SALEM, Ohio — After years of planning, public comments and revision, the U.S. Food and Drug Administration has finalized the rules governing produce safety and the auditing of food imported into the U.S.
The new rules — referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule — were announced Nov. 13, and are part of the comprehensive food safety overhaul in 2011, through the Food Safety Modernization Act (FSMA).
The rules focus on “prevention” and seek to combat foodborne illness before it occurs. According to the FDA and the Centers for Disease Control and Prevention, an estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases. Approximately 128,000 are hospitalized, and 3,000 die each year.
The new rules regulate industry accountability and best practices for food importers and the produce community.
“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,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine, in a released statement.
The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms, according to FDA.
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.
Public comments and input received from farmers have helped shape the final rule, which the FDA said will reduce the risk of harmful contamination, while also allowing flexibility for farmers.
The rule is scale-based, and applies differently to different size farms. Produce that is used for personal or on-farm consumption, for example, is exempt. And farms that have an average annual value of produce sold during the previous three-years of $25,000 or less, are also exempt.
The Foreign Supplier Verification programs 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.
The FDA has also finalized a rule on Accredited Third-Party Certification, which is part of FSMA’s new food import safety system. This rule establishes a program for the accreditation of third-party certification bodies (auditors) to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.
Compliance dates for produce growers, except for those involving sprouts, range from two to four years.
Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three years, have four years.
Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three years, have three years to comply, and all other farms have two years.
Although the rules have been made final, the implementation and enforcement will depend on adequate funding.
“The ultimate success of FSMA depends on full funding of the president’s FY 2016 budget request,” Taylor said. “This will help us train FDA and state food safety staff on the new system, fund our state partners to work with farmers on produce safety, provide technical assistance to small farms and food businesses, and successfully implement the new import system that U.S. consumers deserve and Congress envisioned.”
The Produce Marketing Association, a trade group of producers, retailers and distributors, said the final rules “reflect many, but not all,” of the amendments producers have argued for.
Jim Gorny, PMA’s vice president of food safety, said publication of the new rules is not an endpoint, “but rather a beginning, which now requires understanding, planning, implementation and verification by businesses.”
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