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FDA to kick off standardized research project to help in writing produce safety regulations

by Joan Murphy | October 06, 2011

WASHINGTON — Officials from the the Food & Drug Administration asked the produce industry to support a government-led standardized research strategy for soil amendments and water quality, the results of which could be used to prove farms can take an alternative approach to meeting new produce-safety standards.

Two busloads of attendees of the United Fresh Produce Association’s Washington Public Policy Conference headed to the FDA’s College Park, MD, office Oct. 4 on the last day of the three-day meeting to hear from FDA regulators charged with writing the new produce safety regulations, coordinating outbreaks and overseeing import issues.

The popular session allows a wider swath of the industry an opportunity to hear first-hand about federal regulations and inspection priorities.

The FDA officials explained the agency’s “current thinking” in leaning towards not identifying “high-risk” commodities in the FDA Food Safety Modernization Act regulation, which is due out in early 2012, instead listing “risky practices” that could trigger tighter regulatory controls.

During listening sessions on the rule, the FDA heard concerns about two issues: raw manure used as a soil amendment, and the quality of water applied directly to edible portions of the crops, explained Samir Assar, a member of the produce safety staff at the FDA’s Office of Food Safety.

For the issue of water quality and soil amendments, FDA is exploring letting companies follow an alternate approach to the standards by coming up with a validated study that shows the company’s safeguards are equivalent. They also might be flexible about taking into account diversity, he said.

But to lean on these alternate approaches, Mr. Assar said that the FDA needs a standardized research project tailored only to meet the needs of the produce rule to show whether these approaches would work.

Specifically, research should answer questions on whether human pathogens, if present in raw manure or irrigation water, survive in the environment and on fresh produce.

“There’s not enough [research] out there right now for our regulatory purposes,” he explained.

The FDA has already reached out to the Western Center for Food Safety at the University of California-Davis to hold a workshop on a standardized research protocol, and the agency is establishing a research network of produce experts, including researchers at the U.S. Department of Agriculture.

On another topic of interest to the industry, Mr. Assar said that the FDA plans to collect 1,500 samples of a yet-to-be-finalized list of produce commodities during fiscal 2012, although he confirmed that sprouts would be on the list. The FDA plans to sample a similar number of import samples.

Texas Produce Association President John McClung complained that papayas being shipped from south of the border are being held up because there is a “lack of urgency to clear loads that are not contaminated.”

Mr. McClung said that the FDA staffers with responsibility to make decisions on shipments recently were out of the office for training.

“If it takes 10 days to two weeks to clear, [the shipment] is gone,” he said.

There is hope that the Voluntary Qualified Importer Program, a user fee-supported program that is designed to speed shipments through U.S. checkpoints, could make the process easier, although it would not apply to more risky foods like papayas, said Don Kraemer, the FDA’s acting deputy director of operations, a key player who is coordinating all the prevention control regulations in FSMA.

The FDA also is hoping its PREDICT computer screening system will make it easier for the agency to assess the safety of products using a combination of factors, including facility inspection results.

Fourteen of the 16 field offices are using the new screening system, with the Southwest import district scheduled to be phased in by the end of the year, said Ted Poplawski, assistant to the director of the FDA’s Division of Import Operations & Policy.

While the ongoing Listeria outbreak associated with cantaloupes was not mentioned by the FDA staff at the nearly two-hour briefing, Robert Morrissey, executive director of the National Watermelon Association, said that these outbreaks are tarnishing the reputation of watermelons and confusing consumers.

“We’ve been working with the FDA for over three years to remove watermelon from the high-risk melon category,” Mr. Morrissey said.

Outbreaks associated with cantaloupes result in million-dollar losses for watermelon producers, and the latest consumer surveys show confusion in the marketplace about the safety of melons, he added.

Mr. Kraemer assured Mr. Morrissey that the FDA’s latest approach to produce safety standards of singling out risky practices rather than commodities will benefit products that follow low-risk practices.