I 
111TH CONGRESS 
1ST SESSION 
H. R. 875 
To establish the Food Safety Administration within the Department of Health 
and Human Services to protect the public health by preventing food- 
borne illness, ensuring the safety of food, improving research on contami-
nants leading to food-borne illness, and improving security of food from 
intentional contamination, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 4, 2009 
Ms. DELAURO (for herself, Ms. ESHOO, Ms. DEGETTE, Ms. SCHAKOWSKY, 
Mr. ENGEL, Ms. CASTOR of Florida, Mr. MURPHY of Connecticut, Ms. 
SUTTON, Mrs. LOWEY, Ms. SLAUGHTER, Mr. HINCHEY, Mr. MCGOVERN, 
Ms. WASSERMAN SCHULTZ, Ms. HIRONO, Mr. GRIJALVA, Mr. SCHAUER, 
Mr. NADLER of New York, Mr. BISHOP of New York, Ms. LINDA T. 
SA´NCHEZ of California, Mr. MCDERMOTT, Mr. RYAN of Ohio, Ms. GIF-
FORDS, Mr. FILNER, Mr. HALL of New York, Ms. LEE of California, Ms. 
PINGREE of Maine, Ms. KAPTUR, Mr. BISHOP of Georgia, Ms. MOORE 
of Wisconsin, and Mr. DEFAZIO) introduced the following bill; which was 
referred to the Committee on Energy and Commerce, and in addition to 
the Committee on Agriculture, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
To establish the Food Safety Administration within the 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. 
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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 
‘‘Food Safety Modernization Act of 2009’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Findings; purposes. 
Sec. 3. Definitions. 
TITLE I—ESTABLISHMENT OF THE FOOD SAFETY 
ADMINISTRATION 
Sec. 101. Establishment of the food safety administration. 
Sec. 102. Consolidation of food safety functions. 
Sec. 103. Additional duties of the administration. 
TITLE II—ADMINISTRATION OF FOOD SAFETY PROGRAM 
Sec. 201. Administration of national program. 
Sec. 202. Registration of food establishments and foreign food establishments. 
Sec. 203. Preventive process controls to reduce adulteration of food. 
Sec. 204. Performance standards for contaminants in food. 
Sec. 205. Inspections of food establishments. 
Sec. 206. Food production facilities. 
Sec. 207. Federal and State cooperation. 
Sec. 208. Imports. 
Sec. 209. Resource plan. 
Sec. 210. Traceback requirements. 
Sec. 211. Accredited laboratories. 
TITLE III—RESEARCH AND EDUCATION 
Sec. 301. Public health assessment system. 
Sec. 302. Public education and advisory system. 
Sec. 303. Research. 
Sec. 304. Working group on improving foodborne illness surveillance. 
Sec. 305. Career-spanning training for food inspectors. 
Sec. 306. Food-Borne Illness Health Registry. 
Sec. 307. Study on Federal resources. 
TITLE IV—ENFORCEMENT 
Sec. 401. Prohibited acts. 
Sec. 402. Food detention, seizure, and condemnation. 
Sec. 403. Notification and recall. 
Sec. 404. Injunction proceedings. 
Sec. 405. Civil and criminal penalties. 
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Sec. 406. Presumption. 
Sec. 407. Whistleblower protection. 
Sec. 408. Administration and enforcement. 
Sec. 409. Citizen civil actions. 
TITLE V—IMPLEMENTATION 
Sec. 501. Reorganization plan. 
Sec. 502. Transitional authorities. 
Sec. 503. Savings provisions. 
Sec. 504. Conforming amendments. 
Sec. 505. Additional technical and conforming amendments. 
Sec. 506. Regulations. 
Sec. 507. Authorization of appropriations. 
Sec. 508. Limitation on authorization of appropriations. 
SEC. 2. FINDINGS; PURPOSES. 
(a) FINDINGS.—Congress finds that— 
(1) the safety of the food supply of the United 
States is vital to the public health, to public 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; 
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(4) the safety and security of the food supply 
require a systemwide approach to prevent food-borne 
illness involving the integrated efforts of Federal, 
State and local agencies; a thorough, broad-based, 
and coordinated approach to basic and applied 
science; and intensive, effective, and efficient 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 
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(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 
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 
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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; 
(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— 
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(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; 
(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, including internally gen-
erated, scientifically and statistically valid stud-
ies, 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-
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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; 
(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-
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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 
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 
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or frozen, or other products that the Administrator 
determines by regulation to pose a significant risk of 
hazardous contamination. 
(7) CATEGORY 3 FOOD ESTABLISHMENT.—The 
term ‘‘category 3 food establishment’’ means a food 
establishment (other than a category 1 or category 
2 establishment) that processes cooked, pasteurized, 
or otherwise ready-to-eat seafood or other animal 
products, fresh produce in ready-to-eat raw form, or 
other products that pose a risk of hazardous 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 
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found on or in food can cause human illness, injury, 
or death. 
(11) HAZARDOUS CONTAMINATION.—The term 
‘‘hazardous contamination’’ refers to the presence of 
a contaminant in food at levels that pose a risk of 
human illness, injury, or death or are capable of 
reaching levels that pose such risk during the shelf 
life of the product. 
(12) FOOD.—The term ‘‘food’’ means a product 
intended to be used for food or drink for a human 
or an animal and components thereof. 
(13) FOOD ESTABLISHMENT.— 
(A) IN GENERAL.—The term ‘‘food 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-
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lishment in which food is prepared for or served 
directly to the consumer, or fishing vessel 
(other than a fishing vessel engaged in proc-
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; 
(B) the provisions of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et 11 
seq.) and of any other Acts that are 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 studying, 
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surveying, containing, or preventing food-borne 
illness; and 
(D) the provisions of this Act. 
(16) FOREIGN
FOOD
ESTABLISHMENT.—The 
term ‘‘foreign food establishment’’ means any 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 
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(D) any other territory or possession of the 
United States. 
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; 
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(2) serve as the food safety leader within the 
Department of Health and Human Services and co-
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 relevant 
international food safety bodies and discussions; 
(4) promulgate regulations to ensure the safety 
and security of the food supply from all forms of 
contamination, including intentional contamination; 
and 
(5) oversee within the Department of Health 
and Human Services— 
(A) in consultation with the Director of the 
Centers for Disease Control and Prevention, all 
activities related to foodborne illness surveil-
lance and investigation of foodborne illness out-
breaks; 
(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; 
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(D) coordination and prioritization of food 
safety research and education programs with 
other Federal agencies; 
(E) prioritization of food safety efforts and 
deployment of food safety resources to achieve 
the greatest possible benefit in reducing food- 
borne illness; 
(F) coordination of the response to food- 
borne illness outbreaks with other Federal and 
State agencies; and 
(G) integration of food safety activities 
with State and local agencies. 
SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS. 
(a) TRANSFER OF FUNCTIONS AND RESOURCES.— 
For each component of the Department of Health and 
Human Services or the Department of Commerce specified 
in subsection (b), there are transferred to the 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— 
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(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; 
(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 and enforcement of the food safety law; 
(5) the personnel and assets of the Office of the 
Commissioner of Food and Drugs used to support— 
(A) the Center for Food Safety and 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 
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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-
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. 
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(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 
developing recommendations with respect to the de-
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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— 
(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; 
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(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; 
(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; 
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(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; 
(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 and collaborate with other agen-
cies and State or local governments in carrying out 
inspection, enforcement, research, and monitoring; 
(8) implement a national system to identify the 
food products posing the greatest public health risk 
and to analyze the effectiveness of existing food safe-
ty programs, in conjunction with the Centers for 
Disease Control and Prevention and other Federal 
agencies; 
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(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 
(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 
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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-
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, 
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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 list the 
name of any establishment that fails to reregister, 
and such delisting shall be treated as a suspension. 
(5) DISCLOSURE EXEMPTION.—The disclosure 
requirements under section 552 of title 5, United 
States Code, shall not apply to— 
(A) the list compiled under paragraph (4); 
and 
(B) information derived from the list under 
paragraph (4), to the extent that it discloses 
the identity or location of a specific person. 
(6) SUSPENSION OF REGISTRATION.— 
(A) IN GENERAL.—The Administrator may 
suspend the registration of a domestic food 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-
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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 
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 
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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. 
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; 
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(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; 
(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-
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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 
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-
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