Page:United States Statutes at Large Volume 121.djvu/986

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[121 STAT. 965]
[121 STAT. 965]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 965

(4) A reliable mechanism to track patterns of adulteration in food would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health. (b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following: ‘‘SEC. 417. REPORTABLE FOOD REGISTRY.

21 USC 350f.

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‘‘(a) DEFINITIONS.—In this section: ‘‘(1) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to an article of food, means a person that submits the registration under section 415(a) for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. ‘‘(2) REPORTABLE FOOD.—The term ‘reportable food’ means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. ‘‘(b) ESTABLISHMENT.— ‘‘(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from— ‘‘(A) Federal, State, and local public health officials; or ‘‘(B) responsible parties. ‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly review and assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this Act to protect the public health. ‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.— ‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to be issued, an alert or a notification with respect to a reportable food using information from the Reportable Food Registry as the Secretary deems necessary to protect the public health. ‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a notification under any other provision of this Act. ‘‘(d) REPORTING AND NOTIFICATION.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food, the responsible party shall— ‘‘(A) submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such subsection); and ‘‘(B) investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

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