This guidance describes the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals.

The human food safety evaluation of new animal drugs used in food-producing animals helps ensure that food derived from treated animals is safe for human consumption.  Sponsors are required to furnish to CVM scientific data or information necessary to demonstrate that residues of the new animal drug in the edible tissues of treated animals are safe (see section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)).  In general, studies conducted to provide this information must be conducted in accordance with FDA’s Good Laboratory Practice (GLP) regulations.  See Title 21, Code of Federal Regulations, part 58 (21 CFR part 58).

FDA conducts a human food safety assessment of new animal drugs for use in food-producing animals through hazard identification, hazard characterization, exposure assessment, and mitigation of human exposure to drug residues in food derived from treated animals.  CVM developed this guidance to inform sponsors of the scientific data and/or information that may provide an acceptable basis to determine that the residue of a new animal drug in or on food, when consumed, presents a reasonable certainty of no harm to humans.  This guidance describes a recommended approach for providing human food safety scientific data and/or information.  CVM acknowledges that alternate approaches also may be appropriate and encourages sponsors to discuss with CVM whether an alternate approach may be appropriate for specific new animal drugs.

This guidance provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

• Determining an acceptable daily intake (ADI);
• Calculating safe concentrations;
• Assignment of a tolerance;
• Calculation of a withdrawal period and a milk discard time; and
• Evaluation of carcinogenic compounds

It is intended to be used in conjunction with other CVM Guidance for Industry (GFI) documents that are cited in this guidance or listed on FDA’s website.

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