I 
108TH CONGRESS 
2D SESSION 
H. R. 5259
To establish the Food Safety Administration to protect the public health 
by preventing food-borne illness, ensuring the safety of food intended 
for human consumption, improving research on contaminants leading 
to food-borne illness, and improving security of food from intentional 
contamination. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 7, 2004
Ms. DELAURO (for herself, Ms. SLAUGHTER, Ms. LEE, and Ms. ROYBAL-AL-
LARD) introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Agri-
culture, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
A BILL 
To establish the Food Safety Administration to protect the 
public health by preventing food-borne illness, ensuring 
the safety of food intended for human consumption, im-
proving research on contaminants leading to food-borne 
illness, and improving security of food from intentional 
contamination.
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 2004’’. 
(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 establishments and foreign food establishments. 
Sec. 203. Preventative 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. 
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. Food detention, seizure, and condemnation. 
Sec. 403. Notification and recall. 
Sec. 404. Injunction proceedings. 
Sec. 405. Civil and criminal penalties. 
Sec. 406. Presumption. 
Sec. 407. Whistleblower protection. 
Sec. 408. Administration and enforcement. 
Sec. 409. Citizen civil actions. 
TITLE V—IMPLEMENTATION 
Sec. 501. Definition. 
Sec. 502. Reorganization plan. 
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions. 
Sec. 505. Conforming amendments. 
Sec. 506. Additional technical and conforming amendments. 
Sec. 507. Regulations. 
Sec. 508. Authorization of appropriations. 
Sec. 509. Limitation on authorization of appropriations. 
Sec. 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, system-wide approach to pre-
venting food-borne 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 
high-risk for food-borne illnesses; 
(C) an increasing volume of imported food, 
without adequate monitoring and inspection; 
and 
(D) 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 food-borne illness; 
(6) the Federal food safety system is frag-
mented, with at least 12 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 food-borne illness; 
(7) the fragmented Federal food safety system 
and outdated laws preclude an integrated, system-
wide approach to preventing food-borne illness, to 
the effective and efficient operation of the Nation’s
food safety program, and to the most beneficial de-
ployment 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’’—
(A) to regulate food safety and labeling to 
protect the public health; 
(B) to ensure that food establishments ful-
fill their responsibility to produce food in a
manner that protects the public health of all 
people in the United States; 
(C) to lead an integrated, system-wide ap-
proach to food safety and to make more effec-
tive and efficient use of resources to prevent 
food-borne illness; and 
(D) to provide a single focal point for food 
safety leadership, both nationally and inter-
nationally; 
(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 
(3) to modernize the Federal food safety laws 
to achieve more effective application and efficient 
management of the laws for the protection and im-
provement 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).
food establishment, nonprofit food establish-
ment in which food is prepared for or served di-
rectly to the consumer, or fishing vessel (other 
than a fishing vessel engaged in processing, 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, confined ani-
mal-feeding operation, or animal feed production fa-
cility. 
(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, 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 Egg Products Inspection Act (21 
U.S.C. 1031 et seq.); 
(F) the Sanitary Food Transportation Act 
of 1990 (49 U.S.C. App. 2801 et seq.); 
(G) the provisions of the Humane Methods 
of Slaughter Act of 1978 (Public Law 95–448) 
administered by the Food Safety and Inspection 
Service; 
(H) the provisions of this Act; and 
(I) 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. 
(16) FOREIGN FOOD ESTABLISHMENT.—
(A) IN GENERAL.—The term ‘‘foreign food 
establishment’’ means a slaughterhouse, fac-
tory, warehouse, or facility located outside the 
United States that processes food that is im-
ported into the United States without further
processing or packaging inside the United 
States. 
(B) FURTHER
PROCESSING
OR
PACK-
AGING.—A food shall not be considered to have 
undergone further processing or packaging sole-
ly because labeling was added or a similar activ-
ity of a de minimis nature was carried out with 
respect to the food. 
(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 harvesting, slaughter, 
packing, preparation, or manufacture of food. 
(20) SAFE.—The term ‘‘safe’’ refers to human 
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. 
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 
(4) oversee—
(A) implementation of Federal food safety 
inspection, 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 possible benefit 
in reducing food-borne illness; 
(E) coordination of the Federal response to 
food-borne 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-
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 establishments and imports; 
(5) the resources and facilities of the Office of 
the Commissioner of the Food and Drug Adminis-
tration that support—
(A) the Center for Food Safety and Ap-
plied Nutrition;
(B) the Center for Veterinary Medicine; 
and 
(C) the Office of Regulatory Affairs facili-
ties and resources described in paragraph (4); 
(6) the Center for Veterinary Medicine of the 
Food and Drug Administration; 
(7) the resources and facilities of the Environ-
mental Protection Agency that control and regulate 
pesticide residues in food; 
(8) the part of the Research, Education, and 
Economics mission area of the Department of Agri-
culture related to food safety and animal feed re-
search; 
(9) 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; and 
(10) such other offices, services, or agencies as 
the President designates by Executive order to carry 
out this Act. 
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 
(a) OFFICERS AND EMPLOYEES.—The Administrator 
may—
(1) appoint officers and employees for the Ad-
ministration in accordance with the provisions of
title 5, United States Code, relating to appointment 
in the competitive service; and 
(2) fix the compensation of those officers and 
employees in accordance with chapter 51 and with 
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.
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 for human consumption meet their responsi-
bility to prevent or minimize food safety hazards re-
lated 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 and specific points of potential 
contamination extending from the farm or ranch to 
the consumer that may render food unsafe for 
human consumption; 
(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 reduce 
potential health risks; and 
(5) opportunities for intentional contamination. 
(c) PROGRAM ELEMENTS.—In carrying out the pro-
gram, the Administrator shall—
(1) implement a national system for the reg-
istration of food establishments and foreign food es-
tablishments and regular unannounced inspection of 
food establishments; 
(2) enforce the adoption of process controls in 
food establishments, based on best available sci-
entific and public health considerations 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 sampling program to ensure 
that industry programs and procedures that prevent 
food contamination are effective on an ongoing basis 
and that food meets the 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, and monitoring; 
(7) have access to the surveillance data of the 
Centers for Disease Control and Prevention, and 
other Federal Government agencies, in order to im-
plement a national surveillance system to assess the 
health risks associated with the human consumption 
of food; 
(8) develop public education risk communica-
tion and advisory programs; 
(9) implement a research program to further 
the purposes of this Act; and 
(10) coordinate and prioritize food safety re-
search and educational programs with other agen-
cies, including State or local agencies. 
SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND 
FOREIGN FOOD ESTABLISHMENTS. 
(a) IN GENERAL.—The Administrator shall by regu-
lation require that any food establishment or foreign food 
establishment engaged in processing food for human con-
sumption in the United States be registered with the Ad-
ministrator.
(b) REGISTRATION REQUIREMENTS.—
(1) IN GENERAL.—To be registered under sub-
section (a)—
(A) in the case of a food establishment, the 
owner, operator, or agent in charge of the food 
establishment shall submit a registration to the 
Administrator; and 
(B) in the case of a foreign food establish-
ment, the owner, operator, or agent in charge 
of the foreign food establishment shall—
(i) submit a registration to the Ad-
ministrator; and 
(ii) provide the name, address, and 
emergency contact information of the 
United States agent for the foreign food 
establishment. 
(2) REGISTRATION.—A food establishment or 
foreign food establishment shall submit a registra-
tion under paragraph (1) to the Administrator 
that—
(A) identifies the name, address, and emer-
gency contact information of each food estab-
lishment or foreign food establishment that the 
registrant operates under this Act and all trade
names under which the registrant conducts 
business relating to food; 
(B) lists the primary purpose and business 
activity of each food establishment or foreign 
food establishment, including the dates of oper-
ation if the food establishment or foreign food 
establishment is seasonal; 
(C) lists the types of food processed or sold 
at each food establishment or, for foreign food 
establishments selling food for consumption in 
the United States, identifies the specific food 
categories of that food as listed under section 
170.3 of title 21, Code of Federal Regulations; 
and 
(D) not later than 30 days after a change 
in the products, function, or legal status of the 
food establishment or foreign food establish-
ment (including cessation of business activities), 
notifies the Administrator of the 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 and assign a registration number to 
each food establishment and foreign food establish-
ment.
(4) LIST.—The Administrator shall compile and 
maintain an up-to-date list of food establishments 
and foreign food establishments that are registered 
under this section. 
(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 registered 
person. 
(6) SUSPENSION OF REGISTRATION.—
(A) IN GENERAL.—The Administrator may 
suspend the registration of a food establishment 
or foreign food establishment, including the fa-
cility of an importer, for violation of a food 
safety law. 
(B) NOTICE
AND
OPPORTUNITY
FOR 
HEARING.—The Administrator shall provide no-
tice to a registrant immediately upon the sus-
pension of the registration of the facility and 
provide registrant with an opportunity for a 
hearing within 3 days of the suspension.
(7) REINSTATEMENT.—A registration that is 
suspended under this section may be reinstated pur-
suant to criteria published in the Federal Register 
by the Administrator. 
SEC. 203. PREVENTATIVE 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—
(1) process food in a sanitary manner; 
(2) limit the presence of potentially harmful 
contaminants in food; 
(3) implement appropriate measures of prevent-
ative process control to minimize and reduce the 
presence and growth of contaminants in food and 
meet the performance standards established under 
section 204; 
(4) process all fully processed or ready-to-eat 
food in a sanitary manner, using reasonably avail-
able techniques and technologies to eliminate any po-
tentially harmful contaminants; and 
(5) label food intended for final processing out-
side commercial food establishments with instruc-
tions for handling and preparation for consumption 
that, when adhered to, will destroy contaminants. 
(b) REGULATIONS.—Not later than 1 year after the 
effective date of this Act, the Administrator shall promul-
gate regulations that—
(1) require all food establishments to adopt pre-
ventative process controls that are—
(A) adequate to protect the public health; 
(B) meet relevant regulatory and food 
safety standards; and 
(C) limit the presence and growth of con-
taminants in food prepared in a food establish-
ment; 
(2) set standards for sanitation; 
(3) meet any performance standards for con-
taminants established under section 204; 
(4) require recordkeeping to monitor compli-
ance; 
(5) require sampling and testing at a frequency 
and in a manner sufficient to ensure that process 
controls are effective on an ongoing basis and that 
regulatory standards are being met; and 
(6) provide for agency access to records kept by 
food establishments and submission of copies of the
records to the Administrator, as the Administrator 
determines appropriate. 
(c) PROCESSING
CONTROLS.—The Administrator 
may require any person with responsibility for or control 
over food or food ingredients to adopt process controls, 
if the process controls are needed to ensure the protection 
of the public health. 
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS 
IN FOOD. 
(a) IN GENERAL.—To protect the public health, the 
Administrator shall establish by regulation and enforce 
performance standards that define, with respect to specific 
food-borne contaminants and foods, the level of food safety 
performance that a person responsible for producing, proc-
essing, or selling food shall meet. 
(b) IDENTIFICATION OF CONTAMINANTS; PERFORM-
ANCE STANDARDS.—
(1) IN
GENERAL.—Not later than 6 months 
after the date of enactment of this Act, the Adminis-
trator shall identify the food-borne contaminants 
and food that contribute significantly to the risk of 
food-borne illness. 
(2) PERFORMANCE
STANDARDS.—As soon as 
practicable after the identification of the contami-
nants under paragraph (1), the Administrator shall
establish appropriate performance standards to pro-
tect against all food-borne contaminants. 
(3) SIGNIFICANT CONTAMINANTS.—The Admin-
istrator shall establish performance standards for 
the 5 most significant contaminants associated with 
raw meat, poultry, and seafood not later than 3 
years after the date of enactment of this Act. 
(c) PERFORMANCE STANDARDS.—
(1) IN GENERAL.—The performance standards 
established under this section shall 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, in addition to any 
zero-tolerance standards in effect on the day be-
fore the date of enactment of this Act, when 
necessary to protect against significant 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-
graph (A), (B), or (C), standards that define 
required performance in terms of ‘‘best reason-
ably achievable performance’’, using best avail-
able technologies, interventions, and practices. 
(2) BEST REASONABLY ACHIEVABLE PERFORM-
ANCE
STANDARDS.—In developing best reasonably 
achievable performance standards, the Administrator 
shall collect, or contract for the collection of, data on 
current best practices and food safety outcomes re-
lated to the contaminants 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 en-
actment of this Act shall remain in effect until re-
vised or revoked by the Administrator. 
(d) ENFORCEMENT.—
(1) IN GENERAL.—Not later than 1 year after 
the promulgation of a performance standard under 
this section, the Administrator shall implement a 
sampling program to determine whether food estab-
lishments are complying with the performance stand-
ards promulgated under this section. The program 
established under this paragraph shall be at least as 
stringent as the Hazard Analysis and Critical Con-
trol Point System requirements established under
part 417 of title 9, Code of Federal Regulations (or 
successor regulation). 
(2) INSPECTIONS.—If the Administrator deter-
mines that a food establishment fails to meet a 
standard promulgated under this section, and such 
establishment fails to take appropriate corrective ac-
tion as determined by the Administrator, the Admin-
istrator 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. 
(e) NEWLY IDENTIFIED CONTAMINANTS.—Notwith-
standing any other provision of this section, the Adminis-
trator shall promulgate interim performance standards for 
newly identified contaminants as necessary to protect the 
public health.
SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS. 
(a) IN GENERAL.—The Administrator shall establish 
an inspection program, which shall include sampling and 
testing of food and food establishments, to determine if 
each food establishment—
(1) is operating in a sanitary manner; 
(2) has continuous systems, interventions, and 
processes in place to minimize or eliminate contami-
nants in food; 
(3) is in compliance with applicable perform-
ance standards established under section 203, and 
other regulatory requirements; 
(4) is processing food that is safe for human 
consumption and 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 in compliance with the requirements 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) and (d):
(1) CATEGORY 1 FOOD ESTABLISHMENTS.—A 
category 1 food establishment shall be subject to 
antemortem 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 and 
destroyed or reprocessed them in a manner ac-
ceptable to the Administrator; and 
(C) that applicable performance standards 
and other provisions of the food safety law have 
been satisfied. 
(2) CATEGORY 2 FOOD ESTABLISHMENTS.—A 
category 2 food establishment shall be randomly in-
spected at least daily. 
(3) CATEGORY 3 FOOD ESTABLISHMENTS.—A 
category 3 food establishment shall—
(A) have ongoing verification that its proc-
esses are controlled; and 
(B) be randomly inspected at least month-
ly.
(4) CATEGORY 4 FOOD ESTABLISHMENTS.—A 
category 4 food establishment shall be randomly in-
spected at least quarterly. 
(5) CATEGORY 5 FOOD ESTABLISHMENTS.—A 
category 5 food establishment shall be randomly in-
spected at least annually. 
(c) ALTERNATIVE
INSPECTION
FREQUENCIES.—
With respect to a category 2, 3, 4, or 5 food establishment, 
the Administrator may establish alternative inspection fre-
quencies for subcategories of food establishments or indi-
vidual establishments, to foster risk-based allocation of re-
sources, subject to 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) Regulations of alternative inspection fre-
quencies for subcategories of food establishments 
under paragraph (1) and for a specific food estab-
lishment under paragraph (4) shall provide that—
(A) category 2 food establishments shall be 
inspected at least monthly; and 
(B) category 3, 4, and 5 food establish-
ments shall be inspected at least annually.
(3) 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 pro-
duced in the proposed subcategory of establish-
ments; and 
(E) the overall record of compliance with 
the food safety law among establishments in the 
proposed subcategory, including compliance 
with applicable performance standards and the 
frequency of recalls. 
(4) The Administrator may adopt alternative 
inspection frequencies for a specific establishment, 
subject to paragraphs (2) and (5) and shall periodi-
cally publish a list of establishments subject to alter-
native inspections.
(5) In adopting alternative inspection fre-
quencies for a specific establishment, the Adminis-
trator shall consider—
(A) the criteria in paragraph (3); 
(B) whether products from the specific es-
tablishment have been associated with a case or 
an outbreak of food-borne illness; and 
(C) the record of the establishment of com-
pliance with the food safety law, including com-
pliance with applicable performance standards 
and the frequency of recalls. 
(6) Before establishing alternative inspection 
frequencies for subcategories of establishments or in-
dividual establishments, the Administrator shall—
(A) determine, based on the best available 
evidence, that the alternative uses of the re-
sources required to carry out the inspection ac-
tivity would make a greater contribution to pro-
tecting the public health and reducing the risk 
of food-borne illness than the use of resources 
described in subsection (b); 
(B) describe the alternative uses of re-
sources in general terms when issuing the regu-
lation or order that establishes the alternative 
inspection frequency;
(C) consider the supporting evidence that 
an individual food establishment shall submit 
related to whether an alternative inspection fre-
quency should be established for such establish-
ment by the Administrator; and 
(D) include a description of the alternative 
uses in the annual resource plan required in 
section 209. 
(d) INSPECTION TRANSITION.—The Administrator 
shall manage the transition to the inspection system de-
scribed in this Act as follows: 
(1) In the case of a category 1 or 2 food estab-
lishment, the Administrator shall continue to imple-
ment the applicable inspection mandates of the Fed-
eral Meat Inspection Act (21 U.S.C. 601 et seq.), 
the Poultry Products Inspection Act (21 U.S.C. 451 
et seq.), and the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) until—
(A) regulations required to implement this 
section have been promulgated; 
(B) the performance standards required by 
section 204(c) have been promulgated and im-
plemented for 1 year; and
other aspects of the process control system have 
been made such that the Administrator deter-
mines that compliance with the food safety law 
is achieved; and 
(B) following the demonstration required 
in subparagraph (A), issue an order authorizing 
the establishment to operate subject, at a min-
imum, to—
(i) the inspection requirement applica-
ble to the establishment under subsection 
(b)(3); and 
(ii) such other inspection or compli-
ance measures determined by the Adminis-
trator necessary to assure compliance with 
the food safety law. 
(5) In the case of a category 4 or 5 food estab-
lishment, the inspection requirements of this Act 
shall be implemented as soon as possible after—
(A) the promulgation of the regulations re-
quired to implement this section; 
(B) the publication of the first resource 
plan under section 209; and 
(C) the commencement of the first fiscal 
year in which the Administration is operating 
with budgetary resources that Congress has ap-
propriated following consideration of the re-
source plan under section 209. 
(e) OFFICIAL MARK.—
(1) IN GENERAL.—
(A) ESTABLISHMENT.—Before the comple-
tion of the transition process under paragraphs 
(1) through (3) of subsection (d), the Adminis-
trator shall by regulation establish an official 
mark that shall be affixed to a food product 
produced in a category 1, 2, or 3 establishment, 
subject to subparagraph (B). 
(B) PREREQUISITE.—The official mark re-
quired under subparagraph (A) shall be affixed 
to a food product by the Administrator if the 
establishment has been inspected by the Admin-
istrator in accordance with the inspection fre-
quencies under this section and the establish-
ment is in compliance with the food safety law. 
(2) CATEGORY 1, 2, OR 3 FOOD ESTABLISH-
MENTS.—In the case of products produced in a cat-
egory 1, 2, or 3 food establishment—
(A) products subject to Federal Meat In-
spection Act (21 U.S.C. 601 et seq.), the Poul-
try Products Inspection Act (21 U.S.C. 451 et 
seq.), the Egg Products Inspection Act (21
U.S.C. 1031 et seq.), and the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) as of the date of enactment of this Act 
shall remain subject to the requirement under 
those Acts that they bear the mark of inspec-
tion pending completion of the transition proc-
ess under paragraphs (1) through (3) of sub-
section (d); 
(B) the Administrator shall publicly certify 
on a monthly basis that the inspection fre-
quencies required under this Act have been 
achieved; and 
(C) a product from an establishment that 
has not been inspected in accordance with the 
required frequencies under this section shall not 
bear the official mark and shall not be shipped 
in interstate commerce. 
(3) CATEGORY
AND
FOOD
ESTABLISH-
MENTS.—In the case of a product produced in a cat-
egory 4 or 5 food establishment the Administrator 
shall provide by regulation for the voluntary use of 
the official mark established under paragraph (1), 
subject to—
(A) such minimum inspection frequencies 
as determined appropriate by the Adminis-
trator; 
(B) compliance with applicable perform-
ance standards and other provisions of the food 
safety law; and 
(C) such other requirements the Adminis-
trator considers appropriate. 
(f) IMPLEMENTATION.—Not later than 1 year after 
the effective date of this Act, the Administrator shall issue 
regulations to implement subsections (b) through (d). 
(g) 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 of the food safety 
agencies in effect on the day before the 
date of enactment of this Act, upon pres-
entation of appropriate credentials and at
reasonable times and in a reasonable man-
ner, to have access to and copy all records 
maintained by or on behalf of such food es-
tablishment representative in any format 
(including paper or electronic) and at any 
location, that are necessary 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; 
(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 unsafe for human consumption, 
is adulterated or misbranded, or otherwise fails 
to meet the requirements of this Act. 
(h) PROTECTION OF SENSITIVE INFORMATION.—
(1) IN GENERAL.—The Administrator shall de-
velop and maintain procedures to prevent the unau-
thorized disclosure of any trade secret or confiden-
tial information obtained by the Administrator. 
(2) LIMITATION.—The requirement under this 
subsection does not—
(A) limit the authority of the Adminis-
trator to inspect or copy records or to require 
the establishment or maintenance of records 
under this Act; 
(B) have any legal effect on section 1905 
of title 18, United States Code; 
(C) extend to any food recipe, financial 
data, pricing data, personnel data, or sales data 
(other than shipment dates relating to sales); or 
(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. 
(i) BRIBERY OF OR GIFTS TO INSPECTOR OR OTHER 
OFFICERS AND ACCEPTANCE OF GIFTS.—Section 22 of 
the Federal Meat Inspection Act (21 U.S.C. 622) shall 
apply to an inspection under this Act. 
SEC. 206. FOOD PRODUCTION FACILITIES. 
In carrying out the duties of the Administrator and 
the purposes of this Act, the Administrator shall have the 
authority, with respect to food production facilities, to—
(1) visit and inspect food production facilities in 
the United States and in foreign countries to inves-
tigate bioterrorism threats and for other critical food 
safety purposes;
(2) review food safety records as required to be 
kept by the Administrator to carry out traceback 
and for other critical 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. 
SEC. 207. FEDERAL AND STATE COOPERATION. 
(a) IN GENERAL.—The Administrator shall work 
with the States to carry out activities and programs that 
contribute to the national food safety program so that 
Federal and State programs function in a coordinated and 
cost-effective manner. 
(b) STATE ACTION.—The Administrator shall work 
with States to—
(1) continue, strengthen, or establish State food 
safety programs, especially with respect to the regu-
lation of retail commercial food establishments, 
transportation, harvesting, and fresh markets; 
(2) establish inspection programs and require-
ments to ensure that food under the jurisdiction of 
the State is safe for human consumption; and
(3) support recall authorities at the State and 
local levels. 
(c) ASSISTANCE.—To assist in planning, developing, 
and implementing a food safety program, the Adminis-
trator may provide to a State—
(1) advisory assistance; 
(2) technical and laboratory assistance and 
training (including necessary materials and equip-
ment); and 
(3) financial 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 personnel and services of those agencies 
in carrying out this Act. 
(2) TRAINING.—Agreements with a State under 
this subsection may provide for training of State em-
ployees. 
(3) MAINTENANCE OF AGREEMENTS.—The Ad-
ministrator shall maintain any agreement that is in 
effect on the day before the date of enactment of 
this Act until the Administrator evaluates such 
agreement and determines whether to maintain or 
substitute such agreement.
(e) AUDITS.—
(1) IN GENERAL.—The Administrator shall an-
nually conduct a comprehensive review of each State 
program that provides services to the Administrator 
in carrying out the responsibilities under this Act, 
including mandated inspections under section 205. 
(2) REQUIREMENTS.—The review shall—
(A) include a determination of the effec-
tiveness of the State program; and 
(B) identify any changes necessary to en-
sure enforcement of Federal requirements 
under this Act. 
SEC. 208. IMPORTS. 
(a) IN GENERAL.—Not later than 2 years after the 
effective date of this Act, the Administrator shall establish 
a system under which a foreign government or foreign 
food establishment seeking to import food to the United 
States shall submit a request for certification to the Ad-
ministrator. 
(b) CERTIFICATION STANDARD.—A foreign govern-
ment or foreign food establishment requesting a certifi-
cation to import food to the United States shall dem-
onstrate, in a manner determined appropriate by the Ad-
ministrator, that food produced under the supervision of 
a foreign government or by the foreign food establishment
has met standards for food safety, inspection, labeling, 
and consumer protection that are at least equivalent to 
standards applicable to food produced in the United 
States. 
(c) CERTIFICATION APPROVAL.—
(1) REQUEST
BY
FOREIGN
GOVERNMENT.—
Prior to granting the certification request of a for-
eign government, the Administrator shall review, 
audit, and certify the food safety program of a re-
questing foreign government (including all statutes, 
regulations, and inspection authority) as at least 
equivalent to the food safety program in the United 
States, as demonstrated by the foreign government. 
(2) REQUEST BY FOREIGN FOOD ESTABLISH-
MENT.—Prior to granting the certification request of 
a foreign food establishment, the Administrator shall 
certify, based on an onsite inspection, the food safe-
ty programs and procedures of a requesting foreign 
firm as at least equivalent to the food safety pro-
grams and procedures of the United States. 
(d) LIMITATION.—A foreign government or foreign 
firm approved by the Administrator to import food to the 
United States under this section shall be certified to ex-
port only the approved food products to the United States 
for a period not to exceed 5 years.
(e) WITHDRAWAL OF CERTIFICATION.—The Admin-
istrator may withdraw certification of any food from a for-
eign government or foreign firm—
(1) if such food is linked to an outbreak of 
human illness; 
(2) following an investigation by the Adminis-
trator that finds that the foreign government pro-
grams and procedures or foreign food establishment 
is no longer equivalent to the food safety programs 
and procedures in the United States; or 
(3) following a refusal to allow United States 
officials to conduct such audits and investigations as 
may be necessary to fulfill the requirements under 
this section. 
(f) RENEWAL
OF CERTIFICATION.—The Adminis-
trator shall audit foreign governments and foreign food 
establishments at least every 5 years to ensure the contin-
ued compliance with the standards set forth in this sec-
tion. 
(g) REQUIRED ROUTINE INSPECTION.—The Admin-
istrator shall routinely inspect food before it enters the 
United States to ensure that it is—
(1) safe for human consumption;
(2) labeled as required for food produced in the 
United States; and
(3) otherwise meets requirements under the 
food safety law. 
(h) ENFORCEMENT.—The Administrator—
(1) may deny importation of food from any for-
eign government that does not permit United States 
officials to enter the foreign country to conduct such 
audits and inspections as may be necessary to fulfill 
the requirements under this section; 
(2) may deny importation of food from any for-
eign government or foreign firm that does not con-
sent to an investigation by the Administration when 
food from that foreign country or foreign firm is 
linked to a food-borne illness outbreak or is other-
wise found to be adulterated or mislabeled; and
(3) is authorized to promulgate rules and regu-
lations to carry out the purposes of this section, in-
cluding setting terms and conditions for the destruc-
tion of products that fail to meet the standards of 
this Act. 
(i) DETENTION AND SEIZURE.—Any food imported 
for consumption in the United States may be detained, 
seized, or condemned pursuant to section 402. 
SEC. 209. RESOURCE PLAN. 
(a) IN GENERAL.—The Administrator shall prepare 
and update annually a resource plan describing the re-
sources required, in the best professional judgment of the 
Administrator, to develop and fully implement the national 
food safety program established under this Act. 
(b) CONTENTS OF PLAN.—The resource plan shall—
(1) describe quantitatively the personnel, finan-
cial, and other resources required to carry out the 
inspection of food establishments under section 205 
and other requirements of the national food safety 
program; 
(2) allocate inspection resources in a manner 
reflecting the distribution of risk and opportunities 
to reduce risk across the food supply to the extent 
feasible based on the best available information, and 
subject to section 205; and 
(3) describe the personnel, facilities, equipment, 
and other resources needed to carry out inspection 
and other oversight activities, at a total resource 
level equal to at least 50 percent of the resources re-
quired to carry out inspections in food establish-
ments under section 205—
(A) in foreign establishments; 
(B) at the point of importation; and 
(C) at the point of production on farms, 
ranches, and feedlots.
(c) GRANTS.—The resource plan shall include rec-
ommendations for funding to provide grants to States and 
local governments to carry out food safety activities in re-
tail and food service facilities and the required inspections 
in food establishments.
(d) SUBMISSION OF PLAN.—The Administrator shall 
submit annually to the Committee on Appropriations of 
the Senate, the Committee on Appropriations of the House 
of Representatives, and other relevant committees of Con-
gress, the resource plan required under this section. 
SEC. 210. TRACEBACK. 
(a) IN GENERAL.—The Administrator, in order to 
protect the public health, shall establish requirements for 
tracing food and food producing animals from point of ori-
gin to retail sale, subject to subsection (b). 
(b) 
APPLICABILITY.—Traceability 
requirements 
shall—
(1) be established in accordance with regula-
tions and guidelines issued by the Administrator; 
and 
(2) apply to food production facilities and food 
establishments.
(c) RELATIONSHIP TO COUNTRY OF ORIGIN LABEL-
ING.—Nothing contained in this section prevents or inter-
feres with implementation of the country of origin labeling
requirements of subtitle D of the Agricultural Marketing 
Act of 1946 (7 U.S.C. 1638 et seq.). 
TITLE III—RESEARCH AND 
EDUCATION 
SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) IN GENERAL.—The Administrator, acting in co-
ordination with the Director of the Centers for Disease 
Control and Prevention and with the Research Education 
and Economics mission area of the Department of Agri-
culture, shall—
(1) have access to the applicable data systems 
of the Centers for Disease Control and Prevention; 
(2) maintain an active surveillance system of 
food, food products, and epidemiological evidence 
submitted by States to the Centers for Disease Con-
trol and Prevention based on a representative pro-
portion of the population of the United States; 
(3) assess the frequency and sources of human 
illness in the United States associated with the con-
sumption of food; and 
(4) maintain a state-of-the-art DNA matching 
system and epidemiological system dedicated to food-
borne illness identification, outbreaks, and contain-
ment. 
(b) PUBLIC HEALTH SAMPLING.—
(1) IN GENERAL.—Not later than 1 year after 
the effective date of this Act, the Administrator shall 
establish guidelines for a sampling system under 
which the Administrator shall take and analyze sam-
ples of food—
(A) to assist the Administrator in carrying 
out this Act; and 
(B) to assess the nature, frequency of oc-
currence, and quantities of contaminants in 
food. 
(2) REQUIREMENTS.—The sampling system de-
scribed in paragraph (1) shall provide—
(A) statistically valid monitoring, including 
market-based studies, on the nature, frequency 
of occurrence, and quantities of contaminants 
in food available to consumers; and 
(B) at the request of the Administrator, 
such other information, including analysis of 
monitoring and verification samples, as the Ad-
ministrator determines may be useful in assess-
ing the occurrence of contaminants in food. 
(c) ASSESSMENT OF HEALTH HAZARDS.—
(1) IN
GENERAL.—Through the surveillance 
system referred to in subsection (a) and the sam-
pling system described in subsection (b), the Admin-
istrator shall—
(A) rank food categories based on the haz-
ard to human health presented by the food cat-
egory; 
(B) identify appropriate industry and regu-
latory approaches to minimize hazards in the 
food supply; and 
(C) assess the public health environment 
for emerging diseases, including zoonosis, for 
their risk of appearance in the United States 
food supply. 
(2) COMPONENTS OF ANALYSIS.—The analysis 
under subsection (b)(1) may include—
(A) a comparison of the safety of commer-
cial processing with the health hazards associ-
ated with food that is harvested for recreational 
or subsistence purposes and prepared non-
commercially; 
(B) a comparison of the safety of food that 
is domestically processed with the health haz-
ards associated with food that is processed out-
side the United States;
(C) a description of contamination origi-
nating from handling practices that occur prior 
to or after the sale of food to consumers; and
(D) use of comparative risk assessments. 
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM. 
(a) PUBLIC EDUCATION.—
(1) IN GENERAL.—The Administrator, in co-
operation with private and public organizations, in-
cluding the cooperative extension services and appro-
priate State and local entities, shall establish a na-
tional public education program on food safety. 
(2) REQUIREMENTS.—The program shall pro-
vide—
(A) information to the public regarding 
Federal standards and best practices and pro-
motion of public awareness, understanding, and 
acceptance of those standards and practices; 
(B) information for health professionals—
(i) to improve diagnosis and treatment 
of food-related illness; and 
(ii) to advise individuals at special 
risk for food-related illnesses; and 
(C) such other information or advice to 
consumers and other persons as the Adminis-
trator determines will promote the purposes of 
this Act. 
(b) HEALTH ADVISORIES.—The Administrator, in 
consultation with other Federal departments and agencies 
as the Administrator determines necessary, shall work 
with the States and other appropriate entities—
(1) to develop and distribute regional and na-
tional advisories concerning food safety; 
(2) to develop standardized formats for written 
and broadcast advisories; 
(3) to incorporate State and local advisories 
into the national public education program estab-
lished under subsection (a); and 
(4) to present prompt, specific information re-
garding foods found to pose a threat to the public 
health. 
SEC. 303. RESEARCH. 
(a) IN GENERAL.—The Administrator shall conduct 
research to carry out this Act, including studies—
(1) to improve sanitation and food safety prac-
tices in the processing of food; 
(2) to develop improved techniques to monitor 
and inspect food; 
(3) to develop efficient, rapid, and sensitive 
methods to detect contaminants in food;