FDA releases sweeping food safety rules

The Obama administration ‘s release Thursday of two final food safety rules represents the biggest update to America’s system of protecting the public against foodborne illness since 1906.

Under the regulations, both U.S. and foreign manufacturers will be required to write and implement new plans that indicate the possible problems that could affect the safety of their products and outline steps their facilities would take to prevent or significantly minimize the likelihood of those problems occurring.

Manufacturers will be required to verify and document that those preventative controls they’ve established are working.

Michael Taylor, FDA’s deputy commissioner for Foods and Veterinary Medicine, said the records will give FDA a basis for oversight and accountability when responding to food safety problems and illness outbreaks when they occur.

This is a major shift in the way the U.S. protects its food supply from a reactive to a proactive approach. 

The Food Safety Modernization Act (FSMA), passed in 2010, was intended to fundamentally shift the government from responding to food safety issues to preventing them.

The Centers for Disease Control and Prevention estimates that 48 million people, 1 in 6 Americans, get sick each year from foodborne diseases and approximately 128,000 are hospitalized and 3,000 people die as a result each year.

Small manufacturers of people food, those with fewer than 500 full-time equivalent employees, will have two years to comply with the rules, while full industry compliance is required within one year. Small manufactures of animal food will have three year to comply with the preventative controls rule while full industry compliance is required within two years.

The rules are expected to cost domestic human food manufacturing $382 million a year and foreign food manufacturers $820 million a year. Though FDA said the benefits are hard to quantify, the break-even point is when 157,000 illnesses are prevented a year.

Compliance costs for domestic and foreign animal food manufacturers is expected to be anywhere from $135.6 to $166.7 million a year, while total annualized benefits for pets are estimated to be between $10.1 to $138.0 million.

The Grocery Manufacturers Association (GWA) welcomed the new rules Thursday.

“FSMA ensures that prevention is the cornerstone of our nation’s food safety strategy, places new responsibilities on food and beverage manufacturers, and provides the FDA with the authorities it needs to further strengthen our nation’s food safety net,” GWA President and CEO Pamela Bailey said in a news release.  

GWA said the food and beverage industry s committed to working with Congress to get the funding necessary for FDA to fill implement the law. 

“FSMA represents a comprehensive system of preventative measures so it is essential that FDA be appropriately resourced to effectively implement and enforce all of the food safety mandates set forth in the law.  The food and beverage industry is committed to working with Congress, the Obama Administration and all stakeholders to ensure that Congress appropriates the necessary funding for FDA to fully implement FSMA.”