§ 2578a. Equivalence determinations

Statutory text

In general

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.

FDA determination

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.

Notice

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.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1994
Trade Agreements Act of 1979
Pub. L. 96–39 title IV § 492 · 93 Stat. 144
Enacted · 19 U.S.C. § 2578a
Pub. L. 96–39, title IV, § 492, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4971
Source evidence
Code source credit
Pub. L. 96–39, title IV, § 492, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4971
1996
Miscellaneous Trade and Technical Corrections Act of 1996
Pub. L. 104–295 § 20(d)(1) · 110 Stat. 3514
Substituted · 19 U.S.C. § 2578a(c)
Pub. L. 104–295 substituted “phytosanitary” for “phystosanitary” before “measure of the Food and Drug Administration”
Source evidence
Code amendment note
Subsec. (c). Pub. L. 104–295 substituted “phytosanitary” for “phystosanitary” before “measure of the Food and Drug Administration”.
Enacted provision · exact public law section
(1) Section 492(c) of the Trade Agreements Act of 1979 (19 U.S.C. 2578a(c)) is amended by striking “phystosanitary” and inserting “phytosanitary”.

1 of 2 references resolved to an enrolled provision · 1 partial

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.

Credits

1994–1996 · 2 acts

1994Pub. L. 96–39, title IV, § 492, as added Pub. L. 103–465, title IV, § 432, Dec. 8, 1994, 108 Stat. 4971
1996amended Pub. L. 104–295, § 20(d)(1), Oct. 11, 1996, 110 Stat. 3529.

Show as published

(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.)