124 STAT. 3955 PUBLIC LAW 111–353—JAN. 4, 2011 a foreign supplier verification program in compliance with such section 805.’’. (c) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is amended by adding ‘‘or the importer (as defined in section 805) is in violation of such section 805’’ after ‘‘or in violation of section 505’’. (d) EFFECTIVE DATE.—The amendments made by this section shall take effect 2 years after the date of enactment of this Act. SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 301, is amended by adding at the end the following: ‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. ‘‘(a) IN GENERAL.—Beginning not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall— ‘‘(1) establish a program, in consultation with the Secretary of Homeland Security— ‘‘(A) to provide for the expedited review and importa- tion of food offered for importation by importers who have voluntarily agreed to participate in such program; and ‘‘(B) consistent with section 808, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have volun- tarily 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 Sec- retary. ‘‘(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 805. ‘‘(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 appro- priate. Guidelines. Deadline. 21 USC 384b. 21 USC 331 note.
