The rule is the latest of seven major regulation changes that implement the core provisions of the Food Safety Modernization Act, requiring food facilities to complete and maintain a written defense plan that assesses their potential weaknesses in the case of a deliberate attack. The rule, slated for publication of Friday, states the food manufacturers need to comply with the rules within three to five years from its publication, depending on their size.
The FDA estimates that the implementation of the rule will cost companies an average of $280 million to $490 million annually for 10 years, with the first-year cost running between $680 million to $930 million. The cost, counting only domestic firms, will be about $90 million to $150 million annually, with a first-year cost of between $220 to $300 million. The FDA expects the rule to cost between $27,000 to $47,000 per company and between $9,000 and $16,000 per facility annually.
The FDA said the costs and benefits will break even if the rule will prevent 28 to 48 attacks each year that are similar to attacks that have happened previously in the U.S., or prevent one to two attacks yearly that are similar to typical food-related illness outbreaks, or would prevent a catastrophic terrorist attack with thousands of deaths once every 270 to 460 years.
“Today’s rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” Stephen Ostroff, the FDA’s incoming deputy commissioner for foods and veterinary medicine, said in a statement. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”
Food facilities will need to identify and implement mitigation strategies to address their unique weak points, establish food defense monitoring procedures and corrective actions, verify that their system is working, ensure that people assigned to food defense jobs have appropriate training, as well as maintain appropriate records.
Three provisions will be implemented from the Federal Food, Drug and Cosmetic Act, as amended by the FSMA, that relate to intention food attacks. The three provisions in turn relate to facilities that manufacture, process, pack and hold food, and facilities that deal with fruits and vegetables and facilities that handle high-risk foods. The provision of high-risk foods exempt farms from the rule but do not exempt farms that produce milk.
The rule will not apply to small business that include subsidiaries and affiliates that make less that $10 million per year. The rule does not apply to facilities that hold food, unless the food is in liquid storage tanks, facilities that package food if the container holding the food remains intact, facilities handling some alcoholic beverages, and facilities that deal with animal feed.
The rule was first proposed in December of 2013 and takes into consideration more that 200 public comments. The revisions, mostly prompted by comments, include requiring companies to consider the possibility of insider attacks, specifying the elements that should be considered when making a vulnerability assessment: the potential health impact if a contaminant is added to the food, the degree of physical access to a given product, and the ability of an attacker to successfully contaminate the food.
