WASHINGTON - The U.S. Food and Drug Administration on Friday proposed two new food safety rules that are intended to help prevent foodborne illness. The proposed rules implement the FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days; FDA is encouraging Americans to review and comment on the proposed rules.

"The FDA Food Safety Modernization Act is a common sense law that shifts the food safety focus from reactive to preventive," said Health and Human Services Secretary Kathleen Sebelius in a press release. "With the support of industry, consumer groups and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families."

According to the FDA, the burden of foodborne illness is substantial, with one in six Americans suffering from a foodborne illness every year. The two FSMA rules are part of an integrated reform effort that focuses on prevention and addresses the safety of foods produced domestically and imported, with additional rules to be published shortly.

The first rule proposed would require food makers of products to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. The FDA is proposing that many food manufacturers be in compliance with the new preventive controls rules one year after the final rules are published in the Federal Register but small and very small businesses would be given additional time.

The FDA is also proposing enforceable safety standards for the production and harvesting of produce on farms. This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables.

Additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards to strengthen the quality of third party food safety audits overseas. Approximately 15% of the food consumed in the United States is imported, with much higher proportions in certain higher risk categories, such as produce. The FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed today for human food.

The FDA plans to coordinate the comment periods on the major FSMA proposals as fully as possible to better enable public comment on how the rules can best work together to create an integrated, effective and efficient food safety system.