EA-97-258 - Ohio State University

October 23, 1997

EA 97-258

E. Gordon Gee, Ph.D., President
The Ohio State University
Bricker Hall
Office of President
190 North Oval Mall, Room 205
Columbus, OH 43210-1357

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES-$13,000 and DEMAND FOR INFORMATION (Inspection Reports No. 030-02640/96003(DNMS); and No. 030-02640/97001(DNMS) and OI Investigation Report No. 3-96-041)

Dear Dr. Gee:

This refers to the inspections conducted between June 1996 and April 1997, and the investigation conducted by the NRC Office of Investigations (OI) between August 1996 and May 1997 at The Ohio State University (OSU) in Columbus, Ohio. The inspection reports and the synopsis of the OI findings were sent to your staff by letters dated January 27, June 12, and July 10, 1997. On July 17, 1997, a transcribed predecisional enforcement conference was held in the NRC Region III office with members of the OSU staff to discuss the violations, their causes, and proposed corrective actions.

Based on the information developed during the inspection, the investigation, and the information provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice), and the circumstances surrounding them have been described in detail in the subject inspection reports.

The violations cited in Section I.A of the Notice involve failure to conduct physical inventories of brachytherapy and other sealed and unsealed sources and failure to dispose of accumulated radioactive waste. The violations involving failure to conduct physical inventories are directly repetitive of violations cited in the June 10, 1994 enforcement action against OSU. On numerous occasions since 1991, NRC inspectors have brought to the attention of your staff and to those who preceded your staff, violations and other concerns regarding deficiencies in the accountability and control of licensed material and the accumulation and long term storage of unusable radioactive material at OSU. Additionally, OSU self-assessments disclosed problems or suspected problems associated with the sealed source inventory and accountability programs including at least one known missing source, and with the long term storage of orphaned sources and uncharacterized waste. Notwithstanding these prior notices and self-assessments, known or suspected problems were not adequately addressed in a timely manner, and certain problems were allowed to continue. The failure to correct known violations and known conditions with the potential to result in violations of NRC requirements are considered willful in that they represent a careless disregard for NRC regulations and license conditions by those responsible for program activities at OSU.

The NRC is corresponding directly with OSU's former radiation safety officer (RSO) concerning this issue. You will receive a copy of that correspondence under separate cover.

The OI investigation revealed that problems were not addressed because the radiation safety office did not have sufficient resources available. The resources that were available were used to handle more pressing program areas such as patient services and research activities. Although the resource problems which led to NRC violations were brought to the attention of OSU management, the problems were not corrected effectively. Moreover, the issue of willfully allowing violations to continue uncorrected because of resource deficiencies was the subject of an enforcement action that the NRC took against OSU in 1994. ⁽¹⁾ The NRC stated in that enforcement action:

It is of particular concern that the [OSU] Audit Subcommittee clearly knew, by May 18, 1993, if not sooner, that there were specific directives in the University's new NRC license that the radiation safety staff had not been able to comply with completely, and that NRC had issued penalties at peer institutions for similar problems, and yet no action was taken by the subcommittee or the committee to curtail licensed activities as necessary to bring the remaining program into compliance, nor did committee or University officials contact the NRC to discuss the situation and determine a course of action. You should be aware that licensees who operate in knowing noncompliance of NRC requirements may be subject to significant enforcement sanctions including criminal sanctions. The radiation safety officer and the radiation safety committee must have authority to curtail activities as necessary and must exercise that authority to assure compliance at all times.

As part of the 1994 enforcement action, NRC requested that OSU develop and submit a Radiation Safety Improvement Plan that focused, in part, on assuring sufficient resources to prevent a recurrence of this problem. NRC made the Radiation Safety Improvement Plan a condition of OSU's license by Confirmatory Order dated November 8, 1994 (EA 94-215). However, the Radiation Safety Improvement Plan has failed to prevent the recurrence of similar willful violations, therefore, the NRC is issuing the Demand for Information set forth below.

The above failures are of significant safety and regulatory concern because of the potential for material to enter into the public domain and affect public health and safety. NRC relies on its licensees, particularly those with broadscope programs of the magnitude of OSU's, to conduct licensed activities with integrity. Failure to implement timely and effective corrective actions for previously identified problems resulted in the violations discussed in Section I.A of the Notice. These violations represent a very significant regulatory concern and are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level II problem.

The violations in Section I.B of the Notice involve the failure to make timely reports to the NRC. These violations are of regulatory concern because when notifications are not made as required, NRC cannot execute its regulatory responsibility in a timely manner. Therefore, these violations have been categorized in accordance with the Enforcement Policy as a Severity Level III problem.

The violations in Section I.C of the Notice involve the failure to secure and control licensed material. Each NRC licensee has the responsibility of protecting public health and safety by assuring that licensed material is secured and controlled from unauthorized removal. Failure to effectively control licensed material is of significant safety concern because this failure may result in an inadvertent release of radioactive material into the public domain. In this case, two packages containing licensed material have not been found and may be in the public domain. Therefore, these violations are categorized in accordance with the Enforcement Policy as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,000 is considered for a Severity Level II problem and a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation or problem. Because your facility has been the subject of escalated enforcement action in the last two inspections, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy.

As to the violations in Section I of the Notice, the NRC has determined that credit for identification is warranted since OSU identified problems with radioactive material inventory andwaste storage that needed corrective action. The former RSO was aware of the existence of the inventory violation and other problems that likely represented violations; however, this individual, along with OSU management, did not take sufficient corrective action to address these problems upon learning of them. At the predecisional enforcement conference, your staff presented corrective actions taken and/or planned to address the violations. Those actions included: (1) creation of a full set of standard operating procedures in an effort to clarify program requirements for all users, (2) addition of resources to address radiation safety program and staff needs, (3) disposal of 2000 cubic feet of radioactive waste including numerous sealed sources, (4) implementation of an enforcement and sanction program for researchers that fail to follow requirements, and (5) heightened program oversight by the Offices of Business and Administration and Environmental Health and Safety. Although actions were taken to rectify program deficiencies, credit for Corrective Action is not warranted. Section VI.B.2.c of the Enforcement Policy states, "Notwithstanding eventual good comprehensive corrective action, if immediate corrective action was not taken to restore safety and compliance once the violation was identified, corrective action would not Dr. E. Gee be considered prompt and comprehensive." In this case, such action was not taken and therefore, normally, a base civil penalty of $4,000 would be proposed. However, the violations in Section I.A of the Notice reflect particularly poor performance. The RSO and management allowed the violations, some of which were repetitive, to continue after initial identification, demonstrating careless disregard for NRC requirements. Therefore, the NRC is exercising discretion in accordance with Section VII.A.1(g) of the Enforcement Policy and is proposing a civil penalty twice the base, or $8,000 for the violations identified in Section I.A of the Notice.

Credit for Identification is not appropriate for the violations in Sections I.B and I.C because NRC identified Violations I.B.1, I.B.2, and I.C.1, and because both examples in Violation I.C.2, involving loss of licensed material, were essentially self-disclosing. Credit for Corrective action is appropriate for the violations in Sections I.B and I.C based on improvements in procedures for reporting to NRC and securing licensed materials outlined in your letter dated July 16, 1997, and as described at the predecisional enforcement conference.

Therefore, to emphasize: (1) the need for senior licensee management to provide sufficient oversight, direction, and resources to assure that Commission requirements are met; (2) the unacceptability of violations that represent careless disregard of NRC requirements; and (3) the need for prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, and the Acting Deputy Director for Regulatory Effectiveness, to issue the following proposed penalties which are addressed in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties:

A. Section I.A - Severity Level II problem at twice the base in the sum of $8,000,

B. Section I.B - Severity Level III problem at the base amount of $2,500, and

C. Section I.C - Severity Level III problem at the base amount of $2,500.

The violations in Section II of the Notice include the failure to use the proper laboratory gear and equipment, the failure to evaluate the solubility of releases into the sanitary sewerage, release of insoluble material into the sanitary sewerage, failure to block and brace packages, and failure to appropriately place shipping papers in a transport vehicle. Each of these violations are of more than minor concern and have been categorized at Severity Level IV in accordance with the Enforcement Policy.

Demand for Information

In addition to the Notice of Violation and Proposed Imposition of Civil Penalties (NOV), the NRC is issuing this Demand for Information (DFI) because, as discussed above, the Radiation Safety Improvement Plan developed by OSU and required as a condition of OSU's NRC license failed to prevent recurrent willful violations caused by inadequate resources being devoted to the radiation safety program. Moreover, OSU has exhibited continued poor performance in the areas of radioactive material security, sealed source inventory and accountability, and disposal of stored radioactive waste; and has demonstrated significant deficiencies in its overall ability to effectively manage licensed activities. Therefore, in addition to the response required above, the Commission requires further information concerning the ability of OSU to effectively conduct program activities as a broadscope licensee. Accordingly, pursuant to sections 81, 161c, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.204 and 10 CFR 30.32(b), in order to determine whether further action should be taken to assure compliance with NRC regulatory requirements, OSU is required, pursuant to this Demand for Information, to submit to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 60 days of the date of this DFI, the following information, in writing and under oath or affirmation:

A. Why should the NRC not take action to rescind the OSU broadscope license and issue in its place a limited, more restrictive license until NRC inspections of OSU demonstrate, over time, that OSU has the ability to manage a broadscope program?

B. Why did the Radiation Safety Improvement Plan (RSIP) developed by OSU and required by NRC Confirmatory Order dated November 8, 1994 (EA 94-215) fail to prevent violations resulting from inadequate resources being devoted to the radiation safety program?

C. In light of the past failures of the RSIP, why should NRC conclude that OSU will, in the future, comply with NRC requirements? Your response should consider specific changes OSU will effect as a result of the failures of the RSIP to assure that, in the future:

(1) adequate resources are devoted to the radiation safety program;

(2) violations of NRC requirements, or problems that could lead to violations, that are known to the radiation safety officer or other OSU managers are not allowed to continue uncorrected; and

(3) in the event that adequate resources are not available, the radiation safety officer and the radiation safety committee, both individually and collectively, have sufficient authority and direction to exercise that authority so as to curtail activities as necessary to assure compliance at all times.

In response to C. above, you should provide your views concerning the need for a permanent procedure or process to periodically (such as quarterly) poll the radiation safety officer and other key personnel to determine whether they are aware of any current or potential violations of NRC requirements, whether caused by lack of resources or otherwise; consider and record their responses at meetings of the radiation safety committee; forward the responses and the committee's action on them to upper OSU management, and establish actions that must be taken, and individuals responsible for taking them, to assure that the steps in C(3) are taken when necessary. You should also provide your views concerning the need for periodic outside audits to provide confidence to OSU senior management that resources are adequate and that NRC requirements are being met by OSU.

You are required to respond to this letter and should follow the instructions specified above in responding to the DFI and the instructions in the enclosed NOV when preparing your response to the NOV. After reviewing your responses, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC requirements. Because the issuance of this Notice constitutes escalated enforcement action, OSU may be subjected to increased inspection effort.

Finally, we note that, were it not for the corrective actions that OSU put into place between the inspections at issue and the predecisional enforcement conference, the NRC would have considered more stringent enforcement action.

Questions concerning this Demand for Information should be addressed to James Lieberman, Director, Office of Enforcement, who can be reached at (301) 415-2741.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely,

Original signed by J. Caldwell for A. Bill Beach Regional Administrator

Docket No. 030-02640
License No. 34-00293-02

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalties

cc w/encl:
Alex Shumate, Chairman
Bricker Hall
Board of Trustees
190 North Oval Mall, Room 19
Columbus, OH 43210-1356

Janet G. Pichette
Vice President for Business
and Administration
The Ohio State University
108 Bricker Hall
190 North Oval Mall
Columbus, OH 43212-1362

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTIES

The Ohio State University Columbus, Ohio

Docket No. 030-02640 License No. 34-00293-02 EA 97-258

During NRC inspections conducted between June 1996 and April 1997 and an investigation conducted between August 1996 and May 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose civil penalties pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalties are set forth below:

I. Violations Assessed Civil Penalties

A. Control of Licensed Material

1. 10 CFR 35.59(g) requires, in part, that a licensee in possession of a sealed source or brachytherapy source conduct a quarterly physical inventory of all such sources in its possession.

Contrary to the above, the licensee did not conduct a physical inventory of four brachytherapy sources that were in storage and not in use from October 8, 1993 to April 4, 1994, at which time the sources could not be located. (01012)

2. Condition 15 of License No. 34-00293-02, amendment #71 dated June 29, 1992, requires that the licensee conduct a physical inventory every 3 months to account for all sources and/or devices received and possessed pursuant to 10 CFR 35.59, 10 CFR 35.400 and 10 CFR 35.500 and every 6 months for all other sources and/or devices. Amendment #74 dated July 2, 1993 requires, in part, that the licensee conduct a physical inventory every six months for all other sealed and unsealed sources and/or devices.

Contrary to the above, between June 29, 1992, and April 5, 1996, six sealed sources other than those possessed pursuant to 10 CFR 35 were not physically inventoried every 6 months. Specifically: (1) a 22 millicurie cesium-137 sealed source was not physically inventoried from approximately June 1993 until it was identified as missing in June 1994; (2) an 8 millicurie americium-241 sealed source was not physically inventoried between June 29, 1992, and April 21, 1994, and between December 23, 1994, and March 29, 1996; and (3) four cobalt-60 sealed sources ranging in activity from approximately 0.4 millicuries to 2 millicuries were not physically inventoried from June 29, 1992, until April 3, 1996. Additionally, a physical inventory of unsealed sources was not performed between 1994 and July 1996. (01022)

3. Condition 20 of License No. 34-00293-02, amendment # 71, dated June 29, 1992, requires that radioactive waste awaiting disposal via shipment to a final disposal site not be stored for a period greater than 2 years. Condition 21, amendment #71, requires that waste currently possessed exceeding the storage provisions of Condition 20 be disposed of within one year of the issuance of this license. (The license was amended in its entirety (issued) on June 29, 1992).

Contrary to the above, radioactive waste possessed by the licensee and waiting to be characterized and disposed via shipment to a final disposal site was stored within the Bulk Chemical Warehouse and Corrosive Storage Bunkers from at least the inception of the requirement in June 1992 through July 1996. This exceeds the storage time limitations of both Conditions 20 and 21. (01032)

These violations represent a Severity Level II problem (Supplement VI).
Civil Penalty - $8,000.

B. Reporting Requirements

1. 10 CFR 20.2201 (a)(i) and (ii) require, in part, that each licensee report by telephone to the NRC, immediately after its occurrence becomes known, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in appendix C to Part 20, under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas; or within 30 days after it becomes known that any material in quantities greater than 10 times the quantity specified in appendix C to part 20 is lost, stolen or missing.

Contrary to the above, on two occasions, the licensee failed to make an immediate telephone report or a 30 day report to the NRC that licensed material in an aggregate quantity greater than 1,000 times the quantity specified in appendix C to 10 CFR 20 was missing. Specifically, in April 1994, four cesium-137 brachytherapy sealed sources totaling approximately 35 millicuries were identified as missing, and in June 1994, one 12 millicurie cesium-137 sealed source was also identified by the licensee as missing, and in neither case did the licensee make an immediate report or a 30 day report to the NRC. (02013)

2. Condition 15 of License No. 34-00293-02, amendment #53 dated April 2, 1982 and Condition 13, amendment #71 dated June 29, 1992 require, in part, that if a leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall file a report to the NRC within five days of the test describing the equipment involved, the test results, and the corrective action taken.

Contrary to the above, as of June 24, 1996, the licensee failed to file a report with the NRC regarding a sealed source which was leaking in excess of regulatory limits. Specifically, on March 25, 1991, a sealed source containing a nominal activity of 8 millicuries of americium-241 was identified to have greater than 0.005 microcuries of removable contamination and the licensee did not file the required report with the NRC. (02023)

These violations represent a Severity Level III problem (Supplement IV).
Civil Penalty - $2500.

C. Security of Radioactive Material

1. 10 CFR 20.1801 requires, in part, that the licensee secure from unauthorized removal or access licensed material that is stored in unrestricted areas. As defined in 10 CFR 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on the evenings of June 25, 27, and December 3, 1996, the licensee did not secure from unauthorized removal or limit access to licensed material stored in unrestricted areas. Specifically, licensed material totaling approximately 15 millicuries of sulfur-35, 15 millicuries of carbon-14, 10 millicuries of tritium and 250 microcuries of phosphorus-32 was stored in six research laboratories located in the Biological Science building, Graves Hall, and Medical Research Facility. The material was not secured from unauthorized removal nor was access to it limited by the licensee. (03013)

2. 10 CFR 20.1802 requires, in part, that the licensee control and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on February 26 and March 28, 1997, the licensee did not maintain control and constant surveillance of two packages containing licensed material located in an unrestricted area. Specifically, on two separate occasions a package containing 250 microcuries of phosphorus-32 was left unattended and unsecured in the receiving department and subsequently within an unlocked transport vehicle. Both packages were lost or stolen and could not be located. (03023)

These violations represent a Severity Level III problem (Supplement IV).
Civil Penalty - $2500.

II. Violations Not Assessed a Civil Penalty

A. Condition 40 of License No. 34-00293-02 requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in applications dated July 29, 1986 and February 21, 1991, and several referenced letters.

Item 15 of the application dated July 29, 1986, entitled "General Rules for The Safe Use Of Radioactive Material" requires that all laboratory procedures in the Approved Supervisor's approved application for the use of radioactive materials be followed. Item 15 also requires that laboratory coats and disposable gloves be worn.

The experimental protocol (lab procedure) for "In Vivo Phosphorylation of Cells and Explants" submitted by an Approved Supervisor applicant and approved by the Radiation Safety Committee requires, in part, that workers use double gloves. The procedure also specifies that tissue samples be placed into screw cap flasks with 3 milliliters of media and 3 millicuries of P-32.

Contrary to the above, a researcher did not follow all approved laboratory procedures during the in vivo cell phosphorylation experiment. Specifically, on March 6, 1996, a researcher conducted an experiment using a snap-type cap and vial which contained 2.5 millicuries of phosphorus-32. During the experiment, pressure buildup caused the snap cap to be expelled and contaminate the experimental apparatus. In addition, gloves and a lab coat were not worn while handling the vial which resulted in contamination to the skin of the researcher's right hand during retrieval of the vial cap. (04014)

This is a Severity Level IV violation (Supplement VI).

B. 10 CFR 20.1501 requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present. Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

10 CFR 20.2003(a)(1) requires that licensed material discharged into the sanitary sewerage system be readily soluble or readily dispersible biological material in water.

Contrary to the above: (1) the licensee did not make surveys (evaluations) to assure compliance with 10 CFR 20.2003(a)(1), which limits the disposal of licensed material by release into the sanitary sewerage system to readily soluble or readily dispersible biologic material; and (2) the licensee discharged small quantities of licensed material that was not readily soluble or readily dispersible biological material into the sanitary sewer. Specifically, from January 1994 to August 1996, based on the results of an evaluation conducted in August and September 1996, the licensee discharged 1.21 millicuries of H-3, 0.35 millicuries of C-14 and approximately 0.5 millicuries of I-125, in insoluble form, into the sanitary sewer. (04024)

This is a Severity Level IV violation (Supplement IV).

C. 10 CFR 71.5(a) requires, in part, that a licensee who transports licensed material outside the site of usage as specified on the NRC license, or on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.

49 CFR 177.842 requires, in part, that packages of radioactive materials be so blocked or braced that they cannot change position during conditions normally incident to transportation.

Contrary to the above, between January 1995 and June 25, 1996, the radiation safety office routinely transported DOT labeled packages containing varying quantities and types of radioactive material from the Ohio State University receiving dock to various campus research buildings on public highways and, on numerous occasions, the packages were not blocked and braced within the transport vehicle such that they could not change position during conditions normally incident to transportation. (04034)

This is a Severity Level IV violation (Supplement V).

D. 10 CFR 71.5(a) requires that a licensee who transports licensed material outside the site of usage as specified on the NRC license, or on public highways, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.

49 CFR 177.817(e) requires, in part, that the driver of a motor vehicle containing hazardous material ensure that the shipping paper is readily available to, and recognizable by, authorities in the event of accident or inspection. Specifically, the driver shall clearly distinguish the shipping paper, if it is carried with other shipping papers or other papers of any kind, by either distinctively tabbing it or by having it appear first.

Contrary to the above, between January 1995 and June 25, 1996, the radiation safety office routinely transported radioactive material packages from the Ohio State University receiving dock to various campus research buildings on public highways, and the driver of the vehicle did not ensure that the shipping paper was clearly distinguished from other documents carried in a binder within the transport vehicle. (04044)

This is a Severity Level IV violation (Supplement V).

Pursuant to the provisions of 10 CFR 2.201, The Ohio State University (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 60 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalties (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalties by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalties, in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalties will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation(s) listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalties should not be imposed. In addition to protesting the civil penalties, in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalties, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing civil penalties.

Upon failure to pay any civil penalties due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234(c) of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalties, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint, North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at Lisle, Illinois
this 23rd day of October 1997

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1. The NRC issued a Notice of Violation for a Severity Level II problem and a Severity Level III problem for a total $17,750 civil penalty for a programmatic breakdown on June 10, 1994 (EA 94-032).