FDA Final Rule
The U.S. Food and Drug Administration on May 26 issued a final rule aimed at preventing the adulteration of food from acts intended to cause wide-scale harm to human health, including acts of terrorism targeting the food supply. With the issuance of this rule, the F.D.A. has finalized all seven major rules implementing the core of the F.D.A. Food Safety Modernization Act (F.S.M.A.).
Under the new rule, both domestic and foreign food facilities, for the first time, will be required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. Facilities will have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.
“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., the F.D.A.’s incoming deputy commissioner for foods and veterinary medicine. “The rule will work in concert with other components of F.S.M.A. by preventing food safety problems before they occur.”
The rule was proposed in December 2013. The final version took into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates, and others.
“The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies and ensure that the mitigation strategies are working as intended,” the F.D.A. said.
Food manufacturers will be required to comply with the new rule within three to five years after its publication, depending on the size of the business. Businesses that are not small or very small and do not qualify for exemptions would have to comply no later than three years after the publication of the final rule. Small businesses, those employing fewer than 500 persons, would have four years to comply.
The rule does not apply to very small businesses, those averaging less than $10 million per year, except that such facilities would be required to provide for official review, on request, documentation to show that they qualify for this exemption. They will have to comply with these modified requirements within five years.
“We welcome today’s release by F.D.A. of its final rule on prevention of intentional product adulteration, the last of the seven major foundational rules for F.S.M.A.,” said Pamela G. Bailey, president and chief executive officer of the Grocery Manufacturers Association. “Food and beverage manufacturers have an unwavering commitment to the safety and integrity of their products, and this final rule will further help manufacturers to ensure they have the necessary protocols in place, both at home and abroad, to protect their products from willful acts of adulteration.
“G.M.A. will continue its work to support the effective implementation of F.S.M.A. and will maintain a leadership role on behalf of industry to educate food and beverage manufacturers on what it will take to comply with the law, both in the United States and the entire global supply chain.”