They are the Produce Safety rule, the Foreign Supplier Verification Programs (FSVP) rule, and the Accredited Third-Party Certification rule.
The rules are scheduled for publication in the Federal Register November 27.
General compliance dates for the Produce Safety rule are in January 2017 for covered activities involving sprouts and in January 2018 for those not involving sprouts.
The general compliance date for the FSVP rule is May 2017.
FDA must publish the final Model Accreditation Standards guidance and the final user fee rule before the third-party certification program may be implemented, said law firm Keller & Heckman.
The rules build on the preventive controls rules the FDA finalized in September, which mandate modern preventive practices in food processing and storage facilities. The agency has finalized five of seven rules as part of FSMA.
“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.”
United Fresh and PMA reaction
Tom Stenzel, United Fresh president and CEO, said it was confident the majority of fresh produce brands are already in compliance with the standards.
“The Produce Safety and Foreign Supplier Verification rules are the culmination of years of efforts by FDA and the fresh produce industry to develop reasonable, fair and practical standards for both domestic and foreign growers, based on the best available science,” he said.
“We will be reviewing the rules closely to make sure our industry and government officials have clear and common expectations in implementing these requirements.
“We also intend to work diligently with FDA, USDA, other countries’ regulatory agencies, state departments of agriculture and universities to ensure that all growers understand and meet these standards.”
Jim Gorny, Produce Marketing Association, VP of food safety and technology, said the rules reflect many, but not all, of the amendments PMA and other trade organizations recommended in comments to FDA.
“We’re pleased that FDA considered the practical needs of the produce industry; however, we still have concerns and questions about some of the specific implementation details regarding these rules,” he said.
“The publication of these FSMA rules is not an endpoint but rather a beginning, which now requires understanding, planning, implementation and verification by businesses.”
About the rules and more reaction
Standards in the Produce Safety 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.
The Foreign Supplier Verification Programs rule requires importers to verify that foreign suppliers are producing food that meets US safety standards and they are achieving the same level of food safety as domestic farms and facilities.
The Accredited Third-Party Certification rule establishes a program for accreditation of third-party certification bodies (auditors) to do food safety audits and to certify that foreign facilities and produced by such facilities meet applicable food safety requirements.
Taylor said the success of FSMA depends on full funding of the President’s FY 2016 budget request.
“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 US consumers deserve and Congress envisioned.”
Hillary Thesmar, FMI VP of Food Safety Programs, said FDA’s rule should support rather than supplant global food safety practices.
“The final foreign supplier verification rule will significantly impact food retailers importing products into the US. We believe the rule should be in line with other GFSI-benchmarked schemes, like FMI’s Safe Quality Food Institute program,” she said.
“We are anticipating a long road ahead with FSMA implementation; we look forward to working closely with the agency and the food retail industry’s supply chain partners on implementing a consistent system that only strengthens the safest food supply in the world."
The Grocery Manufacturers Association (GMA) welcomed the release of the final FSMA rules.
“These rules place new responsibilities on food and beverage manufacturers and provide the FDA with the regulatory oversight and authorities it needs to further strengthen our nation’s food safety net.
“FSMA represents a comprehensive system of preventive measures so it is essential that FDA be appropriately resourced to effectively implement and enforce all of the food safety mandates set forth in the law.
“The food and beverage industry is committed to working with Congress, the Obama Administration and all stakeholders to ensure that Congress appropriates the necessary funding for FDA to fully implement FSMA.”