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Proposed FSMA Rule on Food Defense Likely to Affect Most Food Facilities

Jan 08, 2014

As 2013 wound to a close, the Food and Drug Administration issued its sixth major proposed rule for the year under the Food Safety Modernization Act (FSMA). Known as the food defense rule, the “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration” addresses potential acts of terrorism that could cause massive public harm and economic disruption. Because FDA has focused on processes that are likely to occur at most food manufacturing facilities, all IDFA members will need to review the rule to determine how it will affect their facilities.

As currently written, the proposed rule would require each facility to prepare a Food Defense Plan that would include key action steps, focused mitigation strategies and procedures for monitoring, taking corrective actions and verifying activities. Companies would be required to document all food defense activities, and these documents would be subject to FDA inspection.

IDFA offers two opportunities to learn more about the proposed rule and its considerable impact on dairy facilities. One is a detailed memorandum prepared by Hogan Lovells US LLP, IDFA’s outside counsel. Members may login below to read the memo.

The other is a webinar, which will be held January 14, 1:30 – 3:45 p.m. The presenters will be Joe Levitt, partner at Hogan Lovells, who will focus on the key points of the rule, and Colin Barthel, food defense policy analyst at FDA, who will discuss the agency’s Food Defense Plan Builder software program and other tools that members may use to comply with the rule when it is finalized.

Comments on the proposed rule are due by March 31, 2014. Because this closing date is mandated by court order, it is unlikely that FDA will extend the deadline as it has for previous FSMA proposed rules.

For more information on the proposed rule, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

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