P4: Regulatory processes for fermentation substances used in animal food

Many fermentation products, including biomasses, are used in animal foods as sources of nutrients, like protein.  There is increased interest in the use of novel animal food substances that include materials obtained from traditional fermentation processes, which utilize new organisms, and those obtained from biofuel production, which may originate from algae.  Animal food, which includes pet food, falls under the regulatory authority of the United States Food and Drug Administration (FDA).  Within FDA, animal food is addressed by the Center for Veterinary Medicine’s (CVM) Division of Animal Feeds.  The Federal Food, Drug, and Cosmetic Act (FFDCA) requires substances added to animal food be safe and achieve their intended purpose.  Two pathways are available to address the legal use of novel substances and biomasses in animal food.  The food additive petition process is described in regulation 571 in Title 21 of the Code of Federal Regulations (21 CFR 571).  When FDA approves a food additive petition, a regulation in 21 CFR 573 is established addressing the petitioned use of the substance in animal food.  Alternatively, firms may chose to make a determination that a particular use of a substance in animal food is exempt from the premarket requirements of the FFDCA because this use is generally recognized as safe (GRAS) by qualified experts.  Firms can notify CVM about their GRAS determination through the animal food GRAS notification program.  CVM maintains an internet list of animal food GRAS notices and CVM’s conclusions about each notice.  More information is available at http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/default.htm .