ML20205B858

Proposed Rule 10CFR2, Policy & Procedure for Enforcement Actions;Policy Statement

ML20205B858
Person / Time
Issue date:	10/06/1988
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:
References
FRN-53FR40293, RULE-PR-2 PR-881006, NUDOCS 8810260332
Download: ML20205B858 (84)

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14UCLEAR REGULATORY COMMIS$10N 10 CFR Part 2 '88 OCT 13 P2 :45

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Policy and Procedure for Enforcement Actions; Policy Statenent i

• DOC"EI : '."'3ER ng PR0c inu : tut.E b J AGENCY: Nuclear Regulatory Connission. 9 ACTION: Policy statement: Revision.

SUMMARY

The NRC is publishing revisions to its Enforcement Policy (1) to provide for greater discretion in deternining whether to issue a civil penalty for certain licensee-identifica and-corrected violations; (2) to provide for highar civil penalties for NRC-identified violations, licensee's failures to take action in response to prior notice of concerns at any of its f acilities.

and rnultiple examples of significant violations; (3', to clarify the assessment factors for corrective action, past performance, and duration; (4) to tradify the severity level examples involving violaticns of 10 CFR 50.59 and rnedical misadninistrations; (5) to revise the Transportation and Safeguards supplements; and (6) to nake minor deletions and language changes. The Enforcement Policy staterent is intended to inform licensees, vendors, and the public of the bases for taking various enforcement actions. The policy is codified as Appendix C to 10 CFR Part 2.

(upon publication DATES: This revised statement of policy is effective _in Fed. Reg.) , Iggg while cernments on the changes are being received.  ! abmit ccmments on or i before (60 Days) , 1988.

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ADDRESSEES: Send comments to: Secretary, U.S. Nuclear Regulatory Connission, Washington, DC 20555. ATTN: Docketing and Service Branch.

Hand deliver connents to: Or.e White Flint North,11555 Rockville Pike, Rockville, MD between 7:45 a.m. to 4:15 p.m.

Connents may also be delivered to the NRC Pubite Docurent Room, 2120 L Street, NW between 7:45 a.m. and 4: 15 p.m.

Copies of connents may be examined at the NRC Public Document Room, 2120 L Street,fN., Washington, DC.

FOR FURTHER INFORMATION CONTACT: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555 (301-492-0741).

SUPPLEMENTAkY INFORMATION:

Background:

.The Coiunission's Enforcement Policy wks first issued on September 4,1980.

Since that tik.e the Enforcement Policy has been rrtised on a number of occasions, l

most recently on March 23, 1988 (53 FR 9429). Based on additional experience, the Comission has determineo that it is appropriate to r.ake additional changes in its Policy and Procedure for Enforcement Actions. The primary changes being rade involve providing greater incentives for licensees to identify and correct violations by decreasing civil penalties for certain of those violations

and increasing civil penalties where the licensee fails to identify, prevent, 7

or correct violaticiis, and revising the Transportation and Safeguards supplements of. the Enforcement Policy. The Enforcement Policy is codified in 10 CFR Part 2, Appendix C of the Commission's regulations to provide widespread dissemination of this policy. However, the Enforcement Policy is a policy statement and not

[ a regulation. The Commission may accordingly deviate from the Enforcement Policy as is appropriate under the circumstar ;es of a particular case. A similar statement is being added to the Enforcement Policy to avoid any implicatiens that codification of the Policy in the Code of Federal Regulations indicates that the Commission inter.4 that the Enforcement Policy is a binding regulation.

Revisions to the Enforcement Policy Revisions to the policy new being made are described in the following e

paragraphs. Only the sections to which changes were made are discussed here.

The numbering of the sections tracks the section numbers in the policy.

V.A. 110TICE OF VIOLATION This section has been changed to provide the staff with the flexibility e not to issue a Notice of Violation for inspection findings which involve

, isolated violations at a Severity Level V. Such violations are by definition of minor regulatory concern. Cocumentation of the violation i., an inspection report or official field notes is sufficient provided corrective action is q uncerway before the inspection endt. "Official field notes" are an alternative to inspection reports used in the matarials program for smaller 3

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1 licensees. Given the minor concern with such violations, a formal reply frodalicenseeisnotneedednorisexpenditureofagencyresourcesto prepare a Notice of Violation normally warranted. A Notice of Violation may be. issued if the violation was willful, if past corrective actions have not been sufficient, or if the circumstances warrant increasing the  ;

severity of Level V violations to a higher severity level.

V.B CIVIL PENALTY

1. EXERCISE OF DISCRETION (SECTION V.G)

The current policy in Section V.B. provides that civil penalties are imposed, absent mitigating circumstances, for Severity Level I and II violations but are considered for Severity Level III violations.

Section VIII, Responsibilities, provides that the staff has the discretion as to whether or not it should propose a civil penalty after considering the principles in the Enforcement Policy, the technical significance of the violations, and the surrounding circumstances.

Thus, the policy as written provides the staff with discretion as to  ;

whether or not to propose a civil penalty for a violation at'a Severity Level III. However, the NRC practice has been that civil penalties are issued for Severity Level III violations absent mitigating circum-stances. The staff may, under appropriate circumstances, classify a violation at a Severity Level IV even if the supplements provide a similar example at a Severity Level III based on the significance and circumstances of the violation because the examples in the supplements are by the policy, examples and not controlling. However, once the 4

1 determination is made that a violation should be categorized at a Severity Level III, the violation is of significant regulatory concern, and a civil penalty is proposed absent mitigating circumstances unless the staff seeks Commission approval not to issue a penalty.

There are three Severity Level III situations where it may not be appropriate to issue civil penalties in the interest of encouraging licensee identification, reporting, and correction of violations and minimizing the potential to provide disincentives for licensees to identify and correct violations. Accordingly, the policy has been changed in Sections V.B. and V.G. to provide three additional examples for exercising discretion in not proposing civil penalties. This should increase incentives for a licensee to scrutinize its operations at its own initief 1 The first example involves licensee identified and corrected violations where the violation was (1) not reasonably preventable by licensee action in response to a previous regulatory concern or prior notice of i

a problem within two years of the it,spection or since the last two inspections, (2) not willful, and (3) not representative of a breakdown l

in management controls.

, This change is intended to avoid penalizing a licensee whose current performance is consistent with the object 1ves of the policy, i.e., identifying, reporting, and correcting violations.

Under this provision the staff may exercise discretion and not propose a civil penalty for a Severity Level III violation even if the violation '

l existed for an extended duration. This provision would not be used for Severity Level I!! violations involving release of radioactive material i

or overexposures in excess of. regulatory limits because of the significance of such failures, l -

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The second example involves past violations that are not likely to be identified during routine surveillance or QA activities of a licensee.

Many licensees have or are embarking on major voluntary efforts to review past activities. From a safety perspective clearly there are benefits for both a 'icensee and the public to have past problems such as those involving engineering, design, or installation iden;ified, reported and corrected before a system with deficiencies is called upon to operate. In these cases discretion could be exercised regardless of prior notice, past performance, or duration tn avoid disincentives for a licensee who is aggressively pursuing a formal program to identify and correct past problems. If a licensee's program identifies Severity Level III violations, the staff would not intend to subsequently exercise further discretion for similar violations later identified unless the licensee's program is being accelerated to provide assurance that similar significant 1. sues do not exist.

The third example involves additional occurrences of a violation for which enforcement action has baen taken. This change is to encourage a licensee, as part of corrective actions, to locate additional violations with the same root cause without the concern that it may be penalized if it identifies additional violations, reports, and corrects them. In applying this example, the staff will consider the reasonableness of the licensee's action, the timeliness of the action, and whether the later violations change the safety signiff-cance or character of the initial regulatory concern.

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These examples are, as indicated, examples of where discretion may be exercised. Whether or not to exercise the discretion is dependent on the circumstances of the particular case.

In addition to the three additional examples of discretion being provided, the Deputy Executive Director for Regional Operations' authority to not issue a civil penalty, as stated in Section VII of the Policy, based on the merits of the case is restated in this section. This discretion is expected to be used only where application of the guidance in the policy is unwarranted and requires advance notice to the Commission.

2. Mitigating and Escalating Factors

a. Identification and Reporting This factor is being retitled and changed to permit a penalty to be increased if flRC identifies a violation. This is designed to provide an additional incentive for licensees to identify violations. Given the number of licensees' employees and the limited number of flRC inspectors, Severity Level I, II, or III violations should be identified first by licensees and, therefore, flRC should not be.

identifying significant violations. Thus, it is appropriate to increase a penalty if fiRC identifies the violation. This factor has also been changed to delete the refer = ce to the length of time the violation occurred because that is considered under the duration factor. The issue under this factor is whether a licensee should have reasonably identified the violation earlier.

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b. Corrective Action This factor is being changed to delete the term "unusually." In the past, the policy has been applied to require corrective action to not only be prompt and extensive but to be unusually so before a full 50% mitigation is allowed for corrective action. In some cases there is nothing unusual about the corrective action even though-it is clear that prompt and extensive corrective action was taken.

This clarification is intended to provide the discretion for 50%

mitigation when quality action is taken. Whether or not to grant 50% mitigation will be based primarily on the three factors stated in the policy: timeliness, initiative, and comprehensiveness. The weight to be given to each of these elements is dependent on the circumstances of the particular case.

c. Past Performance 4

In the past the time period for assessing prior performance for a Severity Level III or greater violation has not been specified. The policy has been changed to state that the past two years or the period within the last two inspections, whichever is the longer period, should be the normal interval for considering past performance. This time period should allow ' sufficient time to determine a performance trend for applying this factor. This time period maybe longer (two past inspections rather than one past inspection) than the time period for considering civil penalties for repetitive Severity Level IV violations because some material licensees are inspected at a ,

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frequency greater than one year and a longer time period, i.e., two past inspections, is needed to establish a performance trend for those licensees.

In addition, this factor has been changed to provide more flexibility in considering past performance.in the assessment process. Currently, past performance focuses on prior performance in the area of concern though overall performance can be considered. The effect of deleting the reference to general area of concern is to permit greater consideration of overall performance. With the change both overall performance and performance in the area of concern may be considered.

d. Prior Notice This factor has been changed to permit a penalty to be increased up to 100% of the base penalty rather than 50%. This change is being made to provide incentives to respond to notices of safety concerns.

If a licensee is put on notice of a problem by its own actions, its responsible employees, industry, or NRC and fails to take action to prevent a Severity Level III violation, then a penalty should be substantially increased.

Another important change to this factor is to consider notice arising out of activities of a licensee at other facilities it controls whether or not under different licenses. This change comes out of .

the lessons learned from the Tennessee Valley Authority problems but is equally applicable to other reactors and material licensees who 9

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-l I hold more than one license or have more than one facility or location.

If a licensee is aware of a significant issue at one of its facilities.  ;

that'needs corrective action, NRC expects that the licensee will consider f l

the application of corrective action at all other licensed operations l it controls. The failure to act in such a responsible manner will now l be the basis for increasing a penalty to provide additional incentives for the licensee to idontify and correct its problems. A licensee should not be dependent on the NRC to identify a violation ~ once the licensee has had reasonable notice of a poter.tial problem. This does not mean every similar violation at another facility of the licensee will be cause for escalation. But esca*ation may occur if it was reasonable to expect the licensee to consider the need for corrective action at its other facilities.

e. Multiple Examples This factor has been changed to permit a penalty to be increased up to 100% of the base penalty rather than 50%. This change is being made to be able to better reflect the added significance of multiple violations.

f. Duration The policy has been clarified by making duration a specific factor to consider in.the assessment process and to assign a percentage to be applied to the base amount. This was done to provide greater a,ssurance of uniform application of the duration factor. Section 234 of the Atomic Energy A,ct of 1954, as amended, provides that cont'inuing -

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violations may receive separate daily assessments. Whether to do so is a function of the circumstances of each case. It is clearly appropriate to have daily assessments where there is willful conduct, ,

i.e., a licensee permitted a violation to continue. In other cases an increased assessment may be warranted based on significance. It is appropriate, for those cases for which a penalty is not assessed on a daily basis, to be able to increase a penalty up to 100% to address the significance of the violation.

It is recognized that a number of factors consider duration. Prior notice does so from the view that the licensee may have had time to avoid a violation from occurring. But that is different from the duration of a violation. When a penalty is not mitigated for licensee

identification because of.the. age of the violation, NRC is focusing attention on the fact that a licensee performing as expected should have identified the violation earlier and not that the violation is more significant because of the length of time the violation existed.

Under the duration factor the issue is whether the violation is more significant because of its duration.

V.D. ESCALATION OF ENFORCEMENT SANCTIONS.

This section has been changed to delete the reference to progression based on a single license. This is an area where judgment and discretion are required. The policy is changed ta maximize the flexibility in this area. As described earlier, the prior notice section of the policy is also being changed to specifically consider the issue of th'e failure to take 4 4 4

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corrective action for similar violations at other facilities controlled by a licensee.

V.E. ENFORCEMENT ACTIONS INVOLVING INDIVIDUALS This section .is being clarified to indicate that enforcement action may be taken against an individual's license or against a corporate license that may impact an individual where the person's conduct plac.8 into question NRC's reasonable assurance that licensed activities will be properly conducted. Actionable conduct includes matters that raise integrity, competence, fitness for duty, or other issues that may not necessarily be a violation of Ccomission requirements. Also added in this section is a provision to indicate that action would not be taken for a willful violation in an emergency provided the standards of 10 CFR 50.54(x) are met.

Y.G. DISCRETION t

In addition to the changes already described, this section is being changed L to clarify that where discretion is exercised to not issue a Notice of ,

Violation, the violation will be described in an inspection report or official field notes. This will assist the agency in tracking repetitive concerns-for purposes of past perfor:iance.

VIII. RESPONSIBILITIES The change in this section clarifies that judgment is exercised in issuing ,

Notices of Violations as well as civil penalties. For example, w' hile most -

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,iolations result in at least a flotice of Violation, discretion may be exercised in developing the particular citation to use including the number of examples of the violation to be included in the citatien and the legal requirement violated. In addition, discretion may be exerciseo in determining whether there is sufficient evidence to issue a citation.

Similarly, discretion may bo exercised in determining the appropriate severity level after considering the guidance in the supplements which are examples and not controlling. For example, it may be appropriate to categorize an overexposure violation resulting from a "hot particle" at a lower severity level than described for the level of exposure because of the significance of the particular exposure.

The last sentence of footnote 5 has been deleted because it is not needed in the policy. Should there be additional delegation to Regional Off. ices, the policy can be changed at that time.

SUPPLEliEllT I - REACTOR OPERATI0llS Exarrple C.6. involving violations of 10 CFR 50.59 bas been changed to clearly indicate that a licensee who violates that requirement and operates in an unanalyzed condition may be subject to a Severity Level III citation even if, after the fact, it turns oJt that an unreviewed safety question or a conflict with a technical specification does not exist.

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This is designed to capture the circumetances where a reasonable engineer would need to perform an evaluation b.efore concluding that an unreviewed safety question or a conflict with a technical specification did not exist

. but did not do the evaluation. '

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A change also has been made to this supplement as well as Supplements III, Safeguards, IV, Health Physics, V, . Transportation, and VI, Fuel Cycle and liaterial Programt, to provide an express example of a Severity Level III problem for multiple 4r recurring violations that collectively reflect a

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potentially significant lack of attention or carelessness toward licensed responsibilities. Although the practice of grouping a number of violations individur.lly which may be of minor concern but collectively are of a significant regulatory concern is permitted under the existing Enforcement Policy, express examples illustrating this practice may be helpful.

SUPPLEMENT III - SAFEGUARDS This supplement has been extensively rewritten to provide more flexibility to address the significance of safeguards violations. In addition, similar examples of different severity levels for types of violations have been added. The most significant change is to 4ddress the area of access control violations which is one of the most frequent issues, resulting in escalated enforcement action in the safeguards area. The significar:e of an access control problem is a. function of the ease of exploitation. The policy has been changed to consider the predictability, identifiability, and case of passage of the vulnerability demonstrated by the violation in determining the severity level. of an access control violation. Predictability refers to a vulnerability that lasts for a long period of time (and is known to exist) or if it recurs with some predictable regularity or schedule, allowing the potential intruder to know when to attempt the penetration.

Idehtifiability refers to the ease with which an observer can (l') see tha opening, and (2) know'that it leads somewhere advantageous to a saboteur.

Ease,of passage refers to the structure of the opening, whether the 14 ,

1 potential intruder'can maneuver himself/herself along the interior of the pathway to gain access to the area, and includes the environment of the opening, i.e., whether there is continuous flushing or some other environmental factor that makes the pathway inhospitable to humans.

SUPPLEi1ENT V - TRANSPORTATION This supplement has been changed to make the radiation levels and j contamination levels more consistent with the health physics examples in Supplement IV. In addition, flexibility has been added to address violations associated with shipping papers, labeling, and packaging.

Examples have been added for Severity Level IV violations to indicate that failure to register as an authorized user of NRC-Certified Transport packages or to assure that packages meet applicable requirements are more ulan a minor regulatory concern.

SUPPLEMENT VI - FUEL CYCLE AfiD PATERIALS PROGRAll This supplement has been changed to provide ti.it multiple errors that result in diagnostic misadministrations or a recurrent violation that results in a diagnostic misadministration may be categorized at a Severity Level III.

This change is being made to emphasize the need to comply with requirements in order to avoid unnecessary and unsuspected exposures to the public.

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List of Subjects in 10 CFR Part 2 Administrative practice and procedure, Antitrust, 8yproduct material, Classified information, Environmental protection, Nuclear materials, Nuclear power piants and reactors, Penalty, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552, the NRC is adopting the following statement of policy as Appendix C to 10 CFR Part 2.

Part 2 - Rules of Fractice for Domestic Licensing Proceedings

1. The authority citation for Part 2 is revised 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, P239). Section 2.105 also issued under Pub. L.97-415, 96 Stat. 2073 (42 U.S.C. 2239). Sections 16

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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 ~2.600-2.606 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, 2.700 also issued under 5 U.S.C. 557. Section 2.764 and Table 1A of Appendix C also issued under Sections 135,141, Pub. L.97-425, 96 Stat. 2232, 2241 (42 U.S.C.

10155,10161). Section 2.790 also issued under sec. 103, 68 Stat. 936, as amended (42U.S.C.2133)and5U.S.C.552.' Sections 2.800and2.808also 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).

1 Subpart K also issued under sec. 189, 68 Stat. 955~(42 U.S.C. 2239); sec.

! 134, Pub. L.97-425, 96 Stat. 2230 (42 U.S.C. 10154). Appendix A also issued under sec. 6, Pt.6. L.91-580, 84 Stat. 1473 (42 U.S.C. 2135).

l Appendix E also issued under sec.10, Pub. L.99-240, 99 Stat.1842 (42 i U.S.C. 2021b et seq.).

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

i APPENDIX C - GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS l The folicwing statement of general policy and procedure explains the enforcement.

! - policy and procedures of the U.S. Nuclear Regulatory Connission and its staff in initiating enforcement actions, and of presiding officers, the Atomic Safety l and Licensing Appeal Boards, and the Comission in reviewing these actions.

i This statement is applicable to enforcement in matters involving the public health and safety, the comon defense ano security, and the environment.1/ This l II Antitrust enforeccent matters will be dealt with on a case-by-case

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.I statement of general policy and procedure is published in the Code of Federal Regulations to provide widespread dissemination of the Comissions Enforcement Policy. However, this is a policy statement and not a regulatlon. The Connission l may deviate from this statement of policy and procedure as is appropriate under f the circumstances of a particular case.

I. INTRODUCTION AND PURPOSE i i

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 cemmon 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 E performance, and l

by example, that of industry, including the prompt identification and

! reporting of potential safety problems .

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. Each enforcement action is I dependent on the circumstances of the case and requires the exercise of E heT term "vendor" meaas a supplier of products or services to be used in an NRC-licensed facility or activity.

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I discretion after consideration of these policies and procedures. In no case, however, will licensees who cannot achieve and maintain adcouate 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 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 1

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 viole. tion of certain specified licensing provisions of the Act, rules, orders, and license tems 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 l imposition of civil penalties for viol"ations of regulations implementing l

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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),or161(o)oftheAct. 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 FRANEWORK 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.

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, 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 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 NRC 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.

l l  !!!. SEVERITY OF VIOLATIONS Regulatory requirements 2/ have varying degrees of safety, safeguards, or environmental significance. Therefore, the relative importance of each l violation must be identified as the first step in the enforcement process.

l M The term "requirement" as used in this policy means a legally binding requirement such as a statute, regulation, license condition, technical l

specification, or order.

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Consequently, violations are categorized in terms of five levels of severity to show their relative importance within each of the following eight activity areas:

1. Reactor Operations; II. Facility Construction; III. Safeguards; IV. Health Physics; V. Transportation; VI. Fuel Cycle and Materials Operations; VII. Miscellaneous Matters; and VIII. Emergency Preparedness.

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 violatic'ns are of very significant regulatory concern. In general, violations that are inc,luded in these

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1 severity categories involve actual or high potential impact on the public.

Severity Level III violati'ons are cause for significant concern. Severity Level IV violations are less serious but are of more than minor concern; i.e., if lef t 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 insnediacy 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 VI!! for determining the appropriate severity level fr' violations in each of the eight activity areas, the examples are neither exhaustive nor controlling.

These examples do not create new requirements. Each is designed to l illustrate the significance which the NRC places on a particular type of j

violation of NRC requirements. Each of the examples in the supplements is predicated on a violation of a regulatory requirement, t

In each case, the severity of a violation will be characterized at the-i level best suited to the significance of the particular violation.

In some cases, violations may be evaluated in the aggregate and a single h severity level assigned for a group of violations, i

The severity level of a violation may be increased if the circumstan.ces surrounding the matter involve careless disregard of requirements, deception.

l or other indications of willfulness. The tem "willfulness" as used here l

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embraces a spectrum of violations ranging from deliberate intent to violate or fals'ify 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 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 matter.

4 24

IV. EliFORCEliENT 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 nonconformance on the part of a vendor, the NRC will normally hold an enforcement conference with the licensee or vendor prior to taking enforcement action. The NRC may also elect to hold an enforcement conference for other violations, e.g., Severity Level lY 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 information 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 l r

be told when a meeting is an enforcement conference. Enforcement  !

conferences will not normally be open to the public.

When needed to protect the public health and safety or cournon defense and security, escalated enforcement action, such as the issuance rI an

~

imediately effective order modifying, suspending, or revoking a license, will be taken prior to the enforcement conferencc. In such cases, an

- . 25 .

enforcement conference may be held after the escalated enforcement action is taken.

Y. E.NFORCEMENT 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 con-current jurisdiction, such as in tra.1sportation matters. Usually 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 invnived. For the vast majority of violations, action by an NRC regional office is appro-priate 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 Nonconfor-mance will be issued. The relatively small number of cases involving elevated enforcement action receives substantial attention by the public, and may have 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 activities.

26

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 rasponses to notices of violation to be under oath. Normally, responses under oath will be required only in conncction with civil penalties and orders.

NRC uses the notice of violation as the standard cethod 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.

However, violation findings warra'iting the exercise of discretion under Section V.G.1 will generally not result in a Notice of Violation. In addition, for isolated Severity Level V violations, a notice of violation normally will not be issued regardless of who identifies the violation provided that the licensee has initiated appropriate corrective action before the inspection ends. In these situations, a formal response from the licensee is not required and the inspection report or official field notes serves to document the violations and the corrective actions.

However, a notice of violation will normally be issued for willful 27

r. .

violations, if past corrective actions for similar violations have not been sufficient to prevent ecurrence, or if the circumstances warrant "

increasing the severity of Level V violations to a higher severity level.

Licensees are not ordinarily cited for violations resulting from matters 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

+1 axcuse persuanel errors.

4 B. CIVIL DENALTY 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 2nergy Reorganization Act. Civil penalties are designed to emphasize the need for lasting remedial action and to deter future violations.

Civil penalties are proposed absent mitigating circumstances for Severity t.evel I and !! violations, are considered for Severity Level III violations, and may be imposed for Severity Level IV violations that are similar 2/

to previous violations for which the licensee did not take effective corrective action. .

El The word "similar " as used in this policy, refers to those violations '

which could have been reasonably expected to have been prevented by the licensee's corrective action for the previous violation.

28 '

I.

1 l In applying this guidance for Severity Level III violations, NRC may, notwithstanding the mitigating and escalating factors in this section, refrain from proposing a civil penalty for violations that warrant the exercise of discretion under Section V.G. As to Severity Level IV 1

l violations, NRC normally considers civil penalties only for similar Severity Level IV violations that occur af ter the date of the last l

inspection or within two years, whichever period is greater.

i l

Civil penalties will normally 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 Commission l requirement including those at any severity level.

l l NRC imposes uifferent levels of penalties for different severity level I

violations and different classes of licensees. Tables 1A and IB show the base civil penalties for various reactor, fuel cycle, and materials programs. The structure of these tables genera 1Iy takes into account the gravity of the violation as a primary consideratior, and the ability to pay l 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 economic impact of d 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 concuct licensed activities. The deterrent effect of civil penalties is 9 .

9

, 29 .

l 1

best served when the amounts of such penalties take into account a licensee's "ability to pay." In determining the amounts of civil 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.

1 NRC attaches great importance to comprehensive licensee programs for i

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. .lo encourage licensee self-identification and correction a' violations and to avoid potential concealment of problems of safety significance, application of

^

the adjustment facters 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 '

i willfulness, flagrant flRC-identified violations, repeated poor performance  ;

in an area of concern, or serious breakdewn in management controls,flRC l c  :

i intends to apply its full enforcement authority where such action is j

! {

] warranted, including issuing appropriate orders and asscssing civil [

s 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 l ranagement involvement, direct or indirect, in a violation msy lead to an increase in the civil penalty, the lack of such involvement may not be i used to nitigate a civil penalty. , ,

f 30 - -

lj ;

Allowance of mitigation could encourage lack of management invol,vement in licensed activities and a dec* case 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 1A and 18 identify the base civil penalty values for different. severity levels, activity areas, and classes of licensees. After considering all 5 relevent circumstances, adjustments to these values may be made for the factors described below:

1. Identification and Reporting Reduction of up to 50% of the base civil penalty shown in Table 1 may be given when a licensee identifies the violation and promptly reports the violation to the NRC. In weighing this factor, consideration will be given to, among other things, 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 a reduction in penalty if the licensee does not take irm=:ditte action to correct the problem upon discovery. On the other hand the base penalty may be increased by as much as 50%

if the NRC identifies the violation provided the licensee should have reasonably discovered the violation before the NRC identified it.

2. Corrective Action to Prevent; Recurrence Recognizing that corrective action is always required to meet

. regulatory requirements, the promptness and extent to which the 4

31 .

licensee takes corrective action, including actions to prevent recurrence, may resu't; in'up to a 50% increase or decrease in the base civil penalty shown in Table 1. For example, very 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 tha corrective action is only minimally acceptable. In weighing this  !

factor, consideration will be given to, among other things, the ,

timeliness of the corrective actiot hgree of licensee initiative, and comprehenstveness of the corrective action--such as whether the  !

action is focused narrowly to the specific violation or broadly to  ;

the general area of concern.

t

3. Past Performance <

Reduction by as much as 100% of the base civil penalty shown in Table 1 may be given for prior good performance. On the other hand, -

l the base civil penalty may be increased as much as 100t for prior i

l poor performance. ,

i l

In weighing this factor, consideration will be given to, among other things, the effectiveness of previous corrective action i

) - for similar problems, overall performance such as Systematic  !

Assessment of Licensee Performance (SALP) evaluations for power reac+ ors, and prior performance including Severity Level IV and V  ;

1 I 32

-_- -_-_,. ,__-_-- -- - . - ._  ? _ _ . . _ _ _ - - -

violations in the area of concern. For example, failure to implemene previous corrective action for prior similar problems may result in an increase in the civil penalty. For purposes of assessinj past performance, violations within the past two years of the inspection at issue or the period within the last two inspections whichever is longer will be conside'.sJ.

4 Prior Notice of Similar Events The base civil penalty may be increased as much as 100% for cases where the licensee had prior knowleoge of a potential problem as a result of a licensee review, a specific NRC or industry notifications or other reasonable indication of a potential problem, and had failed to take effective preventive steps. Prior notice may include findings of NRC, the licensee, or inaustry made at other facilities of the licensee where it is reasonable to expect the licensee to take action to prevent similar problems at the facility subject to the enforcement action at issue.

5. Multiple Occurrences The base civil penalty may be increased as much as 100% where multiple examples of a particular violation are identified during the inspection period.

6. Duration 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:

33

t .

1 (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 1

separate violation and, as such, subject to a separate additional l

l civil penalty.

l l

l l (2) If a licensee (a) is unaware of a condition resulting in a continuing violation, but clearly should have been aware of the condition or (b) had n 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 l correct the condition, but failed to do so.

(3) Alternatively, whether or not a licensee is aware or clearly should have been aware of a violation that continues for more than I

one day, the base civil penalty may be increased as much as 100%

' to reflect the added significance resulting from the duration of the violation. l l

The above factors are additive. However, in no instance will a civil penalty for any one violation exceed $100,000 per day. I 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 tlolations which contributed to or 9

34

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 fundame,ntal 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 l have been reported.

i l

1 l

I f

l 1 .

l 3'5 t .

. TABLE 1A BASE CIVIL PENALTIES Transportation Plant Operations, Type A

. Const, Health Greater than Quantity physics and EP Safeauards Type A Ouantity 1,/ or less 2/ '

a. Power Reactors $100,000 $100,000 $100,000 $5,000

b. Test Reactors 10,000 10,000 10,000 2,000

c. Research Reactors & 5,000 5,000 5,000 1,000 I Critical Facilities

d. Fuel Fabricators 25,000 100,000 4/

~

25,000 5,000 and Industrial Processors 3/

s

e. Mills and Uranium 10,000 -- 5,000 2,000 Conversion Facilities

f. Industrial Users 10,000 -- 5,000 2,000 of Material 5/

g. Waste Disposal 10,000 -- 5,000 2,000 Licensees

, h. Academic or Medical 5,000 -- 2,500 1,000 Institutions 6/

1. Independent spent 25,000 100,000 25,000 5,000 fuel and monitored retrievable storage installations l

j. Other itaterial 1,000 -- 1,500 1,000 Licensees 1/ Includes irradiated fuel, high level waste, unirradiated fissile material, and any other quantities reouiring Type B packeging.  ;

2/ Includes low specific activity waste (LSA), low level waste, Type A packages, '

and excepted quantities and articles.

3/ Large firms engaged in manufacturing or distribution of byproduct, source, or special nuclear material.  !

4/ This amount refers to Category 1 liceasees (as defined in 10 CFR 73.2).

Licensed fuel fabricators not authorized to possess Category 1 material have l a base penalty amount of. 550,000. l

, 5/ Includes industrial .'adiographers, nuclear pharmacies, and other industrial users.

[

6/ This applies to nonprofit institutions not otherwise categorized under sections "a" through "g" fn this table.

36 . .-

r- .

TABLE IB BASE CIVIL PENALTIES BASE CIVIL PENALTY Af0VNT SEVERITY LEVEL (% of Amount Listed in Table 1A)

I 100%

II 80%

!!I 50%

IV 15%

Y 5%

i 4

] *

- - 37

rn. -

[.

l C. ORDERS t  ;

n.

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 (see10CFR2.202and2.204). Orders ,

may be issued as follows. 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, j (2) Suspension Orders may be used:  ;

(a) To remove a threat to the public health and. safety, common i t

defense and security, or the environment; (b) To stop facility construction when (i) further work could f preclude or significantly hinder the identification or  :

correction of an improperly constructed safety-related system or component, or (11) the licensee's quality assurance program j implementation is not adequate to provide confidence that  !

construction activities are being properly carried out; 1

(c) When the licensee has not responded adequately to other j enforcement action; f

l I

38

J (d) When the licensee interferes with the conduct of an inspection  ;

or investigation; or  ;

i (e) For any reason not mentioned above for which license revocation f is legally authorized. '

Suspensions may apply to all or part of the licensed activity. l 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.

l (3) Revocation Orders may be used:  ;

c t

i

) (a) When a licensee is unable or unwillirg to comply with NRC  !

requirements,  !

(b) When a liceesee refuses to correct a violation, f

l (c) When a licensee does not respond to a notice of violation where  !

r j a response was required, 1  :

l e ,

] (d) When a licensee refuses to pay a fee requ' ired by 10 CFR (

Part 170, or i  !

l (e) For any'other reason for w5f ch revocation is authorized under  !

> . r l Section 186 of the Atomic Energy Act (e.g., any condition which i E

would warrant refusal of a license on an original application). [

I

. 39 , .- .  !

(4) Cease and Desist 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 imediately, without prior opportunity for hearing, whenever it is determined 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 !!RC 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 thould not be issued ir the proposed manner.

D. ESCALATION OF ENFORCEMEtiT SANCTIONS NRC considers violations of Severity Level 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 applyirg the sanction (s) appropriate to the case in accordance with the criteria described in Sections V.B and V.C.

Examples of enforcement actions that could be taken for similar Severity Level I, II, or III violations are set forth in Table 2. Tne actual progression to be used in a particular ca~se will depend on the ,

40.

i circumstances. However, enforcecient sanctions will normally escalate for l

recurring similar violations.

I<

e 41

i

• i 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 the last insaection or within the previous of two years (whiciever period is greater)

Violation-1st 2nd 3rd I a+b a+b+c d II a a+b a+btc l III a a+b  :

I

a. Civil penalty

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

i

c. Show cause for modification or rcyocation of the license, as  ;

appropriate. ,

, d. Further action, as appropriate. f l

e i

i i

l l

42 l

E. EfiFORCEMENT ACTIONS INVOLVING INDIVIDUALS Enforcement actions involving individuals, including licensed operators, are significant personnel actions, which will be closely controlled and judiciously applied. An enforcement t.: tion will normally be taken only whn there is little doubt that the individual fully understood, or t i.ould have understoud, his or her responsibility; knew, or should have .

known, the required actions; and knowingly, or with careless disregard (i.e., with more than mere negligence) failed to take required actions which have actual or potential safety significance. Most transgressions of individuls at the level of Severity Level III, IV, or Y violations will be headled by citing only the facility licensee.

More serious violations, including those' involving the irtegrity of an individual (e.g., lying to the NRC) concern ng r.itters within the scope of the individual's responsibilities, will be considered for enforcement action against the individual. Action against the individual, hcwever, will not be taken if the haproper action by the individual was caused by management failures. The following examples of situations illustrate this concept:

Inadvertent individual mistakes resulting fren inadequate training or guidance provided by the facility licensee. .

Inadvertently missing an insignificant procedural requirement when

~

i the action is routine, fairly unccmplicated, and there is no unusual circumstance ind.icating that the procedures should be referred to and followed step-by-step.

. 43 .

Compliance with an express direction of canagement, such as the Shift Supervisor or Plant Manager, resulted in a violation unless the individual did not express his or her concern or objection to the direction.

• Individual error directly resulting from folicwing the technical advice of an expert unless the advice was clearly unreasonable and the licensed individual should have recognized it as such.

• Violations resulting from inadequate procedures unless the individual used a faulty procedure knewing it was faulty and had not attempted to get the procedure corrected.

Examples of situations which c'ould result in enforcement actions against individuals include, but are not limited to, violations which involve:

Recognizing a violation of procedural requirements and willfully not taking corrective action.

Willfully performing unauthorized bypassing of reouired reactor safety systems.

• Willfully defeating alarms which have safety significance.

Unauthorized abandoning of reactor controls.

Inattention to duty such as sleeping, being intoxicated while on duty, or otherwise riot meeting requirerents for fitness for duty.

44

Willfully taking actions that violate Technical Specification Limiting Conditions for Operation (enforcement action for a willful violation will not be taken if the operator meets the standards of 10 CFR 50.54(x),

i.e., unless the operator acted unreasonably considering all the relevant circumstances surrounding the emergency.)

Falsifying records required for NRC regulations or by the facility licensee.

Willfully failing to take "immediate actiors" of emergency procedures.

Willfully withholding safety significant information rather than

, making such information known to appropriate supervisory or technical personnel.

Any proposed enforcement action against individuals must be done with the concurrence of the Deputy Executive Director for Regional Operations. The opportunity for an Enforcement Conference with the individual will usually be provided.

Examples of sanctions that may be appropriate against NRC-licensed operators are:

issu'ance of a letter of reprimand to be placed in the operator's license file, issuance of a Hotice of Violation, and 45

9 suspension for a specified period, modification, or revocation of the licenst. ,

Thesanctionsarelistedinescalatingorderofsignificance.$/ The particular sanction to be used should be determined on a case-by-case basis. ,

In addition, NRC ray take enforcement action where the conduct of the 1

individual places in question the NRC's reasonable assurance that licensed activities will be properly conducted.

The NRC may take enforcement action for reasons that would warrant refusal to issue a license on an .

original application. Accordingly, enforcement action may be taken  :

regarding matters that raise issues of integrity, competence, fitness for  !

l

. duty, or other matters that may not necessarily be a violation of specific (

Comission requirements. l i

In the case of an unlicensed individual, an Order modifying the facility

license to require the removal of the individual from all r.uclear-related  !>

activities fer a specified period of tint or indefinitely may be appropriate.

)

F. REOPENING CLOSED ENFORCEMENT ACTIONS  !

l f

4 If significant new information is received or obtained by NRC which l t

l l

SI ' Except fer individuals subject to civil penalties under section 205 of the j Energy Reorganization Act of 1974, as amended, NRC will not normally impose ,

However, section 234 of the Atomic i a civil penalty)against Energy Act (AEA an individual.gives the Connission authority to impose! '

for violations on "any person." "Person" is broadly defined in Section 11s f

! of the AEA to include individuals, a variety of organizations, and any i representatives or agents. This gives the Commission authwity to impose '

< civil penalties on employees of licensees or on separate entities when a l violation of a requirement directly imposed on them is comitted.

46  ;

_ -_ a

indicates that an enforcement sanction was incorrectly applied, consideration may be given, dependent on the circumstances, to '

reopening a closed enforcement action to increase or decrease the severity of a sanction or to correct the record. Reopening decisions '

w!11 be made on a case-by-case basis, are expected to cccur rarely, and require the specific approval of the Deputy Executive Director for Regional Operations.

G. EXERCISE OF DISCRETION Because the NRC wants to encourage and support licensee initiative I

i for self-identification and correction of problems, NRC may exercise discretion as follows:

1. NRC may refrain from issuing a notice of violation for a violation described in an inspection report or official field notes that meets all of the following criteria: i i

a. It was identified by the licensee; l

b. It is normally classified at a Severity Level IV or Y;

c. It was reported, if required; I

d. It was or will be corrected, including reasures to prevent recurrence, within a reasunable time; and  !

i

. 47 .

e. It was not a willful violation or a Violation that could reasonably be expected to have been prevented by the licensee's corrective action for a previous violation.

2. The NRC may refrain fror.1 issuing a notice of violation or a proposed civil penalty for violations described in an inspection report or official field notes that meet all of the following criteria:

a. (i) The NRC has taken significant enforcement action based upon a major safety event contributing to an extended shutdown of an operating reactor or a material licensee (or a work stoppage at a construction site), or the licensee is forced into an extended shutdown or work stoppage related to generally poor performance over a long period; (ii) the licensee has developed and is -

aggressively implementing during the shutdown a comprehensive program for problem identification and correction; and (iii) NRC concurrence is needed by the licensee pr for to restart; i

1

b. Non-willful violations are identifi40 by the licensee as the result of its comprehensive program, or as a result of an

! employee allega*. ion to the licensee. If NRC identifies the violation, the NRC should determine whether enforcement action is necessary to achieve remedial action;

c. The violations are based upon activities of the licensee prior to the events leading to the shutdown; and O

48 -

The violations would normally not be categorized as higher than Severity Level !!! violations under the NRC's Enforcenent Policy.

t

3. The NRC may refrain from proposing a civil penalty for a Severity L

Level !!! violation not involving an overexposure or relwase of I radioactive material that meets all of the following criteria:

a. It was identified by the licensee and reported; i

i t

b. Comprehensive corrective action has been taken or is well ,

underway within a reasonable time following identification;

c. It was not a violation that either (i) was reasontbly preventable by the licensee's action in response to a previous regulatory {

concern identified within the past two years of the inspection or since the last two inspections which ever is longer or  !

i (ii) reasonably should have been corrected prior to the [

violation because the licensee had prior notice of the problem involved; and' i

l

d. It was not a willful violation or indicative of a breakdown in [

, management controls.

• l l  !

i 4 The t$C may refrain from proposing a civil penalty for a Severity  !

Level !!! violattor, involving a past problem, such as in engineering,.

j design, or installation, that r.eets the following criteria * '

i f 49 ,

a ,

i

a. It was identified by a licensae as a result of a licensee's voluntary formal effort such as a Safety System Functicaal l Inspection, Design Reconstitution Program, or othar program 1

that has a defined scope and timetable which is being ,

aggressively implemented and reported; l

l

b. Comprehensive corrective action has been taken or is well  !

undensay within a reasonable time following identification; ,

and .

t

c. It was not likely to be identified by routine licensee efforts  ;

such as normal surveillance or QA activities.

1

5. If the NRC issues an enforcement action for a violation at a Severity Level !!! violation and as part of the corrective action for that violation, the licensee identifies other examples of the violation i with the same root cause, the NRC may refrain from issuing an additional enforcement action. In determining whether to exercise this discretion, the NRC will consider whether the licensee acted  !

reasonably and in a timely manner appropriate to the safety  !

significance of the initial violation, the comprehensiveness of the corrective action, whether the matter was reported, and whether l the additional violation (s) substantially change the safety significance or character of the regulatory concern arising cut of the initial violation. }

Notwithstanding paragraphs 2, 3, 4, and 5 above, a civil penalty may l I be proposed yhen judgment warrants it on the basis of the circumstances l

50 t .

=

I i

of the individual case. For example, civil penalties may be warranted i where multiple Severity Level III viclations are discovered or where  !

the violation is willful. In addition, as provided in Section VIII, I

Responsibilities, the Deputy Executive Director for Regional Operations may refrain from issuing a civil penalty or a notice of violation for a j Severity Level !!! violation based on the merits of the case after l considering the guidance in this statement of policy and such factors as '

the age of the violation, the safety significance of the violatlon, the r overall performance of the licensee, and circumstances, if any, that have i changed since the violation provided prior notice has been given the Comission. This discretion is expected to be exercised only where appiteation of the normal guidance in the Policy is unwarranted. l t

P H. RELATED ADMINISTRATIVE ACTIONS l

In a:fdition to the formal enforcement mechanisms of notices of violation, f l

civil penalties, and orders, NRC also uses administrative techanisms, such  !

as bulletins, information notices, generic letters, notices of deviation, notices of nonconformance, and confirmatory action letters to supplement I its enforcement program. NRC expects licensees and vendors to adhere to I any obligations and consnitments resulting from these processes and will  !

not hesitate to issue appropriate orders to licensees to make sure that  ;

such comitments are met. l l

(1) Bulletins, Information Notices, and Generic Letters are written

(

notifications to groups of licensees identifying specific problems  !

I and recemending specific actions.

l i

L

(2) Notices of Deviation are written notices describing a licensee's l failure to satisfy a commitment where the comitment involved has not been made a legally binoing requirement. A notice o'f deviation l 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's agreement to take certain actions to remove significant  !

concerns about health and safety, safeguards, or the environment.

(4) Notices of Nonconformanca are written notices describing non-licensees'  :

failures to meet commitments which have not been made legally binding requirements by 'NRC. An example is a comitment 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 l planned), the results achieved, the dates when corrective actions I will be completed, and measures taken to preclude recurrence. I i

I I

!. REFERRALS TO DEPARTMENT OF JUSTICE  :

t Alleged or suspected criminal violations of the Atomic Energy Act (and of other relevant Federal laws) are referred to the Department of Justice for (

L investigation. Referral to the Department of' Justice doet not preclude the NRC from taking other enforcement action under this General Statement  !

of Policy. However, such actions wiil be coordinated with the Department of Justice to the extent practicable.

52 , j

. -. --t

. l l

l VI. INACCURATE AND INCOMPLETE INFORMATION I

i A violation of the regulations on submitting complete and accurate I information whether or not considered a material false statement, can result in the full range of enforcement sanctions. The labeling of a communication failure as a material false statement will be made on a case-by-case basis and will be reserved for egregious violations.

Violations involving inaccurate or incomplete information or the failure to provide significant information identified by a licensee normally will be categorized based on the guidance herein, in Section III "Severity of Violations," and in Supplement VII.

The Commission recognizes that oral information may in some situations be inherently less reliable than written sub'mittals because of the absence of an opportunity for reflection and management review. However, the Connission must be able to rely on oral connunications from licensee officials concerning significant information. A licensee officici for purposes of application of the Enforcement Policy means a first line supervisor or above as well as a licensed individual, radiation safety officer, or a person listed on a license as an autk ized user of licensed material. Therefore, in determining whether to take enforcement action for an oral statement, consideration may be given to such factors as (1) the degree of knowledge that the communicator should have had, regarding the matter, in view of his or her position, training, and experience (2) the opportunity and time available prior to the connunication to assure the accuracy or completeness of the information, f (3) the degree of intent or negligence, if any, involved. (4) the 1

53

formality of the communication, (5) the reasonableness of NRC reliance on the information, (6) the importance of the information which was wrong or not provided, and (7) the reasonableness of the explanation for not providing complete and accurate information.

Absent at least careless disregard, an incomplete or inaccurate unsvorn oral statement normally will not be subject to enforcement action unless it involves significant information provided by a licensee official.

However, enforcement action may be taken for an unintentionally incomplete or inaccurate oral statement provided to the NRC by a licensee official or others on behalf of a licensee, if a record was made of the oral information and provided to *he licensee thereby permitting an opportunity to correct the oral information, such as if a transcript of the communication or meeting sunnary containing the error was mace available to the licensee and was not subsequently corrected in a timely manner.

When a licensee has corrected irtaccurate or incomplete information, the decision to issue a citation for the initial inaccurate or incomplete information normally will be dependent on the circumstances, including the ease of detection of the error, the timeliness of the correction, whether the NRC or the licensee identified the problem with the cossnunication, and whether the NRC relied on the information prior to the correction. Generally, if the matter was promptly identified and

! corrected by the licensee prior to reliance by the NRC, or before the NRC raised a question about the information, no enforcement action will be taken for the initial inaccurate or incomplete information. On the other hand, if the misinformation is identifiec after the NRC relies on 54 -

it, or after some question is raired regarding the accuracy of the information, then some enforcement action normally will be taken even if it is in fact corrected. However, if the in.tial submittal was accurate when made but later turns out to be erroneous cecause of newly discovered information or advance in technology, a citation normally would not be appropriate if, when the new information became available, the initial submittal was corrected.

The failure to correct inaccurate or incomplete information which the licensee does not iden*.ify as significant normally will not constitute a separate violation. However, the circumstances surrounding the failure to correct may be considered relevant to the determination of enforcement action for the initial inaccurate or incomplete statement. For example, an unintentionally inaccurate or incomplete submission may be treated as a more severe matter if the licensee later determines that the initial submittal was in error and does not correct it or if there were clear opportunities to identify the error. If information not corrected was recognized by a licensee as significant, a separate citation may be mado for the failure to provide significant information. In any event, in serious cases where the licensee's actions in not correcting or providing information raise questions about its comitment to safety or its fundamental trustworthiness, the Comission may exercise its authority to issue orders modifying, suspending, or revoking the license. The Comission recognizes that enforcement determinations must be made on a case-by-case basis, taking into consideration the issues described above.

55

VII. 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 Level I, II, or III, press releases 4re issued at the time of the order or the proposed imposition of the civil penalty. Press releases are oft normally issued for Notices of Violation.

VIII. RESP 0NSIBILITIES The Deputy Executive Director for Regional Operations (DEDRO), as the principal enforcement officer of the NRC, has been delegated the a'Jthority toissuenoticesofviolations,civilpenalties,andorders.5/ Regional  !

Administrators may also issue notices of violation for Severity Level IV l and Y violations and may sign notices of violation for Severity Level III  :

l violations with no proposed civil penalty and proposed civil penalty  !

actions with the concurrence of the OEDRO. In recognition that the t

regulation of nuclear activities in many cases does not lend itself to a mechanistic treatment, the DEDRO or the Regional Administrator must 1

El The Director, Office of Enfor nt, acts for the Deputy Executive Director for Regional Operations in the latter's absence or as directed.  ;

The Directors of the Offices of Nuclear Reactor Regulation, Nuclear '

Matarial Safety and Safeguards, and Special Projects have also been  ;

celegated authority to issue orders, but it is expected that normal use of l this authority by NRR, NHSS, and OSP will be confined to actions necessary i

in the interest of public health and safety. The Director, Office of ,

Administration and Reso Jrces Management, has been delegated the authority to i issue orders where licensees violate Comission regulations by nonpayment of l

license fees, r 56

exercise judgment and discretion in determining the severity levels of the violations and the appropriate enforcement sa'nctions, including the decision to issue a Notice of Violation, or to propose or impose a civil penalty and the amount of such penalty, af ter 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 Connission will be consulted prior to taking action in the following situations (unless the urgency of the situation dictr.ce* i n :...te action):

(1) An action affecting a licensee's operat'on that requires balancing the public health and safety or comon defense and security implications of not operating with the potential radiological or other hazards associated with continued operation; (2) Proposals to impose civil penalties in amounts greater than 3 times .

the Severity Level I values shown in Table IA; l

(3) Any proposed enforcement action that involves a Severity Level I i

violation; l

(4) Any enforcement action that involves a finding of a material false statement; I

l (5) Refraining from taking enforce: rent action for matters meeting the criteria of Section V.G 2.  ;

57

-l (6) Any a . tion the Office Director believes warrants Commission involve-mentt or l t

r E

(7) Any proposed enforcement action on which the Coamission asks to be consulted. f I

i t

IX. VENDOR ENFORCEMENT i e

The Commission's enforcement policy is also applicable to non-licensees [

t (vendors). Vendors of products or services provided for use in nuclear  :

activities are subject to certain requirements designed to ensure that  ;

t the products or services supplied that could affect safety are of high j quality. Through procurement contracts with reactor licensees, vendors  ;

are required to have quality assurance programs that meet applicable requirements including 10 CFR Part 50. Appendix B, and 10 CFR Part 71 Subpart H. Vendors of reactor and materials licensees and Part 71 [

t licensees are subject to the requirements of 10 CFR Part 21 regarding f reporting of defects in basic components.

l 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 service, that could have an adverse effect on j u

safety. As part of the effort of ensuring that licensees fulfill their obilgations in this regard, the NRC inspects reactor vendors to  !

j determine if they are meeting their obligations. These inspections I include examination of the quality assurance programs and their implementation by the vendors through examination of product quality.

l

' ~

58  ;

i

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 hava occurrei, or that vendors have failed to fulfill contractual commitments the- m sdversely affect the quality of a safety significant product or servict enforcement action will be taken. Notices of Violation and civil pena.s es will be useo, as appropriate, for licensee failures to ensure that their idors have programs that meet applicable requirements including Part 21.

..otices 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 ano co.isciously fail to provide the notice reouired by 10 CFR 21.21(b)(1).

Notices of Nonconformance will be used for vendors which fail to meet commitments related to NRC activities.

SUoPLEMENT I - SEVERITY CATEGORIES REACTOR OPERATIONS A. Severity 1 - Violations involv'ing for example:

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

2. Asystemk designed to prevent or mitigate a serious safety event not I

5/ "3ystem" as used in these supplements, in ludes aoministrative and managerial control systems, as well as physical systems.

59

t.eing able to perform its intended safety function 1/ when actually called upon to work;

3. An accidental criticality; or

4. Release cf radioactivity offsite greater than ten (10) times the TechnicalSpecificationslimit.El B. Severity II - Violations involving for exan,we:

1. A system designed to prevent or mitigate serious safety events not being able to perform its intended safety function; or

2. Release of radioactivity offsite greater than five (5) times the Technical Specifications limit.

C. Severity III - Violations involving for example:

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

f E! directed "Intended safety toward a lossfunction" of reoundancy. meansFor the total safetke, examp considering unction, a BWR's and high is not 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 cperable.

E/ The Technical Specification limit as used in this Supplement (Items A.4, B.2  !

and C.5) does not apply to the instantaneous release limit.

60

~

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);

3. Dereliction of duty on the part of personnel involved in' licensed activities; 4 Changesinreactorpara$eterswhichcauseunanticipatedreductionsin i margins of safety; 1

t

5. Release of radioactivity offsite greater than the Technical Specifications limit; l

6. A significant failure to meet the requirements of 10 CFR 50.59, including a failure such that a required license amendment was not sought; l

1 61 i . .

7. Licensee failure to anduct adequate oversight of vendors resulting in the use of products or services which are of defective or indeterminate quality and which have safety significance; or

8. Breakdown in the control of licensed activities involving a number of violations that are related or, if isolated, that are recurring violations that collectively represent a potentially significant lack of attention or carelessness toward licensed responsibilities. -

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 allotted by the Action Statement, such as:

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

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

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 1 -

safety or nvironmental significance; or

4. Failure to make a required Licensee Event Report.

62

r, 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 completed EI in such a manner that it would not have satisfied its intended safety related purpose.

8. Severity II - Violations involving for example:

1. A breakdown in the Quality Assurance (QA) program as exemplified by deficiencies in construction QA related to' more than one work activity (e.g., structural, piping, electrical, foundations). Such 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.

C. Severity III - Violations involving for examplo:

2/"Completed"meanscompletionofconstructionincludingreviewandacceptance by the construction QA organization.

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 such audits, and normally involves niultiple 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 i

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 or.e or more Quality Assurance Criterion not amounting to Severity Level I, II, or III violations tha't have more than ninor safety or environn: ental significance.

E. Severity V - Violations that have minor safety or environmental significance.

SUPPLEMENT.III - SEVERITY CATEGORIES SAFEGUARDS A. Severity I - Violations involving for example:

64

1. An act of radiological sat,1tage or actual theft, loss, or diversion of a formula quantity of siacial n! clear material El in which the security system did not function at required; or

2. Actual undetected entry of an unauthu' red individual El into a vital area E I from outside the protecte area who represents a threat.

B. Severity II - Violations involving for example:

1. Actual theft, loss or diversion of special nuclear material of moderate strategic significance E l in which the security system did not function as required;

2. Failure or inability to control access such that an unauthorized individual could easily gain undetected access E l into a vital area fro:n outside the protected area; or

$ / ee S 10 CFR 73.2.

El An ut.tuthorized individual is someone who was not authorized ior entrance into ti,e area in question, or not authorized to enter in the manner entered.

El The phrase "vital area" includes vital areas, material access areas, and controlled access areas.

E! See 10 CFR 73.2.

El In determining whether access can be easily gained, factors such as predictability, identifiability, and ease of passage should be considered.

65

4 I

3. Failure to have a security system designed or used to prevent the-theft, loss, or diversion of SNM of moderate strategic significance ,

or greater amounts or acts of radiological sabotage. ,

..I~

C. Severity III - Violations involving for example:

1. Failure to conduct an adequate search at the access control point that results in the introduction to the protected area of itents that may be useful in radiological sabotage or theft of SM;

2. Failure or inability to cont.rol access such that an un uthorized individual could eas11y gain udetected access into a vital area from inside the p'rotected area or to the protected area from outside the protected area; i

l 3. Significant failure of the safeguards systems designed or used .J to prevent or detect the theft, loss, or diversion of SNM or radiological sabotage; ,

4 Failure to properly secure or protect classified or other sensitive safeguards information which would significantly as.sist an individual in an act of radiological sabotage or theft. of special nuclear material; -

t

5. Significant failure to take compensatory measures for a known security situation that could easily allow unauthorized and undetected access to a protected or vital area; 66 1 i _ _ _ . _ _ _ _ . - _ _. __ _ , _ . _ _ _ - _ _ - - _ _

n .

1.

6. Significant failure to respond to a suspected event in either a timely manner or with an' adequate response force; or

7. Breakdown in the security system involving a number of ~ violations

'that are related or, if isolated, that are recurring violations >

that collectively reflect a potentially significant lack of attention or carelessness toward licensed responsibilities.

D. Severity IV - Violations involving for example:

1. Failure of a safeguards system designed or used to prevent or detect the theft, loss, or diversion of SNM or radiological l sabotage; l

I 2. Failure to respond to a suspected event in either a timely manner l

!* or with an adequate response force; *

3. 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; 4 Failure to make, maintain, or provide log entries in accordance with 10 CTR 73.71(c) and (d); -

.5. Failure to conduct a proper search at the access control point; 4

F 67

~

6. Failure to properly secure or protect classified or other sensitive safeguards information which wculd not significantly assist an individual in an act of radiological sabotage or theft of special nucleer material;

7. Failure to co'ntrol access such that an opportunity exists that could allow unauthorized and undetected access into the protected area or from the protected area into a vital area but which was not easily axploitable;

8. Inadequate compensatory measures for a known security situation that

,, could allow unauthorized and undetected access;

9. Failure to properly test a security system: or

. 10. Other violations that have more than minor safeguards significance.

E. Severity V - Vsolations that have minor safeguards significance such as:

1. Isolated failure to log a security event in accordance with 10 CFR 73.71(c); or

2. Other violations that have minor safeguards significance.

4 68

_ . - _- - . . _______---_--__ 1 _._ _ - . _ _ _ _ _ _ __ ,

r j

I SUPPLEMEllT IV - SEVERITY CATEGORIES HEALTH P.lYSICS 10 CFR PART 20 1E/

A. Severity I - Violaticos involving for example:

1. 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;

2. Annual whole body exposure of a member of the public in excess of 2.5 rems of radiation; a

e

3. Release 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 quantities r.r 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 limit' af -

10 CFR 20.103.

B. Severity II - Violations involving for example:

11/ Personnel oveie: posures and associated violations, incurred during a lifesaving effort, will be treated on a case-by-case basis.

4 9

69 M

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 forwarms;

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 unrestricteri area in excess of five times the limits of 10 CFR 20.106; 4 Failure to make an innediate notification as required by 10 CFR 20.403(a)(1)and10CFR20.403(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.

i i C. Severity III - Violations involving for example: ,

, 1. Single exposure of a wor.'.er 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 t the feet, ankles, hands or forearms; 1

F i

70

2. A rartiation level in an unrestricted area such that an individual

, could receive greater than 100 mii',irem in a one hour period or 500 millirem in any seven consecutive days;

3. 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);

4 Substantial potential for an exposure or release in excess of 10 CFR 20 whether or not such exposure or release e: curs (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);

5. 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 !!;

7. Exposure of a worker in restricted areas in excess of the limits of 10 LFR 20.103;

8. Release fo'r unrestricted use of contaminated or radioactive material or equipment which poses a realistic potential for significant  ;

exposure to nembers of the public, or which reflects a programmatic (rather than isolated) weakness in the radiation control program; 71

9. Cumulative worker exposur'e above. regulatory limits when such cumu-lative exposure reflects a programmatic, 'rather than an isolated e weakness in radiation protection;

-10. Conduct of licensee activities by a technically unqualified person;

11. Significant failure to control licensed material; or

12. Breakdown in the radiation safety program involving a number of violations that are related or, if isolated, that are recurring that collectively represent a potentially significant lack of attention or carelessness toward licensed responsibilities.

D. Severity IV - Violations involving for example:

r

1. Exposures in excess of the limits of 10 CFR 20.101 not constituting Severity Level I, II, or III violations;

2. A radia' ion 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 mate a 30-day notification required by 10 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 72

. 1

5. Any other estter that has more than minor sa'fety or environmental significance.

E. Severity V - Violations that have minor safety or environmental significance.

SUPPLEMENT V - SEVERITY CATEGORIES TRAE WTATION El A. Severity.I - Violations of NRC transportation requirerents involving for example:

1. Annual whole body radiation exposure of a member of the public i'n excess of 2.5 rems of radiation; i 2. Surface contamination in excess of 50 times the NRC limit; or 1

6

3. External radiation levels in excess of 10 times the NRC limit.

}

l.

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

l l 1. Anrual whole body exposure of a member of the public in excess of i

0.5 rems of radiation; l .

El Some transportation requirements are applied to more than one licensee involved in the same activity such as e shipper and a carrier. When a

! violation of such a requirement occurs, enforcement action will be directed against the responsible licensee which, under the circumstances

[ of the case, may be one or more of the licensees involved.

I .

2. Surface contamination in excess of 10, but not more than 50 times the NRC limit; 3 External radiation levels in excess of five, but not more than 10 times the NRC limit; or 4 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. Surface contamination in excess,of five but not more than 10 times the NRC limit; '

2. External radiation in excess of one but not more th&n five times the NRC limit;

3. Any noncompliance with labeling, placarding, shipping paper, packaging, loaoin5, or other requirements that could reasonably result in the folicwing: ,

a. Significant failure to identify the type, quantity, or form of material;

b. Failure of the carrier or recipient t.o exercise adequate controls; or 4

4 74 4

~

M'

c. Substantial potential for personnel exposure or contamination, orimpropertransferofmater[al;

4. Failure to make required initial notificatiun asscciated with l

Severity Level III violations; or t

5. Breakdown in the licensee's program for the transportation of licensed material ir.volving a number of violations that are related or, if isolated, that are recurring violations that collectively reflect a potentially significant lack of attention or carelessness toward licensed responribilities.

L

0. Severity IV - Violations of NRC transportation requirements involving for example:

1. Breach of package integrity without external radiation levels exceeding the NRC' limit or without contamination levels exceeding t

j five times the NRC limits; '

l

}

2. Surface contamination in excess of but not more than five times the NRC limit; ,

F

3. Failure to register as an authorized user of an NRC-Certified '

Transport packages, t

i 4

4 Noncompliante with shipping papers, rnarking, labeling, placarding {

packaging or loading not amounting to a Severity Level I, II, or l

!!! violation;

4 '

5. Failure to demonstrate that packages for special form radioactive material meets applicable' regulatory requirements; i

6. Failure to demonstrate that packages meet 00T Specifications for 7A Type A' packages; or

7. Other violations that have more than minor safety or environmental significance.

E. Severity V - Violations that have minct safety or environmental significance.

SUPPLEMENT VI - SEVERITY CATEGORIES FUEL CYCLE AND MATTRIALS OPERATIONS A. Sevcricy I ' Violations involving for example:

l 1. Radiation levels, contamination levels, or releases that exceed 10 l times the li'mits specified in the license; l 2. A system designed to prevent or mitigate a serious safety event not c 4

. being operable when actually required to perform its design fune. tion; or i

1 L

3. A nuclear criticality accident. '

l 4

l 2  ?

B. Severity !! - Violations involving for e.Mample: t i i 1 76 ,

, _ . - . . _ _ _ , _ _ _ _ _ _ _ . , , , _ . . _ ,-, _....,__.,_,__,..-r_..m__ _ , - _ . , _ . _ , - . , _ _ , _ _ . - _ _ - _ . . _ _ , , , , _ . .

~~~ -

,; 3 4

,o P

Radiation levels, contamination levels, or releases that exceed five 1.

times the limits specified in the license; or

2. A system designed to prevent or mitigate a serious safety event being inoperable.

C. Severity III - Violations involving for example:

1. Failure to control access to licensed materials for radiation i purposes as specified by NRC requirements;

2. Possession er use of unauthorized equipment or materials in the conduct of licensee activities wnich 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; j

6. Medical therapeutic misadministration or the failure to report such

! a misadministration; i 7. Multiple errors of the same or similar root cause that results in i

diagnostic misadministrations over the inspection period, or a recurrent violation from the previous inspection period that

- results in a diagnostic misadministration; or 77

8. Breakdown in the control of licensed activities involving a number of

( violations that are related or, if isolated, that are recurring violations that collectivaly represent a potentially significant lack l

l of attention or carelessness toward licensed responsibilities.

, D. Severity IV - Violations involving for example:

l

1. Failure to maintain patients hospitali::ed who have cobalt-60, cesium-137, or iridium-192 implants or to conduct required leakage or contamination tests, or to use properly calibrated equipment; f

(

I 2. Other violations that have more than minor safety or environmental )

I /

significance; or

3. Medical diagnostic misadministration or a failure to report such a misadministration. ,

1 l

l E. Severity V - Violations that have minor safety or environmental i significance.

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

78

-- -____________n

i- '

I l

1. Inaccurate or incomplete information E l t. hat is provided to the NRC (a) deliberately with the knowledge of a licensee official that i the information is incomplete or inaccurate, or (b) if the informa-tion, had it been complete and accurate at the time provided, likely would have resulted in regulatory action such as an imediate order required by the public health and safety.

2. Incomplete or inaccurate information that the NRC requires be kept by a licensee which is (a) incomplete or inaccurate because of falsification by or with the knowledge of a licensee official, or (b) if the information, had it been complete and accurate when reviewed by the NRC, likely would have resulted in regulatory action such as an imed;ste order required by public health and safety

^ '

considerations; l

3. Information that the licensee has identified as having significant implications for public health and safety or the comon defense and security ("significant information identified by a licensee") and is deliberately withheld from the Comission; 4 Action by senior corporate management in violation of 10 CFR 50.7 or similar regulations against an employee; er 1 5. A knowing and intentional failure to provide the notict required by Part 21.

E in applying the examples in this supplemnt regarding inaccurate or incomplete information and records, reference also should.be made to the guidance in Section VI.

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B. Severity II - Violations ir.volving for example:

1. Inaccurate or ir. complete information which is provided to the flRC (a) by a licensee official because of careless disregard for the complete-ness or accuracy of the information, or (b) if the information, had it been complete and accurate at the time provided, likely would have resulted in regulatory action such as a show cause order or a different regulatory position;

2. Incomplete or inaccurzte information which the flRC requires be kept by a licensee which is (a) incomplete or inaccurate because of careless I disregard for the accuracy of the information on the part of a licensee official, or (b) if the information, had it been complete and accurate when reviewed by the flRC. likely woul' d have' resulted in regulatory action such as a show cause order or a different regulatory position;

3. "Significant information identified by a licensee" and not provided to J

the Conunission because of careless disregard on the part of a licensee official; 4 Action by plant managerrent above first-line supervision in violation

of 10 CFR 50.7 or similar regulations against an employee; or S. A failure to provide the notice required by Part 21.

C. Severity !!! - Violations involving for example:

1. Incomplete or inaccurate information which is provided to the flRC ,

I (a) because of inadequate actions on the part of licensee officials l

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but not amounting to a Severity Level I or II violation, or (b) if the information, had it been complete and accurate at the time provided, likely would have resulted in a reconsideration of a regulatory position or substantial further inquiry such as an additional inspection or a formal request for information;

2. Inconplete or inaccurate information which the NRC requires be kept by a licensee which is (a) incomplete or inaccurate because of inadequate actions on the part of licensee officials but not amounting to a Severity Level I or II violation, or (b) if the information, hao it been complete and accurate when reviewed by the NRC, likely would have resulted in a reconsideration of a regulatory position or substantial further inquiry such as an additional inspection or a formal request for information;

3. Failure to provide "significant information identified by a licensee" to the Coninission and not amounting to a Severity Level I or II violation; 4 Action by first-line supervision in violation of 10 CFR 50.7 or similar regulations against an employee; or

5. 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.

D. Severity IV - Violations involving for example: ,

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1. Inconplete or inaccurate information of more than minor significance

'which is provided to the NRC but not amounting to a Severity Level I, II, or III violation;

2. Information which the NRC requires be kept by a licensee and which is incomplete or inaccurate and of more than minor significance but not amounting to a Severity Level I, II, or III violation; or

3. Inadequate review or failure to review under Part 21 or other procedural violttions associated with Part 21 with more than minor safety significance.

E. Severity V - Violations of miner procedural requirements of Part 21.

1. Incomplete or inaccurate information which is provided to the Commission and the incompleteness or inaccuracy is of minor significance; i

2. Information which the NRC requires be kept by a licensee which is incomplete or inaccurate and the inrompleteness or inaccuracy is of minor significance; or

3. Hinor procedural requirements of Part 21.

SUPPLEMENT VIII - SEVERITY CATEGORIES ENERGENCY PREPAREDHESS A. Severity.! - Violations involving for example:

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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).  ;

i B. Severity II - VI)lations involving for example:

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 1

2. Licensee failure to meet or implement more than one emergency j planning standard involvirg assessment or notification.

C. Severity III - 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.

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D. Severity IV - Violaticns involving for example:

Liceraee failure to meet ar implemeni: any emergency planning standard or requirement not directly related to assessment and notification.

E. Seve'ity r V - Violations that have mh or safety or environmental sianificance.

Do,ted at Rockville, MD, this 6th day of October 1988, i Fo' the Nuclear Regulatory Comission.

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'x NamuelJ.Chil.W b

Secretary of the Comission. a t

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