§ 384a. Foreign supplier verification program

(a) In general

(1) Verification requirement Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is—

(A) produced in compliance with the requirements of section 350g of this title or section 350h of this title, as appropriate; and

(B) is not adulterated under section 342 of this title or misbranded under section 343(w) of this title.

(2) Importer defined For purposes of this section, the term “importer” means, with respect to an article of food—

(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or

(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.

(b) Guidance

Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.

(c) Regulations

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a).

(2) Requirements The regulations promulgated under paragraph (1)—

(A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with—

(i) processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under section 350g of this title or section 350h of this title (taking into consideration variances granted under section 350h of this title), as appropriate; and

(ii)section 342 of this title and section 343(w) of this title. 21, Code of Federal Regulations (or any successor regulations).

(f) Additional exemptions

The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public.

(g) Publication of list of participants

The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.

(June 25, 1938, ch. 675, § 805, as added Pub. L. 111–353, title III, § 301(a), Jan. 4, 2011, 124 Stat. 3953.)

Effective Date

Effective Date

Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as an Effective Date of 2011 Amendment note under section 331 of this title.

Miscellaneous

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.