Page:United States Statutes at Large Volume 108 Part 5.djvu/664

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108 STAT. 4154 PUBLIC LAW 103-396—(XTT. 22, 1994 The use of an animal drug that results in residues exceeding a safe level established under clause (i) shall be considered an unsafe use of such drug under paragraph (1). Safe levels may be established under clause (i) either by regulation or order. "(C) The Secretary may by general regulation provide access to the records of veterinarians to ascertain any use or intended use authorized under subparagraph (A) that the Secretary has determined may present a risk to the public health. "(D) If the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug authorized under subparagraph (A) presents a risk to the public health or that an analytical method required under subparagraph (B) has not been developed and submitted to the Secretary, the Secretary may, by order, prohibit any such use. "(5) If the approval of an application filed under section 505 is in effect, the drug under such application shall not be deemed unsafe for purposes of paragraph (1) and shall be exempt from the requirements of section 502(f) with respect to a use or intended use of the drug in animals if such use or intended use— "(A) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-clientpatient relationship, as defined by the Secretary; and "(B) is in compliance with regulations promulgated by the Secretary that establish the conditions for the use or intended use of the drug in animals.", (b) OTHER AMENDMENTS. — (1) SECTION 301.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended— (A) in paragraph (e), by striking "507(d) or (g)," and inserting "507(d) or (g), 512(a)(4)(C),"; and (B) by adding at the end the following: "(u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary, under section 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).". (2) SECTION 512(e).—Section 512(e)(1)(A) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(e)(l)(A)) is amended by inserting before the semicolon the following: "or the condition of use authorized under subsection (a)(4)(A)". (3) SECTION 512(1).— Section 512(1)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)(l)) is amended by striMng "relating to experience" and inserting "relating to experience, including experience with uses authorized under subsection (a)(4)(A),". 21 USC 360b (c) REGULATIONS. —Not later than 2 years after the date of "°*®- the enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations to implement paragraphs (4)(A) and (5) of section 512(a) of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)). 21 USC 360b (d) EFFECTIVE DATE.— The amendments made by this section '^o**- shall take effect upon the adoption of the final regulations under subsection (c). SEC. 3. MAPLE SYRUP. (a) PREEMPTION. — Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-l(a)) is amended— (1) in paragraph (1), by inserting at the end the following: "except that this paragraph does not apply to a standard of