ML23151A375

PR-002 - 50FR47716 - General Statement of Policy and Procedure for Enforcement Actions

ML23151A375
Person / Time
Issue date:	11/20/1985
From:	Chilk S NRC/SECY
To:
References
PR-002, 50FR47716
Download: ML23151A375 (1)

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REFERENCE:

KEYWORD: ADAMS Template: SECY-067 11/20/1985 PR-002 - 50FR47716 - GENERAL STATEMENT OF POLICY AND PROCEDURE FORENFORCEMENT ACTIONS PR-002 50FR47716 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

PAGE 1 OF 2 STATUS OF RULEMAKING RECORD 1 OF 2 PROPOSED RULE: PR-002 RULE NAME: GENERAL STATEMENT OF POLICY AND PROCEDURE FOR ENFO RCEMENT ACTIONS PROPOSED RULE FED REG CITE: 50FR47716 PROPOSED RULE PUBLICATION DATE: 11/20/85 NUMBER OF COMMENTS: 10 ORIGINAL DATE FOR COMMENTS: 01/21/85 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 49FR08583 FINAL RULE PUBLICATION DATE: 11/20/85 TES ON: COMM. APPRVED REVISIONS BY A 5-0 VOTE PER SRM. SECY SGND ITEM ON 1 ATUS 1/14/85 & IT WAS EFFECTIVE 2/18/86. ONLY ONE FR PUB. VOL. 1 (11/14 F RULE /85-3/14/86). THIS WAS A REV OF THE POLICY STTMT PUB. AT 49FR8583. PRESS PAGE DOWN OR ENTER TO SEE RULE HISTORY OR STAFF CONTACT PRESS ESC TO SEE ADDITIONAL RULES, (E) TO EDIT OR (S} TO STOP DISPLAY PAGE 2 OF 2 HISTORY OF THE RULE PART AFFECTED: PR-002 RULE TITLE: GENERAL STATEMENT OF POLICY AND PROCEDURE FOR ENFO RCEMENT ACTIONS ROPOSED RULE SECY PAPER: FINAL RULE SECY PAPER: 85-256 lb PROPOSED RULE SRM DATE: FINAL RULE SRM DATE: DATE PROPOSED RULE I I SIGNED BY SECRETARY: 11/14/85 DATE FINAL RULE 10/23/85 SIGNED BY SECRETARY: 11/14/85 STAFF CONTACTS ON THE RULE CONTACT!: JANE A. AXELRAD CONTACT2: PRESS PAGEUP TO SEE STATUS OF RULEMAKING MAIL STOP: 9604MNBB PHONE: 492-4909 MAIL STOP: PHONE: PRESS ESC TO SEE ADDITIONAL RULES, (E) TO EDIT OR (S} TO STOP DISPLAY

DOCKET NO. PR-002 (50FR47716} In the Matter of GENERAL STATEMENT OF POLICY AND PROCEDURE FOR ENFO RCEMENT ACTIONS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/14/85 12/27/85 11/14/85 FEDERAL REGISTER NOTICE: 10 CFR PART 2; GENERAL STATEMENT OF POLICY AND PROCEDURE FOR ENFORCEMENT ACTIONS 12/22/85 COMMENT OF MARVIN I. LEWIS ( l} 12/31/85 12/20/85 COMMENT OF COMMONWEALTH EDISON COMPANY (D.L. FARRAR} ( 2} 01/09/86 01/02/86 COMMENT OF STS CONSULTANTS, LTD (JOHN P. GNAEDINGER} ( 3} 01/13/86 01/13/86 COMMENT OF GEORGIA POWER COMPANY (GEORGIA POWER COMPANY} ( 4} 01/21/86 01/21/86 COMMENT OF CLIENT UTILITIES & LAW FIRM (TROY B. CONNER, JR.} ( 5} 01/24/86 01/21/86 COMMENT OF WASHINGTON PUBLIC POWER SUPPLY SYSTEM 01/27 /86 (G.C. SORENSEN} (

6) 01/21/86 COMMENT OF WESTINGHOUSE ELECTRIC CORPORATION

( E. P. RAHE, JR. ) (

7) 02/04/86 01/28/86 COMMENT OF BALTIMORE GAS & ELECTRIC COMPANY (J.A. TIERNAN) (

8) 02/11/86 02/07/86 COMMENT OF COMBUSTION ENGINEERING (A.E. SCHERER} (

9} 03/14/86 03/10/86 COMMENT OF AIF COMM. ON POWER PLANT DESIGN, ETC. (J.W. WILLIAMS, JR.) (

10)

. SJ fMtS(RPR ellll8Qlfll RULE -~ (1./~ Atomic_lndu~trialforum,lnc. (°',-0 477 // *) 7101 Wisconsin Avenue ~LJ t-1',., /C.0/ Bethesda, MD 20814-4891 Telephone: (301) 654-9260 TWX 7108249602 ATOMIC FOR DC March 10, 1986 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch

Dear Sir:

DOtKETrn USNRC. "86 HAR 14 P1 :43 The NRC published in the November 20, 1985, Federal Register a revised "General Statement of Policy and Procedure for Enforce-ment Actions") SO FR 47716-47725) and solicited comments on the rev1s1on. The Atomic Industrial Forum's Committee on Power Plant Design, Construction and Operation has reviewed the revised general statement of policy and offers the following comments on the indicated sections for your consideration. 10CFR2, Appendix C, Section VIII, Vendor Enforcement 3rd Paragraph, 2nd Sentence - "Notices of violation and civil penalties will be used, as appropriate, for licensee failures to ensure that their vendors have programs that meet applicable requirements including Part 21." This could be deemed to be inconsistent with Part 21 itself which (1) applies directly to the vendor (10CFR21.2) and (2) requires entities to which the regulation applies to adopt appropriate procedures to implement 10CFR21 (10CFR21.21). The implication that a licensee has responsibility for the adequacy of procedures adopted by an organization which is independently subject to Part 21 is not addressed by section 206 of the energy reorganization act of 1974, as amended, 10CFR21 itself, or NUREG-0302, Rev. 1. If licensees (or their agents) are made responsible for the adequacy of vendors' Part 21 programs/procedures, this will force each licensee to impose its own interpretation of what constitutes an adequate program on the vendor. The vendor could be subjected to a multiplicity of interpretations if dealing with more than one licensee.. If vendors are forced to develop multiple programs to conform to various interpretations by different licensees, finan-cial consequences and the complexity of requirements could force

U. S. NUCLEAR REG D02K & ~ MISS Ot H ~/Bl% f dlHSf,.,L /t /)~,tr,efrul,-

C Secretary March 10, 1986 even more vendors to discontinue business activities with the nuclear industry. Therefore NRC should clarify the vendor respon - sibility for Part 21 programs as to how vendors are subject to this requirement under the law, and delete the second sentence of the third paragraph. 3rd Paragra~h, 4th Sentence - "Civil penalties will only be imposed against individual directors or responsible officers of a vendor organization who knowingly and consciously fail to provide .the notice required by 10CFR21.21(6)(1)." The intent of this statement is unclear.

• It is assumed that indi -

vidual directors or responsible officers can only be subjected to civil penalties pursuant to 10CFR21 for a knowing and conscious failure to provide notification, but could not be individually sanctioned for any other violation of 10CFR21. Any other viola-tion would have to be pursued against the vendor organization (as an entity) under 10CFR2, Subpart B. Therefore, NRC should clarify its intent with respect to violations which involve neither directors nor responsible officers, or knowing and conscious failures to provide notification. JWW:bbb Sincerely, J'7-_... w"'.,A.-(,w~i::..,1~1,<.i,\\a-Cmt,sc.-,~~ 7r e Chairman Committee on Power Plant Design, Construction & Operation

COMBUSTION~ ENGINEERING Mr. Samuel J. Chilk Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D. C. 20555 00£"6 !MffiR p R /J 0 RULE (5~ FR. 477/~ February 7, 1986 LD-86-010 DOCKETED U5NRC '86 FEB 11 All :06 OFF/CE. :;,

t.

OOCKETtNG & ~f iJr.f BRANCH Attention:

Subject:

Docketing and Service Branch Comments on NRC Enforcement Policy

Dear Mr. Chilk:

On November 20, 1985, the NRC issued for comment a "General Statement of Policy and Procedure for Enforcement Actions ". After examining the Policy St atement and upon cons ideration of the comments submitted by Westinghouse on this subject on January 21, 1986, Combustion Engineering concurs with the Westinghouse comments and we recommend their careful consideration. If there are any questions, please feel free to contact me or Mr. J.E. Rogers of my staff at (203) 285-5204. AES/bkm Power Systems Combustion Engineering, Inc. Very truly yours, COMBUSTION ENGINEERING, INC. ~cherer:.-is;c_.-.-, Director Nuclear Licensing 1000 Prospect Hill Road Post Office Box 500 Windsor, Connecticut 06095-0500 (203) 688-1911 Telex 99297 FEB 13 1986

BALTIMORE GAS AND ELECTRIC DOCKETED FEB *4198 CHARLES CENTER* P. 0. BOX 1475

• BALTIMORE, MARYLAND DOCKETING&

EBVICEBRAN JOSEPH A. TIERNAN VICE P RES I DENT NUCLEAR E N E RGY Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D. C. 20555 ATTENTION: Docketing and Service Branch January 28, 1986

REFERENCE:

Request for Public Comments on Proposed Change to Enforcement Policy; 10 CFR 2, Appendix C Gentlemen: The following comments are submitted by the Baltimore Gas and Electric Company in response to the Federal Register Notice of November 20, 1985, regarding the revised general statement of policy for enforcement actions. We welcome this opportunity to comment on the Commission's proposed revision to its Enforcement Policy. We request you consider the following comments on the items addressed in the policy change. Based on the reasoning provided in the Federal Register Notice, our Company supports any revision that codifies past NRC practices regarding the enforcement policy for vendor defects. However, we are concerned that the proposed revision could lead to an expansion of the current policy and allow the NRC greater latitude in issuing Notices of Violation to licensees for uncontrollable vendor defects. The Commission has not provided sufficient detail on their policy application to assure these concerns have been adequately addressed. In the course of our review, we noted that the new Section VIII, "Vendor Enforcement", clearly states: When inspections determine that violations of NRC requirements have occurred, or that vendors have failed to fulfill contractual commitments that could adversely affect the quality of a safety significant product or service, enforcement action will be taken. Notices of Violation and civil penalties will be used, as appropriate, for licensees' failures to ensure that their vendors have programs that meet applicable requirements including Part 21. Using this revised policy as guidance, it is likely that Notices of Violations may be issued more frequently to licensees for vendor defects and QA program problems. There seems to be an assumption that licensed utilities lack any existing or effective vendor audit programs. We do not believe this assumption is valid. cknowle FEB 7 1986 d by ~!rd..................pt

,,. i U S. NUCLEAR 0 1 '..(... 0 c.,, .J

• Secretary of the Commission January 28, 1986 Page 2 The policy rev1s1on should consider whether or not the vendor problem area(s) could reasonably be detected by a comprehensive licensee vendor auditing program required by 10 CFR 50, Appendix B.

Some defects or problems may not be easily or reasonably identified and corrected by simply enhancing existing QA programs. We feel that the existing control programs are sufficient. Listed below are some examples of those defects that we feel can not be easily detected.

1.

Defective material which the vendor certifies meets specifications, but does not when demonstrated by actual performance in the field.

2.

Vendor specification problems with subcontractor(s) (e.g. our specifica-tions to the vendor are correct, but the subcontractor provides product with improper specifications to vendor). These problems could be due to negligence on the part of the subcontractor or vendor.

3. Vendor fails to inform the licensee of a problem or defect. This failure is not due to a faulty or inefficient control program but rather due to personnel error or negligence. That is, the vendor could fail to provide technical information to update manuals, procedures, etc. because of negligence and not auditable program weakness.

4.

Vendor delivers defective components or information for reasons of subterfuge or under fraudulent conditions. Any Enforcement Policy revision should recognize that some defects could go undetected until after the fact. We believe that an effective program identifies these type defects with adequate timely resolution. To further burden vendors with additional enforcement requirements would only force more companies out of business and discourage potential industry suppliers in the future. The NRC should not alter its enforcement policy practices by penalizing licensees for vendor defects unless the Vendor Performance Branch is willing and prepared to fully investigate and make a determination on cases similar to the examples given above. We acknowledge that licensees should ensure that vendors have adequate control programs and that those programs are effectively utilized by the vendor. However, licensees should not be held accountable for defects or problems beyond their control. Simply enforcing (citing) licensees because vendor-supplied equipment or information is faulty or inadequate without first identifying the root cause appears to be punitive and will do little to enhance safety. We feel that the NRC should seriously consider putting this policy change through the Backfit process since it has such a potential impact on the licensee. In addition to this potential change in practice, the proposed revision also suggests the severity level which would be assigned for vendor related "licensee violations." The policy statement would identify by example a Severity Level ill violation as a "licensee failure to conduct adequate oversight of vendors resulting in the use of products or services which are of defective or indeterminate quality and which have safety significance."

' i.. Secretary of the Commission January 28, 1986 Page 3 Aside from the ambiguous nature of the preceding example; it would appear that only Severity Level m violations would be issued for inadequate vendor oversight. In reality some situations may warrant citing at a lower severity level. Therefore, we recommend that examples be provided such that Severity Level IV or V violations may be considered for issuance where the resulting product or service defect had "more than minor safety" or "minor safety" significance. Instances of Severity Level m violations should be rare. In actuality, other areas of the existing Enforcement Policy provide the mechanism for enforcement of these problems and would lead to consistently lower severity categories than the proposed policy in most instances. Although our Company generally agrees with any effort to codify past practices, we are concerned that the proposed revision may actually lead to a significant departure from current policy. In addition to our earlier recommendations, we feel that the Commission should state explicitly in the Statements of Consideration that the revisions merely codify past practice, and that the revisions do not and are not intended to expand the scope of existing NRC enforcement authority. When the NRC recently amended 10 CFR 2.201, the Commission received many comments expressing concern that 'the revision signaled an extension of NRC enforcement authority. Similar concerns now exist regarding changes proposed to the Enforcement Policy. The Commission was clear when revising 10 CFR 2.201 that the revision did not expand its enforcement authority. We believe that the Commission should be just as clear when revising its Enforcement Policy. Should you have questions regarding these comments, we would be pleased to discuss them with you. JAT/SRC/dlm cc: D. A. Brune, Esquire J. E. Silberg, Esquire D. H. Jaffe, NRC T. Foley, NRC Very truly yours, J. A. Tiernan Vice President - Nuclear Energy

Joc<<StWMBiRPR PROPOS{URULE -~ (~FR 477!~) Westinghouse Electric Corporation Water Reactor Divisions Secretary U.S. Nuclear Regulatory Commission Washington. D.C. 20555 {J) Attention: Docketing and Service Branch

Dear Sir:

Nuclear Technology Division Box 355 Pittsburgh Pennsylvania 15230-0355 January 21, 1986 NS-NRC-86-3102

Subject:

Comments on Proposed Revised General Statement of Policy and Procedure for Enforcement Actions This letter is submitted by Westinghouse Electric Corporation ( 11Westinghouse 11 ) to the Nuclear Regulatory Commission ( 11 Commission 11 ) in response to the Commission's request for comments on proposed revised General Statement of Policy and Procedure for Enforcement Actions (50 F.R. 47716, November 20, 1985). The Commission's current General Statement of Policy and Procedure for Enforcement Actions (49 F.R. 8583, effective March 8, 1984) was initially published for comment in October 1980. At that time Westinghouse submitted a letter of comment, NS-TMA-2360, dated December 30, 1980. The general position taken by Westinghouse in that comment letter has not changed. Among the points made by Westinghouse in its comments was that the focus of the enforce-ment policy on the responsibility of licensees to assure safe and environ-mentally acceptable operation is appropriate. Limiting the application of the policy to vendors and supply firms only in the area of failures to report under the provisions of 10 CFR 21 is equally appropriate. The current proposal for revision of the policy statement deviates from this fundamental emphasis. The current revised policy statement seems to ignore the basic thrust and the success of past enforcement efforts by the Commission. It also seems to ignore the current state of the industry and the realities of the market place. Acknowl

• JAN 2 8 1986 fi-

'1 b.Y Qtlrd..***************

.s SI

NS-NRC-86-3102 January 21, 1986 In the past, Commission enforcement efforts have held the utility-operator responsible for vendor performance to Corrmission requirements. The utility contracts for and audits such perfonnance. The Cormiission audits both the utility and the vendor to assure compliance. This system devotes the appropriate resources of both government and private sector and is working. To change now and place the Commission in the position of enforcement directly with vendors of any tier is a serious miscalculation of the balance of resources and the focus of compliance. To devote Corrmission resources to directly enforce compliance with literally hundreds of vendors 1s questionable and perhaps unattainable. Faced with a choice, the vendor will staff and price its goods and services to satisfy Convnission enforcement activ.ities or, as is increasingly the case with small businesses, discontinue supply to the nuclear industry. The utility position, especially with respect to small businesses, becomes untenable with respect to diversity and competitiveness of supply. The focus of the industry today is on safe plant operation to supply economically competitive electricity supported by competent vendors and suppliers accountable to the ut111ty. The focus of the Commission enforcement policy should be the same and thereby encourage and reinforce these utility efforts rather than preempt or nullify by direct enforcement action. Clearly, therefore, the revised General Statement of Policy and Procedure now being proposed is more than the mere publication of "minor revisionsu to the Corrmission's enforcement policy. As discussed below, the characterization of the revisions in the opening paragraph of-the current Federal Register notice as "minor* may be inappropriate and misleading. Specifically, Westinghouse comnents address:, o Acknowledged limits to the Convnission regulatory authority. o Whether vendors are to be made de facto licensees of the Commission o Improper Corrmission enforcement of contractual obligations between vendors and licensees o Improper application of civil penalties to vendors o Improper implementation of 10 CFR 21 through licensees o Use of violation rather than non-conformance and corrective action. The Corrmiss~on has frequently admitted that its regulatory authority is limited to NRC licensees or persons who are required to obtain a license under the Atomic Energy Act of 1954, as ~mended, or the Energy Reorganization Act of 1974. For example, in its September 28, 1983 promulgation of the final rule on "Authority to Issue Notices of Violation to Non-Licensees and Delega-tion of Author1ty to Regional Admin.istrators 11, the Commiss_ion took cognizance

NS-NRC-86-3102 January 21, 1986 of_ this limitation on its regulatory authority. Indeed, in that notice the Commission stated that in some regulatory areas the Congress extended the Co11111ission 1s statutory authority to include nonlicensees, citing as its only example Section 206 of the Energy Reorganization Act which was, in part, the impetus for the rule change then being made. Westinghouse believes that the Co111T1ission 1s recognition of its limited authority over nonlicensees was correct and that the instant revised General Statement of Policy and Procedure substantially departs from that recognition. Thus, Westinghouse believes that the revised General Statement of Policy and Procedure now being proposed by the COfTITlission exceeds the authority of the Commission. Moreover, Westinghouse does not believe that an extension of the policy statement to vendo'rs is warranted or appropriate. As noted above, the original ROlicy statement was limited to addressing the conduct of activities by Commis~ion ~icensees. By extendjng the policy statement to include vendors, the Comnission appears to be diffusing the direction of its enforce-ment activity and confusing the role of the vendor with the role of the licensee. The effect of the extension of the coverage of the policy statement to vendors appears to make vendors de facto* licensees of the Commission without utilizing the procedural safeguards whereby the Commission issues licenses. For example, the notice of nonconformance for vendors parallels the notice of devtation for licensees; the confirmatory action letters are to be to both vendors and licensees alike. Even with regard to civil penalties, it is possible, as discussed below, to interpret the Corrrnission statement as authorizing civil penalties against vendors for failure to meet Comnission regulations beyond those contained in 10 CFR Part 21. Although the Corrrnission may have authority to license vendors directly, it has not done so. The Corrrnission should not attempt indirectly to achieve such licensing through the adoption of the proposed General Statement of Policy and Procedure. One major problem with the Co111T1ission 1s proposed revised General Statement of Policy and Procedure is that it is based, at least in part, on the notion that the NRC's role in enforcement is to enforce the contractual arrangements between vendors and licensees. Under Part VIII of the proposed policy, enforcement action will be taken against vendors in two instances: (1) when inspections determine that violation of NRC requirements has occurred, and (2) when inspection determines that vendors have failed to fulfill contractual corrrnitments that could adversely ~ffect the quality of a safety significant product or service. In effect, the second instance puts the Corrmission in the position of enforcing contracts between vendors and licensees as a means of protecting the public health and safety*. We believe this indireGt method of obtaining compliance with Corrrnission regulations is inappropriate. Westinghouse believes that the Corrmission lacks authority to base enforcement actions on breaches of contract between a vendor and a licensee, and that the provision which states that enforcement action will take place where a vendor fails to fulfill a contractual co111T1itment is improper. There is no question that, in some regulatory areas, Congress has extended the Convnission's authority to include nonlicensees as well as

NS-NRC-86-3102 January 21, 1986 11censees. In those areas, enforcement act1on can be taken where statutory v1olat1on or v1olat1on of regulat1ons implementing the,statute occurs. With regard to the protection of the public health and safety, the only area that we are aware such authority has been extended to the Commission is pursuant to Section 206 of the Energy Reorganization Act relating to reporting of defects and noncompliance. The Congress hps not authorized the Convnission to protect the public health and safety by acting as an extra-judicial contract enforcing agency. It is the responsibility of the licensees to make certa1n that their procurement documents require contractors and subcontractors to comply w1th certain commission requirements, 1ncluding those relating to an appropriate quality assurance program. The licensees should be accountable for any violation of this requirement. As part of the licensees' overall responsibility, they must make certain that the vendors comply with their contractual convnitments. If a vendor does not so comply and there ts a consequent breach of Commission quality assurance requirements, enforcement should be ag9inst the licensees and not by means of an action under which the vendors are found to be in breach of contract. As currently written, the language relating to failure to fulfill contractual commitments could have results opposite to those intended by the Commission. The Commission interest is in making certain that applicable requirements of Conmission regulations are met. A licensee, however, may elect by contract to impose greater obligations on a vendor with respect to products or services whose quality affects safety. Under the proposed statement as drafted, if a vendor program meets applicable requirements of NRC regulations but fails to meet those contractual conmitments above and beyond NRC requirements, the NRC can take an enforcement action where such failure can adversely affect the quality of a safety significant product or service. Thus, there will be an incentive to contract only for those items which are required by NRC regulation and a disincentive to make contractual commitments to a higher standard. Moreover, by becoming involved in the licensee/vendor contractual relationship, as opposed to focusing on safety and on the obliga-tions of its licensee, the Convnission opens the door to attempts by licensees to contractually impose a licensee's responsibility on its vendors. In CODnection with the notice of violation and civ~l penalties, tbe proposed statement is unclear whether the only notice of violation to be issued directly to vendors is for violation of Part 21 or whether vendors also will be subject to notice of violation and civil penalties where their programs do not m~et other applicable Commission requirements. This lack of clar1ty stems from describing an enforcement action to be taken for violation of NRC requirements or vendor contractual conmitments. The proposed statement says (Part VIII}: nNotices of Violation and civil penalties will be*used, as appropriate, for licensees failures to ensure that their vendors have programs to meet applicable requirements including Part 21.* Westinghouse believes what was intended was that such notices of violation and civil penalties will be levied against licensees. However, the literal language may allow a notice of violat1on and civil penalties to be used against vendors for a licensee's

NS-NRC-86-3102 January 21, 1986 failure to ensure that the vendors have an adequate program. Westinghouse suggests that the words "against licensees" be inserted after the words "civil penaltiesu in the above-quoted sentence to make it clear that vendors are not subject to notices of violation or civil penalties, except for their own violations of Part 21. Westinghouse further suggests that references which tie enforcement action to vendor's failure to fulfill contractual commitments be deleted and that enforcement actions against licensees be taken with regard to vendors only where there is a matter of safety significance and a violation of licensee*s obligations to the Commission. Returning to the same unclear language:

• ... licensees failure to ensure that their vendors have programs to meet applicable requirements including Part 21. 0 raises a troublesome area of licensee responsibility to audit vendor compliances with Part 21, an area heretofore reserved to Convnis-sion audits for compliance.

Here, direct Comnission enforcement appears to be the statutory mandate of Section 206 and any utility efforts to assure compliance would not have the force and effect of Commission imposed sanc-tions. A vendor with twenty or more utility customers would have an enormous burden to satisfy the several utility audits. The enforcement policy should be reworded to make it clear that the Conmission will e_nforce Part 21 directly with vendors and not through audits by licensees. In Section V.E. of the proposed statement of policy, there is a discussion of related administrative actions which can be taken against vendors. The policy statement, carrying forth a concept found in the current policy statement with respect to licensees, provides that *Notices of Noncon-formance are written notices describing nonlicensees' failure to meet convnit-ments which have not been made legally binding requirements by NRC. 1 Westing-house objects to any concept of enforcement action or related administrative actions based upon alleged failure to meet non-legally binding commitments. Unless an action has risen to the dignity of a legally binding col111litment by the NRC, it should not be the subject of administrative or enforcement action which results in a notice of nonconformance or other type of informal mecha-nism. Notices of nonconformance, when used in this manner, give the public and the Congress the erroneous impression that there has been a thwarting of NRC law or regulations when, in fact, because any "comnitmentsn have not been made legally binding, there has been no such deviation from Commission requirements. Westinghouse suggests that the NRC review its provisions with regard to administrative action where there has not been any violation of NRC requirements and adopt appropriate regulations to obtain the desired adminis-trative result without burdening licensees or vendors with the stigma which accompanies the notice of nonconformance. It is especially noteworthy that any revision to the General Statement of Policy and Procedure for enforcement should include a ch&nge 1Q the definition of a violation. Current Commission enforcement policy seems to be based on the premise that perfection is required, and any deviation from Commission regulations is a de facto violation necessitating enforcement action. However, as the Atomic Safety and Licensing Appeal Board made clear I

NS-NRC-86-3102 January 21, 1986 in the Callaway case, perfection is not required (ALAB-740, 18 NRC at 346 (1983)). It should,___tollow, therefore, that not all deviations from Cornnission regulations should be classified as violations, and the enforcement policy should be revised accordingly. Westinghouse submits that if a ltcensee has an acceptable program for identifying and evaluating deviations and takes prompt corrective action as appropriate, those deviations should be classified as nonconfonnances even if they involved what would now be termed *a violation.a Failure to take appropriate action in a timely manner could raise the deviation to the level of a violation depending on circumstances (for example, if management ignores the deviation after learning that it had significant safety implications). Failure to have an adequate process for identifying and evaluating deviations also could be in violation in and of itself if an unacceptable number of deviations were to go undetected for an extended period of time. (See the Callaway Appeal Board decision on this point.) A ~ystem of this type could provide incentives for early identification and correction of deviattons adversely affecting the safe management of a facility, and such a change is worthy of consideration by the Commission. As the policy statement now stands, the general tone is unfair, particularly to those who openly and thoroughly report deviations. Underlying the concerns expressed above is the fundamental question as to whether Cornnission enforcement policy, which to date has been appro-priately focused on licensee compliance, should be diffused and diluted by incorporating vendor compliance provisions beyond those required to.comply with Section 206 of the Energy Reorganization Act. If, as stated by the introduction to the proposed revised statemen~. the revisions are minor and* are intended merely to describe how the enforcement policy applies to vendors, the revisions are not needed and only add confusion in areas which heretofore have not been the subject of controversy. On the other hand, if, contrary to the Commission characterization, the revisions are more than minor, there does not seem to be any adequate justification for changing the enforcement policy as it has heretofore applied to vendors. The basic concern is that the broad and inexact language used in the revised General Statement of Policy and Procedure will be interpreted to extend COfTDllission enforcement activities beyond those which are appropriate or_authorized by law. The result in terms of overall enforcement policy will be counterproductive. Westinghouse urges the Cornnission to reconsider the need for revision at this time of its General Statement of Policy and Procedure for Enforcement Actions. If the Cornnission continues to believe that such revisions are needed, Westinghouse urges the modifications discussed above, and the change in emphasis referred to above be adopted by the Cornnission.

NS-NRC-86-3102 January 21, 1986 Westinghouse appreciates the opportunity to conment on the proposed enforcement policy and will be available for further amplification of our views should the Commission deem advisable. Very truly yours, ~~ E. P. Rahe, Jr, gr. Nuclear Safety artment TMD/bek/1217n

~ "~IJLE PR-..z.,. rt) (~R<.-47716) - Washington Public Power Supply Systmn;~-c P.O. Box 968 3000 George Washington Way Richland, Washington 99352 (509) 372-5000 January 21, 1986 Mr. Samuel J. Chilk Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention:

Subject:

Docketing and Service Branch COMMENTS ON PROPOSED REVISION TO ENFORCEMENT POLICY '86 JAN 24 A10 :34 OFF'.:_ t', S~C\\, OJCI\\ETING

• SE.f'\\1, 1 RANCH The Washin~ton Public Power Supply System notes with interest the Commissions proposed changes to its enforcement policy. The Commission's interest in improving this area is understandable, and its efforts to date have largely been laudatory. However, we feel that some of the proposed changes may actually encourage developments that will run counter to the Commission's safety concerns.

Our specific comments are set forth in the attachment to this letter. Should you have any questions regarding our comments, please contact me. Very truly yours, Ac~ G. C. Sorensen, Manager Regulatory Programs Attachment

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ATTACHMENT 1 COMMENTS ON COMMISSION'S PROPOSED REVISION TO ENFORCEMENT POLICY The Commission's proposed policy rev1s1on states that the inspection program is based on the premise that licensees have the primary responsibility for the procurement of quality products and services for use in licensed activities. That is consonant with previous Commission policy, makes extremely good sense, and should continue to be the basis for the program. The revision, however, now calls for NRG enforcement actions directly to the vendor. We feel that this additional channel of NRG activity seriously dilutes the licensee's responsibilities. Current relationships between the NRC and its licensees rest on firm legal ground. All parties involved understand and accept the relationship. Within the bounds of the relationship, the NRG has several enforcement tools with which to ensure compliance or performance. The NRC does not have such an effective or clear legal relationship with vendors. Beyond the NSSS vendors, there is generally not a long history of a relationship with the NRG with all the understanding that such a relationship engenders. Consequently, the NRG will be 11breaking new ground 11 Direct NRG involvement with vendors, especially when it starts out being largely negative, e.g., fines, is more likely to produce anger, frustration, and exits from the nuclear marketplace, than it is likely to produce improved performance and greater vendor enthusiasm for quality. In addition to dilution of responsibility, a program of heavy, direct NRG involvement with vendors will weaken the quality control and quality assurance activities of utility licensees. Third party NRG inspection and potential enforcement actions directly with the vendor will inherently cause increased licensee monitoring to keep abreast of NRG activities. This action will complicate communication and liaison activities necessary for the licensee to maintain responsibility for the vendor's program. Title 10 CFR, Part 21 addresses the reporting of defects in goods or services supplied by vendors to licensees, and already gives the NRG an avenue for enforcement action. This section of 10CFR has been used for this purpose. Utility licensees have grave concerns over the potential loss of quality vendors due to the advent of the proposed vendor enforcement actions. Significant negative vendor reaction was experienced during the review and implementation of 10CFR Part 21. This reaction is certain to be repeated with the proposed increase in NRG enforcement action and the accompanying avenue for imposition of vendor civil penalties.

Corrnnents Corrnnission's Revision of Enforcement Policy Page 2 If the potential for civil penalties precipitates vendors to drop out of the nuclear business, licensees will be faced with the impact of design changes and related costs for replacement components. If the vendor does remain in the nuclear business, he will certainly increase prices to reflect the increased risk of exposure to civil penalties from direct NRC enforcement at the vendor level. In Table 18 of the proposed rule, the Commission is proposing that fines be levied for Severity IV and V violations at 15% and 5%, respectively, of the Severity Level I amount. Severity Level IV and V violations do not have significant implications for public health and safety or for the environment. The Corrnnission's current policy on these two severity levels seems to more accurately reflect their level of importance. Additionally, the Commission has been grouping several Level IV violations to make a Level III violation. This seems to provide ample opportunity to get a licensee's attention. Table 18 should be changed to drop the fines for Levels IV and V.

.,,\\\\&I UMBER PR /r) """""'.,....,O RULE - r/4'1 {§; TROY B. CONNER, JR. MARK J. WETTERHAHN ROBERT M. RADER DOUGLAS K. OLSON JESSICA H. LAVERTY NILS N. NICHOLS ROBERT H. PURL BERNHARD O. BECHHOEFER OP COUNSEL LAW OFF E n m (_§l; J=(l 477/t&J ) CONNER & WETT:siliAHN, P.C. 1/ 17 47 PENNSYLVANIA AVENUE, N. W. WASHINGTON, D. C. 20006 086 JAN 21 P3:14 January 21, 1986 r*,. r ~- - ~- c ~. ~ ~: ] 1,, I\\ 4 1 'l1 ~ ~ l ' ' ! L :.....,..,.. ~ / 12021 833-3500 CABLE ADDRESS: ATOMLAW Mr. Samuel J. Chilk Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: Proposed Rulemaking to Revise the Commission's Enforcement Policy to Apply to Vendors of Products or Services Supplied to the Nuclear Industry

Dear Mr. Chilk:

In a recent notice published at 50 Fed. Reg. 47716, the Nuclear Regulatory Commission ("NRC" or "Commission") stated its intention to revise its General Statement of Policy and Procedure for NRC Enforcement Actions, as set forth in 10 C. F. R. Part 2, Appendix C. The purpose of the changes, which the notice describes as "minor revisions," is to apply the NRC's enforcement policy to "vendors of products or ser-vices that are supplied to the nuclear industry for ultimate use in facilities or activities that are licensed by the NRC."1/ We submit the following comments on behalf of our firm as well as our client utilities. The Commission states its belief that the proposed revision is editorial only and therefore "reflects for the most part the NRC' s practices that have evolved over the years and are currently in use."2/ We have no quarrel, of course, with the basic principle -that a licensee "should be held primarily responsible for the procurement of high quality products that are to be used in nuclear 1/ 50 Fed. Reg. at 47716. 2/ Id. at 47717. AN 2 4 198 Ackl'IO', (r-...,1 hw Ctird... '. '. * *

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Mr. Samuel J. Chilk January 21, 1986 Page 2 activities," 3/ and that toward required to-maintain quality include inspection and audit assurance programs. that end, a licensee is assurance programs which of its vendor's quality The Commission further explains,

however, that en-forcement action against a reactor licensee will be taken for "significant breakdowns" in a vendor's quality assurance program "that have resulted in the use of products or services of defective or indeterminate quality that have safety significance."4/

The proposed rule itself states that enforcement action will be taken, inter alia, when "vendors have failed to fulfill contractual commitments that could adversely affect the quality of a safety significant product or service."l/ If the Commission means to say that licensees may be cited for failing to implement their own quality assurance programs, including necessary inspections and audits relat-ing to materials, services and equipment provided by vendors and suppliers, its current Policy Statement is adequate. If it means something more, for example, that reactor licensees will now be cited for a new category of penalties based upon vicarious liability without fault for vendor "nonconfor-mances," the changes are unjustified and illegal. The logical underpinning of strict and vicarious liability, if that is what the Commission proposes, is that reactor licensees need economic incentives or do not possess sufficient economic incentives to enforce their own quality assurance programs with regard to vendors. This merely perpetuates the stereotypical assumption by some that licensees consciously weigh the economic costs of violating NRC requirements. The Commission's own Advisory Committee for Review of the Enforcement Policy recently urged the Commission to reject this view and the Commission should do so here.~/ The NRC may deny, suspend or revoke a permit to Id. Id. Id. at 47722. See Re ort of the Advisor Committee for Review of the Enforcement Po icy at 43-45 November 22, 1985).

Mr. Samuel J. Chilk January 21, 1986 Page 3 construct or a license to operate a reactor. It is there-fore wholly unnecessary to create yet another category of penalties on the mistaken premise that licensees require the constant threat of civil penalties to maintain a vigilant and watchful eye over their vendors and suppliers. More than a year ago, the Commission formally estab-lished and sought the advice of its newly appointed Advisory Committee. 7 / The NRC gave the Advisory Committee a broad charter in reviewing the NRC' s current enforcement policy "to determine whether it has achieved its defined purposes and to provide the Commission with recommendations on any changes it believes advisable."8/ Notwithstanding this broad charter, the Commission elected not to wait for its Advisory Committee's report before publishing its proposed revisions. Nothing in the exhaustive analysis of the report even remotely suggests any need to formulate new theories for imposing civil penalties based on a licensee's oversight of vendor activities. Nothing in the report nor anything else cited by the Commission in its proposed change really explains why the current Policy Statement is inadequate or exactly what particular problems the Commission is attempt-ing to rectify. Contrary to the Commission's characterization, we do not regard its proposed amendment of Appendix C as effecting only "minor revisions" to existing enforcement policy if, in

fact, reactor licensees are to be cited for vendor 49 Fed. Reg. 35273 (September 6, 1984).

Re ort of the Advisor Committee for Review of the Enforcement Policy at November 22, 1985. In subsequent correspondence, the Commission's Executive Director for Operations asked the Advisory Committee to determine: (1) Is the current enforcement policy improving compliance with the NRC requirements by: (a) obtaining prompt and corrective actions; (b) deterring future violations; and (c) encouraging development or improvement of a licensee's own programs for detection of incipient problems; (2) Does the current enforcement policy either as written or implemented have any negative impacts on safety; (3) Are their alternative or more effective enforcement options available to the Commission to improve compliance with its requirements? Id.

Mr. Samuel J. Chilk January 21, 1986 Page 4 nonconformances, regardless of the adequacy or intensity of a licensee's vendor oversight. If that is the case, the proposed policy of making licensees answerable in civil penalties for the errors of its vendors is an extraordinary and unprecedented measure. Moreover, it is totally unclear just how far the Commission expects its new policy to reach. The Commission flatly states, for example, that "[t]he Commission's enforcement policy is also applicable to non-licensees (vendors)."9/ Taken literally, the NRC intends to apply existing enforcement policy in its totality to vendors whenever the NRC deems it appropriate, and licensees will be potentially liable for civil penalties assessed. The problem is complicated by the vast number of sub-contractors utilized by a licensee's primary contrac-tors. The proposed changes leave room for unlimited appli-cation of.NRC enforcement policy to each of these many firms and suppliers so that licensees could be assessed penalties based on a sub's II nonconf orrnance. " This has the result of leaving a licensee's audit and inspection responsibilities under Part 50, Appendix B open-ended. We do not believe that a disclaimer by the Commission that it does not intend to take extreme or unjust enforcement actions is a suffi-cient substitute for a textually fair enforcement policy. The Commission implicitly takes the position that vendors, as such, are beyond its regulatory jurisdiction, except within the confines of reporting requirements under 10 C.F.R. Part 21 and packaging and shipping requirements under Part 71. In all other aspects, the proposed change cites the quality assurance responsibilities of reactor licensees under 10 C.F.R. Part 50, Appendix B, as a basis for making a reactor licensee vicariously liable for civil penalties in an enforcement action against its vendor. The Commission therefore apparently believes that it is obligated to create a wholly new category of civil liability for its reactor licensees because of its inability, legal or otherwise, to regulate vendors and suppliers directly. Thus, the NRC will issue "Notices of Nonconformance" to vendors describing their "failure to meet commitments which 9/ 50 Fed. Reg. at 47722.

Mr. Samuel J. Chilk January 21, 1986 Page 5 have not been made legally binding requirements by NRC,"10/ but will not attempt to assess a civil penalty against the vendor for nonconformances. Rather, the NRC will merely "request" written explanations and a statement of corrective actions from vendors. Vendors will be assessed civil penalties only insofar as individual directors or responsi-ble officers knowingly and consciously violate the reporting requirements of 10 C.F.R. §21.21(b) (1) *.!_!/ We see no basis for issuing notices of violation to reactor licensees or assessing licensees civil penalties on account of a "failure" to ensure that a vendor meets its requirements under Part 21, as the Commission proposes.12/ In Section 206 of the Energy_Reorganization Act of 1974,42. U.S.C. §5846, Congress authorized the Commission to assert direct regulatory control over vendors. Therefore, Congress unmistakably meant for vendors to have independent respon-sibilities to report defects and noncompliance to the Commission. The Commission implemented this legislative intent in Part 21 by imposing direct responsibility upon vendors for compliance.

Moreover, in subsection (d) of Section 206, Congress authorized the Commission "to conduct such reasonable inspections and other enforcement activities as needed to insure compliance with the provisions of this section."

Accordingly, the Commission cannot shirk its statutory responsibilities for moni taring compliance with Part 21 itself by delegating this responsibility to licens-ees. Further, the Commission lacks statutory authority to make reactor licensees liable for Part 21 violations by

vendors, assuming that the licensee has not by its own knowledge or actions independently violated Part 21.

The only requirement under Section 21.31 is that each licensee must "assure that each procurement document for a facility, or a basic component... specifies, when applicable, that the provisions of 10 C.F.R. Part 21 apply." The decision to assess penalties against reactor licensees for vendor "nonconforrnances" reflects a regretta-ble mind set that the NRC's enforcement program cannot work l.Q_/ Id. .!_!/ Id. QI Id.

Mr. Samuel J. Chilk January 21, 1986 Page 6 unless someone is the target of a civil penalty. The evidence is to the contrary: Strict and vicarious liability is unnecessary for the sound enforcement of the NRC's quality assurance requirements. Again, the Commission has not cited a single instance of any licensee activity, policy or practice which necessitates this change. Further, the new liability under the proposed revisions may not be legally imposed under the Atomic Energy Act. Although the NRC discusses the statutory bases for its enforcement jurisdiction, specifically including the imposi-tion of civil penalties, nowhere does it cite any statutory authority for assessing penalties against reactor licensees based upon vendor "nonconformances.13/ The Commission has expressly acknowledged that nonconformances do not consti-tute a violation of its regulations.14/ As an example of a possible nonconformance, the Commission cites "a commitment made in a procurement contract with a licensee as required by 10 C.F.R. Part 50, Appendix B."15/ Yet, the nonconfor-mance will apparently be the basisfor assessing penalties against a reactor licensee, irrespective of the fact that no regulation has been violated. As a result of the Commission's struggle to legitimize its jurisdiction over vendors via licensees, its new policy on vendor enforcement seems almost deliberately obscure and ambiguous. As

noted, the Commission states that its 13/

Thus, Section 234 of the

Act, 42 u.s.c.

§2282, authorizes the NRC to impose civil penalties for the violation of "any rule, regulation, or order issued thereunder, or any term, condition, or limitation of any license issued thereunder, or *.

• any violation for which a

license may be revoked *... " Other statutory pro~isions cited by the NRC merely authorize the imposition of civil penalties for violations of regulations implementing those provisions, for knowing and conscious failure to provide safety-related information to the NRC, and for criminal sanctions against those who knowingly and willfully violate NRC requirements, interfere with NRC inspectors or attempt or cause sabotage. .!_!/ 50 Fed. Reg. at 47722. 12_/ Id.

Mr. Samuel J. Chilk January 21, 1986 Page 7 "enforcement policy is also applicable to non-licensees (vendors),"161 but it is far from clear whether the Commis-sion is referring to existing requirements for vendors and suppliers under 10 C.F.R. Parts 21 and 71, or whether the entire panoply of enforcement policies and actions will apply. Further, after reciting that the NRC will determine whether violations of NRC requirements have occurred, or vendors have failed to fulfill contractual commitments that could adversely affect the quality of a safety significant product or service, the Commission 1wuely states that "enforcement action will be taken."- Here again, it appears that a licensee will be held vicariously liable for any vendor "nonconformances," independent of the licensee's knowledge pf or responsibility for th~ occurrence. In the same vein, the proposed changes state that the "NRC expects licensees and vendors to adhere to any obliga-tions and commitments" resulting from enforcement actions and that it "will not hesitate to issue appropriate orders to licensees to make sure that such commitments are met."181 This provision could be construed to mean that licensees will be subjected to enforcement actions because of a vendor's failure to meet its commitments to the NRC. Another objectionable ambiguity in the proposed policy is the declaration that licensees will be assessed penalties for failing "to ensure that their vendors have programs that meet applicable requirements including Part 21."191

First, as noted, the NRC has clearly asserted regulatoryjurisdic-tion over non-licensees for Part 21 violations.201 As we stated, the NRC ought not to ask utilities to enforce its regulations as to requirements imposed directly upon non-licensees themselves.

Second, it is far from certain exactly what are the "applicable requirements." _!ii Id. Y._I Id. ~I Id. at 47721 (emphasis added). 1.2_1 Id. at 47722. ];QI Id. at 47717.

Mr. Samuel J. Chilk January 21, 1986 Page 8 Reactor licensees have always had to meet the require-ments under 10 C.F.R. Part 50, Appendix B, for ensuring quality assurance in their procurement of material, equip-ment and services. It is well established that this in-cludes programs for document and material control, in-spections and audits. In fact, quality assurance require-ments under Appendix B for licensees with respect to their vendors and suppliers have remained unchanged for the past 15 years. As the recently proposed imposition of a $900,000 civil penalty against Toledo Edison for quality assurance violations at Davis-Besse amply demonstrates, the Commission already has all the regulatory powers -it needs to enforce quality assurance standards for reactor components, systems and structures. In sum, the proposed Policy Statement is utterly devoid of any information justifying a new category of civil penalties. It carries an unprecedented potential for strict and vicarious liability on the basis of a licensee's oversight of its vendors' quality assurance programs. The proposed revisions are fraught with a far greater potential for creating confusion and unfairness than for solving any minor problem in the current phraseology of the policy perceived by the Commission. Sincerely, TBC/dlf

I Georgia Power Company Vogtle Quality Concern Program Post Office Box 11593 Mart1'lez, Georgia 30907 8593 MISUSED WORDS AND EXPRE SSIONS (59 Tfuzn. Any sentence with than ( to express com-parison) should be examined to make sure no essential words are missing. I'm probably closer to my I'm probably closer to my mother than my father. mother than to my father. (Ambiguous.) It looked more like a cor-morant than a heron. I'm probably closer to my mother than my father is. It looked more lilce a cor-morant than like a heron. Tlumlnng you in advance. This sounds as if the writer meant, "It will not be worth my while to write to you again." In making your request, write, "Will you please," or "I shall be obliged." TI1en, later, if you feel moved to do so, or if the circumstances call for it, write a letter of acknowledgment. Tluit. Which. Tfuzt is the defining, or restrictive pronoun, which the nondefining, or nonrestrictive. See Rule 3. The lawn mower that is broken is in the garage. (Tells which one) The lawn mower, which is broken, is in the garage. ( Adds a fact about the only mower in question) The use of which for that is common in written and spoken language ("Let us now go even unto Bethlehem, and see this thing which is come to pass.") Occasionally which seems preferable to tfuzt, as in the sentence from the Bible. But it would be a convenience to all if these two pronouns were used with precision. The careful writer, watchful for small conveniences, goes which. hunting, removes the defining whiches, and by so doing improves bis work. The fo,e,eubk futUTe. A clicM, and a fuzzy one. How much of the future is foreseeable? Ten Ininutes? Ten years? Any of it? By whom is it foreseeable? Seers? Experts? Everybody? j Vo t. \\ E.. B. "Buy it, study it, enjoy it. It's as timeless as a book can be in our age of volubility." -The New York Times E The lements* s&1e Third Edition $1.95

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47716 Federal Register / Vol. 50, No. 224 / Wednesday, November 20 1965 / Rules and Regulations L..*.J F-y 0BLlS' yp - 315/ QrnS 0o F oS Prt () _B /J\\P I ~ r, I L, NUCLEAR REGULA TORY COMMISSION 10 CFR Part 2 General Statement of Policy and Procedure for Enforcement Actions AGENCY: Nuclear Regulatory Commission, ACTION: Revised general statement of

policy, I

SUMII.AR\\': The NRC is publishing minor revisions to its enforcement policy (49 FR 8583 (March 8, 1984)) to describe how its enforcemer:t poiicy app!i_es to vendors of products or services that are supplied to 1!1.: nuclear industry for ultimate u3e in facili ties or activities that are licensed by the NRC, The policy statemrni is intended to inform licensees, vendors, and the public of the bases fo r tdking vJrious enforcement actions. The policy is Cl>dified as Appendix C to Part 2 of Title 10 of the Code of Ft}deral Regula tions, DATES: This revised statement of policy is effective February 18, '1986, Submit comments on or before January 21, 1986. Comments received after this date will be considered if it is practical to do so, but assurance of considP.ration cannot be giv(?n except as to comments received on or before this da te, DRESSES: Any comments or tiugg%tions should be sent 10: Secretary of the Commission. U.S, Nuclear Regulatory Commission. Washington. D.C. 20555, Attention: Docketing a d Service Branch. Copies of c 1!),ffients may be examined in e ,S, Nuclear Regulatory__c_om 1ssion Public !OCUment-Room. 1717 H Street, NW,, Washington. DC. FOR FURTHER INFORMATION CONTACT: Jane A. Axelrad, Director, Enforcement Staff, Office of Inspection and Enforcement, U.S. NuclP.ar Regulatory Commission, Washington, DC 20555 (301-492-4909). SUPPLEMENTARY INFORMATION:

Background

The criteria used by the Commission to conduct its enforcement activities were first published on October 17, 1972 (:i7 FR 21902), These criteria were subsequently modified on January 3, 1975 (40 FR 820) and on December 3, 1979 (4~ FR 77135). In late 1979, the Commission directed L11e staff to prepare a comprehensive statement of enforcement policy. This staff effort was given added urgency by the enactment of Pub. L 96-295 (signed June 30, 1980), that, among* other things, amended section 234 of the Atomic Energy Act to raise the maximum civil penalty the NRC can impose from $5,000 to $100,000 per violation per day and eliminated the provi:;ion limiting the total civil penalties for any 30-day period to $25,000. On September 4, 1980, the Commission approved a proposed general statement of policy on enforcement. Commenis were solicited on the policy and a series of public meetings was held. On March 9, 1982. the Commission published a final version of the policy (47 FR 9987). These revisions were published in the Federal RP.gister ( 49 FR 8583) and became effective on March 8, 1984, The Commission subsequently decided that the enforcement policy should be revised to add a section regarding vendor enforcement. Accordingly, the Commission is tod-,y revising the enforcement policy to indicate how it has been and is being applied to vendors and to license.es' control of vendor activitl~s, The ter~ " R(jor" as it is used in the discussio hi :~ follows means a supplier o oclucts or services to be used in an RC-licensed facility or

activity, V endor Program-Description and Objectives The agef1c:y's enforcement program for vendors h:is baen and should continue to he designed to further the basic ol.Jjeclive of the vendor inspection program. That objective is to increase

• public health and safety by providing increased assurance that the products and services provided by unlicensed orgimizations for use in licensed activities meet NRC requirements. The program is based, however, on the premise that licensees have the primary responsibility for the procurement of quality products and services for use in licensed activities.

The vendor community is a large and diverse group of companies that includes the architect engineering and nuclear steam supply system manufacturing firms, component and equipment manufactw=ers, testing facilities, and mjltenal manufacturers and suppliers th'at provide a wide variety of equipment. parts and services. These companies are motivated by different considerations than licensees and the degree of NRC contact with the various companies differs. For example, for utilities a;-id ma terials licensees, the need for the safe and reliable conduct of licensed activities is a strong incentive for the procurement of quality products and services. NRC issuance of a license provides a direct mechanism through inspection and enforcement for ensuring tlrnt this incentive is maintained. Except in limited circumstances such as when a vendor seeks a license to manufacture a facility under Appendix M of 10 CFR Part 50, or approval of a standard design under Appendix O of the same part, vendors are not licensed or otherwise subject to a licensing type review by the NRC and the NRC has limited direct control over their activities. Vendors do. however, exist iJl a very competitive environment and their incentive to provide goad q,1ality products and services is based on financial considerations rather than on the need to obtain and maintain a license. To ensure that licensees obtain quality products and that defective products are identified and reported in a timely manner, the Commission has promulgated certain regulatory requirements, The most important of these is 10 CFR Part 50, Appendix B. These requirements regarding quality assurance programs are directly applicable to reactor licer.sees for scJfety-related componen!i, and are made c:pplicable indirectly to their vendors through their procurement contracts with these licensee!!. Title 10, CFR, Part 21 addresses the reporting of defects in goods or services supplied for licensed activities for both reactor and materials licensees. The NRC inspection program for licensees and vendors was designed lo /,Arc /1/V 5'11 r~>v, Tlt~tJ <A ?-, au I L----

Federal Register / Vol. 50, No. 224 / Wednesday, November 20, 1985 / Rules and Regulations 47717 determine whether licensees and vendors were conducting their activities so as to promote safety and compliance with these requirements. The vendor inspection program does not presently include inspection of vendors of licensees licensed under Parts 30. 40, and 70 for which no specific quality assurance requirements comparable to Appendix B exist. It does include inspections of holders of spent fuel cask certificates under Part 71 and their suppliers. The \\'endor inspection program is being directed to determine if reactor licensees are adequately monitoring the activities of their vendors. Vendor inspections are conducted at vendor shops principally to examine whether they have been complying wth Appendix B of 10 CFR Part SO as they are required to do under their procurement contracts with licensees. The scope and focus of these inspections ha,*e evolved with the industry as its emphasis has shifted from construction-related activities to procurement of replacement parts, modifications. outage support and other related services. However, the philosophy that the licensee should be held primarily responsible for the . p9curement of high quality products L-fl\\at are to be used in nuclear activities has remained unchanged. In furtherance of this philosophy. reactor licensees have been held primarily accountable from an enforcement standpoint if violations of Appendix B to 10 CFR Part 50 are identified. Escalated enforcement action. if appropriate, is taken against a reactor licensee for significant breakdowns in the licensee's ndor's quality assurance program that have resulted in the use of products or services of defective or indeterminate quality that have safety significance. Notices of Nonconformance and Notices of Violation are issued to vendors for failures to meet quality commitments and Part 21 respectively. These notices can also be issued to materials licensees and their \\'endors for violations of Part 21. problem and the measures to be taken to pre\\'ent recurrence. The NRC also issues Notices of Violation to vendors when the NRC has direct statutory authority over them. See 10 CFR 2.201. For example, pursuant to Section 206 of the Energy Reorganization Act, 42 U.S.C. 5846. and the Commission's implementing regulation, 10 CFR Part 21, persons who supply certain types of components are subject to reporting and related requirements intended to ensure that the Commission is promptly informed of defects in such components. The NRC has issued Notices of Violation to non-licensees, for violations of Part 21. These included violations involving inadequate implementation of procedures to address the review and reporting of defects, and failure to pass on Part 21 requirements in procurement documents. Revisions to the Enforcement Policy The existing Enforcement Policy does not contain any references to Yendors and is geared to enforcement against licensees. The Commission has decided to add a section to the existing policy describing its present enforcement policy for vendors including the use of Notices of Nonconformance and to change certain references to licensees to include non-licensees where appropriate. Accordingly, the Commission is publishing the attached propo~e

• ions to the Enforcement Polic. whi will take effect thirty days after ose of the comment period.

The proposed revision to the enforcement policy reflects fo lie most part the NRC-s practices that have evolved over the years and are currently in use. The Commission believes that the provisions of the revised policy are sufficient to achieve NRC objectives with respect to the health and safety of the public, compliance with legal requirements, and conformance to commitments and obligations of vendors. In the following paragr e re,*isions to the policy hich re being The NRC has issued Notices of made now are descril/ed; , ly the Nonconformance to,1endors of reactor sections to which changes were made licensees when deviations from are discusse_d here. The numbering of contracts. quality assurance programs or the sections tracks the section numbers internal procedures were discovered or in the policy. identified during the inspection process. A nonconformance involves a failure t~.,.,J,-lntroduct,on and Purpose satisfy a commitment or obligation thaV The purpose was expanded to has or could cause a vendor product or encompass vendor activities. service to be unacceptable. The NRC H' £ f, 1 C r expects vendors to respond in writing to

• n orcemen.

on1erences Notices of Nonconformance describing The use of enforcement conferences their corrective action to rr.medy the has been expanded to include meeting with vendors for significant findings of nonconformance. V. Enforcement Actions

1. References to the Notice of Nonconformance for vendors were added.

2. Vendors were deleted from the section on Notices of Deviation becausf the Notice of Nonconformance is used for vendors.

3. The use of Confirmatory Action Letters was expanded to include

\\*endors.

4. A section on Notices ot Nonconfonnance was added to recognize its use as an administrative tool for vendors.

Vil/. Vendor Enforcement A n~w section was added to explain how the NRC's enforcement policy applies to vendor activities. This new

• section describes the requirements that are applicable to vendors and the enforcement sanctions available for violations of those requirements.

Sup.plement I A new example was added to Supplement I, Severity Level III for violations involving operating plants in which. through inadequate oversight of vendor activities, a safety significant product or sen*ice of defective or indeterminate quality is used at a plant. List of Subjects in_to CFR Part 2 Administrative practice and procedure, Antitrust. Byproduct material. Classified information, Environmental protection. Nuclear materials, Nuclear power plants and reactors, Penalty, Sex discrimination. Source material. Special nuclear material. \\-\\'aste treatment end disposal. Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended. and section 552 of Title 5 of the United States Code, the following statement of policy is published as Appendix C to 10 CFR Part 2 as a document subject to codification effective thirty days after the close of the comment period. PART 2-RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS

1. The authority citation for Part 2 continues to read as follows:

Authority: Secs. 161. 181. 68 Stat. 9-18. 953. as amended (42 U.S.C. 2201. 2231): sec. 191. as amended. Pub. L. 87--015. 76 Stat. 409 (42 U.S.C. 22-U]: sec. 201. 88 Stat. 1242. as ame,;ded [42 U.S.C. 5841 ): 5 U.S.C. 552. Section 2.101 also issued under secs. 53. f\\2.

63. Ell. 10:1. 104. 105. 68 Stat. 930. 932. 933. 935.

!l'.l6. 9:17. 938. us amended (42 U.S.C. 2(li 3.

4m8 Federal Register / Vol. 50, No. 224 / Wednesday, November 20, 1985 / Rules and Regulations 2092. 2093, 2111. 2133. 2134. 2135): sec. 102, Pub. L 91-190. 83 Stat. 853, as amended (42 U.S.C. -1332): sec. 301, 88 Stat. 1248 (42 U.S.C. 5871). Sections 2.102. 2.103. Z.104. 2.105. 2.721 also issued under secs. 102. 103, 104, 105, 183. 189, 68 Stat. 936, 937, 938. 954. 955, as amended (42 U.S.C. 2132. 2133, 2134, 2135. 2233, 2239). Section 2.105 also issued under Pub. L 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under sees. 186, 234. 68 Stat. 955. 83 Stat. 444. as amended (42 U.S.C. 2236. 2282): sec. 206, 88 Stat. 1246 (42 U.S.C. 5846). Sections 2.300-2.309 also issued under Pub. L 97-415. 96 Stat. 2071 (42 U.S.C. 2133). Sections 2.600--2.606 also issued under sec. 102, Pub. L 91-190, 83 Stat. 853 as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770 also issued under 5 U.S.C. 557, Section 2.790 also issued under sec. 103. 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. Section 2.809 also issued under 5 U.S.C. 553 and sec. 29, Pub. L 85--256, 71 Stat. 579, as amended (42 U.S.C. 2039). Appendix A also issued under sec. 6, Pub. L 91-580, 84 Stat. 1473 (42 U.S.C. 2135).

2. Appendix C to Part 2 is revised to read as follows:

Appendix C-General Statement of Policy and Procedure for NRC Enforcement Actions The following statement of general policy and procedure explains the enforcement policy and procedures of the U.S. Nuclear Regulatory Commission and its staff in initiating enforcement actions, and of presiding officers, the Atomic Safety and Licensing Appeal Boards, and the Commission in reviewing these actions. This statement is applicable to enforcement in matters involving the public health and safety, the common defense and security, and the environment.' I. Introduction and Purpose The purpose of the NRC enforcement program is to promote and protect the radiological health and safety of the public, including employees' health and safety. the common dt!fense and security, and the environment by:

• Ensuring compliance with NRC regulations and license conditions:
• Obtaining prompt correction of violations and adverse quality conditions which may affect safety;
• Deterring future violations and
• occurrences of conditions adverse to quality:

and

• Encouraging improvement of licensee and vendor'" performance, and by example, that of industry, including the prompt identifica lion and reporting of potential safety problems.

Consistent with the purpose of this program, prompt and vigorous enforcement action will be taken when dealing with licensees or vendors who do not achieve the necessary meticulous attention to detail and 'Antitrust enfor,;ement mallers will be dealt with on a case-by-case basis. "The lerm.. v~ndor** me&ns a supplier of proJucts or servi,;es to be used in an NRC-lii:P.nsed facility or activity. the high standard of complia e NRC expects. It is the Commissio intent that sanctions should be designed to ensure that a licensee or vendor does not deliberate!:.- profit from violations of NRC requirements. Each enforcement action is dependent on the circumstances of the case and requires the exercise of discretion after consideration of these policies and procedures. In no case. however. will licensees who cannot achieve and maintain adequate levels of protection be permitted to conduct licensed activities. II. Statutory Authority and Procedural Framework A. Statutory Authority The NRC's enforcement jurisdiction is drawn from the Atomic Energy Act of 1954. as amended. and the Energy Reorganization Act (ERA) of 1974, as amended. Section 161 of the Atomic Energy Act authorizes NRC to conduct inspections and investigations and to issue orders as may be necessary or desirable to promote the common defense and security or lo protect health or to minimize danger to life or property. Section 186 authorizes NRC to revoke licenses under certain 5itcumstances (e.g., for material false slel"ments, in response to conditions that would have warranted refusal of a license on an original application, for a licensee's failure to build or operate a facility in accordance with the terms of the permit or license. and for violation of an NRC regulation). Section 234 authorizes NRC to impose civil penalties not to exceed $100,000 per violation per day for the violation of certain specified licensing provisions of the Act, rules, orders, and license terms implemP.nting these provisions, and for violations for which licenses can be revoked. In addition to the enumerated provisions in section 234, sections 84 and 147 authorize the imposition of civil penalties for violations of regulations implementing those provisions. Section 232 authorizes NRC to seek injunctive or other equitable relief for violation of regulatory requirements. Section 206 of the Energy Reorganization Act authorizes NRC to impose civil penalties for knowing and conscious failures to provide certain safety information to the NRC. Chapter 18 of the Atomic Energy Act provides for varying levels of criminal penalties (i.e~ monetary fines and imprisonment) for willful violations of the Act and regulations or orders issued under sections 65, 161(b), 161(i), or 161(0) of the Act. Section 223 provides that criminal penalties may be imposed on certain individuals employed by firms constructing or supplying basic components of any utilization facility if the individual knowingly and willfully violates NRC requirements such that a basic component could be significantly impaired. Section 235 provides that criminal penalties may be imposed on persons who interfere with inspectors. Section 236 provides that criminal penalties may be imposed on persons who attempt to or cause sabotage at a nuclear facility or to nuclear fuel. Alleged or suspected criminal violations of the Atomic Energy Act are referred to the Department of Justice for appropriate action. B. Procedural Framework Subpart B of 10 CFR Part Z of NRC's regulations sets forth the procedures the NRC uses in exercising its enforcement authority. 10 CFR Z.201 sets forth the procedures for issuing notices of violation. The procedure to be used in assessing civil penalties is set forth in 10 CFR 2.205. This regulation provides that the appropriate NRC Office Director initiates the civil penalty process by issuing a notice of violation and proposed imposition of a civil penalty. The licensee is provided an opportunity to contest in writing the proposed imposition of a civil penalty. After evaluation of the licensee's response. the Director may mitigate, remit. or impose the civil penalty. An opportunity is provided for a hearing if a civil penalty is imposed. The procedure for issuing an order to show cause why a license should not be modified. suspended. or revoked or why such other action should not be taken is et forth in 10 CFR 2.202. The mechanism for modifying a license by order is set forth in 10 CFR 2.204. These sections of Part 2 provide an opportunity for a hearing to the affected licensee. However. the NRC is authorized to make orders immediately effective if the public health. afety or interest so requires or, in the case of an order to show cause. if the alleged violation is willful. Ill. Severity of Violations Regulatory requirements 2 have varying degrees of safety, safeguards. or environmental significance. Therefore. the relative importance of each violation must be identified as the first step in the enforcement proceH. Consequently, violations are categorized in terms of five levels of severity to show their relative importance within each of the following eight activity areas: I. Reactor Operations: II. Facility Construction; Ill. Safeguards: IV. Health Physics; V. Transportation; VI. Fuel Cycle and Materials Operations: VII. Miscellaneous Matters: and VIII. Emergency Preparedness. Licenaed activities not direclty covered by one of the above listed areas, e.g., export lir,ense activities, will be placed in the activity area most suitable in light of the particular violation involved. Within each activity area. Severity Level I has been assigned to violations that are the most significant and Severity Level V violations ere the least significant. Severity Level I and II violations are of very significant regulatory concern. In general, violations that are included in these severity categories involve actual or high potential impact on the public. Severity Level Ill violations are cause for significant concern. Severity Level IV violations are less serious but are of more than minor concern: i.e.. if left uncorrected, they could lead to a more serious concern. ' The term "requirement" as used in this policy means legally binding requirement such as a statute. regulation. license condition. technical specification. or or<l P.r. I l

WY Federal Register / Vol. 50, Nu. 224 / Wednesday. November 20, 1985 / Rules and Regulations 47719 Severitv Level V violations* are of ntinor safety ~r environmental concern. Co~1parisons of significance between a ctivity areas are inappropriate. For example. the im mediacy of any hazard to the public associa ted with Severity Level I violations in Reactor Operations is not directly comparaule to that associated with Severity Level I violations in Rea ~tor Construction. While examples are provided in Suppiements I through vru for determining the appropriate severity level for violations in each o[ the eight activity areas. the examples

ire neither exhaus tive nor controlling. These examples do not cri

ate new requirements.

.,,Eac~ designed to il!ustrnt~ the significance . whir.h he NRC plar.e~ on" i,arllr.u!ar typr. of L vio ~,wn of NRC: rc:quirements. Each of the ex.amplois in the suppl1:ments is predicated on a viuiation ol re!!ulator)' requirement. In each ca~e. the severity of a violation will be characteri.i:ed at the level best suited to the significance of the par!ir ular violation. In some cases. violations may be evaluated in the aggregate and a sing!e se\\*r.rity level assigned for a group of violations. The severity level of a violation may be increased if the circumstances surrounding the matter involve carrless disrC)lard of reqliirements. deception, or other indications of willfulness. The terra "wi!lfulness" as used here embraces a spectrum of violations ranging from delibt!rate intent to violate or falsJy to and including careless disregard for req~ i Is. Wilifulness does not include act whi do not ri~e to the level of careless

dis,

. e.g.. in11d\\'ertent clerical errors in a document submitted to the NRC. In de termining the specific severity level of a violation involving willfulness. cor.siderntion will be given to such factors as the position of the person involved in the violation (e.g.* first-line supervisor or senior manager). the significance or any underlying violation. the intent of the violator (i.e.. negligence not amounting to careless disregard, careless disregard. or deliberaleness), and the economic advantage. if any, gained as a result of the violation. The relative weight given to each of these factors in arriving at th r appropriate severity level will be dependent on the circumsta nces of the , iol~tion. The NRC expects t'icensees to provide full, complete. timely, and accurate information

i nd reports. Accordingly. unless otherwise u t~gom

.ed in the Supplements, the severity l:*vcl of a violation involving the failure to m.,J..e d reGuired report lo the NRC will be liased upon the significance of and the circumstances surrounding the matter Iha s1,uuld ha ve been reported. A licensee will

""' noru:ally be cited for a failure to report a r <>11d:tiun or event unless the licensee was ly aware of the condition or event t fa iled lo report. However. the se.1:rity ll!vel of an untimely report. in '; *nl: ast lo no ri,porl. may be reduced '*i***:it11ni; on lhe circumstances surrounding tl,t-: mdlter. t \\ '

• f.nforcr.mr.nt Conferences

\\\\ he never the NkC has learned of the ' *., **er.Le uf

• potenli;.l violation £or whicn a

'.":'1 µ,* nd!ty or uther es~ai<<tcd enforcement ..,, m.,~ l,c w,1rr11illc<.!, ur recurring nonwnformance on the part of a vendor. the

-;Re *.,*i ll m,rmally hold an enforcr.ment crn,ference with the licensee or vendor prior tn tal,.inl! enforcement action. The NRC may al8o elect to hold an enforcement conference for other viol *ons. e.g.. Severity Level IV violation r.i f repeated, could lead to escalate norcement action. The purpose of the enforcement conferen.:1! is to: (1) Discuss the violations or nonconformance. their significance and causes. and the licensee's or vendor's corrective actions. (2) determine whether there are any aggravating or mitigatin_g ci~

ta~ces, and (3) o~tain other informatton t_~~ tll help determine: the appropriate ~ ement action. In addition, during the_enforcemt:nt conference, the licensee or vendor will be given an opportunity to explain_ to the NRC what corrective actions (if any) were taken or will be taken following discovery of the potential violation or nonconformance. Licensees or ver.dors will be told when a meetimz is an enforcement conference. Enforc;ment conferences will not norm11lly be open to the public. When needed to protect the public health and safety or common defense and security. escalated enforcement action. such as the issuance of an immediately effective* o.-der modifying, suspending. or revoking a license. will be taken prioc to the enforcement conference. lo such cases, an enforc~ment conference may be held after the esca!ated enforcement action is taken. V. Enforcement Actions fhis section describes the cr:forcement sanctions available to NRC and specifies the conditions under which each may be used. The basic sanctions are notices of violation, civil penalties. and orders of various types. Additionally, related administrative mechanisms such as bulletins and confirmatory action letters. notices of nonconforinance and notices of deviation are used to supplement the enforcement program. In selecting the enforcement sanctions to be applied, NRC will consider enforcement actions taken by other Federal or State regulator;. bodies having concurremt jurisdiction. such as in transportation matters. With very limited exceptions. whenever a violation of NRC requirements is identified. enforcement action is taken. The nature and extent of the enforcement action is intended to reflect the seriousness of the violation involved. For the vast majority of violations, action by an NRC regional office is appropriate in the form of a Notice of Viola tion requiring a formal response from the recipients describing its corrective actions. In situations involving nonconformance on the part of vendor. a Notice of Nonconformance will be issued. The relatively small number of cases in\\'olving cle-.,.ated enforcement action receives substantial attention by the public, and may ha ve significant impact on the licensee's operation. These elevated enforcement actions include civil penalties; orders modifying. suspending or revoking licenses: or orders to cease and desist from designated activHies. A. Notice of Violation A notice of violation is a written notice settins forth one or more violations of a legally binding requirement. The notice normally requires the recipient to provide a written statement desc * *ng (1) corrective step wh' ave been taken and the results achiev (2) corrective steps hie

• iii be taken to prevent recurrence; an

(:l) thP. date when full compli;:nce will be achieved. NRC mny require responses to notices of violation to be under oath. Norma lly. response, under oath will be required only in r.onnection with civil per.allies and orders. NRC uses the 11oticc of violation as the st;:ndard method for formalizing the e:<.istence of a \\io!ation. A notice of violation is normally the only enforcement action taker.. except in cases where the criteria for civil penalties ar:d orders, as set forth in Section V.B and V.C, respectively, arc meL In such ca8es. t!ie notice of violation will be issued in conjunction with the elevated actions. Decause the NRC wanb to encourage and support licensee initiative: for self-identification end correction of problems, NRC will no: generally issue a notice of violation for a violation that meets all of the following tests: (1) It was identified t,y the licensee: l2) Ii fits in Severity Level IV or V: (3) It was reported; if required: (4) It was or will be corrected, including measures to prevent recurrence, within a reasonable time; and (5) It was not a violation that could reasonably be expected to have been prevented by the licensee's corrective action for a previous violation. Licensees are not ordinarily cited for ,*iolation resulting from matters not within their control. s1:ch ns equipment failures that were not not avoidable by reasonable licensee quality assurance measures or ma nagement controls. Generally, however, licensees are held responsible for the acts of thier emplovees. Accordingly, this policy should not be construed to excuse personnel errors. Enforcement actions involving individuals. including licensed operators, will be de termined on a case-by-case basis and must be approved by the Director of the responsible Program Office.*,

8. Cil'i! Penalty A civil penalty is a monetary penalty that may be imposed for violation of: (a) Certain specified licensing provisions of the Atomic Energy Act or supplementary NRC rules or orders. (b) any requirement for which a license may be revoked. or (c) reporting requirements under section 206 of the Energy

• Section 234 of the Atomic Energy Act gives the Commission authc,rity to iml)Ose civil penalties for violatior.s on "any person" "Person" is bro.<dly defined in Section 11s of the AEA lo include individuals. a variety of organizations. and any representatives or agents. This gives the Commis~ion authurity to impose civil penalties on employees of licensees or on separate entities when a violation of a n,quirement direct!)' imposed on tl-:cm is ccimmittcd.

47720 Federal Register / Vol. 50, No. 224 / Wednesday, November 20. 1!l85 / Rules and Regulations Re,1rg3nizat.ion Act. Civil penalties are desil(ned to t!mphasizc the need fur lasting re1"1ctlial action and to deter future violations. r;enerally. civil penalties are imposed for S,*\\*erily Level I viola lions. are imposed at,,ent mitigating circumstances for Severity I.e*,el II violations. are considt!rcd for Scvr.rity Level Ill violations. and may be V imposed for Severity Level IV \\*iolatio!ls that arP. similar

• to previous viola lions fnr which the licensee did not take cffoct corrccti\\'e nc~ion.

In apµlying this guidance ror Sev,:rity Level IV violatiuns, NRG normally cun,iders c;ivil (W!laltics only for similar Severity Lr.\\*el IV viol~tions that or.cur :1ft~r the d;,tc, of lhP. last i1:spec;tion or ""ithin t*,vo yr:ars. whichever pr.riod i~ greater. Civil pen.1lties will normally be as.;essed for knowing and conscious violdtions of the r";.,orting requirements of Section 20fl of the En~:*gy Reorg:iniz:ition Ar.I. and for any wi!lful violation of any Commission re11uirement including those at nny sev,,rity Ii:-.-el. NRC imposes different l,~~*els of penalties for different severit\\,' level viol:,ti,Jns and diff P.rent dasaes of licenseP.S. Tal>IP,5 1A and 18 show the base civil p,malties for vari011s re,1ct1Jr. fuel cycle, and ma tr.rials pngrnms. T?1.; structure of these tables gc>nernlly takes iotn ar.count the gravity of the violation as a i,rir.1ary consideration and the ah:lity to pay as a second'.lry consideration. GP.aerally. op-?r:itions involving greater nur.lear mriterial invenluries and greater potential consequences to the public and lit:ensce ernµloyeP.s rer.eive higher civil penaltir.s. R,~garding the secondary factor of ability of v.,_rious classes of licensees t.o pay the ch*il 1ie*1dlties. it is not the NRC's intention that the economic impact of a r.ivil penalty be such that it puts a licensee out of business (urd<!rs. rathr.r than civil penalties. am used whim the intent is to terminatr. licensed nctivitie~) or adve~sely affocts a licensP.e's dbility to safely cond!1ct licr.nsP.d ac!ivities. The deterrent effect of civil pr.n,;lties is bf!st ~e,ved when the amounts of such p,malti,~s tal.;P. into account a licP.nse~*s "ahility to j.Jay:* In determining the ammrnt~ of civil p,,naltie~ fur licens~es for \\\\*hom thr. tablt-!s de nut renect the a')ili ty lo pay. NRC will con,;ider as necessary an incr?.:J S<! or dP;;rease on a case-l,y-case ha~is. !'!RC: attar.he~ !F~at importan,.e tu curnprehensive licensP.e progra111s for rl.-ter:tion. correctio!1. 'lr.d,t,porting of µrol,lems that ma:,, constitute,,i,* le-<<l to, vi<1l.1tion of regulatcry re411irc:nents. This is emphasiZl'J l,y giving Cl'Cdit for dfc:ctive licen~ee audit progr.1ms when liccn:.P.e~ find, correct. and rl'port p1*oblc111s expeditiously anJ t~ffr*ctivcly. To etu..:o~:r.1~c l,r:1!nJP.I? self* itlen!ification anJ corrr.rfion oi violations an r:I to avoid putP.nti.11 con,:e,1lment,,r p,*,,1,Iems of :lofety ~igaifir..1r1cc. Hpplica tion of the adjustment faGtors set forth helow may result in no civil penalty being :,ssP.ssed fur ,*1<1laticns which are identifir.d. rrpnrted (if 1 T!,~.,..ord "sin,i?,1;:* as usnd m this pnli~y. refers 10 t.,,J._e violations whi,:h r.nuld h:n*** li::cn r~asonahlv P.xp~cted to havP he"n p; P\\,-n<P<i hy thP. li...:P./1s:-e*s corret:tivc act1tJn for thr. 111*c1.*i.111s v111,,t:1on. tP.Ql<ircd]. and effectively corrected by the lic,~r.s~~- On the other har.d. ineffer.tive licensee programs for pr<<hlem identification or correction are unaccr.pt,b!e. In cas,,s in v,,lvirig wiilfulness, flagrant NRC-i<lcntified vi c; l.,tiuns, repc,.t,~tl poor µerformunc;e in an ar.ia of concern, or serious breilkdown in mdnagcment cuntrols, NRG intends lo apply its fu!l enforr.ement authority wht!re such action is warran ted. including issuing appropriate orders and assessing civil p~nnlties for continuing vio!;;tions on a per day La.,i,. up :o the s!<1tutory limi t of $100.000 per, iol~liun. per day. In !his reg.ird. whi!c m.1 !1~~~~ent in'.:<lh*e!lH:~nt. direct or indirect, in,;,iolaiillt, 1nay le.id to un ir.crease in th P. civi! p,)na!ty, the lack of such involvement m.*y not be used to mitigate a civil penalty. i\\liowqnce of mitii;;ation could encourage la*;k of management involvement in !ir:ensed a,*ti\\*i'.ies and a rlecreasP. in protection of th!! public he'llth and s.,fety. "!RC rcviP.ws each proposed ci-,il penal!y cu,e 'lit its own merits and ~djusts the buse r.i-. ii penalty val!1es upward or downward uppropriat,dy. Tabl*?s IA anrl 113 identify th?. l,use civil penalty values for differer,\\ si:verit_\\, le~,:ls. ar.tivity ;ircas. and classes of lir.ensccs. After cun~idering all relevant ,:i:*,~umstances, adi ustments IO these values m,,y be made fur the factors described beluw:

1. Prompt ldr-nlification and Reporting R~duction of up to 50"':, of the base civil pe!'.aity rn:iy be gi~en w!wn a !ic,msee iu,intifi,is the violation a nd promptly reports the violation to thP. NRC. In weighing this fa,;lor, consideration will be given to, among other things, the length of ti me the viulation existed prior to disco*.'ery. the opportunity 8\\"di!ablc to disco\\*er the viola tion, the case of discovery anJ the promptness and cor.1p!eteness of any req,iired report. No wnsidocation wili be given to this factor if th,! licensee does not takP. immediate ;J;;tiun to correct the prnblcm upon discovery.

2. Correctivt! Action to Prevent Re,*>Jrrencc, Recognizin~ that co;rectivP. ar.ti o,1 is a!-.vays rnquircd to me?.t regulatory requir,~ments. the promptness and extent to which the licensee takt)s corrective action, itl':luuing at:tions to prevr:nt recurrenr.1), may be considered in modifying tr.e civil :iendlty to be as~essed. Um1~uul:y p;ompt and extensive correction action in;;y re~ull in reducing the proposed ci,il pem,lt}..i ~ much a~ so*,; of the base value shown in T;il;ie 1.

On the other hanJ. the dvil prmul'.y n1dy be in~reascd as much as so*:r,; of the IJH,e -,ulue if ir it,H:ion of corrective acti,:rn is not µrnmpt or if the cor: ec:tive action is only minim,dly ar:,.cptJblc. ln weigltin)! this factor, r.r.r:sider:1:ion will be given to, a:nong other th ings. the t11ne!in,!;;s uf the l..ur:-ccti\\ e t1ctinn, d,*:iri,e 01 iicenst?e initi;Hiv~. and co mi1 r:?hen~1veness of the corr~cti vc.:ic:tiu11-5c,,:h as wh~tl:L'r :he action is focL:;r,d 1.:::-ruwiy lu the specifk viol;ili,1!1 or broadly tn tht: g1!n1!ral a1 ea oi t:uncer11. 3 l',i~\\ P,!rfurmancc RPrlucti,rn bv as much as 11~1**:, llf the base c;*,*ii p,m*tlty shown in T~l>le 1 m:1v I.Jc givP.n fur prior i;nod performant:P. in thP. Jl~nr,ral art!,l of con,:ern. On tli r. *J1hr.r hand. tlw bnse r:i*;il pP.nalty may he inr.rP.ascd as mu..:h as 1(1'1% fnr -pri,,r poor µ,'rfo:-~1ance in the ge*11*ral a~~a of concern. In weighing this factor. con,id<-rdtion will ht-? >?iven :.--,,.1 mun~ oiher th ing -;. th'! effcr. tiv,!rH!'iS,1f pre\\ iou s corrl..'c.:li\\*t! 3cti(.ln for si;nil~r prul,lem~. overnll perforn1an..:e such

is SvstP.m

itic i\\ssr.%mcnt of Licensee P,*rforrnan,.e (SALPJ,~c*aluatior,s for power reacl<Jrs, and rrior ~nforcerwrnt history including Severity l.evP,l fV and V viol;itions in the o:*~a of conc,irn. For example. [,1ilure to irnplt:rn~nt previoi~s corrective uc:titJn for pr:or *;ir:1 ilu r probl<:ms !ltq* re,ult ir, :rn inr.r-.!,l s~ iP !~;J r.ivi l p *~n ulty.

4. Prior :\\01ir:e of Simibr F.,ents Th,, hJ~~ r.ivil pena:ty may hr. incre:i~~d as much a:; 3ll'li', for c:1ses where tr.*? licensee had pri,ir ~.n,,w 1i:dge of a probl~m a5 a result of a

!i.-ens<)e,!udit. or.-;pec:fir: :,me 'Jr industry 11ohfir:1!i*>i1. ~n<l had f;~il,"!d t:J t:1ke Cffective pr*~*JP.'ll lS<! ;t!'pil.

5. \\lulliplt' Oct11rrenc,1s Tl-,P. ilJ~c civ:l penalty n::*y bl! inCt"casP.d as m:j*:h *!s :;c ';) when~ 1n1~h'. ;:!1~ ex;tmp:es of a p:irti;:1Ila.r vwLition arc :drn'.ified during the iP"pcc:tion ;Y.:riod.

Th,, dlJ0,.-e for.tors are additive. 1 lowever. in no in-;t~nc,: will a r;i,,il Jh!nalt:i fo, any one vi<J L11iori exce,?d 5Hl0.!"JCIJ p,,r d,;y. Th P. duralifJn of a violation mriv.J!so be considt:rt<d in,;ssessi1;g il ci,*ii pendity. A greater civil p,,nalty mAy be in1pos~d if a vi r,Iatic;n co1:tinues ior rr.orP. th,;n a d:,y. For P.':~rnpie: (!} If J licr.n;P.e is awdre of the P.xistcnce of ,,:ond i<i<rn which re:;,_dts in an ongr:in8

• iolation ~r,d fails to ir: :ti;:3te corrP.~tive

.11:tion. P.uch day the condition e,d~ted may h~ r:un~irJt?r,~d as a scp..:ir~:e violation anti. as s*Jt.:h, subjer.t to a scµ :1rate additional civil p;*nal ty. (2) lf a licPnSl-!t! is unaware of a CfJndition r8s*tlti!,g in a continui ng violation. but clParly s::oulJ ~ave l,er.n ;Jware of the condition or_ h-,J an,Jpµ'lrtuniiy to r:orrect thP. condition Liut r~ il-~d t,1 rl0 so, a St>p,irc>te viol;ition ijnd

11:,*,id;irt :-:ivi! f)*if"laity ;n;1y be considered for

,:,1*.r. d.,y 1r.,ll ihP. liCP'.lSP.e r:IParly should h;1*:,_. L"?t*:1 :a\\'flrc of th~,~onditinr, or had an iH*:J *l * !,!1 "tv l*> ccH:-r*1:t ti!e c 1J1H.lit io~. b11t f:;;i,.,J 10 di, So). 13 1 Aiternntivcly. whet hc:r or net a li r.'?nsee i.;.1w;1rP *Jr,houl.J h-we bcPil aw<!*E: of a viulJ1i,1!"", th:,! c0ntinl!?.s for tnor~ tr'~n one di!V, th r. civil nena!tv irrr,05~d for one vi;;l;;tir,n r.1nv*b,! in c'.rP.8s-:d to refler.t the ,..:.d\\.L*d si';lriific;1nr;e re:,; 11!ting fron1 the d11rnti 11n,,r t~e viol.1ti on. TltP T,!1:l**s ~nr:1 the mi*igati rl,~t,~l r,1i1~ 1> t.hP. <:ivi! pP!1 :-d ~i*~-* \\.Vhir.h i!~~*~~ -=<'d fqr P.n,:h vi,)ht i.J r:. h.i--... :.,,r ri t '. 11? f*H1d.1m~ 1~t::1 l :.;r1d~rlvi n~ c.iu~P.s nt" a r:,,i,1.,n, f1Jr VI. h11:h ~nforcc.,~er:t action d;;t,;;.Jt.: tu h~ w1! ,,, fl',. !h~ r.u mulati ve total ~1 H :i ll \\*1 n: :1 1i,J11 w!ii ch ontrib r;t eJ tn 'lr 1.v~r~ 11 :, fl *,,n!*J~h t i: _..,.. :-qu~:v:P.s of th ~t prqiJ1:**n m*!.., !;e ll:! ::;,?il ~lll th e anv1 u:1 i. shown 1:, th,~ !.J hl c f,1r.1 p;*'Jb!em of !hJ t Se,.,erity l,.-,v~!. f1 :0 il1j1*s1 *d. n -1:: f:Vd!U.t!ioi-, uf $~Ch r,1 1.l!ipl :: *: i,,l :1?i*1n:i *;l,nw':3 that more than one tuntL;:n,..**:.tt !*r"ohl l-.! n~ is !n\\*o!'IP.d. f!nch of

• shi<:h. if vi*!**st;<l i11,i ~!" ~~1d f"! 1itlv. c;1)11ld iead to ri*.*i! ~~'1'-'ltY ~H*ti,Jn b~:- i'-..:*!lf. th,in 'i~p ;-,:-JtP.

Federal Register / Vol. 50, No. 224 / Wednesday, November 20, 1985 / Rules and Regulations 47721 civil penalties may be assessed Coreach sur.h fundamental problem. In addition. the failure to make a required report of an event req11iring such reporting is considered a separate problem and will normally be assessed a separate ci\\'il penalty. if the licensee is aware of the matter th t should have been reported. TABLE 1A.-8ASE CtVIL PEN... LTIES

a. Pow et" reactors...........................

b. Test reactors *********************************-*--*********-**-*-***-**************

Plan1 operatt0ns. construe* bOn. h<lalth physics and EP Sategua,ds T ransportaoon Gre1ter tt,ar, type A quantity' Ty~A quan1ity 0< k!SS 1

c. Research reactors aoo cnt...:al tac~1bes *- ******.. -*******************************..

$ 1()(),000 10,000 5.000 25.000 10.000 10,000 10,000 5,000 $100,000 10,000 5.000

• 100,000

$100,000 10,000 5.000 $5,000 2.000 1,000 5,000 2.000 2.000 2,000 1,000 1,000

d. Fu<>I labncaton ana ondustnal p,oce,s,o,s ' *****-*****************

e. Mills and !J!'3neum convef'9()n l~ties......

I. lf'do,str,al usars of,nat-1 *................. -.............. -........ *-********.. g. Was18 c:!i,posa* iic:en,ees....................................

h. Acadie,ntc or rneclica! ins:titubOnll * ------ ----- *******************-******

i. Other macena: llce!lsees................................. ***-***.. ****........... _..

1,000 25,000 5.000 5.0CO 5,000 2.500 2.500 ' Incl~ irTadiated f\\ief, hi9f' leYet waste. unirradiated fu!S,:e rr.at&o>I, a"'1 anf o.'he< quantities requiri.-,g Type B paci<aging. 'Includes low specmc IIC1r"'Y.. s,e (LSAI. low level was1e. Type A. pac ages. and e,cepted quan1ities and orucles. 2 Large tirms engaged in manulacti;nng o, dlstn!luhon of byf,<oduct 50'.;(Ce. °' special nuclear rnatenat

• Thos *moum ~"" 10 Catego,y t ~censees (as defined in 10 CFR 73.2(0011. l.Jc&r.sed 1\\101 labtoca'.O<S not aulliO<ited to possess Catego,y 1 ma1eriaf ~*""
• base -lty amount ol $SO.Ow.

~ lnctudes tndustrial radtograpners. nuclear pharrnaocs. and other tr;J"Jstna: user$. 'This arrli.-, fo aonpt"Oftt tfl!lllif'Ution!I n('I! othtrwi!oe catP!'unzP.d under !'t:Cl i1Jr.J.

• • .,.. lhro*u;h.. El.. iu thlS rab!~.

TABLE 18.-BASE CIVIL PENALTIES BaseO.*I Penalty amount 1 I... 11............. -.... *- **-*----.. *-***--... -.... ---..,... _ 111............ -..... --*-**---*--.. ***.. **---........ --.. -. 1 Percenl of amount l'ed in tahle 1.'\\.* C. Orders 100 80 50 15 5 An order is a written NRC directive to modify. suspend. or revoke a license: to cease and desist from a given practice or activity: or to take such other action as may be proper (see 10 CFR 2.202 and 2.204). Orders maybe issued as set forth below. Orders may also be issued in lieu of. or in addition to. civil penalties. as appropriate. (1) License Modification Orders are issued when some change in licensee equipment. procedures, or management controls is necessary. (2) Suspension Orders may be used: (a) To remove a threat to the public health and safety. common defense and security. or the enviro11ment: (bl To stop facility construction when: (ii Further work could preclude or significantly hinder the identification or correction of an improperly constructed safety-related system or component, or (ii) the licensee's quality assurance program implementation is not adequate to provide confidence that construction activities are being properly carried out; (cl When the licensee has not responded adequately to other enforcement action: (d) When the licensee interferes with the conduct of lln inspection or investigation: or (el For any reason not mentioned above for which license revocation is legally aulhorized. Suspensions mi.y apply to all or part of the licensed activity. Ordinarily. a licensed activity is not suspended (nor is a suspension prnlongrd) for foilurP. to comply with requirements where such failure is not willful und adequate corrective action has been taken. (3) Re"'ocation Orders maybe used: (a) When a licensee is unable or unwilling to comply with NRC requirements, (i:,) When a licensee refuses to correct a \\*iolatior.. (cl When a lic.ensee does not respond to a notice of violation where a response was

required, (d) When a licensee refuses to pay a fee required by 10 CFR Part 170, or (e) For any other reason for which revocation is authorized under Section 186 of the Atomic Energy Act (e.g.. any condition which would warrant refusal of a license on an original application).

(4) Cease and Desist Orders are typicallly used to stop an unauthorized activity that has continued after notification by NRC that such Activity is unauthorized. Orders are made effective immediately. without prior opportunity for hearing. whenever it is determined that the public health. interests, or safety so requires, or when the order is responding lo a violation involving willfulness. Otherwise, a prior opportunity for a hearing on the order is afforded. For cases in which the NRC believes a basis could reasonably exist for not taking the action as proposed. the licensee will ordinarily be afforded an opportunity to show cause why the order should not be issued in the proposed manner. D. Escalation of Enforcement Sanctions NRC considers violations of Severity Levels I. II. or Ill to be serious. If serious violations occur. NRC will. where necessary. issue orders in conjunction with civil penalties to achie\\'e immediate corrective actions and to deter further recurrence of serious violations. NRC carefully considers the circumstances of each case in selecting and applying the sanction(s) appropriate to the case in accordance with the criteria described in Sections V.B and V.C. above. Examples of enforcement actions that could be IHken for similar Severity Level I. II. or Ill violations are set forth in Table 2. The actual progression to be used in a particular case will depend on the circumstances. However. enforcement sanctions will normally escalate for recurring similar violatioru:. Normally the progression of enforcement actions for similar \\'iolations will be based on violations under a single l:cense. When more that one facility is covered by a single license, the normal progression will be based on similar violations al an individual facility and not on similar violations under the same license. Howe\\'er. it should be noted that und~r some circumstances. e.g.. where there is common control 0\\'er some facet of facility operations. similar violations may be charged even though the second violation ocurred at a different facility or under a different license. For example. a physical security violation at Ur.:t 2 of a dual unit plant that repeats an earlier violation al Unit 1 might be considered similar. TABLE 2.-EXAMPLES Of PROGRESSION OF CALATEO ENFOFiCEMENT ACTiONS FOR SIMI-LAR VIOLATIONS IN THE SAME ACTIVITY AREA UNDER THE SAME LICENSE I.. II.. l!I Nu-ol sm>ila,.-ono from 1l>e cate aJ \\~ last ---- °' ""1llin the prev:ous 2 year, (whctiev. penod,s ~*eate<I 1s1 2nd 3rd a + b a a+b+c a+ b d a+b + c a+b

a. Civil penalty.

b. Suspension of affected operations until the Office Director is satisfied that there is reasonable assurance that the licensee can operate in compliance with the applicable requirements: or modification of the license.

as appropriate.

c. Show cause for modification or revocation of the license. as appropriate.

d. Further action. as appropriate.

£. Related Administrotii'e Actions

• In addition to the formal enforcement mechanisms of notices of violation, civil penalties. and orders, NRC also uses administrative mechanisms. such as bulletins.

circulars. information notices, generic letters. notices of de\\'iation. notices of nonconformance and confirmatory action l~tters to supplement its enforcement program. NRC expects tlcensees and vendors to adhere to any obligations and commitments resulting from these processes and will not hesitate to issue appropriate orders to licensees lo make sure that such commitments are met. (1) Bulietins, Circulars. Information Notices and Generic Letters are written notifications to groups of licensees identifying specific problems and recommending specific actions. (2) Notices of Deviation are written notices describing a licensee's failure to satisfy a commitment where the commitment invol\\'ed has not bt<en made a legally binding requirement. A notice of deviation requests a licensee to provide a written explanation or st,,iement describing corrective steps taken

l 47722 Federal Register / Vol. 50, No. 224 / Wednesday, November 20. 1985 / Rules and Regulations (or pldm1cd), the results achieved. and the date when correc!iv*~ ;1ction will be con:pleted. (:JJ Confirmatory Action Letters arr. letters c.;unfi rn~ing a 1iccnSHt:*s or :-t vendor's '!)1rP.t::ncnt to take,c,*rtain actions lo remove significant concerns ubuut h;,aith and s~fi,ty, s:ifeg,;ards. or the euvircnrnent. (4) Notices of Nonc::mformance are written nr,:iccs describing r:;:in!icensees' failure to m.:ct commitments which have not been m,1dr; legally binding rcG:.:iren,ents by NRC. An example is a comrnitmr.n! madr, i;1 a pi,:.curemeat contract with a licen,ee as rquired by 10 CFR Pa.rt 50, Appendix B. N,Jtice,; _of Nouconforrnanccs req*;,,.Mt non-lir;ensees to provide \\Hi!ten explanations or statements describing corrective sreps (taken or planned), the result;; acl:iev~d. the dates when corrective actions will be compieted. and measures lakP.n to preclude rccmrer,ce. F Rr::_ferrals to Depart,,;eat of /uslic<" Al1e8cd or su:;p t-; l !f:i criminal vic!at?o:1~ of the Atomic Energy Act (and of l*lher n,l ~:\\'ant FcJeral laws) are rcfprred to tl*r. Department of Justice for invcstigaticm. Rt'!P.rrai to the O,:partment of jt1stir.e dnes not µreclurie the Nl<C fr,,,n t:Jking other t:rtf1.,rr.ri:n*int action 1n1dci th is

• Ccn :~r:l St..:tPw.i::nt 0f fJ(:li::v.

However, such aciic*ns w ill be c,,urd ;1; :1ted with the Department of Jll~ t,c:*: \\(' :t,~ extent p:*actica ble. VI. Public Disclosure of Er.f<irccment Actions i:? accordacce,..,d1h 1c Ci:H. 2.790. ~11 e1 iiorcement actions a!i.d Ucenc;,:,ec;* responses are publicly available for ir.sr,ecl;on. In aJditiun, press reieases a,f gene,~ !iy issued for* civi! penalties and orders. In the case of orders and civil p,!nH!ri C's reh1ted to viola tions at S C'v.:rity Leve! I. II. or ill. press rel eases are issued at the time of 1he order or

he proposed imi:-o'.,i lion of the r.i*:il p<>n?.lty.

P1*ess releases arc not norma!lv i,,ued for Notices o f Violaticn. VII. Responsibilities The Direct1Jr, Office nf Insperti,:,n,111d Enforcement. as the princioal enforcement ,,ff:c;,r of the NRC. ha~ ucen ddeg;;ted the ~n:h0ritv to !ssut) nutiec:~ <if vit~!a!io;,s. r.ivil pen1::lties.,.rnd Grckrs. ' Regional Admin:strutors may.1lsa i:-;~uc noti,:e!i of violation for Sevr!ritv Le\\*el IV and V violations and m;i:,- ;i~n n:)licrs 1Jf \\*iol~tion for s~veritv L*!vel II',*io::l'inns 1*::th no Pr<!l'tJs~d :i vi! ;;c** :d11*,ind prnposetl r.ivil pe;,;dt y ct <::~ion..; *.vith !bf-c~ncurrr-nce of the Dire:.;:,.,. IF.. 1~1 :*P.ct13r,i~irn th:i t the r1_1gulation of r.*1cle~:* ac.tivi!i'?~ iil :-::::11~y c:.iscs do<.:s not lt'nJ i~S1!lf to il :nec!,;_1n1stir vtr,~at!:1PfH. the Di r~cta r, iE 0r th ~ 'R\\:~iu:i,~i.'\\d::-: :*; i:;tr~tl.or rhe Uirc**:oi~,1f -b:..: <~i: !r., ::, of'.'\\ ~;\\..!,,;_.: f\\,-:act ~u-Rcg,.;ldt!('r. and Nu:;;i:,1r \\ ldt~. :J.I ~,..dety a:lJ Sa r~s u;.!rd:; ha *.*e abo l..,l:(; ;' <l!*it:g("!cJ t::r.;i!dt authority. but it i~ exp,~clcc~ th:!t t i~11n:j: ti'- *~ of this a:1thm ity by NRR :rnC \\i:\\'1ss h "i!I t"1£' Clltd i:.~d to ctrlitJns ner.,..,snry in *h<: i:~te.. es! of p::~~!i.:. h1:a!t h ,t:"'d s;ifcty. Th~ LJi:-r,,..,or o :*fke nf /',dp;in*.. tr:.i!:on. h,Vi he.. ~n.ie!-J~:1 tcd the aurhority to ;55: u*: c :dt!rs w h*:*re iit.:tn5*?~S viul..:!!e C,jmin i., s ion it:gul c. no:\\~ by non ;:-:n *,;11~*1t of lice~ --...:- tt~s. 11 t!- :1l t'l!lnf':l to c.1w:..1J(!r the reddeJariun tJf :;umc: 01.~*;...,f 1:1c::;e ,1t'1hn;1ties to th~.'.Jn1io1 ~:,r:i10,..}._,f :h.1 :\\".C P.**gian.1 1 O ffi 1.:,.. ::1 o*:cr ?l:e :!:.-xr ~p,..,*-*-.. 1 :,*t:;, !::-. must exP.rcise judjjment and disuetion in determining the severity levels of the violations and the appropriate enfot'cemer.l sanctions. includinii the decision to impose a civil penalty anJ the a mount of such penalty. after crmsidi,ring the general princiµlcs of this slat~ment of policy and the technir.al sign:ficance of the violations and the surroundir.g circumst,mces. The C(lmmi;sion will be provided writtrm no!ificati::w of all enforcement ac:i1Jns invo!vi n)l civil pP.n:ilties or orders. The C1Jmmisslon will be consulted prior to taking enforcr.ment er.lion in the following situations (un!!!~S the urgency of the situation dictates imm,Jdiatt.? action}: (1) An acticn Hif;~cting a licensee's opernticn that reqttires balancing the pub!ic health.1nd safety or common defense and security implications of not operating with the potenti;il raJiological or other ha1.ards 11ssociatwl with continued operation. (2) Propflsals to impose civil penalties in amounts greater th:m 3 times the Sevr.rity Level I v,!lur.s shown in Table 1.-\\: (3 ) Any proposed enforcement actinn that involves a Se,*erity Level I viol.;!,on: (4) Any enforcement action that involves a finding of a materia! false statement: (5) Ar,y action that Office Direc:tnr believes w-,rr,,nrs Commission involvemt>nt; or (6) Any proposed enforcement acti,m on which the Commission asks tu be consulted. VIII. Vendor Enforcement The Commission's enforcement policy is also applic11ble to non-licensees (vendors]. Vendors of products or servicPs provided for use ir. nuclear activities are subject to certain req ui rements designed to ensure t!u:t tfie products or services supplied that could affect safety are of high quality. Thro ug h procurement contracts with reactor iicens:!es, vendors 11.e rt>quired to have quality a~surance programs !hat meet appl icdblc iequirements including 10 CFR Part :,0, Appendix B. and 10 CFR Part 71. Subpart H. Vendors of rca*r.tor and materials licensees and Part 71 licensees are subjer;t to the n,quiremenls of 10 CfR Part 21 rega rding reporting of defects in basic components. The NRC conducts inspections oi reactor licensees to determine whether thev are ensuring that vendors are meeti!Jg their contractual flbligations with reg:;rd to quality of products or servic,~s that could h., ve a:1 advcr8t? effect on S;!foty. As part of the effort of e nsuring that licensees fulfill th:cir obiigalions in this regard. the "liRC inspects reactor vendors to cictermine if.!wy are n.t*eting thP.ir obii5Jtions. Thes\\: in:;pections inclurlP. examination cf thP. qu:ilit:: !lssur.1nce µrtJgr.i ms and their impt.,menta tiun by the Vt!nd,1rs th roJgh examination of prc,dur. t qua lity. The 1'.~C ma y also inspect vendors, incbdi1,g,upplier,; of Part 71 and matr:rials licenst',es. to determin" whr,;h.,r the} are r.o mi,lying v..-ith Pdrl 21. \\\\'h P.n ias;iec!ions detcrr1i11e Iha! viola !ions of NRC re']uircments have occurr,, J, o~ tl;at vendors ha v,i foiled to fuiLll comrnc tu.11 cnrn01 (!;11ents tliut.:.o;.ild advP.rsc!y nlft:ct the qu~H~y uf a s.1f~ry sig,.ific2.1; t proCuct 0 r 'ie iv!ce. enf0 rct!ment actiou *wii! be lul--ch. i\\o!iuis ;,f Violati,m and civii penal ks w iil b~ :..i~=d...,,.; appr1)r1J*i;! te. f*lr licr:r...;:::c o; fa ilure:; to ensure that their vendors have programs that meet 11pplicable requirements including P,u*t 21. Not~s of Violation will be issued for vendor hicK violate Part 21. Civil penalties will only e imposed Aga;nst individual directors or responsible officers of a vendor organization who knowingly and conscioul!ly foil to provide the notice required by 10 CFR 21.21(0)(1). Notices of rrco formance will l,e used for venJ1Jr which

• 11 to meet commitments relate

,JRC activitie~ Supplement I-Severity Categories Reactor Operations A. Severity I-Violations involving for example:

1. A Safety Limit. as defined in 10 CFR 50.36 and the Technical Specifications. being exce~dr,d:

2. A system

• dcsi!lncd to prevent or mitigate a selio11s sdr.ty !.'vent not being able to pe:1forr.. its inl~nded s;ifety function 7 when actually called upon to work:

3. An accidental criii.;ality; or

4. Reiease of radioactivity ofisite greater than ten (10) times the Technical Spcci !!1.-:tdions H1nit.1 B. Sc\\*.;rily ll-Violali0r.s involving for example:

1. A system designed to prevent or mitigate serious safely events not being able to pnform :ls intended safety function: or

2. R(:leasc of radia.ciivity offsite greater than five (5) times tht? Technical Specifications limit.

C. Severity 11[-Vi-Jlations involving for examplP.:

1. A siimificant violation of a Technical Specific;ticn Limiting Condition for Operation where the appropriate Action St;,te:m i'nt was not Sntisfi~d within the time allott.;d by the Action Stat~ment, such as:

a. In a prcsBurized water reactor, in the applicable modes, ha*:ing one high-pressure s;_i[~ty injection pump inopr.rable for a period in e:xcr:,s of that allowed by the action ~tatcrn?.nt: or

b. In a boiling watr!r r~:ir;tor. one primary corH.; inrnent isolation valve inoperable for a pP.riod i~ c xc:!SS of ch:1t allowed by the action st:i t<?ment.

2. A sys!P.m designed to prevent or mitigate H sP.rious safety eveni not being able to p~ rfo rrr. its intcndP.d function under certain condi tions (e.g., safety system not operable unless cffsite power is available: materials or ctJmponents not enviroP.mcnta!ly q*Jalified):

3. Dere!;ction of duty on the part of p!'c,;onr.~I involved in licensed activities:

,.. Svst P.m" as usl?d in thc$e supplements. indudes ..irln11;i.:S,ii-1t1\\C and mc: r::i~~dJ i con~rul i,ys tcn1 s. as '-' l*li,1.;.:.,:.y~i1.:a! sys! 1:ms. 7 **111:~:td~d :;.J f,!'ty Lwction** means the total

,...:!f~!t \\* fi..:.:~ction. c:i<l is not dire(;t t!d \\ow-Hd rt los~ of rcJ~,;;dJ!tr:v. For e.xa.11:pl -1. r;c~~i Jering a 0\\VR's hi8h p! esc:;::re i=:Ccs :::?p,1bil!ty. t!:e viol,Hion must result in com~lcl~,nva lid<< tio n of buth HPCI and i\\DS c..Lh~-.*.,::1*111.; >\\ li)ss of 0n ~ st: b-iystP.m do&os ~ot

.k~t*,:t t!*,** 1:;!t:nO,*d --:.ifr. r~* fqp1:tioa ~~ iong as the C,l!h* r ~~\\h~ ~tt:m i.; op-?r-ib)e.

'fi1r Tc.:r.hr. ical s:..i~c:f,, d tion iimit as 1J~ecJ 1n this !):..:.;::-~il;,, m ti1 t (lt e:-ns A.-&. O.:.!.rnd C.5) dut:s f'!ot a pply !*: tlit:> 1!"!:.:'1r.!Jnt:o*.1i, rd\\*J,;,:, l i1r.i !.

Federal Register / Vol. 50, No.. 224 / Wednesday, November 20. 1985 / Rules and Regulations 47723

4. Changes in reactor parameter cause ummticipllled reductions in safely:

5. Release of radiactivity offsilc grealcr t!rnn the Technical Specifications limit;

6. f.,ilure to meet the requirements of 10 CFR 50.S!I such that a required license

,mP.ndmcnt w;is not sought

or

7. Licensee failure to conduct <1dequatc c"*ersight of vendors r

• ng in the use of products or services,*hie a.F f defective or indeterr.iinate quality
• whic h,we s<<fety significance.

D. Severity IV-Violations involving for ex;;mple:

1. A less significant viohition of a Technical Specification Limiting Condition for Operation where the appropriate Action Statement was not satisfied within the time allotted by the Action Statement. such as:

a. In a pressurized water reactor, a 5%

deficiency in the required volume of the condensate storage tank: or

b. In a boiling water reactor, one subsystem of the two independent MSIV leakage control subsystems inoperable.

2. F<1ilure ~

eet the requirements of 10 CFR 50.59 that docs not result in a Severity Level I. II. or Ill viola tiori:

Y.failure to meet regu!.. to:*y requirements

. at have more than minor s<1fetv or em*ironr.iental significance: or *

4. failure to make a required Licensee Event Report.

/ E. Severity Level V-Violations that h<1ve minor safety or environmental significance. Supplement 11-Se\\*erity Categories Port SO Facility Construction A. Severity I-Viola *ans involving a structure or syslem trial is comp!eted

• in such a manner that it would not have satisfied its intended safety related purpose.

B. Severity II-Violations involving for e\\llmple:

1. A breakdown in the qu<1lity assurance program as exemplified by deficiencies in construction QA related to more than one work activity (e.g.. structural. piping.

electricHI or foundations]. Such deficicnciEC,S normally involve the licensee's failure to conduct adeq*Jate audits or to take prompt corrective action on the basis of such audits a nd normally involvP. multiple examples of deficient construction or construction of unknown quality due to inadequate program implementation: or

2. A structure or system th t is completed in such a manner that it could have an

,,d"r,rse effect on the safety of operations. C. Se\\*crity 1!1-Violatic,ns involving for example:

1. :\\ deficiency in a licensee quality ass11ra nce program for con5truction rP.lated to "single work acti\\'ity (e.g.. structural. piping.

Plectrical. or foundations). Such significant ddiciency normally involves the licensee's foi!ure to conduct adequate audits or to take prompt corrective action on the basis of such a11dits. and normally involves multiple

• • • .awples of deficient construction or

'* "Comp!eted" means completion of conslruc:ion i.,c!uding review and acceptance h.\\* the rri,:~ 11 111 *11,i., Q :\\ org:1nizc:tion. construction of unknown qu<1lity due to

4. Failure to implement approved inadequate program implementation:

compensatory measures when the central (or

2. Failure to confirm the design safety secondary) alarm station is inoperable:

requirements of a structure or system as a

5. failure to conduct a proper search Ht the re8ult of inadequ<<te preoperationnl test access control point that results in program implementation: or introduction to the site of firearms.

3. Failure to make a required 10 CfR

~ ives, incendiary devices. or other items 50.SS(e) report. whi. could be used for industrial sabotage: D. Severity IV-Violations involving failure to meet regulatory requirements including

6. Failure to properly secure or protect one or more Quality Assurance Criterion not c!assified or other sensitive Sllfeguards amounting to Severity Level I. II. or Ill information which would significantly <<ssist violations that have more than minor safety an indi"idual in an act of radiological or environmental significance.

sabotage or theft of special nuclear mHteri;,I. E. Severity V-Violations that have minor D. Severity IV-Vic,h1tions involving for safety or environmental significance. example:

1. failure to establish or maintain safegua,ds systems designed or used to prevent or detect the unauthorized removal of SNM of low strategic significance "from areas of authorized use or storage:

Supplement 111-Sevcrity Categories Safeguards A. Severity I-Violations involving for example:

1. An act of radiological sabotage or actual theft. loss. or diversion of a formula quantity

.of strategic special nuclear material ' 0 (SSNMJ:

2. Actiwl entry of an unauthorized indi"idual into a vital area or material access area from Ol!!side the protected area (i.e..

penetration of both barriers] th<1t was not detected at the time of entry: or

3. Failure to promptly report knowledge of an actual or attempted theft or diversion of SSNM or an act of radiological sabotage.

B. Sev~rity II-Violations involving for example:

1. Actual theft. loss or diversion of special nuclear material (SNM) of moderate stra tegic significance: 11

2. failure to control access such that al!

three elements of <<ccess control (barrier. monitoring. and response] at the protected area or vital area are inadequate or two of three elements are inadequate in both the protected and vital area:

3. failure to implement approved compensatory measures when the central and secondary alarm stations are inoperable:

4. failure to establish or maintain safeguards systems designed or used to prevent or detect the unauthorized removal of a formula quantity of SNM from a reas of authorized use or storage: or

5. failure to use established transportation security systems designed or used to pre\\'er.t the theft. loss. or diversion of a formula quantity of SNM or acts of radiological sabotage.

C. Severity III-Violations invo!ving for example:

1. failure to control access such !hat two of the three elements of access control at the vital area or protected area barrier are inadequate:

2. failure to control access to a transport vehicle or the SNM being transported that does not constitute a Severity I or II \\'iolation:

J. failure to establish or maintain safeguards systems designed or used to prevent or detect the unauthorized removal of SNM of moderate strategic significance from areas of authorized use or storage: '"Ser 10 CFR 73.Z[Lul "s~e 111 CFR 73.2(,)

2. Failure to implement 10 CfR P.irts 25 and 95 and information addressed under Section 142 of the Act, and the NRC approved security plan relevant to those parts:

3. failure to control access to a vital are.

or material access area from inside the protected area or failure to control access t the protected area in that one of the three E:lements of access control is inadequate:

4. f;iilure to properly secure or protect classified o~~ensitive safeguards informatio which-would not significantly assist an in ual in an act of radiological sabotage or theft of special nuclear material:

or

5. Other violations. such asJ ilure to follow an approved security plan. that have more than minor safeguards significance.

E. Sevcritv V-Violations that ha\\'e minor safeguards ;igniiicance. Supplement IV-Severity Categories Health Physics 10 CFR Part 20 i, A. Severity I-Violations involving for e,ample:

1. Single exposure of a worker in excess of ZS rems of radiation to the whole body. 150 rr:ms to the skin of the whole bodv. or 375 rems to the feet. ankles. hands. or* forearm.

2. Annual whole body exposure of a member of the public in excess of 2.5 rems radiatio~:

3. Relea~e of radioactive material to an unrestricted area in excess of ten times the limits of 10 CFR 20.106:

4. Disposal of licensed material in quanticies or concentrations in excess of ten times the limits of 10 CFR 20.303: or

5. Exposure of a worker in restricted areas ofter. times the limits of 10 CFR 20.103.

B. Severity II-Violations involving for example:

1. Single exposure of a worker in excess of 5 rems of radiation to the whole body. 30 rems to the skin of the whole body or 75 rems to the ff:et. a nkles. hands or forearms:

2. Anr.ual whole body exposure of a member cf the public in excess of 0.5 rems of r;.idiation:

See 10 CFR 73.Z(yJ 1::. Perscnnel oveiexposures and c!Ssociated \\ ir:!;..t! i(,:.s. incurred durinR a life sa\\*ing e:ffort.,.._. ;11 h~ tre:,t?.d r*r: a cnse-by-cc1se bttsis.

47724 Federal Register / Vol. 50, No. 224 / Wednesday, November 20, 1985 / Rules and Reguiations

3. Release of radioactive material to an unrestricted area in excess of five times !he limits of 10 CFR 20.106:

4. failure lo makP. an imme'1iate notification as required by 10 CFR

~!0.40J(a)lt) and 10 CPR 20.403fa)(2);

5. Disposal of licensed material in quantities or concentrations in excess of five limes thP. limits or 10 CFR 20.303; or

(}. Exposure of a worlcer in restricted areas in excess of five times the limits of 10 CFR 21).103. C. Severity 1!1-Violatinns involving for example:

1. Single exposure of a workP.r in excess of 3 rems of radi11tion to the whole body, 7.5 re ms to the skin of the whole body, or 18.75 rems tn the feet, ankles. hands or forearms:

2. A radiation lev'!I in an onrestricted area

• uch that an individual could re1:eive greater than 100 millirem in a one hour period or 500 millirem in any seven consecutive days:

3. Failure to make a 24-hour notification as r'!quired by 10 CFR 20A03(b} or an immediate notification required by HJ CFR Z0.402(a);

4. Substantial pott'!ltial for an exposure or release in excess of10 CFR Part 20 whether or not such expooure or releasP. occurs (e.g.,

enlry into high radiation areas, such as under reac!or ve:;sels or in the vir.ini ty of exposed radiographic sour<:~s. wilhout havir.g performed an adP.11uate s'Jrvey, opl!l'sJtion of a radiation facility wilh a nonfunctioning interlock system);

5. Release of radioar,tive ma terial to an ur: restrk ted ar~a in excess of th~ limits of 10 CFR 20.1:J6;

6. Improper disposal of licensed ma terial not coverl?d in SP.veritv Lei*el I or JI;

7. Exposure of a worl<er in restiic!ed areas in excess of the limit, of 10 CFR 20.lOJ;

8. Release for unres!.icted use of contaminated or radioactivt! ma terial or equipr-ient which poses a realistic potential fe r significant exposure to members of the pul.J!ic, or which rcflec,s a progr:, rnmatic

(,a,her than isolated) weakness in the r;,diation control program;

9. Cumulaiive worl,er exposure above regulatory limits when ;;uch cumulative exposure reflects a programmatic, rather than a n isolated weakness in 1adiati,m protection:

10. Conduct of licensee activi ties by a te,::hni::ally unqualii'ied person; or

11. Significant fa ilure to control licensed m;it~rial.

D. Se*;eri!y IV-Violation,; involving for exa mple:

1. 'E:-.post,res in excess of :he limits of 10 CFR 20.101 not ccnstituting &:!verity Level I.

II. or iii.,iolati<rns:

2. A l"!'diation level in an unrestricted area such tha t an individual could receive greater th;in 2 millirem in a one-hour period or 100 millirem in any seven consecutive days:

3. f ;iilure to IT'.-!ke a 30-day notification ri?qui, ~d by 11) CFR 20.4">-5:

4. fai!ure to make A fo llowup w ritten rep<,rt a s required by ttl CFR 2G..;021b). 20,408, and 20.409: or

5. An v other ma tier !hal has more thHn minor s~fety or er.vi romcnta l sisnificance.

E. Sc-.,erily V-Violatio11s tha t hdvc minor ,,. fety,ir euviroment:11 signi fic,rnce. Supplement V-5"erity Categories Tronsportotion ** A. Severity I-Violations of NRC transporl.oltion requirement* involving for example:

1. Annual whole body radiation exposure of a member of the public in excess of0.5 rems of radiation; or Z. Breach of package integrity resuliing in surface contamination or external radiation levels in excess of ten times the NRC lim its.

B. Severity II-Violations of NRC tnmsportation req>Jircmenls irrvolving for example:

1. Breach of package integn1y nisulting in surface contamination or external radiation levels in excess oi NRG requirements;

2. Surface contamination or extemnl radiation levels in excess of five times NRC limits that did not result from a breach of

• package integity; or

3. Failure to make required initial notificarJon! associated with Severity Level I or JI vi1Jla lions.

C. Severity Ill-Violations of NRC trnnspo:tation requirements involving for example:

1. Breach of package integrity;

2. S'Jrface contaminaticn or externa l radiation k!vels in P.xcess of, but less than a factor of five above NRC rP.quirements, th:::

did not result from a breach of package intP.grity; V

3. Any noncompliance with laberfing.

placarding, shipping paper. packagmg, loading, or other requirem~nts tha t could reasonably result in the following:

a. Improper ide-ntification of the type.

quantity, or form of material:

b. Failure of tltt! carrier or recipient to exercise adequa te control;r, OT

c. Substantial potential for personnel exposure or contamination. or impmper transfer of material; or

4. Failure to :nake required initial notificaiion associated wilh Severity L<!H I ill violations.

D. Severity IV-Violations of NRC transportation req'lirements involving for example:

1. Pad.age selection or preparation requirements wh;ch do not result in a breach of pack~g!? i:iteg~ity or surfa~ c.>nt., mina iion or el\\ternal rndia lJon levels in excess of Nl<C requirements; or

2. Olher violaiion~ that ha~e more than mi11or safety or environmental sig.1ifican,:;.2.

E. Severity V-Vio!a tiun; tha t h,ne minor safety or environmental :;igr.ifi,;i!r:t:e. Supplement VI-Severity Categories Fuel Cyr.le and Materials Operotiuns A. Severity I-Violations ir.volving for exam;,le:

1. Radiation le*1els, contaminatio n levels. or release~ that exceed ten times the limits specmed in th?. license; u Sorn*: innsptJrta tkl?l requirf?rnen ts are.:1ppfi *:?d to more than one h,:Pf'lRtt ;nvolv"'d !n thP. samP.

aciivity ""ch as * ~t:ipJl"r flO t.r R 73.20) and a carrier 110 Cl'R 7fJ.20a ). When a si:,lation of such a rt?~u1rc.-,H?nt 1M.u:-,;. cnlOrcemrmt a,~t1on wiH u~ direcl C'!d ~s~inr1 t the i"=:iµo nsible liccn.:.ee w hk h. ,rnd ~r th'? circ um,;t c1 n r.1!S tJf tht? CJ -;e, m a y h~ 'JO~ nr tn*lrt.: of th,~ li1*,*:1s<'cs i,1,.,oh.P.d.

2. A system designed to prevent or mitigate a seri01Js safety event not being operable when actually required to perform its design function; or

3. A nuclear criticality accident B. Severity II-Violations involving for exarnple:

1. Radiati Ii levels, contamination levels. or releases th t exceed five times the limits sp'.!ci fied in the license; or

2. A system designed to prevent 0 1* mitigate a serio*Js safety event being inoperable.

C. Severity Ill-Violations involving for e~ample:

1. F~ilure to control access to licensed materials for radiation purposes as specified by NRC requirements;

2. Possessi,m or use of unauthorized eqnipment or mdt a s

• the conduct of licensee activilie whic egrades safety;

3. Use of radioa

• ce material on humans

v. bP.re s1,ch use is not aulhorized:

4. Conduci of licensed activities by a technically unqualified person:

5. P..adiation levels. contamination levels, or releases that exceed the limits specified in I he license: or.

6. ~ledic.il thernpeutic misadministr" tions.

D. Severity IV-Violations involvin3 for exd?0ple:

1. Failure to maintain patients hospitalized who have cobalt~. cesiurh-137, or iridittm-192 implants or to conduct required leakage or contamination tests, or to use prcperly cali brated equipment;

2. Olher violations that have more than minm safety or environmental significance; or

3. Fa ilure to report medical diagnostic r,1isadr.1inistrations.

E. SP.verity V-Violations that ha*1e minor s;;fe,y or environmental significance. Supplement Vl!-Severity Categories Misc,?!loneous Matters A. Seventy I-Violations involv;ng for example: J. A Ma terial False Statement (Mr S) ' 5 in which the statement made w as deliberately fdlse:

2. Falsification of recort1s which r-.:RC rt:4ui;*es ~ kept of signific.. nt information in

,,.-r:ich ihe records were dclibera!ely fa lsified by o; with the knowledge of manage ment;

3. A knowing and intentior.al failure to

µrov,ee lhP. notice required by Part 21: or

4. Action by senior corporate management ir.,,io!alion of Section 210 of the ERA against

i,1 '!mplcyee.

• ' In es1,rr,ce, a f\\.!ateric'I Fu lse Sta te mem is tt stdterr:e:1t tha t l6 f.ilse by omjssion or commi~sion a'lJ is r~levant to the n!gulatory pro,;.csa. As can be

!:!,!*:n in :he ~xampfes. in determining the speofic ~~eri!y lc*,et of a vi*Jlntion involving m a te, ici f fu l:ie std t~rr,~~ts or fal3ifica iion of records, considr.;ation " ;:1 he givP.n to,,,ch fa ct,,,.,, as the P°"ition of the person involved in the violation fe.g... flr..t li ne ~t*pe..-viso!' or,-enior manager). the significance of 1i1e i:1f,1rma lion in'loived. and the in,en\\ of the viul.::or (i.'?... ne6Hgence not amounting to carel~s::t dic; r~'.c,d td, ca ~ l1!~S d i3re~a rrl, or d:!lib:,.iat en~as). 1 rye :.!lt~ :lve wr.i;;ht giv*m tfl c,3i;h o f !h~ f,1l:to~ in arriv'n~ at the ~ppropriatP. sP.v-,Mty level will be d1ipn1,Jeiont ()n the circumstan1:P. ~ o f,h-e v iola t+on.

Federal -Register / Vol. 50. No. 224 / Wednesday, November 20. 1985 / Rules and Regulations 47725 B. Severity 11-Vio!ations invo!ving tor ex.imple:

1. A MFS or a repo1 li~g failure. invol\\'ing informatio which. had it liecn a\\'ailalile to the NRC an accurate at the time thr ir,formation 5ho1drl ha, c ber,n sul*mittc:d.

wot!ld havr res*Jltrd :r> n*guh,tor~*,1ction or would likely h;,\\*c, rc~*.il!r*d in NRC sec*king fmthcr infnrrnatinn:

2. A MFS in wl,it.h th,, fabc ;*,11.:rn,*nt w,:s made with ca,1*lt:f; d1:,rep.rd:

,.i, ) . 3. Delib:-rnie f;,1 1..i fic."ti:.--.n ~r re7or~~ \\\\ l:i~ !':RC requi re~ li<: kcr,:,nrnl,*,q: !.J8n,f1c* *A infoi:11uti0n:

4. Ar.lion l:y plant r.wn.. g1:mPr1: r. bon: first -

line s*.1pNvisinn in \\'iolntion of s1*ction 210 of thr EHA c:s<<in~t an emplo.vec: r,1 fo. A fr, ;lurc lo ptu\\'i<fo the, notiu: r1::q1dn:d bv l'~r! 21.

• r:. Sf'vr.dry ll-\\'i,1!11tioi1 :, iri \\'l,l\\*i~~ ft1r c:xample:

1. A MrS not 1>mc,,1nti ~p to ;, Se,*,~rity Lr vPI I c,r II violatic,n.

2. Oeliticrate folslhr.~ tion. or l<< l~ifica,i11n b, or with t kr1~l\\*;!r:dgt! vf 1::0.... i.:bf:llH~ni. u!

rewrd.,. i ~ !:e NRC rrq :lire~ br: kui:,1 that did nril 1 1 \\*l' r.i~ni fH:<lr,t inf(r1 rna tiun.

i. /\\ chH1 l.,v fi, ; t-l;nC' '.' u:,,*rvisior: in

• ic,iatiUi1 oi ~ecnon ~10 uf The~ El{~~ c1g;1in~t l!n c,mplo~ (;c,; or

4. [nnd,1quall! n:d, *;..f ur f:, '. ;!.!i t.: IG t;,.* \\ ii'I \\*,

such that. if :i!"'. npprcpri cih:* rt*\\*ie;., hud li~c:i' mcHie FtS requii*cd. a l\\,rt '.!1 rrpc,~t would have hei,n muh,. D. Sf-vc1*ity l\\'-\\'io!nt!ons itn*olving fc*r ex,irni:,lc::

1. lnade:quatc r"viuw or failure tu review under f'art 21 or other procedural violations a~sor.iated with Part 21 wi!h more' than mmor safety significa r.re:

2. A folse statenwnt caused l..,v an inad vert!'nt cle,

• I or similar e~ror inn>lving infr, rma!ion
• i
• had it bee:n a\\'ailable to 1',;RC and ncc,iratc at the time the information shc,,ild have li<:er. suhmitled.,,*ould prol.,<<ltly not have resul tr.d in regulatory ac;tion or NHC sc-eking additional information: or E. Severilv V- \\'ic,!atic,ns of minor prnrPdurnl ~equirtmcnts of Pa;t 21.

Sur,r,le1nr.ol VIII-Severity Catet:ori,,s f.'r,:er... cr 1,cJ* ! 1rr;.1c 1rc*dt,r-3.-.. A. S,*veri!v 1-'.'ic,li, tiuns iri\\'Ol\\' ing fc,r exa rnp!c: lu a gr,neral em~rgency. licf:r.sec fai lure to promptly: (1 )"Com,ctly cl~s;:ify the e\\'cnt. (2) make r.:q uir~d no?ifir.at ions to rr.sponsible Federal. State, and local agencies. or(~) re; r,c,nd to the event (e.g.. assess i.ctual or potcn ti,,l off site ronsequences. activate emre rgency resp011s1: facilities. and augmi-n! shift ~taff). B. Sevr.ritv 11-Viola:iuns ir;v0h ing for exrlrnple:

1. !n a site :, rf:a emergl'f,q'. lic(*nsec failu;c to prc*n*~*!ly: (11 Corret:tl.v c:la~sif_\\* the evt:nt.

(2i nrnkc rc,411ir<*d r.olifica! ions tt, re r. rwnsibl1: Federal. State. and ior.al agencies. or* {31 respond to the e\\'cnt (e.!(.. as~c~; actual or polr,ntial off site consc4uener.,;, activ<<lt: 1:mcrgenr.y resron~r-f,,dli!ics. and nugml'm sl,ift staff): or

2. 1.ic:ensce foilurc> to me-et or im~*lemcnl more than one cme~~!'ncy pl~n11i ng st<<ncfard invol\\'ing c1~~t!~*smr1it or nl*t~fic:11liun.

C. Severity 111-Vit,la!ions invc,h-ini; for Pxnrr.p\\e:

1. In an.ilert. licens-:e f...ilurP. t(I promptly:

(I/ Ct,rrtctly d,:ssify the event. (2) m;ike re41tir;,d no:,fiL,1 linn, to responsible Federal. St,,il:,,n,d lnc;; I o£encics. oc {3) respond to the c;\\*enl [e.g.. assess ac!ua! or po!.:ntial 0ffsi h.: con~r:qllcncc: s. L! Cti,*ule e11u~rgcncy r~spo::se fr,ci!itil'S. and tn.:s:nc*ni shift !--t.:aff}: or

2. Lir:c11,ee f,1il11re tn meP.I w inrpler.11,n l ont* *: mE-,)1':ncy plannin~ stancl;,rrl im*olvin~

c,sst*:--~ rr,~nt or no-t-Hicalion. D.' Sc\\*Crity IV-Vio!atirms inrnl\\ inf! for rxu mple: l.ic:r:n,('(* fa ilure !Cl met-I or imp!c:menl any 1:mc,rg<:ncy p!a;.n:ng st:,nch,nl l*r rr,quiren,ent no! o;rec~l\\* relnteci to as~cssrnc !1t a11ci noUfictt tiofl. E. S;,vrri<',' V-Vioiatio,,s th,,l hnve minor t:iifrly c,r cn~*irnr.me;ital siFnificance. O;:tP.d i!l Wa~hini;tnr:. D.C.. th i~ l~th d;iy of r,ovP.ri:lJc*r 1[}8~. h i: th,: t\\aC!f*t-ir Rt:gui~ttory Cc1mfili~c;ion. S,imcc.i 1-Chill.:. Sec:-t*tary af the C(lnrmission. [FR D0c:. ~;-:;ge Filed 11-1'.}-R:i. 8:.;:i.. mJ B!LLING COOE 7:,90-01-"4

'86 JnN -9 P 3 :37 STS Consultants Ltd. Consulting Engineers

• L 1 : r*

ur ..,.,-- ;* c. E.1*1, 11 r 00 l*t.i 1"-l l 111 Pfingsten Road Northbrook, Illinois 60062 (312) 273-5440 Mr. Samuel J. Chilk, Secretary to the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 BR NCH Attention: Docketing and Service Branch

Dear Mr. Chilk:

January 2, 1986 We received a copy of 47716 Federal Register, Volume 50, Number 224, regarding revisions. in the rules and regulations. We have no objections to the revisions, and consider them a more rational approach that is consistent with the basic structural authority system represented by the Nuclear Regulatory Commission Rules and Regulations. However, there are several aspects of this set of rules and regulations that might be worth considering. In the first place, the goal of this document is "the procurement of quality products and services for use in licensed activities". If this is the goal, then why is it that most products and services used in nuclear power plants are obtained in competitive bidding? "Pity the man who knows the price of everything, and the value of nothing". This is true, even in the geotechnical field, and particularly true in field testing and engineering services that are performed during con-struction of nuclear power plants. If you think anybody can get the highest quality services for the cheapest price, then you don't understand what it takes to produce quality services such as we would hope to provide on a nuclear power plant. Secondly, your assumption is that the "incentive" to firms such as our own, is based on financial considerations, rather than on the need to obtain and maintain a license.

U.S. NUCLF.A" DOCKET' OFFI 0 rn~~f ISSIO .r::::110 .. Y

Mr. Samuel J. Chilk January 2, 1986 Page 2 It has been our observation that power companies have a greater interest in financial considerations than many vendors of products and services. I am attaching a document prepared by a committee of which I was Chairman, on the Design and Analysis of Nuclear Safety R~lated Earth Structures. If you really want to improve performance of nuclear power plants, why don't you incorporate a peer review concept such as is proposed in this document? This is much more likely to improve the design and construction of nuclear power plants, than is the mere posting of a list of penalties for nonconformance. At least, if peers are used to judge the quality of design and construction, you can be assured of a high level of judgment on the part of those determining whether there is, or is not, nonconformance. The mere creation of a public body doesn't automatically assure the public that the services provided by employees of the Federal Regulatory Commission are of the "state of the art" that is necessary for the design and construction of nuclear power plants. Just as this new doctnnent implies that the NRC is better able to judge the performance of vendors and offices of professional services, than are the power companies, it seems surprising that the competence of the Nuclear Regulatory Commission to monitor particularly the more complex engineering aspects of nuclear power plant design and construction, is not also a question that should be raised. You should adopt a system of sapiential authority to replace your traditional system of structural authority. It seems to me that the Nuclear Regulatory Commission would be well advised to undertake a group such as the Building Research Board of the National Academy of Sciences to make a critical review of the effectiveness of the quality assurance program, and at the same time to consider a number of factors such as the elimination of competitive bidding to improve the performance of the vendors of services and products, to consider peer review by sapiential authorities instead of regulatory agency personnel, and to try to create a win-win system for the con-struction of nuclear power plants to replace the present adversarial system which is exacerbated by the posting of statutory fines for nonconformance. Also, all parties to the construction process should be selected based on their attitude, not the cheapest price, and they should be paid a fair price, not a cheapest price. Sincerely, STS CONSULTANTS LTD. ~~. JPG/sg Enclosure

t ~rn .. * ~£~IID£liIID -N~12s Guideline for Desigrf arid Analysis of Nuclear Safety Related Earth Structures APRIL 1982 AMERICAN SOCIETY OF CIVIL ENGINEERS -1 l ' i l j l l j I I l

N-725 Guideline for Design and Analysis of Nuclear Safety Related Earth Structures Approved April, 1982 Published by the American Society of Civil Engineers 345 East 47th Street New York, New York 10017-2398

Library of Congress Cataloging in Publication Data American Society of Ovil Engineers. N-725 guideline for design and analysis of nuclear safety related earth structure. M Approved, Apnl, 1982~ Includes bibliographical references and index.

1. Atorruc power-plants--Des1gn and construchon.

2. Ovil engmeenng.

Earthwork. I. Title. TH4581.A427 1983 621 48'35 83-72214 ISBN 0-87262-375-0 Copyright e 1983 by the American Society of Ovil Engineers, All Rights Reserved. Library of Coruess Catalog Card No. 83-72214 ISBN-0-87262-3T:>-O Manufactured in the Uruted States of Amenca.

N-725 COMivUTTEE MEivIBERS Fred R. Brown Shannon & Wilson, Inc. ll0S N. 38th Street Seattle, WA 98103 John T. Chen Office of Standards Development U.S. Nuclear Regulatory Commission Washington, DC 20555 Joseph L. Ehasz Ebasco Services Two Rector Street New York, NY 10006 Larry Holish Sargent & Lundy 55 East Monroe Street Chicago, IL 60603 David Hendron Woodward Oyde Consultants 55 East Monroe Street Chicago, IL 60603 Jack C Jones Harza Engineering Company 150 South Wacker Drive Chicago, IL 60606 William D. Kovacs National Bureau of Standards BR-162 Washington, DC 20234 Stanley C. Rossier Stone & Webster Engineering Corp. P.O. Box 2325 Boston, MA 02107 Marshall L. Silver Dept. of Materials Engineering University of Illinois at Chicago Circle Chicago, IL 60680 A. G. Stassburger Pacific Gas & Electric Company 77 Beale Street San Francisco, CA 94106 David E. Troxell D' Appolonia Consulting Engineers, Inc. 10 Duff Road Pittsburgh, PA 15235 Julio E. Valera Earth Sciences Associates 701 Welch Road Palo Alto, CA 94304 John P. Gnaedinger, Chairman STS Consultants Ltd. 111 Pfingsten Road Northbrook, IL 60062

MEMBERSHIP ROSTER Committee on Nuclear Standards John D. Stevenson, Dr. Structural Mechanics Associates 3645 Warrensville Center Road Oeveland, OH 44122 Joseph Antebi, Dr. Simpson, Gurnpertz & Heger, Inc. 16% Massachusetts Avenue Cambridge, MA 02138 Richard Bettinger Pacific Gas & Electric Co. 245 Market Street San Francisco, CA 94106 Ted M. Brown Wiss, Janney, Elstner & Assoc. 330 Pfingsten Road Northbrook, IL 60062 James F. Costello Office of Nuclear Reg. Research Nuclear Regulatory Commission Washington, DC 20555 Robert P. Kennedy, Dr. Structural Mechanics Assoc., Inc. 4740 Von Korman Newport Beach, CA 92660 Morton I. Goldman, Dr. NUS CORPORATION 4 Research Place Rockville, NID 20850 Walter A. Von Riesemann Design Technology Division 5431 Sandia Labs Albuquerque, NM 87115 John P. Gnaedinger STS Consultants Ltd. 111 Pfingsten Road Northbrook, IL 60062 Charles B. Miczek Stone & Webster P.O. Box 2325 Boston, MA 02107 Randolph Broman EDS Nuclear 220 Montgomt:!ry Strt:!t:!t Sdn Fran1..isco, CA 94111 ASCE Chairman General Interest Consumer Consumer General Interest General Interest Producer General Interest Consumer Producer Consultant

FOREWORD For earth structures, it is recognized that the use of nominal material parame-ters and design assumption alone is often inadequate. Coupled with these should be site verification of design assumptions and materials parameters, evaluation of the interrelationship between construc-tion methods and analytical treatment, and verification testing (to assure com-pliance with project specifications based on the design and monitoring of the earth structures-both during and subsequent to construction). Because of the need for continuity from design and analysis through actual construction, Section 7.0 (which deals with inspection, in-strumentation and monitoring) is in-cluded in this standard, although the standard itself is primarily concerned with design and analysis. Sampling, te~ting and interpretation of data, appropriate recognition of results and their limitations, and recognition of the interrelationship of the many sets of data; characteristics and other parameters are crucial to the proper performance of the design and construction discussed in this standard. It is for these reasons that responsibil-ity for the design and construction of safety-related earth structures rest only with engineers who are experienced in one or more of the various phases of earth structures design and construction (including soil and rock mechanics, geol-ogy, field sampling, laboratory testing, analytical methods, specifications, con-struction control and instrumentation). Such engineers shall also have adequate understanding of the hydrological aspects of impoundments, fluid motion effects and of seismological inputs to the site. This standard includes administrative requirements dealing with responsibili-ties and peer review, as well as scope, in Section 1.0. Section 2.0 includes a reason-able breadth of defimhons to make the standard usable for individuals knowledgeable in the geotechnical and foundation design field. Site investigations cannot m them-selves be standardized with regard to vii application to a particular project because of the wide range in soil and rock con-ditions that exist in nature, and the in-numerable design alternatives that are typically present for the design of earth structures. Therefore, informative refer-ences have been included in Section 3.0 on Site Investigation, with additional per-tinent references in specific sections of the standard. The essential elements of the standard are: (1) Section 4.0 covers earth structures used to form the ultimate heat sink (reservoirs) including dams, dikes, and baffles; (2) Section 5.0 covers earth structures normally used to protect the nu-clear plant site from extreme hydrodynamic loads including dams, dikes, breakwaters, sea-walls, and revetments; (3) Section 6.0 covers earth structures used to maintain site contours, the stability of natural and cut slopes, fills and retaining walls. Section 7.0, Inspection and Monitoring, relates to unique problems associated with geotechnical site conditions and construction necessitating a close relationship between geotedmical stud-ies and design, construction aspects and related monitoring, and onsite verifica-tion of actual conditions encountered with regard to original studies and design assumption. Because variability of geotechnical conditions from point to point on a site is expected, the geotech-rucal study cannot be completed until the project is completed, with momtoring providing additional design verification. Earth structures involve unique con-struction processes for each project. And soil conditions present~ contrast to many elements of nucle::ir power plants that are manufactured (and can be held to narrow limits of variability and tested for approv-al within those limits). This prevents, in this standard, use of restrictive or defini-

viii tive requirements that might be entirely feasible for other aspects of nuclear pow-er plant construction. Natural soil and rock conditions. are subject to considerable variab1hty. This element is not typical of the kind of structural problems inherent to nuclear power plants. Such natural variability must be recognized. There are also numerous analytical procedures avail-DESIGN AND ANALYSIS able, some of which may be particularly applicable to particular soil or foundation conditions while not applicable to others. For these reasons, Section 1.2.3 on Peer Review is incorporated with this stan-dard. It is recommended as the process most likely to mirnmize major problems and at the same time minimize over-design. 1 1 1 1

Section 1.0 1.1 1.2 1.2.l 1.2.2 1.2.3 1.2.3.1 1.2.3.2 1.2.3.3 1.2.3.4 2.0 3.0 4.0 4.1 4.1.1 4.1.2 4.2 4.2.l 4.2.2 4.2.3 4.3 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.4.1 4.4.4.2 4.4.5 4.4.6 4.5 4.5.1 4.5.2 5.0 5.1 5.1.1 5.1.2 5.2 5.2.1 5.2.2 5.3 5.4 5.4.1 5.-t.2 5.4.3 TABLE OF CONTENTS Page Purpose, Scope and Administrative Requirements...................... 1 Purpose and Scope................................................... 1 Administrative Requirements.......................................... 1 Responsibilities....................................................... 1 Quality Assurance.................................................... 1 Peer Review......................................................... 1 Initiation of Review.................................................. 1 Qualificahon of ReV1ewer............................................. 1 Revie\\v Requirements................................................. 1 Documentation....................................................... 2 Definitions........................................................... 2 Site Investigation..................................................... 3 uitimate Heat Sink Earth Structure-Darns, Dikes and Embankments.... 4 Scope............................................................... 4 Purpose............................................................. 4 Use and Type of Structures........................................... 4 Site Investigation..................................................... 5 Seismology and Geology.............................................. 5 Hydrology........................................................... 5 Geotechnical......................................................... 5 Materials............................................................ 5 Design.............................................................. 5 Design Parameters................................................... 5 Operating Conditions................................................. 6 Static Loading Cond.ibons............................................. 6 Static Stability and Performance....................................... 6 Dams and Dikes..................................................... 6 Baffles............................................................... 6 Dynamic Loading Conditions......................................... 6 Dynamic Stability and Performance.................................... 7 Analytical Methods................................................... 7 Methods of Static Analysis............................................ 7 Methods of Dynamic Analysis......................................... 8 Site Protection Earth Structures-Darns, Breakwaters, Seawalls, Revetments.......................................................... 8 Scope............................................................... 8 Purpose............................................................. 8 Use and Type of Structures........................................... 8 Site Investigation..................................................... 8 Waterfront AssoLiated Parameters................................... 8 Geotechn1cal......................................................... 9 Matenals........................................................... 9 Design.............................................................. 10 Operating Condihons................................................ 10 Static Lo.:iding Performance.......................................... 10 Static Lo,.1Jing Conditions.......................................... 10 IX

( X 5.4A 5.5 6.0 6.1 6.1.1 6.1.2 6.1.2.1 6.1.2.2 6.2 6.2.1 6.2.2 6.2.3 6.3 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.5 6.5.1 6.5.1.1 6.5.1.2 6.5.1.3 6.5.1.4 6.5.1.5 6.5.2 6.5.2.1 6.5.2.2 6.5.2.3 6.6 6.6.1 6.6.1.1 6.6.1.2

• 7.0 7.1 7.2 7.2.1 7.3 7.3.1 7.3.2 7.3.2.1 7.3.2.2 7.3.2.3 7.4 7.5 7.5.1 7.5.2 DESIGN AND ANALYSIS Dynamic Loading Condibons......................................... 10 Analytical Methods................................................... 10 Site Contour Earth Structures-Retaining Walls, Natural Slopes, Cuts and Fills........................................................ 10 Scope............................................................... 10 Purpose........................................................... 10 Use and Type of Structure............................................ 10 Retaining Walls...................................................... 10 Natural Slopes, Cuts and Fills......................................... 10 Site Investigation..................................................... 11 Seismology and Geology.............................................. 11 Hydrology........................................................... 11 Geotechnical......................................................... 11 Materials............................................................ 11 Design.............................................................. 11 Design Parameters................................................... 11 Operating Conditions................................................. 11 Static Loading Conditions............................................. 12 Static Stability and Performance....................................... 12 Dynamic Loading Condition.......................................... 12 Dynamic Stability and Performance.................................... 12 Other Design Considerations.......................................... 13 Performance Criteria.................................................. 13 Analytical Methods and Procedures................................... -13 Retaining Walls...................................................... 13 Earth Pressure Computation.......................................... 13 Stability Against Sliding.............................................. 14 Stability Against Overturning......................................... 14 Foundation Stability.................................................. 14 Overall Stability...................................................... 14 Analysis of Slopes.................................................... 14 General Provisions................................................... 14 Static Analysis....................................................... 14 Dynamic Analysis.................................................... 14 Specific Provision.......................................... _.......... 15 Protection of Slopes.... :............................................. 15 Stabilization of Potential Slide Areas................................... 15 Special Provision Regarding Erosion................................... 15 Inspection, Instrumentation and Monitoring for Construction............ 15 Introduction......................................................... 15 Design Verification................................................... 16 Geologic Verification.................................................. 16 Construction Specification............................................. 16 Introduction......................................................... 16 Information Addressed in the Construction Specification................ 16 Materials............................................................ 16 Placement and Compaction.......................................,... 16 Drainage............................................................. 17 Construction Process Review.......................................... 17 Verification Testing................................................... 17 Excavation........................................................... 17 Stockpiling........................................................... 18

NUCLEAR SAFETY RELATED EARTH STRUCTURES xi 7.5.3 7.5.4 7.5.5 7.5.6 7.6 7.6.1 7.6.2 7.6.3 7.7 7.7.1 7.7.2 8.0 9.0 Borro\\v Areas........................................................ 18 Test Fills............................................................. 18 Backfill Verification................................................... 18 On-site Laboratory................................................... 18 Performance Monitoring.............................................. 18 Monitoring for Seepage or Groundwater Control....................... 19 Deformation Monitoring.............................................. 19 Stress and Load Measurement........................................ 19 Quality Assurance/Quality Control.................................... 19 Qualification of Personnel............................................. 19 Requirements for Equipment Cahbration............................... 19 References........................................................... 19 Index................................................................ 23

N-725 GUIDELINE FOR DESIGN AND ANALYSIS OF NUCLEAR SAFETY RELATED EARTH STRUCTURES 1.0 Purpose, Scope and Ad-ministrative Requirements

1.1 Purpose and Scope

The purpose of this standard is to describe parameters and present guidelines and criteria to be used in construction of those earth struc-rures forming part of the ultimate heat sink or act to protect nuclear power plant sites from flood, storm surge or other types of natural or marunade extreme load phenomena. Such structures are identified as safety related (Seismic Cate-gory I('1) strucrures. Also include~ a~e earth structures required to mamtam finished grade and ground contours at nuclear power plant sites. Construchon includes all administra-tive, quality assurance and regulatory re-quirements, material selection, ~esi~, installation, examination and morutonng associated with the safety related earth strucrures. Included in this standard are requirements for earth dams, dikes, baf-fles, breakwaters, seawalls, revetments, cut and narural slopes, retaining walls, and compacted fills, whether of natural or cement stabilized materials. It includes idenl:J.fical:J.on of design margins of safety. 1.2 Administrative Requirements 1.2.1 Responsibilities. The Owner shall prepare a Design Specification for e~rth structures which shall define the basis of design and other applicable criteria. The Design Specification shall include the followmg: (1) the function and boundaries of the earth structure (2) the speafic load requirements (in-cluding load combination) to be considered m design of the earth structure (3) behavior and operational require-ments for the earth structure (4) the design life (5) acceptance testing requirements (if any) (6) monitoring and construchon proc-ess review required of the Ceotech-nical Engineer. The Geotechnical Engineer shall have the responsibility of preparing the Con-struction Specification as described in Section 7.3. In accordance with the scope of this standard, several of the above activities are discussed herein as they pertain to the construction of nuclear safety-related earth structures. 1.2.2 Quality Assurance. Quality Assurance programs that comply with the Code of Federal Regulations 10 CFR SO, Appendix B,<'1 shall be established with regard to all elements in the design and construction of safetv related earth struchues of nuclear po....:er plants. The design, inspecl:J.on, and review services performed by the owner or his agen~ do not relieve a contractor of the respons1btl-ity for performing the work in ac~~rd~nce with the critena, plans and speafications and applicable regulatory requirements. Each contractor shall retain responsibility for the quality control of his own services and workmanship. 1.2.3 Peer Review 1.2 3.1 Initiation of Review. Indepen-dent reviews shall be conducted by the Owner to provide assurance that the quality of satety related earth structures is in accordance with the standards of the profession, that objectives of the work are met and the safety of the public is pro-vided for. The owner should select one or more peer reviewers and define the depth of the review. 1.2.3.2 Qualification of Reviewer. Peer reviewers shall possess the technical qualifications, practical experience, and professional judgment required of the work to be reviewed. 1.2.3 3 Review Requiremerzts. Peer re-view shall include a cnt1cal independent assessment of the validity of the follow-mg items as used m the development of the design. (1) design basis loads (2) material properties (3) design concepts (4) methods of an.-ily~is (5) safety factLirs

2 It does not necessarily include a complete check of detailed calculations. Upon com-pletion of the review, peer reviewers shall present their findings to the origina-tor of the work and the Owner. 1.2.3.4 Documentation. The results of the peer review are documented by -the reviewer. The record of the peer review identifies the reviewer, the scope of the review, and all pertinent findings con-cerning the project. 2.0 Definitions The following definitions are provided to assure a uniform understanding of some selected terms as they are used in this standard. Baffl~Any earth, rock or earth/rock con-structed barrier used to control flow or direction of water (such as used in cool-ing reservoirs). A baffle may be par-tially or totally submerged. Breakwater-A massive offshore structure constructed of rubble, rock, and/or per-formed armor units designed to dis-sipate wave energy before a wave reaches shore or to control intake or discharge water flow paths to prevent recirculation. Bulkhead-Any permanent continuous wall containing wood, masonry, steel or concrete members driven or in* stalled for the purpose of retaining an earthbank, water or other materials. Category 1 Structure-{See Safety Related Earth Structure). Construction Process R.eoi~A review to verify that the necessary assumptions made in the design and analysis of the earthwork are compatible with the actual construction method and se-quence. Construction Process--All those activities (including conformance with appli-cable regulatory or administrative re-quirements, design, material selec-tions, fabrication, erection and ex-amination) necessary to construct the earth structures of a nuclear power plant. Constructwn Specification-A document prepared by the Geotechnical En-DESIGN A;-..;o ANALYSIS gineer, which contains sufficient detail to provide a complete basis, including inspection, test or monitoring require-ments for construction of earth struc-tures in accordance with the applicable Design Specification. Contractor-An organization under con-tract to furnish items or services related to the construction of earth structures. Criteria-Parameters which must be com-plied with by a design, analysis, or by construction procedures or results. Dam-Any earth, rock or earth-rock con-structed barrier which, together with appurtenant works, impounds water. Dike-Any earth, rock or earth-rock con-structed barrier which contains a canal, stream or other water carrying channel or which restrains the flow of water or other liquid after a failure of another impounding barrier (such as a dam or tank). Also, massive placement of soil,

• stone or rock fill designed to protect nuclear plant sites from flooding or to otherwise channel or divert water away from a site.

Engineer-A person or organization hav-ing design and analysJS responsibility for construction of a nuclear power plant. Examination-A phase of quality control which, by means of observation of measurement, determines conform-ance of structures to predetermined quality standards. Geoteclmzcal Engineer-A person or organ-ization competent and recognized as knowledgeable to provide services dealing with soil and rock mechanics and foundation engineering. Geotechnical Seruias--Services performed by a geotechnical engineer. Monitoring-{see Verification). Operatmg Basis Earthquake---(OBE)-The earthquake whch, considering regional and local geology, seismology and specific characteristics of local sub-surface material, could reasonably be expected to affect the plant site during its operating life. It is that earthquake that produces the vibratory ground mobon for which those features of a nuclear power plant necessary for con-tinued operation (without undue nsk

NUCLEAR SAFETY RELATED EARTH STRUCTURES 3 to the health and safety of the public) are designed to remain functional. Owner-The company or corporation who has, or will have, title to the facil-ity of installation under construction. Peer Review-A review by a peer(s) of the originator of the work to assure that the quality of the geotechnical work is in accordance with the standards of the profession and that objectives of the work are met (see Section 1.2.3). Performance Monitoring-Activities con-ducted to define the state of the com-pleted work relative to design assump-tions. Monitoring may be prior to, during, or subsequent to construction. Quality Assurance-The planned or systematic actions necessary to provide a means to control and measure the characteristics of an item, process or facility to established requirements. Retaining Wall-Any permanent struc-tural element built to support a vertical, or near vertical, earth bank to retain water or other materials. Revetment-Facings of stone, precast armor units etc., built along the water-front to protect a scarp, embankment, or short structure against erosion by wave action or currents. They are built to protect against direct wave attack by absorbing wave energy in their in-terstices and on their surface. Safe Shutdown Earthquake (SSE)-That earthquake based upon evaluation of the maximum earthquake potential, considering regional and local geology and seismology and specific character-istics of local subsurface material. It is that earthquake which produces the maximum vibratory ground motion for which those structures, systems and components important to safety are de-signed to remain functional. Safety Related Earth Structure-Earth struc-tures necessary for requued safe opera-tion of systems necessary to the safe shutdown of the nucle;ir pl,rnt, en-gineered safeguards or to control re-lease of radioactiV1ty. Seawalls--Massive structures along the waterfront of rubble, rock, stone, con-crete and/or preformed armor units de-signed to prevent waterfront erosion or damage due to wave action, and de-signed to take full impact of the design wave. Slope, Natural-An inclined soil or rock surface resulting from natural geologic processes. Slope, Cut-An inclined soil or rock sur-face resulting from excavation of soil and/or rock. Specification-A concise statement of the require_ments or criteria to be satisfied by construction indicating the pro-cedure by which it may be determined whether given requirements are satis-fied. Standard-Result of a particular standardization effort approved by a recognized authority. Standards in-clude Codes and Guidelines. Testing-Determination or verification of the capability of an item to meet speci-fied requirements by subjecting it to a set of physical, environmental or op-erating conditions. Wtimate Heat Sink-That body of matter, usually liquid, which absorbs heat ini-tially generated in a nuclear reactor core and which is necessary to keep the temperature of the reactor core within specified limits. Venficatzon-An act of confirming or sub-stantiating that an activity or condition has been implemented in c'l.Ccordance with specified requirements. Verification, Des1gn-Venfication of assumptions, analytical methods, and design concepts used in the design analysis. Venfication, Excavation-Verification that soil and rock conditions in excavated areas are consistent with conditions assumed when preparing earth struc-ture designs. Verzficatzon, Geologic-Verification that exposed sml and rock conditions are consistent with conditions shown on boring logs and profiles. 3.0 Site Investigation Site investigation shall consider geolo-gy, topography, seismology, matenals availability, and design function. The seismological and geological in-vestigations for these structures shall be consistent with other safety related struc-tures at the s1tt>.

4 Each section of this standard discusses site investigahons to identify special con-siderations in performing such work. Hmyever, at the end of this Section 3.0 are identified reference matenals on site inveshgations, mcludmg laboratory test-ing, that are generally applicable. Geophysical explorahon methods such as seismic refrachon, reflection, and elec-tncal resisbVlty should be used to locate ground water table, faulting, and de-termine depth to bedrock (if applicable). The subsurface exploration program should consist of borings, test pits, tren-ches or inspection shafts to reveal critical stratificahon, ground water table and obtain representative and undisturbed test samples. Laboratory testing to determine soil parameters should include standard classification tests, strength tests on un-disturbed samples and consolidation test-ing (if appropriate). In situ strength tests to determine strength parameters are also recommended. Static or dynamic Dutch cone penetration test (CP'D and standard penetration tests (SP'D should be consid-ered to qualitatively evaluate in situ den-sities of cohesionless soils for correlation with static and dynamic parameters. A qualitative measure must employ a site determined correlation. The ground water table level shall be recorded m selected boreholes, with sufficient hme allowed for stabilization of the water level. Any data relevant to the variability of the ground water table and the source of variation should be investigated. Of particular importance are: ANSI N 174 "Guidelines for Evaluating Site-Related Geotechnical Parameters for Nuclear Power Sites," Prepared by ANS Committee 2.11, ANSI, 1978 ASCE "Subsurface Investigation for Design and Construction of Founda-tions of Buildings" Manual No. 56, 1976 ASTM Book of Standards, Part 19, "Natural Building Stones; Soil and Rock; Peats, Mosses, and Humus" ASTM "Special Procedures for Testing Soil and Rock for Engineering Pur-poses," STP 479 DESIG!\\' A;\\;D Ar-:-:AL );SI~ NRC Regulatory Guide 1.132 "Site In-vestigahons for Foundations of Nuclear Power Plants," U.S. Nuclear Regula-tory Comm1ss10n Office of Standards, Sept. 1977 NRC Regulatory Guide 1 135 "Normal Water Le\\*el and Discharge at Nuclear Power Plan ts," U.S. Nuclear Regula-tory Commission Office of Standards, Sept. 1977 ANSI N 45.2.20 "Supplementary Qual-ity Assurance Requirements for Sub-surface lnvestiga tions Prior to Con-struction Phase of Nuclear Power Plants," American National Standards Institute, 1979 ANSI N 45.2.5 "Supplementary Qual-ity Assurance Requirements for In-stallation, Inspection and Testing of Structural Concrete, and Structural Steel, Soils and Foundations During the Construction Phase of Nuclear. Power Plants QA-76-5" 1978 Code of Federal Regulations 10 CFR 100 Appendix A "Seismic and Geo-logical Siting Criteria for Nuclear Pow-er Plants," U.S. Atomic Energy Com-mission, November 1973. 4.0 Ultimate Heat Sink Earth Structure-Dams, Dikes, and Embankments 4.1 Scope 4.1.1 Purpose. The purpose of this sec-tion is to descnoe parameters and to present guidelines and criteria to be used in construction of ultimate heat sink structures, and to identify factors which should be considered throughout their c_onception, siting, design, and opera. tion. 4.1.2 Use and Type of Structures. Dus section includes earth structures, which are a means of water conveyance, !ID-poundment, diversion or control. These include but are not limited to the follow-ing: {a) cooling water supply reservoirs (b) essential cooling ponds (c) essential heat sinks (d) waste-water retention structures (e) flood-protechon dikes and levees I

NUCLEAR SAFFfY RELATED EARTH STRUCTURES 5 The maintenance of water retaining func-tion is the prime consideration in the application of these structures. 4.2 Site Investigation. A general discus-sion of site investigation applicable to all earth structures is presented in Section 3. 4.2.1 Seismology and Geology. General seismic siting criteria are given in 10 CFR 100, Appendix A.en Various other references provide useful information on the requirements, which must be satisfied by a thorough seismplogic and geologic investiga-tion.it ID! 4.2.2 Hydrology. Structures in com-bination with their appurtenant works (spillways, overflow sections, etc.) shall be designed to withstand historical and design basis floods as determined in ac-cordance with Ai'\\J"SI N 170.011 4.2.3 Geotechnical. In the construction of earth structures, the structure cross section, materials of construction and their graduation, zoning and placement shall be consistent with site geology and foundation conditions. Investigations shall be undertaken and sufficient in-formation obtained so that the engineer can design a structure which meets those requirements. References that discuss re-quired geotechnical investigations in considerable detail should be con-suited. m,2. u 14 l!,,._ 111 4.3 Materials. The Geotechnical En-gineer shall verify that materials used, and the specified manner in which they are used and placed, are compatible with the design. References that discuss selec-tion of materials and appropriate cross sections and zoning include references 11 and 12 through 19. Locally available materials may be used if they a~e appropnate. The embankment should be properly zoned to proV1de the following: (a) an impervious zone (b) trans1hon zones bet*ween core and shells (c) seepage control (d) static and seismic stability (e) wave protechon. Laboratorv te~ts shall be conducted tu evo.1lu.ite ~quired ch.ir,1etenstics of var-ious materials to be used in construction of embankments; these include classifica-tion tests and tests to evaluate gradation, compaction, strength and compression characteristics of the various types of materials. 112. i,. :ia. n. 2<1 4.4 Design 4.4.1 Design Parameters.Parameters to be established for the design and safety evaluation of darns, dikes and baffles shall include the following: (a) a geotechnical profile along the en-tire length of the structure founda-tion and across the structure foundation at Y4 the '-0dth in equal intervals, or more, in order to pro-vide a basis for design (b) soil properhes sampled and tested under anticipated environmental and loading conditions including strength, compressibility, per-meability and durability (c) the potential for ground surface rupture or displacement due to geologic factors (d) ground surface vertical and hori-zontal acceleration and damping coefficients for the SSE (e) the design depth of water for the structure (f) the height, length and period for the design wind = generated wave (g) the characteristics of the maximum probable wave which could im-pinge upon the structures (i.e. average of highest one percent of all waves, Hi, or tsunami, or dam = break wavet'n) (h) properties and qualities of available cast shapes, rubble, stone, rock and filter materials used for con-struction of the structure (i) cross sections showing structure geometry and composition of mate-rials (j) liquefachon potential of structure/ soil foundatmns under (a) the SSE and (b) hydrodyno.1m1c change~ m effective stress (k) stability of the structure and its foundat10n under all design load-1 n g cond1t1ons (including hydrodynamic force system:, assoo<1ted with the SSE)

6

0) ability of the structure to withstand continual hydrodynamic forces without relative movement of its in-ternal components, which are suf-ficient to cause structural failure.

4.4.2 Operating Conditions. Operating conditions for impoundments will vary according to purpose, location (on-stream or off-stream) and other conditions unique to the plant being considered. These conditions may influence design of the structure as well as loading con-ditions, factors of safety-slope protection, materials of construction, zoning, seep-age analyses, and other parameters. They may influence the design of ancillary facilities. The Geotechnical Engineer shall consider all normal operating conditions in design of the structure, as well as an-ticipated transients, abnormal and ex-treme environmental conditions, which are considered as design basis during the life of the structure (as defined by the Owner in the design specifications). 4.4.3 Static Loading Conditions. The I'-- following conditions shall be considered I r dams and dikes: * \\ \\'1'---.) -:---... ( nng construction (2). d of construction Sudden drawdown from spillway crest to minimum pool evaluation: This may not be necessary if size of outlet or other passive means does not permit sudden drawdown. The relative permeability of the dam's upstream material and the potential rate of the maximum drawdown should be considered. (4) Sudden drawdown from top of spillway gates to crest of spillway (if any), if such a condition could occur. (5) Full reservoir or partial pool, down-stream slope, steady seepage: The critical case should be determined through a parametric study of the factors influencing the selection of condition. Generally, the full reser-voir case will govern unless it is an assured temporary condition. Steady seepage with a reservoir surcharge may fall into this cate-gory. DESIGN A;s.;D AN,~LYSI,5 (6) Sudden drawdown on downstream slope: This case may occur where the downstream toe is subject to prolonged flooding and then rapid reduction of the toe water level. This case will not normally be cnb-cal where the downstream toe is relatively porous. 4.4.4 Static Stability and Perfonnana 4.4.4.1 Dams and Dikes. Factors of safety for tmbankment stability studies should be based upon the ratio of avail-able strength to apphed stress or other load effects. The minimum factors of safety for the static loading conditions listed in Paragraph 4.4.3 shall be as fol-lows: Condition Minimum Factor of Safety 1 1.1 2 1.3 \\ 3 1.0 4 1.2 5 1.5 6 1.2 In using these minimum recommended safety margins the Geotechnical Engineer should have a high degree of confidence in the reliability of the values used for the following parameters: (a) type and gradation of material (identification) (b) thoroughness and completeness of field explorat10n and laboratory testing (performance of materials) (c) loading conditions (d) degree of control and workman-ship expected. 4.4.4.2 Baffles. For baffles (or dams which may be submerged), the fully sub-merged and drawdown conditions shall. be cq_nsidered. The effects of the failure of an earth structure upon the containing dike shall also be considered. Considera-tion shall be given to the flow of water through and over the earth structure. The minimum factor of safety of the baffle and its containing dike (or dam) shall be the same, or greater, as for the dike (or dam) itself. 4.4.5 Dynamic Loading Conditwns. The effects of earthquake-induced forces, cur-rents, floating debris, and wave act10n on

NUCLEAR SAFETY RELATED EARTH STRUCTURES 7 behavior and peformance of safety class earth darns, dikes and baffles must be considered. The postulated failure con-ditions due to a dynamic load to be evalu-ated are as follows: (1) Failure due to disruption of the structure by major differential fault movement in the dam foundation. (2) Slope failure induced by SSE vibra-tory ground motions. (3) Sliding of structures on weak foundation materials or materials whose strength may be reduced by liquefaction. (4) Piping failure or seepage through cracks induced by ground motions. (5) Overtopping of the structure due to seiches in the reservoir, slides or rock-falls into the reservoir or fail-ure of the spillway or outlet works. Other dynamic-induced forces to be con-sidered in design are: (a) transfer of momentum effects from moving currents at design max-imum flood condition (b) impact of any postulated floating missiles at design maximum flood condition (c) design wave load effect (including the effect of wave frequency and momentum). In general, failure mode (1) is precluded by siting restriction. While earth struc-tures tend to be able to accommodate relahvely large differential ground mo-tion, at the present time there is no ac-ceptable design procedure that would accommodate major differential fault movement in the reservoir embankment foundation. If the darn or dike is sited in a region (as defined by Federal Regulation) where such differential fault motion is credible, the dam or dike shall be assumed to fail. 4.4.6 Dynamic Stability and Perfor-mance. Dunng an earthquake, large cyclic inerha forces are induced in an earth dam. These forces may be sufficiently large and may occur with sufficient cycles to produce excess pore water pre~sures or cause a reduction in shear strength of certain types of materials used in con-struction of an earth structure Depend-ing on the severity of the ground vibra-tory motions and the types of embank-ment materials, small to large permanent deformations of the embankment could occur during or after an earthquake. In loose saturated cohesionless soils com-plete loss of strength may occur, leading to failure of an earth structure. This same phenomena could also result from the effects of dynamic wave action, although the dynamic frequency characteristics of wave action make it a much less likely occurrence. Dams containing cohesive materials or well-compacted and graded materials gen~rally suffered little or no damage as a result of strong ground shaking.(22) In assessing the safety of an earth dam during and aft~r an earthquake (or other dynamic loading) the following factors should be considered: (a) the magnitude and type of an-ticipated loading (b) the degree of confidence in the method of analysis used in defini-tion of material and design parameters. The following minimum factor of safety is specified for the dynamic loading con-ditions listed in Section 4.4.5. Condihon Minimum Factor of Safety 1 Precluded by sihng criteria.. 2 1.3 3 1.3 4 1.2 5 1.3

• Must evaluate based on the impact of a failure 4.5 Analytical Methods 4.5.1 Methods of Static Analysis. Vari-ous analytical methods for evaluating the static stability of an earth dam ex-ist.ro "* "* ' The state of the art of static analytical methods is probably sub-stantially more advanced than other facets of dam design, and for a given set of mput data, most of these acceptable techniques will give results consistent with each other.

The method utilized shall be compat-ible with the,mticipated mode of failure, dam cro;,s-section and soil test data. The complexity of the method selected should

8 also be consistent with the size of the structure. Whichever method is used, the Geotechnical Engmeer shall state the jus-tification for the method used. Analyses shall be performed for the various loading conditions given m Sec-tion 4.4.3. The critical failure surface shall be presented for each case together with its corresponding factor of safety. The analyses shall take into consideration such variables as material types used for each zone of the dam, dam geometry, variability of soil properties (including location of phreatic surface and vanation of pore pressures within the embank-ment). 4.5.2 Methods of Dynamic Anal-ysis. Various methods of analysis are available for evaluating the seismic sta-bility of an earth dam. (17 throusJ> '" These may be classified as follows: (a) pseudo-static methods (b) simplified procedures (c) dynamic response analyses. Conventional pseudo-static methods of analysis are acceptable if the seismic coefficient selected appropriately reflects the geologic and seismologic conditions of the site and if the materials are not subject to significant loss of strength un-der dynamic loads. Values of shear stre~gthPoJ used in this type of analysis should reflect any anticipated loss of strength due to the postulated design earthquake. Although pseudo-static methods of analysis are simple to use, they do not provide information on the magnitude of permanent deformations, which would develop within the embankment as a re-sult of an earthquake. Where this in-formation is of importance, methods (b) and (c) should -be used. In recent years several simplified procedures have been developed based on Newmark's orig-inal concept of cumulative deforma-tion.C11-

21. 29* 33* 3' J6J These simplified pro-cedures may be used for earth dams con-structed of materials that are not subject to significant loss of strength due to cyclic loading. (These include cohesive soils and well-compacted materials).

Dynamic response analyses using state-of-the-art methods shall be con-DESIGN AND ANAL YSlS ducted for those dams located in highly seismic areas (or constructed of materials that could undergo significant loss of strength due to cyclic loading; i e., hy-draulic fill dams and tailing dams). Finite element techniques have been widely used for this purpose (although in recent years finite difference methods have also been developed. (JO ' 1* 32 " " '°1 Appropnate dynanuc material properties and ground motion parameters defined for the site shall be used in analyses. Considerable experience and engineering judgment are necessary in assessing the stability of an earth dam based on the results of a com-p lex computer dynamic response analysis. In all cases, the results of such analyses shall be verified by general equi-m,rium checks. 5.0 Site Protection Earth Structures-Dams, Dikes, Breakwaters, Seawalls, Revetments 5.1 Scope 5.1.1 Purpose. The purpose of this Section is to descnbe criteria to be used as a guide in the design, evaluation and construction of those dams, dikes, breakwaters, seawalls and revetments classified as Seismic Category I. This standard is intended to identify factors to be considered in the consb ucbon of those structures and should in no way limit the mvesbgation and analysis deemed neces-sary for determination of the suitability of such a structure and its site. 5.1.2 Use and Type of Stnictures. Dams, dikes, breakwaters, seawalls, and revet-ments are intended primarily to protect the nuclear plant site from hydraulic loads. 5.2 Site Investigations. A general dis-cuss10n of site investigations can be found in Section 3.0. The mvestigat10n of sites for hydraulic protection earth struc-tures shall be conducted in conformance with the following basic guidelines. 5.2.1 Waterfront Associated Pawmeters. These consist of natural shore and offshore zone characteristics, water mo-tion characterisbcs, and shorefront be-havior patterns. These shall be evaluated in conformance with Ref. 40 lnvesbga-

NUCLEAR SAFETY RELATED EARTH STRUCTURES 9 tion requirements shall be sufficient to clearly define the following basic water-front associated parameters: (a) coastal area and offshore profiles from the land bluff or escarpment for a sufficient distance offshore to define that depth of bed below stillwater level which can control the design wave form (b) bathymetric and topographic con-tour maps of bed area sufficient to define the immediate influence of such features upon design of the structure (c) natural protection features in-fluencing water waves and flood (d) exposure to storm attack (e) characteristics of water waves, cur-rents, surges and floods 4illuenc-ing the earth structure (f) rate and composition of littoral transport and drift

• (g) long-term stability of shoreline in terms of erosion or accretion rates.

Water and water level investigation re-quirements for design of the above struc-tures shall include the following basic informa tion:<111 (a) stillwater or mean water level (b) astronomical tide data (c) seiche, wave setup and storm surge predictions (d) design maximum flood elevation. A determination of wind-generated water wave conditions as a basis for de-sign shall include:<111 (a) evaluation of all wave data appli-cable to the project site (b) determination of the significant wave height and range of periods for the wave spectrum (c) determination of the design depth of water at the structure (d) determination of the design wave height, direction and condition (breaking, nonbreaking or broken) at structure site (e) analysis of the frequency of occur-rence of design cond1hons. 5.2.2 Geotcchn1cal. Geotechnic.11 parameters con~isting of geologic, groundwater, foundat10n eng1neenng and earthwork parameters shall be evalu-ated in conformance with Ref. 2. Geotechnical investigation shall be suf-ficient to clearly define the following ba-sic items: (a) subsurface profiles along the length of the structure, and subsurface sections across the structure, pre-pared in a manner sufficient to de-fine the spatial arrangement of soil and rock materials that could in-fluence the structure design or safety (b) detailed geologic and engineering descriptions of each material identi-fied on the subsurface profiles and sections (c) definition of physical properties, strength characteristics, and dynamic properties of the soil and rock materials defined on the sub-surface profiles. In establishing geotechnical site design parameters, if structures being consid-ered are not at the nuclear plant site, then a literature review and search equivalent to that performed to develop nuclear plant site design parameters shall be un-dertaken to establish appropriate geo-logic, seismic, and natural phenomena. Establishment of detailed geotechnical characteristics of subsurface materials shall include: (a) surface geophysical surveys (b) exploratory borings and excavations (c) borehole geophysical surveys (d) sampling of soil and rock materials (e) the in-situ testing of soil and rock materials (f) the laboratory testing of soil and rock materials. Specific techniques and references applicable for each of the above outlined in reference (4) Speaal Procedures. 5.3 Materials. The investigation of soil, precast,.1rmour, rock, rubble or stone for the constructwn of earth waterfront structures shall be sufficiently extensive to idenhfy sources of adequate quality and volume for each of the required mJteriJls Selection of a structure type and determination of the feasibility of the structures are dependent upun an ade-

10 quate source and its associated quality. In general, Section 4.3 material selection re-quirements are equally applicable to site protection structures. 5.4 Design. Parameters to be es-tablished for the design and safety evaluation of dams, dikes, breakwaters, seawalls, revetments are generally the same as those given in Section 4.4. 5.4.1 Operating Conditions. Design conditions for site protection structures are generally those associated with ex-treme hydrological phenomena. How-ever, normal operating conditions (which include erosion, weathering seepage or other normal operating phenomena that would affect performance of the pro-tective structure) shall be considered in design. 5.4.2 Static Loading Conditions. The following conditions shall be considered for protective structures: (1) During construction (2) End of construction (3) Design maximum flood evaluation as a hydrostatic load (4) Load case where maximum design surcharge is present and water level is at its design minimum elevation. 5.4.3 Static Stability and Perfomiance. Fac-tors of safety for structural capacity should be based upon the rat10 of avail-able strength to applied stress or other load effects. The minimum factors safety for the static loading condition listed in Paragraph 5.4.2 shall be as follows: Condition Minimum Factor of Safety 1 1.1 2 1.3 3 1.2 4 1.5 In using these minimum recommended safety margins the Geotechnical Engineer should have a high degree of confidence in the reliability of values used for the following parameters: (a) type and gradation of material (b) thoroughness and completeness of field exploration and laboratory testing DESIGN AND ANALYSIS (c) certainty of loading condit10ns (d) degree of control and workman-ship that can be assured. 5.4.4 Dynamic Loading Conditions The dynamic force applicable to site protec-tion structures are the same as those con-sidered in Section 4.4.5. 5.5 Analytiau Methods. The analytical methods applicable to ultimate heat sink structures are also applicable to site pro-tection structures. 6.0 Site Contour Earth Structures-Retaining Walls, Natural Slopes, Cuts and Fills 6.1 Scope. 6.1.1 Purpose. The purpose of this Sec-tion is to describe criteria to be used as a guide in the design, evaluation and con-struction of those site contour control structures such as retaining walls, slopes,

• cuts and fills (classified as Seismic Cate-1 gory I). 'This standard is intended to iden-tify factors to be considered in construc-tion of those structures and should in no way limit the investigation and analysis deemed necessary for determination of the suitability of such a structure-or the effect such an earth structure would have on other nuclear plant structures.

6.1.2 Use and Type of Structure 6.1.2.1 Retaining Walls. A retaining wall is any permanent structural element built to support an earth bank that cannot support itself. It is used primarily to con-trol site contours and may have specific application to construction of elevated or depressed roadways, erosion protection facilities, bridge abutments and retaining potentially unstable hillsides. Principal

• types of retaining walls considered in this standard include gravity walls, sem1grav-ity walls, cantilever walls, counterfort walls, buttressed walls, crib and bin walls, reinforced earth walls and an-chored (or tie back) walls. The emphasis in this Section is on the design of earth structures used as retaining walls, and determination of loads on walls made of other materials.

6.1.2.2 Natural Slopes, Cuts and Fills. Natural slopes considered in this section

NUCLEAR SAFETY RELATED EARTH STRUCTURES 11 are any landforms existing on, or adja-cent to, the proposed site. A cut slope is any slope resulting from the excavation of in situ soils. Manmade fills are provided to maintain site grade. Slopes, cuts and fills covered by this specification are pro-vided primarily to maintain site contours (and whose failure would adversely affect the function of any safety related nuclear plant structure). 6.2 Site Investigation. A general discus-sion of site investigation applicable to all earth structures is presented in Section 3.0. 6.2.1 Seismology and Geology. General seismic geology siting criteria are given in 10 CFR 100, Appendix A.(1> Various other references provide useful information on requirements that must be satisfied by a thorough seismologic and geologic in-vestiga hon.<' IOl 6.2.2 Hydrology. Earth structures used as retaining walls, slopes, cuts and fills are particularly sensitive to surface water erosion and groundwater level and movement. Such structures shall be de-signed to withstand historical and design basis flooding and precipitation in ac-cordance with ANSI N 170. "11 6.2.3 Geotechnical. In the construction of earth structures it is imperative that the structure cross-section, materials of con-struction and their gradation, zoning and placement be consistent with site geology and foundation conditions. In-vestigations shall be undertaken and suf-ficient information obtained so that the engineer can, with confidence, design a structure meeting those require-ments. References discussing the re-quired geotechnical investigations in considerable detail should be con-sulted.111*,,. IJ '-'* 1** 17* "" Since natural slopes and cuts consider the use of in situ m.:iteri.:ils, available liter-ature and information concerning the foundation geology of the sods (and of rocks on the site) shall be consulted. Past records of construchon in the are<1 and old well logs shall also be examined. Air-photo interpretation and site reconnais-sance should be completed to reveal old slide scarps or other evidence of slope movements. Cro,;s-sections and profiles of the slope should be made in sufficient quantity and detail to represent the slope and foundation conditions. 6.3 Materials. Section 4.3 material selection requirements are equally appli-cable to retaining walls, slopes and fills. 6.4 Design 6.4.1 Design Parametl?1's. Parameters to be established for the design and safety evaluation of retaining walls, natural slopes, cuts and fills shall include the following: (a) a geotechnical profile along the en-tire length and across the structure at intervals not to exceed 250 feet, which is adequate to serve as a basis for design (b) the potential for ground surface rupture or displacement due to geological factors (c) ground surface acceleration value for the SSE (d) properties of available cast shapes, rubble, stone, rock, in situ and fil-ter matenals used for construction of the structure (e) cross-sections showing structure geometry and composition of mate-rials (f) liquefaction potential of the earth structure and its foundation under (a) the SSE and (b) hydrodynamic changes in effective stress caused by the maximum design event (g) stability of the structure and its foundation under hydrodynamic and surcharge force systems associ-ated with maximum design event (h) hydrological parameters shall be in accordance with ANSI N 170."'1 6.4.2 Operating Conditions. Operating conditions for contour control structures will vary according to the purpose, loca-hon and other conditions unique to the plant bemg considered. These conditions may influence the design of ancillary faaltt1es. The Geotechmcal Engineer shall consider all normal operahng conditions in design of the structure, as well as an-ticipated transients, abnorm<1I and ex-treme environmental conditions consid-ered as de~1gn b<1sis dunng the life of the structure.

12 6.4.3 Static Loading Co11d1tio11s. The follo1/2'lng conditions shall be considered for contour control structures: (1) During construction (2) End of construcbon (3) Maximum design surcharge to in-clude any loading above grade by earth, material, structure, equip-men t and vehicles for design against sliding (4) Load condition 3 coincident with most disadvantageous ground water design level (5) Maximum design surcharge to in-clude any loading above grade by earth, material, structure, equip-men t and vehicles for design against overturning (6) Load condition 5 coincident with most disadvantageous ground water design level (7) Design maximum flood and pre-cipitation as a hydrostatic load. 6.4.4 Statzc Stability and Performance. Factors of safety for slope stability studies should be based upon the rate of avail-able strength to applied stress or other load effects. The minimum factors of safety for the static load conditions listed in Section 6.4.3 shall be as follows: Condition Minimum Factor of Safety 1 1.3 2 2.0 3 1.5 4 1.3 s 2.on 6 1.8 7 1.0

• For foundation failure by bearing in clay use a F.S. of 3.0. In using these minimum recommended safety margins the Geotechnical Engineer should have a high degree of confidence in the reliabil-ity of the values used for the following parameters:

(a) type and gradation of material (b) thoroughness and completeness of field exploration and laboratory testing (c) certainty of loading conditions (d) degree of control and workman-ship that can be assured. DESIGN AND ANAJ.-YSIS 6 4.5 Dy11a1111c Loading Condi/1011. The effects of earthquake-induced forces, dynamic surcharge loadings and the dynamic effects of the Design Maximum Flood and Preap1tahon<111 must be consid-ered. The postulated loading condihons due to dynamic loads to be evaluated are as follows: (1) Failure due to disruption of struc-ture by major differential fault movement due to a SSE (2) Slope failure induced by SSE vibra-tory ground motion (3) Sliding of the earth structure on weak foundation materials or mate-rials whose strength may be re-duced by liquefaction (4) Failure due to dynamic surcharge load effects if any (4) Failure due to dynamic loads associated with the MaXJmum De-sign Flood or Precipitation. 6.4.6 Dynamic Stability and Performance.

• During an earthquake, or in response to other dynamic load phenomena, large cyclic forces may be induced in a slope or fill. These forces may be sufficiently large and may occur with a sufficient number of cycles to produce excess pore water pressures or reduction in shear strength of certain types of materials used in con-

-struction of an earth structure. Depend-ing on the severity of the ground vibra-tory motions and the types of embank-ment materials, small to large permanent deformations of the embankment could occur during or after an earthquake. In loose saturated cohesionless soils com-plete loss of strength may occur, leading to failure of an earth structure. This same phenomena could also result from the. effects of dynamic wave action although the dynamic frequency characteristics of wave action make it a much less likelv occurrence. Structures containing cohe-sive materials or well-compacted and graded materials generally suffered little or no damage as a result of strong ground shaking.C221 In assessing the safety of an earth structure during and after an earthquake-or other dynamic loading-the following factors should be consid-ered:

NUCLEAR SAFETY RELATED EARTH STRUCTURES 13 (1) The magnitude and type of an-ticipated loading (2) The degree of confidence in the method of analysis used and in the definition of material and design parameters. The following minimum factor of safety is specified for the dynamic load con-ditions listed in Section 6.4.5: Condition 1 2 3 4 5 Minimum Factor of Safety Precluded by Siting Critena* 1.3 1.3 1.3 1.2 (general) 1.0 (local)

• Must evaluate based on the impact of a failure 6.4.7 Other Design Considerations. Other considerations that may affect the design shall be investigated as necessary:

(1) Removal of lateral support includ-ing action of: (a) erosion by streams, rivers, etc. (b) waves and longshore tidal cur-rents (c) subaerial weathering, wetting and drying and frost action. (2) Removal or creation of new slope by rock fall, slide or subsidence (faulting). (3) Subterranean erosion, solution car-bonates, salt, gypsum, and collapse of caverns, subsidence of mine areas, dispersive soils. (4) Overloading of weak underlying soil layer(s) by fill. (5) Overloading of sloping bedding planes. (6) Oversteepening of cuts in unstable soil or rock and undercuttmg of steeply adverse dippmg bedding planes. 6.4.8 Performance Criteria. The per-formance of any slope must be judged on the following basis* (1) Downslope Movements. Down-slope movements, whether for nat-ural or manmade slopes, shall not interfere with the ability of the plant to perform its safety func-tions This necessitates cons1derJ-tion of the proximity of the slope to Gass I structures and the specific function of the slope, if any. (The definition of slope failure is de-pendent on these conditions). (2) Erosion and Undercutting. Erosion and undercutting of the toe of the slope shall be controlled so that they will not affect the overall stability or function of the slope. (3) Creep. If the plant and/or adjoining facilities are sited on a slope, creep movements of sufficient magnitude can constitute a failure, as well as general massive instability of the slope. The potential for creep and the magnitude that can be tolerated shall be evaluated. 6.5 Analytical Methods and Procedures 6.5.1 Retaining Walls. Once the soil types and design parameters have been established, the type of retaining struc-ture can be selected. Generally the

• foundation conditions, the height of wall, or the expected lateral load narrows the selection process considerably. Typical dimensions and guidelines for sizing the proportions of retaining structures are given in various foundation texts."1 -12

.[J) The structural adequacy of the individual members should be determined by the Geotechnical Engineer or Engineer based on the imposed loads, using applicable Standards. 6.5.1.1 Earth Pressure Camputatwn. As defined previously, earth pressures act-ing on the wall are computed using appropriate soil properties (usually strength) and available earth pressure theories. The design magnitude and dis-tribution of these pressures should also take into consideration the type of backfill and its characteristics and drainage pro-visions, and the method and direction of compaction. Clayey soils can produce high earth pressures and should be avoided if possible. Free draining clean granular soils generally result m lower horizontal earth loadings For conventional retaming walls, con-venient empirically established design charts are available for different types of backfill,.,, These curve~ have also been reproJuced in most geotechnical

14 engineering text books that cover this subject. 6.5.1.2 Stability Against Sliding. The pressures acting on the wall tend to cause the wall to slide along its base. The stabil-ity against sliding shall be analyzed by summing up the horizontal forces. In practice, conservative factors and judg-ment must be applied to the analyses by neglected small passive resistance at the toe and accounting for disturbances dur-ing construction by applying reduction in strength along the base. A foundation key sometimes must be provided to attain a higher factor of safety.

6. 5.1. 3 Stability Against Over-turning. The pressures acting on the wall also tend to overturn the wall about its toe. The wall shall, therefore, be checked so that the structure *,vill be safe against overturning. In making this evaluation, all of the short and long term loads de-scribed previously shall be considered and used where appropriate, both in front of and behind the wall. Also, possi-ble future excavations, erosion, uplift, liquefaction and other potential undesir-able influences should be considered, es-pecially with respect to the soils in front of the wall (i.e., the resisting forces).

6.5.1.4 Foundation Stability. Instabili-ties can develop due to a soil-bearing failure of the wall base. In addition to bearing, the expected settlements should also be studied to be sure that they will be within acceptable limits. 6.5.1.5 Overall Stability. Analyses should be performed to assure that the overall wall, the weight of the fill behind the wall and any upslope or downslope unstable driving forces will not cause a deep-seated bearing or sliding failure ex-tending beneath the entire structure. 6.5.2 Analysis of Slopes 6.5.2.1 General Provisions (1) Methods, A description of the method(s) of slope stability analysis used shall be provided. A definition(s) of factor of safety shall be stated. The method of analysis should reflect the antiapated mode of failure and methods of analysis for flow slides, sliding block DESIGN AND ANALYSIS (wedge), rock slides and lateral spreading may be required The critical failure surface should also be presented. (2) Design Parameters. Design soil parameters relahng physical char-acteristics, strength, consolidation and chemical properties shall be evaluated for each statigraphic unit composing the slope for both static and dynamic conditions. A de-scription of the groundwater level and flow conditions, if any, shall be given. 6.5.2.2 Static Analysis (1) Appropriate methods of analysis as described in the literature are re-quired to determine the most criti-cal failure surface in the slope. Methods such as Taylor's friction circle method,<"1 Bishop's method of slices,<46> Lowe and Karafiath,147) Spencer's method, 1481, Rendulic's. logarithmic spiral,<.,, or the irregular failure plane method of Morgenst-ern and PriceC50l are all applicable limit equilibrium analyses. (2) These analyses shall consider var-iables such as: slope shape, soil stratification, variability of s01l properties, driving and resisting forces acting on the slope and varia-tion of pore pressures within the slope. (3) The influence of adverse conditions (such as floods, freezing, change in ground water conditions, rapid drawdown, steady seepage and their possibility of occurrence) shall be investigated. (4) The theoretical assumptions of any particular method of analyse. should be reviewed to determin their effect on the resultant failure surfaces* and their factors of safety. "1..i 5ll 6.5.2.3 Dynamic.Analysis (1) Various methods of analysis are applicable for evaluating the seis-mic stability of natural slopes. These include the following: (a) pseudo-static methods (b) simplified procedures for cal-

NUCLEAR SAFETY RELATED EARTH STRUCTURES 15 culating earthquake-induced deformations (for example, Newmark's Cumulative De-formation Procedure) (c) Dynamic Response Analvsis (2) For slopes comprised of 'clayey materials, materials that are com-pacted and moderately dense, and materials that undergo little or no loss of strength due to cyclic load-ing procedures (a) and (b) above provide adequate methods of anal-ysis. For loose to moderately dense saturated cohesionless soils and materials showing a significant loss of stre~gth due to cyclic loading, a d~arruc response analysis is re-qwred. Two-dimensional finite ele-ment analyses using equivalent-linear, strain-compatible dynamic properties-together with the re-sults of laboratory stress-controlled cyclic triaxial or cyclic simple shear tests-are often used for this pur-pose. An appropriate acceleration time history is required for use as an input motion to the model when conducting a dynamic response analysis. (3) In the_ above analyses, the equiv-alent linear model representation of shear modulus vs strain relation is suggested. (4) The forces obtained from the above analyses may be considered as analogous pseudo-static forces that can be incorporated as part of the loading applied to the static method of analysis. (5) Special considerations should be 1:1ade for the possibility of liquefac-tion of slope materials if site and laboratory investigations indicate susceptible deposits. Effects of lateral spreading should be consid-ered. 6.6 Specific Provision 6.6 1 Prot.!Ltwn of Slopes 6 6 1.1 Stab1li;;ation of Potential Slide Areas. Provisions should be made for stab1liL1tion of slopes against mass slid-ing or other movements m all potentially unstable areas under consideration. Such provisions could include: (1) Reduction of loads-flattening of natural slopes, lowering ground water level by means of internal drains, or removal of soil at the top of the slide area. (2) Reduction of excess pore water pressures by improving surface and internal drainage. (3) Increase of resisting forces by berms or earth buttresses at the toe. (4) Use of structural support, such as retaining walls, earth or rock an-chors, or sheet piling. (5) Special methods of soil stabilization such as a cement, lime, flyash or asphalt stabilization, or densifica-tion by preloading or vibratory methods. . 6.6.1.2 Special Provisions Regarding Ero-swn (1) Soil Erosion. Provisions should be made to minimize soil erosion and ~p on natural and cut slopes by 1:1amtenance of sufficient vegeta-tion on the slopes, paved ditches, use of rip rap, to prevent gullying and other erosive features that could affect the stability of the slope.. Erosion and poor drainage are frequently the cause of failures. (2) Wave Protection. Slopes affected by wave action should be protected by rock rip rap or equivalent. (3) Chemical Interaction. Chemical tests shall be performed to de-termine the interaction between the chemistry of the soil, pore water, and eroding water for the evaluation of dispersion poten-tial. en 34 o,i 7.0 Inspection, Instrumentation and Monitoring for Con-struction 7.1 Introduction. Often, the design and analysis of earth structures based on nominal material properties and design assumphons alone are inadequate Cou-pled with design and analysis must be:

16 (1) Verification of design assumphons and material parameters (2) Evaluation of the inter-relationship between construction methods and analytical treatment (3) Verification testing to assure com-pliance with construchon specifica-tions based on the design (4) Monitoring of the earth structures both during and subsequent to con-struction. Because of the need for a continuity from design and analysis through actual construction, this section is included in this standard. It is intended that this section provide for the testing of materials and assure a continuity of service throughout the en-tire geotechnical engineering program. It is recommended that these functions be completed so that all steps in the process from initial site feasibility studies to op-eration of !he plant be completed-and that a mechanism for changes in design be provided if required. It is recommended that a qualified on-site geotechnical engineer be present at all times during earthwork activities to provide continuous observation. 7.2 Design Verification. This function is defined as the verification of assumptions pertinent to the design analysis. Because of the uncertainties inherent in subsurface exploration, it is necessary that field observations show the actual conditions agree with those assumed in design. This includes, but is not linuted to, observation of areas that have been excavated of existing geologic conditions or the review of bearing conditions prior to backfill or construction. The conditions actually encountered shall be assessed for, their effect on design. Design verification should be performed by the operation that was responsible for the original geotechnical design and analysis. The actual conditions should be reviewed to determine how the work is affected and the design modified as appropriate. It is recommended that one organization maintain overall responsibility for veri-fication activities. Coordination of the on-site verification shall be required so that verification can DESIGN AND ANALYSIS be accomplished at that point in site con-struction which provides that best oppor-tunity for observation. This coordinahon shall be provided by the on-site Geotech-mcal Engineer to the necessary organiza-tions. Techniques and test methods used dur-ing design verification, such as plate load tests or rock soundness testmg, shall be in accordance with methods accepted m the geotechnical profession. P

• u 141 7.2.1 Gealogic Verification.

When sub-surface conditions are revealed during ex-cavation, it shall be verified that the ex-posed soil and rock materials are con-sistent with that shown on the boring logs and profiles. Included shall be ven-fication of the stratigraphy, classification and geologic mapping. Particular interest shall be made to such geologic features as faulting. Also, as required, verification of bearing areas shall be made to determine adequacy. For rock verifica hon, this could include rock soundness determina-* tion, while for soils it could include plate load tests. Consideration shall also be given to the performance of additional laboratory testing or to in situ testing (to verify strength parameters used in the analysis). Examples of this would be in situ direct shear tests on soil or rock or obtaining block samples for laboratory testing. 7.3 Constmction Specification 7.3.1 Introduction. The analyses and design of earth structures by the Geotech-nical Engineer are based upon certain de-sign assumptions, including strengths, materials properties and other parame-ters. The Geotechnical Engineer shall provide Construction Plans and Speci-fications. 7.3.2 Information Addressed in the Con. struction Specifications. As a minimum, the following areas should be addressed in the Construction Specification. 7.3.2.1 Materials. Materials consistent with the design should be specified, and procedures defined for verification of their use, by visual as well as laboratory tests. 7.3.2.2 Placement and Compaction. Pla~e-ment and compaction procedures and lift thicknesses should be speafied or com-

NUCLEAR SAFETY RELATED EARTH STRUCTURES 17 paction criteria established as part of t~e specification. Test fills may be required. Care should be taken to assure that over-compaction is not achieved as this may tend to increase lateral stresses, possibly affecting stability or integrity of the struc-ture. 7.3.2.3 Drainage. Most earth structures have, as a minimum, some type of drain-age system. Detailed drawings of drain-age requirements shall be included in the specifications and, for clarity, shall in-clude such details as pipe size and type, filter material types and layer thickness and pipe slope requirements. 7.4 Construction Process Review. In addition to the preparation of a Design Specification, it shall be the responsibility of the Geotechnical Engineer that per-forms the design and analysis of the earth structures to review the construct10n pro-cedures proposed by the constructor. The review shall be performed by the Geotechnical Engineer prior to beginning of construction on a particular activity. The purpose of the review shall be to provide another step in the continuity of geotechnical service by assuring that necessary assumptions made in the de-sign and analysis are not invalidated by the construction method or sequence so as to affect performance of the structure. During construction, it shall be the responsibility of the on-site Geotechnical Engineer to observe the actual construc-tion process to verify that the construc-tion method or sequence is properly performed In addition, it shall be the responsibility of this individual to provide verification during con-struction of those steps which could affect performance. 7.5 Verification Testing. Verification testing shall be performed using standard or specified procedures. Venfication test-ing ts the in-process inspection and test-ing that is performed to verify that the Construction Spec1ficat1ons and Pro-cedures are satisfactorily fulfilled. This achvity shall be supervISed by a Geo tech-nical Engineer In general, for safety-related earthwork, verificahon testing is associated with excavation, backfilling or the construction of embankments or retaining structures. Discussed below are several typical activities. 7.5.1 Excavation. Excavation is the process of removing soil or rock so that a structure may be founded below existing grade, or the removal of undesirable materials which will, in turn, be replaced with material of improved properties commonly referred to as engineered backfill. As a part of excavation work, a de-watering system may be required to low-er the groundwater table. Responsibility for the design and installation of a de-watering system, including the possible conduction of a pump test, shall be de-fined. As part of a dewatering system, p1ezometers or other devices to monitor the groundwater level shall be installed to verify performance of the system. A pro-gram for the periodic reading of these mstruments shall be established. Sus-pended solids in water removed shall be measured periodically to verify that soil material (fines) are not being pumped. Inspection services for excavation work shall be dependent upon the scope of the work and whether it is intended to reuse excavated materials. For excavation mate-rials that are classified as "spoil" only, irISpection services shall be required to verify that excavation has been com-pleted to the specification limits, that all unsuitable material is removed, and all "spoil" material is disposed of in areas designated for this use. If excavated materials are to be separated as "spoil," or for reuse, inspection shall be requued in the excavation to visually classify mate-rials for either reuse or disposal. DISposal areas that are used for materials to be later reclaimed shall be inspected to pre-vent inadvertent. dumping of "spoil" material. For excavahon performed to de-sign slopes, inspection services shall be provided to assure that slopes, benches, etc., c~nform to project specifications. Observations should be made by the Geotechnical Engineer to venfy dunng excavahon that the matenal actually en-countered is found to be as expected based on borings The presence of ex-traneous or une'(pected m.itenal may re-quire exploration and evaluation.

18 7.5.2 Stockpiling. The stockriling of materials shall include soils and rock from excavation work as discussed above or the bringing on-site of materials for later use Stockpiling of excavated materi-als shall include the in~pection men-tioned above. For materials brought on-site, an inspection shall be conducted upon arrival to verify that they meet proj-ect specifications. Inspection in stockpil-ing areas shall be provided as required. 7.5.3 Borrow Areas. When a borrow area is in use, inspection services are re-quired to verify that materials are re-moved as specified. Visual classification of soils shall be supplemented by periodic verification testing-depending on how the material is specified. This testing is not to be misconstrued as being replace-ment for backfill testing discussed below. 7.5.4 Test Fills. To determine an adequate technique for material place-ment so that the Construction Specifica-tions and Procedures are met, a test fill may be required by the Geotechnical En-gineer. The test fill should consider mate-rial type, lift thickness, type of equipment (if this is a variable), number of passes, and the means for reducing or increasing moisture content if necessary. Inspection services shall be provided to document different techniques employed and to sample the test fill for gradation, mois-ture content and in situ density and lift thickness for comparison with project specifications. 7.5.5 Backfill Verification. Backfill veri-fication shall include testing and con-tinuous visual inspection services pro-vided to assure the placement of earth and/or rock materials in accordance with project specifications. Included are the placement of materials for foundation-bearing areas, backfilling up to grade around structures, placement of materials for constructing embankments and dikes (including cores and drains) and the placement of materials for erosion protec-tion such as rip rap. Backfill verifications shall include continuous visual inspec-tion to assure proper lift thickness, place-men t of materials in zones, and the num-ber of passes by compaction equipment. Testing services shall be conducted at DESIGN A~D ANAL YSlS specified intervals, u~ually in terms of quantity of material placed or a minimum daily testing quota. Such testing shall be performed to verify specifications and may include gradation, moisture content, and in-situ density and compachon char-acteristics. 7.5.6 On-Site Laboratory. For a quality assurance/quality control testing associ-ated with earthwork verification, an on-site laboratory should be provided and staffed by the organization responsible for this work. The equipment used in verification testing shall be as described in the testing standard adopted for use. Equipment shall be calibrated as discussed in Section 7.7.2.. 7.6 Performance Monitoring. Perfor-mance monitoring is conducted to assure that the completed work satisfies design assumptions. Included may be plate-load tests, pressuremeter tests, settlements

• monitoring, groundwater monitoring, geophysical methods, and* in-situ den-sification verification.

Performance monitoring shall be im-plemented so that sufficient data are obtained, including base-line data pnor to construction if necessary. Base-line data should include testing conducted to obtain in-situ densities prior to a densifi-cation program. Monitoring shall be ex-tended beyond the construction period as reqUll"ed to verify design a5sumptions. The results of such monitoring should be available to, and evaluated by, the organ-ization responsible for design and anal-ysis. It is recommended that the concept and implementation of performance monitoring be stipulated by the design organization. The purpose of the per-formance monitoring is not to verify work. as construction progresses, but rather to provide verification that design assump-tions have been met. Performance monitoring shall be conducted in accor-dance with accepted test procedures, with calibrated equipment, and at ade-quate testing frequencies. Discussed below are several general areas to be considered in developing a performance monitoring program. Addi-tional programs besides those discussed

NUCLEAR SAFETY RELATED EARTH STRUCTURES 19 below should be considered as reqwred. 7.6.1 Monitoring for Seepage or Groundwater Control. Performance monitoring may be required to verify de-sign assumptions associated with seep-age or groundwater control. This could include: dissipation of excess pore pres-sures due to embankment or dike con-struction, assumed pressure distribu-tions, or the cutoff of seepage by grouting or slurry walls. 7.6.2 Defomuztion Monitoring. Deforma-tion monitoring shall include both place-ment of monuments to serve as reference points and installation of deformation points to define movement of subsurface strata or a structure. Deformation monitoring shall include a defined sur-veying program with adequate installa-tion or benchmarks. Vertical movements may be monitored to determine either settlement or heave of a structure or by establishing them at desired depths in the subgrade. The reference benchmarks shall be located so that they are un-affected by construction activities. Lateral movements shall be monitored where re-quired using instruments such as in-clinometers. Lateral movement measure-ments should be considered for ex-cavated slopes and retaining walls. 7.6.3 Stress and Load Measure-ment Instrumentation may be installed to verify design assumptions associated with embankment or retaining walls con-struction or structure-bearing pressures. This could include: strut load measure-ment (both for temporary or permanent bracing for retaining wa!.ls), loads in tie backs for retaining walls, total stresses due to placement of an embankment to determine end-of-construction con-ditions, monitoring of bearing pressures (both dunng and after construction) to verify assumed contact pressures and predicted settlements history. 7.7 Quality Assurance!Qual1ty Con-trol. Organizahons perfonning verifica-tion, momtonng or inspection services shall have established Quality Assurance/ Quality Control programs wluch satisfy requirements of 10 CRF 50, AppendLx B as it pertains to their work. Responsibility for the Quality Assurance/Quality Con-trol program shall be with the organiza-tion performing that work. ANSI N 45.2.5-1978 Supplementary Quality Assurance Requirements for In-stallation, Inspection and Testing of Structural Concrete, and Structural Steel, Sous and Foundations During the Con-struction Phase of Nuclear Power Plants, QA-76-5, (8) is pertinent.

7. 7.1 Qualification of Personnel. Per-sonnel involved in the verification testing program and support pesonnel for the performance monitoring program shall be qualified as needed for their activities in accordance with ANSI N 45.2.6.

Geotechnical engineers and geologists involved in design verificahon, the con-struction review process and perfor-mance monitoring shall be qualified to perform their assignments. Qualification of these personnel shall be demonstrated by their education, experience and appro-priate licensing. c,,i 7.7.2 Requirements for Equipment Calibration. Calibration shall be required for all instruments or test equipment that provide quantity measurement used in design verification, verification-testing or performance monitoring programs. Calibration requirements shall include initial acceptance criteria, frequencies for recalibration and tolerance limits. Toler-ance limits shall be established based on the instrument and the quantity being measured. 8.0 References (1) Code of Federal Regulations 10 CFR 100 Appendix A MSe1Smic and Geological Sit-ing Cntena for Nuclear Power Plants, N U.S. Atomic Energy Commission, November 1973, 10 CFR 40 Appendix 8. (2) ANSI N 174 MGuidelrnes for Evaluating Site-Related Geotechrucal Parameters for Nuclear Fac1hties," Prepared by ANS Comnuttee 2.11, ANSI, 1978. (3) ASCE "Subsurface lnvestigahon for De-sign and Construction of Found.:it1ons of Buildings," Manual No. 56, 1976. (4) ASTM MSpeaal Procedures for Testing Sot! & Rocks for Engmeenng Purposes," STP 479 (5) Regulatory Guide 1.132 MSite In-* veshgatwns for Found.1t1ons of ~ucle.ir

20 Power Plants," U.S Nuclrar Regulatory Comm1ss10n Office of Standards, Sep-tember, 1977 (6) Regulatory Guide 1 135 "Normal Water Level and Di<.eharge at Nuclear Power Plants," U S Nuclear Regulatory Com-m1~sion Office of Standards, September, 1977. (7) ANSI N 45.2.20 HSupplementary Quality

Assurance Requirements for Subsurface Investigations Prior to Construction Phase of Nuclear Power Plants," Amer-ican Nahonal Standards Inst:Jtute, 1979.

(8) ANSI N 45.2.5-1978, "Supplementary Quality Assurance Requirements for In-stallation, Inspection and Testing of Structural Concrete, and Structural Steel, Soils and Foundations During the Con-struction Phase of Nuclear Power PlantsH QA-76-5. (9) Regulatory Guide 1.70 "Standard Format and Content of Safety Analysis Reports for Nuclear Power Plants" U.S. Nuclear Regulatory Commission, ReV1s1on 3. (10) Department of the Anny HRecommended Guidelines for Safety Inspection of Dams,# Office of the Chief of Engineers, Washington, D.C. (11) ANSI N-170, #Standard for Determirung Design Basis Flooding at Power Reactor Sites,# Amencan Nudear Society, ANS-2 Subcorruruttee, Proposed Standard. (12) U.S. Army Corps of Engineers, HEngmeenng and Design of Earth and Rock-Fill Dams: General Design and Construction Cons1derabons," Engi-neers Manual EM 110-2-2300, U.S. Army Waterways E>..penment StatJon, Vicks-burg, Miss1ss1pp1, 1971. (13) U S. Bureau of Reclamabon, HDesign of Small Dams," 2nd Edition, Department of the Interior, 1973. (14) U.S. Bureau of Reclamation, "Earth Man-ual," Bureau of Reclamahon, Denver, Colorado, 1974. (15) Sherard, et al., HEarth and Earth-Rock Dams, H John Wiley and Sons, Inc., New York, 1963. (16) Knappen, T. T. and Lowe, J., HEarth Dams," Handbook of Applied Hydrau-lics, DaV1S, McGraw-Hill Book Company, New York, 1952. (17) Cederagren, Harry R., HSeepage, Dram-age, and Flow Nets," John Wiley & Sons, Inc., New York, 1%2. (18) Sowers, George F. and Sally, H. L., "Earth and Rock-Fill Dam Engineermg," Asia Publishing House, New York, 1962. (19) Independent Panel to ReVJew Cause of Teton Dam Failure, "Fatlure on Teton DESIG~ AND A:--..:AL YSIS Dam," Report to U S Dl'p.irtment ol In-tenor and State of Idaho, December 1976 (20) Taylor, D. W., "Fundamentals of Soil Me-chanics," John Wiley & 50ns, Inc., New York, 1948 (21) American Sooet: for Testing and Matcn-a)s, 1977, Annual Book of Standards, Part 19, Philadelplua, Pennsylvania. (22) Seed, H. B, Makd1s1, F. I, and De Alba, P., "Performance of Earth Dams Dunng Earthquakes," Journal of the Geotechmcal Engineenng Div1s10n, ASCE, Vol., 104, No. GI7, July, 1978, pp. 967-994. (23) Lowe, John rn, HStability AnalyS1s of Embankments," Journal of Soil Me-chanics and Foundahons D1v1s1on, ASCE Vol. 93, No. SM4, July 1%7 (24) Whitman, Robert V and Bailey, William A., "Use of Computers for Slope Stab1hty Analysis," Journal of the Soil Mechanics and Foundahons Division, ASCE, Vol 93, No. SM4, July, 1%7 (25) Spencer, E., u A Method of Analysis of the Stabil1tv of Embankments Assuming Par-allel I~ter-Slice Forces," Geotechnique, Vol. 17, No. 1, March 1967, pp 11-26. (26) Siegel, R.A., HComputer Analysis of General Slope Stability Problems," JHRP-75-8, Jomt Highway Research Project, Purdue Uruversity, 1975. (27) Newmark, N. M. HEffects of Earthquakes on Dams and Embankments," Geotech-nique, Vol. 5, No 2, June 1965, pp. 139-160. (28) Sarma, S. K., HSeismic Stabtlity of Earth Dams and Embankments," Geo tech-nique, Vol 25, Np. 4, December 1975, pp. 743-761. (29) Seed, H. B., and ldnss, I. M., "A Sim-plified Procedure for E\\"alua ting So~) Liquefaction Potenhal," Journal of the Soil Mechanics and Foundations Division, ASCE, Vol. 97, No. SM9, September 1971, pp. 249-274. (30) Seed, H. B., et al., "Dynamic Analysis of the Slide in the Lower San Fernando Dam Durmg the Earthquake of February:e9,. 1971, "ASCE Journal of the Geotechni Engineering Div., September 1975. (31) Seed, H. B., uslope Stability Dunng Earthquakes," ASCE Journal of the Sou Mecharucs and Foundations Div., July 1%7. (32) Seed, H. B. et al., 'Toe Slides m the San Fernando Dam Dunng the Earthquake of February 9, 1971," ASCE Journal of the Geotechnical Engineenng Div., July 1975 (33) R. E. Goodman and H B Seed, HEarth-quake Induced Displacement m Sand Embankments," ASCE Journal of the Soil

NUCLEAR SAFETY RELATED EARTH STRUCTURES 21 Mechamcs and Foundations Div., March 1965. (34) U.S. Army Corps of Engineers, #Earth-quake Design and Analysis for Corps of Engineers Dams," ER 1110-2-1806, April 1977. (35) Franklin, A. G., and Chang, F. K., #Earth-quake ~es15tance of Earth and Rock-Fill Dams, M Report 5, Permanent Dis-placements of Earth Embankments by Newmark Sliding Block Analysis, Water-ways Experiment Stabon, Vicksburg, MI 1977. (36) Makdis1, F. I. and Seed, H. B., #Simplified Procedures for Estimating Dam and Embankment Earthquake-Induced De-formations," Journal of the Geotechnical Engineering DiV1S10n, ASCE, Vol. 104, No. G17, July 1978, pp. 84~7. (37) Idriss, I. M., Hwang, R., Seed, H. B. MQuad--1. A Computer Program for Evaluating the Seismic Response of Soil Structures by Vanable Dampmg Finite Element Procedures," Earthquake Engineering Research Center, Report 73-16, Uruversity of California, Berkeley. (38) Seed, H. Bolton, #Sot! Liquefaction and Cyclic Mobility Evaluation for Level Ground Dunng Earthquakes," Journal of the Geotechrucal Engineenng Division, ASCE, Vol. 105, No. GT2, Proc. Paper 14380, February 1971, pp. 201-255. (39) Theirs, G. R., and Seed, H. B., #Strength and Stress-Strain Charactenstics of Gays Sub1ected to Seismic Loading Con-ditions," Vibration Effects of Earthquakes on Sous and Foundations, ASTM STP -l.50, American Society for Testmg and Maten-als, 1%9, pp. 3--56. (40) U.S Army Coastal Engineering Research Center, HShore Protectton Manual," Vol. I, II and m, Department of the Army, Corps of Engineers 1973. U.S Govern-ment Pnnting Office, Washington, D.C, Stock No. ~-00077. (41) Teng, W. C, #Foundation Design," Prenbce-Hall, Inc. Englewood Cliffs, N.J. 1962, pp 466. (42) Peck, R. 8., Hanson, W. E., and Thom-bum, T. H., uFoundabon Engmeenng, H second ed1hon, John Wiley and Sons, Inc. New York, 1974, pp. SH. (43) Bowles, J. E, MFoundahon Analys15 and Oe51gn," second ed1t1on, McGraw-H1l1 Book Company, Ne*.v York., 1977, pp 750. (-H) Naval Facilities Engm~nng Command Design Manual "Sot! Mechanics, Founda-tiorlS, and Earth Structures," NA VFAC DM-7, March 1971, Department of the Navy, Naval Faalities Engineering Com-mand, Alexandria, VA. (45) Taylor, D. W. (1937) "Stability of Earth Slopes," Journal of Boston Sooety of Civil Engineers, Vol. XXIV, No. 3, July. (Re-printed in "Contnbutions to Sot! Me-charucs, 1925-1940. 1 Boston Soaety of Ovil Engineers, 1940, pp. 337-386. (46) Bishop, A. W., (1955) "'The Use of the Slip Circle in the Stability Analysis of Slopes," Geotechnique, Vol. 5, No. 1, March, pp 7-17. (47) Lowe, J., III and Karafiath, L. (1960) HEffect of Anisotropic Consolidation on the Undrained Shear Strength of Com-pacted Clays, H Proceedings, Research Conference on Shear Strength of Cohe-sive Soils, ASCE, Boulder, CO, June 1960, pp. 837-358. (48) Spencer, E. (1967) HA Method of Analysis of the Stability of Embankments Assum-mg Parallel Inter-Slice Forces," Geo tech-nique, Vol. 17, No. 1 March, pp. 11-26. (49) Rendulic, L. (1935) "Ein Be1trag Zur Be-shmmung der Gleits1cherhe1t,H Der Bauingenieur, Vol. No. 19/20 (50) Morgenstern, N. R. and Price, V. E. (1965) "'The Analysis of the Stability of General Slip Surfaces, M Geotechruque, Vol. 15, No. 1, March, pp. 79-93. (51) U.S. Nuclear Regulatory Committee, HStandard Review Plan" Sechon 2 5, Stability of Slopes, 1975. (52) U.S. Nuclear Regulatory Cornrniss10n,

1. Regulatory Guide 3 11, Design, Con-struction and Inspection of Embankments Retention Systems for Uranium Mills, Revision 1, March 1977, p. 9.

(53) Sherard, J. L, Decker, R. S., and Ryker, N. L., MPipmg in Earth Dams of Dis-persive Oay," Proceedings of the Speaal-ty Conference on Performance of Earth and Earth-Supported Structures, ASCE, Vol. 1, Part 1, 1972, p. 589--626. (54) Sherard, J. L., Decker, R. S., and Ryker, N. L., uHydraulic Fractunng in Low Darns of Dispersive Oay," Proceedings of the Specialty Conference on Performance of Earth and Earth-Supported Structures, ASCE, Vol. I, Part 1, 1972, pp. 653--689 (55) ANSI N 45 2 6, "Qualifications of Inspec-hon, Exarnmahon and Teshng Personnel for the Construction Pha:,e of Nuclear Power Plants" QA-76-6.

Acceptance testing requirements, l Analyt:1.cal methods, 7--8, 10, 13--15 Backfill verificabon, 18 Baffle, (def.) 2, 6 Borrow areas, 18 Breakwater, (def.) 2, 8 Bulkhead, (def) 2 Category l structure, (def.) 2 Cherrucal mteracbon, 15 Construction process, (def.) 2 Construction process review, 1, (def) 2, 17 Construction sped.ficabon, 1, (def.) 2, 16 Contour control structures, 10-15 Contractor, (def.) 2 Criteria, (def) 2 Cuts, 10-11 Darns, (def.) 2, 4, 6, 8 Deformation monitoring, 19 Design criteria, l Design life, l Design parameters, 5--6, 11 Design speofication, l Design verification, 16 Dtkes, (def.) 2, 4, 6, 8 Drainage, 17 Dynamic analysis, 8, 14-15 Dynamic loading conditions, 6-7, 10, 12 Dynamic stability, 7, 12-13 Earth pressure computation, 13 Embankments, 4 Engineer, (def) 2 Equipment cahbrabon, 19 Examinabon, (def) 2 Excavahon, 17 Fills, 10-12 Foundation stability, 14 Geologic verification, 16 Geologists, 19 Geology, 5, 11 Geotechnical, 5, 11 Geotechrucal engmeer, 1, (def) 2, 19 Geotechnical parameters, 9 Geotechnical services, (def) 2 Groundwater control, 19 Hydrology, 5, 11 Irutiat1on of review, l Inspection, 15--19 lnstrurnent.ihon, 15--19 Load rne,burcment, 19 Load requirements, 1 Matenals, 5, 9-10, 11, l6 Momtonng, l, 15--19 On-s1tt! laburatorv, 18 Oper.itmg b.1"1" earthyu.ike, (def) '.! INDEX 21 Operahng conditions, 6, 10, 11 Operational requirements, 1 Overall stab1hty, 14 Owner, (def.) 3 Peer review, 1, (def) 3 Performance cnteria, 13 Performance momtonng, (def) 3, 18 Placement and compacb.on, 16-17 Protection of slopes, 15 Qualification of personnel, 19 Qualification of reviewer, l Quality assurance, 1, (def.) 3, 19 Quality control, 19 Retaining walls, (def.) 3, 10, 11, 13 Revetments, (def.) 3, 8 Review documentab.on, 2 Review requuements, 1 Safe shutdown earthquake, (def) 3 Safety_related eacth structure, (def) 3 Seawalls, (d4) 3, 8 Seepage, 19 Seismology, 5, 11 Site contour earth structures, 10-15 Site investigation, 3--4, 5, 8, 11 Site protection earth 5tructures, ~10 Slope stability, 12 Slope stability analysis, 14-15 Slope stabilization, 15 Slope, cut, (def.) 3 Slope, natural, (def.) 3, 10-11 Soil erosion, 15 Speafication, (def.) 3 Stability against overturning, 14 Stability agamst sliding, 14 Standard, (def) 3 Static analys1S, 7--8, 14 Stabc loading conditions, 6, 10, 12 Static stability, 6, 12 Static stability and performance, 10 Stockpiling, 18 Stress measurement, 19 Test fills, 18 Testing, (def.) 3 Ultimate heat sink, (def.) 3 Ulhmate heat smk structures, 4--8 Venficatlon, (def) 3 Venf1cahon testing, 17 Venficat1on, design, (def) 3 Vcnlic.it1on, excavation, (d,:f.) 3 Venficat1on, geologic, (def) 3 Water level inve,,hgation, 9 Watt!rfront associated parameters, ~9 Wave proteLhon, 15 Wind-gener.it~d water wave conditwn~, 9

• e Commonwealth Edison One First Nati onal Plaza, Chicago, Illinois Address Reply to Post Office Box 767 Chicago, Il linois 60690 JQCKU t~UM!3tl< PR**_ 11 f P.QP f:O RULE.

J,

(~ FR_ 417/t,) December 20, 1985 Mr. Samuel J. Chilk, Secretary U.S. Nuclear Regulatory Commission Attn: Docketing and Service Branch 1717 H Street N.W. Washington DC 20555 Re: General Statement of Policy and Procedure for "B5 DEC 31 A11 :17 GFF !. : *;;: " OOCKE.Tt~JG '_:.,,,:,,,r :* << SE1<1* 1r BRANCH Enforcement Actions 50 Fed. Reg. 47716 (November 20, 1985)

Dear Mr. Chilk:

This letter provides Commonwealth Edison Company's ("Edison") comments on the proposed revisions to the above referenced policy statement regarding Enforcement. The proposed revisions to the Enforcement Policy are intended to increase assurance that the Nuclear Regulatory Commission's ("NRC" or Commission") requirements are met for products and services provided to NRC licensees by unlicensed vendors. This goal is to be realized by two basic methods: (1) direct NRC action against vendors; and (2) increased licensee exposure to penalties for failure adequately to oversee vendors. As a practical matter, increased licensee exposure to penalties appears to be the dominant method of those proposed to ensure vendor compliance with NRC requirements. Edison believes, for the reasons discussed below, that primary reliance on the exposure of licensees to substantial penalities is not the appropriate method for ensuring vendor compliance with NRC requirements. Edison recognizes its responsibility for procuring goods and services which meet the regulatory requirements in 10 CFR Part 50, Appendix B Section VII and has vigorously pursued that responsibility. Edison's motivation has not been the fear of civil penalities, but rather the desire to build safe and reliable nuclear power plants which produce a profit while fulfilling Edison's responsibility to provide needed electricity. This motivation continues unabated and will continue to ensure that Edison will vigorously i mplement the Section VII requi rements on Quality Assurance. Under these circumstances, imposition of substantial penalties for the occasional lapse due to inevitable human error cannot serve to improve Edison's i mplementation of its Quality Assurance progr am. Rather, the only result of such penalties will be increased economic consequences. Therefore, Edison believes that the Commission should focus primarily on vendors to achieve the aims desired to be achieved by these proposed changes in the

U.S. N CLEAR RcGfl!ATORY COMMISSION DO'"KETll-'G c!'l SE~V!C~ SECTION OFFf(t r:~ T!'"'. :;,_'" ~TA Y o~ * ~ cc* * *, Potfr r'

• Enforcement Policy.

Accordingly, the proposed rev1s1ons to the Enforcement Policy should be modified to restore to its properly subordinate role any reliance on substantial penalties against licensees to ensure vendor compliance with NRC requirements. In addition to the above general considerations, the new example of a Severity Level III violation for deficiencies in a licensee's oversight of vendors' quality assurance programs contains several ambiguities and is inconsistent with other examples of violations at the same severity level.

1.

No criteria are stated for determining the adequacy of a licensee's oversight of a vendor. In the absence of explicit criteria, a licensee's purchase of non-conforming products or services could be taken a conclusive evidence of inadequacy of licensee oversight of its vendor. Such a result would be unfair because no oversight can be expected to be perfect.

Moreover, in the absence of explicit criteria, different situations can be expected to give rise to inconsistent interpretations of adequacy.

Therefore, to prevent the imposition of an unfairly strict standard, and the inconsistent application of the Enforcement Policy, the Commission should state explicitly the criteria that will be used to judge adequacy for the purposes of the new example. As an example, one set of appropriate criteria is the criteria used to judge a licensee's compliance with Section VII of Appendix B to 10 CFR Part so.

2.

Inconsistent safety standards are being applied by g1v1ng equal weight to products and services which are either defective or of indeterminate quality. A product or service of initially indeterminate quality may prove ultimately to satisfy regulatory requirements and, thus, not to present a safety concern. Edison recognizes the Commission's desire to encourage licensees to determine the quality of products and services in advance of their use. As explained above, Edison makes such determinations now because it is in Edison's own best interests to do so and not because of any threat of penalty. Accordingly, Edison believes the Commission's goal can be accomplished just as effectively by providing a lesser penalty for the use of products and services for which quality is shown to ultimately satisfy regulatory requirements.

3.

The term "defective quality" is undefined. A strict, literal interpretation of the term would include any defect, no matter how insignificant. Even if the term is limited to deviations from regulatory requirements, the term could be read to treat all such deviations equally, even though not all deviations have equal safety significance. Therefore, to ensure that the safety significance of defects is a factor in the determination of a penalty, the Commission should provide guidance on interpreting the term "defective quality".

• 4.

The term 0 safety significance" is used inconsistently with its other uses in the Enforcement Policy. For the most part, this term is used to characterize regulatory requirements or violations. In the proposed new example, the term will be used to describe covered products and services. This use will only serve to further confuse the already confused situation regarding the categorization of equipment by adding a third category in addition to the currently ill-defined categories of important to safety and safety-related. Accordingly, Edison suggests that the covered products and services be characterized by already existing terminology or by more precisely defined terminology. Thank you for this opportunity to provide our comments. /L~~ I D. L. Farrar Director of Nuclear Licensing 1013K

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10 CFR PART 2 CFr- * - n,::-sr.,.,..) GENERAL STATEMENT OF POLICY AND PROCEDURE FOR ENFORCEMENT~ AOiiIONS' - ~ ~ f AGENCY: Nuclear Regulatory Corrmission. ACTION: Revised general statement of policy.

SUMMARY

The NRC is publishing minor revisions to its enforcement policy (47 FR 8583 (March 8, 1984)) to describe how its enforcement policy applies to vendors of products or services that are supplied to the nuclear industry for ultimate use in facilities or activities that are licensed by the NRC. The policy statement is intended to inform licensees, vendo rs, and the public of the bases for taking various enforcement actions. The policy is codified as Appendix C to Part 2 of Title 10 of the Code of Federal Regulations. DATES: This revised statement of policy is effective February 18, 1986. Comment Period: Submit coll111ents on or before Jan. 21, 1986. Corrments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date. 1

ADDRESSEES: Any corrments or suggestions should be sent to: Secretary of the Commission, U.S. Nuclear Regulatory Corrmission, Washington, D.C. 20555, Atten-tion: Docketing and Service Branch. Copies of co1111T1ents may be examined in the U.S. Nuclear Regulatory Co111T1ission Public Document Room, 1717 H Street, NW., Washington, D.C. FOR FURTHER INFORMATION CONTACT: Jane A. Axelrad, Director, Enforcement Staff, Office of Inspection and Enforcement, U.S. Nuclear Regulatory Co111T1ission, Washington, D.C. 20555 (301-492-4909). SUPPLEMENTARY INFORMATION: Background.: The criteria used by the CoITITiission to conduct its enforcement activities were first published on October 17, 1972 (37 FR 21962). These criteria were subsequently modified on January 3, 1975 (40 FR 820) and on December 3, 1979 (44 FR 77135). In late 1979, the Commission directed the staff to prepare a comprehensive statement of enforcement policy. This staff effort was given added urgency by the enactment of Pub. L. 96-295 (signed June 30, 1980), that, among other things, amended Section 234 of the Atomic Energy Act to raise the maximum civil penalty the NRC can impose from $5,000 to $100,000 per violation per day and eliminated the provision limiting the total civil penalties for any 30-day period to $25,000. On September 4, 198Q, the CoIT1Tiission approved a proposed general statement of policy on enforcement. Comments were solicited on the policy and a series of public meetings was held. On March 9, 1982, the CoIT1Tiission published a final version of the policy (47 FR 9987). These revisions 2

were published in the Federal Register (49 FR 8583) and became effective on March B; 1984. The Commission subsequently decided that the enforcement policy should be revised to add a section regarding vendor enforcement. Accordingly, the Corrmission is today revising the enforcement policy to indicate how it has been and is being applied to vendors and to licensees' control of vendor activities. The term 11vendor 11 as it is used in the discussion which follows means a supplier of products or services to be-used in-an NRC--licensed facility-or activity.---- Vendor Program - Description and Objectives The agency's enforcement program for vendors has been and should continue to be designed to further the basic objective of the vendor inspection program. That objective is to increase public health and safety by providing increased assurance that the products and services provided by unlicensed organizations for use in licensed activities meet NRC requirements. The program is based, however, on the premise that licensees have the primary responsibility for the procurement of quality products and services for use in licensed activities. The vendor cormtunity is a large and diverse group of companies that includes the architect engineering and nuclear steam supply system manufacturing finns, component and equipment manufacturers, testing facilities, and material manufacturers and suppliers that provide a* wide variety of equipment, parts and services. These companies are motivated by different considerations than licensees and the degree of NRC contact with the various companies differs. 3

For example, for utilities and materials licensees, the need for the safe and reliable conduct of licensed activities is a strong incentive for the procurement of quality products and services. NRC issuance of a license provides a direct mechanism through inspection and enforcement for ensuring that this incentive is maintained. Except in limited circumstances such as when a vendor seeks a license to manufacture a facility under Appendix M of 10 CFR Part 50, or approval of a standard design under Appendix 0 of the same part, vendors are not licensed or otherwise subject to a licensing type review by the,NRC and the NRC has limited direct control over their activities. Vendors do, however, exist in a very competitive environment and their incentive to provide good quality products and services is based on financial considerations rather than on the need to obtain and maintain a license. To ensure that licensees obtain quality products and that defective products are identified and reported in a timely manner, the ColTlllission has promulgated certain regulatory requirements. The most important of these is 10 CFR Part 50, Appendix B. These requirements regarding quality assurance programs are directly applicable to reactor licensees for safety-related components and are made applicable indirectly to their vendors through their procurement contracts with these licensees. Title 10, CFR, Part 21 addresses the reporting of defects in goods or services supplied for licensed activities for both reactor and materials licensees. The NRC inspection program for licensees and vendors was designed to determine whether licensees and vendors were conducting their activities so as to promote safety and compliance with these requirements. The vendor inspection program does not presently include inspection of vendors of licensees licensed under 4

Parts 30, 40, and 70 for which no specific quality assurance requirements comparable to Appendix B exist. It does include inspections of holders of spent fuel cask certificates under Part 71 and their suppliers. The vendor inspection program is being directed to determine if reactor licensees are adequately monitoring the activities of their vendors. Vendor inspections are conducted at vendor shops principally to examine whether they have been complying with Appendix B to 10 CFR Part SO as they are required to do under their procurement contracts with licensees. The scope and focus of these inspections -have evolved with the industry as its-emphasis has shifted from construction-related activities to procurement of replacement parts, modifications, outage support and other related services. However, the philosophy that the licensee should be held primarily responsible for the procurement of high quality products that are to be used in nuclear activities has remained unchanged. In furtherance of this philosophy, reactor licensees have been held primarily accountable from an enforcement standpoint if violations of Appendix B to 10 CFR Part SO are identified. Escalated enforcement action, if appropriate, is taken against a reactor licensee for significant breakdowns in the licensee 1s or vendor 1s auality assurance program that have resulted in the use of products or services of defective or indeterminate auality that have safety significance. Notices of Nonconformance and Notices of Violation are issued to vendors for failures to meet quality commitments and Part 21 respectively. These Notices can also be issued to materials licensees and their vendors for violations of Part 21. The NRC has issued Notices of Nonconformance to vendors of reactor licensees when deviations from contracts, quality assurance programs or internal procedures s

were discovered or identified during the inspection process. A nonconforrnance involves a failure to satisfy a commitment or obligation that has or could cause a vendor product or service to be unacceptable. The NRC expects vendors to respond in writing to Notices of Nonconfonnance describing their corrective action to remedy the problem and the measures to be taken to prevent recurrence. The NRC also issues Notices of Violation to vendors when the NRC has direct statutory authority over them. See 10 CFR 2.201. For example, pursuant to Section 206 of the Energy Reorganization Act, 42 U.S.C. 5846, and the Commission's implementing regulation, 10 CFR Part 21, persons who supply certain types of components are subject to reporting and related requirements intended to ensure that the ColTITiission is promptly informed of defects in such components. The NRC has issued Notices of Violation to non-licensees, for violations of Part 21. These included violations involving inadequate implementation of procedures to address the review and reporting of defects, and failures to pass on Part 21 requirements in procurement documents. Revisions to the Enforcement Policy The existing Enforcement Policy does not contain any references to vendors and is geared to enforcement against licensees. The Commission has decided to add a section to the existing policy describing its present enforcement policy for vendors including the use of Notices of Nonconformance and to change certain references to licensees to include non-licensees where appropriate. Accordingly, the Commission is publishing the attached proposed revisions to the Enforcement "I, Policy, which will take effect thirty days after the close of the comment period. The proposed revision to the enforcement policy reflects for the most part the NRC's practices that have evolved over the years and are currently in use. 6 '

The Corrnnission believes that the provisions.of the revised policy are sufficient to achieve NRC objectives with respect to the health and safety of the public, compliance with legal requirements, and conformance to commitments and obligations of vendors. In the following paragraphs, the revisions to the policy which are being made now are described. Only the sections to which changes were made are discussed here. The numbering of the sections tracks the section numbers in the policy. I. Introduction and Purpose The purpose was expanded to encompass vendor activities. IV. Enforcement Conferences

v.

The use of enforcement conferences has been expanded to include meetings with vendors for significant findings of nonconformance. Enforcement Actions

1.

References to the Notice of Nonconformance for vendors were added.

2.

Vendors were deleted from the section on Notices of Deviation because the Notice of Nonconformance is used for vendors.

3.

The use of Confinnatory Action Letters was expanded to include vendors.

4.

A section on Notices of Nonconformance was added to recognize its use 7

as an administrative tool for vendors. VIII. Vendor Enforcement A new section was added to explain how the NRC 1s enforcement policy applies to vendor activities. This new section describes the requirements that are applicable to vendors and the enforcement sanctions available for violations of those requirements. Supplement I A new example was added to Supplement I, Severity Level III for violations_ involving operating plants in which, through inadequate oversight of vendor activities, a safety significant product or service of defective or indeterminate quality is used at a plant. LIST OF SUBJECTS IN 10 CFR PART 2 Administrative practice and procedure, Antitrust, Byproduct material, Classified infonnation, Environmental protection, Nuclear materials, Nuclear power plants and reactors, Penalty, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal. Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and Section 552 of Title 5 of the United States Code, the following statement of policy is published as Appendix C to 10 CFR Part 2 as a document subject to codification effective thirty days after the close of the comment period. 8

PART 2 - RULES OF PRACTICE FOR DOMESTIC LIEENSING PROCEEDINGS

1.

The authority citation for Part 2 continues to read as follows: Authority: Secs. 161, 181, 68 Stat. 948, 953, as amended (42 U.S.C. 2201, 2231); sec. 191, as amended, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 2241); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); 5 U.S.C. 552. Section 2.101 also issued under secs. 53, 62, 63, 81, 103, 104, 105, 68 Stat. 930, 932, 933, 935, 936, 937, 938, as amended (42 U.S.C. 2073, 2092, 2093, 2111, 2133, 2134, 2135); sec. 102, Pub. L. 91-190, 83 Stat. 853, as amended (42 U.S.C. 4332); sec. 301, 88 Stat. 1248 (42 U.S.C. 5871). Sections 2.102, 2.103, 2.104, 2.105, 2.721 also issued under secs. 102, 103, 104, 105, 183, 189, 68 Stat. 936, 937, 938, 954, 955, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2233, 2239). Section 2.105 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 2.200-2.206 also issued under secs. 186, 234, 68 Stat. 955, 83 Stat. 444, as amended (42 U.S.C. 2236, 2282); sec. 206, 88 Stat. 1246 (42 U.S.C. 5846). Sections 2.300-2.309 also issued under Pub. L. 97-415, 96 Stat. 2071 (42 U.S.C. 2133). Sections 2.600-2.606 also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 as amended (42 U.S.C. 4332). Sections 2.700a, 2.719 also issued under 5 U.S.C. 554. Sections 2.754, 2.760, 2.770 also issued under 5 U.S.C. 557, Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42 U.S.C. 2133) and 5 U.S.C. 552. Sections 2.800 and 2.808 also issued under 5 U.S.C. 553. Section 2.809 also issued under 5 U.S.C. 553 and sec. 29, Pub. L. 85-256, 71 Stat. 579, as amended (42 U.S.C. 2039). Appendix A also issued under sec. 6, Pub. L. 91-580, 84 Stat. 1473 (42 U.S.C. 2135).

2.

Appendix C to Part 2 is revised to read as follows: 9

APPENDIX C - GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS The following statement of general policy and procedure explains the enforcement policy and procedures of the U.S. Nuclear Regulatory Commission and its staff in initiating enforcement actions, and of presiding officers, the Atomic Safety and Licensing Appeal Boards, and the Corrrnission in reviewing these actions. This statement is applicable to enforcement in matters 1nvolving,the public health and safety, the common defense and security, and the environment,1/ I. INTRODUCTION AND PURPOSE The purpose of the NRC enforcement program is to promote and protect the-radiological health and safety of the public, including employees' health and safety, the corrrnon defense and security, and the environment by: Ensuring compliance with NRC regulations and license conditions; Obtaining prompt correction of violations and adverse quality conditions which may affect safety;, Deterring future violations and occurrences of conditions adverse to quality; and Encouraging improvement of licensee and vendor QI performance, and by example, that of industry, including the prompt identification and reporting of potential safety problems. 1/ Antitrust enforcement matters will be dealt with on a case-by-case basis. ~/ The term "vendor" means a supplier of products or services to be used in an NRC-licensed facility or activity. 10

I I. Consistent with the purpose of this program, prompt and vigorous enforce-ment action will be taken when dealing with licensees or vendors who do not achieve the necessary meticulous attention to detail and the high standard of compliance which the NRC expects. It is the CoITJTiission's intent that sanctions should be designed to ensure that a licensee or vendor does not deliberately profit from violations of NRC requirements. Each enforcement action is dependent on the circumstances of the case and requires the exercise of discretion after consideration of these policies and procedures. In no case, however, will licensees who cannot achieve and maintain adequate levels of protection be permitted to conduct licensed activities. STATUTORY AUTHORITY AND PROCEDURAL FRAMEWORK A. STATUTORY AUTHORITY The NRC I s enforcement juri sdi cti on is drawn from the Atomi.c Energy Act of 1954, as amended, and the Energy Reorganization Act (ERA) of 1974, as amended. Section 161 of the Atomic Energy Act authorizes NRC to conduct inspections and inv~stigations and to issue orders as may be necessary or desirable to 'promote the common defense and security or to protect health or to minimize danger to life or property. Section 186 authorizes NRC to revoke licenses under certain circumstances (e.g., for material false statements, in response to conditions that would have warranted refusal of a license on an original application, for a licensee's failure to build or operate a facility in accordance with the terms of the permit or license, and for 11

violation of an NRC regulation). Section 234 authorizes NRC to impose civil penalties not to exceed $100,000 per violation per day for the violation of certain specified licensing provisions of the Act, rules, orders, and license terms implementing these provisions, and for violations for which licenses can be revoked. In addition to the enumerated provisions in section 234, sections 84 and 147 authorize the imposition of civil penalties for violations of regulations implementing those provisions. Section 232 authorizes NRC to seek injunctive or other equitable relief for violation of regulatory requirements. Section 206 of the Energy Reorganization Act authorizes NRC to impose civil penalties for knowing and conscious failures to provide certain safety information to the NRC. Chapter 18 of the Atomic Energy Act provides for varying levels of criminal penalties (i.e., monetary fines and imprisonment) for willful violations of the Act and regulations or orders issued under Sections 65, 161(b), 161(i), or 161(0) of the Act. Section 223 provides that criminal penalties may be imposed on certain individ-uals employed by firms constructing or supplying basic components of any utilization facility if the individual knowingly and willfully violates NRC requirements such that a basic component could be significantly impaired. Section 235 provides that criminal penalties may be imposed on persons who interfere with inspectors. Section 236 provides that criminal penalties may be imposed on persons who attempt to or cause sabotage at a nuclear facility or to nuclear fuel. Alleged or suspected criminal violations of the Atomic Energy 12

Act are referred to the Department of Justice for appropriate action. B. PROCEDURAL FRAMEWORK Subpart B of 10 CFR Part 2 of NRC's regulations sets forth the procedures the NRC uses in exercising its enforcement authority. 10 CFR 2.201 sets forth the procedures for issuing notices of violation. The procedure to be used in assessing civil penalties is set forth in 10,CFR 2.205. This regulation provides that the appropriate NRC Office Director initiates the civil penalty process by issuing a notice of /: violation and proposed imposition of a civil penalty. The Ticensee is provided an opportunity to contest in writing the proposed imposition of a civil penalty. After evaluation of the licensee's response, the Director may mitigate, remit, or impose the civil penalty. An opportunity is provided for a hearing if a civil penalty is imposed. The procedure for issuing an order to show cause why a license should not be modified, suspended, or revoked or why such other action should not be taken is set forth in 10 CFR 2.202. The mechanism for modifying a license by order is set forth in 10 CFR 2.204. These sections of Part 2 provide an opportunity for a hearing to the affected licensee. However, the NPC is authorized to make orders immediately effective if the public health, safety or interest so requires or, in the case of an order to show cause, if the alleged violation is willful. 13

III. SEVERITY OF VIOLATIONS Regulatory requirements~/ have varying degrees of safety, safeguards, or environmental significance. Therefore, the relative importance of each violation must be identified as the first step in the enforcement process. Consequently, violations are categorized in terms of five levels of severity to show their relative importance within each of the following eight activity areas: I. Reactor Operations; II. Facility Constru'ction; II I. Safeguards; IV. Health Physics; V. Transportation; VI. Fuel Cycle and Materials Operations; VII. Miscellaneous Matters; and VIII.Emergency Preparedness. ~/The terin 11 requirement 11 as used in this policy means a legally binding requirement such as a statute, regulation, license condition, technical specification, or order. 14

Licensed activities not directly covered by one of the above listed areas, e.g;, export license activities, will be placed in the activity area most suitable in light of the particular violation involved. Within each activity area, Severity Level I has been assigned to violations that are the most significant and Severity Level V violations are the least significant. Severity Level I and II violations are of very significant regulat_ory concern. In general, violations that are included in these severity categories involve actual or high potential impact on the public. Severity Level III violations are cause for significant concern. Severity Level IV violations are less serious but are of more than minor concern; i.e., if left uncorrected, they could lead to a more serious concern. Severity Level V violations are of minor safety or environmental concern. Comparisons of significance between activity areas are inappropriate. For example, the irrvnediacy of any hazard to the public associated with Severity Level I violations in Reactor Operations is not directly comparable to that associated with Severity Level I violations in Reactor Construction. While examples are provided in Supplements I through VIII for determining the appropriate severity level for violations in each of the eight I activity areas, the examples are neither exhaustive nor controlling. These examples do not create new requirements. Each is des.igned to illustrate the significance which the NRC places on a particular type of violation of NRC requirements. Each of the examples in the supplements i~ predicated on a violation of a regulatory requirement. 15

In each case, the severity of a violation will be characterized at the level best suited to the significance of the particular violation. In some cases, violations may be evaluated in the aggregate and a single severity level assigned for a group of violations. The severity level of a violation may be increased-if the circumstances surrounding the matter involve careless disregard of requirements, deception, or other indications of willfulness. The term 11willfulness 11 as used here embraces a spectrum of violations ranging from deliberate intent to violate or falsify to and including careless disregard for requirements. Willfulness does not include acts which do not rise to the level of careless disregard, e.g., inadvertent clerical errors in a document submitted to the NRC. In determining the specific severity level of a violation involving willfulness, consideration will be given to such factors as the position of the person involved in the violation (e.g., first-line supervisor or senior manager), the significance of any underlying violation, the intent of the violator (i.e., negligence not amounting to careless disregard, careless disregard, or deliberateness), and the economic advantage, if any, gained as a result of the violation. The relative weight given to each of these factors in arriving at the appropriate severity level will be dependent on the circumstances of the violation. The NRC expects licensees to provide full, complete, timely, and accurate information and reports. Accordingly, unless otherwise categorized in the Supplements, the severity level of a violation involving the failure to make a required report to the NRC will be based upon the significance of 16

IV. and the circumstances surrounding the matter that should have been reported. A licensee will not normally be cited for a failure to report a condition or event unless the licensee was actually aware of the condition or event which it failed to report. However, the severity level of an untimely report, in contrast to no report, may be reduced depending on the circumstances surrounding the maiter. ENFORCEMENT CONFERENCES Whenever the NRC has learned of the existence of a potential violation for which a civil penalty or other escalated enforcement action may be warranted, or recurring nonconfonnance on the part of a vendor, the NRC will nonnally hold an enforcement conference-with the licensee or vendor prior to taking enforcement action. The NPC may also elect to hold an enforcement conference for other violations, e.g., Severity Level IV violation which, if repeated, could lead to escalated enforcement action. The purpose of the enforcement conference is to (1) discuss the violations or nonconformance, their significance and causes, and the licensee's or vendor's corrective actions, (2) determine whether there are any aggravating or mitigating circumstances, and (3) obtain other informa-tion which will help determine the appropriate enforcement action. In addition, during the enforcement conference, the licensee or vendor will be given an opportunity to explain to the NRC what corrective actions (if any) were taken or will be taken following discovery of the potential violation or nonconformance. Licensees or vendors will be told when a meeting is an enforcement conference. Enforcement con-ferences will not nonnally be open to the public. 17

V. When needed to protect the public health and safety or cormnon defense and security, escalated enforcement action, such as the issuance of an in111ediately effective order modifying, suspending, or revoking a license, will be taken prior to the enforcement conference. In such cases, an enforcement conference may be held after the escalated enforcement action is taken. ENFORCEMENT ACTIONS This section describes the enforcement sanctions available to NRC and specifies the conditions under' which each may be used. The basic sanctions are notices of violation, civil penalties, and orders of various types. Additionally, related administrative mechanisms such as bulletins and confirmatory action letters, notices of nonconformance and notices of deviation are used to supplement the enforcement program. In selecting the enforcement sanctions to be applied, NRC will consider enforcement actions taken by other Federal or State regulatory bodies having concurrent jurisdiction, such as in transportation matters. With very limited exceptions, whenever a violation of NRC requirements is identified, enforcement action is taken. The nature and extent of the enforcement action is intended to reflect the seriousness of the violation involved. For the vast majority of violations, action by an NRC regional office is appropriate in the form of a Notice of Violation requiring a formal response from the recipient describing its corrective actions. In situations involving nonconformance on the part of vendor, a Notice of Nonconformance will be issued. The relatively small number of cases involving elevated enforcement action receives substantial attention by 18

the public, and may have significant impact on the licensee 1s operation. These elevated enforcement actions include civil penalties; orders modifying, suspending or revoking licenses; or orders to cease and desist from designated activities. A. NOTICE OF VIOLATION A notice of violation is a written notice setting forth one or more violations of a legally binding requirement. The notice normally requires the recipient to provide a written statement describing (1) corrective steps which have been taken and the results achieved; (2) corrective steps which will be taken to prevent recurrence; and (3) the date when full compliance will be achieved. NRC may require responses to notices of violation to be under oath.

Normally, responses under oath will be required only in connection with civil penalties and orders.

NRC uses the notice of violation as the standard method for formalizing the existence of a violation. A notice of violation is normally the only enforcement action taken, except in cases where the criteria for civil penalties and orders, as set forth in Sections V.B and V.C, respectively, are met. In such cases, the notice of violation will be issued in conjunction with the elevated actions. Because the NRC wants to encourage and support licensee initiative for self-identification and correction of problems, NRC will not 19

generally issue a notice of violation for a violation that meets all of the following tests: (1) It was identified by the licensee; (2) It fits in Severity Level IV or V; (3) It was reported, if required; (4) It was or will be corrected, including measures to prevent recurrence, within a reasonable time; and (5) It was not a violation that could reasonably be ~xpect~d to have be~n prevented by the licensee's corrective action for a pre v i o u s _v i o l at i on. Licensees are not ordinarily cited for violations resulting from m~tters not within their control, such as equipment failures that were not avoidable by reasonable licensee quality assurance measures or management controls. Generally, however, licensees are held responsible for the acts of their employees. Accordingly, this policy should not be construed to excuse personnel errors. Enforce-ment actions involving ind1viduals, including licensed operators, will be determined on a case-by-case basis and must be approved by 20

the Director of the responsible Program Office.11 B. CIVIL PENAL TY A civil penalty is a monetary penalty that may be imposed for violation of (a) certain specified licensing provisions of the Atomic Energy Act or supplementary NRC rules or orders, (b) any requirement fo~ which a license may be revoked, or (c) reporting requirements under Section 206 of the-Energy Reorganization Act. Civil penalties are designed to emphasize the need for lasting remedial action and to deter future violations. Generally, civil penalties are imposed for Severity Level I violations, are imposed absent mitigating circuMstances for Severity Level II violations, are considered for Severity Level III violations, and may be imposed for Severity Level IV violations that are similar~/ to previous violations for which the licensee did not take effective corrective action. 11section 234 of the Atomic Energy Act gives,the Commission authority to impose civil penalties for violations on "any person. 11 "Person" is broadly defined in Section lls of the AEA to include individuals, a variety of organizations, and any representatives or agents. This gives the Co1T111ission authority to impose civil penalties on employees of licensees or on separate entities when - a violation of a requirement directly imposed on them is corrnnitted. ~/The word 11 similar, 11 as used in this policy, refers to those violations which could have been reasonably expected to have been ~revented by the licensee's corrective action for the previous violation. 21

In applying this guidance for Severity.Level IV violations, NRC nonnally considers civil penalties only for similar Severity Level IV violations that occur after the date of the last inspection or within two.years, whichever period is greater. Civil penalties will nonnally be assessed for knowing and conscious violations of the reporting requirements of Section 206 of the Energy Reorganization Act, and for any willful violation of any Corrmission requirement including those at any severity level. NRC' imposes different levels of penalties for different severity level violations and different classes of licensees. Tables IA and 18 show the base civil penalties for various reactor~ fuel cycle, and materials programs. The structure of these tables generally takes into account the gravity of the violation as a primary consi.deration and the ability to pay as a -secondary consideration. Generally, operations involving greater nuclear material inventories and greater potential consequences to the public and licensee employees receive higher civil penalties. Regarding the secondary factor of ability of various classes of licensees to pay the civil penalties, it is not the NRC's intention that the econ9mic impact of a civil penalty be such that it puts a licensee out of business (orders, rather than civil penalties, are used when the intent is to terminate licensed activities) or adversely affects a licensee's ability to safely conduct licensed activities. The deterrent effect of civil penalties is best served when the amounts of such penalties take into account a lfcensee's "ability to pay. 11 In determining the amounts of civil 22

penalties for licensees for whom the tables do not reflect the ability to pay, NRC will consider as necessary an increase or decrease on a case-by-case basis. NRC attaches great importance to comprehensive licensee programs for detection, correction, and reporting of problems that may constitute, or lead to, violation of regulatory requirements. This is emphasized by giving credit for effective licensee audit programs when licensees find, correct, and report problems expeditiously and effectively. To encourage licensee self-identification and correction of violations and to avoid potential concealment of problems of safety significance, application of the adjustment factors set forth below may result in no civil penalty being assessed for violations which are identified, reported (if required), and effectively corrected by the licensee. On the other hand, ineffective licensee programs for problem identification or correction are unacceptable. In cases involving willfulness, flagrant NRC-identified violations, repeated poor performance in an area of concern, or serious breakdown in management controls, NRC intends to apply its full enforcement authority where such action is warranted, including issuing appropriate orders and assessing civil penalties for continuing violations on a per day basis, up to the statutory limit of $100,000 per violation, per day. In this regard, while management involvement, direct or indirect, in a violation may lead to an increase in the civil penalty, the lack of such involvement may not be used to mitigate a civil penalty. 23

Allowance of mitigation could encourage lack of management involvement in licensed activities and a decrease in protection of the public health and safety. NRC reviews each proposed civil penalty case on its own merits and adjusts the base civil penalty values upward or downward appropriately. Tables lA and 18 identify the base civil penalty values for different severity levels, activity areas, and classes of licensees. After considering all relevant circumstances, adjustments to these values may be made for the factors described below:

1.

Prompt Identification and Reporting Reduction of up to 50% of the base civil penalty may be given when a licensee identifies the violation ar.c promptly reports the violation to the NRC. In weighing this factor, consider-ation will be given to, among other things, the length of time the violation existed prior to discovery, the opportunity available to discover the violation, the ease of discovery and the promptness and completeness of any required report. No consideration will be given to this factor if the licensee does not take immediate action to correct the problem upon discovery.

2.

Corrective Action to Prevent Recurrence Recognizing that corrective action is always required to meet regulatory requirements, the promptness and extent to which the licensee takes corrective action, including actions to prevent recurrence, may be considered in modifying the civil penalty to 24

be assessed. Unusually prompt and extensive corrective action may result in reducing the proposed civil penalty as much as 50% of the base value shown in Table 1. On the other hand, the civil penalty may be increased as much as 50% of the base value if initiation of corrective action is not prompt or if the corrective action is only minimally acceptable. In weighing this factor, consideration will be given to, among other things, the timeliness of the corrective action, degree of licensee initiative, and comprehensiveness of the corrective action--such as whether the action is focused narrowly to the specific violation or broadly to the general area of concern.

3.

Past Performance Reduction by as much as 100% of the base civil penalty shown in Table 1 may be given for prior good perfonnance in the general area of concern. On the other hand, the base civil penalty may be increased as much as 100% for prior poor performance in the general area of concern. In weighing this factor, consideration will be given to, among other things, the effectiveness of previous corrective action for similar problems, overall performance such as Systematic Assess-ment of Licensee Performance (SALP) evaluations for power reactors, and prior enforcement history including Severity Level IV and V violations in the area of concern. For example, failure to implement previous corrective action for prior similar problems may result in an increase in the civil penalty. 25

• 4.

Prior Notice of Similar Events

5.

The base civil penalty may be increased as much as 50% for cases where the licensee had prior knowledge of a problem as a result of a licensee audit, or specific NRC or industry notification, and had failed to take effective preventive steps. Multiple Occurrences The base civil penalty may be increased as much as 50% where multiple examples of a particular violation are identified during the inspection period. The above factors are additive. However, in no instance will a civil penalty for any one violation exceed $100,000 per day. The duration of a violation may also be considered in assessing a civil penalty. A greater civil penalty may be imposed if a violation continues for more than a day. For example: (1) If a licensee is aware of the existence of a condition which results in an ongoing violation and fails to initiate corrective action, each day the condition existed may be considered as a separate violation and, as such, subject to a separate additional civil penalty. (2) If a licensee is unaware of a condition resulting in a continuing violation, but clearly should have been aware of the 26

condition or had an opportunity to correct the condition but failed to do so, a separate violation and attendant civil penalty may be considered for each day that the licensee clearly should have been aware of the condition or had an opportunity to correct the condition, but failed to do so. (3) Alternatively, whether or not a licensee is aware or should have been aware of a violation that continues for more than one day, the civil penalty imposed for one violation may be increased to reflect the added significance resulting from the duration of the violation. The Tables and the mitigating factors determine the civil penalties which may be assessed for each violation. However, to focus on the fundamental underlying causes of a problem for which enforcement action appears to be warranted, the cumulative total for all violations which contributed to or were unavoidable consequences of that problem may be based on the amount shown in the table for a problem of that Severity Level, as adjusted. If an evaluation of such multiple violations shows that more than one fundamental problem is involved, each of which, if viewed independently, could lead to civil penalty action by itself, then separate civil penalties may be assessed for each such fundamental problem. In addition, the failure to make a required report of an event requiring such reporting is considered a separate problem and will normally be assessed a separate civil penalty, if the licensee is aware of the matter that should have been rep~rted. 27

-1 i J, ** TABLE lA BASE CI~IL Pt~ALTIES Transportation Plant Operations, Type A Const, Hea 1th Greater than Quantity Phtsics and EP Safeguards Ttee A Quantitt l/ or less '!:_/

a.

b.

c.

d.

e.

f.

g.

h.

i.

Power Reactors $100,000 $100,000 $100,000 $5,000 Test Reactors 10,000 10,000 10,000 2,000 Research Reactors & 5,000 5,000 5,000 1,000 Critical Facilities Fuel Fabricators 25,000 100,000 1/ 25,000 5,000 and Industrial Processors'}_/ Mills and Uranium 10,000 5,000 2,000 Conversion Facilities Industrial Users 10,ODO 5,000 2,000 of Material§_/ Waste Disposal 10,000 5,000 2,000 Licensees Academic or Medical 5,000 2,500 1,000 Institutions§_/ Other Material 1,000 2,500 1,000 Licensees Includes irradiated fuel, high level waste, unirradiated fissile material, and any other quantities requiring Type B packaging. Includes low specific activity waste (LSA), low level waste, Type A packages, and excepted quantities and articles. '}_/ Large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material. 1/ This amount refers to Category 1 licensees (as defined in 10 CFR 73.2 (bb)). Licensed fuel fabricators not authorized to possess Category 1 material have a base penalty amount of $50,000. §_/ Includes industrial radiographers, nuclear pharmacies, and other industrial users. §_/ This applies to nonprofit institutions not otherwise categorized under sections "a" through 11g 11 in this table. 28

SEVERITY LEVEL I II I II IV V TABLE 1B BASE CIVIL PENALTIES BASE CIVIL PENALTY AMOUNT (% of Amount Listed in Table lA) 29 100% 80% 50% 15% 5%

C. ORDERS An order is a written NRC direc ive to modify, suspend, or revoke a license; to cease and desist frlm a given practice or activity; or to take such other action as may be proper (see 10 CFR 2.202 and 2.204). Orders may be issued as set for!h below. Orders may also be issued in lieu of, or in addition to, ivil penalties, as appropriate. (1) License Modification Order are issued when some change in licensee equipment, proced res, or management controls is necessary. (2) Suspension Orders may be u ed: (a) To remove a threat to the public health and safety, common defense and security, or the environment; (b) To stop facility cons1 ruction when (i) further work could preclude or significartly hinder the identification or correction of an improperly constructed safety-related system or component, lr (ii) the licensee 1s quality assurance program imdlementation is not adequate to provide confidence that consJruction activities*are being properly carried out; 30

(c) When the licensee has not responded adequately to other enforcement action; ' (d) When the licensee interferes with the conduct of an inspec-tion or investigation; or (e) For any reason not mentioned above for which license revocation is legally authorized. Suspensions may apply to all or part of the licensed activity. Ordinarily, a licensed activity is not suspended (nor is a suspension prolonged) for failure to comply with requirements where such failure is not willful and adequate corrective action has been taken. (3) Revocation Orders may be used: (a) When a licensee is unable or unwilling to comply with NRC requirements, (b) When a licensee refuses to correct a violation, (c) When a licensee does not respond to a notice of violation where a response was.required, (d) When a licensee refuses to pay a fee required by 10 CFR Part 170, or 31

I I ** (e) For any other reason for which revocation is authorized under Section 186 of the Atomic Energy Act (e.g., any condition which would warrant refusal of a license on an original application). (4) Cease and Des.1st Orders are typically used to stop an unauthorized activity that has continued after notification by NRC that such activity is unauthorized. Orders are made effective irm,ediately, without prior opportunity for hearing, whenever it is detennined that the public health, interest, or safety so requires, or when the order is responding to a violation involving willfulness. Otherwise, a prior opportunity for a hearing on the order is afforded. For cases in which the NRC*believes a basis could reasonably exist for not taking the action as proposed, the licensee will ordinarily be afforded an opportunity to show cause why the order should not be issued in the proposed manner. D. ESCALATION OF ENFORCEMENT SANCTIONS NRC considers violations of Severity Levels I, II, or III to be serious. If serious violations occur, NRC will, where necessary, issue orders in conjunction with civil penalties to achieve immediate corrective actions and to deter further recurrence of serious violations. NRC carefully considers the circumstances of each case in selecting and applying the sanction(s) appropriate to the case in accordance with the criteria described in Sections V.B and V.C, above. 32

Examples of enforcement actions that could be taken for similar Severity Level I, II, or III violations are set forth in Table 2. The actual progression to be used in a particular case will depend on the circumstances. However, enforcement sanctions will nonnally escalate for recurring similar violations. Nonnally the progression of enforcement actions for similar violations will be based on violations under a single license. When more than one facility is covered by a single license, the nonnal progression will be based on similar violations at an individual facility and not on similar violations under the same license. However, it should be noted that under some circumstances, e.g., where there is corranon control over some facet of facility operations, similar violations may be charged even though the second violation occurred at a different facility or under a different license. For example, a physical security violation at Unit? of a dual unit plant that repeats an earlier violation at Unit 1 might be considered similar. 33

TABLE 2 EXAMPLES OF PROGRESSION OF ESCALATED ENFORCEMENT ACTIONS FOR SIMILAR VIOLATIONS IN THE SAME ACTIVITY AREA UNDER THE SAME LICENSE Number of similar violations from the date Severity of Violation of the last inspection or within the previous t~o years (whichever period is greater) I II III

a.

Civil penalty 1st a+b a 2nd a+b+c a+b a 3rd d a+b+c a+b

b.

Suspension of affected operations until the Office Director is satis-~ fied that there is reasonable assurance that the licensee can operate in compliance with the applicable requirements; or modification of the license, as appropriate.

c.

Show cause for modification or revocation of the license, as appro-priate.

d.

Further action, as appropriate. 34

E. RELATED ADMINISTRATIVE ACTIONS In addition to the formal enforcement mechanisms of notices of viola-tion, civil penalties, and orders, NRC also uses administrative mechanisms, such as bulletins, circulars, information notices, generic letters, notices of deviation, notices of nonconformance and confirmatory action letters to supplement its enforcement program. NRC expects licensees and vendors to adhere to any obligations and commitments resulting from these processes and will not hesitate to issue appropriate orders to licensees to make sure that such corrrnitments are met. (1) Bul]etins, Circulars, Information Notices and Generic Letters are written notifications to groups of licensees identifying specific problems and recoIT1Tiending specific actions. (2) Notices of Deviation are written notices describing a licensee's failure to satisfy a commitment where the commitment involved has not been made a legally binding requirement. A notice of deviation requests a licensee to provide a written explanation or statement describing corrective steps taken (or planned), the results achieved, and the date when corrective action will be completed. (3) Confirmatory Action Letters are letters confirming a licensee's or a vendor 1s agreement to take certain actions to remove significant concerns about health and safety, safeguards, or the environment. 35

(4) Notices of Nonconformance are \\tlritten notices describing non-licensees' failures to meet corrmitments which have not been made legally binding requirements by _NRC. An example is a corrnnitment made in a procurement contract with a licensee as required by 10 CFR Part 50, Appendix B. Notices of Nonconformances request non-licensees to provide written explanations or statements describing corrective steps (taken or planned), the results achieved, the dates when corrective actions will be completed, and measures taken to preclude recurrence. F. REFERRALS TO DEPARTMENT OF JUSTICE Alleged or suspected criminal violations of the Atomic Energy Act (ar:id of other relevant Federal laws) are referred to the Department of Justice for investigation. Referral to the Department of Justice does not preclude the NRC from taking other enforcement action under this General Statement of Policy. However, such actions will be coordinated with the Department of Justice to the extent practicable. VI. PUBLIC DISCLOSURE OF ENFORCEMENT ACTIONS In accordance with 10 CFR 2.790, all enforcement actions and licensees* responses are publicly available for inspection. In addition, press releases are generally issued for civil penalties and orders. In the case of orders and civil penalties related to violations at Severity Levels I, II, or III, press releases are issued at the time of the order or the proposed imposition of the civil penalty. Press releases are.not normally issued for Notices of Violation. 36

VII. RESPONSIBILITIES The Director, Office of Inspection and Enforcement, as the principal enforcement officer of the NRC, has been delegated the authority to issue notices of violations, civil penalties, and orders.~/ Regional Administrators may also issue notices of violation for Severity Level IV and V violations and may sign notices of violation for Severity Level III violations with no proposed civil penalty and proposed civil penalty actions with the concurrence of the Director, IE. In recognition that the regulation of nuclear activities in many cases does not lend itself to a mechanistic treatment, the Director, IE or the Regional Administrator must exercise judgment and discretion in determining the severity levels of the violations and the appropriate enforcement sanctions, including the decision to impose a civil penalty and the amount of such penalty, after considering the general principles of this statement of policy and the technical significance of the violations and the surrounding circumstances. The Commission will be provided written notification of all enforcement actions involving civil penalties or orders. The Commission will be consulted prior to takifig enforcement action in the following situations (unless the urgency of the situation dictates immediate action): ~/The Directors of the Officef of Nuclear Reactor Regulation and Nuclear Material Safety and Safeguards have also been delegated similar authority, but it is expected that normal use of this authority by NRR ar.d NMSS will be confined to actions necessary in the interest of public health and safety. The Director, Office of Administration, has been delegated the authority to issue orders where -licensees violate Conmission regulations by nonpayment of license fees. It is planned to consider redelegation of some or all of these authorities to the Administrators of the NRC Regional Offices over the next several years. 37

(1) An action affecting a licensee 1s operation that requires balancing the public health and safety or comnon defense and security impli-cations of not operating with the potential radiological or other hazards associated with continued operation. (2) Proposals to impose civil penal~ies in amounts greater than 3 times the Severity Level I values shown in Table lA; (3) Any proposed enforcement action that inv.olves a Severity Level I violation; (4) Any enforcement action that involves a finding of a material false statement; (5) Any action the Office Director believes warrants Commission involve-ment; or (6) Any proposed enforcement action on which the Co1TJTiission asks to be consulted.. VIII. VENDOR ENFORCEMENT The Corrmission 1s enforcement policy is also applicable to non-licensees (vendors). Vendors of products or services provided for use in nuclear activities are subject to certain requirements designed to ensure that the products or services supplied that could affect safety are of high quality. Through procurement contracts with reactor licensees, vendors are required to have quality assurance programs that meet applicable 38

requirements including 10 CFR Part sot Appendix Bt and 10 CFR Part 71, Subpart H. Vendors of reactor and materials licensees and Part 71 licensees are subject to the requirements of 10 CFR Part 21 regarding reporting of defects in basic components. The NRC conducts inspections of reactor licensees to determine whether they are ensuring that vendors are meeting their contractual obligations with regard to quality of products or services that could have an adverse effect on safety. As part of the effort of ensuring that licensees fulfill their obligations in this regard, the NRC inspects reactor vendors to determine if they are meeting their obligations. These inspections include examination of the quality assurance programs and their implementation by the vendors through examination of product quality. The NRC may also inspect vendors, including suppliers of Part 71 and materials licensees, to determine whether they are complying with Part 21. When inspections determine that violations of NRC requirements have occurred, or that vendors have failed to fulfill contractual commitments that could adversely affect the quality of a safety significant product or service, enforcement action will be taken. Notices of Violatio~ and civil penalties will be used, as appropriate, for licensee failures to ensure that their vendors have programs that meet applicable requirements including Part 21. Notices of Violation will be issued for vendors which violate Part 21. Civil penalties will only be imposed against individual directors or responsible officers of a vendor organization who knowingly and consciously fail to provide the notice required by 10 CFR 21.2l(b)(l). Notices of NonconfonTiance will be used for vendors which fail to meet commitments related to NRC activities. 39

SUPPLEMENT I - SEVERITY CATEGORIES REACTOR OPERATIONS A. Severity I - Violations involving for example:

1.

A Safety Limit, as defined in 10 CFR 50.36 and the Technical Specifi-cations, being exceeded;

2.

A syste~/ designed to prevent or mitigate a serious safety event not being able to perform its intended safety functionZ/ when actually called upon to work;

3.

An accidental criticality; or

4.

Release of radioactivity offsite greater than ten (10) times the Technical Specifications limit.~/ .§/ 11system 11 as used in these supplements, includes administrative and managerial control systems, as well as physical systems. Z/ 11 Intended safety function" means the total safety function, and is not directed toward a loss of redundancy. For example, considering a BWR 1s high pressure ECCS capability, the violation must result in complete invalidation of both HPCI and ADS subsystems. A loss of one subsystem does not defeat the intended safety function as long as the other subsystem is operable. ~/The Technical Specification limit as used in this Supplement (Items A.4, 8.2 and C.5) does not apply to the instantaneous release limit. 40

B. Severity II - Violations involving for example: C.

1.

A system designed to prevent or mitigate serious safety events not being ~able to perfonn its intended safety function; or

2.

Release of radioactivity offsite greater than five (5) times the Technical Specifications limit. Severity III - Violations involving for example:

1.

A significant violation of a Technical Specification Limiting Condition for Operation where the appropriate Action Statement was not satisfied within the time allotted by the Action Statement, such as:

a. In a pressurized water reactor, in the applicable modes, having one high-pressure safety injection pump inoperable for a period in excess of that allowed by the action statement; or

b. In a boiling water reactor, one primary containment isolation valve inoperable for a period in excess of that allowed by the action statement.

2.

A system designed to prevent or mitigate a serious safety event not being able to perform its intended function under certain conditions (e.g., safety system not operable unless offsite power is available; materials or components not environmentally qualified); 41

3.

Dereliction of duty on the part of personnel involved in licensed activities;

4.

Changes in reactor parameters which cause unanticipated reductions in margins of safety;

5.

Release of radioactivity offsite greater than the Technical Specifications limit;

6.

Failure to meet the requirements of 10 CFR 50.59 such that a required license amendment was not sought; or

7.

Licensee failure to conduct adequate oversight of vendors resulting in the use of products or services which are of defective or indeterminate quality and which have safety significance. D. Severity IV - Violations involving for example:

1. A less significant violation of a Technical Specification Limiting Condition for Operation where the appropriate Action Statement was not satisfied within the time alloted by the Action Statement, such as:

a. In a pressurized water reactor, a 5% deficiency in the required volume of the condensate storage tank; or

b. In a boiling water reactor, one subsystem of the two independent MSIV leakage control subsystems inoperable.

42

2. Failure to meet the requirements of 10 CFR 50.59 that does not result in a Severity Level I, II, or III violation;

3. Failure to meet regulatory requirements that have more than minor safety or environmental significance; or

4. Failure to make a required Licensee Event Report.

E. Severity Level V - Violations that have minor safety or environmental significance. SUPPLEMENT II - SEVERITY CATEGORIES PART 50 FACILITY CONSTRUCTION A. Severity I - Violations involving a structure or system that is completeJ/ in such a manner that it would not have satisfied its intended safety related purpose. B. Severity II - Violations involving for example:

1.

A breakdown in the quality assurance program as exemplified by deficiencies in construction QA related to more than one work activity (e.g., structural, piping, electrical, foundations). Such ~111completed 11 means completion of construction including review and acceptance by the construction QA organization. 43

c.

deficiencies normally involve the licensee's failure to conduct adequate audits or to take prompt corrective action on the basis of such audits and normally involve multiple examples of deficient construction or construction of unknown quality due to inadequate program implementation; or

2.

A structure or system that is completed in such a manner that it could have an adverse effect on the safety of operations. Severity III - Violations involving for example:

1.

A deficiency in a licensee quality assurance program for construction related to a single work activity (e.g., structural, piping, elec-trical or foundations). Such significant deficiency normally involves the licensee's failure to conduct adequate audits or to take prompt corrective action on the basis of suer audits, and normally involves multiple examples of deficient construction or construction of unknown quality due to inadequate program implementation;

2.

Failure to confirm the design safety requirements of a structure or system as a result of inadequate preoperational test program implementation; or

3.

Failure to make a required 10 CFR 50.55(e) report. D. Severity IV - Violations involving failure to meet regulatory requirements including one or more Quality Assurance Criterion not amounting to Severity Level I, II, or III violations that have more than minor safety or environmental significance.

E-. Severity V - Violations that have minor safety or environmental significance. SUPPLEMENT III - SEVERITY CATEGORIES SAFEGUARDS A. Severity I - Violations involving for example:

1.

An act of radiological sabotage or actual theft, loss, or diversion of a fonnula quantity of strategic special nuclear materiar101 (SSNM);

2.

Actual entry of an unauthorized individual into a vital area or material access area from outside the protected area (i.e., penetration of both barriers) that was not detected at the time of entry; or

3.

Failure to promptly report knowledge of an actual or attempted theft or diversion of SSNM or an act of radiological sabotage. B. Severity II - Violations involving for example:

1.

Actual theft, loss or diversion of special nuclear material (SNM) of moderate strategic significance;.!1/ lO/See 10 CFR 73.2(bb) .!.!1see 10 CFR 73.2(x) 45

2.

Failure to control access such that all three elements of access control (barrier, monitoring, and res.ponse) at the protected area or vital area.are inadequate or two of three elements are inadequate in both the protected and vital area;

3.

Failure to implement approved compensatory measures when the central and secondary alann stations are inoperable; 4. Failure to establish or maintain safeguards systems designed or used to_ prevent or detect the unauthorized removal of a fonnula quantity of SNM from areas of authorized use or storage; or

5.

Failure to use established transportation security systems designed or used to prevent the theft, loss, or diversion of a fonnula quantity of SNM or acts of radiological sabotage. C. Severity III - Violations involving for example:

1.

Failure to control access such that two of the three elements of access control at the vital area or protected area barrier are inadequate;

2.

Failure to control access to a transport vehicle or the SNM being transported that does not constitute a Severity I or II violation;

3.

Failure to establish or maintain safeguards ~ystems designed or used to prevent or detect the unauthorized removal of SNM of moderate strategic significance from areas of authorized use or storage; 46

4.

Failure to implement approved compensatory measures when the central (or secondary) alarm station is inoperable;

5.

Failure to conduct a proper search at the access control point that results in introduction to the site of firearms, explosives, incendiary devices, or other items which could be used for industrial sabotage; or

6.

Failure to properly secure or protect classified or other sensitive safeguards information which would significantly assist an individual in an act of radiological sabotage or theft of special nuclear material. D. Severity IV - Violations involving for example:

1.

Failure to establish or maintain safeguards systems designed or used to prevent or detect the unauthorized removal of SNM of low strategic significance ]1/ from areas of authorized use or storage;

2.

Failure to implement 10 CFR Parts 25 and 95 and information addressed under Section 142 of the Act, and the NRC approved security plan relevant to those parts;

3.

Failure to control access to a vital area or material access area from inside the protected area or failure to control access to the protected area in that one of the three elements of access control is inadequate; 111see 10 CFR 73.2(y) 47

E.

4.

Failure to properly secure or protect classified or other sensitive safeguards information which would not significantly assist an indi-vidual in an act of raciological sabotage or theft of special nuclear material; or

5.

Other violations, such as failure to follow an approved security plan, that have more than minor safeguards significance. Severity V - Violations that have minor safeguards significance. SUPPLEMENT IV - SEVERITY CATEGORIES HEALTH PHYSICS 10 CFR PART 2011/ A. Severity I - Violations involving for example:

2.

Single exposure of a worker in excess of 25 rems of radiation to the whole body, 150 rems to the skin of the whole body, or 375 rems to the feet, ankles, hands, or forearms; Annual whole body exposure of a member of the public in excess of 2.5 rems of radiation;

3.

Release of radioactive material to an unrestricted area in excess of ten times the limits of 10 CFR 20.106; 131Personnel overexposures and associated violations, incurred during a life saving effort, will be treated on a case~by-case basis. 48

4.

Disposal of licensed material in quantities er concentrations in excess of ten times the limits of 10 CFR 20.303; or

5.

Exposure of a worker in restricted areas of ten times the limits of 10 CFR 20.103. B. Severity II - Violations involving for example:

1.

Single exposure of a worker in excess of 5 rems of radiation to the whole body, 30 rems to the skin of the whole body, or 75 rems to the feet, ankles, hands or forearms;

2.

Annual whole body exposure of a member of the public in excess of 0.5 rems of radiation;

3.

Release of radioactive material to an unrestricted area in excess of five times the limits of 10 CFR 20.106;

4.

Failure to make an immediate notification as required by 10 CFR 20.403(a)(l) and 10 CFR 20.403(a)(2);

5.

Disposal of licensed material in quantities or concentrations in excess of five times the limits of 10 CFR 20.303; or

6.

Exposure of a worker in restricted areas in excess of five times the limits of 10 CFR 20.103. 49

C. Severity III - Violations involving for example:

1.

Single exposure of a worker in excess of 3 rems of radiation to the whole body, 7.5 rems to the skin of the whole body, or 18.75 rems to the feet, ankles, hands or forearms; 2.. A radiation level in an unrestricted area such that an individual could receive greater than 100 millirem in a one hour period or 500 millirem in any seven consecutive days;

3.

4.

5.

Failure to make a 24-hour notification as required by 10 CFR 20.403(b) or an immediate notification required by 10 CFR 20.402(a); Substantial potential for an exposure or release in excess of 10 CFR 20 whether or not such exposure or release occurs (e.g., entry into high radiation areas, such as under reactor vessels or in the vicinity of exposed radiographic sources, without having performed an adequate survey, operation of a radiation facility with a nonfunctioning interlock system); Release of radioactive material to an unrestricted area in excess of the limits of 10 CFR 20.106;

6.

Improper disposal of licensed material not covered in Severity Levels I or II;

7.

Exposure of a worker in restricted areas in excess of the limits of 10 CFR 20.103; 50

8.

Release for unrestricted use of contaminated or radioactive material or equipment which poses a realistic potential for significant exposure to members of the public, or which reflects a programmatic (rather than isolated) weakness in the radiation control program;

9.

Cumulative worker exposure above regulatory limits when such cumu-lative exposure reflects a prograrrmatic, rather than an isolated weakness in radiation protection;

10.

Conduct of licensee activities by a technically unqualified person; or

11.

Significant failure to control.licensed material. D. Severity IV - Violations involving for example:

1.

2.

Exposures in excess of the limits of 10 CFR 20.101 not constituting Severity Level I, II, or III violations; A radiation level in an unrestricted area such that an individual could receive greater than 2 millirem in a one-hour period or 100 millirem in any seven consecutive days;

3.

Failure to make a 30-day notification required by io CFR 20.405;

4.

Failure to make a followup written report as required by 10 CFR 20.402(b), 20.408, and 20.409; or 51

5.

Any other matter that has more than minor safety or environmental significance. E. Severity V - Violations that have minor safety or environmental signif-icance. SUPPLEMENT V - SEVERITY CATEGORIES TRANSPORTATIO~/ A. Severity I - Violations of NRC transportation requirements involving for example.:

1.

Annual whole body radiation exposure of a member of the public in excess of 0.5 rems of radiation; or

2.

Breach of package integrity resulting in surface contamination or external radiation levels in excess of ten times the NRC limits. 141some transportation requirements are applied to more than one licensee involved in the same activity such as a shipper (10 CFR 73.20) and a carrier (10 CFR 70.20a). When a violation of such a requirement occurs, enforcement action will be directed against the responsible licensee which, under the circumstances of the ca*se, may be one or more of the licensees involved. 52

B. Severity II - Violations of NRC transportation requirements involving for example:

1.

Breach of package integrity resulting in surface contamination or external radiation levels in excess of NRC requirements;

2.

Surface contamination or external radiation levels in excess of five times NRC limits that did not result from a breach of package integrity; or

3.

Failure to make required initial notifications associated with Severity Level I or II violations. C. Severity III - Violations of NRC transportation requirements involving for example:

1.

Breach of package integrity;

2.

Surface contamination or external radiation levels in excess of, but less than a factor of five above NRC requirements, that did not result from a breach of package integrity;

3.

Any noncompliance with labelling, placarding, shipping paper, packaging, loading, or other requirements that could reasonably result in the fo 11 owing: 53

4.

a.

Improper identification of the type, quantity, or form of material;

b.

Failure of the carrier or recipient to exercise adequate controls; or

c.

Substantial potential for personnel exposure or contamination, or improper transfer of material; or Failure to make required initial notification associated with Severity Level III violations. D. Severity IV - Violations of NRC transportation requirements involving for example:

1.

Package selection or preparation requirements which do not result in a breach of package integrity or surface contamination or external radiation levels in excess of NRC requirements; or

2.

Other violations that have more than minor safety or environmental significance. E. Severity V - Violations that have minor safety or environmental significance. 54

SUPPLEMENT VI - SEVERITY CATEGORIES FUEL CYCLE AND MATERIALS OPERATIONS A. Severity I - Violations involving for example:

1.

Radiation levels, contamination levels, or releases that exceed ten times the limits specified in the license;

2.

~ system designed to prevent or mitigate a serious safety event not being operable when actually required to perform its design function; or

3.

A nuclear criticality accident. B. Severity II - Violations involving for example:

1.

Radiation levels, contamination levels, or releases that exceed five times the limits specified in the license; or

2.

A system designed to prevent or mitigate a serious safety event being i noperab 1 e. C. Severity III - Violations involving for example:

1.

Failure to control access to licensed materials for radiation purposes as specified by NRC requirements; 55

2.

Possession or use of unauthorized equipment or materials in the conduct of licensee activities which degrades safety;

3.

Use of radioactive material on humans where such use is not authorized;

4.

Conduct of licensed activities by a technically unqualified person; 5. Radiation levels, contamination levels, or releases that exceed the limits specified in the license; or

6.

Medical therapeutic misadministrations. D. Severity IV - Violations involving for example:

1.

Failure to maintain patients hospitalized who have cobalt-60, cesium-137, or iridium-192 implants or to conduct required leakage or contamination tests, or to use properly calibrated equipment;

2.

Other violations that have more than minor safety or environmental significance; or

3.

Failure to report medical diagnostic misadministrations. E. Severity V - Violations that have minor safety or environmental significance. 56

SUPPLEMENT VII - SEVERITY CATEGORIES MISCELLANEOUS MATTERS A. Severity I - Violations involving for example: ( B.

1.

A Material False Statement (MFS).1§_/ in which the statement made was deliberately false; 2

• Falsification of records which NRC requires be kept of significant information in which the records were deliberately falsified by or with the knowledge of management;

3.

A knowing and intentional failure to provide the notice required by _ Part 21; or

4.

Action by senior corporate management in violation of Section 210 of the ERA against an employee. Severity II - Violations involving for example:

1.

A MFS or a reporting failure, involving information which, had it been available to the NRC and accurate at the time the information 1.§_/In essence, a Material False Statement is a statement that is false by omission or co0111ission and is relevart to the regulatory process. As can be seen in the examples, in determining the specific severity level of a violation involving material false statements or falsification of records, consideration will be given to such factors as the position of the person involved in the violation (e.g., first line supervisor or senior manager), the significance of the information involved, and the intent of the violator (i.e., negligence not amounting to careless disregard, careless disregard, or deliberateness). The relative weight given to each of these factors in arriving at the appropriate severity level will be dependent on the circumstances of the violation. 57

should have been submitted, would have resulted in regulatory action or would likely have resulted in NRC seeking further information;

2.

A MFS in which the false statement was made with careless disregard;

3.

Deliberate falsification of records which NRC requires be kept involving significant information;

4.

Action by plant management above first-line supervision in violation of section 210 of the ERA against an employee; or

5.

A failure to provide the notice required by Part 21. C. Severity III - Violations involving for example:

1.

A MFS not amounting to a Severity Level I or II violation.

2.

Deliberate falsification, or falsification by or with the knowledge of management, of records which the NRC requires be kept that did not involve significant information.

3.

Action by first-line supervision in violation of section 210 of the ERA against an employee; or

4.

Inadequate review or failure to review such that, if an appropriate review had been made as required, a Part 21 report would have been made. 58

D. Severity IV - Violations involving for example:

1.

Inadequate review or failure to review under Part 21 or other procedural violations associated with Part 21 with more than minor safety significance;

2.

A false statement caused by an inadvertant clerical or similar error involving information which, had it been available to NRC and accurate at the time the information should have been submitted, would probably not have resulted in regulatory action or NRC seeking additional information; or E. Severity V - Violations of minor procedural requirements of Part 21. SUPPLEMENT VIII - SEVERITY CATEGORIES EMERGENCY PREPAREDNESS A. Severity I - Violations involving for example: In a general emergency, licensee failure to promptly (1) correctly classify the event, (2) make required notifications to responsible Federal, State, and local agencies, or (3) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift staff). B. Severity II - Violations involving for example: 59

' i C,, I

1.

In a site area emergency, licensee failure to promptly (1) correctly classify the event, (2) make required notifications to responsible Federal, State, and local agencies, or (3) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift staff); or

2.

Licensee failure to meet or implement more than one emergency planning standard involving assessment or notification. Severity Ill - Violations involving for example:

1.

In an alert, licensee failure to promptly (1) correctly classify the __ event, (2) make required notifications to responsible Federal, State, and local agencies, or (3) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response faci-lities, and augment shift staff); or

2.

Licensee failure to meet or implement one emergency planning standard involving assessment or notification. D. Severity IV - Violations involving for example: 60

Licensee failure to meet or implement any emergency planning standard or requirement not directly related to assessment and notification. E. Severity V - Violations that have minor safety or environmental significance. +h 'n Dated at Washington, D.C., this ;4 day of, ( (}1/'-". 1985. For the Nuclear Regulatory Commission. Secretary of the Corrmission. 61}}