view current print edition







Produce groups urge the FDA to change off-farm packinghouse rules under FSMA

WASHINGTON — Different standards for packinghouses under the Food Safety Modernization Act based on their location will cause confusion within the industry and are not science-based, produce industry groups told officials at the Food & Drug Administration during a Thursday public meeting on FSMA changes.

Under the FDA's current interpretation of FSMA, on-farm packinghouses would need to meet produce safety standards, but off-farm operations, which must register with the FDA, would have to meet more extensive and costly preventive control requirements.

Registered facilities that only handle raw agriculture commodities and don't conduct further processing should be covered under the produce safety rule, Reggie Brown, executive vice president of the Florida Tomato Exchange, argued during the meeting held in College Park, MD. Food safety and public heath benefits are likely to be best served by a single rule, he said.

"The current regulation as proposed will result in confusion in the produce industry by requiring those actually subject to registration to establish an independent food-safety program for raw agricultural commodities rather than those established by the produce rule," he said, adding that all the additional recordkeeping, staffing and testing requirements for off-farm operations based "only on the physical location of the operation is not practical."

David Gombas, senior vice president for food safety and technology at the United Fresh Produce Association, urged the FDA to add language to the FSMA rules that would allow off-farm facilities that meet produce safety requirements to automatically satisfy preventive controls.

FDA staff acknowledged the issue has not been put to rest by the latest fixes to its farm definition.

"We're considering [this issue] ourselves," Rebecca Buckner, the FDA's implementation manager, said during the day-long meeting.

But the issue is not easy to resolve because the statute requires facilities registered with the FDA to meet preventive controls, said Jenny Scott, senior adviser at the Office of Food Safety at the FDA. Only farms and retail operations are exempted from registering with the FDA as facilities.

"We are looking at all those definitions and what can and can't change," said Scott. "We certainly appreciate your thoughts of how a facility that has to register could be moved into the produce rule that applies to farms.

"I'm sure that's an area where you have your legal counsel looking at very carefully," she quipped.

Gombas also urged the FDA to back off product testing as a verification tool for raw agricultural commodities.

"You test one strawberry or apple, you've tested one strawberry or apple," he said. "The results tell you nothing about the rest."

He also proposed a simpler, modified approach to water testing and urged the FDA to move away from its complicated testing standard in the produce safety rule.

In other comments, consumer groups urged the FDA to scrap its current proposed small business definition of less than $1 million in annual food sales for the preventive controls rule, suggesting the large number of exempted processors and foreign suppliers will put consumers at risk.