[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1496 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 1496

   To establish a comprehensive program to ensure the safety of food 
products intended for human consumption which are regulated by the Food 
                        and Drug Administration.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 27, 2003

 Mr. Pallone introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To establish a comprehensive program to ensure the safety of food 
products intended for human consumption which are regulated by the Food 
                        and Drug Administration.

    Be it enacted by the Senate and House of 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 2003''.
    (b) Table of Contents.--

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
                 TITLE I--NATIONAL FOOD SAFETY PROGRAM

Sec. 101. Administration of national program.
Sec. 102. Process controls to reduce the adulteration of food products.
Sec. 103. Inspections of processors and importers.
Sec. 104. Tolerances for contaminants in food.
Sec. 104. State and Federal cooperation.
Sec. 106. Imports.
                    TITLE II--RESEARCH AND EDUCATION

Sec. 201. Public health assessment system.
Sec. 202. Public education and advisory system.
Sec. 203. Research.
                         TITLE III--ENFORCEMENT

Sec. 301. Amendments to the Federal Food, Drug, and Cosmetic Act.
                        TITLE IV--AUTHORIZATION

Sec. 401. Authorization of appropriations.

SEC. 2. DEFINITIONS.

    For purposes of this Act:
            (1) The term ``contaminants'' includes bacteria, chemical 
        contaminants, natural toxins, viruses, parasites, and physical 
        hazards that when found on or in food can cause human illness 
        or injury.
            (2) The term ``facility'' includes any factory, warehouse, 
        establishment, or importer that handles or processes food.
            (3) The term ``process'' means the commercial harvesting, 
        preparation, manufacture, or 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. 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. 103. 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 2003 to the same extent and in the 
same manner as they apply to enforcement of this Act.''.

SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD.

    (a) Tolerances.--The Secretary shall establish 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. 105. 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. 106. 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 103(c).
    (e) Agreements With Foreign Nations.--
            (1) The Secretary may enter into an agreement with any 
        nation desiring to export food products to the United States. 
        Prior to concluding such an agreement, the Secretary shall 
        evaluate the food safety program of the foreign nation to 
        determine if such program provides at least the same level of 
        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 415 the 
following new sections:

``SEC. 416. 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 2003 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. 417. 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 2003 may be assessed a civil 
        penalty by the Secretary of not more than $100,000 for each 
        such act. Each such act and each day 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. 418. WHISTLEBLOWER PROTECTION.

    ``(a) In General.--No employee or other person may be harassed, 
prosecuted, held liable, or discriminated against in any way because 
that person--
            ``(1) has commenced, caused to be commenced, or is about to 
        commence a proceeding, testified or is about to testify at a 
        proceeding, or assisted or 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 2003, the Federal 
Food, Drug, and Cosmetic Act, the Meat Inspection Act, or the Poultry 
Products Inspection Act; or
            ``(2) is refusing to violate or assist in violation of law, 
        rule, or regulation.
    ``(b) Procedures.--The process and procedures with respect to 
prohibited discrimination under subsection (a) shall be governed by the 
applicable provisions of 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. 419. 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. 420. 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. 421. 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:
    ``(hh) The failure or refusal to comply with an order issued under 
section 416(b)(2) or 416(d).
    ``(ii) The failure to comply with the Consumer Food Safety Act of 
2003.''.

                        TITLE IV--AUTHORIZATION

SEC. 401. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--There are authorized to be appropriated, to carry 
out this Act, such sums as may be necessary for fiscal year 2004 and 
for fiscal year 2005.
    (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 2004 and for 
fiscal year 2005, for carrying out State program assistance activities 
under section 105.
    (c) Research Program Authorization.--Of the funds authorized to be 
appropriated under subsection (a), there are authorized to be 
appropriated such sums as may be necessary for fiscal year 2004 and for 
fiscal year 2005, for carrying out the research program authorized by 
section 203.
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