§2578a — Title 19 Customs Duties | U.S. Code

Summary

An agency cannot say a foreign country's sanitary or plant-health rule is "equivalent" to a U.S. rule unless the foreign rule gives at least the same level of protection as the U.S. rule. If the Commissioner wants to make an equivalence decision about a U.S. rule that must be made by formal regulation under the Federal Food, Drug, and Cosmetic Act or another FDA law, the Commissioner must publish a proposed regulation explaining why the foreign rule provides the same level of protection, let people comment, and consider those comments before issuing a final rule. If the U.S. rule does not require formal rulemaking, the Commissioner must publish a notice in the Federal Register saying why the foreign rule is as protective, allow public comment, and consider those comments before making a final decision.

Title 19, §2578a

Customs Duties — Source: USLM XML via OLRC

(a)An agency may not determine that a sanitary or phytosanitary measure of a foreign country is equivalent to a sanitary or phytosanitary 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 phytosanitary protection as the comparable sanitary or phytosanitary measure established under the authority of Federal law.

(b)If the Commissioner proposes to issue a determination 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 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 interested 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.

(c)If the Commissioner proposes to issue a determination 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.

Notes & Related Subsidiaries

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.

§2578a Equivalence Determinations