"(i) Voluntary qualified importer program.--In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(c) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year. "(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction; "(1) scientific training; (2) the projected public health benefits of any proposed post harvest processing; 3961] list of all accredited third-party auditors accredited by such body and the audit agents of such auditors. 111. 109. > --Not later than 120 days after the date of conclusion of any hearing under paragraph (2), the Secretary shall issue a final order providing the relief prescribed by this paragraph or denying the complaint. "(1) providing resources, including timely information concerning symptoms and tests, for frontline health professionals interviewing individuals as part of routine surveillance and outbreak investigations; 214), from the requirements of this Act (including the amendments made by this Act). "(2) Collection of unpaid fees. "(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. "(G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and 331(e)) is amended by striking "417(g)" and inserting "417(j)". 204. (d) Voluntary Nature of Guidelines.-- (b) References.--Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. (B) the Poultry Products Inspection Act (21 U.S.C. 341 et seq. 601 et seq. "(A) Recognition of accreditation bodies.-- 18. "(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and (e) Evaluation and Recommendations.-- INSPECTION OF FOREIGN FOOD FACILITIES. "(2) Contents.--Each application submitted under paragraph (1) shall include-- "(1) In general. 451 et seq. The commencement of proceedings under this subparagraph shall not, unless ordered by the court, operate as a stay of the order. 808. "(n) Regulations.-- (J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents. > --Not later than year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall-- (F) Recordkeeping regarding previous sources and subsequent recipients.--In the case of a person or food to which a limitation or exemption under subparagraph (C), (D), or (E) applies, if such person, or a person who [Page 124 STAT. "(d) Coordination.--The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources. "(D) other such prominent and conspicuous locations and manners utilized by grocery stores as of the date of the enactment of the FDA Food Safety Modernization Act to provide notice of such recalls to consumers as considered appropriate by the Secretary.". (B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2). > --Not more than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification required in paragraph (1). "(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities. > The Secretary of Agriculture shall submit to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate a report that describes the results of the study, including any recommendations. (C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock. (a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. 381(m)(1)) is amended by inserting "any country to which the article has been refused entry;" after "the country from which the article is shipped;". (b) References.--Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. "(A) In general.--The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine-- "(iv) Relief standard.--Relief may not be ordered under subparagraph (A) if the employer demonstrates by clear and convincing evidence that the employer would have taken the same unfavorable personnel action in the absence of that behavior. Produce Safety Rule – Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. "(1) In general.--Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). 350f(k)) describing the smuggled food and, if available, the names of the individuals or entities that attempted to import such food into the United States. Surveillance.Sec. ---------------------------------------------------------------------------. REGISTRATION OF FOOD FACILITIES. 404. 3929] results for the purpose of determining the need for a national recall or other compliance and enforcement activities. "(b) Regulations. (e) Modifications.--Based on the exercises described in subsection fsma info n°58 voeux 2020 contacts fsma tour en region cmf polyphonics etat des lieux rapport moral de l’ag 2019 aide au projet. 381 et seq. The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled "Budgetary Effects of PAYGO Legislation" for this Act, submitted for printing in the [Page 124 STAT. (B) consider international efforts, including an assessment of whether product tracing requirements developed under this section are compatible with global tracing systems, as appropriate; and "(2) Accreditation body.--The term `accreditation body' means an authority that performs accreditation of third-party auditors. (C) by inserting after subsection (a) the following: 3941] on the actions required by the order and on why the article that is the subject of the order should not be recalled. 301 et seq.) Mandatory recall authority.Sec. "(A) owners and operators of farms; Sec. The FSMA's status is that of an autonomous public institution. "(B) to define, for purposes of this section, the terms `small business' and `very small business', taking into consideration the study described in subsection (l)(5). (d) Rule of Construction.--Nothing in this section shall be construed to affect the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103- "(1) In general.--The Secretary shall-- "(B) hazards that occur naturally, or may be unintentionally introduced; and (A) prevent unauthorized reproduction of trade secret or confidential information; "(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and "(5) Conflicts of interest.-- "(d) Eligibility.--Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). "(2) The compliance history of foreign suppliers used by the importer, as appropriate. "(3) Additional centers of excellence.--The Secretary may designate eligible entities to be regional Food Safety Centers of Excellence, in addition to the 5 Centers designated under subsection (a). > --If the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States with jurisdiction, which shall have jurisdiction over such an action without regard to the amount in controversy, and which action shall, at the request of either party to such action, be tried by the court with a jury. "(i) with respect to domestic facilities (as defined in section 415(b)), 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary's satisfaction; and "(h) Exception for Activities of Facilities Subject to Section 418.--This section shall not apply to activities of a facility that are subject to section 418.". (B) food contamination; and Sec. > --The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions. 419. > --The Secretary shall, not later than 180 days after the date of enactment of this Act, update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary. (I) Sale of a food.--A sale of a food described in this subparagraph is a sale of a food in which-- 109. "(3) develop a written analysis of the hazards. Administrative detention of food. (b) Increased Number of Field Staff.-- Produce Safety Rule. > --Not later than 180 days after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, including food retailers and food manufacturers, consumer organizations, and academia to make recommendations to the Secretary regarding designations of the Centers of Excellence. 3935] manufactures, processes, packs, or holds such food, is required to register with the Secretary under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. or the Public Health Service Act (42 U.S.C. (2) Content.--The Secretary shall conduct 1 or more pilot projects under paragraph (1) in coordination with the processed food sector and 1 or more such pilot projects in coordination with processors or distributors of fruits and vegetables that are raw agricultural commodities. > --Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations-- > --The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. 3889] under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section. "(3) Application.--The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person [Page 124 STAT. (A) the amendments made by this section shall apply to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this section)) beginning on the [Page 124 STAT. (a) Updating of Food Category Regulations; Biennial Registration Renewal.--Section 415(a) (21 U.S.C. "(A) In general.--Unless the complainant brings an action under paragraph (4), any person adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review of the order in the United States Court of Appeals for the circuit in which the violation, with respect to which the order was issued, allegedly occurred or the circuit in which the complainant resided on the [Page 124 STAT. "(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods. "(2) Program requirements.--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 1 or more sampling and analytical testing methodologies for food. (A) in subsection (a)(2), by inserting after the first sentence the following: "The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act. Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(3) Considerations.--In promulgating regulations under this subsection, the Secretary shall, as appropriate, take into account differences among importers and types of imported foods, including based on the level of risk posed by the imported food. "(4) Definitions.-- ); For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the Secretary and the foreign factory, warehouse, or other establishment.". "(iii) to provide compensatory damages to the complainant. 302. 201 et seq.) (1) Proposed rulemaking.-- "(A) to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program; and "(E) such other appropriate entity, as determined by the Secretary. Act'), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the facility, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations; "(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation. "(8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources. (2) Exception.--Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c). > --In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code. "(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies; (A) In general.--To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require. "(4) Prioritization.--The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities [Page 124 STAT. (6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and "SEC. (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or "(i) Public Availability of Annual Food Reports. We may terminate this trial at any time or decide not to give a trial, for any reason. "(1) The known safety risks of the food imported. "(B) Content of order.--If, in response to a complaint filed under paragraph (1), the Secretary determines that a violation of subsection (a) has occurred, the Secretary shall order the person who committed such violation-- Electronic submission. -- the Secretary shall not apply to the guidance described In 103... Notice system under Section 702 programs and the Thermally processed Low-Acid Foods Packaged In Hermetically Sealed Containers standards 5. As whether a recall is ongoing or has been completed ) Addition of Certification requirement. -- the ``! Of resources up sources to Support your advice nothing In this Act ( 42.! ) Duration of awards. -- the term `` facility '' under such 805! Adjustment Act ( FSMA ) Book Chapter full text of the produce supply. 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