I
106TH CONGRESS
1ST SESSION
H. R. 1612
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
APRIL 28, 1999
Mr. PALLONE (for himself, Ms. DELAURO, Mr. SERRANO, Mr. RUSH, Mr.
SANDERS, Mr. OLVER, Ms. KILPATRICK, Mr. RANGEL, Mr. FROST, Mr.
STARK, Mr. WAXMAN, Mr. KUCINICH, Ms. JACKSON-LEE of Texas, Mr.
BONIOR, and Mrs. JONES of Ohio) introduced the following bill; which
was referred to the Committee on 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 1999’’.
(b) TABLE OF CONTENTS.—
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
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TITLE I—NATIONAL FOOD SAFETY PROGRAM
Sec. 101. Administration of national program.
Sec. 102. Registration of processors and importers.
Sec. 103. Process controls to reduce the adulteration of food products.
Sec. 104. Inspections of processors and importers.
Sec. 105. Tolerances for contaminants in food.
Sec. 106. State and Federal cooperation.
Sec. 107. 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.
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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
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(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
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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. REGISTRATION OF PROCESSORS AND IMPORT-
ERS.
(a) IN GENERAL.—Any facility engaged in processing
of food products and any person who imports food prod-
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ucts shall register with the Secretary. Application for reg-
istration shall be made to the Secretary using such forms
and containing such information as the Secretary shall
prescribe by regulation within 24 months after the date
of enactment of this Act. Upon receipt and review of a
completed application, the Secretary shall issue to the ap-
plicant a certificate of registration unless good cause is
shown why such application should be denied. The Sec-
retary shall promptly notify any applicant of such denial,
include a written explanation of the reasons for such de-
nial, and provide an opportunity for a hearing or re-
application upon request.
(b) SUSPENSION OF REGISTRATION.—
(1) The registration may be suspended imme-
diately by the Secretary for—
(A) failure to permit access for inspection
under this Act;
(B) violation of this Act or regulation
issued under this Act, where the Secretary de-
termines that such suspension is likely to pre-
vent a significant risk of adverse health con-
sequences; or
(C) conviction of the applicant or reg-
istrant in any Federal or State court of—
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(i) any felony other than a felony
based upon the acquiring, handling, or dis-
tribution of adulterated or misbranded
food; or
(ii) more than one violation of any law
other than a violation involving any fraud
in connection with transactions in food.
(2) Any registration suspended under para-
graph (1) may be reinstated whenever the Secretary
determines that suspension is no longer necessary.
(c) EXEMPTION AUTHORITY.—The Secretary may by
regulation exempt classes of facilities from the require-
ments of subsection (a) if the Secretary determines that
the registration of such facilities or persons is not needed
for effective enforcement of this Act.
SEC. 103. 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
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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;
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(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. 104. INSPECTIONS OF PROCESSORS AND IMPORTERS.
(a) NATURE OF INSPECTIONS.—
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(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.—
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(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
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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-
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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-
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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 1998 to the same extent and in the same manner
as they apply to enforcement of this Act.’’.