FDA’s implementation of the Food Safety Modernization Act (FSMA) is off to a strong start in 2016, with an injection of $104.5 million in additional funding from Congress in the omnibus appropriations bill passed December 18. The substantial increase in funding for fiscal year 2016 will increase the agency’s ability to advance plans for training and outreach relating to the five FSMA final rules released to date and the two additional final rules anticipated this year.
FDA plans to “work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements,” noted Deputy Commissioner for Global Regulatory Operations and Policy, Howard Sklamberg, and Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor, in a December 21 post on the FDA Voice blog site.
But the agency won’t be giving out free passes to bad actors. It is “strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t,” Sklamberg and Taylor said.
Over the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and more than $694 million in fines and restitutions, they noted.
An important first question for any company committed to compliance with the new FSMA regulations is whether its products are covered or exempted. FDA is currently working on numerous guidance documents to help companies find answers to these and other key questions. The agency is preparing guidance for small or very small businesses on the human food and animal food rules, as well as hazard analysis and preventive controls, environmental monitoring, allergen controls, and validation of process controls for human food. It is also preparing guidance on current good manufacturing practices (CGMPs), hazard analysis and preventive controls, and on human food by-products for use as animal food.
Agency officials are still working on some of the thornier questions for these guidance documents. The additional FY2016 funding from Congress should help the agency commit the resources needed to complete these important compliance tools.