FDA is required by the Federal Food, Drug and Cosmetic Act to determine whether any new food additive or new animal drug for use in food-producing animals is safe for the target animal, as well as for consumers utilizing edible products derived from the treated animals. The sponsor of the new compound is required to furnish the FDA the scientific data necessary for demonstrating that the residues of the sponsored compound in the edible products are safe. FDA has developed a series of guidelines to inform sponsors of the scientific data that the FDA believes will provide an acceptable basis for determining the safety of the compound. The FDA is guided by caution based on good, sound, well-documented scientific principles.

FDA approval of growth-enhancing technologies is guided by caution based on sound science. FDA does not consider any new human or animal drug approvable until it is proven both safe and effective. The sponsor of a new drug must provide thorough, well-validated scientific studies that prove the safety of the new compound:

• To the health of the target animal
• To humans consuming the treated animal for food
• To the environment at the time of manufacture and of use in the animal

The Food Safety Inspection Service (FSIS) maintains an ongoing program to detect residues in food animals.

For more information on the safety, efficacy and other requirements that are part of the FDA approval process, visit www.fda.gov.