Here’s a belated happy birthday wish to the Food Safety Modernization Act. FSMA, the biggest change to U.S. food law in nearly a century, was signed into law Jan. 4, 2011. FSMA is huge – not only because of the changes it created but because of the sheer volume of paper it required and continues to require.
FSMA created a new regulatory paradigm – prevention of instead of reaction to food safety issues. The idea behind FSMA was to give FDA better tools to regulate food safety, in concert with requiring ongoing steps by everyone in the food supply chain to identify potential food safety hazards and then to put measures in place to mitigate or eliminate those hazards. For imported foods, foreign suppliers are subject to what’s referred to as the “Human Food Rule” and must constantly be able to produce records to demonstrate compliance. FSMA’s Foreign Supplier Verification Programs rule makes the importer responsible for having records for each entry that demonstrate the food was produced safely. More importantly, the FSVP regulation makes the importer responsible for the safety of the food.
Many in the industry have taken steps to comply with FSMA. Though it required changes – on a varying scale based on what companies had in place pre-FSMA – it’s doable. Others have skated by, either doing nothing and hoping for the best or paying only some attention to FSMA. If your company fits into that category, you’re playing with fire!
FDA’s mantra as FSMA was rolled out was “Educate While We Regulate.” For the most part, those days are over. The regulations have been around for 10 years and the first compliance date for importers, for example, was nearly four years ago. The agency, rightfully so, says that’s long enough for those subject to the regulation to be in compliance. So, if you fall into the category of those who’ve done little or nothing to come into compliance, you should be nervous if FDA comes to look at your FSVP records.
If, on the other hand, your firm has taken steps to do what’s necessary to comply, FDA is still using enforcement discretion. That means an FDA investigator is more likely grant some leeway and give some time to correct shortcomings to a firm that’s made a concerted attempt at compliance.
The Food Safety Preventive Controls Alliance, a public/private partnership funded by FDA, developed courses for some of the seven major FSMA regulations. I strongly recommend you take the course(s) associated with the rule(s) to which your firm is subject. It’s the best way to get the information you need to comply and it’s delivered in a way that facilitates understanding of the rules. I served on the task force that developed the FSVP course and lead AFI’s FSVP training. Information on AFI’s offerings is available at afius.org/fsvp. Information on FSVP sessions offered by others and FSPCA courses on other FSMA rules can be found on the FSPCA website. Once there, one can search by course, language, location, etc.
FSMA was needed and it’s the base on which future food safety regulations will be built. If I were a betting man, I’d only put my money on companies that are taking FSMA seriously.