Bill > HR2203

This bill amends the Federal Food, Drug, and Cosmetic Act to create a new regulatory category called "zootechnical animal food substances" (ZAFS), which are specialized additives for animal feed that aim to modify digestive processes, reduce foodborne pathogens, or alter an animal's gastrointestinal microbiome without providing direct nutritional value. The bill establishes specific criteria for these substances, explicitly excluding medications, hormones, and certain animal drugs from this classification. Under the proposed legislation, manufacturers seeking to introduce a ZAFS must submit a detailed petition to the FDA, including comprehensive data about the substance's intended effect, required quantity, and research methodologies. The bill mandates that ZAFS products must be labeled with a disclaimer stating they are not for disease treatment and can include statements about their intended functional effects. Additionally, the legislation requires the FDA to evaluate these substances as food additives, assessing their safety and ability to achieve the stated intended effect. Importantly, the bill includes a rule of construction that prevents the government from mandating the use of these substances, leaving their implementation optional for animal producers. This legislation aims to create a clear regulatory pathway for innovative animal feed technologies while maintaining strict safety standards.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/2203/all-info