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FDA briefs produce businesses on regulations, outbreaks

by Joan Murphy | September 15, 2010
WASHINGTON — A new U.S. Food & Drug Administration survey of leafy greens and tomatoes that has resulted in several Class 1 recalls was just one of the topics discussed during a town hall meeting organized by the United Fresh Produce Association during its Washington Public Policy Conference, held here Sept. 14-16.

Busloads of attendees traveled to the FDA's College Park, MD, headquarters Sept. 15 for a two-hour town hall meeting to hear the latest on FDA regulations, research and outbreak investigations. The event has become a popular session for produce business leaders attending the conference.

But at the meeting, FDA officials did not say when two eagerly awaited regulations — a proposed produce safety regulation and a proposed updating of the Good Manufacturing Practices standard for food processors — might be published.

FDA officials are busy reading the 900 comments it received when it asked for input on produce safety in July, said Samir Assar, director of FDA’s produce safety staff.

Common themes have emerged from the comments so far, he said, such as the rule should be flexible, science-based, hold imports to the same standard, include education, leverage existing compliance mechanisms, and tap federal and state agencies as well as third-party audits to ensure compliance.

Fresh-cut processors are keeping an eye out for a revamped GMP rule, which has not been updated since 1986.

The FDA has just wrapped up a survey of current food-safety practices at domestic facilities, and the agency is looking at reports from the Reportable Food Registry that can identify areas where preventative controls have not worked in preventing contaminated food, said Paul South, a chemist for the FDA’s Office of Food Safety.

David Gombas of United Fresh said in an earlier session that he expected the two regulations would have been released by now and suggested FDA was "sitting back and waiting" until Congress completes action on food-safety legislation before moving ahead with the regulations.

But it is a new research project at the FDA that has some industry members concerned. FDA researchers have found Salmonella at Virginia tomato farms and in retail samples of bagged and loose leafy greens at grocery stores.

The agency took 8,000 leafy green samples to get a baseline for microbiological contamination, and found three Salmonella-positive samples and two E. coli O157:H7-positive samples in bagged spinach and hearts of Romaine, said Thomas Hammack, acting director of the FDA’s Division of Microbiology.

“We need a baseline to see what’s happening at the retail level,” he said.

FDA plans to look for Salmonella, E. coli and Listeria in 2011 in 4,000 bagged lettuce and spinach products, Mr. Hammack said, adding that producers would be notified as soon as results are available.

The FDA has been conducting tests at some of Virginia’s Eastern Shore tomato farms as part of a research project that is exploring why the region has been the cause of outbreaks. Earlier this year, it found a strain of Salmonella at a farm that Mr. Hammack suspects might be linked to sporadic illnesses during August.

Tomatoes and lettuce are the leading cause of produce outbreaks from 1996 to 2010, said Sherri McGarry, director of the FDA’s Division of Public Health & Biostatistics and center emergency coordinator. There is a tremendous room for improvement when it comes to tracing the cause of outbreaks, she said.

Ms. McGarry blamed poor traceability practices as the reason the FDA is unable to establish what is making people sick in outbreaks at Mexican-style restaurants and sandwich shops where lettuce, tomatoes and cheese are common foods.

The biggest problem for FDA investigators is that they lose the trail for products once they are repackaged and thus cannot match the product that enters a packaging plant with the product that comes out, she said.

But Tom Stenzel, president and chief executive officer of United Fresh, suggested that FDA’s problem of tracking Mexican food outbreaks might be a breakdown in epidemiology and not traceability problems in the produce industry. The FDA should be able to track restaurant produce suppliers, he said.

An attendee complained that FDA is notifying produce suppliers early in outbreak investigations and a company has no way of knowing how firm the information may be or if it is one of eight suppliers under investigation as part of the traceback.

Ms. McGarry said that the FDA’s approach to outbreak investigations has evolved over time. The agency is now “more proactive” and moves ahead with less information at hand, she said.

“The public wants us to trace back fast,” she added.