1.Short title; table of
contents
(a)This Act may be cited as the Food Safety Modernization Act of
2009
.
(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 THE FOOD SAFETY
ADMINISTRATION
Sec. 101. Establishment of the food safety
administration.
Sec. 102. Consolidation of food safety functions.
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. Preventive 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 requirements.
Sec. 211. Accredited laboratories.
Title III—RESEARCH AND EDUCATION
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
Sec. 304. Working group on improving foodborne illness
surveillance.
Sec. 305. Career-spanning training for food
inspectors.
Sec. 306. Food-Borne Illness Health Registry.
Sec. 307. Study on Federal resources.
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. Reorganization plan.
Sec. 502. Transitional authorities.
Sec. 503. Savings provisions.
Sec. 504. Conforming amendments.
Sec. 505. Additional technical and conforming
amendments.
Sec. 506. Regulations.
Sec. 507. Authorization of appropriations.
Sec. 508. Limitation on authorization of
appropriations.
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 and international trade;
(3)recent ongoing
events demonstrate that the food safety program at the Food and Drug
Administration is not effective in controlling hazards in food coming from
farms and factories in the United States and food and food ingredients coming
from foreign countries, and these events have adversely affected consumer
confidence;
(4)the safety and
security of the food supply require a systemwide approach to prevent food-borne
illness involving the integrated efforts of Federal, State and local agencies;
a thorough, broad-based, and coordinated approach to basic and applied science;
and intensive, effective, and efficient management of the Nation’s food safety
program;
(5)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)the threat of
intentional contamination of the food supply;
(C)a growing number
of people at high risk for food-borne illnesses, including an increasing
population of aging and immune-compromised consumers, together with infants and
children;
(D)an increasing
volume of imported food, without adequate monitoring, inspection, and systems
for prevention of food safety problems; and
(E)maintenance of
rigorous inspection of the domestic food processing and food service
industries;
(6)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;
(7)the Food and Drug
Administration, an agency within the Department of Health and Human Services,
has regulatory jurisdiction over the safety and labeling of 80 percent of the
American food supply, encompassing all foods except meat, poultry, and egg
products, as well as drugs, medical devices, and biologics;
(8)rapid technological
advance and the expansion and globalization of industries in all areas of Food
and Drug Administration jurisdiction present challenges and require leadership
beyond the capacity of any one agency or agency head to provide;
(9)in the food safety
area, the Food and Drug Administration implements provisions of the Federal
Food, Drug, and Cosmetic Act that are 70 years old and that antiquated law
limits the Food and Drug Administration’s role largely to reacting to and
correcting food safety problems after they occur, rather than working with the
food industry to systematically prevent problems;
(10)the Food and Drug
Administration’s effectiveness is further impaired by fragmentation of
leadership and management within the Administration, as major food safety
responsibilities are dispersed across the Administration’s Center for Food
Safety and Applied Nutrition, Center for Veterinary Medicine, and Office of
Regulatory Affairs;
(11)there is no
official with the full-time responsibility and budget authority for food safety
at the Food and Drug Administration and food safety competes unsuccessfully
with the drug and medical device programs for senior agency management
attention and resources; and
(12)improving Federal
oversight of food safety requires a modern food safety mandate, clear
authorities, and a dedicated official within the Department of Health and Human
Services with budget authority to manage an integrated organizational structure
and report directly to the Secretary.
(b)The
purposes of this Act are—
(1)to establish an
agency within the Department of Health and Human Services to be known as the
Food Safety Administration
to—
(A)regulate food
safety and labeling to strengthen the protection of the public health;
(B)ensure that food
establishments fulfill their responsibility to process, store, hold, and
transport food in a manner that protects the public health of all people in the
United States;
(C)lead an
integrated, systemwide approach to food safety and to make more effective and
efficient use of resources to prevent food-borne illness;
(D)provide a single
focal point within the Department of Health and Human Services for food safety
leadership, both nationally and internationally; and
(E)provide an
integrated food safety research capability, including internally generated,
scientifically and statistically valid studies, in cooperation with academic
institutions and other scientific entities of the Federal and State
governments;
(2)to
transfer to the Food Safety Administration the food safety, labeling,
inspection, and enforcement functions that, as of the day before the date of
the enactment of this Act, are performed by various components of the Food and
Drug Administration and the National Oceanic and Atmospheric
Administration;
(3)to modernize and
strengthen the Federal food safety law to ensure more effective application and
efficient management of the laws for the protection and improvement of public
health; and
(4)to establish that
food establishments have responsibility to ensure that all stages of
production, processing, and distribution of their products or products under
their control satisfy the requirements of this law.
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)(2).
(3)
(A)The term adulterated has the meaning given
that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342).
(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 (other than a seafood processing establishment) that
slaughters, for the purpose of producing food, animals that are not subject to
inspection under the Federal Meat Inspection Act or poultry that are not
subject to inspection under the Poultry Products Inspection Act.
(6)Category 2 food
establishmentThe term
category 2 food establishment means a seafood processing
establishment or other food establishment (other than a category 1
establishment) not subject to inspection under the Federal Meat Inspection Act,
the Poultry Products Inspection Act, or the Egg Products Inspection Act, that
processes raw seafood or other raw animal products, whether fresh or frozen, or
other products that the Administrator determines by regulation to pose a
significant risk of hazardous contamination.
(7)Category 3 food
establishmentThe term category 3 food establishment
means a food establishment (other than a category 1 or category 2
establishment) that processes cooked, pasteurized, or otherwise ready-to-eat
seafood or other animal products, fresh produce in ready-to-eat raw form, or
other products that pose a risk of hazardous contamination.
(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 toxin or
manufactured toxicant, 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 hazardous contamination
refers to the presence of a contaminant in food at levels that pose a risk of
human illness, injury, or death or are capable of reaching levels that pose
such risk during the shelf life of the product.
(12)The term food means a product
intended to be used for food or drink for a human or an animal and components
thereof.
(13)
(A)The term food establishment means a
slaughterhouse (except those regulated under the Federal Meat Inspection Act or
the Poultry Products Inspection Act), factory, warehouse, or facility owned or
operated by a person located in any State that processes food or a facility
that holds, stores, or transports food or food ingredients.
(B)For
the purposes of registration, the term food establishment does not
include a food production facility as defined in paragraph (14), 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, or confined
animal-feeding operation.
(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, quality, nutritional composition, labeling, and
inspection of food, infant formulas, food additives, pesticide residues, and
other substances present in food;
(B)the provisions of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any
other Acts that are administered by the Center for Veterinary Medicine of the
Food and Drug Administration;
(C)the provisions of
the Public Health Service Act that relate in any way to studying, surveying,
containing, or preventing food-borne illness; and
(D)the provisions of
this Act.
(16)Foreign food
establishmentThe term foreign food establishment
means any category 1 through 5 food establishment or food production facility
located outside the United States that processes or produces food or food
ingredients for consumption in the United States.
(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
slaughter, packing, preparation, or manufacture of food.
(20)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
THE FOOD SAFETY ADMINISTRATION</header>
<section id="HA6958E1886C449999BCCF143C0C63D48"><enum>101.</enum><header>Establishment
of the food safety administration</header>
<subsection id="H3AA0A237B061479B87FFD8A17B58FE2B"><enum>(a)</enum><header>Establishment</header>
<paragraph commented="no" id="H55C1FFD0D7064FF6A3194C8FF8AC00DA"><enum>(1)</enum><header>In
general</header><text>There is established in the Department of Health and
Human Services an agency to be known as the <quote>Food Safety
Administration</quote>.</text>
</paragraph><paragraph commented="no" id="HD3642432738B4D989BF62BBB87D463BC"><enum>(2)</enum><header>Head of the
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, for a term of 5 years, and who may
be reappointed.</text>
</paragraph><paragraph commented="no" id="H1DBCDD60E21E4614B5C4F2CF913F3C41"><enum>(3)</enum><header>Delegation</header><text>All
the authorities and responsibilities assigned to the Secretary of Health and
Human Services in the food safety law are hereby assigned to the
Administrator.</text>
</paragraph></subsection><subsection id="H8AB3F17B4F8643A6AB7FC6C1EC7C5F7E"><enum>(b)</enum><header>Duties of
Administrator</header><text>The Administrator shall—</text>
<paragraph id="HB96B2D0CA03A4B56BDEFA1E086415124"><enum>(1)</enum><text>administer and
enforce the food safety law;</text>
</paragraph><paragraph id="H5752878690664D99823F00ECDD013455"><enum>(2)</enum><text>serve as the food
safety leader within the Department of Health and Human Services and
coordinator of all Department activities related to ensuring the safety,
quality, and proper labeling of the food supply;</text>
</paragraph><paragraph id="HDB41E2F1D57D4776B7ECD987DD8F4316"><enum>(3)</enum><text>represent the
United States in relevant international food safety bodies and
discussions;</text>
</paragraph><paragraph id="H174CEA0D15CD415DB827BC03DCEDD8BB"><enum>(4)</enum><text>promulgate
regulations to ensure the safety and security of the food supply from all forms
of contamination, including intentional contamination; and</text>
</paragraph><paragraph id="H946666AD75724F5EB6AC652772E643AB"><enum>(5)</enum><text>oversee within the
Department of Health and Human Services—</text>
<subparagraph id="HE5B89F34E35442D983C2DE522DB6DE96"><enum>(A)</enum><text display-inline="yes-display-inline">in consultation with the Director of the
Centers for Disease Control and Prevention, all activities related to foodborne
illness surveillance and investigation of foodborne illness outbreaks;</text>
</subparagraph><subparagraph id="H0EDCDDFDF53C49F4A796CD1CE64F75AF"><enum>(B)</enum><text>implementation of
food safety inspection, enforcement, and research efforts to protect the public
health;</text>
</subparagraph><subparagraph id="H96F6A3D6D2E246049221E170E7BE1349"><enum>(C)</enum><text>development of
consistent and science-based standards for safe food;</text>
</subparagraph><subparagraph id="H5830C892C2EF4302980095FD662270BB"><enum>(D)</enum><text>coordination and
prioritization of food safety research and education programs with other
Federal agencies;</text>
</subparagraph><subparagraph id="H90EB540D49D444BF8E1490FEBA23FDE"><enum>(E)</enum><text>prioritization of
food safety efforts and deployment of food safety resources to achieve the
greatest possible benefit in reducing food-borne illness;</text>
</subparagraph><subparagraph id="H4E7E492A1C1C412B82D5C1B83BD89115"><enum>(F)</enum><text>coordination of
the response to food-borne illness outbreaks with other Federal and State
agencies; and</text>
</subparagraph><subparagraph id="HB82F5F6D2AFE4FB7B32EF0D2009F3029"><enum>(G)</enum><text>integration of
food safety activities with State and local agencies.</text>
</subparagraph></paragraph></subsection></section><section id="H4404358ADD8D46F0A23E5BA547450200"><enum>102.</enum><header>Consolidation
of food safety functions</header>
<subsection id="H2F34DEAB621C470297AB003D6731AD4E"><enum>(a)</enum><header>Transfer of
Functions and Resources</header><text>For each component of the Department of
Health and Human Services or the Department of Commerce specified in subsection
(b), there are transferred to the Administration all functions, personnel, and
assets (including facilities and financial resources) of those components as of
the day before the date of the enactment of this Act (including all related
functions of any officer or employee of the component) that relate to
administration or enforcement of the food safety law, as determined by the
President.</text>
</subsection><subsection id="HB8ACAFF4C3624C6E9151C0A297F4EFD8"><enum>(b)</enum><header>Transferred
Functions and Resources</header><text>The components referred to in subsection
(a) are—</text>
<paragraph id="HB06F6C5AD9E94F7BB2EB1BD98B002973"><enum>(1)</enum><text>the Center for
Food Safety and Applied Nutrition of the Food and Drug Administration;</text>
</paragraph><paragraph id="H251149C5099F4E90B37B31CB67B91114"><enum>(2)</enum><text>the Center for
Veterinary Medicine of the Food and Drug Administration;</text>
</paragraph><paragraph id="HA1432CE1B31F4F56B6A9CCE7A9EEDFBD"><enum>(3)</enum><text>the National
Center for Toxicological Research of the Food and Drug Administration;</text>
</paragraph><paragraph id="H7E20D29D21E54C6DADC2DEB409087D6F"><enum>(4)</enum><text display-inline="yes-display-inline">the personnel and assets of the Office of
Regulatory Affairs of the Food and Drug Administration used to administer and
conduct inspections of food establishments and imports and conduct laboratory
analyses and other investigations relating to food safety and enforcement of
the food safety law;</text>
</paragraph><paragraph id="H7C6EC0F7ED2A4B2594A65FA1621BB0FD"><enum>(5)</enum><text>the personnel and
assets of the Office of the Commissioner of Food and Drugs used to
support—</text>
<subparagraph id="HD6A0BF0D9E7442399F4F83D5003DC0CF"><enum>(A)</enum><text>the Center for
Food Safety and Applied Nutrition;</text>
</subparagraph><subparagraph id="HDEF8E9E3EEFD49E6B504348554B54E72"><enum>(B)</enum><text>the Center for
Veterinary Medicine;</text>
</subparagraph><subparagraph id="HDDF7A39B33EF4CD39648D78FA21F3D50"><enum>(C)</enum><text>the National
Center for Toxicological Research; and</text>
</subparagraph><subparagraph id="H6A7B0DA1E10B43FAB9C593A97E60C189"><enum>(D)</enum><text>the personnel and
assets of the Office of Regulatory Affairs described in paragraph (4);
and</text>
</subparagraph></paragraph><paragraph id="HC7EDA4D3F0B1485B8C06FDB2476EEEEB"><enum>(6)</enum><text>the personnel and
assets of the National Marine Fisheries Service of the National Oceanic and
Atmospheric Administration of the Department of Commerce used to administer the
seafood inspection program.</text>
</paragraph></subsection><subsection id="HAB055AB0E8D54208BE148D4CDA8149CF"><enum>(c)</enum><header>Renaming and
reservation of agency identity</header><text>The Food and Drug Administration
in the Department of Health and Human Services is hereby renamed the Federal
Drug and Device Administration and may be referred to as
<quote>FDA</quote>.</text>
</subsection><subsection id="H9FBD915C711845068F814533E62FE8C5"><enum>(d)</enum><header>Sharing of
facilities and resources</header><text>The Food Safety Administration and the
Federal Drug and Device Administration shall enter into such agreements
concerning the sharing of facilities and other resources as may be appropriate
to make efficient use of such facilities and resources and achieve their
respective missions.</text>
</subsection></section><section id="H4CB91E2859DE4D63A1FE247DDA8CFA48"><enum>103.</enum><header>Additional
duties of the administration</header>
<subsection id="HB14000339EDE4F9E9B93050050FEC38D"><enum>(a)</enum><header>Officers and
Employees</header><text>The Administrator may—</text>
<paragraph id="HC51B107D0D7E41A18E714685ED11B174"><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="H79A3F7D8992A41EE91B4426710A2682B"><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="HD664D76608274443A07304D23441DB17"><enum>(b)</enum><header>Experts and
Consultants</header><text>The Administrator may—</text>
<paragraph id="H275C7DE56A294FD3BE1DD632A16F1679"><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="HE42E35A2309146EBBD6F5CA4276477A7"><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="HD1FDFA7C52E845ECAA23F166B55BD878"><enum>(c)</enum><header>Bureaus,
Offices, and Divisions</header><text>The Administrator may establish within the
Administration such bureaus, offices, and divisions as the Administrator
determines are necessary to perform the duties of the Administrator.</text>
</subsection><subsection id="H10BE7056312F490FA56B7BC1FD45F01F"><enum>(d)</enum><header>Advisory
committees</header>
<paragraph id="H9DC9811C676E4478972175BF31D745A5"><enum>(1)</enum><header>In
general</header><text>The Administrator shall establish advisory committees
that consist of representatives of scientific expert bodies, academics,
industry specialists, and consumers.</text>
</paragraph><paragraph id="HDCE10159A22A473384A6C0D7541C6FA9"><enum>(2)</enum><header>Duties</header><text>The
duties of an advisory committee established under paragraph (1) may include
developing recommendations with respect to the development of new processes,
research, communications, performance standards, and inspection.</text>
</paragraph></subsection></section><enum>II</enum><header>ADMINISTRATION OF
FOOD SAFETY PROGRAM</header>
<section id="H30BB3300BED84575B635F7E747391365"><enum>201.</enum><header>Administration
of national program</header>
<subsection id="HCD20E9C04C014B168893204BBFFE4500"><enum>(a)</enum><header>In
general</header><text>The Administrator shall—</text>
<paragraph id="HC56DBAA45F514220BA21AFAD70FF3680"><enum>(1)</enum><text>develop,
administer, and annually update a national food safety program (referred to in
this section as the <quote>program</quote>) to protect public health;
and</text>
</paragraph><paragraph id="H258AE3FDD704487B89FE5DF5B121589F"><enum>(2)</enum><text>ensure that
persons who produce, process, or distribute food meet their responsibility to
prevent or minimize food safety hazards related to their products.</text>
</paragraph></subsection><subsection id="H6EC01FBE7A884814AF4703DE615684BE"><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="H204C967ADE9947E1B0CD73588DAD7FD"><enum>(1)</enum><text>the severity of the
potential health risks;</text>
</paragraph><paragraph id="H9D4C0CB044B3410784413042AFDF895C"><enum>(2)</enum><text>the sources of
potentially hazardous contamination or practices extending from the farm or
ranch to the consumer that may increase the risk of food-borne illness;</text>
</paragraph><paragraph id="HD73233026A0F480A9409496CA0065446"><enum>(3)</enum><text>the potential for
persistence, multiplication, or concentration of naturally occurring or added
contaminants in food;</text>
</paragraph><paragraph id="HC1D2C7C33B7A4F9BAB47F171C56B9D00"><enum>(4)</enum><text>the potential for
hazardous contamination to have cumulative toxic effects, multigenerational
effects, or effects on specific categories of consumers;</text>
</paragraph><paragraph id="H47B4FF8D0D9A4CA0BC4FF316FF36852"><enum>(5)</enum><text>opportunities
across the food production, processing, distribution, and retail system to
reduce potential health risks; and</text>
</paragraph><paragraph id="H115353A110754A4583AB5699A68E809B"><enum>(6)</enum><text>opportunities for
intentional contamination of food or food ingredients.</text>
</paragraph></subsection><subsection id="H32F737C06ECB43368FA9E7F856DB97BB"><enum>(c)</enum><header>Program
elements</header><text>In carrying out the program, the Administrator
shall—</text>
<paragraph id="H9CD6854197B14DB597C93E66257085D4"><enum>(1)</enum><text>adopt and
implement a national system for the registration of food establishments and
foreign food establishments, as provided in section 202 of this Act;</text>
</paragraph><paragraph id="HB2D47E44CB4848A3923C08F51C28A341"><enum>(2)</enum><text>adopt and
implement a national system for regular unannounced inspection of food
establishments;</text>
</paragraph><paragraph id="H9FE47F5CD58E4AE7B5A75BFC0F634CC"><enum>(3)</enum><text>require and enforce
the adoption of preventive process controls in food establishments, based on
the best available scientific and public health considerations and best
available technologies;</text>
</paragraph><paragraph id="HE90573C367354C7CAF81A78EAA034EE3"><enum>(4)</enum><text>establish and
enforce science-based standards for—</text>
<subparagraph id="H967FD51DAF3F4A70B4386311546356A8"><enum>(A)</enum><text>potentially
hazardous substances that may contaminate food; and</text>
</subparagraph><subparagraph id="H9F992B415CBB4B45805C64B5BDC9E3B8"><enum>(B)</enum><text>safety and
sanitation in the processing and handling of food;</text>
</subparagraph></paragraph><paragraph id="HCA59373B4CCC4654BA070014E96D857F"><enum>(5)</enum><text>implement a
statistically valid sampling program with the stringency and frequency to
independently monitor 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="H792C6B743B02433B9520B86CF407EAB5"><enum>(6)</enum><text>implement
appropriate surveillance procedures and requirements to ensure the safety and
security of imported food;</text>
</paragraph><paragraph id="H3BF8D81E63584C64B3511343579194BD"><enum>(7)</enum><text display-inline="yes-display-inline">coordinate and collaborate with other
agencies and State or local governments in carrying out inspection,
enforcement, research, and monitoring;</text>
</paragraph><paragraph id="H2BFA049DB17A42A488451FBD50988367"><enum>(8)</enum><text>implement a
national system to identify the food products posing the greatest public health
risk and to analyze the effectiveness of existing food safety programs, in
conjunction with the Centers for Disease Control and Prevention and other
Federal agencies;</text>
</paragraph><paragraph id="H4B9E4E75210147A1B3E221AD5DC16D71"><enum>(9)</enum><text>develop public
education, risk communication, and advisory programs;</text>
</paragraph><paragraph id="HC3DF27A52A9B405BBF48B427F8BBA5F6"><enum>(10)</enum><text>implement an
applied research program to further the purposes of this Act;</text>
</paragraph><paragraph id="H4682594ACB824D879CFF85A77CC4B8B5"><enum>(11)</enum><text>coordinate and
prioritize food safety research and educational programs with other Federal
agencies and with State and local governments; and</text>
</paragraph><paragraph id="H904094A47B474E8598A8029E8988A47B"><enum>(12)</enum><text display-inline="yes-display-inline">provide technical assistance to farmers and
food establishments that are small business concerns (meeting the requirements
of section 3(a) of the Small Business Act and the regulations promulgated
thereunder) to assist with compliance with the requirements of this Act.</text>
</paragraph></subsection></section><section id="H8C12BC5E368A421698FEB39B217871A1"><enum>202.</enum><header>Registration of
food establishments and foreign food establishments</header>
<subsection id="H1AB7E715426B447AA027E5F6F4420095"><enum>(a)</enum><header>In
general</header><text>Any food establishment or foreign food establishment
engaged in manufacturing, processing, packing, or holding food for consumption
in the United States shall register annually with the Administrator.</text>
</subsection><subsection id="HF02523A276244C22AFBBD23F049DB78B"><enum>(b)</enum><header>Registration
requirements</header>
<paragraph id="H958B27ED2E9646318F7D97426CFBF223"><enum>(1)</enum><header>In
general</header><text>To be registered under subsection (a), a food
establishment shall submit a registration or reregistration to the
Administrator.</text>
</paragraph><paragraph id="H69D082DB496748D0921C2C0684371409"><enum>(2)</enum><header>Registration</header><text>Registration
under this section shall begin within 90 days of the enactment of this Act.
Each such registration shall be submitted to the Secretary through an
electronic portal and shall contain such information as the Secretary, by
guidance, determines to be appropriate. Such registration shall contain the
following information:</text>
<subparagraph id="H7E8E488E53664D9E83A9003D0034A259"><enum>(A)</enum><text>The name, address,
and emergency contact information of each domestic food establishment or
foreign food establishment that the registrant owns or operates under this Act
and all trade names under which the registrant conducts business in the United
States relating to food.</text>
</subparagraph><subparagraph id="H7B2BE26CAAF54A8EA2B430007CD1256E"><enum>(B)</enum><text>The primary
purpose and business activity of each domestic food establishment or foreign
food establishment, including the dates of operation if the domestic food
establishment or foreign food establishment is seasonal.</text>
</subparagraph><subparagraph id="HCF390D635FBB4939B48D996307A988BD"><enum>(C)</enum><text display-inline="yes-display-inline">The types of food processed or sold at each
domestic food establishment or, for foreign food establishments selling food
for consumption in the United States, the specific food categories of that food
as listed under section 170.3(n) of title 21, Code of Federal Regulations, or
such other categories as the Administrator may designate in guidance, action
level, or regulations for evaluating potential threats to food
protection.</text>
</subparagraph><subparagraph id="H0320104C5729410C9869AD10EFF08210"><enum>(D)</enum><text>The name, address,
and 24-hour emergency contact information of the United States distribution
agent for each domestic food establishment or foreign food establishment, who
shall maintain information on the distribution of food, including lot
information, and wholesaler and retailer distribution.</text>
</subparagraph><subparagraph id="HEA5BE33F7C854667A8348B819FD2D78F"><enum>(E)</enum><text>An assurance that
the registrant will notify the Administrator of any change in the products,
function, or legal status of the domestic food establishment or foreign food
establishment (including cessation of business activities) not later than 30
days after such change.</text>
</subparagraph></paragraph><paragraph id="HC01CCAEA48974D7DA770B356D05FB1D7"><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,
designate each establishment as a category 1, 2, 3, 4, or 5 food establishment,
and assign a registration number to each domestic food establishment and
foreign food establishment.</text>
</paragraph><paragraph id="H47B6FD4E290C4BCAA8BB1202EE8349FF"><enum>(4)</enum><header>List</header><text>The
Administrator shall annually compile a list of domestic food establishments and
a list of foreign food establishments that are registered under this section.
The Administrator may establish the manner of and any fees required for
reregistration and any circumstances by which either such list may be shared
with other governmental authorities. The Administrator may remove from either
list the name of any establishment that fails to reregister, and such delisting
shall be treated as a suspension.</text>
</paragraph><paragraph id="H337CE3C0252D4D1EA3D2511371E5C1FF"><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="H02BE6AF4B35D4EC886E26933DB2298E2"><enum>(A)</enum><text>the list compiled
under paragraph (4); and</text>
</subparagraph><subparagraph id="HCAA1FFAC9D5E423E8CFE9D5F1D1569A5"><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 person.</text>
</subparagraph></paragraph><paragraph id="H0D9FC42BFB9D4516B0AF562502892BC6"><enum>(6)</enum><header>Suspension of
registration</header>
<subparagraph id="H0BF5995E11494182B3582B92005FB97F"><enum>(A)</enum><header>In
general</header><text>The Administrator may suspend the registration of a
domestic food establishment or foreign food establishment, including the
facility of an importer, for violation of a food safety law that is either
repeated or could result in serious adverse health consequences or death to
humans or animals.</text>
</subparagraph><subparagraph id="HDE418A83673F4DBB85BF1F9F0092ACC7"><enum>(B)</enum><header>Notice and
opportunity for hearing</header><text>The Administrator shall provide notice of
an intent to suspend the registration of an establishment under this paragraph
to a registrant and provide the registrant with an opportunity for an
administrative hearing within 3 days. The Administrator may issue a written
order of suspension following the hearing, if the Administrator finds that a
violation described in subparagraph (A) has occurred.</text>
</subparagraph><subparagraph commented="no" id="HF52DDE29B665463AB5045EC85DBEA9A6"><enum>(C)</enum><header>Judicial
review</header><text>The issuance of an order of suspension under subparagraph
(B) shall be considered to be a final agency action subject to judicial review
in accordance with the provisions of chapter 7 of title 5, United States
Code.</text>
</subparagraph></paragraph><paragraph id="HBE5FCDF74C7B487F003EB8D7313EE777"><enum>(7)</enum><header>Reinstatement</header><text>A
registration that is suspended under this section may be reinstated based on a
showing that adequate process controls have been instituted that would prevent
future violations and there are assurances from the registrant that the
violations will not be repeated.</text>
</paragraph></subsection><subsection id="H3D01CE97CEA3456286321D8E00003956"><enum>(c)</enum><header>Transitional
provision</header><text>During the 6-month period following the date of the
enactment of this Act, a food establishment is deemed to be registered in
accordance with this section if the establishment is registered under section
415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d).</text>
</subsection><subsection id="H566AAACCDE8143409E1DC7D8719CF03E"><enum>(d)</enum><header>Repeal</header><text>Effective
at the end of the 6-month period following the date of the enactment of this
Act, section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d)
is repealed.</text>
</subsection></section><section id="H7C120FE8ED5F4B7585242F413E89EA8"><enum>203.</enum><header>Preventive
process controls to reduce adulteration of food</header>
<subsection id="HE6162485B200406794F000004BBC112"><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 carry out their responsibilities under the food
safety law.</text>
</subsection><subsection id="HB7603B4714B0482F89A79E59562F94A0"><enum>(b)</enum><header>Regulations</header><text>Not
later than 1 year after the date of the enactment of this Act, the
Administrator shall promulgate regulations that require all food
establishments, within time frames determined by the Administrator—</text>
<paragraph id="H2E051885A28D42309C3BEDCC29F60331"><enum>(1)</enum><text>to adopt
preventive process controls that—</text>
<subparagraph id="HD3245C6FB42342190096007345893034"><enum>(A)</enum><text>reflect the
standards and procedures recognized by relevant authoritative bodies;</text>
</subparagraph><subparagraph id="H1D63BA84045846FBAC23D06115EFCF79"><enum>(B)</enum><text>are adequate to
protect the public health;</text>
</subparagraph><subparagraph id="HCD4E36AFF4D34A88AE3C00E200FBFBFA"><enum>(C)</enum><text>meet relevant
regulatory and food safety standards;</text>
</subparagraph><subparagraph id="H283C901FB5BC445A82F5946677E2EFF"><enum>(D)</enum><text>limit the presence
and growth of contaminants in food prepared in a food establishment using the
best reasonably available techniques and technologies; and</text>
</subparagraph><subparagraph id="HE1CA845A03B345F0AEE87B00FD4056D2"><enum>(E)</enum><text>are tailored to
the hazards and processes in particular establishments or environments;</text>
</subparagraph></paragraph><paragraph id="H7AE1D26C6DB34352936EFDF2A2D70016"><enum>(2)</enum><text>to establish a
sanitation plan and program that meets standards set by the
Administrator;</text>
</paragraph><paragraph id="HC863F38DD0B345B4B564E9CA6FCFDFB5"><enum>(3)</enum><text>to meet
performance standards for hazardous contamination established under section
204;</text>
</paragraph><paragraph id="H02B444F16D164ECA8FAA2F725700CBD2"><enum>(4)</enum><text>to implement
recordkeeping to monitor compliance with regulatory requirements;</text>
</paragraph><paragraph id="H31A38F2B74CE40BBB363AEDAC9394841"><enum>(5)</enum><text>to implement
recordkeeping and labeling of all food and food ingredients to facilitate their
identification and traceability in the event of a recall or market
removal;</text>
</paragraph><paragraph id="HF478FB87C50642379DC2B485E933588E"><enum>(6)</enum><text>to implement
product and environmental sampling 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;</text>
</paragraph><paragraph id="H12EF679533F340E3B48C3E33CCE19014"><enum>(7)</enum><text>to label food
intended for final processing outside commercial food establishments with
instructions for handling and preparation for consumption that will destroy
microbial contaminants; and</text>
</paragraph><paragraph id="HF8E43C3B09E545FE8F608023D8FBD77D"><enum>(8)</enum><text>to provide for
agency access to records kept by the food establishments and submission of
copies of records to the Administrator, as the Administrator determines
appropriate.</text>
</paragraph></subsection><subsection id="HD66A98285CE9469C9C39BC115D515746"><enum>(c)</enum><header>Specific hazard
controls</header><text>The Administrator may require any person with
responsibility for or control over food or food ingredients to adopt specific
hazard controls, if such controls are needed to ensure the protection of the
public health.</text>
</subsection></section><section id="H42E506DC9DB242A4BEBD409969244100"><enum>204.</enum><header>Performance
standards for contaminants in food</header>
<subsection id="H9D1A9BE6C4FF478FBC265B20345C547C"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">To protect the public
health, the Administrator shall establish by guidance document, action level,
or regulation and enforce performance standards that define, with respect to
specific foods and contaminants in food, the level of food safety performance
that a person responsible for producing, processing, or selling food shall
meet.</text>
</subsection><subsection id="HDC29D8421E374ED5BBB3532E9FC515B9"><enum>(b)</enum><header>Identification
of contaminants; performance standards</header>
<paragraph id="H07EF74DC5F0846F69251B06E2924968D"><enum>(1)</enum><header>List of
contaminants</header><text display-inline="yes-display-inline">Not later than 6
months after the date of the enactment of this Act, the Administrator shall
publish in the Federal Register a list of the contaminants in foods that have
the greatest adverse impact on public health in terms of the number and
severity of illnesses and number of deaths associated with foods regulated
under this Act. Where appropriate, the Administrator shall indicate whether the
risk posed by a contaminant is generalized or specific to particular foods or
ingredients.</text>
</paragraph><paragraph id="H01D81C796D3A40128CAD6CF72555965"><enum>(2)</enum><header>Performance
standards</header>
<subparagraph id="HFAE6EC44E68A4AC8BE42D000B4200002"><enum>(A)</enum><header>Establishment</header><text>The
Administrator shall establish by guidance document, action level, or regulation
a performance standard for each contaminant in the list under paragraph (1) at
levels appropriate to protect against the potential adverse health effects of
the contaminant.</text>
</subparagraph><subparagraph id="HE67FB2F91058477C93F38B041373F03B"><enum>(B)</enum><header>Timing</header><text>The
Administrator shall establish a performance standard under subparagraph (A) for
each contaminant in the list under paragraph (1)—</text>
<clause id="H216BF879CE0843A29BD034B61EC03D74"><enum>(i)</enum><text>as
soon as practicable; or</text>
</clause><clause id="H33CB0C7640EB4D29AC3F19E79F94036E"><enum>(ii)</enum><text>in
the case of a contaminant described in subparagraph (C), by the date described
in such subparagraph.</text>
</clause></subparagraph><subparagraph id="H6EDF51988DFA46C3855445CFC5931714"><enum>(C)</enum><header>Significant
contaminants</header><text>The list under paragraph (1) (and any revision
thereto) shall identify the 5 most significant contaminants in the list (in
terms of the number and severity of illnesses and number of deaths associated
with foods regulated under this Act). Not later than 3 years after a
contaminant is so identified, the Administrator shall promulgate a performance
standard under subparagraph (A) for the contaminant.</text>
</subparagraph></paragraph><paragraph id="H476EC56F333246F793B0E394C86D3D00"><enum>(3)</enum><header>Review;
revision</header><text>Not less than every 3 years, the Administrator shall
review and, if necessary, revise—</text>
<subparagraph id="H6F17621A268F40ACA89E2DA118FBFA3D"><enum>(A)</enum><text>the list of
contaminants under paragraph (1); and</text>
</subparagraph><subparagraph id="H273C7C66277C46FEB63866BF37C7A0BC"><enum>(B)</enum><text>each performance
standard established under paragraph (2).</text>
</subparagraph></paragraph></subsection><subsection id="HE9DDC6BF62FD4C229B00AEB30076B5F4"><enum>(c)</enum><header>Performance
standards</header>
<paragraph id="HFAEA24B44DC6440FB26D00608C3B6F33"><enum>(1)</enum><header>In
general</header><text>The performance standards established under this section
may include—</text>
<subparagraph id="HB6280A7A86D048E9B8D4897F29F2CD93"><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="H5690322F65894D59BF6EB2001BF45B47"><enum>(B)</enum><text>zero tolerances,
including any zero tolerance performance standards in effect on the day before
the date of the enactment of this Act, when necessary to protect against
significant adverse health outcomes;</text>
</subparagraph><subparagraph id="HC741948641F941D5A91EAA6F6B0813B3"><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="HD30709D3D17D4F89A25984BA83C06CF8"><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 on the basis of reliable
information on the best reasonably achievable performance, using best available
technologies, interventions, and practices.</text>
</subparagraph></paragraph><paragraph id="H2DB71D7D382D40F2B7CADB71C2A66608"><enum>(2)</enum><header>Best reasonably
achievable performance standards</header><text>In developing best reasonably
achievable performance standards under paragraph (1)(D), 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="HA8BC8447DB07421C90E49798F20005E4"><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 the enactment of
this Act shall remain in effect until revised or revoked by the
Administrator.</text>
</paragraph></subsection><subsection id="HCFA94715B52D43A0A4538DF6054F1200"><enum>(d)</enum><header>Enforcement</header>
<paragraph id="H6067542F376D4E658E413E5BE1005086"><enum>(1)</enum><header>In
general</header><text>In conjunction with the establishment of a performance
standard under this section, the Administrator shall develop a statistically
valid sampling program with the stringency and frequency sufficient to
independently monitor whether food establishments are complying with the
performance standard and implement the program within 1 year of the
promulgation of the standard.</text>
</paragraph><paragraph id="H9C2E100F8AA64E268EA9D2E7042B2F45"><enum>(2)</enum><header>Inspections</header><text>If
the Administrator determines that a food establishment fails to meet a standard
promulgated under this section, the Administrator shall, as appropriate—</text>
<subparagraph id="H2BA96B2146A34F1BB285671FE0663940"><enum>(A)</enum><text>detain, seize, or
condemn food from the food establishment under section 402;</text>
</subparagraph><subparagraph id="HD90BC95229E741E89735C06EF26EAFB"><enum>(B)</enum><text>order a recall of
food from the food establishment under section 403;</text>
</subparagraph><subparagraph id="H85C4E58A19C4475782A67998776DF76E"><enum>(C)</enum><text>increase the
inspection frequency for the food establishment;</text>
</subparagraph><subparagraph id="H553C254427614A2B859C2BD3CB3D1941"><enum>(D)</enum><text>withdraw the mark
of inspection from the food establishment, if in use; or</text>
</subparagraph><subparagraph id="H7F6C772F4A3D435788A2D942CE5300DA"><enum>(E)</enum><text>take other
appropriate enforcement action concerning the food establishment, including
withdrawal of registration.</text>
</subparagraph></paragraph></subsection><subsection id="H1B97E8F72C184D668F7260A87E236862"><enum>(e)</enum><header>Newly identified
contaminants</header><text>Notwithstanding any other provision of this section,
the Administrator shall establish interim performance standards for newly
identified contaminants as necessary to protect the public health.</text>
</subsection></section><section id="HF726D2D21804434FBDEBA8C349E4E5C"><enum>205.</enum><header>Inspections of
food establishments</header>
<subsection id="H8DD32AB9797846D4AED4E2623F5945ED"><enum>(a)</enum><header>In
general</header><text>The Administrator shall establish an inspection program,
which shall include statistically valid sampling of food and facilities to
enforce performance standards. The inspection program shall be designed to
determine if each food establishment—</text>
<paragraph id="H8203E3240DB443B7ADD5B8F0548672A2"><enum>(1)</enum><text>is operated in a
sanitary manner;</text>
</paragraph><paragraph id="H903EBDA35E314B1B999D4D9606BB2460"><enum>(2)</enum><text>has continuous
preventive control systems, interventions, and processes in place to minimize
or eliminate contaminants in food;</text>
</paragraph><paragraph id="HAFBAF25E98394ADA9E4B5804DB5F158B"><enum>(3)</enum><text>is in compliance
with applicable performance standards established under section 204, and other
regulatory requirements;</text>
</paragraph><paragraph id="H169A84DDB1A842A89896EAF1022911C7"><enum>(4)</enum><text>is processing food
that is not adulterated or misbranded;</text>
</paragraph><paragraph id="H823A255E6D4049C8A13DD1FA60ED361E"><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="H65D3F8CB2A804CB8B2D099ACD49DC2BD"><enum>(6)</enum><text>is otherwise in
compliance with the requirements of the food safety law.</text>
</paragraph></subsection><subsection id="HB7E19BF0F8334389B7AC5143C61C3124"><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), (d), and (e):</text>
<paragraph id="H735A0A332B9F4EB79C1010BD8B947E00"><enum>(1)</enum><header>Category 1 food
establishments</header><text>A category 1 food establishment shall be subject
to antemortem, postmortem, 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="H8365BAB2DF3F43E0AC4DD5512363FA2F"><enum>(A)</enum><text>diseased animals
are not offered for slaughter;</text>
</subparagraph><subparagraph id="HECBC86CADE8B4F8CBA85C1FCF6FFBAEB"><enum>(B)</enum><text>the food
establishment has successfully identified and removed from the slaughter line
visibly defective or contaminated carcasses, has avoided cross-contamination,
and has destroyed or reprocessed such carcasses in a manner acceptable to the
Administrator; and</text>
</subparagraph><subparagraph id="HA10104CD48D54E5D88C5D0C2FE420271"><enum>(C)</enum><text>applicable
performance standards and other provisions of the food safety law, including
those intended to eliminate or reduce pathogens, have been satisfied.</text>
</subparagraph></paragraph><paragraph id="H86D6F42DA1C942858FCB85726DA2C5C4"><enum>(2)</enum><header>Category 2 food
establishments</header><text>A category 2 food establishment shall—</text>
<subparagraph id="H9139B29BCBAE47C08BFAA5326B04960"><enum>(A)</enum><text>have ongoing
verification that its processes are controlled; and</text>
</subparagraph><subparagraph id="H9A063DF5293E4280ABA5D9B4D34E8CAC"><enum>(B)</enum><text>be randomly
inspected at least weekly.</text>
</subparagraph></paragraph><paragraph id="H9DC0BD25188846AF92003763FC5EFC2E"><enum>(3)</enum><header>Category 3 food
establishments</header><text>A category 3 food establishment shall—</text>
<subparagraph id="H8259297CA30D470293A3C8BADB87F07C"><enum>(A)</enum><text>have ongoing
verification that its processes are controlled; and</text>
</subparagraph><subparagraph id="HCEC7748F5E46457495BCC711B203C9BD"><enum>(B)</enum><text>be randomly
inspected at least monthly.</text>
</subparagraph></paragraph><paragraph id="HF553D40EA8924041A2422C1DDC55CD8F"><enum>(4)</enum><header>Category 4 food
establishments</header><text>A category 4 food establishment shall—</text>
<subparagraph id="HE606504EA0744C4FAA4DA44C38C55772"><enum>(A)</enum><text>have ongoing
verification that its processes are controlled; and</text>
</subparagraph><subparagraph id="HF6AE8056C1134F419154BB13334BDBD6"><enum>(B)</enum><text>be randomly
inspected at least quarterly.</text>
</subparagraph></paragraph><paragraph id="H456DB4A7AF1D44719616B97513B905F0"><enum>(5)</enum><header>Category 5 food
establishments</header><text>A category 5 food establishment shall—</text>
<subparagraph id="H480C4F0564C44E1E8D16A01EB6E2DF98"><enum>(A)</enum><text>have ongoing
verification that its processes are controlled; and</text>
</subparagraph><subparagraph id="HC082F4025A3B4F91B61C16C03F4E6788"><enum>(B)</enum><text>be randomly
inspected at least annually.</text>
</subparagraph></paragraph></subsection><subsection id="H8AFF7D2E86744E49AE77A508FAE1F3C2"><enum>(c)</enum><header>Establishment of
inspection procedures</header><text>The Administrator shall establish
procedures under which inspectors shall take random samples, photographs, and
copies of records in food establishments.</text>
</subsection><subsection id="H7CE9284705614CB28CA10000DFF7B6D"><enum>(d)</enum><header>Alternative
inspection frequencies</header><text>With respect to a subcategory of food
establishment under category 2, 3, 4, or 5, the Administrator may establish
alternative increasing or decreasing inspection frequencies for subcategories
of food establishments or individual establishments, to foster risk-based
allocation of resources. Before establishing an alternative inspection
frequency for a subcategory of food establishments or individual
establishments, the Administrator shall take into consideration the evidence
described in paragraph (2)(D) and the overall record of compliance described in
paragraph (2)(E) for such subcategory. In establishing alternative inspection
frequencies under this subsection, the Administrator shall comply with the
following criteria and procedures:</text>
<paragraph id="H650A165D5D37432BAC00A280EAB47EC1"><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="H63B1EA3624E14173B84378B33D01DCF1"><enum>(2)</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="H357AA4C8A9484353B6BA92271F5BFFFD"><enum>(A)</enum><text>the nature of the
food products being processed, stored, or transported;</text>
</subparagraph><subparagraph id="H540ACA11648A46B5B2DE1F8107F4CFB5"><enum>(B)</enum><text>the manner in
which food products are processed, stored, or transported;</text>
</subparagraph><subparagraph id="H3F79B6AF817F444F9BDCFF0AEE246E2"><enum>(C)</enum><text>the inherent
likelihood that the products will contribute to the risk of food-borne
illness;</text>
</subparagraph><subparagraph id="H40695EE531C2465087E37BFDD793C5A8"><enum>(D)</enum><text>the best available
evidence concerning reported illnesses associated with the foods processed,
stored, held, or transported in the proposed subcategory of establishments;
and</text>
</subparagraph><subparagraph id="HB306EA1D80514761AAB040B8F795E217"><enum>(E)</enum><text>the overall record
of compliance with 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="H79DFBB96ADE649BF829C11A8E04FAE1C"><enum>(3)</enum><text>The Administrator
may adopt alternative inspection frequencies for increased or decreased
inspection for a specific establishment and shall annually publish a list of
establishments subject to alternative inspections.</text>
</paragraph><paragraph id="H87FF175656104B40A6BBFF4DAAD05B30"><enum>(4)</enum><text>In adopting
alternative inspection frequencies for a specific establishment, the
Administrator shall consider—</text>
<subparagraph id="HB5AA8C3ED9334AE5A03300FBFBF478BE"><enum>(A)</enum><text display-inline="yes-display-inline">the criteria in paragraph (2), together
with any evidence submitted from the individual food establishment supporting a
request for an alternative inspection frequency, including the establishment’s
record for implementing effective preventive process control systems;</text>
</subparagraph><subparagraph id="HED13AAB94BFA4E26A9DDBCA259FBABB0"><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="H5E461CD1612A404FB2C2DE0356C4DF00"><enum>(C)</enum><text>the
establishment’s record of compliance with food safety law, including compliance
with applicable performance standards and the frequency of recalls.</text>
</subparagraph></paragraph></subsection><subsection id="H1A4891FB8A04453C829FE4B15FFE841E"><enum>(e)</enum><header>Effective
date</header><text>The inspection mandates shall go into effect 2 years after
the date of the enactment of this Act.</text>
</subsection><subsection id="H2505A5F8A8414901976474C1F8074FA7"><enum>(f)</enum><header>Maintenance and
inspection of records</header>
<paragraph id="HE65A3108BC2E43B3B5B6BB5772018691"><enum>(1)</enum><header>In
general</header>
<subparagraph id="HB2C10DF5C79A48C991F484642F1CF5CE"><enum>(A)</enum><header>Records</header><text>A
food establishment shall—</text>
<clause id="H5353A05CEDCC4474AE5C6224B2E0981F"><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="H6FC01C08B4A847A286C21C8711D3705"><enum>(ii)</enum><text>permit the
Administrator, in addition to any authority transferred to the Administrator
pursuant to section 102, 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="HBA1653C331164258A62BF5D7696600A8"><enum>(I)</enum><text>to determine
whether the food is contaminated or not in compliance with the food safety law;
or</text>
</subclause><subclause id="H17580BE56EAC436F85946125DBAFD00"><enum>(II)</enum><text>to track the food
in commerce.</text>
</subclause></clause></subparagraph><subparagraph id="H5D248A18A06D4F09825637CCD055B19"><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="H7610CB216B3B45C2A74BB3D76207E6AD"><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="H3BA2172823084B44A9CFCB980063BFB1"><enum>(3)</enum><header>Requirements</header><text>The
records in paragraph (1) shall include records describing—</text>
<subparagraph id="H979DE0AD3D4E4C858224CEEE1D54F940"><enum>(A)</enum><text>the origin,
receipt, delivery, sale, movement, holding, and disposition of food or
ingredients;</text>
</subparagraph><subparagraph id="H8982277A05664DAD90FE1E346C73F6D0"><enum>(B)</enum><text>the identity and
quantity of ingredients used in the food;</text>
</subparagraph><subparagraph id="H1B9C33A4363648A2BE9EA2E4380C0E1"><enum>(C)</enum><text>the processing of
the food;</text>
</subparagraph><subparagraph id="H10BD5E9270754D8BBDF1B66EB747E313"><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="HE9578A086DD84E17BDB97503C2D14BBF"><enum>(E)</enum><text>consumer
complaints concerning the food or packaging of the food;</text>
</subparagraph><subparagraph id="H849928526A854AC09C3166565EFFA167"><enum>(F)</enum><text>the production
codes, open date codes, and locations of food production; and</text>
</subparagraph><subparagraph id="H42FA08494A264186B4840390B51F87D"><enum>(G)</enum><text>other matters
reasonably related to whether food is adulterated or misbranded, or otherwise
fails to meet the requirements of this Act.</text>
</subparagraph></paragraph></subsection><subsection id="H55D7EE0715FF48E6A6944EB232F3F61F"><enum>(g)</enum><header>Protection of
sensitive information</header>
<paragraph id="HED837F76B9464AC182F02CAD38E74683"><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 commercially
valuable confidential information obtained by the Administrator.</text>
</paragraph><paragraph id="H7F1BA563BE814B65992E4D4B18261F28"><enum>(2)</enum><header>Limitation</header><text>The
requirements under this subsection and subsection (f) do not—</text>
<subparagraph id="H27C6C39CA22B4D6CB9F2C0E3BDC9E15F"><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="H2FE66B329F3448E2853B4729058EB001"><enum>(B)</enum><text>have any legal
effect on section 1905 of title 18, United States Code;</text>
</subparagraph><subparagraph id="H23B1678FA619402F9EA50589BCB338A0"><enum>(C)</enum><text>extend to any food
recipe, financial data, pricing data, or personnel data;</text>
</subparagraph><subparagraph id="HAF2EB0E2910A4DE7BCDCF6085EF30403"><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; or</text>
</subparagraph><subparagraph id="HEFC084F3CA4741FB9D6137ADDAF7D873"><enum>(E)</enum><text>limit the
authority of the Administrator to promulgate regulations to permit the sharing
of data with other governmental authorities.</text>
</subparagraph></paragraph></subsection><subsection id="H3AFF8A3497994309BD924793FE9B7CA2"><enum>(h)</enum><header>Bribery of or
gifts to inspector or other officers and acceptance of gifts</header><text>Any
person or agent or employee thereof that gives, pays, or offers, directly or
indirectly, to the Administrator or any employee or other designee thereof
authorized to perform any duty under the food safety law any money or other
thing of value, with intent to influence the discharge of any duty under such
law, shall be imprisoned for not more than 5 years, fined in accordance with
title 18, United States Code, or both. Any Administrator, employee, or other
designee that solicits or accepts any money or other thing of value from any
person, with intent to influence the discharge of any duty under the food
safety law, shall be summarily discharged from office and imprisoned for not
more than 5 years, fined in accordance with title 18, United States Code, or
both.</text>
</subsection></section><section id="H38A7794B2EDE482ABE3DA5773C473C08"><enum>206.</enum><header>Food production
facilities</header>
<subsection id="HA73AF89BF844489783BD9464068F5703"><enum>(a)</enum><header>Authorities</header><text>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="H9B4934AC2F7B46D9B0C5D3F7A6692396"><enum>(1)</enum><text>visit and inspect
food production facilities in the United States and in foreign countries to
determine if they are operating in compliance with the requirements of the food
safety law;</text>
</paragraph><paragraph id="H3AC56977B5DC4071873B69261313FD7B"><enum>(2)</enum><text>review food safety
records as required to be kept by the Administrator under section 210 and for
other food safety purposes;</text>
</paragraph><paragraph id="HC92250DF7E8849779EDD6C3311520054"><enum>(3)</enum><text>set good practice
standards to protect the public and animal health and promote food
safety;</text>
</paragraph><paragraph id="HB2DA9BE37628494DAEEE90EFD300AB45"><enum>(4)</enum><text>conduct monitoring
and surveillance of animals, plants, products, or the environment, as
appropriate; and</text>
</paragraph><paragraph id="H46E6DE5D25A842EBB096D0A2C2870097"><enum>(5)</enum><text>collect and
maintain information relevant to public health and farm practices.</text>
</paragraph></subsection><subsection id="H7B0214C033294A6DB08EE544F5091431"><enum>(b)</enum><header>Inspection of
records</header><text>A food production facility shall permit the Administrator
upon presentation of appropriate credentials and at reasonable times and in a
reasonable manner, to have access to and ability to copy all records maintained
by or on behalf of such food production establishment in any format (including
paper or electronic) and at any location, that are necessary to assist the
Administrator—</text>
<paragraph id="H0495A538E624432A9E751FB8D7A6641E"><enum>(1)</enum><text>to determine
whether the food is contaminated, adulterated, or otherwise not in compliance
with the food safety law; or</text>
</paragraph><paragraph id="HE8BCBA7F7AEA4802B8FD45E77EE6985B"><enum>(2)</enum><text>to track the food
in commerce.</text>
</paragraph></subsection><subsection id="H78BD4D0A6C4E446A8CC94C81B6882ED6"><enum>(c)</enum><header>Regulations</header><text>Not
later than 1 year after the date of the enactment of this Act, the
Administrator, in consultation with the Secretary of Agriculture and
representatives of State departments of agriculture, shall promulgate
regulations to establish science-based minimum standards for the safe
production of food by food production facilities. Such regulations
shall—</text>
<paragraph id="H545A6902D42646E286FEF4DCA278B336"><enum>(1)</enum><text>consider all
relevant hazards, including those occurring naturally, and those that may be
unintentionally or intentionally introduced;</text>
</paragraph><paragraph id="HBEB640C46FC24E67AB91F9F9482BF248"><enum>(2)</enum><text>require each food
production facility to have a written food safety plan that describes the
likely hazards and preventive controls implemented to address those
hazards;</text>
</paragraph><paragraph id="H800DBAE5C9374D33B246291F6B08046E"><enum>(3)</enum><text>include, with
respect to growing, harvesting, sorting, and storage operations, minimum
standards related to fertilizer use, nutrients, hygiene, packaging, temperature
controls, animal encroachment, and water;</text>
</paragraph><paragraph id="HBE611604536340789D017C904B8169F0"><enum>(4)</enum><text>include, with
respect to animals raised for food, minimum standards related to the animal’s
health, feed, and environment which bear on the safety of food for human
consumption;</text>
</paragraph><paragraph id="H0D71740A5BEB4224AFD51E00D962EC62"><enum>(5)</enum><text>provide a
reasonable period of time for compliance, taking into account the needs of
small businesses for additional time to comply;</text>
</paragraph><paragraph id="H34754A3AF72F4266BC7D242257E7E8D5"><enum>(6)</enum><text>provide for
coordination of education and enforcement activities by State and local
officials, as designated by the Governors of the respective States; and</text>
</paragraph><paragraph id="HA6C448E6480B4AB889AF6E216EE89C2F"><enum>(7)</enum><text>include a
description of the variance process under subsection (d) and the types of
permissible variances which the Administrator may grant under such
process.</text>
</paragraph></subsection><subsection id="H5D48DF52A965448BB4B64BCA7ECA8B87"><enum>(d)</enum><header>Variances</header><text>States
and foreign countries that export produce intended for consumption in the
United States may request from the Administrator variances from the
requirements of the regulations under subsection (c). A request shall—</text>
<paragraph id="H6B209702EEB845299FC17C79C676C425"><enum>(1)</enum><text>be in
writing;</text>
</paragraph><paragraph id="H67FE0A6057104D13BB8C0349E057DEAE"><enum>(2)</enum><text>describe the
reasons the variance is necessary;</text>
</paragraph><paragraph id="H51E4CBD7D0B4454892D0ABB0E43151E3"><enum>(3)</enum><text>describe the
procedures, processes, and practices that will be followed under the variance
to ensure produce is not adulterated; and</text>
</paragraph><paragraph id="H7C2333DCD7024384A007F473001BD65C"><enum>(4)</enum><text>contain any other
information required by the Administrator.</text>
</paragraph></subsection><subsection id="HB26637B133D94D65B8AA16A3F5D7E693"><enum>(e)</enum><header>Approval or
disapproval of variances</header><text>If the Administrator determines after
review of a request under subsection (d) that the requested variance provides
equivalent protections to those promulgated under subsection (c), the
Administrator may approve the request. The Administrator shall deny a request
if it is—</text>
<paragraph id="HD76D4ADF6A1041E6819112A5BA6BC7F"><enum>(1)</enum><text>not sufficiently
detailed to permit a determination;</text>
</paragraph><paragraph id="H4200D8D6203B4838966C06CD44191651"><enum>(2)</enum><text>fails to cite
sufficient grounds for allowing a variance; or</text>
</paragraph><paragraph id="HAD997FA6B40D49C2BAC2B76E2F1CC15"><enum>(3)</enum><text>does not provide
reasonable assurances that the produce will not be adulterated.</text>
</paragraph></subsection><subsection id="H99E606D22F0441B19BAAD46E28F12D52"><enum>(f)</enum><header>Enforcement</header><text>The
Administrator may coordinate with the agency or department designated by the
Governor of each State to perform activities to ensure compliance with this
section.</text>
</subsection><subsection id="H0FDA5BAAF4CF4598A016E99CE9A6F2E3"><enum>(g)</enum><header>Imported
produce</header><text display-inline="yes-display-inline">Not later than 1 year
after the date of the enactment of this Act, the Administrator shall promulgate
regulations to ensure that raw agricultural commodities and minimally processed
produce imported into the United States can meet standards for food safety,
inspection, labeling, and consumer protection that are at least equal to
standards applicable to such commodities and produce produced in the United
States.</text>
</subsection></section><section id="HBF5AA70112FC46D49544C6DC8B3C3E88"><enum>207.</enum><header>Federal and
State cooperation</header>
<subsection id="H7DE83BBF4660408B9B884B003E53E6C"><enum>(a)</enum><header>In
General</header>
<paragraph id="H70A6ADA9D3F147B88996BD98EEE885BD"><enum>(1)</enum><header>Authority</header><text>The
Administrator shall strengthen and expand food-borne illness surveillance
systems to—</text>
<subparagraph id="HD7F747F807274590AA007D3E69CC8676"><enum>(A)</enum><text>inform and
evaluate efforts to prevent food-borne illness; and</text>
</subparagraph><subparagraph id="H0A4232A32D6E42619F408000F7AB6923"><enum>(B)</enum><text>enhance the
identification and investigation of, and response to, food-borne illness
outbreaks.</text>
</subparagraph></paragraph><paragraph id="HE66ED34A5936474E8F9800E417089874"><enum>(2)</enum><header>Food-borne
illness outbreak</header><text>For purposes of this section, the term
<term>foodborne illness outbreak</term> means the occurrence of 2 or more cases
of a similar illness resulting from the ingestion of a common food.</text>
</paragraph></subsection><subsection id="H43390CDEBFD448EE928D00E8A586054C"><enum>(b)</enum><header>Food-Borne
Illness Surveillance Systems</header><text>The Administrator, in collaboration
with the Centers for Disease Control and Prevention, shall enhance food-borne
illness surveillance systems to improve the collection, analysis, reporting,
and usefulness of data on food-borne illnesses by—</text>
<paragraph id="H31F299FD14A34185B407E3D4185BE855"><enum>(1)</enum><text>coordinating
food-borne illness surveillance systems, including complaint systems, in order
to—</text>
<subparagraph id="H62605F1BEB554B9A8DC9B3A66CB24AA"><enum>(A)</enum><text>produce better
information on illnesses associated with foods, including sources and risk
factors for infections by emerging pathogens; and</text>
</subparagraph><subparagraph id="HEA1B984E577045B8AF8F5564A5C908FB"><enum>(B)</enum><text>facilitate sharing
of data acquisition and findings on a more timely basis among governmental
agencies, including the Food Safety Administration, the Food Safety and
Inspection Service, and State and local agencies, and with the public;</text>
</subparagraph></paragraph><paragraph id="HD99DED938F794463A5B433C1E068D542"><enum>(2)</enum><text>augmenting such
systems to improve attribution of a food-borne illness outbreak to a specific
food;</text>
</paragraph><paragraph id="H6F46FCEDB5774797B9007BAD299B9E9F"><enum>(3)</enum><text>developing
improved epidemiological tools for obtaining quality exposure data,
microbiological methods for classifying cases and detecting clusters, and
improved tracebacks to rapidly and specifically identify contaminated food
products;</text>
</paragraph><paragraph id="HDE3120A6BB4A4156901F0242A492C32"><enum>(4)</enum><text>expanding capacity
of such systems for implementation of fingerprinting strategies for food-borne
infectious agents, including parasites and hepatitis A, in order to increase
pathogen discovery efforts to identify new or rarely documented causes of
food-borne illness;</text>
</paragraph><paragraph id="HAE32BDD89D8F4F1692F1F707B0467D90"><enum>(5)</enum><text>allowing timely
public access to de-identified, aggregate surveillance data;</text>
</paragraph><paragraph id="HDC5C1B39260D475090F00942930139B4"><enum>(6)</enum><text>at least annually,
publishing current reports on findings from such systems;</text>
</paragraph><paragraph id="H9EBC835AFBF04B85AB996C16D5AD00F"><enum>(7)</enum><text>exploring
establishment of registries for long-term case follow-up to better characterize
late complications of food-borne illness;</text>
</paragraph><paragraph id="HB2E063EBFF5641B88F7E7B27CAC6FB4C"><enum>(8)</enum><text>increasing
participation in national networks of public health and food regulatory
agencies and laboratories to—</text>
<subparagraph id="H8E2752EDB44E4FBAAFA7B3E1003D0071"><enum>(A)</enum><text>allow public
health officials at the Federal, State, and local levels to share and accept
laboratory analytic findings; and</text>
</subparagraph><subparagraph id="HFD034E802C0A466BB1EAF40040115220"><enum>(B)</enum><text>identify
food-borne illness outbreaks and attribute such outbreaks to specific foods
through submission of standardized molecular subtypes (also known as
<quote>fingerprints</quote>) of food-borne illness pathogens to a centralized
database; and</text>
</subparagraph></paragraph><paragraph id="HF3E42A1D3F3243748FC953CFEF0776BC"><enum>(9)</enum><text>establishing a
flexible mechanism for rapidly supporting scientific research by academic
centers of excellence, which may include staff representing academic clinical
researchers, food microbiologists, animal and plant disease specialists,
ecologists, and other allied disciplines.</text>
</paragraph></subsection><subsection id="H5418D4589B3444F7A0656BB83CBB94D3"><enum>(c)</enum><header>Improving State
Surveillance Capacity</header><text>The Administrator, in collaboration with
the Director of the Centers for Disease Control and Prevention, shall improve
capacity for surveillance in the States by—</text>
<paragraph id="H31106D0520D24FD1B9F678D927927900"><enum>(1)</enum><text>supporting
outbreak investigations with needed specialty expertise, including
epidemiological, microbiological, and environmental expertise, to assist
identification of underlying common sources and contributing factors;</text>
</paragraph><paragraph id="H12A3CD071D3C47E7805898006385389D"><enum>(2)</enum><text>identifying,
disseminating, and supporting implementation of model practices at the State
and local level for—</text>
<subparagraph id="H4AB7A73866D246E987DC3747EE31267F"><enum>(A)</enum><text>facilitating rapid
shipment of clinical isolates from clinical laboratories to State public health
laboratories to avoid delays in testing;</text>
</subparagraph><subparagraph id="H634DEC4E7C4D4041AB22EAE0322073DB"><enum>(B)</enum><text>conducting rapid
and more standardized interviewing of cases associated with major enteric
pathogens, including prior to designation of clusters as food-borne illness
outbreaks;</text>
</subparagraph><subparagraph id="HDAA7E90AFF3B466B931B861ECF6012A2"><enum>(C)</enum><text>conducting and
evaluating rapid and standardized interviews of healthy control persons;</text>
</subparagraph><subparagraph id="H863A856838AC4615A3E16C5789C0A132"><enum>(D)</enum><text>sharing
information on a timely basis—</text>
<clause id="HB11F0EC6591349ED9BEC4C800003FDF2"><enum>(i)</enum><text>within public
health and food regulatory agencies;</text>
</clause><clause id="H90C93F3FC3864529B14D7917056C783B"><enum>(ii)</enum><text>among such
agencies;</text>
</clause><clause id="HAB72D3C704C5453E93EC50193886FC6"><enum>(iii)</enum><text>with the food
industry;</text>
</clause><clause id="HC8782D5B929B40419C0000E4105DCEA8"><enum>(iv)</enum><text>with healthcare
providers; and</text>
</clause><clause id="H4F167172D92F4DCE9B8C9B50C312A18C"><enum>(v)</enum><text>with
the public;</text>
</clause></subparagraph></paragraph><paragraph id="H266D7AD31E9747A2BB7225F97C1913E2"><enum>(3)</enum><text>developing,
regularly updating, and disseminating training curricula on food-borne illness
surveillance investigations, including standard sampling methods and laboratory
procedures;</text>
</paragraph><paragraph id="H277F14BE99CA40630031AA2516D1ECF9"><enum>(4)</enum><text>integrating new
molecular diagnostic tools for parasites into web-based consultation services
for parasitic infections to accelerate the identification of these food-borne
infectious agents;</text>
</paragraph><paragraph id="H3496AB515C424B9296F0BB27D8ACC86"><enum>(5)</enum><text>supporting research
to develop and deploy new subtyping methods for salmonella, E. coli,
campylobacter, and other pathogens, to increase the speed and accuracy of
diagnoses;</text>
</paragraph><paragraph id="HDE3E48D8A8E1425481CD782CDDD872C1"><enum>(6)</enum><text>determining
minimum core competencies for public health laboratories, and developing
self-evaluation and proficiency-testing tools for such laboratories;</text>
</paragraph><paragraph id="HC374EC31E9014875B79329A570F3F9F7"><enum>(7)</enum><text>facilitating
regional public health laboratory partnerships to leverage resources, including
equipment and physical space, and increase surge capacity;</text>
</paragraph><paragraph id="H43F63EF735A3405DB2E73B935EA51B51"><enum>(8)</enum><text>providing
technical assistance, which may include the detailing of officers and employees
of the Administrator, to State and local public health and food regulatory
agencies;</text>
</paragraph><paragraph id="HF401128955C34CBF98F0F200DC34ED3E"><enum>(9)</enum><text>partnering with
the Food Safety Administration to increase communication, coordination, and
integration of food-borne illness surveillance and outbreak investigation
activities; and</text>
</paragraph><paragraph id="H615E7F367EE74A9796F4F0AA105C6E23"><enum>(10)</enum><text>developing and
periodically updating response and interview procedures so that such procedures
are standardized and tested.</text>
</paragraph></subsection><subsection id="HE501C8B35E154496AE7D008D00B0418"><enum>(d)</enum><header>Program
Activities</header><text>The Administrator shall carry out activities to
support core food safety functions of State and local public health
laboratories, including—</text>
<paragraph id="H16A56D23839C4AD38F6047E0C6E58C4F"><enum>(1)</enum><text>establishing
fellowships, stipends, and scholarships to address critical workforce
shortages;</text>
</paragraph><paragraph id="HB5766DB5411F4D97918C2572CE1F3901"><enum>(2)</enum><text>training and
coordination of State and local personnel;</text>
</paragraph><paragraph id="H2A44FAF5C4A44B6DBD74D82D16F8FF67"><enum>(3)</enum><text>establishing
partnerships between private and public laboratories to facilitate sharing of
positive enteric specimens and improve surge capacity;</text>
</paragraph><paragraph id="H91EBC4D17C084BA0AF9200F5DC0559CB"><enum>(4)</enum><text>strengthening
capacity to participate in existing or new food-borne illness surveillance
systems; and</text>
</paragraph><paragraph id="H2ECE919F321C4E0FA3C88F2456004BD4"><enum>(5)</enum><text>purchasing and
maintaining data systems hardware and software and laboratory equipment.</text>
</paragraph></subsection><subsection id="H88822B49EE454EA3A6E9B374B74B566"><enum>(e)</enum><header>Plan To improve
food safety capacity at the State and local level</header>
<paragraph id="HE1942709A3AB4406B154B47C73794200"><enum>(1)</enum><header>Goals</header><text display-inline="yes-display-inline">The Administrator shall leverage and
enhance the food safety capacity and roles of State and local agencies and
integrate State and local agencies as fully as possible into national food
safety efforts, in order to achieve the following goals:</text>
<subparagraph id="H743B7516D7024B87895043DE4DF87447"><enum>(A)</enum><text>Improve food-borne
illness outbreak response and containment.</text>
</subparagraph><subparagraph id="H7330F90F930246E886A1A7EBA6CDDA1F"><enum>(B)</enum><text>Improve the
contribution of food-borne illness surveillance and investigation to the
prevention of food-borne illness.</text>
</subparagraph><subparagraph id="HA2601329403D4656B83575C437523E12"><enum>(C)</enum><text>Strengthen
oversight of food safety at the retail level.</text>
</subparagraph><subparagraph id="HE6690CF0864447AA87116F21C4D200D1"><enum>(D)</enum><text>Strengthen the
capacity of State and local agencies to carry out inspections and enforce
safety standards in food processing establishments, as part of a national
strategy and plan to provide an adequate level of inspection and achieve
compliance with safety standards in such establishments.</text>
</subparagraph><subparagraph id="H9868698AB4694AB2AF95CD1FA416EF4B"><enum>(E)</enum><text>Make more
effective use of the Nation’s combined food safety resources to reduce the
burden of food-borne illness.</text>
</subparagraph></paragraph><paragraph id="H0678A68480AF4EAC83A05672B4FFD00"><enum>(2)</enum><header>Survey</header><text>In
preparation for development of the plan required by paragraph (3), the
Administrator shall, not later than 1 year after the date of enactment of this
part, complete a survey of State and local capacities, and needs for
enhancement, with respect to—</text>
<subparagraph id="HCAA61CE0F82D4D8E9E59A29F8D899400"><enum>(A)</enum><text>staffing levels
and expertise available to perform food safety functions;</text>
</subparagraph><subparagraph id="H703AB8729D854C7BA435D7BBA889E1D"><enum>(B)</enum><text>laboratory capacity
to support surveillance, outbreak response, inspection, and enforcement
activities;</text>
</subparagraph><subparagraph id="HD46D43D385C041FEA77C90D7CE832FE9"><enum>(C)</enum><text>information
systems to support data management and sharing of food safety information among
State and local agencies and with counterparts at the Federal level;</text>
</subparagraph><subparagraph id="HBC4CF5F07482454797CD8BD4E796FAEB"><enum>(D)</enum><text>legal authorities
of State and local agencies to support the roles of such agencies in a national
food safety system; and</text>
</subparagraph><subparagraph id="HCF4F81EF99604A07B1C6C3E708A9077"><enum>(E)</enum><text>organizational
arrangements for managing and coordinating food safety activities.</text>
</subparagraph></paragraph><paragraph id="H2A487C0A217742B1A63F6096F1CD6238"><enum>(3)</enum><header>Plan</header><text>Taking
into account the goals established in paragraph (1), results from the survey
required in paragraph (2), and consultations with State and local agencies and
other food safety stakeholders, the Administrator shall, not later than 2 years
after the date of enactment of this part, develop, publish, and begin
implementation of a plan that includes the following elements:</text>
<subparagraph id="H678DEC9A02464055BD27CE3D125DCC6D"><enum>(A)</enum><text>Criteria for
assessing the adequacy of State and local capacity to perform food safety
functions as part of a national food safety system.</text>
</subparagraph><subparagraph id="H5E26B05B0B424C129950DC1209EBF098"><enum>(B)</enum><text>Priorities for
enhancing the capacity of State and local agencies.</text>
</subparagraph><subparagraph id="HEF98B0C68052481C96BCB507CE03ECAC"><enum>(C)</enum><text>Action plans for
meeting the highest priority capacity needs, including budget requirements and
financing plans that take into account Federal, State, and local
resources.</text>
</subparagraph><subparagraph id="H9BD84CAB432E44ADA3DF3811790608F6"><enum>(D)</enum><text>Improved
coordination and information flow among Federal, State, and local agencies to
strengthen food-borne illness surveillance, outbreak response, and
investigation and to ensure that agencies at all levels have the information on
origins and causes of food-borne illness that such agencies need to plan
preventive measures.</text>
</subparagraph><subparagraph id="H0EAA08E5547B4551BB974D006916DE12"><enum>(E)</enum><text>Integration of the
inspection and compliance programs in food processing establishments of the
Food Safety Administration and State and local agencies, including—</text>
<clause id="H7899FCDE025B4E2DADDAF48446EE890"><enum>(i)</enum><text>joint
planning and priority setting to ensure that the collective effort has the
greatest possible impact on achieving compliance with food safety standards and
reducing food-borne illness;</text>
</clause><clause id="H76DE5629E7B84C8494E1D64000D4B4F6"><enum>(ii)</enum><text>elimination of
barriers to the free flow of information among the Food Safety Administration
and State and local agencies with respect to inspection and compliance programs
and integration of State and Federal inspection and laboratory data
systems;</text>
</clause><clause id="HF8E3A3CFAA8E40A6A4A2B000E7ECD4DC"><enum>(iii)</enum><text>steps to expand,
and ensure the vigor and consistency of, State inspection of processing
establishments under contract to the Food Safety Administration; and</text>
</clause><clause id="H975F1398691947DE9F20412F88950063"><enum>(iv)</enum><text>reliance by the
Food Safety Administration on State inspection and food sample analyses in
Federal enforcement activities.</text>
</clause></subparagraph></paragraph><paragraph id="H8B44EEA24C3742DE97657DA95000C5F9"><enum>(4)</enum><header>Food Safety
Capacity Building Grants</header><text>The Administrator shall make grants to
State and local agencies to enhance State and local food safety capacity and
programs and support achievement of the goals established in paragraph (1). In
awarding such grants, the Administrator shall take into account the criteria
and priorities established by the Administrator under paragraph (3).</text>
</paragraph><paragraph id="HFA382A9CD5604F7F943D001580505E43"><enum>(5)</enum><header>Report to
Congress</header><text>Not later than 1 year after the date of enactment of
this part, and on an annual basis thereafter, the Administrator shall submit to
Congress a report that describes—</text>
<subparagraph id="H6F347E46FB194985948ED372B593DE77"><enum>(A)</enum><text>progress made in
implementing this section, including any obstacles to such implementation;
and</text>
</subparagraph><subparagraph id="HD4ABF2AA536E4DBB98FC98D6EECC1C3E"><enum>(B)</enum><text>any legislative
recommendations or additional resources needed for full implementation.</text>
</subparagraph></paragraph></subsection><subsection id="H97AB531A04EB4FB490FA7DFED2E9406"><enum>(f)</enum><header>Service
agreements</header>
<paragraph id="HBAA4CDFB7A91452FBE4D9204AF14BED1"><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
qualified personnel and services of those agencies in carrying out this
Act.</text>
</paragraph><paragraph id="H2F2A0CA11F9849AFB4419F8C8744F888"><enum>(2)</enum><header>Training</header><text>Agreements
with a State under this subsection shall provide for training of State
employees.</text>
</paragraph><paragraph id="H8E0D0B1572FA4E10BCF2CE174100051F"><enum>(3)</enum><header>Maintenance of
agreements</header><text>The Administrator shall maintain any agreement
described in paragraph (1) that is in effect on the day before the date of the
enactment of this Act until the Administrator evaluates such agreement and
determines whether to maintain or substitute such agreement.</text>
</paragraph><paragraph id="HD21FBDB671C74DB5B32029D0C00CCCF"><enum>(4)</enum><header>Commissioning</header><text>Where
necessary and appropriate to fulfill the provisions of this Act or other food
safety law, the Administrator shall, as part of any service agreement,
commission qualified State and local regulatory officials and inspectors to
assist the Administrator in carrying out the food safety law and accord such
commissioned officials and inspectors access to information in possession of
the Administrator as if they were Federal employees.</text>
</paragraph></subsection></section><section id="H55A1FA845D3A491ABD22CD392DB50084"><enum>208.</enum><header>Imports</header>
<subsection id="H6E788BADBFCF454D815ECE004F189557"><enum>(a)</enum><header>In
general</header><text>All imported food under this Act shall meet requirements
for food safety, inspection, labeling, and consumer protection that are at
least equal to those applicable to food grown, manufactured, processed, packed,
or held for consumption in the United States.</text>
</subsection><subsection id="H17CC2095402C471EAF85C493B359381F"><enum>(b)</enum><header>Certification
system</header><text>Not later than 2 years after the date of the enactment of
this Act, the Administrator shall establish a system under which food products
offered for importation into the United States shall be certified by the
accredited foreign government in the country of export or by an accredited
certifying agent meeting all applicable standards under this section.</text>
<paragraph id="H0CE925E67D4C4DBB81289E6BB8A5F7A3"><enum>(1)</enum><text>Category 1, 2, and
3 food establishments shall secure certification of products from the
accredited foreign government in the country where the products are produced
and must enter the United States through ports designated by the
Administrator.</text>
</paragraph><paragraph id="H7BEFB405831C4C9B933B99AF992DA6"><enum>(2)</enum><text>Category 4 and 5
food establishments shall be certified either by—</text>
<subparagraph id="H6BCC2DCB9BB74BA1966E56A9AB13AC3E"><enum>(A)</enum><text>the accredited
foreign government in the country where the products are produced; or</text>
</subparagraph><subparagraph id="H526035D77AE24BEFBCE31CC98E7D927D"><enum>(B)</enum><text>a certifying agent
that has been accredited under subsection (c).</text>
</subparagraph></paragraph><paragraph id="H68A7C462DF5A49928E3FA4D6D6070043"><enum>(3)</enum><text>Beginning not
later than 5 years after the date of the enactment of this Act, food from
category 4 and 5 food establishments that is not certified by an accredited
entity described in subsection (c) shall not enter the United States except
through ports of entry that are located in a metropolitan area with an
accredited food testing laboratory.</text>
</paragraph></subsection><subsection id="H60DAF0CC187A479B815E12A51EB59497"><enum>(c)</enum><header>Certification
standard</header>
<paragraph id="H7EB77D7C0CD34A91B14C0747C8781505"><enum>(1)</enum><header>In
general</header><text>A foreign government or third party agent requesting
accreditation to certify food for entry into the United States shall
demonstrate, in a manner determined appropriate by the Administrator, that food
produced under the supervision of the foreign government or third party agent,
respectively, can meet standards for food safety, inspection, labeling, and
consumer protection that are at least equal to standards applicable to food
produced in the United States.</text>
</paragraph><paragraph id="H9321BE086E0E414A94225F8545CDB693"><enum>(2)</enum><header>Request by
foreign government</header><text>Prior to accrediting a foreign government, the
Administrator shall—</text>
<subparagraph id="HAADEED3CFBC4415AAD18F9D682814300"><enum>(A)</enum><text>review and audit
the food safety program of the requesting foreign government (including all
statutes, regulations, and inspection authority); and</text>
</subparagraph><subparagraph id="H41D8F6F1D815401FA078816DA829B815"><enum>(B)</enum><text>determine that the
exporting country—</text>
<clause id="HAEBC083AE2584522A64FB1AB3C3514F3"><enum>(i)</enum><text>administers a food
control program that requires food exporters to implement hazard control
measures for physical, chemical, and biological contaminants;</text>
</clause><clause id="H99D85F8311F14B20820001D0BA84DFB0"><enum>(ii)</enum><text>ensures sanitary
operations of facilities;</text>
</clause><clause id="H71119A12BDB94A06A94EE63832C844E7"><enum>(iii)</enum><text>utilizes testing
and verification programs; and</text>
</clause><clause id="H57F6DFA85DE64357B290C1425E42E1A3"><enum>(iv)</enum><text>administers an
effective enforcement program.</text>
</clause></subparagraph></paragraph><paragraph id="HC106ED3E884F4BF4857D9D009D1C2904"><enum>(3)</enum><header>Request by a
certifying agent</header><text>Prior to accrediting a certifying agent, the
Administrator shall—</text>
<subparagraph id="H46B06234B10C4B2C00DD282F88ED2198"><enum>(A)</enum><text>review the
training and qualifications of auditors and other employees used by the
agent;</text>
</subparagraph><subparagraph id="HC3BBEB5845E142FCB3BB57EC5DCF4F"><enum>(B)</enum><text>ensure that any such
auditors have completed such training as may be required by the Administrator
for the conduct of food safety inspections; and</text>
</subparagraph><subparagraph id="H8758ABFE185847F39E7E7D5CC8D007D6"><enum>(C)</enum><text>conduct reviews of
internal systems and such other investigation as the Administrator deems
necessary to determine that the certifying agent is capable of auditing food
establishments—</text>
<clause id="H4B897079FD7849C48DA999B7F0AB3704"><enum>(i)</enum><text>to
assess the adequacy of systems and standards in use; and</text>
</clause><clause id="HBA52CE57361F42F28F9CE8A426F23A2"><enum>(ii)</enum><text>to
ensure that food approved by the agent for import to the United States meets
the requirements of this Act.</text>
</clause></subparagraph></paragraph><paragraph id="H7895B3B067784ECB0099DDD6BBFBC64F"><enum>(4)</enum><header>Certification to
accompany each shipment</header><text>As a condition of accrediting any foreign
government or certifying agent, such government or agent shall agree to issue a
written and electronic certification to accompany each shipment intended for
import to the United States from any food establishment which the government or
agent certifies, subject to requirements set forth by the Administrator.</text>
</paragraph></subsection><subsection id="H9B5FFA9C8DE44899BE64D8DE8444439C"><enum>(d)</enum><header>Audits;
inspections</header><text>Following any accreditation under subsection (c), the
Administrator may at any time—</text>
<paragraph id="H2046623F9BFB4E718DB5B44BD36696"><enum>(1)</enum><text>conduct an on-site
audit of any food establishment registered under section 202, with or without
the certifying agent; or</text>
</paragraph><paragraph id="H9ACC1EBE5F274CC8B9AFED55FE913255"><enum>(2)</enum><text>require a
certifying agent to submit an onsite audit report and any other reports or
documents which the agent requires as part of the audit process, including
documentation that the food establishment is in compliance with registration
requirements and prior notice requirements for food imported to the United
States.</text>
</paragraph></subsection><subsection id="H6835136A7A06450481F5A7791D114900"><enum>(e)</enum><header>Limitation</header><text>A
foreign government or other certifying agent accredited by the Administrator to
certify food for import to the United States under this section may certify
only the food products or food categories for importation to the United States
that are specified in the grant of accreditation.</text>
</subsection><subsection id="H60BFA1FB407A48E8A321091D6BECBBF2"><enum>(f)</enum><header>Withdrawal of
accreditation</header><text display-inline="yes-display-inline">The
Administrator may withdraw accreditation from a foreign government or
certifying agent—</text>
<paragraph id="HCF72746C277F4555AE1DEC23FA4E2FDB"><enum>(1)</enum><text>if food approved
by the foreign government or certifying agent is linked to an outbreak of human
illness;</text>
</paragraph><paragraph id="H4AC20DA688994632875D4D7ED6103813"><enum>(2)</enum><text>following an
investigation and finding by the Administrator that the programs of the foreign
government, or a foreign food establishment certified by the certifying agent,
are no longer equal to those applied to food grown, manufactured, processed,
packed, or held in the United States; or</text>
</paragraph><paragraph id="H3E01981990A1455A8C4927003D5BCEEA"><enum>(3)</enum><text>following a
refusal to allow United States officials to conduct such audits and
investigations as may be necessary to ensure continued compliance with the
requirements of this section.</text>
</paragraph></subsection><subsection id="H614B1755EEC84547BD9600567C5CEF00"><enum>(g)</enum><header>Renewal of
accreditation</header><text>The Administrator shall audit foreign governments
and certifying agents whenever needed, but no less than once every 3 years, to
ensure the continued compliance with the requirements set forth in this
section. Renewal of accreditation shall occur following each satisfactory
audit.</text>
</subsection><subsection id="H094AF4E38CD84A4695C98516B4EE59AF"><enum>(h)</enum><header>Required routine
inspection</header><text>The Administrator shall routinely inspect food before
or at entry into the United States to ensure ongoing compliance with food
safety law and where appropriate, as part of the audit of any certifying
entity.</text>
</subsection><subsection id="HD49B389E0BDA4293ADEEC40986E7F249"><enum>(i)</enum><header>Enforcement</header><text>The
Administrator may—</text>
<paragraph id="HCD245198DC00471DB6E2DC67540090A3"><enum>(1)</enum><text>deny importation
of food from any foreign country if the government of such country does not
permit United States officials to enter the foreign country to conduct such
audits and inspections as may be necessary to fulfill requirements under this
section;</text>
</paragraph><paragraph id="H1E6EACA524EA417991C8B19F2C27A578"><enum>(2)</enum><text>deny importation
of food from any foreign country or foreign food establishment that does not
consent to a timely investigation by the Administration when food from that
foreign country or foreign food establishment is linked to a food-borne illness
outbreak or is otherwise found to be adulterated or misbranded;</text>
</paragraph><paragraph id="H086B5E64C83B401AADADDD959E6BCBA1"><enum>(3)</enum><text>promulgate
regulations to carry out the purposes of this section, including setting terms
and conditions for the destruction of products that fail to meet the
requirements of this Act; and</text>
</paragraph><paragraph id="HDE023981CCCC4932ACE41E7F658C907E"><enum>(4)</enum><text>establish such
fees as are necessary to carry out the implementation of the accreditation and
inspection programs required under this section.</text>
</paragraph></subsection><subsection id="HD4F94B5012A64372A6D88E52271F1800"><enum>(j)</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 or recalled
pursuant to section 403.</text>
</subsection><subsection id="HDA780A136AF4425FB71EE0AAF322195F"><enum>(k)</enum><header>Certifying
agents</header><text>Entities eligible for accreditation as a certifying agent
under subsection (c) may include—</text>
<paragraph id="HA5A3AD05372D43C6A92D007EF8130730"><enum>(1)</enum><text>a
State or regional food authority; or</text>
</paragraph><paragraph id="HC7A08AD3B3CE4D79A439EAD98E768FC"><enum>(2)</enum><text>a
foreign or domestic cooperative that aggregates the products of growers or
processors for importation.</text>
</paragraph></subsection><subsection id="HD0C156E5389344AC0067576BA60399C"><enum>(l)</enum><header>Avoiding
Conflicts of Interest With Certifying Agents</header>
<paragraph id="H39DB2DA5CB9A44ADB77D59C2FB5E7882"><enum>(1)</enum><header>In
general</header><text>To be eligible for accreditation under subsection (c), a
certifying agent shall—</text>
<subparagraph id="H39B0FEA25F1D4B6383254BB08FA1A711"><enum>(A)</enum><text>not be owned,
managed, or controlled by any person that owns or operates an establishment
whose products are to be certified by such agent;</text>
</subparagraph><subparagraph id="HAA6CBA3864A342A4BB0710EC84455125"><enum>(B)</enum><text>have procedures to
ensure against the use, in carrying out audits of food establishments under
this section, of any officer or employee of such agent that has a financial
conflict of interest regarding an establishment whose products are to be
certified by such agent; and</text>
</subparagraph><subparagraph id="H683F8669689F44A6AA9203827200EAF1"><enum>(C)</enum><text>annually make
available to the Secretary, disclosures of the extent to which such agent, and
the officers and employees of such agent, have maintained compliance with
subparagraphs (A) and (B) relating to financial conflicts of interest.</text>
</subparagraph></paragraph><paragraph id="H9949534D11694663BAE4DC1F25B10028"><enum>(2)</enum><header>Regulations</header><text>The
Secretary shall promulgate regulations not later than 18 months after the date
of the enactment of this Act to ensure that there are protections against
conflicts of interest between a certifying agent and the establishments whose
products are to be certified by such agent. Such regulations shall
include—</text>
<subparagraph id="HB8960D3466C24B219B73E2EA64AED21"><enum>(A)</enum><text>requiring that
domestic audits performed under this section be unannounced;</text>
</subparagraph><subparagraph id="HD8219328275E4C4B938C5E748D89E63B"><enum>(B)</enum><text>a structure,
including timing and public disclosure, for fees paid by food establishments to
certifying agents to decrease the potential for conflicts of interest;
and</text>
</subparagraph><subparagraph id="HF813074FC92E493E9C8887C547B98E81"><enum>(C)</enum><text>appropriate limits
on financial affiliations between a certifying agent and any person that owns
or operates an establishment whose products are to be certified by such
agent.</text>
</subparagraph></paragraph></subsection></section><section id="HA858238CACC8406F87A947C51A47CF2"><enum>209.</enum><header>Resource
plan</header>
<subsection id="H975F44417FD343B599851C9BFE5B9CE1"><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 id="H850D538947D34F7497C7B6240FB3681"><enum>(b)</enum><header>Contents of
plan</header><text>The resource plan shall—</text>
<paragraph id="H7D57DFD9D3224485B000273557BC52A1"><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 this Act;</text>
</paragraph><paragraph id="HB6D779341FA8426386F9D22E401C9652"><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 id="HF4C4AD43417F4C4196A2F625078E5287"><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 and food production facilities under section
206—</text>
<subparagraph id="HC21F2AF11C32426BBEC122E3E5BF21C9"><enum>(A)</enum><text>in foreign
establishments and production facilities; and</text>
</subparagraph><subparagraph id="H1CB52767307F4A809355E7F015A7A2D0"><enum>(B)</enum><text>at the point of
importation.</text>
</subparagraph></paragraph></subsection><subsection id="H7074A8C40E8C4766B599634B8F281734"><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 and
inspections of food establishments and food production facilities and include
resources to audit such programs.</text>
</subsection><subsection id="H8E118F4E2F404CF684F41A6B4FBA9A4"><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="HF462A471744A469AAB9970D89609114F"><enum>210.</enum><header>Traceback
requirements</header>
<subsection id="H94AB2AA7F8884880926575B8F5219F9C"><enum>(a)</enum><header>In
general</header><text>The Administrator, in order to protect the public health,
shall establish a national traceability system that enables the Administrator
to retrieve the history, use, and location of an article of food through all
stages of its production, processing, and distribution.</text>
</subsection><subsection id="H3F5DD1E29F7040D4AA0082F91693AA5E"><enum>(b)</enum><header>Applicability</header><text>Traceability
requirements under this section shall apply to food from food production
facilities, food establishments, and foreign food establishments.</text>
</subsection><subsection id="H760E1A12A8DA47C292BABEE6C9E5F109"><enum>(c)</enum><header>Requirements</header>
<paragraph id="H15DBAC8C0A4E4954BD76E67FD9946319"><enum>(1)</enum><header>Standards</header><text>The
Administrator shall establish standards for the type of information, format,
and timeframe for food production facilities and food establishments to submit
records to aid the Administrator in effectively retrieving the history, use,
and location of an item of food.</text>
</paragraph><paragraph id="H3FFBDFFACF5645D69474668EDC661947"><enum>(2)</enum><header>Rule of
construction</header><text>Nothing in this section shall be construed as
requiring the Administrator to prescribe a specific technology for the
maintenance of records or labeling of food to carry out the requirements of
this section.</text>
</paragraph><paragraph id="H46DAE450B57B41F1BBD460450015BF77"><enum>(3)</enum><header>Availability of
records for inspection</header><text>Any records that are required by the
Administrator under this section shall be available for inspection by the
Administrator upon oral or written request.</text>
</paragraph><paragraph id="HAC7F76298A064184B08101C082DBCC3F"><enum>(4)</enum><header>Demonstration of
ability</header><text>The Administrator, during any inspection, may require a
food establishment to demonstrate its ability to trace an item of food and
submit the information in the format and timeframe required under paragraph
(1).</text>
</paragraph></subsection><subsection id="HD5A1F204520F4849B58B51B6D81BBD32"><enum>(d)</enum><header>Relationship to
other requirements</header>
<paragraph id="H72D6D012797B4D038C84B7F715ACC990"><enum>(1)</enum><header>Consistency with
existing statutes and regulations</header><text>To the extent possible, the
Administrator should establish the national traceability system under this
section to be consistent with existing statutes and regulations that require
recordkeeping or labeling for identifying the origin or history of food or food
animals.</text>
</paragraph><paragraph id="H1939B52C91A248009E98AAA5F857064B"><enum>(2)</enum><header>Existing
laws</header><text>For purposes of this subsection, the Administrator should
review the following:</text>
<subparagraph id="HE62CA77557E54ACFB4CD6085BEA071B"><enum>(A)</enum><text>Country of origin
labeling requirements of subtitle D of the Agricultural Marketing Act of 1946
(7 U.S.C. 1638 et seq.).</text>
</subparagraph><subparagraph id="H29DA2FFE4FB547BDB7C8DCC3568E906E"><enum>(B)</enum><text>The Perishable
Agricultural Commodities Act of 1930 (7 U.S.C. 499a–t).</text>
</subparagraph><subparagraph id="H6314C54F1A3C400E95E695BACCFFE000"><enum>(C)</enum><text>Country of origin
labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. §
1340).</text>
</subparagraph><subparagraph id="H4A650E1D9EFD452382463B9748002042"><enum>(D)</enum><text>The National
Animal Identification System as authorized by the Animal Health Protection Act
of 2002 (7 U.S.C. 8301 et seq.).</text>
</subparagraph></paragraph><paragraph id="H2A4627071641466DB78D21A2005767D9"><enum>(3)</enum><header>Certain
requirements</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 (7 U.S.C. 1638 et
seq.).</text>
</paragraph></subsection></section><section id="H64E7D3C9C60E4B1286C780F2C8F472A2"><enum>211.</enum><header>Accredited
laboratories</header>
<subsection id="HF0B41364DB7941DE8CAC00EDDB2039B1"><enum>(a)</enum><header>Establishment of
program</header><text>The Administrator shall establish a program for
accrediting laboratories to perform sampling and testing for purposes of this
Act. Such program shall include—</text>
<paragraph id="HC66E469F0E504D19985DE268A6576FE4"><enum>(1)</enum><text>standards for
appropriate sampling and analytical procedures;</text>
</paragraph><paragraph id="H2A5C4C2852EA405A9BA1002780C671B9"><enum>(2)</enum><text>training and
experience qualification levels for individuals who conduct sampling and
analysis;</text>
</paragraph><paragraph id="H0A23E874905A4A9881C1DF678468D256"><enum>(3)</enum><text>annual onsite
visits to audit the performance of an accredited laboratory; and</text>
</paragraph><paragraph id="H9D64B2848A3B464E0084E7AB8E654400"><enum>(4)</enum><text>such additional
requirements as the Administrator determines to be appropriate.</text>
</paragraph></subsection><subsection id="H2B90C8926AD44C88A8ABF5B3BB28B7B4"><enum>(b)</enum><header>Requirements</header><text>To
be accredited under this section, a laboratory shall—</text>
<paragraph id="H23E49BBB69C64508B0D5956351F293ED"><enum>(1)</enum><text>prepare and submit
an application for accreditation to the Administrator;</text>
</paragraph><paragraph id="HC5F241ECA9364DEB825C993F28F2A084"><enum>(2)</enum><text>meet required
tests and standards established by the Administrator; and</text>
</paragraph><paragraph id="H471DA26D82AA4DB4808BFAF5853EEDB"><enum>(3)</enum><text>comply with such
terms and conditions as are determined necessary by the Administrator.</text>
</paragraph></subsection><subsection id="H20A25741EEE74B5DBB264E8600A4A975"><enum>(c)</enum><header>Accrediting
bodies</header><text>The Administrator may approve State agencies or private,
nonprofit entities as accrediting bodies to act on behalf of the Administrator
in accrediting laboratories under this section. The Administrator shall—</text>
<paragraph id="HEA3F39C476414ECC9D55E6E184A81500"><enum>(1)</enum><text>in making such
approvals—</text>
<subparagraph id="HD96BBBF661674452B65413006143BF1E"><enum>(A)</enum><text>oversee and review
the performance of any accrediting body acting on behalf of the Administrator
to ensure that such accrediting body is in compliance with the requirements of
this section; and</text>
</subparagraph><subparagraph id="H20BAE2BF3AB942A1BF126847A46B60BB"><enum>(B)</enum><text>have the right to
obtain from an accrediting body acting on behalf of the Administrator and from
any laboratory that may be certified by such a body all records and materials
that may be necessary for the oversight and review required by subparagraph
(A);</text>
</subparagraph></paragraph><paragraph id="H66562A9D6A6C4CBDB501000537B1BAC5"><enum>(2)</enum><text>reevaluate
accreditation bodies approved under paragraph (1) whenever—</text>
<subparagraph id="H1B3E7CF372F94BE1AC24FD954D00AAFA"><enum>(A)</enum><text>the Administrator
determines a laboratory accredited by the accrediting body is no longer in
compliance with this section;</text>
</subparagraph><subparagraph id="H7220D9507B9E4E6CA600281BC6002EDF"><enum>(B)</enum><text>the Administrator
determines the accrediting body is no longer in compliance with the
requirements of this section; or</text>
</subparagraph><subparagraph id="H7F0D32C8C6AA4692A01D2BAD0011A44C"><enum>(C)</enum><text>no less than once
every 5 years; and</text>
</subparagraph></paragraph><paragraph id="H53F1CF908A80476C8787B016A844696E"><enum>(3)</enum><text>promptly revoke
the approval of any accreditation body found not to be in compliance with the
requirements of this section.</text>
</paragraph></subsection><subsection id="HC8EA756665B248B8847617E324301E5E"><enum>(d)</enum><header>Revocation of
accreditation</header><text>The Administrator shall revoke the accreditation of
any laboratory that fails to meet the requirements this section.</text>
</subsection></section><enum>III</enum><header>RESEARCH AND
EDUCATION</header>
<section id="HAAC89B41BA4E4B8CBAE99C7CE429F859"><enum>301.</enum><header>Public health
assessment system</header>
<subsection id="HE73319B621754492B7DE0029889EB5A3"><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 food safety
and research programs of the Department of Agriculture, shall—</text>
<paragraph id="H80B859FCFA1346788EAF6CBAED18480"><enum>(1)</enum><text>identify on an
ongoing basis the priorities for collection of epidemiological data and for
other food safety research and data collection that are most important to
implementing the food safety law and reducing the public health burden of
food-borne illness;</text>
</paragraph><paragraph id="H24C1CF41E5064563A6BAF9B766551BA7"><enum>(2)</enum><text>have full access
for purposes of implementing the food safety law to the applicable data and
data systems of the Centers for Disease Control and Prevention, including data
made available to the Centers by a State;</text>
</paragraph><paragraph id="H88AE1115E40243E1A0FCF2F4680928DC"><enum>(3)</enum><text>provide
appropriate support and input on the design and implementation by the Centers
for Disease Control and Prevention and the States of an active surveillance
system that provides information on the incidence and causes of food-borne
illness which is timely, detailed, and representative of the population of the
United States;</text>
</paragraph><paragraph id="HC7B4E5F4118D4E9F9B2507A459A0B94B"><enum>(4)</enum><text>based on data and
information obtained from the Centers for Disease Control and Prevention, the
States, and other sources, assess the incidence, distribution, public health
impact, and causes of human illness in the United States associated with the
consumption of food, and conduct research and analysis to devise effective and
feasible interventions to reduce food-borne illness;</text>
</paragraph><paragraph id="H44BBE4A3874F4618B515D28DF0BF16C6"><enum>(5)</enum><text>maintain a
state-of-the-art DNA matching system and epidemiological system dedicated to
food-borne illness identification, outbreaks, and containment; and</text>
</paragraph><paragraph id="H3DBE3DC34E334CD6919490466763B9D4"><enum>(6)</enum><text>utilize
surveillance data created by means of monitoring and statistical studies
conducted as part of its own inspection.</text>
</paragraph></subsection><subsection id="H727594ABD65B4586BAABA5BE74A017A1"><enum>(b)</enum><header>Public health
sampling</header>
<paragraph id="HBEB8498496794CACABB235ACE215E5D8"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the enactment 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="HAB387975F19844AC89D1414099B23DFF"><enum>(A)</enum><text>to assist the
Administrator in carrying out this Act; and</text>
</subparagraph><subparagraph id="HFB98EDF0FAD94C39B62CFA3D884FA4C"><enum>(B)</enum><text>to assess the
nature, frequency of occurrence, and quantities of contaminants in food.</text>
</subparagraph></paragraph><paragraph id="H3EA6F33E86DC4E4398F5D276BCEC3C9D"><enum>(2)</enum><header>Requirements</header><text>The
sampling system described in paragraph (1) shall provide—</text>
<subparagraph id="H6FB13523A919459885BFD966EBD9B1DC"><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="HD85E8C927773497E9DB7D997B5F7DE6F"><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="H15EFDD0C42754062952FAD1413519091"><enum>(c)</enum><header>Assessment of
health hazards</header>
<paragraph id="H890B45079C7C4FB29421C551AD06C582"><enum>(1)</enum><header>In
general</header><text>Through the surveillance system and analyses referred to
in subsection (a) and the sampling system described in subsection (b), the
Administrator shall—</text>
<subparagraph id="HAEA5532A297F464F82DA9C4ECEF4D65B"><enum>(A)</enum><text>rank food
categories based on the hazard to human health presented by the food category
and specific chemical and microbiological hazards associated with foods in
those categories;</text>
</subparagraph><subparagraph id="H02059A751EB7490FA700AA9B1E526EDD"><enum>(B)</enum><text>identify
appropriate industry and regulatory approaches to minimize hazards in the food
supply; and</text>
</subparagraph><subparagraph id="HF5D7F8B355B5489F97001262E0D00080"><enum>(C)</enum><text>assess the
conditions affecting the likelihood that emerging pathogens and diseases,
including zoonosis, will affect the safety of the food supply and possible
strategies for minimizing the potential risk to public health associated with
emerging pathogens and diseases.</text>
</subparagraph></paragraph><paragraph id="H2C8435F5BD8E473C869B3F123D7D9470"><enum>(2)</enum><header>Components of
analysis</header><text>The analysis under subsection (b)(1) may include—</text>
<subparagraph id="H275DA34E04B54D8B8CF593EA9408EC60"><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="H10B520D4B85B4A92AE5E289EC2A5ED26"><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="H0EB77B6FE6DB468A8F8CFF78001D3659"><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 id="H0B3170E451244C429E4C878CA82DA12"><enum>(D)</enum><text>use of comparative
risk assessments.</text>
</subparagraph></paragraph></subsection></section><section id="HC21CC3705F114A4FB764729E827CD555"><enum>302.</enum><header>Public
education and advisory system</header>
<subsection id="H8E985D3F92DC4A0FAAC4E66EB75DDC"><enum>(a)</enum><header>Public
education</header>
<paragraph id="H90399931E31D42F5B51273D5ACAA9780"><enum>(1)</enum><header>In
general</header><text>The Administrator, in cooperation with private and public
organizations, including the cooperative extension services and building on the
efforts of appropriate State and local entities, shall establish a national
public education program on food safety.</text>
</paragraph><paragraph id="H4D91A7EC87674AFB8E3E3985974DCEF3"><enum>(2)</enum><header>Requirements</header><text>The
program shall provide—</text>
<subparagraph id="HCA6272EF93B8451C8BC58F5577EE7EDA"><enum>(A)</enum><text>information to the
public regarding Federal standards and best practices, and promotion of public
awareness and understanding of those standards and practices;</text>
</subparagraph><subparagraph id="HFCB1811DFC274A509F5898C2EBCF3B87"><enum>(B)</enum><text>information for
health professionals—</text>
<clause id="HF48256082D1B4E70A2162873644883F4"><enum>(i)</enum><text>to
improve diagnosis and treatment of food-related illness; and</text>
</clause><clause id="H60317E2AEDD445EE89E3004F26005F5C"><enum>(ii)</enum><text>to
advise individuals at special risk for food-related illnesses; and</text>
</clause></subparagraph><subparagraph id="H4DE052945E554625AA251FCE007D00C6"><enum>(C)</enum><text>such other
information or advice, including on safe food handling practices, to consumers
and other persons as the Administrator determines will promote the purposes of
this Act.</text>
</subparagraph></paragraph></subsection><subsection id="H04A35AFD02054D44AC001E6EFA290056"><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="H90C6746C514844249E5F858BA0037947"><enum>(1)</enum><text>to develop and
distribute regional and national advisories concerning food safety;</text>
</paragraph><paragraph id="H820E3A65152C4A0989AD57D7C5A612"><enum>(2)</enum><text>to
develop standardized formats for written and broadcast advisories;</text>
</paragraph><paragraph id="HE8522D0369114742902D3C266D033419"><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="HC5004E47D9714ACAA61C14EE42B70053"><enum>(4)</enum><text>to present prompt,
specific information regarding food found to pose a threat to the public
health, including by identifying the retailers and food establishments where
such food has been sold.</text>
</paragraph></subsection></section><section id="H94989E5B3CFA41ADA770DC9E9240A1B0"><enum>303.</enum><header>Research</header>
<subsection id="H2CD8CE7FEACE43D597F03012ADD573A4"><enum>(a)</enum><header>In
general</header><text>The Administrator shall conduct research to carry out
this Act, including studies to—</text>
<paragraph id="HB763105D779941FA84C0FB456EF1BCCF"><enum>(1)</enum><text>improve sanitation
and food safety practices in the processing of food;</text>
</paragraph><paragraph id="H869E9C9A433A4C8D9DBF2389C94DD816"><enum>(2)</enum><text>develop improved
techniques to monitor and inspect food;</text>
</paragraph><paragraph id="HB714A54E0E5C49D6B493001C87970000"><enum>(3)</enum><text>develop efficient,
rapid, and sensitive methods to detect contaminants in food;</text>
</paragraph><paragraph id="HBD2BEB0BA13E4FF389D0BF2F43D199A"><enum>(4)</enum><text>determine the
sources of contamination of contaminated food;</text>
</paragraph><paragraph id="H17A3A9EF854444ED869C77857967DA08"><enum>(5)</enum><text>develop food
consumption data;</text>
</paragraph><paragraph id="H02EAEDC736964ACCAB001200FE9E46F8"><enum>(6)</enum><text>identify ways that
animal production techniques could improve the safety of the food
supply;</text>
</paragraph><paragraph id="H167F6BF32C1A4C1B8F0336E0D3AD18B2"><enum>(7)</enum><text>draw upon research
and educational programs that exist at the State and local level;</text>
</paragraph><paragraph id="HD5EFA3835F2A41328B63A7418FFA558F"><enum>(8)</enum><text>utilize the DNA
matching system and other processes to identify and control pathogens;</text>
</paragraph><paragraph id="H411A3645F25E4FBA8009816EF625B966"><enum>(9)</enum><text>address common and
emerging zoonotic diseases;</text>
</paragraph><paragraph id="HC23FA5EA07B54F9F87CC82AE4ED2A585"><enum>(10)</enum><text>develop methods
to reduce or destroy harmful pathogens before, during, and after
processing;</text>
</paragraph><paragraph id="HC0C9A75022484546846D00AD9E8C2C84"><enum>(11)</enum><text>analyze the
incidence of antibiotic resistence as it pertains to the food supply and
develop new methods to reduce the transfer of antibiotic resistance to humans;
and</text>
</paragraph><paragraph id="H7363AB3D07824CEDB424D2F1E95F182E"><enum>(12)</enum><text>conduct other
research that supports the purposes of this Act.</text>
</paragraph></subsection><subsection id="H197EE33EF13A47D2B863C92152BC1BD5"><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><section id="H4843CC860E484A9CA0D50182632308C"><enum>304.</enum><header>Working group on
improving foodborne illness surveillance</header><text display-inline="no-display-inline">Not later than 180 days after the date of
enactment of this Act, the Administrator shall establish a diverse working
group of experts and stakeholders from Federal, State, and local food safety
and health agencies, the food industry, consumer organizations, and academia.
Such working group shall provide the Administrator, through at least annual
meetings of the working group and an annual public report, advice and
recommendations on an ongoing and regular basis regarding the improvement of
food-borne illness surveillance, including advice and recommendations
on—</text>
<paragraph id="HAEDC5E422BD64E82BB2717A3EE611449"><enum>(1)</enum><text>the priority needs
of regulatory agencies, the food industry, and consumers for information and
analysis on food-borne illness and its causes that can be used to prevent
food-borne illness;</text>
</paragraph><paragraph id="HD70A4EA5863F426C80F0D5113B55C975"><enum>(2)</enum><text>opportunities to
improve the effectiveness of initiatives at the Federal, State, and local
levels, including coordination and integration of activities among Federal
agencies, and between the Federal, State, and local levels of
government;</text>
</paragraph><paragraph id="H62F8565CEBCD47F5801FFD5000BAC173"><enum>(3)</enum><text>improvement in the
timeliness and depth of access by regulatory and health agencies, the food
industry, academic researchers, and consumers to food-borne illness
surveillance data collected by government agencies at all levels, including
data compiled by the Centers for Disease Control and Prevention;</text>
</paragraph><paragraph id="HBFE1B054650F4786ACBCB0FB717BB78E"><enum>(4)</enum><text>key barriers to
improvement in food-borne illness surveillance and its utility for preventing
food-borne illness at Federal, State, and local levels; and</text>
</paragraph><paragraph id="H2507132E349F4C6CAAE505A361006CD5"><enum>(5)</enum><text>specific actions
to reduce barriers to such improvement, implement the working group’s
recommendations, with measurable objectives and timelines, and identification
of resource and staffing needs.</text>
</paragraph></section><section id="H4B1DE9A7CC8142ADB2CB40EFFF721BA0" section-type="subsequent-section"><enum>305.</enum><header>Career-spanning
training for food inspectors</header>
<subsection id="H2FA7DE42B72042A0A021ABF7933D0955"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Administrator
shall make a grant to an entity described in subsection (c) to provide training
to Federal, State, and local food inspectors.</text>
</subsection><subsection id="H5F7D009218164BFFA200E4C76788A534"><enum>(b)</enum><header>Use of
funds</header><text>The Administrator may make a grant under this section to an
applicant only if the applicant agrees to use the grant to provide regular,
standardized, graduated, career-spanning training, based on a curriculum
developed by the Association of Food and Drug Officials, to Federal, State, and
local food inspectors.</text>
</subsection><subsection id="H51C0EA33C0374F89850067181D527C04"><enum>(c)</enum><header>Eligible
entity</header><text>An entity described in this subsection is an entity
that—</text>
<paragraph id="HC72A94524015412C83A380052093F3CC"><enum>(1)</enum><text>is described in
section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C.
501(c)(3));</text>
</paragraph><paragraph id="HD56070585FDF46A195AAFFA53E24BA20"><enum>(2)</enum><text>has the capability
to train not less than 1,000 food inspectors per year; and</text>
</paragraph><paragraph id="HB670668A0A67437D862EF1FA0088321F"><enum>(3)</enum><text>offers both
on-site and off-site training for food inspectors.</text>
</paragraph></subsection></section><section id="H4CCDC7A98DBF4E9DB388F8E8976E6D98"><enum>306.</enum><header>Food-Borne
Illness Health Registry</header>
<subsection id="H7BCB3DFC960F454487CC2EB30070F3C1"><enum>(a)</enum><header>Purpose</header><text display-inline="yes-display-inline">The purpose of the registry under
subsection (b) is to stimulate research on the trends, sources, health
outcomes, and preventive strategies related to food-borne disease.</text>
</subsection><subsection id="HFE6243DE075D49EEB734178CEB77700"><enum>(b)</enum><header>Registry</header><text display-inline="yes-display-inline">For the purpose described in subsection
(a), the Secretary of Health and Human Services, acting through the Director of
the Centers for Disease Control and Prevention, shall develop and maintain a
registry, to be known as the Food-Borne Illness Health Registry, consisting of
data on the trends, sources, health outcomes, and preventive strategies related
to food-borne disease.</text>
</subsection></section><section id="H8B6C363DA90641E5A9F5975634AA4FE5"><enum>307.</enum><header>Study on
Federal resources</header><text display-inline="no-display-inline">Not later
than one year after the date of the enactment of this Act, the Comptroller
General of the United States shall complete a study on the Federal resources
being dedicated to food-borne illness and food safety research and submit a
report on the results of such study to the Congress.</text>
</section><enum>IV</enum><header>ENFORCEMENT</header>
<section id="HBC6CD6AEE3A34860902C4DB67DCFA5C"><enum>401.</enum><header>Prohibited
acts</header><text display-inline="no-display-inline">It is prohibited—</text>
<paragraph id="H9E48E441A303439481C8F16903D0737F"><enum>(1)</enum><text>to manufacture,
introduce, deliver for introduction, or receive in interstate commerce any food
that is adulterated, misbranded, or otherwise unsafe;</text>
</paragraph><paragraph id="HA020CA39745D41D684A14C6946C9D900"><enum>(2)</enum><text>to adulterate or
misbrand any food in interstate commerce;</text>
</paragraph><paragraph id="H6B8024DB3188496F88C1B75600B9A373"><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="H76BB4371BE244F748504E318898EC246"><enum>(4)</enum><text display-inline="yes-display-inline">to refuse to permit access to a food
establishment or food production facility for the inspection and copying of a
record as required under sections 205(f) and 206(a);</text>
</paragraph><paragraph id="HDCD2C6F6B440411D8EEC7069DA064D59"><enum>(5)</enum><text>to fail to
establish or maintain any record or to make any report as required under
sections 205(f) and 206(b);</text>
</paragraph><paragraph id="HDB0AEAFD8EBC4334A6AFDBEF978DC8A4"><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="HD619E504E66D4247B6FA100F78FE9F2"><enum>(7)</enum><text>to
fail to provide to the Administrator the results of testing or sampling of
food, equipment, or material in contact with food, that is positive for any
contaminant under section 205(f)(1)(B);</text>
</paragraph><paragraph id="HFFE20DF409B741B0858C1227D6B5D4A8"><enum>(8)</enum><text>to fail to comply
with a provision, regulation, or order of the Administrator under section 202,
203, 204, 206, or 208;</text>
</paragraph><paragraph id="H6BC677C008594082925661D59D2909B3"><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 food for commerce, except in compliance with the
food safety law;</text>
</paragraph><paragraph id="HA37657C2CDB04F4EB7D72006183BB791"><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="H236C8570CFDB4538AAC100B433CA2973"><enum>(11)</enum><text>to fail to comply
with a recall or other order under section 403; or</text>
</paragraph><paragraph id="H12419357DCA941EB8263C3100062482D"><enum>(12)</enum><text>to otherwise
violate the food safety law.</text>
</paragraph></section><section id="H557069E3A49643E9B297122257D2FDB"><enum>402.</enum><header>Food detention,
seizure, and condemnation</header>
<subsection id="HA3194DA1ACA24746807BE6023FD561C"><enum>(a)</enum><header>Administrative
detention of food</header>
<paragraph id="H5F99D1700E274A18009973BE1BD97246"><enum>(1)</enum><header>Expanded
authority</header><text>The Administrator shall have authority under section
304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to
administratively detain and seize any food regulated under this Act that the
Administrator has reason to believe is unsafe, is adulterated or misbranded, or
otherwise fails to meet the requirements of the food safety law.</text>
</paragraph><paragraph id="HFA5D4A0011C84F358B17144FA0A58B00"><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, is adulterated or misbranded, or otherwise
fails to meet the requirements of this the food safety law, the officer,
employee, or agent may order the food detained.</text>
</paragraph><paragraph id="H013295BD5AAD4AE7B5EA64C9A48AF9"><enum>(3)</enum><header>Period of
detention</header>
<subparagraph id="HCD8D9C799B0E4ACFA083F9FC7065DC25"><enum>(A)</enum><header>In
general</header><text>A food may be detained under paragraph (1) or (2) 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="H8DB60DDD31D44C9182D64C3898CD4CA6"><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="H08609BCB8F69418900B6421597F8C6C6"><enum>(4)</enum><header>Security of
detained food</header>
<subparagraph id="H2496DAE2487E41829008C7345426BF51"><enum>(A)</enum><header>In
general</header><text>A detention order under this subsection—</text>
<clause id="HA9BB732B777D4E3B8F7231A9DE8CCCB9"><enum>(i)</enum><text>may
require that the food be labeled or marked as detained; and</text>
</clause><clause id="H98C1693A6CC3438600C8052F9B87E2A0"><enum>(ii)</enum><text>shall require
that the food be removed to a secure facility, if appropriate.</text>
</clause></subparagraph><subparagraph id="HBFA5F74561F944B7B594B5F993FCDED5"><enum>(B)</enum><header>Food subject to
an order</header><text>A food subject to a detention order under this
subsection 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="HB3A2093415DA46E89EDE019E54A69D00"><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="HCCDB5D2F59BC4276855477B383EA963C"><enum>(b)</enum><header>Appeal of
detention order</header>
<paragraph id="HC24DD8D6F57D4D618F9090ED7605AF93"><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 under subsection (a) if the food were seized
under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334),
may appeal the order to the Administrator.</text>
</paragraph><paragraph id="H3798378B3B164BD18B202B4B7EA697A3"><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="H67FB497602FE4091821757F9CDCE70CA"><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="H1760774B68E0496C91207B795C058FC8"><enum>(4)</enum><header>Termination</header><text>A
detention order under subsection (a) shall be considered to be terminated if,
after 5 days, the Administrator has failed—</text>
<subparagraph id="H088F9A97B73D458682908C1D046CF1A8"><enum>(A)</enum><text>to provide an
opportunity for an informal hearing; or</text>
</subparagraph><subparagraph id="H6DA4D41E90284E78B2E7C5569EE3E92"><enum>(B)</enum><text>to confirm, modify,
or terminate the order.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H78B49B647F3D4BEC858BC23294746DBF"><enum>(5)</enum><header>Effect of
instituting court action</header><text>If the Administrator initiates an action
under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332)
or section 304(a) of that Act (21 U.S.C. 334(a)) for a food subject to a
detention order under subsection (a), the process for the appeal of the
detention order with respect to such food shall terminate.</text>
</paragraph></subsection><subsection id="HBBC8D92567DC4C68BDB1F1F20095C379"><enum>(c)</enum><header>Condemnation of
food</header>
<paragraph id="HF03A1D6F02D148F5B69B10B961C8CDF8"><enum>(1)</enum><header>In
general</header><text>After confirming a detention order, the Administrator may
order the food condemned.</text>
</paragraph><paragraph id="HFE108A578FE74C57B9F2CEF5596488CB"><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="H57AA8AD64FAB455FBE6D14E1F52C8120"><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="H915263066A9C4C9EB95981BCA21366A8"><enum>(d)</enum><header>Temporary holds
at ports of entry</header>
<paragraph id="HAB34051655E24D599B757DA5738FF9CF"><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, 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="H7B6F4BEC8CFD4CC8A8A20106D824382B"><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="HA9EFD3BEAEDD4E9F841BCBC5A100E22F"><enum>(3)</enum><header>Prohibition on
transfer</header><text>During the period in which 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="H099C9FC74E3F4553A29B31DFE240D6F"><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><paragraph id="H5468CEB521724F21BC6E74A5BBFC3893"><enum>(5)</enum><header>Prohibition on
reexport</header><text>A food found unfit for human or animal consumption shall
be prohibited from reexport without further processing to remove the
contamination and reinspection by the Administration.</text>
</paragraph></subsection></section><section id="H6C7B2DCFAAB14B82BB9299F2A410AA1B"><enum>403.</enum><header>Notification
and recall</header>
<subsection id="HCDB856BCD20D4E52A428EF8E74C4649"><enum>(a)</enum><header>Notice to
Administrator of violation</header>
<paragraph id="H00D85EC378114FF2910026782D2EBDA2"><enum>(1)</enum><header>In
general</header><text>A person 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="HB9E45FD382A540A98124FB29A31CDAB"><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="H190EA18E7C3449C8A4D51CB4BD40FCF8"><enum>(b)</enum><header>Recall and
consumer notification</header>
<paragraph id="HAEF91930EBB34480AA18107C7C85DAAE"><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="HFC66442392474213B06772C9AB3DB0C7"><enum>(A)</enum><text>cease distribution
of the food;</text>
</subparagraph><subparagraph id="H4765CB817076460F965F5F4F00A9CCFD"><enum>(B)</enum><text>notify all
persons—</text>
<clause id="HBD95C526B8BD40388F00238F9000DB61"><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="HC94F7AAD9C684AD7938C49C263A398C9"><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="H5614A5252D9C4EBF9F9892C4ED7B4300"><enum>(C)</enum><text>recall the
food;</text>
</subparagraph><subparagraph id="HA967B707DB6D4C84A569ABEEE100E034"><enum>(D)</enum><text>in conjunction
with the Administrator, provide notice of the finding of the
Administrator—</text>
<clause id="HB1850A9C80FF4D72BC3C6FCC2FF352A9"><enum>(i)</enum><text>to
consumers to whom the food was, or may have been, distributed; and</text>
</clause><clause id="HC475A3D7F02944DB9B9444E685E45900"><enum>(ii)</enum><text>to
State and local public health officials; or</text>
</clause></subparagraph><subparagraph id="H8C632B2C7C0842AB9E7CC51C0071C583"><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="HC668E361A5034E33ADA5BDA71BDE508"><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="HE6DEC3AAD25D4B76858F906295C5EA66"><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="H02B4F9F490CB40F4A726D4D8C61076A9"><enum>(i)</enum><text>at
the expense of the food establishment; or</text>
</clause><clause id="H96E1BB8522DD45028E40714CA25B7201"><enum>(ii)</enum><text>in
an emergency (as determined by the Administrator), at the expense of the
Administration; and</text>
</clause></subparagraph><subparagraph id="H486D0638F0E6405BB0E3716133BEA389"><enum>(B)</enum><text>by order, require,
as the Administrator determines to be necessary, the person to
immediately—</text>
<clause id="H94C121CD723146D3861F46C26473754B"><enum>(i)</enum><text>cease distribution
of the food; and</text>
</clause><clause id="HE2654421CA5F45AE80C7318D1659B07B"><enum>(ii)</enum><text>notify all
persons—</text>
<subclause id="HEDCF49AF82734F9589A7B1219BC3AFA"><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="H00947E472A2D42589DF952DF24E4CF56"><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="HD5F1C887A3154AD9AEF505F7CDDA5793"><enum>(3)</enum><header>Notification to
consumers by Administrator</header><text>The Administrator shall, as the
Administrator determines to be necessary—</text>
<subparagraph id="H725887AC60574C539F00A158EB7CF7CA"><enum>(A)</enum><text>provide notice of
the finding of the Administrator under paragraph (1)—</text>
<clause id="HD61D9DEC8610488CB2FA5079B7D0B66D"><enum>(i)</enum><text>to
consumers to whom the food was, or may have been, distributed; and</text>
</clause><clause id="HBB9477D2060E414E98729F8CEC6E7620"><enum>(ii)</enum><text display-inline="yes-display-inline">to State and local public health officials;
and</text>
</clause></subparagraph><subparagraph id="H872FE43CC3844E0EA73497CAE2C679BE"><enum>(B)</enum><text>provide notice to
the public of the names and addresses of retail locations at which recalled
food products were available for sale.</text>
</subparagraph></paragraph><paragraph id="HEFD888AB5C1E4BFEBBFDBE627EF4FE00"><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="HB6C31855A0D44C069D29E74222F2FFA"><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="HAD447A5A97BC4903A9795BCC71DC69"><enum>(A)</enum><text>persons that
processed, distributed, or otherwise handled the food; and</text>
</subparagraph><subparagraph id="H6DC305718F1B4BE1A286AA56C5E03023"><enum>(B)</enum><text>persons to which
the food has been transported, sold, distributed, or otherwise handled.</text>
</subparagraph></paragraph></subsection><subsection id="H69F228073D094DD8B4919C07AB86F21D"><enum>(c)</enum><header>Informal
hearings on orders</header>
<paragraph id="HDAE866B92D7C494CA721F0F2C9009347"><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="H7326F1D464F44B668C8F90953256AB67"><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="H6DF9250464E2460D82AE05B2B72F5050"><enum>(d)</enum><header>Post-hearing
recall orders</header>
<paragraph id="H4B536021C85449B0831E89C703256B9E"><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="H554E11B410724E7F83F3A9EF36621929"><enum>(A)</enum><text>amend the order to
require recall of the food or other appropriate action;</text>
</subparagraph><subparagraph id="HDF9C4522ECFD411DAA5B5525FEE923BA"><enum>(B)</enum><text>specify a
timetable in which the recall shall occur;</text>
</subparagraph><subparagraph id="H43E34938B0314FC9915F64B63C00799F"><enum>(C)</enum><text>require periodic
reports to the Administrator describing the progress of the recall; and</text>
</subparagraph><subparagraph id="H3E7903240CAB49BD8B9176E5650906A"><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="H0799310C72F14B9B8649EB008412162D"><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="HDE631794C44642D9A7E2ECFBE005CAE7"><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="HEDB58BAFF292463C87D1CD5800B510E"><enum>404.</enum><header>Injunction
proceedings</header>
<subsection id="H0EF70D1CB8CA4AEB9559E408A97CF2BF"><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, 208, or 401 (or
a regulation promulgated thereunder).</text>
</subsection><subsection id="HA5EF93262B2146A4AF36BADF064900E3"><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="H0535C4F398DA4DC6AF095449928681C7"><enum>405.</enum><header>Civil and
criminal penalties</header>
<subsection id="H1B8ACE22A2DF42AF83A3B54D8BE001D7"><enum>(a)</enum><header>Civil
sanctions</header>
<paragraph id="HEB4A8A066CB042DE985F2388DF75D8A9"><enum>(1)</enum><header>Civil
penalty</header>
<subparagraph id="H0A49B4355D1F4870AB77233300C97BA7"><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 the food
safety law) may be assessed a civil penalty by the Administrator of not more
than $1,000,000 for each such act.</text>
</subparagraph><subparagraph id="H5FFE302C01A149189B0038E6C528FF0"><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="HC01B0A6F3C8842839F2121C728F11265"><enum>(2)</enum><header>Other
requirements</header>
<subparagraph id="HA244F37038F6498FB51D84A9007C24C"><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="HA9BBAE6811674FAA9626AD149B04C7E9"><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="H9142349981B14B8986154E7E32719060"><enum>(i)</enum><text>the
gravity of the violation;</text>
</clause><clause id="HCAF59F430A774D9EA0D31452925C5F00"><enum>(ii)</enum><text>the
degree of culpability of the person;</text>
</clause><clause id="H949B751ECBD64E0EA714A00D97F80C"><enum>(iii)</enum><text>the
size and type of the business of the person; and</text>
</clause><clause id="H1CD58190C53F46C2B66EF7C2D26F594"><enum>(iv)</enum><text>any
history of prior offenses by the person under the food safety law.</text>
</clause></subparagraph><subparagraph id="H6007FDCCD0114CBFB4B46252100087E7"><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="HF02981CE3FC74DA1AC707B75459419F0"><enum>(b)</enum><header>Criminal
sanctions</header>
<paragraph id="H5E09F9B18CB54719A400DC2D95AEED99"><enum>(1)</enum><header>Offense
resulting in serious illness</header><text>Notwithstanding section 303(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of
any provision of section 301 of such Act (21 U.S.C. 301) with respect to an
adulterated or misbranded food results in serious illness, the person
committing the violation shall be imprisoned for not more than 5 years, fined
in accordance with title 18, United States Code, or both.</text>
</paragraph><paragraph id="H31C4F8BBFEAA4E67A758D5D4308DD8AC"><enum>(2)</enum><header>Offense
resulting in death</header><text>Notwithstanding section 303(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of any
provision of section 301 of such Act (21 U.S.C. 331) with respect to an
adulterated or misbranded food results in death, the person committing the
violation shall be imprisoned for not more than 10 years, fined in accordance
with title 18, United States Code, or both.</text>
</paragraph></subsection><subsection id="H30BFDC79A77E476790EA26AA1D7BE0F5"><enum>(c)</enum><header>Judicial
review</header>
<paragraph id="H11B2C72000DD4059ADB899DB87AEB07C"><enum>(1)</enum><header>In
general</header><text>An order assessing a civil penalty against a person under
subsection (a) shall be a final order unless the person—</text>
<subparagraph id="H1028BBD5445B43368352E3FE3D4682BD"><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="H3FF2F11CE89C4039AF4C7B9FEA05BB7C"><enum>(B)</enum><text>simultaneously
serves a copy of the petition by certified mail to the Administrator.</text>
</subparagraph></paragraph><paragraph id="H5CFD4EF680F14B96BE81927DC722D567"><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="H15D436204366421C9072065BE588F3EA"><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="H883E5E5A65444ECE8C3C037CBE9E71EA"><enum>(d)</enum><header>Collection
actions for failure To pay</header>
<paragraph id="H76F1ED05E99B4483B9BAF31E5FEA377"><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="H5184335032F34420B930F959DF350240"><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="H88D3034AFFC94FFB900441CED7B6F1D4"><enum>(e)</enum><header>Penalties paid
into account</header><text>The Administrator—</text>
<paragraph id="H71DF5DE133A84E1F89D6C001EE3BD14"><enum>(1)</enum><text>shall deposit
penalties collected under this section in an account in the Treasury;
and</text>
</paragraph><paragraph commented="no" id="HC200EB4FE7F847E4AF8DB6646FFBD32"><enum>(2)</enum><text>may use the funds
in the account, without further appropriation or fiscal year limitation—</text>
<subparagraph commented="no" id="HCEF7680F7EDE486FACD4F1D83EE6168"><enum>(A)</enum><text>to carry out
enforcement activities under the food safety law; or</text>
</subparagraph><subparagraph commented="no" id="H2F14AEE9BF6C4C2A8FDC88AA00AFA953"><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="HF1959B76BB1D4ABDB02695BFC18D5182"><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="H3F895A2E100F480992B026FBF283EFBD"><enum>(g)</enum><header>Remedies not
exclusive</header><text>The remedies provided in this section are in addition
to, and not exclusive of, other remedies that may be available.</text>
</subsection></section><section id="H94E17E02843C45E391ABE32B1FDA7955"><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="H7E3D8D1EEB414A37B4723FD269CFE64E"><enum>407.</enum><header>Whistleblower
protection</header>
<subsection id="H343FA7B4F6084A2882A51C48AAC19C"><enum>(a)</enum><header>In
general</header>
<paragraph id="HDF35429401EE47ADA205B3274827007C"><enum>(1)</enum><header>Prohibition</header><text>No
Federal employee, employee of a Federal contractor or subcontractor, or covered
individual may be discharged, demoted, suspended, threatened, harassed, or in
any other manner discriminated against, because of any lawful act done by the
employee or covered individual to—</text>
<subparagraph id="HCE1749C6181E494280C9DFDDAE825FF7"><enum>(A)</enum><text>provide
information, cause information to be provided, or otherwise assist in an
investigation regarding any conduct that the covered individual reasonably
believes constitutes a violation of any law, rule, or regulation, or that the
covered individual reasonably believes constitutes a threat to the public
health, when the information or assistance is provided to, or the investigation
is conducted by—</text>
<clause id="HA2DBEE12280445D8BDBD7EC49886CA48"><enum>(i)</enum><text>a
Federal regulatory or law enforcement agency;</text>
</clause><clause id="HE6656043BFCB4FB3A270C4499654A94F"><enum>(ii)</enum><text>a
Member or committee of Congress; or</text>
</clause><clause id="H55BE00B632D7443780D1633FAF845DF"><enum>(iii)</enum><text>a
person with supervisory authority over the covered individual (or such other
individual who has the authority to investigate, discover, or terminate
misconduct);</text>
</clause></subparagraph><subparagraph id="HBE9E2046B25944A69B6100156D6677EB"><enum>(B)</enum><text>file, cause to be
filed, testify, participate in, or otherwise assist in a proceeding or action
filed or about to be filed relating to a violation of any law, rule, or
regulation; or</text>
</subparagraph><subparagraph id="H31DFA42573DF4D3385B128E130CDC4D9"><enum>(C)</enum><text>refused to violate
or assist in the violation of any law, rule, or regulation.</text>
</subparagraph></paragraph><paragraph id="H3959DF00C50D4E4284C7526DA9D3251D"><enum>(2)</enum><header>Definition</header><text>For
the purposes of this section, the term <term>covered individual</term> means an
individual who is an employee of—</text>
<subparagraph id="H1039A6A91C0F4B18A159CEE0426039DA"><enum>(A)</enum><text>a food
establishment;</text>
</subparagraph><subparagraph id="H747FD6A92DEA443BADC97C93154B9238"><enum>(B)</enum><text>a food production
facility;</text>
</subparagraph><subparagraph id="HD758F484559D46C3915349C340911C1C"><enum>(C)</enum><text>a
restaurant;</text>
</subparagraph><subparagraph id="HC039EDB4FB7C4E42BA62BFFDC11C42FA"><enum>(D)</enum><text>a retail food
establishment other than a restaurant;</text>
</subparagraph><subparagraph id="H56B088ED0428426FA118B2E3870033E7"><enum>(E)</enum><text>a nonprofit food
establishment in which food is prepared for or served directly to the
consumer;</text>
</subparagraph><subparagraph id="H5B612DF4FD5242AEBF858EFDB2DDB01"><enum>(F)</enum><text>a fishing vessel;
or</text>
</subparagraph><subparagraph id="HA6453354BBE04F34AE009FB9EBA9EDB2"><enum>(G)</enum><text>an agent of any of
the above.</text>
</subparagraph></paragraph></subsection><subsection id="H4096844E02634C8D8CE15000E9F335F1"><enum>(b)</enum><header>Enforcement
action</header>
<paragraph id="H578085CA68694A9CB0A7A94277BB6353"><enum>(1)</enum><header>In
general</header><text>A covered individual who alleges discharge or other
discrimination by any person in violation of subsection (a) may seek relief
under subsection (c) by filing a complaint with the Secretary of Labor. If the
Secretary of Labor has not issued a final decision within 180 days after the
date on which the complaint is filed and there is no showing that such delay is
due to the bad faith of the claimant, the claimant may bring an action at law
or equity for de novo review in the appropriate district court of the United
States, which shall have jurisdiction over such an action without regard to the
amount in controversy.</text>
</paragraph><paragraph id="H824481E78D0B4EC5B3076640E3CF57E1"><enum>(2)</enum><header>Procedure</header>
<subparagraph id="H624E1392D6A14B5CA3D0907556FABABD"><enum>(A)</enum><header>In
general</header><text>An action under paragraph (1) shall be governed under the
rules and procedures set forth in section 42121(b) of title 49, United States
Code.</text>
</subparagraph><subparagraph id="HA2B4F5015BD74800AC91758DF7E16B7B"><enum>(B)</enum><header>Exception</header><text>Notification
under section 42121(b)(1) of title 49, United States Code, shall be made to the
person named in the complaint and to the person’s employer.</text>
</subparagraph><subparagraph id="HE487D6704B054AE3B66C2200C729EEA5"><enum>(C)</enum><header>Burdens of
proof</header><text>An action brought under paragraph (1) shall be governed by
the legal burdens of proof set forth in section 42121(b) of title 49, United
States Code.</text>
</subparagraph><subparagraph id="H7776496B147B47489E00CAE738C35900"><enum>(D)</enum><header>Statute of
limitations</header><text>An action under paragraph (1) shall be commenced not
later than 90 days after the date on which the violation occurs.</text>
</subparagraph></paragraph></subsection><subsection id="H09AE54D760774A5C8971C3032410EFE1"><enum>(c)</enum><header>Remedies</header>
<paragraph id="H1F2AA5DD56CC42D6AAB81FF20297D26B"><enum>(1)</enum><header>In
general</header><text>A covered individual prevailing in any action under
subsection (b)(1) shall be entitled to all relief necessary to make the covered
individual whole.</text>
</paragraph><paragraph id="H3759626CBA64447F81D039409DD31BF7"><enum>(2)</enum><header>Compensatory
damages</header><text>Relief for any action described in paragraph (1) shall
include—</text>
<subparagraph id="H91C13AB92A584F6EB524A1D1542C8DA9"><enum>(A)</enum><text>reinstatement with
the same seniority status that the covered individual would have had, but for
the discrimination;</text>
</subparagraph><subparagraph id="H1B510003077441B78FB8C7A67CDBBD66"><enum>(B)</enum><text>the amount of any
back pay, with interest; and</text>
</subparagraph><subparagraph id="H107D5748FAA64067B4C13783DD7D3B08"><enum>(C)</enum><text>compensation for
any special damages sustained as a result of the discrimination, including
litigation costs, expert witness fees, and reasonable attorney’s fees.</text>
</subparagraph></paragraph></subsection><subsection id="H7BA860A565C9434B8DADF65EC405D57C"><enum>(d)</enum><header>Rights retained
by the covered individual</header><text>Nothing in this section shall be
construed to diminish the rights, privileges, or remedies of any covered
individual under any Federal or State law, or under any collective bargaining
agreement.</text>
</subsection></section><section id="HFA7B0BCCFB3C428986EA6F209E9573CD"><enum>408.</enum><header>Administration
and enforcement</header>
<subsection id="H7AB00F9656A7404B8700C0421463735E"><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 Federal Trade Commission Act (15 U.S.C. 46, 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="HCCB40B6C6F104FFF8938EAC49F879967"><enum>(b)</enum><header>Inquiries and
actions</header>
<paragraph id="H6DB75AB920A54646ABCED41C0064661E"><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="HC9547AE4EC0843209784E5A499BED6B9"><enum>(2)</enum><header>Powers</header><text>The
powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15
U.S.C. 49 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="H8AC22617AE194F6EA68CFBDC13ECBF89"><enum>409.</enum><header>Citizen civil
actions</header>
<subsection id="HFA22B916B5EF4494854DDF3319466D69"><enum>(a)</enum><header>Civil
actions</header><text>A person may commence a civil action against—</text>
<paragraph id="H5719C7D34131463C92B000A500685849"><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="H8C9539946B7F4C139D31FAA1C27C003E"><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="H008096BD89BE49A182921300FCCF26CD"><enum>(b)</enum><header>Court</header><text display-inline="yes-display-inline">In an action commenced under this
section:</text>
<paragraph id="H13D3910D316447F4A76B483C2CC118FA"><enum>(1)</enum><header>In
general</header><text>The action shall be commenced—</text>
<subparagraph id="H84E0D4ED1813437A8E00B606F593D695"><enum>(A)</enum><text>in the case of a
civil action against a person, the United States district court for the
district in which the defendant resides, is found, or has an agent; and</text>
</subparagraph><subparagraph id="HD7F05B8BFBF9451DBCDA0031A953AED2"><enum>(B)</enum><text>in the case of a
civil action against the Administrator, any United States district
court.</text>
</subparagraph></paragraph><paragraph id="HAFDCEB5823334210A8006FD95FDF0860"><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="HDCEC9D7B62704BAA80B9C015F0657405"><enum>(3)</enum><header>Damages</header><text>The
court may—</text>
<subparagraph id="H89D76B65E01F4B519F0337B2FBC67D48"><enum>(A)</enum><text>award damages, in
the amount of damages actually sustained; and</text>
</subparagraph><subparagraph id="HE6942C5EAC464316BB28E2248162F5B2"><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="HE5F86A8AEDD946098D22ABC21821DA"><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="H9510F805467D48C6B47689F0DD8C577C"><enum>501.</enum><header>Reorganization
plan</header>
<subsection id="HB62EF0CF0F91496F9D4746925DBB7366"><enum>(a)</enum><header>Submission of
plan</header><text>Not later than 180 days after the enactment of this Act, the
President shall transmit to the appropriate congressional committees a
reorganization plan regarding the following:</text>
<paragraph id="H03BE69688848407AAD07E2B00008048"><enum>(1)</enum><text>The transfer of
agencies, personnel, assets, and obligations to the Administration pursuant to
this Act.</text>
</paragraph><paragraph id="HA4F86CBEEE054EC189C14FFF35FBE8"><enum>(2)</enum><text>Any
consolidation, reorganization, or streamlining of agencies transferred to the
Administration pursuant to this Act.</text>
</paragraph></subsection><subsection id="HE6CE5B752B4C4549AE367E00D3934B9D"><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="H9E9CDFD6C7A148E7B5609FDA4CCADF44"><enum>(1)</enum><text>The timetable for
transfer and identification of any functions of agencies designated to be
transferred to the Administration pursuant to this Act that will not be
transferred promptly to the Administration under the plan.</text>
</paragraph><paragraph id="H9C02B9222E1F450EACBF8E183ECE2F11"><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="H78E269AE9C80404294614D47CDA0CAA5"><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="H7BC742337ADF40F99F54D1DFCE48A0FF"><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="HEEA246AC45E8429093FD8C3F9667005C"><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="H4D5ACB354C0E44DEA66E436266FE5055"><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.</text>
</paragraph></subsection><subsection id="HEACF7F21DA5D4F2DA4D2E1CEC550E5F4"><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="H98C6D42D550A46BAA29090B51259DD10"><enum>(d)</enum><header>Effective
date</header>
<paragraph id="H970B8153BF36487FAB6DCBF003C77F7"><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="H4A6BA865055E4F58B9AC6CBECE1D5F97"><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="H09A98B897847480BA1AAB2A79725A0CE"><enum>(B)</enum><text>the end of the
12-month period beginning on the date of the enactment of this Act.</text>
</subparagraph></paragraph><paragraph id="H2B66F3B6DF3F4F6D8E32390018B7013F"><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="H6BC6EA51EFA74470A865918D84C900A6"><enum>(3)</enum><header>Supersedes
existing law</header><text>Paragraph (1) shall apply notwithstanding section
905(b) of title 5, United States Code.</text>
</paragraph></subsection></section><section id="HC9A2DE411787431295C6FD1870FCAA5D"><enum>502.</enum><header>Transitional
authorities</header>
<subsection id="H84449A6F2D52497DB61462F9724E6E93"><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 date of the enactment 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="H1B2485EBCC1547EFBB35FF475443A2D9"><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 provide services or detail
personnel to assist with the transition.</text>
</subsection><subsection id="HB8B9CC3360464C3091EB32EA74DD9F2"><enum>(c)</enum><header>Acting
officials</header>
<paragraph id="HA2E127B82ACD4672BF7DF68FB3E44822"><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 date of the
enactment 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="HDCC9F330C48F4AE6AEAB41EFF95DD099"><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="H8A9B63D555CF4C6F003EEC2D082C7760"><enum>(A)</enum><text>the rates provided
by this Act for the respective offices in which they act; or</text>
</subparagraph><subparagraph id="H0084522EA5B24A38A73132179FAD4526"><enum>(B)</enum><text>the rates provided
for the offices held at the time of designation.</text>
</subparagraph></paragraph><paragraph id="HF1F40407D4E9421FA66E6E7E96DEE326"><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="H6A58D16753A84243A87B47006520F9B0"><enum>(d)</enum><header>Transfer of
personnel, assets, obligations, and function</header>
<paragraph id="HC1C7EC9A9D9C436DB4CE925F55016FCB"><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 id="HD343EB4C369E4E48828935B903AAF302"><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 id="H1CAC4BE17E3842819773A0E0004BE878"><enum>503.</enum><header>Savings
provisions</header>
<subsection id="H0F463328F4754AE0B6A5BF2E5A37CB3"><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, tolerance, guidance, permit, personnel action, agreement, grant,
contract, certificate, license, registration, user fees, 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 id="H3AD2AA2274F0489F83B0252576D08695"><enum>(b)</enum><header>Pending
proceedings</header><text>Subject to the authority of the Administrator under
this Act—</text>
<paragraph id="HDA40F6FE73424BF49E30EFD567795E8D"><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 or modification could have occurred if such enactment or
transfer had not occurred; and</text>
</paragraph><paragraph id="H3A020BB80AFA4B159FCF9BFC6973A75F"><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, superseded, 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 id="H9A7EC39E5AA64B8985798D4D2EC49DF7"><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 id="HCA964BA8932044858D7F8CB17876C34B"><enum>(d)</enum><header>References</header>
<paragraph id="HAB7FA84FCF3C4753AE06D57C803171D"><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 law shall be deemed to be a reference to the Administration or
the Administrator, respectively.</text>
</paragraph><paragraph id="H4CDAF799B0B042CC8E4B4166D715AF3E"><enum>(2)</enum><header>Statutory
reporting requirements</header><text>Statutory reporting requirements that
applied in relation to such an agency immediately before the date of the
enactment of this Act shall continue to apply following such transfer if they
refer to the agency by name.</text>
</paragraph></subsection></section><section id="HD8EC07DE88114A35BD16AEE25CFEFD4B"><enum>504.</enum><header>Conforming
amendments</header>
<subsection id="HC803719C8F224B7C915142E8BDA6F69E"><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: <quote>Administrator of Food
Safety.</quote>.</text>
</subsection></section><section id="H55C6BF22E5FC4E3198D92F1C99155584"><enum>505.</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 501, 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="HED7AF88DE6DE48E0ADCD3EA3075BCF90"><enum>506.</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="HAE6DA5E9F79943689EF988A963B77C70"><enum>507.</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="H3202EEADA43142FB8E49A67E00162C86"><enum>508.</enum><header>Limitation on
authorization of appropriations</header><text display-inline="no-display-inline">For the fiscal year that includes the date
of the enactment of this Act, the amount authorized to be appropriated to carry
out this Act shall not exceed—</text>
<paragraph id="H7C4FF37310BE4527B6DBD00243168B5"><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 id="HC96D91B2B41C4E7BA1EAE939825F8C36"><enum>(2)</enum><text>the amount
appropriated for those agencies for that purpose for the preceding fiscal year,
if, as of the date of the enactment of this Act, appropriations for those
agencies for the fiscal year that includes such date have not yet been
made.</text>
</paragraph></section>