Guideline No. 3
General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals
Revised July 1994
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
FDA is required by the general safety provisions of sections 409, 512, and 706 of the Federal Food, Drug, and Cosmetic Act (the act) to determine whether each food additive, new animal drug, or color additive proposed for use in food-producing animals is safe for those animals and whether the edible products derived from treated animals are safe. The pertinent regulations implementing the statutory provisions are found at 21 CFR part 70, 21 CFR 514.1, and 21 CFR Part 570.
The sponsor of the compound is required to furnish to FDA the scientific data necessary for demonstrating that the residues of the sponsored compound in the edible products of treated animals are safe. FDA has developed a series of guidelines to inform sponsors of the scientific data that FDA believes will provide an acceptable basis for determining the safety of the compound. The individual guidelines are listed below.
A guideline represents the agency's position on a procedure or practice at the time of its issuance. A guideline is not a legal requirement. A person may follow the guideline or may choose to follow alternate procedures or practices. If a person chooses to use alternate procedures or practices, that person may wish to discuss the matter further with FDA/CVM to prevent an expenditure of money and effort on activities that might later be determined to be unacceptable. The guideline does not bind the agency, and it does not create or confer any rights, privileges, immunities, or benefits for or on any person. When a guideline states a requirement imposed by statute or regulation, however, the requirement is law and its force and effect are not changed in any way by virtue of its inclusion in the guideline.
Although sections 409, 512, and 706 of the act and their implementing regulation vary slightly in wording, they have a common purpose- assuring the safety of the residues that people will consume from tissues of treated animals. Therefore, FDA believes that the same testing requirements should apply to a new animal drug or a food or color additive used in food-producing animals. When evaluating the safety of a new animals drug, section 512(d)(2) of the act directs that FDA:
"shall consider, among other relevant factors, (A) the probable consumption of such drug and of any substance formed in or on food because of the use of such drug, (B) the cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance, (C) safety factors which in the opinion of experts, qualified by scientific training and experience to evaluate the safety of such drugs, and (D) whether the conditions of use prescribed, recommended, or suggested in the proposed labeling are reasonably certain to be followed in practice."
The guidelines describe studies that the sponsor may conduct to meet these statutory provisions. FDA describes in guidelines I and IV appropriate scientific studies for obtaining information on the probable consumption of the sponsored compound and its residues. FDA describes in guidelines II and III appropriate scientific studies for obtaining information on the toxicity (cumulative effect) of the sponsored compound and its residues and the safety factors normally used. FDA describes in guideline VII appropriate studies for showing the safety of "biomass" products. Finally, FDA describes in guideline VIII the studies necessary to perform the risk assessment on bound residues of carcinogenic veterinary drugs.
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