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subject to subsections (c) and (d): (1) Category 1 food establishments A category 1 food establishment shall be subject to antemortem and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that— (A) diseased animals are not offered for slaughter; (B) the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses and destroyed or reprocessed them in a manner acceptable to the Administrator; and (C) that applicable performance standards and other provisions of the food safety law have been satisfied.
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(2) Category 2 food establishments A category 2 food establishment shall be randomly inspected at least daily. (3) Category 3 food establishments A category 3 food establishment shall— (A) have ongoing verification that its processes are controlled; and (B) be randomly inspected at least monthly. (4) Category 4 food establishments A category 4 food establishment shall be randomly inspected at least quarterly. (5) Category 5 food establishments A category 5 food establishment shall be randomly inspected at least annually.
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(c) Alternative inspection frequencies With respect to a category 2, 3, 4, or 5 food establishment, the Administrator may establish alternative inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources, subject to the following criteria and procedures: (1) Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).
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(2) Regulations of alternative inspection frequencies for subcategories of food establishments under paragraph (1) and for a specific food establishment under paragraph (4) shall provide that— (A) category 2 food establishments shall be inspected at least monthly; and (B) category 3, 4, and 5 food establishments shall be inspected at least annually. (3) In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider— (A) the nature of the food products being processed, stored, or transported;
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(B) the manner in which food products are processed, stored, or transported; (C) the inherent likelihood that the products will contribute to the risk of food-borne illness; (D) the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of establishments; and (E) the overall record of compliance with the food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
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(4) The Administrator may adopt alternative inspection frequencies for a specific establishment, subject to paragraphs (2) and (5) and shall periodically publish a list of establishments subject to alternative inspections. (5) In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider— (A) the criteria in paragraph (3); (B) whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and (C) the record of the establishment of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls.
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(6) Before establishing alternative inspection frequencies for subcategories of establishments or individual establishments, the Administrator shall— (A) determine, based on the best available evidence, that the alternative uses of the resources required to carry out the inspection activity would make a greater contribution to protecting the public health and reducing the risk of food-borne illness than the use of resources described in subsection (b); (B) describe the alternative uses of resources in general terms when issuing the regulation or order that establishes the alternative inspection frequency;
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(C) consider the supporting evidence that an individual food establishment shall submit related to whether an alternative inspection frequency should be established for such establishment by the Administrator; and (D) include a description of the alternative uses in the annual resource plan required in section 209. (d) Inspection transition The Administrator shall manage the transition to the inspection system described in this Act as follows: (1) In the case of a category 1 or 2 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq.
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), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq. ), and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) until— (A) regulations required to implement this section have been promulgated; (B) the performance standards required by section 204(c) have been promulgated and implemented for 1 year; and (C) the establishment has achieved compliance with the other applicable provisions of the food safety law. (2) In the case of a category 1 or 2 food establishment that,
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within 2 years after the promulgation of the performance standards required by section 204(c), has not achieved compliance with the food safety law, the Administrator shall— (A) issue an order prohibiting the establishment from operating pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; and (B) following the demonstration required in subparagraph (A), issue an order authorizing the food establishment to operate subject, at a minimum,
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to— (i) the inspection requirement applicable to the establishment under subsection (b) (1) or (2); and (ii) such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the applicable food safety law. (3) In the case of a category 3 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq.
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), and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) until— (A) the regulations required to implement this section have been promulgated; (B) the first resource plan under section 209 has been submitted; and (C) for individual establishments, compliance with the food safety law has been demonstrated. (4) In the case of a category 3 food establishment that, within 1 year after the promulgation of the regulations required to implement this section, have not demonstrated compliance with the food safety law,
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the Administrator shall— (A) issue an order prohibiting the establishment from operating, pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; and (B) following the demonstration required in subparagraph (A), issue an order authorizing the establishment to operate subject, at a minimum, to— (i) the inspection requirement applicable to the establishment under subsection (b)(3);
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and (ii) such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the food safety law. (5) In the case of a category 4 or 5 food establishment, the inspection requirements of this Act shall be implemented as soon as possible after— (A) the promulgation of the regulations required to implement this section; (B) the publication of the first resource plan under section 209; and (C) the commencement of the first fiscal year in which the Administration is operating with budgetary resources that Congress has appropriated following consideration of the resource plan under section 209.
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(e) Official mark (1) In general (A) Establishment Before the completion of the transition process under paragraphs (1) through (3) of subsection (d), the Administrator shall by regulation establish an official mark that shall be affixed to a food product produced in a category 1, 2, or 3 establishment, subject to subparagraph (B).
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(B) Prerequisite The official mark required under subparagraph (A) shall be affixed to a food product by the Administrator if the establishment has been inspected by the Administrator in accordance with the inspection frequencies under this section and the establishment is in compliance with the food safety law. (2) Category 1, 2, or 3 food establishments In the case of products produced in a category 1, 2, or 3 food establishment— (A) products subject to Federal Meat Inspection Act ( 21 U.S.C. 601 et seq.
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), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq. ), the Egg Products Inspection Act ( 21 U.S.C. 1031 et seq. ), and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. )
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as of the date of enactment of this Act shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under paragraphs (1) through (3) of subsection (d); (B) the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this Act have been achieved; and (C) a product from an establishment that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce.
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(3) Category 4 and 5 food establishments In the case of a product produced in a category 4 or 5 food establishment the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to— (A) such minimum inspection frequencies as determined appropriate by the Administrator; (B) compliance with applicable performance standards and other provisions of the food safety law; and (C) such other requirements the Administrator considers appropriate.
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(f) Implementation Not later than 1 year after the effective date of this Act, the Administrator shall issue regulations to implement subsections (b) through (d). (g) Maintenance and inspection of records (1) In general (A) Records A food establishment shall— (i) maintain such records as the Administrator shall require by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and (ii) permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act,
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upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator— (I) to determine whether the food is contaminated or not in compliance with the food safety law; or (II) to track the food in commerce.
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(B) Required disclosure A food establishment shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant. (2) Maintenance of records The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator. (3) Requirements The records in paragraph (1) shall include records describing— (A) the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
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(B) the identity and quantity of ingredients used in the food; (C) the processing of the food; (D) the results of laboratory, sanitation, or other tests performed on the food or in the food establishment; (E) consumer complaints concerning the food or packaging of the food; (F) the production codes, open date codes, and locations of food production; and (G) other matters reasonably related to whether food is unsafe for human consumption, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
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(h) Protection of sensitive information (1) In general The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the Administrator.
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(2) Limitation The requirement under this subsection does not— (A) limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act; (B) have any legal effect on section 1905 of title 18, United States Code; (C) extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales); or (D) limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403.
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(i) Bribery of or gifts to inspector or other officers and acceptance of gifts Section 22 of the Federal Meat Inspection Act ( 21 U.S.C. 622 ) shall apply to an inspection under this Act. 206. Food production facilities In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to— (1) visit and inspect food production facilities in the United States and in foreign countries to investigate bioterrorism threats and for other critical food safety purposes;
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(2) review food safety records as required to be kept by the Administrator to carry out traceback and for other critical food safety purposes; (3) set good practice standards to protect the public and animal health and promote food safety; (4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and (5) collect and maintain information relevant to public health and farm practices. 207.
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Federal and State cooperation (a) In general The Administrator shall work with the States to carry out activities and programs that contribute to the national food safety program so that Federal and State programs function in a coordinated and cost-effective manner.
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(b) State action The Administrator shall work with States to— (1) continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets; (2) establish inspection programs and requirements to ensure that food under the jurisdiction of the State is safe for human consumption; and (3) support recall authorities at the State and local levels.
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(c) Assistance To assist in planning, developing, and implementing a food safety program, the Administrator may provide to a State— (1) advisory assistance; (2) technical and laboratory assistance and training (including necessary materials and equipment); and (3) financial and other aid. (d) Service agreements (1) In general The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise, the personnel and services of those agencies in carrying out this Act.
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(2) Training Agreements with a State under this subsection may provide for training of State employees. (3) Maintenance of agreements The Administrator shall maintain any agreement that is in effect on the day before the date of enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement. (e) Audits (1) In general The Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out the responsibilities under this Act, including mandated inspections under section 205.
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(2) Requirements The review shall— (A) include a determination of the effectiveness of the State program; and (B) identify any changes necessary to ensure enforcement of Federal requirements under this Act. 208. Imports (a) In general Not later than 2 years after the effective date of this Act, the Administrator shall establish a system under which a foreign government or foreign food establishment seeking to import food to the United States shall submit a request for certification to the Administrator.
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(b) Certification standard A foreign government or foreign food establishment requesting a certification to import food to the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of a foreign government or by the foreign food establishment has met standards for food safety, inspection, labeling, and consumer protection that are at least equivalent to standards applicable to food produced in the United States.
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(c) Certification approval (1) Request by foreign government Prior to granting the certification request of a foreign government, the Administrator shall review, audit, and certify the food safety program of a requesting foreign government (including all statutes, regulations, and inspection authority) as at least equivalent to the food safety program in the United States, as demonstrated by the foreign government.
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(2) Request by foreign food establishment Prior to granting the certification request of a foreign food establishment, the Administrator shall certify, based on an onsite inspection, the food safety programs and procedures of a requesting foreign firm as at least equivalent to the food safety programs and procedures of the United States. (d) Limitation A foreign government or foreign firm approved by the Administrator to import food to the United States under this section shall be certified to export only the approved food products to the United States for a period not to exceed 5 years.
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(e) Withdrawal of certification The Administrator may withdraw certification of any food from a foreign government or foreign firm— (1) if such food is linked to an outbreak of human illness; (2) following an investigation by the Administrator that finds that the foreign government programs and procedures or foreign food establishment is no longer equivalent to the food safety programs and procedures in the United States; or (3) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section.
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(f) Renewal of certification The Administrator shall audit foreign governments and foreign food establishments at least every 5 years to ensure the continued compliance with the standards set forth in this section. (g) Required routine inspection The Administrator shall routinely inspect food before it enters the United States to ensure that it is— (1) safe for human consumption; (2) labeled as required for food produced in the United States; and (3) otherwise meets requirements under the food safety law.
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(h) Enforcement The Administrator— (1) may deny importation of food from any foreign government that does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill the requirements under this section; (2) may deny importation of food from any foreign government or foreign firm that does not consent to an investigation by the Administration when food from that foreign country or foreign firm is linked to a food-borne illness outbreak or is otherwise found to be adulterated or mislabeled;
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and (3) is authorized to promulgate rules and regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of this Act. (i) Detention and seizure Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402. 209. Resource plan (a) In general The Administrator shall prepare and update annually a resource plan describing the resources required, in the best professional judgment of the Administrator, to develop and fully implement the national food safety program established under this Act.
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(b) Contents of plan The resource plan shall— (1) describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of the national food safety program; (2) allocate inspection resources in a manner reflecting the distribution of risk and opportunities to reduce risk across the food supply to the extent feasible based on the best available information, and subject to section 205; and (3) describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities,
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at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205— (A) in foreign establishments; (B) at the point of importation; and (C) at the point of production on farms, ranches, and feedlots. (c) Grants The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities in retail and food service facilities and the required inspections in food establishments.
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(d) Submission of plan The Administrator shall submit annually to the Committee on Appropriations of the Senate, the Committee on Appropriations of the House of Representatives, and other relevant committees of Congress, the resource plan required under this section. 210. Traceback (a) In general The Administrator, in order to protect the public health, shall establish requirements for tracing food and food producing animals from point of origin to retail sale, subject to subsection (b).
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(b) Applicability Traceability requirements shall— (1) be established in accordance with regulations and guidelines issued by the Administrator; and (2) apply to food production facilities and food establishments. (c) Relationship to country of origin labeling Nothing contained 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. ). 301. Public health assessment system (a) In general The Administrator,
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acting in coordination with the Director of the Centers for Disease Control and Prevention and with the Research Education and Economics mission area of the Department of Agriculture, shall— (1) have access to the applicable data systems of the Centers for Disease Control and Prevention; (2) maintain an active surveillance system of food, food products, and epidemiological evidence submitted by States to the Centers for Disease Control and Prevention based on a representative proportion of the population of the United States; (3) assess the frequency and sources of human illness in the United States associated with the consumption of food;
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and (4) maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment. (b) Public health sampling (1) In general Not later than 1 year after the effective date of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food— (A) to assist the Administrator in carrying out this Act; and (B) to assess the nature, frequency of occurrence, and quantities of contaminants in food.
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(2) Requirements The sampling system described in paragraph (1) shall provide— (A) statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and (B) at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.
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(c) Assessment of health hazards (1) In general Through the surveillance system referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall— (A) rank food categories based on the hazard to human health presented by the food category; (B) identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and (C) assess the public health environment for emerging diseases, including zoonosis, for their risk of appearance in the United States food supply.
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(2) Components of analysis The analysis under subsection (b)(1) may include— (A) a comparison of the safety of commercial processing with the health hazards associated with food that is harvested for recreational or subsistence purposes and prepared noncommercially; (B) a comparison of the safety of food that is domestically processed with the health hazards associated with food that is processed outside the United States; (C) a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and (D) use of comparative risk assessments. 302.
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Public education and advisory system (a) Public education (1) In general The Administrator, in cooperation with private and public organizations, including the cooperative extension services and appropriate State and local entities, shall establish a national public education program on food safety.
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(2) Requirements The program shall provide— (A) information to the public regarding Federal standards and best practices and promotion of public awareness, understanding, and acceptance of those standards and practices; (B) information for health professionals— (i) to improve diagnosis and treatment of food-related illness; and (ii) to advise individuals at special risk for food-related illnesses; and (C) such other information or advice to consumers and other persons as the Administrator determines will promote the purposes of this Act.
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(b) Health advisories The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities— (1) to develop and distribute regional and national advisories concerning food safety; (2) to develop standardized formats for written and broadcast advisories; (3) to incorporate State and local advisories into the national public education program established under subsection (a); and (4) to present prompt, specific information regarding foods found to pose a threat to the public health. 303.
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Research (a) In general The Administrator shall conduct research to carry out this Act, including studies— (1) to improve sanitation and food safety practices in the processing of food; (2) to develop improved techniques to monitor and inspect food; (3) to develop efficient, rapid, and sensitive methods to detect contaminants in food; (4) to determine the sources of contamination of contaminated food; (5) to develop food consumption data; (6) to identify ways that animal production techniques could improve the safety of the food supply; and (7) to conduct other research that supports the purposes of this Act.
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(b) Contract authority The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section. 401. Prohibited acts It is prohibited— (1) to manufacture, introduce, deliver for introduction, or receive into interstate commerce any food that is adulterated, misbranded, or otherwise unsafe for human consumption; (2) to adulterate or misbrand any food in interstate commerce; (3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
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(4) to refuse to permit access to a food establishment for the inspection and copying of a record as required under section 205(g); (5) to fail to establish or maintain any record or to make any report as required under section 205(g); (6) to refuse to permit entry to or inspection of a food establishment as required under section 205; (7) to fail to provide to the Administrator the results of a testing or sampling of a food, equipment, or material in contact with contaminated food under section 205(h); (8) to fail to comply with a provision, regulation,
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or order of the Administrator under section 202, 203, 204, or 208; (9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any such food for commerce, except in compliance with the food safety law; (10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained; (11) to fail to comply with a recall or other order under section 403; or (12) to otherwise violate the food safety law. 402.
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Food detention, seizure, and condemnation (a) Administrative detention of food (1) Expanded authority The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ) to administratively detain and seize any food that the Administrator has reason to believe is unsafe for human consumption, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
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(2) Detention authority If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe for human consumption, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, the officer or employee may order the food detained.
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(3) Period of detention (A) In general A food may be detained for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action. (B) Perishable food The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.
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(4) Security of detained food (A) In general A detention order— (i) may require that the food be labeled or marked as detained; and (ii) shall require that the food be removed to a secure facility, if appropriate. (B) Food subject to an order A food subject to a detention order shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.
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(C) Delivery of food This subsection does not authorize the delivery of a food in accordance with execution of a bond while the article is subject to the order. (b) Appeal of detention order (1) In general A person who would be entitled to be a claimant for a food subject to a detention order if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ), may appeal the order to the Administrator.
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(2) Action by the Administrator Not later than 5 days after an appeal is filed under paragraph (1), the Administrator, after providing an opportunity for an informal hearing, shall confirm, modify, or terminate the order involved. (3) Final agency action Confirmation, modification, or termination by the Administrator under paragraph (2) shall be considered a final agency action for purposes of section 702 of title 5, United States Code.
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(4) Termination The order shall be considered to be terminated if, after 5 days, the Administrator has failed— (A) to provide an opportunity for an informal hearing; or (B) to confirm, modify, or terminate the order. (5) Effect of instituting court action If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 332 ) or section 304(a) of that Act ( 21 U.S.C. 334(a) ), the process for the appeal of the detention order shall terminate.
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(c) Condemnation of food (1) In general After confirming a detention order, the Administrator may order the food condemned. (2) Destruction of food Any food condemned shall be destroyed under the supervision of the Administrator. (3) Release of food If the Administrator determines that, through reprocessing, relabeling, or other action, a detained food can be brought into compliance with this Act, the food may be released following a determination by the Administrator that the relabeling or other action as specified by the Administrator has been performed.
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(d) Temporary holds at ports of entry (1) In general If an officer or qualified employee of the Administration has reason to believe that a food is unsafe for human consumption, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, and the officer or qualified employee is unable to inspect, examine, or investigate the food when the food is offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Homeland Security to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours,
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to enable the Administrator to inspect or investigate the food as appropriate. (2) Removal to secure facility The Administrator shall work in coordination with the Secretary of Homeland Security to remove a food held in accordance with paragraph (1) to a secure facility as appropriate. (3) Prohibition on transfer During the period in which the food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.
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(4) Delivery in accordance with a bond The delivery of the food in accordance with the execution of a bond while the food is held is not authorized. 403.
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Notification and recall (a) Notice to Administrator of violation (1) In general A person (other than a household consumer or other individual who is the intended consumer of a food) 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 Administrator of the identity and location of the food. (2) Manner of notification Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.
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(b) Recall and consumer notification (1) Voluntary actions If the Administrator 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 and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Administrator, the Administrator shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity to— (A) cease distribution of the food;
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(B) notify all persons— (i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or (ii) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food; (C) recall the food; (D) in conjunction with the Administrator, provide notice of the finding of the Administrator— (i) to consumers to whom the food was, or may have been, distributed; and (ii) to State and local public health officials; or (E) take any combination of the measures described in this paragraph,
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as determined by the Administrator to be appropriate in the circumstances. (2) Mandatory actions 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 Administrator, the Administrator shall— (A) have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator— (i) at the expense of the food establishment; or (ii) in an emergency (as determined by the Administrator), at the expense of the Administration; and (B) by order, require,
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as the Administrator determines to be necessary, the person to immediately— (i) cease distribution of the food; and (ii) notify all persons— (I) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or (II) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
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(3) Notification to consumers by Administrator The Administrator shall, as the Administrator determines to be necessary, provide notice of the finding of the Administrator under paragraph (1)— (A) to consumers to whom the food was, or may have been, distributed; and (B) to State and local public health officials. (4) Nondistribution by notified persons 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.
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(5) Availability of records to Administrator Each person referred to in paragraph (1) that processed, distributed, or otherwise handled food shall make available to the Administrator information necessary to carry out this subsection, as determined by the Administrator, regarding— (A) persons that processed, distributed, or otherwise handled the food; and (B) persons to which the food has been transported, sold, distributed, or otherwise handled.
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(c) Informal hearings on orders (1) In general The Administrator shall provide any person subject to an order under subsection (b) 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. (2) Scope of the hearing In a hearing under paragraph (1), the Administrator 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. (d) Post-Hearing recall orders (1) Amendment of order If,
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after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that there is a reasonable probability that the food that is the subject of an order under subsection (b), if consumed, would present a threat to the public health, the Administrator, as the Administrator determines to be necessary, may— (A) amend the order to require recall of the food or other appropriate action; (B) specify a timetable in which the recall shall occur; (C) require periodic reports to the Administrator describing the progress of the recall; and (D) provide notice of the recall to consumers to whom the food was,
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or may have been, distributed. (2) Vacation of orders If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the order, the Administrator shall vacate the order. (e) Remedies not exclusive The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available. 404.
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Injunction proceedings (a) Jurisdiction The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 207, or 401 (or a regulation promulgated under that section). (b) Trial In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury. 405.
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Civil and criminal penalties (a) Civil sanctions (1) Civil penalty (A) In general 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 Administrator of not more than $10,000 for each such act. (B) Separate offense Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
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(2) Other requirements (A) Written order The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.
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(B) Amount of penalty Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering— (i) the gravity of the violation; (ii) the degree of culpability of the person; (iii) the size and type of the business of the person; and (iv) any history of prior offenses by the person under the food safety law. (C) Review of order The order may be reviewed only in accordance with subsection (c).
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(b) Criminal sanctions (1) In general Except as provided in paragraphs (2) and (3), a person that knowingly produces or introduces into commerce food that is unsafe for human consumption or otherwise adulterated or misbranded shall be imprisoned for not more than 1 year or fined not more than $10,000, or both.
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(2) Severe violations A person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 3 years or fined not more than $100,000, or both. (3) Exception No person shall be subject to the penalties of this subsection— (A) for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith,
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unless that person refuses to furnish (on request of an officer or employee designated by the Administrator)— (i) the name, address and contact information of the person from whom that person purchased or received the food; (ii) copies of all documents relating to the person from whom that person purchased or received the food; and (iii) copies of all documents pertaining to the delivery of the food to that person; or (B) if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food,
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stating that the food is not adulterated or misbranded within the meaning of this Act.
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(c) Judicial review (1) In general An order assessing a civil penalty under subsection (a) shall be a final order unless the person— (A) 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 (B) simultaneously serves a copy of the petition by certified mail to the Administrator.
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(2) Filing of record Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued. (3) Standard of review The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
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(d) Collection actions for failure To pay (1) In general If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator 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.
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(2) Limitation on review In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.
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(e) Penalties paid into account The Administrator— (1) shall deposit penalties collected under this section in an account in the Treasury; and (2) may use the funds in the account, without further appropriation or fiscal year limitation— (A) to carry out enforcement activities under food safety law; or (B) to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
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(f) Discretion of the Administrator to prosecute Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section. (g) Remedies not exclusive The remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available. 406.
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Presumption 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. 407. Whistleblower protection (a) In general No employee or inspector of a food establishment or other person may be harassed, prosecuted, held liable, or discriminated against in any way because that person— (1) has commenced, caused to be commenced, or is about to commence a proceeding, has testified or is about to testify at a proceeding, or has assisted or participated or is about to assist or participate in any manner in a proceeding or other action,
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to carry out the objectives, functions, or responsibilities specified in the food safety law; or (2) is refusing to violate or assist in the violation of a law described in paragraph (1), including a regulation issued under that law. (b) Procedures (1) In general A person alleging a violation of subsection (a) may file a complaint in accordance with section 31105(b) of title 49, United States Code.
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(2) Administration Except as provided in paragraphs (3) and (4), the process, procedures, and remedies under subsections (b), (c), and (d) of section 31105 of title 49, United States Code, with respect to allegations of violations of subsection (a) of that section shall be the process, procedures, and remedies that apply with respect to allegations of violations of subsection (a).
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(3) Alternative process The person filing a complaint under paragraph (1) may elect to use an alternative dispute resolution procedure, including mediation or arbitration, in lieu of the hearing described in section 31105(b) of title 49, United States Code. (4) Administrator The powers and duties that apply to the Secretary of Labor under section 31105 of title 49, United States Code, shall apply to the Administrator under the food safety law.
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(c) Burdens of proof The legal burdens of proof with respect to a violation of subsection (a) shall be governed by the applicable provisions of sections 1214 and 1221 of title 5, United States Code. 408. Administration and enforcement (a) In general 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.
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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 Administrator 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.
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(b) Inquiries and actions (1) In general The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States. (2) Powers 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 chapter by any United States district court of competent jurisdiction. 409.
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Citizen civil actions (a) Civil actions A person may commence a civil action against— (1) a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or (2) the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.
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(b) Court (1) In general 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. (2) Jurisdiction The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.
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(3) Damages The court may— (A) award damages, in the amount of damages actually sustained; and (B) if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties. (c) Remedies not exclusive The remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available. 501. Definition For purposes of this title, the term transition period means the 12-month period beginning on the effective date of this Act.