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 illness or death among sensitive populations. 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 contamination refers to the presence of a contaminant in food.

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 Products 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 foreign food establishment means a slaughterhouse, factory, warehouse, or facility located outside the United States that processes food for consumption that is imported into the United States or food ingredients. 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. The term statistically valid means, with respect to a study, evaluated and conducted under standards established by the National Institute of Standards and Technology.

In this section: The term appropriate level of protection means a level of food safety and public health protection that— if achievable by commercially available techniques, reduces a known pathogen or contaminant to a level that does not present a demonstrated risk of illness or death to consumers, including sensitive groups; or in all other cases, is the lowest reasonably achievable level of a microbiologic or contaminant food safety hazard that can best protect public health.

The term food safety objective means an objective that establishes the maximum frequency or concentration of a microbial or contaminant hazard in a regulated food product at the time of handling and consumption by a consumer that still provides the appropriate level of protection. The term pathogen reduction performance standard means a standard that establishes the degree to which a step or combination of steps in the production, processing, distribution, or preparation of a food must operate to achieve the required level of control over microbiological contamination.

The term performance criteria means a criteria that establishes the effect of one or more control measures needed to meet or contribute to meet a performance objective. The term performance objective means an objective that establishes the maximum frequency or concentration of a microbial or contaminant hazard in a regulated food product during a processing step that contributes to the achievement of a food safety objective or other end measure or a performance standard. The term public health goals and objectives means goals and objectives establishing the desired outcome associated with reducing the burden of foodborne disease in society.

In order to protect the public health and promote food safety, the Secretary shall prescribe— pathogen surveys to determine current levels of food contamination and to enable the Secretary to assess compliance; public health goals and objectives; and pathogen reduction performance standards— to reduce pathogens in food; and to achieve public health goals and objectives. In consultation with the Secretary of Health and Human Services, and taking into account data available from the Centers for Disease Control and Prevention, the Secretary shall identify the pathogens that make a significant contribution to the total burden of foodborne disease associated with food.

The Secretary shall— publish a list of the pathogens described in paragraph

(1)not later than 180 days after the date of enactment of this section; and update and publish the list annually thereafter. Not later than 180 days after the date of enactment of this section, the Secretary shall initiate the planning and subsequent implementation of comprehensive surveys to determine the current levels and incidence of contamination of food products with the pathogens listed under subsection (c), including the variation in levels and incidence of contamination among establishments. Not later than 2 years after the date of enactment of this section, the Secretary shall compile, and publish in the Federal Register, the results of the surveys. At least once every 3 years after the preceding surveys are conducted, the Secretary shall— conduct surveys described in paragraph (1); and compile and publish the results of the surveys in accordance with paragraph (2). Not later than 1 year after the completion of pathogen surveys under subsection (d), and in coordination with the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention, the Secretary shall establish public health goals and food safety objectives to achieve measurable population-based targets and food safety targets for the reduction of foodborne illness and the exposure of the public to pathogens. The goals described in subsection (b)(2) shall be updated every 2 years according to current epidemiological studies in foodborne illness and the most recently updated information from the Centers for Disease Control and Prevention about the prevalence of foodborne illness. The pathogen reduction performance standards required under subsection

(b)shall ensure the lowest level or incidence of contamination that is reasonably achievable using the best available processing technology and practices. In determining what is reasonably achievable, the Secretary shall consider data on current levels or incidence of contamination, including what is being achieved by establishments in the upper quartile of performance in controlling the level or incidence of contamination. Not later than 3 years after the date of enactment of this section, the Secretary shall propose pathogen reduction performance standards for at least 2 pathogens from the list published under subsection (c). Not later than 1 year after proposing pathogen reduction standards for the initial pathogens under paragraph (3), and annually thereafter, the Secretary shall propose a pathogen reduction performance standard for at least 1 pathogen each year from the list published under subsection

(c)until standards have been proposed for all pathogens on the list. Not later than 1 year after proposing a pathogen reduction standard for a pathogen under this subsection, the Secretary shall promulgate a final pathogen reduction standard and propose sampling standards and procedures for the pathogen in regulated products. The performance standards established under this section shall include— food safety objectives that set the level of a contaminant that provides the appropriate level of protection; zero tolerances, including zero tolerances for fecal matter, in addition to any zero-tolerance standards in effect on the day before the date of enactment of this section, when necessary to protect against significant adverse health outcomes; performance objectives, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; in the absence of data to support a performance standard described in paragraph (1), (2), or (3), as determined by the Secretary, standards that define required performance in terms of best reasonably achievable performance, using best available technologies, interventions, and practices; or any other food safety objectives or performance criteria, as determined by the Secretary. Not later than 3 years after promulgation of a final pathogen reduction performance standard for a pathogen under subsection (f)(5), the Secretary shall review each standard to determine whether the standard continues to ensure the lowest level or incidence of contamination that is reasonably achievable using the best available processing technology and practices, taking into account the most recent survey conducted under subsection (d). The goals described in subsection

(e)shall be— used in addition to the most recent survey conducted under subsection

(d)to evaluate the pathogen performance standards set by the Secretary; and considered when the Secretary reviews and revises the final pathogen reduction performance standards in accordance with subsection (f). The Secretary shall revise the standards, as necessary, to comply with subsection (f). Not later than 1 year after the promulgation of a performance standard under this section, the Secretary shall implement a sampling program to determine whether food establishments are complying with the performance standards promulgated under this section. The program established under this paragraph shall be at least as stringent as the Hazard Analysis and Critical Control Point System requirements established under part 417 of title 9, Code of Federal Regulations (or successor regulation). If the Secretary determines that a food establishment fails to meet a standard promulgated under this section, and the food establishment fails to take appropriate corrective action as determined by the Secretary, the Secretary shall, as appropriate— order a recall of food from the food establishment under section 269; require enhanced inspection of the food establishment; withdraw the mark of inspection from the food establishment; or take other appropriate enforcement action concerning the food establishment, including revocation of the grant of inspection. Notwithstanding any other provision of this section, the Secretary shall promulgate interim performance standards for newly identified contaminants as necessary to prevent disease outbreaks or other hazards to the public health. The Secretary shall ensure that, as compared to regulations under chapter III of title 9, Code of Federal Regulations, that are in effect as of September 1, 2013, regulations promulgated under this part relating to— carcass inspection and safety are at least as stringent; the frequency of inspection services are at least as frequent; and staffing levels are at least as high so as to ensure public health. Not later than 180 days after the date of enactment of this section or the subsequent adoption of performance standards under section 264, the Secretary shall require that food establishments described in subsection

(b)sample for the presence of identified pathogens at any points in production or processing that are identified by the Secretary. This section applies to— all slaughterhouses or processing establishments that produce more than 25,000 pounds of trim per day; or grinding facilities that grind more than 25,000 pounds of trim or bench trim per day; and effective beginning on the date that is 3 years after the date of enactment of this section— to all food establishments that produce or grind trim or bench trim; and such other food establishments as are designated by the Secretary. To carry out this section, the Secretary shall— establish sampling standards and procedures; define appropriate sampling plans for food establishments through guidance documents; promulgate regulations that require that the food establishment takes corrective action when violative products are found through testing and establishes measures to prevent reoccurrence; and upon inspection, review the definition of lot sizes established by food establishments to ensure that— there is a rational justification for the lot size; and no lot is more than 2,000 pounds. Food establishments undertaking testing under this section shall use— sampling standards and procedures determined by the Secretary under section 264(f)(5); and a laboratory accredited under section 266. Not later than 2 years after the date of enactment of this section, the Secretary shall— establish a program for the testing of meat and meat food products by accredited laboratories; establish and maintain on the Internet Web site of the Department an up-to-date and publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information considered appropriate by the Secretary about the accreditation bodies and laboratories; and require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of the accreditation body or the accreditation of the laboratory. The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct one or more sampling and analytical testing methodologies for meat and meat food products. The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under this subsection beyond the number so qualified on the date of enactment of this section. In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available. Accreditation bodies recognized by the Secretary under paragraph

(1)may accredit laboratories that operate outside the United States, so long as the laboratories meet the accreditation standards applicable to domestic laboratories accredited under this subsection. The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall— consult existing standards for guidance; and include— methods to ensure that— appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate; internal quality systems are established and maintained; procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and individuals who conduct the sampling and analyses are qualified by training and experience to do so; and any other criteria determined appropriate by the Secretary. To ensure compliance with the requirements of this subsection, the Secretary— shall periodically, and in no case less frequently than once every 5 years, reevaluate accreditation bodies recognized under paragraph

(1)and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this subsection, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by the accreditation body to continue to perform testing as described in this subsection. Not later than 30 months after the date of enactment of this section, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection (a)(1)(B)— in response to a specific testing requirement under this Act (including implementing regulations), when applied to address an identified or suspected meat or meat food product safety problem; and as required by the Secretary, as the Secretary considers appropriate, to address an identified or suspected food safety problem. The results of any testing under this section shall be sent directly to the applicable food establishment and the Secretary, unless the Secretary by regulation exempts test results from the submission requirement if the Secretary determines that the results do not contribute to the protection of public health. Test results required to be submitted may be submitted to the Secretary through electronic means. The Secretary may waive requirements under this subsection if— a new methodology has been developed and validated but a laboratory has not yet been accredited to perform the methodology; and the use of the methodology is necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by a recognized accreditation body on the registry established by the Secretary under subsection

(a)result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities. Nothing in this section limits the ability of the Secretary to review and act on information from food testing, including determining the sufficiency of the information and testing. The Secretary, in order to protect the public health, shall establish requirements for a national system for tracing food and food-producing animals from point of slaughter to retail sale, subject to subsection (b). Traceability requirements shall— be established in accordance with regulations and guidelines issued by the Secretary; and apply to food establishments. The Secretary shall implement tracing protocols using methods and technologies to enable the Food Safety and Inspection Service to rapidly trace adulterated food to— the source of the contamination to determine the original site source of the adulteration or contamination; and destinations to which the food has been shipped. Tracing protocols under this subsection shall include the collection of documentary and other relevant material to enable rapid tracing, including— food establishment identification data; a description of the food; shipping marks; bar coding; and disclosure of sole-source or multiple-source origin. The collection of documentary and other relevant material to enable rapid tracing under subparagraph

(A)shall occur at the time that transfer of the relevant food is completed. The onsite inspector and a responsible food establishment representative shall certify that the documentary and other tracing material collected under subparagraph

(A)are complete and accurate. If a food sample tests positive or is indicated to test positive for a contaminant, the Secretary shall immediately conduct a trace— to identify all sites of contamination, including preparation, packaging, and slaughtering establishments; to identify the original source of contamination; and to identify any recipient of the food, other than the consumer, or food that may have been similarly affected. Nothing in this section prevents or interferes with implementation of the country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.). The Secretary shall ensure that international audits of eligible foreign country food safety systems shall— occur no less than annually; and be of sufficient scope to protect public health. As soon as practicable after the date of enactment of this section, the Secretary shall promulgate regulations under which the Secretary may remove a country from the appropriate list maintained by the Secretary of countries allowed to import one or more foods into the United States if— the country refuses to allow the Secretary to conduct such onsite audits as the Secretary determines to be necessary to verify the safety of the food to be imported; or imports of food from the country have been suspended more than once during a 5-year period for major food safety infractions. 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 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; or 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. Not later than 1 year after the date of enactment of this section, the Secretary shall develop a system of escalating penalties for situations in which there are serious or egregious violations of any food safety laws. The Secretary shall design the system under subsection

(a)based on sound methodology so as to provide incentives to reduce repeated serious or egregious violations. For purposes of this section, the Secretary shall define the term serious or egregious violation of any food safety law , which— shall include any current violations that are grounds for a suspension, withholding, or revocation of grant of inspection under a food safety law; and may include any other violations that constitute a severe violation of major food safety law requirements, which may include intransigent repeated noncompliance for less than serious violations that indicate a food establishment is unwilling or negligent to bring the food establishment into compliance over a period of repeat circumstances lasting at least 1 year since the last documented severe violation. Not later than 180 days after the date of enactment of this section, the Secretary shall establish performance-based fees for food establishments requiring nonroutine inspection services due to severe or repeated violations of food safety laws. Fees established under this section shall include, at minimum, fees for— food safety assessments in response to serious or repeated food safety violations; humane handling assessments in response to serious or repeated violations of Public Law 85–765 (commonly known as the Humane Methods of Slaughter Act of 1958 ) ( 7 U.S.C. 1901 et seq. ); any actions or enhanced inspections associated with a mandatory recall; and follow-up microbiological testing associated with any nonroutine requirements. The Secretary shall establish the amount of the fees at a level that recuperates the full costs or a reasonable portion of the nonroutine inspection services. The Secretary may adjust the terms, conditions, and rates of fees established under this section so as to minimize economic impacts on small and very small establishments. The Secretary shall use any fees collected under this section to bolster inspection or other programs in the Office of Field Operations, without the need for further appropriation. Not later than 1 year after the date of enactment of this section, the Secretary shall publish and make publically available guidance in the form of a list of eligible types of violations for nonroutine inspection fees, including estimated rates for services. . Section 296(b) of the Department of Agriculture Reorganization Act of 1994 ( 7 U.S.C. 7014(b) ) is amended— in paragraph (6)(C), by striking or at the end; in paragraph (7), by striking the period at the end and inserting ; or ; and by adding at the end the following: the authority of the Secretary to carry out food safety activities under part II of subtitle G. .

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