Authority to protect the public health from contaminated imported foods

(a)

Authority

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by inserting after subsection (o) the following:

(p)(1)The Secretary may refuse admission into the United States to any food (or any type of food) from a country, growing area, producer, manufacturer, or shipper if the Secretary makes a determination under paragraph (2) or an emergency determination under paragraph (3) to refuse admission to food (or the type of food involved) from such country, growing area, producer, manufacturer, or shipper. (2)(A)The Secretary may make a determination to refuse admission to food (or any type of food) from a country, growing area, producer, manufacturer, or shipper if such food (or type of food)— (i)has been associated with repeated and separate outbreaks of foodborne disease or has been repeatedly determined by the Secretary to be adulterated within the meaning of section 402; (ii)presents a reasonable probability of causing significant adverse health consequences or death; and (iii)is likely, without systemic intervention or changes, to cause disease or be adulterated again. (B)The Secretary shall rescind a determination under this paragraph if the Secretary finds that such determination, because of remedial action or other circumstances, is no longer justified. (C)A country, growing area, producer, manufacturer, or shipper may submit a request to the Secretary to rescind a determination under this paragraph. Any such request shall be accompanied by supporting evidence. (D)Not later than 90 days after the submission of a request under subparagraph (C), the Secretary shall take action on such request. The Secretary’s action may include— (i)rescinding under subparagraph (B) the determination; or (ii)continuing to refuse admission to the food involved and requesting additional information or remedial action. (E)If the Secretary does not take action on a request under subparagraph (C) within 90 days after the date of submission of such request, effective on the 91st day after the date of such submission, the food initially refused admission under paragraph (1) may be imported into the United States. (3)(A)The Secretary may make an emergency determination to refuse admission to food (or any type of food) from a country, growing area, producer, manufacturer, or shipper if such food (or type of food) has been strongly associated with a single outbreak of foodborne disease that has caused serious adverse health consequences or death. (B)An emergency determination under this paragraph shall be in effect— (i)for a 30-day period; or (ii)until the Secretary rescinds the emergency determination. (4)Subject to paragraph (5), the Secretary may issue a determination under paragraph (2) or an emergency determination under paragraph (3) immediately. (5)Any refusal to admit food under this subsection shall be done in a manner consistent with bilateral, regional, and multilateral trade agreements and the rights and obligations of the United States under the agreements. (6)Not later than 90 days after the date of the enactment of the Imported Food Safety Improvement Act of 2009, the Secretary shall promulgate final regulations to carry out this subsection.

(b)

Effective date

Section 801(p) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall take effect on the effective date provided in the regulations promulgated under section 801(p)(6) of such Act or the date that is 90 days after the date of the enactment of this Act, whichever is earlier. (c)

Conforming amendment

Subsection (a) of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended, in the third sentence by striking then such article shall be refused admission and inserting or (4) such article is food subject to a determination in effect under paragraph (2) or (3) of subsection (p), then such article shall be refused admission.