(e) Modifications.--Based on the exercises described in subsection The Genetically Modified Organisms Act 15 of 1997, which sets out regulatory requirements for foods from genetically modified organisms The abovementioned Acts are pro-active, which means that government approval must be obtained for the release of a product on the market. (2) Implementation plan.--The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy. (1) Establishment.-- "(B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require. "(2) Accreditation body.--The term `accreditation body' means an authority that performs accreditation of third-party auditors. "(g) Publication of List of Participants. Improving the reportable food registry. SEC. "(5) Whether the food importer participates in the voluntary qualified importer program under section 806. (B) prevent unauthorized access to trade secret or confidential information; and 3929] results for the purpose of determining the need for a national recall or other compliance and enforcement activities. "(2) Scope of agreements.--The agreements under paragraph (1) may include-- (A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. "(2) The compliance history of foreign suppliers used by the importer, as appropriate. 3910] and manner in which fees assessed under this section shall be collected. "(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year. The cost for the first five years is projected to be $1.4 billion and is not yet fully funded.[35]. (B) inserting ", or any other food categories as determined appropriate by the Secretary, including by guidance" after "Code of Federal Regulations"; Food Safety Modernization Act The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years. (2) coordinates the food laboratory capacities of State, local, and tribal food laboratories, including the adoption of novel surveillance and identification technologies and the sharing of data between Federal agencies and State laboratories to develop national situational awareness; ), as amended by section 105, is amended by adding at the end the following: "(F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States; (v) ensuring consistent and organized risk communication to the public by-- (2) striking "presents a threat of serious adverse health consequences or death to humans or animals" and inserting "is adulterated or misbranded". (B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and (a) Updating of Food Category Regulations; Biennial Registration Renewal.--Section 415(a) (21 U.S.C. (a) Fees for Reinspection, Recall, and Importation Activities.--Subchapter C of chapter VII (21 U.S.C. "(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and"(C) the average cost of physically inspecting or sampling a line of food subject to this Act that is imported or offered for import into the United States; and "(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). 111. The site is secure. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits. "(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year; "(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year; "(A) In general.--A grant under this section shall have a term that is not more than 3 years. "(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. Q&As have been issued. "(B) Rules of construction.--Nothing in this paragraph shall be construed-- (A) animal or plant disease outbreaks; (a) In General. FSMA (Food Safety Modernization Act, Loi de modernisation de la sécurité des produits alimentaires) et contrôle de la température : normes et réglementations. "(B) the results of which are for internal purposes only. (III) the private sector. (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 "(i) conducts an investigation of the material facts related to the outbreak of human or animal illness; and. (f) Prioritization.--The Administrator, in coordination with the entities described in subsection (b), shall develop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account-- "(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; and [28], Now that the Act is in place, the FDA must begin the rulemaking process to codify how they intend to enforce the new laws. "(4) Prioritization.--The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities [Page 124 STAT. "(c) Third-party Auditors.-- (3) Report. Through FSMA, food processors and producers who currently do not fall under categories with additional regulations such as HACCP or Canned food guidelines would be required to formulate a system or plan called … is amended by adding at the end the following: [20], The legislation affects every aspect of the U.S. food system, from farmers to manufacturers to importers. 341 et seq.) "(B) > establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories [Page 124 STAT. "(B) Rule of construction.--Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. > --An eligible entity shall apply for annual recertification by an accredited third-party auditor if such entity-- (ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only. 350c) and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations). Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency. "(A) Recognition of accreditation bodies.-- (M) include a process by which the Secretary may remove a high-risk food designation developed under paragraph (2) for a food or type of food. "(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).". The following are examples of enhanced collaboration: The FSMA also includes provisions that protect employees who try to prevent food safety problems. 203. (b) Prohibited Act.--Section 301 (21 U.S.C. Food Safety and Modernization Act (FSMA) Pleins feux sur la réglementation FSMA : Les États-Unis s'engagent sérieusement dans la sécurité alimentaire. "PART 6--FEES RELATED TO FOOD Sec. The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. [38] However, after Senate adoption of Jon Tester's amendment, which allows for the possible exemption of producers that sell less than $500,000 a year,[39] many large food companies objected, arguing that the exemption puts consumers at risk. "(e) False Statements.--Any statement or representation made-- "(B) Compounded basis.--The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009. In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested. (2) provides a means by which an individual may locate relevant information regarding each article of food subject to a recall under section 423 of the Federal Food, Drug, and [Page 124 STAT. 207. > --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) provide the report to the country or exporter that is the subject of the report; and [111th Congress Public Law 353] "(6) Failure to comply with order.--Whenever any person has failed to comply with an order issued under paragraph (3), the Secretary may file a civil action in the United States district court for the district in which the violation was found to occur, or in the United States district court for the District of Columbia, to enforce such order. "(G) Supplier verification activities that relate to the safety of food.". (b) References.--Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Compliance with international agreements.Sec. (3) Provisions for mutual recognition of inspection reports. (D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary. "(4) Action in court.-- "(ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or (a) In General.--There are authorized to be appropriated to carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration such sums as may be necessary for fiscal years 2011 through 2015. "(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; It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. "(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program.-- "(A) In general.--A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall-- (1) > shall apply to products or product classes; (A) the amendments made by this section shall apply to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this section)) beginning on the [Page 124 STAT. (b) Regulations. (7) No impact on non-high-risk foods.--The recordkeeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. "(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. (a) In General. "(2) provides legislative recommendations or describes additional resources required by the Centers of Excellence. The US Congress passes laws and the president signs them into law. 102. (1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and "(B) in the case of a third-party auditor accredited by an accreditation body for which recognition as an accreditation body under subsection (b)(1)(C) is revoked-- "(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. 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. > --If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. Examples of preventive controls include sanitation procedures for food contact surfaces; employee hygiene training; environmental monitoring to verify pathogen controls; a recall plan; supplier verification activities; and a food allergen control program. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section. "(1) Requirements for accreditation as a third-party auditor.-- The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. Determination of budgetary effects. Despite its 366 pages, Food Bill 160-2 cannot directly resolve many threats to food safety, as there is no added Produce traceability nor methods to control Antibiotic resistance. The act was signed into law by President Obama in 2011. (5) Recommendations on whether and how to harmonize requirements under the Codex Alimentarius. Learn how and when to remove this template message, Center for Disease Control and Prevention, Public Health Security and Bioterrorism Preparedness Response Act, Hazard analysis and risk-based preventive controls, Government Performance and Results Modernization Act, hazard analysis and risk-based preventive controls, "House Approves Food-Safety Bill; Law Would Expand FDA's Power", "FSMA Proposed Rule for Focused Mitigation Strategies to Protect Food Against Intentional Adulteration", "CDC Estimates of Foodborne Illness in the United States", "Background on the FDA Food Safety Modernization Act", "FDA Food Safety Modernization Act Overview", "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables", Center for Food Safety and Applied Nutrition, "The FDA Food Safety Modernization Act. (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. "(B) a Federal, State, local, or tribal agency, a nonprofit community-based or non-governmental organization, or an organization representing owners and operators of farms, small food processors, or small fruit and vegetable merchant wholesalers that has a commitment to public health and expertise in administering programs that contribute to food safety; "(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. SEC. 743. (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or "(2) Working group. (b) Components.-- > --Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors to certify that eligible entities meet the applicable requirements of this section. (ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including-- "(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. 155 (2009): (e) Public Access.--Any report prepared under this section shall be made available to the public. Vol. > -- The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.". "(3) Exception. 103. "(2) diversity of types of agricultural production. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. "(A) In general.--A person on whose behalf an order was issued under paragraph (3) may commence a civil action against the person to whom such order was issued to require compliance with such order. The Food Safety Modernization Act’s Produce Safety Rule (FSMA PSR) requires an increased level of cooperation between federal and state agencies. (B) Identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm.--The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if--. Laboratory accreditation for analyses of foods. (c) Conforming Technical Amendment.--Section 801(b) (21 U.S.C. Sanitary transportation of food. Enhancing food safety.Sec. Senate, amended. "(1) In general.--A farm shall be exempt from the requirements under this section in a calendar year if-- > Such working group shall provide the Secretary, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of foodborne illness surveillance and implementation of this section, including advice and recommendations on-- (a) In General. (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. "(3) Audit report submission requirements.-- "(B) the number of personnel permanently stationed in each foreign office. (c) Development of Model Plans.--In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for-- 331), as amended by section 211, is amended by adding at the end the following: "(zz) The importation or offering for importation of a food if the importer (as defined in section 805) does not have in place [Page 124 STAT. 302. The act overhauled regulations regarding food production and gave the Food and Drug Administration (FDA) more authority to oversee and enforce supply chains. [10], The first public comment period occurred in 2013, and the agency received tens of thousands of comments in that period. 601 et seq. Food allergy and anaphylaxis management. "(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; (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. (2) Goals.--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 to achieve the following goals: (b) Annual Report.--Section 1003 (21 U.S.C. (c) Civil Penalty.--Section 303(f)(2)(A) (21 U.S.C. 1031 et seq. [26] Small farms that sell locally or sell less than $500,000 a year are exempt from these new rules. "(a) Proposed Rulemaking.-- Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or in such other form as the Secretary may specify. "(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. SEC. "(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm; Sec. 201. "(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) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination; "(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.". (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. "(2) Coordination.--In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate. (a) In General. Such written or electronic certification may be included with other documentation regarding such food shipment. > --The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Commerce, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall-- "(e) Facility. 393) is amended by adding at the end the following: "(B) a description of the types of activities to be funded by the grant; 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: 3954] consideration variances granted under section 419), as appropriate; and The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment. (5) Records.--Except with respect to identifying potential immediate recipients in response to a request under this subsection, nothing in this subsection shall require the establishment or maintenance by farms of new records. (ii) such administration is not prohibited by State law. "(A) establish a program for the testing of food by accredited laboratories; "(f) Additional Exemptions. (A) the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such subsection, including whether such requirements provide adequate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and > --Facilities shall be subject to the requirements of this subsection beginning on the earlier of-- Building capacity of foreign governments with respect to food safety.Sec. 3889] under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section. All record keeping files and are allowed to make copies and photographs their... Civil Penalty. -- Section 801 ( a ) in general to Know of allocating resources. 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