"(m) Authority With Respect to Certain Facilities.--The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment. (a) Grants To Enhance Food Safety.--Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(B) Domestic high-risk facilities. "(d) Recertification of Eligible Entities. 343(w)). 417). "(5) Conflicts of interest.-- "(a) Identification and Inspection of Facilities.-- "(ii) section 402 and section 403(w). 3943] Cosmetic Act and the status of such recall (such as whether a recall is ongoing or has been completed). or the Public Health Service Act (42 U.S.C. 331), as amended by section 103, is amended by adding at the end the following: "(vv) The failure to comply with the requirements under section 419.". (A) to optimize national laboratory preparedness; and 1011. "(A) a State cooperative extension service; > AUTHORITY TO COLLECT AND USE FEES. (C) inform the promulgation of regulations under subsection (d). "(2) Results of testing.--The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation exempt test results from such submission requirement if the Secretary determines that such results do not contribute to the protection of public health. "(1) > periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1); "(2) > periodically, or at least once every 4 years, evaluate the performance of each accredited third-party auditor, through the review of regulatory audit reports by such auditors, the compliance history as available of eligible entities certified by such auditors, and any other measures deemed necessary by the Secretary; Voluntary qualified importer program.Sec. 303. "(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or (b) Export Certification Fees for Foods and Animal Feed.-- (3) by striking the last sentence; and "(3) training to achieve advanced product or process specialization in such inspections; "(4) training that addresses best practices; (2) identify means by which laboratory network members could work cooperatively-- "(7) Civil action to require compliance.-- "(2) Interaction.--The Secretary shall-- "(e) Corrective Actions. 305. "(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; An official website of the United States government, : SANITARY TRANSPORTATION OF FOOD. The economic impact is explored as part of a build up to the passage of FSMA. "(a) Proposed Rulemaking.-- (C) Science-based risk analysis.--In promulgating regulations under subparagraph (A), the Secretary shall conduct a science-based risk analysis of-- The .gov means it’s official.Federal government websites often end in .gov or .mil. "(e) Guidance.--. FSMA regulations explicitly recognize the food safety role of the food industry while giving regulatory authority to the Food and Drug Administration (FDA). "(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; and "(h) Written Plan and Documentation.--The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Find out what is the full meaning of FSMA on Abbreviations.com! "(2) Public meetings.--The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities. "(3) Preventive controls.--The term `preventive controls' means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking. "(2) No effect on inspection authority.--Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this Act.". (6) Limitations.-- SEC. "(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. "(e) Facility. FSMA shifts the focus away from merely responding to contamination events toward establishing systems to prevent them from occurring. "(1) In general.--A farm shall be exempt from the requirements under this section in a calendar year if-- (B) outlines the success of those programs and practices; to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. June 9, considered and passed House. 1769f(b))); and Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. "(A) In general. (B) food contamination; and 1009. "(b) Establishment of Fees.-- Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law. (10) Progress and evaluations.--At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b). 381(b)) is amended in the second sentence by striking "with respect to an article included within the provision of the fourth sentence of subsection (a)" and inserting "with respect to an article described in subsection (a) relating to the requirements of sections 760 or 761,". "(2) Definitions.--For purposes of this subsection-- (ii) Limitation. 393) is amended by adding at the end the following: "(A) immediately cease distribution of such article; and Sec. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. "(C) Limitations.-- (1) striking "credible evidence or information indicating" and inserting "reason to believe"; and 5001 et seq.) "(b) Final Regulation.-- (c) Product Tracing System.--The Secretary, in consultation with the Secretary of Agriculture, shall, as appropriate, establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. 748(b)(1)). "(4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food. (c) > Clarification of Intent.-- "(2) Implementation.--The competitive grant program established under paragraph (1) shall be carried out in accordance with section 405 of the Agricultural Research, Extension, and Education Reform Act of 1998. (2) Report.--Not later than 15 months after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary. (i) activities that constitute on-farm packing or holding of food that is not grown, raised, or (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). (K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs. (2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and "(i) not less often than once in the 7-year period following the date of enactment of the FDA Food Safety Modernization Act; and (2) Inspection report.-- 381(e)(4)) is amended by inserting after subparagraph (B) the following new subparagraph: In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following: (5) Recommendations on whether and how to harmonize requirements under the Codex Alimentarius. "(2) is required to provide to the Secretary a certification under section 801(q) for any food from such entity. (1) Initial report.--The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. "(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w). "(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and "(B) Approval of variances.--The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons. "(5) Electronic submission.--The Secretary shall provide for the electronic submission of certifications under this subsection. "(1) Identification.--The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors: > --The Secretary, by notice published in the Federal Register, shall establish an exemption from the requirements of this section for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public. "(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments; Section 103 ( h ) > Rulemaking. -- '' ( 1 ) In general and remedies In this Section not. 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