Federal rules will make food manufacturers analyze risks and implement controls for possible food safety problems, whether from their own facilities or from suppliers.
They also will have to work to minimize harm where problems could occur, correct shortcomings, and watch for problems through measures including environmental and product testing.
The Food and Drug Administration described the rules being applied to human and animal foods, as well as including comments on the process and background information, in a pair of Federal Register notices published Sept. 17. The rules take effect Nov. 16, and the FDA will allow one year for most businesses to comply and up to three years for the smallest businesses to comply.
The rules are the first two of seven planned in implementing the Food Safety Modernization Act, which was signed in January 2011. In describing the need for the rules, an agency announcement cites foodborne illnesses from contaminated spinach and peanuts as well as a Centers for Disease Control and Prevention estimate that 48 million Americans are sickened by foodborne diseases each year.
The Federal Register notice also indicates the rules under the 2011 legislation will help the agency focus on prevention rather than reaction.
“FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur,” the Federal Register notice states. “The law also provides new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur.”
The rules published in September will make food producers evaluate “reasonably foreseeable” hazards for each type of animal food manufactured, processed, packed or held, according to the FDA notice. And the preventive controls should provide assurance that such hazards are minimized or eliminated.
Many of the activities covered in the rules must be performed or overseen by someone who has completed training on risk-based preventive measures or has the experience needed to develop a food safety system, according to the FDA.
In the announcement, Dr. Stephen Ostroff, acting FDA commissioner, said the rules put the U.S. “on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day.”