The U.S. Food and Drug Administration (FDA) has issued a final guidance titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry.” The guidance outlines FDA’s concerns about foodborne illness outbreaks associated with the consumption of raw and lightly-cooked sprouts, and provides firms with recommended steps to prevent contamination during the production of seed for sprouting.

According to FDA, there were 52 reported outbreaks of foodborne illness linked to sprouts from 1996–2020, resulting in more than 2,700 cases of illness. Although contamination can occur at any point along the sprout supply chain, FDA identifies seed as the most likely source of contamination in many outbreaks. The Produce Safety Rule (PSR) includes sprout-specific requirements for sprout growers. However, FDA does not consider seed for sprouting to be covered produce under the PSR and, therefore, the growing, conditioning, and distribution of seed for sprouting is not subject to PSR requirements. Although seed used for sprouting is not covered by PSR, FDA considers seed used for sprouting to be food.

The final guidance recommends that all players in the sprout seed supply chain become informed about the food safety practices, processes, and procedures followed by the firm(s) from which they source their seed, where the seed will go after it leaves their firm, and whether their seed is likely to be used to produce sprouts for human consumption. The final guidance acknowledges that the practices and conditions appropriate for producing seed for sprouting will likely necessitate an elevated level of food safety precautions.

Consistent with the draft guidance published in June 2019, the final guidance recommends that seed for sprouting be grown using Good Agricultural Practices (GAPs) or in conformance with international standards, such as the Codex Alimentarius Committee’s “International Code of Hygienic Practice for Fresh Fruits and Vegetables.” In addition, the final guidance clarifies that testing should not be used in place of GAPs or Codex standards.