FDA releases rules to implement FSMA
The FDA has released its long-awaited implementation documents for the Food Safety Modernization Act (FSMA). The two rules will be placed in the Federal Register and will be available for public comment over 120 days.
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. FDA is proposing that many food manufacturers be in compliance 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 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, according to FDA.
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.
Produce industry leaders welcomed the release of the rules and promised cooperation within the industry and with government officials as the review process gets underway.
“We’re pleased to see the proposed rules released and are eager to review and assess them,” said Bryan Silbermann, president and CEO of Produce Marketing Association. “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.”
David Gombas, senior vice president of food safety and technology at United Fresh, said the organization would work closely with the industry and FDA regulators during the review period.
“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,” Gombas said.
This involvement continues a record of advocacy for food safety by United, said Ray Gilmer, vice president of issues management and communications.
“United Fresh Produce Association has been among the most vocal supporters of comprehensive modernization of the food safety system in the United States, 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,” Gilmer said.
“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.”
More rules are to follow “soon,” according to FDA. They will 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. FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed today for human food.
To view the Federal Register notice about the two rules released on Jan. 4, click on the following links:
- Federal Register Notice for the Proposed Rule “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”
- Federal Register Notice for the Proposed Rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”
- FDA Food Safety Modernization Act (FSMA)