Lettuce Safety Initiative

The Food and Drug Administration (FDA) developed the Lettuce Safety Initiative as a response to the recurring outbreaks of E. coli O157:H7 associated with fresh and fresh-cut lettuce. The Initiative is intended to reduce public health risks by focusing on the product, agents, and areas of greatest concern. An important goal of the Initiative is to demonstrate FDA's commitment and concern about the safety of lettuce to the industry. The Initiative supports the goals of the 2004 FDA Produce Safety Action Plan, which is intended to minimize the incidence of foodborne illness associated with consumption of fresh produce. The Initiative will begin with this fall's lettuce harvest season.

A majority of the outbreaks traced product back to California. Outbreak and farm investigational data have been reviewed in order to develop and most effectively target resources. Using a risk-based approach, resources will be directed toward the areas that are most likely to be the source of contamination, based on (1) current though limited information; and, (2) the season and geographic region historically associated with outbreaks. FDA will continue to coordinate and closely collaborate with the State of California's Department of Health Services and Department of Food and Agriculture.

The objectives of the Lettuce Safety Initiative are as follows:

• Assess current industry approaches and actions to address the issue of improving lettuce safety. If appropriate, stimulate segments of the industry to further advance efforts in addressing all aspects of improving lettuce safety.
• Alert consumers early and respond rapidly in the event of an outbreak.
• Document observations that identify practices that potentially lead to product contamination. Then, develop and/or refine guidance and policy that will minimize opportunities for future outbreaks and/or identify research needs.
• Consider regulatory action, as appropriate, based on conditions and practices that could lead to, or spread contamination, or when lettuce has been adulterated.

To begin the Initiative, FDA, in cooperation with California's Department of Health Services and Department of Food and Agriculture, will issue an assignment to visit farms and cooling and packing facilities, and inspect processors, focusing on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs). FDA will evaluate practices and processes for potential sources of contamination. Other components of the Initiative include continuing outreach with the industry at all points in the supply chain, facilitating and promoting research on lettuce safety, and working with federal, state and local public health officials in disease detection and outbreak response.