109 HR 2236 IH: Consumer Food Safety Act of 2005
U.S. House of Representatives
2005-05-10
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.
1.Short title; table of contents
(a)This Act may be cited as the Consumer Food Safety Act of 2005
.
(b)
Sec. 1. Short title; table of contents
Sec. 2. Definitions
Title I—National food safety program
Sec. 101. Administration of national program
Sec. 102. Process controls to reduce the adulteration of food products
Sec. 103. Inspections of processors and importers
Sec. 104. Tolerances for contaminants in food
Sec. 104. State and Federal cooperation
Sec. 106. Imports
Title II—Research and education
Sec. 201. Public health assessment system
Sec. 202. Public education and advisory system
Sec. 203. Research
Title III—Enforcement
Sec. 301. Amendments to the Federal Food, Drug, and Cosmetic Act
Title IV—Authorization
Sec. 401. Authorization of appropriations
2.For purposes of this Act:
(1)The term contaminants includes bacteria, chemical contaminants, natural toxins, viruses, parasites, and physical hazards that when found on or in food can cause human illness or injury.
(2)The term facility includes any factory, warehouse, establishment, or importer that handles or processes food.
(3)The term process means the commercial harvesting, preparation, manufacture, or transportation of food products.
(4)The term Secretary means the Secretary of Health and Human Services.
<enum>I</enum><header>National food safety program</header>
<section id="H208716816DB94AD3B6DEBB2DBD55EE00"><enum>101.</enum><header>Administration of national program</header>
<subsection id="HA8F5414BEBF74F74BDA355E0A002917D"><enum>(a)</enum><header>In general</header>
<paragraph id="H7C09D72801A1434E84E79ED48924EB24"><enum>(1)</enum><text>Persons who produce or process food for human consumption have the responsibility to prevent or minimize food safety hazards related to their products. The Secretary shall administer a national program for the purpose of protecting human health by ensuring that the food industry has effective programs in place to assure the safety of food products consumed in the United States.</text></paragraph>
<paragraph id="HCD7FDCA6F926466D9F9BFAA8CCDB738"><enum>(2)</enum><text>The program shall—</text>
<subparagraph id="HB9ADBC2F242A485BAFF2ED57B92230D6"><enum>(A)</enum><text>be based on a comprehensive analysis of the hazards associated with different food products and with the harvesting, processing, and handling of different food products, including the identification and evaluation of—</text>
<clause id="H6952396E4F4F4FE5A164A2370E200E8"><enum>(i)</enum><text>the severity of the potential health risks;</text></clause>
<clause id="H62CE89C033E143ACBE3D4892C23EF1B9"><enum>(ii)</enum><text>the sources and specific points of potential contamination that may render food products unsafe for human consumption; and</text></clause>
<clause id="H3BC06D00684A43C1815B72DCC34AEE"><enum>(iii)</enum><text>the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in foods and food products;</text></clause></subparagraph>
<subparagraph id="HE1609F8662D64455AEDC003882531681"><enum>(B)</enum><text>take into consideration the distinctive characteristics of food production and processing;</text></subparagraph>
<subparagraph id="HE97D77617CA04F7FB607A224F3D22A"><enum>(C)</enum><text>establish inspection and oversight procedures to monitor that facilities are utilizing preventive controls to minimize or eliminate identifiable hazards; and</text></subparagraph>
<subparagraph id="H2FF8C3A6FDFB4BE9B7FB4308A98C22B"><enum>(D)</enum><text>require each food processing facility to annually register with the Secretary.</text></subparagraph></paragraph></subsection>
<subsection id="HD55F1CC3F4CF459F963EE6C184C5F545"><enum>(b)</enum><header>Program elements</header><text>The program shall provide for—</text>
<paragraph id="H37B1152CB0F24DAC821EAF852BE7A103"><enum>(1)</enum><text>implementation of a national system for the registration and quarterly inspection of facilities and importers. Quarterly inspections can be waived by plants that meet the Secretary’s standards for exceptional or negligible-risk facilities or importers;</text></paragraph>
<paragraph id="HBA165536790E4A678993DAC73C726627"><enum>(2)</enum><text>development of a program to oversee the implementation of process controls in food processing facilities;</text></paragraph>
<paragraph id="HBCEB5627692C494DAFF3009799EEA2E4"><enum>(3)</enum><text>the establishment and enforcement of health-based standards for (A) substances which may contaminate food and (B) safety and sanitation in the processing and handling of food products;</text></paragraph>
<paragraph id="H805174589B1D4AE7A5C626575546738B"><enum>(4)</enum><text>implementation of a sampling program to ensure that industry programs to prevent food contamination are effective and that food products meet the standards established in paragraph (1);</text></paragraph>
<paragraph id="H1545CFC160434C5E9077F2C3137508C2"><enum>(5)</enum><text>implementation of procedures and requirements to ensure the safety of imported food products;</text></paragraph>
<paragraph id="HB5990AA4C4014E8D9B88003E91708CC9"><enum>(6)</enum><text>coordination with other Federal agencies or State governments in carrying out inspection, enforcement, and monitoring;</text></paragraph>
<paragraph id="H6A3224C5A7F7464AB34800C7001F5043"><enum>(7)</enum><text>implementation of a national surveillance system to assess the health risks associated with the human consumption of food products, in cooperation with the Secretary of Agriculture and the Centers for Disease Control and Prevention;</text></paragraph>
<paragraph id="H3CE41B927BC84C0600148245F307587C"><enum>(8)</enum><text>development of public education and advisory programs; and</text></paragraph>
<paragraph id="HF733AF3C9C65405B8E8443174CE596C8"><enum>(9)</enum><text>implementation of a research program in furtherance of the purposes of this Act.</text></paragraph></subsection></section>
<section id="H27C1F902890A4AF69B1F966423594BE6"><enum>102.</enum><header>Process controls to reduce the adulteration of food products</header>
<subsection id="H0B5FF31924FF4C3793CDEEF81C4248DC"><enum>(a)</enum><header>In general</header><text>The Secretary shall, upon the basis of the best available scientific and technological data, prescribe regulations to—</text>
<paragraph id="H2D7559324D994557B5B415EA331173FB"><enum>(1)</enum><text>limit the presence of human pathogens and other potentially harmful substances in food products;</text></paragraph>
<paragraph id="H536726458E604FDFB5D338007161FFE0"><enum>(2)</enum><text>ensure that all registered facilities implement appropriate measures to control and reduce the presence and growth of human pathogens and other potentially harmful substances on food products;</text></paragraph>
<paragraph id="H26EF4D7E439F4A9CAB0092F004E9C2F7"><enum>(3)</enum><text>ensure that all fully processed or ready-to-eat food products are processed in a sanitary manner, using reasonably available techniques and technologies to eliminate any human pathogens or other potentially harmful substances likely to cause foodborne illness; and</text></paragraph>
<paragraph id="H01F51A9EBFBF4C17BA5B346CB38D0092"><enum>(4)</enum><text>ensure that food products intended for final processing outside commercial establishments are labeled with instructions for handling and preparation for consumption which, when adhered to, will destroy any human pathogens or other potentially harmful substance likely to cause foodborne illness.</text></paragraph></subsection>
<subsection id="HDAB7F2922DCD4402BAE658432BE800F"><enum>(b)</enum><header>Regulations</header><text>The Secretary shall, within one year of the enactment of this Act, issue regulations that require all registered facilities to adopt processing controls adequate to protect public health and to limit the presence and growth of human pathogens and other potentially harmful substances in food products prepared in any registered facility. Such regulations shall—</text>
<paragraph id="H15409285B28C464E9604D86C7181623"><enum>(1)</enum><text>set standards for sanitation;</text></paragraph>
<paragraph id="H7ECA9B2060054FC5B05F1DFB24EC0A8"><enum>(2)</enum><text>set tolerances for biological, chemical, and physical hazards as appropriate;</text></paragraph>
<paragraph id="HC93FE499C01048329FD6C0E8751C3FD1"><enum>(3)</enum><text>require process controls to assure that food is safe and that relevant regulatory and safety standards are met;</text></paragraph>
<paragraph id="H4C7D0E74B7EA4F7DB0006ECEBD2DD3B1"><enum>(4)</enum><text>require recordkeeping to monitor compliance;</text></paragraph>
<paragraph id="H48A3A68F923E4929A3993F8E4694607E"><enum>(5)</enum><text>require sampling to assure that processing controls are effective and that regulatory standards are being met; and</text></paragraph>
<paragraph id="HF712B061B6454C1883EFF35BF8566609"><enum>(6)</enum><text>provide for agency access to records kept by official establishments and submission of copies of such records to the Secretary as the Secretary deems appropriate.</text></paragraph><continuation-text continuation-text-level="subsection">Public access to records that relate to the adequacy of measures taken by official establishments to protect the public health and to limit the presence and growth of human pathogens and other potentially harmful substances shall be governed by <external-xref legal-doc="usc" parsable-cite="usc/5/552">5 U.S.C. 552 et seq.</external-xref> The Secretary may, as the Secretary deems necessary, require any person, firm, or corporation with responsibility for or control over food ingredients to adopt processing controls, where such processing controls are needed to assure the protection of public health.</continuation-text></subsection></section>
<section id="HC52C1DC61F9B47E4B9EEE85B8956D3AB"><enum>103.</enum><header>Inspections of processors and importers</header>
<subsection id="HA0B53360EC254CBE87F1D7010077B1E0"><enum>(a)</enum><header>Nature of inspections</header>
<paragraph id="H5C1CED0ABFD54FE2A207403F38AC53F9"><enum>(1)</enum><text>The inspection system shall provide for frequent unannounced inspections of food processing and importing facilities to determine if such facilities are operated in a sanitary manner and if food products are unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>). Inspections shall include review of processing records and sampling of food products.</text></paragraph>
<paragraph id="HA573F32462994CA500007BCDCB8F4EA"><enum>(2)</enum><text>Inspections shall be conducted at least quarterly, unless the Secretary determines that the facility is an exceptional or negligible-risk facility under standards established by the Secretary.</text></paragraph>
<paragraph id="H03DA87AF0FC8466CBD818DAB9FFA1256"><enum>(3)</enum><text>Standards for exceptional or negligible-risk facilities shall consider the hazards associated with the type of product being produced; and the facility’s history of compliance, food safety problems and such other factors as the Secretary may deem appropriate. The Secretary shall specify an alternative inspection frequency for each facility which is deemed exceptional or negligible-risk. Each inspection shall include an examination of whether the facility continues to meet the standards for exceptional or negligible-risk facilities.</text></paragraph></subsection>
<subsection id="H6F45FBC780644BDD85AC000232870000"><enum>(b)</enum><header>Conduct of inspections</header>
<paragraph id="H312DAAB8B8C1457582B136E9736007C"><enum>(1)</enum><text>An inspection under subsection (a) of any domestic, foreign, or importing facility shall extend to all things therein (including records required to be maintained under subsection (e), processes, controls, and premises) that bear on whether food products are in compliance with this Act or the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>). Access to records may include the copying of such records.</text></paragraph>
<paragraph id="HCCA12CFF1B384BC19D1D98F5EFEF9170"><enum>(2)</enum><text>In conducting such inspections, officers or employees duly designated by the Secretary, upon presenting appropriate credentials to the owner, operator, or agent in charge, are authorized—</text>
<subparagraph id="HBAAF2D6EA2344FC2A3B35523EC1DAD94"><enum>(A)</enum><text>to enter at reasonable times any facility in which persons are engaged in the food processing or importing of food products, or to enter any vehicle being used to transport or hold such food products;</text></subparagraph>
<subparagraph id="H306330D8C0474E34ADD9E7CA2512CC8"><enum>(B)</enum><text>to inspect in a reasonable manner such facility or vehicle and all pertinent equipment, finished and unfinished materials, containers, labeling, processes, controls, and premises; and</text></subparagraph>
<subparagraph id="HB0E2F78848E4425B9DC7F73E87AE0384"><enum>(C)</enum><text>to collect and retain samples of food products or ingredients or of any other items found during an inspection that may contribute to a finding of whether such food products are unsafe for human consumption or adulterated or misbranded under the Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text></subparagraph></paragraph>
<paragraph id="HCABDD940487E403AA9A57C6FE77C0010"><enum>(3)</enum><text>Immediately after completion of inspection, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed which indicate that either processing controls are inadequate to prevent or minimize food safety hazards or that any food from such facility is unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text></paragraph></subsection>
<subsection id="H7D4BA4A48A954857BF6681240781D39"><enum>(c)</enum><header>Product detention and condemnation</header>
<paragraph id="HC94DE4E5ECAF460DA4314F3408CAE2A8"><enum>(1)</enum><text>If, during an inspection conducted under this section, an officer or employee making the inspection has reason to believe that a food product is unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), such officer or employee may order the food product segregated, impounded, and if objection is not made within 48 hours, condemned. If objection is made, such food products that are in perishable form may be processed to the extent necessary to prevent spoilage, and a hearing shall be commenced expeditiously.</text></paragraph>
<paragraph id="H44BEDDF5728E464BB5B703FA4694F5E7"><enum>(2)</enum><text>If the Secretary determines that, through relabeling or other action, such food products can be brought into compliance with this Act and the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), the food may be released following a determination by the Secretary that such relabeling or other action as specified by the Secretary has been performed.</text></paragraph>
<paragraph id="HDDE2CCF145E340EAB99684D081D93C87"><enum>(3)</enum><text>Any food product condemned without objection, or after hearing and judicial review, shall be destroyed under supervision of the Secretary.</text></paragraph></subsection>
<subsection id="H6FAE98ED4FEE433BB41BB238BEB6A380"><enum>(d)</enum><header>Official mark</header><text>The Secretary shall prescribe by regulation the conditions under which any food product shall display an official mark, when needed to facilitate exports, that signifies that the food product has been processed in accordance with standards approved by the Secretary. Such a mark may be subject to a fee.</text></subsection>
<subsection id="HE640ED8134BA4856987F04DF494B24A3"><enum>(e)</enum><header>Maintenance of records</header><text>Each facility or person registered under this section shall maintain and make available for inspection by the Secretary such records as the Secretary may prescribe. Such records shall be maintained for a reasonable period of time as determined by the Secretary. The records shall include, but are not limited to, information concerning—</text>
<paragraph id="H1A385CD2DDF042ACA5C780A5415300C4"><enum>(1)</enum><text>the origin, receipt, delivery, sale, movement, holding, and disposition of food products or ingredients; the identity and amount of ingredients used in the food; the processing of the food; the results of laboratory, sanitation, or other quality control tests performed on the food or in the facility; consumer complaints concerning the food or its packaging; and</text></paragraph>
<paragraph id="H094E9484D9F144A9937FDC039C059B15"><enum>(2)</enum><text>other matters reasonably related to whether food products may be unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text></paragraph></subsection>
<subsection id="H4E65A05E910D414F9C0034A866000143"><enum>(f)</enum><header>Other inspection rights and duties</header><text>Section 704 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) is amended by adding at the end the following new subsection:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H88F20A881BFA45A7AE087BA2172C5388">
<subsection id="H676049B241D94316917B80D85B82D81B"><enum>(h)</enum><text>The rights and duties under this section of duly designated officers and employees and of other persons shall apply to enforcement of the <short-title>Consumer Food Safety Act of 2005</short-title> to the same extent and in the same manner as they apply to enforcement of this Act.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<section id="HAECEB7D167454475BD45ED06E210D1FD"><enum>104.</enum><header>Tolerances for contaminants in food</header>
<subsection id="H8EB9E2DC73BF4A46B700C2A81617DA31"><enum>(a)</enum><header>Tolerances</header><text>The Secretary shall establish tolerances limiting the quantity of contaminants, except for pesticide residues regulated under section 408 or food additives regulated under section 409 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), that, when found in food products, may render such products unsafe for human consumption. Contaminants include but are not limited to bacteria, chemical contaminants, natural toxins, viruses and parasites that when found on or in food can cause human illness. Such tolerances may include indicators (including indicator organisms) from which it may reasonably be inferred that a contaminant is present in a food product. In developing a tolerance, the Secretary shall take into account the extent to which consumers may be exposed to such contaminant from sources other than food, and the extent to which such contaminant can be avoided or minimized in the commercial handling and processing of such food.</text></subsection>
<subsection id="H82A6EC842A124CCEABCADC44368B6376"><enum>(b)</enum><header>Regulations</header>
<paragraph id="HD875D68E6794458E9F5C7854F5717B3"><enum>(1)</enum><text>The Secretary, after notice and an opportunity for comment, shall promulgate regulations to implement subsection (a) within 48 months after the date of enactment of this Act. In promulgating such regulations, the Secretary shall establish tolerances for the contaminants that the Secretary determines are having the greatest public health impact as early as feasible after implementation of this Act.</text></paragraph>
<paragraph id="H5887F4FEF6554AD0A075F99BCB4BCD9"><enum>(2)</enum><text>A tolerance established under this section shall be based on—</text>
<subparagraph id="H3D855A0C733A40D78134534BFF5BAC64"><enum>(A)</enum><text>a scientific analysis of the health risks attributable to the contaminant for which the tolerance is established; and</text></subparagraph>
<subparagraph id="HDF8F47569FFF41AF9B075B675CFA0045"><enum>(B)</enum><text>analysis of the risks for sensitive groups, such as children, elderly, pregnant women and the immune compromised.</text></subparagraph></paragraph>
<paragraph id="H93244D32293646FCBD72C4D67E27BBA4"><enum>(3)</enum><text>The Secretary shall, in a timely manner, issue revisions to the regulations under paragraph (1) which take into account new information. The Secretary may contract with the National Academy of Sciences to provide such data or assistance as the Secretary deems necessary.</text></paragraph></subsection>
<subsection id="H5184EBB10A194358A9687E635713A793"><enum>(c)</enum><header>Report</header><text>The Secretary shall report to the Congress on the progress of the Secretary in establishing tolerances under this section. The report shall include a description of the research that has been conducted with respect to such tolerances and the research that must be conducted before additional tolerances may be established, the health significance of the lack of such additional tolerances, a timetable for the establishment of such tolerances, and the estimated costs, including costs of research, associated with the establishment of such tolerances. The report shall be transmitted on or about the end of the 18th month after the date of enactment of this Act, and biennially thereafter during the 6-year period that begins on such date of enactment.</text></subsection></section>
<section id="H3116B00AEA394654AB1DC0C6EB3D8000"><enum>105.</enum><header>State and Federal cooperation</header>
<subsection id="HE23F132F6D8E47B7AF62CBDAD7761CB"><enum>(a)</enum><header>In general</header><text>The Secretary shall work with the States in undertaking activities and programs that contribute to the national food safety program so that State and Federal programs function in a coordinated and cost-effective manner. With the assistance provided in subsection (b), the Secretary shall encourage States to—</text>
<paragraph id="H1E07871A86B641D2B23D371F3322E176"><enum>(1)</enum><text>continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets; and</text></paragraph>
<paragraph id="H217EEB7CA9B94D73A3543B4674F90078"><enum>(2)</enum><text>establish procedures and requirements for ensuring that food products under the jurisdiction of the State are not unsafe for human consumption.</text></paragraph></subsection>
<subsection id="HAB77C8F7BC72406B00C4CB8603190556"><enum>(b)</enum><header>Assistance</header>
<paragraph id="H5EE2342C99314EE19400FE25BE29EFC"><enum>(1)</enum><text>The Secretary may provide to a State, for planning, developing, and implementing a food safety program—</text>
<subparagraph id="H1B76380B2F1944BEA6B7A7A81CE32B2B"><enum>(A)</enum><text>advisory assistance;</text></subparagraph>
<subparagraph id="H89A862BD0AA544CBA7EAC530E65C2C60"><enum>(B)</enum><text>technical and laboratory assistance and training (including necessary materials and equipment); and</text></subparagraph>
<subparagraph id="H6E0AC7AB9E534FCF9DBD8D1078052B9D"><enum>(C)</enum><text>financial and other aid.</text></subparagraph></paragraph></subsection>
<subsection id="H138235E838CE4970B8B4DCF7B8B00183"><enum>(c)</enum><header>Service agreements</header><text>The Secretary may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the personnel, services, and facilities of such agencies in carrying out their responsibilities under this Act. Such an agreement shall provide that any compliance records, notices, or reports issued in connection with activities under the agreement and in the possession of the agency or government which entered into the agreement shall be made available in accordance with <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code. Agreements with a State under this subsection may provide for training of State employees.</text></subsection></section>
<section id="H7FEC379DAC234BDB99D47DC7D79C84B7"><enum>106.</enum><header>Imports</header>
<subsection id="H35B2502F0CD7489BB6B931313F13B85B"><enum>(a)</enum><header>Role of Secretary</header><text>Within 24 months after the date of enactment of this Act, the Secretary shall establish and administer a comprehensive and efficient system to ensure the safety of food imported into the United States. The Secretary shall routinely inspect processing facilities in exporting nations and imports at ports of entry into the United States. The Secretary shall assure the effective operation through verification and other activities as the Secretary considers necessary.</text></subsection>
<subsection id="H7C76E2F4D66A4B868EF6D1E1C3FB2987"><enum>(b)</enum><header>Import requirements</header>
<paragraph id="H219D1C3484B740CABC7424CA65C9166"><enum>(1)</enum><text>No food product may enter the United States, or be withdrawn from a warehouse, for consumption in the United States if such food product—</text>
<subparagraph id="H125FE4404F814A18A17C1B86866B2116"><enum>(A)</enum><text>appears unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>);</text></subparagraph>
<subparagraph id="H613F01913CF44F429F7DEE00DDE06711"><enum>(B)</enum><text>is not marked or labeled as required by regulations for domestic or imported articles; or</text></subparagraph>
<subparagraph id="H70C15593E090465280A22495BEDC9EEE"><enum>(C)</enum><text>does not comply with the requirements of this section.</text></subparagraph></paragraph>
<paragraph id="H12C4FE323FAF42FEB9D05837957CD9F2"><enum>(2)</enum><text>Upon entry for consumption in the United States, food products that are not prohibited from entry or from withdrawal from a warehouse under paragraph (1) shall be deemed to be and treated as domestic food products, except that all labeling of such products shall clearly identify the country of origin to facilitate the identification of products linked to outbreaks of illness.</text></paragraph></subsection>
<subsection id="HD0D0552905DA49F9A762AB65ADF5E26"><enum>(c)</enum><header>Inspection of imports</header>
<paragraph id="H018704F2A7FD4FBE9E74CADBD8A60821"><enum>(1)</enum><text>Food products that are offered for importation, or withdrawn from a warehouse, for consumption in the United States, shall be subject to examinations inspections, sampling, and such other procedures at the port of entry or in the exporting nation by officers or employees duly designated by the Secretary. Such procedures shall be conducted with such frequency and in such manner as the Secretary may prescribe by regulation.</text></paragraph>
<paragraph id="H81091407AE7847FAA6E6DECE335B9B6"><enum>(2)</enum><text>Food products from a nation that is certified for such food products under subsection (e)(3) shall be subject to random examinations, inspections, sampling, and other procedures. Food products from a nation that is not certified for such food products under subsection (e)(3) shall be subject to such intensified examinations, inspections, sampling, and other verification procedures, including inspection in the country of origin, as the Secretary determines are necessary to ensure compliance with this Act.</text></paragraph></subsection>
<subsection id="H7B7B90E5C1474DDE92732D6F719C3666"><enum>(d)</enum><header>Detention of imported food product</header><text>If during an inspection or other verification procedure carried out under this section, an officer or employee conducting the procedure has reason to believe that a food product is unsafe for human consumption, or adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), such officer or employee may order the food product segregated, impounded, and if objection is not made within 48 hours, condemned. If objection is made, such food products that are in perishable form may be processed to the extent necessary to prevent spoilage, and a hearing shall be commenced expeditiously. The final condemnation or other disposition of such food product shall be subject to the provisions of section 103(c).</text></subsection>
<subsection id="H405C24A269644C859709EEB8C7FB400"><enum>(e)</enum><header>Agreements with foreign nations</header>
<paragraph id="H9364511D40BA44CB9714F7C7821E50DA"><enum>(1)</enum><text>The Secretary may enter into an agreement with any nation desiring to export food products to the United States. Prior to concluding such an agreement, the Secretary shall evaluate the food safety program of the foreign nation to determine if such program provides at least the same level of protection, with respect to food products intended for export to the United States, as domestic laws that affect the safety of the food supply. In such evaluation, the Secretary shall consider—</text>
<subparagraph id="HA1BDAE0C7C234CF1A4B8B6B100D84660"><enum>(A)</enum><text>the potential for health, sanitary, environmental, or other conditions within the foreign nation to adversely affect the safety of food products exported from such nation; and</text></subparagraph>
<subparagraph id="H7753AA932AFB43269D444B52C1A869AD"><enum>(B)</enum><text>how well the food safety programs of the foreign nation functions to minimize any adverse effects on such safety.</text></subparagraph></paragraph>
<paragraph id="H423EF7F613654559AC0177C1C760498"><enum>(2)</enum><text>Any agreement under this subsection with a nation desiring to export food products to the United States shall—</text>
<subparagraph id="HE1EC4ECD9A6244BE8C5E82FCFFBC5B36"><enum>(A)</enum><text>require that the exporting nation shall—</text>
<clause id="HB5CAF96557BE47009DF597283E6D5109"><enum>(i)</enum><text>establish and maintain a food safety system that is adequate to ensure that the food products intended for export to the United States are safe for human consumption, and not adulterated or misbranded under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>); and</text></clause>
<clause id="HD308DF0D364146A5AFC4DD293300BF7B"><enum>(ii)</enum><text>promptly notify the Secretary of any violations affecting the safety of food products exported or intended for export to the United States;</text></clause></subparagraph>
<subparagraph id="HABA9BB656EFF4C35BFD646261D20FC58"><enum>(B)</enum><text>provide for such activities (whether in the exporting nation or at the port of entry during importation) by the Secretary, including examinations, inspections, sampling, and testing, at such stages in the growth or harvest of food, or in the processing or handling of food products, as the Secretary considers appropriate to ensure that the food safety program of the exporting nation continues to provide at least the same level of protection, with respect to food products intended for export to the United States, as domestic laws that affect the safety of the food supply; and</text></subparagraph>
<subparagraph id="H4925F0C0D7924A82A1C95059B6F3C9CF"><enum>(C)</enum><text>provide for reciprocity with respect to the treatment of food imports and exports between the United States and the exporting nation.</text></subparagraph></paragraph>
<paragraph id="H23B0E1EBEBD94F1D81C5E645611342C5"><enum>(3)</enum><text>If the Secretary determines that a nation desiring to export food products to the United States has a program that provides at least the saline level of protection, with respect to food products intended for export to the United States, as domestic laws that affect the safety of the food supply, the Secretary shall, upon entry into force of an agreement under subsection (e)(1), certify the types of food products for which the nation maintains such a program.</text></paragraph>
<paragraph id="H1476E675559E47438DBBA3FC6D759308"><enum>(4)</enum>
<subparagraph display-inline="yes-display-inline" id="H20F43D2C8D224D108CD940CB7961A4E8"><enum>(A)</enum><text>The Secretary shall periodically or for good cause, and not less than once every 3 years, review certifications made under paragraph (3), and shall revoke the certification of any nation that the Secretary determines is not maintaining a food safety program that provides at least the same level of protection, with respect to food products intended for export to the United States, as domestic laws that affect the safety of the food supply.</text></subparagraph>
<subparagraph indent="up1" id="H9B7B89F36C8A4763B1736646367900B"><enum>(B)</enum><text>The Secretary shall review and modify, as needed, an agreement made under paragraph (1) with any nation whose certification has been revoked under subparagraph (A) of this paragraph.</text></subparagraph></paragraph></subsection></section>
<enum>II</enum><header>Research and education</header>
<section id="H866C3A021E784FB3A973BC8E89ABA9D1"><enum>201.</enum><header>Public health assessment system</header>
<subsection id="HDC85396876934CA488CEA2BDBF1E97B9"><enum>(a)</enum><header>Cooperation with the Centers for Disease Control and Prevention</header><text>The Secretary shall work, through the Centers for Disease Control and Prevention, to include food in an active surveillance system, based on a representative proportion of the population of the United States, and to assess more accurately the frequency and sources of human illness in the United States associated with the consumption of food.</text></subsection>
<subsection id="H9E54B63E28CB42D4823CCDCCECA9F86"><enum>(b)</enum><header>Public health sampling</header>
<paragraph id="HE2F2449BDBCF42C1A960CC073E687C00"><enum>(1)</enum><text>Within 12 months after the date of enactment of this Act, the Secretary in cooperation with the Secretary of Agriculture shall establish guidelines for a sampling system under which the Secretary and the Secretary of Agriculture shall take and analyze samples of food products to assist the Secretary in carrying out this Act and the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), and to more accurately assess the nature, frequency of occurrence, and amounts of contaminants in food products.</text></paragraph>
<paragraph id="HF0384645841F4CB7AE489CD5B68051C1"><enum>(2)</enum><text>Such sampling system shall provide—</text>
<subparagraph id="HF11106E4E4534A8CA8D853E6F59BA466"><enum>(A)</enum><text>statistically valid monitoring, including market-basket studies, on the nature, frequency of occurrence, and amounts of contaminants in food products available to consumers; and</text></subparagraph>
<subparagraph id="H956F62F0D6BF4CE78DB8C88560F4BD99"><enum>(B)</enum><text>at the request of the Secretary, such other information, including analysis of monitoring and verification samples, as the Secretary determines may be useful in assessing the occurrence of contaminants in food products.</text></subparagraph></paragraph></subsection>
<subsection id="HE74CD47DEF414ED3AB925D6E149E5FEF"><enum>(c)</enum><header>Assessment of health hazards</header><text>Through the surveillance system referred to in subsection (a) and the sampling system described in subsection (b), the Secretary shall rank food categories based on their hazard to human health and identify appropriate industry and regulatory approaches to minimize hazards in the food supply. Such analysis could include—</text>
<paragraph id="HC5B094768AF7442E9B115F8D72C919D7"><enum>(1)</enum><text>the safety of commercial harvesting and processing, as compared with the health hazards associated with food products that are harvested for recreational or subsistence purposes and prepared noncommercially;</text></paragraph>
<paragraph id="HA3A4CC95554540648698E670EE9E96E"><enum>(2)</enum><text>the safety of food products that are domestically harvested and processed, as compared with the health hazards associated with food products that are harvested or processed outside the United States; and</text></paragraph>
<paragraph id="H0E2A8D9BC98747E881A0018AAE803F4"><enum>(3)</enum><text>contamination originating from handling practices that occur prior to or after sale of food products to consumers.</text></paragraph></subsection></section>
<section id="HEE0F85D8F93048E18DE87F5F2E598C1"><enum>202.</enum><header>Public education and advisory system</header>
<subsection id="HAD5F07013180406CB4CF0504E74DEC25"><enum>(a)</enum><header>Public education</header><text>The Secretary, in cooperation with private and public organizations, including the cooperative extension services and appropriate State entities, shall design and implement a national public education program on food safety. The program shall provide—</text>
<paragraph id="H3AD4D0BB046844CBB84B2289A24CADD4"><enum>(1)</enum><text>information to the public regarding Federal standards and good practice requirements and promotion of public awareness understanding and acceptance of such standards and requirements;</text></paragraph>
<paragraph id="HD851723B0C3447CB836EAFF24CB9092"><enum>(2)</enum><text>information to health professionals so that they may improve diagnosis and treatment of food-related illness and advise individuals whose health conditions place them in particular risk; and</text></paragraph>
<paragraph id="H9658F373C2E74F7A8943BE1D8E0082AD"><enum>(3)</enum><text>such other information or advice to consumers and other persons as the Secretary determines will promote the purposes of this Act.</text></paragraph></subsection>
<subsection id="H1B090C33E7844932923B362447148936"><enum>(b)</enum><header>Health advisories</header><text>The Secretary, in consultation with the Secretary of Agriculture and the Administrator of the Environmental Protection Agency, shall work with the States and other appropriate entities to—</text>
<paragraph id="H8FE53AA0007847178FB7E2A9D9002116"><enum>(1)</enum><text>develop and distribute regional and national advisories concerning food safety;</text></paragraph>
<paragraph id="H1EDCB825BBEB4D8E8DC100A1AC335133"><enum>(2)</enum><text>develop standardized formats for written and broadcast advisories; and</text></paragraph>
<paragraph id="H71BFAC5DC3094EE7A3500012E653F356"><enum>(3)</enum><text>incorporate State and local advisories into the national public education program required under subsection (a).</text></paragraph></subsection></section>
<section id="H7D67E0B307814B97BB4C57A047C08935"><enum>203.</enum><header>Research</header>
<subsection id="HF12024688E3F432FB9D33DF78728EC8F"><enum>(a)</enum><header>In general</header><text>The Secretary shall conduct research to assist in the implementation of this Act, including studies to—</text>
<paragraph id="HD6C0DECD07594A30BF51ED3FE249615E"><enum>(1)</enum><text>improve sanitation and food safety practices in the processing of food products;</text></paragraph>
<paragraph id="HC9C2CA6AE1DB4D02BE31569232866847"><enum>(2)</enum><text>develop improved techniques for the monitoring of food and inspection of food products;</text></paragraph>
<paragraph id="H77D00A52A5F84363B597CD15ECE70684"><enum>(3)</enum><text>develop efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in food products;</text></paragraph>
<paragraph id="H67D3F734059941A7AB03252EB813EE4C"><enum>(4)</enum><text>determine the sources of contamination of food and food products with contaminants; and</text></paragraph>
<paragraph id="HFD4C2C2D1DD844DB83783568B0169CAB"><enum>(5)</enum><text>develop consumption data with respect to food products.</text></paragraph></subsection>
<subsection id="H78486DA74EAA47180041AA63EFC66CD"><enum>(b)</enum><header>Contract authority</header><text>The Secretary is authorized to enter into contracts and agreements with any State, university, other government agencies or other persons to carry out the activities under this section.</text></subsection></section>
<enum>III</enum><header>Enforcement</header>
<section id="HD0124A12C7204C51B920E2722D4CB4FA"><enum>301.</enum><header>Amendments to the Federal food, drug, and Cosmetic Act</header>
<subsection id="H4E0D7B7E4C06414D99C128E89C7EFB21"><enum>(a)</enum><header>In general</header><text>The <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended by adding after section 415 the following new sections:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H84205509D5624DC284FBE1CCB3009EB6">
<section id="H3D988C4BA739486E8C6D84C47F12593E"><enum>416.</enum><header>Notification and recall</header>
<subsection id="H979C034E563E4555BCBB4D009C6E7852"><enum>(a)</enum><header>Notice to Secretary of adulteration or misbranding</header><text>Any person (other than a household consumer or other individual who is the intended consumer of an article of food) that has a reasonable basis for believing that any article of food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be adulterated or misbranded or otherwise in violation of the <short-title>Consumer Food Safety Act of 2005</short-title> shall immediately notify the Secretary, in such manner and by such means as the Secretary may by regulation prescribe, of the identity and location of such article.</text></subsection>
<subsection id="H53E74AFFA25543BC92D676CA384261A6"><enum>(b)</enum><header>Recall and consumer notification</header>
<paragraph id="H3571097A52354340892CA7C441E5E8D9"><enum>(1)</enum><header>Voluntary procedures</header><text>If the Secretary finds, upon notification under subsection (a) or otherwise, that any article of food is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and there is a reasonable probability that such article, if consumed, would present a threat to public health, as determined by the Secretary, the Secretary shall provide the appropriate persons (including the manufacturers, importers, distributors, or retailers) with an opportunity to—</text>
<subparagraph id="HCFBBAF502ACA46D1A7C2B3700038282B"><enum>(A)</enum><text>cease distribution of such article;</text></subparagraph>
<subparagraph id="H3A349FD4DC3F42BFB1DC31DBCF39121"><enum>(B)</enum><text>notify all persons—</text>
<clause id="HCD94D385658843CE882758491FFB3596"><enum>(i)</enum><text>producing, manufacturing, packing, processing, preparing, treating, packaging, distributing, or holding such article; or</text></clause>
<clause id="H5B9306B0D45443EFB00064EDE732BDD0"><enum>(ii)</enum><text>to which such article has been distributed, transported, or sold, to immediately cease distribution of such article;</text></clause></subparagraph>
<subparagraph id="H3F7E1AA9E22C4E6CA9887742733E163C"><enum>(C)</enum><text>recall such article;</text></subparagraph>
<subparagraph id="H9400576917BD4D48B9D3849BF34D38C"><enum>(D)</enum><text>provide, in consultation with the Secretary, notice to consumers to whom such article was, or may have been, distributed; or</text></subparagraph>
<subparagraph id="H67757C13182247C48E468D630093FB1B"><enum>(E)</enum><text>take any combination of the above measures, as appropriate in the circumstances.</text></subparagraph></paragraph>
<paragraph id="H71AC5371B5E044ECBB60E4BCFB70005D"><enum>(2)</enum><header>Pre-hearing order to cease distribution and give notice</header><text>If such person refuses to or does not voluntarily cease distribution, make notification, recall such article, or provide notice to consumers, as applicable, within the time and in the manner prescribed by the Secretary, the Secretary shall, by order, require, as the Secretary deems necessary, such person to—</text>
<subparagraph id="HDFF2D20F97A6496291C7BBB1FBFB5701"><enum>(A)</enum><text>immediately cease distribution of such article;</text></subparagraph>
<subparagraph id="H0C301112BA3F4F748268D3221294F9FD"><enum>(B)</enum><text>immediately notify all persons—</text>
<clause id="HB5F62D215EA94DBE97E1FA6E56044C6"><enum>(i)</enum><text>producing, manufacturing, packing, processing, preparing, treating, packaging, distributing, or holding such article; or</text></clause>
<clause id="H27B08967D63443A09E27C77CE1F67CD9"><enum>(ii)</enum><text>to which such article has been distributed, transported, or sold, to immediately cease distribution of such article; or</text></clause></subparagraph>
<subparagraph id="H51B971356B88412300FD19885C3BCA8B"><enum>(C)</enum><text>immediately take the actions specified in both subparagraphs (A) and (B).</text></subparagraph></paragraph>
<paragraph id="HFC63B5B44F914C80AB9FC0D1662FA547"><enum>(3)</enum><header>Notification of consumers by Secretary</header><text>The Secretary shall, as the Secretary deems necessary, provide notice to consumers to whom such article was, or may have been, distributed.</text></paragraph></subsection>
<subsection id="H325C5AE0B37B4E28ADB4D87D5745CD75"><enum>(c)</enum><header>Hearing on order</header><text>The Secretary shall provide any person subject to an order under subsection (b) with an opportunity for a hearing, to be held as soon as possible but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.</text></subsection>
<subsection id="HBF5D347ED483462C8D9FFFC6C1D8FAC"><enum>(d)</enum><header>Post-hearing recall order</header>
<paragraph id="H57BC1ADA52CE40D5A048DD5C90ABC91"><enum>(1)</enum><header>Amendment of order</header><text>If, after providing opportunity for a hearing under subsection (c), the Secretary determines that there is a reasonable probability that the article that is the subject of an order under subsection (b), if consumed, presents a threat to public health, the Secretary, as the Secretary deems necessary, may—</text>
<subparagraph id="H9B3A571CB62B43D4AC9545A2B138100"><enum>(A)</enum><text>amend the order to require recall of such article or other appropriate action;</text></subparagraph>
<subparagraph id="H2BA51CDE798746CF94EE00B5ECD92880"><enum>(B)</enum><text>specify a timetable in which the recall shall occur;</text></subparagraph>
<subparagraph id="H97BB485FF079420C8865A156199C3F97"><enum>(C)</enum><text>require periodic reports to the Secretary describing the progress of the recall; and</text></subparagraph>
<subparagraph id="H51C780D551D741DCB45D7805CC57E6C8"><enum>(D)</enum><text>provide notice to consumers to whom such article was, or may have been, distributed.</text></subparagraph></paragraph>
<paragraph id="HC4752BB99FBE4E30B98724E5F5002B96"><enum>(2)</enum><header>Vacation of order</header><text>If, after such a hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.</text></paragraph></subsection>
<subsection id="H83576A45BA9A458A953785DABF39611B"><enum>(e)</enum><header>Remedies not exclusive</header><text>The remedies provided in this section shall be in addition to and not exclusive of other remedies that may be available.</text></subsection></section>
<section id="H4621761D56F84C81884C4980E22C7E73"><enum>417.</enum><header>Civil penalties</header>
<subsection id="HAEF2F7F466114C7599DA348C596C90BB"><enum>(a)</enum><header>In general</header>
<paragraph id="H893C2EE3B28E4AC4A7A89D19D56DED55"><enum>(1)</enum><header>Acts subject to penalty; penalty amount</header><text>Any person that commits an act that violates this Act with respect to food or the <short-title>Consumer Food Safety Act of 2005</short-title> may be assessed a civil penalty by the Secretary of not more than $100,000 for each such act. Each such act and each day during which such act continues shall be a separate offense.</text></paragraph>
<paragraph id="HD18412FFCE8A4820B29470913191B9FF"><enum>(2)</enum><header>Notice and hearing</header><text>No penalty shall be assessed by the Secretary under this section unless such person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections <external-xref legal-doc="usc" parsable-cite="usc/5/554">554</external-xref> and <external-xref legal-doc="usc" parsable-cite="usc/5/556">556</external-xref> of title 5, United States Code.</text></paragraph>
<paragraph id="HC5588DADD7094BA3AB89F339F778C6F5"><enum>(3)</enum><header>Other requirements</header><text>The amount of such civil penalty shall be assessed by the Secretary by written order, taking into account the gravity of the violation, degree of culpability, size and type of business, and any history of prior offenses; and may be reviewed only as provided in subsection (b).</text></paragraph></subsection>
<subsection id="HCE6AFA9E3D414B17BEC47E06019C697B"><enum>(b)</enum><header>Judicial review</header><text>An order assessing a civil penalty under subsection (a) shall be final and conclusive unless the person files, within 30 days from the effective date of the order, an application for judicial review in the Court of Appeals of the United States for the circuit in which such person resides or has its principal place of business or in the United States Court of Appeals for the District of Columbia Circuit by filing a notice of appeal in such court and by simultaneously sending a copy of such notice by certified mail to the Secretary. The Secretary shall promptly file in such court a certified copy of the record upon which such penalty was assessed. The findings of the Secretary shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.</text></subsection>
<subsection id="HAF630886A3414A4D8BA463E0C18D008E"><enum>(c)</enum><header>Collection actions</header><text>If any person fails to pay an assessment of a civil penalty after it has become a final and unappealable order, or after the appropriate court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General, who shall institute a civil action to recover the amount assessed in an appropriate district court of the United States. In such collection action, the validity and appropriateness of the Secretary’s order imposing the civil penalty shall not be subject to review.</text></subsection>
<subsection id="HCD42F9530A504868BAF01CA63F8565DE"><enum>(d)</enum><header>Penalties paid into treasury</header><text>All penalties collected under authority of this section shall be paid into the Treasury of the United States.</text></subsection>
<subsection id="HAAEABEBC23AE4EA780D292386E597D4C"><enum>(e)</enum><header>Secretary’s discretion to prosecute</header><text>Nothing in this Act shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, violations of this Act whenever the Secretary believes that the public interest will be adequately served by assessment of civil penalties.</text></subsection>
<subsection id="H056EEDF217424B0400E8121FD2708F00"><enum>(f)</enum><header>Remedies not exclusive</header><text>The remedies provided in this section shall be in addition to and not exclusive of other remedies that may be available.</text></subsection></section>
<section id="HC98F81751C844B9CACE28976D6B5C42D"><enum>418.</enum><header>Whistleblower protection</header>
<subsection id="H6A15464E0B0A46FC948D6D4E6272A8D"><enum>(a)</enum><header>In general</header><text>No employee or other person may be harassed, prosecuted, held liable, or discriminated against in any way because that person—</text>
<paragraph id="H8EE00768A8AB42969F7FCFCCB4B2B43"><enum>(1)</enum><text>has commenced, caused to be commenced, or is about to commence a proceeding, testified or is about to testify at a proceeding, or assisted or participated or is about to assist or participate in any manner in such a proceeding or in any other action to carry out the purposes, functions, or responsibilities of the <short-title>Consumer Food Safety Act of 2005</short-title>, the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, the Meat Inspection Act, or the Poultry Products Inspection Act; or</text></paragraph>
<paragraph id="H83EE4E950BCE4A7692EF001B7E94A1C1"><enum>(2)</enum><text>is refusing to violate or assist in violation of law, rule, or regulation.</text></paragraph></subsection>
<subsection id="HC69409A1AADF498C9B305CC9F3796423"><enum>(b)</enum><header>Procedures</header><text>The process and procedures with respect to prohibited discrimination under subsection (a) shall be governed by the applicable provisions of <external-xref legal-doc="usc" parsable-cite="usc/49/31105">section 31105</external-xref> of title 49, United States Code, unless the party bringing an action under this subsection chooses alternative dispute resolution procedures such as mediation or arbitration.</text></subsection>
<subsection id="H2A52B34D83AB411D004E683818F4EEFD"><enum>(c)</enum><header>Burdens of proof</header><text>The legal burdens of proof with respect to prohibited discrimination under subsection (a) shall be governed by the applicable provisions of sections <external-xref legal-doc="usc" parsable-cite="usc/5/1214">1214</external-xref> and <external-xref legal-doc="usc" parsable-cite="usc/5/1221">1221</external-xref> of title 5, United States Code.</text></subsection></section>
<section id="HD9B8A2BC11DA459EA4E1EFF0BE68FA70"><enum>419.</enum><header>Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts</header><text display-inline="no-display-inline">For the efficient administration and enforcement of this chapter, the provision (including penalties) of sections 46, 48, 49, and 50 of title 15 (except subsections (c) through (h) of section 46 and <external-xref legal-doc="usc" parsable-cite="usc/15/49">section 49</external-xref> of title 15), are made applicable to the jurisdiction, powers, and duties of the Secretary in administrating and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections <external-xref legal-doc="usc" parsable-cite="usc/15/49">49</external-xref> and <external-xref legal-doc="usc" parsable-cite="usc/15/50">50</external-xref> of title 15 on the district courts of the United States may be exercised for the purposes of this chapter by any appropriate court.</text></section>
<section id="HFA6D5D15AD514E1EB5F5277BEEA8A17C"><enum>420.</enum><header>Traceback</header><text display-inline="no-display-inline">The Secretary may impose on a food product requirements for the traceability of such type or class of food product whenever such requirements are necessary to assure the protection of the public health. Traceability requirements shall be established in accordance with regulations and guidelines issued by the Secretary.</text></section>
<section id="H7C8F91058F9B48BF98848FAB9B2D52B7"><enum>421.</enum><header>Citizen’s civil actions</header><text display-inline="no-display-inline">Any person may commence a civil action against—</text>
<paragraph id="HAA7C5581CDCC4C67864DB81851A66754"><enum>(1)</enum><text>any person who violated any rule, tolerance, order, or other action of the Secretary to ensure the safety of food products; or</text></paragraph>
<paragraph id="H444811F3EA2A4378BB734D70A6F8C28D"><enum>(2)</enum><text>the Secretary where there is alleged a failure of the Secretary to perform any act or duty to ensure the safety of food products, which is not discretionary.</text><continuation-text continuation-text-level="section">The district courts shall have jurisdiction, without regard for the amount in controversy, or the citizenship of the parties, to enforce such rule, tolerance, order, or other action of the Secretary, or to order the Secretary to perform such act or duty. The suit shall be commenced in the district in which the defendant resides or is found or has an agent. The court may award damages sustained and if the court determines it to be in the interest of justice, may award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties. The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by common law or under Federal or State law.</continuation-text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H2684D82CB21A48D2B6EB7CC7C5154CE6"><enum>(b)</enum><header>Conforming amendment; prohibited Act</header><text>Section 301 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H2F8A93FE505B4CF1A096C76EA7F0C823">
<item indent="up5" id="HDB9BB814719F4CFCA7075F7463952F76"><enum>(hh)</enum><text>The failure or refusal to comply with an order issued under section 416(b)(2) or 416(d).</text></item>
<item indent="up5" id="H5250E202D3074CF98E2D9FBB16B5F1E9"><enum>(ii)</enum><text>The failure to comply with the <short-title>Consumer Food Safety Act of 2005</short-title>.</text></item><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<enum>IV</enum><header>Authorization</header>
<section id="H4653E684C9DE4C34A3586D57B454E14D"><enum>401.</enum><header>Authorization of appropriations</header>
<subsection id="H54D8487ED9CA4115A2FD4FFAF8279300"><enum>(a)</enum><header>In general</header><text>There are authorized to be appropriated, to carry out this Act, such sums as may be necessary for fiscal year 2006 and for fiscal year 2007.</text></subsection>
<subsection id="H4A926D20D3B64FE4B3FE57C7AD3B5148"><enum>(b)</enum><header>Assistance to States</header><text>Of the funds authorized to be appropriated under subsection (a), there are authorized to be appropriated such sums as may be necessary for fiscal year 2006 and for fiscal year 2007, for carrying out State program assistance activities under section 105.</text></subsection>
<subsection id="HB9EC65B68A0448F181DA3363B9F8D3E6"><enum>(c)</enum><header>Research program authorization</header><text>Of the funds authorized to be appropriated under subsection (a), there are authorized to be appropriated such sums as may be necessary for fiscal year 2006 and for fiscal year 2007, for carrying out the research program authorized by section 203.</text></subsection></section>