The rules establish enforceable safety standards for produce farms, make importers accountable for verifying that imported food meets U.S. safety standards, and establish a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.
“The recent multistate outbreak of Salmonella in imported cucumbers that has killed four Americans, hospitalized 157 and sickened hundreds more, is exactly the kind of outbreak these rules can help prevent,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. “The rules will help better protect consumers from foodborne illness and strengthen their confidence that modern preventive practices are in place, no matter where in the world the food is produced.”
The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce which are designed to work across the wide diversity of produce farms. The standards in the final rule include requirements for water quality, employee health and hygiene, wild and domesticated animals, biological soil amendments of animal origin (such as compost and manure), and equipment, tools and buildings. When followed, the standards are designed to help minimize the risk of serious illness or death from consumption of contaminated produce.
The agency has also released an Environmental Impact Statement for the produce rule.
The Foreign Supplier Verification Programs (FSVP) rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards and that they are achieving the same level of food safety as domestic farms and food facilities.
In 2013, USDA estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans. The final rule ensures that food importers conduct verification activities (such as audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records) based on risks linked to the imported food and the performance of the foreign supplier.
FDA has also finalized a rule on Accredited Third-Party Certification, which establishes a program for the accreditation of auditors to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. To prevent potentially harmful food from reaching U.S. consumers, FDA can require, in specific circumstances, that a food offered for import be accompanied by a certification from an accredited third-party certification body.
The first two FSMA rules, on preventive controls in human and animal food, were finalized at the end of August. The last two rules, for sanitary transport and for intentional adulteration, must be finalized by March 31, 2016, and May 31, 2016, respectively.