The past five years have seen two historic updates to longstanding regulatory regimes, both aimed at improving safety. We all want the food we eat and the products we encounter to be harmless, and the Food Safety Modernization Act and the Consumer Product Safety Improvement Act aim to make them safer.

For food and consumer product companies, however, this increased safety is accompanied by the heightened cost of regulatory compliance and risk of civil litigation. the ultimate impact of both reforms is still far from clear. Here, food safety and product liability experts break down the risks and offer their recommendations for navigating the new requirements.

The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA), which became law in January 2011, is the biggest change to food safety regulation since Franklin D. Roosevelt signed the Food, Drug and Cosmetic Act in 1938. It came on the heels of a string of headline-grabbing outbreaks of foodborne illnesses: In 2006, E. coli-tainted spinach killed three people and sickened hundreds, and a Salmonella outbreak was linked to peanut butter. Salmonella sickened people across 43 states in 2008 and was linked to contaminated chili peppers, tomatoes and cilantro. And in the summer of 2010, nearly 2,000 cases of Salmonella led to a recall of hundreds of millions of eggs. 

Each of these cases and numerous similar outbreaks led the Food and Drug Administration (FDA) to identify that a problem existed and then trace it back to certain products and facilities, where investigators probed the source and cause of the contamination to prevent future outbreaks. The central goal of FSMA was to change the paradigm from reaction to prevention. 

To this end, FSMA requires facilities that manufacture, process and package food products to develop and implement food safety plans tailored to the specific risks of their products and facilities, encompassing policies and procedures to prevent contamination and other safety hazards. Processors also have to monitor their supply chains to ensure that at every step of the way, proper preventive controls are in place.

The requirement has been in place since July 2012, but the FDA has not yet issued regulations implementing the rules—in fact, the delay was the subject of a lawsuit two public interest groups filed in August 2012 seeking to force the FDA and Office of Management and Budget to enforce FSMA.

The legislation provides a framework for what companies are expected to do: conduct an analysis of reasonably foreseeable risks, implement controls to prevent those hazards, and monitor systems to ensure compliance and effectiveness and to adjust as necessary. What this entails is not new to food companies—a Hazard Analysis and Critical Control Points (HACCP) program, good manufacturing practices (GMP) and other measures are concepts well-known in the food industry, says Joseph Levitt, a partner at Hogan Lovells and the former director of the FDA's Center for Food Safety and Applied Nutrition. 

Additionally, FSMA gives the FDA more oversight over imported food suppliers and imposes new requirements on importers, mandates more frequent and robust FDA inspections of food-processing and -handling facilities and gives the FDA mandatory recall authority. 

Loaded Standard

The Food Safety Modernization Act (FSMA) gives the Food and Drug Administration (FDA) mandatory recall authority, although the FDA itself has said it will use such authority only in rare instances and accompanied by a hearing, and only after distributors have a chance to conduct a voluntary recall. Joseph Levitt, a partner at Hogan Lovells and the former director of the FDA's Center for Food Safety and Applied Nutrition, says that because most companies will listen to the FDA's recommendation to voluntarily recall suspect products, it's not clear the agency will have to exercise this power.