应通报食品注册(Federal Food, Drug, and Cosmetic Act Sec. 350f - Reportable food registry)

　　Note: This section was posted in February 2008.

　　Sec. 417. [21 USC 350f] Reportable food registry.

　　（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） [21 USC § 350d（a）] for a food facility that is required to register under section 415（a） [21 USC § 350d（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 [enacted Sept. 27, 2007], 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 [21 USC §§ 301 et seq.].

　　（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.

　　（2） No report required. A responsible party is not required to submit a report under paragraph （1） if--

　　（A） the adulteration originated with the responsible party;

　　（B） the responsible party detected the adulteration prior to any transfer to another person of such article of food; and

　　（C） the responsible party--

　　（i） corrected such adulteration; or

　　（ii） destroyed or caused the destruction of such article of food.

　　（3） Reports by public health officials. A Federal, State, or local public health official may submit a report about a reportable food to the Food and Drug Administration through the electronic portal established under subsection （b） that includes the data elements described in subsection （e） that the official is able to provide.

　　（4） Report number. The Secretary shall ensure that, upon submission of a report under paragraph （1） or （3）, a unique number is issued through the electronic portal established under subsection （b） to the person submitting such report, by which the Secretary is able to link reports about the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food.

　　（5） Review. The Secretary shall promptly review a report submitted under paragraph （1） or （3）.

　　（6） Response to report submitted by a responsible party. After consultation with the responsible party that submitted a report under paragraph （1）, the Secretary may require such responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, 1 or more of the following:

　　（A） Amend the report submitted by the responsible party under paragraph （1） to include the data element described in subsection （e）（9）.

　　（B） Provide a notification--

　　（i） to the immediate previous source of the article of food, if the Secretary deems necessary;

　　（ii） to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

　　（iii） that includes--

　　（I） the data elements described in subsection （e） that the Secretary deems necessary;

　　（II） the actions described under paragraph （7） that the recipient of the notification shall perform, as required by the Secretary; and

　　（III） any other information that the Secretary may require.

　　（7） Subsequent reports and notifications. Except as provided in paragraph （8）, the Secretary may require a responsible party to perform, as soon as practicable, but in no case later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph （C） or paragraph （6）（B）, 1 or more of the following:

　　（A） Submit a report to the Food and Drug Administration through the electronic portal established under subsection （b） that includes those data elements described in subsection （e） and other information that the Secretary deems necessary.

　　（B） Investigate the cause of the adulteration if the adulteration of the article of food may have originated with the responsible party.

　　（C） Provide a notification--

　　（i） to the immediate previous source of the article of food, if the Secretary deems necessary;

　　（ii） to the immediate subsequent recipient of the article of food, if the Secretary deems necessary; and

　　（iii） that includes--

　　（I） the data elements described in subsection （e） that the Secretary deems necessary;

　　（II） the actions described under this paragraph that the recipient of the notification shall perform, as required by the Secretary; and

　　（III） any other information that the Secretary may require.

　　（8） Amended report. If a responsible party receives a notification under paragraph （6）（B） or paragraph （7）（C） with respect to an article of food after the responsible party has submitted a report to the Food and Drug Administration under paragraph （1） with respect to such article of food--

　　（A） the responsible party is not required to submit an additional report or make a notification under paragraph （7）; and

　　（B） the responsible party shall amend the report submitted by the responsible party under paragraph （1） to include the data elements described in paragraph （9）, and, with respect to both such notification and such report, paragraph （11） of subsection （e）.

　　（e） Data elements. The data elements described in this subsection are the following:

　　（1） The registration numbers of the responsible party under section 415（a）（3） [21 USC § 350d（a）（3）].

　　（2） The date on which an article of food was determined to be a reportable food.

　　（3） A description of the article of food including the quantity or amount.

　　（4） The extent and nature of the adulteration.

　　（5） If the adulteration of the article of food may have originated with the responsible party, the results of the investigation required under paragraph （1）（B） or （7）（B） of subsection （d）, as applicable and when known.

　　（6） The disposition of the article of food, when known.

　　（7） Product information typically found on packaging including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article of food.

　　（8） Contact information for the responsible party.

　　（9） The contact information for parties directly linked in the supply chain and notified under paragraph （6）（B） or （7）（C） of subsection （d）, as applicable.

　　（10） The information required by the Secretary to be included in a notification provided by the responsible party involved under paragraph （6）（B） or （7）（C） of subsection （d） or required in a report under subsection （d）（7）（A）.

　　（11） The unique number described in subsection （d）（4）.

　　（f） Coordination of Federal, State, and local efforts.

　　（1） Department of Agriculture. In implementing this section, the Secretary shall--

　　（A） share information and coordinate regulatory efforts with the Department of Agriculture; and

　　（B） if the Secretary receives a report submitted about a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department of Agriculture.

　　（2） States and localities. In implementing this section, the Secretary shall work with the State and local public health officials to share information and coordinate regulatory efforts, in order to--

　　（A） help to ensure coverage of the safety of the food supply chain, including those food establishments regulated by the States and localities that are not required to register under section 415 [21 USC § 350d]; and

　　（B） reduce duplicative regulatory efforts.

　　（g） Maintenance and inspection of records. The responsible party shall maintain records related to each report received, notification made, and report submitted to the Food and Drug Administration under this section for 2 years. A responsible party shall, at the request of the Secretary, permit inspection of such records as provided for section 414 [21 USC § 350c].

　　（h） Request for information. Except as provided by section 415（a）（4） [21 USC § 350d（a）（4）], section 552 of title 5, United States Code, shall apply to any request for information regarding a record in the Reportable Food Registry.

　　（i） Safety report. A report or notification under subsection （d） shall be considered to be a safety report under section 756 [21 USC § 379v] and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report or the notification constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.

　　（j） Admission. A report or notification under this section shall not be considered an admission that the article of food involved is adulterated or caused or contributed to a death, serious injury, or serious illness.

　　（k） Homeland Security notification. If, after receiving a report under subsection （d）, the Secretary believes such food may have been deliberately adulterated, the Secretary shall immediately notify the Secretary of Homeland Security. The Secretary shall make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security.

更多有关《联邦食品、药品和化妆品法》的内容，请点击《联邦食品、药品和化妆品法》第II章及第IV章食品法规汇总。

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