<enum>I</enum><header>Establishment of food safety administration</header><section id="HB6DA8C3651FA4945815571E6FC3B9C8C"><enum>101.</enum><header>Establishment of Food Safety Administration</header><subsection id="HEEBC3A6EE9284E52B5BA3330EA6282E9"><enum>(a)</enum><header>Establishment</header><paragraph id="H2184A75B329A4EE5977CA8B3FF7F3BA3"><enum>(1)</enum><header>In general</header><text>There is established within the Department of Health and Human Services an agency to be known as the <quote>Food Safety Administration</quote>.</text></paragraph><paragraph id="HE982732E3BDB42A1A71D41EA2FFDF0E0"><enum>(2)</enum><header>Head of administration</header><text>The Administration shall be headed by the Administrator of Food Safety, who shall have food safety expertise, and be appointed by the President, by and with the advice and consent of the Senate.</text></paragraph><paragraph id="H857B9CDBB7EB4BB49E4A1D3DBB5D1090"><enum>(3)</enum><header>Effect</header><text>The Federal Food and Drug Administration shall be renamed <quote>Federal Drug Administration</quote> and retain responsibility for carrying out its responsibilities related to drugs, cosmetics, devices, biological products, color additives, and tobacco. The Commissioner of Food and Drugs shall be renamed the <quote>Commissioner of Drugs</quote>, and shall retain the responsibilities of the Commissioner of Food and Drugs, except such responsibilities that relate to food, which shall be assumed by the Administrator of Food Safety. Each reference in statute to the <quote>Food and Drug Administration</quote> shall be deemed a reference to the <quote>Federal Drug Administration</quote>, and each reference in statute to the <quote>Commissioner of Food and Drugs</quote> shall be deemed a reference to the <quote>Commissioner of Drugs</quote>.</text></paragraph></subsection><subsection id="H6F559078A5E6433985AECF8E1F6FD515"><enum>(b)</enum><header>Duties of the administrator</header><text>The Administrator shall—</text><paragraph id="HC2E117D272DF4E64B529B21469384453"><enum>(1)</enum><text>administer and enforce all authorities under chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HEA7D4644D5044A7AAEDCB53680E2D172"><enum>(2)</enum><text>serve as a representative to international food safety bodies and discussions;</text></paragraph><paragraph id="HD785BEB0E7B7491D9A4D92E8CCDEC70F"><enum>(3)</enum><text>promulgate and enforce regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; and</text></paragraph><paragraph id="H060F75792F31484F81A18BB6A58CDEA3"><enum>(4)</enum><text>oversee—</text><subparagraph id="HCC21B1071AE440B4AD9AB351ED380BD0"><enum>(A)</enum><text>implementation of Federal food safety;</text></subparagraph><subparagraph id="HA7ADDB1AC5EC4FF5B450B2D538AF81D1"><enum>(B)</enum><text>inspection, labeling, enforcement, and research efforts to protect the public health;</text></subparagraph><subparagraph id="H135F0525335B4D3D9776D4CB889BE249"><enum>(C)</enum><text>development of consistent and science-based standards for safe food;</text></subparagraph><subparagraph id="H4FCACDA65B2C42E0A047C3CB273213A3"><enum>(D)</enum><text>safety reviews and reassessments of food additives;</text></subparagraph><subparagraph id="H9A5E2361BBE1485CB6F29C218EED321D"><enum>(E)</enum><text>establishment and enforcement of tolerances for poisonous or deleterious substances;</text></subparagraph><subparagraph id="H601FE749FD3E444C95A7452F8AF98EDE"><enum>(F)</enum><text>monitoring and enforcement of pesticide residue tolerances in or on foods;</text></subparagraph><subparagraph id="H91F13D5CD80E4E3DBE5AE6FDA1449453"><enum>(G)</enum><text>coordination and prioritization of food safety research and education programs with other Federal agencies;</text></subparagraph><subparagraph id="H1EEA88D7031E462885EDEDFC5EC188E2"><enum>(H)</enum><text>prioritization of Federal food safety efforts and deployment of Federal food safety resources to achieve the greatest benefit in reducing foodborne illness;</text></subparagraph><subparagraph id="H37A16E8A6A3143AA9DD1BACC4FF36EE6"><enum>(I)</enum><text>coordination of the Federal response to foodborne illness outbreaks with other Federal and State agencies; </text></subparagraph><subparagraph id="H75F813B867784429AC023F9F9FF4A986"><enum>(J)</enum><text>integration of Federal food safety activities with State and local agencies; and</text></subparagraph><subparagraph id="H86E37908734E4E18B3BAA50B5186B390"><enum>(K)</enum><text>assignment of tolerances for animal drugs used in food-producing animals.</text></subparagraph></paragraph></subsection></section><section id="HEF5E09EB04CD4B50B6271AF246F8AADC"><enum>102.</enum><header>Transfer of authority, functions, and agencies</header><subsection id="HD98A5DC07D60446F9ED1D50B734C2CC0"><enum>(a)</enum><header>Transfer of authority</header><text>The Agency shall assume responsibility for carrying out chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>) and maintain all enforcement authorities with respect to food held by the Food and Drug Administration on the date of enactment of this Act.</text></subsection><subsection id="H04FF4DF43B6648DCBBB9C0A40C866C85"><enum>(b)</enum><header>Transfer of functions</header><text>For each Federal agency, office, and center specified in subsection (c), there are transferred to the Administration all functions that the head of the Federal agency exercised on the day before the date of enactment of this Act (including all related functions of any officer or employee of the Federal agency) that relate to administration or enforcement of the food safety law, as determined by the President.</text></subsection><subsection id="H03AA3167326344719857CED0AE93F738"><enum>(c)</enum><header>Transferred agencies</header><text>The Federal agencies referred to in subsection (b) are—</text><paragraph id="HA8237A4D835C419688FA4E32CB8032FD"><enum>(1)</enum><text>the resources and facilities of the Center for Food Safety and Applied Nutrition of the Food and Drug Administration that administer chapter IV of the Federal Food, Drug, and Cosmetics Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HE7F00E1EB10D496F8FF7C9CA9751182B"><enum>(2)</enum><text>the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration that administer and conduct inspections of food and feed facilities and imports;</text></paragraph><paragraph id="HCA6F88CBD5574ED99D86D76BDD2C09A2"><enum>(3)</enum><text>the resources and facilities of the Center for Veterinary Medicine of the Food and Drug Administration that administer chapter IV of the Federal Food, Drug, and Cosmetics Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HBB701EFB85694C8A9DB344FE22020322"><enum>(4)</enum><text>the Office of Food Policy and Response of the Food and Drug Administration; and</text></paragraph><paragraph id="HEA2D0C0DE60B45C49972F2724747D958"><enum>(5)</enum><text>such other offices, services, or agencies as the President designates by Executive order to carry out this Act.</text></paragraph></subsection><subsection id="H5BF3D37BBAD342A5BF687F9D42DB1228"><enum>(d)</enum><header>Conforming amendment</header><text>Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H91DC4388E0954F2F8A95BCC3C9E10C72"><section id="H06A75FC1B948487694F83E630C2A2DAC"><enum>703.</enum><header>Regulation of food</header><text display-inline="no-display-inline">Notwithstanding any other provision of this Act, beginning on the date that is 180 days after the date of enactment of the <short-title>Food Safety Administration Act of 2022</short-title>, any authority under this Act that relates to food shall be under the authority of the Food Safety Administration, and shall be carried out by the Administrator of Food Safety. Any reference in this Act to authorities related to food held by the Secretary shall be deemed to be references to authorities held by the Administrator of Food Safety.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="HF72DABD61FB347A5A545D2DF3809C17C"><enum>103.</enum><header>Additional duties of the administration</header><subsection id="HA18BF8ABE8E34AE9A7369C7E3C023D76"><enum>(a)</enum><header>Officers and employees</header><text>The Administrator may—</text><paragraph id="H1DEA693EC6354918904B0D8BEA9D2074"><enum>(1)</enum><text>appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and</text></paragraph><paragraph id="H686D4BBBBB0742F4965FC18A10F601B6"><enum>(2)</enum><text>fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.</text></paragraph></subsection><subsection id="H5AB8560DA244402FBC694705EEC4EE49"><enum>(b)</enum><header>Experts and consultants</header><text>The Administration may—</text><paragraph id="HADBDC27CD8B240AEB3D0BF149C305D3D"><enum>(1)</enum><text>procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and</text></paragraph><paragraph id="H333616E0CD05490BBD45D1431BD084B8"><enum>(2)</enum><text>pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.</text></paragraph></subsection><subsection id="H793C96D4A9B14CF9BBF5DA9C0AF73C8E"><enum>(c)</enum><header>Bureaus, offices, and divisions</header><text>The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.</text></subsection><subsection id="H54F135F6011644AE90CDC122A0AE7431"><enum>(d)</enum><header>Advisory committees</header><paragraph id="HC7833CFDC3A145A2928F5C2072592016"><enum>(1)</enum><header>In general</header><text>The Administrator shall establish advisory committees that consist of representative of scientific expert bodies, academics, industry specialists, and consumers.</text></paragraph><paragraph id="HDC1E364906BD45A59B7C52464E9BA159"><enum>(2)</enum><header>Duties</header><text>The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of regulatory science and processes, research, communications, performance standards, and inspection.</text></paragraph></subsection></section>

117 HR 8358 IH: Food Safety Administration Act of 2022 U.S. House of Representatives 2022-07-13 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

Short title

This Act may be cited as the

Food Safety Administration Act of 2022

Definitions

In this Act:(1)

Administration

The term Administration means the Food Safety Administration established under section 101(a)(1).(2)

Administrator

The term Administrator means the Administrator of Food Safety appointed under section 101(a)(2).(3)

Facility

The term facility means any factory, warehouse, or establishment that is subject to the requirements of section 415 or 419 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d; 350h).

Effective date

This Act, including the amendments made by this Act, shall take effect 180 days after the date of enactment of this Act.

Funding

(a)

Transfer of funds

The appropriations, allocations, and other funds that relate to the authorities, functions, and agencies transferred under section 102 shall be transferred to the Administration.(b)

Authorization of appropriations

There are authorized to be appropriated to carry out this section, such sums as may be necessary for fiscal year 2023 and each fiscal year thereafter.

<enum>I</enum><header>Establishment of food safety administration</header><section id="HB6DA8C3651FA4945815571E6FC3B9C8C"><enum>101.</enum><header>Establishment of Food Safety Administration</header><subsection id="HEEBC3A6EE9284E52B5BA3330EA6282E9"><enum>(a)</enum><header>Establishment</header><paragraph id="H2184A75B329A4EE5977CA8B3FF7F3BA3"><enum>(1)</enum><header>In general</header><text>There is established within the Department of Health and Human Services an agency to be known as the <quote>Food Safety Administration</quote>.</text></paragraph><paragraph id="HE982732E3BDB42A1A71D41EA2FFDF0E0"><enum>(2)</enum><header>Head of administration</header><text>The Administration shall be headed by the Administrator of Food Safety, who shall have food safety expertise, and be appointed by the President, by and with the advice and consent of the Senate.</text></paragraph><paragraph id="H857B9CDBB7EB4BB49E4A1D3DBB5D1090"><enum>(3)</enum><header>Effect</header><text>The Federal Food and Drug Administration shall be renamed <quote>Federal Drug Administration</quote> and retain responsibility for carrying out its responsibilities related to drugs, cosmetics, devices, biological products, color additives, and tobacco. The Commissioner of Food and Drugs shall be renamed the <quote>Commissioner of Drugs</quote>, and shall retain the responsibilities of the Commissioner of Food and Drugs, except such responsibilities that relate to food, which shall be assumed by the Administrator of Food Safety. Each reference in statute to the <quote>Food and Drug Administration</quote> shall be deemed a reference to the <quote>Federal Drug Administration</quote>, and each reference in statute to the <quote>Commissioner of Food and Drugs</quote> shall be deemed a reference to the <quote>Commissioner of Drugs</quote>.</text></paragraph></subsection><subsection id="H6F559078A5E6433985AECF8E1F6FD515"><enum>(b)</enum><header>Duties of the administrator</header><text>The Administrator shall—</text><paragraph id="HC2E117D272DF4E64B529B21469384453"><enum>(1)</enum><text>administer and enforce all authorities under chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HEA7D4644D5044A7AAEDCB53680E2D172"><enum>(2)</enum><text>serve as a representative to international food safety bodies and discussions;</text></paragraph><paragraph id="HD785BEB0E7B7491D9A4D92E8CCDEC70F"><enum>(3)</enum><text>promulgate and enforce regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; and</text></paragraph><paragraph id="H060F75792F31484F81A18BB6A58CDEA3"><enum>(4)</enum><text>oversee—</text><subparagraph id="HCC21B1071AE440B4AD9AB351ED380BD0"><enum>(A)</enum><text>implementation of Federal food safety;</text></subparagraph><subparagraph id="HA7ADDB1AC5EC4FF5B450B2D538AF81D1"><enum>(B)</enum><text>inspection, labeling, enforcement, and research efforts to protect the public health;</text></subparagraph><subparagraph id="H135F0525335B4D3D9776D4CB889BE249"><enum>(C)</enum><text>development of consistent and science-based standards for safe food;</text></subparagraph><subparagraph id="H4FCACDA65B2C42E0A047C3CB273213A3"><enum>(D)</enum><text>safety reviews and reassessments of food additives;</text></subparagraph><subparagraph id="H9A5E2361BBE1485CB6F29C218EED321D"><enum>(E)</enum><text>establishment and enforcement of tolerances for poisonous or deleterious substances;</text></subparagraph><subparagraph id="H601FE749FD3E444C95A7452F8AF98EDE"><enum>(F)</enum><text>monitoring and enforcement of pesticide residue tolerances in or on foods;</text></subparagraph><subparagraph id="H91F13D5CD80E4E3DBE5AE6FDA1449453"><enum>(G)</enum><text>coordination and prioritization of food safety research and education programs with other Federal agencies;</text></subparagraph><subparagraph id="H1EEA88D7031E462885EDEDFC5EC188E2"><enum>(H)</enum><text>prioritization of Federal food safety efforts and deployment of Federal food safety resources to achieve the greatest benefit in reducing foodborne illness;</text></subparagraph><subparagraph id="H37A16E8A6A3143AA9DD1BACC4FF36EE6"><enum>(I)</enum><text>coordination of the Federal response to foodborne illness outbreaks with other Federal and State agencies; </text></subparagraph><subparagraph id="H75F813B867784429AC023F9F9FF4A986"><enum>(J)</enum><text>integration of Federal food safety activities with State and local agencies; and</text></subparagraph><subparagraph id="H86E37908734E4E18B3BAA50B5186B390"><enum>(K)</enum><text>assignment of tolerances for animal drugs used in food-producing animals.</text></subparagraph></paragraph></subsection></section><section id="HEF5E09EB04CD4B50B6271AF246F8AADC"><enum>102.</enum><header>Transfer of authority, functions, and agencies</header><subsection id="HD98A5DC07D60446F9ED1D50B734C2CC0"><enum>(a)</enum><header>Transfer of authority</header><text>The Agency shall assume responsibility for carrying out chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>) and maintain all enforcement authorities with respect to food held by the Food and Drug Administration on the date of enactment of this Act.</text></subsection><subsection id="H04FF4DF43B6648DCBBB9C0A40C866C85"><enum>(b)</enum><header>Transfer of functions</header><text>For each Federal agency, office, and center specified in subsection (c), there are transferred to the Administration all functions that the head of the Federal agency exercised on the day before the date of enactment of this Act (including all related functions of any officer or employee of the Federal agency) that relate to administration or enforcement of the food safety law, as determined by the President.</text></subsection><subsection id="H03AA3167326344719857CED0AE93F738"><enum>(c)</enum><header>Transferred agencies</header><text>The Federal agencies referred to in subsection (b) are—</text><paragraph id="HA8237A4D835C419688FA4E32CB8032FD"><enum>(1)</enum><text>the resources and facilities of the Center for Food Safety and Applied Nutrition of the Food and Drug Administration that administer chapter IV of the Federal Food, Drug, and Cosmetics Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HE7F00E1EB10D496F8FF7C9CA9751182B"><enum>(2)</enum><text>the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration that administer and conduct inspections of food and feed facilities and imports;</text></paragraph><paragraph id="HCA6F88CBD5574ED99D86D76BDD2C09A2"><enum>(3)</enum><text>the resources and facilities of the Center for Veterinary Medicine of the Food and Drug Administration that administer chapter IV of the Federal Food, Drug, and Cosmetics Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>);</text></paragraph><paragraph id="HBB701EFB85694C8A9DB344FE22020322"><enum>(4)</enum><text>the Office of Food Policy and Response of the Food and Drug Administration; and</text></paragraph><paragraph id="HEA2D0C0DE60B45C49972F2724747D958"><enum>(5)</enum><text>such other offices, services, or agencies as the President designates by Executive order to carry out this Act.</text></paragraph></subsection><subsection id="H5BF3D37BBAD342A5BF687F9D42DB1228"><enum>(d)</enum><header>Conforming amendment</header><text>Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H91DC4388E0954F2F8A95BCC3C9E10C72"><section id="H06A75FC1B948487694F83E630C2A2DAC"><enum>703.</enum><header>Regulation of food</header><text display-inline="no-display-inline">Notwithstanding any other provision of this Act, beginning on the date that is 180 days after the date of enactment of the <short-title>Food Safety Administration Act of 2022</short-title>, any authority under this Act that relates to food shall be under the authority of the Food Safety Administration, and shall be carried out by the Administrator of Food Safety. Any reference in this Act to authorities related to food held by the Secretary shall be deemed to be references to authorities held by the Administrator of Food Safety.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="HF72DABD61FB347A5A545D2DF3809C17C"><enum>103.</enum><header>Additional duties of the administration</header><subsection id="HA18BF8ABE8E34AE9A7369C7E3C023D76"><enum>(a)</enum><header>Officers and employees</header><text>The Administrator may—</text><paragraph id="H1DEA693EC6354918904B0D8BEA9D2074"><enum>(1)</enum><text>appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and</text></paragraph><paragraph id="H686D4BBBBB0742F4965FC18A10F601B6"><enum>(2)</enum><text>fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.</text></paragraph></subsection><subsection id="H5AB8560DA244402FBC694705EEC4EE49"><enum>(b)</enum><header>Experts and consultants</header><text>The Administration may—</text><paragraph id="HADBDC27CD8B240AEB3D0BF149C305D3D"><enum>(1)</enum><text>procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and</text></paragraph><paragraph id="H333616E0CD05490BBD45D1431BD084B8"><enum>(2)</enum><text>pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.</text></paragraph></subsection><subsection id="H793C96D4A9B14CF9BBF5DA9C0AF73C8E"><enum>(c)</enum><header>Bureaus, offices, and divisions</header><text>The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.</text></subsection><subsection id="H54F135F6011644AE90CDC122A0AE7431"><enum>(d)</enum><header>Advisory committees</header><paragraph id="HC7833CFDC3A145A2928F5C2072592016"><enum>(1)</enum><header>In general</header><text>The Administrator shall establish advisory committees that consist of representative of scientific expert bodies, academics, industry specialists, and consumers.</text></paragraph><paragraph id="HDC1E364906BD45A59B7C52464E9BA159"><enum>(2)</enum><header>Duties</header><text>The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of regulatory science and processes, research, communications, performance standards, and inspection.</text></paragraph></subsection></section><enum>II</enum><header>Administration of food safety program</header><section id="HC56FA3D6216944988F9B389EC133ADC8"><enum>201.</enum><header>Establishment of inspection program</header><subsection id="H045D49631B7640408E5F793D2F2BC627"><enum>(a)</enum><header>In general</header><text>The Administrator shall establish an inspection program, which shall include inspections of food facilities subject to subsection (b) and in accordance with section 202.</text></subsection><subsection id="HC51012386B4348F388626016073E2485"><enum>(b)</enum><header>Facility categories</header><text>Not later than 6 months after the date of enactment of this Act, the Administrator shall issue formal guidance defining the criteria by which food facilities will be divided into <quote>high-risk,</quote><quote>intermediate-risk,</quote> and <quote>low-risk</quote> facilities.</text></subsection><subsection id="H0B4F8966373940BF84A69C0D53E67A88"><enum>(c)</enum><header>Inspection frequencies</header><text>Frequency of inspections of food facilities under this Act shall be based on the categories defined pursuant to subjection (b) and in accordance with section 202.</text></subsection></section><section id="H914C36FFB3D94C27AFD56DE5733922AD"><enum>202.</enum><header>Inspections of food facilities</header><subsection id="H2EAD4875C7164A98A420902BD9216B05"><enum>(a)</enum><header>Frequency of inspections</header><paragraph id="HCC2B36E82DC349A29E6A1F4EDAFE46C5"><enum>(1)</enum><header>High-risk facilities</header><text>The Administrator shall inspect high-risk facilities not less than once per a year.</text></paragraph><paragraph id="H7D1CD2CB5EBD42F297F4B0FE185A472A"><enum>(2)</enum><header>Intermediate-risk facilities</header><text>The Administrator shall inspect intermediate-risk facilities not less than once every 2 years.</text></paragraph><paragraph id="HEF7373ADB9C1443CB331726194F4F692"><enum>(3)</enum><header>Low-risk facilities</header><text>The Administrator shall inspect low-risk facilities, which shall include warehouses or similar facilities that engage in packaging or distribution, and pose very minimal public health risk, not less than once every 3 years.</text></paragraph></subsection><subsection id="H7DCAAB8C99D84CE783A25BF669CA79EA"><enum>(b)</enum><header>Infant formula manufacturing facilities</header><text>The Administrator shall inspect the facilities of each manufacturer of infant formula not less than every 6 months.</text></subsection><subsection id="H00A362F27D60444A9F6B137E5947A05D"><enum>(c)</enum><header>Federal and State cooperation</header><text>The Administrator shall contract with State officials to carry out half of the safety inspections required under this section.</text></subsection></section><section id="H5C84558A53EE41FB844BF6A0C3575048"><enum>203.</enum><header>Compliance checks</header><text display-inline="no-display-inline">Not later than 30 days after issuing a form that is equivalent to an FDA Form 483 to a facility, pursuant to an inspection under section 704 of Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>), the Administrator shall conduct a follow-up compliance check with the facility.</text></section><section id="H0C8DA36D614C403D99D73EC8059E2307"><enum>204.</enum><header>Traceability rule</header><text display-inline="no-display-inline">Not later than November 7, 2022, the Administrator shall promulgate a final rule that is based on the proposed rule issued by the Food and Drug Administration titled, <quote>Requirements for Additional Traceability Records for Certain Foods</quote> (85 Fed. Reg. 59984 (Sept. 23, 2021)).</text></section><section id="H05531AC8D80146D69B63D972ADF6EE1B"><enum>205.</enum><header>Notice of circumstances that could lead to a shortage</header><text display-inline="no-display-inline">Chapter IV of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H9DC9881811BD4DB3B9162EE873D46B06"><section id="H35B6B9B39D184FC2BA2D2DFFAD69A37D"><enum>424.</enum><header>Notice of circumstances that could lead to a shortage</header><subsection id="HCD5356C19CCE4CFEA48646F8D97D357D"><enum>(a)</enum><header>Notice requirement</header><text>Not later than 5 business days after a manufacturer of infant formula or essential medical food becomes aware of circumstances that could lead to a shortage of infant formula or essential medical food in the United States, such manufacturer shall give written notice of such circumstances to the Administrator.</text></subsection><subsection id="HCCC67CC96A8B4D0C98C599CA5D957A55"><enum>(b)</enum><header>Fines</header><text>If the Administrator finds that a manufacturer of infant formula or essential medical food is in violation of the requirement of this section to give written notice, such violation shall be treated as an infraction for purposes of imposing a fine in accordance with title 18, United States Code. </text></subsection><subsection id="HCBC4336CBB104DA8BF4CFADDB60AC049"><enum>(c)</enum><header>Definitions</header><text>In this section:</text><paragraph id="HEDE537E0F00C4205AE302D76581353A7"><enum>(1)</enum><text>The term <term>Administrator</term> means the Administrator of Food Safety.</text></paragraph><paragraph id="H48EBC12293594225B7110BB3EC35FCB4"><enum>(2)</enum><text>The term <term>essential medical food</term> means a food that—</text><subparagraph id="HEBC8554DC8F44281A8A78E2079CE99CF"><enum>(A)</enum><text>is formulated to be consumed or administered enterally under the supervision of a physician;</text></subparagraph><subparagraph id="H5D37A14C19EB47F4899F5C4A901702B6"><enum>(B)</enum><text>is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and</text></subparagraph><subparagraph id="H91DE2BF2C1EB4BA1871FB90BFEA66CCA"><enum>(C)</enum><text>is identified by the Administrator as being essential for any urgent medical condition. </text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>