Intentional Contamination: Are You Prepared for the FBI?

On the evening of April 16, the emergency room of Special Care Hospital is packed with people needing care. This is routine for a typical Saturday evening, but what is unusual is that a number of people are arriving with the same odd set of symptoms. So the trauma physician in charge contacts the City Health Department, which then reports to CDC.

Meanwhile, the health department receives a similar call from another hospital; ill individuals with similar signs and symptoms continue to arrive at emergency rooms and physicians’ offices; other counties are reporting patients with similar symptoms; and CDC receives information from three other states in the region with sporadic cases having similar signs and symptoms.

The characteristics of the illness are atypical of most bacterial foodborne illness, as they include tremors, muscle cramps, neck pain, nausea and heart palpitations, along with rapid acute onset, increased blood pressure and rapid heartbeat—so the focus for the laboratory is narrowed to that of chemical toxic contamination.

Through further investigation, the source is narrowed to Burger Chain A, but because the victims ate burgers from several of the chain’s facilities, it was deduced that it most likely was not due to an error within a single establishment but to a food or ingredient shared by all or some of the individual units.

Given that the event is an unexplained possible chemical contamination of unknown origin, one of the health officers raises the possibility that the contamination is an intentional act....

When the Bioterrorism Act was passed in June 2002, food defense was top of mind for the food and beverage industry, which was considered to be high risk. But as the years passed, and no major incident occurred or was known to have been attempted, and food defense plans remained voluntary (though “encouraged”) for FDA- and USDA-regulated plants, industry priorities began to shift back to food safety.

Then in 2009, the HHS Inspector General’s office conducted a survey of food facilities randomly selected from the FDA’s registration database. As depicted in a National Academies Press publication (http://1.usa.gov/1QfuOFj), the report concluded “most food manufacturers and distributors cannot identify the suppliers or recipients of their ingredients or products despite federal rules requiring them to do so. A quarter of the food facilities contacted by investigators as part of the study were not even aware that they were supposed to be able to trace their suppliers.”

FSMA’s proposed food defense rule, however, may change all that. Under the proposed rule, food facilities would be required to have a written food defense plan addressing vulnerabilities in the production process; identify and adopt strategies to address the vulnerabilities; establish monitoring procedures, corrective actions, system verification, and training; and maintain records.
 

Back to the Scenario.

But what does all this have to do with the scenario with which this article was opened? (And what happened next?)

The situation is an abridged version of a scenario in FDA’s Food Related Emergency Exercise Bundle (FREE-B), a compilation of intentional and similar unintentional food contamination scenarios and exercises. 

The training suite was developed in 2011 to assist government regulatory and public health agencies in assessing existing food emergency response plans, protocols, and procedures. But with scenarios regularly added to the compilation, the table-top exercises also include application for food and beverage facilities.

The most current is “Mass Mayhem.” Published in July, it features an outbreak of foodborne illness at a large public venue. The scenario detailed in this article is from “Insider Addition” focused on the intentional chemical contamination of a raw meat product at the processing facility. Meat which was then distributed to “Burger Chain A.”

While providing training on such incidents, the scenario also provides managers with information on the process and activities that are conducted by federal and state agencies in the case of a contamination—and what to expect if your facility is involved in what is suspected to be an intentional contamination.
 

The Process.

To continue the abridged FREE-B scenario ... Once the health officer raises the possibility that the contamination is an intentional act, the state health authorities contact state law enforcement who contacts the area or regional center. Also contacted are the local FBI field office, the state chemical terrorism lab coordinator, and the internal law enforcement agencies of the USDA, FDA, and CDC.

As traceback continues, it is determined that the ground beef patties are the only product that came from a single source and were distributed only to this burger chain. So the FBI, local law enforcement, state regulatory officials, and USDA FSIS contact the originating meat processor, informing it of the possible link between its product and a foodborne illness outbreak of unusual origin. Plant management agrees to cooperate, begins gathering processing records, and within a few hours, the firm’s attorney joins the investigation group. The FBI, FSIS, and state regulatory officials visit the plant; the FSIS Consumer Safety Inspector (CSI) assigned to the plant also is present.

The team reviews the chemicals used in the facility and their storage and handling, and samples are taken to confirm that the containers are holding the labeled chemical. An assessment is done of all aspects of the food processing plant, including environmental sampling, an audit of the firm’s food defense plan, and other food safety parameters.

Plant management begins a review of employee background checks and an inspection of the staff areas. Eventually, three empty bottles are found in the pocket of a freezer coat in the locker assigned to “Jim Waters,” a shift supervisor. A review of video surveillance shows that on Thursday, April 14, at 11:30 a.m., Waters was loitering around a combo bin of ground beef during processing; then, looking nervous, he took an object from his pocket and held it in his hand. Although the angle of the video made it impossible to see the object, Waters is detained by law enforcement for questioning as he leaves his shift for the day.

During questioning, Waters acknowledges having a grudge against the company because of the firing of his brother. He then admits to putting 10 ounces of a homemade Clenbuterol solution, into three combo loads the week before, all of which were made into patties for Burger Chain A. Clenbuterol is a veterinary drug not FDA-approved for human use in the U.S. The amount Waters dumped into the loads was enough for each ground beef patty to have an average concentration much higher than typical of adult off-label use. Since it was probably not uniformly distributed, many patties would have had very high doses capable of causing acute symptoms. Additionally, Clenbuterol in food is heat stable, so cooking would not have affected it.

As soon as the tampering was discovered, plant operations were suspended, all product put on hold, an immediate recall issued on all of the plant’s ground beef products, and the firm called its first line distributors, telling them to immediately stop use of all ground beef patties.

The processor then issued a detailed press release, and a virtual Joint Information Center (JIC) was established so risk communicators from law enforcement, DHS, USDA FSIS, CDC, and state health authorities could collaborate on a common media message. In cases of intentional contamination, the FBI takes overall authority, working closely with USDA or FDA, who writes the incident report. The DHS communicates with the Food and Agriculture Sector Coordinating Council and provides situational awareness and information gathering to support the investigation. Information related to the intentional contamination is only released by the FBI from the JIC.

Meanwhile, the White House Homeland Security staff is apprised of the situation, and local hospitals and clinics informed so they could tailor treatment to the Clenbuterol poisoning. As the week progresses, state and/or federal EPA representatives and FSIS inspectors observe the destruction and disposal of all returned suspect products at the processing plant.

After establishing the date that Waters purchased the Clenbuterol and reviewing his work schedule, investigators were able to determine the date range to which the recalled product could be limited. The plant brought in a specialty cleaning and sanitation firm to thoroughly clean its processing equipment and food production facility; the cleaning was validated; and the FSIS, EPA, OSHA, and their state counterparts informed of the efficacy of the process.

Waters was prosecuted under the Federal Anti-Tampering Act. He had been employed by the company for 13 years, and no one had suspected that he would throw his career away over an incident with his brother.
 

Are You Ready?

While the flow of traceback of an intentional contamination is similar to that of an unintentional contamination, this scenario provides food facilities with a look at the depth of investigation conducted when an intentional act is suspected. To determine if you’re prepared should such an investigation be needed at your facility, gather your team and review the questions in “What Would You Do? (page 25).

In a 2012 update on FREE-B, FDA cited a statement from a 1957 speech by President Dwight D. Eisenhower, “Plans are worthless, but planning is everything.” Developing, exercising and revising emergency response plans and procedures are integral to the successful outcome to any event, the update stated, adding, “It is the hope of the food defense oversight team that the FREE-B can be the tool that brings folks together before the ‘real-event’ happens; helping our stakeholders to be ready and prepared for everything and anything that may come their way.”

FDA plans to add two more food-related emergency exercises: “Wat’er You Thinking” on possible contamination of a municipal water supply and “Foul Fodder” on contamination of food or animal feed. To view and download any of the training scenarios, visit http://1.usa.gov/1KQzVxx.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.