Sec. 402. Mandatory recall authority
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/bill/116/s/1995/is/section-402A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
If the Administrator determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Administrator shall provide to the owner, operator, or agent in charge of the facility that created, caused, or was otherwise responsible for that article of food an opportunity to cease distribution and recall that article of food in a manner and within a time period determined by the Administrator.
If the owner, operator, or agent in charge of a facility refuses to, or does not voluntarily, cease distribution or recall an article of food in the manner and within the time period determined by the Administrator under subsection (a), the Administrator may by order require, as the Administrator determines to be necessary— that owner, operator, or agent— to immediately cease distribution of that article of food; and as applicable, to immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling that article of food; and any person to which that article of food has been distributed, transported, or sold, to immediately cease distribution of that article of food.
If an article of food covered by a recall order issued under paragraph
(1)has been distributed 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 owner, operator, or agent of a facility under paragraph (1)(A)(ii) shall include such information as is necessary for the warehouse-based, third-party logistics provider to identify the article of food. Nothing in this paragraph shall be construed— to exempt a warehouse-based, third-party logistics provider from the requirements of food safety law; or to exempt a warehouse-based, third-party logistics provider from being the subject of a mandatory recall order. If the Administrator requires an owner, operator, or agent in charge of the facility to cease distribution under paragraph (1)(A)(i) of an article of food identified under subsection (a), the Administrator may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health. The Administrator shall provide the owner, operator, or agent in charge of the facility 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, on the actions required by the order and on why the article that is the subject of the order should not be recalled. If, after providing opportunity for an informal hearing under subsection (c), the Administrator determines that removal of the applicable article of food from commerce is necessary, the Administrator shall, as appropriate— amend the order to require recall of such article or other appropriate action; specify a timetable in which the recall shall occur; require periodic reports to the Administrator describing the progress of the recall; and provide notice to consumers to whom such article was, or may have been, distributed. If, after an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the applicable order, or that such actions should be modified, the Administrator shall vacate the order or modify the order, as appropriate. The Administrator shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Administrator has provided the Administrator of the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall the alcohol beverage under the authority of the Administrator of the Alcohol and Tobacco Tax and Trade Bureau. The Administrator shall work with State and local public health officials in carrying out this section, as appropriate. In conducting a recall under this section, the Administrator shall— ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification— of the recall to consumers and retailers to whom the applicable article of food was, or may have been, distributed; and that includes, at a minimum— the name of the article of food subject to the recall; a description of the risk associated with such article; and to the extent practicable, information for consumers about similar articles of food that are not affected by the recall; provide to the public a list of retail consignees receiving products for which there is determined to be a reasonable probability that eating the food will cause serious adverse health consequences or death to humans or animals; and if available, publish on the internet website of the Administration an image of the article that is the subject of the press release described in paragraph (1). The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Administrator. Nothing in this section shall affect the authority of the Administrator to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of the food safety law or under the Public Health Service Act ( 42 U.S.C. 201 et seq.). To assist in carrying out the requirements of this subsection, the Administrator shall establish an incident command operation or a similar operation that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals. To reduce the potential for miscommunication during recalls or regarding investigations of a foodborne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph
(1)shall use regular staff and resources of the Administration to— ensure timely and coordinated communication within the Administration, including enhanced communication and coordination between different agencies and organizations within the Administration; ensure timely and coordinated communication from the Administration, including public statements, throughout the duration of the investigation and related foodborne illness outbreak; identify a single point of contact within the Administration for public inquiries regarding any actions by the Administrator related to a recall; coordinate with Federal, State, local, and Tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as defined in section 25(b) of the Richard B. Russell National School Lunch Act ( 42 U.S.C. 1769f(b) )); and conclude operations at such time as the Administrator determines appropriate. The Administrator may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks. Fees described in section 743 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–31 ) for not complying with a recall order are applicable to all food facilities under this Act as if— the term responsible party means owner, operator, or agent in charge of the facility ; and references to section 423 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C.350 ) are references to section 402 of this Act. l
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- 21 USC 379j–31
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