FDA Issues Draft Guidances for Tomatoes, Leafy Greens and Melons

July 31, 2009

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

• Prevent harm to consumers
• Use good data and analysis to ensure effective food safety inspections and enforcement of the law
• Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

• An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
• Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
• Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

 

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  FDA Commissioner Margaret A. Hamburg, M.D., discusses aspects of the FDA’s draft guidances on leafy greens, tomatoes, and melons with consumers, growers, and others during a visit to the Eastern Market, a fresh-food market in Washington, D.C. on July 31, 2009. Dr. Hamburg, HHS Secretary Kathleen Sebelius, Agriculture Secretary Tom Vilsack, and Jerold R. Mande, deputy undersecretary for food safety at USDA (far right), emphasized that prevention will be key to their strategy to keep America’s food supply safe.

  Photo: HHS/Christopher Smith

  News Release: HHS Secretary Sebelius, Agriculture Secretary Vilsack Announce New Strategies to Keep America's Food Supply Safe
• Questions and Answers on FDA’s Proposed Commodity-Specific Guidances (CSGs)
• The Draft Guidances
  • Guide to Minimize Microbial Food Safety Hazards of Tomatoes
  • Guide to Minimize Microbial Food Safety Hazards of Melons
  • Guide to Minimize Microbial Food Safety Hazards of Leafy Greens