Even though the deadline for large facilities to comply with the FDA’s rigorous new “preventive controls rule for human food” is Sept. 16, the need for additional training means the agency’s inspectors likely won’t start enforcing it until January, according to Food Safety News.
The rule, part of the 2011 Food Safety Modernization Act, requires facilities that manufacture, process, pack or store food to have a food-safety plan that analyzes potential problems in their system and specifies preventive action to address those problems. They also must document that those actions are working. As Donna Garren, a regulatory affairs and technical specialist with the American Frozen Food Institute, put it: “It’s a lot to take in—like drinking from a fire hose.”
Small and mid-sized companies have until September 2017, and very small companies have until September 2018, says Food Safety News.
FDA statistics show that foodborne illness strikes an estimated one in six Americans each year; about 128,000 people are hospitalized, and an estimated 3,000 die each year from foodborne illnesses.
“The FDA regulates about 80 percent of the U.S. food supply — approximately $602 billion in domestic food and $64 billion in imported food each year,” says Food Safety News. “The preventive controls rule will cover an estimated 97,600 domestic and 109,200 foreign facilities.”