The produce industry is submitting comments to the Food and Drug Administration about Food Safety Modernization Act rulemaking.

The FDA is accepting written comments until May 16.

In March, the United Fresh Produce Association, Washington, D.C., requested comments from its leader members who served on the group’s leadership and councils about the FSMA.

David Gombas, United Fresh’s senior vice president of food safety and technology, said the organization received comments from a wide spectrum of growers of row crops, bush crops and tree crops, and from packinghouses, retailers, foodservice buyers and scientists.

Though the association and its members plan to submit comments individually and as a group, Gombas said the industry needs to see all five rules in the FDA’s suite of interlocking regulations.

So far, the FDA has only released the produce and preventive controls rules. The others — the foreign supplier verification, animal preventive controls and third-party accreditation — remain at the Office of Management and Budget, Gombas said.

“Generally speaking, we think the FDA did (as good of a) job as it could on the first round,” Gombas said, speaking of the FSMA’s proposed rules.

“It’s very clear they spent a lot of time thinking through this and how to meet the statutory requirements in a way that would be enforceable on farms. They took a light hand approach on some things like animals and recordkeeping and a heavier hand with water and compost.”


Jim Gorny, senior adviser for produce safety at the FDA’s Center for Food Safety and Applied Nutrition, Washington, D.C., said many are submitting detailed questions involving their operations.

The comments assist the agency in developing the companion documents and help industry understand what is and isn’t in compliance, he said.

“The FDA hasn’t taken a one-size-fits-all approach to produce in the Food Safety Modernization Act,” Gorny said. “We’ve taken on all the key routes of contamination that are known. People are still digesting what the FDA has released and are trying to understand the proposed rule’s implications for their business.

“No one’s saying we’ve missed the mark. We’re getting detailed questions to the nitty-gritty. That doesn’t mean we haven’t considered it and we’ve asked a lot of questions. We acknowledge that we don’t have all the answers inside the Beltway. We want to make sure the rules are workable, practical and (push) the ball forward on food safety.”

Areas of concern to the produce industry include definitions of farms and facilities, Gombas said.

Loophole for small growers?

The proposed rules require a Web seminar to explain the large and complicated zone between a farm and a facility, Gombas said. He said United Fresh wants the FDA to simplify who is required to follow the produce safety rules and the preventive controls rules.

Because scientists haven’t developed accurate E. coli testing procedures, Gombas said the FDA needs to place scientific details into accompanying guidance documents instead of in the rules.

Saying pathogens don’t know what size of farms they’re attacking, Gombas said United Fresh still contends it’s inappropriate to exempt operations simply because of size.

As only 15 or 20 of the more than 300 produce commodities have ever suffered an outbreak, United Fresh notes the proposed rules fail to address fruits and vegetables that haven’t been involved in recalls.

Because scientists don’t know why they haven’t been involved in illnesses isn’t a reason to assume they could be, as FDA now assumes, Gombas said.

Walter Ram, vice president of food safety for The Giumarra Cos., Los Angeles, said fresh produce has largely been exempt from regulation until FSMA but the act’s produce safety rule will represent much of that regulation.

“I think the FSMA overall will be good for the industry as long as the regulations reflect real-world situations,” Ram said.

“Our industry has already had some influence on pending regulations with the current commodity-specific food safety guidelines, including those for tomatoes, cantaloupes and leafy greens.

“The FDA got a lot right with the produce safety rule but there are still a lot of details that we are working on with them. They are being very open in talking to the industry and they are certainly listening.”

Gorny commends the industry for its safety research programs and cites industry collaboration in funding the University of California-Davis’s Center for Produce Safety’s research.

He said groups as diverse as leafy greens growers, the National Mango Board, the California Melon Research Board and the California and Washington departments of agriculture are involved.

Gorny lauded organizations including the California Citrus Quality Council, the National Watermelon Association and the California Strawberry Commission for developing national guidance documents.

He said the FDA’s Food Safety Preventive Controls Alliance and Sprout Safety Alliance should help grower-shippers and processors better prepare for safety practices.