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FDA Issues Draft Guidance on Reducing Microbial Hazards in Seed for Sprouting

The U.S. Food and Drug Administration (FDA) has issued a draft guidance, titled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.” This draft guidance document provides food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.

FDA reported that between January 1996 and August 2018, contaminated sprouts were associated with 50 outbreaks, which resulted in more than 2,600 cases of foodborne illness. In the Federal Register notice about the draft guidance, FDA explains that the document “will make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of FDA’s serious concern with the continuing outbreaks of food borne illness associated with the consumption of raw and lightly-cooked sprouts…”

The Produce Safety Rule, as required by the FDA Food Safety Modernization Act (FSMA), includes sprout-specific requirements. (Keller and Heckman’s detailed summary of the rule is available here.) However, since FDA considers seeds used for sprouting to be outside the definition of “covered produce” under the rule, the Agency did not prescribe specific requirements in the Produce Safety Rule to prevent the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed. The draft guidance includes steps that those in the sprout seed supply chain should take to reduce microbial food safety hazards, such as proper training of personnel, storing seed for sprouting separately from seed for other uses, and ensuring that food contact surfaces are cleaned regularly.

The draft guidance will be available for public comment for 60 days until August 26, 2019. Comments should be identified with the docket number FDA-2018-D-4534 and can be submitted electronically at

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 176


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...