I 
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 sur-
veillance of foodborne pathogens (including foodborne pathogens identi-
fied as antibiotic resistant), and improving security of food from inten-
tional 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 deter-
mined 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 out-
comes associated with foodborne illnesses, improving the 
surveillance of foodborne pathogens (including foodborne 
pathogens identified as antibiotic resistant), and improv-
ing security of food from intentional contamination, and 
for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives 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. 
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(A) emerging pathogens and other con-
taminants 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 in-
fants and children; 
(C) a concern regarding food fraud for eco-
nomic gain, especially with mislabeling and in-
tentionally 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, in-
spection, 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 frag-
mented, with at least 15 Federal agencies sharing 
responsibility for food safety, and operates under 
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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, system-
wide approach to preventing foodborne illness, to the 
effective and efficient operation of the Nation’s food 
safety program, and to the most beneficial deploy-
ment of food safety resources; 
(8) the National Academy of Sciences rec-
ommended in the report ‘‘Ensuring Safe Food from 
Production to Consumption’’ that Congress establish 
by statute a unified and central framework for man-
aging Federal food safety programs, and rec-
ommended modifying Federal statutes so that in-
spection, 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 safe-
ty leadership in the United States undercuts the 
ability of the United States to exert food safety lead-
ership 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— 
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(1) to establish a single agency to be known as 
the ‘‘Food Safety Administration’’ to— 
(A) regulate food safety and related label-
ing 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 ap-
proach to food safety and to make more effec-
tive and efficient use of resources to prevent 
foodborne illness; 
(D) provide a single focal point for food 
safety leadership, both nationally and inter-
nationally; and 
(E) provide an integrated food safety re-
search capability, utilizing internally generated, 
scientifically and statistically valid studies or 
other food safety initiatives, in cooperation with 
academic institutions, food safety nonprofit or-
ganizations, and other scientific entities of the 
Federal and State governments, to achieve the 
continuous 
improvement 
of 
research 
on 
foodborne illness and contaminants; 
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(2) to transfer to the Food Safety Administra-
tion the food safety, labeling, inspection, and en-
forcement 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 protec-
tion and improvement of public health. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) ADMINISTRATION.—The term ‘‘Administra-
tion’’ means the Food Safety Administration estab-
lished under section 101(a)(1). 
(2) ADMINISTRATOR.—The term ‘‘Adminis-
trator’’ means the Administrator of Food Safety ap-
pointed under section 101(a)(3). 
(3) ADULTERATED.— 
(A) IN
GENERAL.—The term ‘‘adulter-
ated’’ 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; 
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(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 Prod-
ucts 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 defini-
tions cited in subparagraph (A), poisonous or 
deleterious substances in food shall be treated 
as an added substance if the poisonous or dele-
terious substances are known to cause serious 
illness or death in persons, including in sen-
sitive populations. 
(4) AGENCY.—The term ‘‘agency’’ has the 
meaning given the term in section 551 of title 5, 
United States Code. 
(5) CATEGORY
FOOD
FACILITY.—The term 
‘‘category 1 food facility’’ means a facility that 
slaughters animals for food. 
(6) CATEGORY
FOOD
FACILITY.—The term 
‘‘category 2 food facility’’ means a facility that proc-
esses— 
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(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
FOOD
FACILITY.—The term 
‘‘category 3 food facility’’ means a facility— 
(A) that processes meat, poultry, or sea-
food, 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
FOOD
FACILITY.—The term 
‘‘category 4 food facility’’ means a facility that proc-
esses food but is not a category 1, 2, or 3 food facil-
ity. 
(9) CATEGORY
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, 
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decomposition, parasites, allergens, and unapproved 
food or color additives. 
(11) CONTAMINATION.—The term ‘‘contamina-
tion’’ 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, man-
ufactures, 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’’ in-
cludes any product (including a meat food prod-
uct, as defined in section 1(j) of the Federal 
Meat Inspection Act (21 U.S.C. 601(j))), capa-
ble for use as human and animal food that is 
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made in whole or in part from any animal, in-
cluding cattle, sheep, swine, goat, or poultry (as 
defined in section 4 of the Poultry Products In-
spection Act (21 U.S.C. 453)), and animal feed. 
(14) FOOD FACILITY.— 
(A) IN GENERAL.—The term ‘‘food facil-
ity’’ means a domestic or foreign food manufac-
turer, slaughterhouse, processor, packer, ware-
house, 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, proc-
esses, or holds food intended for consump-
tion 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 estab-
lishment in which food is prepared for or 
served directly to the consumer; or 
(ii) a fishing vessel (other than a fish-
ing vessel engaged in processing, as that 
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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 fa-
cility, or confined animal-feeding operation. 
(16) FOOD SAFETY LAW.—The term ‘‘food safe-
ty 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, label-
ing, 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 adminis-
tered 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); 
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(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; 
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(B) section 1(n) of the Federal Meat In-
spection Act (21 U.S.C. 601(n)) for food regu-
lated under such Act; 
(C) section 4(h) of the Poultry Products 
Inspection Act (21 U.S.C. 453(h)) for food reg-
ulated under such Act; and 
(D) section 4(l) of the Egg Products In-
spection Act (21 U.S.C. 1033(l)) for food regu-
lated under such Act. 
(19) PROCESS.—The term ‘‘process’’ or ‘‘proc-
essing’’ 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 
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contaminant in food is capable of effectively and 
consistently controlling the contaminant. 
(23) STATISTICALLY VALID.—The term ‘‘statis-
tically 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 ADMINISTRA-
TION. 
(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 Adminis-
tration 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 Adminis-
trator shall— 
(1) administer and enforce the food safety law; 
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(2) serve as a representative to international 
food safety bodies and discussions; 
(3) promulgate regulations to ensure the secu-
rity of the food supply from all forms of contamina-
tion, 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 ef-
forts and deployment of Federal food safety re-
sources to achieve the greatest benefit in reduc-
ing 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 ac-
tivities with State and local agencies. 
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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 agen-
cies 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 Nu-
trition of the Food and Drug Administration; 
(3) the part of the Agriculture Marketing Serv-
ice 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 Adminis-
tration that administer and conduct inspections of 
food and feed facilities and imports; 
(5) the Center for Veterinary Medicine of the 
Food and Drug Administration; 
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(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 Agri-
culture 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 re-
lated 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 Ad-
ministration 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 
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subchapter III of chapter 53 of that title, relating to 
classification and General Schedule pay rates. 
(b) EXPERTS
AND CONSULTANTS.—The Adminis-
trator may— 
(1) procure the services of temporary or inter-
mittent 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, in-
cluding transportation and per diem in lieu of sub-
sistence 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 Ad-
ministrator may establish within the Administration such 
bureaus, offices, and divisions as the Administrator deter-
mines are necessary to perform the duties of the Adminis-
trator. 
(d) ADVISORY COMMITTEES.— 
(1) IN GENERAL.—The Administrator shall es-
tablish advisory committees that consist of rep-
resentatives of scientific expert bodies, academics, 
industry specialists, and consumers. 
(2) DUTIES.—The duties of an advisory com-
mittee established under paragraph (1) may include 
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developing recommendations with respect to the de-
velopment of regulatory science and processes, re-
search, 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 asso-
ciated with different food and with the processing of dif-
ferent 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; 
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(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 pro-
gram, the Administrator shall— 
(1) adopt and implement a national system for 
the registration of food facilities and regular unan-
nounced inspection of food facilities; 
(2) verify and enforce the adoption of preven-
tive process controls in food facilities, based on the 
best available scientific and public health consider-
ations and best available technologies; 
(3) establish and enforce science-based stand-
ards 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 pro-
gram to ensure that industry programs and proce-
dures that prevent food contamination are effective 
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on an ongoing basis and that food meets the per-
formance 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, en-
forcement, research, and monitoring; 
(7) access the surveillance data of the Centers 
for Disease Control and Prevention, and other Fed-
eral Government agencies, in order to develop and 
implement a national surveillance system to assess 
the health risks associated with the human consump-
tion of food or to create surveillance data and stud-
ies to mitigate food threats (such as antibiotic resist-
ance) or to identify the ways that food contamina-
tion 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 in-
volved in responding to or monitoring a foodborne 
outbreak; 
(10) develop public education risk communica-
tion and advisory programs; 
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(11) implement a basic and applied research 
program to further the purposes of this Act; and 
(12) coordinate and prioritize food safety re-
search and educational programs with other agen-
cies, 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 sub-
section (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 reg-
istered 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 en-
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actment of this Act, such facilities shall file an 
amended registration within 180 days of such 
date of enactment to deliver the information re-
quired by paragraph (2). 
(2) CATEGORIES.—In addition to the informa-
tion required under section 415 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350d) to be in-
cluded in registration, a food facility shall— 
(A) list the facility’s primary purpose and 
business activity, including the dates of oper-
ation 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 iden-
tified in the registration, designate the facility as a 
category 1, 2, 3, 4, or 5 food facility for the pur-
poses of inspection, and assign a registration num-
ber to each food facility. 
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(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 Cos-
metic Act (21 U.S.C. 350d(a)(5)); and 
(B) may establish regulations on how the 
list may be shared with other governmental au-
thorities. 
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE 
ADULTERATION OF FOOD. 
(a) IN GENERAL.—The Administrator shall review 
existing regulations on hazard analysis and process con-
trols 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; 
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(5) label food intended for final processing out-
side 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 Ad-
ministrator determines that a foodborne contaminant pre-
sents the risk of serious adverse health consequences or 
death to consumers, causes food to be adulterated, or 
could promote the spread of communicable disease de-
scribed in section 361 of the Public Health Service Act 
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(42 U.S.C. 264), the Administrator shall issue a perform-
ance 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 deter-
mine 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 promul-
gated under this section, and such facility fails to 
take appropriate corrective action as determined by 
the Administrator, the Administrator shall, as ap-
propriate— 
(A) detain, seize, or condemn food from 
the food facility under section 209(i); 
(B) order a recall of food from the food fa-
cility 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 
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(E) take other appropriate enforcement ac-
tion concerning the food facility, including sus-
pension of registration. 
(c) NEWLY IDENTIFIED CONTAMINANTS.—Notwith-
standing any other provision of this section, the Adminis-
trator shall promulgate interim performance standards for 
newly identified contaminants as necessary to protect the 
public health. 
(d) REVOCATION BY ADMINISTRATOR.—All perform-
ance standards, tolerances, action levels, or other similar 
standards with respect to food in effect on the date of en-
actment 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 contami-
nants in food; 
(3) uses validated process controls and ongoing 
verification; 
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(4) is in compliance with applicable perform-
ance standards established under section 204, proc-
ess control regulations, and other requirements; 
(5) is processing food that is safe and not adul-
terated 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 FRE-
QUENCIES.—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, post-
mortem, 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 iden-
tified and removed from the slaughter line visi-
bly defective or contaminated carcasses, has 
avoided cross-contamination, and has destroyed 
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or reprocessed contaminated carcasses in a 
manner acceptable to the Administrator; and 
(C) applicable performance standards and 
other provisions of the food safety law, includ-
ing those intended to eliminate or reduce patho-
gens, 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 Adminis-
trator on request that ongoing verification 
shows that its processes are controlled; and 
(B) be randomly inspected at least month-
ly. 
(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
PROCE-
DURES.—The Administrator shall establish procedures 
under which inspectors or safety officers inspect food fa-
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cilities, 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 allo-
cation of resources, the Administrator may establish, 
in accordance with this subsection, alternative in-
creased or decreased inspection frequencies for— 
(A) one or more subcategories of food fa-
cilities 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 sub-
category of food facilities and the alternative in-
spection frequency of that subcategory under 
subparagraph (A), the Administrator shall con-
sider— 
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(i) the nature of the foods being proc-
essed, 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 con-
cerning reported illnesses associated with 
the foods produced in the proposed sub-
category of facilities; and 
(v) the overall record of compliance 
with the food safety law among facilities in 
the proposed subcategory, including com-
pliance with applicable performance stand-
ards and the frequency of recalls. 
(3) SPECIFIC FACILITIES.— 
(A) IN GENERAL.—The Administrator— 
(i) may establish an alternative in-
spection frequency for increased or de-
creased inspection for a specific food facil-
ity; and 
(ii) shall annually publish a list of 
food facilities subject to alternative inspec-
tion frequencies under clause (i). 
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(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 alter-
native inspection frequency should be es-
tablished for that facility by the Adminis-
trator; 
(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 com-
pliance 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
CAT-
EGORIES 2, 3, AND 4.—An alternative inspection fre-
quency for a subcategory of food facilities or a spe-
cific food facility under this subsection shall be— 
(A) in the case of a category 2 food facil-
ity, not less frequently than monthly; and 
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(B) in the case of a category 3 or 4 food 
facility, not less frequently than annually. 
(5) REQUIREMENTS
FOR
DECREASED
FRE-
QUENCIES.—Before issuing a regulation or order es-
tablishing a decreased alternative inspection fre-
quency for a subcategory of food facilities or an indi-
vidual food facility under this subsection, the Admin-
istrator shall— 
(A) describe, in general terms, the alter-
native 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 re-
sources 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 de-
scribed 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. 
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(2) LIMIT ON REDUCTION IN INSPECTION FRE-
QUENCY.—For any food facility, the Administrator 
shall not reduce the inspection frequency from the 
frequency required pursuant to the Federal Meat In-
spection 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 dem-
onstrated that sufficient changes in facilities, proce-
dures, personnel, or other aspects of the process con-
trol system have been made such that the Adminis-
trator determines that compliance with the food 
safety law is achieved. 
(f) OFFICIAL MARK.— 
(1) IN GENERAL.— 
(A) ESTABLISHMENT.—Before the comple-
tion of the transition process under subsection 
(e), the Administrator shall by regulation estab-
lish an official mark that can be affixed to a 
food produced in a category 1, 2, or 3 food fa-
cility if— 
(i) the facility is in compliance with 
the food safety law; and 
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(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 facil-
ity— 
(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 inspec-
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tion pending completion of the transition proc-
ess under subsection (e); 
(B) the Administrator shall publicly certify 
on a monthly basis that the inspection fre-
quencies 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 inter-
state 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 Adminis-
trator; 
(B) compliance with applicable perform-
ance standards and other provisions of the food 
safety law; and 
(C) such other requirements as the Admin-
istrator considers appropriate. 
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(g) MAINTENANCE AND INSPECTION OF RECORDS.— 
(1) IN GENERAL.— 
(A) RECORDS.—A food facility shall— 
(i) maintain such records as the Ad-
ministrator requires by regulation, includ-
ing all records relating to the processing, 
distributing, receipt, or importation of any 
food; and 
(ii) permit the Administrator, in addi-
tion to any authority of the food safety 
agencies in effect on the day before the 
date of enactment of this Act, upon pres-
entation of appropriate credentials and at 
reasonable times and in a reasonable man-
ner, to have access to and copy all records 
maintained by or on behalf of such food fa-
cility representative in any format (includ-
ing paper or electronic) and at any loca-
tion, that are necessary to assist the Ad-
ministrator to determine whether the food 
is contaminated or not in compliance with 
the food safety law. 
(B) REQUIRED DISCLOSURE.—A food facil-
ity shall have an affirmative obligation to dis-
close to the Administrator the results of testing 
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or sampling of food, equipment, or material in 
contact with food that is positive for any con-
taminant. 
(2) MAINTENANCE OF RECORDS.—The records 
required by paragraph (1) shall be maintained for a 
reasonable period of time, as determined by the Ad-
ministrator. 
(3) REQUIREMENTS.—The records required by 
paragraph (1) shall include records describing— 
(A) the origin, receipt, delivery, sale, move-
ment, holding, and disposition of food or ingre-
dients; 
(B) the identity and quantity of ingredi-
ents 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 mis-
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branded, or otherwise fails to meet the require-
ments of this Act. 
(h) PROTECTION OF SENSITIVE INFORMATION.— 
(1) IN GENERAL.—The Administrator shall de-
velop and maintain procedures to prevent the unau-
thorized disclosure of any trade secret or confiden-
tial information obtained by the Administrator. 
(2) LIMITATION.—The requirement under this 
subsection does not— 
(A) limit the authority of the Adminis-
trator 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 distribu-
tion records or other records related to food 
subject to a voluntary or mandatory recall 
under section 402; or 
(E) limit the authority of the Adminis-
trator to promulgate regulations to permit the 
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sharing of data with other governmental au-
thorities. 
(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 establish-
ments 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 pur-
poses; 
(3) set good practice standards to protect the 
public and promote food safety; 
(4) partner with appropriate agencies to mon-
itor animals, plants, products, or the environment, 
as appropriate; and 
(5) collect and maintain information relevant to 
public health and farm practices. 
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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-effec-
tive 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 regu-
lation 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 Adminis-
trator may provide to a State— 
(1) advisory assistance; 
(2) technical and laboratory assistance and 
training (including necessary materials and equip-
ment); and 
(3) financial assistance, in kind assistance, and 
other aid. 
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(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 oth-
erwise 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 em-
ployees. 
(3) MAINTENANCE OF AGREEMENTS.—The Ad-
ministrator 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 an-
nually 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 effec-
tiveness of the State program; and 
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(B) identify any changes necessary to en-
sure 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 strin-
gent 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 require-
ments under section 805 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384a). 
(b) RULE
OF CONSTRUCTION.—In applying sub-
section (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 cor-
responding provisions of the food safety law, if any, that 
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apply to such products, as determined by the Adminis-
trator. 
(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 ‘‘sub-
sections (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 es-
tablish a system under which a foreign government seek-
ing to certify food for importation into the United States 
shall submit a request for accreditation to the Adminis-
trator. 
(b) ACCREDITATION STANDARD.—A foreign govern-
ment requesting to be accredited to certify food for impor-
tation into the United States shall demonstrate, in a man-
ner 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. 
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(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, regula-
tions, and inspection authority) meets the standard speci-
fied in subsection (b). 
(d) LIMITATIONS.—Any accreditation of a foreign 
government under this section shall— 
(1) specify the foods covered by the accredita-
tion; and 
(2) be limited to a period not to exceed 5 years. 
(e) WITHDRAWAL OF ACCREDITATION.—The Admin-
istrator 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 re-
quirements under this section. 
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(f) RENEWAL OF ACCREDITATION.—The Adminis-
trator 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 Admin-
istrator 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 ani-
mals— 
(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 inves-
tigation by the Administrator when food from that 
country or foreign facility is linked to a foodborne 
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illness outbreak or is otherwise found to be adulter-
ated or mislabeled; and 
(3) promulgate regulations to carry out the pur-
poses 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 regula-
tions and guidelines issued by the Administrator; 
and 
(2) apply to food production establishments and 
food facilities. 
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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 tech-
nologies 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 consulta-
tion with technology developers to assist them in meeting 
requirements for approval of technologies and products de-
scribed in subsection (a). 
TITLE III—RESEARCH AND 
EDUCATION 
SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) IN GENERAL.—The Administrator, acting in co-
ordination 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 
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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 con-
sumption of food; 
(4) partner with relevant agencies to maintain 
or access a state-of-the-art partial or full genome se-
quencing system and epidemiological system dedi-
cated 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 ana-
lyze samples of food— 
(A) to assist the Administrator in carrying 
out this Act; and 
(B) to assess the nature, frequency of oc-
currence, and quantities of contaminants in 
food. 
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(2) REQUIREMENTS.—The sampling system de-
scribed 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 Ad-
ministrator determines may be useful in assess-
ing 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— 
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(1) in cooperation with private and public orga-
nizations, including the cooperative extension serv-
ices and building on the efforts of appropriate State 
and local entities, establish a national public edu-
cation 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 na-
tional 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 estab-
lished under subsection (a); and 
(4) to present prompt, specific information re-
garding foods found to pose a threat to the public 
health. 
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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 meth-
ods 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 tech-
niques could improve the safety of the food supply; 
(7) draw upon research and educational pro-
grams 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 com-
promised 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; 
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(11) develop methods to reduce or destroy 
harmful pathogens before, during, and after proc-
essing; 
(12) analyze the incidence of antibiotic resist-
ance as it pertains to the food supply and develop 
new methods to reduce infection by antibiotic resist-
ant 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, insti-
tution 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 com-
merce any food that is adulterated, misbranded, 
or otherwise unsafe; 
(B) to adulterate or misbrand any food in 
interstate commerce; 
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(C) to refuse to permit access to a food fa-
cility 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 inspec-
tion 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 contami-
nated food under section 205(g)(1)(B); 
(G) to fail to comply with an applicable 
provision of, or a regulation or order of the Ad-
ministrator 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 
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(2) for a food facility or foreign food facility to 
fail to register under section 202, or to operate with-
out 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 arti-
cle 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 deter-
mined by the Administrator under subsection (a), 
the Administrator may by order require, as the Ad-
ministrator determines to be necessary— 
(A) that owner, operator, or agent— 
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(i) to immediately cease distribution 
of that article of food; and 
(ii) as applicable, to immediately no-
tify all persons manufacturing, processing, 
packing, transporting, distributing, receiv-
ing, 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 para-
graph (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 pro-
vided by the owner, operator, or agent of a fa-
cility under paragraph (1)(A)(ii) shall include 
such information as is necessary for the ware-
house-based, third-party logistics provider to 
identify the article of food. 
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(B) RULES OF CONSTRUCTION.—Nothing 
in this paragraph shall be construed— 
(i) to exempt a warehouse-based, 
third-party logistics provider from the re-
quirements 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
AF-
FECTED.—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 Adminis-
trator may limit the size of the geographic area and 
the markets affected by such cessation if such limi-
tation would not compromise the public health. 
(c) HEARING ON ORDER.—The Administrator shall 
provide the owner, operator, or agent in charge of the fa-
cility subject to an order under subsection (b) with an op-
portunity 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. 
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(d) POST-HEARING RECALL ORDER AND MODIFICA-
TION OF ORDER.— 
(1) AMENDMENT
OF
ORDER.—If, after pro-
viding opportunity for an informal hearing under 
subsection (c), the Administrator determines that re-
moval of the applicable article of food from com-
merce is necessary, the Administrator shall, as ap-
propriate— 
(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 Admin-
istrator 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 de-
termines that adequate grounds do not exist to con-
tinue the actions required by the applicable order, or 
that such actions should be modified, the Adminis-
trator shall vacate the order or modify the order, as 
appropriate. 
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(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 pro-
vided 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 au-
thority of the Administrator of the Alcohol and Tobacco 
Tax and Trade Bureau. 
(f) COOPERATION
AND CONSULTATION.—The Ad-
ministrator 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 re-
garding the recall, as well as alerts and public no-
tices, as appropriate, in order to provide notifica-
tion— 
(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 sub-
ject to the recall; 
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(ii) a description of the risk associated 
with such article; and 
(iii) to the extent practicable, informa-
tion for consumers about similar articles of 
food that are not affected by the recall; 
(2) provide to the public a list of retail con-
signees receiving products for which there is deter-
mined 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 para-
graph (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 distribu-
tion or to recall under any other provision of the food safe-
ty law or under the Public Health Service Act (42 U.S.C. 
201 et seq.). 
(j) COORDINATED COMMUNICATION.— 
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(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 ad-
verse health consequences or death to humans or 
animals. 
(2) REQUIREMENTS.—To reduce the potential 
for miscommunication during recalls or regarding in-
vestigations of a foodborne illness outbreak associ-
ated with a food that is subject to a recall, each inci-
dent command operation or similar operation under 
paragraph (1) shall use regular staff and resources 
of the Administration to— 
(A) ensure timely and coordinated commu-
nication within the Administration, including 
enhanced communication and coordination be-
tween different agencies and organizations with-
in the Administration; 
(B) ensure timely and coordinated commu-
nication from the Administration, including 
public statements, throughout the duration of 
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