Hogan Lovells 2024 Election Impact and Congressional Outlook Report
FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting, conditioning, and holding of seed for sprouting.
The Draft Guidance notes that the FDA has reported 50 outbreaks of foodborne illness associated with sprouts in the last 22 years, resulting in approximately 2,600 illnesses. The agency suggests “contaminated seed is the likely source of most sprout-related outbreaks.” Although seeds for sprouting are not covered by the Produce Safety Rule, FDA clarifies that seeds are nonetheless considered “food” under the Federal Food, Drug, and Cosmetic Act (FFDCA), which makes growers, holders, conditioners, and distributors responsible for taking steps reasonably necessary to prevent adulteration.
Authored by Joe Levitt and Mary Lancaster