The Food & Drug Administration is putting the final touches on its implementation strategy for the new food-safety program, and produce companies should be doing the same, James Gorny, vice president of food safety and technology at the Produce Marketing Association, said at the recent Food Safety Summit in Baltimore.

The Food Safety Modernization Act rule for produce won’t be finalized until later this year, and Gorny said water and manure standards may change, but 80-90 percent of the rule is likely to change little from the proposed version.

It’s time to make company owners and chief executives aware of what’s coming, and don’t just prepare for the produce-safety changes, he said at the Baltimore meeting. All of the seven FSMA regulations, particularly the sanitary transportation rule, will affect how companies do business, he warned.

The FDA is planning education and outreach for produce companies and is working with the National Association of State Departments of Agriculture to develop a farm-based pre-assessment inspection to help farmers know if they’re complying with the law before the FDA starts enforcing it, said Fazila Shakir, fellow with the FDA’s produce safety staff.

Bob Ehart, senior policy adviser for NASDA, warned that no one has rolled out such an ambitious, on-farm food-safety program before, and while farmers want state agriculture agencies to act as “buffers” between companies and the FDA, it’s still unclear how many states will adopt the produce rule changes.

NASDA is in the process of asking states what will be required in terms of resources and training to implement the law.

Ehart said without a steady funding stream to states, Congress might find “passing FSMA was not a really good idea.”

Eva Lauve, scheduling and food-safety manager for Stemilt Growers, a Washington-based tree fruit firm, said she’s 95 percent confident her company can meet the new produce requirements. Stemilt already went through a change in food-safety culture in 2003 when it required growers to maintain food-safety plans. Lauve said the biggest challenge would lie in meeting the new water-testing standards.

In a separate session, Joe Levitt, partner at Hogan Lovells, advised companies preparing for FSMA compliance to live by a simple motto: “You are what your records say you are.” 

FDA will be embracing a systems-based approach to inspections and companies will need to prove they are following a preventive controls program and have the records to show it.

Levitt, a former director of FDA’s Center for Food Safety & Applied Nutrition, suggested that although the agency is moving toward an “educate before you regulate” philosophy, enforcement will be much more swift under FSMA if inspectors find problems.

No one thinks FDA inspections will be a breeze, he added.