Attachment 1.doc

42-08-064 ATTACHMENT 1

SEQ CHAPTER \h \r 1

Guidance for the Development of Requests for Additional Information (RAIs) for COL Applications I. Purpose This style guide provides guidance to NRC staff on the request for additional information (RAI) phase of the COL application review and may be provided to the appropriate contractor for their use in COL applications reviews.

II. Overview and Internal NRC Process The branch seeking additional information prepares the questions, which are reviewed by the branch lead. The questions are forwarded to the project manager (PM). The PM reviews each question to ensure that he or she understands what information is sought, that the question is unambiguous, that the question includes an adequate basis, and that the information sought is necessary for the safety review. The PM may clarify the question but should obtain the concurrence of the technical branch reviewer if the change is of a technical nature. If not already assigned, the PM assigns a unique number to each RAI to link the RAI to a section of the COL application. The PM then forwards the questions to the applicant. The PM and review branch interact with the applicant as necessary to ensure that the applicant understands the questions or to give the applicant the opportunity to identify when the requested information is already available to the staff (i.e., in the UFSAR, Technical Specifications, or other docketed correspondence). Some RAIs are typically dropped during this interaction. The staff then formally transmits the RAIs to the PM, and the PM formally transmits the RAIs, along with any pertinent guidance (i.e., the date by which the applicant must respond) to the applicant.

III. RAI Guidance

1.

An RAI should be limited to the scope of the Rule, 10 CFR Part 52.

a.

An RAI should not imply that the current licensing basis (CLB) is inadequate. CLB issues should be addressed under Part 50.

b.

An RAI should not request information that is already on the docket. Note that the draft RAIs occasionally contain information that is already on the docket if the information is not readily available to the staff. These draft RAIs are typically dropped during interactions with the applicants, as described above.

2.

An RAI should include the appropriate basis for requesting the information. The basis should explain why the information is needed, including how it will be used to help make a reasonable assurance finding.

3.

Judgmental language should be avoided.

a.

Questions should not make adequacy determinations. Staff evaluations and conclusions belong in the SER.

b.

Words like unacceptable, deficient, and deviation should be avoided. Likewise, avoid using phrases like the staff will require that since it is premature to require anything when you are asking questions.

4.

Questions should be focused, not open-ended.

a.

The RAI should be in the form of a question or an imperative to provide what is needed to satisfy the RAI. When the reviewer needs specific information or the underlying issue may not be apparent, the RAI should clearly identify the information requested and/or the underlying issue.

b.

Questions should not pertain to information that is either already available (such as asking about plant technical specifications) or not the applicant’s responsibility.

c.

“If ... then” questions (questions that could lead to follow on questions) should provide both parts of the question.

d.

Ask questions to clarify conflicting or contradictory statements in the application.

Note that reviewers’ RAIs should be limited to their areas (e.g., hydrology reviewers shouldn’t be asking seismology questions). If a reviewer has questions outside their review area, the reviewer must communicate the questions to the appropriate reviewers. The PM can coordinate this communication.

5.

Assign each RAI a unique number that links the RAI to a section of the application.

a.

If an RAI applies to a specific section of the SER, use the section number followed by a unique question number (e.g., the first question related to Section 3.3.4 would be numbered RAI 3.3.4-1).

b.

If the RAI applies to more that one section of the SER, use the next higher section number (e.g., if a question is applicable to Sections 3.3.4, 3.3.5, and 3.3.6, assign the question to Section 3.3, such as RAI 3.3-1). The same RAI question should not be repeated in the various sections.

IV. Sample RAI

10 CFR 100.23 requires a probabilistic seismic hazard analysis or suitable sensitivity analysis in order to address the uncertainties inherent in the estimation of the Safe Shutdown Earthquake

(SSE) ground motion. Regulatory Guide 1.165 (RG 1.165), “Identification and Characterization of Seismic Sources and Determination of Safe Shutdown Earthquake Ground Motion” provides specific guidance with respect to the probabilistic evaluations that should be conducted to address the uncertainties associated with determining the SSE ground motion. RG 1.165 specifies a target or reference probability that is to be used to determine the controlling earthquake(s) magnitude and distance (M, D) and SSE spectra for the site. The reference probability is the annual probability level such that 50 percent of a set of currently operating plants have an annual median probability of exceeding their SSE that is below this level. Section 2.5.2 of the application does not specify that the reference probability (median 10-5) from RG 1.165 was used to determine the controlling earthquake(s) (M,D) for North Anna. Clarify whether the reference probability from RG 1.165 was used to determine the controlling earthquake for North Anna and if a different reference probability was used, then justify the use of the new probability value.

V. Interactions with the Applicant 1.

After an RAI has been forwarded to the PM, the PM may hold teleconferences and/or public meetings before issuing the RAI:

a.

The discussions prevent misunderstanding of the intent of the questions.

b.

If a draft RAI is clarified or resolved before issuance, the PM develops a docketed record of the resolution (i.e., minutes of a public meeting or a teleconference summary). An RAI can only be considered resolved if the information is already in the application or other documents previously submitted to the NRC. If not, the RAI is sent to the applicant so that the applicant’s response will be submitted on the docket.

2.

After the final RAIs have been issued, the applicant may request a teleconference and/or a public meeting:

a.

The teleconferences and/or meetings provide additional clarification of the intent of the RAIs and help the applicant prepare satisfactory responses.

b.

To ensure that the response appropriately addresses the RAI, the applicant may submit a draft response (which the PM dockets in the Agency-Wide Documents Access and Management System (ADAMS) and request a follow up teleconference and/or meeting.

3.

After receiving the applicant’s response to the RAI, the PM may hold a teleconference and/or a public meeting with the applicant:

a.

The purpose of discussing a response with the applicant is to better understand the response and/or clarify areas of disagreement. If the resolution of a response relies on information not submitted to the NRC, the applicant should submit the information on the docket. The submission is not intended to be another RAI or a means to minimize the number of SER open items, but in actual practice this step frequently reduces the number of SER open items.

b.

If the areas of disagreement remain, the unresolved RAI becomes an SER open item.

VI. Receipt of the Responses to the RAIs On receiving the applicant’s response to an RAI, the PM provides a copy to the reviewers. The reviewers have a specified time based on the schedule to review the response for acceptability. If time permits, the PM and the reviewers may discuss incomplete RAI responses with the applicant. The discussions are not to be construed as another RAI. An RAI that remains open becomes a safety evaluation report open item.

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