EA-97-173 - Isomedix Operations, Inc.

May 20, 1997

EA 97-173

Isomedix Operations, Inc.
ATTN: Arnaldo Rosado, Manager
Macco Industrial Park
State Road 690, Kilometer 1.7
Barrio Sabana Hoyos
Vega Alta, Puerto Rico 00692


Dear Mr. Rosado:

This refers to the inspection conducted during the period March 31 through April 1, 1997, at your pool irradiator facility in Vega Alta, Puerto Rico. The inspection included a review of the operation of the irradiator on February 12, 1997, without a certified operator onsite. The incident was voluntarily reported to the NRC on March 19, 1997, by Abbott Health Products, Inc. (AHPI), the licensee at the time of occurrence and discovery of the event. The results of this inspection were discussed with you at the exit meeting on April 1, 1997, and were formally transmitted to you by letter dated April 23, 1997. A closed and transcribed predecisional enforcement conference was conducted in the Region II office on May 8, 1997 with you, members of the Isomedix Operations, Inc. (Isomedix) facility and Corporate staffs, and representatives of AHPI to discuss the apparent violation, the root causes, and corrective actions to preclude recurrence. A list of conference attendees, a copy of the material you provided at the conference, and NRC's presentation materials are enclosed.

Following the conference, on May 15, 1997, AHPI submitted supplemental information to the NRC regarding the circumstances surrounding the identification of the violation, immediate corrective actions taken to prevent recurrence, and a description of the factors to be considered during NRC's assessment of the enforcement policy as it relates to the violation. Also on May 15, 1997, Haythe & Curley, representing Isomedix, submitted a copy of the Asset Purchase Agreement (Agreement) between Isomedix and AHPI related to the March 19, 1997, sale of the irradiator facility at Vega Alta. The letter transmitting the Agreement requested that NRC review Section 25 of the Agreement which describes AHPI's responsibility to indemnify, defend, and hold harmless Isomedix for any violation of regulations applicable to the operation of the facility prior to the closing of the facility sale.

The NRC has completed its review of this case and determined that Isomedix, as the successor licensee and holder of the license transferred from AHPI, has the responsibility for any remedial actions to assure correction of identified violations and to prevent their recurrence. The NRC recognizes that the actual violation discussed during the predecisional enforcement conference and in this letter occurred while the license was issued to AHPI and not Isomedix. However, remedial actions are extremely important since the facility management and staff currently in place at the Vega Alta facility are the same as those who were involved in the events of February 11-12, 1997, and Isomedix is now the licensee of record.

Based on the information developed during the inspection and the information that was provided during and subsequent to the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited against Isomedix as the current licensee in the enclosed Notice of Violation (Notice). The circumstances surrounding the violation are described in detail in the subject inspection report. The violation involved the operation of the irradiator by AHPI without an authorized irradiator operator onsite on February 12, 1997, between the hours of approximately 4:00 a.m. and 6:00 a.m. As clarified during the predecisional enforcement conference, on February 11, 1997, an operator scheduled for an upcoming shift reported his inability to work due to illness. As a result, the certified operator on-shift worked extended hours to cover the vacant shift and attempted to find relief. Subsequently, the certified operator found an individual who was available to work, coordinated the replacement with the Operations Manager, and turned over shift coverage to him. Although the on-coming individual had completed classroom and on-the-job training, the individual was not certified to operate the irradiator unsupervised in that he had not completed the certification process required by 10 CFR 36.51 and the license.

At the conference, facility management admitted the violation and attributed it to a breakdown in communications between the irradiator operator and the Operations Manager and a lack of experience in such matters by the certified operator.

The actions of facility management to audit the Vega Alta operations following receipt of information regarding a similar issue at another facility, and thereby identifying the violation, are to be commended. However, the violation is of significant regulatory concern in that it represents a breakdown in the process to assure that qualified operators were available and on-shift during facility operations. Although the inspection determined that the individual in question was knowledgeable of irradiator operations and emergency response procedures, the violation nevertheless raises a significant safety concern due to the potential for substantial radiological exposures should personnel inappropriately respond to an irradiator malfunction. Inherent in the requirements in 10 CFR 36.51 and 36.65 is the importance that NRC places on the role of the irradiator operator in assuring safe operation of the facility and to act as an additional measure of safety in the event of an emergency situation. Staffing the irradiator with an operator who does not meet these requirements, even on only one occasion, undermines this principle. Furthermore, given the working environment at the time of event (i.e., worker uncertainty regarding the pending facility sale, pervasive absenteeism, and placement of the primary responsibility for acquiring replacement personnel with the certified operator on shift), management should have taken actions to assure certified operators were onshift or to make it clear that the facility operations must be shutdown if one was not available. Based upon this breakdown in the process, the violation is classified in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2250 is considered for a Severity Level III violation occurring after November 12, 1996. Because your Vega Alta facility has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process described in Section VI.B.2 of the Enforcement Policy. At the conference, you stated that your corrective actions included: (1) retraining the entire Vega Alta staff on the requirements for a certified operator to be onsite during irradiator operations; (2) implementation of a formalized shift turnover to include signatures by both the departing and on-coming irradiator operators; (3) maintenance of a list of qualified irradiator operators for use by personnel in assuring their replacements are certified; and (4) issuance of a lessons learned document to all Isomedix irradiator facilities highlighting actions to be taken to prevent operation with inadequately trained personnel. Based on the above, the NRC determined that your corrective actions were comprehensive, and credit was warranted for this factor.

Therefore, to encourage comprehensive corrective action for violations, I have been authorized, after consultation with the Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

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 consider 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 placed in the NRC Public Document Room (PDR).


Original signed by
Bruce S. Mallett for

Luis A. Reyes
Regional Administrator

Docket No. 030-30578
License No. 52-24994-01

Enclosures: Notice of Violation

cc w/encls:
Commonwealth of Puerto Rico

Abbott Health Products, Inc.
c/o Abbott Laboratories
ATTN: Robert E. Davis
Division Vice President
Hospital Products Operations
200 Abbott Park Road
Abbott Park, Illinois 60064-3537

Isomedix Operations, Inc.
ATTN: George Dietz
Senior Vice President
11 Apollo Drive
Whippany, New Jersey 07981


Isomedix Operations, Inc.
Vega Alta, Puerto Rico
Docket No. 030-30578
License No. 52-24994-01
EA 97-173

During an NRC inspection conducted during the period March 31 through April 1, 1997, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 36.65(a)(1) requires that both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite whenever the irradiator is operated using an automatic product conveyor system.

10 CFR 36.2 defines an irradiator operator as an individual who has successfully completed the training and testing described in

10 CFR 36.51 and is authorized by the terms of the license to operate the irradiator without a supervisor present.

Contrary to the above, on February 12, 1997, an irradiator operator who had successfully completed the training and testing described in

10 CFR 36.51 and who was authorized by the terms of Byproduct Materials License No. 52-24994-01 was not onsite for approximately 2.0 hours while the irradiator was operated using an automatic product conveyor system.

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

Pursuant to the provisions of 10 CFR 2.201, the Isomedix Operations, Inc. (licensee) 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 II, 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 previously 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 Atlanta, Georgia
this 20th day of May 1997

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