DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.

SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS. (a) Debarment Authority.— (1) Permissive debarment.—Section 306(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended— (A) in subparagraph (A), by striking “or” after the comma at the end; (B) in subparagraph (B), by striking the period at the end and inserting “, or”; and (C) by adding at the end the following subparagraph: “(C) a person from importing an article of food or offering such an article for import into the United States.”. (2) Amendment regarding debarment grounds.—Section 306(b)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended— (A) in paragraph (2), in the matter preceding subparagraph (A), by inserting “subparagraph (A) or (B) of’ before “paragraph (1)”;116 STAT. 666 (B) by redesignating paragraph (3) as paragraph (4); and (C) by inserting after paragraph (2) the following paragraph: “(3) Persons subject to permissive debarment; food importation.—A person is subject to debarment under paragraph (1)(C) if— “(A) the person has been convicted of a felony for conduct relating to the importation into the United States of any food; or “(B) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.”. (b) Conforming Amendments.—Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended— (1) in subsection (a), in the heading for the subsection, by striking “Mandatory Debarment—” and inserting “Mandatory Debarment; Certain Drug Applications—”; (2) in subsection (b)— (A) in the heading for the subsection, by striking “Permissive Debarment.—” and inserting “Permissive Debarment; Certain Drug Applications; Food Imports.—”; and (B) in paragraph (2), in the heading for the paragraph, by striking “permissive debarment.—” and inserting “permissive debarment; certain drug applications.— (3) in subsection (c)(2)(A)(iii), by striking “subsection (b)(2)” and inserting “paragraph (2) or (3) of subsection (b)”; (4) in subsection (d)(3)— (A) in subparagraph (A)(i), by striking “or (b)(2)(A)” and inserting “ or paragraph (2)(A) or (3) of subsection (b)”; (B) in subparagraph (A)(ii)(II), by inserting “in applicable cases,” before “sufficient audits”; (C) in subparagraph (B), in each of clauses (i) and (ii), by inserting “or subsection (b)(3)” after “subsection (b)(2)(B)”; and (D) in subparagraph (B)(ii), by inserting before the period the following: “or the food importation process, as the case may be”. (c) Effective Dates.—Section 306(1)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(1)(2)) is amended— (1) in the first sentence— (A) by striking “and” after “subsection (b)(2),”; and (B) by inserting “, and subsection (b)(3)(A)” after “subsection (b)(2)(B)”; and (2) in the second sentence, by inserting “, subsection (b)(3)(B),” after “subsection (b)(2)(B)”. (d) Prohibited Act.—Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended by section 303(b) of this Act, is amended by adding at the end the following: “(cc) The importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of, a person debarred under section 306(b)(3).”. 116 STAT. 667 (e) Importation by Debarred Persons.—Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 303(c) of this Act, is amended by adding at the end the following subsection: “(k) (1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 306(b)(3), such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. “(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 306(b)(3) if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this Act, as determined by the Secretary.”.