Washington, DC - The U.S. Food and Drug Administration today released a proposed draft guidance, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting,” intended to make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of the agency’s serious concerns with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts.

Incorporating aspects of the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables Annex II, Annex for Sprout Production; the International Sprout Growers Association-Institute for Food Safety and Health’s “U.S. Sprout Production Best Practices”; and Good Agricultural Practices, the FDA’s draft guidance issued today provides the agency’s recommendations to firms throughout the production chain of seed for sprouting. It states that if a grower, holder, conditioner, or distributor reasonably believes that its seeds are expected to be used for sprouting, we recommend that the grower, holder, conditioner, or distributor take steps that are reasonably necessary to prevent those seeds from becoming contaminated. We also recommend that firms throughout the supply chain – from seed production and distribution through sprouting – review their current operations related to seeds for sprouting.

During the 60-day comment period for this draft guidance, stakeholders will be able to provide comments on the draft provisions. For more information on this guidance, as well as instructions on how to submit your comments, please visit Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.

“Over the past 22 years, the FDA has investigated 50 reported outbreaks of foodborne illness associated with contaminated sprouts. Together, these outbreaks resulted in more than an estimated 2,600 cases of illness. Last year, there were two reported outbreaks associated with sprouts, resulting in more than an estimated 100 illnesses. Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks, as this commodity is inherently more susceptible to these issues because they are grown in warm and humid conditions that are favorable for bacteria like Salmonella, Listeria and E. coli,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. “The FDA is committed to taking swift action to respond to outbreaks related to sprouts and keep our food supply safe, but we also know that measures to prevent issues from happening in the first place are an important element of protecting consumers. By studying outbreaks related to sprouts over the years, we have been able to recommend changes in the industry to help lower the incidence of sprout-related outbreaks. Today’s new draft guidance is another critical step, like the Sprout Safety Alliance or sprout-specific requirements of the Produce Safety Rule, the agency is taking to prevent illnesses related to sprouts.”