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
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
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
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
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
“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
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
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.