21 USC 384a - Foreign supplier verification program

United States Code

USC most recently checked for updates: Jan 18, 2025

§ 384. Importation of prescription drugs

§ 384b. Voluntary qualified importer program

U.S. Code
Notes

§ 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.1

 So in original.

(B)

shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.

(3)

Considerations

In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food.

(4)

Activities

Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

(d)

Record maintenance and access

Records of an importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.

(e)

Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP

This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:

(1)

The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(2)

The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.

(3)

The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).

The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 2

 So in original. Probably should be “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.)

cite as: 21 USC 384a