Page:United States Statutes at Large Volume 124.djvu/3966

 124 STAT. 3940 PUBLIC LAW 111–353—JAN. 4, 2011 ‘‘SEC. 423. MANDATORY RECALL AUTHORITY. ‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article. ‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION AND GIVE NOTICE.— ‘‘(1) IN GENERAL.—If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to— ‘‘(A) immediately cease distribution of such article; and ‘‘(B) as applicable, immediately notify all persons— ‘‘(i) manufacturing, processing, packing, trans- porting, distributing, receiving, holding, or importing and selling such article; and ‘‘(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article. ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— ‘‘(A) IN GENERAL.—If an article of food covered by a recall order issued under paragraph (1)(B) has been distrib- uted to a warehouse-based third party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse- based third party logistics provider to identify the food. ‘‘(B) RULES OF CONSTRUCTION.—Nothing in this para- graph shall be construed— ‘‘(i) to exempt a warehouse-based third party logis- tics provider from the requirements of this Act, including the requirements in this section and section 414; or ‘‘(ii) to exempt a warehouse-based third party logis- tics provider from being the subject of a mandatory recall order. ‘‘(3) DETERMINATION TO LIMIT AREAS AFFECTED.—If the Sec- retary requires a responsible party to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Secretary may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health. ‘‘(c) HEARING ON ORDER.—The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, Deadline. Determination. 21 USC 350l.