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FDA Finalizes Key FSMA Rules

FDA Finalizes Key FSMA Rules

<p>Under the preventative controls rules, animal and human food facilities must develop and implement plans that identify potential food-safety hazards and outline steps to prevent or greatly minimize the chance that a food-safety issue will arise, according to FDA.</p>

The U.S. Food and Drug Administration (FDA) has finalized preventative controls rules for animal and human foods under the 2011 Food Safety Modernization Act (FSMA).

The development, announced last week and coming more than 4 years after President Obama signed the sweeping food-safety legislation into law, “sets us 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," said Stephen Ostroff, M.D., acting FDA commissioner in a Sept. 10 press release.

Under the preventative controls rules, which were scheduled to be published in the Federal Register on Sept. 17, animal and human food facilities must develop and implement plans that identify potential food-safety hazards and outline steps to prevent or greatly minimize the chance that a food-safety problem will arise, according to FDA.

The two rules are part of seven FSMA rules that FDA plans to finalize by 2016.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules," said Michael R. Taylor, FDA’s deputy commissioner for foods and veterinary medicine, in the press release. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first."

The preventative controls regulations cover registered food facilities. Very small businesses that are not exempt from the requirements have three years to comply with the regulations, small firms have two years, and others have one year after the rule is published in the Federal Register.

FDA estimates the annual costs of compliance is $381 million, but that is a pittance compared to the cost of foodborne illness.

“We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion," FDA noted in the final rule.

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