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July 15, 2016 Practice Points

FDA Issues FSMA Final Rule on Intentional Adulteration of the Food Supply

By Karen Woodward

In May 2016, the Food & Drug Administration (FDA) released the final rule under the Food Safety Modernization Act (FSMA) regarding mitigation strategies for protecting food against intentional adulteration. The primary purpose of the rule is to protect the food supply from acts intended to cause large-scale harm, such as acts of terrorism. In developing the rule, FDA worked closely with intelligence sources and studied potential areas of vulnerability in the food-supply chain.

The release of the final rule could not have been more timely, given that it comes less than one month after the widely publicized incident involving a man who sprayed a liquid solution containing rat poison and anti-coagulant medicine on produce and the salad bar at a Whole Foods Market and other grocery stores in Ann Arbor, Michigan.

The rule applies, with some exceptions, to U.S. and foreign companies who are required to register as food facilities under the Food, Drug, & Cosmetic Act. Covered entities are required to create a food-defense plan that (1) identifies vulnerabilities and actionable process steps, (2) provides mitigation strategies as well as food defense monitoring procedures, and (3) lays out corrective actions and verification processes. The required food-defense plan has been compared to the Hazard Analysis Critical Control Point (HACCP) system, with which most large food companies are already well aware.

Because the rule is described by FDA as "the first of its kind," the FDA has set a longer timeline for compliance. Large companies will have as long as three years to comply but should begin the compliance-planning process immediately. FDA is offering training and resources to assist companies in their implementation of the rule, as described on the FDA website, including

  • the establishment of an Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance to develop training resources for industry and regulators;
  • the eventual publication of guidance documents;
  • the current availability of resources that were developed for FDA's voluntary food-defense program;
  • the availability of the Mitigation Strategies Database, which is an online listing of mitigation strategies for use in a food operation to reduce the risk of intentional adulteration; and
  • the opportunity to submit questions either online or by mail to the FDA FSMA Food Safety Technical Assistance Network, which is a general source of information regarding FSMA implementation.

Notably, the Mass Torts Committee is sponsoring a breakout session at the 2017 Environmental, Mass Torts, and Products Liability Committees' Joint CLE Seminar, entitled, "Food Defense: Litigation Threats and New Strategies relating to Protecting the Nation's Food Supply," that will cover these very issues. The conference will be held January 26–28, 2017 at the Resort at Squaw Creek in Olympic Valley, CA. Registration for the conference will open in fall 2016. 

Keywords: mass torts, FSMA, Food Safety, Adulteration, FDA

Karen Woodward is a partner with Sedgwick Law in Los Angeles, California.

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