Proposed FDA rules apply to the Food Safety Modernization Act (FSMA) and are available for public comment until May 16, 2013. The first rule 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. 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 smaller businesses would be given additional time.

FDA also seeks public comment on the second rule, 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. Smaller farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.  

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. FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed for human food.  

In related news, FDA recently issued a final rule amending the criteria for administrative detention of food to prevent potentially unsafe food from reaching the marketplace. The final rule adopts the interim rule published in May 2011 without change. The interim rule amended the criteria for ordering administrative detention to permit FDA to detain food administratively if it believes it is adulterated or misbranded.

Before the passage of FSMA, FDA was able to detain a food product only when it had credible evidence that product presented a threat of serious adverse health consequences or death to humans or animals. Under the final rule, FDA can now detain food if the agency believes it is adulterated or misbranded. Authorities can keep the products out of the marketplace for a maximum of 30 days while the agency determines whether to take further enforcement action, such as seizure.