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 process-
ing;
(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 process-
ing 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. REGISTRATION OF PROCESSORS AND IMPORT-
ERS.
(a) IN GENERAL.—Any facility engaged in processing
of food products and any person who imports food prod-
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—
(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
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. 104. 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 1998 to the same extent and in the same manner
as they apply to enforcement of this Act.’’.
SEC. 105. 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.
(c) REPORT.—The Secretary shall report to the Con-
gress on the progress of the Secretary in establishing tol-
erances under this section. The report shall include a de-
scription of the research that has been conducted with re-
spect to such tolerances and the research that must be
conducted before additional tolerances may be established,
the health significance of the lack of such additional toler-
ances, a timetable for the establishment of such toler-
ances, and the estimated costs, including costs of research,
associated with the establishment of such tolerances. The
report shall be transmitted on or about the end of the 18th
month after the date of enactment of this Act, and bienni-
ally thereafter during the 6-year period that begins on
such date of enactment.
SEC. 106. STATE AND FEDERAL COOPERATION.
(a) IN GENERAL.—The Secretary shall work with the
States in undertaking activities and programs that con-
tribute to the national food safety program so that State
and Federal programs function in a coordinated and cost-
effective manner. With the assistance provided in sub-
section (b), the Secretary shall encourage States to—
(1) continue, strengthen, or establish State food
safety programs, especially with respect to the regu-
lation of retail commercial food establishments,
transportation, harvesting, and fresh markets; and
(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. 107. 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 conduct-
ing the procedure has reason to believe that a food product
is unsafe for human consumption, or adulterated or mis-
branded under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.), such officer or employee may
order the food product segregated, impounded, and if ob-
jection is not made within 48 hours, condemned. If objec-
tion is made, such food products that are in perishable
form may be processed to the extent necessary to prevent
spoilage, and a hearing shall be commenced expeditiously.
The final condemnation or other disposition of such food
product shall be subject to the provisions of section 104(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 mon-
itoring 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 consum-
ers and other persons as the Secretary determines
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—