The Food Defense rule requires companies in the US and abroad to take steps to prevent intentional adulteration of the food supply.
FDA said the benefits of actions required by the rule are a reduction in the possibility of illness and death resulting from intentional adulteration of food.
The rule was proposed in December 2013 and more than 200 comments were submitted.
Who is covered?
There are 3,400 covered firms that operate 9,800 facilities. It does not cover farms or alcoholic beverages under certain conditions. More information is available in the Federal Register notice.
Domestic and foreign facilities will be required to complete and maintain a written food defense plan that assesses potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.
Facilities have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify the system is working, ensure that personnel receive appropriate training and maintain certain records.
A reanalysis is required every three years or when certain criteria are met.
Stephen Ostroff, incoming deputy commissioner for foods and veterinary medicine at FDA, said the rule will work with other components of FSMA by preventing problems before they occur.
“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply.”
Food manufacturers are required to comply within three to five years after publication of the final rule, depending on size of the business.
Very small businesses have to comply with modified requirements within five years after the publication of the final rule, small businesses have four years and other businesses have three.
A webinar to present the final rule will be on June 21.
GMA welcomes rule
Pamela Bailey, president and CEO of the Grocery Manufacturers Association (GMA), said it welcomed the final rule on prevention of intentional product adulteration.
“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.”
She said FSMA ensures that prevention is the cornerstone of the country’s food safety strategy.
“It places new responsibilities on food and beverage manufacturers and provides the FDA with the resources and authorities it needs to further strengthen our nation’s food safety net.
“GMA will continue its work to support the effective implementation of FSMA 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 US and the entire global supply chain.”