With or Without FSEA, FDA Will Establish Standards to Prevent Microbial Hazards in Fresh ProduceAugust 11, 2009
FDA has published three draft guidances that instruct growers, packers, processors, transporters, retailers and others on the prevention of microbial hazards in tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the guidances “will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.” Coincidentally, the guidances were published on the heels of House passage of the Food Safety Enhancement Act (“FSEA”) of 2009 (see our post here). Section 104 of FSEA would explicitly authorize FDA to establish by regulation science-based standards for the safe growing, harvesting, packing, sorting, transporting, and holding of raw agricultural commodities for which FDA has determined that such standards are needed to minimize the risk of serious adverse health consequences or death to humans or animals. Although FDA has now made clear its intention to establish such standards based on its existing statutory authority, FSEA could help make it easier for FDA to fulfill the Commissioner’s commitment to establish those standards within two years by providing FDA with more explicit authority.
The three new guidances target the risks inherent to specific types of commodities. However, all three guidances reference the agency’s 1998 draft guidance that more generally describes good agricultural practices or GAPs (see FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables). Notably, section 104 of FSEA calls on the agency to update its GAP guidance. The three new guidances also reference FDA’s Current Good Manufacturing Practices Regulations, as well as the agency’s Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (these are minimally processed and altered in form prior to being packaged for use by the consumer or retail establishment such as ready-to-eat salad mixes). The three new guidances complement, rather than replace, these pre-existing recommendations and requirements.
For each of the three guidances, the agency examined pre-existing industry guidelines on the specific commodities as a foundation for its own guidance. The guidances recommend measures specifically crafted to ward against risks likely to occur during production and harvest, post harvest, fresh-cut processing, distribution and retail and food service. The guidances address environmental assessments, worker health and hygiene, water quality, product tracing and records at these stages along the food supply chain. For instance, the guidances contain suggestions for adequate toilet facilities and handwashing, convincing sick workers to stay home, ensuring that water used to wash plants is not contaminated, deterring contamination from animals or other elements on soil, ensuring the equipment and transports are not contaminated, and establishing appropriate use of gloves.
Comments on the guidances should be submitted by November 3 at www.regulations.gov using docket numbers FDA-2009-D-0346 (tomatoes), FDA-2009-D-0347 (melons), or FDA-2009-0348 (leafy greens).