Sponsors (10)
The bill creates a clearer pathway and marketing ability for validated zootechnical additives that could reduce foodborne pathogens and improve producer efficiency, at the cost of higher compliance burdens, potential delays in approving beneficial products, and reduced veterinary/therapeutic oversight that could raise animal-health and misuse risks.
Farmers and livestock producers could reduce foodborne pathogens in animals, lowering the risk of contaminated meat reaching consumers.
Farmers and small animal-product businesses can rely on validated zootechnical claims to choose effective additives, potentially improving animal growth efficiency and lowering production costs.
Manufacturers and regulators gain a clearer, codified regulatory pathway (food-additive petition with data requirements) that increases regulatory certainty and could speed authorization of safe products.
Farmers, veterinarians, and consumers could face increased animal-health and misuse risks because treating zootechnical substances as food additives (rather than drugs) may reduce veterinary oversight for products that affect animal biology.
Small manufacturers and some producers will face higher compliance costs and potential market-entry delays due to new data and labeling requirements for zootechnical products.
Farmers and consumers could lose timely access to promising pathogen-reduction tools if petitions are denied for failing to prove intended zootechnical effects, delaying adoption of effective interventions.
Based on analysis of 2 sections of legislative text.
Creates a statutory category for zootechnical animal feed substances, treats them as food additives, and sets petition, labeling, and approval rules.
Official title: Amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of zootechnical animal food substances.
Introduced May 22, 2025 by Roger Wayne Marshall · Last progress May 22, 2025
Creates a new legal category called “zootechnical animal food substance” for ingredients added to animal feed or drinking water that change the gut microbiome or reduce foodborne human pathogens without acting as drugs. It declares those substances to be food additives, sets specific petition and labeling requirements, excludes certain substances (like drugs, hormones, ionophores), and prevents the Secretary from treating them as drugs solely because of their intended microbiome or pathogen-reduction effects. Requires the Secretary of Health and Human Services (FDA) to process these petitions under the food-additive (section 409) framework, to set conditions of use in regulations, to deny petitions that do not show the intended zootechnical effect, and to require labeling that disclaims animal disease treatment while allowing claims about zootechnical effects. Also adds a misbranding penalty for omitting the required label statement and clarifies the Secretary cannot mandate use of these substances or additives.