Page:United States Statutes at Large Volume 108 Part 6.djvu/404

 108 STAT. 4972 PUBLIC LAW 103-465—DEC. 8, 1994 ^^J"^! "(c) NOTICE.— If the Commissioner proposes to issue a deterpuWication mioation of the equivalency of a sanitary or ph3^sanitary measure of a foreign country to a sanitary or phystosanitary measure of the Food and Drug Administration that is not required to be promulgated as a rule under the Federal Food, Drug, and Cosmetic Act or otier statute administered by the Food and Drug Administration, the Commissioner shall publish a notice in the Federal Register that identifies the basis for the determination that the measiu^ provides at least the same level of sanitary or phytosanitary protection as the comparable Federal sanitary or phytosanitary measure. The Commissioner shall provide opportunity for interested persons to conmient on the notice. The Commissioner shall not issue a final determination on the issue of equivalency without taking into account the comments received. 19 USC 2578b. "SEC. 493. DEFINITIONS. "(a) IN GENERAL.— As used in this subtitle: "(1) AGENCY.— The term 'agency^ means a Federal department or agency (or combination of Federal depsuiments or agencies). "(2) COMMISSIONER.— The term 'Commissioner' means the Commissioner of Food and Drugs. " (3) INTERNATIONAL STANDARD-SETTING ORGANIZATION. — The term International standard-setting organization' means an organization consisting of representatives of 2 or more countries, the purpose of whicn is to negotiate, develop, promulgate, or amend an international standard. "(4) SANITARY OR PHYTOSANITARY STANDARD. —The term 'sanitary or phytosanitary standard' means a standard intended to form a basis for a sanitary or phytosanitary measure. "(5) INTERNATIONAL STANDARD. — The term International standard' means a standard, guideUne, or recommendation— "(A) regarding food safety, adopted by the Codex Alimentarius Commission, including a standard, guideUne, or recommendation regarding decomposition elaborated by the Codex Committee on Fish and Fishery Products, food additives, contaminants, hygienic practice, and methods of analysis and sampling; "(B) regarding animal heedth and zoonoses, developed under the auspices of the International Of&ce of Epizootics; "(C) regarding plant health, developed under the auspices of the Secretariat of the International Plant Protection Convention in cooperation with the North American Plant Protection Organization; or "(D) establishea by or developed under any other international organization agreed to by the NAFTA countries (as defined in section 2(4) of the North American Free Trade Agreement Implementation Act) or by the WTO members (as defined in section 2(10) of the Uruguay Round Agreements Act). "(b) OTHER DEFINITIONS. — The definitions set forth in section 463 apply for purposes of this subtitie except that in applying paragraph (7) of section 463 with respect to a sanitary or phytosanitary measure of a foreign country, any reference iu such paragrsmh to the United States shall be deemed to be a reference to that foreign country.".

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