March 2011

A Polsinelli Shughart Update

FDA Prepares to Implement New Food Safety Legislation

In January 2011, President Obama signed the FDA Food Safety Modernization Act into law. Years of debate and wrangling between FDA, consumer protection groups and the food industry culminated in passage of the Act – a product of last-minute legislative maneuvering up until the very end of Congress’ “lame duck” session. In one of his first official statements on the new Act, Deputy Commissioner for Food Michael Taylor outlined the FDA’s immediate priorities under the new law.

Background

The FDA Food Safety Modernization Act represents one of the two most significant revisions to the agency’s regulation of food since the passage of the original Federal Food, Drug, and Cosmetic Act of 1938. Far more detailed than the 1938 Act, the new FDA Food Safety Modernization Act attempts to change the paradigm for food safety – including imposing significant, new responsibilities on a wide variety of companies and actors in the food industry. Deputy Commissioner Taylor characterized this as a change from a reactive to a preventative approach, in which the federal government, state governments and industry will be required to work in partnership to keep the food supply safe with industry participants taking a far more active role.

Notable Provisions

Among its most notable features, the FDA Food Safety Modernization Act:

1. Puts risk analysis at the forefront of modern food safety
2. Changes how the FDA will target its inspections
3. Imposes direct importer accountability
4. Provides mandatory recall authority
5. Will impose food traceability requirements

What Does This Mean?

During the next 6 to 24 months, FDA will begin producing some of the more than 50 guidance documents, reports and regulations which will define the new food safety regime. Food producers, shippers, manufacturers, processors, distributors and importers will face rapidly evolving requirements which can significantly affect their daily business operations and costs. FDA is also ramping-up to meet aggressively increasing domestic and foreign inspection mandates. Well-informed companies will anticipate many of the new developments and, also, take advantage of openings to help shape FDA’s and the industry’s thinking. Companies which fail quickly to adapt face financial losses and market irrelevance.

For More Information

For more information, please contact:

• Jason W. Sapsin at 720.931.1175 or jsapsin@polsinelli.com

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