(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). > --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. (G) Grocery stores. > --If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. ", (a) Development and Submission of Strategy.-- (1) In general. The U.S. Food Safety Modernization Act (FSMA) is a significant and far reaching update of the laws and subsequent regulations that affect the safety of domestically produced and imported foods regulated by the Food and Drug Administration (FDA).  The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010. 743. 305. ), as amended by section 201, is amended by adding at the end the following: "SEC. "(i) In general.--An accredited third party auditor may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 13-month period. The act was signed into law by President Obama in 2011. Food Safety Modernization Act (FSMA) The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. 214), from the requirements of this Act (including the amendments made by this Act). 3961] list of all accredited third-party auditors accredited by such body and the audit agents of such auditors. 3939] achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and staffing needs. Prior notice of imported food shipments. "(2) provides legislative recommendations or describes additional resources required by the Centers of Excellence. (3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies. 421. 1012. Voluntary qualified importer program.Sec. (C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act, as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities. (b) Addition of Certification Requirement.--Section 801 (21 U.S.C. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. 9831 et seq. > ACCREDITATION OF THIRD-PARTY AUDITORS. "(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and 3954] consideration variances granted under section 419), as appropriate; and "(B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as described in this section. "(iv) any other information required by the Secretary that relates to or may influence an assessment of compliance with this Act. "(ii) whether a facility is eligible to receive a facility certification under section 806(a) for purposes of participating in the program under section 806. Dec. 21, House concurred in Senate Share. "(A) In general.--The Secretary shall withdraw Accreditation from an accredited third-party auditor-- (1) highest-risk biological, chemical, and radiological threat agents; The full text of the law found on this page is being provided as an additional service from the FDA. (a) In General.--Chapter IV (21 U.S.C. "(iii) the scope of the audit; and Nothing in this Act (or an amendment made by this Act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party. 331(d)) is amended by inserting "415," after "404,". 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. CONGRESSIONAL RECORD: 601 et seq. "(2) Factors to be considered in requiring certification.-- "(B) Vacating of order.--Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall promptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate.  This summer, the pilot projects results will be accomplished with hopes of developing a complete product tracing system with the information received. (e) Definition.--In this subsection, the term "smuggled food" means any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead. is amended by adding at the end the following: 405. > --The Secretary shall promulgate regulations not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act to implement this section and to ensure that there are protections against conflicts of interest between an accredited third-party auditor and the eligible entity to be certified by such auditor or audited by such audit agent. "(1) geographic diversity; and Hazard analysis and risk-based preventive controls. "(i) in support of admission of an article of food under section 801(a); and (2) Content.--The guidance documents issued under paragraph (1) shall-- "(4) Effect of suspension.--If the registration of a facility is suspended under this subsection, no person shall import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food from such famility into interstate or intrastate commerce in the United States. 3904] food in the normal course of business, or, in the case of Internet sales, in an electronic notice. > --Not later than 180 days after promulgation of a final rule under subsection (d), the Secretary shall issue a small entity compliance guide setting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the recordkeeping requirements under such subsection. SEC. SEC. "(1) In general.--The Secretary may require, as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity described in paragraph (3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with applicable requirements of this Act. 181 et seq. "(3) contact information for the responsible party as provided in subsection (e)(8); and (C) by inserting after subsection (a) the following: "(i) Requirement To Reanalyze. (3) Authorization of appropriations.--To carry out the activities described in paragraph (1), there is authorized to be appropriated $24,000,000 for each fiscal years 2011 through 2015. Decontamination and disposal standards and plans.Sec. "(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.". (B) to provide surge capacity during emergencies; and "(A) the date on which the Secretary issues regulations under paragraph (5); or  The amendment also applies to all operations that the FDA classified as a "very small business." > --Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act. "(C) a finding by the Secretary, supported by scientific, risk-based evidence, that-- "(2) Required additional information.-- "(1) In general.--The Secretary shall-- 381(a)) is amended by inserting "or (4) the recordkeeping requirements under section 204 of the FDA Food Safety Modernization Act (other than the requirements under subsection (f) of such section) have not been complied with regarding such article," in the third sentence before "then such article shall be refused admission". (G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period. (B) detect, track, and remove smuggled food (as defined in section 309) from commerce. The intent of the law is to ensure the US food supply is safe by focusing on the prevention of contamination, rather than on response to contamination. (D) ensure that the public health benefits of imposing additional recordkeeping requirements outweigh the cost of compliance with such requirements; "(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water; Systèmes de vision In-Sight® Caméras intelligentes de qualité industrielle, faciles à utiliser et dotées de la technologie de vision industrielle avancée. Therefore, it was necessary for the FDA to undertake comprehensive reforms in its approach to food safety through the Food Safety Modernization Act (FSMA; more than 50 regulations and guidelines). 350b) is amended-- (A) the term "community supported agriculture program" has the same meaning given the term "community supported agriculture (CSA) program" in section 249.2 of title 7, Code of Federal Regulations or any successor regulation); and  Attempts to add the bill to the continuing resolution for government funding were scrapped over the objection of Senator Tom Coburn. A recipient of a grant described in the preceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. (IV) any other activities that the Secretary determines appropriate; (f) > No Effect on HACCP Authorities.--Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(2) in bulk or batch form, prior to being packaged for the final consumer. > --The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. (ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results; "(b) Eligible Entities; Application.-- (i) immediately investigating animal disease outbreaks and suspected food contamination; "(E) Reliance on federal, state, or local inspections.--In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation. 306. 422. "(b) Establishment of Fees.-- (A) identifies State and local agencies with the authority to require the mandatory recall of food, and evaluates use of such authority with regard to frequency, effectiveness, and appropriateness, including consideration of any new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant authority to have been an error;  In addition, it is supplied to diverse food chain distribution channels which could be involved in imported and domestic products. "(d) Program Coordination.-- (G) at least annually, publishing current reports on findings from such systems; "(i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to receive a food certification under section 801(q); or "(I) is located-- "(4) Definitions.--In this subsection: "(c) Hearing on Order. (c) Table of Contents.--The table of contents for this Act is as follows: TITLE I--IMPROVING CAPACITY TO PREVEN… "(3) Content.--The regulations promulgated under paragraph (1)(A) shall-- 381 et seq. (1) In general. (2) Effect of review. The .gov means it’s official.Federal government websites often end in .gov or .mil. "(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; ), as amended by section 105, is amended by adding at the end the following: (B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and > --Facilities shall be subject to the requirements of this subsection beginning on the earlier of-- (b) Development of Standards.--In carrying out subsection (a), the Administrator, in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of Agriculture, and State, local, and tribal governments, shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases. ), as amended by section 105, is amended by adding at the end the following: Compliance with international agreements.Sec. 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