743. (h) > Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls. (2) by striking "2003 through 2006" and inserting "2011 through 2015". (4) Duration of awards.--The Secretary may award grants under this subsection for a period of not more than 2 years. "(6) Withdrawal of accreditation.-- "(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the [Page 124 STAT. "(A) In general.--In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection. Preventive Controls for Human Food (Part 117) - This requires processors of human food to develop risk-based systems focused on food safety through prevention. "(h) Annual Report Regarding Food.--Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding-- Sec. 350c) and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations). (6) is integrated with relevant laboratory networks administered by other Federal agencies. (F) the United States Warehouse Act (7 U.S.C. Accreditation of third-party auditors.Sec. Sec. (i) immediately investigating animal disease outbreaks and suspected food contamination; (A) striking "conducts business and" and inserting "conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and"; and "(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications. (4) by inserting at the end the following: (1) In general.--The Secretary, in coordination with the Secretary of Agriculture and multiple representatives of State departments of health and agriculture, shall assess-- Sec. "(C) > determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food. "(D) A food allergen control program. "(f) Verification.--The owner, operator, or agent in charge of a facility shall verify that-- "(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement; "(B) ensure timely and coordinated communication from the Department, including public statements, throughout the duration of the investigation and related foodborne illness outbreak; 3961] list of all accredited third-party auditors accredited by such body and the audit agents of such auditors. SEC. (c) Plan.--The plan developed under subsection (a) shall include, as appropriate, the following: (5) responds to food-related emergencies; and (K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs. (E) be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens, and not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business; (F) minimize the number of different recordkeeping requirements for facilities that handle more than 1 type of food; "(i) the consumer of the food; or (3) the projected costs of compliance with such post harvest processing measures; "(2) Rights of employees.--Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. > --Not later than 180 days after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. "(5) training in administrative process and procedure and integrity issues; "(1) In general.--This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility: (c) Conforming Technical Amendment.--Section 801(b) (21 U.S.C. > The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 21, Code of Federal Regulations (or any successor regulations). (3) provides accessible, timely, accurate, and consistent food laboratory services throughout the United States; "(ii) Provision of certification.--Only an accredited third-party auditor or the Secretary may provide a facility certification under section 806(a). Laboratory accreditation for analyses of foods. "(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. "(i) if food certified under section 801(q) or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals; Text for S.510 - 111th Congress (2009-2010): FDA Food Safety Modernization Act 307. 305. Voluntary qualified importer program.Sec. (c) > Advisory Committee Consultation.--In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services. Sec. (11) Supplement, not supplant.--Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection. (1) Report.--Not later than 1 year after the effective date of the final rule promulgated under subsection (d)(1), the Comptroller General of the United States shall submit to Congress a report, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of limiting-- (A) In general. (B) the sale and distribution of such food through a community supported agriculture program; and FSMA consists of 7 sets of rules that apply to different sectors of the food system. "(A) In general.--A grant under this section shall have a term that is not more than 3 years. > --Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year. "(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; > --Not later than 1 year after the date of enactment of this Act, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health. 451 et seq. "(E) conclude operations at such time as the Secretary determines appropriate. Record Keeping Requirements. 350d) is amended-- However, this page will focus on one which is of particular is of interest to Rhode Island producers because of their potential impact on current farm operations. "(B) the term `analogue of an anabolic steroid' means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.". "(7) Regulatory audit.--The term `regulatory audit' means an audit of an eligible entity-- > --The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants. "; Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means. (c) Rule of Construction.--Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 of the Federal Alcohol Administration Act (27 U.S.C. 305. 103. (A) Preparedness goal.--Enhance the preparedness of the agriculture and food system by-- "(6) No preemption.--Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production of food. 381 et seq. You’ve been preparing your operations to meet the FSMA requirements, rather than waiting for them to come full scale. "(B) Audit agents.--An audit agent shall-- (2) alter the jurisdiction between the Alcohol and Tobacco Tax and Trade Bureau and the Secretary of Health and Human Services, under applicable statutes and regulations; "(4) Activities.--Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments. 206. "(ii) a description of the risk associated with such article; and 391 et seq. "(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined. "(C) Penalty.--If such an order is issued under this paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys' and expert witness fees) reasonably incurred, as determined by the Secretary, by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued. "(A) to determine whether such entity is in compliance with the provisions of this Act and with applicable industry standards and practices; and (A) the identity of each article of food that was the subject of a public health advisory described in paragraph (1), an opportunity to cease distribution and recall under subsection (a) of section 423 of the Federal Food, Drug, and Cosmetic Act, or a mandatory recall order under subsection (b) of such section; "(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. "(ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors; and "(B) Types of audits.--An accredited third-party auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities. "(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor; (d) Additional Recordkeeping Requirements for High Risk Foods.-- "(B) Relief.--The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including-- The Food Safety Modernization Act (FSMA) is the most sweeping reform of food safety laws in more than 70 years. "(3) Withdrawal; rule of construction.-- "(C) > Limited annual monetary value of sales.-- [111th Congress Public Law 353] "(2) Final regulation.--The final regulation shall-- > --The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective-- "(bb) not more than 275 miles from such facility; and "(C) Revocation of recognition as an accreditation body.--The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section. 115. "(A) prepare the critical information described under subsection (f) for a reportable food as a standardized one-page summary; (4) recommending methods by which to protect the economy and the public health of the United States from the effects of-- (v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and, (vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food. (5) Consistency with existing plans.--The strategy described in paragraph (1) shall be consistent with-- of this Act.". (J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents. Foods described in the preceding sentence shall be subject solely to the recordkeeping requirements under section 414 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. ); "(1) In general.--The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), including the grant program under this section. "(ww) The failure to comply with section 420.". 1031 et seq. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. > --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. > --If a grocery store sold a reportable food that is the subject of the posting and such establishment is part of chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours after a one page summary described in subsection (g) is published, prominently display such summary or the information from such summary via at least one of the methods identified under paragraph (2) and maintain the display for 14 days. > --To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after the date of enactment of this Act--(A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; and "(6) training in appropriate sampling and laboratory analysis methodology; and Enhancing food safety.Sec. "(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; and SEC. "(A) In general.--The Secretary shall withdraw Accreditation from an accredited third-party auditor-- 417). (D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary. (ii) conducting surveillance to prevent the spread of diseases. "(A) owners and operators of farms; 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. 808. (2) Content.--The report described under paragraph (1)(B) shall-- > --In this section, the term `eligible entity' means an entity-- "(A) that is-- "(1) In general.--If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. "(1) In general. 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