and efficient management of the laws for the protec-
tion and improvement of public health. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) ADMINISTRATION.—The term ‘‘Administra-
tion’’ means the Food Safety Administration estab-
lished under section 101(a)(1). 
(2) ADMINISTRATOR.—The term ‘‘Adminis-
trator’’ means the Administrator of Food Safety ap-
pointed under section 101(a)(3). 
(3) ADULTERATED.— 
(A) IN
GENERAL.—The term ‘‘adulter-
ated’’ has the meaning described in subsections 
(a) through (c) of section 402 of the Federal 
Food, Drug, and Cosmetic 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 that slaughters animals for food. 
(6) CATEGORY 2 FOOD ESTABLISHMENT.—The 
term ‘‘category 2 food establishment’’ means a food 
establishment that processes raw meat, poultry, sea-
food products, regardless of whether the establish-
ment also has a kill step, and animal feed and other 
products that the Administrator determines by regu-
lation to be at high risk of contamination and the 
processes of which do not include a step validated to 
destroy contaminants. 
(7) CATEGORY 3 FOOD ESTABLISHMENT.—The 
term ‘‘category 3 food establishment’’ means a food 
establishment that processes meat, poultry, seafood 
products, and other products that the Administrator 
determines by regulation to be at high risk of con-
tamination and whose processes include a step vali-
dated to destroy contaminants. 
(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 or manufac-
tured toxin, virus, parasite, prion, physical hazard, 
or other human pathogen that when found on or in 
food can cause human illness, injury, or death. 
(11) CONTAMINATION.—The term ‘‘contamina-
tion’’ refers to a presence of a contaminant in food. 
(12) FOOD.— 
(A) IN
GENERAL.—The term ‘‘food’’ 
means a product intended to be used for food 
or drink for a human or an animal. 
(B) INCLUSIONS.—The term ‘‘food’’ in-
cludes any product (including a meat food prod-
uct, as defined in section 1(j) of the Federal 
Meat Inspection Act (21 U.S.C. 601(j))), capa-
ble for use as human food that is made in whole 
or in part from any animal, including cattle, 
sheep, swine, or goat, or poultry (as defined in 
section 4 of the Poultry Products Inspection 
Act (21 U.S.C. 453)), and animal feed.
(C) EXCLUSION.—The term ‘‘food’’ does 
not include dietary supplements, as defined in 
section 201(ff) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(ff)). 
(13) FOOD ESTABLISHMENT.— 
(A) IN GENERAL.—The term ‘‘food estab-
lishment’’ means a slaughterhouse, factory, 
warehouse, or facility owned or operated by a 
person located in any State that processes 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 farm, restaurant, other retail 
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, 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, 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.—The 
term ‘‘foreign food establishment’’ means a slaugh-
terhouse, factory, warehouse, or facility located out-
side the United States that processes food for con-
sumption that is imported into the United States or 
food ingredients. 
(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 
and animal health.
(21) STATE.—The term ‘‘State’’ means— 
(A) a State; 
(B) the District of Columbia; 
(C) the Commonwealth of Puerto Rico; 
and 
(D) any other territory or possession of the 
United States. 
(22) 
VALIDATION.—The 
term 
‘‘validation’’ 
means the obtaining of evidence that the food hy-
giene control measure or measures selected to con-
trol a hazard in food is capable of effectively and 
consistently controlling the hazard. 
(23) STATISTICALLY VALID.—With respect to a 
study, the term ‘‘statistically valid’’ means evaluated 
and conducted under standards set by the National 
Institute of Standards and Technology. 
TITLE I—ESTABLISHMENT OF 
FOOD SAFETY ADMINISTRATION 
SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRA-
TION. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—There is established in the 
executive branch an agency to be known as the 
‘‘Food Safety Administration’’.
(2) STATUS.—The Administration shall be an 
independent establishment (as defined in section 104 
of title 5, United States Code). 
(3) HEAD OF ADMINISTRATION.—The Adminis-
tration shall be headed by the Administrator of Food 
Safety, who shall be appointed by the President, by 
and with the advice and consent of the Senate. 
(b) DUTIES
OF ADMINISTRATOR.—The Adminis-
trator shall— 
(1) administer and enforce the food safety law; 
(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; 
(10) the Animal and Plant Inspection Health 
Service of the Department of Agriculture; and 
(11) 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. 
(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— 
(1) administer a national food safety program 
(referred to in this section as the ‘‘program’’) to 
protect public health; and 
(2) ensure that persons who produce or process 
food meet their responsibility to prevent or minimize 
food safety hazards related to their products. 
(b) COMPREHENSIVE ANALYSIS.—The program shall 
be based on a comprehensive analysis of the hazards asso-
ciated with different food and with the processing of dif-
ferent food, including the identification and evaluation 
of— 
(1) the severity of the 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; 
(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) adopt and implement a national system for 
the registration of food establishments and foreign 
food establishments and regular unannounced in-
spection 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 statistically valid sampling pro-
gram to ensure 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; 
(5) implement procedures and requirements to 
ensure the safety and security of imported food;
(6) coordinate with other agencies and State or 
local governments in carrying out inspection, en-
forcement, research, and monitoring; 
(7) 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 or to create surveillance data and studies; 
(8) develop public education risk communica-
tion and advisory programs; 
(9) implement a basic and applied research pro-
gram 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 in the United 
States be registered with the Administrator. 
(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, designate each establishment as a 
category 1, 2, 3, 4, or 5 food establishment, and as-
sign a registration number to each food establish-
ment and foreign food establishment. 
(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. The Administrator may establish 
regulations by which such list may be shared with 
other governmental authorities. 
(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 carry out their responsibilities to— 
(1) process food in a sanitary manner so that 
it is free of dirt and filth; 
(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 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 contaminants that contribute to the greatest 
number of illnesses or deaths associated with raw 
meat, poultry, and seafood not later than 3 years 
after the date of enactment of this Act. The Admin-
istrator shall revise such standards not less often 
than every 3 years. 
(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, including zero toler-
ances for fecal matter, in addition to any zero- 
tolerance standards in effect on the day before 
the date of enactment of this Act, when nec-
essary 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 
statistically significant sampling program to deter-
mine whether food establishments are complying 
with the performance standards promulgated under
this section. The program established under this 
paragraph shall be at least as stringent as the Haz-
ard Analysis and Critical Control Point System re-
quirements established under part 417 of title 9, 
Code of Federal Regulations (or successor regula-
tion). 
(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, includ-
ing withdrawal of registration. 
(e) NEWLY IDENTIFIED CONTAMINANTS.—Notwith-
standing any other provision of this section, the Adminis-