President Obama signed into law the new food safety bill, the FDA Food Safety Modernization Act, on January 4, 2011.
Though commonly described in terms of the new powers it gives FDA, it’s the new obligations that fall directly on food businesses that will make the biggest difference to most companies.
It gives the US Food and Drug Administration several new enforcement powers and also places new obligations on most food makers (not counting small businesses and not counting meat and poultry businesses, which are regulated by the US Department of Agriculture, which is not affected by this law.)
For food companies, the new requirement for implementing hazard analysis and critical control point programs – to be implemented in 18 months – represents the most complex new obligation. It will require companies to evaluate their processes, identify hazards, put in place controls against those hazards, and maintain records of their actions, otherwise the food they make will be adulterated and unlawful. Importantly, smaller businesses are exempt from requirements such as these.
Additionally, imported foods as well will soon face new requirements including certification that they were made in compliance with GMPs.
Many of the law’s provisions require FDA to make regulations to implement them, so companies should be alert to the process in coming months, because they will have opportunities to offer their views on proposed regulations and thus shape their final form.
As for those enforcement powers, FDA gets some ammunition that fits in between its Warning Letters and its big weapons of court-ordered seizure, injunction or criminal prosecution: Now it can order recalls of food; can suspend a facility’s registration if there’s a probability of adverse health consequences or death; can put food under administrative detention on a belief that it’s thought to be adulterated or misbranded; and can demand to see documents during inspections of food plants when there’s a possible danger to health.
FDA also is ordered to prioritize food inspections according to risk, and to increase the rate of inspections. They have to study what foods are at high risk of intentional contamination (such as by terrorists) and set rules to protect them. Imported foods are now going to come from suppliers who can verify they are made in compliance with good manufacturing practices, and will set up a system of third-party auditors to check them out.
Eric F. Greenberg, P.C. is ready to assist all food companies with understanding and complying with this far-reaching new law, and with providing comments on proposed regulations.