21 U.S.C. § 384b (FOOD AND DRUGS)
§ 384b. Voluntary qualified importer program
(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.)
heading: Statutory Notes and Related Subsidiaries
heading: Construction
text: Nothing in this section to be construed 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 2251 and 2252 of this title.