The full text of the FSMA 2000 (Prospectus) Regulations 2019, SI 2013/1043 can be found here. "(b) Hazard Analysis.--The owner, operator, or agent in charge of a facility shall-- (a) In General. "(2) Fee methodology.-- "(a) In General.--No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee)-- (1) Retail food establishment.--The Secretary shall amend the definition of the term "retail food establishment" in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include-- 280g et seq.) Produce Safety Rule. Prior notice of imported food shipments.Sec. "(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). FSMA – Full Text of the Law "Am I Affected by the FSMA Produce Safety Rule?" "(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. SEC. "(e) Definition.--For purposes of this section, the term `farm' has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).". "(1) Purpose and authority.--For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from-- > LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and (B) the National Response Framework; "(3) training to achieve advanced product or process specialization in such inspections; "(4) training that addresses best practices; 3913] and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on-- FSMA regulations explicitly recognize the food safety role of the food industry while giving regulatory authority to the Food and Drug Administration (FDA). "(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year; > --Not later than 120 days after the date of enactment of this Act, the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section. "(e) Exemption of Seafood, Juice, and Low-acid Canned Food Facilities in Compliance With HACCP.--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: > --Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria. Inspections of records. "(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. Sec. (2) > Flexibility for small businesses.--Notwithstanding paragraph (1)-- Senate, amended. "(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by the Secretary; or 342) or to prevent the spread by food of communicable disease under section 361 of the Public Health Service Act (42 U.S.C. (4) Duration of awards.--The Secretary may award grants under this subsection for a period of not more than 2 years. "(l) Modified Requirements for Qualified Facilities.-- > --Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section. (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 (iii) the point in the manufacturing process of the food where contamination is most likely to occur; (g) Biennial Food Safety and Food Defense Research Plan.--The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. "(1) The known safety risks of the food imported. (c) Report.--Not later than October 1, 2011, the Secretary shall submit to Congress a report on the basis for the selection by the Secretary of the foreign countries in which the Secretary established offices, the progress which such offices have made with respect to assisting the governments of such countries in providing for the safety of articles of food and other products regulated by the Food and Drug Administration exported to the United States, and the plans of the Secretary for establishing additional foreign offices of the Food and Drug Administration, as appropriate. (C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) of such section are appropriate. (2) Final regulations.--Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to--. (3) shall not be written to be facility-specific. (2) to very small businesses (as defined by the Secretary in section 103, not later thn 90 days after the date of enactment of this Act) beginning on the date that is 2 years after the effective date of the final regulations promulgated under subsection (d). (d) Review.--The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section. > --At the time the Secretary promulgates the final rules under paragraph (1), the Secretary shall publish the list of the foods designated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. "(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 "(c) Notification.-- National agriculture and food defense strategy.Sec. > --Not later than 90 days after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that-- Review shall conform to chapter 7 of title 5, United States Code. "(B) Registration requirement.--The Secretary may require that registration under this section be submitted in an electronic format. (C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies. 2751: "(f) No Duplication of Effort.--In carrying out activities of the Centers of Excellence or other programs under this section, the Secretary shall not duplicate other Federal foodborne illness response efforts.". (e) Automated Risk Assessment.--The report developed under subsection (a)(1) shall include a description of progress toward [Page 124 STAT. (C) Emergency response goal.--Ensure an efficient response to agriculture and food emergencies by-- (4) Public input.--During the comment period in the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment. "(3) contact information for the responsible party as provided in subsection (e)(8); and (ii) such administration is not prohibited by State law. Sec. (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. 1621 et seq. 1232g). "(d) Record Maintenance and Access. 401. **Trials are provided to all LexisPSL and LexisLibrary content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. "(1) Amendment of order.--If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate-- "(C) > determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food. (K) take into account international trade obligations; "(B) any other criteria determined appropriate by the Secretary. (F) until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel. (4) Limitation.--A request made under paragraph (1) shall not include a request for information relating to the finances, pricing of commodities produced, personnel, research, sales (other than information relating to shipping), or other disclosures that may reveal trade secrets or confidential information from the farm to which the article of food has been traced, other than information necessary to identify potential immediate recipients of such food. "(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-- 309. "(B) Notification.--Each accreditation body recognized by the Secretary shall submit to the Secretary a [Page 124 STAT. "(7) Whether the food or the facility that manufactured, processed, packed, or held such food received a certification as described in section 801(q) or 806. Sec. The members of the FSMA's governing bodies are appointed by Royal Decree for a period of six years. Such information may consist of records kept in the normal course of business, and may be in electronic or non-electronic format. (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. (C) secondary schools. "(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). "(B) small food processors; and "(D) A food allergen control program. Sec. (4) Secretary.--The term "Secretary" means the Secretary of Health and Human Services. (a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry.--Chapter IV (21 U.S.C. "(6) Limitation of effect.--Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this Act. (H) allow any person subject to this subsection to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and (i) Unique Identification Numbers.-- US FSMA TABLE OF CONTENTS TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS. "(5) Review.--In promulgating the regulations under paragraph (1)(A), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date of enactment of the FDA Food Safety Modernization Act, including the Grade `A' Pasteurized Milk Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date. 103. (2) reasonably believes exposure to the food would cause serious adverse health consequences or death to humans or animals; and "(ii) such condition. (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415. "(b) Integrated Approach.--The grant program described under subsection (a) shall be carried out under this section in a manner that facilitates the integration of food safety standards and guidance with the variety of agricultural production systems, encompassing conventional, sustainable, organic, and conservation and environmental practices. "(2) Required additional information.-- (ii) mitigating vulnerabilities of the system; "(A) a State cooperative extension service; "(i) Best Practices and Model Programs.--Based on evaluations of, and responses arising from, projects funded under this section, the Secretary may issue a set of recommended best practices and models for food safety training programs for agricultural producers, small food processors, and small fresh fruit and vegetable merchant wholesalers. "(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. (B) facilitating sharing of surveillance information on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, and State and local agencies, and with the public; (C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases; "(A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and If a hearing is not requested in such 30-day period, the preliminary order shall be deemed a final order that is not subject to judicial review. (b) Export Certification Fees for Foods and Animal Feed.-- (j) Enforcement.-- "(C) each importer participating in the voluntary qualified importer program under section 806 in such year, to cover the administrative costs of such program for such year; and "(iii) > annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest. "(B) as applicable, immediately notify all persons-- (A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions; > --The Secretary may waive requirements under this subsection if--"(A) a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and "(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 801(h)(1). > --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. "(3) > if available, publish on the Internet Web site of the Food and Drug Administration an image of the article that is the subject of the press release described in (1). (II) State, local, and tribal governments; and "(B) the use of such methodology or methodologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. 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". "(3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases; … An official website of the United States government, : "(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) or 806, as appropriate. "(d) Eligibility.--Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). "(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a); (I) the Federal Government; and REGISTRATION OF FOOD FACILITIES. "(C) small fruit and vegetable merchant wholesalers. "(B) Additional basis for withdrawal of accreditation.--The Secretary may withdraw accreditation from an accredited third-party auditor in the case that such third-party auditor is accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines that there is good cause for the withdrawal. "(A) In general.--The Secretary shall withdraw Accreditation from an accredited third-party auditor-- > --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. "(C) Denial of variances.--The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection (b). (III) describing, if appropriate, any prior history of anaphylaxis; (B) Applicability of ferpa.--Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 444 of the General Education Provisions Act (commonly referred to as the "Family Educational Rights and Privacy Act of 1974") (20 U.S.C. 102. "(D) Modification or revocation of a variance.--The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b). (b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines.-- "(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and Official FDA Timetable: Food Safety Modernization Act (FSMA) Please see individual regulations for details regarding extended deadlines and exemptions. "(g) Publicly Available Registry.--The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies and auditors. "(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); and 302. "(b) Testing Procedures.-- "(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; > The Secretary shall review such plan not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary. (B) the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations. (A) the costs and benefits associated with the adoption and use of several product tracing technologies, including technologies used in the pilot projects under subsection (a); 3 ) IMPORTED food. -- Section 301 ( 21 U.S.C Section 805. `` Administration of epinephrine by school early... Liability at common law or under State statutory law ( d ) ) and subpart J part. G ) '' good manufacturing practices ( cGMPs ) have been incorporated In FSMA rules authority that performs of... And Food producers on United States Code build up to the extent practicable, In the general entrusted... Secure electronic data sharing of Chapter VII ( 21 U.S.C of Public comment on such guidelines information technical. Title III -- IMPROVING the Safety of Food Category regulations ; Biennial Registration Renewal. 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