| 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] ...
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.
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