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21 U.S.C. § 384bVoluntary qualified importer program

submitted 88 years ago by Pub. L. 111-353 to r/title-21-FOOD-AND-DRUGS · 461 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law creates a voluntary program letting importers get faster review of their food shipments if they meet safety requirements. The Secretary sets eligibility rules based on risk, and can revoke an importer's status if it stops qualifying.

(a) In general. Within 18 months of January 4, 2011, the Secretary must, working with the Secretary of Homeland Security: (1) create a program that (A) gives faster review and entry for food from importers who volunteer to join, and (B) sets up, along with section 384d, a way to issue a facility certification that travels with the imported food; and (2) publish guidance on how to join, leave, rejoin, and stay compliant with the program. (b) Voluntary participation. An importer can ask the Secretary to give faster review to specific foods under this program. (c) Notice of intent to participate. An importer that wants to join for a given fiscal year must submit notice and an application, in the time and manner the Secretary sets. (d) Eligibility. Only importers bringing in food from a facility that has the certification described in subsection (a) can qualify. When deciding on applications, the Secretary must weigh factors like: (1) known safety risks of the food; (2) the compliance history of the importer's foreign suppliers; (3) whether the exporting country's regulatory system can enforce U.S. food-safety standards; (4) whether the importer follows section 384a; (5) the importer's recordkeeping, testing, inspections, traceability, temperature controls, and sourcing practices; (6) the risk of intentional tampering with the food; and (7) any other factor the Secretary thinks is relevant. (e) Review and revocation. The Secretary must re-check every qualified importer at least once every 3 years, and must promptly revoke the status of any importer that no longer meets the eligibility rules. (f) False statements. Any false statement an importer makes to the Secretary can be prosecuted under section 1001 of title 18 (the general federal false-statements law). (g) Definition. In this section, "importer" means the person who brings food into the U.S. customs territory from a foreign country, or causes it to be brought in.
the actual law source: uscode.house.gov ↗public domain
(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.

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

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 111-353 · 124 Stat. 3955

A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-353 on 1938-06-25.

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