EA-97-241 - Merck and Company, Inc.
Michael D. Kastello, D.V.M., PH.D.
Merck and Company, Inc.
Merck, Sharp, and Dohme Research Laboratories
P.O. Box 2000
Rahway, New Jersey 07065
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-14680/97-001)
Dear Dr. Kastello:
This refers to the NRC inspection conducted on April 8-11 and 24, 1997, at the above address in Rahway, New Jersey. During the inspection, two violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated May 23, 1997. In the May 23, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference. In a telephone conversation on June 2, 1997, Mr. Glenn Sturchio, of your staff, requested a conference. The predecisional enforcement conference was held on June 23, 1997, to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be sent to you by separate correspondence.
Based on the information developed during the inspection and the information you provided during the enforcement conference, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding the violations are described in detail in the subject inspection report. The violations involve: (1) the improper disposal of 880 microcuries of iodine-125 at a municipal waste incinerator; and (2) the failure to perform a radiation survey of the package containing the material prior to releasing it for disposal. The user of the material what he incorrectly though was an empty package in a corridor outside his laboratory for routine trash pickup. However, he did not perform the required direct reading survey for fixed contamination and radiation prior to placing it in the corridor. Afterwards, the package, which apparently still contained iodine-125, was removed and disposed of in the normal trash, and incinerated in a local community incinerator.
While the amount of radioactive material was small, and calculations indicate that exposure to the public from the improper disposal was unlikely, these violations, nonetheless, represents a regulatory concern because they involved the improper disposal of radioactive material. Therefore, the violations are classified in the aggregate at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two inspections conducted in 1995 and 1992/1993, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were described in your letter to the NRC, included: (1) initial attempts to locate the material including contacts with the incinerator; (2) survey of the incinerator's ash collection system, including surveys and samples, in an attempt to detect any radioactive material; (3) revision of guidance for receiving and opening packages containing radioactive material, and requiring all users to review and sign the guidance; (4) issuance of a noncompliance letter to the Radioactive Material Holder to reiterate the package opening procedure; and (5) issuance of a radiation safety notice to all radioactive material users, reminding them of the need to do surveys and search packages thoroughly when they are received.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. 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 and its enclosure, will be placed in the NRC Public Document Room (PDR).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-14680
License No. 29-00117-06
Enclosure: Notice of Violation
State of New Jersey
Merck and Company, Inc. Docket No. 030-14680 Rahway, New Jersey License No. 29-00117-06 EA 97-241
During an NRC inspection conducted on April 8-11 and 24, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:
A. 10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain specified procedures.
Contrary to the above, on April 10, 1997, the licensee disposed of 880 microcuries of iodine-125 by release to the non-radioactive trash, a method not authorized by §20.2001.
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.
Contrary to the above, the licensee did not make surveys to assure compliance with 10 CFR 20.2001(a), which describes authorized means of disposing of licensed material. Specifically, on April 10, 1997, the licensee did not perform a survey before disposing of a package, which contained iodine 125, as normal, non-radioactive waste. (02013)
These violations are classified in the aggregate at Severity Level III (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, Merck and Company, Inc., is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
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 King of Prussia, Pennsylvania
this 26th day of June 1997