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FDA Issues Guidelines Specific to Fresh-cut Processors

WASHINGTON The Food and Drug Administration has issued a draft final guidance recommending that processors consider a Hazard Analysis and Critical Control Point system or similar science-based safety program to minimize and eliminate microbial contamination in fresh-cut produce. The voluntary guidelines were formally announced last week in a news teleconference. FDA officials said the draft, which

WASHINGTON — The Food and Drug Administration has issued a draft final guidance recommending that processors consider a Hazard Analysis and Critical Control Point system or similar science-based safety program to minimize and eliminate microbial contamination in fresh-cut produce.

The voluntary guidelines were formally announced last week in a news teleconference. FDA officials said the draft, which complements the agency's existing Good Manufacturing Practice regulations, offers guidance specific to the fresh-cut produce processing industry, and incorporates comments in response to a March 2006 draft. The agency also announced public meetings to gather more information on the subject, scheduled for March 20 in Oakland, Calif., and April 13 in College Park, Md.

“We don't understand enough about how produce becomes contaminated. That is a whole issue,” said Nega Beru, director of the Office of Food Safety in FDA's Center for Food Safety and Applied Nutrition, pointing out that the agency is still collecting information and that there will be a 75-day period for submitting additional data and comments.

The aim of the public meetings is to share findings from recent outbreaks and to gather information on risk factors in processing fresh-cut produce.

The FDA officials stressed that fresh-cut produce is the fastest-growing segment of the produce industry, taking an increasingly large market share and, therefore, more frequently a suspect in E. coli and other microbial outbreaks than in the past.

“It could be that [fresh-cut produce] is implicated more often because there's more consumption of it now, but CDC information shows [the incidence of] outbreaks in produce, totally, have been flat for the past 5 years,” said David Acheson, director of the Office of Food Defense, Communication, and Emergency Response at CFSAN.

The risk of bacterial contamination in fresh-cut processing increases when natural exterior barriers are broken by peeling, slicing, coring or trimming the produce, with or without washing or other treatment, before the produce is packaged for consumers. The practice of usually consuming the finished product raw increases the risk factors, officials said.

The document, entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,” discusses the production and harvesting of fresh produce and provides recommendations for fresh-cut processing in the following areas: (1) personnel health and hygiene, (2) training, (3) building and equipment, (4) sanitation operations and (5) fresh-cut produce production and processing controls, from product specification to packaging, storage and transport. The guide also provides recommendations on record-keeping and on recalls and trace-backs. The 80-page guide is accessible on FDA's website, www.fda.gov.