FDA Issues Draft Guidances for Industry on Microbial Safety of Leafy Greens, Melons, and Tomatoes
The Food and Drug Administration has issued three notices of availability of draft guidances for industry on minimizing microbial food safety hazards of leafy greens, melons, and tomatoes.
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Comments on these draft guidances are due by October 2, 2009.
(According to FDA, these guidances are intended to supplement existing guidances, including the "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables," which apply to fresh produce. See ITT's Online Archives or news, 08022999 9, for BP summary.)
Draft Guidances Offer Recommended Practices for Minimizing Microbial Hazards
FDA states that these guidances are intended to assist domestic firms and foreign firms exporting leafy greens, melons, and tomatoes to the U.S. by recommending practices to minimize the microbial food safety hazards of their products throughout the entire supply chain. It identifies some, but not all, of the preventive measures that these firms may take to minimize these food safety hazards.
These guidances specifically refer to FDA's regulations in 21 CFR 1, subpart J on the establishment, maintenance, and availability of records; and 21 CFR 110 on current good manufacturing practices in manufacturing, packing, or holding human food. The recommendations in these guidances complement, but do not supersede, the requirements in those regulations and any associated recommendations. Further, the recommendations in these guidances do not affect the applicability of any other Federal and State requirements and the responsibility to comply with them.
| Amy Green (leafy greens) | (301) 436-2025 |
| Willard Crawford (melons) | (301) 436-1111 |
| Michelle Smith (tomatoes) | (301) 436-2024 |
FDA's "Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens" (dated July 2009) available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174200.htm
FDA's "Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons" (dated July 2009) available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm174171.htm
FDA's "Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes" (dated July 2009) available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm173902.htm
FDA notice of availability (leafy greens) (FDA-2009-D-0348, FR Pub 08/03/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-18453.pdf
FDA notice of availability (melons) (FDA-2009-D-0347, FR Pub 08/03/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-18452.pdf
FDA notice of availability (tomatoes) (FDA-2009-D-0346, FR Pub 08/03/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-18453.pdf