characterizes the scope of issue resolution in three situations. Paragraph VI.B.4 describes how issues associated with a design certification rule are resolved when an exemption has been granted for a plant referencing the design certification rule. Paragraph VI.B.5 describes how issues are resolved when a plant referencing the design certification rule obtains a license amendment for a departure from Tier 2 information. Paragraph VI.B.6 describes how issues are resolved when the applicant or licensee departs from the Tier 2 information on the basis of paragraph VIII.B.5, which waives the requirement to get NRC approval. Thus, once a matter (
e.g.
, an exemption in the
case of paragraph VI.B.4) was addressed for a specific plant referencing a design certification rule, the adequacy of that matter for that plant would not ordinarily be subject to challenge in any subsequent proceeding or action (such as an enforcement action) listed in the introductory portion of paragraph IV.B, but there would not be any issue resolution on that subject matter for any other plant. Unfortunately, the three design certification rules use the phrase “but only for that proceeding,” which may lead to the erroneous conclusion that issue resolution exists only in the proceeding in which the matter was approved and/or adjudicated, and not in all subsequent proceedings for that plant.
In letters dated November 12, 2001, and November 13, 2001, respectively, General Electric Company and Westinghouse Electric Company reiterated earlier recommendations the two companies had made that Sections VI.B.4 and 5 of the design certification rules state that exemptions and license amendments have finality “but only for that plant.” For the reasons discussed above, the Commission agrees, and the Commission proposes to substitute the phrase “but only for that plant,” in order to clarify that issue resolution on a matter applies in subsequent proceedings for that plant.
Each of the design certification rules in 10 CFR part 52 (Appendices A, B, and C) includes a Section VIII on change processes. These processes apply to changes depending upon the category of design information affected. For plant-specific tier 2 information, the change process established in the rules mirrors, in large part, that in the former 10 CFR 50.59. The proposed rule would amend paragraph VIII.B.5 of the design certification rules to conform the terminology in the 50.59-like change process to that used in the revised § 50.59. This amendment deletes references to unreviewed safety question and safety evaluation, and conforms the evaluation criteria concerning when prior NRC approval is needed. Also, a definition has been added (paragraph II.G) for “departure from a method of evaluation” to support the evaluation criterion in VIII.B.5.b(8).
In an earlier rulemaking (
see
64 FR 53582; October 4, 1999), the Commission revised § 50.59 to incorporate new thresholds for permitting changes to a plant as described in the final safety analysis report without NRC approval. For consistency and clarity, similar changes are now being proposed for 10 CFR part 52 applicants or licensees. Because of some differences in how the change control requirements are structured in the design certification rules, certain definitions contained in § 50.59 are not necessary for or applicable to 10 CFR part 52 and are not being included in this proposed rule. One definition that the Commission is including is the definition from the new § 50.59 for a “departure from a method of evaluation,” which is appropriate to include in this rulemaking so that the eighth criterion in Section VIII.B.5.b of the design certification rules will be implemented as intended.
B. 10 CFR Part 2, Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders
The proposed rule would amend §§ 2.110, 2.400, 2.401, 2.402, 2.403, 2.404, 2.406, 2.500, 2.501, and 2.502 to correct references to former 10 CFR part 52 appendices that have been redesignated as subparts.
C. 10 CFR Part 20, Standards for Protection Against Radiation
The proposed rule would amend § 20.1002 to clarify that the regulations in 10 CFR part 20 also apply to licenses issued under 10 CFR part 52. This conforming change was inadvertently overlooked when the Commission originally promulgated 10 CFR part 52.
D. 10 CFR Part 21, Reporting of Defects and Noncompliance
The proposed rule would amend §§ 21.2, 21.3, and 21.21 to clarify the applicability of 10 CFR part 21 to individuals, corporations, partnerships, or other entities doing business within the United States, and directors and responsible officers of such organizations, that hold a permit or license under 10 CFR part 52. These conforming changes would correct an oversight when the Commission first adopted 10 CFR part 52, to ensure that the requirements in 10 CFR part 21 apply to applicants for, and holders of licenses under 10 CFR part 52, as well as to suppliers of basic components to such licensees.
Combined Licenses, Manufacturing Licenses, Duplicate Design Licenses
The proposed rule would make 10 CFR part 21 applicable to applicants for, and holders of combined licenses, manufacturing licenses, and duplicate design licenses under 10 CFR part 52, and suppliers of basic components to such applicants and holders, by amending paragraphs (a), (b), and (c) of § 21.2 regarding the scope of 10 CFR part 21 and amending the definitions of basic component, commercial grade item, critical characteristics, dedicating entity, dedication, defect, and substantial safety hazard in § 21.3. In addition, the proposed rule would amend § 21.21 to clearly state when a director or responsible officer subject to 10 CFR part 21 must notify the Commission that the director or officer has information reasonably indicating a failure to comply or a defect affecting the construction or operation of a facility or an activity that is subject to the licensing requirements under 10 CFR part 52 or affecting a basic component supplied for a facility or an activity that is subject to the licensing requirements under 10 CFR part 52. The Commission notes that a supplier of safety-related analyses and services to a licensee under part 52 is subject to part 21, inasmuch as such services constitute “basic components;” this is no different than the applicability of part 21 to a supplier of such analyses and services to a licensee under part 50.
Early Site Permits
With respect to early site permits, the Commission proposes to use a different approach, such that the requirements of part 21 do not apply to applicants for early site permits, or holders of early site permits so long as the early site permit is not referenced in any license application. During the pendency of the early site permit application before the NRC, the applicant would be required by 10 CFR 50.9, “Completeness and accuracy of information,” to notify the Commission of any information having a “significant implication for public health and safety or the common defense and security” with respect to the matters covered in the application, pursuant to proposed § 52.111. Failure to abide by the completeness and accuracy requirements in § 50.9 would subject the applicant to potential criminal liability under § 52.113 (proposed § 52.403). In addition, under current § 52.9, the early site permit applicant would be subject to penalties for deliberate misconduct, including submission to the NRC of information known to be incomplete or inaccurate in some material aspect. Finally, during the pendency of an early site permit application, the application has no operative effect with respect to issue resolution under § 52.39; consequently, an early site permit application itself could not result in a “substantial safety hazard” by virtue of the application being referenced in a nuclear power plant licensing proceeding. Therefore, the Commission does not believe that adopting the regulatory overlay of part 21 during the pendency of an early site permit application is necessary to effectuate the Commission's regulatory
responsibilities under the AEA, as amended, including providing reasonable assurance of adequate protection of public health and safety or common defense and security.
The Commission does not believe that part 21 should apply to the early site permit holder after the early site permit has been issued, but before the holder has referenced the permit in a license application.
2
With one exception, the early site permit does not authorize any action by the holder with respect to the construction or operation of a nuclear power plant. The exception is when the early site permit authorizes the holder to conduct the site preparation activities permitted under 10 CFR 50.10(e)(1) (commonly referred to as limited work authorization-1, or LWA-1, activities). However, these activities are related to site clearing and preparation, and do not permit any construction (including subsurface preparation) for “structures, systems and components which prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public.” Thus, the conduct of LWA-1 activities do not appear to have any reasonable possibility of resulting in a “substantial safety hazard.” Furthermore, the inherent nature of an early site permit is site-specific and not susceptible to generic or wide-ranging applicability. For these reasons, the Commission proposes that part 21 should not apply to an early site permit holder until the permit is referenced by a license applicant.
2
The Commission would not permit a license applicant to reference an early site permit which it does not hold (or has rights to the permit contingent upon a NRC decision to issue a license whose application references the early site permit). To otherwise permit referencing of an early site permit by a non-holder would destroy the commercial value of the permit, and would prevent any entity from seeking an early site permit. This would frustrate the Commission's regulatory objective of providing early regulatory approval of siting, emergency preparedness, and environmental matters. Since the early site permit is a license, the relevant requirements of part 21 are those applicable to a licensee.
Once an early site permit holder references the permit in a license application, the Commission believes that the holder should be subject to part 21. The Commission's safety review of a license application referencing an early site permit is limited in accordance with §§ 52.39 and 52.79 (proposed § 52.211), under the precept that the site parameters, terms, and conditions which define the envelope for safe siting of a nuclear power plant have been determined by the NRC in the early site permit proceeding. If the early site permit holder discovers a significant safety concern with respect to its site (
e.g.
, that the specified site parameter for seismic acceleration is less than the projected acceleration due to new information), the concern should be reported to the NRC so that it may be considered in the review of the application referencing the early site permit. This reporting attains special importance given the Commission's proposal (see discussion in Section III.A.8 on referencing an early site permit) not to impose an updating requirement for early site permit information other than that related to emergency preparedness. Accordingly, the Commission concludes that the early site permit holder should be subject to part 21 once it references the permit in a license application.
The Commission believes that changes to part 21 are unnecessary to reflect these determinations with respect to early site permit applicants and holders. A licensee's reporting requirements in part 21 apply only with respect to “basic components” used or to be used in an NRC-licensed or otherwise regulated facility. The safety-related analyses and consulting services supplied to an applicant for an early site permit appear to fall within the definition of “basic component,” in that they constitute “safety-related design [and] analyses * * * associated with component hardware” (
See
10 CFR 21.3, “Basic component,” paragraph (3)). Thus, part 21 could be interpreted as applying to the early site permit holder immediately upon the permit's issuance. However, there appears to be little reasonable likelihood of a “substantial safety hazard” unless and until the early site permit has been referenced by the permit holder in a license application. Once the early site permit has been referenced, the potential for a substantial safety hazard clearly exists if a known defect in site parameters, terms, or conditions defining the envelope for safe plant operation is not disclosed, and a plant is designed, constructed, and allowed to operate which does not reflect the actual limiting parameters and conditions of the site. Thus, no changes to part 21 are necessary to reflect the Commission's intent.
The Commission also proposes that part 21 apply to suppliers of safety-related analyses and services to an early site permit holder in the same manner and extent as part 21 applies to the early site permit holder. Such suppliers would be subject to part 21 only after the early site permit holder references the permit in a license application.
Design Certification Rules
Similar to the approach for early site permit applicants and holders, the Commission proposes that the requirements in part 21 should not apply to the applicant/vendor for a design certification (and/or its successors) during the pendency of its design certification application. During the pendency of the design certification application, the applicant/vendor would be required by 10 CFR 50.9, “Completeness and accuracy of information,” to notify the Commission of any information having a “significant implication for public health and safety or the common defense and security” with respect to the matters covered in the application, pursuant to proposed § 52.111. Failure to abide by the completeness and accuracy requirements in § 50.9 would subject the applicant/vendor to potential criminal liability under § 52.113 (proposed § 52.403). In addition, under current § 52.9, the applicant for a design certification is subject to penalties for deliberate misconduct, including submission to the NRC of information known to be incomplete or inaccurate in some material aspect. Finally, during the pendency of a design certification application, the application has no operative effect with respect to issue resolution under current § 52.63 (proposed § 52.127); consequently, a design certification application itself could not result in a “substantial safety hazard” by virtue of the application being referenced in a nuclear power plant licensing proceeding. Therefore, the Commission does not believe that adopting the regulatory overlay of part 21 during the pendency of a design certification application is necessary to effectuate the Commission's regulatory responsibilities under the AEA, as amended, including providing reasonable assurance of adequate protection to public health and safety or common defense and security.
The Commission also believes that the reporting requirements in part 21 should not apply to the design certification applicant/vendor after the Commission issuance of a final design certification rule but before the design certification rule is referenced by at least one applicant/licensee (nor should either §§ 52.9 or 52.111 be modified to make them applicable to the design certification applicant/vendor). The Commission does not believe that a design certification rule would reasonably result in a “substantial safety hazard” so long as the design certification rule is not actually referenced in a license application (and
thereafter incorporated by reference into a license). It is true that, unlike an early site permit, a design certification rule is of general applicability and that a complete nuclear power plant design could be provided by an entity other than the original design certification applicant/vendor (
see
§ 52.73 (proposed § 52.203)). Nonetheless, unless the other entity provides a design which is subsequently referenced in an NRC license application, there is no “substantial safety hazard” created (although the Commission acknowledges that the entity may incur significant redesign costs if the entity completes substantial parts of the design before submission of the application, only to find upon submission of the application that there were significant defects in the certified design). Upon weighing of all relevant factors, the Commission proposes that part 21 should not apply to the design certification applicant/vendor until a final, Commission-approved design certification rule is referenced by at least one applicant/licensee.
However, the Commission believes that once a design certification rule is referenced by an applicant, the design certification applicant/vendor should be subject to part 21. The Commission's safety review of a license application referencing a design certification rule is limited in accordance with § 52.63 (proposed § 52.127) and § 52.79 (proposed § 52.211). If the design certification applicant/vendor has discovered a significant safety concern with respect to its certified design, it should be reported to the NRC so that it may be considered in the review of the application referencing the design certification rule. While this places a continuing obligation on the design certification applicant/vendor to monitor whether its design has been referenced in a license application, as a practical matter it is likely that the license applicant will have contractually engaged the design certification applicant/vendor prior to submitting the application. In any event, the Commission concludes that the design certification applicant/vendor should be subject to part 21 after its design certification has been referenced by an applicant for a license.
The Commission believes that, with one exception, changes to part 21 are unnecessary to reflect these determinations with respect to design certification applicants/vendors. Designs submitted for certification are “basic components,” as defined in § 21.3, as are any supporting analyses inasmuch as they constitute “safety-related design [and] analysis * * * associated with component hardware whether these services are performed by the component supplier or not.” If the design certification applicant/vendor provides the certified design to a license applicant pursuant to contract or agreement, the design certification applicant/vendor “supplies” the basic component,
see
§ 21.3. However, there is a possibility that an entity other than the applicant/vendor of a design which was certified in a design certification rule may supply the complete plant design to a referencing license applicant.
See
§ 52.73 (proposed § 52.203). For these reasons, the Commission is considering a change to the definition of “supplying or supplies” in § 21.3 to ensure that a design certification applicant/vendor who does not pursuant to contract supply to a license applicant the complete design for the design certification, is also subject to part 21 for this special situation.
For the reasons discussed earlier, the Commission believes that it is reasonable and appropriate to limit the applicability of part 21 such that it is applicable once the design certification rule has been referenced by an applicant, permit holder, or licensee. Therefore, although the potential ambit of part 21 extends to an applicant/vendor of a design certification after issuance of a design certification rule, the Commission has decided not to extend the applicability of part 21 in such a fashion. By contrast, once the design certification rule has been referenced, the potential for a substantial safety hazard exists if a known defect in a design certification rule is not disclosed, the remainder of the plant is designed, the plant constructed, and subsequently allowed to operate. Accordingly, the Commission concludes that part 21 should apply to the design certification applicant/vendor after the design certification rule has been referenced by a license applicant. Finally, the Commission concludes that part 21 should apply to suppliers of safety-related analyses and services to a design certification applicant/vendor in the same manner and extent as part 21 applies to the design certification applicant.
E. 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities
The proposed rule would amend paragraph (a)(1) of § 50.109 (backfit rule) to clearly state the applicability of the backfit rule to some of the licensing processes 10 CFR part 52 and the date that backfit protection commences for those licensing processes. The licensing processes to which the backfitting provisions in § 50.109 apply are standard design approvals, combined licenses, manufacturing licenses, and duplication design licenses issued under subparts E, G, H, and I of 10 CFR part 52, respectively. The backfitting requirement in § 50.109 does not apply to early site permits, early site reviews, and standard design certifications issued under subparts A, B, and D, respectively, in as much as these licensing processes have their own special backfitting provisions (the special backfit requirements set forth in § 52.39, current sections 5 and 6 of Appendix Q (proposed § 52.47), and current § 52.63(a) (proposed § 52.127(a)) apply to early site permits, early site reviews, and standard design certifications, respectively). Section 50.109(a)(1)(vii) sets forth the applicability of these special backfitting provisions for a combined license that references an early site permit, early site review, or design certification rule.
The proposed rule would also remove appendices M, N, O, and Q from 10 CFR part 50. These appendices were transferred to 10 CFR part 52 when it was first promulgated (54 FR 15372; April 18, 1989). However, the Commission failed to remove those appendices from 10 CFR part 50, though the Commission intended to do so (
see
54 FR 15385; April 18, 1989).
F. 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions
The proposed rule would amend paragraph (b)(6) of § 51.20, “Criteria for and identification of licensing and regulatory actions requiring environmental impact statements,” to make clear that issuance of a manufacturing license requires preparation of an environmental impact statement or a supplement to an environmental impact statement. Paragraph (b), which defines types of actions that require an environmental impact statement or a supplement to an environmental impact statement would replace the current reference to Appendix M with a reference to subpart H of 10 CFR part 52 which is the proposed subpart that sets forth the process for manufacturing licenses, formerly contained in Appendix M.
G. 10 CFR Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste
The proposed rule would amend § 72.210 to indicate that a general license would be issued for the storage
of spent fuel in an independent spent fuel storage installation at power reactor sites to persons authorized to possess or operate nuclear power reactors under a combined license or duplicate design license under 10 CFR part 52. The proposed rule would also amend the requirements in § 72.218(b) regarding an application for termination of a reactor operating license and the removal of the spent fuel stored at the reactor site to indicate that this provision also applies to applications for termination of a combined license or duplicate design license.
H. 10 CFR Part 73, Physical Protection of Plants and Materials
The proposed rule would amend § 73.1(b) to clarify that the regulations in 10 CFR part 73 also apply to licenses issued under 10 CFR part 52.
I. 10 CFR Part 140, Financial Protection Requirements and Indemnity Agreements
The proposed rule would amend §§ 140.2, 140.10, 140.11, and 140.13 to correct the language to note that holders of combined licenses issued under 10 CFR part 52 are required to conform with the Commission's financial protection requirements implementing the Price-Anderson Act (Section 170 of the Atomic Energy Act of 1954). The proposed rule would also add new §§ 140.11(c) and 140.13(b). Section 140.11(c) would specify that a holder of a combined license must have and maintain financial protection when the Commission authorizes operation under § 52.231(g). Section 140.13(b) would require that each holder of a combined license who is also the holder of a license under 10 CFR part 70 authorizing ownership, possession, and storage only of special nuclear material at the site of the nuclear reactor have and maintain financial protection in the amount of $1,000,000. Proof of financial protection would be required to be filed with the Commission in the manner specified prior to issuance of the license under 10 CFR part 70.
J. 10 CFR Part 170, Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended
The proposed rule would amend § 170.2 to clarify the applicability of the regulations in 10 CFR part 170 to the licensing processes in 10 CFR parts 50 and 52.
IV. Specific Requests for Comments
In addition to the general invitation to submit comments on the proposed rule, the Commission also requests comments on the following questions:
1. Should the final rule include an updating requirement for other than emergency preparedness information and what portions of the early site permit (ESP) should be subject to the updating requirement? Also, if an updating requirement is adopted, in what manner could an interested person challenge the updated information? (refer to § 52.39(a))
2. Should the final rule include revisions to 10 CFR part 52 to: (1) Distinguish between site characteristics, site parameters, design characteristics, and design parameters; (2) require the Commission to specify the site characteristics and design parameters when issuing early site permits; (3) require the design certification rule to specify the site parameters and design characteristics for the design; (4) require a combined license applicant referencing an early site permit to demonstrate that either the design of the nuclear power plant or the site parameters and design characteristics of a referenced design certification rule fall within the design parameters and site characteristics of the early site permit; and (5) require a combined license applicant referencing a design certification rule to demonstrate that the site parameters and design characteristics of the design certification rule fall within either: (i) The site characteristics of a site, or (ii) the site characteristics and design parameters of a referenced early site permit?
Currently, 10 CFR art 52 uses the various terms, “site parameters,” “postulated site parameters,” “site characteristics,” “physical characteristics,” and “the parameters specified in the early site permit”
See, e.g.,
§§ 52.17, 52.18, 52.21, 52.47 (proposed § 52.107), § 52.79 (proposed § 52.211). In some cases, it appears that different terms are used to apply to the same concept,
e.g.
, “site parameters,” and “postulated site parameters.” In other cases, information which would appear to constitute “site parameters” as used in the current rule is not characterized as such,
e.g.
§ 52.17(a)(1)(i) through (viii).
To address these inconsistencies, the Commission is considering amending 10 CFR part 52, including proposed subparts A, D, and G, to use the terms: “site characteristics,” “site parameters,” “design characteristics,” and “design parameters,” to set forth in clear and unambiguous terms the Commission's requirements on early site permits, design certifications, and combined licenses. “site characteristics” would be the actual physical and demographic values for the site,
e.g.
, the ground force acceleration of a defined earthquake, flood level, or the atmospheric dispersion value. The “design parameters” for an early site permit would include the postulated values for thermal power level, radiological effluents, and type of cooling system for the facility. “Design characteristics” for a design certification would be the actual values for the design,
e.g.
, thermal power level or building height. “Site parameters” for a design certification would include the postulated values for floods, ground force acceleration of a postulated earthquake, and tornado wind speeds.
3. Are there terms and conditions for an ESP that can only be fulfilled after issuance of the referencing combined license, such that “have been met” should be changed to “will be met,” or “have been and will be met”? (refer to proposed § 52.211(a)(1))
4. Should the final rule include a requirement in § 50.34(a) for a construction permit application that references an ESP to demonstrate that the design of the facility falls within the site parameters of the ESP? (refer to proposed § 52.211(a)(1))
5. Should the final rule include a requirement in 10 CFR part 50 to perform testing to qualify advanced reactor designs before licensing? The purpose of this testing requirement would be to demonstrate that new or innovative safety features will perform as predicted in an applicant's safety analysis report, that effects of systems interactions have been found acceptable, and to provide sufficient data for analytical code validation, as required by proposed §§ 52.107(b) and 52.211(b).
6. Should the final rule include a revision to the current § 52.63 (proposed § 52.127) to allow the original design certification applicant to petition the Commission for rulemaking to amend the design certification rule to incorporate “beneficial changes,” including improvements in safety, and/or design changes that would “significantly improve efficiency, reliability and economics.” Refer to letters from Steven A. Hucik, GE Nuclear Energy (March 30, 2002) and Ronald L. Simard, Nuclear Energy Institute (March 22, 2002).
7. Should 10 CFR part 21 apply to: (a) A holder of an early site permit, but only after the holder references the permit in a license application, and (b) an applicant/vendor of a design which is the subject of a design certification rule, but only after the design certification rule is first referenced in a license application. In both cases, the
Commission believes that there is no reasonable possibility of a “substantial safety hazard” until either the early site permit or design certification rule is referenced. The Commission seeks public comment on the Commission's proposed basis for this proposal, and whether there are other factors and policy considerations, either in support of, or in opposition to, the Commission's proposal.
V. Availability of Documents
The NRC is making the documents identified below available to interested persons through one or more of the following methods as indicated.
Public Document Room (PDR).
The NRC Public Document Room is located at 11555 Rockville Pike, Rockville, Maryland.
Rulemaking Website (Web).
The NRC's interactive rulemaking Website is located at
http://ruleforum.llnl.gov
. These documents may be viewed and downloaded electronically via this Website.
NRC's Public Electronic Reading Room (PERR).
The NRC's public electronic reading room is located at
www.nrc.gov/reading-rm.html
.
Document
PDR
Web
PERR
Comments on the draft rule language:
General Electric
X
X
ML013180207
Entergy
X
X
ML013200006
Nuclear Energy Institute
X
X
ML013200158
Westinghouse
X
X
ML013200173
Exelon
X
X
ML020040187
Regulatory History of Design Certification
3
X
ML003761550
VI. Plain Language
The
Presidential memorandum dated June 1, 1998, entitled “Plain Language in Government Writing” directed that the Government's writing be in plain language. This memorandum was published on June 10, 1998 (63 FR 31883). In complying with this directive, the NRC made editorial changes to improve the organization and readability of the existing language of the paragraphs being revised. These types of changes are not discussed further in this document. The NRC requests comments on the proposed rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the
ADDRESSES
caption of the preamble.
3
The regulatory history of the NRC's design certification reviews is a package of 100 documents that is available in NRC's PERR and in the PDR. This history spans a 15-year period during which the NRC simultaneously developed the regulatory standards for reviewing these designs and the form and content of the rules that certified the designs.
VII. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless using such a standard is inconsistent with applicable law or is otherwise impractical. In this proposed rule, the NRC is revising the procedural requirements for early site permits, standard design certifications, and combined licenses for nuclear power plants to make certain corrections and changes based on the experience of the previous design certification reviews and on discussions with stakeholders on these licensing processes. In addition, this proposed rule would amend certain portions of the three design certification rules in 10 CFR part 52, appendices A, B, and C (for U.S. ABWR, System 80+, and AP600 designs, respectively) Design certifications are not generic rulemakings in the sense that design certifications do not establish standards or requirements with which all licensees must comply. Rather, design certifications are Commission approvals of specific nuclear power plant designs by rulemaking. Furthermore, design certification rulemakings are initiated by an applicant for a design certification, rather than the NRC. For these reasons, the Commission concludes that this action does not constitute the establishment of a standard that contains generally applicable requirements.
VIII. Environmental Impact: Categorical Exclusion
The NRC has determined that the changes made in this proposed rule fall within the types of action described in categorical exclusions 10 CFR 51.22(c)(1), (c)(2), and (c)(3). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
4
4
When 10 CFR part 52 was promulgated in 1989, the NRC determined that the regulation met the eligibility criteria for the categorical exclusion set forth in 10 CFR 51.22(c)(3). As stated in the
Federal Register
notice for the final rule (54 FR 15384, April 18, 1989), “It makes no substantive difference for the purpose of the categorical exclusion that the amendments are in a new 10 CFR part 52 rather than in 10 CFR part 50. The amendments are, in fact, amendments to the 10 CFR part 50 procedures and could have been placed in that part.” The categorical exclusion for the current proposed change to 10 CFR part 52 is consistent with the original categorical exclusion determination.
IX. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements contained in 10 CFR Part 52 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq
). These information collection requirements have been submitted to the Office of Management and Budget for review and approval. The proposed changes to 10 CFR parts 2, 20, 21, 50, 51, 72, 73, 140, and 170 do not contain new or amended information collection requirements. Existing requirements were approved by the Office of Management and Budget, approval number(s) 3150-0014, 3150-0035, 3150-0011, 3150-0021, 3150-0132, 3150-0039, and 3150-0002.
The burden to the public for the information collections in 10 CFR part 52 is estimated to average 3,429 hours per response. This includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. The U.S. Nuclear Regulatory Commission is seeking public comment on the potential impact of the information collections contained in the proposed rule 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?
Send comments on any aspect of these proposed information collections, including suggestions for reducing the burden, to the Records Management Branch (T-6 E6), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to
INFOCOLLECTS@NRC.GOV
; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0151, 3150-0011, and 3150-0039), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the information collections or on the above issues should be submitted by August 4, 2003. 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.
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.
X. Regulatory Analysis
The Commission has prepared the following draft regulatory analysis on the substantive changes in this proposed regulation that could impose regulatory burdens. The majority of the changes in this proposed rule involve formatting, reorganization, or process changes that do not affect regulatory burden. These types of changes are not addressed in this regulatory analysis, as they would not affect the burden on future applicants.
The proposed rule contains two amendments that appear to impose regulatory burdens on future applicants for construction permits, combined licenses, and duplicate design licenses who may file an application referencing an early site permit or a certified design. There are no current applicants who would be burdened by the proposed amendments.
The first of these changes requires applicants who reference an early site permit to update and correct emergency planning information and discuss whether the new information materially alters the bases for compliance with the applicable requirements. The second change requires applicants who reference a certified design to include a plant-specific probabilistic risk assessment (PRA) that uses the design-specific PRA and is updated to account for site-specific design information and any design changes.
The Commission believes that, practically speaking, there would be no change in the burden on future applicants resulting from these amendments. This is because the information required by the proposed rule would, in all likelihood, be requested by the NRC staff during the review of the application if these requirements were not adopted. The staff could not perform an adequate review of an application referencing an early site permit without reviewing the most up-to-date emergency planning information. Therefore, if this updated information was not required in the application, the staff would be compelled to request the information from the applicant in order to make a finding that there is reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency.
Likewise, if the Commission did not require an updated PRA in an application for a combined license referencing a certified design, the staff would be compelled to request the information from the applicant. The Commission would need this information in order to assist it in finding that the applicable requirements of 10 CFR part 50 have been met, and in reviewing the licensee's proposed inspections, tests, and analyses that the licensee must perform, and the acceptance criteria that, if met, are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Atomic Energy Act, and the Commission's rules and regulations.
For these reasons, the Commission believes it is prudent to proceed with this proposed rulemaking. The addition of these requirements for applicants for construction permits, combined licenses, and duplicate design licenses is necessary to ensure the NRC staff can meet its regulatory obligations. In addition, giving future applicants notification up front that the staff requires this information in the application will relieve them of a larger burden of having to compile the information during the application review process when the Commission requests the information to complete its review. The need to compile the information during the review process could impact the review schedule and result in other unnecessary burdens on the applicant.
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
heading.
XI. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This proposed rule affects only the licensing of nuclear power plants. The companies that will apply for an approval, certification, permit, site report, or license in accordance with the regulations affected by this proposed rule do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).
XII. Backfit Analysis
The NRC has determined that the backfit rule does not apply to this proposed rule; therefore, a backfit analysis is not required for this proposed rule because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109. The proposed rule would revise the requirements for early site permits, standard design certifications, and combined licenses for nuclear power plants, so it would affect a potential applicant who might, in the future, apply for an early site permit, design certification, or combined license. However, the backfit rule does not apply because the proposed rule would not impose any modifications on a current holder of an early site permit, certified design, or combined license.
List of Subjects
10 CFR Part 2
Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalties, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.
10 CFR Part 20
Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and record keeping requirements, Source material, Special nuclear material, Waste treatment and disposal.
10 CFR Part 21
Nuclear power plants and reactors, Penalties, Radiation protection,
Reporting and record keeping requirements.
10 CFR Part 50
Antitrust, Classified information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, Reporting and record keeping requirements.
10 CFR Part 51
Administrative practice and procedure, Environmental impact statement, Nuclear materials, Nuclear power plants and reactors, Reporting and record keeping requirements.
10 CFR Part 52
Administrative practice and procedure, Antitrust, Backfitting, Combined license, Early site permit, Emergency planning, Fees, Inspection, Limited work authorization, Nuclear power plants and reactors, Probabilistic risk assessment, Prototype, Reactor siting criteria, Redress of site, Reporting and record keeping requirements, Standard design, Standard design certification.
10 CFR Part 72
Administrative practice and procedure, Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Penalties, Radiation protection, Reporting and record keeping requirements, Security measures, Spent fuel, Whistle blowing.
10 CFR Part 73
Criminal penalties, Export, Hazardous materials transportation, Import, Nuclear materials, Nuclear power plants and reactors, Reporting and record keeping requirements, Security measures.
10 CFR Part 140
Criminal penalties, Extraordinary nuclear occurrence, Insurance, Intergovernmental relations, Nuclear materials, Nuclear power plants and reactors, Reporting and record keeping requirements.
10 CFR Part 170
Byproduct material, Import and export licenses, Intergovernmental relations, Non-payment penalties, Nuclear materials, Nuclear power plants and reactors, Source material, Special nuclear material.
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 parts 2, 20, 21, 50, 51, 52, 72, 73, 140, and 170.
PART 2—RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS
1. The authority citation for part 2 continues to read as follows:
Authority:
Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 2241); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841); 5 U.S.C. 552.
Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 114(f), Pub. L. 97-425, 96 Stat. 2213, as amended (42 U.S.C. 10143(f)); sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 (42 U.S.C. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183i, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under secs. 161 b, i, o, 182, 186, 234, 68 Stat. 948-951, 955, 83 Stat. 444, as amended (42 U.S.C. 2201 (b), (i), (o), 2236, 2282); sec. 206, 88 Stat 1246 (42 U.S.C. 5846). Section 2.205(j) also issued under Pub. L. 101-410, 104 Stat. 90, as amended by section 3100(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note). Sections 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770, 2.780 also issued under 5 U.S.C. 557. Section 2.764 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133), and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. Section 2.809 also issued under 5 U.S.C. 553, and sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). Subpart K also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C. 10154). Subpart L also issued under sec. 189, 68 Stat. 955 (42 U.S.C. 2239). Subpart M also issued under sec. 184 (42 U.S.C. 2234) and sec. 189, 68 stat. 955 (42 U.S.C. 2239). Appendix A also issued under sec. 6, Pub. L. 91-560, 84 Stat. 1473 (42 U.S.C. 2135).
2. In § 2.110, paragraph (a) is revised to read as follows:
§ 2.110
Filing and administrative action on submittals for design review or early review of site suitability issues.
(a)(1) A submittal under subpart E of part 52 of this chapter must be subject to §§ 2.101(a) and 2.790 to the same extent as if it were an application for a permit or license.
(2) Except as specifically provided otherwise by the provisions of subpart B to part 52 of this chapter, a submittal under subpart B must be subject to § 2.101(a) (2) through (4) to the same extent as if it were an application for a permit or license.
3. Section 2.400 is revised to read as follows:
§ 2.400
Scope of subpart.
This subpart describes procedures applicable to licensing proceedings that involve the consideration in hearings of a number of applications, filed by one or more applicants pursuant to subpart I of part 52 of this chapter, for licenses to construct and operate nuclear power reactors of essentially the same design to be located at different sites.
4. Section 2.401 is revised to read as follows:
§ 2.401
Notice of hearing on applications under Subpart I of Part 52 for construction permits.
(a) In the case of applications under subpart I of part 52 of this chapter for construction permits for nuclear power reactors of the type described in § 50.22 of this chapter, the Secretary will issue notices of hearing under § 2.104.
(b) The notice of hearing will also state the time and place of the hearings on any separate phase of the proceeding.
5. In § 2.402, paragraph (a) is revised to read as follows:
§ 2.402
Separate hearings on separate issues; consolidation of proceedings.
(a) In the case of applications under subpart I of part 52 of this chapter for construction permits for nuclear power reactors of a type described in § 50.22 of this chapter, the Commission or the presiding officer may order separate hearings on particular phases of the proceeding, such as matters related to the acceptability of the design of the reactor, in the context of the site parameters postulated for the design; environmental matters; or antitrust aspects of the application.
6. Section 2.403 is revised to read as follows:
§ 2.403
Notice of proposed action on applications for operating licenses under Subpart I of Part 52.
In the case of applications under subpart I of part 52 of this chapter for operating licenses for nuclear power reactors, if the Commission has not found that a hearing is in the public interest, the Director of Nuclear Reactor Regulation will, prior to acting thereon, cause to be published in the
Federal Register
, under § 2.105, a notice of proposed action with respect to each
application as soon as practicable after the applications have been docketed.
7. Section 2.404 is revised to read as follows:
§ 2.404
Hearings on applications for operating licenses under Subpart I of Part 52.
If a request for a hearing and/or petition for leave to intervene is filed within the time prescribed in the notice of proposed action on an application for an operating license under subpart I of part 52 of this chapter with respect to a specific reactor(s) at a specific site and the Commission or an atomic safety and licensing board designated by the Commission or by the Chairman of the Atomic Safety and Licensing Board Panel has issued a notice of hearing or other appropriate order, the Commission or the atomic safety and licensing board may order separate hearings on particular phases of the proceeding and/or consolidate for hearing two or more proceedings in the manner described in § 2.402.
8. Section 2.406 is revised to read as follows:
§ 2.406
Finality of decisions on separate issues.
Notwithstanding any other provision of this chapter, in a proceeding conducted under this subpart and subpart I of part 52 of this chapter, no matter which has been reserved for consideration in one phase of the hearing shall be considered at another phase of the hearing except on the basis of significant new information that substantially affects the conclusion(s) reached at the other phase or other good cause.
9. Section 2.500 is revised to read as follows:
§ 2.500
Scope of subpart.
This subpart prescribes procedures applicable to licensing proceedings which involve the consideration in separate hearings of an application for a license to manufacture nuclear power reactors under subpart H of part 52 of this chapter, and applications for construction permits and operating licenses for nuclear power reactors which have been the subject of such an application for a license to manufacture such facilities (manufacturing license).
10. In § 2.501, paragraphs (a), (b)(1)(vii) and (b)(3) are revised to read as follows:
§ 2.501
Notice of hearing on application under Subpart H of Part 52 for a license to manufacture nuclear power reactors.
(a) In the case of an application under subpart H of part 52 of this chapter for a license to manufacture nuclear power reactors of the type described in § 50.22 of this chapter to be operated at sites not identified in the license application, the Secretary shall issue a notice of hearing to be published in the
Federal Register
at least thirty (30) days prior to the date set for hearing in the notice. The notice must be issued as soon as practicable after the application has been docketed. The notice will state:
(1) The time, place, and nature of the hearing and/or the prehearing conference;
(2) The authority within which the hearing is to be held;
(3) The matters of fact and law to be considered; and
(4) The time within which answers to the notice shall be filed.
(b) * * *
(1) * * *
(vii) Whether, in accordance with the requirements of subpart A of part 51 and subpart H of part 52 of this chapter, the license should be issued as proposed.
(3) That, regardless of whether the proceeding is contested or uncontested, the presiding officer will, in accordance with subpart A of part 51 and § 52.245(b) of this chapter,
11. Section 2.502 is revised to read as follows:
§ 2.502
Notice of hearing on application for a permit to construct a nuclear power reactor manufactured under a Commission license issued under subpart H of part 52 of this chapter at the site at which the reactor is to be operated.
The issues stated for consideration in the notice of hearing on an application for a permit to construct a nuclear power reactor(s) which is the subject of an application for a manufacturing license under subpart H of part 52 of this chapter, will be those stated in § 2.104(b) and, in addition, whether the site on which the facility is to be operated falls within the postulated site parameters specified in the relevant application for a manufacturing license.
PART 20—STANDARDS FOR PROTECTION AGAINST RADIATION
12. The authority citation for part 20 continues to read as follows:
Authority:
Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
13. Section 20.1002 is revised to read as follows:
§ 20.1002
Scope.
The regulations in this part apply to persons licensed by the Commission to receive, possess, use, transfer, or dispose of byproduct, source, or special nuclear material or to operate a production or utilization facility under parts 30 through 36, 39, 40, 50, 52, 60, 61, 70, or 72 of this chapter, and in accordance with 10 CFR 76.60 to persons required to obtain a certificate of compliance or an approved compliance plan under part 76 of this chapter. The limits in this part do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with 10 CFR 35.75, or to exposure from voluntary participation in medical research programs.
PART 21—REPORTING OF DEFECTS AND NONCOMPLIANCE
14. The authority citation for part 21 continues to read as follows:
Authority:
Sec. 161, 68 Stat. 948, as amended, sec. 234, 83 Stat. 444, as amended, sec. 1701, 106 Stat. 2951, 2953 (42 U.S.C. 2201, 2282, 2297f); secs. 201, as amended, 206, 88 Stat. 1242, as amended, 1246 (42 U.S.C. 5841, 5846).
Section 21.2 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
15. In § 21.2, paragraphs (a), (b), and (c) are revised to read as follows:
§ 21.2
Scope.
(a) The regulations in this part apply, except as specifically provided otherwise in Parts 31, 34, 35, 39, 40, 60, 61, 63, 70, or Part 72 of this chapter, to:
(1) Each individual, partnership, corporation, or other entity licensed pursuant to the regulations in this chapter to possess, use, or transfer within the United States source material, byproduct material, special nuclear material, and/or spent fuel and high-level radioactive waste, or to construct, manufacture, possess, own, operate, or transfer within the United States, any production or utilization facility or independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation (MRS); and each director and responsible officer of such a licensee; and
(2) Each individual, corporation, partnership, or other entity doing business within the United States, and each director and responsible officer of such organization, that holds a permit or license under part 52 of this chapter or constructs a production or utilization
facility licensed for the manufacture, construction, or operation pursuant to part 50 or part 52 of this chapter, an ISFSI for the storage of spent fuel licensed pursuant to part 72 of this chapter, an MRS for the storage of spent fuel or high-level radioactive waste pursuant to part 72 of this chapter, or a geologic repository for the disposal of high-level radioactive waste under part 60 or 63 of this chapter; or supplies basic components for a facility or activity licensed, other than for export, under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or part 72 of this chapter.
(b) For persons licensed to construct a facility under either a construction permit issued under § 50.23 of this chapter or a combined license issued under § 52.227 of this chapter, or approved to hold a permit for a site or sites for one or more nuclear power facilities under § 52.24 of this chapter, evaluation of potential defects and failures to comply and reporting of defects and failures to comply under § 50.55(e) of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects and failures to comply under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.
(c) For persons licensed to operate a nuclear power plant under part 50 or part 52 of this chapter, evaluation of potential defects and appropriate reporting of defects under §§ 50.72, 50.73 or § 73.71 of this chapter satisfies each person's evaluation, notification, and reporting obligation to report defects under this part and the responsibility of individual directors and responsible officers of such licensees to report defects under section 206 of the Energy Reorganization Act of 1974.
16. Section 21.3 is revised to read as follows:
§ 21.3
Definitions.
As used in this part:
Basic component.
(1)(i) When applied to nuclear power plants licensed pursuant to 10 CFR part 50 or part 52 of this chapter, basic component means a structure, system, or component, or part thereof that affects its safety function necessary to assure:
(A) The integrity of the reactor coolant pressure boundary;
(B) The capability to shut down the reactor and maintain it in a safe shutdown condition; or
(C) The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to those referred to in § 50.34(a)(1), § 50.67(b)(2), or § 100.11 of this chapter, as applicable.
(ii) Basic components are items designed and manufactured under a quality assurance program complying with 10 CFR part 50, appendix B, or commercial grade items which have successfully completed the dedication process.
(2) When applied to other facilities and when applied to other activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee of a facility or activity subject to the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard.
(3) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.
Commercial grade item.
(1) When applied to nuclear power plants licensed pursuant to 10 CFR part 50 or part 52, commercial grade item means a structure, system, or component, or part thereof that affects its safety function, that was not designed and manufactured as a basic component. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected (i.e., one or more critical characteristics of the item cannot be verified).
(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72, commercial grade item means an item that is:
(i) Not subject to design or specification requirements that are unique to those facilities or activities;
(ii) Used in applications other than those facilities or activities; and
(iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).
Commission
means the Nuclear Regulatory Commission or its duly authorized representatives.
Constructing
or
construction
means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to the regulations in this part and consulting services related to the facility or activity that are safety related.
Critical characteristics.
When applied to nuclear power plants licensed pursuant to 10 CFR part 50 or part 52, critical characteristics are those important design, material, and performance characteristics of a commercial grade item that, once verified, will provide reasonable assurance that the item will perform its intended safety function.
Dedicating entity.
When applied to nuclear power plants licensed pursuant to 10 CFR part 50 or part 52, dedicating entity means the organization that performs the dedication process. Dedication may be performed by the manufacturer of the item, a third-party dedicating entity, or the licensee. The dedicating entity, pursuant to § 21.21(c) of this part, is responsible for identifying and evaluating deviations, reporting defects and failures to comply for the dedicated item, and maintaining auditable records of the dedication process.
Dedication.
(1) When applied to nuclear power plants licensed pursuant to 10 CFR part 50 or part 52, dedication is an acceptance process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended safety function and, in this respect, is deemed equivalent to an item designed and manufactured under a 10 CFR part 50, appendix B, quality assurance program. This assurance is achieved by identifying the critical characteristics of the item and verifying their acceptability by inspections, tests, or analyses performed by the purchaser or third-party dedicating entity after delivery, supplemented as necessary by one or more of the following: commercial grade surveys; product inspections or witness at holdpoints at the manufacturer's facility, and analysis of historical records for acceptable performance. In all cases, the dedication process must be conducted in accordance with the applicable provisions of 10 CFR part 50, appendix B. The process is considered complete when the item is designated for use as a basic component.
(2) When applied to facilities and activities licensed pursuant to 10 CFR parts 30, 40, 50 (other than nuclear
power plants), 60, 61, 63, 70, 71, or 72, dedication occurs after receipt when that item is designated for use as a basic component.
Defect
means: (1) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to the regulations in this part if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or
(2) The installation, use, or operation of a basic component containing a defect as defined in this section; or
(3) A deviation in a portion of a facility subject to the construction permit or manufacturing licensing requirements of part 50 or part 52 of this chapter provided the deviation could, on the basis of an evaluation, create a substantial safety hazard and the portion of the facility containing the deviation has been offered to the purchaser for acceptance; or
(4) A condition or circumstance involving a basic component that could contribute to the exceeding of a safety limit, as defined in the technical specifications of a license for operation issued pursuant to part 50 or part 52 of this chapter.
Deviation
means a departure from the technical requirements included in a procurement document.
Director
means an individual, appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, director means the individual.
Discovery
means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in § 21.21(a).
Evaluation
means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.
Notification
means the telephonic communication to the NRC Operations Center or written transmittal of information to the NRC Document Control Desk.
Operating
or
operation
means the operation of a facility or the conduct of a licensed activity which is subject to the regulations in this part and consulting services related to operations that are safety related.
Procurement document
means a contract that defines the requirements which facilities or basic components must meet in order to be considered acceptable by the purchaser.
Responsible officer
means the president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this part.
Substantial safety hazard
means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to public health and safety for any facility or activity licensed, other than for export, pursuant to parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of this chapter.
Supplying
or
supplies
means contractually responsible for a basic component used or to be used in a facility or activity which is subject to the regulations in this part.
17. Section 21.21 is revised to read as follows:
§ 21.21
Notification of failure to comply or existence of a defect and its evaluation.
(a) Each individual, corporation, partnership, dedicating entity, or other entity subject to the regulations in this part shall adopt appropriate procedures to—
(1) Evaluate deviations and failures to comply to identify defects and failures to comply associated with substantial safety hazards as soon as practicable, and, except as provided in paragraph (a)(2) of this section, in all cases within 60 days of discovery, in order to identify a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, and
(2) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within 60 days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the Commission through a director or responsible officer or designated person as discussed in § 21.21(d)(5). The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within 60 days of discovery of the deviation or failure to comply.
(3) Ensure that a director or responsible officer subject to the regulations of this part is informed as soon as practicable, and, in all cases, within the 5 working days after completion of the evaluation described in § 21.21(a)(1) if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity—
(i) Fails to comply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Commission relating to a substantial safety hazard, or
(ii) Contains a defect.
(b) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to § 21.21(a).
(c) A dedicating entity is responsible for—
(1) Identifying and evaluating deviations and reporting defects and failures to comply associated with substantial safety hazards for dedicated items; and
(2) Maintaining auditable records for the dedication process.
(d)(1) A director or responsible officer subject to the regulations of this part or a person designated under § 21.21(d)(5) must notify the Commission when he or she obtains information reasonably indicating a failure to comply or a defect affecting—
(i) The construction or operation of a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of this chapter and that is within his or her organization's responsibility; or
(ii) A basic component that is within his or her organization's responsibility and is supplied for a facility or an activity within the United States that is subject to the licensing requirements under parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72 of this chapter.
(2) The notification to NRC of a failure to comply or of a defect under paragraph (d)(1) of this section and the evaluation of a failure to comply or a deviation under paragraph (a)(1) of this section, are not required if the director or responsible officer has actual knowledge that the Commission has been notified in writing of the defect or the failure to comply.
(3) Notification required by paragraph (d)(1) of this section must be made as follows—
(i) Initial notification by facsimile, which is the preferred method of notification, to the NRC Operations Center at (301) 816-5151 or by
telephone at (301) 816-5100 within two days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this section, on the identification of a defect or a failure to comply. Verification that the facsimile has been received should be made by calling the NRC Operations Center. This paragraph does not apply to interim reports described in § 21.21(a)(2).
(ii) Written notification to the NRC at the address specified in § 21.5 within 30 days following receipt of information by the director or responsible corporate officer under paragraph (a)(3) of this section, on the identification of a defect or a failure to comply.
(4) The written report required by this paragraph must include, but need not be limited to, the following information, to the extent known:
(i) Name and address of the individual or individuals informing the Commission.
(ii) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect.
(iii) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.
(iv) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
(v) The date on which the information of such defect or failure to comply was obtained.
(vi) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part.
(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
(viii) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.
(5) The director or responsible officer may authorize an individual to provide the notification required by this paragraph, provided that, this shall not relieve the director or responsible officer of his or her responsibility under this paragraph.
(e) Individuals subject to this part may be required by the Commission to supply additional information related to a defect or failure to comply. Commission action to obtain additional information may be based on reports of defects from other reporting entities.
PART 50—DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES
18. The authority citation for part 50 continues to read as follows:
Authority:
Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 50.10 also issued under secs. 101, 185, 68 Stat. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.13, 50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80-50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
19. In § 50.8, paragraph (b) is revised to read as follows:
§ 50.8
Information collection requirements: OMB approval.
(b) The approved information collection requirements contained in this part appear in §§ 50.30, 50.33, 50.33a, 50.34, 50.34a, 50.35, 50.36, 50.36a, 50.36b, 50.44, 50.46, 50.47, 50.48, 50.49, 50.54, 50.55, 50.55a, 50.59, 50.60, 50.61, 50.62, 50.63, 50.64, 50.65, 50.66, 50.68, 50.71, 50.72, 50.74, 50.75, 50.80, 50.82, 50.90, 50.91, 50.120, and appendices A, B, E, G, H, I, J, K, R, and S to this part.
20. In § 50.109, paragraph (a)(1) is revised to read as follows:
§ 50.109
Backfitting.
(a)(1) Backfitting is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position after:
(i) The date of issuance of the construction permit for the facility for facilities having construction permits issued after October 21, 1985; or
(ii) Six months before the date of docketing of the operating license application for the facility for facilities having construction permits issued before October 21, 1985; or
(iii) The date of issuance of the operating license for the facility for facilities having operating licenses; or
(iv) The date of issuance of the design approval under subpart E of part 52 of this chapter;
(v) The date of issuance of a manufacturing license under subpart H of part 52 of this chapter;
(vi) The date of issuance of the first construction permit issued for a duplicate design under subpart I of part 52 of this chapter; or
(vii) The date of issuance of a combined license under subpart G of part 52 of this chapter, provided that if the combined license references an early site permit, the provisions in § 52.39 apply with respect to the site characteristics, terms, and conditions of the early site permit. If the combined license references an early site review, the provisions in § 52.47 apply with respect to the staff site report. If the combined license references a design certification rule, the provisions in § 52.127(a) apply with respect to the design matters resolved in the design certification.
Appendix M to Part 50 [Removed]
21. Appendix M to Part 50 is removed.
Appendix N to Part 50 [Removed]
22. Appendix N to Part 50 is removed.
Appendix O to Part 50 [Removed]
23. Appendix O to Part 50 is removed.
Appendix Q to Part 50 [Removed]
24. Appendix Q to Part 50 is removed.
PART 51—ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS
25. The authority citation for Part 51 continues to read as follows:
Authority:
Sec. 161, 68 Stat. 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953, (42 U.S.C. 2201, 2297f); secs. 201, as amended, 202, 88 Stat. 1242, as amended,
1244 (42 U.S.C. 5841, 5842). Subpart A also issued under National Environmental Policy Act of 1969, secs. 102, 104, 105, 83 Stat. 853-854, as amended (42 U.S.C. 4332, 4334, 4335); and Pub. L. 95-604, Title II, 92 Stat. 3033-3041; and sec. 193, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 2243). Sections 51.20, 51.30, 51.60, 51.80. and 51.97 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241, and sec. 148, Pub. L. 100-203, 101 Stat. 1330-223 (42 U.S.C. 10155, 10161, 10168). Section 51.22 also issued under sec. 274, 73 Stat. 688, as amended by 92 Stat. 3036-3038 (42 U.S.C. 2021) and under Nuclear Waste Policy Act of 1982, sec. 121, 96 Stat. 2228 (42 U.S.C. 10141). Sections 51.43, 51.67, and 51.109 also under Nuclear Waste Policy Act of 1982, sec. 114(f), 96 Stat. 2216, as amended (42 U.S.C. 10134(f)).
26. In § 51.20, paragraph (b)(6) is revised to read as follows:
§ 51.20
Criteria for and identification of licensing and regulatory actions requiring environmental impact statements.
(b) * * *
(6) Issuance of a license to manufacture pursuant to Subpart H of Part 52 of this chapter.
27. Part 52 is revised to read as follows:
PART 52—ADDITIONAL LICENSING PROCESSES FOR NUCLEAR POWER PLANTS
General Provisions
Sec.
52.1
Scope.
52.3
Definitions.
52.5
Applicability of 10 CFR Part 50 provisions.
52.8
Information collection requirements: OMB approval.
Subpart A—Early Site Permits
52.11
Scope of subpart.
52.13
Relationship to Subpart F of 10 CFR Part 2 and Subpart B of this part.
52.15
Filing of applications.
52.17
Contents of applications.
52.18
Standards for review of applications.
52.19
Applicability of NRC requirements.
52.21
Hearings.
52.23
Referral to the ACRS.
52.24
Issuance of early site permit.
52.25
Extent of activities permitted.
52.27
Duration of permit.
52.28
Transfer of early site permit.
52.29
Application for renewal.
52.31
Criteria for renewal.
52.33
Duration of renewal.
52.35
Use of site for other purposes.
52.37
Reporting of defects and noncompliance; revocation, suspension, modification of permits for cause.
52.39
Finality of early site permit determinations.
Subpart B—Early Site Reviews
52.41
Scope of subpart.
52.43
Filing and contents of applications.
52.45
Notice of application.
52.46
Referral to the ACRS.
52.47
Issuance of site report.
52.49
Relationship to other subparts.
Subpart C—[Reserved]
Subpart D—Standard Design Certifications
52.101
Scope of subpart.
52.103
Relationship to other subparts.
52.105
Filing of applications.
52.107
Contents of applications.
52.109
Standards for review of applications.
52.111
Applicability of NRC requirements.
52.113
Administrative review of applications.
52.115
Referral to the ACRS.
52.117
Issuance of standard design certification.
52.119
Duration of certification.
52.121
Application for renewal.
52.123
Criteria for renewal.
52.125
Duration of renewal.
52.127
Finality of standard design certifications.
Subpart E—Standard Design Approvals
52.131
Scope of subpart.
52.133
Filing of applications.
52.135
Contents of applications.
52.137
Referral to the ACRS.
52.139
Staff approval of design.
52.141
Finality of the design approval.
52.143
Information requests.
Subpart F—[Reserved]
Subpart G—Combined Licenses
52.201
Scope of subpart.
52.203
Relationship to other subparts.
52.205
Filing of applications.
52.207
Contents of applications; general information.
52.209
Contents of applications; training and qualification of nuclear power plant personnel.
52.211
Contents of applications; technical information.
52.213
Standards for review of applications.
52.215
Applicability of NRC requirements.
52.217
Administrative review of applications.
52.219
Referral to the ACRS.
52.221
Environmental review.
52.223
Authorization to conduct site activities.
52.225
Exemptions and variances.
52.227
Issuance of combined licenses.
52.229
Inspection during construction.
52.231
Operation under a combined license.
Subpart H—Manufacturing Licenses
52.241
Scope of subpart.
52.243
Relationship to other subparts.
52.245
Filing and contents of applications.
52.247
Standards for review of applications.
52.249
Applicability of NRC requirements.
52.251
Referral to the ACRS.
52.253
Issuance of manufacturing license.
52.255
Duration of design approval.
52.257
Finality of the manufacturing license.
Subpart I—Duplicate Design Licenses
52.261
Scope of subpart.
52.263
Relationship to other subparts.
52.265
Filing and contents of applications.
Subpart J—[Reserved]
Subpart K—[Reserved]
Subpart L—[Reserved]
Subpart M—Enforcement
52.401
Violations.
52.403
Criminal penalties.
APPENDIX A—Design Certification Rule for the U.S. Advanced Boiling Water Reactor
APPENDIX B—Design Certification Rule for the System 80+ Design
APPENDIX C—Design Certification Rule for the AP600 Design
Authority:
Secs. 103, 104, 161, 182, 183, 186, 189, 68 Stat. 936, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2133, 2201, 2232, 2233, 2236, 2239, 2282); secs. 201, 202, 206, 88 Stat. 1242, 1244, 1246, as amended (42 U.S.C. 5841, 5842, 5846).
General Provisions
§ 52.1
Scope.
This part governs the issuance of early site permits and staff site reports, design approvals and certifications, and combined, manufacturing, and duplicate design licenses for nuclear power facilities licensed under section 103 or 104b of the Atomic Energy Act of 1954, as amended (68 Stat. 919), and Title II of the Energy Reorganization Act of 1974 (88 Stat. 1242). This part also gives notice to all persons who knowingly provide to any licensee, holder of, or applicant for an approval, certification, permit, site report, or license, or to a contractor, subcontractor, or consultant of any of them, components, equipment, materials, or other goods or services, that relate to the activities of a licensee, holder of, or applicant for an approval, certification, permit, site report, or license, subject to this part, that they may be individually subject to NRC enforcement action for violation of the provisions in 10 CFR 50.5.
§ 52.3
Definitions.
(a) As used in this part—
Combined license
means a combined construction permit and operating license with conditions for a nuclear power facility issued pursuant to subpart C of this part.
Early site permit
means a Commission approval, issued pursuant to subpart A of this part, for a site or sites for one or more nuclear power facilities.
Modular design
means a nuclear power station that
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