WASHINGTON (CN) - Food facilities must prepare to defend their products from terrorists who would contaminate them, the Food and Drug Administration said.
The Dec. 24 proposal is part of the FDA's Food Safety Modernization Act (FSMA). It would apply to domestic and foreign facilities that manufacture, process or ship food and are required to register under the Food, Drug and Cosmetic Act.
Under the proposed regulation, food facilities would be required to prepare and implement a Food Defense Plan that provides mitigation strategies, monitoring procedures and corrective actions. The plan would also require facilities to keep records associated with the plan and to train personnel in awareness and related responsibilities.
Specifically, the plan would require facilities to use a special software program called the CARVER+Shock Vulnerability Assessment to help users with vulnerability assessments.
"It guides users through a series of questions to determine the vulnerability of each of the nodes within their facility," the proposed rule states. "After the vulnerabilities are identified, the software helps users to identify mitigation strategies for reducing the risk of intentional adulteration. Using the software tool, the user can focus resources on protecting the most susceptible points in their system."
In 1984, a religious commune attempted to prevent the general public from voting in local elections in The Dalles, Ore., by contaminating food in restaurants with salmonella. In another incident in 1996, 12 laboratory workers at a large medical facility in Texas became ill from eating donated pastries intentionally contaminated with Shigella dysenteriae, which was later discovered to have come from the facility's stock of cultures.
In 2008, milk farms in China put melamine, a nitrogen-rich industrial by-product, in diluted dairy products to increase the apparent protein content, causing 290,000 infant illnesses and six deaths. The incident also created an economic disruption that ultimately cost the Chinese dairy industry $3 billion, according to the action.
Two related 2009 incidents resulted in 49 people who ate at a restaurant in Lenexa, Kan., to develop rapid and acute onset gastrointestinal and neurological symptoms. Two former employees were found guilty of intentionally contaminating salsa.
"The subject of this proposed rule is protection of food against intentional adulteration caused by acts of terrorism," the agency said in its action.
Regulators say acts of food terrorism may include a disgruntled employee looking to harm an employer, a corporate competitor seeking an edge in a given market or those who want to cause "massive public health harm."
Comments are due by March 31, 2014.