U.S. NUCLEAR REGULATORY COMMISSION

Region III Office of Public Affairs

801 Warrenville Road, Lisle, IL 60532-4351

NEWS ANNOUNCEMENT: RIII-97-109 December 18, 1997

CONTACT: Jan Strasma 630/829-9663

Angela Greenman 630/829-9662

E-mail: opa3@nrc.gov

NRC STAFF PROPOSES $55,000 FINE AGAINST MALLINCKRODT

MEDICAL, INC. FOR RADIATION SAFETY VIOLATIONS

The Nuclear Regulatory Commission staff has proposed a $55,000 fine

against Mallinckrodt Medical, Inc., Maryland Heights, Missouri, for three

radiation safety violations involving an employee radiation overexposure

and two shipping incidents.

On May 14 of this year during routine clean-up of radioactive

rhenium-186 waste and contaminated glassware, an employee received an

exposure in excess of 290 rems to his thumb. (NRC’s annual exposure

limit to the hand of an occupational worker is 50 rems.) The

radionuclide rhenium-186 is used by Mallinckrodt to conduct research. The

contamination occurred either when the employee was cleaning up the waste

material or when he removed his gloves.

Upon exiting the laboratory at the completion of his work, the

employee performed a personal radiation survey. He was unable to get an

accurate dose reading because of radiation emitted from some nearby

radioactive material. The employee did not attempt to conduct another

survey, and left the building for the evening.

The next morning, Mallinckrodt informed him that his routine urine

sample from the previous evening showed levels of radioactivity that

exceeded the company’s limits. The company’s internal limit is a small

fraction of the regulatory limit. A subsequent radiation survey

identified the contaminated thumb. The contaminated material was

successfully removed.

The company also surveyed the building, the employee’s residence and

vehicle, and other places visited by the employee after he left work.

Some items, including toweling and clothing, that were found to be

contaminated at his residence were taken by Mallinckrodt for

decontamination.

In notifying Mallinckrodt of the proposed fine NRC Regional

Administrator A. Bill Beach stated, “The chain of events that allowed

the contamination event to occur and then go undetected indicates that

the controls and procedures that Mallinckrodt established were

insufficient.”

Immediately following the incident, NRC staff conducted a special
inspection at Mallinckrodt, performed independent surveys, and contracted

with a medical consultant to review the employee’s radiation exposure

information. The consultant concluded that no immediate health effects

would be expected.

Mallinckrodt instituted corrective actions following the event which

included making radiation monitoring equipment more accessible to

laboratory personnel.

A $27,500 fine has been proposed for two violations associated with

this May 14 incident: the actual employee overexposure and the failure

to assure an adequate personal radiation survey was conducted prior to

the employee leaving the building.

NRC staff proposed another $27,500 fine for the shipment of two

devices from its manufacturing plant in Missouri on July 8 of this year.

Both packages exceeded the federal radiation limits for shipment of

radioactive materials. The devices produce radioactive technetium-99m

that is used in medical diagnostic procedures. The packages were shipped

to Mallinckrodt’s nuclear pharmacies in New Jersey and Pennsylvania with

radiation levels on the outer surface of the packages of 250 millirem per

hour and 240 millirem per hour, respectively. The federal limit is 200

millirem per hour

(For comparison, the average person in the United States receives

about 300 millirems per year from natural background radiation.)

Mr. Beach noted in the letter that a $13,750 fine was issued in May

of this year for a similar generator shipping violation. As a result,

the July 8 violations are repetitive and the normal fine was increased by

100 percent.

Mallinckrodt has until January 16 to pay the fine or to protest it.

If the fine is protested and subsequently imposed by the NRC staff, the

company may request a hearing.

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