Sec. 201. Food safety

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Subtitle G of the Department of Agriculture Reorganization Act of 1994 ( 7 U.S.C. 6981 et seq. ) is amended— by inserting after the subtitle heading the following: ; and by adding at the end the following: In this part: The term adulterated has the meaning given the term in— in the case of poultry or a poultry product, section 4 of the Poultry Products Inspection Act ( 21 U.S.C. 453 ); in the case of meat or a meat food product, section 1 of the Federal Meat Inspection Act ( 21 U.S.C. 601 ); and in the case of an egg or egg product, section 4 of the Egg Products Inspection Act ( 21 U.S.C. 1033 ).

The term adulterated includes bearing or containing a contaminant that has the potential to cause serious illness or death. The term agency has the meaning given the term in section 551 of title 5, United States Code. The term contaminant includes a biological, chemical, physical, or radiological food safety hazard that when found on or in food can cause human illness, injury, or death. The term food means— a meat or a meat food product (within the meaning of the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq. )); an egg or egg product (as defined in section 4 of the Egg Proucts Inspection Act ( 21 U.S.C. 1033 )); or a poultry or poultry product (as defined in section 4 of the Poultry Products Inspection Act ( 21 U.S.C. 453 )).

The term food establishment means a slaughterhouse, factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients. The term food establishment does not include a farm, restaurant, other retail food establishment, or nonprofit food establishment in which food is prepared for or served directly to the consumer. The term food safety law means— the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq. ); the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq. ); the Egg Products Inspection Act ( 21 U.S.C. 1031 et seq. ); the provisions of Public Law 85–765 (commonly known as the Humane Methods of Slaughter Act of 1958 ) ( 7 U.S.C. 1901 et seq. ) administered by the Food Safety and Inspection Service; this part; and such other provisions of law relating to and requiring food safety, labeling, inspection, and enforcement as the President designates by Executive order as appropriate to include within the jurisdiction of the Secretary.

The term interstate commerce has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). The term misbranded has the meaning given the term in— in the case of poultry or a poultry product, section 4 of the Poultry Products Inspection Act ( 21 U.S.C. 453 ); in the case of meat or a meat food product, section 1 of the Federal Meat Inspection Act ( 21 U.S.C. 601 ); and in the case of an egg or egg product, section 4 of the Egg Products Inspection Act ( 21 U.S.C. 1033 ).

The term process or processing means the commercial harvesting, slaughter, packing, preparation, or manufacture of food. The term safe refers to human and animal health. The term Secretary means the Secretary of Agriculture, acting through the Under Secretary of Food Safety. The term State means— a State; the District of Columbia; the Commonwealth of Puerto Rico; and any other territory or possession of the United States. In this section: The term Class I recall means a food recall classification defined by the Secretary that covers a health-hazard situation in which there is a reasonable probability that the use of the food or food product being recalled will cause a serious, adverse health consequence, or death.

The term retail establishment means a grocery store or other retail establishment that sells food and food products directly to consumers. The term summary notice means the 1-page summary notice described in subsection (d). A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Secretary of the identity and location of the food.

Notification under paragraph

(1)shall be made in such manner and by such means as the Secretary may require by regulation. If the Secretary determines that food is in violation of the food safety law when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce or that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Secretary, the Secretary shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity— to cease distribution of the food; to notify all persons— processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or to which the food has been distributed, transported, or sold, to immediately cease distribution of the food; to recall the food; in conjunction with the Secretary, to provide notice of the finding of the Secretary— to consumers to whom the food was, or may have been, distributed; and to State and local public health officials; or to take any combination of the measures described in this paragraph, as determined by the Secretary to be appropriate in the circumstances. If a person referred to in paragraph

(1)refuses to or does not adequately carry out the actions described in that paragraph within the time period and in the manner prescribed by the Secretary, the Secretary shall— have authority to control and possess the food or recall the food, including ordering the shipment of the food from the food establishment to the Secretary— at the expense of the food establishment; or in an emergency (as determined by the Secretary), at the expense of the Secretary; and by order, require, as the Secretary determines to be necessary, the person to immediately— cease distribution of the food; notify all persons— processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or if the food has been distributed, transported, or sold, to immediately cease distribution of the food; and recall contaminated food. In accordance with subsection (d), the Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1)— to consumers to whom the food was, or may have been, distributed; to State and local public health officials; and to such other persons as the Secretary determines appropriate. A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food. Each person referred to in paragraph

(1)that processed, distributed, or otherwise handled food shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding— persons that processed, distributed, or otherwise handled the food; and persons to which the food has been transported, sold, distributed, or otherwise handled. In the case of any Class I recall, the Secretary shall, to the maximum extent practicable, distribute to each retail establishment that has received or is likely to have received recalled product in the United States a 1-page summary notice containing product information of each food or food product subject to the Class I recall. The Secretary shall require each retail establishment that receives a summary notice to perform 2 of the 3 following actions: To post a copy of the summary notice at each cash register of the retail establishment. To post a copy of the summary notice on the shelving unit on which the food or food product was sold. In the case of a retail establishment that uses a customer card system to track customer purchases or demographics— to place a call to each customer that purchased a recalled food or food product to inform the customer of the Class I recall; or to make available to each customer that purchased a recalled food or food product with a targeted coupon with information about the recalled food or food product. In cooperation with and, when necessary, with direct assistance from the Director of the Centers for Disease Control and Prevention and the Centers of Excellence of the Food and Drug Administration, the Secretary shall provide assistance to regional, State, and local agencies to assist in carrying out this section through activities such as providing resources, including timely information concerning symptoms and tests, for frontline health professionals interviewing individuals as part of routine surveillance and outbreak investigations. The Secretary shall make publicly available the names and locations of retail establishment consignees of recalled food or food products that the Secretary compiles in connection with a recall for which there is a reasonable probability that the use of the food or food product could cause serious adverse health consequences or death. The Secretary shall provide any person subject to an order under subsection

(c)with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order. In a hearing under paragraph (1), the Secretary shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled. If, after providing an opportunity for an informal hearing under subsection (e), the Secretary determines that there is a reasonable probability that the food that is the subject of an order under subsection (c), if consumed, would present a threat to the public health, the Secretary, as the Secretary determines to be necessary, may— amend the order to require recall of the food or other appropriate action; specify a timetable in which the recall shall occur; require periodic reports to the Secretary describing the progress of the recall; and provide notice of the recall to consumers to whom the food was, or may have been, distributed. If, after providing an opportunity for an informal hearing under subsection (e), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order. The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available. Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under a Federal food safety law) may be assessed a civil penalty by the Secretary of not more than $10,000 for each such act. Each act described in clause

(i)and each day during which that act continues shall be considered a separate offense. The civil penalty described in subparagraph

(A)shall be assessed by the Secretary by a written order, which shall specify the amount of the penalty and the basis for the penalty under clause

(ii)considered by the Secretary. Subject to subparagraph (A)(i), the amount of the civil penalty shall be determined by the Secretary, after considering— the gravity of the violation; the degree of culpability of the person; the size and type of the business of the person; and any history of prior offenses by the person under the food safety law. The order may be reviewed only in accordance with paragraph (2). An order assessing a civil penalty under paragraph

(1)shall be a final order unless the person— not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and simultaneously serves a copy of the petition by certified mail to the Secretary. Not later than 45 days after the service of a copy of the petition under subparagraph (A)(ii), the Secretary shall file in the court a certified copy of the administrative record upon which the order was issued. The findings of the Secretary relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole. If any person fails to pay a civil penalty assessed under paragraph

(1)after the order assessing the penalty has become a final order, or after the court of appeals described in paragraph

(2)has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed. In a civil action under subparagraph (A), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to judicial review. The Secretary— shall deposit penalties collected under this section in an account in the Treasury; and may use the funds in the account, without further appropriation or fiscal year limitation— to carry out enforcement activities under food safety law; or to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs. Nothing in this part requires the Secretary to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Secretary finds that the public interest will be adequately served by the assessment of a civil penalty under this section. The remedies provided in this subsection are in addition to, and not exclusive of, other remedies that may be available under this or any other Act. In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist. No Federal employee, employee of a Federal contractor or subcontractor, or any individual employed by a company or other entity that is a regulated establishment or any other entity involved in the food supply system (referred to in this subsection as a covered individual ), may be discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against, because of any lawful act done by the covered individual— to provide information, cause information to be provided, or otherwise assist in an investigation regarding any conduct that the covered individual reasonably believes constitutes a violation of this Act or a food safety law, including any related rules or regulations, or that the covered individual reasonably believes constitutes a threat to the public health, if the information or assistance is provided to, or the investigation is conducted by— a Federal regulatory or law enforcement agency; a Member or committee of Congress; or a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct); to file, cause to be filed, testify, participate in, or otherwise assist in a proceeding or action filed or about to be filed relating to a violation of any law, rule, or regulation; or to refuse to violate or assist in the violation of any law, rule, or regulation. A covered individual who alleges discharge or other discrimination by any person in violation of paragraph

(1)may seek relief under paragraph

(3)by filing a complaint with the Secretary of Labor. If the Secretary of Labor has not issued a final decision by the date that is 210 days after the date on which the complaint is filed and there is no showing that the delay is due to the bad faith of the claimant, the claimant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy. An action under subparagraph

(A)shall be governed under the rules and procedures established in section 1012 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399d ). A covered individual who prevails in any action under subparagraph

(A)shall be entitled to remedies equivalent to relief provided under section 1012(b)(4)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399d(b)(4)(B) ). This subsection shall apply and be carried out in accordance with section 1012 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399d ), including the relation of the whistleblower protection provided under this subsection to the rights of employees, other laws, and international agreements, and the inability of an employee to waive the whistleblower protection. Nothing in this subsection diminishes the rights, privileges, or remedies of any covered individual under any Federal or State law, or under any collective bargaining agreement. The rights and remedies in this subsection may not be waived by any agreement, policy, form, or condition of employment. For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act ( 15 U.S.C. 46 , 48, 49, and 50) (except subsections

(c)through

(h)of section 6 of that Act), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Secretary and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively. The Secretary, in person or by such agents as the Secretary may designate, may prosecute any inquiry necessary to carry out the duties of the Secretary under the food safety law in any part of the United States. The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this part by any United States district court of competent jurisdiction. A person may commence a civil action against the Secretary (in his or her capacity as the Secretary)— if the Secretary fails to perform an act or duty that is not discretionary under a food safety law and the failure to perform that act or duty presents a clear, demonstrated, and serious present threat to public health; but only after the person has— filed a petition with the Secretary; and given the Secretary 180 days to comply with nondiscretionary acts or duties. The action shall be commenced in the United States district court for the district in which the defendant resides, is found, or has an agent. The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to require the Secretary to perform a nondiscretionary act or duty under a food safety law, if— it is proven that— the act or duty is not discretionary and is critical to public health protection; and the Secretary has the appropriate financial resources to perform the act or duty; the Secretary was given 180 days to perform the act or duty prior to the filing of an action; and the Secretary did not perform the act or duty; and the plaintiff presents credible evidence, including, if applicable, evidence representing the current scientific knowledge, that indicates that an act or duty necessary to regulate or control a food safety hazard has not been performed by the Secretary. The court may— require the Secretary to perform the act or duty in question towards a standard of protecting public health; and award the plaintiff part or all of the costs of suit, including reasonable attorney’s fees and reasonable expert witness fees, if— awarding the fees is in the interest of justice; the failure of the Secretary to perform a required act or duty is found to be capricious or negligent; and awarding the fees would not reduce resources applied to public health inspections. .

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