Criminal and terror attacks on food and drugs don’t happen often, but when they do the public doesn’t forget them. Most Americans born before the mid-1970s remember the Chicago Tylenol poisonings of 1982 and the terror that followed them. Two years later, in Oregon, followers of cult-leader Bhagwan Shree Rajneesh launched the largest bioterror attack seen to date on U.S. soil when they inoculated salad bars in 10 restaurants with Salmonella in an effort to prevent their political opponents from voting in large numbers, sickening over 700 people. Japanese consumers faced the same terror when, in late 2013, an employee at a Aqlifoods Co. manufacturing plant deliberately contaminated frozen food with the pesticide malathion, leading to as many as 2,800 cases of reported illness.
Such attacks can cast a shadow of anxiety on the everyday routine of buying and eating meals, and it’s with the goal of reducing that anxiety that the Food Safety Modernization Act’s (FSMA) Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration will begin coming into effect next year.
This final rule is designed to deal specifically with the threat of malicious actors attempting to taint food with the goal of hurting consumers.
Rod Wheeler, founder and CEO of the Global Food Defense Institute, says that in most cases of tampering he encounters from year to year, the actor has been a disgruntled employee or other internal figure. However, he notes, groups like ISIS have encouraged their followers to kill Westerners by poisoning their food supplies.
“Obviously, [terrorists] are talking about this,” he says. “Every year, you’ll hear a little bit of something come through the wire, whether it’s through the government agencies or through some other agency in another country.”
An Old Problem with New Solutions
Earl Arnold, global manager for food defense and FSMA at AIB International, notes that intentional adulteration as a means of waging war on a civilian population has a long history.
“It was first recorded in the Roman times using deceased cattle to contaminate water supplies,” he says.
With that history in mind—and with an eye toward future risks—the Intentional Adulteration rule demands production facilities conduct a vulnerability assessment that considers the public health impact of an adulterant being introduced at each process step, the extent to which the product is accessible at each step, and the ease by which the product could be deliberately contaminated.
“When evaluating all of this,” Arnold says, “you must consider these things could be done by someone welcomed into the facility. If a processing step has a significant vulnerability identified—one that could cause wide scale public health impact—then a facility must develop mitigation to reduce the risk.”
One of the important changes in the Intentional Adulteration rule is the expansion of the idea of what constitutes production security. Arnold notes that until recently, production security has largely been considered a matter of fences, CCTV cameras, and passkey doors—the goal was to keep “bad people” from doing “bad things.”
Amy Kircher, DrPH, director of the University of Minnesota’s Food Protection and Defense Institute, says that FSMA will force a greater depth of understanding about what producers have to do to keep food safe.
“There is a significant culture change happening now,” Dr. Kircher says, “where companies are now having to come into compliance in a way that will be enforced, and so many companies are starting to think about, ‘How do we do vulnerability assessments for our entire company? How do we put mitigation steps in place that are beyond guns, gates, and guards?’”
Novel Vulnerabilities
The FSMA rule prescribes attention to four key activities: 1) bulk liquid receiving and unloading, 2) bulk liquid storage, secondary ingredient handling, 3) and mixing and blending activities.
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