§ 384b. Voluntary qualified importer program

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(a)In general Beginning not later than 18 months after January 4, 2011, the Secretary shall—

(1)establish a program, in consultation with the Secretary of Homeland Security—

(A)to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and

(B)consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and

(2)issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with, such program.

(b)Voluntary participation An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program established by the Secretary under subsection (a).

(c)Notice of intent to participate An importer that intends to participate in the program under this section in a fiscal year shall submit a notice and application to the Secretary of such intent at the time and in a manner established by the Secretary.

(d)Eligibility Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:

(1)The known safety risks of the food to be imported.

(2)The compliance history of foreign suppliers used by the importer, as appropriate.

(3)The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.

(4)The compliance of the importer with the requirements of section 384a of this title.

(5)The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.

(6)The potential risk for intentional adulteration of the food.

(7)Any other factor that the Secretary determines appropriate.

(e)Review and revocation Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.

(f)False statements Any statement or representation made by an importer to the Secretary shall be subject to section 1001 of title 18.

(g)Definition For purposes of this section, the term “importer” means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.

(June 25, 1938, ch. 675, § 806, as added Pub. L. 111–353, title III, § 302, Jan. 4, 2011, 124 Stat. 3955.)

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U.S. Code

statutes-at-large

Public Law 111–353
To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply

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U.S. Code

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June 25, 1938, ch. 675, § 806
Pub. L. 111–353, title III, § 302
124 Stat. 3955

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§ 384b

Voluntary qualified importer program

Fed. Reg.×26

U.S.C.×8

Stat.×1

U.S.C.§ 384d

U.S.C.§ 384a

U.S.C.§ 1001

ActJune 25, 1938, ch. 675, § 806

Pub. L.Pub. L. 111–353, title III, § 302

Stat.124 Stat. 3955

Cites 6Cited by 35 across 3 sources