Page:United States Statutes at Large Volume 124.djvu/3979

124 STAT. 3953 PUBLIC LAW 111–353—JAN. 4, 2011 (b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), as amended by section 206, is amended by adding at the end the following: ‘‘(yy) The knowing and willful failure to comply with the notification requirement under section 417(h).’’. (c) CONFORMING AMENDMENT.—Section 301(e) (21 U.S.C. 331(e)) is amended by striking ‘‘417(g)’’ and inserting ‘‘417(j)’’. TITLE III—IMPROVING THE SAFETY OF IMPORTED FOOD SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. (a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following: ‘‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM. ‘‘(a) IN GENERAL.— ‘‘(1) VERIFICATION REQUIREMENT.—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— ‘‘(A) produced in compliance with the requirements of section 418 or section 419, as appropriate; and ‘‘(B) is not adulterated under section 402 or misbranded under section 403(w). ‘‘(2) IMPORTER DEFINED.—For purposes of this section, the term ‘importer’ means, with respect to an article of food— ‘‘(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or ‘‘(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or con- signee of the article of food at the time of entry of such article into the United States. ‘‘(b) GUIDANCE.—Not later than 1 year after the date of enact- ment of the FDA Food Safety Modernization Act, the Secretary shall issue guidance to assist importers in developing foreign sup- plier verification programs. ‘‘(c) REGULATIONS.— ‘‘(1) IN GENERAL.—Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations to provide for the con- tent of the foreign supplier verification program established under subsection (a). ‘‘(2) REQUIREMENTS.—The regulations promulgated under paragraph (1)— ‘‘(A) shall require that the foreign supplier verification program of each importer be adequate to provide assur- ances that each foreign supplier to the importer produces the imported food in compliance with— ‘‘(i) processes and procedures, including reasonably appropriate risk-based preventive controls, that pro- vide the same level of public health protection as those required under section 418 or section 419 (taking into 21 USC 384a.