FDA has proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. (See page two for comments on the proposed rules from the Produce Marketing Association and United Fresh.)
The rules follow outreach by FDA to the produce industry, the consumer community, other government agencies, and the international community. 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.
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 shortly.
The first rule proposed today would require makers of food to be sold in the U.S, 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. 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.
FDA also seeks public comment on the second proposed rule released today, 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.
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 extensive 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, 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% of the food consumed in the U.S. is imported, with much higher proportions in certain higher risk categories, such as produce.
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.
Produce Associations Pipe Up On Food Safety Proposals
Bryan Silbermann, president and CEO of Produce Marketing Association (PMA), issued the following statement in response to the release of FDA’s proposed rules on produce safety and preventive controls under the Food Safety Modernization Act:
“We’re pleased to see the proposed rules released and are eager to review and assess them. Throughout the regulatory process, we’ve worked diligently with and will continue to inform key decision makers to help guide these regulations in a direction that will best serve public health and our industry’s food safety needs.
“In the coming days we’ll provide an online summary of the proposed rules and will be scheduling a free webinar for members with FDA and PMA experts. And, over the next few months, we’ll read and analyze the proposed rules and work with PMA’s volunteer leaders to submit commentary to the FDA. Once the FDA reviews all the comments submitted, they’ll revise the rules in a final form which will include a timeline for implementation.
“It’s important to remember that these are the first two of many proposed rules that will have implications for every aspect of the global produce supply chain. As more proposed rules are released, we’ll continue to provide updates to our membership and provide commentary to FDA on the industry’s behalf.
“Food safety remains a top priority for our members and we look forward to effective enhancements in food safety that not only protects public health, but bolsters consumer confidence. FDA has put in a great amount of time and effort to develop these proposals and they deserve our focused attention as the agency asks for our input.”
Response From United Fresh
According to Ray Gilmer, vice president of issues management and communications for United Fresh, the association will study the the proposed rules to determine if they have focused on the principles United supported throughout the development of the law.
“United Fresh Produce Association has been among the most vocal supporters of comprehensive modernization of the food safety system in the U.S., working with members of Congress and the Bush and Obama Administrations, and testifying before House and Senate committees more than 10 times to advance improved food safety for fresh produce,” said Gilmer. “We will be analyzing the proposed rules to ensure that they draw upon the principles we have supported throughout the development of the FSMA. The proposed rules must be: 1) commodity-specific, based on best available science; 2) risk-based; 3) consistent no matter where produce is grown or packaged, in the U.S. or imported, large or small operations; and 4) flexible to allow for advances in science and production technology. We are committed to ensuring that those critical provisions, and others, will be integrated into the final rules going forward.”