---
kind: "section"
citation: "19 U.S.C. § 2578a"
title: "19"
title_heading: "Customs Duties"
number: "2578a"
heading: "Equivalence determinations"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/19/2578a"
units:
  - "Chapter 13 — Trade Agreements Act of 1979"
  - "Subchapter II — Technical Barriers to Trade (standards)"
  - "Part F — International Standard-Setting Activities"
---

# §2578a. Equivalence determinations

- (a) **In general—** An [agency](/usc/19/2578b.md?p=a-1) may not determine that a [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) of a foreign [country](/usc/19/1677.md?p=3) is equivalent to a [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) established under the authority of Federal law unless the [agency](/usc/19/2578b.md?p=a-1) determines that the [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) of the foreign [country](/usc/19/1677.md?p=3) provides at least the same level of sanitary or phytosanitary protection as the comparable [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) established under the authority of Federal law.
- (b) **FDA determination—** If the [Commissioner](/usc/19/2578b.md?p=a-2) proposes to issue a determination of the equivalency of a [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) of a foreign [country](/usc/19/1677.md?p=3) 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](/usc/21/301.md) et seq.) or other statute administered by the Food and Drug Administration, the [Commissioner](/usc/19/2578b.md?p=a-2) 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](/usc/19/2575b.md?p=7-A) of a foreign [country](/usc/19/1677.md?p=3) provides at least the same level of sanitary or phytosanitary protection as the comparable Federal [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A). The [Commissioner](/usc/19/2578b.md?p=a-2) shall provide opportunity for interested [persons](/usc/19/1683.md?p=8) to comment on the proposed regulation. The [Commissioner](/usc/19/2578b.md?p=a-2) shall not issue a final regulation based on the proposal without taking into account the comments received.
- (c) **Notice—** If the [Commissioner](/usc/19/2578b.md?p=a-2) proposes to issue a determination of the equivalency of a [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) of a foreign [country](/usc/19/1677.md?p=3) to a [sanitary or phytosanitary measure](/usc/19/2575b.md?p=7-A) 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](/usc/21/301.md) et seq.] or other statute administered by the Food and Drug Administration, the [Commissioner](/usc/19/2578b.md?p=a-2) 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](/usc/19/2575b.md?p=7-A). The [Commissioner](/usc/19/2578b.md?p=a-2) shall provide opportunity for interested [persons](/usc/19/1683.md?p=8) to comment on the notice. The [Commissioner](/usc/19/2578b.md?p=a-2) shall not issue a final determination on the issue of equivalency without taking into account the comments received.

## Source credit

(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.)

## Notes

### 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.