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.

May 10, 2001

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

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.

END