[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1817 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 1817
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
May 10, 2001
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 Representatives 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 2001''.
(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. 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 transportation 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 prevent 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
programs 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, including 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 consumption; and
(iii) the potential for persistence,
multiplication, or concentration of naturally
occurring or added contaminants in foods and
food products;
(B) take into consideration the distinctive
characteristics of food production and processing;
(C) establish inspection and oversight procedures
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 provide 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 exceptional or negligible-
risk facilities or importers;
(2) development of a program to oversee the implementation
of process controls in food processing 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 contamination are effective
and that food products meet the standards established in
paragraph (1);
(5) implementation of procedures and requirements to ensure
the safety of imported food products;
(6) coordination with other Federal agencies or State
governments in carrying out inspection, enforcement, 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 advisory programs;
and
(9) implementation of a research program in furtherance of
the purposes of this Act.
SEC. 102. REGISTRATION OF PROCESSORS AND IMPORTERS.
(a) In General.--Any facility engaged in processing of food
products and any person who imports food products shall register with
the Secretary. Application for registration 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 applicant a certificate
of registration unless good cause is shown why such application should
be denied. The Secretary shall promptly notify any applicant of such
denial, include a written explanation of the reasons for such denial,
and provide an opportunity for a hearing or reapplication upon request.
(b) Suspension of Registration.--
(1) The registration may be suspended immediately 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 determines that
such suspension is likely to prevent a significant risk
of adverse health consequences; or
(C) conviction of the applicant or registrant in
any Federal or State court of--
(i) any felony other than a felony based
upon the acquiring, handling, or distribution
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 paragraph (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 requirements 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 ADULTERATION 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 products;
(2) ensure that all registered facilities implement
appropriate measures to control and reduce the presence and
growth of human pathogens and other potentially harmful
substances on food products;
(3) ensure that all fully processed or ready-to-eat food
products are processed in a sanitary manner, using reasonably
available techniques and technologies 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 labeled with instructions
for handling and preparation for consumption which, when
adhered to, will destroy 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
registered 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 compliance;
(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 substances 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 frequent
unannounced inspections of food processing and importing
facilities to determine if such facilities are operated in a
sanitary manner and if food products are unsafe for human
consumption, or adulterated or misbranded under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
Inspections shall include review of processing records and
sampling of food products.
(2) Inspections shall be conducted at least quarterly,
unless the Secretary determines that the facility 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 appropriate. The Secretary shall specify an alternative
inspection frequency for each facility which is deemed
exceptional or negligible-risk. Each inspection shall include
an examination of whether the facility continues to meet the standards
for exceptional or negligible-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, controls, and premises) that bear on
whether food products 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, operator, or agent in charge, are
authorized--
(A) to enter at reasonable times any facility 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
Cosmetic 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 report in writing setting forth
any conditions or practices 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 Cosmetic 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 inspection has reason to
believe that a food product is unsafe for human consumption, or
adulterated or misbranded 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
objection is not made within 48 hours, condemned. If objection
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.
(2) If the Secretary determines that, through relabeling or
other action, such food products can be brought into compliance
with this Act and the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the food may be released following a
determination by the Secretary that such relabeling or other
action as specified by the Secretary has been performed.
(3) Any food product condemned without objection, 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 processed in accordance with standards approved by the
Secretary. 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 determined 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 ingredients; 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 consumption, or adulterated or
misbranded under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
(f) Other Inspection Rights and Duties.--Section 704 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at
the end the following 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 2001 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 tolerances limiting
the quantity of contaminants, except for pesticide residues regulated
under section 408 or food additives 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 indicators (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 opportunity 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 Congress on the
progress of the Secretary in establishing tolerances under this
section. The report shall include a description of the research that
has been conducted with respect 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 tolerances, a
timetable for the establishment of such tolerances, 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
biennially 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 contribute 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
subsection (b), the Secretary shall encourage States to--
(1) continue, strengthen, or establish State food safety
programs, especially with respect to the regulation 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 safety 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, notices,
or reports issued in connection with activities under the agreement and
in the possession of the agency or government 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
subsection 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 establish and administer a
comprehensive and efficient system 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 effective
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 consumption in the United
States if such food product--
(A) appears unsafe for human consumption, 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 importation, or
withdrawn from a warehouse, for consumption in the United
States, shall be subject to examinations inspections, sampling,
and such other procedures at the port of entry or in the
exporting nation by officers or employees duly designated by
the Secretary. 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 certified 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 intensified 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 carried out under this section, an officer
or employee conducting 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 Cosmetic 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 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
protection, 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 evaluation, the Secretary shall
consider--
(A) the potential for health, sanitary,
environmental, or other conditions within the foreign
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 safety
system that is adequate to ensure that the food
products intended for export to the United
States are safe for human consumption, and not
adulterated or misbranded 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 during
importation) by the Secretary, including examinations,
inspections, sampling, and testing, at such stages in
the growth or harvest of food, or in the processing or
handling of food products, as the Secretary considers
appropriate to ensure that the food safety program of
the exporting 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 between the
United States and the exporting nation.
(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
Secretary 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 program.
(4)(A) The Secretary shall periodically or for good cause,
and not less than once every 3 years, review certifications
made under paragraph (3), and shall revoke the certification of
any nation that the Secretary determines is not maintaining a food
safety 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 enactment of this
Act, the Secretary in cooperation with the Secretary of
Agriculture shall establish guidelines for a sampling system
under which the Secretary 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, frequency 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 monitoring and
verification samples, as the Secretary determines may
be useful in assessing the occurrence of contaminants
in food products.
(c) Assessment of Health Hazards.--Through the surveillance system
referred to in subsection (a) and the sampling system described in
subsection (b), the Secretary 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 associated with food products
that are harvested for recreational or subsistence purposes and
prepared noncommercially;
(2) the safety of food products that are domestically
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 cooperation with private
and public organizations, including the cooperative extension services
and appropriate State entities, shall design and implement a national
public education program on food safety. The program shall provide--
(1) information to the public regarding Federal standards
and good practice requirements and promotion of public
awareness understanding and acceptance 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 consumers and other
persons as the Secretary determines will promote the purposes
of this Act.
(b) Health Advisories.--The Secretary, in consultation with the
Secretary of Agriculture and the Administrator 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 research to assist in
the implementation of this Act, including studies to--
(1) improve sanitation and food safety practices in the
processing of food products;
(2) develop improved techniques for the monitoring of food
and inspection of food products;
(3) develop efficient, rapid, and sensitive methods 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 authorized to enter into
contracts and agreements with any State, university, other government
agencies or other persons 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 adding after section 413 the
following new sections:
``SEC. 414. NOTIFICATION AND RECALL.
``(a) Notice to Secretary of Adulteration or Misbranding.--Any
person (other than a household consumer or other individual who is the
intended consumer of an article of food) that has a reasonable basis
for believing 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 2001 shall
immediately notify the Secretary, in such manner and by such means as
the Secretary may by regulation prescribe, of the identity and location
of such article.
``(b) Recall and Consumer Notification.--
``(1) Voluntary procedures.--If the Secretary 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 or not the first sale) after shipment in interstate
commerce and there is a reasonable probability that such
article, if consumed, would present a threat to public health,
as determined by the Secretary, the Secretary shall provide the
appropriate persons (including the manufacturers, importers,
distributors, or retailers) with an opportunity to--
``(A) cease distribution of such article;
``(B) notify all persons--
``(i) producing, manufacturing, packing,
processing, preparing, treating, packaging,
distributing, or holding such article; or
``(ii) to which such article has been
distributed, transported, or sold, to
immediately cease distribution of such article;
``(C) recall such article;
``(D) provide, in consultation with the Secretary,
notice to consumers to whom such article was, or may
have been, distributed; or
``(E) take any combination of the above measures,
as appropriate in the circumstances.
``(2) Pre-hearing order to cease distribution and give
notice.--If such person refuses to or does not voluntarily
cease distribution, make notification, recall such article, or
provide notice to consumers, as applicable, within the time and
in the manner prescribed by the Secretary, the Secretary shall,
by order, require, as the Secretary deems necessary, such
person to--
``(A) immediately cease distribution of such
article;
``(B) immediately notify all persons--
``(i) producing, manufacturing, packing,
processing, preparing, treating, packaging,
distributing, or holding such article; or
``(ii) to which such article has been
distributed, transported, or sold, to
immediately cease distribution of such article;
or
``(C) immediately take the actions specified in
both subparagraphs (A) and (B).
``(3) Notification of consumers by secretary.--The
Secretary shall, as the Secretary deems necessary, provide
notice to consumers to whom such article was, or may have been,
distributed.
``(c) Hearing on Order.--The Secretary shall provide any person
subject to an order under subsection (b) with an opportunity for a
hearing, to be held as soon as possible but not later than 2 days after
the issuance of the order, on the actions required by the order and on
why the article that is the subject of the order should not be
recalled.
``(d) Post-Hearing Recall Order.--
``(1) Amendment of order.--If, after providing opportunity
for a hearing under subsection (c), the Secretary determines
that there is a reasonable probability that the article that is
the subject of an order under subsection (b), if consumed,
presents a threat to public health, the Secretary, as the
Secretary deems necessary, may--
``(A) amend the order to require recall of such
article or other appropriate action;
``(B) specify a timetable in which the recall shall
occur;
``(C) require periodic reports to the Secretary
describing the progress of the recall; and
``(D) provide notice to consumers to whom such
article was, or may have been, distributed.
``(2) Vacation of order.--If, after such a hearing, the
Secretary determines that adequate grounds do not exist to
continue the actions required by the order, the Secretary shall
vacate the order.
``(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. 415. CIVIL PENALTIES.
``(a) In General.--
``(1) Acts subject to penalty; penalty amount.--Any person
that commits an act that violates this Act with respect to food
or the Consumer Food Safety Act of 2001 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 during which such act
continues shall be a separate offense.
``(2) Notice and hearing.--No penalty shall be assessed by
the Secretary under this section unless such person is given
notice and opportunity for a hearing on the record before the
Secretary in accordance 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 Secretary 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 recover 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 penalties 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. 416. 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 participated 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
responsibilities of the Consumer Food Safety Act of 2001, 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 section 31105 of title 49, United States Code,
unless the party bringing an action under this subsection chooses
alternative dispute resolution procedures such as mediation or
arbitration.
``(c) Burdens of Proof.--The legal burdens of proof with respect to
prohibited discrimination under subsection (a) shall be governed by the
applicable provisions of sections 1214 and 1221 of title 5, United
States Code.
``SEC. 417. ADMINISTRATION AND ENFORCEMENT; APPLICABILITY 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 provisions
of this chapter and to any person with respect to whom such authority
is exercised. The Secretary, in person 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. 418. TRACEBACK.
``The Secretary may impose on a food product requirements for the
traceability of such type or class of food product whenever such
requirements are necessary to assure the protection of the public
health. Traceability requirements shall be established in accordance
with regulations and guidelines issued by the Secretary.
``SEC. 419. CITIZEN'S CIVIL ACTIONS.
``Any person may commence a civil action against--
``(1) any person who violated any rule, tolerance, order,
or other action of the Secretary to ensure the safety of food
products; or
``(2) the Secretary where there is alleged a failure of the
Secretary to perform any act or duty to ensure the safety of
food products, which is not discretionary.
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 action of the Secretary, or to
order the Secretary to perform such act or duty. The suit shall be
commenced in the district 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 reasonable 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 following new subsections:
``(x) The failure or refusal to comply with an order issued under
section 414(b)(2) or 414(d).
``(y) The failure to comply with the Consumer Food Safety Act of
2001.''.
TITLE IV--AUTHORIZATION
SEC. 401. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--There are authorized to be appropriated, to carry
out this Act, such sums as may be necessary for fiscal year 2001 and
for fiscal year 2002.
(b) Assistance to States.--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 2001 and for
fiscal year 2002, for carrying out State program assistance activities
under section 106.
(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 2001 and for
fiscal year 2002, for carrying out the research program authorized by
section 203.
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