S 908 IS

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

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

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 1999'.

(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 contamination of food products.

Sec. 104. Tolerances for contaminants in food.

Sec. 105. Inspections of processors and importers.

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.

In this Act:

(1) CONTAMINANT- The term `contaminant' includes a bacterium, a chemical contaminant, a natural toxin, a virus, a parasite, and a physical hazard, that when found on or in food can cause human illness or injury.

(2) FACILITY- The term `facility' includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer), that handles or processes food.

(3) FOOD- The term `food' has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

(4) FOOD SAFETY LAW- The term `food safety law' means this Act and the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) that relate to food.

(5) PROCESS- The term `process' means the commercial harvesting, preparation, manufacture, or transportation of a food product.

(6) SECRETARY- The term `Secretary' means the Secretary of Health and Human Services.

SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.

(a) IN GENERAL-

(1) FINDING- Congress finds that persons who produce or process food for human consumption have the responsibility to prevent or minimize food safety hazards related to their products.

(2) NATIONAL PROGRAM- The Secretary shall administer, in accordance with the provisions of this Act, a national program for the purpose of protecting public health by ensuring that the food industry has effective programs in place to assure the safety of food products consumed in the United States.

(3) BASIS FOR PROGRAM- The program shall--

(A) be based on a comprehensive analysis of the hazards associated with different food products and with the processing (including harvesting) and handling of different food products, including the identification and evaluation of--

(i) the severity of the potential public health hazards;

(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, including food products; and

(B) take into consideration the distinctive characteristics of food processing and handling.

(b) PROGRAM ELEMENTS- The program shall provide for--

(1) implementation of a national system for the annual registration of facilities (including facilities of importers) with the Secretary;

(2) development of a program to oversee the implementation of process controls in facilities, including the establishment and enforcement of health-based standards for--

(A) substances that may contaminate food; and

(B) safety and sanitation in the processing and handling of food products;

(3) establishment of inspection and oversight procedures to monitor that facilities are utilizing preventive controls to minimize or eliminate identifiable hazards in food;

(4) implementation of a national system for quarterly inspections of facilities (including facilities of importers), except for facilities that meet the Secretary's standards for exceptional or negligible-risk facilities;

(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 relating to the safety of food products;

(7) implementation of a national surveillance system to assess the public health hazards associated with the human consumption of food products, in cooperation with the Director of the Centers for Disease Control and Prevention;

(8) 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 (2);

(9) development of public education and advisory programs relating to the safety of food products; and

(10) implementation of a research program to further the objectives of this Act.

SEC. 102. REGISTRATION OF PROCESSORS AND IMPORTERS.

(a) REGISTRATION-

(1) IN GENERAL- Any facility engaged in processing or handling food products for consumption in the United States, including any facility of an importer, shall be registered with the Secretary. To obtain the registration--

(A) for a domestic facility not described in subparagraph (B), the owner, operator, or agent in charge of the facility shall submit an application to the Secretary; and

(B) for a facility of an importer, or for a foreign facility, the importer seeking to import the food product processed or handled in the facility shall submit the application.

(2) APPLICATION-

(A) IN GENERAL- The applicant shall submit the application to the Secretary in such manner and containing such information as the Secretary shall prescribe by regulation.

(B) SUBMISSION- The applicant shall submit the application not later than 24 months after--

(i) the date of enactment of this Act; or

(ii) the date the facility first processed or handled food, if later than such date of enactment.

(C) CONTENTS- In the case of an application submitted for a foreign facility, the application shall contain, at a minimum, such information as the Secretary may require demonstrating that the facility, and the foreign nation involved, will permit inspections described in this title.

(3) PROCEDURE- Upon receipt and review of a completed application described in paragraph (1), the Secretary shall issue to the applicant a certificate of registration unless the Secretary finds that there is good cause for denial of the application. The Secretary shall promptly notify the applicant of the denial, include in the notification 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) BASIS- The registration of a facility, including the facility of an importer, may be suspended immediately by the Secretary for--

(A) failure to permit access to the facility for inspection under this Act;

(B) violation of a food safety law, including a regulation issued under a food safety law, concerning the facility, in a case in which 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 relating to food, whether or not the felony is based upon the acquisition, handling, or distribution of adulterated or misbranded food; or

(ii) more than 1 violation of any law relating to food, whether or not the violation involves any fraud in connection with transactions in food.

(2) IMPACT- No person may introduce a food product into interstate commerce, or offer a food product for import into the United States, from a facility with a suspended registration.

(3) REINSTATEMENT- Any registration suspended under paragraph (1) may be reinstated whenever the Secretary determines that the 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 is not needed for effective enforcement of a food safety law.

SEC. 103. PROCESS CONTROLS TO REDUCE THE CONTAMINATION OF FOOD PRODUCTS.

(a) IN GENERAL- The Secretary shall, on the basis of the best available scientific and technological data, prescribe regulations to--

(1) limit the presence of contaminants and other potentially harmful substances in food products;

(2) ensure that all facilities registered under section 102 implement appropriate process controls

(3) ensure that all processed or ready-to-eat food products are processed and handled in a sanitary manner, using reasonably available techniques and technologies to minimize any contaminants 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 that, when adhered to, will destroy any contaminant or other potentially harmful substance likely to cause foodborne illness.

(b) REGULATIONS-

(1) IN GENERAL- In implementing subsection (a), the Secretary shall, not later than 1 year after the date of enactment of this Act, issue regulations that require each facility registered under section 102 to adopt process controls adequate to protect public health by controlling and reducing the presence and growth of contaminants and other potentially harmful substances in food products prepared in the facility.

(2) ELEMENTS- Such regulations shall--

(A) set standards for sanitation in food products;

(B) set tolerances for biological, chemical, and physical contaminants in food products, as appropriate;

(C) require process controls to assure that food products are safe and that relevant regulatory and other safety standards, including the standards and tolerances described in subparagraphs (A) and (B), are met;

(D) require recordkeeping to monitor compliance with the process controls;

(E) require sampling (in accordance with the sampling guidelines described in section 201(b)) to assure that the process controls are effective and that regulatory and other safety standards are being met; and

(F) provide for agency access to records kept under subparagraph (D) and submission of copies of such records to the Secretary as the Secretary determines to be appropriate.

(c) RECORDS- Public access to records kept under subsection (b)(2)(D) that relate to the adequacy of measures taken by facilities to protect public health by controlling and reducing the presence and growth of contaminants and other potentially harmful substances in food products shall be governed by section 552 of title 5, United States Code.

(d) PROCESS CONTROLS FOR USE OF FOOD INGREDIENTS- The Secretary may require any person, firm, or corporation that has responsibility for or control over food ingredients and that is registered under section 102 to adopt process controls, to the extent the Secretary determines that such process controls are needed to assure the protection of public health.

SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD.

(a) TOLERANCES- In adopting, under section 103(b)(2), tolerances for facilities registered under section 102, the Secretary shall establish tolerances limiting the quantity, in food products, of contaminants, except for pesticide chemical residues regulated under section 408, or food additives regulated under section 409, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a or 348), that, when found in food products, may render such products unsafe for human consumption. Such tolerances may include indicators (including indicator organisms) from which the presence of a contaminant in a food product may reasonably be inferred. In developing a tolerance for a contaminant, 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 processing and handling of such food.

(b) REGULATIONS-

(1) IN GENERAL- The Secretary, after notice and an opportunity for comment, shall promulgate regulations to implement subsection (a) not later than 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 have the greatest public health impact, as early as feasible after the date of enactment of this Act.

(2) BASIS- A tolerance established under this section shall be based on--

(A) a scientific analysis of the public health risks attributable to the contaminant for which the tolerance is established; and

(B) analysis of the public health risks attributable to the contaminant for sensitive groups, such as children, elderly individuals, pregnant women, and individuals with compromised immune systems.

(3) REVISIONS- The Secretary shall, in a timely manner, issue revisions to the regulations under paragraph (1) that take into account new information relating to the contaminants involved.

(4) DATA OR ASSISTANCE- The Secretary may enter into a contract with the National Academy of Sciences to provide such data or assistance as the Secretary of Health and Human Services determines to be necessary to carry out this subsection.

(c) REPORT- The Secretary shall prepare and submit to Congress a report 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 needs to be conducted before additional tolerances may be established under this section, 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 submitted not later than 18 months 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. INSPECTIONS OF PROCESSORS AND IMPORTERS.

(a) NATURE OF INSPECTIONS-

(1) IN GENERAL- The inspection system referred to in section 101(b)(4) shall provide for regular and unannounced inspections of facilities (including facilities of importers) registered under section 102 to determine if such facilities are operated in a sanitary manner and if food products processed or handled in the facilities is in violation of a food safety law.

(2) SCHEDULE- The Secretary shall inspect each facility described in paragraph (1) at least quarterly, except that the Secretary shall specify an alternative inspection frequency for a facility that the Secretary determines to be an exceptional or negligible-risk facility, under standards issued under paragraph (3).

(3) STANDARDS- The Secretary shall issue standards for determining whether a facility is an exceptional or negligible-risk facility. In issuing the standards, the Secretary shall classify facilities by considering the hazards associated with the type of product being produced at a facility, the facility's history of compliance and food safety problems, and such other factors as the Secretary may determine to be appropriate.

(4) EXAMINATION OF CLASSIFICATIONS- Each inspection of a facility classified as an exceptional or negligible-risk facility shall include an examination of whether the facility is appropriately classified under the standards issued under paragraph (3).

(b) CONDUCT OF INSPECTIONS-

(1) SCOPE- An inspection under subsection (a) of any domestic or foreign facility (including a facility of an importer) shall extend to all things in the facility (including records required to be maintained under subsection (e), processes, controls, and premises) that bear on whether food products are in compliance with a food safety law. The inspection shall include a review of processing or handling records and sampling of food products. Access to records may include the copying of such records.

(2) AUTHORITIES- In conducting such inspections, officers or employees duly designated by the Secretary, on presenting appropriate credentials to the owner, operator, or agent in charge of a facility, are authorized--

(A) to enter at reasonable times any facility described in subsection (a) in which persons are engaged in the processing or handling of food products (including a facility of an importer), which may include entering any vehicle being used to transport or hold food products for processing or handling;

(B) to inspect in a reasonable manner such facility (which may include inspecting a vehicle described in subparagraph (A)), including 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 in violation of a food safety law.

(3) REPORT- Immediately after completion of the 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 that indicate that either process controls are inadequate to prevent or minimize food safety hazards or that any food product from such facility is in violation of a food safety law.

(c) PRODUCT DETENTION AND CONDEMNATION-

(1) IN GENERAL- If, during an inspection conducted under this section of a domestic facility, an officer or employee making the inspection determines that a food product is in violation of a food safety law, such officer or employee may order the food product segregated, impounded, and if objection is not made within 48 hours after the issuance of the impoundment order, condemned. If objection is made within such 48 hours, food products that are in perishable form may be processed to the extent necessary to prevent spoilage, and the Secretary shall expeditiously commence a hearing regarding the determination and any action required for compliance with the food safety laws.

(2) RELEASE- If the Secretary determines that, through relabeling or other action, such food product can be brought into compliance with the food safety laws, the food product may be released following a determination by the Secretary that such relabeling or other action as specified by the Secretary has been performed.

(3) DESTRUCTION- Any food product condemned under paragraph (1)--

(A) in a case in which no objection is made under paragraph (1);

(B) after the hearing and any judicial review; or

(C) after failure of the owner, operator, or agent to perform relabeling or other action described in paragraph (2);

shall be destroyed under supervision of the Secretary.

(d) OFFICIAL MARK- The Secretary shall prescribe by regulation 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 and handled in accordance with standards approved by the Secretary. The Secretary may assess a fee for the use of such a mark. The Secretary shall deposit fees received under this subsection in an account, and may use the funds in the account to carry out enforcement activities under the food safety laws, or to carry out section 106.

(e) MAINTENANCE OF RECORDS- The registrant for each facility registered under section 102 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 information concerning--

(1)(A) the origin, receipt, delivery, sale, movement, holding, and disposition of food products, or

(B) the identity and amount of ingredients used in the food involved;

(C) the processing or handling of the food;

(D) the results of laboratory, sanitation, or other quality control tests performed on the food or in the facility; and

(E) consumer complaints concerning the food or the packaging of the food; and

(2) other matters reasonably related to whether food products processed or handled at the facility may be in violation of a food safety law.

(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:

`(g) Except as otherwise provided in section 106(b) of the Consumer Food Safety Act of 1999, the provisions of the last 2 sentences of subsection (a)(1), and subsections (c) and (d), relating to the powers and duties of officers and employees to enforce this Act, and to the rights and duties of persons with respect to whom such powers are exercised, apply to the powers and duties of officers and employees designated by the Secretary to enforce the Consumer Food Safety Act of 1999, and to the rights and duties of persons with respect to whom such powers are exercised, respectively.'.

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 program established under section 101 so that State food safety programs and the national program function in a coordinated and cost-effective manner. With the assistance provided under 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 food safety programs are not unsafe for human consumption.

(b) ASSISTANCE- The Secretary may provide to a State, for planning, developing, and implementing a food safety program--

(1) advisory assistance;

(2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) financial and other assistance.

(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 that are recorded or issued in connection with activities under the agreement and are in the possession of the agency that entered into the agreement shall be made available in accordance with section 552 of title 5, United States Code. An agreement entered into with a State agency under this subsection may provide for training of State employees.

SEC. 107. IMPORTS.

(a) ROLE OF SECRETARY- Not later than 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 products imported into the United States. In administering the system, the Secretary shall routinely inspect facilities registered under section 102 in exporting nations and imports at ports of entry into the United States, in accordance with this section and section 105. The Secretary shall assure that the facilities are operating in compliance with the food safety laws, through such verification and other activities as the Secretary considers to be necessary.

(b) IMPORT REQUIREMENTS-

(1) SAFETY STANDARDS- No food product may enter the United States, or be withdrawn from a facility for consumption in the United States if such food product appears to be in violation of a food safety law.

(2) TREATMENT- Upon entry for consumption in the United States, food products that are not prohibited from entry or from withdrawal from a facility under paragraph (1) shall be considered to be and treated as domestic food products for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 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) EXAMINATIONS, INSPECTIONS, SAMPLING AND OTHER PROCEDURES- Food products that are offered for importation, or withdrawn from a facility, for consumption in the United States, shall be subject to examinations, inspections, sampling, and such other procedures as the Secretary may determine to be appropriate at the port of entry or at the facility registered under section 102 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) RANDOM OR INTENSIFIED PROCEDURES- 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 under paragraph (1). 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 exporting nation, under paragraph (1), as the Secretary determines are necessary to ensure compliance with the food safety laws.

(d) DETENTION OF IMPORTED FOOD PRODUCT- If, during an inspection or other verification procedure carried out under this section at a port of entry, an officer or employee conducting the procedure determines that a

(e) AGREEMENTS WITH FOREIGN NATIONS-

(1) EVALUATION- The Secretary may enter into an agreement described in paragraph (2) 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 function to minimize any adverse effects on such safety.

(2) REQUIREMENTS- 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 not in violation of the food safety laws; 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 other procedures, at such stages in the growth or harvest of food, or in the processing or handling of food products, as the Secretary considers to be 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) CERTIFICATION- If the Secretary determines that a nation desiring to export food products to the United States has a 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, the Secretary shall, upon entry into force of an agreement under paragraph (1), certify the types of food products for which the nation maintains such a program.

(4) REVIEWS OF CERTIFICATIONS-

(A) IN GENERAL- The Secretary shall periodically or for good cause, and not less than once every 3 years, review certifications made under paragraph (3), and

(B) IMPACT ON AGREEMENTS- 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).

SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

(a) COOPERATION WITH THE CENTERS FOR DISEASE CONTROL AND PREVENTION- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall maintain an active surveillance system for food, to include on a representative proportion of the population of the United States, 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) GUIDELINES- Not later than 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 collect and analyze samples of food products to assist the Secretary in carrying out the food safety laws, and to assess more accurately the nature, frequency of occurrence, and amounts of contaminants in food products.

(2) MONITORING AND OTHER INFORMATION- In carrying out the sampling system, the Secretary and the Secretary of Agriculture shall provide for--

(A) statistically valid monitoring, including the conduct of 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 of Health and Human Services, the collection and analysis of such other information, including analysis of information from monitoring and

(c) ASSESSMENT OF PUBLIC HEALTH HAZARDS- Using information obtained 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 public health and identify appropriate industry and regulatory approaches to minimize hazards in the food supply. In conducting the ranking and identification, the Secretary may determine--

(1) the public health hazards associated with food products that are commercially harvested and prepared, as compared with the public health hazards associated with food products that are harvested for recreational or subsistence purposes and prepared noncommercially;

(2) the public health hazards associated with food products that are domestically harvested and processed, as compared with the public health hazards associated with food products that are harvested or processed outside the United States; and

(3) the extent of 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 State cooperative extension services and appropriate State entities, shall design and implement a national public education program on food safety. In carrying out the program, the Secretary shall--

(1) provide information to the public regarding Federal standards and good practice requirements relating to food safety, and promote public awareness, understanding, and acceptance of such standards and requirements;

(2) provide information to health professionals so that the health professionals may improve diagnosis and treatment of food-related illness and advise individuals whose health conditions place the individuals at particular risk for that illness; and

(3) provide such other information or advice to consumers and other persons as the Secretary determines will promote the objectives of this Act.

(b) HEALTH ADVISORIES- The Secretary, in consultation with the Secretary of Agriculture and the Administrator of the Environmental Protection Agency, and in cooperation with States and other appropriate entities, shall--

(1) develop and distribute regional and national advisories concerning food safety;

(2) develop standardized formats for written and broadcast advisories concerning food safety; and

(3) incorporate State and local advisories, concerning food safety 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 relating to--

(1) improving sanitation and food safety practices in the processing and handling of food products;

(2) developing improved techniques for the monitoring of food and inspection of food products;

(3) developing efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in food products;

(4) determining the sources of contamination of food (including food products); and

(5) developing consumption data with respect to food products.

(b) CONTRACT AUTHORITY- The Secretary is authorized to enter into contracts and agreements with any State, institution of higher education, other government agency, or other person to carry out the activities described in this section.

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--

(1) by inserting after the chapter heading for chapter IV the following:

`Subchapter A--Food Standards'; and

(2) by adding at the end the following:

`Subchapter B--Remedies

`SEC. 421. DEFINITIONS.

`In this subchapter, the term `food safety law' means the Consumer Food Safety Act of 1999 and the provisions of this Act that relate to food.

`SEC. 422. NOTIFICATION AND RECALL.

`(a) NOTICE TO SECRETARY OF VIOLATION- 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 in violation of a food safety law 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, on notification under subsection (a) or otherwise, that any article of food is in violation of a food safety law 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 of the article) 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 to immediately cease such activities with respect to 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 of the finding of the Secretary to consumers to whom such article was, or may have been, distributed; or

`(E) take any combination of the above measures, as determined by the Secretary to be appropriate in the circumstances.

`(2) PRE-HEARING ORDER TO CEASE DISTRIBUTION AND GIVE NOTICE- If such appropriate 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 determines to be 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 to immediately cease such activities with respect to 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 determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) 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 practicable but not later than 2 days after the issuance of the order, on the actions required by the order and on whether the article that is the subject of the order should be recalled.

`(d) POST-HEARING RECALL ORDER-

`(1) AMENDMENT OF ORDER- If, after providing an 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 determines to be 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 of the recall 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. 423. CIVIL PENALTIES.

`(a) IN GENERAL-

`(1) ACTS SUBJECT TO PENALTY; PENALTY AMOUNT- Any person that commits an act that violates a food safety law 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 an 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- Such civil penalty shall be assessed by the Secretary by written order. The amount of the civil penalty shall be determined by the Secretary, taking into account the gravity of the violation, degree of culpability of the person, size and type of business of the person, and any history of prior offenses by the person, and shall be specified in the order. The order 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 after the effective date of the order, an application for judicial review of the order in the United States Court of Appeals 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. The person shall file the application 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 order was issued. The findings of the Secretary relating to the order 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 a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final and conclusive order, or after the court of appeals described in subsection (b) 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 a United States district court of competent jurisdiction. In such action, the validity and appropriateness of the Secretary's order assessing the civil penalty shall not be subject to review.

`(d) PENALTIES PAID INTO ACCOUNT- The Secretary shall deposit penalties collected under this section in an account, and may use the funds in the account to carry out enforcement activities under the food safety laws, or to carry out section 106 of the Consumer Food Safety Act of 1999.

`(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 a food safety law whenever the Secretary believes that the public interest will be adequately served by assessment of civil penalties under this section.

`(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. 424. 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, has testified or is about to testify at a proceeding, or has assisted or participated or is about to assist or participate in any manner in a proceeding or other action, to carry out the objectives, functions, or responsibilities specified in the Consumer Food Safety Act of 1999, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), or the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); or

`(2) is refusing to violate or assist in violation of a law described in paragraph (1), including a regulation issued under that law.

`(b) PROCEDURES-

`(1) IN GENERAL- A person alleging a violation of subsection (a) may file a complaint as described in subsection (b) of section 31105 of title 49, United States Code.

`(2) ADMINISTRATION- The process, procedures, and remedies that apply under subsections (b), (c), and (d) of that section 31105 with respect to allegations of violations of subsection (a) of that section shall be the process, procedures, and remedies that apply with respect to allegations of violations of subsection (a), except as provided in paragraphs (3) and (4).

`(3) ALTERNATIVE PROCESS- The person filing a complaint under paragraph (1) may elect to use an alternative dispute resolution procedure, such as mediation or arbitration, in lieu of the hearing described in subsection (b) of that section 31105.

`(4) SECRETARY- The powers and duties that apply to the Secretary of Labor under that section 31105 shall apply to the Secretary of Health and Human Services.

`(c) BURDENS OF PROOF- The legal burdens of proof with respect to a violation of subsection (a) shall be governed by the applicable provisions of sections 1214 and 1221 of title 5, United States Code.

`SEC. 425. ADMINISTRATION AND ENFORCEMENT; APPLICABILITY OF PENALTY PROVISIONS; CONDUCT OF INQUIRIES; POWER AND JURISDICTION OF COURTS.

`(a) IN GENERAL- For the efficient administration and enforcement of the food safety laws, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of such section 6), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom such powers are exercised, apply to the jurisdiction, powers, and duties of the Secretary and the Attorney General in administering and enforcing the provisions of this chapter and the Consumer Food Safety Act of 1999 and to the rights and duties of persons with respect to whom such powers are exercised, respectively.

`(b) INQUIRIES AND ACTIONS- The Secretary, in person or by such agents as the Secretary may designate, may prosecute any inquiry necessary to carry out the duties of the Secretary under this chapter and the Consumer Food Safety Act of 1999 in any part of the United States, and the powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.

`SEC. 426. 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 public health. Traceability requirements shall be established in accordance with regulations and guidelines issued by the Secretary and shall apply to persons registered under section 102 of the Consumer Food Safety Act of 1999.

`SEC. 427. CITIZEN'S CIVIL ACTIONS.

`(a) CIVIL ACTIONS- Any person may commence a civil action against--

`(1) any person who violates any rule (including a rule establishing a tolerance), order, or other action of the Secretary to ensure the safety of food products; or

`(2) the Secretary, if the Secretary fails to perform any act or duty to ensure the safety of food products that is not discretionary under a food safety law.

`(b) COURT- The action shall be commenced in the United States district court for the district in which the defendant resides or is found or has an agent. The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce such rule (including a rule establishing a tolerance), order, or other action of the Secretary, or to order the Secretary to perform such act or duty. The court may award damages, in the amount of damages actually 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.

`(c) REMEDIES NOT EXCLUSIVE- The remedies provided for in this section shall be in addition to and not exclusive of other remedies that may be available.'.

`SEC. 428. ADMINISTRATION.

`Notwithstanding any other provision of this Act, the remedy for any foreign facility that violates a food safety law shall be suspension of registration under section 102 of the Consumer Food Safety Act of 1999.'.

(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:

`(aa) The failure or refusal to comply with an order issued under section 422(b)(2) or 422(d).

`(bb) The failure to comply with the Consumer Food Safety Act of 1999.'.

SEC. 401. AUTHORIZATION OF APPROPRIATIONS.

(a) IN GENERAL- There are authorized to be appropriated to carry out this Act, other than sections 106 and 203, such sums as may be necessary for each of fiscal years 2000 and 2001.

(b) ASSISTANCE TO STATES- There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2000 and 2001, for carrying out section 106 (relating to State program assistance).

(c) RESEARCH PROGRAM AUTHORIZATION- There are authorized to be appropriated such sums as may be necessary for each of fiscal years 2000 and 2001, for carrying out section 203 (relating to research).