The United States has seen more than its fair share of foodborne illness outbreaks in recent years. There was the 2008 salmonella outbreak in peanut butter, which resulted in the shocking discovery that the Peanut Corporation of America was knowingly distributing contaminated food; the 2011 listeria outbreak in cantaloupes, which ultimately became one of the deadliest foodborne illness outbreaks in U.S. history; and of course, the more recent listeria outbreak in ice cream, which led to the complete recall of all Blue Bell Creameries’ products, leaving ice-cream lovers singing the Blue Bell blues for nearly five months.
Needless to say, civil litigation is a constant concern for companies in the food processing and manufacturing industry. Less obvious perhaps is the potential exposure to criminal charges—just this Monday, in fact, the owner of the Peanut Corporation of America was sentenced to twenty-eight years in prison for the role he played in the events that triggered the 2008 salmonella outbreak. Of course, the best way to reduce exposure to both civil and criminal liability is to take steps to prevent an outbreak from ever occurring.
On September 10, the U.S. Food and Drug Administration (the “FDA”) finalized two new rules designed to help companies do just that. The rules are an outgrowth of the FDA Food Safety Modernization Act (the “FSMA”), which was signed into law on January 4, 2011, and which calls for the FDA to enact a total of seven new rules with the aim of creating a regulatory framework for preventing food safety issues before they occur, instead of reacting to them after the fact. The law also expands the FDA’s authority to enforce compliance with preventative food safety measures and equips it to better handle outbreaks once they occur. The FDA describes the FSMA as “the most sweeping reform of our food safety laws in more than 70 years.”
The recently released rules call for the establishment of “preventive controls” for both human food and animal food, which food manufacturers must implement by specified compliance dates. Specifically, they require companies to identify hazards, implement preventive controls, create oversight and management procedures, and set up verification processes. The rules also clarify the definition of “farms,” which are not subject to the preventive controls rule, and update, clarify, and—in the case of animal food—establish Current Good Manufacturing Practices. The deadlines for compliance with the new rules are staggered over several years, with the smallest businesses having the most time to comply and larger businesses having the least. Food manufacturers should also be on the lookout for a series of guideline documents the FDA is developing to help businesses comply with the new rules. Topics covered by the guideline documents will include hazard analysis and preventive controls, environmental monitoring, food allergen controls, and validation of process controls. The FDA is even developing a Small Entity Compliance Guide to assist small businesses with their compliance efforts.
If all goes according to plan, the new rules under the FSMA will usher the food processing and manufacturing industry into an era of being preventive rather than reactive when it comes to foodborne illness outbreaks. Hopefully, this new approach to food safety will result in fewer outbreaks and saved lives. Despite the burden these new regulations impose on food manufacturers, the Grocery Manufacturers Association—which represents many of the affected companies—welcomed the new rules, saying in a press release, “GMA is proud of its work to support FSMA and has taken a leadership role on behalf of industry [sic] to educate food and beverage manufacturers on what it will take to comply with the law, in the U.S. and along the entire global supply chain. We look forward to continuing those education efforts in the months ahead.”