The Food and Drug Administration Friday released proposed rules detailing standards for produce safety and preventive controls for human food production. The release is a major step in the implementation of the Food Safety Modernization Act – the first large overhaul on food safety laws since the 1930s – which President Obama signed into law two years ago.
Since January 2011, FDA staff have toured farms and facilities nationwide and participated in meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community to develop the new standards.
“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.”
The first rule proposed Friday 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 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 also seeks public comment on the second proposed rule released Friday, which 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.
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 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.”
Before issuing the two rules, the FDA conducted outreach that included five federal public meetings and regional, state, and local meetings in 14 states across the country as well as making hundreds of presentations to ensure that the rules would be flexible enough to cover the diverse industries to be affected. The FDA also visited farms and facilities of varying sizes.
“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. Approximately 15 percent 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 National Sustainable Agriculture Coalition praised Congress for following an approach that supports farms of all sizes, and will review FDA's interperetation of the FSMA.
"With the aim of improving food safety through FSMA, Congress rejected a 'one-size-fits-all' approach to food safety regulations," said Ariane Lotti, NSAC assistant policy director. "A 'one-size-fits-all' approach would put small and mid-sized farm operations out of business, consolidate agricultural markets, and eliminate opportunities for food and farm entrepreneurs in emerging sectors of agriculture – including organic and local and regional food systems. NSAC will be closely reading the rules to determine whether FDA followed Congressional intent."
The United Fresh Produce Association said also they would review FDA's draft rules with their own food safety experts and industry stakeholders.
“United Fresh is pleased that FDA has published the draft rules and look forward to working with all stakeholders to conduct a thorough review,” said Dr. David Gombas, senior vice president, food safety & technology. “We will work closely with members across the produce industry, leading food safety scientists, other stakeholders and the FDA to ensure the proposed rules are practical and effective for enhancing produce food safety.”
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.
The new proposed rules are available for public comment for the next 120 days in the Federal Register.