FDA Proposes Two New Food Safety Rules

The first rule would require makers of food 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 seeks public comment on this proposal. 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 second proposed rule proposes 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, FDA said.

 

The FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.

 

The rules follow extensive outreach by the FDA to the produce industry, the consumer community, other government agencies and the international community, FDA said. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community.

 

“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. “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.”

 

These 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.

 

“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg, M.D. “Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”

 

“We know one-size-fits-all rules won’t work,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

 

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. Improving oversight of imported food is an important goal of FSMA, FDA said.

 

The new proposed rules can be read here and here.