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Dairy Facts 2016

FDA Finalizes Food Defense Rule

Jun 02, 2016

For the first time, the Food and Drug Administration will require food companies to develop action plans to counteract the possibility, however unlikely, that an act of intentional adulteration could affect the U.S. food supply and cause widespread public harm.

With the release last week of the “FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration,” the seventh and final major rule of the Food Safety Modernization Act, FDA outlined plans to require food companies to create and maintain a written food defense plan for their facilities.

Under the new rule, facilities must identify and implement strategies that address significant vulnerabilities, establish and maintain food defense monitoring procedures and corrective actions, maintain records monitoring these actions and ensure that employees are properly trained. Companies will also be required to update and reevaluate these plans every three years.

Businesses with 500 or more employees must comply with the rule by May 2019, and businesses with fewer than 500 employees will have to comply by May 2020. However, if these businesses average less than $10 million in food sales per year, they will have until May 2021 to comply.


The rule applies to most domestic and foreign food facilities registered with FDA, but it does not cover farms. For dairy farms, the agency said that the National Conference on Interstate Milk Shipments would be the appropriate platform to address these operations.

Additional Plan Flexibility

In the final rule, FDA decided not to specify different requirements for “broad” and “focused” mitigation strategies, as it had in the proposed rule, allowing more flexibility and recognizing that both types of strategies can effectively deter intentional adulteration.

“This provides a company more flexibility in selecting strategies that address the unique vulnerabilities a facility has, instead of a one-size-fits-all strategy,” said Emily Lyons, IDFA director of regulatory affairs and counsel.

In the coming months, IDFA will schedule a webinar on the rule that will include speakers from FDA and Hogan Lovells US LLP, IDFA’s outside legal counsel and FSMA experts. These presenters will focus on how the rule applies to dairy companies and how to prepare and update the food defense plans many companies have already created for their facilities.

For more information, visit the FDA website or contact Lyons at

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