EA-02-120 - Meprolight, Inc.
September 9, 2002
1121 12th Street NW
Washington, DC 20005
|SUBJECT: ||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $3,000 (NRC Inspection Report 03035420/2001001 and NRC Office of Investigations Report No. 4-2001-036) |
Dear Mr. Fisher:
The enclosed Notice of Violation (Notice) and Proposed Imposition of Civil Penalty is being issued based on violations of NRC requirements at Meprolight, Inc. (Meprolight). The most significant violation involved the distribution (from your facility in Yonkers, New York), in careless disregard of NRC requirements, of devices containing NRC licensed material prior to obtaining an NRC license to distribute the devices. The violations were identified during the subject inspection conducted on October 26 and November 2 and 14, 2001, and during the subsequent investigation by the NRC's Office of Investigations (OI). The factual summary of the investigation was forwarded to you on June 27, 2002.
A predecisional enforcement conference was held with Meprolight on July 10, 2002, to discuss these findings, the related violations, their causes, and the corrective actions taken or planned. At the conference, you acknowledged that the violations occurred, but denied that Meprolight employees, including yourself, acted with careless disregard of the regulations.
Notwithstanding your denial, the NRC maintains that your distribution of over 2300 products containing licensed material on December 20 and 27, 2000, prior to issuance of the NRC license on January 8, 2001, was done wilfully with careless disregard of NRC regulations. Although you were not in the country when the products were distributed, you acknowledged that as the Operations Manager, you had responsibility for the licensing process and you did not provide specific instructions to other employees to hold shipment of the devices during your absence until the NRC license was issued. In addition, your Director of Operations indicated, in documents sent to the NRC on December 4 and 5, 2000, that he had knowledge that he should not ship materials until the NRC license was issued. Nonetheless, without any regard for whether the license had been issued, the Director of Operations distributed devices in the two shipments prior to the issuance of the NRC license. Therefore, the violation is considered willful. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in the subject inspection report.
The safety significance of the violation was low because the distributed devices were designed for use by individuals with little radiation safety training and they contain small quantities of tritium (a low energy beta emitter). However, violations involving careless disregard of NRC requirements are considered willful and are of significant concern because the NRC's regulatory programs rely upon the integrity of licensee employees to comply with NRC requirements. Because of the willful nature of this violation, it was evaluated in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation.
In accordance with the current version of the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation or problem. Because the violation was willful in nature, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for identification is not warranted because the violation was identified by the NRC. Credit for corrective actions is warranted based on your corrective actions which include, but are not limited to: (1) discussing the problems with involved personnel and management; and (2) adding reviews of the event to the refresher training for all employees.
Therefore, to emphasize the importance of compliance with the regulations and of prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $3,000 for this Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
Other violations identified during the inspection are also described in the enclosed Notice. Those other violations are classified at Severity Level IV.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you may reference any previous correspondence that is applicable to this case to avoid repetitive submissions. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.
Questions concerning this Notice may be addressed to John Kinneman in Region I. Mr. Kinneman can be reached at telephone number (610) 337-5252.
| ||Sincerely, |
|Hubert J. Miller |
Docket No. 030-35420
License No. 08-23873-01E
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. NUREG/BR-0254 Payment Methods (Licensee only)
cc w/enclosure 1 only:
District of Columbia
State of New York
M. Wetterhahn, Winston & Strawn
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Meprolight, Inc. |
| ||License No. 08-23873-01E |
Docket No. 030-35420
During an NRC inspection conducted at Meprolight, Inc., Yonkers, New York, on October 26 through November 14, 2001, and a subsequent investigation by the NRC Office of Investigations (OI) that was concluded on April 30, 2002, one violation of NRC requirements was identified and assessed a civil penalty. In addition, two violations of NRC requirements are not being assessed a civil penalty. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the NRC proposes a civil penalty 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 violations and associated civil penalty are set forth below:
|I. ||VIOLATION ASSESSED A CIVIL PENALTY |
10 CFR 30.3 requires that except for persons exempt as provided in this part and Part 150 of this chapter, no person shall manufacture, produce, transfer, receive, acquire, own, possess, or use byproduct material except as authorized in a specific or general license issued pursuant to the regulations in this chapter.
Contrary to the above, Meprolight transferred (distributed) devices containing byproduct material (tritium) without being authorized by a specific license to do so. Specifically, according to Meprolight invoice records, Meprolight distributed 400 products containing tritium on December 20, 2000, and 1908 products containing tritium on December 27, 2000. These products were distributed before License No. 08-23873-01E was issued on January 8, 2001.
This is a Severity Level III violation (Supplement IV).
Civil Penalty - $3,000.
|II. ||VIOLATIONS NOT ASSESSED A CIVIL PENALTY |
|A. || |
Condition No. 10 of License No. 08-23873-01E states, in part, that the licensee may distribute additional model sights without amending the license provided the models contained in each series meet the maximum and minimum design specifications outlined in Registration Certificate No. NR-119-D-101-E.
Contrary to the above, the licensee distributed Model Numbers ML51038 and ML51039, which were not approved for distribution and were assembled into a plastic frame rather than the metal frame which was contrary to the design specifications outlined in the Registration Certificate No. NR-119-D-101-E.
This is a Severity Level IV violation (Supplement VI).
|B. || |
10 CFR 32.25 (b) requires that each person licensed under 10 CFR 32.22, label or mark each unit so that the manufacturer, processor, producer or initial transferor of the product and the byproduct material in the product can be identified.
License Condition 15A states that the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in the license application dated June 28, 2000.
Section VII.A.6 of the license application dated June 28, 2000, states that mandatory quality control procedures for receiving inspection include selecting a random sample of the devices for inspection of the proper marking and labeling to verify the presence of the logo and symbol.
Contrary to the above, as of October 26, 2001;
| ||1. ||the licensee, licensed under 10 CFR 32.22, did not label or mark units so that the initial transferor of the products and the byproduct material in the product could be identified. Specifically, products with Model Numbers ML11210FS and ML21210FS (containing 15 millicuries of tritium) were not labeled or marked with "M" (the Meprolight logo) nor "H3" (the tritium symbol) and were routinely distributed; and, |
| ||2. ||the quality control inspection of Model Numbers ML11210FS and ML212110FS was not performed to verify the presence of the labeling and marking. |
| ||These are examples of a Severity Level IV violation (Supplement VI) |
Pursuant to the provisions of 10 CFR 2.201, Meprolight, Inc. is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (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. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. 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 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.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty 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 30 days of the date of this Notice, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations 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 penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.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 a civil penalty.
Upon failure to pay any civil penalty 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 penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: F. Congel, 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 I.
Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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).
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 9th day of September 2002
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