I 
115TH CONGRESS 
2D SESSION 
H. R. 7338 
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 improving 
security of food from intentional contamination, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 19, 2018 
Ms. DELAURO introduced the following bill; which was referred to the Com-
mittee 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 juris-
diction 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 improving security of 
food from intentional contamination, and for other pur-
poses. 
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 2018’’. 
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(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. 
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Sec. 509. Limitation on authorization of appropriations. 
Sec. 510. Effective date. 
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 con-
fidence 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 dam-
aging 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 pre-
venting 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 pres-
sures with regard to— 
(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 
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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 
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-
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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— 
(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; 
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(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, in 
cooperation with academic institutions and 
other scientific entities of the Federal and State 
governments, to achieve the continuous im-
provement of research on foodborne illness and 
contaminants; 
(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 ef-
fective date of this Act, are performed by other Fed-
eral agencies; and 
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(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 such 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 Prod-
ucts Inspection Act (21 U.S.C. 453(g)) for 
food regulated under such Act; and 
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(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 that 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— 
(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. 
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(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, 
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. 
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(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 
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.— 
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(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 
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 
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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); 
(F) the Egg Products Inspection Act (21 
U.S.C. 1031 et seq.); 
(G) the Sanitary Food Transportation Act 
of 1990 (49 U.S.C. App. 2801 et seq.); 
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(H) chapter 57 of title 49, United States 
Code; 
(I) Public Law 85–765 (commonly known 
as the ‘‘Humane Methods of Slaughter Act of 
1958’’) (7 U.S.C. 1901 et seq.); 
(J) the provisions of this Act; and 
(K) 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 that 
term in section 201(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(b)). 
(18) MISBRANDED.—The term ‘‘misbranded’’ 
has the meaning given to it 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 In-
spection Act (21 U.S.C. 601(n)) for food regu-
lated under such Act; 
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(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 
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 
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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; 
(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 
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(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. 
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 effective 
date of this Act (including all related functions of any offi-
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cer or employee of the Federal agency) that relate to ad-
ministration or enforcement of the food safety law, as de-
termined 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; 
(6) the resources and facilities of the Office of 
the Commissioner of the Food and Drug Adminis-
tration, known as the Office of Food and Veterinary 
Medicine, that support— 
(A) the Center for Food Safety and Ap-
plied Nutrition; 
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(B) the Center for Veterinary Medicine; 
and 
(C) the Office of Regulatory Affairs facili-
ties and resources described in paragraph (4); 
(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 
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(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 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. 
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(2) DUTIES.—The duties of an advisory com-
mittee established under paragraph (1) may include 
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; 
(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; 
(11) implement a basic and applied research 
program to further the purposes of this Act; and 
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H7338
pamtmann on DSKBFK8HB2PROD with BILLS