On January 4, 2013, the United States Food and Drug Administration (“FDA”) proposed two new rules intended to make the food we eat safer. These proposed rules are part of the Food Safety Modernization Act (“FSMA”), which was signed into law by President Obama on January 4, 2011.
According to the FDA’s press release, before issuing these rules FDA conducted five federal public meetings and regional, state, and local meetings in 14 states across the country. FDA also visited farms of varying sizes and made “hundreds” of presentations “to ensure that the rules would be flexible enough to cover the diverse industries to be affected.” “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.”
The first rule, regarding preventive controls for human food, would require companies making food for consumption in the United States, whether produced at a foreign or domestic-based facility, to have a formal plan for preventing their products from causing foodborne illness, and correcting any problems that may arise. The second rule, regarding standards for produce safety, proposes enforceable science and risk-based safety standards for the production and harvesting of produce – specifically, fruits and vegetables – on farms.
FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after a 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 is proposing that major 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 is seeking public comment on these proposed rules. It intends to coordinate the comment periods on this and other major FSMA proposals to better facilitate the comment process. FDA has also indicated that additional rules are soon to follow, including: (1) new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food; (2) new accreditation standards to strengthen the quality of third party food safety audits overseas; and (3) new preventive control rules for animal food facilities, similar to those being proposed for human food.
Although FDA initially requested comments on the information collection provisions in both proposed rules by February 15, 2013, in response to industry requests, the agency has extended the comment period for all provisions of both proposed rules to May 16, 2013.