WASHINGTON — The Food & Drug Administration on Nov. 13 released the three long-awaited regulations on produce safety, foreign supplier and third-party audits that make up the Food Safety Modernization Act.

While produce businesses may dig into the final produce handling regulations first, the other two regulations will guide FDA’s oversight of imports. FDA already released the two preventive control regulations and is scheduled to publish two remaining rules on sanitary transportation and food defense in 2016.

“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,” Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said during a morning press conference. “The FDA is working with partners across the government and industry to prevent foodborne outbreaks. 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 U.S. Apple Association called the 801-page produce safety rule “the most significant changes to produce safety regulation in 70 years, and have the potential to significantly affect tree fruit production practices.”

“Our Technical Food Safety Task Force and director of regulatory affairs will review the rule and determine how it specifically affects our growers and packers,” said Jim Bair, U.S. Apple’s president and chief executive officer.

“The United Fresh Produce Association has long advocated for federal, risk-based and commodity-specific food-safety standards for all fresh produce, wherever grown, to assure consumers that all producers are growing and distributing the safest possible products," said Tom Stenzel, United Fresh president and chief executive officer. "The Produce Safety and Foreign Supplier Verification rules published today 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. 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 are confident that the overwhelming majority of fresh produce brands that consumers enjoy today are already in compliance with these standards," Stenzel said. "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. We look forward to working with FDA and all of these partners in the coming months and years to assure all of our consumers that filling Half the Plate with fresh produce is the healthiest choice they can make."

Taylor said the FDA built in more flexibility in the final produce rule’s agriculture water standard and testing regime. Most of the larger operations will have two years to comply and all farms will have two more years to comply with the water quality standards and testing and recordkeeping provisions.

More flexibility was added to the verification requirements under the Foreign Supplier Verification Program, he said. That rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards.

The third rule sets up a program for accrediting third-party certification bodies to conduct food-safety audits. Under the new program, the FDA can require in specific circumstances that a food offered for import must be accompanied by a certification from an accredited third-party certification body.

Turning to implementing the 2011 law, Taylor said its ultimate success depends on the $109 million increase requested by President Obama for the FDA’s budget. So far, congressional committees have approved an increase of a little less than half of the administration’s request, but the budget process has yet to be finalized.

“These final rules published today reflect many, but not all, of the amendments PMA and other leading food trade organizations have recommended in their comments to FDA in the last few years,” said Jim Gorny, PMA vice president of food safety and technology. “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.

“The publication of these FSMA rules is not an endpoint but rather a beginning, which now requires understanding, planning, implementation and verification by businesses,” said Gorny. “To that end, we’re pleased to learn FDA will also soon be issuing important companion guidance documents for these final rules that will provide more detailed information about coverage and compliance requirements.”