Page:United States Statutes at Large Volume 110 Part 5.djvu/81

 PUBLIC LAW 104-250—OCT. 9, 1996 110 STAT. 3155 and for minor uses and, within 18 months after the date of enactment of this Act, announce proposals for legislative or regulatory change to the approval process under such section for animal drugs intended for use in minor species or for minor uses. SEC. 3. LIMITATION ON RESIDUES. Section 512(d)(1)(F) (21 U.S.C. 360b(d)(l)(F)) is amended to read as follows: "(F) upon the basis of information submitted to the Secretary as part of the application or any other information before the Secretary with respect to such drug, any use prescribed, recommended, or suggested in labeling proposed for such drug will result in a residue of such drug in excess of a tolerance found by the Secretary to be safe for such drug;". SEC. 4. IMPORT TOLERANCES. Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the following new paragraph at the end: "(6) For purposes of section 402(a)(2)(D), a use or intended use of a new animal drug shall not be deemed unsafe under this section if the Secretary establishes a tolerance for such drug and any edible portion of any animal imported into the United States does not contain residues exceeding such tolerance. In establishing such tolerance, the Secretary shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Secretary to establish tolerances for applications for new animal drugs filed under subsection (b)(1). The Secretary may consider and rely on data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used or data available from a relevant international organization, to the extent such data are not inconsistent with the criteria used by the Secretary to establish a tolerance for applications for new animal drugs filed under subsection (b)(1). For purposes of this paragraph, 'relevant international organization' means the Codex Alimenterius Commission or other international organization deemed appropriate by the Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance established under this paragraph if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.". SEC. 5. VETERINARY FEED DIRECTIVES. (a) SECTION 503. —Section 503(f)(1)(A) (21 U.S.C. 353(f)(1)(A)) is amended by inserting after "other than man" the following: ", other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug,". (b) SECTION 504.—The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 503 the following: "VETERINARY FEED DIRECTIVE DRUGS "SEC. 504. (a)(1) A drug intended for use in or on animal 21 USC 354. feed which is limited by an approved application filed pursuant to section 512(b) to use under the professional supervision of a

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