                        TITLE 19--CUSTOMS DUTIES
 
                CHAPTER 13--TRADE AGREEMENTS ACT OF 1979
 
         SUBCHAPTER II--TECHNICAL BARRIERS TO TRADE (STANDARDS)
 
            Part F--International Standard-Setting Activities
 
Sec. 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 
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) 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.

(c) 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.

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

                       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, as amended, 
which is classified generally to chapter 9 (Sec. 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''.
