[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4755 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 4755
To establish the Food Safety Administration to protect the public
health by preventing foodborne illness, ensuring the safety of food,
improving research on contaminants leading to foodborne illness and the
chronic health outcomes associated with foodborne illnesses, improving
the surveillance of foodborne pathogens (including foodborne pathogens
identified as antibiotic resistant), and improving security of food
from intentional contamination, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 18, 2019
Ms. DeLauro (for herself and Ms. Meng) 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 to protect the public
health by preventing foodborne illness, ensuring the safety of food,
improving research on contaminants leading to foodborne illness and the
chronic health outcomes associated with foodborne illnesses, improving
the surveillance of foodborne pathogens (including foodborne pathogens
identified as antibiotic resistant), 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 ``Safe Food Act of
2019''.
(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 FOOD SAFETY ADMINISTRATION
Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services
and agencies.
Sec. 103. Additional duties of the Administration.
TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM
Sec. 201. Administration of national program.
Sec. 202. Registration of food facilities.
Sec. 203. Preventive process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food facilities.
Sec. 206. Food production establishments.
Sec. 207. Federal and State cooperation.
Sec. 208. Foreign supplier verification program.
Sec. 209. Imports.
Sec. 210. Traceback.
Sec. 211. Food safety technology.
TITLE III--RESEARCH AND EDUCATION
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
TITLE IV--ENFORCEMENT
Sec. 401. Prohibited acts.
Sec. 402. Mandatory recall authority.
Sec. 403. Injunction proceedings.
Sec. 404. Civil and criminal penalties.
Sec. 405. Presumption.
Sec. 406. Whistleblower protection.
Sec. 407. Administration and enforcement.
Sec. 408. Citizen civil actions.
TITLE V--IMPLEMENTATION
Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
SEC. 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;
(3) the safety and security of the food supply requires an
integrated, systemwide approach to preventing foodborne
illness, a thorough and broad-based approach to basic and
applied research, and intensive, effective, and efficient
management of the Nation's food safety program;
(4) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and
the ability to detect all forms of contamination;
(B) an aging and immune-compromised population,
with a growing number of people at high risk for
foodborne illnesses, including infants and children;
(C) a concern regarding food fraud for economic
gain, especially with mislabeling and intentionally
misleading claims;
(D) an increasing volume of imported food, without
adequate monitoring and inspection; and
(E) maintenance of rigorous inspection of the
domestic food processing and food service industries;
(5) Federal food safety standard setting, inspection,
enforcement, and research efforts should be based on the best
available science and public health considerations and food
safety resources should be systematically deployed in ways that
most effectively prevent foodborne illness;
(6) the Federal food safety system is fragmented, with at
least 15 Federal agencies sharing responsibility for food
safety, and operates under laws that do not reflect current
conditions in the food system or current scientific knowledge
about the cause and prevention of foodborne illness;
(7) the fragmented Federal food safety system and outdated
laws preclude an integrated, systemwide approach to preventing
foodborne illness, to the effective and efficient operation of
the Nation's food safety program, and to the most beneficial
deployment of food safety resources;
(8) the National Academy of Sciences recommended in the
report ``Ensuring Safe Food from Production to Consumption''
that Congress establish by statute a unified and central
framework for managing Federal food safety programs, and
recommended modifying Federal statutes so that inspection,
enforcement, and research efforts are based on scientifically
supportable assessments of risks to public health; and
(9) the lack of a single focal point for food safety
leadership in the United States undercuts the ability of the
United States to exert food safety leadership internationally,
which is detrimental to the public health and the international
trade interests of the United States.
(b) Purposes.--The purposes of this Act are--
(1) to establish a single agency to be known as the ``Food
Safety Administration'' to--
(A) regulate food safety and related labeling to
strengthen the protection of the public health;
(B) ensure that food facilities fulfill their
responsibility to produce 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 foodborne illness;
(D) provide a single focal point for food safety
leadership, both nationally and internationally; and
(E) provide an integrated food safety research
capability, utilizing internally generated,
scientifically and statistically valid studies or other
food safety initiatives, in cooperation with academic
institutions, food safety nonprofit organizations, and
other scientific entities of the Federal and State
governments, to achieve the continuous improvement of
research on foodborne illness and contaminants;
(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 enactment of this Act, are
performed by other Federal agencies; and
(3) to modernize and strengthen the Federal food safety
laws to achieve more effective application and efficient
management of the laws for the protection and improvement of
public health.
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)(3).
(3) Adulterated.--
(A) In general.--The term ``adulterated'' has the
meaning given the term in--
(i) section 402 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342) for food
regulated under such Act;
(ii) section 1(m) of the Federal Meat
Inspection Act (21 U.S.C. 601(m)) for food
regulated under such Act;
(iii) section 4(g) of the Poultry Products
Inspection Act (21 U.S.C. 453(g)) for food
regulated under such Act; and
(iv) section 4(a) of the Egg Products
Inspection Act (21 U.S.C. 1033(a)) for food
regulated under such Act.
(B) Inclusion.--In applying the definitions cited
in subparagraph (A), poisonous or deleterious
substances in food shall be treated as an added
substance if the poisonous or deleterious substances
are known to cause serious illness or death in persons,
including in sensitive populations.
(4) Agency.--The term ``agency'' has the meaning given the
term in section 551 of title 5, United States Code.
(5) Category 1 food facility.--The term ``category 1 food
facility'' means a facility that slaughters animals for food.
(6) Category 2 food facility.--The term ``category 2 food
facility'' means a facility that processes--
(A) raw meat, poultry, or seafood in a manner that
may reduce but is not validated to destroy
contaminants; or
(B) other products that the Administrator
determines by regulation to be at high risk of
contamination.
(7) Category 3 food facility.--The term ``category 3 food
facility'' means a facility--
(A) that processes meat, poultry, or seafood, or
other products that the Administrator determines by
regulation to be at high risk of contamination; and
(B) whose processes include one or more steps
validated to destroy contaminants.
(8) Category 4 food facility.--The term ``category 4 food
facility'' means a facility that processes food but is not a
category 1, 2, or 3 food facility.
(9) Category 5 food facility.--The term ``category 5 food
facility'' means a facility that stores, holds, or transports
food prior to delivery for retail sale.
(10) Contaminant.--The term ``contaminant'' includes
biological, chemical, physical, or radiological hazards,
natural toxins, pesticides, drug residues, decomposition,
parasites, allergens, and unapproved food or color additives.
(11) Contamination.--The term ``contamination'' refers to a
presence of a contaminant in food, which may occur naturally or
be introduced into a food.
(12) Feed facility.--The term ``feed facility'' means a
domestic or foreign feed manufacturer, processor, packer,
warehouse, or other facility that--
(A) if operating in the United States,
manufactures, slaughters, processes, or holds animal
feed or feed ingredients; or
(B) if operating elsewhere, manufactures,
slaughters, processes, or holds animal feed or feed
ingredients intended for consumption in the United
States.
(13) Food.--
(A) In general.--The term ``food'' means a product
intended to be used for food or drink for a human or an
animal.
(B) Inclusions.--The term ``food'' includes any
product (including a meat food product, as defined in
section 1(j) of the Federal Meat Inspection Act (21
U.S.C. 601(j))), capable for use as human and animal
food that is made in whole or in part from any animal,
including cattle, sheep, swine, goat, or poultry (as
defined in section 4 of the Poultry Products Inspection
Act (21 U.S.C. 453)), and animal feed.
(14) Food facility.--
(A) In general.--The term ``food facility'' means a
domestic or foreign food manufacturer, slaughterhouse,
processor, packer, warehouse, or other facility that--
(i) if operating in the United States,
manufactures, slaughters, processes, or holds
food or food ingredients; or
(ii) if operating outside the United
States, manufactures, slaughters, processes, or
holds food intended for consumption in the
United States.
(B) Exclusions.--For the purposes of registration,
the term ``food facility'' does not include--
(i) a farm, restaurant, other retail food
establishment, nonprofit food establishment in
which food is prepared for or served directly
to the consumer; or
(ii) a fishing vessel (other than a fishing
vessel engaged in processing, as that term is
defined in section 123.3(k) of title 21, Code
of Federal Regulations).
(15) Food production establishment.--The term ``food
production establishment'' means any farm, ranch, orchard,
vineyard, aquaculture facility, or confined animal-feeding
operation.
(16) 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, labeling, and inspection of food,
infant formulas, food additives, pesticide residues,
and other substances present in food under that Act;
(B) the provisions of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) and of any other
Act that are administered by the Center for Veterinary
Medicine of the Food and Drug Administration;
(C) the Poultry Products Inspection Act (21 U.S.C.
451 et seq.);
(D) the Federal Meat Inspection Act (21 U.S.C. 601
et seq.);
(E) the FDA Food Safety Modernization Act (Public
Law 111-353; 124 Stat. 3885);
(F) the Egg Products Inspection Act (21 U.S.C. 1031
et seq.);
(G) chapter 57 of title 49, United States Code
(formerly known as the ``Sanitary Food Transportation
Act of 1990'');
(H) Public Law 85-765 (commonly known as the
``Humane Methods of Slaughter Act of 1958'') (7 U.S.C.
1901 et seq.);
(I) this Act; and
(J) such other provisions of law related to and
requiring food safety, labeling, inspection, and
enforcement as the President designates by Executive
order as appropriate to include within the jurisdiction
of the Administration.
(17) Interstate commerce.--The term ``interstate commerce''
has the meaning given the 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 the term in--
(A) section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) for food regulated under
such Act;
(B) section 1(n) of the Federal Meat Inspection Act
(21 U.S.C. 601(n)) for food regulated under such Act;
(C) section 4(h) of the Poultry Products Inspection
Act (21 U.S.C. 453(h)) for food regulated under such
Act; and
(D) section 4(l) of the Egg Products Inspection Act
(21 U.S.C. 1033(l)) for food regulated under such Act.
(19) Process.--The term ``process'' or ``processing'' means
the commercial slaughter, packing, preparation, or manufacture
of food.
(20) Safe.--The term ``safe'' refers to human and animal
health.
(21) 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.
(22) Validation.--The term ``validation'' means the act of
obtaining evidence that the process control measure or measures
selected to control a contaminant in food is capable of
effectively and consistently controlling the contaminant.
(23) Statistically valid.--The term ``statistically valid''
means evaluated and conducted under standards set by the
National Institute of Standards and Technology.
TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION
SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.
(a) Establishment.--
(1) In general.--There is established in the executive
branch an agency to be known as the ``Food Safety
Administration''.
(2) Status.--The Administration shall be an independent
establishment (as defined in section 104 of title 5, United
States Code).
(3) Head of 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.
(b) Duties of Administrator.--The Administrator shall--
(1) administer and enforce the food safety law;
(2) serve as a representative to international food safety
bodies and discussions;
(3) promulgate regulations to ensure the security of the
food supply from all forms of contamination, including
intentional contamination; and
(4) oversee--
(A) implementation of Federal food safety
inspection, labeling, enforcement, and research efforts
to protect the public health;
(B) development of consistent and science-based
standards for safe food;
(C) coordination and prioritization of food safety
research and education programs with other Federal
agencies;
(D) prioritization of Federal food safety efforts
and deployment of Federal food safety resources to
achieve the greatest benefit in reducing foodborne
illness;
(E) coordination of the Federal response to
foodborne illness outbreaks with other Federal and
State agencies; and
(F) integration of Federal food safety activities
with State and local agencies.
SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY AND INSPECTION SERVICES
AND AGENCIES.
(a) Transfer of Functions.--For each Federal agency specified in
subsection (b), there are transferred to the Administration all
functions that the head of the Federal agency exercised on the day
before the date of enactment of this Act (including all related
functions of any officer or employee of the Federal agency) that relate
to administration or enforcement of the food safety law, as determined
by the President.
(b) Transferred Agencies.--The Federal agencies referred to in
subsection (a) are--
(1) the Food Safety and Inspection Service of the
Department of Agriculture;
(2) the Center for Food Safety and Applied Nutrition of the
Food and Drug Administration;
(3) the part of the Agriculture Marketing Service that
administers shell egg surveillance services established under
the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
(4) the resources and facilities of the Office of
Regulatory Affairs of the Food and Drug Administration that
administer and conduct inspections of food and feed facilities
and imports;
(5) the Center for Veterinary Medicine of the Food and Drug
Administration;
(6) the Office of Food Policy and Response of the Food and
Drug Administration;
(7) the part of the Research, Education, and Economics
mission area of the Department of Agriculture related to food
and feed safety;
(8) the part of the National Marine Fisheries Service of
the National Oceanic and Atmospheric Administration of the
Department of Commerce that administers the seafood inspection
program;
(9) the part of the Animal and Plant Inspection Health
Service of the Department of Agriculture related to the
management of animals going into the food supply; and
(10) such other offices, services, or agencies as the
President designates by Executive order to carry out this Act.
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 regulatory
science and 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) administer a national food safety program (referred to
in this section as the ``program'') to protect public health;
and
(2) ensure that persons who produce or process 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 health risks;
(2) the sources and specific points of potential
contamination extending from the farm or ranch to the consumer
that may render food unsafe;
(3) the potential for persistence, multiplication, or
concentration of naturally occurring or added contaminants in
food;
(4) opportunities across the food production, processing,
distribution, and retail system to manage and reduce potential
health risks; and
(5) opportunities for intentional contamination.
(c) Program Elements.--In carrying out the program, the
Administrator shall--
(1) adopt and implement a national system for the
registration of food facilities and regular unannounced
inspection of food facilities;
(2) verify and enforce the adoption of preventive process
controls in food facilities, based on the best available
scientific and public health considerations and best available
technologies;
(3) establish and enforce science-based standards for--
(A) substances that may contaminate food; and
(B) safety and sanitation in the processing and
handling of food;
(4) implement a statistically valid sampling program to
ensure that industry programs and procedures that prevent food
contamination are effective on an ongoing basis and that food
meets the performance standards established under this Act;
(5) implement procedures and requirements to ensure the
safety and security of imported food;
(6) coordinate with other agencies and State or local
governments in carrying out inspection, enforcement, research,
and monitoring;
(7) access the surveillance data of the Centers for Disease
Control and Prevention, and other Federal Government agencies,
in order to develop and implement a national surveillance
system to assess the health risks associated with the human
consumption of food or to create surveillance data and studies
to mitigate food threats (such as antibiotic resistance) or to
identify the ways that food contamination spreads through
environments;
(8) partner with relevant agencies to identify and prevent
terrorist threats to food;
(9) establish a process for providing a single point of
contact to assist impacted consumers in navigating Federal,
State, and local agencies involved in responding to or
monitoring a foodborne outbreak;
(10) develop public education risk communication and
advisory programs;
(11) implement a basic and applied research program to
further the purposes of this Act; and
(12) coordinate and prioritize food safety research and
educational programs with other agencies, including State or
local agencies.
SEC. 202. REGISTRATION OF FOOD FACILITIES.
(a) In General.--The Administrator shall require that all food and
feed facilities register before the facility can operate in the United
States or import food, feed, or ingredients into the United States.
(b) Registration Requirements.--
(1) In general.--To be registered under subsection (a)--
(A) all food facilities covered under this Act
shall comply with registration requirements in section
415 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350d);
(B) for food facilities that have not registered
under such section 415 prior to the date of enactment
of this Act, the requirement in subparagraph (A)
applies beginning on the day that is 180 days after the
date of enactment of this Act; and
(C) for food facilities that have registered under
such section 415 prior to the date of enactment of this
Act, such facilities shall file an amended registration
within 180 days of such date of enactment to deliver
the information required by paragraph (2).
(2) Categories.--In addition to the information required
under section 415 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350d) to be included in registration, a food
facility shall--
(A) list the facility's primary purpose and
business activity, including the dates of operation if
the food facility is operating seasonally; and
(B) list the types of food handled at the facility
and identify the activities conducted in the facility,
that are relevant to determining whether the facility
is a category 1, 2, 3, 4, or 5 facility.
(3) Procedure.--Upon receipt of a completed or amended
registration described in paragraph (1), the Administrator
shall notify the registrant of the receipt of the registration,
review the activities identified in the registration, designate
the facility as a category 1, 2, 3, 4, or 5 food facility for
the purposes of inspection, and assign a registration number to
each food facility.
(4) List.--The Administrator--
(A) shall compile and maintain an up-to-date list
of food facilities that are registered under this
section, in accordance with section 415(a)(5) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d(a)(5)); and
(B) may establish regulations on how the list may
be shared with other governmental authorities.
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION OF FOOD.
(a) In General.--The Administrator shall review existing
regulations on hazard analysis and process controls and amend existing
regulations as appropriate, upon the basis of best available public
health, scientific, and technological information, to ensure that those
regulations are working effectively to--
(1) ensure food facilities operate in a sanitary manner so
that food is not adulterated;
(2) limit the presence of contaminants in food;
(3) meet the performance standards established under
section 204;
(4) ensure fully processed or ready-to-eat foods are
processed using reasonably available techniques and
technologies to eliminate contaminants;
(5) label food intended for final processing outside
commercial food facilities with instructions for handling and
preparation for consumption that will destroy contaminants;
(6) require sampling and testing at a frequency and in a
manner sufficient to ensure that process controls are effective
on an ongoing basis and that performance standards are being
met; and
(7) provide for agency access to records kept by food
facilities and submission of copies of the records to the
Administrator, as the Administrator determines appropriate.
(b) Processing Controls.--The Administrator may require any person
with responsibility for or control over food or food ingredients to
adopt process controls, if the process controls are needed to ensure
the protection of the public health.
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.
(a) Performance Standards.--Whenever the Administrator determines
that a foodborne contaminant presents the risk of serious adverse
health consequences or death to consumers, causes food to be
adulterated, or could promote the spread of communicable disease
described in section 361 of the Public Health Service Act (42 U.S.C.
264), the Administrator shall issue a performance standard (in the form
of guidance, action levels, or regulations) to prevent or control the
contaminant.
(b) Enforcement.--
(1) In general.--Not later than 1 year after the
promulgation of a performance standard under this section, the
Administrator shall implement a statistically significant
sampling program to determine whether food facilities are
complying with the standards promulgated under this section.
(2) Actions.--If the Administrator determines that a food
facility fails to meet a standard promulgated under this
section, and such facility fails to take appropriate corrective
action as determined by the Administrator, the Administrator
shall, as appropriate--
(A) detain, seize, or condemn food from the food
facility under section 209(i);
(B) order a recall of food from the food facility
under section 402;
(C) increase the inspection frequency for the food
facility;
(D) withdraw the mark of inspection from the food
facility, if in use; or
(E) take other appropriate enforcement action
concerning the food facility, including suspension of
registration.
(c) Newly Identified Contaminants.--Notwithstanding any other
provision of this section, the Administrator shall promulgate interim
performance standards for newly identified contaminants as necessary to
protect the public health.
(d) Revocation by Administrator.--All performance standards,
tolerances, action levels, or other similar standards with respect to
food in effect on the date of enactment of this Act shall remain in
effect until revised or revoked by the Administrator.
SEC. 205. INSPECTIONS OF FOOD FACILITIES.
(a) In General.--The Administrator shall establish an inspection
program, which shall include sampling and testing of food and food
facilities, to determine if each food facility--
(1) is operating in a sanitary manner;
(2) has continuous systems, interventions, and processes in
place to minimize or eliminate contaminants in food;
(3) uses validated process controls and ongoing
verification;
(4) is in compliance with applicable performance standards
established under section 204, process control regulations, and
other requirements;
(5) is processing food that is safe and not adulterated or
misbranded;
(6) maintains records of process control plans under
section 203, and other records related to the processing,
sampling, and handling of food; and
(7) is in compliance with the requirements of the
applicable food safety law.
(b) Facility Categories and Inspection Frequencies.--Inspections of
food facilities under this Act shall be based on the following
categories and inspection frequencies, subject to subsections (c), (d),
and (e):
(1) Category 1 food facilities.--A category 1 food facility
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 facility has successfully identified
and removed from the slaughter line visibly defective
or contaminated carcasses, has avoided cross-
contamination, and has destroyed or reprocessed
contaminated 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 facilities.--A category 2 food facility
shall be randomly inspected at least daily.
(3) Category 3 food facilities.--A category 3 food facility
shall--
(A) provide documentation to the Administrator on
request that ongoing verification shows that its
processes are controlled; and
(B) be randomly inspected at least monthly.
(4) Category 4 food facilities.--A category 4 food facility
shall be randomly inspected at least quarterly.
(5) Category 5 food facilities.--A category 5 food facility
shall be randomly inspected at least annually.
(c) Establishment of Inspection Procedures.--The Administrator
shall establish procedures under which inspectors or safety officers
inspect food facilities, which shall allow the taking of random
samples, photographs, and copies of records in food facilities.
(d) Alternative Inspection Frequencies.--
(1) In general.--With respect to a category 2, 3, 4, or 5
food facility, to foster a risk-based allocation of resources,
the Administrator may establish, in accordance with this
subsection, alternative increased or decreased inspection
frequencies for--
(A) one or more subcategories of food facilities
under paragraph (2); and
(B) one or more specific food facilities under
paragraph (3).
(2) Determination of subcategories and frequencies.--
(A) In general.--The Administrator shall define, by
regulation, each subcategory of food facilities
established under paragraph (1)(A) and the alternative
inspection frequency of that subcategory.
(B) Considerations.--In defining a subcategory of
food facilities and the alternative inspection
frequency of that subcategory under subparagraph (A),
the Administrator shall consider--
(i) the nature of the foods being
processed, stored, or transported;
(ii) the manner in which foods are
processed, stored, or transported;
(iii) the inherent likelihood that the
foods will contribute to the risk of foodborne
illness;
(iv) the best available evidence concerning
reported illnesses associated with the foods
produced in the proposed subcategory of
facilities; and
(v) the overall record of compliance with
the food safety law among facilities in the
proposed subcategory, including compliance with
applicable performance standards and the
frequency of recalls.
(3) Specific facilities.--
(A) In general.--The Administrator--
(i) may establish an alternative inspection
frequency for increased or decreased inspection
for a specific food facility; and
(ii) shall annually publish a list of food
facilities subject to alternative inspection
frequencies under clause (i).
(B) Considerations.--In establishing an alternative
inspection frequency for a specific food facility, the
Administrator shall consider--
(i) the supporting evidence that the
specific food facility shall submit to the
Administrator relating to whether an
alternative inspection frequency should be
established for that facility by the
Administrator;
(ii) whether products from the specific
food facility have been associated with a case
or an outbreak of foodborne illness;
(iii) the record of the facility of
compliance with the food safety law, including
compliance with applicable performance
standards and the frequency of recalls; and
(iv) the considerations described in
clauses (i) through (iii) of paragraph (2)(B).
(4) Frequency requirements for categories 2, 3, and 4.--An
alternative inspection frequency for a subcategory of food
facilities or a specific food facility under this subsection
shall be--
(A) in the case of a category 2 food facility, not
less frequently than monthly; and
(B) in the case of a category 3 or 4 food facility,
not less frequently than annually.
(5) Requirements for decreased frequencies.--Before issuing
a regulation or order establishing a decreased alternative
inspection frequency for a subcategory of food facilities or an
individual food facility under this subsection, the
Administrator shall--
(A) describe, in general terms, the alternative
uses of resources of the Administration that would have
been required to carry out the inspection activity; and
(B) determine, based on the best available
evidence, that the alternative uses of the resources
would make a greater contribution to protecting the
public health and reducing the risk of foodborne
illness.
(e) Inspection Transition.--The Administrator shall manage the
transition to the inspection system described in this Act as follows:
(1) Regulations.--The Administrator shall promulgate
regulations to implement this section no later than 24 months
after the date of enactment of this Act.
(2) Limit on reduction in inspection frequency.--For any
food facility, the Administrator shall not reduce the
inspection frequency from the frequency required pursuant to
the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) until the food facility has demonstrated that sufficient
changes in facilities, procedures, personnel, or other aspects
of the process control system have been made such that the
Administrator determines that compliance with the food safety
law is achieved.
(f) Official Mark.--
(1) In general.--
(A) Establishment.--Before the completion of the
transition process under subsection (e), the
Administrator shall by regulation establish an official
mark that can be affixed to a food produced in a
category 1, 2, or 3 food facility if--
(i) the facility is in compliance with the
food safety law; and
(ii) has been inspected in accordance with
the inspection frequencies under this section.
(B) Removal of official mark.--The Administrator
shall promulgate regulations that provide for the
removal of the official mark under this subsection if--
(i) the Administrator makes a finding that
the facility is not in compliance with the food
safety law; or
(ii) the Administrator suspends the
registration of the facility.
(2) Category 1, 2, or 3 food facilities.--In the case of
products manufactured, slaughtered, processed, or held in a
category 1, 2, or 3 food facility--
(A) products subject to the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.), the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.), the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.), and
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.) as of the date of enactment of this Act shall
remain subject to the requirement under those Acts that
they bear the mark of inspection pending completion of
the transition process under subsection (e);
(B) the Administrator shall publicly certify on a
monthly basis that the inspection frequencies required
under this section have been achieved; and
(C) a product from a facility that has not been
inspected in accordance with the required frequencies
under this section shall not bear the official mark and
shall not be shipped in interstate commerce.
(3) Category 4 and 5 food facilities.--In the case of a
product manufactured, slaughtered, processed, or held in a
category 4 or 5 food facility, the Administrator shall provide
by regulation for the voluntary use of the official mark
established under paragraph (1), subject to--
(A) such minimum inspection frequencies as
determined appropriate by the Administrator;
(B) compliance with applicable performance
standards and other provisions of the food safety law;
and
(C) such other requirements as the Administrator
considers appropriate.
(g) Maintenance and Inspection of Records.--
(1) In general.--
(A) Records.--A food facility shall--
(i) maintain such records as the
Administrator requires 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 of the food safety agencies in
effect on the day before the date of enactment
of this Act, upon presentation of appropriate
credentials and at reasonable times and in a
reasonable manner, to have access to and copy
all records maintained by or on behalf of such
food facility representative in any format
(including paper or electronic) and at any
location, that are necessary to assist the
Administrator to determine whether the food is
contaminated or not in compliance with the food
safety law.
(B) Required disclosure.--A food facility 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 required by
paragraph (1) shall be maintained for a reasonable period of
time, as determined by the Administrator.
(3) Requirements.--The records required by 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 facility;
(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 unsafe, is adulterated or misbranded, or
otherwise fails to meet the requirements of this Act.
(h) Protection of Sensitive Information.--
(1) In general.--The Administrator shall develop and
maintain procedures to prevent the unauthorized disclosure of
any trade secret or confidential information obtained by the
Administrator.
(2) Limitation.--The requirement under this subsection does
not--
(A) limit the authority of the Administrator to
inspect or copy records or to require the facility 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, personnel data, or sales data (other than
shipment dates relating to sales);
(D) limit the public disclosure of distribution
records or other records related to food subject to a
voluntary or mandatory recall under section 402; or
(E) limit the authority of the Administrator to
promulgate regulations to permit the sharing of data
with other governmental authorities.
(i) Bribery of or Gifts to Inspector or Other Officers and
Acceptance of Gifts.--Section 22 of the Federal Meat Inspection Act (21
U.S.C. 622) shall apply under this Act.
SEC. 206. FOOD PRODUCTION ESTABLISHMENTS.
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 establishments, to--
(1) visit and inspect food production establishments in the
United States and in foreign countries for food safety
purposes;
(2) review food safety records as needed to carry out
traceback and for other food safety purposes;
(3) set good practice standards to protect the public and
promote food safety;
(4) partner with appropriate agencies to monitor animals,
plants, products, or the environment, as appropriate; and
(5) collect and maintain information relevant to public
health and farm practices.
SEC. 207. FEDERAL AND STATE COOPERATION.
(a) In General.--The Administrator shall work with the States to
carry out activities and programs that create a national food safety
program so that Federal and State programs function in a coordinated
and cost-effective manner.
(b) State Action.--The Administrator shall work with States to--
(1) continue, strengthen, or establish State food safety
programs, especially with respect to the regulation of retail
commercial food establishments, transportation, harvesting, and
fresh markets;
(2) continue, strengthen, or establish inspection programs
and requirements to ensure that food under the jurisdiction of
the State is safe; and
(3) support recall authorities at the State and local
levels.
(c) Assistance.--To assist in planning, developing, and
implementing a food safety program, the Administrator may provide to a
State--
(1) advisory assistance;
(2) technical and laboratory assistance and training
(including necessary materials and equipment); and
(3) financial assistance, in kind assistance, and other
aid.
(d) 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 personnel and services of
those agencies in carrying out this Act.
(2) Training.--Agreements with a State under this
subsection may provide for training of State employees.
(3) Maintenance of agreements.--The Administrator shall
maintain any agreement that is in effect on the day before the
date of enactment of this Act until the Administrator evaluates
such agreement and determines whether to maintain or substitute
such agreement.
(e) Audits.--
(1) In general.--The Administrator shall annually conduct a
comprehensive review of each State program that provides
services to the Administrator in carrying out the
responsibilities under this Act, including mandated inspections
under section 205.
(2) Requirements.--The review shall--
(A) include a determination of the effectiveness of
the State program; and
(B) identify any changes necessary to ensure
enforcement of Federal requirements under this Act.
(f) No Federal Preemption.--Nothing in this Act shall be construed
to preempt the enforcement of State food safety laws and standards that
are at least as stringent as those under this Act.
SEC. 208. FOREIGN SUPPLIER VERIFICATION PROGRAM.
(a) In General.--The Administrator shall require that each importer
of products from a feed facility, food facility, or food producer
establishment be in compliance with the foreign supplier verification
program requirements under section 805 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384a).
(b) Rule of Construction.--In applying subsection (a) with respect
to products subject to the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), references
in section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384a) to sections 402, 403(w), 418, and 419 of such Act (21 U.S.C. 342,
343(w), 350g, and 350h) shall be construed to be references to the
corresponding provisions of the food safety law, if any, that apply to
such products, as determined by the Administrator.
(c) Repeal of Exemptions.--Section 805 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384a) is amended--
(1) in subsection (a)(1), by striking ``subsections (e) and
(f)'' and inserting ``subsection (e)'';
(2) by striking subsection (e); and
(3) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
SEC. 209. IMPORTS.
(a) In General.--Not later than 2 years after the date of enactment
of this Act, the Administrator shall establish a system under which a
foreign government seeking to certify food for importation into the
United States shall submit a request for accreditation to the
Administrator.
(b) Accreditation Standard.--A foreign government requesting to be
accredited to certify food for importation into the United States shall
demonstrate, in a manner determined appropriate by the Administrator,
that the foreign government (or an agency thereof) is capable of
adequately ensuring that eligible entities or foods certified by such
government (or agency) meet the requirements of the food safety law.
(c) Request by Foreign Government.--Prior to granting accreditation
to a foreign government under this section, the Administrator shall
review and audit the food safety program of the requesting foreign
government and certify that such program (including all statutes,
regulations, and inspection authority) meets the standard specified in
subsection (b).
(d) Limitations.--Any accreditation of a foreign government under
this section shall--
(1) specify the foods covered by the accreditation; and
(2) be limited to a period not to exceed 5 years.
(e) Withdrawal of Accreditation.--The Administrator may withdraw
accreditation fully or partially from a foreign government if the
Administrator finds that--
(1) food covered by the accreditation is linked to an
outbreak of human illness;
(2) the programs or procedures of the foreign government no
longer meet the standards of the food safety programs and
procedures of the United States; or
(3) the foreign government refuses to allow United States
officials to conduct such audits and investigations as may be
necessary to fulfill the requirements under this section.
(f) Renewal of Accreditation.--The Administrator shall audit
foreign governments accredited under this section at least every 5
years to ensure the continued compliance by such governments with the
standard set forth in subsection (b).
(g) Required Routine Inspection.--The Administrator shall routinely
inspect food or food animals by physical examination before the food or
food animals enter the United States to ensure that the food or food
animals--
(1) are safe;
(2) are labeled as required for food produced in the United
States; and
(3) otherwise meet the requirements of the food safety law.
(h) Enforcement.--The Administrator may--
(1) deny importation of food from any country if the
country's government does not permit United States officials to
enter the country to conduct such audits and inspections as may
be necessary to fulfill the requirements under this section;
(2) deny importation of food from any country or foreign
facility that does not consent to an investigation by the
Administrator when food from that country or foreign facility
is linked to a foodborne illness outbreak or is otherwise found
to be adulterated or mislabeled; and
(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 standards of the
food safety law.
(i) Detention and Seizure.--Any food imported for consumption in
the United States that fails to meet the standards of the food safety
law may be detained, seized, or condemned.
SEC. 210. TRACEBACK.
(a) In General.--The Administrator, in order to protect the public
health, shall establish requirements for a national system for tracing
food, animals, or ingredients from point of origin to retail sale,
subject to subsection (b).
(b) Applicability.--Traceability requirements shall--
(1) be established in accordance with regulations and
guidelines issued by the Administrator; and
(2) apply to food production establishments and food
facilities.
SEC. 211. FOOD SAFETY TECHNOLOGY.
(a) In General.--The Administrator shall establish and implement a
program, to be known as the Food Safety Technology Program, to foster
innovation in food technologies and foods that have the potential to
improve food safety at the point of production, processing, transport,
storage, or final preparation.
(b) Program Described.--The program under this section shall
consist of technical guidance to and consultation with technology
developers to assist them in meeting requirements for approval of
technologies and products described in subsection (a).
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 the
Deputy Under Secretary of Agriculture for Research, Education, and
Economics, shall--
(1) have access to the applicable data systems of the
Centers for Disease Control and Prevention and to the databases
made available by a State;
(2) partner with relevant agencies to maintain or access an
active surveillance system of food and epidemiological evidence
submitted by States to the Centers for Disease Control and
Prevention based on a representative proportion of the
population of the United States;
(3) assess the frequency and sources of human illness in
the United States associated with the consumption of food;
(4) partner with relevant agencies to maintain or access a
state-of-the-art partial or full genome sequencing system and
epidemiological system dedicated to foodborne illness
identification, outbreaks, and containment; and
(5) have access to the surveillance data created via
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 date of
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.--Through the surveillance system
referred to in subsection (a), the sampling system described in
subsection (b), and other available data, the Administrator shall--
(1) rank food categories based on the hazard to human
health presented by the food category;
(2) identify appropriate industry and regulatory approaches
to minimize hazards in the food supply; and
(3) assess the public health environment for emerging
diseases, including zoonosis, for their risk of appearance in
the United States food supply.
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education.--The Administrator shall--
(1) in cooperation with private and public organizations,
including the cooperative extension services and building on
the efforts of appropriate State and local entities, establish
a national public education program on food safety; and
(2) coordinate with other Federal departments and agencies
to integrate food safety messaging into all food-related
agricultural, nutrition, and health promotion programs.
(b) Health Advisories.--The Administrator, in consultation with
such 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 foods
found to pose a threat to the public health.
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) determine the food safety education needs of vulnerable
populations, including children less than 10 years of age,
pregnant women, adults 65 years of age and older, and
individuals with compromised immune systems;
(9) utilize the partial or full genome sequencing system
and other processes to identify and control pathogens;
(10) address common and emerging zoonotic diseases;
(11) develop methods to reduce or destroy harmful pathogens
before, during, and after processing;
(12) analyze the incidence of antibiotic resistance as it
pertains to the food supply and develop new methods to reduce
infection by antibiotic resistant bacteria in humans and
animals; and
(13) conduct other research that supports the purposes of
this Act.
(b) Contract Authority.--The Administrator may enter into contracts
and agreements with any State, institution of higher education, Federal
Government agency, or person to carry out this section.
TITLE IV--ENFORCEMENT
SEC. 401. PROHIBITED ACTS.
It shall be unlawful--
(1) for a person--
(A) to manufacture, introduce, deliver for
introduction, or receive into interstate commerce any
food that is adulterated, misbranded, or otherwise
unsafe;
(B) to adulterate or misbrand any food in
interstate commerce;
(C) to refuse to permit access to a food facility
for the inspection and copying of a record as required
under section 205(g);
(D) to fail to establish or maintain any record or
to make any report as required under section 205(g);
(E) to refuse to permit entry to or inspection of a
food facility as required under section 205;
(F) to fail to provide to the Administrator the
results of a testing or sampling of a food, equipment,
or material in contact with contaminated food under
section 205(g)(1)(B);
(G) to fail to comply with an applicable provision
of, or a regulation or order of the Administrator
under, section 202, 204, or 208;
(H) to slaughter an animal that is capable for use
in whole or in part as human food at a food facility
processing any such food for commerce, except in
compliance with the food safety law;
(I) to fail to comply with a recall or other order
under section 402; or
(J) to otherwise violate the food safety law; and
(2) for a food facility or foreign food facility to fail to
register under section 202, or to operate without a valid
registration.
SEC. 402. MANDATORY RECALL AUTHORITY.
(a) Voluntary Procedures.--If the Administrator determines that
there is a reasonable probability that an article of food (other than
infant formula) is adulterated or misbranded and the use of or exposure
to such article will cause serious adverse health consequences or death
to humans or animals, the Administrator shall provide to the owner,
operator, or agent in charge of the facility that created, caused, or
was otherwise responsible for that article of food an opportunity to
cease distribution and recall that article of food in a manner and
within a time period determined by the Administrator.
(b) Prehearing Order To Cease Distribution and Give Notice.--
(1) In general.--If the owner, operator, or agent in charge
of a facility refuses to, or does not voluntarily, cease
distribution or recall an article of food in the manner and
within the time period determined by the Administrator under
subsection (a), the Administrator may by order require, as the
Administrator determines to be necessary--
(A) that owner, operator, or agent--
(i) to immediately cease distribution of
that article of food; and
(ii) as applicable, to immediately notify
all persons manufacturing, processing, packing,
transporting, distributing, receiving, holding,
or importing and selling that article of food;
and
(B) any person to which that article of food has
been distributed, transported, or sold, to immediately
cease distribution of that article of food.
(2) Required additional information.--
(A) In general.--If an article of food covered by a
recall order issued under paragraph (1) has been
distributed to a warehouse-based, third-party logistics
provider without providing such provider sufficient
information to know or reasonably determine the precise
identity of the article of food covered by a recall
order that is in its possession, the notice provided by
the owner, operator, or agent of a facility under
paragraph (1)(A)(ii) shall include such information as
is necessary for the warehouse-based, third-party
logistics provider to identify the article of food.
(B) Rules of construction.--Nothing in this
paragraph shall be construed--
(i) to exempt a warehouse-based, third-
party logistics provider from the requirements
of food safety law; or
(ii) to exempt a warehouse-based, third-
party logistics provider from being the subject
of a mandatory recall order.
(3) Determination to limit areas affected.--If the
Administrator requires an owner, operator, or agent in charge
of the facility to cease distribution under paragraph (1)(A)(i)
of an article of food identified under subsection (a), the
Administrator may limit the size of the geographic area and the
markets affected by such cessation if such limitation would not
compromise the public health.
(c) Hearing on Order.--The Administrator shall provide the owner,
operator, or agent in charge of the facility subject to an order under
subsection (b) with an opportunity for an informal hearing, to be held
as soon as possible, but not later than 2 days after the issuance of
the order, on the actions required by the order and on why the article
that is the subject of the order should not be recalled.
(d) Post-Hearing Recall Order and Modification of Order.--
(1) Amendment of order.--If, after providing opportunity
for an informal hearing under subsection (c), the Administrator
determines that removal of the applicable article of food from
commerce is necessary, the Administrator shall, as
appropriate--
(A) amend the order to require recall of such
article 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 to consumers to whom such
article was, or may have been, distributed.
(2) Vacating of order.--If, after an informal hearing under
subsection (c), the Administrator determines that adequate
grounds do not exist to continue the actions required by the
applicable order, or that such actions should be modified, the
Administrator shall vacate the order or modify the order, as
appropriate.
(e) Rule Regarding Alcoholic Beverages.--The Administrator shall
not initiate a mandatory recall or take any other action under this
section with respect to any alcohol beverage until the Administrator
has provided the Administrator of the Alcohol and Tobacco Tax and Trade
Bureau with a reasonable opportunity to cease distribution and recall
the alcohol beverage under the authority of the Administrator of the
Alcohol and Tobacco Tax and Trade Bureau.
(f) Cooperation and Consultation.--The Administrator shall work
with State and local public health officials in carrying out this
section, as appropriate.
(g) Public Notification.--In conducting a recall under this
section, the Administrator shall--
(1) ensure that a press release is published regarding the
recall, as well as alerts and public notices, as appropriate,
in order to provide notification--
(A) of the recall to consumers and retailers to
whom the applicable article of food was, or may have
been, distributed; and
(B) that includes, at a minimum--
(i) the name of the article of food subject
to the recall;
(ii) a description of the risk associated
with such article; and
(iii) to the extent practicable,
information for consumers about similar
articles of food that are not affected by the
recall;
(2) provide to the public a list of retail consignees
receiving products for which there is determined to be a
reasonable probability that eating the food will cause serious
adverse health consequences or death to humans or animals; and
(3) if available, publish on the internet website of the
Administration an image of the article that is the subject of
the press release described in paragraph (1).
(h) No Delegation.--The authority conferred by this section to
order a recall or vacate a recall order shall not be delegated to any
officer or employee other than the Administrator.
(i) Effect.--Nothing in this section shall affect the authority of
the Administrator to request or participate in a voluntary recall, or
to issue an order to cease distribution or to recall under any other
provision of the food safety law or under the Public Health Service Act
(42 U.S.C. 201 et seq.).
(j) Coordinated Communication.--
(1) In general.--To assist in carrying out the requirements
of this subsection, the Administrator shall establish an
incident command operation or a similar operation that will
operate not later than 24 hours after the initiation of a
mandatory recall or the recall of an article of food for which
the use of, or exposure to, such article will cause serious
adverse health consequences or death to humans or animals.
(2) Requirements.--To reduce the potential for
miscommunication during recalls or regarding investigations of
a foodborne illness outbreak associated with a food that is
subject to a recall, each incident command operation or similar
operation under paragraph (1) shall use regular staff and
resources of the Administration to--
(A) ensure timely and coordinated communication
within the Administration, including enhanced
communication and coordination between different
agencies and organizations within the Administration;
(B) ensure timely and coordinated communication
from the Administration, including public statements,
throughout the duration of the investigation and
related foodborne illness outbreak;
(C) identify a single point of contact within the
Administration for public inquiries regarding any
actions by the Administrator related to a recall;
(D) coordinate with Federal, State, local, and
Tribal authorities, as appropriate, that have
responsibilities related to the recall of a food or a
foodborne illness outbreak associated with a food that
is subject to the recall, including notification of the
Secretary of Agriculture and the Secretary of Education
in the event such recalled food is a commodity intended
for use in a child nutrition program (as defined in
section 25(b) of the Richard B. Russell National School
Lunch Act (42 U.S.C. 1769f(b))); and
(E) conclude operations at such time as the
Administrator determines appropriate.
(3) Multiple recalls.--The Administrator may establish
multiple or concurrent incident command operations or similar
operations in the event of multiple recalls or foodborne
illness outbreaks.
(4) Fees applicable to all facilities.--Fees described in
section 743 of Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-31) for not complying with a recall order are applicable
to all food facilities under this Act as if--
(A) the term ``responsible party'' means ``owner,
operator, or agent in charge of the facility''; and
(B) references to section 423 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350l) are references
to section 402 of this Act.
SEC. 403. 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, 207, or 401 (or a regulation
promulgated under that section).
(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. 404. CIVIL AND CRIMINAL PENALTIES.
(a) Civil Sanctions.--
(1) Civil penalty.--
(A) In general.--Any person that violates section
401 may be assessed a civil penalty by the
Administrator of not more than $250,000 for each
violation.
(B) Separate offense.--Each violation described in
subparagraph (A) and each day during which that
violation 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.--A written order under
subparagraph (A) may be reviewed only in accordance
with subsection (c).
(b) Criminal Sanctions.--
(1) In general.--Except as provided in paragraphs (2) and
(3), a person that violates subparagraph (A) or (B) of section
401(1) shall be imprisoned for not more than 1 year, fined not
more than $10,000, or both.
(2) Severe violations.--A person that commits a violation
described in paragraph (1) after a conviction of that person
under this section has become final, or commits such a
violation with the intent to defraud or mislead, shall be
imprisoned for not more than 3 years, fined not more than
$100,000, or both.
(3) Exception.--No person shall be subject to the penalties
of this subsection--
(A) for having received, proffered, or delivered in
interstate commerce any food, if the receipt, proffer,
or delivery was made in good faith, unless that person
refuses to furnish (on request of an officer or
employee designated by the Administrator)--
(i) the name, address, and contact
information of the person from whom that person
purchased or received the food;
(ii) copies of all documents relating to
the person from whom that person purchased or
received the food; and
(iii) copies of all documents pertaining to
the delivery of the food to that person; or
(B) if that person establishes a guaranty signed
by, and containing the name and address of, the person
from whom that person received in good faith the food,
stating that the food is not adulterated or misbranded
within the meaning of this Act.
(c) Judicial Review.--
(1) In general.--An order assessing a civil penalty 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--
(i) the court of appeals of the United
States for the judicial circuit in which that
person resides or has its principal place of
business; or
(ii) the United States Court of Appeals for
the District of Columbia Circuit; 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 (c) has entered final judgment in favor
of the Administrator, the Administrator shall refer the matter
to the Attorney General, who shall institute in a district
court of the United States 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 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
may be in addition to, and not exclusive of, other remedies that may be
available.
SEC. 405. 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. 406. WHISTLEBLOWER PROTECTION.
Section 1013 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
399d) shall apply with respect to any violation of, or any act or
omission an employee reasonably believes to be a violation of, any
provision of this Act to the same extent and in the same manner as that
section applies with respect to a violation of, or any act or omission
an employee reasonably believes to be a violation of, any provision of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 407. 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 (15 U.S.C. 46)), 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, 50) on the
United States district courts may be exercised for the purposes
of this chapter by any district court of the United States of
competent jurisdiction.
SEC. 408. 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.--
(1) In general.--The action shall be commenced in the
district court of the United States for the judicial district
in which the defendant resides, is found, or has an agent.
(2) Jurisdiction.--The court described in paragraph (1)
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 described in paragraph (1) 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. DEFINITION.
In this title, the term ``transition period'' means the 12-month
period beginning on the date of enactment of this Act.
SEC. 502. REORGANIZATION PLAN.
(a) Submission of Plan.--Not later than 180 days after the date of
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) Identification of any functions of agencies designated
to be transferred to the Administration pursuant to this Act
that will not be transferred to the Administration under the
plan.
(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 transition period.
(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) Supercedes existing law.--Paragraph (1) shall apply
notwithstanding section 905(b) of title 5, United States Code.
SEC. 503. 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 on the day before the date of 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, on
a reimbursable basis, 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 on the day
before the date of 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. 504. 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, permit, personnel action, agreement,
grant, contract, certificate, license, registration, privilege, or
other administrative action issued, made, granted, or otherwise in
effect or final with respect to that agency on the day before the
transfer date with respect to the transferred functions.
(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 could have occurred if such
enactment or transfer had not occurred; and
(2) orders issued in such proceedings, and appeals from
those orders, and payments made pursuant to such orders, shall
be issued in the same manner on the same terms as if this Act
had not been enacted or the agency had not been transferred,
and any such order shall continue in effect until amended,
modified, superceded, terminated, set aside, or revoked by an
officer of the United States or a court of competent
jurisdiction, or by operation of law.
(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 laws 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 on the
day before the date of enactment of this Act shall continue to
apply following such transfer if the reporting requirements
refer to the agency by name.
SEC. 505. CONFORMING AMENDMENTS.
Section 5313 of title 5, United States Code, is amended by adding
at the end the following new item:
``Administrator of Food Safety.''.
SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.
Not later than 60 days after the submission of the reorganization
plan under section 502, the President shall prepare and submit proposed
legislation to Congress containing necessary and appropriate technical
and conforming amendments to any food safety law to reflect the changes
made by this Act.
SEC. 507. REGULATIONS.
The Administrator may promulgate such regulations as the
Administrator determines are necessary or appropriate to perform the
duties of the Administrator.
SEC. 508. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are necessary
to carry out this Act.
SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.
For the fiscal year that includes the date of 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
enactment of this Act, appropriations for those agencies for
the fiscal year that includes that date of enactment have not
yet been made.
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