NUREG-1600, PR-MISC - 62FR06677 - (NUREG-1600) Policy and Procedure for Enforcement Actions, Policy Statement Amendment

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PR-MISC - 62FR06677 - (NUREG-1600) Policy and Procedure for Enforcement Actions, Policy Statement Amendment
ML23156A474
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Issue date: 02/12/1997
From: Hoyle J
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PR-MISC, 62FR06677
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ADAMS Template: SECY-067 DOCUMENT DATE: 02/12/1997 TITLE: PR-MISC - 62FR06677 - [NUREG-1600] POLICY AND PROCEDURE FOR ENFORCEMENT ACTIONS, POLICY STATEMENT: AMENDMENT CASE

REFERENCE:

PR-MISC 62FR06677 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-MISC (62FR06677)

In the Matter of POLICY AND PROCEDURE FOR ENFORCEMENT ACTIONS; POLICY STATEMENT: AMENDMENT DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 02/10/97 02/06/97 FEDERAL REGISTER NOTICE : POLICY STATEMENT:

AMENDMENT 03/17 /97 03/14/97 COMMENT OF UNITED STATES ENRICHMENT CORPORATION (ROBERT L. WOOLLEY) ( 1) 03/18/97 03/13/97 COMMENT OF SIEMENS POWER CORPORATION (JAMES B. EDGAR) ( 2) 03/18/97 03/14/97 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR.) ( 3)

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Mr. John C. Hoyle Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-000 1 A'ITENTION: Docketing and Service Branch

REFERENCE:

Request for Comments on "Policy and Procedure for Enforcement Actions; Policy Statement" Modify Supplement VI, Fuel Cycle and Materials Operations, 62 Fed. Reg. 6677 (February 12, 1997)

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEl), 1 is submitting the following comments on the amended "Policy and Procedure for Enforcement Actions; Policy Statement" Modifying Supplement VI, Fuel Cycle and Materials Operations which was published in the Federal Register on February 12, 1997. It is appropriate that the Nuclear Regulatory Commission (NRC) update the policy and procedures to reflect the addition of the Gaseous Diffusion Plants (GDPs) certification. As discussed in our comments, however, the NRC has mis-characterized the hazards associated with the GDPs. In addition, some of the modifications to the Severity Level examples do not correctly reflect the hazards and reporting requirements for fuel cycle facilities.

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEfs members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

~cknowledged by card ..............................

MAR 2 0 1997,..,'!",

1 776 I STREET NW SUITE 400 WASHINGTON, DC 20006-3708 PHONE 202 739 8000 FAX 202.785 4019

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Mr. John Hoyle March 14, 1997 The NRC currently has formal guidance to categorize violations. In the revised enforcement policy, however, NRC has bypassed this guidance which includes the investigation of the occurrence, determining root cause(s), and determining if, in fact violations occurred. Only then can the enforcement policy be directed toward the severity and safety significance of the violation(s) to determine the appropriate severity level. Some of the modifications to the Severity Level examples establish a standard that if certain events occur, they are violations simply because they occurred and without formally assessing, either the technical or regulatory significance. By such action the NRC would be making the events reported under Bulletin 91-01 into items requiring enforcement action by the NRC. NEI does not believes this is an appropriate way to implement the enforcement policy.

The GDPs as Category "a" The proposed revision classifies for the purpose of imposing civil penalties each GDP as a category "a" facility. According to the Federal Register notice, this classification is based on the nuclear materials inventory and potential consequences to the public and workers, and, on a secondary basis, the ability to pay. While the GDPs do contain substantial inventories of nuclear materials, this alone does not dictate the "a" classification. The impact of radiological events on the worker and the public is the critical factor, which we believe the NRC has not adequately considered in the revised policy statement. The NRC appears to be imposing the category "a" due to non-radiological hazard. NEI believes the NRC has gone beyond its statutory authority in considering non-radiological hazards to the public and the workers. It is only in the case where the non-radiological hazard results in a radiological hazard to the public or worker that the NRC would have this responsibility.

- With respect to the radiological hazard, NUREG-1140, "A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees" indicated that the most potentially hazardous accident for a fuel cycle facility would be the sudden rupture of a heated multi-ton cylinder of UFs. The fatalities and injuries would be as a result of the chemical toxicity and the radiation dose would be insignificant. 2 On-site non-radiological hazards are the responsibility of the Occupational Safety and Health Administration (OSHA) while off-site non-radiological hazards are the responsibility of the Environmental Protection Agency (EPA). Both of these 2 NUREG-1140, A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees "Acute fatalities would be possible in the immediate vicinity of the release point. Acute permanent injuries may be possible for many hundreds of meters, and clinically observable transient effects that have no known long-term consequences may be possible for distances up to a few miles. These effects would be caused by the chemical toxicity of the UFs and the products resulting from its reaction with moisture. Accompanying radiation doses would not be of significance."

2

Mr. John Hoyle March 14, 1997 have requirements for the handling and safety of the toxic materials referenced in the Federal Register notice. The GDPs must comply with their respective regulations. There has been and should continue to be a clear distinction between the respective agencies on the regulation of non-radiological hazards. The NRC should not blur this distinction in a policy statement on enforcement. It appears that the NRC is basing the category "a" listing on the non-radiological events. The NRC should also take into consideration that EPA's maximum penalty for chemical handling events is approximately $27,500, while OSHA's is $25,000, provided the event is serious and willful. These penalties are consistent with the NRC's category "b". For all of the above reasons the GDPs should be classified as a category "b" - Fuel fabricators, industrial processors, etc. and treated in the same manner.

The category "a" classification for the GDPs specific civil penalty charge made effective with the February 12 Federal Register noticed should be rescinded. As discussed above the classification as category "a" is inappropriate and therefore, any violations and fines against the GDPs would be excessive.

Modified Examples The NRC modified the examples in the Supplement VI. In so doing, however, it has created violations which are not within NRC's statutory authority and/or do not relate to the severity of the event.

Severity Level I example 6 and Severity Level II example 5 The addition of these examples result in the NRC going beyond its regulatory authority. As the examples are written, events and potential events that are industrial/non-radioactive accidents would be classified as NRC violations because the event occurred at a nuclear fuel cycle or nuclear material facility. Industrial accidents, which do not involve radioactive materials, but which could result in injury or loss oflife are within the responsibilities of OSHA or EPA, not the NRC.

These examples should be deleted or revised to properly reflect the responsibilities that are vested in the NRC.

Severity Level II example 2, Severity Level II example 4, Severity Level III example 13, Severity Level III example 14, and Severity Level III example 18 These examples need to be revised to indicate it is only a violation if the licensee continued to operate with the safety system inoperable without a redundant system; or, continued to operate an extensive period of time without putting the system back into operation, relying on the redundant system. Safety systems fail from time to time. Because a safety system is out of service does not mean that the facility is being operated in noncompliance with NRC regulations. The concept of defense in depth is designed to allow for system failures without compromising safety or requiring an immediate shutdown. Similar, safety systems that rely on 3

Mr. John Hoyle March 14, 1997 utilities (air, electricity, etc.) are designed to fail in a safe condition if there is a loss of the utility.

The same is true for criticality control. Fuel cycle facilities use the double contingency factor for criticality control. This requires multi-levels of control so that no one failure will result in an accidental criticality. The requirement that "all" criticality controls must be maintained, is too restrictive. There could be as many as five controls on a single system. If the licensee lost four of them, even under the optimum conditions there could not be a criticality. The licensee would only be in violation if it did not return at least one of the controls to operability in a timely manner. Therefore, this needs to be corrected and the "all" removed. The NRC must also realize that even under optimum conditions for criticality that "no" criticality is possible as long as at least one criticality control parameter is in place.

In addition, Bulletin 91-01 provides that licensees notify the NRC when a degraded safety condition occurs. This would include reductions in safety margins that were unanticipated. These examples would result in the licensee notifying the NRC under 91-01 and receiving a Severity Level III violation. It should not be a violation unless the investigation and root cause analysis indicates that the licensee exceeded the limiting conditions of its license. This example is counter to the concept of licensee self-monitoring. These examples represent a form of double counting and potentially, unfair aggregation. If the licensee doesn't report the failure, he will receive a Level III for not reporting. If the licensee does report the failure, he will receive a Level III for the degraded condition, even if it is within his operating license.

Severity Level III example 5 The "release of toxic material" is only under the NRC's authority when the release involves or impacts licensed radioactive materials. The example does not make this distinction.

We would be pleased to discuss these comments and to respond to any questions the NRC may have.

Sincerely,

~~

Felix M. Killar, Jr.

4

SIEMENS DOCKETED DOCKET NUMBER PR USNRC PROPOSED RU E 5C March 1 3, 1 997 ( (p ~ ,~ /p t,11) "CJ7 MAR 18 AlO :04 JBE:97:026 OFFICE OF SECRETARY The Secretary of the Commission DOCKETING & SERVICE U.S. Nuclear Regulatory Commission BRANCH Attn: Docketing and Service Branch Washington, DC 20555-0001 Gentlemen:

Ref .: Policy and Procedure for Enforcement Actions ; Policy Statement (NUREG-1600),

Federal Register Volume 62 , No . 29 , Dated February 12, 1997 Siemens Power Corporation (SPC) holds NRC Materials License SNM-1227 and engages, at its Richland, Washington plant, in the production of fuel for light water power reactors along with the ancillary activities pertaining to such production. As such, SPC is subject to the NRC's policy and procedures for enforcement actions contained in NUREG- 1600. We feel there has generally been due consideration of the safety significance or challenge to radiological health and safety on the part of NRC in establishing severity levels of violations. SPC supports the maintenance of discretion and flexibility in such considerations because it allows inspectors, thoroughly familiar with the substance and significance of a problem, to propose a severity level truly related to safety significance. As documents such as NUREG- 1600 formalize "examples" to be used in categorizing violations , such examples effectively can become rules as appl ied by the staff. Such use of NUREGs, technical positions , Regulatory Guides, etc. as de facto regulations is not limited to the enforcement policy and is a great concern to licensees because in many cases it bypasses established rulemaking procedures. The proposed examples of severity levels in NUREG-1 600 appear to diminish the due consideration of the safety significance associated with a vio lation.

Additionally, SPC has a number of other concerns with these add itions to the policy . A number of examples abrogate the efficacy of a long standing, effective and internationally accepted safety policy used in dealing with fissile material - the double contingency policy (see the specific discussions of examples B.4, C.14 , C.18, and D.8). The NRC appears to take the pos ition that a criticality accident is possible as a result of a single contingency or loss of one control parameter even though a second contingency (unlikely, independent, and concurrent process upset or process parameter change) has not occurred and a second controlled parameter has been maintained to prevent criticality. The purpose of adhering to the double MAR 2 0 1997 Siemens Power Corporation l\cknowfedged by eanJ - ~..- ...~,,..,

Nuclear Division 21 0 1 Horn Rapids Road Tel: (5 09) 3 75 -81 00 Engineering & M anufacturing P.O. Box 130 Fax: (509) 375 -8402 Richland, W A 99352 -0 130

.'.5. NUCLEAR REGULATORY COMMrS~IOr.

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Distribution JBE:97:026 March 13, 1997 Page 2 contingency principle is to ensure that a criticality accident is not possible when a single control parameter is maintained .

The proposed revisions do not reflect the correct understanding of the hazards and reporting requirements for fuel cycle facilities. In this regard SPC agrees with Westinghouse's position in its January 15, 1997 letter that, "[r]ather than focusing on the stated and appropriate NRC policy to promote and protect radiological health and safety of the pub li c, enforcement has evolved to the point where action is taken against NRC licensees subject to NRC enforcement jurisdiction for every deviation from NRC regulation, regardless of the safety significance of the re.g ulatory violation cited. This focus has created increasingly difficult "error free" compliance burdens to those subject to NRC enforcement without a corresponding measurable increase in overall nuclear safety. At the same time, this focus has placed an undue burden on the NRC staff, which frequent ly must deal with the inconsequential at the expense of concentrating its enforcement resources on those matters having true safety significance."

While SPC generally favors inspector and staff flexibility in the determination of violations and the severity levels thereof, we feel that the additional specific examples containing highly subjective clauses such as " .. . when a critical mass of fissile material was present or reasonably available ... " (B.4 and C. 18); " ... or a change in the quantity or type of radioactive material being processed or used that has radiological significance; "(C.11 ); and other statements which claim failure to follow regulations are violations (e.g. C.5, C.11, and D.4) where failure to follow regulations is understood to have always been the basis for possible violation, allow too much subjectivity.

Finally, certain of the examples (A.6, B.5) appear to increase the potential for dual regulation by NRC and EPA or OSHA (or equivalent state agencies) .

Specifically, SPC has the following comments:

Examples A.6 and B.5 Both of these added (new) examples deal with "a loss of control over licensed or certified activities, including chemical processes that are integral to the licensed or certifie d activity, whether radioactive material is released or not." Example A.6 deals with instances where that loss of control resulted in "significant injury or loss of life" (Severity Level I) whereas Example B.5 relates to instances where that loss of control resulted in a "potential for a significant injury or loss of life" (Severity Level II) .

SPC concurs fully that significant injury, loss of life, or the potential for such are significant regulatory concerns. W.e are also aware that NRC is legitimately interested in licensees' chemical safety programs to the extent that licensees' use of non-radiological chemicals may influence th eir ability to control licensed materials. SPC and the other Part 70-regulated nuclear fuel fabricators do however have ch emical processes that are integral to the conduct of our licensed activities that do not impact the control of, and would not trigger a release of, licensed materials. These systems, although present on a licensee's site and integral to their NRC-licensed primary activities, should not be swept into the regulatory and enforcement purview of the NRC. They are currently and appropriately regulated by OSHA and EPA (or appropriate state-level equivalents). Entry of the NRC into these areas would subject the licensees to dual regulation.

Distribution JBE:97:026 March 13, 1997 Page 3 Example B.2 While this is not a new example, it needs to be mod ified. Having a system designed to mitigate a serious safety event become temporari ly inoperable is only a violation if the licensee continues to operate with the safety system inoperable without a redundant or alternate system; or, continues to operate for an extensive period of time without putting the system back into operation, relying on the redundant system. Safety systems fail from time to time. Because a safety system is out of service does not mean that the facility is being operated in an unsafe manner. The concept of having redundant or alternate systems is to allow for system fa ilures without compromising safety or requiring an immediate shutdown.

Example B.4 This Severity Level II example is worded in a manner that does not align itself with NRC's intent as set forth in their prior discussion of the example on p. 6678 of the applicable Federal Register. The proposed wording states "failure to establish, implement, or maintain fill criticality controls (or control systems) for a single nuclear criticality scenario when a critical mass of fissile material was present or reasonably available, such that a nuclear criticality was possible." Common understanding of this wording would be that if a licensee had established four controls but lost one, he has not maintained fill of the controls and would therefore be subject to a Level II violation.

NRC's prior discussion of this example however makes it clear that they are addressing "the absence of all the criticality safety controls .. " The proposed example should either adopt this wording or be revised to say the "failure to establish, implement, or maintain any criticality controls ... "

Example C.5 This needs to be clarified such that the "release of toxic material" is only under the NRC's responsibility when the release involves or impacts licensed material for the same reasons discussed concerning dual regulation in Examples A.6 and B.5 above.

Example C. 13 This example needs to be clarified . For reasons discussed above in Example 8.2, having a system designed to mitigate a serious safety event become temporarily inoperable is only a violation if the licensee continues to operate with the safety system inoperable without a redundant system; or, continues to operate for an extensive period of time without putting the system back into operation, relying on the redundant system. The concept of defense in depth is designed to allow for system failures without compromising safety or requiring an immediate shutdown. Safety systems that rely on utilities (air, electricity, etc.) are designed to fail in a safe condition if there is a loss of the utility. In add ition, the requirements of Notice 91 -01 require the licensee to notify the NRC when a degraded safety condition occurs. This example would result in the licensee notifying the NRC under 91 -01 requirements and receiving a Severity Level Ill violation. This certainly does not promote the concept of licensee self-monitoring and, in fact, places the licensee in double jeopardy. If the licensee doesn' t report the failure, he will receive a Level Ill violation for not reporting . If the licensee does report the failure he has a Level Ill violation for the degraded cond ition . It is not reasonable to place the licensee in this position .

Distribution JBE:97:026 March 13, 1997 Page 4 Example C. 14 This example needs to be eliminated or clarified because it will essentially penalize a licensee who, in recognition that processes are subject to upset and parameters may change, proactively evaluates and implements a margin of safety into his analyses or operations. Rather than focusing on whether established margins of the safety analysis bounded the parameter change, the licensee will be subject to a Level Ill violation whether the change was bounded or not. More properly, a licensee discovering a reduced (but not eliminated) margin of safety should consider whether (or how) the desired margin can be restored; this should not be accompanied by an NRC Level Ill violation.

Example C. 17 This example needs to be clarified. A severity Level Ill violation determination for equipment failures due to inadequate or improper maintenance that substantially complicates plant recovery from a plant transient must also include consideration of the safety significance of the plant condition. It is possible that failure of certain process/plant equipment due to inadequate maintenance could require an extensive shutdown of the plant from normal production operations without any safety significance.

Example C.18 This example would appear to be a clear initiative to require something beyond the classic "double contingency approach" to criticality prevention. The discussion on p. 6678 of the Federal Register is particularly disturbing when it states that NRC is concerned about the loss of all but one criticality safety control for a critical mass of fissile material "because a nuclear criticality accident was possible." Although SPC would concur with fully reestablishing all criticality controls promptly before operations can proceed, we would not agree that a criticality was indeed possible with the single valid barrier still in place. It must be realized that even under optimum conditions for criticality, that a criticality accident is not possible as long as at least one criticality control parameter is in place.

Example D.8 This example implies that the loss of any criticality control for situations where less than a critical mass was present will dictate at least a Level IV violation. No number of controls - double contingency, triple contingency, etc. - would preclude a violation if you happened to temporaril y lose a single control. This example would (as would example C.18) take an event that was seen as part of the Bulletin 91-01 "early warning" reporting system and make it an enforceable violation. It clearly penalizes licensees for forthright reporting and subjects them to enforcement action related to events that may have been effectively and conservatively addressed by their programs or analyses. It is not reasonable to place the licensee in this position.

Distribution JBE:97:026 March 13, 1997 Page 5 SPC appreciates the opportunity to comment on this important issue. If you have questions regarding these comments, please call me at 509-375-8663.

Very truly yours,

~.Edgar Staff Engineer, Licensing

United States Enrichment Corporation us United States 2 Democracy Center 6903 Rockledge Drive Bethesda. MD 20817 Tel : (301) 564-3200 Fax : (301) 564 - 3201 Enrichment Corporation DOCKET NLl48ER PROPOSED RULE PB &f l5~

March 14, 1997 ( (p). FR. {pit, 71)

Secretary SERIAL: GDP 97-003 7 (j)

US Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Docketing and Service Branch Paducah Gaseous Diffusion Plant (PGDP)

Portsmouth Gaseous Diffusion Plant (PORTS)

Docket Nos. 70-7001 and 70-7002 USEC Comments on "NRC Policy and Procedure for Enforcement Actions; Policy Statement" 62 Fed. Reg. 6667 (February 12, 1997)

Dear Sir:

On behalf of the United States Enrichment Corporation (USEC), I am pleased to provide comments on the NRC's Policy and Procedure for Enforcement Actions in response to the USEC Privatization Act.

The recently amended NRC Enforcement Actions Policy (NUREG-1600) places Gaseous Diffusion Plants (GDPs) in the same base civil penalty category as nuclear power reactors (Category "a") . Placing the GDPs into the power reactor category is inappropriate and excessive, since the primary GDP risks are not nuclear (resulting from radioactivity), nor mandate Category I security protection, but are in fact, primarily associated with hazardous chemical materials with consequences and risks similar to the non-nuclear chemical industry regulated by other federal agencies.

USEC believes that the GDPs should be included in Category "b" of Table IA along with licensed fuel fabrication facilities. This re-assignment more properly recognizes the similar consequences of the hazardous chemical accidents at the GDPs and at other chemical facilities compared to the much higher potential radiological consequences associated with reactor accidents.

The GDPs should not be singled out from other fuel cycle facilities for separate treatment.

MAR 2 O 1997

~clmowledged by card R 111~1 I I IIHM.N ..:fttl Offices in Paducah , Kentucky Portsmouth. Ohio Washington, DC

J.$. NUCLEAR REGULA TORY COMMI~

DOCKETING & SERVICE SECTION

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Docketing and Service Branch March 14, 1997 GDP 97-0037 Page 2 The Nuclear Energy Institute (NEI) is also providing comments to the NRC on the Stafl1s changes to the Enforcement Policy. NEl's comments address both the $110,000 base civil penalties and the changes to those "examples" of violations that apply to the fuel cycle industry as a whole. USEC concurs with NEl's comments, which underscore and support our views. In addition, USEC is also providing additional comments on those Enforcement Policy "examples" of violations that are specific to the GDPs.

We would be pleased to discuss these comments with you. Please contact me at (301) 564-3413 or Ms. Lisamarie Jarriel at (301) 564-3247.

Sincerely, Robert L. Woolley Nuclear Regulatory Assurance and Policy Manager

COMMENTS ON AMENDED USNRC ENFORCEMENT POLICY I. CIVIL PENALTY STRUCTURE The recently amended NRC Enforcement Actions Policy (NUREG-1600) places the Gaseous Diffusion Plants (GDPs) in the same base civil penalty category as nuclear power reactors (Category "a" $110,000). Placing GDPs into the power reactor category is inappropriate since the primary GDP risks are not nuclear (resulting from radioactivity), nor mandate Category I security protection, but are in fact, primarily associated with hazardous chemical materials with consequences and risks similar to the non-nuclear chemical industry regulated by other federal agencies.

Radiological Safety The principal risks associated with nuclear power plants are due to the large inventory of radioactive fission products and the decay heat generated, which requires continued heat removal even after shutdown. Neither of these characteristics exist at the GDPs. Measures of the approximate severity of potential nuclear hazards and radiological consequences of accidents at GDPs are compared to those at a nuclear power plant in the following table.

Table 1 Comparison of Approximate Radiological Hazards Radiological 1000 M E Gaseous Diffusion Plant Hazard Nuclear Power Plant unes unes iodine) [5]1 cascade inventory) [l]

Ra unes unes to Environment for (Noble gases and iodine released (Release from worst

- design basis accident Ra 10 og1ca ose at Site Boundary for Worst Beyond Design Basis Operational from containment in first 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.) [6]

140,000 Rem [7]

postulated operational accident.) [2]

0.9 Rem [3]

Accident The above comparison demonstrates that the potential radiological consequences of accidents at a nuclear power plant are more than 100,000 times those possible at a GDP. In addition, there are approximately 100 nuclear power plants and only two GDPs in the United States.

The radiological effects of a UF 6 release are discussed in NUREG-1140. 2 The NUREG states, in part, "Accompanying radiation doses would not be of significance," and indicates that the 1

Nwnber in brackets indicates the basis for the values (see bases at end of comments).

2 NUREG-1140, "A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees," 1991 .

harmful effects of a UF 6 release are due primarily to the chemical toxicity of the UF6 and the products resulting from its reaction with moisture.

The worst case consequences of an accident at a nuclear power plant could lead to from 3,000 to 80,000 fatalities. [8] By comparison, estimated off-site consequences of a worst case accident at the GDPs could lead to the exposure of approximately 20 to 500 times fewer persons to levels of toxic materials (primarily hydrogen fluoride) that could be life threatening. [4] It is clear that putting the GDPs in the same category as nuclear power plants is not supported by similarity in maximum accident consequences, either radiological or, as shown below, toxicological.

Chemical Safety The GDPs (and the family of fuel manufacturing, refining, milling and fabrication plants) are essentially chemical industrial facilities that handle radioactive material. As indicated above, the majority of GDP on- and off-site accident risks comes from the hazardous, toxic and reactive chemical materials supporting the uranium processing and fabrication operations. Significant inventories of fluorine, hydrogen fluoride, and chlorine trifluoride are used in the process or are bound chemically with the uranium. In addition, as is quite common at industrial facilities, chlorine is used for water treatment. These materials, especially hydrogen fluoride, produced in the reaction of UF6 with atmospheric moisture, are the primary hazardous chemicals of concern at GDP facilities.

Both EPA and OSHA are tasked with ensuring safe operating practices at chemical facilities throughout the U.S. which handle and process hazardous materials. Recently (December 1996) a memorandum of understanding was established between the EPA and OSHA which defines the strategy for these government agencies to jointly investigate major chemical accidents.

Regulatory guidelines for the investigation of chemical accidents are embodied in the OSHA Occupational Safety and Health Act of 1970 and the more recent 29 CFR 1910.119 OSHA regulations on Process Safety Management. EPA's authority over the proper management of hazardous materials at chemical plants such as the GDPs includes the Resource Conservation and Recovery Act, Section 3008; the Comprehensive Environmental Response Compensation and Liability Act, Section 103; the Emergency Planning and Community Right to Know Act, Section 325; the Toxic Substances Control Act, Section 16; and the Clean Air Act, Section 113.

Table 2 summarizes the base NRC civil monetary penalties levied for accidents at nuclear facilities and compares those civil penalties to EPA and OSHA civil penalties for accidents involving highly hazardous chemical materials at U.S. industrial facilities.

Because the potential GDP risk of injury to on-site workers or the off-site public is primarily from accidental hazardous chemical releases, it would be appropriate to assign a civil monetary penalty consistent with the statutory maximum penalty available to the EPA and OSHA, which is on the order of $27,500 per violation. The assignment of the GDPs to the same base civil penalty category as nuclear power reactors is inappropriate and the penalty amount is inconsistent with that utilized by other federal agencies for similar facilities where, like the GDPs, the principal risk is due to non-nuclear hazards.

Table 2 Comparison of Civil Monetary Penalties for U.S. Industry Regulated Industry U.S. Code Citation/Reference Penalty Notes Nuclear Power - Reactors NUREG 1600, Table IA, a $110,000 (I)

Nuclear Fuel Production - Gaseous NUREG 1600, Table IA, a $110,000 (I)

Diffusion Plants Nuclear Fuel Produchon/Manufactunng NUREG 1600, Table IA, b $27,500 (I)

- Fuel Fabrication Facilities Nuclear Fuel Manufactunng/Produchon NUREG 1600, Table I A, c $11 ,000 (I)

- Fuel Refming and Milling Facilities and Test Reactors Nuclear Research Fac11Jt1es NUREU louu, Table IA, d $5,5uu (1)

Chemical, Petrochemical, Industrial EPA - Resource Conservation & $27,500 (2) and Manufacturing Industries - Recovery Act (RCRA)- Violation of Handling Acutely Hazardous Chemical Subtitle C, per violation maximum.

Materials EPA - Clean Air Act - Stationary Air $27,500 (2), (3)

Pollution Sources, Civil Penalty per violation EPA - Toxic Substances Control Act - $27,500 (2)

PCBs, per violation EPA - Emergency Planning &

Community Right-To-Know Act Class I $27,500 (2)

& II Administrative and Civil Penalty, per violation EPA - Comprehensive Environmental $27,500 (2)

Response, Compensation and Liability Act, per violation OSHA Act - Section 17, Penalty $7,000 serious (4)

Structure, per violation $25,000 serious

& willful

\Jotes to 'l able 2:

(I) NUREG 1600.

(2) Adjusted for inflation per 40 CFR Parts 19 and 27, Civil Monetary Penalty Inflation Adjustment Rule, 61 Fed.

Reg. 69,390, December 31, 1996.

(3) Discussions with EPA Enforcement Branch personnel indicate that a serious accidental release (say a one-time discharge) of a regulated hazardous chemical substance would be treated as non-compliance with the Stationary Source Statutes, even though the Station Source Statutes are employed primarily for the regulation of permitted industrial chronic long term releases.

(4) Department of Labor, Occupational Safety & Health Administration, Office of General Industry Compliance Assistance, "Field Inspection Reference Manual (FIRM),Section IV.C, Penalties", September 26, 1994.

Security Significance From a nuclear material safeguards and security perspective, the policy fails to consider the reduced significance of events at a GDP. Nuclear power reactors are required to have armed security officers and a capability to defend the plant against adversaries who are well armed with automatic weapons and explosives. USEC does not possess strategic special nuclear material (Uranium enriched to above 20% U-235). The absence of strategic special nuclear material combined with the low radiological inventory, allows the USEC leased facilities to be placed in Security Protection Category III; which has much lower security protection requirements than Category I in which nuclear power plants fall. For example, a GDP is not required to have alarmed fence lines, CCTV cameras, redundant alarm stations manned 24-hours a day, and supplementary weaponry to counter terrorist adversaries. The requirement to have weapons is based on a radiological sabotage event which is not a design accident for low enriched uranium at the GDPs.

The enforcement policy does not take into account the security posture at the GDPs. The majority of examples describe events which occur at power reactors and are not relevant to the GDPs. Fines of $110,000 are excessive and do not consider the security measures in place or mandated by the NRC.

Ability to Pay With regard to the secondary factor of ability to pay, again it is inappropriate to single out the GDPs from other fuel cycle facilities whose financial resources are similar.

II. MODIFICATION TO ENFORCEMENT POLICY EXAMPLES OF VIOLATIONS Modifications are suggested in Table 3 to the examples of violations for each severity level contained in the Supplements to the Enforcement Policy. These modifications are proposed to provide consistency where appropriate between the Supplements, to clarify the intent of several of the examples, and to eliminate language which appears to exceed NRC's authority. Many of our concerns are described in more detail in the NEI comments, which we endorse. In particular, in addition to the changes which we are proposing in Table 3, we agree in principle to those comments submitted by NEI which discuss why the occurrence of an event such as the unavailability of a safety system or the loss of a criticality control may not necessarily be caused by a violation of NRC requirements and should not necessarily lead to an enforcement action in every case. While such events are serious and necessitate prompt attention, they may not be attributable to a regulatory violation and could occur through no fault of the facility operator.

Therefore, we suggest that the enforcement policy be clarified to address NEI' s comments in this regard.

Table 3 Proposed Modifications to Example Violations Example# Proposed Modification Note A. Severity Level I

5. A $,afety punit, as defined in 10 CFR 76.4 @~ the Technical Safety Requirements, er t:he epplieetieB (1) being exceeded; or
6. Significant injury or loss of life due to a loss of control over licensed or certified ffliffl~UM~ ae#vtties, (2) inehffling ehemieal preeesses that ere integral te t:he lieeesed er eort:ified eetwlly,*v . ~*radieeetwe material is Feleesed er net.

B. Severity Level II 2

  • -.1~*-1.m;!,r.iB:n;~-1iii=

-'----~=========~-----+-------I

  • ;~*1;:.;~; (J)
4. A failure te eM&hlish; implemeBt, er maiM&ill ell l:Bfflii,[)J.11[:l:.!.&l~[criticality controls (or (4) control systems) for a single nuclear criticality scenario when a critical mass of fissile material was present er Fe&SeBeely ft'reileele, such that a nuclear criticality accident was possible; or
5. The potential for a significant injury or loss of life due to a loss of control over licensed or certified (2)

I.ii~- eetivtties, inehtdillg ehemieal preeesses that ftFe iategt'el te the lieensed er eertified eetivlly, vrhether reelteaeti re material is released er net (e.g., mevement efliqttid UF4 eyliatler ey anappre red 1 1 ffletheds).

C. Severity Level III

5. A substantial potential for exposures, radiation levels, contamination levels, or releases, including (2) releases of toxic material n ttli#:illiiiiiil caused by a failure to comply with NRC

. 13. regulations, from licensed or certified activities in excess ofB@[ijregulatory limits; A system designed to prevent or mitigate a serious safety event: (a) Not being able to perform its intended function under certain conditions (e.g., safety system not operable unless utilities available, materials or components not according to specifications) iffiUlffililfi*-Iffi~l!J}y (5) fflidffiiijgf{gf)]iftffi~i ijpf]~jµ; or (b) Being degraded to the exteiit"ii-i'ai 'a"detaHeci"evaiuatfon would"be. req.uTred'fo. determlne*tts operability;

18. A failure to estehlish, maintain, er implemeet 4.lll~iiimffi.mlili.;!1.~[ Ji§((yj[ all but one criticality (6) control (er eeBtrel systems) for a single nuclear criticality scenario when a critical mass of fissile

~~~~~ ~as present er Fe&S8Bft8ly aveileele 1~::111;::~,1~::m1,1~~::~yl[mt::m::1: f:~mlifait UW:ffi!fij, such that a nuclear criticality accident was possible ;

D. Severity Level IV

8. AXa.il_lJ!~ to estehlish, implemeet, or maintain ~pµ~J#,[:~--g~ruffl:)(i.(iJ.~i:J,~§:[:pf:~J.tl w:~~ilffl,~J,jj (6)

.mft§l.).a eritieelity eontrel (er eontrel systeffl) for a single nuclear criticality scenario @,9.j/~

itiii:imlffiiiit1:ijj{ffiiJ!lilmifffllll miIEJlfi when the amount of fissile material available was not, eut eeultl ha*,e eeea sufficient to result in a nuclear criticality.

Notes to Table 3:

(1) Proposed language is intended to be consistent with other Supplements of the Enforcement Policy. In addition, "Safety Limits" are only defined in§ 76.4 and the TSRs. The reference to "the application" in general should be eliminated.

(2) Events that do not involve certified materials or chemical processes that could impact the safety of certified materials should not be included as a violation example. Injuries caused by release of non-radioactive materials are outside the scope of NRC's jurisdiction. If there has been no "radioactive material . .. released" then injury must be due to purely non-radiological hazards.

(3) Proposed language is intended to be consistent with other Supplements of the Enforcement Policy and to clarify that a violation has occurred only if action steps mandated by the license or certificate are not taken.

(4) Proposed language is intended to clarify intent, which we understand is to address the loss of all criticality controls (i.e., the "complete" loss of all such controls). The change is also intended to eliminate ambiguous language (i.e., "or reasonably available").

(5) Proposed language is intended to clarify that a violation has occurred only if action steps mandated by the license or certificate are not taken, (6) USEC endorses NEI's comments concerning these examples~ namely that such events may not be attributable to a regulatory violation and could occur through no fault of the facility operator. In the absence of deleting these examples completely, USEC has, at the very least, proposed language which is intended to (a) clarify intent which we believe is to address a loss of double contingency, but not all criticality controls, (b) clarify that a violation has occurred only if action steps mandated by the license or certificate are not taken, and (c) eliminate ambiguous language (i.e., "or reasonably available" and "but could have been").

References to Table 1: Basis for hazard and risk values

[1] GDP RADIOLOGICAL INVENTORY 1.2 E6 lbs UF6 for 2260 MW

- Based on Table 4.1.1-1 Portsmouth SAR.

0.676 lb U/lb UF6 and 2.2 lb/Kg gives 379 E6 gm U Natural Uranium has specific activity of 7 E-7 Ci/gm, hence 379 E6 x 7 E-7 = 265 Curies (rounded off to 270 Curies)

[2] RELEASE FOR WORST GDP OPERATIONAL ACCIDENT 62,400 lb UF6 release

- Based on Section 3.4.2.1.1.7, Updated SAR, POEF-LMES-89.

Similar to above this corresponds to 13 Curies of Uranium.

[3] GDP SITE BOUNDARY RADIOLOGICAL DOSE Rounded off to 0.9 Rem

- Based on Table 3.4.9, Updated SAR, POEF-LMES-89.

[4] WORST CASE GDP OFF-SITE CONSEQUENCES Threshold for life-threatening effects is 50 mgU uptake or 50 ppm HF.

- Based on Tables 5-6 and 5-7, RTM-96, Supplement for the Portsmouth GDP, Response Technical Manual.

Distance to above thresholds is 2.4 miles and 1.4 miles, respectively.

- Based on Figures 3.4-23 and 3.4-25, Updated SAR, POEF-LMES-89.

Maximum number of persons in one sector out to 2.4 miles is approximately 150. This is 53 at 1-2 miles plus 1/2 of 203 at 2-3 miles to SSW in year 2000.

- Based on Figure 1.3-9, Updated SAR, POEF-LMES-89.

[5] 1000 MWE RADIOLOGICAL INVENTORY 343 E6 Curies of noble gases 715 E6 Curies of Iodine 1.1E9 Curies of noble gases and iodine

- Based on core inventory per MWE by nuclide from WASH-1400.

(6) RELEASE FOR 1000 MWE DESIGN BASIS ACCIDENT 343 E3 Curies of noble gases E3 Curies of Iodine 350 E3 Curies of noble gases and iodine released in first 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />

- Based on item 4 core inventory, 0.1 % per day containment leak rate and a decontamination factor of 100 for 25% of iodine.

(7) 1000 MWE SITE BOUNDARY DOSE FOR BEYOND DESIGN BASIS ACCIDENT 140,000 Rem

- Based on "U.S. Department of Energy Defense Programs Safety Survey Report," November 1993.

[8] WORST CASE 1000 MWE OFF-SITE CONSEQUENCES 3000 to 80,000 fatalities

- Latent cancer fatalities for 5 reference plants for internal initiating events at lE-8/yr. Exceedance frequency from "Severe Accident Risks: An Assessment for Five U.S. Nuclear Power Plants," NUREG-1150, Vol. 1.

DOCKETED lij&-01 -P]

'97 FEB l O A10 :54 NUCLEAR REGULATORY COMMISSION OFFICE OF SECR~/ARY

[NUREG-1600] DOCKE TING &. ,.,EK ICF BHAHCH Pol icy and Procedure for Enforcement Actions; Policy Statement AGENCY: Nuclear Regulatory Commission.

DOCKETN BER PROPOSED RU r5 c.,

(&~F~l,lo17J ACTION: Policy Statement: Amendment.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its General

~

Statement of Policy and Procedure for Enforcement Actions (Enforcement Policy) to modify Supplement VI, "Fuel Cycle and Materials Operations," as well as to reflect recent NRC organizational changes . The Supplement VI amendment is warranted to reflect experience gained through fuel cycle enforcement actions and as a result of the Conmission's recently designated responsibility for jurisdiction over the Gaseous Diffusion Plants (GDPs). The Enforcement Policy is also being amended to establish base civil penalties for GDPs. By a separate action published in this issue in the Federal Register, the Commission has issued a final rule amending the current regulations that govern GDPs. The revision to the Enforcement Policy reflects those amendments.

In addition, the Enforcement Policy is being amended to reflect recent NRC organizational changes . These changes redesignate which NRC officials are delegated the responsibility for performing certain enforcement functions . A

clarification is also being made to remove ambiguity as to when the Commission is to be consulted prior to issuance of certain actions proposing civil penalties.

DATES:

/2~/J,UAAd- I~ 1991 This amendment is effective on [Date~~;f-Publ ilation in the Federal Register]. Comments are due on or before [30 days after publication in the

~ ltf; lt'/97 Federal Regi ster].

ADDRESSES: Send written comments to: The Secretary of the Commission, U.S.

Nuclear Regul atory Commission, Washington, DC 20555-0001. ATTN: Docketing and Service Branch. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm, Federal workdays. Copies of comments rece i ved may be examined at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.

FOR FURTHER IN FORMATION CONTACT: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, (301) 415-2741.

SUPPLEMENTARY INFORMATION:

The Commission's Enforcement Policy was first issued on September 4, 1980. The Enforcement Policy is published as NUREG-1600, "General Statement of Policy and Procedure for NRC Enforcement Actions (60 FR 34381; June 30, 1995)." The Enforcement Policy has been amended on a number of occasions, most recently on October 18, 1996 (61 FR 54461). As a result of experience 2

f gained through fuel cycle enforcement actions and amendments 'to 10 CFR Part 76 being published today as a final regulation, an amendment to the Enforcement Policy is warranted to provide guidance on categorizing potential violations of 10 CFR Part 76 and establish base civil penalties for violation of Part 76.

This amendment to the Enforcement Policy is being issued concurrently with the new rule.

Base Cfyil Penalties Table IA of the policy, which establishes base civil penalti-es for different types of licensees, is being modified to add GOPs to category "a."

The amended table will. provide that the base civil penalty for a Severity Level I violation of the Commission's requirements by a GDP will be at the statutory limit of $110,000. In accordance with Table 1B, base civil penalties for Severity Level II and III ,violations are lesser amounts. In determining the proper civil penalty amount, the* Commission considered the structures of these tables, which generally take into account the gravity of

  • the violation as a primary consideration and the ability*to pay as a secondary consideration.

Generally, operations involving greater nuclear material inventories and greater potential consequences to the public and to workers receive ~igher civil penalties. In the case of GDPs, there are large numbers of workers at the sites, significant source term present (i.e., inventory of licensed material), and various chemical and toxic substances used as part of the GDPs operations. Therefore, in the event of an accident, there is the potential 3

i for significant radiological and non-radiological h~zards to members of the public, including workers, and the environment.

With regard to the secondary factor of ability to pay, it is not the NRC's intention that the economic impact of a civil penalty be so severe that it puts the licensee or certificate holder out of business 1 or adversely affects a licensee's or certificate holder's ability to safely conduct licensed activities. The deterrent effect of civil penalties is best served when the amount of penalties take into account a licensee's or certificate holder's ability to pay. In this case, issuing a civil penalty of less than

(

$110,000 to the Corporation for a significant violation would be disproportionate to the Corporation's significant revenues. In other words, a civil penalty of $110,000 for a Severity Level I violation would be financially appropriate, but not financially crippling. In addition, a penalty based on this amount should get more attention from the Corporation and should have a greater deterrent effect.

Given the financial resources of GDPs, it is appropriate to utilize significant civil penalties to provide an effective deterrence from violating the Connnission's requirements such that the likelihood of performance necessitating a shutdown order would be minimal. Accordingly, a base civil penalty of $110,000 is appropriate in view of the potential consequences during an accident and the ability to pay. In addition, establishing the base civil penalty at the statutory limit would provide, at the outset, a clear 1 Orders, rather than civil penalties, are used when the intent is to suspend or tenninate licensed activities.

4

message concerning the cost of noncompliance and additional motivation to maintain safety and compliance.

severity Levels The policy recognizes that regulatory requiremen~s have varying degrees of safety, safeguards, or environmental significance. Therefore, the relative importance of each violation, including both the technical significance and the regulatory significance, is evaluated as the first step in th~ enforcement process. In considering the significance of a violation, the staff considers the technical significance (i.e., actual and potential consequences) and regulatory significance. Supplement VI, "Fuel Cycle and Materials*

Operations," is being amended to provide additional examples for catego~izing the severity levels of violations.

The changes are:

Severity Level I I. Example A.5, which is being add~d to Supplement VI, is consistent with Supplement I guidance. This example is .applicable for the Gaseous Diffusion Plants (GDPs) because other fuel facilities do not have Technical Safety Requirements (TSRs).

  • Safety limits are those bounds within which the process variables must be maintained for adequate control of the operation and that must not be exceeded in order to protect the integrity of the physical system that is designed to guard against the uncontrolled release of radioactivity.

5

2. Example A.6 is being added to Supplement VI to emphasize that a significant injury or loss of life due to a loss of control over licensed or certified activities, including chemical processes that are integral to the licensed or certified activity, whether radioactive material is released or not, is of very significant regulatory concern. This concern exists because an actual impact to the health and safety of the public or workers has occurred from activities related to the processing of radioactive material.

Severity Level II

1. Example B.4 is being added to Supplement VI to emphasize that, although less significant than Example A.3 in Supplement VI, the absence of all the criticality safety controls for a single anticipated or unanticipated nuclear criticality scenario is of very significant regulatory concern when the availability of fissile material makes a nuclear criticality accident possible.
2. Example B.5 is being added to Supplement VI to underscore that events which do not involve actual significant injuries or loss of life, but reasonably could have if circumstances had been different, are considered of very significant regulatory concern.

Severity Level III

1. Example C.5 is being modified in Supplement VI so that it is consistent with Supplement IV guidance. The NRC considers that a substantial potential for exposures, radiation levels, contamination levels, or releases (including releases of toxic material) caused by the failure to comply with 6

NRC regulations or with procedures established to comply with license conditions to be a significant regulatory concern because it could have serious consequences to the public and licensee employees.

2. Example C.12 is being added to Supplement VI to emphasize that*the failure of a certified facility to comply with a limiting condition for operation is considered a significant regulatory concern. This example is similar to Supplement I guidance and has been selected for the GDPs because other fuel* cycle facilities do not have TSRs.

- 3. Example C.13 is being added to Supplement VI to emphasize that the loss of defense-in-depth over licensed or certified activities is considered a significant regulatory concern. This example is consistent with Supplement I guidance and is applicable to both fuel cycle and gaseous diffusion operations.

4. Example C.14, which is consistent with Supplement I guidance, is being added to Supplement VI. This example is generally applicable to the fuel cycle facilities.
5. Example C.15 is being added to Supplement VI. The failure to meet the requirements of 10 CFR 76.68 is significant because of the importance of certificate holders using the. required process for maintaining and operating the facilities in accordance with the design and procedures described in their safety analysis report when there is uncertainty as to whether an unreviewed safety question is present. An after-the-fact evaluation that demonstrates that an unreviewed safety question was not involved would, in general~ not mitigate the regulatory significance of failing to perform an appropriate evaluation prior to implementation of the change.

7

6. Example C.16 is being added to Supplement VI to emphasize that adequate control over vendors or contractors performing safety-related work or providing safety-related services is a _significant regulatory concern. This example amplifies the NRC's concern that all safety-related activities, I

whether performed by the certificate holder or by one of its contractors, be conducted in accordance with the requirements in the application, TSRs and certificates.

7. Example C.17, which is consistent with the Supplement I guidance, is being added to Supplement VI. This example points out that equipment failures caused by inadequate or improper maintenance that substantially complicates recovery from a plant transient is a significant regulatory concern.
8. Example C.18 is being added to Supplement IV. This example indicates that the absence of all but one criticality safety control for a single anticipated or unanticipated nuclear criticality scenario is a significant regulatory concern when a critical mass of fissile material was present or reasonably available, because a nuclear criticality accident was possible.

Severity Level IV I. Although less significant than the above examples, examples D.5 through D.8 are being added to Supplement VI to stress that such failures are more than a minor concern because they could lead to a more serious concern if left uncorrected.

8

Organizational Changes In addition to the above changes, recent NRC organizational changes have redistributed certain staff functions reporting to the Executive Director for Operations. Under the previous organization, the Deputy Executive Director for Nuclear Material Safety, Safeguards, and Operations Support (DEDS) was delegated the authority to approve and/or issue escalated enforcement actions associated with licensees of the Office of Nuclear Material Safety and Safeguards (NMSS). Similarly, the Deputy Executive Director for Nuclear Reactor Regulation, Regional Operations, and Research (DEDR) was delegated the authority to approve and/or issue escalated enforcement actions associated with licensees of the Office of Nuclear Reactor Regulation (NRR). Based on this distribution of functions, these two Deputy Executive Directors we~e designated as the principal enforcement officers of the NRC.

The NRC organizational changes have replaced the previous two Deputy Executive Director positions with three new Deputy Executive Director positions. Under the new organizational arrangement, the NRC Office of Enforcement (OE) reports to the Deputy Executive Director for Regulatory Effectiveness, Program Oversight, Investigations, and Enforcement (DEDO), and NHSS and NRR both r~port to the Deputy Executive Director for Regulatory Programs (DEDR). This change ~n reporting responsibilities consolidates the technical office oversight under the new DEDR, and redesignates a single deputy, the DED0 as the NRC's principal enforcement officer.

9 Consistent with this change, the NRC Enforcement Policy is being modified to replace all previous references to either Deputy Executive 9

Director with references to the DEDO. As such, the Enforcement Policy will designate the DEDO as having the authority to approve and/or issue escalated enforcement actions associated with either NRR or NMSS licensees. These changes will be reflected in the amendment to NUREG-1600.

Clarification The Co11111ission previously published (61 FR 65088, December 10, 1996) changes to the Enforcement Policy concerning consultation with the Commission prior to issuance of enforcement actions that proposed a civil penalty more than three times the Severity Level value shown in Table IA for a single violation. The Co11111ission is re-publishing that portion of the Policy (Section III.2) with slightly revised language to remove ambiguity and make clear that the requirement applies to a single violation or problem and not the total of multiple penalties that may be proposed in one enforcement action. This is consistent with the Connnission's original understanding and intent.

Paperwork Reduction Act Statement This policy statement does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval number 3150-0136. The approved information collection requirements contained in this policy statement appear in Section VII.C.

10

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB control number.

Small Business Regulatory Enforcement Fairness Act

/

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a "major rule" and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

Accordingly, the NRC Enforcement Policy is amended by:

a. Changing the first paragraph under Section Ill, "Responsibilities,"

by designating the principal enforcement officer of the NRC as *the Deputy Executive Director for Regulatory Effectiveness, Program Oversight, Investigations, and Enforcement (DEDO), hereafter referred to as the Deputy Executive Director," and deleting the references to th~ former Deputy Executive Director for Nuclear Material Safety, Safeguards, and Operations Support (DEDS) and the former Deputy Executive Director for Nuclear Reactor Regulation, Regional Operations, and Research (DEDR).

b. Revising all subsequent references to "the appropriate Deputy Executive Director" to read "the Deputy Executive Director."

11

c. Revising Section III, "Responsibilities,"Section VI, "Enforcement Actions," Subsection B., Table IA, Category a., and Supplement VI, "Fuel Cycle and Materials Operations," as follows:

GENERAL STATEMENT OF POLICY AND PROCEDURE FOR NRC ENFORCEMENT ACTIONS III. RESPONSIBILITIES Unless Commission consultation or notification is required by this policy, the NRC staff may depart, where warranted in the public's interest, from this policy as provided in Section VII, "Exercise of Enforcement Discretion." The Commission will be provided written notification of all enforcement actions involving civil penalties or orders. The Commission will also be provided notice the first time that discretion is exercised for a plant meeting the criteri,a of Section VII.B.2. In addition, the Commission will be consulted prior to taking action in the following situations (unless the urgency of the situation dictates immediate action):

(2) Proposals to impose a civil penalty for a single violation or problem that is greater than 3 times the Severity Level I value shown in Table IA for that class of licensee; 12

YI. EHFORCEMENT ACTIONS 13

B. Civil Penalty TABLE lA-BASE CIVIL PENALTIES

a. Power reactors and gaseous diffusion plants ....... $110,000
b. Fuel fabricators, industrial processors, and independent spent fuel and monitored retrievable storage installations .................. $27,500
c. Test reactors, mills and uranium conversion facilities, contractors, vendors, waste disposal licensees, and industrial radiographers ...................................... $11,000
d. Research reactors, academic, medical, or other material licensee 1 . . . . . . . . . . . . . . . . . . . . . . . . . $5,500 1

This applies to nonprofit institutions not otherwise categorized in this table, mobile nuclear services, nuclear phannacies, and physician offices.

14

SUPPLEMENT VI--FUEL CYCLE AND MATERIALS OPERATIONS This supplement provides examples of violations in each of the four severity levels as guidance in determining the appropriate severity level for violations in the area of fuel cycle, gaseous diffusion plants, and materials operations.

A. Severity Level I - Violations involving for example:

3. A nuclear criticality accident;
4. A failure to follow the procedures of the quality management program, required by 10 CFR 35.32, that results in a death or serious *injury (e.g., substantial organ impairment) to a patient;
5. A safety limit, as defined in 10 CFR 76.4, the Technical Safety Requirements, or the application being exceeded; or
6. Significant injury or loss of life due to a loss of control over licensed or certified activities, including chemical processes that are integral to the licensed or certified activity, whether radioactive material is released or not.

B. Severity Level II - Violations involving for example:

2. A system designed to prevent or mitigate a serious safety event being inoperable; 15
3. A substantial prograrrmatic failure in the implementation of the quality management program required by 10 CFR 35.32 that results in a misadministration;
4. A failure to establish, implement, or maintain all criticality controls (or control systems} for a single nuclear criticality scenario when a critical mass of fissile material was present or reasonably available, such that a nuclear criticality accident was possible; or
5. The potential for a significant injury or loss of life due to a loss of control over licensed or certified activities, including chemical processes that are integral to the licensed or certified activity, whether radioactive material is released or not (e.g., movement of liquid UF 6 cylinder by unapproved methods}.

C. Severity Level III - Violations involving for example:

1. A failure to control access to licensed materials for radiation protection purposes as specified by NRC requirements; 5.

A substantial potential for exposures, radiation levels, contamination levels, *or releases, including releases of toxic material caused by a failure to comply with NRC regulations, from licensed or certified activities in excess of regulatory limits;

10. A failure to receive required NRC approval prior to the implementation of a change in licensed activities that has radiological or programmatic significance, such as, a change in ownership; lack of an RSO or 16

replacement of an RSO with an unqualified individual; a change in the location where licensed activities are being conducted, or where licensed material is being stored where the new facilities do not meet safety guidelines; or a change in the quantity or type of radioactive material being processed or used that has radiological significance;

11. A significant failure to meet deco1T111issioning requirements including a failure to notify the NRC as required by regulation or license condition, substant.ial failure to meet deco1T111issioning standards, failure to conduct and/or complete deco1T111issioning acti.vities in accordance with regulation or license condition, or failure to meet required schedules without adequate justification;
12. A significant failure to comply with the action statement for*a Technical Safety Requirement Limiting Condition for Operation where the appropriate action was not taken within the required time, such as:

{a) In an autoclave, where a containment isolation valve is inoperable for a period in excess of that allowed by the action stateme~t; or

{b) Cranes or other lifting devices engaged in the movement of cylinders hav*ing inoperable safety components, such as redundant braking systems, or other safety devices for a period in excess of that allowed by the action* statement;

13. A system designed to prevent or mitigate a serious safety event:

{a) Not being able to perfonn its intended function under certain conditions (e.g., safety system not operable unless utilities available, materials or components not according to specifications);* or

{b) Being degraded to the *extent that a detailed evaluation would be required to detennine its operability; 17

14. Changes in parameters that cause unanticipated reductions in margins of safety;
15. A significant failure to meet the requirements of 10 CFR 76.68, including a failure such that a required certificate amendment was not sought;
16. A failure of the certificate holder to conduct adequate oversight of vendors or contractors resulting in the use of products or services ,that are of defective or indeterminate quality and that have safety significance;
17. Equipment failures caused by inadequate or improper maintenance that substantially complicates recovery from a plant transient; or
18. A failure to establish, maintain, or implement all but one criticality control (or control systems) for a single nuclear criticality scenario when a critical mass of fissile material was present or reasonably available, such that a nuclear criticality accident was possible.

D. Severity Level IV - Violations involving for example:

2. Other violations that have more than minor safety or environmental significance;
3. Failure to follow the quality management (QM) program, including procedures, whether or not a misadministration occurs, provided the failures are isolated, do not demonstrate a progranunatic weakness in the implementation of the QM program, and have limited consequences if a misadministration is involved; failure to conduct the required program review; or failure to take corrective actions as required by 10 CFR 35.32;
4. A failure to keep the records required by 10 CFR 35.32 or 35.33; 18
5. A less significant failure to comply with the Action Statement for a Technical Safety Requirement Limiting Condition for Operation when the appropriate action was not taken within the required time;
6. A failure to meet the requirements of 10 CFR 76.68 that does not result in a Severity Level I, II, or III violation;
7. A failure to make a required written event report, as required by 10 CFR 76.120{d)(2); or
8. A failure to establish, implement, or maintain a criticality control
  • (or control system) for a single nuclear criticality scenario when the amount of fissile material available was not, but could have been sufficient to result in a nuclear criticality.

Dated at Rockville, Maryland, this lrJ:!: day of February, 1997.

For the Nuclear Regulatory Commission.

etaryof the Commission.

19

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