Page:United States Statutes at Large Volume 108 Part 6.djvu/403

 PUBLIC LAW 103-465—DEC. 8, 1994 108 STAT. 4971 phytosanitary standcird-setting activities of each international standard-setting organization. agency designated under subsection (a) with respect to each international standard-setting organization shall publish notice in the Federal Register of the information specified in subsection (c) with respect to that organization. The notice shall cover the period enoing on June 1 of the year in which the notice is published, and beginning on the date of the preceding notice under this subsection, except that the first such notice shall cover the 1-year period ending on the date of the notice. "(c) REQUIRED INFORMATION. —The information to be provided in the notice under subsection (b) is— "(1) the sanitary or phytosanitary standards under consideration or planned for consideration by that organization; "(2) for each sanitary or phytosanitary standard specified in paragraph (1)— "(A) a description of the consideration or planned consideration of the standard; "(B) whether the United States is participating or plans to participate in the consideration of the standard; "(C) the agenda for the United States participation, if any; and (D) the agency responsible for representing the United States with respect to the standard. "(d) PUBLIC COMMENT. — The agency specified in subsection (c)(2)(D) shall provide an opportunity for public comment with respect to the standards for which the agency is responsible and sh^ take the comments into account in participating in the consideration of the standards and in proposing matters to be considered by the organization. "SEC. 492. EQUIVALENCE DETERMINATIONS. "(a) IN GENERAL.— An agency may not determine that a sanitary or phytosanitary measmre of a foreign country is equivalent to a sanitary or phytossmitary measure established under the authority of Federal law unless the agency determines that the sanitary or phytosanitary measure of the foreign country provides at least the same level of sanitary or phj^sanitary protection as the comparable sanitary or phytosanitary measure established under the authority of Federal law. "(b) FDA DETERMINATION.—I f the Commissioner proposes to issue a determination of the equivalency of a samtary or phytosanitary measure of a foreign country to a measure that is required to be promulgated as a rule under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statute administered by the Food and Drug Administration, the Commissioner shall issue a proposed regulation to incorporate such determination and shall include in the notice of proposed rulemaking the basis for the determination that the sanitary or phytosanitary measure of a foreign country 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 interestejd persons to comment on the proposed regulation. The Commissioner shall not issue a final regulation based on the proposal without taking into account the comments received. Federal Register, publication. 19 USC 2578a. Regulations.
 * (b) NOTIFICATION.— Not later than June 1 of each year, the

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