I 
108TH CONGRESS 
1ST SESSION H. R. 1496
To establish a comprehensive program to ensure the safety of food products 
intended for human consumption which are regulated by the Food and 
Drug Administration. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 27, 2003
Mr. PALLONE introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To establish a comprehensive program to ensure the safety 
of food products intended for human consumption which 
are regulated by the Food and Drug Administration.
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 
‘‘Consumer Food Safety Act of 2003’’. 
(b) TABLE OF CONTENTS.—
Sec. 1. Short title; table of contents. 
Sec. 2. Definitions. 
TITLE I—NATIONAL FOOD SAFETY PROGRAM 
Sec. 101. Administration of national program. 
Sec. 102. Process controls to reduce the adulteration of food products.
Sec. 103. Inspections of processors and importers. 
Sec. 104. Tolerances for contaminants in food. 
Sec. 104. State and Federal cooperation. 
Sec. 106. Imports. 
TITLE II—RESEARCH AND EDUCATION 
Sec. 201. Public health assessment system. 
Sec. 202. Public education and advisory system. 
Sec. 203. Research. 
TITLE III—ENFORCEMENT 
Sec. 301. Amendments to the Federal Food, Drug, and Cosmetic Act. 
TITLE IV—AUTHORIZATION 
Sec. 401. Authorization of appropriations.
SEC. 2. DEFINITIONS. 
For purposes of this Act: 
(1) The term ‘‘contaminants’’ includes bacteria, 
chemical contaminants, natural toxins, viruses, 
parasites, and physical hazards that when found on 
or in food can cause human illness or injury. 
(2) The term ‘‘facility’’ includes any factory, 
warehouse, establishment, or importer that handles 
or processes food. 
(3) The term ‘‘process’’ means the commercial 
harvesting, preparation, manufacture, or transpor-
tation of food products. 
(4) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services.
TITLE I—NATIONAL FOOD 
SAFETY PROGRAM 
SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM. 
(a) IN GENERAL.—
(1) Persons who produce or process food for 
human consumption have the responsibility to pre-
vent or minimize food safety hazards related to their 
products. The Secretary shall administer a national 
program for the purpose of protecting human health 
by ensuring that the food industry has effective pro-
grams in place to assure the safety of food products 
consumed in the United States. 
(2) The program shall—
(A) be based on a comprehensive analysis 
of the hazards associated with different food 
products and with the harvesting, processing, 
and handling of different food products, includ-
ing the identification and evaluation of—
(i) the severity of the potential health 
risks; 
(ii) the sources and specific points of 
potential contamination that may render 
food products unsafe for human consump-
tion; and
(iii) the potential for persistence, mul-
tiplication, or concentration of naturally 
occurring or added contaminants in foods 
and food products; 
(B) take into consideration the distinctive 
characteristics of food production and proc-
essing; 
(C) establish inspection and oversight pro-
cedures to monitor that facilities are utilizing 
preventive controls to minimize or eliminate 
identifiable hazards; and 
(D) require each food processing facility to 
annually register with the Secretary. 
(b) PROGRAM ELEMENTS.—The program shall pro-
vide for—
(1) implementation of a national system for the 
registration and quarterly inspection of facilities and 
importers. Quarterly inspections can be waived by 
plants that meet the Secretary’s standards for ex-
ceptional or negligible-risk facilities or importers; 
(2) development of a program to oversee the 
implementation of process controls in food proc-
essing facilities; 
(3) the establishment and enforcement of 
health-based standards for (A) substances which
may contaminate food and (B) safety and sanitation 
in the processing and handling of food products; 
(4) implementation of a sampling program to 
ensure that industry programs to prevent food con-
tamination are effective and that food products meet 
the standards established in paragraph (1); 
(5) implementation of procedures and require-
ments to ensure the safety of imported food prod-
ucts; 
(6) coordination with other Federal agencies or 
State governments in carrying out inspection, en-
forcement, and monitoring; 
(7) implementation of a national surveillance 
system to assess the health risks associated with the 
human consumption of food products, in cooperation 
with the Secretary of Agriculture and the Centers 
for Disease Control and Prevention; 
(8) development of public education and advi-
sory programs; and
(9) implementation of a research program in 
furtherance of the purposes of this Act.
SEC. 102. PROCESS CONTROLS TO REDUCE THE ADULTERA-
TION OF FOOD PRODUCTS. 
(a) IN GENERAL.—The Secretary shall, upon the 
basis of the best available scientific and technological data, 
prescribe regulations to—
(1) limit the presence of human pathogens and 
other potentially harmful substances in food prod-
ucts; 
(2) ensure that all registered facilities imple-
ment appropriate measures to control and reduce 
the presence and growth of human pathogens and 
other potentially harmful substances on food prod-
ucts; 
(3) ensure that all fully processed or ready-to-
eat food products are processed in a sanitary man-
ner, using reasonably available techniques and tech-
nologies to eliminate any human pathogens or other 
potentially harmful substances likely to cause 
foodborne illness; and 
(4) ensure that food products intended for final 
processing outside commercial establishments are la-
beled with instructions for handling and preparation 
for consumption which, when adhered to, will de-
stroy any human pathogens or other potentially 
harmful substance likely to cause foodborne illness.
(b) REGULATIONS.—The Secretary shall, within one 
year of the enactment of this Act, issue regulations that 
require all registered facilities to adopt processing controls 
adequate to protect public health and to limit the presence 
and growth of human pathogens and other potentially 
harmful substances in food products prepared in any reg-
istered facility. Such regulations shall—
(1) set standards for sanitation; 
(2) set tolerances for biological, chemical, and 
physical hazards as appropriate; 
(3) require process controls to assure that food 
is safe and that relevant regulatory and safety 
standards are met; 
(4) require recordkeeping to monitor compli-
ance; 
(5) require sampling to assure that processing 
controls are effective and that regulatory standards 
are being met; and 
(6) provide for agency access to records kept by 
official establishments and submission of copies of 
such records to the Secretary as the Secretary 
deems appropriate. 
Public access to records that relate to the adequacy of 
measures taken by official establishments to protect the 
public health and to limit the presence and growth of
human pathogens and other potentially harmful sub-
stances shall be governed by 5 U.S.C. 552 et seq. The 
Secretary may, as the Secretary deems necessary, require 
any person, firm, or corporation with responsibility for or 
control over food ingredients to adopt processing controls, 
where such processing controls are needed to assure the 
protection of public health.
SEC. 103. INSPECTIONS OF PROCESSORS AND IMPORTERS. 
(a) NATURE OF INSPECTIONS.—
(1) The inspection system shall provide for fre-
quent unannounced inspections of food processing 
and importing facilities to determine if such facilities 
are operated in a sanitary manner and if food prod-
ucts are unsafe for human consumption, or adulter-
ated or misbranded under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.). Inspec-
tions shall include review of processing records and 
sampling of food products. 
(2) Inspections shall be conducted at least quar-
terly, unless the Secretary determines that the facil-
ity is an exceptional or negligible-risk facility under 
standards established by the Secretary. 
(3) Standards for exceptional or negligible-risk 
facilities shall consider the hazards associated with 
the type of product being produced; and the facility’s
history of compliance, food safety problems and such 
other factors as the Secretary may deem appro-
priate. The Secretary shall specify an alternative in-
spection frequency for each facility which is deemed 
exceptional or negligible-risk. Each inspection shall 
include an examination of whether the facility con-
tinues to meet the standards for exceptional or neg-
ligible-risk facilities. 
(b) CONDUCT OF INSPECTIONS.—
(1) An inspection under subsection (a) of any 
domestic, foreign, or importing facility shall extend 
to all things therein (including records required to 
be maintained under subsection (e), processes, con-
trols, and premises) that bear on whether food prod-
ucts are in compliance with this Act or the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). Access to records may include the copying of 
such records. 
(2) In conducting such inspections, officers or 
employees duly designated by the Secretary, upon 
presenting appropriate credentials to the owner, op-
erator, or agent in charge, are authorized—
(A) to enter at reasonable times any facil-
ity in which persons are engaged in the food 
processing or importing of food products, or to
enter any vehicle being used to transport or 
hold such food products; 
(B) to inspect in a reasonable manner such 
facility or vehicle and all pertinent equipment, 
finished and unfinished materials, containers, 
labeling, processes, controls, and premises; and 
(C) to collect and retain samples of food 
products or ingredients or of any other items 
found during an inspection that may contribute 
to a finding of whether such food products are 
unsafe for human consumption or adulterated 
or misbranded under the Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.). 
(3) Immediately after completion of inspection, 
the officer or employee making the inspection shall 
give to the owner, operator, or agent in charge a re-
port in writing setting forth any conditions or prac-
tices observed which indicate that either processing 
controls are inadequate to prevent or minimize food 
safety hazards or that any food from such facility is 
unsafe for human consumption, or adulterated or 
misbranded under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.). 
(c) PRODUCT DETENTION AND CONDEMNATION.—
(1) If, during an inspection conducted under 
this section, an officer or employee making the in-
spection has reason to believe that a food product is 
unsafe for human consumption, or adulterated or 
misbranded under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.), such officer or 
employee may order the food product segregated, 
impounded, and if objection is not made within 48 
hours, condemned. If objection is made, such food 
products that are in perishable form may be proc-
essed to the extent necessary to prevent spoilage, 
and a hearing shall be commenced expeditiously. 
(2) If the Secretary determines that, through 
relabeling or other action, such food products can be 
brought into compliance with this Act and the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), the food may be released following a deter-
mination by the Secretary that such relabeling or 
other action as specified by the Secretary has been 
performed. 
(3) Any food product condemned without objec-
tion, or after hearing and judicial review, shall be 
destroyed under supervision of the Secretary. 
(d) OFFICIAL MARK.—The Secretary shall prescribe 
by regulation the conditions under which any food product
shall display an official mark, when needed to facilitate 
exports, that signifies that the food product has been proc-
essed in accordance with standards approved by the Sec-
retary. Such a mark may be subject to a fee. 
(e) MAINTENANCE OF RECORDS.—Each facility or 
person registered under this section shall maintain and 
make available for inspection by the Secretary such 
records as the Secretary may prescribe. Such records shall 
be maintained for a reasonable period of time as deter-
mined by the Secretary. The records shall include, but are 
not limited to, information concerning—
(1) the origin, receipt, delivery, sale, movement, 
holding, and disposition of food products or ingredi-
ents; the identity and amount of ingredients used in 
the food; the processing of the food; the results of 
laboratory, sanitation, or other quality control tests 
performed on the food or in the facility; consumer 
complaints concerning the food or its packaging; and 
(2) other matters reasonably related to whether 
food products may be unsafe for human consump-
tion, or adulterated or misbranded under the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.). 
(f) OTHER INSPECTION RIGHTS AND DUTIES.—Sec-
tion 704 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 374) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) The rights and duties under this section of duly 
designated officers and employees and of other persons 
shall apply to enforcement of the Consumer Food Safety 
Act of 2003 to the same extent and in the same manner 
as they apply to enforcement of this Act.’’.
SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD. 
(a) TOLERANCES.—The Secretary shall establish tol-
erances limiting the quantity of contaminants, except for 
pesticide residues regulated under section 408 or food ad-
ditives regulated under section 409 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), that, 
when found in food products, may render such products 
unsafe for human consumption. Contaminants include but 
are not limited to bacteria, chemical contaminants, natural 
toxins, viruses and parasites that when found on or in food 
can cause human illness. Such tolerances may include in-
dicators (including indicator organisms) from which it 
may reasonably be inferred that a contaminant is present 
in a food product. In developing a tolerance, the Secretary 
shall take into account the extent to which consumers may 
be exposed to such contaminant from sources other than 
food, and the extent to which such contaminant can be
avoided or minimized in the commercial handling and 
processing of such food. 
(b) REGULATIONS.—
(1) The Secretary, after notice and an oppor-
tunity for comment, shall promulgate regulations to 
implement subsection (a) within 48 months after the 
date of enactment of this Act. In promulgating such 
regulations, the Secretary shall establish tolerances 
for the contaminants that the Secretary determines 
are having the greatest public health impact as early 
as feasible after implementation of this Act. 
(2) A tolerance established under this section 
shall be based on—
(A) a scientific analysis of the health risks 
attributable to the contaminant for which the 
tolerance is established; and 
(B) analysis of the risks for sensitive 
groups, such as children, elderly, pregnant 
women and the immune compromised. 
(3) The Secretary shall, in a timely manner, 
issue revisions to the regulations under paragraph 
(1) which take into account new information. The 
Secretary may contract with the National Academy 
of Sciences to provide such data or assistance as the 
Secretary deems necessary.
(2) establish procedures and requirements for 
ensuring that food products under the jurisdiction of 
the State are not unsafe for human consumption. 
(b) ASSISTANCE.—
(1) The Secretary may provide to a State, for 
planning, developing, and implementing a food safe-
ty program—
(A) advisory assistance; 
(B) technical and laboratory assistance 
and training (including necessary materials and 
equipment); and 
(C) financial and other aid. 
(c) SERVICE AGREEMENTS.—The Secretary may, 
under agreements entered into with Federal, State, or 
local agencies, use on a reimbursable basis or otherwise 
the personnel, services, and facilities of such agencies in 
carrying out their responsibilities under this Act. Such an 
agreement shall provide that any compliance records, no-
tices, or reports issued in connection with activities under 
the agreement and in the possession of the agency or gov-
ernment which entered into the agreement shall be made 
available in accordance with section 552 of title 5, United 
States Code. Agreements with a State under this sub-
section may provide for training of State employees.
SEC. 106. IMPORTS. 
(a) ROLE OF SECRETARY.—Within 24 months after 
the date of enactment of this Act, the Secretary shall es-
tablish and administer a comprehensive and efficient sys-
tem to ensure the safety of food imported into the United 
States. The Secretary shall routinely inspect processing 
facilities in exporting nations and imports at ports of entry 
into the United States. The Secretary shall assure the ef-
fective operation through verification and other activities 
as the Secretary considers necessary. 
(b) IMPORT REQUIREMENTS.—
(1) No food product may enter the United 
States, or be withdrawn from a warehouse, for con-
sumption in the United States if such food prod-
uct—
(A) appears unsafe for human consump-
tion, or adulterated or misbranded under the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.); 
(B) is not marked or labeled as required 
by regulations for domestic or imported articles; 
or 
(C) does not comply with the requirements 
of this section. 
(2) Upon entry for consumption in the United 
States, food products that are not prohibited from
entry or from withdrawal from a warehouse under 
paragraph (1) shall be deemed to be and treated as 
domestic food products, except that all labeling of 
such products shall clearly identify the country of 
origin to facilitate the identification of products 
linked to outbreaks of illness. 
(c) INSPECTION OF IMPORTS.—
(1) Food products that are offered for importa-
tion, or withdrawn from a warehouse, for consump-
tion in the United States, shall be subject to exami-
nations inspections, sampling, and such other proce-
dures at the port of entry or in the exporting nation 
by officers or employees duly designated by the Sec-
retary. Such procedures shall be conducted with 
such frequency and in such manner as the Secretary 
may prescribe by regulation. 
(2) Food products from a nation that is cer-
tified for such food products under subsection (e)(3) 
shall be subject to random examinations, inspections, 
sampling, and other procedures. Food products from 
a nation that is not certified for such food products 
under subsection (e)(3) shall be subject to such in-
tensified examinations, inspections, sampling, and 
other verification procedures, including inspection in
the country of origin, as the Secretary determines 
are necessary to ensure compliance with this Act. 
(d) DETENTION OF IMPORTED FOOD PRODUCT.—If 
during an inspection or other verification procedure car-
ried out under this section, an officer or employee con-
ducting the procedure has reason to believe that a food 
product is unsafe for human consumption, or adulterated 
or misbranded under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.), such officer or employee 
may order the food product segregated, impounded, and 
if objection is not made within 48 hours, condemned. If 
objection is made, such food products that are in perish-
able form may be processed to the extent necessary to pre-
vent spoilage, and a hearing shall be commenced expedi-
tiously. The final condemnation or other disposition of 
such food product shall be subject to the provisions of sec-
tion 103(c). 
(e) AGREEMENTS WITH FOREIGN NATIONS.—
(1) The Secretary may enter into an agreement 
with any nation desiring to export food products to 
the United States. Prior to concluding such an 
agreement, the Secretary shall evaluate the food 
safety program of the foreign nation to determine if 
such program provides at least the same level of pro-
tection, with respect to food products intended for
export to the United States, as domestic laws that 
affect the safety of the food supply. In such evalua-
tion, the Secretary shall consider—
(A) the potential for health, sanitary, envi-
ronmental, or other conditions within the for-
eign nation to adversely affect the safety of 
food products exported from such nation; and 
(B) how well the food safety programs of 
the foreign nation functions to minimize any 
adverse effects on such safety. 
(2) Any agreement under this subsection with a 
nation desiring to export food products to the 
United States shall—
(A) require that the exporting nation 
shall—
(i) establish and maintain a food safe-
ty system that is adequate to ensure that 
the food products intended for export to 
the United States are safe for human con-
sumption, and not adulterated or mis-
branded under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.); 
and 
(ii) promptly notify the Secretary of 
any violations affecting the safety of food
products exported or intended for export to 
the United States; 
(B) provide for such activities (whether in 
the exporting nation or at the port of entry dur-
ing importation) by the Secretary, including ex-
aminations, inspections, sampling, and testing, 
at such stages in the growth or harvest of food, 
or in the processing or handling of food prod-
ucts, as the Secretary considers appropriate to 
ensure that the food safety program of the ex-
porting nation continues to provide at least the 
same level of protection, with respect to food 
products intended for export to the United 
States, as domestic laws that affect the safety 
of the food supply; and 
(C) provide for reciprocity with respect to 
the treatment of food imports and exports be-
tween the United States and the exporting na-
tion. 
(3) If the Secretary determines that a nation 
desiring to export food products to the United States 
has a program that provides at least the saline level 
of protection, with respect to food products intended 
for export to the United States, as domestic laws 
that affect the safety of the food supply, the Sec-
retary shall, upon entry into force of an agreement 
under subsection (e)(1), certify the types of food 
products for which the nation maintains such a pro-
gram. 
(4)(A) The Secretary shall periodically or for 
good cause, and not less than once every 3 years, re-
view certifications made under paragraph (3), and 
shall revoke the certification of any nation that the 
Secretary determines is not maintaining a food safe-
ty program that provides at least the same level of 
protection, with respect to food products intended 
for export to the United States, as domestic laws 
that affect the safety of the food supply. 
(B) The Secretary shall review and modify, as 
needed, an agreement made under paragraph (1) 
with any nation whose certification has been revoked 
under subparagraph (A) of this paragraph. 
TITLE II—RESEARCH AND 
EDUCATION 
SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) COOPERATION WITH THE CENTERS FOR DISEASE 
CONTROL AND PREVENTION.—The Secretary shall work, 
through the Centers for Disease Control and Prevention, 
to include food in an active surveillance system, based on 
a representative proportion of the population of the United
States, and to assess more accurately the frequency and 
sources of human illness in the United States associated 
with the consumption of food. 
(b) PUBLIC HEALTH SAMPLING.—
(1) Within 12 months after the date of enact-
ment of this Act, the Secretary in cooperation with 
the Secretary of Agriculture shall establish guide-
lines for a sampling system under which the Sec-
retary and the Secretary of Agriculture shall take 
and analyze samples of food products to assist the 
Secretary in carrying out this Act and the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.), and to more accurately assess the nature, fre-
quency of occurrence, and amounts of contaminants 
in food products. 
(2) Such sampling system shall provide—
(A) statistically valid monitoring, including 
market-basket studies, on the nature, frequency 
of occurrence, and amounts of contaminants in 
food products available to consumers; and 
(B) at the request of the Secretary, such 
other information, including analysis of moni-
toring and verification samples, as the Sec-
retary determines may be useful in assessing
the occurrence of contaminants in food prod-
ucts. 
(c) ASSESSMENT OF HEALTH HAZARDS.—Through 
the surveillance system referred to in subsection (a) and 
the sampling system described in subsection (b), the Sec-
retary shall rank food categories based on their hazard 
to human health and identify appropriate industry and 
regulatory approaches to minimize hazards in the food 
supply. Such analysis could include—
(1) the safety of commercial harvesting and 
processing, as compared with the health hazards as-
sociated with food products that are harvested for 
recreational or subsistence purposes and prepared 
noncommercially; 
(2) the safety of food products that are domes-
tically harvested and processed, as compared with 
the health hazards associated with food products
that are harvested or processed outside the United 
States; and 
(3) contamination originating from handling 
practices that occur prior to or after sale of food 
products to consumers. 
SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM. 
(a) PUBLIC EDUCATION.—The Secretary, in coopera-
tion with private and public organizations, including the
cooperative extension services and appropriate State enti-
ties, shall design and implement a national public edu-
cation program on food safety. The program shall pro-
vide—
(1) information to the public regarding Federal 
standards and good practice requirements and pro-
motion of public awareness understanding and ac-
ceptance of such standards and requirements; 
(2) information to health professionals so that 
they may improve diagnosis and treatment of food-
related illness and advise individuals whose health 
conditions place them in particular risk; and 
(3) such other information or advice to con-
sumers and other persons as the Secretary deter-
mines will promote the purposes of this Act. 
(b) HEALTH ADVISORIES.—The Secretary, in con-
sultation with the Secretary of Agriculture and the Admin-
istrator of the Environmental Protection Agency, shall 
work with the States and other appropriate entities to—
(1) develop and distribute regional and national 
advisories concerning food safety; 
(2) develop standardized formats for written 
and broadcast advisories; and
(3) incorporate State and local advisories into 
the national public education program required 
under subsection (a). 
SEC. 203. RESEARCH. 
(a) IN GENERAL.—The Secretary shall conduct re-
search to assist in the implementation of this Act, includ-
ing studies to—
(1) improve sanitation and food safety practices 
in the processing of food products; 
(2) develop improved techniques for the moni-
toring of food and inspection of food products; 
(3) develop efficient, rapid, and sensitive meth-
ods for determining and detecting the presence of 
contaminants in food products; 
(4) determine the sources of contamination of 
food and food products with contaminants; and 
(5) develop consumption data with respect to 
food products. 
(b) CONTRACT AUTHORITY.—The Secretary is au-
thorized to enter into contracts and agreements with any 
State, university, other government agencies or other per-
sons to carry out the activities under this section.
TITLE III—ENFORCEMENT 
SEC. 301. AMENDMENTS TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add-
ing after section 415 the following new sections: 
‘‘SEC. 416. NOTIFICATION AND RECALL. 
‘‘(a) NOTICE TO SECRETARY OF ADULTERATION OR 
MISBRANDING.—Any person (other than a household con-
sumer or other individual who is the intended consumer 
of an article of food) that has a reasonable basis for believ-
ing that any article of food introduced into or in interstate 
commerce, or held for sale (whether or not the first sale) 
after shipment in interstate commerce, may be adulterated 
or misbranded or otherwise in violation of the Consumer 
Food Safety Act of 2003 shall immediately notify the Sec-
retary, in such manner and by such means as the Sec-
retary may by regulation prescribe, of the identity and lo-
cation of such article. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY
PROCEDURES.—If the Sec-
retary finds, upon notification under subsection (a) 
or otherwise, that any article of food is adulterated 
or misbranded when introduced into or while in 
interstate commerce or while held for sale (whether
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies 
provided in this section shall be in addition to and not 
exclusive of other remedies that may be available. 
‘‘SEC. 417. CIVIL PENALTIES. 
‘‘(a) IN GENERAL.—
‘‘(1) ACTS
SUBJECT
TO
PENALTY; PENALTY 
AMOUNT.—Any person that commits an act that vio-
lates this Act with respect to food or the Consumer 
Food Safety Act of 2003 may be assessed a civil 
penalty by the Secretary of not more than $100,000 
for each such act. Each such act and each day dur-
ing which such act continues shall be a separate of-
fense. 
‘‘(2) NOTICE AND HEARING.—No penalty shall 
be assessed by the Secretary under this section un-
less such person is given notice and opportunity for 
a hearing on the record before the Secretary in ac-
cordance with sections 554 and 556 of title 5, 
United States Code. 
‘‘(3) OTHER REQUIREMENTS.—The amount of 
such civil penalty shall be assessed by the Secretary 
by written order, taking into account the gravity of 
the violation, degree of culpability, size and type of 
business, and any history of prior offenses; and may 
be reviewed only as provided in subsection (b).
‘‘(b) JUDICIAL REVIEW.—An order assessing a civil 
penalty under subsection (a) shall be final and conclusive 
unless the person files, within 30 days from the effective 
date of the order, an application for judicial review in the 
Court of Appeals of the United States for the circuit in 
which such person resides or has its principal place of 
business or in the United States Court of Appeals for the 
District of Columbia Circuit by filing a notice of appeal 
in such court and by simultaneously sending a copy of 
such notice by certified mail to the Secretary. The Sec-
retary shall promptly file in such court a certified copy 
of the record upon which such penalty was assessed. The 
findings of the Secretary shall be set aside only if found 
to be unsupported by substantial evidence on the record 
as a whole. 
‘‘(c) COLLECTION ACTIONS.—If any person fails to 
pay an assessment of a civil penalty after it has become 
a final and unappealable order, or after the appropriate 
court of appeals has entered final judgment in favor of 
the Secretary, the Secretary shall refer the matter to the 
Attorney General, who shall institute a civil action to re-
cover the amount assessed in an appropriate district court 
of the United States. In such collection action, the validity 
and appropriateness of the Secretary’s order imposing the 
civil penalty shall not be subject to review.
‘‘(d) PENALTIES PAID INTO TREASURY.—All pen-
alties collected under authority of this section shall be paid 
into the Treasury of the United States. 
‘‘(e) SECRETARY’S DISCRETION TO PROSECUTE.—
Nothing in this Act shall be construed as requiring the 
Secretary to report for prosecution, or for the institution 
of libel or injunction proceedings, violations of this Act 
whenever the Secretary believes that the public interest 
will be adequately served by assessment of civil penalties. 
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies 
provided in this section shall be in addition to and not 
exclusive of other remedies that may be available. 
‘‘SEC. 418. WHISTLEBLOWER PROTECTION. 
‘‘(a) IN GENERAL.—No employee or other person 
may be harassed, prosecuted, held liable, or discriminated 
against in any way because that person—
‘‘(1) has commenced, caused to be commenced, 
or is about to commence a proceeding, testified or is 
about to testify at a proceeding, or assisted or par-
ticipated or is about to assist or participate in any 
manner in such a proceeding or in any other action
to carry out the purposes, functions, or responsibil-
ities of the Consumer Food Safety Act of 2003, the 
Federal Food, Drug, and Cosmetic Act, the Meat
Inspection Act, or the Poultry Products Inspection 
Act; or 
‘‘(2) is refusing to violate or assist in violation 
of law, rule, or regulation. 
‘‘(b) PROCEDURES.—The process and procedures 
with respect to prohibited discrimination under subsection 
(a) shall be governed by the applicable provisions of sec-
tion 31105 of title 49, United States Code, unless the 
party bringing an action under this subsection chooses al-
ternative dispute resolution procedures such as mediation 
or arbitration. 
‘‘(c) BURDENS OF PROOF.—The legal burdens of 
proof with respect to prohibited discrimination under sub-
section (a) shall be governed by the applicable provisions 
of sections 1214 and 1221 of title 5, United States Code. 
‘‘SEC. 419. ADMINISTRATION AND ENFORCEMENT; APPLICA-
BILITY OF PENALTY PROVISIONS; CONDUCT 
OF INQUIRIES; POWER AND JURISDICTION OF 
COURTS. 
‘‘For the efficient administration and enforcement of 
this chapter, the provision (including penalties) of sections 
46, 48, 49, and 50 of title 15 (except subsections (c) 
through (h) of section 46 and section 49 of title 15), are 
made applicable to the jurisdiction, powers, and duties of 
the Secretary in administrating and enforcing the provi-
sions of this chapter and to any person with respect to 
whom such authority is exercised. The Secretary, in per-
son or by such agents as he may designate, may prosecute 
any inquiry necessary to his duties under this chapter in 
any part of the United States, and the powers conferred 
by said sections 49 and 50 of title 15 on the district courts 
of the United States may be exercised for the purposes 
of this chapter by any appropriate court. 
‘‘SEC. 420. TRACEBACK. 
‘‘The Secretary may impose on a food product re-
quirements for the traceability of such type or class of food 
product whenever such requirements are necessary to as-
sure the protection of the public health. Traceability re-
quirements shall be established in accordance with regula-
tions and guidelines issued by the Secretary. 
‘‘SEC. 421. CITIZEN’S CIVIL ACTIONS. 
‘‘Any person may commence a civil action against—
‘‘(1) any person who violated any rule, toler-
ance, order, or other action of the Secretary to en-
sure the safety of food products; or 
‘‘(2) the Secretary where there is alleged a fail-
ure of the Secretary to perform any act or duty to 
ensure the safety of food products, which is not dis-
cretionary.
The district courts shall have jurisdiction, without regard 
for the amount in controversy, or the citizenship of the 
parties, to enforce such rule, tolerance, order, or other ac-
tion of the Secretary, or to order the Secretary to perform 
such act or duty. The suit shall be commenced in the dis-
trict in which the defendant resides or is found or has 
an agent. The court may award damages sustained and 
if the court determines it to be in the interest of justice, 
may award the plaintiff the costs of suit, including reason-
able attorney’s fees, reasonable expert witness fees, and 
penalties. The remedies provided for in this section shall 
be in addition to and not in lieu of any other remedies 
provided by common law or under Federal or State law.’’. 
(b) CONFORMING AMENDMENT; PROHIBITED ACT.—
Section 301 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 331) is amended by adding at the end the fol-
lowing: 
‘‘(hh) The failure or refusal to comply with an order 
issued under section 416(b)(2) or 416(d). 
‘‘(ii) The failure to comply with the Consumer Food 
Safety Act of 2003.’’.
TITLE IV—AUTHORIZATION 
SEC. 401. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—There are authorized to be appro-
priated, to carry out this Act, such sums as may be nec-
essary for fiscal year 2004 and for fiscal year 2005. 
(b) ASSISTANCE TO STATES.—Of the funds author-
ized to be appropriated under subsection (a), there are au-
thorized to be appropriated such sums as may be nec-
essary for fiscal year 2004 and for fiscal year 2005, for 
carrying out State program assistance activities under sec-
tion 105. 
(c) RESEARCH PROGRAM AUTHORIZATION.—Of the 
funds authorized to be appropriated under subsection (a), 
there are authorized to be appropriated such sums as may 
be necessary for fiscal year 2004 and for fiscal year 2005, 
for carrying out the research program authorized by sec-
tion 203.
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