I 
110TH CONGRESS 
2D SESSION 
H. R. 7143 
To establish the Food Safety Administration within the Department of Health 
and Human Services to protect the public health by preventing food- 
borne illness, ensuring the safety of food, improving research on contami-
nants leading to food-borne illness, and improving security of food from 
intentional contamination, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 26, 2008 
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 within the De-
partment of Health and Human Services to protect the 
public health by preventing food-borne illness, ensuring 
the safety of food, improving research on contaminants 
leading to food-borne illness, and improving security of 
food from intentional contamination, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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Sec. 503. Savings provisions. 
Sec. 504. Conforming amendments. 
Sec. 505. Additional technical and conforming amendments. 
Sec. 506. Regulations. 
Sec. 507. Authorization of appropriations. 
Sec. 508. Limitation on authorization of appropriations. 
SEC. 2. FINDINGS; PURPOSES. 
(a) FINDINGS.—Congress finds that— 
(1) the safety of the food supply of the United 
States is vital to the public health, to public 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 and international 
trade; 
(3) recent ongoing events demonstrate that the 
food safety program at the Food and Drug Adminis-
tration is not effective in controlling hazards in food 
coming from farms and factories in the United 
States and food and food ingredients coming from 
foreign countries, and these events have adversely 
affected consumer confidence; 
(4) the safety and security of the food supply 
require a systemwide approach to prevent food-borne 
illness involving the integrated efforts of Federal, 
State and local agencies; a thorough, broad-based, 
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and coordinated approach to basic and applied 
science; and intensive, effective, and efficient man-
agement of the Nation’s food safety program; 
(5) 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) the threat of intentional contamination 
of the food supply; 
(C) a growing number of people at high 
risk for food-borne illnesses, including an in-
creasing population of aging and immune-com-
promised consumers, together with infants and 
children; 
(D) an increasing volume of imported food, 
without adequate monitoring, inspection, and 
systems for prevention of food safety problems; 
and 
(E) maintenance of rigorous inspection of 
the domestic food processing and food service 
industries; 
(6) Federal food safety standard setting, in-
spection, enforcement, and research efforts should be 
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based on the best available science and public health 
considerations, and food safety resources should be 
systematically deployed in ways that most effectively 
prevent food-borne illness; 
(7) the Food and Drug Administration, an 
agency within the Department of Health and 
Human Services, has regulatory jurisdiction over the 
safety and labeling of 80 percent of the American 
food supply, encompassing all foods except meat, 
poultry, and egg products, as well as drugs, medical 
devices, and biologics; 
(8) rapid technological advance and the expan-
sion and globalization of industries in all areas of 
Food and Drug Administration jurisdiction present 
challenges and require leadership beyond the capac-
ity of any one agency or agency head to provide; 
(9) in the food safety area, the Food and Drug 
Administration implements provisions of the Federal 
Food, Drug, and Cosmetic Act that are 70 years old 
and that antiquated law limits the Food and Drug 
Administration’s role largely to reacting to and cor-
recting food safety problems after they occur, rather 
than working with the food industry to systemati-
cally prevent problems; 
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(10) the Food and Drug Administration’s effec-
tiveness is further impaired by fragmentation of 
leadership and management within the Administra-
tion, as major food safety responsibilities are dis-
persed across the Administration’s Center for Food 
Safety and Applied Nutrition, Center for Veterinary 
Medicine, and Office of Regulatory Affairs; 
(11) there is no official with the full-time re-
sponsibility and budget authority for food safety at 
the Food and Drug Administration and food safety 
competes unsuccessfully with the drug and medical 
device programs for senior agency management at-
tention and resources; and 
(12) improving Federal oversight of food safety 
requires a modern food safety mandate, clear au-
thorities, and a dedicated official within the Depart-
ment of Health and Human Services with budget 
authority to manage an integrated organizational 
structure and report directly to the Secretary. 
(b) PURPOSES.—The purposes of this Act are— 
(1) to establish an agency within the Depart-
ment of Health and Human Services to be known as 
the ‘‘Food Safety Administration’’ to— 
(A) regulate food safety and labeling to 
strengthen the protection of the public health; 
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(B) ensure that food establishments fulfill 
their responsibility to process, store, hold, and 
transport food in a manner that protects the 
public health of all people in the United States; 
(C) lead an integrated, systemwide ap-
proach to food safety and to make more effec-
tive and efficient use of resources to prevent 
food-borne illness; 
(D) provide a single focal point within the 
Department of Health and Human Services for 
food safety leadership, both nationally and 
internationally; and 
(E) provide an integrated food safety 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; 
(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 the enactment of this Act, are performed by 
various components of the Food and Drug Adminis-
tration and the National Oceanic and Atmospheric 
Administration; 
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(3) to modernize and strengthen the Federal 
food safety law to ensure more effective application 
and efficient management of the laws for the protec-
tion and improvement of public health; and 
(4) to establish that food establishments have 
responsibility to ensure that all stages of production, 
processing, and distribution of their products or 
products under their control satisfy the requirements 
of this law. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) ADMINISTRATION.—The term ‘‘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)(2). 
(3) ADULTERATED.— 
(A) IN
GENERAL.—The term ‘‘adulter-
ated’’ has the meaning given that term in sec-
tion 402 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 342). 
(B) INCLUSION.—The term ‘‘adulterated’’ 
includes bearing or containing a contaminant 
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that causes illness or death among sensitive 
populations. 
(4) AGENCY.—The term ‘‘agency’’ has the 
meaning given that term in section 551 of title 5, 
United States Code. 
(5) CATEGORY 1 FOOD ESTABLISHMENT.—The 
term ‘‘category 1 food establishment’’ means a food 
establishment (other than a seafood processing es-
tablishment) that slaughters, for the purpose of pro-
ducing food, animals that are not subject to inspec-
tion under the Federal Meat Inspection Act or poul-
try that are not subject to inspection under the 
Poultry Products Inspection Act. 
(6) CATEGORY 2 FOOD ESTABLISHMENT.—The 
term ‘‘category 2 food establishment’’ means a sea-
food processing establishment or other food estab-
lishment (other than a category 1 establishment) not 
subject to inspection under the Federal Meat Inspec-
tion Act, the Poultry Products Inspection Act, or the 
Egg Products Inspection Act, that processes raw 
seafood or other raw animal products, whether fresh 
or frozen, or other products that the Administrator 
determines by regulation to pose a significant risk of 
hazardous contamination. 
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(7) CATEGORY 3 FOOD ESTABLISHMENT.—The 
term ‘‘category 3 food establishment’’ means a food 
establishment (other than a category 1 or category 
2 establishment) that processes cooked, pasteurized, 
or otherwise ready-to-eat seafood or other animal 
products, fresh produce in ready-to-eat raw form, or 
other products that pose a risk of hazardous con-
tamination. 
(8) CATEGORY 4 FOOD ESTABLISHMENT.—The 
term ‘‘category 4 food establishment’’ means a food 
establishment that processes all other categories of 
food products not described in paragraphs (5) 
through (7). 
(9) CATEGORY 5 FOOD ESTABLISHMENT.—The 
term ‘‘category 5 food establishment’’ means a food 
establishment that stores, holds, or transports food 
products prior to delivery for retail sale. 
(10) CONTAMINANT.—The term ‘‘contaminant’’ 
includes a bacterium, chemical, natural toxin or 
manufactured toxicant, virus, parasite, prion, phys-
ical hazard, or other human pathogen that when 
found on or in food can cause human illness, injury, 
or death. 
(11) HAZARDOUS CONTAMINATION.—The term 
‘‘hazardous contamination’’ refers to the presence of 
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a contaminant in food at levels that pose a risk of 
human illness, injury, or death or are capable of 
reaching levels that pose such risk during the shelf 
life of the product. 
(12) FOOD.—The term ‘‘food’’ means a product 
intended to be used for food or drink for a human 
or an animal and components thereof. 
(13) FOOD ESTABLISHMENT.— 
(A) IN GENERAL.—The term ‘‘food estab-
lishment’’ means a slaughterhouse (except those 
regulated under the Federal Meat Inspection 
Act or the Poultry Products Inspection Act), 
factory, warehouse, or facility owned or oper-
ated by a person located in any State that proc-
esses food or a facility that holds, stores, or 
transports food or food ingredients. 
(B) EXCLUSIONS.—For the purposes of 
registration, the term ‘‘food establishment’’ 
does not include a food production facility as 
defined in paragraph (14), restaurant, other re-
tail food establishment, nonprofit food estab-
lishment in which food is prepared for or served 
directly to the consumer, or fishing vessel 
(other than a fishing vessel engaged in proc-
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essing, as that term is defined in section 123.3 
of title 21, Code of Federal Regulations). 
(14) FOOD PRODUCTION FACILITY.—The term 
‘‘food production facility’’ means any farm, ranch, 
orchard, vineyard, aquaculture facility, or confined 
animal-feeding operation. 
(15) FOOD SAFETY LAW.—The term ‘‘food 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, qual-
ity, nutritional composition, labeling, and in-
spection of food, infant formulas, food addi-
tives, 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 11 
seq.) and of any other Act that are adminis-
tered by the Center for Veterinary Medicine of 
the Food and Drug Administration; 
(C) the provisions of the Public Health 
Service Act that relate in any way to surveying, 
containing, or preventing food-borne illness; and 
(D) the provisions of this Act. 
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(16) FOREIGN
FOOD
ESTABLISHMENT.—The 
term ‘‘foreign food establishment’’ means any cat-
egory 1 through 5 food establishment or food pro-
duction facility located outside the United States 
that processes or produces food or food ingredients 
for consumption in the United States. 
(17) 
INTERSTATE
COMMERCE.—The 
term 
‘‘interstate commerce’’ has the meaning given that 
term in section 201(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(b)). 
(18) MISBRANDED.—The term ‘‘misbranded’’ 
has the meaning given that term in section 403 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343). 
(19) PROCESS.—The term ‘‘process’’ or ‘‘proc-
essing’’ means the commercial slaughter, packing, 
preparation, or manufacture of food. 
(20) STATE.—The term ‘‘State’’ means— 
(A) a State; 
(B) the District of Columbia; 
(C) the Commonwealth of Puerto Rico; 
and 
(D) any other territory or possession of the 
United States. 
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TITLE 
I—ESTABLISHMENT 
OF 
THE FOOD SAFETY ADMINIS-
TRATION 
SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINIS-
TRATION. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—There is established in the 
Department of Health and Human Services an agen-
cy to be known as the ‘‘Food Safety Administra-
tion’’. 
(2) HEAD OF THE ADMINISTRATION.—The Ad-
ministration shall be headed by the Administrator of 
Food Safety, who shall be appointed by the Presi-
dent, by and with the advice and consent of the Sen-
ate, for a term of 5 years, and who may be re-
appointed. 
(3) DELEGATION.—All the authorities and re-
sponsibilities assigned to the Secretary of Health 
and Human Services in the food safety law are here-
by assigned to the Administrator. 
(b) DUTIES
OF ADMINISTRATOR.—The Adminis-
trator shall— 
(1) administer and enforce the food safety law; 
(2) serve as the food safety leader within the 
Department of Health and Human Services and co-
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ordinator of all Department activities related to en-
suring the safety, quality, and proper labeling of the 
food supply; 
(3) represent the United States in international 
food safety bodies and discussions; 
(4) promulgate regulations to ensure the safety 
and security of the food supply from all forms of 
contamination, including intentional contamination; 
and 
(5) oversee within the Department of Health 
and Human Services— 
(A) all activities related to foodborne ill-
ness surveillance and investigation of foodborne 
illness outbreaks; 
(B) implementation of food safety inspec-
tion, enforcement, and research efforts to pro-
tect the public health; 
(C) development of consistent and science- 
based standards for safe food; 
(D) coordination and prioritization of food 
safety research and education programs with 
other Federal agencies; 
(E) prioritization of food safety efforts and 
deployment of food safety resources to achieve 
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the greatest possible benefit in reducing food- 
borne illness; 
(F) coordination of the response to food- 
borne illness outbreaks with other Federal and 
State agencies; and 
(G) integration of food safety activities 
with State and local agencies. 
SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS. 
(a) TRANSFER OF FUNCTIONS AND RESOURCES.— 
For each component of the Department of Health and 
Human Services or the Department of Commerce specified 
in subsection (b), there are transferred to the Administra-
tion all functions, personnel, and assets (including facili-
ties and financial resources) of those components as of the 
day before the date of the enactment of this Act (including 
all related functions of any officer or employee of the com-
ponent) that relate to administration or enforcement of 
the food safety law, as determined by the President. 
(b) TRANSFERRED FUNCTIONS AND RESOURCES.— 
The components referred to in subsection (a) are— 
(1) the Center for Food Safety and Applied Nu-
trition of the Food and Drug Administration; 
(2) the Center for Veterinary Medicine of the 
Food and Drug Administration; 
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(3) the National Center for Toxicological Re-
search of the Food and Drug Administration; 
(4) the personnel and assets of the Office of 
Regulatory Affairs of the Food and Drug Adminis-
tration used to administer and conduct inspections 
of food establishments and imports and conduct lab-
oratory analyses and other investigations relating to 
food safety; 
(5) the personnel and assets of the Office of the 
Commissioner of Food and Drugs used to support— 
(A) the Center for Food Safety and Ap-
plied Nutrition; 
(B) the Center for Veterinary Medicine; 
(C) the National Center for Toxicological 
Research; and 
(D) the personnel and assets of the Office 
of Regulatory Affairs described in paragraph 
(4); and 
(6) the personnel and assets of the National 
Marine Fisheries Service of the National Oceanic 
and Atmospheric Administration of the Department 
of Commerce used to administer the seafood inspec-
tion program. 
(c) RENAMING AND RESERVATION OF AGENCY IDEN-
TITY.—The Food and Drug Administration in the Depart-
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ment of Health and Human Services is hereby renamed 
the Federal Drug and Device Administration and may be 
referred to as ‘‘FDA’’. 
(d) SHARING OF FACILITIES AND RESOURCES.—The 
Food Safety Administration and the Federal Drug and 
Device Administration shall enter into such agreements 
concerning the sharing of facilities and other resources as 
may be appropriate to make efficient use of such facilities 
and resources and achieve their respective missions. 
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 
(a) OFFICERS AND EMPLOYEES.—The Administrator 
may— 
(1) appoint officers and employees for the 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 
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 
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(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 
developing recommendations with respect to the de-
velopment of new processes, research, communica-
tions, performance standards, and inspection. 
TITLE II—ADMINISTRATION OF 
FOOD SAFETY PROGRAM 
SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM. 
(a) IN GENERAL.—The Administrator shall— 
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(1) develop, administer, and annually update a 
national food safety program (referred to in this sec-
tion as the ‘‘program’’) to protect public health; and 
(2) ensure that persons who produce, process, 
or distribute food meet their responsibility to pre-
vent 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 potential health risks; 
(2) the sources of potentially hazardous con-
tamination or practices extending from the farm or 
ranch to the consumer that may increase the risk of 
food-borne illness; 
(3) the potential for persistence, multiplication, 
or concentration of naturally occurring or added 
contaminants in food; 
(4) the potential for hazardous contamination 
to have cumulative toxic effects, multigenerational 
effects, or effects on specific categories of con-
sumers; 
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(5) opportunities across the food production, 
processing, distribution, and retail system to reduce 
potential health risks; and 
(6) opportunities for intentional contamination 
of food or food ingredients. 
(c) PROGRAM ELEMENTS.—In carrying out the pro-
gram, the Administrator shall— 
(1) adopt and implement a national system for 
the registration of food establishments and foreign 
food establishments, as provided in section 202 of 
this Act; 
(2) adopt and implement a national system for 
regular unannounced inspection of food establish-
ments; 
(3) require and enforce the adoption of preven-
tive process controls in food establishments, based 
on the best available scientific and public health con-
siderations and best available technologies; 
(4) establish and enforce science-based stand-
ards for— 
(A) potentially hazardous substances that 
may contaminate food; and 
(B) safety and sanitation in the processing 
and handling of food; 
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(5) implement a statistically valid sampling pro-
gram with the stringency and frequency to independ-
ently monitor that industry programs and proce-
dures that prevent food contamination are effective 
on an ongoing basis and that food meets the stand-
ards established under this Act; 
(6) implement appropriate surveillance proce-
dures and requirements to ensure the safety and se-
curity of imported food; 
(7) coordinate with other agencies and State or 
local governments in carrying out inspection, en-
forcement, research, and monitoring; 
(8) implement a national system to identify the 
food products posing the greatest public health risk 
and to analyze the effectiveness of existing food safe-
ty programs, in conjunction with the Centers for 
Disease Control and Prevention and other Federal 
agencies; 
(9) develop public education, risk communica-
tion, and advisory programs; 
(10) implement an applied research program to 
further the purposes of this Act; 
(11) coordinate and prioritize food safety re-
search and educational programs with other Federal 
agencies and with State and local governments; and 
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(12) provide technical assistance to farmers and 
food establishments that are small business concerns 
(meeting the requirements of section 3(a) of the 
Small Business Act and the regulations promulgated 
thereunder) to assist with compliance with the re-
quirements of this Act. 
SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND 
FOREIGN FOOD ESTABLISHMENTS. 
(a) IN GENERAL.—Any food establishment or foreign 
food establishment engaged in manufacturing, processing, 
packing, or holding food for consumption in the United 
States shall register annually with the Administrator. 
(b) REGISTRATION REQUIREMENTS.— 
(1) IN GENERAL.—To be registered under sub-
section (a), a food establishment shall submit a reg-
istration or reregistration to the Administrator. 
(2) REGISTRATION.—Registration under this 
section shall begin within 90 days of the enactment 
of this Act. Each such registration shall be sub-
mitted to the Secretary through an electronic portal 
and shall contain such information as the Secretary, 
by guidance, determines to be appropriate. Such reg-
istration shall contain the following information: 
(A) The name, address, and emergency 
contact information of each domestic food es-
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tablishment or foreign food establishment that 
the registrant owns or operates under this Act 
and all trade names under which the registrant 
conducts business in the United States relating 
to food. 
(B) The primary purpose and business ac-
tivity of each domestic food establishment or 
foreign food establishment, including the dates 
of operation if the domestic food establishment 
or foreign food establishment is seasonal. 
(C) The types of food processed or sold at 
each domestic food establishment or, for foreign 
food establishments selling food for consump-
tion in the United States, the specific food cat-
egories of that food as listed under section 
170.3(n) of title 21, Code of Federal Regula-
tions, or such other categories as the Adminis-
trator may designate in guidance, action level, 
or regulations for evaluating potential threats 
to food protection. 
(D) The name, address, and 24-hour emer-
gency contact information of the United States 
distribution agent for each domestic food estab-
lishment or foreign food establishment, who 
shall maintain information on the distribution 
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of food, including lot information, and whole-
saler and retailer distribution. 
(E) An assurance that the registrant will 
notify the Administrator of any change in the 
products, function, or legal status of the domes-
tic food establishment or foreign food establish-
ment (including cessation of business activities) 
not later than 30 days after such change. 
(3) PROCEDURE.—Upon receipt of a completed 
registration described in paragraph (1), the Admin-
istrator shall notify the registrant of the receipt of 
the registration, designate each establishment as a 
category 1, 2, 3, 4, or 5 food establishment, and as-
sign a registration number to each domestic food es-
tablishment and foreign food establishment. 
(4) LIST.—The Administrator shall annually 
compile a list of domestic food establishments and a 
list of foreign food establishments that are registered 
under this section. The Administrator may establish 
the manner of and any fees required for reregistra-
tion and any circumstances by which either such list 
may be shared with other governmental authorities. 
The Administrator may remove from either such list 
the name of any establishment that fails to rereg-
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ister, and such delisting shall be treated as a sus-
pension. 
(5) DISCLOSURE EXEMPTION.—The disclosure 
requirements under section 552 of title 5, United 
States Code, shall not apply to— 
(A) the list compiled under paragraph (4); 
and 
(B) information derived from the list under 
paragraph (4), to the extent that it discloses 
the identity or location of a specific person. 
(6) SUSPENSION OF REGISTRATION.— 
(A) IN GENERAL.—The Administrator may 
suspend the registration of a domestic food es-
tablishment or foreign food establishment, in-
cluding the facility of an importer, for violation 
of a food safety law that is either repeated or 
could result in serious adverse health con-
sequences or death to humans or animals. 
(B) NOTICE
AND
OPPORTUNITY
FOR 
HEARING.—The Administrator shall provide no-
tice of an intent to suspend the registration of 
an establishment under this paragraph to a reg-
istrant and provide the registrant with an op-
portunity for an administrative hearing within 3 
days. The Administrator may issue a written 
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order of suspension following the hearing, if the 
Administrator finds that a violation described 
in subparagraph (A) has occurred. 
(C) JUDICIAL REVIEW.—The issuance of 
an order of suspension under subparagraph (B) 
shall be considered to be a final agency action 
subject to judicial review in accordance with the 
provisions of chapter 7 of title 5, United States 
Code. 
(7) REINSTATEMENT.—A registration that is 
suspended under this section may be reinstated 
based on a showing that adequate process controls 
have been instituted that would prevent future viola-
tions and there are assurances from the registrant 
that the violations will not be repeated. 
(c) TRANSITIONAL PROVISION.—During the 6-month 
period following the date of the enactment of this Act, a 
food establishment is deemed to be registered in accord-
ance with this section if the establishment is registered 
under section 415 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350d). 
(d) REPEAL.—Effective at the end of the 6-month 
period following the date of the enactment of this Act, sec-
tion 415 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 350d) is repealed. 
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SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE 
ADULTERATION OF FOOD. 
(a) IN GENERAL.—The Administrator shall, upon the 
basis of best available public health, scientific, and techno-
logical data, promulgate regulations to ensure that food 
establishments carry out their responsibilities under the 
food safety law. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Administrator shall 
promulgate regulations that require all food establish-
ments, within time frames determined by the Adminis-
trator— 
(1) to adopt preventive process controls that— 
(A) reflect the standards and procedures 
recognized by relevant authoritative bodies; 
(B) are adequate to protect the public 
health; 
(C) meet relevant regulatory and food safe-
ty standards; 
(D) limit the presence and growth of con-
taminants in food prepared in a food establish-
ment using the best reasonably available tech-
niques and technologies; and 
(E) are tailored to the hazards and proc-
esses in particular establishments or environ-
ments; 
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(2) to establish a sanitation plan and program 
that meets standards set by the Administrator; 
(3) to meet performance standards for haz-
ardous contamination established under section 204; 
(4) to implement recordkeeping to monitor com-
pliance with regulatory requirements; 
(5) to implement recordkeeping and labeling of 
all food and food ingredients to facilitate their iden-
tification and traceability in the event of a recall or 
market removal; 
(6) to implement product and environmental 
sampling at a frequency and in a manner sufficient 
to ensure that process controls are effective on an 
ongoing basis and that regulatory standards are 
being met; 
(7) to label food intended for final processing 
outside commercial food establishments with instruc-
tions for handling and preparation for consumption 
that will destroy microbial contaminants; and 
(8) to provide for agency access to records kept 
by the food establishments and submission of copies 
of records to the Administrator, as the Adminis-
trator determines appropriate. 
(c) SPECIFIC HAZARD CONTROLS.—The Adminis-
trator may require any person with responsibility for or 
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control over food or food ingredients to adopt specific haz-
ard controls, if such controls are needed to ensure the pro-
tection of the public health. 
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS 
IN FOOD. 
(a) IN GENERAL.—To protect the public health, the 
Administrator shall establish by guidance document, ac-
tion level, or regulation and enforce performance stand-
ards that define, with respect to specific foods and con-
taminants in food, the level of food safety performance 
that a person responsible for producing, processing, or 
selling food shall meet. 
(b) IDENTIFICATION OF CONTAMINANTS; PERFORM-
ANCE STANDARDS.— 
(1) LIST OF CONTAMINANTS.—Not later than 6 
months after the date of the enactment of this Act, 
the Administrator shall publish in the Federal Reg-
ister a list of the contaminants in foods that have 
the greatest adverse impact on public health in 
terms of the number and severity of illnesses and 
number of deaths associated with foods regulated 
under this Act. Where appropriate, the Adminis-
trator shall indicate whether the risk posed by a con-
taminant is generalized or specific to particular 
foods or ingredients. 
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(2) PERFORMANCE STANDARDS.— 
(A) ESTABLISHMENT.—The Administrator 
shall establish by guidance document, action 
level, or regulation a performance standard for 
each contaminant in the list under paragraph 
(1) at levels appropriate to protect against the 
potential adverse health effects of the contami-
nant. 
(B) TIMING.—The Administrator shall es-
tablish a performance standard under subpara-
graph (A) for each contaminant in the list 
under paragraph (1)— 
(i) as soon as practicable; or 
(ii) in the case of a contaminant de-
scribed in subparagraph (C), by the date 
described in such subparagraph. 
(C) SIGNIFICANT
CONTAMINANTS.—The 
list under paragraph (1) (and any revision 
thereto) shall identify the 5 most significant 
contaminants in the list (in terms of the num-
ber and severity of illnesses and number of 
deaths associated with foods regulated under 
this Act). Not later than 3 years after a con-
taminant is so identified, the Administrator 
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shall promulgate a performance standard under 
subparagraph (A) for the contaminant. 
(3) REVIEW; REVISION.—Not less than every 3 
years, the Administrator shall review and, if nec-
essary, revise— 
(A) the list of contaminants under para-
graph (1); and 
(B) each performance standard established 
under paragraph (2) or 
(c) PERFORMANCE STANDARDS.— 
(1) IN GENERAL.—The performance standards 
established under this section may include— 
(A) health-based standards that set the 
level of a contaminant that can safely and law-
fully be present in food; 
(B) zero tolerances, including any zero tol-
erance performance standards in effect on the 
day before the date of the enactment of this 
Act, when necessary to protect against signifi-
cant adverse health outcomes; 
(C) process standards, such as log reduc-
tion criteria for cooked products, when suffi-
cient to ensure the safety of processed food; and 
(D) in the absence of data to support a 
performance standard described in subpara-
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graph (A), (B), or (C), standards that define 
required performance on the basis of reliable in-
formation on the best reasonably achievable 
performance, using best available technologies, 
interventions, and practices. 
(2) BEST REASONABLY ACHIEVABLE PERFORM-
ANCE
STANDARDS.—In developing best reasonably 
achievable performance standards under paragraph 
(1)(D), the Administrator shall collect, or contract 
for the collection of, data on current best practices 
and food safety outcomes related to the contami-
nants and foods in question, as the Administrator 
determines necessary. 
(3) REVOCATION BY ADMINISTRATOR.—All per-
formance standards, tolerances, action levels, or 
other similar standards in effect on the date of the 
enactment of this Act shall remain in effect until re-
vised or revoked by the Administrator. 
(d) ENFORCEMENT.— 
(1) IN GENERAL.—In conjunction with the es-
tablishment of a performance standard under this 
section, the Administrator shall develop a statis-
tically valid sampling program with the stringency 
and frequency sufficient to independently monitor 
whether food establishments are complying with the 
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performance standard and implement the program 
within 1 year of the promulgation of the standard. 
(2) INSPECTIONS.—If the Administrator deter-
mines that a food establishment fails to meet a 
standard promulgated under this section, the Ad-
ministrator shall, as appropriate— 
(A) detain, seize, or condemn food from 
the food establishment under section 402; 
(B) order a recall of food from the food es-
tablishment under section 403; 
(C) increase the inspection frequency for 
the food establishment; 
(D) withdraw the mark of inspection from 
the food establishment, if in use; or 
(E) take other appropriate enforcement ac-
tion concerning the food establishment, includ-
ing withdrawal of registration. 
(e) NEWLY IDENTIFIED CONTAMINANTS.—Notwith-
standing any other provision of this section, the Adminis-
trator shall establish interim performance standards for 
newly identified contaminants as necessary to protect the 
public health. 
SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS. 
(a) IN GENERAL.—The Administrator shall establish 
an inspection program, which shall include statistically 
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valid sampling of food and facilities to enforce perform-
ance standards. The inspection program shall be designed 
to determine if each food establishment— 
(1) is operated in a sanitary manner; 
(2) has continuous preventive control systems, 
interventions, and processes in place to minimize or 
eliminate contaminants in food; 
(3) is in compliance with applicable perform-
ance standards established under section 204, and 
other regulatory requirements; 
(4) is processing food that is not adulterated or 
misbranded; 
(5) maintains records of process control plans 
under section 203, and other records related to the 
processing, sampling, and handling of food; and 
(6) is otherwise in compliance with the require-
ments of the food safety law. 
(b) ESTABLISHMENT CATEGORIES AND INSPECTION 
FREQUENCIES.—The resource plan required under section 
209, including the description of resources required to 
carry out inspections of food establishments, shall be 
based on the following categories and inspection fre-
quencies, subject to subsections (c), (d), and (e): 
(1) CATEGORY 1 FOOD ESTABLISHMENTS.—A 
category 1 food establishment shall be subject to 
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antemortem, postmortem, and continuous inspection 
of each slaughter line during all operating hours, 
and other inspection on a daily basis, sufficient to 
verify that— 
(A) diseased animals are not offered for 
slaughter; 
(B) the food establishment has successfully 
identified and removed from the slaughter line 
visibly defective or contaminated carcasses, has 
avoided cross-contamination, and has destroyed 
or reprocessed such carcasses in a manner ac-
ceptable 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 ESTABLISHMENTS.—A 
category 2 food establishment shall— 
(A) have ongoing verification that its proc-
esses are controlled; and 
(B) be randomly inspected at least weekly. 
(3) CATEGORY 3 FOOD ESTABLISHMENTS.—A 
category 3 food establishment shall— 
(A) have ongoing verification that its proc-
esses are controlled; and 
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(B) be randomly inspected at least month-
ly. 
(4) CATEGORY 4 FOOD ESTABLISHMENTS.—A 
category 4 food establishment shall— 
(A) have ongoing verification that its proc-
esses are controlled; and 
(B) be randomly inspected at least quar-
terly. 
(5) CATEGORY 5 FOOD ESTABLISHMENTS.—A 
category 5 food establishment shall— 
(A) have ongoing verification that its proc-
esses are controlled; and 
(B) be randomly inspected at least annu-
ally. 
(c) 
ESTABLISHMENT
OF
INSPECTION
PROCE-
DURES.—The Administrator shall establish procedures 
under which inspectors shall take random samples, photo-
graphs, and copies of records in food establishments. 
(d) ALTERNATIVE
INSPECTION
FREQUENCIES.— 
With respect to a subcategory of food establishment under 
category 2, 3, 4, or 5, the Administrator may establish 
alternative increasing or decreasing inspection frequencies 
for subcategories of food establishments or individual es-
tablishments, to foster risk-based allocation of resources. 
Before establishing an alternative inspection frequency for 
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a subcategory of food establishments or individual estab-
lishments, the Administrator shall take into consideration 
the evidence described in paragraph (2)(D) and the overall 
record of compliance described in paragraph (2)(E) for 
such subcategory. In establishing alternative inspection 
frequencies under this subsection, the Administrator shall 
comply with the following criteria and procedures: 
(1) Subcategories of food establishments and 
their alternative inspection frequencies shall be de-
fined by regulation, subject to paragraphs (2) and 
(3). 
(2) In defining subcategories of food establish-
ments and their alternative inspection frequencies 
under paragraphs (1) and (2), the Administrator 
shall consider— 
(A) the nature of the food products being 
processed, stored, or transported; 
(B) the manner in which food products are 
processed, stored, or transported; 
(C) the inherent likelihood that the prod-
ucts will contribute to the risk of food-borne ill-
ness; 
(D) the best available evidence concerning 
reported illnesses associated with the foods 
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processed, stored, held, or transported in the 
proposed subcategory of establishments; and 
(E) the overall record of compliance with 
food safety law among establishments in the 
proposed subcategory, including compliance 
with applicable performance standards and the 
frequency of recalls. 
(3) The Administrator may adopt alternative 
inspection frequencies for increased or decreased in-
spection for a specific establishment and shall annu-
ally publish a list of establishments subject to alter-
native inspections. 
(4) In adopting alternative inspection fre-
quencies for a specific establishment, the Adminis-
trator shall consider— 
(A) the criteria in paragraph (3), together 
with any evidence submitted from the individual 
food establishment supporting a request for an 
alternative inspection frequency, including the 
establishment’s record for implementing effec-
tive preventative process control systems; 
(B) whether products from the specific es-
tablishment have been associated with a case or 
an outbreak of food-borne illness; and 
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(C) the establishment’s record of compli-
ance with food safety law, including compliance 
with applicable performance standards and the 
frequency of recalls. 
(e) EFFECTIVE DATE.—The inspection mandates 
shall go into effect 2 years after the date of the enactment 
of this Act. 
(f) MAINTENANCE AND INSPECTION OF RECORDS.— 
(1) IN GENERAL.— 
(A) 
RECORDS.—A 
food 
establishment 
shall— 
(i) maintain such records as the Ad-
ministrator shall require by regulation, in-
cluding all records relating to the proc-
essing, distributing, receipt, or importation 
of any food; and 
(ii) permit the Administrator, in addi-
tion to any authority transferred to the 
Administrator pursuant to section 102, 
upon presentation of appropriate creden-
tials and at reasonable times and in a rea-
sonable manner, to have access to and 
copy all records maintained by or on behalf 
of such food establishment representative 
in any format (including paper or elec-
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tronic) and at any location, that are nec-
essary to assist the Administrator— 
(I) to determine whether the food 
is contaminated or not in compliance 
with the food safety law; or 
(II) to track the food in com-
merce. 
(B) REQUIRED DISCLOSURE.—A food es-
tablishment shall have an affirmative obligation 
to disclose to the Administrator the results of 
testing or sampling of food, equipment, or ma-
terial in contact with food, that is positive for 
any contaminant. 
(2) MAINTENANCE OF RECORDS.—The records 
in paragraph (1) shall be maintained for a reason-
able period of time, as determined by the Adminis-
trator. 
(3) REQUIREMENTS.—The records in para-
graph (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; 
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(D) the results of laboratory, sanitation, or 
other tests performed on the food or in the food 
establishment; 
(E) consumer complaints concerning the 
food or packaging of the food; 
(F) the production codes, open date codes, 
and locations of food production; and 
(G) other matters reasonably related to 
whether food is adulterated or misbranded, or 
otherwise fails to meet the requirements of this 
Act. 
(g) PROTECTION OF SENSITIVE INFORMATION.— 
(1) IN GENERAL.—The Administrator shall de-
velop and maintain procedures to prevent the unau-
thorized disclosure of any trade secret or commer-
cially valuable confidential information obtained by 
the Administrator. 
(2) LIMITATION.—The requirements under this 
subsection and subsection (f) do not— 
(A) limit the authority of the Adminis-
trator to inspect or copy records or to require 
the establishment or maintenance of records 
under this Act; 
(B) have any legal effect on section 1905 
of title 18, United States Code; 
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(C) extend to any food recipe, financial 
data, pricing data, or personnel data; 
(D) limit the public disclosure of distribu-
tion records or other records related to food 
subject to a voluntary or mandatory recall 
under section 403; or 
(E) limit the authority of the Adminis-
trator to promulgate regulations to permit the 
sharing of data with other governmental au-
thorities. 
(h) BRIBERY OF OR GIFTS TO INSPECTOR OR OTHER 
OFFICERS AND ACCEPTANCE OF GIFTS.—Any person or 
agent or employee thereof that gives, pays, or offers, di-
rectly or indirectly, to the Administrator or any employee 
or other designee thereof authorized to perform any duty 
under the food safety law any money or other thing of 
value, with intent to influence the discharge of any duty 
under such law, shall be imprisoned for not more than 5 
years, fined in accordance with title 18, United States 
Code, or both. Any Administrator, employee, or other des-
ignee that solicits or accepts any money or other thing 
of value from any person, with intent to influence the dis-
charge of any duty under the food safety law, shall be 
summarily discharged from office and imprisoned for not 
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more than 5 years, fined in accordance with title 18, 
United States Code, or both. 
SEC. 206. FOOD PRODUCTION FACILITIES. 
(a) AUTHORITIES.—In carrying out the duties of the 
Administrator and the purposes of this Act, the Adminis-
trator shall have the authority, with respect to food pro-
duction facilities, to— 
(1) visit and inspect food production facilities in 
the United States and in foreign countries to deter-
mine if they are operating in compliance with the re-
quirements of the food safety law; 
(2) review food safety records as required to be 
kept by the Administrator under section 210 and for 
other food safety purposes; 
(3) set good practice standards to protect the 
public and animal health and promote food safety; 
(4) conduct monitoring and surveillance of ani-
mals, plants, products, or the environment, as ap-
propriate; and 
(5) collect and maintain information relevant to 
public health and farm practices. 
(b) INSPECTION OF RECORDS.—A food production 
facility shall permit the Administrator upon presentation 
of appropriate credentials and at reasonable times and in 
a reasonable manner, to have access to and ability to copy 
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all records maintained by or on behalf of such food pro-
duction establishment in any format (including paper or 
electronic) and at any location, that are necessary to assist 
the Administrator— 
(1) to determine whether the food is contami-
nated, adulterated, or otherwise not in compliance 
with the food safety law; or 
(2) to track the food in commerce. 
(c) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Administrator, in 
consultation with the Secretary of Agriculture and rep-
resentatives of State departments of agriculture, shall pro-
mulgate regulations to establish science-based minimum 
standards for the safe production of food by food produc-
tion facilities. Such regulations shall— 
(1) consider all relevant hazards, including 
those occurring naturally, and those that may be un-
intentionally or intentionally introduced; 
(2) require each food production facility to have 
a written food safety plan that describes the likely 
hazards and preventive controls implemented to ad-
dress those hazards; 
(3) include, with respect to growing, harvesting, 
sorting, and storage operations, minimum standards 
related to fertilizer use, nutrients, hygiene, pack-
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aging, temperature controls, animal encroachment, 
and water; 
(4) include, with respect to animals raised for 
food, minimum standards related to the animal’s 
health, feed, and environment which bear on the 
safety of food for human consumption; 
(5) provide a reasonable period of time for com-
pliance, taking into account the needs of small busi-
nesses for additional time to comply; 
(6) provide for coordination of education and 
enforcement activities by State and local officials, as 
designated by the Governors of the respective States; 
and 
(7) include a description of the variance process 
under subsection (d) and the types of permissible 
variances which the Administrator may grant under 
such process. 
(d) VARIANCES.—States and foreign countries that 
export produce intended for consumption in the United 
States may request from the Administrator variances from 
the requirements of the regulations under subsection (c). 
A request shall— 
(1) be in writing; 
(2) describe the reasons the variance is nec-
essary; 
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(3) describe the procedures, processes, and 
practices that will be followed under the variance to 
ensure produce is not adulterated; and 
(4) contain any other information required by 
the Administrator. 
(e) APPROVAL OR DISAPPROVAL OF VARIANCES.—If 
the Administrator determines after review of a request 
under subsection (d) that the requested variance provides 
equivalent protections to those promulgated under sub-
section (c), the Administrator may approve the request. 
The Administrator shall deny a request if it is— 
(1) not sufficiently detailed to permit a deter-
mination; 
(2) fails to cite sufficient grounds for allowing 
a variance; or 
(3) does not provide reasonable assurances that 
the produce will not be adulterated. 
(f) ENFORCEMENT.—The Administrator may coordi-
nate with the agency or department designated by the 
Governor of each State to perform activities to ensure 
compliance with this section. 
(g) IMPORTED PRODUCE.—Not later than 1 year 
after the date of the enactment of this Act, the Adminis-
trator shall by regulation establish procedures for equiva-
lency with foreign countries that intend to export raw agri-
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cultural commodities and minimally processed produce to 
the United States. 
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 complies with the 
food safety law; 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 and continue to a State— 
(1) advisory assistance; 
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(2) technical and laboratory assistance and 
training (including necessary materials and equip-
ment); and 
(3) financial, in-kind, and other aid. 
(d) SERVICE AGREEMENTS.— 
(1) IN
GENERAL.—The Administrator may, 
under agreements entered into with Federal, State, 
or local agencies, use on a reimbursable basis or oth-
erwise the qualified personnel and services of those 
agencies in carrying out this Act. 
(2) TRAINING.—Agreements with a State under 
this subsection shall provide for training of State 
employees. 
(3) MAINTENANCE OF AGREEMENTS.—The Ad-
ministrator shall maintain any agreement that is in 
effect on the day before the date of the enactment 
of this Act until the Administrator evaluates such 
agreement and determines whether to maintain or 
substitute such agreement. 
(4) COMMISSIONING.—Where necessary and ap-
propriate to fulfill the provisions of this Act or other 
food safety law, the Administrator shall, as part of 
any service agreement, commission qualified State 
and local regulatory officials and inspectors to assist 
the Administrator in carrying out the food safety 
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(1) IN GENERAL.—A person that has reason to 
believe that any food introduced into or in interstate 
commerce, or held for sale (whether or not the first 
sale) after shipment in interstate commerce, may be 
in violation of the food safety law shall immediately 
notify the Administrator of the identity and location 
of the food. 
(2) MANNER
OF
NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Administrator may re-
quire by regulation. 
(b) RECALL AND CONSUMER NOTIFICATION.— 
(1) VOLUNTARY
ACTIONS.—If the Adminis-
trator determines that food is in violation of the food 
safety law when introduced into or while in inter-
state commerce or while held for sale (whether or 
not the first sale) after shipment in interstate com-
merce and that there is a reasonable probability that 
the food, if consumed, would present a threat to 
public health, as determined by the Administrator, 
the Administrator shall give the appropriate persons 
(including the manufacturers, importers, distribu-
tors, or retailers of the food) an opportunity to— 
(A) cease distribution of the food; 
(B) notify all persons— 
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