1.
Short title; table of contents
(a)
This Act may be cited as the Safe Food Act of 2004
.
(b)
The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.
TITLE I—Establishment of Food Safety Administration
Sec. 101. Establishment of Food Safety
Administration.
Sec. 102. Consolidation of separate food safety and inspection
services and agencies.
Sec. 103. Additional duties of the Administration.
TITLE II—Administration of food safety program
Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food
establishments.
Sec. 203. Preventative process controls to reduce adulteration
of food.
Sec. 204. Performance standards for contaminants in
food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.
Sec. 208. Imports.
Sec. 209. Resource
plan.
Sec. 210. Traceback.
TITLE III—Research and education
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
TITLE IV—Enforcement
Sec. 401. Prohibited Acts.
Sec. 402. Food detention, seizure, and
condemnation.
Sec. 403. Notification and recall.
Sec. 404. Injunction proceedings.
Sec. 405. Civil and criminal penalties.
Sec. 406. Presumption.
Sec. 407. Whistleblower protection.
Sec. 408. Administration and enforcement.
Sec. 409. Citizen civil actions.
TITLE V—Implementation
Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming
amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of
appropriations.
Sec. 510. Effective date.
2.
(a)
Congress finds that—
(1)
the safety of the food supply of the United States is vital to
the public health, to public confidence in the food supply, and to the success
of the food sector of the Nation's economy;
(2)lapses in the
protection of the food supply and loss of public confidence in food safety are
damaging to consumers and the food industry, and place a burden on interstate
commerce;
(3)the safety and
security of the food supply requires an integrated, system-wide approach to
preventing food-borne illness, a thorough and broad-based approach to basic and
applied research, and intensive, effective, and efficient management of the
Nation's food safety program;
(4)
the task of preserving the safety of the food supply of the
United States faces tremendous pressures with regard to—
(A)
emerging pathogens and other contaminants and the ability to
detect all forms of contamination;
(B)
an aging and immune compromised population, with a growing number
of people at high-risk for food-borne illnesses;
(C)
an increasing volume of imported food, without adequate
monitoring and inspection; and
(D)
maintenance of rigorous inspection of the domestic food
processing and food service industries;
(5)
Federal food safety standard setting, inspection, enforcement,
and research efforts should be based on the best available science and public
health considerations and food safety resources should be systematically
deployed in ways that most effectively prevent food-borne illness;
(6)
the Federal food safety system is fragmented, with at least 12
Federal agencies sharing responsibility for food safety, and operates under
laws that do not reflect current conditions in the food system or current
scientific knowledge about the cause and prevention of food-borne
illness;
(7)the fragmented
Federal food safety system and outdated laws preclude an integrated,
system-wide approach to preventing food-borne illness, to the effective and
efficient operation of the Nation's food safety program, and to the most
beneficial deployment of food safety resources;
(8)the National
Academy of Sciences recommended in the report Ensuring Safe Food from
Production to Consumption
that Congress establish by statute a unified
and central framework for managing Federal food safety programs, and
recommended modifying Federal statutes so that inspection, enforcement, and
research efforts are based on scientifically supportable assessments of risks
to public health; and
(9)the lack of a
single focal point for food safety leadership in the United States undercuts
the ability of the United States to exert food safety leadership
internationally, which is detrimental to the public health and the
international trade interests of the United States.
(b)
The purposes of this Act are—
(1)
to establish a single agency to be known as the Food
Safety Administration
—
(A)
to regulate food safety and labeling to protect the public
health;
(B)to ensure that
food establishments fulfill their responsibility to produce food in a manner
that protects the public health of all people in the United States;
(C)to lead an
integrated, system-wide approach to food safety and to make more effective and
efficient use of resources to prevent food-borne illness; and
(D)
to provide a single focal point for food safety leadership, both
nationally and internationally;
(2)
to transfer to the Food Safety Administration the food safety,
labeling, inspection, and enforcement functions that, as of the day before the
effective date of this Act, are performed by other Federal agencies; and
(3)
to modernize the Federal food safety laws to achieve more
effective application and efficient management of the laws for the protection
and improvement of public health.
3.
In this Act:
(1)
The term Administration means the Food Safety
Administration established under section 101(a)(1).
(2)
The term Administrator means the Administrator of
Food Safety appointed under section 101(a)(3).
(3)
(A)
The term adulterated has the meaning described in
subsections (a) through (c) of section 402 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
342(a)–(c)).
(B)
The term adulterated includes bearing or containing
a contaminant that causes illness or death among sensitive populations.
(4)The
term agency
has the meaning given that term in section 551 of
title 5, United States Code.
(5)
Category 1 food establishmentThe term
category 1 food establishment means a food establishment that
routinely slaughters animals for human consumption.
(6)Category 2 food
establishmentThe term category 2 food establishment
means a food establishment that processes raw meat, poultry, seafood products,
and other products that the Administrator determines by regulation to be at
high risk of contamination and the processes of which do not include a step
validated to destroy contaminants.
(7)Category 3 food
establishmentThe term category 3 food establishment
means a food establishment that processes meat, poultry, seafood products, and
other products that the Administrator determines by regulation to be at high
risk of contamination and whose processes include a step validated to destroy
contaminants.
(8)Category 4 food
establishmentThe term category 4 food establishment
means a food establishment that processes all other categories of food products
not described in paragraphs (5) through (7).
(9)Category 5 food
establishmentThe term category 5 food establishment
means a food establishment that stores, holds, or transports food products
prior to delivery for retail sale.
(10)
The term contaminant includes a bacterium, chemical,
natural or manufactured toxin, virus, parasite, prion, physical hazard, or
other human pathogen that when found on or in food can cause human illness,
injury, or death.
(11)The
term contamination refers to a presence of a contaminant in
food.
(12)
(A)
The term food means a product intended to be used
for food or drink for a human.
(B)
The term food includes any product (including a meat
food product, as defined in section 1(j) of the Federal Meat Inspection Act (21
U.S.C. 601(j))), capable for use as human food that is made in whole or in part
from any animal, including cattle, sheep, swine, or goat, or poultry (as
defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)).
(C)The
term food does not include dietary supplements, as defined in
section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(ff)).
(13)
(A)
The term food establishment means a slaughterhouse,
factory, warehouse, or facility owned or operated by a person located in any
State that processes food.
(B)
For the purposes of registration, the term food
establishment does not include a farm, restaurant, other retail food
establishment, nonprofit food establishment in which food is prepared for or
served directly to the consumer, or fishing vessel (other than a fishing vessel
engaged in processing, as that term is defined in section 123.3 of title 21,
Code of Federal Regulations).
(14)The term food production
facility means any farm, ranch, orchard, vineyard, aquaculture facility,
confined animal-feeding operation, or animal feed production facility.
(15)
The term food safety law means—
(A)
the provisions of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) related to and requiring the safety, labeling, and
inspection of food, infant formulas, food additives, pesticide residues, and
other substances present in food under that Act;
(B)the provisions of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and of any
other Act that are administered by the Center for Veterinary Medicine of the
Food and Drug Administration;
(C)
the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.);
(D)
the Federal Meat Inspection Act (21 U.S.C.
601 et seq.);
(E)
the Egg Products Inspection Act (21 U.S.C.
1031 et seq.);
(F)the Sanitary Food
Transportation Act of 1990 (49 U.S.C. App. 2801 et seq.);
(G)the provisions of
the Humane Methods of Slaughter Act of 1978 (Public Law 95–448) administered by
the Food Safety and Inspection Service;
(H)the provisions of
this Act; and
(I)
such other provisions of law related to and requiring food
safety, labeling, inspection, and enforcement as the President designates by
Executive order as appropriate to include within the jurisdiction of the
Administration.
(16)
Foreign food establishment
(A)
The term foreign food establishment means a
slaughterhouse, factory, warehouse, or facility located outside the United
States that processes food that is imported into the United States without
further processing or packaging inside the United States.
(B)
Further processing or packaging
A food shall not be considered to have undergone further
processing or packaging solely because labeling was added or a similar activity
of a de minimis nature was carried out with respect to the food.
(17)
The term interstate commerce has the meaning given
that term in
section 201(b) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
321(b)).
(18)The
term misbranded has the meaning given that term in section 403 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
(19)
The term process or processing means
the commercial harvesting, slaughter, packing, preparation, or manufacture of
food.
(20)
The term safe refers to human health.
(21)
The term State means—
(A)
a State;
(B)
the District of Columbia;
(C)
the Commonwealth of Puerto Rico; and
(D)
any other territory or possession of the United States.
<enum>I</enum>
<header>Establishment of Food Safety Administration</header>
<section id="ID94D627065CE64906B6CE925C028F61EE">
<enum>101.</enum>
<header>Establishment of Food Safety Administration</header>
<subsection id="ID0F810944AE0D4BF19DF128F927DA2F20">
<enum>(a)</enum>
<header>Establishment</header>
<paragraph id="ID8FD07311A9ED428597C27337F1D0BAB1">
<enum>(1)</enum>
<header>In general</header>
<text>There is established in the executive branch an agency to be
known as the <quote>Food Safety Administration</quote>.</text>
</paragraph><paragraph id="ID76B258DBA4DA471293D634C20000F8DB">
<enum>(2)</enum>
<header>Status</header>
<text>The Administration shall be an independent establishment (as
defined in section 104 of title 5, United States Code).</text>
</paragraph><paragraph id="IDFDFFBC65DE434DA18EF05F00229D8E76">
<enum>(3)</enum>
<header>Head of Administration</header>
<text>The Administration shall be headed by the Administrator of Food
Safety, who shall be appointed by the President, by and with the advice and
consent of the Senate.</text>
</paragraph></subsection><subsection id="ID01E2A5433C924E71A464588FF4E88FC4">
<enum>(b)</enum>
<header>Duties of Administrator</header>
<text>The Administrator shall—</text>
<paragraph id="ID92D7BB20F05E4827BB033011F500C132">
<enum>(1)</enum>
<text>administer and enforce the food safety law;</text>
</paragraph><paragraph id="idA0EF3089861F45D78F2B7059DF210042"><enum>(2)</enum><text>serve as a
representative to international food safety bodies and discussions;</text>
</paragraph><paragraph id="id12FD835D83854655B9122C240B06693D"><enum>(3)</enum><text>promulgate
regulations to ensure the security of the food supply from all forms of
contamination, including intentional contamination; and</text>
</paragraph><paragraph id="IDDDD9C930590941DAB5063CAFE4833C51">
<enum>(4)</enum>
<text>oversee—</text>
<subparagraph id="ID6EC94D9A45EA46CF9E002B1FDE9217FA">
<enum>(A)</enum>
<text>implementation of Federal food safety inspection, enforcement,
and research efforts, to protect the public health;</text>
</subparagraph><subparagraph id="ID76947AB4A4BA4B5491F9FD217BF21453">
<enum>(B)</enum>
<text>development of consistent and science-based standards for safe
food;</text>
</subparagraph><subparagraph id="ID26BCDB75010546F3BF21EED3F2CDF861">
<enum>(C)</enum>
<text>coordination and prioritization of food safety research and
education programs with other Federal agencies;</text>
</subparagraph><subparagraph id="id64105136FA4A47FA81ECF479B6EA550A"><enum>(D)</enum><text>prioritization of
Federal food safety efforts and deployment of Federal food safety resources to
achieve the greatest possible benefit in reducing food-borne illness;</text>
</subparagraph><subparagraph id="IDF7583C25B17244520050501EA67F5526">
<enum>(E)</enum>
<text>coordination of the Federal response to food-borne illness
outbreaks with other Federal and State agencies; and</text>
</subparagraph><subparagraph id="ID1288CD7D8E1C4A00954431E2E99BA447">
<enum>(F)</enum>
<text>integration of Federal food safety activities with State and
local agencies.</text>
</subparagraph></paragraph></subsection></section><section id="IDE4F7A108D46F47258897AA1E05002151">
<enum>102.</enum>
<header>Consolidation of separate food safety and inspection services
and agencies</header>
<subsection id="ID93468AD843A540449FD7FCB6062FD849">
<enum>(a)</enum>
<header>Transfer of functions</header>
<text>For each Federal agency specified in subsection (b), there are
transferred to the Administration all functions that the head of the Federal
agency exercised on the day before the effective date 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="IDB6875F1B71F543B8A82ED803909F2B4D">
<enum>(b)</enum>
<header>Transferred agencies</header>
<text>The Federal agencies referred to in subsection (a) are—</text>
<paragraph id="ID36B5A96883754D22A2B4EEAA32EAEA1F">
<enum>(1)</enum>
<text>the Food Safety and Inspection Service of the Department of
Agriculture;</text>
</paragraph><paragraph id="ID035EDD99F33743C4B041CB61BA603364">
<enum>(2)</enum>
<text>the Center for Food Safety and Applied Nutrition of the Food and
Drug Administration;</text>
</paragraph><paragraph id="ID337F2C76D0074045ABA9C0BCF14C6DEB">
<enum>(3)</enum>
<text>the part of the Agriculture Marketing Service that administers
shell egg surveillance services established under the Egg Products Inspection
Act (21 U.S.C. 1031 et seq.);</text>
</paragraph><paragraph id="id79742197674D40AAA593059D0229B5BA"><enum>(4)</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 establishments
and imports;</text>
</paragraph><paragraph id="idC3C743F9983D4E80A5A1B04F9E1950F9"><enum>(5)</enum><text>the resources and
facilities of the Office of the Commissioner of the Food and Drug
Administration that support—</text>
<subparagraph id="id59E84BD6498441B8AF314137B3775B78"><enum>(A)</enum><text>the Center for
Food Safety and Applied Nutrition;</text>
</subparagraph><subparagraph id="idD82B4F61E2DC406FBC13474D2F9F63C6"><enum>(B)</enum><text>the Center for
Veterinary Medicine; and</text>
</subparagraph><subparagraph id="id9BC3E98A76284A649064D65B7E058040"><enum>(C)</enum><text>the Office of
Regulatory Affairs facilities and resources described in paragraph (4);</text>
</subparagraph></paragraph><paragraph id="idA73AC946423B4ACEA26789330507C43C"><enum>(6)</enum><text>the Center for
Veterinary Medicine of the Food and Drug Administration;</text>
</paragraph><paragraph id="idB8168C5678E64B049649E94129AC12D4"><enum>(7)</enum><text>the resources and
facilities of the Environmental Protection Agency that control and regulate
pesticide residues in food;</text>
</paragraph><paragraph id="idAE0AE53CDA244EF8B2434D23FD7FDA5D"><enum>(8)</enum><text>the part of the
Research, Education, and Economics mission area of the Department of
Agriculture related to food safety and animal feed research;</text>
</paragraph><paragraph id="ID32C8502D192C4712ADCE5E19EFF04554">
<enum>(9)</enum>
<text>the part of the National Marine Fisheries Service of the National
Oceanic and Atmospheric Administration of the Department of Commerce that
administers the seafood inspection program; and</text>
</paragraph><paragraph id="IDCBC0A71F5A76436583C0EE347D245800">
<enum>(10)</enum>
<text>such other offices, services, or agencies as the President
designates by Executive order to carry out this Act.</text>
</paragraph></subsection></section><section id="ID86787AB2FB4945689C4F00086B25D445">
<enum>103.</enum>
<header>Additional duties of the Administration</header>
<subsection id="ID3936FAA045BE434C908F429E25AEFA50">
<enum>(a)</enum>
<header>Officers and employees</header>
<text>The Administrator may—</text>
<paragraph id="IDFD2CB53EAF5E4711A18878FF87A851C0">
<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="ID34E889059420465DB17B0031317F9F82">
<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="ID453A380756D84D5D8D30A97C81EA2B00">
<enum>(b)</enum>
<header>Experts and consultants</header>
<text>The Administrator may—</text>
<paragraph id="ID7ADCCC02DDB44A968B640327F64E47C2">
<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="ID0641972A153A4D08AD003988F6FE997D">
<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="IDF7A9EBBE9F7042C486FC8BC6B61D77B6">
<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></section>
<enum>II</enum>
<header>Administration of food safety program</header>
<section id="IDE00DBF1D5E6C43E4909E6D22BE18C907">
<enum>201.</enum>
<header>Administration of national program</header>
<subsection id="IDCC0F006CCCBD41F8BCA12F76506B6D90">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator shall—</text>
<paragraph id="ID2A29CE8F618845F4864BA077F049935E">
<enum>(1)</enum>
<text>administer a national food safety program (referred to in this
section as the <quote>program</quote>) to protect public health; and</text>
</paragraph><paragraph id="IDD668B04CA44349D300045547184B32BA">
<enum>(2)</enum>
<text>ensure that persons who produce or process food for human
consumption meet their responsibility to prevent or minimize food safety
hazards related to their products.</text>
</paragraph></subsection><subsection id="ID7279F704E01E4931BDED877637E7F9DA">
<enum>(b)</enum>
<header>Comprehensive analysis</header>
<text>The program shall be based on a comprehensive analysis of the
hazards associated with different food and with the processing of different
food, including the identification and evaluation of—</text>
<paragraph id="IDBBC5501C37294CAEBF0827A38836B5F1">
<enum>(1)</enum>
<text>the severity of the potential health risks;</text>
</paragraph><paragraph id="ID41CE932D35CB411BAFBF24C16E9CA6EB">
<enum>(2)</enum>
<text>the sources and specific points of potential contamination
extending from the farm or ranch to the consumer that may render food unsafe
for human consumption;</text>
</paragraph><paragraph id="IDAE0EC561F0194FF087C7A19B34ADD595">
<enum>(3)</enum>
<text>the potential for persistence, multiplication, or concentration
of naturally occurring or added contaminants in food;</text>
</paragraph><paragraph id="id7B2EA14C584E4F5DB312B538A48F1A43"><enum>(4)</enum><text>opportunities
across the food production, processing, distribution, and retail system to
reduce potential health risks; and</text>
</paragraph><paragraph id="id5B9EB925BBE34CF991B68940D490CADE"><enum>(5)</enum><text>opportunities for
intentional contamination.</text>
</paragraph></subsection><subsection id="ID6E338E80327F452391C7DC2C4F91E3EB">
<enum>(c)</enum>
<header>Program elements</header>
<text>In carrying out the program, the Administrator shall—</text>
<paragraph id="IDE8556648B07249E38D419B4BBC91C2AD">
<enum>(1)</enum>
<text>implement a national system for the registration of food
establishments and foreign food establishments and regular unannounced
inspection of food establishments;</text>
</paragraph><paragraph id="IDB211740E453B41808C62041600D81F00">
<enum>(2)</enum>
<text>enforce the adoption of process controls in food establishments,
based on best available scientific and public health considerations and best
available technologies;</text>
</paragraph><paragraph id="ID9E0D37EC020349C1843B00219ED25178">
<enum>(3)</enum>
<text>establish and enforce science-based standards for—</text>
<subparagraph id="IDC57F83D56703402694F72BEB6E6EF7FB">
<enum>(A)</enum>
<text>substances that may contaminate food; and</text>
</subparagraph><subparagraph id="ID24925E57828C40269194B793E41758FE">
<enum>(B)</enum>
<text>safety and sanitation in the processing and handling of
food;</text>
</subparagraph></paragraph><paragraph id="IDC4EFF85D4ED84A8AB86258940819CFBD">
<enum>(4)</enum>
<text>implement a sampling program to ensure that industry programs and
procedures that prevent food contamination are effective on an ongoing basis
and that food meets the standards established under this Act;</text>
</paragraph><paragraph id="IDE21A1038FDC842CA00A6DED306A68D5E">
<enum>(5)</enum>
<text>implement procedures and requirements to ensure the safety and
security of imported food;</text>
</paragraph><paragraph id="ID1E2345B09F5A452AA8CC5DA66B2CF313">
<enum>(6)</enum>
<text>coordinate with other agencies and State or local governments in
carrying out inspection, enforcement, and monitoring;</text>
</paragraph><paragraph id="ID69822CECC35141F0BE204400405C33AB">
<enum>(7)</enum>
<text>have access to the surveillance data of the Centers for Disease
Control and Prevention, and other Federal Government agencies, in order to
implement a national surveillance system to assess the health risks associated
with the human consumption of food;</text>
</paragraph><paragraph id="ID15840A3B4B64444DAA71B2C1A4CF6509">
<enum>(8)</enum>
<text>develop public education risk communication and advisory
programs;</text>
</paragraph><paragraph id="ID1DF85B779A6B4F4BB000007D5EC65D13">
<enum>(9)</enum>
<text>implement a research program to further the purposes of this Act;
and</text>
</paragraph><paragraph id="idF08912EDED0B4EEC92A734A74A308145"><enum>(10)</enum><text>coordinate and
prioritize food safety research and educational programs with other agencies,
including State or local agencies.</text>
</paragraph></subsection></section><section id="ID8BF4848C81E9484FB556B38181204604">
<enum>202.</enum>
<header>Registration of food establishments and foreign food
establishments</header>
<subsection id="ID6BD41C45540347A2BD6BC239599E717D">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator shall by regulation require that any food
establishment or foreign food establishment engaged in processing food for
human consumption in the United States be registered with the
Administrator.</text>
</subsection><subsection id="ID24DFC7542CA44A27A96B2F50EBF3832D">
<enum>(b)</enum>
<header>Registration requirements</header>
<paragraph id="IDB8DDBF853BAE46718359E9DCC54C28DA">
<enum>(1)</enum>
<header>In general</header>
<text>To be registered under subsection (a)—</text>
<subparagraph id="IDD399F6AB3EF4424F853804B56605831F">
<enum>(A)</enum>
<text>in the case of a food establishment, the owner, operator, or
agent in charge of the food establishment shall submit a registration to the
Administrator; and</text>
</subparagraph><subparagraph id="ID0A64287B0C83434488A6C966DA738D47">
<enum>(B)</enum>
<text>in the case of a foreign food establishment, the owner, operator,
or agent in charge of the foreign food establishment shall—</text>
<clause id="IDD078E52D00304DBE0063D9C4B7C445F2">
<enum>(i)</enum>
<text>submit a registration to the Administrator; and</text>
</clause><clause id="ID7E024E4C04934A22A085E4E82EB2F57D">
<enum>(ii)</enum>
<text>provide the name, address, and emergency contact information of
the United States agent for the foreign food establishment.</text>
</clause></subparagraph></paragraph><paragraph id="IDED2674F2DE414D5C83622C62FFC97630">
<enum>(2)</enum>
<header>Registration</header>
<text>A food establishment or foreign food establishment shall submit a
registration under paragraph (1) to the Administrator that—</text>
<subparagraph id="ID677CD1ADB9CC486B89E842C439A844BE">
<enum>(A)</enum>
<text>identifies the name, address, and emergency contact information
of each food establishment or foreign food establishment that the registrant
operates under this Act and all trade names under which the registrant conducts
business relating to food;</text>
</subparagraph><subparagraph id="ID63BEAF1392E54558AF5188A9E1C2D5B5">
<enum>(B)</enum>
<text>lists the primary purpose and business activity of each food
establishment or foreign food establishment, including the dates of operation
if the food establishment or foreign food establishment is seasonal;</text>
</subparagraph><subparagraph id="IDA775E170BE3248E49273DA7FC096FCE8">
<enum>(C)</enum>
<text>lists the types of food processed or sold at each food
establishment or, for foreign food establishments selling food for consumption
in the United States, identifies the specific food categories of that food as
listed under section 170.3 of title 21, Code of Federal Regulations; and</text>
</subparagraph><subparagraph id="ID79A6C1E619C84FF99420DADF3FC9886C">
<enum>(D)</enum>
<text>not later than 30 days after a change in the products, function,
or legal status of the food establishment or foreign food establishment
(including cessation of business activities), notifies the Administrator of the
change.</text>
</subparagraph></paragraph><paragraph id="ID533CA36EF49B488FA16397ACE1483F27">
<enum>(3)</enum>
<header>Procedure</header>
<text>Upon receipt of a completed registration described in paragraph
(1), the Administrator shall notify the registrant of the receipt of the
registration and assign a registration number to each food establishment and
foreign food establishment.</text>
</paragraph><paragraph id="ID26331B7C0F1241528D8C4CB03FA09C51">
<enum>(4)</enum>
<header>List</header>
<text>The Administrator shall compile and maintain an up-to-date list
of food establishments and foreign food establishments that are registered
under this section.</text>
</paragraph><paragraph id="id2C1343457967490C811290AFED78C84C"><enum>(5)</enum><header>Disclosure
exemption</header><text>The disclosure requirements under section 552 of title
5, United States Code, shall not apply to—</text>
<subparagraph id="idF05B9A11E1C647B2A99381089D3C934F"><enum>(A)</enum><text>the list compiled
under paragraph (4); and</text>
</subparagraph><subparagraph id="id78CE2D76FB264786A2956820C0F5CDD2"><enum>(B)</enum><text>information
derived from the list under paragraph (4), to the extent that it discloses the
identity or location of a specific registered person.</text>
</subparagraph></paragraph><paragraph id="ID7E55B8663E9F4B7F80444CF3149EC077">
<enum>(6)</enum>
<header>Suspension of registration</header>
<subparagraph id="id3075534D8CD64A71BE6258BCF7D667AB"><enum>(A)</enum><header>In
general</header><text>The Administrator may suspend the registration of a food
establishment or foreign food establishment, including the facility of an
importer, for violation of a food safety law.</text>
</subparagraph><subparagraph id="idD7180976B76147B6BBEF34A6DB691545"><enum>(B)</enum><header>Notice and
opportunity for hearing</header><text>The Administrator shall provide notice to
a registrant immediately upon the suspension of the registration of the
facility and provide registrant with an opportunity for a hearing within 3 days
of the suspension.</text>
</subparagraph></paragraph><paragraph id="id5016333C18E94EED86A333D09049523B"><enum>(7)</enum><header>Reinstatement</header><text>A
registration that is suspended under this section may be reinstated pursuant to
criteria published in the Federal Register by the Administrator.</text>
</paragraph></subsection></section><section id="IDBBE819EBDF2A45DE85DA37FD2168C496">
<enum>203.</enum>
<header>Preventative process controls to reduce adulteration of
food</header>
<subsection id="ID0EF3D0D0BD8D4AD991BF35A4946766E9">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator shall, upon the basis of best available public
health, scientific, and technological data, promulgate regulations to ensure
that food establishments—</text>
<paragraph id="id421DCA336D924A248FAAE74A1F57AAA8"><enum>(1)</enum><text>process food in a
sanitary manner;</text>
</paragraph><paragraph id="ID47AC361C36C24339B7E95E8507271337">
<enum>(2)</enum>
<text>limit the presence of potentially harmful contaminants in
food;</text>
</paragraph><paragraph id="ID84240EDAC5A7446291000052E546433D">
<enum>(3)</enum>
<text>implement appropriate measures of preventative process control to
minimize and reduce the presence and growth of contaminants in food and meet
the performance standards established under section 204;</text>
</paragraph><paragraph id="ID120152418EB44FE69B0000D3369200BC">
<enum>(4)</enum>
<text>process all fully processed or ready-to-eat food in a sanitary
manner, using reasonably available techniques and technologies to eliminate any
potentially harmful contaminants; and</text>
</paragraph><paragraph id="IDAACAA66107C441ED9EA4764D18331178">
<enum>(5)</enum>
<text>label food intended for final processing outside commercial food
establishments with instructions for handling and preparation for consumption
that, when adhered to, will destroy contaminants.</text>
</paragraph></subsection><subsection id="ID51C68221A20044E0AFC7BD49DA9ED94D">
<enum>(b)</enum>
<header>Regulations</header>
<text>Not later than 1 year after the effective date of this Act, the
Administrator shall promulgate regulations that—</text>
<paragraph id="IDBEFD9F9684234D8A855355623935E814">
<enum>(1)</enum>
<text>require all food establishments to adopt preventative process
controls that are—</text>
<subparagraph id="IDAE4501DFEA6C47E1826772AFB59B88AA">
<enum>(A)</enum>
<text>adequate to protect the public health;</text>
</subparagraph><subparagraph id="id62897FF1944A4EAFA3D525044261F8F8"><enum>(B)</enum><text>meet relevant
regulatory and food safety standards; and</text>
</subparagraph><subparagraph id="ID75F8E3DAA9784154AC00DD1272E165CD">
<enum>(C)</enum>
<text>limit the presence and growth of contaminants in food prepared in
a food establishment;</text>
</subparagraph></paragraph><paragraph id="ID7B97A349F81F4E6EA059617669959441">
<enum>(2)</enum>
<text>set standards for sanitation;</text>
</paragraph><paragraph id="ID98FB6B2971274269B34D9F227B5D1EBD">
<enum>(3)</enum>
<text>meet any performance standards for contaminants established under
section 204;</text>
</paragraph><paragraph id="IDFFD86DD3A413454AABDF9C41C14B0561">
<enum>(4)</enum>
<text>require recordkeeping to monitor compliance;</text>
</paragraph><paragraph id="IDDE4E1A81364A43689CB86BD2DF614632">
<enum>(5)</enum>
<text>require sampling and testing at a frequency and in a manner
sufficient to ensure that process controls are effective on an ongoing basis
and that regulatory standards are being met; and</text>
</paragraph><paragraph id="ID6D6B5F2090114D499208FB3D46412B8B">
<enum>(6)</enum>
<text>provide for agency access to records kept by food establishments
and submission of copies of the records to the Administrator, as the
Administrator determines appropriate.</text>
</paragraph></subsection><subsection id="ID08B757495BF54DA1BD22DD03E4685725">
<enum>(c)</enum>
<header>Processing controls</header>
<text>The Administrator may require any person with responsibility for
or control over food or food ingredients to adopt process controls, if the
process controls are needed to ensure the protection of the public
health.</text>
</subsection></section><section id="ID28D87D31147749DC814F829FC68B247C">
<enum>204.</enum>
<header>Performance standards for contaminants in food</header>
<subsection id="ID38910605acca4a01876c05925c4c2167"><enum>(a)</enum><header>In
general</header><text>To protect the public health, the Administrator shall
establish by regulation and enforce performance standards that define, with
respect to specific food-borne contaminants and foods, the level of food safety
performance that a person responsible for producing, processing, or selling
food shall meet.</text>
</subsection><subsection id="ID526910b3635e4f6d8152dc23a1389a1f"><enum>(b)</enum><header>Identification
of contaminants; performance standards</header>
<paragraph id="IDb33fabe6cdd948d7a96a73dfe3ead51f"><enum>(1)</enum><header>In
general</header><text>Not later than 6 months after the date of enactment of
this Act, the Administrator shall identify the food-borne contaminants and food
that contribute significantly to the risk of food-borne illness.</text>
</paragraph><paragraph id="IDa6350618417443159f430f3ea445500d"><enum>(2)</enum><header>Performance
standards</header><text>As soon as practicable after the identification of the
contaminants under paragraph (1), the Administrator shall establish appropriate
performance standards to protect against all food-borne contaminants.</text>
</paragraph><paragraph id="ID8223ff216f7b42f782bd8681c96f9111"><enum>(3)</enum><header>Significant
contaminants</header><text>The Administrator shall establish performance
standards for the 5 most significant contaminants associated with raw meat,
poultry, and seafood not later than 3 years after the date of enactment of this
Act.</text>
</paragraph></subsection><subsection id="IDd86d5b3bb63f48b99815935b8ebe91a9"><enum>(c)</enum><header>Performance
standards</header>
<paragraph id="IDba08e74a46944d1e9097914615ae9a83"><enum>(1)</enum><header>In
general</header><text>The performance standards established under this section
shall include—</text>
<subparagraph id="ID22e0bc48c8be45fbb2a4e2f1c948202d"><enum>(A)</enum><text>health-based
standards that set the level of a contaminant that can safely and lawfully be
present in food;</text>
</subparagraph><subparagraph id="IDe44d215cef494f8eb3a4c828e1024d24"><enum>(B)</enum><text>zero tolerances,
in addition to any zero-tolerance standards in effect on the day before the
date of enactment of this Act, when necessary to protect against significant
adverse health outcomes;</text>
</subparagraph><subparagraph id="ID867c647d29d545cba9b9d261d8b57ea9"><enum>(C)</enum><text>process
standards, such as log reduction criteria for cooked products, when sufficient
to ensure the safety of processed food; and</text>
</subparagraph><subparagraph id="ID6a3fcda2ed0f4082a177d7d08e5b2d57"><enum>(D)</enum><text>in the absence of
data to support a performance standard described in subparagraph (A), (B), or
(C), standards that define required performance in terms of “best reasonably
achievable performance”, using best available technologies, interventions, and
practices.</text>
</subparagraph></paragraph><paragraph id="ID66baa38135ba44acb4892ebca5968e1a"><enum>(2)</enum><header>Best reasonably
achievable performance standards</header><text>In developing best reasonably
achievable performance standards, the Administrator shall collect, or contract
for the collection of, data on current best practices and food safety outcomes
related to the contaminants and foods in question, as the Administrator
determines necessary.</text>
</paragraph><paragraph id="ID502ffa54ae8243aa8f73c3ad4e450862"><enum>(3)</enum><header>Revocation by
administrator</header><text>All performance standards, tolerances, action
levels, or other similar standards in effect on the date of enactment of this
Act shall remain in effect until revised or revoked by the
Administrator.</text>
</paragraph></subsection><subsection id="ID2F5C13E0A59943E585CEAB34000343BB">
<enum>(d)</enum>
<header>Enforcement</header>
<paragraph id="IDD3D4A5DA67AB4AB087E9932824C9E24E">
<enum>(1)</enum>
<header>In general</header>
<text>Not later than 1 year after the promulgation of a performance
standard under this section, the Administrator shall implement a sampling
program to determine whether food establishments are complying with the
performance standards promulgated under this section. The program established
under this paragraph shall be at least as stringent as the Hazard Analysis and
Critical Control Point System requirements established under part 417 of title
9, Code of Federal Regulations (or successor regulation).</text>
</paragraph><paragraph id="IDFBCD497354584E119BD178C1A81952B2">
<enum>(2)</enum>
<header>Inspections</header>
<text>If the Administrator determines that a food establishment fails
to meet a standard promulgated under this section, and such establishment fails
to take appropriate corrective action as determined by the Administrator, the
Administrator shall, as appropriate—</text>
<subparagraph id="IDDDDC9ECF5EAE46088C4E659CA423FD82">
<enum>(A)</enum>
<text>detain, seize, or condemn food from the food establishment under
section 402;</text>
</subparagraph><subparagraph id="IDAA5D49A9D67E4A5EB437F7E6295E8C25">
<enum>(B)</enum>
<text>order a recall of food from the food establishment under section
403;</text>
</subparagraph><subparagraph id="IDA0F2CCCE615C4C31AB5300E4A36764E0">
<enum>(C)</enum>
<text>increase the inspection frequency for the food
establishment;</text>
</subparagraph><subparagraph id="ID392578CC02944C069DEE58A840AC15A0">
<enum>(D)</enum>
<text>withdraw the mark of inspection from the food establishment, if
in use; or</text>
</subparagraph><subparagraph id="ID4ABD5CC4ED1D4F5E806DB322BC4678FB">
<enum>(E)</enum>
<text>take other appropriate enforcement action concerning the food
establishment.</text>
</subparagraph></paragraph></subsection><subsection id="id376DC5BC18234A5691B87C137A6C8D15"><enum>(e)</enum><header>Newly
Identified contaminants</header><text>Notwithstanding any other provision of
this section, the Administrator shall promulgate interim performance standards
for newly identified contaminants as necessary to protect the public
health.</text>
</subsection></section><section id="ID3CAE5D985D1C4DB9AFC5584B3D3D1F89">
<enum>205.</enum>
<header>Inspections of food establishments</header>
<subsection id="ID76382bd4736c4265a3efcbd01134adfd"><enum>(a)</enum><header>In
general</header><text>The Administrator shall establish an inspection program,
which shall include sampling and testing of food and food establishments, to
determine if each food establishment—</text>
<paragraph id="ID8d52104efa424f04a9fd25a88e103fdb"><enum>(1)</enum><text>is operating in a
sanitary manner;</text>
</paragraph><paragraph id="ID273a35c60ef44437beb3d7a91475987b"><enum>(2)</enum><text>has continuous
systems, interventions, and processes in place to minimize or eliminate
contaminants in food;</text>
</paragraph><paragraph id="ID89db5ec9c2d4402cb796f947b5ba41e8"><enum>(3)</enum><text>is in compliance
with applicable performance standards established under section 203, and other
regulatory requirements;</text>
</paragraph><paragraph id="ID0e87e946debb46a0ac1c957797200707"><enum>(4)</enum><text>is processing
food that is safe for human consumption and not adulterated or
misbranded;</text>
</paragraph><paragraph id="IDd35c343d39f4418d8ca603f8ae7ff943"><enum>(5)</enum><text>maintains records
of process control plans under section 203, and other records related to the
processing, sampling, and handling of food; and</text>
</paragraph><paragraph id="IDdd2bc07c811d491b8e8c95219076ff5f"><enum>(6)</enum><text>is in compliance
with the requirements of the food safety law.</text>
</paragraph></subsection><subsection id="id64E3E59FEEE1461E977C4EEF9112D4C7"><enum>(b)</enum><header>Establishment
categories and inspection frequencies</header><text>The resource plan required
under section 209, including the description of resources required to carry out
inspections of food establishments, shall be based on the following categories
and inspection frequencies, subject to subsections (c) and (d):</text>
<paragraph id="id5F018283D540405DB8FFA8A7193523FF"><enum>(1)</enum><header>Category 1 food
establishments</header><text>A category 1 food establishment shall be subject
to antemortem and continuous inspection of each slaughter line during all
operating hours, and other inspection on a daily basis, sufficient to verify
that—</text>
<subparagraph id="idDE075520CEDD4741B6AD63029D066A61"><enum>(A)</enum><text>diseased animals
are not offered for slaughter;</text>
</subparagraph><subparagraph id="id22B38261F3724CA2A56AC56F3563732A"><enum>(B)</enum><text>the food
establishment has successfully identified and removed from the slaughter line
visibly defective or contaminated carcasses and destroyed or reprocessed them
in a manner acceptable to the Administrator; and</text>
</subparagraph><subparagraph id="id998D075A40864AE08A9CABBED26B476C"><enum>(C)</enum><text>that applicable
performance standards and other provisions of the food safety law have been
satisfied.</text>
</subparagraph></paragraph><paragraph id="id433F495BFD294662A4DEB2815A1AB963"><enum>(2)</enum><header>Category 2 food
establishments</header><text>A category 2 food establishment shall be randomly
inspected at least daily.</text>
</paragraph><paragraph id="id5E43F560B5624AC3A48D9F67E99EB0DE"><enum>(3)</enum><header>Category 3 food
establishments</header><text>A category 3 food establishment shall—</text>
<subparagraph id="idCA75856D17B441C29AB206B6DD1B68E2"><enum>(A)</enum><text>have ongoing
verification that its processes are controlled; and</text>
</subparagraph><subparagraph id="id61AF0891CE7D4259BD23C901DD7A6824"><enum>(B)</enum><text>be randomly
inspected at least monthly.</text>
</subparagraph></paragraph><paragraph id="id76E31EED0A9B422487416C9CFAE763AC"><enum>(4)</enum><header>Category 4 food
establishments</header><text>A category 4 food establishment shall be randomly
inspected at least quarterly.</text>
</paragraph><paragraph id="id6D2DAC2A1A5A42E5A82AB7D5E08FC793"><enum>(5)</enum><header>Category 5 food
establishments</header><text>A category 5 food establishment shall be randomly
inspected at least annually.</text>
</paragraph></subsection><subsection id="idA3F85BD7BA2D4221BC826479795C1997"><enum>(c)</enum><header>Alternative
inspection frequencies</header><text>With respect to a category 2, 3, 4, or 5
food establishment, the Administrator may establish alternative inspection
frequencies for subcategories of food establishments or individual
establishments, to foster risk-based allocation of resources, subject to the
following criteria and procedures:</text>
<paragraph id="id871852216CF24FD8A74A6009B60D789A"><enum>(1)</enum><text>Subcategories of
food establishments and their alternative inspection frequencies shall be
defined by regulation, subject to paragraphs (2) and (3).</text>
</paragraph><paragraph id="idC5DE2A60E2E7480F87333967808C9831"><enum>(2)</enum><text>Regulations of
alternative inspection frequencies for subcategories of food establishments
under paragraph (1) and for a specific food establishment under paragraph (4)
shall provide that—</text>
<subparagraph id="id4335B62B7B23438CAB54588B8B5C4AFF"><enum>(A)</enum><text>category 2 food
establishments shall be inspected at least monthly; and</text>
</subparagraph><subparagraph id="idB464B6BE7DD444AA9C106100766DF799"><enum>(B)</enum><text>category 3, 4,
and 5 food establishments shall be inspected at least annually.</text>
</subparagraph></paragraph><paragraph id="idA7207400D19B431F80AF655CF3E9C5DE"><enum>(3)</enum><text>In defining
subcategories of food establishments and their alternative inspection
frequencies under paragraphs (1) and (2), the Administrator shall
consider—</text>
<subparagraph id="id91B58E66BDB841968796D8F0E1FF4F52"><enum>(A)</enum><text>the nature of the
food products being processed, stored, or transported;</text>
</subparagraph><subparagraph id="id1725E34F3CAE4065A2D580998C9657FF"><enum>(B)</enum><text>the manner in
which food products are processed, stored, or transported;</text>
</subparagraph><subparagraph id="id4F10CB5C534E424EA93D1598516EBD41"><enum>(C)</enum><text>the inherent
likelihood that the products will contribute to the risk of food-borne
illness;</text>
</subparagraph><subparagraph id="idB5053E9FAFB04F628E9B1F33BFFA4C6B"><enum>(D)</enum><text>the best
available evidence concerning reported illnesses associated with the foods
produced in the proposed subcategory of establishments; and</text>
</subparagraph><subparagraph id="idD4FCA4A2B98F4670BCD0E8D8F315F4F5"><enum>(E)</enum><text>the overall
record of compliance with the food safety law among establishments in the
proposed subcategory, including compliance with applicable performance
standards and the frequency of recalls.</text>
</subparagraph></paragraph><paragraph id="id1E259879CF0043DAA913CC98DF3DF800"><enum>(4)</enum><text>The Administrator
may adopt alternative inspection frequencies for a specific establishment,
subject to paragraphs (2) and (5) and shall periodically publish a list of
establishments subject to alternative inspections.</text>
</paragraph><paragraph id="idD7B75426BC194F6BBDB6D5D585D8ED1B"><enum>(5)</enum><text>In adopting
alternative inspection frequencies for a specific establishment, the
Administrator shall consider—</text>
<subparagraph id="idD7B48D46DF384A01AF1807A48BBEBA51"><enum>(A)</enum><text>the criteria in
paragraph (3);</text>
</subparagraph><subparagraph id="id83E2F1B844664171840861F8ADFF2FF8"><enum>(B)</enum><text>whether products
from the specific establishment have been associated with a case or an outbreak
of food-borne illness; and</text>
</subparagraph><subparagraph id="id0BF91296C5DF4DBB9D4081F169B3A29E"><enum>(C)</enum><text>the record of the
establishment of compliance with the food safety law, including compliance with
applicable performance standards and the frequency of recalls.</text>
</subparagraph></paragraph><paragraph id="id8CC4B31248D346AA8B8C76643D655557"><enum>(6)</enum><text>Before
establishing alternative inspection frequencies for subcategories of
establishments or individual establishments, the Administrator shall—</text>
<subparagraph id="id7390DDA6875846098333FF0153C347D0"><enum>(A)</enum><text>determine, based
on the best available evidence, that the alternative uses of the resources
required to carry out the inspection activity would make a greater contribution
to protecting the public health and reducing the risk of food-borne illness
than the use of resources described in subsection (b);</text>
</subparagraph><subparagraph id="idA1D85FC4AC72424E872E20CB9B8E4F34"><enum>(B)</enum><text>describe the
alternative uses of resources in general terms when issuing the regulation or
order that establishes the alternative inspection frequency;</text>
</subparagraph><subparagraph id="id63CFBB5FBB754821839AFAE6267142BE"><enum>(C)</enum><text>consider the
supporting evidence that an individual food establishment shall submit related
to whether an alternative inspection frequency should be established for such
establishment by the Administrator; and</text>
</subparagraph><subparagraph id="id371B7C703022464294BD2D8D883F0D8D"><enum>(D)</enum><text>include a
description of the alternative uses in the annual resource plan required in
section 209.</text>
</subparagraph></paragraph></subsection><subsection id="id0976D04792C64BC0BA45564E333C45C9"><enum>(d)</enum><header>Inspection
transition</header><text>The Administrator shall manage the transition to the
inspection system described in this Act as follows:</text>
<paragraph id="id923FF42812ED4928A4E2AC899E84A86C"><enum>(1)</enum><text>In the case of a
category 1 or 2 food establishment, the Administrator shall continue to
implement the applicable inspection mandates of the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
until—</text>
<subparagraph id="idAFD51CB2A1E14BFCB76B73D1748FDB5F"><enum>(A)</enum><text>regulations
required to implement this section have been promulgated;</text>
</subparagraph><subparagraph id="idADD9166D91574A8E9762A1DA40E5A79E"><enum>(B)</enum><text>the performance
standards required by section 204(c) have been promulgated and implemented for
1 year; and</text>
</subparagraph><subparagraph id="id86151CF4A54C466EBF4F20AD56A45E28"><enum>(C)</enum><text>the establishment
has achieved compliance with the other applicable provisions of the food safety
law.</text>
</subparagraph></paragraph><paragraph id="id16A66827125243C3BC7C08FFF3329FBE"><enum>(2)</enum><text>In the case of a
category 1 or 2 food establishment that, within 2 years after the promulgation
of the performance standards required by section 204(c), has not achieved
compliance with the food safety law, the Administrator shall—</text>
<subparagraph id="id7AEC5A439F644DAD940EEAB680C1F613"><enum>(A)</enum><text>issue an order
prohibiting the establishment from operating pending a demonstration by the
establishment that sufficient changes in facilities, procedures, personnel, or
other aspects of the process control system have been made such that the
Administrator determines that compliance with the food safety law is achieved;
and</text>
</subparagraph><subparagraph id="idCC48E126576C4A929E2FDCEA84DCD5BD"><enum>(B)</enum><text>following the
demonstration required in subparagraph (A), issue an order authorizing the food
establishment to operate subject, at a minimum, to—</text>
<clause id="id6F46560F7CE147E4B51394D3AF32B640"><enum>(i)</enum><text>the
inspection requirement applicable to the establishment under subsection (b) (1)
or (2); and</text>
</clause><clause id="idB4B15E91B571484E9E5B3DE0CA596F39"><enum>(ii)</enum><text>such other
inspection or compliance measures determined by the Administrator necessary to
assure compliance with the applicable food safety law.</text>
</clause></subparagraph></paragraph><paragraph id="id48C46CC8EF0C442B97A856EB8C10ACE7"><enum>(3)</enum><text>In the case of a
category 3 food establishment, the Administrator shall continue to implement
the applicable inspection mandates of the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
until—</text>
<subparagraph id="id6AB9737581CE49BA90F91F8BD181380E"><enum>(A)</enum><text>the regulations
required to implement this section have been promulgated;</text>
</subparagraph><subparagraph id="idA6CBA0E598EE476F8959A4D5A8E78D11"><enum>(B)</enum><text>the first
resource plan under section 209 has been submitted; and</text>
</subparagraph><subparagraph id="idC8E91CE4388F4BD2AF5F9F66F42654B6"><enum>(C)</enum><text>for individual
establishments, compliance with the food safety law has been
demonstrated.</text>
</subparagraph></paragraph><paragraph id="id8049A9D4B5CB4FCC9E333448DDEFA90C"><enum>(4)</enum><text>In the case of a
category 3 food establishment that, within 1 year after the promulgation of the
regulations required to implement this section, have not demonstrated
compliance with the food safety law, the Administrator shall—</text>
<subparagraph id="id06B08D80F28F4FB2B0F5D504E5299877"><enum>(A)</enum><text>issue an order
prohibiting the establishment from operating, pending a demonstration by the
establishment that sufficient changes in facilities, procedures, personnel, or
other aspects of the process control system have been made such that the
Administrator determines that compliance with the food safety law is achieved;
and</text>
</subparagraph><subparagraph id="idD3F2FDF0F8144476BE66C65308A1009A"><enum>(B)</enum><text>following the
demonstration required in subparagraph (A), issue an order authorizing the
establishment to operate subject, at a minimum, to—</text>
<clause id="idBCC088B17CBB4A6489621A82E439B4E4"><enum>(i)</enum><text>the
inspection requirement applicable to the establishment under subsection (b)(3);
and</text>
</clause><clause id="id6D3C7E812D514F1E9CE1B2AB2171F907"><enum>(ii)</enum><text>such other
inspection or compliance measures determined by the Administrator necessary to
assure compliance with the food safety law.</text>
</clause></subparagraph></paragraph><paragraph id="id66DF0DAEE2EA42E28F19EB275F08BD92"><enum>(5)</enum><text>In the case of a
category 4 or 5 food establishment, the inspection requirements of this Act
shall be implemented as soon as possible after—</text>
<subparagraph id="idBD9C20B8ECBC467DA5914C6B5AB0C616"><enum>(A)</enum><text>the promulgation
of the regulations required to implement this section;</text>
</subparagraph><subparagraph id="id03AC0AED4C394FEF8822092C84057668"><enum>(B)</enum><text>the publication
of the first resource plan under section 209; and</text>
</subparagraph><subparagraph id="idC160814301D7425D98705A55B7769B1D"><enum>(C)</enum><text>the commencement
of the first fiscal year in which the Administration is operating with
budgetary resources that Congress has appropriated following consideration of
the resource plan under section 209.</text>
</subparagraph></paragraph></subsection><subsection id="id8D590E45DFDA4C82BA4CDDE5266D32EB"><enum>(e)</enum><header>Official
mark</header>
<paragraph id="idABD4A9A0C3884ADA8B8A9514A9780F28"><enum>(1)</enum><header>In
general</header>
<subparagraph id="idC13DA17881DB4145903F2633279ED2B9"><enum>(A)</enum><header>Establishment</header><text>Before
the completion of the transition process under paragraphs (1) through (3) of
subsection (d), the Administrator shall by regulation establish an official
mark that shall be affixed to a food product produced in a category 1, 2, or 3
establishment, subject to subparagraph (B).</text>
</subparagraph><subparagraph id="id4201DC12C84C41D9ACED3F5A196B0EFF"><enum>(B)</enum><header>Prerequisite</header><text>The
official mark required under subparagraph (A) shall be affixed to a food
product by the Administrator if the establishment has been inspected by the
Administrator in accordance with the inspection frequencies under this section
and the establishment is in compliance with the food safety law.</text>
</subparagraph></paragraph><paragraph id="idB57FA0ED1B824210A2AE5B65C27245CB"><enum>(2)</enum><header>Category 1, 2,
or 3 food establishments</header><text>In the case of products produced in a
category 1, 2, or 3 food establishment—</text>
<subparagraph id="id1F2063841B804A6986D3FB3A571180D7"><enum>(A)</enum><text>products subject
to Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), the Egg Products Inspection Act (21
U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) as of the date of enactment of this Act shall remain subject to
the requirement under those Acts that they bear the mark of inspection pending
completion of the transition process under paragraphs (1) through (3) of
subsection (d);</text>
</subparagraph><subparagraph id="id34092772E9AE4141BBFAF6695876595F"><enum>(B)</enum><text>the Administrator
shall publicly certify on a monthly basis that the inspection frequencies
required under this Act have been achieved; and</text>
</subparagraph><subparagraph id="idA98B47581BFA4A78ABE3EAB0EA4D848D"><enum>(C)</enum><text>a product from an
establishment that has not been inspected in accordance with the required
frequencies under this section shall not bear the official mark and shall not
be shipped in interstate commerce.</text>
</subparagraph></paragraph><paragraph id="id3225A2C391C84B7FA70E33A54BE152EB"><enum>(3)</enum><header>Category 4 and
5 food establishments</header><text>In the case of a product produced in a
category 4 or 5 food establishment the Administrator shall provide by
regulation for the voluntary use of the official mark established under
paragraph (1), subject to—</text>
<subparagraph id="id0820A5B61A40408698461062EB265A57"><enum>(A)</enum><text>such minimum
inspection frequencies as determined appropriate by the Administrator;</text>
</subparagraph><subparagraph id="idD10140DCE2544715BF06954956A3F540"><enum>(B)</enum><text>compliance with
applicable performance standards and other provisions of the food safety law;
and</text>
</subparagraph><subparagraph id="id9A8EE0668DA1423F86FB35CDB0E895B1"><enum>(C)</enum><text>such other
requirements the Administrator considers appropriate.</text>
</subparagraph></paragraph></subsection><subsection id="idBA8218AE0AB74C548533344A140FCA77"><enum>(f)</enum><header>Implementation</header><text>Not
later than 1 year after the effective date of this Act, the Administrator shall
issue regulations to implement subsections (b) through (d).</text>
</subsection><subsection id="ID3441E270BC084292875D67D346EE3530">
<enum>(g)</enum>
<header>Maintenance and inspection of records</header>
<paragraph id="IDCC846A137A9E42E2B700E9919D44A3DA">
<enum>(1)</enum>
<header>In general</header>
<subparagraph id="idC2D3F959579A4DD59901307BAE475E2C"><enum>(A)</enum><header>Records</header><text>A
food establishment shall—</text>
<clause id="id1D4DBB96FBD94C979EA17B0537361B8F"><enum>(i)</enum><text>maintain such
records as the Administrator shall require by regulation, including all records
relating to the processing, distributing, receipt, or importation of any food;
and</text>
</clause><clause id="id397FD04F447C4C399C02441FC26F6F39"><enum>(ii)</enum><text>permit the
Administrator, in addition to any authority of the food safety agencies in
effect on the day before the date of enactment of this Act, upon presentation
of appropriate credentials and at reasonable times and in a reasonable manner,
to have access to and copy all records maintained by or on behalf of such food
establishment representative in any format (including paper or electronic) and
at any location, that are necessary to assist the Administrator—</text>
<subclause id="id7CCF29327472405FB39C6823EF0D0883"><enum>(I)</enum><text>to determine
whether the food is contaminated or not in compliance with the food safety law;
or</text>
</subclause><subclause changed="not-changed" commented="no" display-inline="no-display-inline" id="id4B169BCA591F4618A6EDADDE104C9AE8" reporting-committee-number="1"><enum>(II)</enum><text>to track the food in
commerce.</text>
</subclause></clause></subparagraph><subparagraph id="idB1203FF8060D49B9B3C823D9EC1289AD"><enum>(B)</enum><header>Required
disclosure</header><text>A food establishment shall have an affirmative
obligation to disclose to the Administrator the results of testing or sampling
of food, equipment, or material in contact with food, that is positive for any
contaminant.</text>
</subparagraph></paragraph><paragraph id="IDCAA386BE7D0D45B58B6CC3C5632703D7">
<enum>(2)</enum>
<header>Maintenance of records</header>
<text>The records in paragraph (1) shall be maintained for a reasonable
period of time, as determined by the Administrator.</text>
</paragraph><paragraph id="ID4AD3F51D515C47D8B265FA093E89D8BF">
<enum>(3)</enum>
<header>Requirements</header>
<text>The records in paragraph (1) shall include records
describing—</text>
<subparagraph id="ID6C1AAD4227F7424FB2723F814F915F38">
<enum>(A)</enum>
<text>the origin, receipt, delivery, sale, movement, holding, and
disposition of food or ingredients;</text>
</subparagraph><subparagraph id="ID9A9E894D0A874F60AB943004DF9D5129">
<enum>(B)</enum>
<text>the identity and quantity of ingredients used in the food;</text>
</subparagraph><subparagraph id="IDA498CDFA3DCD42D1AFF85D9156C30569">
<enum>(C)</enum>
<text>the processing of the food;</text>
</subparagraph><subparagraph id="ID9BE709CE0BAD4C72AAD492F94CDBC767">
<enum>(D)</enum>
<text>the results of laboratory, sanitation, or other tests performed
on the food or in the food establishment;</text>
</subparagraph><subparagraph id="ID3DBA98EEFC9E4B81B92F452DA000F674">
<enum>(E)</enum>
<text>consumer complaints concerning the food or packaging of the
food;</text>
</subparagraph><subparagraph id="idC0EDC816B6EA494A8A9B9867332C0166"><enum>(F)</enum><text>the production
codes, open date codes, and locations of food production; and</text>
</subparagraph><subparagraph id="IDC8F5840B1AAA427BB26C89EE2EFF8D6D">
<enum>(G)</enum>
<text>other matters reasonably related to whether food is unsafe for
human consumption, is adulterated or misbranded, or otherwise fails to meet the
requirements of this Act.</text>
</subparagraph></paragraph></subsection><subsection id="id56389FD687AF447A9614CEF2CE8509B8"><enum>(h)</enum><header>Protection of
sensitive information</header>
<paragraph id="id4C2CA62CDD764AFBA325520850224EF9"><enum>(1)</enum><header>In
general</header><text>The Administrator shall develop and maintain procedures
to prevent the unauthorized disclosure of any trade secret or confidential
information obtained by the Administrator.</text>
</paragraph><paragraph id="id1F1F66D8A6A14881B4EA56882E794F1C"><enum>(2)</enum><header>Limitation</header><text>The
requirement under this subsection does not—</text>
<subparagraph id="id9186AFB02ECE4117B39A8BF0159D76F7"><enum>(A)</enum><text>limit the
authority of the Administrator to inspect or copy records or to require the
establishment or maintenance of records under this Act;</text>
</subparagraph><subparagraph id="id13594845AE6D4A26BFF044655DF38A2B"><enum>(B)</enum><text>have any legal
effect on section 1905 of title 18, United States Code;</text>
</subparagraph><subparagraph id="idA487D14A57C244DBB82578F6F7AB328E"><enum>(C)</enum><text>extend to any
food recipe, financial data, pricing data, personnel data, or sales data (other
than shipment dates relating to sales); or</text>
</subparagraph><subparagraph id="idC81DC06B7B4A4A63A8617041C31AFD2D"><enum>(D)</enum><text>limit the public
disclosure of distribution records or other records related to food subject to
a voluntary or mandatory recall under section 403.</text>
</subparagraph></paragraph></subsection><subsection id="id0A6C1759BB8B4EE6886E0F90A8546D05"><enum>(i)</enum><header>Bribery of or
gifts to inspector or other officers and acceptance of
gifts</header><text>Section 22 of the Federal Meat Inspection Act (21 U.S.C.
622) shall apply to an inspection under this Act.</text>
</subsection></section><section id="idCEC232F9FA1F4DC093FF0EB83F6F3EF6"><enum>206.</enum><header>Food
production facilities</header><text display-inline="no-display-inline">In
carrying out the duties of the Administrator and the purposes of this Act, the
Administrator shall have the authority, with respect to food production
facilities, to—</text>
<paragraph id="idB7FD5A1E06BD4F44A07B5A0920E476F0"><enum>(1)</enum><text>visit and inspect
food production facilities in the United States and in foreign countries to
investigate bioterrorism threats and for other critical food safety
purposes;</text>
</paragraph><paragraph id="id5CDD881F2C6F40BA82A7C8244F13FDD3"><enum>(2)</enum><text>review food
safety records as required to be kept by the Administrator to carry out
traceback and for other critical food safety purposes;</text>
</paragraph><paragraph id="id99126F63A30F4FFCAF4314B908753C25"><enum>(3)</enum><text>set good practice
standards to protect the public and animal health and promote food
safety;</text>
</paragraph><paragraph id="id0F9E9B02E13F45508F07C7F64D03263B"><enum>(4)</enum><text>conduct
monitoring and surveillance of animals, plants, products, or the environment,
as appropriate; and</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="idE03C9404072C4A778DB6BF40079C3B6F" reporting-committee-number="1"><enum>(5)</enum><text>collect and maintain
information relevant to public health and farm practices.</text>
</paragraph></section><section id="ID5763A97B5DAC4CB8B687B74E6167C027">
<enum>207.</enum>
<header>Federal and State cooperation</header>
<subsection id="IDB1045FC8F1DE42B0B923CABA49E6ECDD">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator shall work with the States to carry out
activities and programs that contribute to the national food safety program so
that Federal and State programs function in a coordinated and cost-effective
manner.</text>
</subsection><subsection id="ID7846539FC81040E399E8961F47115C2C">
<enum>(b)</enum>
<header>State action</header>
<text>The Administrator shall work with States to—</text>
<paragraph id="ID1EB631A710034C628F506EA77680884D">
<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;</text>
</paragraph><paragraph id="ID6879AF2A346944E595B284C06E75D000">
<enum>(2)</enum>
<text>establish inspection programs and requirements to ensure that
food under the jurisdiction of the State is safe for human consumption;
and</text>
</paragraph><paragraph id="idBB210F106B9A4EAC837B6098542469A6"><enum>(3)</enum><text>support recall
authorities at the State and local levels.</text>
</paragraph></subsection><subsection id="ID86FAB247FE0D43049E091C79EC97A891">
<enum>(c)</enum>
<header>Assistance</header>
<text>To assist in planning, developing, and implementing a food safety
program, the Administrator may provide to a State—</text>
<paragraph id="ID79325BAF020C4C8AA63C8D1326749608">
<enum>(1)</enum>
<text>advisory assistance;</text>
</paragraph><paragraph id="ID178E87CA57BD47CEA83761A4617962F6">
<enum>(2)</enum>
<text>technical and laboratory assistance and training (including
necessary materials and equipment); and</text>
</paragraph><paragraph id="IDD9692642BE4A43698B1D8291A0A76135">
<enum>(3)</enum>
<text>financial and other aid.</text>
</paragraph></subsection><subsection id="ID9F22B8DB896F4C42B765906626D5A517">
<enum>(d)</enum>
<header>Service agreements</header>
<paragraph id="ID23FDE27FCCA444EBA7F15D2ED88C2DE0">
<enum>(1)</enum>
<header>In general</header>
<text>The Administrator may, under agreements entered into with
Federal, State, or local agencies, use on a reimbursable basis or otherwise,
the personnel and services of those agencies in carrying out this Act.</text>
</paragraph><paragraph id="ID62503F76D85341FCB02C8B5CE6B4B3F7">
<enum>(2)</enum>
<header>Training</header>
<text>Agreements with a State under this subsection may provide for
training of State employees.</text>
</paragraph><paragraph id="id03BF98F3385B4822A3E9EE6F7370F08A"><enum>(3)</enum><header>Maintenance of
agreements</header><text>The Administrator shall maintain any agreement that is
in effect on the day before the date of enactment of this Act until the
Administrator evaluates such agreement and determines whether to maintain or
substitute such agreement.</text>
</paragraph></subsection><subsection id="ID6297C035D1654DD6AB007F995C08FC8E">
<enum>(e)</enum>
<header>Audits</header>
<paragraph id="IDD36326AD9BB44C95B1FC57BF004C41AF">
<enum>(1)</enum>
<header>In general</header>
<text>The Administrator shall annually conduct a comprehensive review
of each State program that provides services to the Administrator in carrying
out the responsibilities under this Act, including mandated inspections under
section 205.</text>
</paragraph><paragraph id="ID29B9BA213BF14C39BAD25E48CA086CAB">
<enum>(2)</enum>
<header>Requirements</header>
<text>The review shall—</text>
<subparagraph id="IDCA48BA023F7747DD8EDC67592515379D">
<enum>(A)</enum>
<text>include a determination of the effectiveness of the State
program; and</text>
</subparagraph><subparagraph id="ID7E3DFE7D7C234105A825073FBE006360">
<enum>(B)</enum>
<text>identify any changes necessary to ensure enforcement of Federal
requirements under this Act.</text>
</subparagraph></paragraph></subsection></section><section id="IDEE45B9AC7F3F430DAFAFB3C1AFC21D81">
<enum>208.</enum>
<header>Imports</header>
<subsection id="ID966F45D1FEF7408593C59D5473D3B69F">
<enum>(a)</enum>
<header>In general</header><text>Not later than 2 years after the
effective date of this Act, the Administrator shall establish a system under
which a foreign government or foreign food establishment seeking to import food
to the United States shall submit a request for certification to the
Administrator.</text>
</subsection><subsection id="ID623E83FAFBD342B287F4CDD750C0AB12">
<enum>(b)</enum>
<header>Certification standard</header><text>A foreign government or
foreign food establishment requesting a certification to import food to the
United States shall demonstrate, in a manner determined appropriate by the
Administrator, that food produced under the supervision of a foreign government
or by the foreign food establishment has met standards for food safety,
inspection, labeling, and consumer protection that are at least equivalent to
standards applicable to food produced in the United States.</text>
</subsection><subsection id="id2936826880D948968F52B2B5EE292276"><enum>(c)</enum><header>Certification
approval</header>
<paragraph id="idA9BD00B598D848DF8E874A42ECC38FD1"><enum>(1)</enum><header>Request by
foreign government</header><text>Prior to granting the certification request of
a foreign government, the Administrator shall review, audit, and certify the
food safety program of a requesting foreign government (including all statutes,
regulations, and inspection authority) as at least equivalent to the food
safety program in the United States, as demonstrated by the foreign
government.</text>
</paragraph><paragraph id="id88FA6D05930242D3B8825C966ED7515E"><enum>(2)</enum><header>Request by
foreign food establishment</header><text>Prior to granting the certification
request of a foreign food establishment, the Administrator shall certify, based
on an onsite inspection, the food safety programs and procedures of a
requesting foreign firm as at least equivalent to the food safety programs and
procedures of the United States.</text>
</paragraph></subsection><subsection id="id56991A8045AA4240BE99FAC155CCA468"><enum>(d)</enum><header>Limitation</header><text>A
foreign government or foreign firm approved by the Administrator to import food
to the United States under this section shall be certified to export only the
approved food products to the United States for a period not to exceed 5
years.</text>
</subsection><subsection id="id3879C6F7E7DB449593076F34138EB4BC"><enum>(e)</enum><header>Withdrawal of
certification</header><text>The Administrator may withdraw certification of any
food from a foreign government or foreign firm—</text>
<paragraph id="id86275871F235429F94D09B870B8D2715"><enum>(1)</enum><text>if such food is
linked to an outbreak of human illness;</text>
</paragraph><paragraph id="idE25CA1D4C06544628B7A82E089BA5A3D"><enum>(2)</enum><text>following an
investigation by the Administrator that finds that the foreign government
programs and procedures or foreign food establishment is no longer equivalent
to the food safety programs and procedures in the United States; or</text>
</paragraph><paragraph id="id7DF9FB4C3BF24360810FEEE79A56B2E5"><enum>(3)</enum><text>following a
refusal to allow United States officials to conduct such audits and
investigations as may be necessary to fulfill the requirements under this
section.</text>
</paragraph></subsection><subsection id="id66807AC72572406BAEB5CDA80BE9081C"><enum>(f)</enum><header>Renewal of
certification</header><text>The Administrator shall audit foreign governments
and foreign food establishments at least every 5 years to ensure the continued
compliance with the standards set forth in this section.</text>
</subsection><subsection id="id116C69FD1D1B42A496E84D07137C0770"><enum>(g)</enum><header>Required
routine inspection</header><text>The Administrator shall routinely inspect food
before it enters the United States to ensure that it is—</text>
<paragraph id="idDEC8BB1F7E3B47148D0E9DB7DA32CBD6"><enum>(1)</enum><text>safe for human
consumption;</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id682B654B569C4DE7947F794534D815BA" reporting-committee-number="1"><enum>(2)</enum><text>labeled as required for
food produced in the United States; and</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id0CD557AA4440457E8268860FD8BA0E9E" reporting-committee-number="1"><enum>(3)</enum><text>otherwise meets
requirements under the food safety law.</text>
</paragraph></subsection><subsection id="ID235B8A6F2C474EA7BC7FC98687EB46F0">
<enum>(h)</enum>
<header>Enforcement</header><text>The Administrator—</text>
<paragraph id="ID68F021A2E46A4E268C7E71318EDD73AB">
<enum>(1)</enum><text>may deny importation of food from any foreign
government that does not permit United States officials to enter the foreign
country to conduct such audits and inspections as may be necessary to fulfill
the requirements under this section;</text>
</paragraph><paragraph id="idD29E9AD544A14CB897D6790B0BA55D67"><enum>(2)</enum><text>may deny
importation of food from any foreign government or foreign firm that does not
consent to an investigation by the Administration when food from that foreign
country or foreign firm is linked to a food-borne illness outbreak or is
otherwise found to be adulterated or mislabeled; and</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id118012E41F8049069B034DE4C6A4E68B" reporting-committee-number="1"><enum>(3)</enum><text>is authorized to
promulgate rules and regulations to carry out the purposes of this section,
including setting terms and conditions for the destruction of products that
fail to meet the standards of this Act.</text>
</paragraph></subsection><subsection id="idA4B8BF2366EF4F4FB0202AF3A759D866"><enum>(i)</enum><header>Detention and
seizure</header><text>Any food imported for consumption in the United States
may be detained, seized, or condemned pursuant to section 402.</text>
</subsection></section><section display-inline="no-display-inline" id="s1">
<enum>209.</enum>
<header>Resource plan</header>
<subsection display-inline="no-display-inline" id="id851D2CC2AC8045FD936118016DE00AF8"><enum>(a)</enum><header>In
general</header><text>The Administrator shall prepare and update annually a
resource plan describing the resources required, in the best professional
judgment of the Administrator, to develop and fully implement the national food
safety program established under this Act.</text>
</subsection><subsection display-inline="no-display-inline" id="id6FAD36A2326542108777D86F0A7FE847"><enum>(b)</enum><header>Contents of
plan</header><text>The resource plan shall—</text>
<paragraph display-inline="no-display-inline" id="idEF73BF01B2CA47F7BF66022B402132CC"><enum>(1)</enum><text>describe
quantitatively the personnel, financial, and other resources required to carry
out the inspection of food establishments under section 205 and other
requirements of the national food safety program;</text>
</paragraph><paragraph display-inline="no-display-inline" id="id2C9DFB980E154E7B9CE950EFC6D4D720"><enum>(2)</enum><text>allocate
inspection resources in a manner reflecting the distribution of risk and
opportunities to reduce risk across the food supply to the extent feasible
based on the best available information, and subject to section 205; and</text>
</paragraph><paragraph display-inline="no-display-inline" id="id7D1FB4012E934359A05CDBF7499196D9"><enum>(3)</enum><text>describe the
personnel, facilities, equipment, and other resources needed to carry out
inspection and other oversight activities, at a total resource level equal to
at least 50 percent of the resources required to carry out inspections in food
establishments under section 205—</text>
<subparagraph display-inline="no-display-inline" id="idC2352CAC8198479488EF4F2511726C70"><enum>(A)</enum><text>in foreign
establishments;</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="id9752511F8638447B9F1BF6FF316A42ED"><enum>(B)</enum><text>at the point of
importation; and</text>
</subparagraph><subparagraph display-inline="no-display-inline" id="idA341DA47A45E41FD80086D936CD3D02D"><enum>(C)</enum><text>at the point of
production on farms, ranches, and feedlots.</text>
</subparagraph></paragraph></subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="idE09F1F4FFE15431CAC5FFA04636EBD0A" reporting-committee-number="1"><enum>(c)</enum><header>Grants</header><text>The
resource plan shall include recommendations for funding to provide grants to
States and local governments to carry out food safety activities in retail and
food service facilities and the required inspections in food
establishments.</text>
</subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="id58073E4384DC4950BF082AF6EBCCD3DA" reporting-committee-number="1"><enum>(d)</enum><header>Submission of
plan</header><text>The Administrator shall submit annually to the Committee on
Appropriations of the Senate, the Committee on Appropriations of the House of
Representatives, and other relevant committees of Congress, the resource plan
required under this section.</text>
</subsection></section><section id="ID7516F4D4FFCD46FFB710001036B69DEF">
<enum>210.</enum>
<header>Traceback</header>
<subsection id="IDC9C5BF6550004CB19BDA00CB6C204DD8">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator, in order to protect the public health, shall
establish requirements for tracing food and food producing animals from point
of origin to retail sale, subject to subsection (b).</text>
</subsection><subsection id="ID86DAA6DB2EA84726B1929438687CC9E0">
<enum>(b)</enum>
<header>Applicability</header>
<text>Traceability requirements shall—</text>
<paragraph id="ID86990E9677404A41BB602B9410240554">
<enum>(1)</enum>
<text>be established in accordance with regulations and guidelines
issued by the Administrator; and</text>
</paragraph><paragraph id="IDCDA09AE2D7B546B2AFD88BFA3C3031E5">
<enum>(2)</enum>
<text>apply to food production facilities and food
establishments.</text>
</paragraph></subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="id23DA7D9C8F824F5594E89822C5DECA53" reporting-committee-number="1"><enum>(c)</enum><header>Relationship to country
of origin labeling</header><text>Nothing contained in this section prevents or
interferes with implementation of the country of origin labeling requirements
of subtitle D of the Agricultural Marketing Act of 1946 (<external-xref legal-doc="usc" parsable-cite="usc/7/1638">7 U.S.C. 1638</external-xref> et
seq.).</text>
</subsection></section>
<enum>III</enum>
<header>Research and education</header>
<section id="ID55077A7FE7704C9395022EF1CCC6DD9D">
<enum>301.</enum>
<header>Public health assessment system</header>
<subsection id="IDD80FFF9170D2484EAA13953D29C2B4DB">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator, acting in coordination with the Director of
the Centers for Disease Control and Prevention and with the Research Education
and Economics mission area of the Department of Agriculture, shall—</text>
<paragraph id="IDAD89BDD6FB5D41B2A2C32DFC15A02C74">
<enum>(1)</enum>
<text>have access to the applicable data systems of the Centers for
Disease Control and Prevention;</text>
</paragraph><paragraph id="idE530B25A938543C2A076B0300A034FA3"><enum>(2)</enum><text>maintain an
active surveillance system of food, food products, and epidemiological evidence
submitted by States to the Centers for Disease Control and Prevention based on
a representative proportion of the population of the United States;</text>
</paragraph><paragraph id="IDFB400BFB195A468A93A3F8E3FB37F62C">
<enum>(3)</enum>
<text>assess the frequency and sources of human illness in the United
States associated with the consumption of food; and</text>
</paragraph><paragraph id="id63044393BA6D4B8FB370A5973716D676"><enum>(4)</enum><text>maintain a
state-of-the-art DNA matching system and epidemiological system dedicated to
food-borne illness identification, outbreaks, and containment.</text>
</paragraph></subsection><subsection id="ID5F3D75907464449980332405DBEE42F7">
<enum>(b)</enum>
<header>Public health sampling</header>
<paragraph id="ID22FE208B721349DD8DFD8F94E0D066E2">
<enum>(1)</enum>
<header>In general</header>
<text>Not later than 1 year after the effective date of this Act, the
Administrator shall establish guidelines for a sampling system under which the
Administrator shall take and analyze samples of food—</text>
<subparagraph id="ID69AB74DBD9B042B6B97489989217C1D0">
<enum>(A)</enum>
<text>to assist the Administrator in carrying out this Act; and</text>
</subparagraph><subparagraph id="IDD253557CF9944824A5F2AF2000683496">
<enum>(B)</enum>
<text>to assess the nature, frequency of occurrence, and quantities of
contaminants in food.</text>
</subparagraph></paragraph><paragraph id="IDF90D40BAECF944B7A1809314EACC8853">
<enum>(2)</enum>
<header>Requirements</header>
<text>The sampling system described in paragraph (1) shall
provide—</text>
<subparagraph id="ID851869A11E50405C82A18F5DD2E6EC17">
<enum>(A)</enum>
<text>statistically valid monitoring, including market-based studies,
on the nature, frequency of occurrence, and quantities of contaminants in food
available to consumers; and</text>
</subparagraph><subparagraph id="ID3634AC4C6A624D5696A32F7EA7001ED6">
<enum>(B)</enum>
<text>at the request of the Administrator, such other information,
including analysis of monitoring and verification samples, as the Administrator
determines may be useful in assessing the occurrence of contaminants in
food.</text>
</subparagraph></paragraph></subsection><subsection id="IDDC91E0684BE84B76AE009B0000FB5443">
<enum>(c)</enum>
<header>Assessment of health hazards</header>
<paragraph id="ID28178CC6447C4348BB292C2FE270FA65">
<enum>(1)</enum>
<header>In general</header>
<text>Through the surveillance system referred to in subsection (a) and
the sampling system described in subsection (b), the Administrator
shall—</text>
<subparagraph id="IDA4992B7145004BCE93A1BB7F6CA272E0">
<enum>(A)</enum>
<text>rank food categories based on the hazard to human health
presented by the food category;</text>
</subparagraph><subparagraph id="ID2FC89687C22C4625AE813E505C4CFDF5">
<enum>(B)</enum>
<text>identify appropriate industry and regulatory approaches to
minimize hazards in the food supply; and</text>
</subparagraph><subparagraph id="id5FAC0AEBFCD640459C440547879EC247"><enum>(C)</enum><text>assess the public
health environment for emerging diseases, including zoonosis, for their risk of
appearance in the United States food supply.</text>
</subparagraph></paragraph><paragraph id="ID772F6CD38C1B42F68CF44921BC9FC485">
<enum>(2)</enum>
<header>Components of analysis</header>
<text>The analysis under subsection (b)(1) may include—</text>
<subparagraph id="IDA8D5DD32CD6D4F7099CFA898A1910061">
<enum>(A)</enum>
<text>a comparison of the safety of commercial processing with the
health hazards associated with food that is harvested for recreational or
subsistence purposes and prepared noncommercially;</text>
</subparagraph><subparagraph id="ID1851B42E62DD4EA9B3B5AC8854BB6BA0">
<enum>(B)</enum>
<text>a comparison of the safety of food that is domestically processed
with the health hazards associated with food that is processed outside the
United States;</text>
</subparagraph><subparagraph id="ID3764AA888B39417BB94F5DBBBE82C849">
<enum>(C)</enum>
<text>a description of contamination originating from handling
practices that occur prior to or after the sale of food to consumers;
and</text>
</subparagraph><subparagraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id9423A9DC65854E3DB784A667CB860F28" reporting-committee-number="1"><enum>(D)</enum><text display-inline="yes-display-inline">use of comparative risk assessments.</text>
</subparagraph></paragraph></subsection></section><section id="ID21942CB4561F432C81778FD1ECCC0021">
<enum>302.</enum>
<header>Public education and advisory system</header>
<subsection id="ID92FC3399BB71440DBB02477634747CA5">
<enum>(a)</enum>
<header>Public education</header>
<paragraph id="ID7B0307E2E9744A7AB029D35F7DDF7136">
<enum>(1)</enum>
<header>In general</header>
<text>The Administrator, in cooperation with private and public
organizations, including the cooperative extension services and appropriate
State and local entities, shall establish a national public education program
on food safety.</text>
</paragraph><paragraph id="ID5A03BFAFB6E648FAABF1847C9F00C269">
<enum>(2)</enum>
<header>Requirements</header>
<text>The program shall provide—</text>
<subparagraph id="IDE0D9290C23874FE19309858F73815B6B">
<enum>(A)</enum>
<text>information to the public regarding Federal standards and best
practices and promotion of public awareness, understanding, and acceptance of
those standards and practices;</text>
</subparagraph><subparagraph id="IDDB77A97CD56B43A181E21DF33BEE7558">
<enum>(B)</enum>
<text>information for health professionals—</text>
<clause id="IDD64AA023CEED454AB06162860049BA5C">
<enum>(i)</enum>
<text>to improve diagnosis and treatment of food-related illness;
and</text>
</clause><clause id="ID8F80049649A94720A906D5E1DC8990DD">
<enum>(ii)</enum>
<text>to advise individuals at special risk for food-related illnesses;
and</text>
</clause></subparagraph><subparagraph id="IDECD1A12597A846AFA1A4B4DDE0F52CDB">
<enum>(C)</enum>
<text>such other information or advice to consumers and other persons
as the Administrator determines will promote the purposes of this Act.</text>
</subparagraph></paragraph></subsection><subsection id="ID11FD0E1EF41A44EBAA1CFD9FBB20B2C3">
<enum>(b)</enum>
<header>Health advisories</header>
<text>The Administrator, in consultation with other Federal departments
and agencies as the Administrator determines necessary, shall work with the
States and other appropriate entities—</text>
<paragraph id="ID13AAC0E9388B4AD9AA40724DEF6DBE53">
<enum>(1)</enum>
<text>to develop and distribute regional and national advisories
concerning food safety;</text>
</paragraph><paragraph id="ID38CCD1C09A224AFD0035E11361E83EF2">
<enum>(2)</enum>
<text>to develop standardized formats for written and broadcast
advisories;</text>
</paragraph><paragraph id="IDA54CCF7BBFA24BAD83FF79041BFFE8A6">
<enum>(3)</enum>
<text>to incorporate State and local advisories into the national
public education program established under subsection (a); and</text>
</paragraph><paragraph id="id67489A0EC77142A1AE25253B0B5314DC"><enum>(4)</enum><text>to present
prompt, specific information regarding foods found to pose a threat to the
public health.</text>
</paragraph></subsection></section><section id="ID4B03E28B17FA409F893DB810BDDD3048">
<enum>303.</enum>
<header>Research</header>
<subsection id="ID982B66BD034B45A1994BBF5600F0052D">
<enum>(a)</enum>
<header>In general</header>
<text>The Administrator shall conduct research to carry out this Act,
including studies—</text>
<paragraph id="IDFB455225184343D192DAF7E0DAE78BE0">
<enum>(1)</enum>
<text>to improve sanitation and food safety practices in the processing
of food;</text>
</paragraph><paragraph id="IDDAF260E5C7DA4F1AAA454D635E392C37">
<enum>(2)</enum>
<text>to develop improved techniques to monitor and inspect
food;</text>
</paragraph><paragraph id="IDDB608050ED6A46489C1F54B710437135">
<enum>(3)</enum>
<text>to develop efficient, rapid, and sensitive methods to detect
contaminants in food;</text>
</paragraph><paragraph id="ID8D30943F64C443A5AD292700082FDA9B">
<enum>(4)</enum>
<text>to determine the sources of contamination of contaminated
food;</text>
</paragraph><paragraph id="ID90B39D8820014838B1D1802736D18044">
<enum>(5)</enum>
<text>to develop food consumption data;</text>
</paragraph><paragraph id="ID96F7B8675A534A6E895DA6B1E867B5D7">
<enum>(6)</enum>
<text>to identify ways that animal production techniques could improve
the safety of the food supply; and</text>
</paragraph><paragraph id="id23A8E6FAF93B480FAD4DFA0170CF57D4"><enum>(7)</enum><text>to conduct other
research that supports the purposes of this Act.</text>
</paragraph></subsection><subsection id="ID5D6C9222EE884756B5059D8125F69083">
<enum>(b)</enum>
<header>Contract authority</header>
<text>The Administrator may enter into contracts and agreements with
any State, university, Federal Government agency, or person to carry out this
section.</text>
</subsection></section>
<enum>IV</enum>
<header>Enforcement</header>
<section id="IDA4FB65BF1E8042448810AFE6830173D2">
<enum>401.</enum>
<header>Prohibited Acts</header>
<text display-inline="no-display-inline">It is prohibited—</text>
<paragraph id="IDEF8C363DCC31419AA17D5E2B0811D494">
<enum>(1)</enum>
<text>to manufacture, introduce, deliver for introduction, or receive
into interstate commerce any food that is adulterated, misbranded, or otherwise
unsafe for human consumption;</text>
</paragraph><paragraph id="IDE2B98ABEB23E4283A9BC3F48766B8804">
<enum>(2)</enum>
<text>to adulterate or misbrand any food in interstate commerce;</text>
</paragraph><paragraph id="ID36E41D7B8C394AA8AA46B3F03EE387D5">
<enum>(3)</enum>
<text>for a food establishment or foreign food establishment to fail to
register under section 202, or to operate without a valid registration;</text>
</paragraph><paragraph id="ID4FB2F69BF94E44A18175AB7B2057007C">
<enum>(4)</enum>
<text>to refuse to permit access to a food establishment for the
inspection and copying of a record as required under section 205(g);</text>
</paragraph><paragraph id="IDE267564C4F234087BF3618BE7BD0E5AC">
<enum>(5)</enum>
<text>to fail to establish or maintain any record or to make any report
as required under section 205(g);</text>
</paragraph><paragraph id="IDBED68C13434C4014A900C7752E5288DE">
<enum>(6)</enum>
<text>to refuse to permit entry to or inspection of a food
establishment as required under section 205;</text>
</paragraph><paragraph id="id2422D0BA16274387ABE6625AFBDD5EE4"><enum>(7)</enum><text>to fail to
provide to the Administrator the results of a testing or sampling of a food,
equipment, or material in contact with contaminated food under section
205(h);</text>
</paragraph><paragraph id="ID98B68C3431E5495B976714FFD390D5E1">
<enum>(8)</enum>
<text>to fail to comply with a provision, regulation, or order of the
Administrator under section 202, 203, 204, or 208;</text>
</paragraph><paragraph id="IDE4B40EC0604449718FD8F4D5F7BB61B3">
<enum>(9)</enum>
<text>to slaughter an animal that is capable for use in whole or in
part as human food at a food establishment processing any such food for
commerce, except in compliance with the food safety law;</text>
</paragraph><paragraph id="IDCFAA726291A54788ACF6FCD82DCC7C95">
<enum>(10)</enum>
<text>to transfer food in violation of an administrative detention
order under section 402 or to remove or alter a required mark or label
identifying the food as detained;</text>
</paragraph><paragraph id="ID804A755EEFD8462A8C1E81D37368319C">
<enum>(11)</enum>
<text>to fail to comply with a recall or other order under section 403;
or</text>
</paragraph><paragraph id="ID293C7CD2C0F7461CBBC9A7A600163900">
<enum>(12)</enum>
<text>to otherwise violate the food safety law.</text>
</paragraph></section><section id="ID8EB3BA7208A04963B400BE808D5B5E8D">
<enum>402.</enum>
<header>Food detention, seizure, and condemnation</header>
<subsection id="ID624FD6C4ED30493CB35047E039E3E6C1">
<enum>(a)</enum>
<header>Administrative detention of food</header>
<paragraph id="ID5C6C49192D7B41CABBAE990081F639C4">
<enum>(1)</enum>
<header>Expanded authority</header>
<text>The Administrator shall have authority under
<external-xref legal-doc="act" parsable-cite="FFDCA/304">section 304</external-xref> of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/334">21 U.S.C. 334</external-xref>) to
administratively detain and seize any food that the Administrator has reason to
believe is unsafe for human consumption, is adulterated or misbranded, or
otherwise fails to meet the requirements of the food safety law.</text>
</paragraph><paragraph id="IDEB38C858C97D46FB994DCCA7007EDF5D">
<enum>(2)</enum>
<header>Detention authority</header>
<text>If, during an inspection conducted in accordance with section 205
or 208, an officer, employee, or agent of the Administration making the
inspection has reason to believe that a domestic food, imported food, or food
offered for import is unsafe for human consumption, is adulterated or
misbranded, or otherwise fails to meet the requirements of this Act, the
officer or employee may order the food detained.</text>
</paragraph><paragraph id="ID63D1809DDC6142F2806DD168D45C2875">
<enum>(3)</enum>
<header>Period of detention</header>
<subparagraph id="IDD0C5F3DB9C0F4FB9BA16A9908F165704">
<enum>(A)</enum>
<header>In general</header>
<text>A food may be detained for a reasonable period, not to exceed 20
days, unless a longer period, not to exceed 30 days, is necessary for the
Administrator to institute a seizure action.</text>
</subparagraph><subparagraph id="ID9C8A55DD982B47F1A071AB38382B0420">
<enum>(B)</enum>
<header>Perishable food</header>
<text>The Administrator shall provide by regulation for procedures to
institute a seizure action on an expedited basis with respect to perishable
food.</text>
</subparagraph></paragraph><paragraph id="ID1459F4B096D24849AA5BBB2BF3E800A5">
<enum>(4)</enum>
<header>Security of detained food</header>
<subparagraph id="IDA20699B845094BA5BF85C6AC818FF7DD">
<enum>(A)</enum>
<header>In general</header>
<text>A detention order—</text>
<clause id="IDD0D7632D79FA4615B5814D00CB907B6F">
<enum>(i)</enum>
<text>may require that the food be labeled or marked as detained;
and</text>
</clause><clause id="ID5F0FAABA1DAA47939BE681CA93E05FD1">
<enum>(ii)</enum>
<text>shall require that the food be removed to a secure facility, if
appropriate.</text>
</clause></subparagraph><subparagraph id="IDF2DFA9F995B64F419644D188BC945CBB">
<enum>(B)</enum>
<header>Food subject to an order</header>
<text>A food subject to a detention order shall not be transferred by
any person from the place at which the food is removed, until released by the
Administrator or until the expiration of the detention period applicable under
the order, whichever occurs first.</text>
</subparagraph><subparagraph id="ID194028E295E54EFDA4C5E6A26033CEE3">
<enum>(C)</enum>
<header>Delivery of food</header>
<text>This subsection does not authorize the delivery of a food in
accordance with execution of a bond while the article is subject to the
order.</text>
</subparagraph></paragraph></subsection><subsection id="ID9110EA7FE1644BD88FDB9F24C6CA8E69">
<enum>(b)</enum>
<header>Appeal of detention order</header>
<paragraph id="ID17006E98CE5642DAA7BD4DB535B3B7D9">
<enum>(1)</enum>
<header>In general</header>
<text>A person who would be entitled to be a claimant for a food
subject to a detention order if the food were seized under section 304 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/334">21 U.S.C.
334</external-xref>), may appeal the order to the Administrator.</text>
</paragraph><paragraph id="ID7E537A92191946460045C000303B6306">
<enum>(2)</enum>
<header>Action by the Administrator</header>
<text>Not later than 5 days after an appeal is filed under paragraph
(1), the Administrator, after providing an opportunity for an informal hearing,
shall confirm, modify, or terminate the order involved.</text>
</paragraph><paragraph id="ID660B28716C3A472BBB64EEE86F11155C">
<enum>(3)</enum>
<header>Final agency action</header>
<text>Confirmation, modification, or termination by the Administrator
under paragraph (2) shall be considered a final agency action for purposes of
section 702 of title 5, United States Code.</text>
</paragraph><paragraph id="ID2222E513A3444BD697A072787B4C93D1">
<enum>(4)</enum>
<header>Termination</header>
<text>The order shall be considered to be terminated if, after 5 days,
the Administrator has failed—</text>
<subparagraph id="IDCDA39DCAADE54087BD6BCFC1893D621F">
<enum>(A)</enum>
<text>to provide an opportunity for an informal hearing; or</text>
</subparagraph><subparagraph id="ID5845E3D61962455C9523E5BF00A34B4B">
<enum>(B)</enum>
<text>to confirm, modify, or terminate the order.</text>
</subparagraph></paragraph><paragraph id="ID6A0167DD69B94A9BBA558FA9F91E294F">
<enum>(5)</enum>
<header>Effect of instituting court action</header>
<text>If the Administrator initiates an action under
<external-xref legal-doc="act" parsable-cite="FFDCA/302">section 302</external-xref> of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/332">21 U.S.C. 332</external-xref>) or
section 304(a) of that Act (<external-xref legal-doc="usc" parsable-cite="usc/21/334(a)">21 U.S.C.
334(a)</external-xref>), the process for the appeal of the detention order
shall terminate.</text>
</paragraph></subsection><subsection id="IDFEE18BB5517E491E98E166B462771318">
<enum>(c)</enum>
<header>Condemnation of food</header>
<paragraph id="IDC2FF7A6B55964EA0BC23487EE6FFA5A0">
<enum>(1)</enum>
<header>In general</header>
<text>After confirming a detention order, the Administrator may order
the food condemned.</text>
</paragraph><paragraph id="ID01DB129498294B3F8874A0ABC98C6DD1">
<enum>(2)</enum>
<header>Destruction of food</header>
<text>Any food condemned shall be destroyed under the supervision of
the Administrator.</text>
</paragraph><paragraph id="ID599D41D1CA234439B4A1FB007DF042F5">
<enum>(3)</enum>
<header>Release of food</header>
<text>If the Administrator determines that, through reprocessing,
relabeling, or other action, a detained food can be brought into compliance
with this Act, the food may be released following a determination by the
Administrator that the relabeling or other action as specified by the
Administrator has been performed.</text>
</paragraph></subsection><subsection id="IDC9A74F0FBDA14C849EE3A8C2B2DEB986">
<enum>(d)</enum>
<header>Temporary holds at ports of entry</header>
<paragraph id="ID80C6F3B07BAD4B82824F4FB4EF7D8D92">
<enum>(1)</enum>
<header>In general</header>
<text>If an officer or qualified employee of the Administration has
reason to believe that a food is unsafe for human consumption, is adulterated
or misbranded, or otherwise fails to meet the requirements of this Act, and the
officer or qualified employee is unable to inspect, examine, or investigate the
food when the food is offered for import at a port of entry into the United
States, the officer or qualified employee shall request the Secretary of
Homeland Security to hold the food at the port of entry for a reasonable period
of time, not to exceed 24 hours, to enable the Administrator to inspect or
investigate the food as appropriate.</text>
</paragraph><paragraph id="ID766F979002D947389FBC503C95EE54FE">
<enum>(2)</enum>
<header>Removal to secure facility</header>
<text>The Administrator shall work in coordination with the Secretary
of Homeland Security to remove a food held in accordance with paragraph (1) to
a secure facility as appropriate.</text>
</paragraph><paragraph id="IDA4EA1C08F972428ABF78BA94AB51AAA1">
<enum>(3)</enum>
<header>Prohibition on transfer</header>
<text>During the period in which the food is held, the food shall not
be transferred by any person from the port of entry into the United States, or
from the secure facility to which the food has been removed.</text>
</paragraph><paragraph id="ID53B6E991DDF740D1863EE5209D7E4FAC">
<enum>(4)</enum>
<header>Delivery in accordance with a bond</header>
<text>The delivery of the food in accordance with the execution of a
bond while the food is held is not authorized.</text>
</paragraph></subsection></section><section id="ID5D32C95E38D14EB1AF00FDC2575998C4">
<enum>403.</enum>
<header>Notification and recall</header>
<subsection id="IDE004377AA3614594AC2F81BD827E5CEC">
<enum>(a)</enum>
<header>Notice to Administrator of violation</header>
<paragraph id="ID3BAB6AD7EED74C8082D200EC33A21875">
<enum>(1)</enum>
<header>In general</header>
<text>A person (other than a household consumer or other individual who
is the intended consumer of a food) that has reason to believe that any food
introduced into or in interstate commerce, or held for sale (whether or not the
first sale) after shipment in interstate commerce, may be in violation of the
food safety law shall immediately notify the Administrator of the identity and
location of the food.</text>
</paragraph><paragraph id="ID62117C0BB3D74C9A96896EFFB1803BE6">
<enum>(2)</enum>
<header>Manner of notification</header>
<text>Notification under paragraph (1) shall be made in such manner and
by such means as the Administrator may require by regulation.</text>
</paragraph></subsection><subsection id="IDDA3E909F1F5B465500D100F55CD4A930">
<enum>(b)</enum>
<header>Recall and consumer notification</header>
<paragraph id="IDECF5A6A44B3249FFAE405BADE56B929E">
<enum>(1)</enum>
<header>Voluntary actions</header>
<text>If the Administrator determines that food is in violation of the
food safety law 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 that there is a reasonable probability that the food, if consumed,
would present a threat to public health, as determined by the Administrator,
the Administrator shall give the appropriate persons (including the
manufacturers, importers, distributors, or retailers of the food) an
opportunity to—</text>
<subparagraph id="ID152A515E531545ECA5B8731FD9EE7B00">
<enum>(A)</enum>
<text>cease distribution of the food;</text>
</subparagraph><subparagraph id="ID10213B68F819433DBAAFE1EC56B758D2">
<enum>(B)</enum>
<text>notify all persons—</text>
<clause id="ID0009B7249BEA4E46B68B29C448B9B100">
<enum>(i)</enum>
<text>processing, distributing, or otherwise handling the food to
immediately cease such activities with respect to the food; or</text>
</clause><clause id="ID01BF5F362D514B35B106E0FF793B2626">
<enum>(ii)</enum>
<text>to which the food has been distributed, transported, or sold, to
immediately cease distribution of the food;</text>
</clause></subparagraph><subparagraph id="ID65339AEC9842431C86A17B8F9EDECF76">
<enum>(C)</enum>
<text>recall the food;</text>
</subparagraph><subparagraph id="ID652146772DA34CD4B2178D5479ED27FE">
<enum>(D)</enum>
<text>in conjunction with the Administrator, provide notice of the
finding of the Administrator—</text>
<clause id="id740266D30F634F40B9012E383CC8A857"><enum>(i)</enum><text>to
consumers to whom the food was, or may have been, distributed; and</text>
</clause><clause id="id9D2A014E2E174030AFF87874738C5252"><enum>(ii)</enum><text>to
State and local public health officials; or</text>
</clause></subparagraph><subparagraph id="ID88CE48952AF84C6500E40081CEE4883D">
<enum>(E)</enum>
<text>take any combination of the measures described in this paragraph,
as determined by the Administrator to be appropriate in the
circumstances.</text>
</subparagraph></paragraph><paragraph id="IDE0BF2B4CFD7C43B0BF167E05B65C2214">
<enum>(2)</enum>
<header>Mandatory actions</header>
<text>If a person referred to in paragraph (1) refuses to or does not
adequately carry out the actions described in that paragraph within the time
period and in the manner prescribed by the Administrator, the Administrator
shall—</text>
<subparagraph id="idB181456CCDA5433C92EA0AB28844341F"><enum>(A)</enum><text>have authority to
control and possess the food, including ordering the shipment of the food from
the food establishment to the Administrator—</text>
<clause id="id3079D6AB8CBC4930B9EE129AB8B63FAC"><enum>(i)</enum><text>at
the expense of the food establishment; or</text>
</clause><clause id="idA5F2E28B9F6D48049E88653438A08DDC"><enum>(ii)</enum><text>in
an emergency (as determined by the Administrator), at the expense of the
Administration; and</text>
</clause></subparagraph><subparagraph id="id8600E18E83384055A3CC1858570CD9C6"><enum>(B)</enum><text>by order,
require, as the Administrator determines to be necessary, the person to
immediately—</text>
<clause id="ID47225DA01A0D4303AEDAFA7FBA0500F6">
<enum>(i)</enum>
<text>cease distribution of the food; and</text>
</clause><clause id="IDEF42C2944B9A45BFBFD41F7530BCF4BC">
<enum>(ii)</enum>
<text>notify all persons—</text>
<subclause id="IDF65F3CA104D741F295A311AF665C963F">
<enum>(I)</enum>
<text>processing, distributing, or otherwise handling the food to
immediately cease such activities with respect to the food; or</text>
</subclause><subclause id="IDCD783123FACE4D92A5AC00D9BDC0CD03">
<enum>(II)</enum>
<text>if the food has been distributed, transported, or sold, to
immediately cease distribution of the food.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="ID89BEC8D7249C488D8C32D19130B9A200">
<enum>(3)</enum>
<header>Notification to consumers by Administrator</header>
<text>The Administrator shall, as the Administrator determines to be
necessary, provide notice of the finding of the Administrator under paragraph
(1)—</text>
<subparagraph id="idF1ACA08A61154E84AFB329D976F299E6"><enum>(A)</enum><text>to consumers to
whom the food was, or may have been, distributed; and</text>
</subparagraph><subparagraph id="idEEDA6475B8EC4D0CBA39C04CC3C24521"><enum>(B)</enum><text>to State and
local public health officials.</text>
</subparagraph></paragraph><paragraph id="ID27E6BE4AA85444F69888B4E744A18DBA">
<enum>(4)</enum>
<header>Nondistribution by notified persons</header>
<text>A person that processes, distributes, or otherwise handles the
food, or to which the food has been distributed, transported, or sold, and that
is notified under paragraph (1)(B) or (2)(B) shall immediately cease
distribution of the food.</text>
</paragraph><paragraph id="IDE104ACBD68014E3C96F7E2CDF3CA98C8">
<enum>(5)</enum>
<header>Availability of records to Administrator</header>
<text>Each person referred to in paragraph (1) that processed,
distributed, or otherwise handled food shall make available to the
Administrator information necessary to carry out this subsection, as determined
by the Administrator, regarding—</text>
<subparagraph id="ID1989F4887E2A46DF823345676B214247">
<enum>(A)</enum>
<text>persons that processed, distributed, or otherwise handled the
food; and</text>
</subparagraph><subparagraph id="IDE26BBC36BEB34A92A74C65AF7B49DDE8">
<enum>(B)</enum>
<text>persons to which the food has been transported, sold,
distributed, or otherwise handled.</text>
</subparagraph></paragraph></subsection><subsection id="IDB331657DD5E543D18387A294AC1300AC">
<enum>(c)</enum>
<header>Informal hearings on orders</header>
<paragraph id="IDC11A59C4F82D4815896C18351D051944">
<enum>(1)</enum>
<header>In general</header>
<text>The Administrator shall provide any person subject to an order
under subsection (b) with an opportunity for an informal hearing, to be held as
soon as practicable but not later than 2 business days after the issuance of
the order.</text>
</paragraph><paragraph id="ID2CCDAF47B4E24D8D8E0700B5018E28F6">
<enum>(2)</enum>
<header>Scope of the hearing</header>
<text>In a hearing under paragraph (1), the Administrator shall
consider the actions required by the order and any reasons why the food that is
the subject of the order should not be recalled.</text>
</paragraph></subsection><subsection id="IDE0339F05E76542E298715C00E6CE0117">
<enum>(d)</enum>
<header>Post-Hearing recall orders</header>
<paragraph id="ID14DDA93CA8074436ACDDF74786FAA998">
<enum>(1)</enum>
<header>Amendment of order</header>
<text>If, after providing an opportunity for an informal hearing under
subsection (c), the Administrator determines that there is a reasonable
probability that the food that is the subject of an order under subsection (b),
if consumed, would present a threat to the public health, the Administrator, as
the Administrator determines to be necessary, may—</text>
<subparagraph id="IDAAC75955844C401A840318255E155755">
<enum>(A)</enum>
<text>amend the order to require recall of the food or other
appropriate action;</text>
</subparagraph><subparagraph id="ID25D621136619469694C259DBE98422DF">
<enum>(B)</enum>
<text>specify a timetable in which the recall shall occur;</text>
</subparagraph><subparagraph id="IDE15003AA92CA4D8CA559E4208D7269D9">
<enum>(C)</enum>
<text>require periodic reports to the Administrator describing the
progress of the recall; and</text>
</subparagraph><subparagraph id="ID712A4A3E4C9B4B26BB0200D56E9E1499">
<enum>(D)</enum>
<text>provide notice of the recall to consumers to whom the food was,
or may have been, distributed.</text>
</subparagraph></paragraph><paragraph id="IDBED71B8155BC4EDD9D7FDDAA6949C624">
<enum>(2)</enum>
<header>Vacation of orders</header>
<text>If, after providing an opportunity for an informal hearing under
subsection (c), the Administrator determines that adequate grounds do not exist
to continue the actions required by the order, the Administrator shall vacate
the order.</text>
</paragraph></subsection><subsection id="ID6E90FD6A2CEB4A4AA745AFBC872E1C58">
<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="ID4A28A3315DFC45E09DF700D413AEE7CD">
<enum>404.</enum>
<header>Injunction proceedings</header>
<subsection id="ID58E2D64E9A7C41318302CA4CC60871F3">
<enum>(a)</enum>
<header>Jurisdiction</header>
<text>The district courts of the United States, and the United States
courts of the territories and possessions of the United States, shall have
jurisdiction, for cause shown, to restrain a violation of section 202, 203,
204, 207, or 401 (or a regulation promulgated under that section).</text>
</subsection><subsection id="ID26AA78BB63234A2886C0308FF2053D57">
<enum>(b)</enum>
<header>Trial</header>
<text>In a case in which violation of an injunction or restraining
order issued under this section also constitutes a violation of the food safety
law, trial shall be by the court or, upon demand of the accused, by a
jury.</text>
</subsection></section><section id="ID6D0F9E89EBEB4D5B9DBD615300BA0055">
<enum>405.</enum>
<header>Civil and criminal penalties</header>
<subsection id="IDC3C372E111844A0B9B5E2BD1DF8C0165">
<enum>(a)</enum>
<header>Civil sanctions</header>
<paragraph id="ID99949CBF0917439F8812457498001EF3">
<enum>(1)</enum>
<header>Civil penalty</header>
<subparagraph id="ID66A1C8C9902941C5B194F4669538DA47">
<enum>(A)</enum>
<header>In general</header>
<text>Any person that commits an act that violates the food safety law
(including a regulation promulgated or order issued under a Federal food safety
law) may be assessed a civil penalty by the Administrator of not more than
$10,000 for each such act.</text>
</subparagraph><subparagraph id="ID99BEFF7A49B64FBEB9F689701436DB5E">
<enum>(B)</enum>
<header>Separate offense</header>
<text>Each act described in subparagraph (A) and each day during which
that act continues shall be considered a separate offense.</text>
</subparagraph></paragraph><paragraph id="IDDC1379EA302D46129C01B214D401CF67">
<enum>(2)</enum>
<header>Other requirements</header>
<subparagraph id="IDD06CEB25A5234B22AB7043435BCC2B67">
<enum>(A)</enum>
<header>Written order</header>
<text>The civil penalty described in paragraph (1) shall be assessed by
the Administrator by a written order, which shall specify the amount of the
penalty and the basis for the penalty under subparagraph (B) considered by the
Administrator.</text>
</subparagraph><subparagraph id="ID37E86CD28DD345B0BD0474747DAA7D07">
<enum>(B)</enum>
<header>Amount of penalty</header>
<text>Subject to paragraph (1)(A), the amount of the civil penalty
shall be determined by the Administrator, after considering—</text>
<clause id="ID3A9D6FF825334A01BC007643757D5593">
<enum>(i)</enum>
<text>the gravity of the violation;</text>
</clause><clause id="IDBA3F0C31454B44A69B101FDD63857F58">
<enum>(ii)</enum>
<text>the degree of culpability of the person;</text>
</clause><clause id="ID4EC11954F82B4D65AE29BD5F001F918C">
<enum>(iii)</enum>
<text>the size and type of the business of the person; and</text>
</clause><clause id="ID1F535413B8884365B122659FDF813643">
<enum>(iv)</enum>
<text>any history of prior offenses by the person under the food safety
law.</text>
</clause></subparagraph><subparagraph id="ID1EFBAF13B7314F64AD54E898703B63E2">
<enum>(C)</enum>
<header>Review of order</header>
<text>The order may be reviewed only in accordance with subsection
(c).</text>
</subparagraph></paragraph></subsection><subsection id="ID1E631DE07B644CFA893BC17873E7D2CF">
<enum>(b)</enum>
<header>Criminal sanctions</header>
<paragraph id="IDFC507589BE454A969C12B54FDB6712CE">
<enum>(1)</enum>
<header>In general</header>
<text>Except as provided in paragraphs (2) and (3), a person that
knowingly produces or introduces into commerce food that is unsafe for human
consumption or otherwise adulterated or misbranded shall be imprisoned for not
more than 1 year or fined not more than $10,000, or both.</text>
</paragraph><paragraph id="ID677FB217735145D3002ECF807FAC2F87">
<enum>(2)</enum>
<header>Severe violations</header>
<text>A person that commits a violation described in paragraph (1)
after a conviction of that person under this section has become final, or
commits such a violation with the intent to defraud or mislead, shall be
imprisoned for not more than 3 years or fined not more than $100,000, or
both.</text>
</paragraph><paragraph id="ID415876F4BEC44A74004FF63C3B00CCC9">
<enum>(3)</enum>
<header>Exception</header>
<text>No person shall be subject to the penalties of this
subsection—</text>
<subparagraph id="IDB5C6823FD13C4F3688DA607600C225EA">
<enum>(A)</enum>
<text>for having received, proffered, or delivered in interstate
commerce any food, if the receipt, proffer, or delivery was made in good faith,
unless that person refuses to furnish (on request of an officer or employee
designated by the Administrator)—</text>
<clause id="IDE2FBCC786B704409A4E90998AA1FB424">
<enum>(i)</enum>
<text>the name, address and contact information of the person from whom
that person purchased or received the food;</text>
</clause><clause id="ID970CB3B7852A41C385702D7919BF232E">
<enum>(ii)</enum>
<text>copies of all documents relating to the person from whom that
person purchased or received the food; and</text>
</clause><clause id="ID3DFDFEA379894E9887D7951B9FFF13B5">
<enum>(iii)</enum>
<text>copies of all documents pertaining to the delivery of the food to
that person; or</text>
</clause></subparagraph><subparagraph id="ID6469716AE3AA47BE92FDCEA22E2CFDF7">
<enum>(B)</enum>
<text>if that person establishes a guaranty signed by, and containing
the name and address of, the person from whom that person received in good
faith the food, stating that the food is not adulterated or misbranded within
the meaning of this Act.</text>
</subparagraph></paragraph></subsection><subsection id="ID0F8EBCC2523C4C3CB2AF9F3CF2B58BB0">
<enum>(c)</enum>
<header>Judicial review</header>
<paragraph id="IDDA949B9CA1D1456891160000CC9148FF">
<enum>(1)</enum>
<header>In general</header>
<text>An order assessing a civil penalty under subsection (a) shall be
a final order unless the person—</text>
<subparagraph id="IDC3AB189C95794389AF8D09B766F2006C">
<enum>(A)</enum>
<text>not later than 30 days after the effective date of the order,
files a petition for judicial review of the order in the United States court of
appeals for the circuit in which that person resides or has its principal place
of business or the United States Court of Appeals for the District of Columbia;
and</text>
</subparagraph><subparagraph id="IDCE9654DDD9734CEBA5DA6553DBD1F427">
<enum>(B)</enum>
<text>simultaneously serves a copy of the petition by certified mail to
the Administrator.</text>
</subparagraph></paragraph><paragraph id="ID0EC65858F6494F64806C1C07E9003523">
<enum>(2)</enum>
<header>Filing of record</header>
<text>Not later than 45 days after the service of a copy of the
petition under paragraph (1)(B), the Administrator shall file in the court a
certified copy of the administrative record upon which the order was
issued.</text>
</paragraph><paragraph id="IDD048A4B84AF74B40AFE5001D57093142">
<enum>(3)</enum>
<header>Standard of review</header>
<text>The findings of the Administrator relating to the order shall be
set aside only if found to be unsupported by substantial evidence on the record
as a whole.</text>
</paragraph></subsection><subsection id="ID583B63507DDF4AE29200C4F34E27C3C5">
<enum>(d)</enum>
<header>Collection actions for failure To pay</header>
<paragraph id="ID03DD672C80144C1C9DEB64206868E400">
<enum>(1)</enum>
<header>In general</header>
<text>If any person fails to pay a civil penalty assessed under
subsection (a) after the order assessing the penalty has become a final order,
or after the court of appeals described in subsection (b) has entered final
judgment in favor of the Administrator, the Administrator shall refer the
matter to the Attorney General, who shall institute in a United States district
court of competent jurisdiction a civil action to recover the amount
assessed.</text>
</paragraph><paragraph id="ID85D35696358848A7ADBE06DFA6E974FC">
<enum>(2)</enum>
<header>Limitation on review</header>
<text>In a civil action under paragraph (1), the validity and
appropriateness of the order of the Administrator assessing the civil penalty
shall not be subject to judicial review.</text>
</paragraph></subsection><subsection id="ID84525768769345B6BB562BC834866B9E">
<enum>(e)</enum>
<header>Penalties paid into account</header>
<text>The Administrator—</text>
<paragraph id="ID3F2698D33E0D4057ADC392E319023B71">
<enum>(1)</enum>
<text>shall deposit penalties collected under this section in an
account in the Treasury; and</text>
</paragraph><paragraph id="ID0B703E2E510B4EBC004B48ACF39BF206">
<enum>(2)</enum>
<text>may use the funds in the account, without further appropriation
or fiscal year limitation—</text>
<subparagraph id="IDEFFDED8ECDAD4D26BE9C367144B1F114">
<enum>(A)</enum>
<text>to carry out enforcement activities under food safety law;
or</text>
</subparagraph><subparagraph id="ID9C9309A57C9D4E109C0050915BB83614">
<enum>(B)</enum>
<text>to provide assistance to States to inspect retail commercial food
establishments or other food or firms under the jurisdiction of State food
safety programs.</text>
</subparagraph></paragraph></subsection><subsection id="ID1E14084F529A4B7494EB8040B353C76C">
<enum>(f)</enum>
<header>Discretion of the Administrator to prosecute</header>
<text>Nothing in this Act requires the Administrator to report for
prosecution, or for the commencement of an action, the violation of the food
safety law in a case in which the Administrator finds that the public interest
will be adequately served by the assessment of a civil penalty under this
section.</text>
</subsection><subsection id="ID9A9428B958F24F349D53E4FF5DDEEC02">
<enum>(g)</enum>
<header>Remedies not exclusive</header>
<text>The remedies provided in this section may be in addition to, and
not exclusive of, other remedies that may be available.</text>
</subsection></section><section id="id4FD01107CB7B4A02894B752F46340A7D"><enum>406.</enum><header>Presumption</header><text display-inline="no-display-inline">In any action to enforce the requirements of
the food safety law, the connection with interstate commerce required for
jurisdiction shall be presumed to exist.</text>
</section><section id="ID3FD5EECE6EBC40BEBF544513724E15A7">
<enum>407.</enum>
<header>Whistleblower protection</header>
<subsection id="ID4C67363E8DD64B69AC4881CA3183B717">
<enum>(a)</enum>
<header>In general</header>
<text>No employee or inspector of a food establishment or other person
may be harassed, prosecuted, held liable, or discriminated against in any way
because that person—</text>
<paragraph id="IDBE1C188EA3CB4FCE82A3DC7545A745CE">
<enum>(1)</enum>
<text>has commenced, caused to be commenced, or is about to commence a
proceeding, has testified or is about to testify at a proceeding, or has
assisted or participated or is about to assist or participate in any manner in
a proceeding or other action, to carry out the objectives, functions, or
responsibilities specified in the food safety law; or</text>
</paragraph><paragraph id="ID4A937D68FC704514972443A192ABF9A5">
<enum>(2)</enum>
<text>is refusing to violate or assist in the violation of a law
described in paragraph (1), including a regulation issued under that
law.</text>
</paragraph></subsection><subsection id="ID5238962C4EDC45E8BEE92786B6DFF29D">
<enum>(b)</enum>
<header>Procedures</header>
<paragraph id="ID4FF363F5D471441CAEBC6437FB0014E0">
<enum>(1)</enum>
<header>In general</header>
<text>A person alleging a violation of subsection (a) may file a
complaint in accordance with section 31105(b) of title 49, United States
Code.</text>
</paragraph><paragraph id="ID02E6B3F2942E422500BB22DA8EEA65F0">
<enum>(2)</enum>
<header>Administration</header>
<text>Except as provided in paragraphs (3) and (4), the process,
procedures, and remedies under subsections (b), (c), and (d) of section 31105
of title 49, United States Code, with respect to allegations of violations of
subsection (a) of that section shall be the process, procedures, and remedies
that apply with respect to allegations of violations of subsection (a).</text>
</paragraph><paragraph id="IDE606E09ECF20404EBBD6472807BD2659">
<enum>(3)</enum>
<header>Alternative process</header>
<text>The person filing a complaint under paragraph (1) may elect to
use an alternative dispute resolution procedure, including mediation or
arbitration, in lieu of the hearing described in section 31105(b) of title 49,
United States Code.</text>
</paragraph><paragraph id="ID637682D1475548FB90B6C24261BDE440">
<enum>(4)</enum>
<header>Administrator</header>
<text>The powers and duties that apply to the Secretary of Labor under
section 31105 of title 49, United States Code, shall apply to the Administrator
under the food safety law.</text>
</paragraph></subsection><subsection id="ID554DCCA217B74B53A16B182395441C12">
<enum>(c)</enum>
<header>Burdens of proof</header>
<text>The legal burdens of proof with respect to a violation of
subsection (a) shall be governed by the applicable provisions of sections 1214
and 1221 of title 5, United States Code.</text>
</subsection></section><section id="ID39BE43CBBB05461EB54878C8E338BE69">
<enum>408.</enum>
<header>Administration and enforcement</header>
<subsection id="IDB2281A7D83FF46D5BF7253EBE2E11B62">
<enum>(a)</enum>
<header>In general</header>
<text>For the efficient administration and enforcement of the food
safety law, the provisions (including provisions relating to penalties) of
sections 6, 8, 9, and 10 of the <act-name parsable-cite="FTCA">Federal Trade
Commission Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/15/46">15 U.S.C.
46</external-xref>, 48, 49, and 50) (except subsections (c) through (h) of
section 6 of that Act), relating to the jurisdiction, powers, and duties of the
Federal Trade Commission and the Attorney General to administer and enforce
that Act, and to the rights and duties of persons with respect to whom the
powers are exercised, shall apply to the jurisdiction, powers, and duties of
the Administrator and the Attorney General in administering and enforcing the
provisions of the food safety law and to the rights and duties of persons with
respect to whom the powers are exercised, respectively.</text>
</subsection><subsection id="ID1638CF4575BD407DB7981C3103373E97">
<enum>(b)</enum>
<header>Inquiries and actions</header>
<paragraph id="ID8B92CB6187654754A0799D3EB703A477">
<enum>(1)</enum>
<header>In general</header>
<text>The Administrator, in person or by such agents as the
Administrator may designate, may prosecute any inquiry necessary to carry out
the duties of the Administrator under the food safety law in any part of the
United States.</text>
</paragraph><paragraph id="IDF6D4DFF392494DBB8FFF56246079E232">
<enum>(2)</enum>
<header>Powers</header>
<text>The powers conferred by sections 9 and 10 of the
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/15/49">15 U.S.C. 49</external-xref> and 50) on
the United States district courts may be exercised for the purposes of this
chapter by any United States district court of competent jurisdiction.</text>
</paragraph></subsection></section><section id="ID33211615109546F5AFE6DEEC2DF78B61">
<enum>409.</enum>
<header>Citizen civil actions</header>
<subsection id="ID8CC10A5E98204C93A5BE17461772EF43">
<enum>(a)</enum>
<header>Civil actions</header>
<text>A person may commence a civil action against—</text>
<paragraph id="IDA77F915CA3FB4FCFBB9409EEFC006658">
<enum>(1)</enum>
<text>a person that violates a regulation (including a regulation
establishing a performance standard), order, or other action of the
Administrator to ensure the safety of food; or</text>
</paragraph><paragraph id="IDCD6A430E345643F68D434DB8AEC75143">
<enum>(2)</enum>
<text>the Administrator (in his or her capacity as the Administrator),
if the Administrator fails to perform an act or duty to ensure the safety of
food that is not discretionary under the food safety law.</text>
</paragraph></subsection><subsection id="ID2EB06FF3C20144A3B62D36E6EFDE223C">
<enum>(b)</enum>
<header>Court</header>
<paragraph id="ID73FE5F30D77A45B6A437151E0069C935">
<enum>(1)</enum>
<header>In general</header>
<text>The action shall be commenced in the United States district court
for the district in which the defendant resides, is found, or has an
agent.</text>
</paragraph><paragraph id="IDA1433D4553314898AB5786F3F1219800">
<enum>(2)</enum>
<header>Jurisdiction</header>
<text>The court shall have jurisdiction, without regard to the amount
in controversy, or the citizenship of the parties, to enforce a regulation
(including a regulation establishing a performance standard), order, or other
action of the Administrator, or to order the Administrator to perform the act
or duty.</text>
</paragraph><paragraph id="ID7BC138327E8943C79DF702FE8005B13D">
<enum>(3)</enum>
<header>Damages</header>
<text>The court may—</text>
<subparagraph id="IDCECCD00A6FC74F6791CAD9A114D37715">
<enum>(A)</enum>
<text>award damages, in the amount of damages actually sustained;
and</text>
</subparagraph><subparagraph id="ID75AE8E6A70F5446BA452C822640140CB">
<enum>(B)</enum>
<text>if the court determines it to be in the interest of justice,
award the plaintiff the costs of suit, including reasonable attorney’s fees,
reasonable expert witness fees, and penalties.</text>
</subparagraph></paragraph></subsection><subsection id="ID91FDA68C022E473A8B12CA8DEDF626F1">
<enum>(c)</enum>
<header>Remedies not exclusive</header>
<text>The remedies provided for in this section shall be in addition
to, and not exclusive of, other remedies that may be available.</text>
</subsection></section>
<enum>V</enum>
<header>Implementation</header>
<section id="id7955FC0E2190413EAC5A8077A4730557"><enum>501.</enum><header>Definition</header><text display-inline="no-display-inline">For purposes of this title, the term
<term>transition period</term> means the 12-month period beginning on the
effective date of this Act.</text>
</section><section id="idDA9896F010D84EEBA7BDAE430A4AC919"><enum>502.</enum><header>Reorganization
plan</header>
<subsection id="id0CD80B441336465E9EFEB104115CE44A"><enum>(a)</enum><header>Submission of
plan</header><text>Not later than 180 days after the effective date of this
Act, the President shall transmit to the appropriate congressional committees a
reorganization plan regarding the following:</text>
<paragraph id="id83DE4611EFF140C09E2042891D816305"><enum>(1)</enum><text>The transfer of
agencies, personnel, assets, and obligations to the Administration pursuant to
this Act.</text>
</paragraph><paragraph id="id9EED567935CB44508B4F00F48219CECB"><enum>(2)</enum><text>Any
consolidation, reorganization, or streamlining of agencies transferred to the
Administration pursuant to this Act.</text>
</paragraph></subsection><subsection id="id00DF4D303DAD40DB8D313269FF720E74"><enum>(b)</enum><header>Plan
elements</header><text>The plan transmitted under subsection (a) shall contain,
consistent with this Act, such elements as the President determines
appropriate, including the following:</text>
<paragraph id="id1EC2638E2B9A4FC490EF607908019BCD"><enum>(1)</enum><text>Identification of
any functions of agencies designated to be transferred to the Administration
pursuant to this Act that will not be transferred to the Administration under
the plan.</text>
</paragraph><paragraph id="id4DB4AF54BAE542BFACC62E46CCBD1D4B"><enum>(2)</enum><text>Specification of
the steps to be taken by the Administrator to organize the Administration,
including the delegation or assignment of functions transferred to the
Administration among the officers of the Administration in order to permit the
Administration to carry out the functions transferred under the plan.</text>
</paragraph><paragraph id="id41535702692D484DB2396277F9363622"><enum>(3)</enum><text>Specification of
the funds available to each agency that will be transferred to the
Administration as a result of transfers under the plan.</text>
</paragraph><paragraph id="idCB98DC2B809041A8AFACE4CBC1249223"><enum>(4)</enum><text>Specification of
the proposed allocations within the Administration of unexpended funds
transferred in connection with transfers under the plan.</text>
</paragraph><paragraph id="idA8E66764729449609DD9EA3D89C23481"><enum>(5)</enum><text>Specification of
any proposed disposition of property, facilities, contracts, records, and other
assets and obligations of agencies transferred under the plan.</text>
</paragraph><paragraph id="id2168867D9A9E4E4BAE45B07D12BD4F71"><enum>(6)</enum><text>Specification of
the proposed allocations within the Administration of the functions of the
agencies and subdivisions that are not related directly to ensuring the safety
of food intended for human consumption.</text>
</paragraph></subsection><subsection id="id4FD57A8A42914BF594A9C2DC6A5C4CFC"><enum>(c)</enum><header>Modification of
plan</header><text>The President may, on the basis of consultations with the
appropriate congressional committees, modify, or revise any part of the plan
until that part of the plan becomes effective in accordance with subsection
(d).</text>
</subsection><subsection id="idD7C1604C57174E29A18546B2C2F63055"><enum>(d)</enum><header>Effective
date</header>
<paragraph id="idE6EE4C05F5674360B7D6436F151E3243"><enum>(1)</enum><header>In
general</header><text>The reorganization plan described in this section,
including any modifications or revisions of the plan under subsection (c),
shall become effective for an agency on the earlier of—</text>
<subparagraph id="id99CBA95594A748869B8811CA16E644DC"><enum>(A)</enum><text>the date
specified in the plan (or the plan as modified pursuant to subsection (c)),
except that such date may not be earlier than 90 days after the date the
President has transmitted the reorganization plan to the appropriate
congressional committees pursuant to subsection (a); or</text>
</subparagraph><subparagraph id="idBA44FA8C7958421384439F6C2F9F9FC3"><enum>(B)</enum><text>the end of the
transition period.</text>
</subparagraph></paragraph><paragraph id="id85F6FC75151D4C4C92DA3F72F4DD5866"><enum>(2)</enum><header>Statutory
construction</header><text>Nothing in this subsection may be construed to
require the transfer of functions, personnel, records, balances of
appropriations, or other assets of an agency on a single date.</text>
</paragraph><paragraph id="idCF241F27590049E9A67EF2226E2DD50A"><enum>(3)</enum><header>Supercedes
existing law</header><text>Paragraph (1) shall apply notwithstanding section
905(b) of title 5, United States Code.</text>
</paragraph></subsection></section><section id="idD3CA6532EC204B1D947C0E7E3687DA32"><enum>503.</enum><header>Transitional
authorities</header>
<subsection id="idF464135F259D43B6B0B2CA9E956CE50E"><enum>(a)</enum><header>Provision of
assistance by officials</header><text>Until the transfer of an agency to the
Administration, any official having authority over or function relating to the
agency immediately before the effective date of this Act shall provide the
Administrator such assistance, including the use of personnel and assets, as
the Administrator may request in preparing for the transfer and integration of
the agency to the Administration.</text>
</subsection><subsection id="idBC00CD4E7B5C47E18D009A96C28A72AD"><enum>(b)</enum><header>Services and
personnel</header><text>During the transition period, upon the request of the
Administrator, the head of any executive agency may, on a reimbursable basis,
provide services or detail personnel to assist with the transition.</text>
</subsection><subsection id="id487E1B0A395E48BC8A6B5C88FDA3B6ED"><enum>(c)</enum><header>Acting
officials</header>
<paragraph id="idB643FA32E7254F89B7CFF67923B857CC"><enum>(1)</enum><header>In
general</header><text>During the transition period, pending the advice and
consent of the Senate to the appointment of an officer required by this Act to
be appointed by and with such advice and consent, the President may designate
any officer whose appointment was required to be made by and with such advice
and consent and who was such an officer immediately before the effective date
of this Act (and who continues to be in office) or immediately before such
designation, to act in such office until the same is filled as provided in this
Act.</text>
</paragraph><paragraph id="idBED8DD1DF2CE4889BC5A4FED0AC0DC25"><enum>(2)</enum><header>Compensation</header><text>While
acting pursuant to paragraph (1), such officers shall receive compensation at
the higher of—</text>
<subparagraph id="id542076DEA2894F798DBC0584FF107C8D"><enum>(A)</enum><text>the rates
provided by this Act for the respective offices in which they act; or</text>
</subparagraph><subparagraph id="idFCF610AF2F6A4D8DA446A942688F54F0"><enum>(B)</enum><text>the rates
provided for the offices held at the time of designation.</text>
</subparagraph></paragraph><paragraph id="idFFA7FAEE9670480B9EBC265DC6EC88F0"><enum>(3)</enum><header>Limitation</header><text>Nothing
in this Act shall be construed to require the advice and consent of the Senate
to the appointment by the President to a position in the Administration of any
officer whose agency is transferred to the Administration pursuant to this Act
and whose duties following such transfer are germane to those performed before
such transfer.</text>
</paragraph></subsection><subsection id="idFF025E1C23194EF8BA67EF64B6D25A00"><enum>(d)</enum><header>Transfer of
personnel, assets, obligations, and function</header>
<paragraph id="idEDD1ECB9CF7E4D98A81020265243F5AA">
<enum>(1)</enum>
<header>In general</header>
<text>Consistent with section 1531 of title 31, United States Code, the
personnel, assets, liabilities, contracts, property, records, and unexpended
balances of appropriations, authorizations, allocations, and other funds that
relate to the functions transferred under subsection (a) from a Federal agency
shall be transferred to the Administration.</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id44FEADDDFCCB48329B3E9F2059052D08" reporting-committee-number="1"><enum>(2)</enum><header>Unexpended
funds</header><text>Unexpended funds transferred under this subsection shall be
used by the Administration only for the purposes for which the funds were
originally authorized and appropriated.</text>
</paragraph></subsection></section><section changed="not-changed" commented="no" display-inline="no-display-inline" id="idBC1CBF685B894D4BB8F81A4F1891E722" reporting-committee-number="1"><enum>504.</enum><header>Savings
provisions</header>
<subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="idA6CB7FC4218C41128E8ED1A912D2C598" reporting-committee-number="1"><enum>(a)</enum><header>Completed administrative
actions</header><text>The enactment of this Act or the transfer of functions
under this Act shall not affect any order, determination, rule, regulation,
permit, personnel action, agreement, grant, contract, certificate, license,
registration, privilege, or other administrative action issued, made, granted,
or otherwise in effect or final with respect to that agency on the day before
the transfer date with respect to the transferred functions</text>
</subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="id41BFC465E25D4A31BE45108C04B7CB9F" reporting-committee-number="1"><enum>(b)</enum><header>Pending
proceedings</header><text>Subject to the authority of the Administrator under
this Act—</text>
<paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id3C7E462F992345E0B5F02C6150619FBA" reporting-committee-number="1"><enum>(1)</enum><text>pending proceedings in an
agency, including notices of proposed rulemaking, and applications for
licenses, permits, certificates, grants, and financial assistance, shall
continue notwithstanding the enactment of this Act or the transfer of the
agency to the Administration, unless discontinued or modified under the same
terms and conditions and to the same extent that such discontinuance could have
occurred if such enactment or transfer had not occurred; and</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id92CE7CF9B536497C8EA006AC97DF0E37" reporting-committee-number="1"><enum>(2)</enum><text>orders issued in such
proceedings, and appeals therefrom, and payments made pursuant to such orders,
shall issue in the same manner on the same terms as if this Act had not been
enacted or the agency had not been transferred, and any such order shall
continue in effect until amended, modified, superceded, terminated, set aside,
or revoked by an officer of the United States or a court of competent
jurisdiction, or by operation of law.</text>
</paragraph></subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="id9B54DAEC862849FD9BCE66B310743632" reporting-committee-number="1"><enum>(c)</enum><header>Pending civil
actions</header><text>Subject to the authority of the Administrator under this
Act, any civil action commenced with regard to that agency pending before that
agency on the day before the transfer date with respect to the transferred
functions shall continue notwithstanding the enactment of this Act or the
transfer of an agency to the Administration.</text>
</subsection><subsection changed="not-changed" commented="no" display-inline="no-display-inline" id="id736C0CA068154B2583C79A715FC07043" reporting-committee-number="1"><enum>(d)</enum><header>References</header>
<paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="idF8D26ADB3AFD44B993D4129FF05A225D" reporting-committee-number="1"><enum>(1)</enum><header>In
general</header><text>After the transfer of functions from a Federal agency
under this Act, any reference in any other Federal law, Executive order, rule,
regulation, directive, document, or other material to that Federal agency or
the head of that agency in connection with the administration or enforcement of
the food safety laws shall be deemed to be a reference to the Administration or
the Administrator, respectively.</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="id8B188BCD9E484AC18ECF3E8E4549FB63" reporting-committee-number="1"><enum>(2)</enum><header>Statutory reporting
requirements</header><text>Statutory reporting requirements that applied in
relation to such an agency immediately before the effective date of this Act
shall continue to apply following such transfer if they refer to the agency by
name.</text>
</paragraph></subsection></section><section id="IDE5E176DE823D4AA4A92F023FE5C01F46">
<enum>505.</enum>
<header>Conforming amendments</header>
<subsection id="idCE7BFD05B14C43CDBAC6D72B866CFA6E"><enum>(a)</enum><header>Executive
schedule</header><text>Section 5313 of title 5, United States Code, is amended
by inserting at the end the following new item:</text>
<quoted-block display-inline="no-display-inline" id="idEA58D67B6D25457F97F9CCCB6B23821F" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="paragraph">“Administrator of Food
Safety.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id0BA531A0832B496285152C155D6C880E"><enum>(b)</enum><header>Repeal of
certain provisions</header><text>Section 18 of the Poultry Products Inspection
Act (<external-xref legal-doc="usc" parsable-cite="usc/21/467">21 U.S.C. 467</external-xref>), section
401 of the Federal Meat Inspection Act (<external-xref legal-doc="usc" parsable-cite="usc/21/671">21 U.S.C.
671</external-xref>), and section 18 of the Egg Products Inspection Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/1047">21 U.S.C. 1047</external-xref>) are
repealed.</text>
</subsection></section><section id="id3BF61FFB767B4E589BF9535014AF1731"><enum>506.</enum><header>Additional
technical and conforming amendments</header><text display-inline="no-display-inline">Not later than 60 days after the submission
of the reorganization plan under section 502, the President shall prepare and
submit proposed legislation to Congress containing necessary and appropriate
technical and conforming amendments to the Acts listed in section 3(15) of this
Act to reflect the changes made by this Act.</text>
</section><section id="IDBF770194DEA242B89EE3B500D53B3077">
<enum>507.</enum>
<header>Regulations</header>
<text display-inline="no-display-inline">The Administrator may
promulgate such regulations as the Administrator determines are necessary or
appropriate to perform the duties of the Administrator.</text>
</section><section id="IDDA8628F6F42F451CACFB0021F8376BFF">
<enum>508.</enum>
<header>Authorization of appropriations</header>
<text display-inline="no-display-inline">There are authorized to be
appropriated such sums as are necessary to carry out this Act.</text>
</section><section id="ID0CDBDDE3DDA04837A6095E5544DAC54X"><enum>509.</enum>
<header>Limitation on authorization of appropriations</header>
<text display-inline="no-display-inline">For the fiscal year that
includes the effective date of this Act, the amount authorized to be
appropriated to carry out this Act shall not exceed—</text>
<paragraph id="ID9920AE519A604BB4B3FABD31BDB2F6DX">
<enum>(1)</enum>
<text>the amount appropriated for that fiscal year for the Federal
agencies identified in section 102(b) for the purpose of administering or
enforcing the food safety law; or</text>
</paragraph><paragraph changed="not-changed" commented="no" display-inline="no-display-inline" id="ID3D088F4BC2C044C181005B5E503E1BDX" reporting-committee-number="1"><enum>(2)</enum><text>the amount appropriated
for those agencies for that purpose for the preceding fiscal year, if, as of
the effective date of this Act, appropriations for those agencies for the
fiscal year that includes the effective date have not yet been made.</text>
</paragraph></section><section id="IDD79DB0FD56D444AFB38D4794F94200AF">
<enum>510.</enum>
<header>Effective date</header>
<text display-inline="no-display-inline">This Act takes effect on the
date of enactment of this Act.</text>
</section>