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-
For purposes of this section, the term "importer" means, with respect to an article of food-
Not later than 1 year after January 4, 2011, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.
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).
The regulations promulgated under paragraph (1)-
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.
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.
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.
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:
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 chapter2 21, Code of Federal Regulations (or any successor regulations).
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.
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.
1So in original.
2So in original. Probably should be "title".
21 U.S.C. § 384a
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATESection effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111-353 set out as an Effective Date of 2011 Amendment note under section 331 of this title.
CONSTRUCTIONNothing in this section to be construed to apply to certain alcohol-related facilities, 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 2206, 2251, and 2252 of this title.