FDA Proposes New Food Safety Rules

January 7, 2013

On January 4, 2013, the U.S. Food and Drug Administration (FDA) proposed two new food safety rules designed to help prevent foodborne illness. The proposed rules implement portions of the Food Safety Modernization Act (FSMA), a 2011 law that shifted the FDA’s focus from responding to contamination to preventing it. The FDA will provide a 120-day period for the public to comment on the proposed rules. Comments are due by May 16, 2013.

The first proposed rule would add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventative controls for human food. The rule would require makers of food to be sold in the United States to develop a formal plan for preventing their food products from causing foodborne illness, as well as plans for correcting any problems that arise. The FDA is proposing that many food manufacturers be required to comply with the preventative control rules within one year after a final rule is published. The FDA plans to provide small businesses with additional time to comply with the new controls.

The second proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Produce that is rarely consumed raw, produce for personal or on-farm consumption, and produce that is not a raw agricultural commodity would be exempt from the new standards. Additionally, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption.  The FDA is proposing that larger farms be in compliance with most of the new requirements within 26 months after a final rule is published. Small farms would be given additional time to comply.

The FDA also announced that additional food safety rules will soon be released. These rules will include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food, accreditation standards to strengthen the quality of third party food safety audits overseas, and preventative control rules for animal food facilities.

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