NRC NEWS

 U.S. NUCLEAR REGULATORY COMMISSION 

 Office of Public Affairs, Region I

 475 Allendale Road, King of Prussia, Pa.

 Web Site: http://www.nrc.gov/OPA

No. I-05-005 January 26, 2005

Contact: Diane Screnci, 610/337-5330 Email: opa1@nrc.gov

Neil Sheehan, 610/337-5331

COMPANY AGREES TO ADDITIONAL CORRECTIVE ACTIONS AT PUERTO RICO

IRRADIATION FACILITY UNDER ALTERNATE DISPUTE RESOLUTION SETTLEMENT

As part of an agreement reached with the Nuclear Regulatory Commission, Baxter Healthcare

Corp. has agreed to take additional corrective actions at a commercial irradiation facility it operates in

Puerto Rico.

The agreement was achieved through the NRC’s Alternate Dispute Resolution (ADR) Process,

during which the agency and the company discussed the terms of a $44,000 civil penalty levied against

the company last year. That action stemmed from an event last April in which two workers failed to

follow procedures at the facility, creating the possibility of a lethal exposure to radiation for the

employees.

Under the agreement, Baxter has agreed to implement additional corrective actions, specifically

reviews of irradiator operations, maintenance, radiation safety and the Radiation Safety Officer (RSO)

and Assistant RSO functions by a qualified consultant. Those reviews will last at least until sometime

in 2007. The settlement also calls for the NRC to change the amount of the proposed civil penalty for

violations of agency requirements to $31,200.

The new terms of the enforcement action have been confirmed via a Confirmatory Order issued

by the NRC to the company.

“This demonstrates once again that the Alternate Dispute Resolution Process can work and

achieve a result that protects the public health and safety while at the same time improving the

efficiency and effectiveness of the enforcement process,” said Frank J. Congel, Director of the NRC’s

Office of Enforcement.

Baxter requested the use of the ADR Process after the NRC issued the proposed civil penalty to

the company on Oct. 25, 2004. ADR is a process in which a neutral mediator with no decision-making

authority assists the NRC and licensees in reaching an agreement resolving any differences regarding

an enforcement action. An ADR mediation session between the NRC staff and Baxter representatives

– led by a professional mediator arranged through Cornell University’s Institute of 
2

Conflict Management – was held on Dec. 13, 2004, in Philadelphia. That session led to the settlement

agreement.

The event that prompted the enforcement action occurred on April 21, 2004, when an irradiator

operator and an assistant were performing work at Baxter’s Puerto Rico irradiator, which is used to

sterilize medical equipment. To ensure that workers are not exposed to unacceptable levels of

radiation, such irradiators are equipped with safety interlocks designed to prevent entry when the

radioactive sources are in the unshielded position. During this event, however, the interlocks were

bypassed, or temporarily disabled.

Consequently, the workers entered the irradiator at a time when a radioactive source rack was

stuck in the unshielded position. They quickly left the area after a radiation monitor carried by the

irradiator operator indicated elevated radiation levels.

The problem for which the fine is being issued involves a failure by Baxter employees to follow

emergency and abnormal event procedures after the source rack fault indicator on the console was

illuminated and the source travel alarm sounded for an extended period; the operators’ failure to

adequately check the irradiator cell radiation monitor and radiation levels outside prior to entering the

irradiator, and to perform other surveys; and a failure to supply an individual radiation monitoring

device to a worker (the assistant operator) entering the irradiator and to require its use. The NRC staff

and Baxter have agreed to disagree on whether the last violation was “willful.”

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