Page:United States Statutes at Large Volume 121.djvu/988

This page needs to be proofread.
[121 STAT. 967]
[121 STAT. 967]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 967

dkrause on GSDDPC44 with PUBLAW

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). ‘‘(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).

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00965

Fmt 6580

Sfmt 6581

M:\STATUTES\2007\59194PT1.001

APPS10

PsN: 59194PT1