fsma full text

307. "(iii) the scope of the audit; and Such regulations shall-- (i) the children are capable of self-administering medication; and 350c) and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods. (d) Waiver.--The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference. "(1) In general. "(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 801(h)(1). (i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food; (ii) Limitation. The Secretary shall ensure that the pilot projects under paragraph (1) reflect the diversity of the food supply and include at least 3 different types of foods that have been the subject of significant outbreaks during the 5-year period preceding the date of enactment of this Act, and are selected in order to-- (A) relate only to information that is reasonably available and appropriate; Produce Safety Rule. "(a) In General. (f) Farms.-- "(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases; Such study shall include an evaluation of the costs associated with development and implementation [Page 124 STAT. GRANTS TO ENHANCE FOOD SAFETY. (IV) any other activities that the Secretary determines appropriate; > --The Secretary shall establish offices of the Food and Drug Administration in foreign countries selected by the Secretary, to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by 302. "(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory. "(3) Biennial registration renewal. (I) contaminated agriculture and food products; and Mandatory recall authority.Sec. "(c) Effect of Section.-- (II) the term "commingled raw agricultural commodity" shall not include types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that standards promulgated under section 419 of the Federal Food, Drug, and Cosmetic Act (as added by section 105) would minimize the risk of serious adverse health consequences or death; and "(ii) Direct accreditation.--If, by the date that is 2 years after the date of establishment of the system described in clause (i), the Secretary has not identified and recognized an accreditation body to meet the requirements of this section, the Secretary may directly accredit third-party auditors. SEC. 381) is amended by adding at the end the following new subsection: The .gov means it’s official.Federal government websites often end in .gov or .mil. "SEC. 306. "(A) Recognition of accreditation bodies.-- Determination of budgetary effects. FSMA Full Text (Official) Liên hệ ; Địa chỉ: Tòa nhà IBC, số 01A - Công trường Mê Linh, Bến Nghé, quận 1, Tp. 241 et seq. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period. "(3) Exception. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. "(B) in determining the applied research agenda for the National Integrated Food Safety Initiative, take into consideration the needs articulated by participants in projects funded by the program under this section. > --In making a request under paragraph (1), the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, shall issue a written notice to the owner, operator, or agent of the farm to which the article of food has been traced. (a) Grants To Enhance Food Safety.--Section 1009 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(e) Limitation.--Subsection (a) shall not apply with respect to an employee of an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or such entity's agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, rule, regulation, standard, or ban under this Act.". "(B) a description of the types of activities to be funded by the grant; (1) In general.--The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security-- "(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate. (i) Unique Identification Numbers.-- (1) Section 301(d) (21 U.S.C. IMPROVING THE REPORTABLE FOOD REGISTRY. (II) identifying any food to which the child is allergic; 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;". (1) by redesignating subsection (c) as subsection (d); and "(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act. 333(f)(2)(A)) is amended by inserting "or any person who does not comply with a recall order under section 423" after "section 402(a)(2)(B)". Authority to require import certifications for food.Sec. "(b) Guidance.--Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs. or any other statute, including any authority related to securing the borders of the United States, managing ports of entry, or agricultural import and entry inspection activities. (a) Improving Training.--Chapter X (21 U.S.C. "(1) undertake examinations, inspections, and investigations, and related food safety activities under section 702; The following Banking & Finance practice note provides comprehensive and up to date legal information covering: For information, see the full text of the FSMA 2000. Sec. ); "(2) Action by grocery store.--A notification described under paragraph (1)(B) shall include the date and time such summary was posted on the Internet website of the Food and Drug Administration. "(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.". The Secretary may promulgate such regulations on an interim final basis. "(A) the term `reinspection' means-- "(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that is located-- (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. "(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and 1232g). "(3) Multiple recalls.--The Secretary may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks necessitating such action by the Department of Health and Human Services.". (I) integrating foodborne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration Center; and The contract or memorandum shall contain provisions regarding reimbursement. (b) Foodborne Illness Surveillance Systems.-- "(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. (D) augmenting such systems to improve attribution of a foodborne illness outbreak to a specific food; "(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. (a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. ), as amended by section 202, is amended by adding at the end the following: "SEC. "(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement; Inspection of foreign food facilities. "(B) the responsible party for a domestic facility (as defined in section 415(b)) and an importer who does not comply with a recall order under section 423 or under section 412(f) in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year; The model standards shall include-- "(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 (2) Biennial reports.--On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that-- > --Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations-- To view the latest version of this document and thousands of others like it, sign-in to LexisPSL or register for a free trial. FSMA regulations explicitly recognize the food safety role of the food industry while giving regulatory authority to the Food and Drug Administration (FDA). Navigate the law quickly and efficiently with Lexis. SEC. "(e) Authorization of Appropriations.--There is authorized to be appropriated such sums as may be necessary to carry out this section. > --Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program's Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations), where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include-- "(b) Partnerships With State and Local Officials.-- "(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. 3969] committed a violation of subsection (a) of the Secretary's findings. Improving the training of State, local, territorial, and tribal food safety officials.Sec. "(i) the consumer of the food; or "(g) Supplement Not Supplant.--Grant funds received under this section 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 section. "(7) No delegation.--The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.". "(c) Criteria.-- "(D) Reinstatement. (b) Suspension of Registration.-- "(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant. Such exercises shall be carried out, to the maximum extent practicable, as part of the national exercise program under section 648(b)(1) of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. "(A) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with-- (1) In general.--To carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities of the Office of Regulatory Affairs of the Food and Drug Administration, the Secretary of Health and Human Services shall increase the field staff of such Centers and Office with a goal of not fewer than-- (ii) preventing additional human illnesses; "SEC. "(ii) such condition. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply. is amended by adding at the end the following: 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.". FSMA consists of 7 sets of rules that apply to different sectors of the food system. "(3) Increasing the number of qualified laboratories.--The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph (b) beyond the number so qualified on the date of enactment of the FDA Food Safety Modernization Act. 7801). 334(h)(1)(A)) is amended by-- (1) In general. … 331(e)) is amended by striking "417(g)" and inserting "417(j)". Sanitary transportation of food. 305. 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. (C) was adulterated as described in subparagraph (A) on a particular farm (as defined in section 1.227 of chapter 21, Code of Federal Regulations (or any successor regulation)). "(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration. (c) Improving Food Safety and Defense Capacity at the State and Local Level.-- (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 (c) Public Notification.--If the Secretary-- 405. "(i) In general.--A facility is a qualified facility under this subparagraph if clause (ii) applies-- "(A) amend the order to require recall of such article or other appropriate action; Sec. 6333(c)). 207. > --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. "(7) Reaccreditation. (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-- (L) not require-- "(6) False statements.--Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title 18, United States Code. (D) 5,000 staff members in fiscal year 2014. > --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 "(H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements. (E) Exemption of other foods.--The Secretary may, by notice in the Federal Register, modify the requirements under this subsection with respect to, or exempt a food or a type of facility from, the requirements of this subsection (other than the requirements under subparagraph (F), if applicable) if the Secretary determines that product tracing requirements for such food (such as bulk or commingled ingredients that are intended to be processed to destroy pathogens) or type of facility is not necessary to protect the public health. 303. The filing of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. (5) Recommendations on whether and how to harmonize requirements under the Codex Alimentarius. "(B) Records.--Following any accreditation of a third-party auditor, the Secretary may, at any time, require the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent of such auditor. "(2) Investigation.-- "(h) Limitations.-- "(D) Bad faith claim.--If the Secretary finds that a complaint under paragraph (1) is frivolous or has been brought in bad faith, the Secretary may award to the prevailing employer a reasonable attorneys' fee, not exceeding $1,000, to be paid by the complainant. "(ii) Waiver.--The Secretary may waive the application of clause (i) if the Secretary determines that there is insufficient access to accredited third-party auditors in a country or region. (1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and 155 (2009): (1) provides ongoing surveillance, rapid detection, and surge capacity for large-scale food-related emergencies, including intentional adulteration of the food supply; "(C) Consumer.--For purposes of subparagraph (B), the term `consumer' does not include a business. 418. Sec. (d) Voluntary Nature of Guidelines.-- "(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 "(6) Application date. > --The Secretary shall establish procedures to reinstate the accreditation of a third-party auditor for which accreditation has been withdrawn under paragraph (6)-- (7) Priority.--In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 1124(c) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 17. "(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards). > TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN Foreign offices of the Food and Drug Administration.Sec. "(d) Crediting and Availability of Fees.--Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. (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; > Not later than 30 days after the date of notification of findings under this paragraph, the person alleged to have committed the violation or the complainant may file objections to the findings or preliminary order, or both, and request a hearing on the record. 306. "(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; 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: "(i) In general. (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; (G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available. (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. (5) Consistency with existing plans.--The strategy described in paragraph (1) shall be consistent with-- "(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. In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested. "(B) Award.--The court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys' and expert witness fees) to any party whenever the court determines such award is appropriate. (D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary. 106. (a) In General.--Chapter IV (21 U.S.C. "(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary inspected in the previous fiscal year; (B) food contamination; and (a) In General.--Chapter IV (21 U.S.C. "(C) Limitations.-- (e) Evaluation and Recommendations.-- "(1) In general.--To assist in carrying out the requirements of this subsection, the Secretary shall establish an incident command operation or a similar operation within the Department of Health and Human Services that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals. (b) Guidance Documents and Regulations.--Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. "(f) Additional Exemptions. (1) In general.--The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b). (B) the feasibility of such technologies for different sectors of the food industry, including small businesses; and (a) In General.--The Administrator of the Environmental Protection Agency (referred to in this section as the "Administrator"), in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency. 743. > --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. 1012. Inspection of foreign food facilities.Sec. (1) to small businesses (as defined by the Secretary in section 103, not later than 90 days after the date of enactment of this Act) beginning on the date that is 1 year after the effective date of the final regulations promulgated under subsection (d); and "(d) No Limit on Secretarial Authority.--Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.". Through FSMA, the U.S. "(c) Regulations.-- > --The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, [Page 124 STAT. 07:32:23 RA Proof 6.6.2000 ii c. 8 Financial Services and Markets authority ( FSMA ) 125-149... 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