[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 875 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 875
To establish the Food Safety Administration within the Department of
Health and Human Services to protect the public health by preventing
food-borne illness, ensuring the safety of food, improving research on
contaminants leading to food-borne illness, and improving security of
food from intentional contamination, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 4, 2009
Ms. DeLauro (for herself, Ms. Eshoo, Ms. DeGette, Ms. Schakowsky, Mr.
Engel, Ms. Castor of Florida, Mr. Murphy of Connecticut, Ms. Sutton,
Mrs. Lowey, Ms. Slaughter, Mr. Hinchey, Mr. McGovern, Ms. Wasserman
Schultz, Ms. Hirono, Mr. Grijalva, Mr. Schauer, Mr. Nadler of New York,
Mr. Bishop of New York, Ms. Linda T. Sanchez of California, Mr.
McDermott, Mr. Ryan of Ohio, Ms. Giffords, Mr. Filner, Mr. Hall of New
York, Ms. Lee of California, Ms. Pingree of Maine, Ms. Kaptur, Mr.
Bishop of Georgia, Ms. Moore of Wisconsin, and Mr. DeFazio) introduced
the following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Agriculture, for a period
to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To establish the Food Safety Administration within the Department of
Health and Human Services to protect the public health by preventing
food-borne illness, ensuring the safety of food, improving research on
contaminants leading to food-borne illness, and improving security of
food from intentional contamination, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Food Safety
Modernization Act of 2009''.
(b) Table of Contents.--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.
SEC. 2. FINDINGS; PURPOSES.
(a) Findings.--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) Purposes.--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.
SEC. 3. DEFINITIONS.
In this Act:
(1) Administration.--The term ``Administration'' means the
Food Safety Administration established under section 101(a)(1).
(2) Administrator.--The term ``Administrator'' means the
Administrator of Food Safety appointed under section 101(a)(2).
(3) Adulterated.--
(A) In general.--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) Inclusion.--The term ``adulterated'' includes
bearing or containing a contaminant that causes illness
or death among sensitive populations.
(4) Agency.--The term ``agency'' has the meaning given that
term in section 551 of title 5, United States Code.
(5) Category 1 food establishment.--The 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 establishment.--The 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 establishment.--The 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 establishment.--The 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 establishment.--The term ``category 5
food establishment'' means a food establishment that stores,
holds, or transports food products prior to delivery for retail
sale.
(10) Contaminant.--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) Hazardous contamination.--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) Food.--The term ``food'' means a product intended to
be used for food or drink for a human or an animal and
components thereof.
(13) Food establishment.--
(A) In general.--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) Exclusions.--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) Food production facility.--The term ``food production
facility'' means any farm, ranch, orchard, vineyard,
aquaculture facility, or confined animal-feeding operation.
(15) Food safety law.--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 establishment.--The 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) Interstate commerce.--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) Misbranded.--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) Process.--The term ``process'' or ``processing'' means
the commercial slaughter, packing, preparation, or manufacture
of food.
(20) State.--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.
TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.
(a) Establishment.--
(1) In general.--There is established in the Department of
Health and Human Services an agency to be known as the ``Food
Safety Administration''.
(2) Head of the administration.--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.
(3) Delegation.--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.
(b) Duties of Administrator.--The Administrator shall--
(1) administer and enforce the food safety law;
(2) 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;
(3) represent the United States in relevant international
food safety bodies and discussions;
(4) promulgate regulations to ensure the safety and
security of the food supply from all forms of contamination,
including intentional contamination; and
(5) oversee within the Department of Health and Human
Services--
(A) 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;
(B) implementation of food safety inspection,
enforcement, and research efforts to protect the public
health;
(C) development of consistent and science-based
standards for safe food;
(D) coordination and prioritization of food safety
research and education programs with other Federal
agencies;
(E) prioritization of food safety efforts and
deployment of food safety resources to achieve the
greatest possible benefit in reducing food-borne
illness;
(F) coordination of the response to food-borne
illness outbreaks with other Federal and State
agencies; and
(G) integration of food safety activities with
State and local agencies.
SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.
(a) Transfer of Functions and Resources.--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.
(b) Transferred Functions and Resources.--The components referred
to in subsection (a) are--
(1) the Center for Food Safety and Applied Nutrition of the
Food and Drug Administration;
(2) the Center for Veterinary Medicine of the Food and Drug
Administration;
(3) the National Center for Toxicological Research of the
Food and Drug Administration;
(4) 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;
(5) the personnel and assets of the Office of the
Commissioner of Food and Drugs used to support--
(A) the Center for Food Safety and Applied
Nutrition;
(B) the Center for Veterinary Medicine;
(C) the National Center for Toxicological Research;
and
(D) the personnel and assets of the Office of
Regulatory Affairs described in paragraph (4); and
(6) 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.
(c) Renaming and Reservation of Agency Identity.--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 ``FDA''.
(d) Sharing of Facilities and Resources.--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.
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.
(a) Officers and Employees.--The Administrator may--
(1) 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
(2) 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.
(b) Experts and Consultants.--The Administrator may--
(1) procure the services of temporary or intermittent
experts and consultants as authorized by section 3109 of title
5, United States Code; and
(2) 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.
(c) Bureaus, Offices, and Divisions.--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.
(d) Advisory Committees.--
(1) In general.--The Administrator shall establish advisory
committees that consist of representatives of scientific expert
bodies, academics, industry specialists, and consumers.
(2) Duties.--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.
TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM
SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.
(a) In General.--The Administrator shall--
(1) develop, administer, and annually update a national
food safety program (referred to in this section as the
``program'') to protect public health; and
(2) ensure that persons who produce, process, or distribute
food meet their responsibility to prevent or minimize food
safety hazards related to their products.
(b) Comprehensive Analysis.--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--
(1) the severity of the potential health risks;
(2) 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;
(3) the potential for persistence, multiplication, or
concentration of naturally occurring or added contaminants in
food;
(4) the potential for hazardous contamination to have
cumulative toxic effects, multigenerational effects, or effects
on specific categories of consumers;
(5) opportunities across the food production, processing,
distribution, and retail system to reduce potential health
risks; and
(6) opportunities for intentional contamination of food or
food ingredients.
(c) Program Elements.--In carrying out the program, the
Administrator shall--
(1) adopt and implement a national system for the
registration of food establishments and foreign food
establishments, as provided in section 202 of this Act;
(2) adopt and implement a national system for regular
unannounced inspection of food establishments;
(3) 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;
(4) establish and enforce science-based standards for--
(A) potentially hazardous substances that may
contaminate food; and
(B) safety and sanitation in the processing and
handling of food;
(5) 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;
(6) implement appropriate surveillance procedures and
requirements to ensure the safety and security of imported
food;
(7) coordinate and collaborate with other agencies and
State or local governments in carrying out inspection,
enforcement, research, and monitoring;
(8) 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;
(9) develop public education, risk communication, and
advisory programs;
(10) implement an applied research program to further the
purposes of this Act;
(11) coordinate and prioritize food safety research and
educational programs with other Federal agencies and with State
and local governments; and
(12) 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.
SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND FOREIGN FOOD
ESTABLISHMENTS.
(a) In General.--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.
(b) Registration Requirements.--
(1) In general.--To be registered under subsection (a), a
food establishment shall submit a registration or
reregistration to the Administrator.
(2) Registration.--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:
(A) 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.
(B) 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.
(C) 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.
(D) 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.
(E) 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.
(3) Procedure.--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.
(4) List.--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.
(5) Disclosure exemption.--The disclosure requirements
under section 552 of title 5, United States Code, shall not
apply to--
(A) the list compiled under paragraph (4); and
(B) information derived from the list under
paragraph (4), to the extent that it discloses the
identity or location of a specific person.
(6) Suspension of registration.--
(A) In general.--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.
(B) Notice and opportunity for hearing.--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.
(C) Judicial review.--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.
(7) Reinstatement.--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.
(c) Transitional Provision.--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).
(d) Repeal.--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.
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION OF FOOD.
(a) In General.--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.
(b) Regulations.--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--
(1) to adopt preventive process controls that--
(A) reflect the standards and procedures recognized
by relevant authoritative bodies;
(B) are adequate to protect the public health;
(C) meet relevant regulatory and food safety
standards;
(D) limit the presence and growth of contaminants
in food prepared in a food establishment using the best
reasonably available techniques and technologies; and
(E) are tailored to the hazards and processes in
particular establishments or environments;
(2) to establish a sanitation plan and program that meets
standards set by the Administrator;
(3) to meet performance standards for hazardous
contamination established under section 204;
(4) to implement recordkeeping to monitor compliance with
regulatory requirements;
(5) 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;
(6) 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;
(7) 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
(8) 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.
(c) Specific Hazard Controls.--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.
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.
(a) In General.--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.
(b) Identification of Contaminants; Performance Standards.--
(1) List of contaminants.--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.
(2) Performance standards.--
(A) Establishment.--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.
(B) Timing.--The Administrator shall establish a
performance standard under subparagraph (A) for each
contaminant in the list under paragraph (1)--
(i) as soon as practicable; or
(ii) in the case of a contaminant described
in subparagraph (C), by the date described in
such subparagraph.
(C) Significant contaminants.--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.
(3) Review; revision.--Not less than every 3 years, the
Administrator shall review and, if necessary, revise--
(A) the list of contaminants under paragraph (1);
and
(B) each performance standard established under
paragraph (2).
(c) Performance Standards.--
(1) In general.--The performance standards established
under this section may include--
(A) health-based standards that set the level of a
contaminant that can safely and lawfully be present in
food;
(B) 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;
(C) process standards, such as log reduction
criteria for cooked products, when sufficient to ensure
the safety of processed food; and
(D) 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.
(2) Best reasonably achievable performance standards.--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.
(3) Revocation by administrator.--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.
(d) Enforcement.--
(1) In general.--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.
(2) Inspections.--If the Administrator determines that a
food establishment fails to meet a standard promulgated under
this section, the Administrator shall, as appropriate--
(A) detain, seize, or condemn food from the food
establishment under section 402;
(B) order a recall of food from the food
establishment under section 403;
(C) increase the inspection frequency for the food
establishment;
(D) withdraw the mark of inspection from the food
establishment, if in use; or
(E) take other appropriate enforcement action
concerning the food establishment, including withdrawal
of registration.
(e) Newly Identified Contaminants.--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.
SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.
(a) In General.--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--
(1) is operated in a sanitary manner;
(2) has continuous preventive control systems,
interventions, and processes in place to minimize or eliminate
contaminants in food;
(3) is in compliance with applicable performance standards
established under section 204, and other regulatory
requirements;
(4) is processing food that is not adulterated or
misbranded;
(5) maintains records of process control plans under
section 203, and other records related to the processing,
sampling, and handling of food; and
(6) is otherwise in compliance with the requirements of the
food safety law.
(b) Establishment Categories and Inspection Frequencies.--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):
(1) Category 1 food establishments.--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--
(A) diseased animals are not offered for slaughter;
(B) 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
(C) applicable performance standards and other
provisions of the food safety law, including those
intended to eliminate or reduce pathogens, have been
satisfied.
(2) Category 2 food establishments.--A category 2 food
establishment shall--
(A) have ongoing verification that its processes
are controlled; and
(B) be randomly inspected at least weekly.
(3) Category 3 food establishments.--A category 3 food
establishment shall--
(A) have ongoing verification that its processes
are controlled; and
(B) be randomly inspected at least monthly.
(4) Category 4 food establishments.--A category 4 food
establishment shall--
(A) have ongoing verification that its processes
are controlled; and
(B) be randomly inspected at least quarterly.
(5) Category 5 food establishments.--A category 5 food
establishment shall--
(A) have ongoing verification that its processes
are controlled; and
(B) be randomly inspected at least annually.
(c) Establishment of Inspection Procedures.--The Administrator
shall establish procedures under which inspectors shall take random
samples, photographs, and copies of records in food establishments.
(d) Alternative Inspection Frequencies.--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:
(1) Subcategories of food establishments and their
alternative inspection frequencies shall be defined by
regulation, subject to paragraphs (2) and (3).
(2) In defining subcategories of food establishments and
their alternative inspection frequencies under paragraphs (1)
and (2), the Administrator shall consider--
(A) the nature of the food products being
processed, stored, or transported;
(B) the manner in which food products are
processed, stored, or transported;
(C) the inherent likelihood that the products will
contribute to the risk of food-borne illness;
(D) the best available evidence concerning reported
illnesses associated with the foods processed, stored,
held, or transported in the proposed subcategory of
establishments; and
(E) 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.
(3) 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.
(4) In adopting alternative inspection frequencies for a
specific establishment, the Administrator shall consider--
(A) 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;
(B) whether products from the specific
establishment have been associated with a case or an
outbreak of food-borne illness; and
(C) the establishment's record of compliance with
food safety law, including compliance with applicable
performance standards and the frequency of recalls.
(e) Effective Date.--The inspection mandates shall go into effect 2
years after the date of the enactment of this Act.
(f) Maintenance and Inspection of Records.--
(1) In general.--
(A) Records.--A food establishment shall--
(i) 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
(ii) 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--
(I) to determine whether the food
is contaminated or not in compliance
with the food safety law; or
(II) to track the food in commerce.
(B) Required disclosure.--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.
(2) Maintenance of records.--The records in paragraph (1)
shall be maintained for a reasonable period of time, as
determined by the Administrator.
(3) Requirements.--The records in paragraph (1) shall
include records describing--
(A) the origin, receipt, delivery, sale, movement,
holding, and disposition of food or ingredients;
(B) the identity and quantity of ingredients used
in the food;
(C) the processing of the food;
(D) the results of laboratory, sanitation, or other
tests performed on the food or in the food
establishment;
(E) consumer complaints concerning the food or
packaging of the food;
(F) the production codes, open date codes, and
locations of food production; and
(G) other matters reasonably related to whether
food is adulterated or misbranded, or otherwise fails
to meet the requirements of this Act.
(g) Protection of Sensitive Information.--
(1) In general.--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.
(2) Limitation.--The requirements under this subsection and
subsection (f) do not--
(A) limit the authority of the Administrator to
inspect or copy records or to require the establishment
or maintenance of records under this Act;
(B) have any legal effect on section 1905 of title
18, United States Code;
(C) extend to any food recipe, financial data,
pricing data, or personnel data;
(D) limit the public disclosure of distribution
records or other records related to food subject to a
voluntary or mandatory recall under section 403; or
(E) limit the authority of the Administrator to
promulgate regulations to permit the sharing of data
with other governmental authorities.
(h) Bribery of or Gifts to Inspector or Other Officers and
Acceptance of Gifts.--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.
SEC. 206. FOOD PRODUCTION FACILITIES.
(a) Authorities.--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--
(1) 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;
(2) review food safety records as required to be kept by
the Administrator under section 210 and for other food safety
purposes;
(3) set good practice standards to protect the public and
animal health and promote food safety;
(4) conduct monitoring and surveillance of animals, plants,
products, or the environment, as appropriate; and
(5) collect and maintain information relevant to public
health and farm practices.
(b) Inspection of Records.--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--
(1) to determine whether the food is contaminated,
adulterated, or otherwise not in compliance with the food
safety law; or
(2) to track the food in commerce.
(c) Regulations.--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--
(1) consider all relevant hazards, including those
occurring naturally, and those that may be unintentionally or
intentionally introduced;
(2) 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;
(3) 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;
(4) 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;
(5) provide a reasonable period of time for compliance,
taking into account the needs of small businesses for
additional time to comply;
(6) provide for coordination of education and enforcement
activities by State and local officials, as designated by the
Governors of the respective States; and
(7) include a description of the variance process under
subsection (d) and the types of permissible variances which the
Administrator may grant under such process.
(d) Variances.--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--
(1) be in writing;
(2) describe the reasons the variance is necessary;
(3) describe the procedures, processes, and practices that
will be followed under the variance to ensure produce is not
adulterated; and
(4) contain any other information required by the
Administrator.
(e) Approval or Disapproval of Variances.--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--
(1) not sufficiently detailed to permit a determination;
(2) fails to cite sufficient grounds for allowing a
variance; or
(3) does not provide reasonable assurances that the produce
will not be adulterated.
(f) Enforcement.--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.
(g) Imported Produce.--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.
SEC. 207. FEDERAL AND STATE COOPERATION.
(a) In General.--
(1) Authority.--The Administrator shall strengthen and
expand food-borne illness surveillance systems to--
(A) inform and evaluate efforts to prevent food-
borne illness; and
(B) enhance the identification and investigation
of, and response to, food-borne illness outbreaks.
(2) Food-borne illness outbreak.--For purposes of this
section, the term ``foodborne illness outbreak'' means the
occurrence of 2 or more cases of a similar illness resulting
from the ingestion of a common food.
(b) Food-Borne Illness Surveillance Systems.--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--
(1) coordinating food-borne illness surveillance systems,
including complaint systems, in order to--
(A) produce better information on illnesses
associated with foods, including sources and risk
factors for infections by emerging pathogens; and
(B) 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;
(2) augmenting such systems to improve attribution of a
food-borne illness outbreak to a specific food;
(3) 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;
(4) 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;
(5) allowing timely public access to de-identified,
aggregate surveillance data;
(6) at least annually, publishing current reports on
findings from such systems;
(7) exploring establishment of registries for long-term
case follow-up to better characterize late complications of
food-borne illness;
(8) increasing participation in national networks of public
health and food regulatory agencies and laboratories to--
(A) allow public health officials at the Federal,
State, and local levels to share and accept laboratory
analytic findings; and
(B) identify food-borne illness outbreaks and
attribute such outbreaks to specific foods through
submission of standardized molecular subtypes (also
known as ``fingerprints'') of food-borne illness
pathogens to a centralized database; and
(9) 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.
(c) Improving State Surveillance Capacity.--The Administrator, in
collaboration with the Director of the Centers for Disease Control and
Prevention, shall improve capacity for surveillance in the States by--
(1) supporting outbreak investigations with needed
specialty expertise, including epidemiological,
microbiological, and environmental expertise, to assist
identification of underlying common sources and contributing
factors;
(2) identifying, disseminating, and supporting
implementation of model practices at the State and local level
for--
(A) facilitating rapid shipment of clinical
isolates from clinical laboratories to State public
health laboratories to avoid delays in testing;
(B) conducting rapid and more standardized
interviewing of cases associated with major enteric
pathogens, including prior to designation of clusters
as food-borne illness outbreaks;
(C) conducting and evaluating rapid and
standardized interviews of healthy control persons;
(D) sharing information on a timely basis--
(i) within public health and food
regulatory agencies;
(ii) among such agencies;
(iii) with the food industry;
(iv) with healthcare providers; and
(v) with the public;
(3) developing, regularly updating, and disseminating
training curricula on food-borne illness surveillance
investigations, including standard sampling methods and
laboratory procedures;
(4) 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;
(5) 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;
(6) determining minimum core competencies for public health
laboratories, and developing self-evaluation and proficiency-
testing tools for such laboratories;
(7) facilitating regional public health laboratory
partnerships to leverage resources, including equipment and
physical space, and increase surge capacity;
(8) 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;
(9) partnering with the Food Safety Administration to
increase communication, coordination, and integration of food-
borne illness surveillance and outbreak investigation
activities; and
(10) developing and periodically updating response and
interview procedures so that such procedures are standardized
and tested.
(d) Program Activities.--The Administrator shall carry out
activities to support core food safety functions of State and local
public health laboratories, including--
(1) establishing fellowships, stipends, and scholarships to
address critical workforce shortages;
(2) training and coordination of State and local personnel;
(3) establishing partnerships between private and public
laboratories to facilitate sharing of positive enteric
specimens and improve surge capacity;
(4) strengthening capacity to participate in existing or
new food-borne illness surveillance systems; and
(5) purchasing and maintaining data systems hardware and
software and laboratory equipment.
(e) Plan To Improve Food Safety Capacity at the State and Local
Level.--
(1) Goals.--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:
(A) Improve food-borne illness outbreak response
and containment.
(B) Improve the contribution of food-borne illness
surveillance and investigation to the prevention of
food-borne illness.
(C) Strengthen oversight of food safety at the
retail level.
(D) 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.
(E) Make more effective use of the Nation's
combined food safety resources to reduce the burden of
food-borne illness.
(2) Survey.--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--
(A) staffing levels and expertise available to
perform food safety functions;
(B) laboratory capacity to support surveillance,
outbreak response, inspection, and enforcement
activities;
(C) information systems to support data management
and sharing of food safety information among State and
local agencies and with counterparts at the Federal
level;
(D) legal authorities of State and local agencies
to support the roles of such agencies in a national
food safety system; and
(E) organizational arrangements for managing and
coordinating food safety activities.
(3) Plan.--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:
(A) Criteria for assessing the adequacy of State
and local capacity to perform food safety functions as
part of a national food safety system.
(B) Priorities for enhancing the capacity of State
and local agencies.
(C) Action plans for meeting the highest priority
capacity needs, including budget requirements and
financing plans that take into account Federal, State,
and local resources.
(D) 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.
(E) Integration of the inspection and compliance
programs in food processing establishments of the Food
Safety Administration and State and local agencies,
including--
(i) 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;
(ii) 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;
(iii) steps to expand, and ensure the vigor
and consistency of, State inspection of
processing establishments under contract to the
Food Safety Administration; and
(iv) reliance by the Food Safety
Administration on State inspection and food
sample analyses in Federal enforcement
activities.
(4) Food safety capacity building grants.--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).
(5) Report to congress.--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--
(A) progress made in implementing this section,
including any obstacles to such implementation; and
(B) any legislative recommendations or additional
resources needed for full implementation.
(f) Service Agreements.--
(1) In general.--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.
(2) Training.--Agreements with a State under this
subsection shall provide for training of State employees.
(3) Maintenance of agreements.--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.
(4) Commissioning.--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.
SEC. 208. IMPORTS.
(a) In General.--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.
(b) Certification System.--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.
(1) 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.
(2) Category 4 and 5 food establishments shall be certified
either by--
(A) the accredited foreign government in the
country where the products are produced; or
(B) a certifying agent that has been accredited
under subsection (c).
(3) 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.
(c) Certification Standard.--
(1) In general.--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.
(2) Request by foreign government.--Prior to accrediting a
foreign government, the Administrator shall--
(A) review and audit the food safety program of the
requesting foreign government (including all statutes,
regulations, and inspection authority); and
(B) determine that the exporting country--
(i) administers a food control program that
requires food exporters to implement hazard
control measures for physical, chemical, and
biological contaminants;
(ii) ensures sanitary operations of
facilities;
(iii) utilizes testing and verification
programs; and
(iv) administers an effective enforcement
program.
(3) Request by a certifying agent.--Prior to accrediting a
certifying agent, the Administrator shall--
(A) review the training and qualifications of
auditors and other employees used by the agent;
(B) ensure that any such auditors have completed
such training as may be required by the Administrator
for the conduct of food safety inspections; and
(C) 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--
(i) to assess the adequacy of systems and
standards in use; and
(ii) to ensure that food approved by the
agent for import to the United States meets the
requirements of this Act.
(4) Certification to accompany each shipment.--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.
(d) Audits; Inspections.--Following any accreditation under
subsection (c), the Administrator may at any time--
(1) conduct an on-site audit of any food establishment
registered under section 202, with or without the certifying
agent; or
(2) 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.
(e) Limitation.--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.
(f) Withdrawal of Accreditation.--The Administrator may withdraw
accreditation from a foreign government or certifying agent--
(1) if food approved by the foreign government or
certifying agent is linked to an outbreak of human illness;
(2) 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
(3) 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.
(g) Renewal of Accreditation.--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.
(h) Required Routine Inspection.--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.
(i) Enforcement.--The Administrator may--
(1) 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;
(2) 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;
(3) 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
(4) establish such fees as are necessary to carry out the
implementation of the accreditation and inspection programs
required under this section.
(j) Detention and Seizure.--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.
(k) Certifying Agents.--Entities eligible for accreditation as a
certifying agent under subsection (c) may include--
(1) a State or regional food authority; or
(2) a foreign or domestic cooperative that aggregates the
products of growers or processors for importation.
(l) Avoiding Conflicts of Interest With Certifying Agents.--
(1) In general.--To be eligible for accreditation under
subsection (c), a certifying agent shall--
(A) not be owned, managed, or controlled by any
person that owns or operates an establishment whose
products are to be certified by such agent;
(B) 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
(C) 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.
(2) Regulations.--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--
(A) requiring that domestic audits performed under
this section be unannounced;
(B) 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
(C) 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.
SEC. 209. RESOURCE PLAN.
(a) In General.--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.
(b) Contents of Plan.--The resource plan shall--
(1) 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;
(2) 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
(3) 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--
(A) in foreign establishments and production
facilities; and
(B) at the point of importation.
(c) Grants.--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.
(d) Submission of Plan.--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.
SEC. 210. TRACEBACK REQUIREMENTS.
(a) In General.--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.
(b) Applicability.--Traceability requirements under this section
shall apply to food from food production facilities, food
establishments, and foreign food establishments.
(c) Requirements.--
(1) Standards.--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.
(2) Rule of construction.--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.
(3) Availability of records for inspection.--Any records
that are required by the Administrator under this section shall
be available for inspection by the Administrator upon oral or
written request.
(4) Demonstration of ability.--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).
(d) Relationship to Other Requirements.--
(1) Consistency with existing statutes and regulations.--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.
(2) Existing laws.--For purposes of this subsection, the
Administrator should review the following:
(A) Country of origin labeling requirements of
subtitle D of the Agricultural Marketing Act of 1946 (7
U.S.C. 1638 et seq.).
(B) The Perishable Agricultural Commodities Act of
1930 (7 U.S.C. 499a-t).
(C) Country of origin labeling requirements of
section 304 of the Tariff Act of 1930 (19 U.S.C. Sec.
1340).
(D) The National Animal Identification System as
authorized by the Animal Health Protection Act of 2002
(7 U.S.C. 8301 et seq.).
(3) Certain requirements.--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.).
SEC. 211. ACCREDITED LABORATORIES.
(a) Establishment of Program.--The Administrator shall establish a
program for accrediting laboratories to perform sampling and testing
for purposes of this Act. Such program shall include--
(1) standards for appropriate sampling and analytical
procedures;
(2) training and experience qualification levels for
individuals who conduct sampling and analysis;
(3) annual onsite visits to audit the performance of an
accredited laboratory; and
(4) such additional requirements as the Administrator
determines to be appropriate.
(b) Requirements.--To be accredited under this section, a
laboratory shall--
(1) prepare and submit an application for accreditation to
the Administrator;
(2) meet required tests and standards established by the
Administrator; and
(3) comply with such terms and conditions as are determined
necessary by the Administrator.
(c) Accrediting Bodies.--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--
(1) in making such approvals--
(A) 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
(B) 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);
(2) reevaluate accreditation bodies approved under
paragraph (1) whenever--
(A) the Administrator determines a laboratory
accredited by the accrediting body is no longer in
compliance with this section;
(B) the Administrator determines the accrediting
body is no longer in compliance with the requirements
of this section; or
(C) no less than once every 5 years; and
(3) promptly revoke the approval of any accreditation body
found not to be in compliance with the requirements of this
section.
(d) Revocation of Accreditation.--The Administrator shall revoke
the accreditation of any laboratory that fails to meet the requirements
this section.
TITLE III--RESEARCH AND EDUCATION
SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.
(a) In General.--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--
(1) 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;
(2) 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;
(3) 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;
(4) 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;
(5) maintain a state-of-the-art DNA matching system and
epidemiological system dedicated to food-borne illness
identification, outbreaks, and containment; and
(6) utilize surveillance data created by means of
monitoring and statistical studies conducted as part of its own
inspection.
(b) Public Health Sampling.--
(1) In general.--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--
(A) to assist the Administrator in carrying out
this Act; and
(B) to assess the nature, frequency of occurrence,
and quantities of contaminants in food.
(2) Requirements.--The sampling system described in
paragraph (1) shall provide--
(A) statistically valid monitoring, including
market-based studies, on the nature, frequency of
occurrence, and quantities of contaminants in food
available to consumers; and
(B) 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.
(c) Assessment of Health Hazards.--
(1) In general.--Through the surveillance system and
analyses referred to in subsection (a) and the sampling system
described in subsection (b), the Administrator shall--
(A) 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;
(B) identify appropriate industry and regulatory
approaches to minimize hazards in the food supply; and
(C) 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.
(2) Components of analysis.--The analysis under subsection
(b)(1) may include--
(A) 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;
(B) 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;
(C) a description of contamination originating from
handling practices that occur prior to or after the
sale of food to consumers; and
(D) use of comparative risk assessments.
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education.--
(1) In general.--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.
(2) Requirements.--The program shall provide--
(A) information to the public regarding Federal
standards and best practices, and promotion of public
awareness and understanding of those standards and
practices;
(B) information for health professionals--
(i) to improve diagnosis and treatment of
food-related illness; and
(ii) to advise individuals at special risk
for food-related illnesses; and
(C) 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.
(b) Health Advisories.--The Administrator, in consultation with
other Federal departments and agencies as the Administrator determines
necessary, shall work with the States and other appropriate entities--
(1) to develop and distribute regional and national
advisories concerning food safety;
(2) to develop standardized formats for written and
broadcast advisories;
(3) to incorporate State and local advisories into the
national public education program established under subsection
(a); and
(4) 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.
SEC. 303. RESEARCH.
(a) In General.--The Administrator shall conduct research to carry
out this Act, including studies to--
(1) improve sanitation and food safety practices in the
processing of food;
(2) develop improved techniques to monitor and inspect
food;
(3) develop efficient, rapid, and sensitive methods to
detect contaminants in food;
(4) determine the sources of contamination of contaminated
food;
(5) develop food consumption data;
(6) identify ways that animal production techniques could
improve the safety of the food supply;
(7) draw upon research and educational programs that exist
at the State and local level;
(8) utilize the DNA matching system and other processes to
identify and control pathogens;
(9) address common and emerging zoonotic diseases;
(10) develop methods to reduce or destroy harmful pathogens
before, during, and after processing;
(11) 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
(12) conduct other research that supports the purposes of
this Act.
(b) Contract Authority.--The Administrator may enter into contracts
and agreements with any State, university, Federal Government agency,
or person to carry out this section.
SEC. 304. WORKING GROUP ON IMPROVING FOODBORNE ILLNESS SURVEILLANCE.
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--
(1) 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;
(2) 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;
(3) 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;
(4) key barriers to improvement in food-borne illness
surveillance and its utility for preventing food-borne illness
at Federal, State, and local levels; and
(5) 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.
SEC. 305. CAREER-SPANNING TRAINING FOR FOOD INSPECTORS.
(a) In General.--The Administrator shall make a grant to an entity
described in subsection (c) to provide training to Federal, State, and
local food inspectors.
(b) Use of Funds.--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.
(c) Eligible Entity.--An entity described in this subsection is an
entity that--
(1) is described in section 501(c)(3) of the Internal
Revenue Code of 1986 (26 U.S.C. 501(c)(3));
(2) has the capability to train not less than 1,000 food
inspectors per year; and
(3) offers both on-site and off-site training for food
inspectors.
SEC. 306. FOOD-BORNE ILLNESS HEALTH REGISTRY.
(a) Purpose.--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.
(b) Registry.--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.
SEC. 307. STUDY ON FEDERAL RESOURCES.
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.
TITLE IV--ENFORCEMENT
SEC. 401. PROHIBITED ACTS.
It is prohibited--
(1) to manufacture, introduce, deliver for introduction, or
receive in interstate commerce any food that is adulterated,
misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate
commerce;
(3) for a food establishment or foreign food establishment
to fail to register under section 202, or to operate without a
valid registration;
(4) 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);
(5) to fail to establish or maintain any record or to make
any report as required under sections 205(f) and 206(b);
(6) to refuse to permit entry to or inspection of a food
establishment as required under section 205;
(7) 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);
(8) to fail to comply with a provision, regulation, or
order of the Administrator under section 202, 203, 204, 206, or
208;
(9) 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;
(10) 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;
(11) to fail to comply with a recall or other order under
section 403; or
(12) to otherwise violate the food safety law.
SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNATION.
(a) Administrative Detention of Food.--
(1) Expanded authority.--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.
(2) Detention authority.--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.
(3) Period of detention.--
(A) In general.--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.
(B) Perishable food.--The Administrator shall
provide by regulation for procedures to institute a
seizure action on an expedited basis with respect to
perishable food.
(4) Security of detained food.--
(A) In general.--A detention order under this
subsection--
(i) may require that the food be labeled or
marked as detained; and
(ii) shall require that the food be removed
to a secure facility, if appropriate.
(B) Food subject to an order.--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.
(C) Delivery of food.--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.
(b) Appeal of Detention Order.--
(1) In general.--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.
(2) Action by the administrator.--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.
(3) Final agency action.--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.
(4) Termination.--A detention order under subsection (a)
shall be considered to be terminated if, after 5 days, the
Administrator has failed--
(A) to provide an opportunity for an informal
hearing; or
(B) to confirm, modify, or terminate the order.
(5) Effect of instituting court action.--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.
(c) Condemnation of Food.--
(1) In general.--After confirming a detention order, the
Administrator may order the food condemned.
(2) Destruction of food.--Any food condemned shall be
destroyed under the supervision of the Administrator.
(3) Release of food.--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.
(d) Temporary Holds at Ports of Entry.--
(1) In general.--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.
(2) Removal to secure facility.--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.
(3) Prohibition on transfer.--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.
(4) Delivery in accordance with a bond.--The delivery of
the food in accordance with the execution of a bond while the
food is held is not authorized.
(5) Prohibition on reexport.--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.
SEC. 403. NOTIFICATION AND RECALL.
(a) Notice to Administrator of Violation.--
(1) In general.--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.
(2) Manner of notification.--Notification under paragraph
(1) shall be made in such manner and by such means as the
Administrator may require by regulation.
(b) Recall and Consumer Notification.--
(1) Voluntary actions.--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--
(A) cease distribution of the food;
(B) notify all persons--
(i) processing, distributing, or otherwise
handling the food to immediately cease such
activities with respect to the food; or
(ii) to which the food has been
distributed, transported, or sold, to
immediately cease distribution of the food;
(C) recall the food;
(D) in conjunction with the Administrator, provide
notice of the finding of the Administrator--
(i) to consumers to whom the food was, or
may have been, distributed; and
(ii) to State and local public health
officials; or
(E) take any combination of the measures described
in this paragraph, as determined by the Administrator
to be appropriate in the circumstances.
(2) Mandatory actions.--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--
(A) have authority to control and possess the food,
including ordering the shipment of the food from the
food establishment to the Administrator--
(i) at the expense of the food
establishment; or
(ii) in an emergency (as determined by the
Administrator), at the expense of the
Administration; and
(B) by order, require, as the Administrator
determines to be necessary, the person to immediately--
(i) cease distribution of the food; and
(ii) notify all persons--
(I) processing, distributing, or
otherwise handling the food to
immediately cease such activities with
respect to the food; or
(II) if the food has been
distributed, transported, or sold, to
immediately cease distribution of the
food.
(3) Notification to consumers by administrator.--The
Administrator shall, as the Administrator determines to be
necessary--
(A) provide notice of the finding of the
Administrator under paragraph (1)--
(i) to consumers to whom the food was, or
may have been, distributed; and
(ii) to State and local public health
officials; and
(B) provide notice to the public of the names and
addresses of retail locations at which recalled food
products were available for sale.
(4) Nondistribution by notified persons.--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.
(5) Availability of records to administrator.--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--
(A) persons that processed, distributed, or
otherwise handled the food; and
(B) persons to which the food has been transported,
sold, distributed, or otherwise handled.
(c) Informal Hearings on Orders.--
(1) In general.--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.
(2) Scope of the hearing.--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.
(d) Post-Hearing Recall Orders.--
(1) Amendment of order.--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--
(A) amend the order to require recall of the food
or other appropriate action;
(B) specify a timetable in which the recall shall
occur;
(C) require periodic reports to the Administrator
describing the progress of the recall; and
(D) provide notice of the recall to consumers to
whom the food was, or may have been, distributed.
(2) Vacation of orders.--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.
(e) Remedies Not Exclusive.--The remedies provided in this section
shall be in addition to, and not exclusive of, other remedies that may
be available.
SEC. 404. INJUNCTION PROCEEDINGS.
(a) Jurisdiction.--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).
(b) Trial.--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.
SEC. 405. CIVIL AND CRIMINAL PENALTIES.
(a) Civil Sanctions.--
(1) Civil penalty.--
(A) In general.--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.
(B) Separate offense.--Each act described in
subparagraph (A) and each day during which that act
continues shall be considered a separate offense.
(2) Other requirements.--
(A) Written order.--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.
(B) Amount of penalty.--Subject to paragraph
(1)(A), the amount of the civil penalty shall be
determined by the Administrator, after considering--
(i) the gravity of the violation;
(ii) the degree of culpability of the
person;
(iii) the size and type of the business of
the person; and
(iv) any history of prior offenses by the
person under the food safety law.
(C) Review of order.--The order may be reviewed
only in accordance with subsection (c).
(b) Criminal Sanctions.--
(1) Offense resulting in serious illness.--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.
(2) Offense resulting in death.--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.
(c) Judicial Review.--
(1) In general.--An order assessing a civil penalty against
a person under subsection (a) shall be a final order unless the
person--
(A) 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
(B) simultaneously serves a copy of the petition by
certified mail to the Administrator.
(2) Filing of record.--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.
(3) Standard of review.--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.
(d) Collection Actions for Failure To Pay.--
(1) In general.--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.
(2) Limitation on review.--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.
(e) Penalties Paid Into Account.--The Administrator--
(1) shall deposit penalties collected under this section in
an account in the Treasury; and
(2) may use the funds in the account, without further
appropriation or fiscal year limitation--
(A) to carry out enforcement activities under the
food safety law; or
(B) to provide assistance to States to inspect
retail commercial food establishments or other food or
firms under the jurisdiction of State food safety
programs.
(f) Discretion of the Administrator To Prosecute.--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.
(g) Remedies Not Exclusive.--The remedies provided in this section
are in addition to, and not exclusive of, other remedies that may be
available.
SEC. 406. PRESUMPTION.
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.
SEC. 407. WHISTLEBLOWER PROTECTION.
(a) In General.--
(1) Prohibition.--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--
(A) 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--
(i) a Federal regulatory or law enforcement
agency;
(ii) a Member or committee of Congress; or
(iii) a person with supervisory authority
over the covered individual (or such other
individual who has the authority to
investigate, discover, or terminate
misconduct);
(B) 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
(C) refused to violate or assist in the violation
of any law, rule, or regulation.
(2) Definition.--For the purposes of this section, the term
``covered individual'' means an individual who is an employee
of--
(A) a food establishment;
(B) a food production facility;
(C) a restaurant;
(D) a retail food establishment other than a
restaurant;
(E) a nonprofit food establishment in which food is
prepared for or served directly to the consumer;
(F) a fishing vessel; or
(G) an agent of any of the above.
(b) Enforcement Action.--
(1) In general.--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.
(2) Procedure.--
(A) In general.--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.
(B) Exception.--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.
(C) Burdens of proof.--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.
(D) Statute of limitations.--An action under
paragraph (1) shall be commenced not later than 90 days
after the date on which the violation occurs.
(c) Remedies.--
(1) In general.--A covered individual prevailing in any
action under subsection (b)(1) shall be entitled to all relief
necessary to make the covered individual whole.
(2) Compensatory damages.--Relief for any action described
in paragraph (1) shall include--
(A) reinstatement with the same seniority status
that the covered individual would have had, but for the
discrimination;
(B) the amount of any back pay, with interest; and
(C) compensation for any special damages sustained
as a result of the discrimination, including litigation
costs, expert witness fees, and reasonable attorney's
fees.
(d) Rights Retained by the Covered Individual.--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.
SEC. 408. ADMINISTRATION AND ENFORCEMENT.
(a) In General.--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.
(b) Inquiries and Actions.--
(1) In general.--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.
(2) Powers.--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.
SEC. 409. CITIZEN CIVIL ACTIONS.
(a) Civil Actions.--A person may commence a civil action against--
(1) 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
(2) 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.
(b) Court.--In an action commenced under this section:
(1) In general.--The action shall be commenced--
(A) 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
(B) in the case of a civil action against the
Administrator, any United States district court.
(2) Jurisdiction.--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.
(3) Damages.--The court may--
(A) award damages, in the amount of damages
actually sustained; and
(B) 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.
(c) Remedies Not Exclusive.--The remedies provided for in this
section shall be in addition to, and not exclusive of, other remedies
that may be available.
TITLE V--IMPLEMENTATION
SEC. 501. REORGANIZATION PLAN.
(a) Submission of Plan.--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:
(1) The transfer of agencies, personnel, assets, and
obligations to the Administration pursuant to this Act.
(2) Any consolidation, reorganization, or streamlining of
agencies transferred to the Administration pursuant to this
Act.
(b) Plan Elements.--The plan transmitted under subsection (a) shall
contain, consistent with this Act, such elements as the President
determines appropriate, including the following:
(1) 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.
(2) 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.
(3) Specification of the funds available to each agency
that will be transferred to the Administration as a result of
transfers under the plan.
(4) Specification of the proposed allocations within the
Administration of unexpended funds transferred in connection
with transfers under the plan.
(5) Specification of any proposed disposition of property,
facilities, contracts, records, and other assets and
obligations of agencies transferred under the plan.
(6) 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.
(c) Modification of Plan.--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).
(d) Effective Date.--
(1) In general.--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--
(A) 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
(B) the end of the 12-month period beginning on the
date of the enactment of this Act.
(2) Statutory construction.--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.
(3) Supersedes existing law.--Paragraph (1) shall apply
notwithstanding section 905(b) of title 5, United States Code.
SEC. 502. TRANSITIONAL AUTHORITIES.
(a) Provision of Assistance by Officials.--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.
(b) Services and Personnel.--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.
(c) Acting Officials.--
(1) In general.--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.
(2) Compensation.--While acting pursuant to paragraph (1),
such officers shall receive compensation at the higher of--
(A) the rates provided by this Act for the
respective offices in which they act; or
(B) the rates provided for the offices held at the
time of designation.
(3) Limitation.--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.
(d) Transfer of Personnel, Assets, Obligations, and Function.--
(1) In general.--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.
(2) Unexpended funds.--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.
SEC. 503. SAVINGS PROVISIONS.
(a) Completed Administrative Actions.--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.
(b) Pending Proceedings.--Subject to the authority of the
Administrator under this Act--
(1) 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
(2) 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.
(c) Pending Civil Actions.--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.
(d) References.--
(1) In general.--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.
(2) Statutory reporting requirements.--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.
SEC. 504. CONFORMING AMENDMENTS.
(a) Executive Schedule.--Section 5313 of title 5, United States
Code, is amended by inserting at the end the following new item:
``Administrator of Food Safety.''.
SEC. 505. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.
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.
SEC. 506. REGULATIONS.
The Administrator may promulgate such regulations as the
Administrator determines are necessary or appropriate to perform the
duties of the Administrator.
SEC. 507. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are necessary
to carry out this Act.
SEC. 508. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.
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--
(1) 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
(2) 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.
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