19 U.S.C. § 2578b — Definitions

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). Page 756 TITLE 19—CUSTOMS DUTIES § 2581 1 See References in Text note below. (2) Commissioner The term ‘‘Commissioner’’ means the Com- missioner of Food and Drugs. (3) International standard-setting organization The term ‘‘international standard-setting organization’’ means an organization con- sisting of representatives of 2 or more coun- tries, the purpose of which is to negotiate, de- velop, promulgate, or amend an international standard. (4) Sanitary or phytosanitary standard The term ‘‘sanitary or phytosanitary stand- ard’’ means a standard intended to form a basis for a sanitary or phytosanitary measure. (5) International standard The term ‘‘international standard’’ means a standard, guideline, or recommendation— (A) regarding food safety, adopted by the Codex Alimentarius Commission, including a standard, guideline, or recommendation re- garding decomposition elaborated by the Codex Committee on Fish and Fishery Prod- ucts, food additives, contaminants, hygienic practice, and methods of analysis and sam- pling; (B) regarding animal health and zoonoses, developed under the auspices of the Inter- national Office 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) established by or developed under any other international organization agreed to by the USMCA countries (as defined in sec- tion 4502 of this title) or by the WTO mem- bers (as defined in section 3501(10) of this title). (b) Other definitions The definitions set forth in section 2575b of this title apply for purposes of this part except that in applying paragraph (7) of section 2575b of this title with respect to a sanitary or phytosanitary measure of a foreign country, any reference in such paragraph to the United States shall be deemed to be a reference to that foreign country. (Pub. L. 96–39, title IV, § 493, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4972; amended Pub. L. 116–260, div. O, title VI, § 602(f), Dec. 27, 2020, 134 Stat. 2154.) Editorial Notes AMENDMENTS 2020—Subsec. (a)(5)(D). Pub. L. 116–260 substituted ‘‘the USMCA countries (as defined in section 4502 of this title)’’ for ‘‘the NAFTA countries (as defined in section 2(4) of the North American Free Trade Agree- ment Implementation Act)’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2020 AMENDMENT Pub. L. 116–260, div. O, title VI, § 602(g), Dec. 27, 2020, 134 Stat. 2154, provided that: ‘‘This section [amending this section, sections 2702 to 2703a, 3721, 3722, and 4362 of this title, section 11 of Title 35, Patents, and section 2296b of Title 42, The Public Health and Welfare] and the amendments made by this section shall take effect on July 1, 2020.’’ 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. SUBCHAPTER III—MISCELLANEOUS PROVISIONS § 2581. Auction of import licenses (a) In general Notwithstanding any other provision of law, the President may sell import licenses at public auction under such terms and conditions as he deems appropriate. Regulations prescribed under this subsection shall, to the extent practicable and consistent with efficient and fair adminis- tration, insure against inequitable sharing of imports by a relatively small number of the larger importers. (b) ‘‘Import license’’ defined For purposes of this section, the term ‘‘import license’’ means any documentation used to ad- minister a quantitative restriction imposed or modified after July 26, 1979 under— (1) section 125, 203, 301, or 406 of the Trade Act of 1974 (19 U.S.C. 2135, 2253, 2411, or 2436), (2) the International Emergency Economic Powers Act (50 U.S.C. 1701–1706), (3) authority under the notes of the Har- monized Tariff Schedule of the United States, but not including any quantitative restriction imposed under section 22 of the Agricultural Adjustment Act of 1934 (7 U.S.C. 624), (4) the Trading With the Enemy Act (50 U.S.C. App. 1–44),1 (5) section 204 of the Agricultural Act of 1956 (7 U.S.C. 1854) other than for meat or meat products, or (6) any Act enacted explicitly for the pur- pose of implementing an international agree- ment to which the United States is a party, in- cluding such agreements relating to commod- ities, but not including any agreement relat- ing to cheese or dairy products. (Pub. L. 96–39, title XI, § 1102, July 26, 1979, 93 Stat. 307; Pub. L. 100–418, title I, § 1214(k), Aug. 23, 1988, 102 Stat. 1158.) Editorial Notes REFERENCES IN TEXT The International Emergency Economic Powers Act, referred to in subsec. (b)(2), is Pub. L. 95–223, title II, Dec. 28, 1977, 91 Stat. 1626, which is classified generally to chapter 35 (§ 1701 et seq.) of Title 50, War and Na- tional Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1701 of Title 50 and Tables. The Harmonized Tariff Schedule of the United States, referred to in subsec. (b)(3), is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of this title. The Trading With the Enemy Act, referred to in sub- sec. (b)(4), is act Oct. 6, 1917, ch. 106, 40 Stat. 411, which