ML040430041
| ML040430041 | |
| Person / Time | |
|---|---|
| Site: | Nuclear Energy Institute |
| Issue date: | 06/22/2004 |
| From: | Lyons J NRC/NRR/DRIP/RNRP |
| To: | Heymer A Nuclear Energy Institute |
| Wilson J, NRR/DRIP/RNRP, 415-3145 | |
| References | |
| Download: ML040430041 (5) | |
Text
June 22, 2004 Mr. Adrian Heymer Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708
SUBJECT:
APPLICABILITY OF 10 CFR PART 21
Dear Mr. Heymer:
The purpose of this letter is to clarify the Nuclear Regulatory Commission (NRC) staffs response to a question that was asked at the Workshop on the Construction Inspection Program Framework Document, which was held on August 27, 2003. During the workshop, a question was asked about a statement in NRCs Inspection Procedure 35002, Early Site Permit Pre-Docketing Quality Assurance Controls Meeting. Section f of procedure 35002-03.01 instructs the NRC staff to Emphasize the applicability of the 10 CFR Part 21 reporting requirements to contracts for activities conducted prior to submission of the application. The questioner asked about the applicability of this statement to early site permit (ESP) applicants and particularly pre-applicants. In response, the NRC staff stated that 10 CFR Part 21 is applicable to ESP applicants, but did not provide an answer at that time regarding pre-applicants. In addition, the NRC committed to review Inspection Procedure 35002 to determine if a revision is necessary.
The NRC has reviewed 10 CFR Part 21 and determined that it is not directly applicable to pre-applicants for an ESP, in the sense that the pre-applicant does not have any obligation under the regulations, during the pre-application phase, to comply with the requirements of Part 21.
However, 10 CFR § 21.1 states the requirements of Section 206 of the Energy Reorganization Act of 1974 (1974 Act), that any individual director or responsible officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed or regulated pursuant to the Atomic Energy Act of 1954, as amended (AEA), or the 1974 Act, must immediately report to the NRC defects that could create a substantial safety hazard, if uncorrected, and failures to comply relating to substantial safety hazards, unless he or she has actual knowledge that the Commission has been adequately informed of such defect of failure to comply. The reporting requirements applicable to persons subject to Part 21 are set forth in 10 CFR § 21.21. In addition, 10 CFR § 50.55(e)(1) requires, among other things, that a holder of a construction permit subject to Part 50 who obtains information reasonably indicating that the facility fails to comply with the AEA or any applicable requirement of the Commission relating to a substantial safety hazard, or a defect in the facility, must notify the Commission of the failure to comply or defect through a director, responsible officer, or designated person.
A. Heymer Since an ESP, in effect, is a partial construction permit, § 50.55(e) requirements apply to the ESP holder immediately upon issuance of the ESP. However, 10 CFR § 21.2(b) provides, among other things, that a persons evaluation and reporting of defects and failures to comply under § 50.55(e) satisfy that persons corresponding obligations under Part 21. Therefore, an ESP holder need only satisfy its reporting requirements under § 50.55(e), and need not make any separate reports under Part 21.
With respect to a firm . . . supplying the components of any facility or activity which is licensed or regulated pursuant to the [AEA], covered by Part 21, § 21.3(1)(i) defines a basic component as a system, structure, and component or parts thereof that affect its safety function, as specified therein, and this includes safety-related design and analysis or consulting services associated with component hardware, whether these services are performed by the component supplier or others, as set forth in § 21.3(3). To the extent an ESP will be based on such analysis or consulting service, the ESP holders suppliers of such services will be obligated to treat these matters in accordance with Part 21 requirements.
The ESP holder and its suppliers obligations to comply with the above requirements have two aspects, namely, (1) a backward looking or retrospective aspect with respect to existing information, and (2) a forward looking or prospective aspect with respect to future information.
The retrospective obligation is that the ESP holder and its suppliers, upon issuance of the ESP, must report all known substantial safety defects in basic components, as defined in Part 21.
The prospective obligation is that the ESP holder and its suppliers must report all substantial safety defects in basic components discovered subsequent to ESP issuance. The ESP holder and its suppliers are required to meet these requirements upon issuance of the ESP, and must continue to meet them throughout the term of the ESP. Accordingly, safety-related design and analysis or consulting services must be procured and controlled, or dedicated, in a manner sufficient to allow the ESP holder and its contractors, as applicable, to comply with the above-described reporting requirements of 10 CFR § 50.55(e) and Part 21. If this is not done, the ESP holder will not be in compliance with § 50.55(e) upon issuance of the ESP, nor will its suppliers of such services be in compliance with Part 21 at that time.
Further, the NRC staff does not believe that the underlying regulatory purpose of Section 206 of the 1974 Act, Part 21, and § 50.55(e) is satisfied if an ESP applicant or pre-applicant procures safety-related design and analysis or consulting services, which are included in the definition of basic component under Part 21, but does not ensure that either: (1) the supplier of such design and analysis or services knows that it is under an obligation, pursuant to Part 21, to inform the NRC or the ESP holder (or applicant), as appropriate, of any defects in the supplied basic component, or (2) the basic component is dedicated in accordance with Part 21.
Therefore, unless an ESP applicant can demonstrate in its application that there is reasonable assurance that the § 50.55(e) and Part 21 obligations-both retrospective and prospective-will be met, either through a Part 21 reporting program or an equivalent alternative, which could include dedication of safety-related design and analysis or consulting services, the NRC could not find that the requirements of these regulations will be satisfied.
Finally, we note that the applicability of 10 CFR § 50.55(e) and Part 21 to ESP applicants and pre-applicants and their suppliers of safety-related design and analysis or consulting services is an issue in the NRCs ongoing rulemaking to amend 10 CFR Part 52, and the outcome of that rulemaking may affect future applications filed under Part 52.
A. Heymer The purpose of inspection procedure 35002-03.01.f is to notify prospective applicants that control of the information described above in a manner sufficient to allow the ESP holder to satisfy 10 CFR Part 21 will be necessary. Accordingly, the NRC staff has determined that Inspection Procedure 35002 does not need to be revised.
Sincerely,
/RA/
James E. Lyons, Program Director New, Research and Test Reactors Program Division of Regulatory Improvement Programs Office of Nuclear Reactor Regulation Project No. 689 cc: See next page
ML040430041 OFFICE PM:RNRP SC:RNRP DIPM:IEPB OGC PD:RNRP NAME JWilson LDudes DThatcher RWeisman JLyons DATE 06/18/2004 2/17/2004 2/12/2004 6/17/2004 6/18/2004 ESP-Generic Mr. James F. Mallay, Director Regulatory Affairs cc: FRAMATOME, ANP 3315 Old Forest Road Mr. David Lochbaum Lynchburg, VA 24501 Union of Concerned Scientists 1707 H Street, NW Mr. Ernie H. Kennedy Suite 600 Vice President New Plants Washington, DC 20006-3919 Nuclear Plant Projects Westinghouse Electric Company Mr. Paul Gunter, Director 2000 Day Hill Road Reactor Watchdog Project Windsor, CT 06095-0500 Nuclear Information & Resource Service 1424 16th Street, NW, Suite 404 Dr. Regis A. Matzie Washington, DC 20036 Senior Vice President and Chief Technology Officer Mr. Russell Bell Westinghouse Electric Company Nuclear Energy Institute 2000 Day Hill Road Suite 400 Windsor, CT 06095-0500 1776 I Street, NW Washington, DC 20006-3708 Mr. Gary Wright, Director Division of Nuclear Facility Safety Mr. Thomas P. Miller Illinois Emergency Management Agency U.S. Department of Energy 1035 Outer Park Drive Headquarters - Germantown Springfield, IL 62704 19901 Germantown Road Germantown, MD 20874-1290 Mr. Vince Langman Licensing Manager Mr. James Riccio Atomic Energy of Canada Limited Greenpeace 2251 Speakman Drive 702 H Street, NW, Suite 300 Mississauga, Ontario Washington, DC 20001 Canada L5K 1B2 Rod Krich Mr. David Ritter Vice President, Licensing Projects Research Associate on Nuclear Energy Exelon Nuclear Public Citizens Critical Mass Energy 4300 Winfield Road and Environmental Program Warrenville, IL 60555 215 Pennsylvania Avenue, SE Washington, DC 20003 Patricia Campbell Winston & Strawn Mr. Tom Clements 1400 L Street, NW 6703 Guide Avenue Washington, DC 20005 Takoma Park, MD 20912 Mr. Eddie Grant Mr. Paul Leventhal Exelon Generation Nuclear Control Institute 200 Exelon Way, KSA3-E 1000 Connecticut Avenue, NW Kennett Square, PA 19348 Suite 410 Washington, DC 20036
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