On January 4, 2011 President Obama signed the Food Safety Modernization Act (FSMA) into law. The culmination of years of work by advocates, victims of foodborne illness and their families, and the regulated food industry, FSMA was seen as a game changer. It gave FDA new power to regulate food safety. Most importantly, once fully implemented, FSMA was designed to transform FDA from an agency whose primary mission is response to foodborne illness to one working proactively to prevent these outbreaks from occurring at all.
An essential part of establishing this new paradigm is a series of proposed rules, four of which were scheduled to be released in January 2012. As January passed, followed by February, then spring, summer, and fall, the clamoring from advocates and the industry for the release of the rules grew louder and louder. Finally, in January 2013, a year later, two of the four rules were released. These two rules address produce safety and preventive controls in processed food.
Earlier this week FDA released an additional set of documents that can help to explain some of the reasons for the long delay. These documents show that the two rules were held up at OMB (the agency that must review all agency rulemaking), where extensive changes were made to their content. Most notably, OMB removed requirements for environmental and end-product pathogen testing as well as a proposed supplier approval verification program.
While what remains is still an improvement over the existing system, it is far weaker than what FDA had initially proposed. There are likely many reasons why these changes were made, but these considerations will matter very little to the parents of a child whose foodborne illness could have been prevented by one of the nixed measures.