19 U.S.C. § 2578a — Equivalence determinations

Page 755 TITLE 19—CUSTOMS DUTIES § 2578b (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 consider- ation by that organization; (2) for each sanitary or phytosanitary stand- ard specified in paragraph (1)— (A) a description of the consideration or planned consideration of the standard; (B) whether the United States is partici- pating or plans to participate in the consid- eration of the standard; (C) the agenda for the United States par- ticipation, if any; and (D) the agency responsible for representing the United States with respect to the stand- ard. (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 shall take the com- ments into account in participating in the con- sideration of the standards and in proposing matters to be considered by the organization. (Pub. L. 96–39, title IV, § 491, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4970.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on the date of entry into force of the WTO Agreement with respect to the United States (Jan. 1, 1995), except as otherwise provided, see section 451 of Pub. L. 103–465, set out as a note under section 3601 of this title. Executive Documents DESIGNATION OF AGENCY Secretary of Agriculture designated under this sec- tion as official responsible for informing public of sani- tary and phytosanitary standard-setting activities of each international standard-setting organization, see par. (4) of Proc. No. 6780, Mar. 23, 1995, 60 F.R. 15847, set out as a note under section 3511 of this title. § 2578a. Equivalence determinations (a) In general An agency may not determine that a sanitary or phytosanitary measure of a foreign country is equivalent to a sanitary or phytosanitary meas- ure established under the authority of Federal law unless the agency determines that the sani- tary or phytosanitary measure of the foreign country provides at least the same level of sani- tary or phytosanitary protection as the com- parable sanitary or phytosanitary measure es- tablished under the authority of Federal law. (b) FDA determination If the Commissioner proposes to issue a deter- mination of the equivalency of a sanitary 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 Cos- metic Act (21 U.S.C. 301 et seq.) or other statute administered by the Food and Drug Administra- tion, the Commissioner shall issue a proposed regulation to incorporate such determination and shall include in the notice of proposed rule- making the basis for the determination that the sanitary or phytosanitary measure of a foreign country provides at least the same level of sani- tary or phytosanitary protection as the com- parable Federal sanitary or phytosanitary meas- ure. The Commissioner shall provide oppor- tunity for interested persons to comment on the proposed regulation. The Commissioner shall not issue a final regulation based on the pro- posal without taking into account the com- ments received. (c) Notice If the Commissioner proposes to issue a deter- mination of the equivalency of a sanitary or phytosanitary measure of a foreign country to a sanitary or phytosanitary 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 [21 U.S.C. 301 et seq.] or other 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 measure 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 comment on the notice. The Commissioner shall not issue a final determination on the issue of equivalency without taking into account the comments received. (Pub. L. 96–39, title IV, § 492, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4971; amended Pub. L. 104–295, § 20(d)(1), Oct. 11, 1996, 110 Stat. 3529.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (b) and (c), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. AMENDMENTS 1996—Subsec. (c). Pub. L. 104–295 substituted ‘‘phytosanitary’’ for ‘‘phystosanitary’’ before ‘‘measure of the Food and Drug Administration’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on the date of entry into force of the WTO Agreement with respect to the United States (Jan. 1, 1995), except as otherwise provided, see section 451 of Pub. L. 103–465, set out as a note under section 3601 of this title. § 2578b. Definitions (a) In general As used in this part: (1) Agency The term ‘‘agency’’ means a Federal depart- ment or agency (or combination of Federal de- partments or agencies).