ML15344A461
| ML15344A461 | |
| Person / Time | |
|---|---|
| Issue date: | 12/15/2015 |
| From: | Kerri Kavanagh NRC/NRO/DCIP/CQAB |
| To: | Nichol M Nuclear Energy Institute |
| Belen-Ojeda A, NRO/DCIP, 415-6263 | |
| References | |
| NEI 14-09 | |
| Download: ML15344A461 (5) | |
Text
December 15, 2015
Mr. Marc Nichol
Senior Project Manager, Quality Issues and Licensing Action Nuclear Energy Institute 1201 F Street NW, Suite 1100 Washington, DC 20004
SUBJECT:
NUCLEAR REGULATORY COMMISSION REVIEW OF "INDUSTRY PROPOSED RESPONSES TO NRC INITIAL COMMENTS ON NEI 14-09"
On November 5, 2015, a Category 3 public meeting was held between the U.S. Nuclear Regulatory Commission (NRC) and Nuclear Energy Institute (NEI). The NRC staff conducted this meeting to discuss NEI's proposal to address concerns related to the results of the staff's initial review of NEI 14-09, "Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance." NEI presented di fferent perspectives for NRC consideration on NEI 14-09.
The staff conducted a detailed review of the industry's responses in "Industry Proposed Responses to NRC Initial Comments on NEI 14-09.
" Additional issues have been identified which the staff is requesting be addressed in the proposed revision to NEI 14-09 prior to submittal for review. The additional items are discussed below:
- 1. NEI 14-09, Section 6.6, paragraph 3, states in part, "An evaluation that ends in the Supplier being unable to complete the evaluation and unable to make a determination of Reportability requires no communication (either written or telephonic) to the NRC. All 10 CFR 21.21(b) communications are between the Seller and the Purchaser. Once the Seller has determined that they cannot complete an evaluation a 10 CFR 21.21(b)
"Transfer of Information" is communicated to all identified potentially affected Purchasers within five (5) working days of that decision."
The staff believes the use of the phrase in quotes, "Transfer of Information," may create the impression of a specific requirement. The staff proposes the elimination of the term to be replaced with, "Once the seller has determined that they cannot complete an evaluation, 10 CFR 21.21(d), then purchasers must be informed. The seller should provide all necessary information for the purchaser to perform the evaluation."
- 2. NEI 14-09, Section 5.3, paragraph 2, states in part, "The requirements of 10 CFR 50.55(e) only applies directly to Licensees and agents working on their behalf (i.e.
engineering, procurement and construction (EPC) contractors)."
The requirements of 10 CFR 50.55(e) only applies directly to Licensees. The staff proposes the elimination of the phrase: "and agents working on their behalf (i.e. engineering, procurement and construction (EPC) contractors)."
- 3. NEI 14-09, Section 5.3, last paragraph, states in part, "The requirements of 10 CFR 50.55(e) do not apply to vendors except only in cases where vendors are working for a Licensee as agents on their behalf (i.e. engineering, procurement and construction (EPC) contractors)."
The requirements of 10 CFR 50.55(e) do not apply to vendors. The staff proposes the elimination of the phrase: "except only in cases where vendors are working for a Licensee as agents on their behalf (i.e. engineering, procurement and construction (EPC) contractors)."
- 4. NEI 14-09, Section 5.5, "50.69," includes information about Risk-Informed categorization and treatment of structures, systems and components for nuclear power reactor. However, the staff noted that this section does not include information about the applicability and scope of the regulation. The staff proposes to add description of how this regulation is voluntarily, applies to licensees and applicants, but not to vendors.
The staff also reviewed SECY-11-0135, "Staff Plans to Develop the Regulatory Basis for Clarifying the Requirements in Title 10 of the Code of Federal Regulations Part 21, Reporting of Defects and Noncompliance," to determine what topic for improvement the proposed new guidance will resolve. The staff noted that the topic discussed below has not been addressed in NEI 14-09.
- 1. The evaluation of counterfeit fraudulent and suspect items (CFSI) under 10 CFR Part 21. In order to address this issue, the staff proposes that an addition be made to Section
8.5, "Substantial Safety Hazard," under a new heading entitled, "Counterfeit, Fraudulent, and Suspect Items". The following wording is proposed: "The NRC does not have a formal reporting mechanism that specifically addresses CFSI. However, Part 21 is appropriate for reporting substantial safety hazards of which CFSI can be a potential subset and therefore, within the scope of NRC's regulatory jurisdiction."
In addition, the staff reviewed the recommendations from the Office of the Inspector General's (OIG's) audit OIG-11-A-08, "Audit of the U.S. Nuclear Regulatory Commission's Implementation of 10 CFR Part 21, Reporting of Defects and Noncompliance," dated June 2011 and OIG-10-A-20, "Audit of NRC's Vendor Inspection Program," dated September 28, 2010. The review was conducted to determine if any of the recommendations contained staff commitments to implement actions related to evaluation and reporting under the regulation. The staff did identify proposed commitments and determined that the proposed new guidance will resolve most of the commitments.
The staff recommends NEI to submit the new revision of NEI 14-09 "Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance" to the NRC for final review and endorsement in a Regulatory Guide.
Please direct any inquiries to Aixa Belen at 301-415-6263 or via e-mail aixa.belen@nrc.gov; or Paul Prescott at 301-415-3026 or via e-mail at paul.prescott@nrc.gov.
Sincerely,
/RA/ Kerri Kavanagh, Chief Quality Assurance and Vendor Inspection Branch Division of Construction Inspection and Operations Programs
Office of New Reactors
ML15344A461 *via e-mail NRO-002 OFFICE NRO/DCIP/MVIB NRO/DCIP/QVIB NRO/DCIP/QVIB NAME ABelen PPrescott KKavanagh DATE 12/14/15 12/15/15 12/15/15 Letter to Marc Nichol from Kerri Kavanagh dated December 15, 2015
SUBJECT:
NUCLEAR REGULATORY COMMISSION REVIEW OF "INDUSTRY PROPOSED RESPONSES TO NRC INITIAL COMMENTS ON NEI 14-09"
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