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Produce groups share FSMA concerns at first two-day FDA meeting on proposed rules

WASHINGTON -- Produce companies may be focusing on changes coming from the new safe-growing standards proposed by the U.S. Food & Drug Administration, but another one of its regulations, preventive controls, may have broader effect throughout the produce supply chain, Kathy Means, vice president of government relations and public affairs at the Produce Marketing Association, told FDA officials March 1.

Scores of stakeholders lined up at the Feb. 28-March 1 public meeting in Washington, DC, to comment on two massive regulations proposed under the FDA Food Safety Modernization Act on Jan. 16.  Nearly 500 people signed up to attend the two-day meeting, and FDA has scheduled two other public meetings in Chicago on March 11 and Portland on March 27 to hear comments.

Ms. Means urged FDA to stay flexible in writing final preventive control regulations, so the rules “unlock the industry’s creativity and be adaptable to emerging science.” The preventive controls, which extend the HACCP food-safety system to all registered food facilities, will apply to an array of firms in the produce supply chain, including shippers, wholesales, repackers and distribution centers.

“Operators may be slow to adopt new and better ways of protecting public health if they fear FDA may second-guess new safeguards that do not match the rules and may risk penalties,” she said.”If the rules are too narrow, operators will cling to those requirements, regardless of the advances in science,” she warned.

PMA and the United Fresh Produce Association expressed concern about the food-safety law’s exemption for small farms, a provision they opposed during the FSMA legislative debate. Under FDA’s proposal, commodities rarely consumed raw or destined for processing are exempt, along with farms with sales of less than $25,000 a year and a qualified exemption for farms that meet certain distribution and income criteria.

David Gombas, United Fresh’s senior vice president of food safety and technology, said the exemption could allow small operations to “side-step food-safety practices,” and that “pathogens don’t know what size operation they’re on.”

“Because an exemption based on size is not science-based, we urge as narrow an exemption as possible,” Ms. Means said.

While Dr. Gombas praised FDA for exempting certain fresh produce commodities rarely consumed raw from the produce-safety standards, at least one consumer advocate disagreed at the public meeting.

“By codifying this list in regulations, it will be next-to-impossible for the agency to respond rapidly to evolving contamination problems,” said Sandra Eskin, director of the Pew Charitable Trusts’ food-safety campaign, who suggested FDA move the exempted fruit and vegetable list into a guidance document.

Ms. Eskin and other consumer groups also pledged to make the case for product and environmental testing in the final preventive controls regulation. FDA did not include these testing requirements in the proposal, but FDA officials have said some form of testing is likely to survive in the final rule and asked for a large amount of information on how food companies use testing to verify food safety programs.

But FDA should not add costly product and environmental testing, along with supplier verification controls, in a final rule without allowing the food industry time to comment, said Leon Bruner, Grocery Manufacturer Association’s senior vice president for scientific and regulatory affairs.

FDA is moving ahead with drafting guidance documents for the produce safety rule, said Jim Gorny, FDA’s senior advisor to FDA’s Office of Food Safety, one of the speakers at the meeting.

The agency has contracted with Deloitte & Touche, which is working with Leavitt Partners and the Institute of Food Technologists, to update its Good Agricultural Practices guidance document under FSMA, he said. FDA is working on a small farm compliance guide, overall compliance policy strategy and is staffing up a national technical assistance network to be unveiled in April that will house experts to handle routine to complex questions from industry on FSMA.