There’s no question that the U.S. Food and Drug Administration (FDA) is behind schedule in implementing the Food Safety Modernization Act (FSMA).
Signed by President Obama on January 4, 2011, this landmark food safety law aimed to shift the focus from responding to contamination to preventing it from occurring in the first place. However, several FSMA-required regulations have yet to be implemented and are still sitting at the Office of Management and Budget (OMB) pending approval—20 months after the proposal became law.
Whether due to presidential election politics, unrealistic deadlines, a lack of federal funding or some combination of the three, FDA has repeatedly missed mandatory deadlines for issuing final regulations required under the FSMA.
Two public health groups have gone so far as to file a lawsuit against the agency asking for the court to order officials at both the FDA and OMB to start enforcing the law. They claim that this delay has left the nation’s public health in jeopardy, highlighting the recurring foodborne illness outbreaks.
FDA has responded by filing a motion to dismiss the suit arguing that the development of these food safety rules is a massive responsibility to undertake in such a limited amount of time. Its lawyers argue that while the agency has been unable to meet statutory deadlines outlined in the FSMA, it is far more important to take the time to carefully develop such regulations than just hastily adopt them.
Additionally, many argue that the reelection of President Obama will lead to the opening of the floodgates to FSMA implantation. Especially given the FDA’s recent decision to flex its regulatory muscle and shut down operations at a peanut processing plant suspected of producing unsafe food. This was the agency’s first use of its registration suspension authority under the FSMA.
How to Prepare for FSMA’s Implementation
The first step to effectively preparing for the implementation of FSMA mandates is to have a clear understanding of what to expect. While the release of the rules might not immediately lead to full implementation of the law, industry members should carefully review such directives and identify any changes that need to be made to any procedures and plans that are currently in place. That way, staff members won’t be caught off guard down the road and have to scramble to ensure regulatory compliance.
Once the rules are released by the OMB, the public will have 60 days to comment. Those within the industry should take the time to carefully draft responses to each FSMA-mandated rule. For instance, concerns over expenses tied to the implementation of the law have already been voiced by many within the industry. And while it is never promised that FDA will take action, it’s always worth the time and effort to make sure your voice is heard. But don’t stop there, assuming your opinion will change things. Prepare for the changes required under the rule as drafted.
And don’t forget that some of the authority granted to the FDA under FSMA doesn’t require a rule-making process. One food plant was already shuttered. Another company may soon face a mandatory recall. A third may have its registration to operate pulled. Are you ready for each of those scenarios? They could come without warning.
Mike Rozembajgier is vice president of recalls for ExpertRECALL.