Home > 106th Congressional Bills > H.R. 1497 (eh) To amend the Small Business Act with respect to the women's business center program. [Engrossed in House] ...

H.R. 1497 (eh) To amend the Small Business Act with respect to the women's business center program. [Engrossed in House] ...

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  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.



                             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,


    (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.

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.

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.


    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.



    (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 
                            (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; 
                    (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 
            (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 
            (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; 
            (9) implementation of a research program in furtherance of 
        the purposes of this Act.


    (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 
    (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.


    (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 
                    (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.''.


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