POLICY ISSUE

NOTATION VOTE

April 15, 2002 SECY-02-0067

FOR: The Commissioners

FROM: William D. Travers

Executive Director for Operations

SUBJECT: INSPECTIONS, TESTS, ANALYSES, AND ACCEPTANCE CRITERIA (ITAAC)

FOR OPERATIONAL PROGRAMS (PROGRAMMATIC ITAAC)

PURPOSE:

To request the Commission’s approval that applications for combined licenses (COLs) for a

nuclear power plant submitted in accordance with the requirements of Title 10 of the Code of

Federal Regulations (10 CFR) Part 52 Subpart C contain inspections, tests, analyses, and

acceptance criteria (ITAAC) for operational programs required by regulations such as training

and emergency planning (so-called programmatic ITAAC). The Commission asked the staff

for a recommendation in its September 6, 2000, staff requirements memorandum (SRM) for

SECY-00-0092, “Combined License Review Process,” dated April 20, 2000.

BACKGROUND:

Subpart C of 10 CFR Part 52 sets forth a process for issuing a COL for a nuclear power

facility. A COL authorizes construction and subject to conditions precedent, operation of a

nuclear power facility. Subsection (c) of 10 CFR Section 52.79 requires that the COL

application include ITAAC that are necessary and sufficient to demonstrate that the facility

has been constructed and will operate in conformity with the COL, the Atomic Energy Act of

1954, as amended, and the Commission’s regulations. Subsection (g) of 10 CFR 52.103

requires that the Commission find that the acceptance criteria in the COL have been met

before a facility is authorized to operate.

CONTACTS:

Joseph M. Sebrosky, NRR 

415-1132

Robert M. Weisman, OGC 

415-1696
The Commissioners - 2 -

In SECY-00-0092 the staff provided a basis for its stated position that programmatic ITAAC

are necessary to meet the requirements of 10 CFR Part 52 and the Atomic Energy Act. In the

SRM on SECY-00-0092, the Commission provided guidance to the staff in this area and

directed that the “staff should formally provide the Commission with a recommendation as to

how to proceed on programmatic ITAAC, the basis for this recommendation, a discussion of

alternatives proposed by stakeholders, a legal analysis supporting the recommendation, and a

thorough description of how the staff would implement its recommendation.” The SRM also

directed the staff to seek comment and continue to work with stakeholders on the need for and

the scope of the ITAAC for programmatic areas. The staff sought stakeholder input on this

issue through a Federal Register Notice issued on June 25, 2001 (66 FR 33718). 

DISCUSSION:

Attachment 1 to this SECY paper is the staff’s response to the Commission’s SRM. 

Attachment 2 contains a brief history of the issue to place the arguments for and against

programmatic ITAAC in perspective. Attachment 3 is an example of a programmatic ITAAC

from the design certification for the AP600. Attachment 4 is an illustrative example ITAAC on

emergency planning from SECY-95-090, “Emergency Planning Under 10 CFR Part 52.”

These examples give a sense of how the staff has developed, and will develop, programmatic

ITAAC.

RECOMMENDATIONS:

Consistent with its recommendation in SECY-00-0092, the staff recommends that COL

applications for nuclear power plants submitted in accordance with the requirements of

10 CFR Part 52 Subpart C must contain ITAAC for operational programs required by

regulations such as training and emergency planning, to the extent that such ITAAC are

necessary and sufficient to support the finding 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. The staff will work with its stakeholders to develop ITAAC

for these and other areas.

RESOURCES:

The resources to develop ITAAC in these areas are in the NRR budget as part of the new

reactor licensing budget.
The Commissioners - 3 -

COORDINATION:

The Office of the General Counsel has no legal objections to this paper.

/RA/

William D. Travers

Executive Director

 for Operations

Attachments: 1. ITAAC for Operational Programs

2. History of ITAAC

3. Design Reliability Assurance Program ITAAC From the AP600 Certified

Design

4. Illustrative ITAAC on Emergency Planning from SECY-95-090
Attachment 1

COORDINATION:

The Office of the General Counsel has no legal objections to this paper.

/RA/

William D. Travers

Executive Director

 for Operations

Attachments: 1. ITAAC for Operational Programs

2. History of ITAAC

3. Design Reliability Assurance Program ITAAC From the AP600 Certified

Design

4. Illustrative ITAAC on Emergency Planning from SECY-95-090

Accession #ML020700641 *See previous concurrence

OFC NRLPO Tech Ed BC:IIPB DD:NRLPO D:NRLPO

NAME JSebrosky PKleene MJohnson* MGamberoni JLyons

DATE / /02 3/4/02 3/12/02 04/05/02 04/05/02

NRR LT OGC NRR ET DEDRP EDO

NAME J. Lyons J. Moore WBorchardt WKane WTravers

DATE 04/05/02 04/05/02 04/09/02 04/15/02 04/15/02

OFFICIAL RECORD COPY
Attachment 1

Inspections, Tests, Analyses, and

Acceptance Criteria for

Operational Programs
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Table of Contents

I. Background ............................................................. 1

I.a Description of the Issue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

I.b Discussion of June 2001 Federal Register Notice Comments . . . . . . . . . . . . . . . . 3

Summary and Discussion of Comments and Alternatives Proposed by

Stakeholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Interpretation of the Energy Policy Act of 1992 ........................ 4

Licensing Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Regulatory Bases for Required Commission Findings . . . . . . . . . . . . . . . . . . . 7

ITAAC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Other Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

II. Discussion ............................................................. 8

II.a Recommendation for Programmatic ITAAC and Basis for Recommendation . . . 9

II.b Office of the General Counsel Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

II.c Implementation Recommendation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
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I. Background

Subpart C of 10 CFR Part 52 sets forth a process for issuing a combined license (COL) for a

nuclear power facility. A COL authorizes construction and subject to conditions precedent,

operation of a nuclear power facility. Subsection (c) of 10 CFR Section 52.79 requires that

the COL application include ITAAC that are necessary and sufficient to demonstrate that the

facility has been constructed and will operate in conformity with the COL, the Atomic Energy

Act of 1954, as amended, and the Commission’s regulations. Subsection (g) of 10 CFR

52.103 requires that the Commission find that the acceptance criteria in the COL have been

met before a facility is authorized to operate.

In SECY-00-0092, “Combined License Review Process,” dated April 20, 2000, the staff 

provided a basis for its stated position that programmatic ITAAC are necessary to meet the

requirements of 10 CFR Part 52 and the Atomic Energy Act. In the SRM on SECY-00-0092 

the Commission asked the staff to seek comment on and continue to work with stakeholders

on the need for and scope of the ITAAC for programmatic areas. The NRC accordingly sought

public comments on this issue through a Federal Register Notice (FRN) dated June 25, 2001. 

The SRM also directed the staff to provide the Commission a formal recommendation on how

to proceed with programmatic ITAAC, the basis for this recommendation, a discussion of

alternatives proposed by stakeholders, a legal analysis supporting the recommendation, and a

thorough description of how the staff would implement its recommendation. The alternatives

proposed by stakeholders are discussed in Section I.b of this attachment, along with the

comments in response to the FRN. The other items are discussed In Sections II.a through II.c. 

The staff believes that the interpretation of 10 CFR 52.79(c) and section 185b. of the Atomic

Energy Act are key to the resolution of this issue. These requirements are discussed

throughout the paper. As a matter of reference the staff quotes these requirements below. 

The first sentence of 10 CFR 52.79(c) states the following:

The application for a combined license must include the proposed inspections,

tests, and analyses, including those applicable to emergency planning, which

the licensee shall perform and the acceptance criteria therefor which are

necessary and sufficient to provide reasonable assurance that, it the

inspections, tests and analyses are performed and the acceptance criteria met,

the facility has been constructed and will operate in conformity with the

combined license, the provisions of the Atomic Energy Act, and the NRC’s

regulations. 

In the Energy Policy Act of 1992, Congress amended section 185 of the Atomic Energy Act to

add a new section 185b., which provides for the issuance of COLs containing ITAAC. 

Section 185b. states:

After holding a public hearing under section 189a.(1)(A), the Commission shall

issue to the applicant a combined construction and operating license if the

application contains sufficient information to support the issuance of a combined

license and the Commission determines that there is reasonable assurance that

the facility will be constructed and will operate in conformity with the license, the

provisions of this Act, and the Commission’s rules and regulations. The

Commission shall identify within the combined license the inspections, tests,

and analyses, including those applicable to emergency planning, that the
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licensee shall 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

this Act, and the Commission’s rules and regulations. Following issuance of the

combined license, the Commission shall ensure that the prescribed inspections,

test, and analyses are performed and, prior to operation of the facility, shall find

that the prescribed acceptance criteria are met. Any finding made under this

subsection shall not require a hearing except as provided in section 189a.(1)(B).

I.a Description of the Issue

In SECY-00-0092 the staff described the issue as follows:

Because ITAAC are the sole source of acceptance criteria, it is essential that the

COL ITAAC include all significant issues that require satisfactory resolution

before fuel loading. The COL ITAAC consist of the ITAAC from the referenced

Design Control Document (Tier 1 information), plus the ITAAC resulting from the

COL proceeding, which include the ITAAC for the site-specific design information

and the regulations applicable to a COL applicant. 

In SECY-00-0092 the staff also addressed the Nuclear Energy Institute’s (NEI’s) argument that

the intent of Part 52 and Congress was that COL ITAAC pertain only to hardware and

design-related issues and that ITAAC on “programmatic topics” are neither required nor

preferred:

The Energy Policy Act of 1992 and Part 52 [Sections 52.79(c) and 52.97(b)(1)]

clearly require that ITAAC must verify that applicable regulations have been met

before a facility can be authorized to operate. These regulations make no

distinction between hardware and design-related issues, versus “programmatic

topics.” Thus, the so-called “programmatic” ITAAC (i.e., emergency plans) are

consistent with the licensing process in Part 50 [Section 50.57(a)(1)] and were

included by Congress and understood by the Commission to be prerequisites

for operation under a COL. In addition, the NRC has already approved socalled “programmatic” ITAAC as part of the design certification process and,

therefore, [ITAAC] are required to be successfully completed before the

Commission can authorize operation. In conclusion, “programmatic” ITAAC are

necessary to meet the requirements of 10 CFR Part 52 and the 1954 Act. 

In a May 14, 2001, letter NEI gave its interpretation of the regulations for COL ITAAC:

In SECY-00-0092, the NRC staff interprets the 1992 Energy Policy Act and

Part 52 to require that COLs contain ITAAC on operational programs. Our

longstanding interpretation of these requirements is that COL ITAAC may and

should be focused on verifying the proper construction of the plant and that

ITAAC on operational programs are not required. Our strong preference for this

view is based on the underlying intent and objectives of Congress and Part 52

as well as important policy considerations, including continued reliance on the

existing NRC inspection and oversight activities.

History of ITAAC
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Because of the staff’s disagreement with NEI on the interpretation of 10 CFR Part 52 and the

1992 Energy Policy Act a history of the development of ITAAC is provided in Attachment 2. 

The staff believes that the history of the development of ITAAC is consistent with, and

supports, the staff’s recommendation discussed in Section II.a.

I.b Discussion of June 2001 Federal Register Notice Comments

In the September 5, 2000, SRM on SECY-00-0092 the Commission provided guidance to the

staff in the area of programmatic ITAAC and directed that “in connection with the Part 52

rulemaking, the staff should specifically seek comment on and continue to work with

stakeholders on the need for and scope of the ITAAC for programmatic areas.” As noted in

the SRM, the staff originally intended to solicit comments on this issue as part of the

10 CFR Part 52 rulemaking update. However, in a May 14, 2001, letter, NEI provided its views

on the issue of programmatic ITAAC and requested “early resolution of this issue to allow

licensees, the NRC, and other stakeholders to be clear on how key Part 52 requirements on

the scope of COL ITAAC are to be met.” 

Accordingly, the NRC staff sought comments on the need for and scope of ITAAC for

programmatic areas separate from the Part 52 update rulemaking through an FRN published

on June 25, 2001 (66 FR 33718). The staff also sent letters and in some cases made phone

calls to the following stakeholders to inform them about the issue and request comment:

Westinghouse, Department of Energy, Electric Power Research Institute, General Electric,

Nuclear Information and Resource Service, Union of Concerned Scientists, NEI, and Public

Citizen. The staff also used the occasion of a July 2001 workshop on future licensing to ask

for comments on the issue.

The staff received 13 comment letters in response to the FRN: 10 of the comment letters were

from industry, 2 comment letters were from the Illinois Department of Nuclear Safety (IDNS),

and 1 comment letter was received from the public interest group, Public Citizen. The

comment letters from industry included 2 letters from Exelon, and letters from: NEI, Southern

Company, Tennessee Valley Authority, General Electric, Entergy, Westinghouse, Dominion,

and PSEG Nuclear. In its July 31, 2001, comment letter NEI repeated the position stated in its

May 14, 2001, letter. All of the industry comment letters endorsed NEI’s May 14, 2001, letter. 

Public Citizen’s and the IDNS’s letters provide a different interpretation of the requirements

contained in 10 CFR 52.79(c) and the Atomic Energy Act than that found in NEI’s

May 14, 2001, letter.

Summary and Discussion of Comments and Alternatives Proposed by Stakeholders

The SRM on SECY-00-0092 directed the staff to provide the Commission with a discussion of

the alternatives proposed by stakeholders for programmatic ITAAC. The alternatives are

discussed here because the comments in response to the FRN also proposed alternatives. 

The comments fit into the following categories:

 interpretation of the Energy Policy Act of 1992

 the licensing process

 regulatory bases for required Commission findings
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 ITAAC compliance

 other comments

Interpretation of the Energy Policy Act of 1992

NEI and IDNS discussed the interpretation of the Energy Policy Act of 1992. NEI asked the

following question in its comment letter, “Is the NRC’s staff’s interpretation of the statutory

requirement the only reasonable interpretation and, if not, does a different interpretation make

more sense from a policy perspective?”

NEI’s discussion of the Energy Policy Act, its legislative history, and the SOCs support NEI’s

interpretation that ITAAC are intended to demonstrate that the design approved by the NRC

was properly constructed (i.e., that the ITAAC are intended to focus on “hardware”). NEI also

believes that the inclusion of the requirement for emergency planning ITAAC in the Energy

Policy Act is not “dispositive” either way. NEI wrote: 

It is not unreasonable to assume, therefore, that the Congressional intent was

formed by experiences in Part 50 operating license proceedings where

emergency planning became a pivotal issue (e.g., Shoreham, Seabrook). As a

result, the inclusion of emergency planning ITAAC most likely was an expression

of interest in ensuring that fundamental decisions of site suitability for emergency

planning purposes were resolved at the COL stage. 

NEI contends that ITAAC developed for emergency planning should be hardware-oriented.

The staff also received a comment from the IDNS with a different interpretation of the Energy

Policy Act of 1992. IDNS quoted section 185b of the act and then stated:

The department believes that the plain language of the Atomic Energy Act (Act)

makes clear the requirement of an applicant to provide assurance, specifically

with respect to emergency planning, that the facility will be operated in

conformity with the license before the license is issued. The above-emphasized

language “...has been constructed and will be operated...” along with the

specific mention of “... emergency planning...” reflects the clear intent of

Congress to include operational programs within the scope of ITAAC in COL

applications. 

The staff agrees with IDNS. The staff stated in SECY-00-0092 that 

the Energy Policy Act of 1992 and Part 52 [Sections 52.79(c) and 52.97(b)(1)]

clearly require that ITAAC must verify that applicable regulations have been met

before a facility can be authorized to operate. These regulations make no

distinction between hardware and design-related issues, versus “programmatic

topics.” Thus, the so-called “programmatic” ITAAC (i.e., emergency plans) are

consistent with the licensing process in Part 50 [Section 50.57(a)(1)] and were

included by Congress and understood by the Commission to be prerequisites

for operation under a COL. 

The staff disagrees with NEI’s belief that emergency planning ITAAC should be limited to

hardware-oriented ITAAC. The staff did some work on developing emergency planning ITAAC

but then stopped because there were no prospective near-term COL applicants. This effort
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culminated in SECY-95-090. In this SECY the staff identified the issues associated with

emergency planning ITAAC. An attachment to SECY-95-090 provided an illustrative

emergency planning ITAAC, addressing 2 of the 16 planning standards of 10 CFR 50.47(b).

(Attachment 4 to this SECY paper contains these ITAAC). SECY-95-090, which includes a

discussion of stakeholders’ comments, gives no indication that there was any intention of

limiting emergency planning ITAAC to hardware-related issues. In fact, the major

commitments in the proposed emergency planning ITAAC in the SECY relate to the

assignment of emergency planning responsibilities, and the conduct of a full-participation

exercise that tests as much of the licensee, State, and local emergency plans as possible. 

These proposed ITAAC can hardly be considered hardware-oriented.

Licensing Process

The NEI and other industry letters expressed the concern that programmatic ITAAC are not

objective, which is contrary to the goal of achieving a stable and predictable licensing process. 

Westinghouse noted that “programmatic ITAAC insert a significant degree of uncertainty in the

licensing process and could thus inhibit the ordering of advanced reactors...”

The staff recognized in the SOCs for the final rule in 1989 that “not every finding the

Commission must make before operation begins under a combined license will necessarily

always be based on wholly self-implementing acceptance criteria.” Furthermore some of the

ITAAC that were developed for the certified designs could be considered subjective. Although

making ITAAC as objective as possible may be a goal, it is not a requirement. The staff tried

to make the ITAAC for the certified designs as self-evident and as objective as possible. The

staff will do the same in developing ITAAC for a COL.

The staff also notes that in the Energy Policy Act of 1992, Congress granted the Commission

authority to permit interim operation while a hearing proceeded if, after considering the

petitioners’s prima facie showing and answers thereto, the Commission determines there will

be reasonable assurance of adequate protection during interim operation. The staff believes

that this provision helps to limit the uncertainty in the licensing process while still allowing for

focused public involvement.

Public Citizen commented that “ITAAC serves as a last-chance control on the safety of a

proposed new plant before the fuel is loaded and the plant is put into operation. After a COL is

issued, the public has no direct standing to challenge a safety issue unless the NRC grants an

optional hearing after the ITAAC is implemented.” Public Citizen also argued that each phase

of the licensing, design, construction, and operation of a proposed nuclear facility should

provide for the reexamination of issues relevant to ITAAC, with mandatory public participation

on the record.

Public Citizen’s comment regarding hearing opportunities is similar to several comments that

the Commission addressed in the SOCs for 10 CFR Part 52. The SOCs noted that “public

interest groups take a dim view of the proposed rule’s limitations on the hearing, though their

reasons are not the industry’s. UCS says that a licensing proceeding without uncertainty is a

sham.” The staff responded to these comments in the SOCs as follows:

There have to be substantial limits on the issues that can be raised after

construction. A licensing proceeding without any uncertainty in result may be a

sham, but the bulk of the uncertainty should be addressed and resolved prior to,

not after, construction. Part 52 does not remove uncertainty, it simply
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reallocates it to the beginning of the licensing process. The alternative

apparently offered by opponents of limits on the post-construction hearing is, in

effect, to double the uncertainty by considering every design issue twice.

Clearly Part 52 addresses this issue. Specifically, 10 CFR 52.103(b) states that a request for

hearing “shall show, prima facie, that — (1) One or more of the acceptance criteria in the

combined license have not been, or will not be met; and (2) The specific operational

consequences of nonconformance that would be contrary to providing reasonable assurance

of adequate protection of the public health and safety.” The need for ITAAC is not, however,

driven by consideration of the potential scope of any hearings. Rather, ITAAC are needed to

verify implementation matters which could not be fully resolved prior to issuance of a COL. 

In separate comments IDNS and Public Citizen expressed concern regarding the potential

COL application for the pebble bed modular reactor (PBMR). Exelon has indicated that it

intends to submit a COL application for the PBMR without first receiving a design certification

in accordance with 10 CFR Part 52 Subpart B. Exelon plans to pursue design certification on

a separate track. Both IDNS and Public Citizen expressed concern that Exelon’s plans to

pursue a COL first without having a design certification would result in a less rigorous process

for the PBMR review. IDNS wrote:

Part 52 allows applicants to submit a non-precertified design and place it on a

site without seeking an early site permit, thereby introducing numerous

variables that impact the handling of programmatic ITAAC. There must be

assurance that satisfactory programs are in place when needed to support plant

construction and operation when applicants vary from the original process

intended in Part 52. For these applicants who vary from the original three-step

process, ITAAC must be at the front end of the process.

Public Citizen similarly wrote “the public will not have a constructive opportunity to make an

informed challenge about design safety in a combined license hearing if the design is not

certified yet.”

Part 52 allows various sequences and combinations of its Subpart A—Early Site Permits,

Subpart B—Standard Design Certifications, and Subpart C— Combined Licenses. An applicant

can reference an approved early site permit with an approved certified design in its application

for a combined license under Subpart C, but this is not a requirement. An applicant may submit

a COL application without referencing a certified design. In that case the applicant must 

provide the technical information required by Subpart B and ITAAC for the staff’s review and

approval. In response to IDNS’s comment that ITAAC must be at the front end of the process, 

the staff notes that all applicants, including COL applicants not referencing a certified design,

must have approved ITAAC before a COL could be granted. 

Referencing a certified design narrows the scope of the proceeding on the application for a

facility license. Therefore, in response to Public Citizens’ comment, the staff believes that the

public will have a constructive opportunity to make an informed challenge in a combined license

hearing regardless of whether the application references a certified design.

Regulatory Bases for Required Commission Findings

NEI proposed an alternative for the required Commission finding if programmatic ITAAC are not

included in a COL application. NEI wrote:
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It is not the one-time verification of ITAAC on operational programs that will

provide the NRC with reasonable assurance that the facility will be operated as

licensed. The inclusion of programmatic ITAAC would be little more than a

checklist of program elements and thus would do little in verifying a licensee’s

ongoing ability to implement such programs. Rather, it is continued compliance

with operational program requirements and the ongoing NRC oversight of

licensee performance that provides this reasonable assurance.

NEI’s argument is that the NRC does not have to rely on the development and implementation

of programmatic ITAAC to ensure the adequacy of operational programs. NEI noted that

“under Part 52, the NRC retains its authority under Section 186 of the Atomic Energy Act and

10 CFR 50.100 to take enforcement action for any violation of the COL, FSAR, or any other

regulations, including the suspension or revocation of the COL if necessary.” NEI also argued

that members of the public can raise questions through the 10 CFR 2.206 process.

The staff agrees with NEI’s assessment that regardless of whether programmatic ITAAC are

included in the COL the Commission retains its authority under 10 CFR 50.100 to revoke,

suspend or modify licenses for cause. In fact, it is well understood that NRC oversight will

continue after the ITAAC have been met and before (and after) commercial operation of a

nuclear power plant. For example, NRC will oversee startup testing and low-power testing of

the plant as well as subsequent operation over the period of the license. The staff believes

that NEI’s comment confuses the issue. In the narrow context of NEI’s position with respect to

this aspect of the ITAAC matters, the issue is not NRC’s oversight function but under what

conditions a hearing will be granted after construction is completed. 

The staff notes that if the ITAAC are met, they 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. As clearly stated in 52.103(b)

the criteria for a hearing and the Commission’s ability to prohibit fuel load after construction is

completed are tied to the ITAAC. The staff believes that in order to comply with the Energy

Policy Act the hearing opportunity, and the Commission’s decision on whether to allow fuel

loading, should not be limited to nonprogrammatic areas. Further, the staff believes that

programs such as emergency planning, and radiation protection are critical to the Commission’s

finding in accordance with 52.103(g) that prior to operation of the facility the acceptance criteria

in the combined license are met. The staff believes, therefore, that programs such as these

must be verified to ensure that they are correctly implemented before an authorization to load

fuel is issued.

ITAAC Compliance

Public Citizen expressed concern that licensees and not the NRC will be in charge of

demonstrating conformity with the ITAAC before fuel load; there is no independent NRC

evaluator in the process. (A similar comment was received from the Union of Concerned

Scientists (UCS) during the 10 CFR Part 52 rulemaking.) The staff believes that Public Citizen

has misunderstood the role of the NRC in the construction inspection process.

The SOCs for the 1989 version of 10 CFR Part 52 noted that Section 52.99

envisions a “sign-as-you-go” process in which the staff signs off on inspection

units and notice of the staff’s sign-off is published in the Federal Register. UCS

says that it is “totally inappropriate” for the Commission, while construction is
-8-

going on, to sign off on inspections and thus put matters beyond dispute which

might otherwise be raised after construction is complete. However, UCS has

misunderstood the Commissions’s role in the inspection process. While

construction is going on, only the staff signs off on inspections. The Commission

makes no findings with respect to construction until construction is complete.

With respect to NRC’s role, the staff envisions that the construction inspection process under

10 CFR Part 52 will be fundamentally the same as the construction inspection process under

10 CFR Part 50. The Commission never envisioned that the staff would be responsible for

directly performing all ITAAC. Indeed, the staff does not have the resources to do so, nor did

the staff do so for similar requirements during the construction of the current fleet of reactors. 

Licensees are required to directly perform all ITAAC. The staff will assure that the ITAAC have

been met through audit-type inspections, which is consistent with how operating reactors are

currently inspected and how plants were inspected during construction in the past.

Other Comments

Public Citizen objected to the term “programmatic ITAAC” stating that “it connotes a casual and

routine activity.” The staff notes that although the term “programmatic ITAAC” has been

adopted relatively recently, the substantive issue has been discussed in previous SECY papers

such as SECY-92-214, “Development of ITAAC for Design Certifications.” The staff uses the

term to frame the issue, however, it does not use it in the Part 52 rule itself because the staff

believes that COL ITAAC will verify implementation of both hardware and procedural

requirements.

II. Discussion

The SRM for SECY-00-0092 states that “the staff should formally provide the Commission with

a recommendation as to how to proceed on programmatic ITAAC, the basis for this

recommendation, a discussion of alternatives proposed by stakeholders, a legal analysis

supporting the recommendation, and a thorough description of how the staff would implement

its recommendation. This section of the paper addresses all of these requirements except

alternatives proposed by stakeholders which are addressed above. 

II.a Recommendation for Programmatic ITAAC and Basis for Recommendation 

Consistent with its recommendation in SECY-00-0092, the staff recommends that COL

applications for nuclear power plants submitted in accordance with the requirements of

10 CFR Part 52 Subpart C contain ITAAC for operational programs required by regulations

such as, for example, training and emergency planning (programmatic ITAAC). The staff

further recommends that no changes or clarifications to 10 CFR Part 52 are needed because

its clear language already requires that programmatic ITAAC be required in a COL application.

The staff’s basis for this recommendation is the following:

1) The inclusion of programmatic ITAAC in the COL application is in accordance with the

Energy Policy Act of 1992 and the requirements of 10 CFR Part 52. 

Section 52.79(c) requires that the COL application include ITAAC that are necessary

and sufficient to demonstrate that the facility has been constructed and will operate in
-9-

conformity with the COL, the Atomic Energy Act of 1954 and the Commission’s

regulations. In addition, pursuant to Section 52.103(g), the Commission must find that

all acceptance criteria specified in the license are met before facility operation. 

Because ITAAC are the sole source of acceptance criteria for subsequent resolution of

items which cannot be fully evaluated prior to issuance of a COL, it is essential that the

COL ITAAC include all significant issues that require satisfactory resolution before fuel

loading. The staff stated in SECY-00-0092 that the COL ITAAC would consist of the

ITAAC from the referenced design certification rulemaking (Tier 1 information), plus the

ITAAC resulting from the COL proceeding, which include the ITAAC for the site-specific

design information and the ITAAC for the regulations applicable to a COL applicant.

The Energy Policy Act of 1992 and Part 52 (Sections 52.79(c) and 52.97(b)(1)) clearly

require that ITAAC verify that applicable regulations have been met before a facility can

be authorized to operate. These regulations make no distinction between hardware

and design-related issues, versus programmatic topics. 

2) The inclusion of programmatic ITAAC in the Commission’s finding under

10 CFR Part 52 is consistent with similar Commission findings made in

10 CFR Part 50. 

The Commission’s finding in 10 CFR 52.103(g) was modeled after the Commission

finding in 10 CFR Part 50. Section 50.57 requires that the Commission find, among

other things, that the facility will operate in conformity with the provisions of the Atomic

Energy Act and the rules and regulations of the Commission. It was never the staff’s

intention to limit the finding in 10 CFR Part 52 to hardware related issues because the

Atomic Energy Act does not limit the Commission’s finding to these issues.

3) The NRC has already approved programmatic ITAAC as part of the design certification

process.

The best example of a programmatic ITAAC is the design reliability assurance program

(DRAP). The DRAP ITAAC for the AP600 certified design are contained in

Attachment 3 of this paper. If programmatic ITAAC were not included in the COL

application, the staff could not explain to stakeholders why DRAP ITAAC are included

in the certified design ITAAC, but similar ITAAC are not required for other

programmatic areas in the COL application.

II.b Office of the General Counsel Review

The legal basis for the staff’s recommendation is as follows. As more fully explained below,

the Office of the General Counsel has advised the staff that section 185b. of the Act requires

the Commission to include in a COL ITAAC for determining whether a COL holder has properly

implemented operational programs approved in the COL where such a determination is

necessary to provide reasonable assurance that the facility will be operated in conformity with

applicable requirements. Examination of the legislative history of Section 185b. does not

compel a different result. In the Energy Policy Act of 1992, Congress amended section 185 of

the Atomic Energy Act to add a new section 185b., which provides for the issuance of COLs

containing ITAAC. Section 185b. states:
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After holding a public hearing under section 189a.(1)(A), the Commission shall

issue to the applicant a combined construction and operating license if the

application contains sufficient information to support the issuance of a combined

license and the Commission determines that there is reasonable assurance that

the facility will be constructed and will operate in conformity with the license, the

provisions of this Act, and the Commission’s rules and regulations. The

Commission shall identify within the combined license the inspections, tests,

and analyses, including those applicable to emergency planning, that the

licensee shall 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

this Act, and the Commission’s rules and regulations. Following issuance of the

combined license, the Commission shall ensure that the prescribed inspections,

test, and analyses are performed and, prior to operation of the facility, shall find

that the prescribed acceptance criteria are met. Any finding made under this

subsection shall not require a hearing except as provided in section 189a.(1)(B). 

Atomic Energy Act of 1954, as amended, Section 185b.; 42 U.S.C. § 2235. The new section

185b. and section 185a. (in its current form, and as it existed then) require the same

substantive findings, and differ solely with respect to the timing of the issuance of the

operating license (“OL”) and the COL. Since an OL under section 185a. is issued after

construction (in the absence of Part 52), that section requires the Commission to find that “the

facility has been constructed” in accordance with applicable requirements. In contrast, the

parallel requirements for a COL issued under section 185b. before construction, per force, are

in terms of how the facility “will be constructed.” Sections 185a. and 185b. both require the

Commission to find that the facility “will operate” in conformity with applicable standards. 

Because the COL is issued prior to the commencement of construction, one must then look to

the second sentence of Section 185b. to determine what happens after COL issuance. 

The second sentence of section 185b. requires the Commission to include in a COL ITAAC

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 this Act,

and the Commission’s rules and regulations.” This standard for the inclusion of ITAAC in a

COL requires ITAAC with respect to two matters: first, that the facility “has been constructed”

in accordance with applicable requirements, and second, that the facility “will be operated” in

conformity with those requirements. Section 185b. requires that the acceptance criteria in

ITAAC must be sufficient to provide reasonable assurance that a facility “will be operated” in

accordance with all applicable requirements. The two requirements of the statute are

separate, and the requirements with respect to construction do not limit the nature of the

ITAAC which must be developed to support a finding that the facility will operate in accordance

with all applicable requirements. Therefore, the ITAAC must include acceptance criteria for

the COL holder’s proper implementation of the operational programs approved in its COL

when the staff determines that verification of such implementation is necessary for a finding of

reasonable assurance that the facility will be operated in conformity with the regulations. This

statutory scheme requiring a COL to include ITAAC with respect to operational programs is

consistent with the Commission’s implementation of Section 185a. of the statute. It has been

the agency’s practice in reviewing applications for operating licenses to make predictive

findings with respect to the acceptability of operational programs, and to determine prior to

issuance of the operating license that the procedures are in place to correctly implement those
-11-

programs. There is nothing in the legislative history which would indicate that Congress

intended that the agency change its practices in this regard.

Examination of the legislative history of Section 185b. reveals statements that support the

staff’s interpretation set forth above. Moreover, the legislative history of the many licensing

reform bills introduced in Congress during the early to mid-1980's clearly shows that the

Commission consistently took the position that it would be necessary to verify, among other

things, that operational programs have been properly implemented after facility construction

has been completed. The staff acknowledges that the legislative history of section 185b. of

the Energy Policy Act, as enacted in 1992, is somewhat confusing in this regard, and does

contain statements that are inconsistent with the staff’s construction. The remarks of a

legislator, however, even the sponsor of a bill, do not override the plain meaning of a statute. 

In a letter dated May 14, 2001, from Marvin Fertel, NEI, to Chairman Meserve, NEI asserts that

ITAAC should only apply to whether a plant has been constructed in compliance with the design

approved in the COL, and refers to portions of the legislative history of the Energy Policy Act of

1992 in support of its position. NEI argues that “[i]t is not the one-time verification of ITAAC on

operational programs that will provide the NRC with reasonable assurance that the facility will

be operated as licensed. . . . Rather, it is continued compliance with operational program

requirements and the ongoing NRC oversight of licensee performance that provides this

reasonable assurance.”

Applicants could develop and implement some operational programs before receiving a COL. 

In such a case ITAAC may not be necessary. It may not be possible, however, for an applicant

to develop and implement all operational programs fully before COL issuance, or an applicant

might choose not to do so. Section 185b., requires that ITAAC be “sufficient” to provide

reasonable assurance that the COL holder has met all applicable substantive requirements. 

Whether a licensee has properly completed the implementation of those operational programs

which were not fully developed and implemented before COL issuance must be verified in order

to determine whether the licensee has met all substantive requirements. The oversight process

will be the vehicle for the agency to continue to have reasonable assurance that the programs

are being implemented correctly once the plant begins operation. Therefore, section 185b.

requires ITAAC to verify the implementation of operational programs in certain instances, and

NEI’s argument is incorrect.

Moreover, under the NEI interpretation, section 185b. would require that the Commission

include in the COL only those ITAAC needed to assure that the “facility has been constructed”

in conformity with applicable requirements. NEI’s interpretation would require a reading limiting

the scope of the phrase “and will be operated” in the second sentence of section 185b. solely to

whether the facility has been constructed as designed, and thus will be operated, in accordance

with applicable requirements. Such an interpretation, while possible, would deprive these words

of any real meaning. As discussed above, such an approach would be inconsistent with

longstanding agency practice in implementing similar provisions of the statute. The staff

believes that the Commission should not, therefore, adopt the NEI approach. 

II.c Implementation Recommendation

The staff’s recommendation, if adopted, would entail considerable interaction with

stakeholders in developing COL ITAAC that are as objective as possible. In SECY-95-090 the

staff attempted to develop ITAAC for emergency planning, which is one of the programmatic

areas. However, the staff believes that COL ITAAC also need to be developed in the areas
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discussed below. The staff will assemble a group of individuals from headquarters and the

regions to work with interested stakeholders on establishing the guidelines for such

programmatic ITAAC. The New Reactor Licensing Project Office in NRR will take the lead in

this effort and will work with the Inspection Program Branch in the Division of Inspection

Program Management in NRR and with appointed representatives from the regions to develop

the guidelines. This approach is consistent with the requirements contained in the SRM for

SECY-00-0092.

List of Programmatic ITAAC

The staff believes that the COL ITAAC should include ITAAC in the following areas:

 ITAAC from the design certification rulemaking, which is contained in the Tier 1

material of the certified designs

 ITAAC resulting from the COL proceeding:

 ITAAC for the site-specific design information if the application references a

certified design

 if the application does not reference a certified design, the COL ITAAC must

include ITAAC for the design commensurate with the ITAAC that are included in

the certified designs

 ITAAC for regulations applicable to a COL applicant

The staff will work with its stakeholders to develop an approach for ITAAC for operational

programs required by regulations applicable to a COL applicant (i.e., programmatic ITAAC).

ITAAC under consideration include the following: 

emergency planning program physical security program

quality assurance program fire protection program

radiation protection program access authorization program

fitness for duty program training program

licensed operator program reportability program

containment leak rate test program maintenance rule program

inservice inspection and inservice testing

program

equipment qualification program

The staff will use the lessons learned from the development of SECY-95-090 and the process

used in the past to assess and communicate construction completion status to identify areas

requiring COL ITAAC. The process used to assess and communicate construction completion

status is outlined in Inspection Procedure 94300, “Status of Plant Readiness for an Operating

Licensee.” The process culminates in a letter from the applicable NRC Regional Administrator

to the Director of NRR with a recommendation on whether to allow fuel loading based on the

results of inspections done by the region. The staff believes that this process provided a
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historical record of what programs require inspection and review before a licensee can load

fuel under 10 CFR Part 50. The staff will review this historical record to determine what

programs may need ITAAC under 10 CFR Part 52. The staff may identify additional

programmatic ITAAC during this effort.
Attachment 2

History of Inspections, Tests,

Analyses, and Acceptance Criteria
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History of Inspections, Tests, Analyses and Acceptance Criteria (ITAAC)

Because of the staff’s disagreement with the Nuclear Energy Institute (NEI) on the

interpretation of 10 CFR Part 52 and the 1992 Energy Policy Act a history of the development

of ITAAC is in order to place the arguments in perspective. The history of ITAAC in this

attachment covers the following areas:

 Three Mile Island Unit 2 aftermath

 1986 Atomic Industrial Forum (AIF) position paper on standardization

 1987 policy statement on nuclear power plant standardization

 1988 proposed 10 CFR Part 52 rule

 1989 final 10 CFR Part 52 rule

 1992 changes to 10 CFR Part 52

 lessons learned from design certification reviews

The history of ITAAC is intertwined with the history of nuclear power plant standardization,

particularly standardization of the processes for issuing combined construction permits and

conditional operating licenses. In the early years of the nuclear power industry, there were

many first-time nuclear plant applicants, designers, and consultants, and many novel design

concepts. Accordingly, the process was structured to allow licensing decisions to be made

while design work was still in progress and to focus reviews on individual plant-specific and sitespecific considerations. Construction permits were commonly issued with the understanding

that open safety issues would be addressed and resolved during construction and that issuance

of a construction permit did not constitute Commission approval of any design feature. 

Consequently, the operating license review was very broad in scope. 

The fundamental premise of 10 CFR Part 52 Subpart C is that with a mature nuclear industry it

is possible to describe and evaluate plant designs on a generic basis, and to have designs

essentially complete in scope and level of detail prior to construction. This makes it possible to

combine the construction permit proceeding with much of the operating license proceeding into

a single proceeding for the issuance of a combined construction permit and conditional

operating license. Full-power operation can then be authorized under the combined license

following an opportunity for a hearing on a more limited set of issues related to whether

acceptance criteria for an ITAAC have not or will not be met.

The following discussion provides background on how the concept of ITAAC was developed. 

Three Mile Island Unit 2 Aftermath

The Rogovin Commission Report on Three Mile Island (TMI) recommended that the two-stage

licensing process

be abolished for nuclear plants of conventional design. Instead, a single

licensing proceeding should be held prior to construction in which design plans

that are as detailed as possible should be considered and approved. Once a

license is granted, jurisdiction to oversee construction and confirm that the plant

is constructed consistently with the design plans should be placed in the NRC

Staff.
-2-

The report suggested the need for, but provided no guidance on, the process the staff should

use to confirm that the plant is constructed “consistently with the design plans” and what, if any,

public involvement was appropriate after the plant was constructed.

1986 Atomic Industrial Forum (AIF) Position Paper on Standardization

In a March 20, 1986, letter to Chairman Palladino, the AIF submitted a position paper on

standardization for the Commission’s consideration. This paper proposed design information

requirements for final design approval (FDA) and design certification (DC) applications. The

paper stated that

applications for FDAs and DCs should define the tests, inspections, analyses,

and acceptance criteria related thereto necessary to assure that the designs are

properly installed in the plant. These tests, inspections, analyses, and

acceptance criteria would be implemented in a series of sign-as-you-go reviews

through construction and pre-operation.

This was one of the first mentions of the concept of ITAAC in industry documents related to the

one-step licensing process.

In November 1986 the AIF released a widely distributed report on “Standardization of Nuclear

Power Plants in the U.S.” Appendix B of this report contained proposed design information

requirements for design certification and construction for operating license applications. The

preamble for the appendix stated that

to support the NRC review and approval of a standard design to lead to a DC or

COL, the plant or subsystem design must be sufficiently complete so that the

applicant and the NRC have a clear definition of all safety aspects in order that

construction and testing can be performed in accordance with preapproved

methodology and procedures and measured against preapproved acceptance

criteria. 

The appendix then lists design and engineering information that should be in the application

depending on the scope of the design and whether the application is for a DC or a COL. The

list of proposed information includes such areas as the quality assurance program, the

emergency plans, the security plan, and the radiation protection plan. Thus, in 1986, the

nuclear power industry did not distinguish between programmatic ITAAC and other ITAAC.

1987 Policy Statement on Nuclear Power Plant Standardization

In 1987 the Commission announced its intention to proceed with rulemaking on

standardization in a Policy Statement on Nuclear Power Plant Standardization (52 FR 34884;

September 15, 1987). The background section of the FRN noted that the Commission

forwarded to Congress in January 1987 a proposed Nuclear Power Plant Standardization and

Licensing Act of 1987. The Act included a legislative proposal for issuance of a combined

construction permit and operating license. The background section explained that “the

one-step licensing process would give licensees greater assurance that if the facility is

constructed in accordance with the terms of the application/permit, it will be permitted to

operate once construction is complete.” 

The policy statement includes the following sentences:
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The rulemaking to obtain the design certification will cover the criteria necessary

for design and construction of a plant; the quality assurance program; and

whatever tests, analyses, and inspection criteria are necessary to assure that the

plant is built within the certified design specifications.... The design certification

application should also propose, for staff review and approval, the tests,

analyses, inspections and acceptance criteria that are considered necessary to

provide reasonable assurance that a plant which references the certified design

is built and operated within the specifications of the final design.

The Nuclear Management and Resources Council (NUMARC) commented on the one-step

licensing process and the concept of ITAAC in a November 10, 1987 letter:

The COL should be issued after public hearing if the application contains

sufficient information to support the issuance of the COL, and the Commission

determines there is reasonable assurance the facility will be constructed and

operated in conformity with the application, the provisions of the Atomic Energy

Act, and the rules and regulations of the Commission. This also is consistent

with the proposed legislation submitted to the Congress by the NRC.

In sum, the safety determination that a plant is designed and can be

constructed and operated in conformance with the conditions of the license,

should be made by the Commission when the COL is issued. The license will

detail the inspections, tests, and analyses which must be performed, and the

acceptance criteria which must be met in order to provide reasonable assurance

of adequate protection of the public health and safety. Such provisions,

together with the ongoing reviews and inspections made by the staff during

construction to verify that the construction conforms to the COL and that

preoperational requirements have been met, are entirely adequate to allow the

plant to commence operation upon completion of construction under the COL.

NUMARC thus supported the concept of ITAAC in the one-step licensing process.

1988 Proposed 10 CFR Part 52 Rule

In the statements of considerations (SOCs) that accompanied the proposed rule for

10 CFR Part 52 in 1988, the staff explained its basis for including ITAAC in the proposed rule:

Section 52.97 provides that the Commission may issue a combined license for a

facility if the applicable requirements of §§ 50.40, 50.42, 50.43, and 50.50 have

been met and there is reasonable assurance that the facility will be constructed

and operated in conformity with the license, the provisions of the Atomic Energy

Act, and the Commission’s regulations. In addition to technical specifications,

the license will include the inspections, tests, and analyses that the licensee

shall perform and the acceptance criteria therefor which will provide reasonable

assurance that the facility has been constructed and will be operated in

accordance with those requirements. The Commission will verify the licensee’s

compliance... through its inspection program (§52.99).

Furthermore:

Before the facility may operate, the holder of the combined license must apply

for authorization of operation under the combined license. The Commission will
-4-

publish a notice of the proposed authorization in the Federal Register pursuant

to 10 CFR 2.105. Within 30 days, any person whose interests may be affected

by the authorization may request a hearing on the basis (1) that there has been

a nonconformance with the license, the Atomic Energy Act, or the

Commission’s regulation and orders, which has not been corrected and which

could materially and adversely affect the safe operation of the facility; or (2) that

some modification to the site or the design is necessary to assure adequate

protection of public health and safety or the common defense and security. The

petitioner must set forth with reasonable specificity the facts and arguments

which form the basis for the request. These provisions are designed to accord

finality to the Commission’s earlier decisions regarding the facility and to assure

that the operating license proceeding is focused on significant safety issues.

NUMARC commented on the use of ITAAC in a November 7, 1988, letter:

An element essential to the practical implementation of design standardization

and a meaningful combined license process is the effective use of tests,

inspections, analyses and acceptance criteria in the design certification and

combined license process. The proposed rule does not make it sufficiently

clear that successful completion of such tests, inspections and analyses and

compliance with the related acceptance criteria by the holder of a combined

license provide a requisite demonstration that the plant has been constructed

and will operate in conformance with the requirements of the combined license.

The final rule addresses this comment and many other comments on the use of ITAAC and

the process for hearings after construction is complete.

The proposed 10 CFR Part 52 findings for a combined license are modeled on the findings in

10 CFR 50.57(a). Section 50.57 requires that the Commission find, among other things, that

the facility will operate in conformity with the provisions of the Atomic Energy Act and the rules

and regulations of the Commission. The basis for this language is Section 185 of the Atomic

Energy Act. The 10 CFR 50.57 finding was adopted in the proposed rule’s language in

Section 52.97 (discussed above) and in Section 52.103(b), which states that “if a hearing is not

requested, or if all requests are denied, the Commission may authorize operation under the

combined license as provided in § 50.56, upon making the findings in § 50.57.” It was never

the staff’s intention to limit the Part 52 finding to hardware related issues because the Atomic

Energy Act does not limit the Commission’s finding to these issues.

In its comments on the proposed § 52.103(b) NUMARC stated:

There is no provision in proposed § 52.103 that requires the NRC to allow

facility operation if the licensee builds the plant in conformance with the

combined license, the Atomic Energy Act, and Commission regulations.

(Contrast this with Section 185 of the Act and with 10 CFR § 50.56). In any

event, the Commission should be obliged to issue a combined license, and later

to sanction facility operation, if the rules’ requirements are met, rather than

giving the Commission direction (i.e., “may”) to do so.

As discussed below, the Commission changed the wording of the Section 52.103 finding in the

final 1989 version of the rule. The revised wording addresses NUMARC’s comment. 
-5-

1989 Final 10 CFR Part 52 Rule

The SOCs for the final rule addresses the comments on the proposed rule as follows:

The deepest differences among the commenters concern the consequences of

standardization and other devices for early resolution of licensing issues for the

licensing process. One commenter believes that, once a plant is built under a

combined license, there need be no hearing at all before operation begins. 

Several of these commenters characterize the proposed rule’s provision for an

opportunity for hearing just before operation as the old two-step licensing

process under a different name. Others believe not only that there should be

such a hearing but also that resolution of issues in earlier proceedings does not

entail any restriction on the issues which may be raised in the hearing after

construction. Many of the commenters attribute to the Commission an intent to

do away with public participation in the licensing process.

The Commission has given more consideration to this issue than to any other

procedural question raised by the proposed rule. As a result, the proposed

rule’s provisions on hearings just before operation have been revised in the final

rule.... However, the final rule still provides for an opportunity for a hearing on

limited issues before operation under a combined license. But the mere fact of

this opportunity does not mean that the rule is hiding the old two-step process

under a different name. By far the greater part of the issues which in the past

have been considered in operating license hearing would, under the new rule,

be considered at the combined license stage or in a certification proceeding,

including the bulk of emergency planning issues. Similarly, the mere fact that

any hearing prior to operation would be limited does not mean that the

Commission is attempting to remove the public from the licensing process. The

rule does not prevent the public from participating in the resolution of any

operating license issue. It simply moves the bulk of the issues up front in the

licensing process to the design certification, early site permit, and combined

license parts of the process.

The SOCs further noted that one of the important questions about a combined license is

“whether, in cases where all design issues are resolved before construction begins, there

should be a hearing after construction is complete, and if so, what issues should be

considered at the hearing.” The SOCs discussed the comments and stated that most

commenters, whatever their affiliation, believed that there should be the opportunity for a

hearing after construction is complete:

In this regard, every commenter who believes there should be such an

opportunity for hearing also believes that an issue in the hearing should be

whether construction has been completed in accord with the terms of the

combined license and the final rule so provides. Also, under section 185 of the

Atomic Energy Act, the Commission must find, prior to facility operation, that the

facility has been constructed and will operate in conformity with the application

and the rules and regulations of the Commission. This statutory finding, in the

context of Subpart C of this rule, translates into two separate but related

regulatory findings: that compliance with the acceptance criteria in the

combined license will provide reasonable assurance that the facility has been

constructed and will operate in accordance with the Commission’s
-6-

requirements, and that the acceptance criteria have in fact been satisfied. The

former finding will be made prior to issuance of the combined license, and will

necessarily be the subject of any combined license hearing under section 189a

of the Act. The latter finding cannot by its nature be made until later, after

construction is substantially complete, and therefore cannot by its nature be the

subject of any hearing prior to issuance of the combined license. Thus, to the

extent that an opportunity for hearing should be afforded prior to operation, it

should be confined to the single issue that cannot have been litigated

earlier—whether the acceptance criteria are satisfied. 

In this version of the rule 10 CFR 52.97(b) reiterated that

the Commission shall identify in the license the tests, inspections, and analyses

that the licensee shall perform and the acceptance criteria therefor which are

necessary and sufficient to provide reasonable assurance that, if the tests,

inspections, and analyses are performed and the acceptance criteria met, 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 regulations.

As discussed above, the Commission also changed the finding in 10 CFR 52.103 partly based

on the comment that it received from NUMARC. The finding in the final rule § 52.103(c) reads

as follows:

Prior to loading fuel, the Commission shall find that the acceptance criteria in

the combined license have been met and that, accordingly, the facility has been

constructed and will operate in conformity with the Atomic Energy Act and the

Commission’s regulation. 

Again the finding is not limited to hardware related issues.

1992 Changes to 10 CFR Part 52

Part 52 was changed in 1992 to conform the language of Part 52 to the provisions of the

Energy Policy Act of 1992. For example, 10 CFR 52.97(b) was split and paragraph (b)(1) was

changed to add a requirement relative to emergency planning. Specifically 52.97(b)(1) now

reads:

The Commission shall identify within the combined license the inspections,

tests, and analyses, including those applicable to emergency planning, that the

licensee shall 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.

In addition to linking emergency planning and ITAAC, the SOCs for the 1992 rule stated that 

there was a new paragraph (g), “which is a modified version of old § 52.103(c). The

Commission has done nothing in this section other than to incorporate the language of the

Energy Policy Act into its rule.” The revised language § 52.103(g) now reads:

Prior to operation of the facility, the Commission shall find that the acceptance

criteria in the combined license are met.
-7-

The Commission’s use of this language implies that the acceptance criteria include those that if

met are necessary and sufficient to provide reasonable assurance that the facility will be

operated in conformity with the license, the provisions of the Atomic Energy Act, and the

Commission’s rules and regulations. If ITAAC did not include programmatic ITAAC, the Part 52

finding would be much narrower than the comparable finding for an operating license in Part 50. 

Lessons Learned From Design Certification Reviews

Concerns related to programmatic areas started in the early 1990s. Several SECY papers at

this time address the ITAAC issue, as did several letters from industry. The issue of

programmatic ITAAC is discussed in some of these papers and letters. For example, in

SECY-92-214, “Development of ITAAC for Design Certifications,” the staff stated:

Since the ITAAC are primarily system oriented, the staff is considering additional

ITAAC to be developed during the combined license (COL) review and

proceeding which, in combination with the design certification ITAAC, would 

meet the necessary and sufficient standard to provide reasonable assurance that 

the facility has been constructed and will operate in conformity with the license, 

the provisions of the Atomic Energy Act, and the Commission’s regulations that 

are necessary to support fuel loading. These COL ITAAC will verify 

implementation of both hardware (e.g., site-specific design features) and 

licensee specific “soft” procedural requirements (e.g., training, quality assurance, 

etc.). The staff will use the results of its construction and preoperational 

inspection programs to independently verify that both design certification and 

COL ITAAC have been met.

In a letter dated August 26, 1992, NUMARC raised concerns regarding the use of ITAAC to

verify procedural and programmatic requirements. NUMARC also wrote letters dated

October 5, November 5, and November 17, 1992, commenting on programmatic ITAAC. 

NUMARC’s position was that ITAAC should be associated with hardware and material

aspects of the design. In its August 26, 1992, letter, NUMARC stated that “operational and

programmatic issues are best addressed during the deliberations and review of a COL

application, and are not an appropriate subject for ITAAC at design certification.” The staff

responded to these letters in a letter dated November 25, 1992 as follows:

It is important to remember the fundamental requirement for ITAAC, as we

continue our interaction on its development. Specifically, ITAAC must be

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. During meetings with you on November 10 and November 19,

1992, the staff agreed to focus its near term efforts upon resolving the scope

of ITAACs associated with design certification. We discussed an approach to

quality assurance, welding and equipment qualification which appears may

resolve your concerns and ensure that design certification ITAAC meet the

necessary and sufficient standard.

The staff then described its approach to resolving ITAAC issues for the three designs that

have been certified. During the review of the three designs that were certified, issues

associated with the ITAAC that were in the scope of the certified design were resolved. Some
-8-

of these issues involved ITAAC that were related to programs. Other issues involved more

subjective ITAAC. Attachment 3 to this paper is an example of programmatic ITAAC—the

design reliability assurance program (DRAP) ITAAC for the AP600 certified design. The other

certified designs (the advanced boiling water reactor and the System 80+) have similar DRAP

ITAAC. Therefore, the staff believes that it has already developed and certified ITAAC in a

programmatic area.

The staff also discussed the development of emergency planning ITAAC in SECY-95-090,

“Emergency Planning Under 10 CFR Part 52.” This SECY discusses the process for

developing and implementing emergency planning ITAAC. SECY-95-090 states that: 

The Commission will identify, in the combined license, the ITAAC necessary

and sufficient to demonstrate that the emergency plans meet the 16 emergency

planning standards in 10 CFR 50.47(b) and the requirements of Appendix E to

10 CFR Part 50. The acceptance criteria for each license will be based on the

evaluation criteria in NUREG-0654/FEM-REP-1, Revision 1.

An attachment to SECY-95-090 provided an illustrative emergency planning ITAAC,

addressing 2 of the 16 planning standards (Attachment 4 to this SECY paper). The staff noted

that these ITAAC needed substantial refinement.

The staff believes that the ITAAC in Attachments 3 and 4 can serve as a starting point for

developing other programmatic ITAAC.
Attachment 3

Design Reliability Assurance

Program ITAAC from the AP600

Certified Design
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Attachment 4

Illustrative ITAAC on 

Emergency Planning 

from SECY-95-090
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