I 
110TH CONGRESS 
1ST SESSION H. R. 3624 
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 
SEPTEMBER 20, 2007 
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 2007’’. 
(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. 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6211
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
Sec. 103. Inspections of processors and importers. 
Sec. 104. Tolerances for contaminants in food. 
Sec. 105. 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 OF APPROPRIATIONS 
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. 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
TITLE I—NATIONAL FOOD 
SAFETY PROGRAM 
SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM. 
(a) IN GENERAL.—Persons who produce or process 
food for human consumption have the responsibility to 
prevent or minimize food safety hazards related to their 
products. The Secretary shall administer a national pro-
gram for the purpose of protecting human health by en-
suring that the food industry has effective programs in 
place to assure the safety of food products consumed in 
the United States. 
(b) 
PROGRAM
REQUIREMENTS.—The 
program 
shall— 
(1) be based on a comprehensive analysis of the 
hazards associated with different food products and 
with the harvesting, processing, and handling of dif-
ferent food products, including the identification and 
evaluation of— 
(A) the severity of the potential health 
risks; 
(B) the sources and specific points of po-
tential contamination that may render food 
products unsafe for human consumption; and 
(C) the potential for persistence, mul-
tiplication, or concentration of naturally occur-
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
ring or added contaminants in foods and food 
products; 
(2) take into consideration the distinctive char-
acteristics of food production and processing; 
(3) establish inspection and oversight proce-
dures to monitor that facilities are utilizing preven-
tive controls to minimize or eliminate identifiable 
hazards; and 
(4) require each food processing facility to an-
nually register with the Secretary. 
(c) ADDITIONAL PROGRAM ELEMENTS.—The pro-
gram shall provide for— 
(1) implementation of a national system for the 
registration and quarterly inspection of facilities and 
importers, which quarterly inspections may be 
waived by plants that meet the Secretary’s stand-
ards for exceptional or negligible-risk facilities or im-
porters; 
(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 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
(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 under 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. 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
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. 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
(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 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
human pathogens and other potentially harmful sub-
stances shall be governed by section 552 of title 5, United 
States Code. 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 whether such 
facilities are operated in a sanitary manner and 
whether food products are unsafe for human con-
sumption, or adulterated or misbranded under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). Inspections shall include review of proc-
essing 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 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
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 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
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.— 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS
(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 
VerDate Aug 31 2005 
05:49 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H3624.IH
H3624
ccoleman on PROD1PC69 with BILLS