HR 875 IH


111th CONGRESS

1st Session

H. R. 875
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.


IN THE HOUSE OF REPRESENTATIVES

February 4, 2009
Ms. DELAURO (for herself, Ms. ESHOO, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. ENGEL, Ms. CASTOR of Florida, Mr. MURPHY of Connecticut, Ms. SUTTON, Mrs. LOWEY, Ms. SLAUGHTER, Mr. HINCHEY, Mr. MCGOVERN, Ms. WASSERMAN SCHULTZ, Ms. HIRONO, Mr. GRIJALVA, Mr. SCHAUER, Mr. NADLER of New York, Mr. BISHOP of New York, Ms. LINDA T. SANCHEZ of California, Mr. MCDERMOTT, Mr. RYAN of Ohio, Ms. GIFFORDS, Mr. FILNER, Mr. HALL of New York, Ms. LEE of California, Ms. PINGREE of Maine, Ms. KAPTUR, Mr. BISHOP of Georgia, Ms. MOORE of Wisconsin, and Mr. DEFAZIO) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned


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A BILL
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, 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 `Food Safety Modernization Act of 2009'.

(b) Table of Contents- The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings; purposes.

Sec. 3. Definitions.

TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of the food safety administration.

Sec. 102. Consolidation of food safety functions.

Sec. 103. Additional duties of the administration.

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

Sec. 201. Administration of national program.

Sec. 202. Registration of food establishments and foreign food establishments.

Sec. 203. Preventive process controls to reduce adulteration of food.

Sec. 204. Performance standards for contaminants in food.

Sec. 205. Inspections of food establishments.

Sec. 206. Food production facilities.

Sec. 207. Federal and State cooperation.

Sec. 208. Imports.

Sec. 209. Resource plan.

Sec. 210. Traceback requirements.

Sec. 211. Accredited laboratories.

TITLE III--RESEARCH AND EDUCATION

Sec. 301. Public health assessment system.

Sec. 302. Public education and advisory system.

Sec. 303. Research.

Sec. 304. Working group on improving foodborne illness surveillance.

Sec. 305. Career-spanning training for food inspectors.

Sec. 306. Food-Borne Illness Health Registry.

Sec. 307. Study on Federal resources.

TITLE IV--ENFORCEMENT

Sec. 401. Prohibited acts.

Sec. 402. Food detention, seizure, and condemnation.

Sec. 403. Notification and recall.

Sec. 404. Injunction proceedings.

Sec. 405. Civil and criminal penalties.

Sec. 406. Presumption.

Sec. 407. Whistleblower protection.

Sec. 408. Administration and enforcement.

Sec. 409. Citizen civil actions.

TITLE V--IMPLEMENTATION

Sec. 501. Reorganization plan.

Sec. 502. Transitional authorities.

Sec. 503. Savings provisions.

Sec. 504. Conforming amendments.

Sec. 505. Additional technical and conforming amendments.

Sec. 506. Regulations.

Sec. 507. Authorization of appropriations.

Sec. 508. Limitation on authorization of appropriations.

SEC. 2. FINDINGS; PURPOSES.

(a) Findings- Congress finds that--

(1) the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation's economy;

(2) lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce and international trade;

(3) recent ongoing events demonstrate that the food safety program at the Food and Drug Administration is not effective in controlling hazards in food coming from farms and factories in the United States and food and food ingredients coming from foreign countries, and these events have adversely affected consumer confidence;

(4) the safety and security of the food supply require a systemwide approach to prevent food-borne illness involving the integrated efforts of Federal, State and local agencies; a thorough, broad-based, and coordinated approach to basic and applied science; and intensive, effective, and efficient management of the Nation's food safety program;

(5) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to--

(A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;

(B) the threat of intentional contamination of the food supply;

(C) a growing number of people at high risk for food-borne illnesses, including an increasing population of aging and immune-compromised consumers, together with infants and children;

(D) an increasing volume of imported food, without adequate monitoring, inspection, and systems for prevention of food safety problems; and

(E) maintenance of rigorous inspection of the domestic food processing and food service industries;

(6) Federal food safety standard setting, inspection, enforcement, and research efforts should be based on the best available science and public health considerations, and food safety resources should be systematically deployed in ways that most effectively prevent food-borne illness;

(7) the Food and Drug Administration, an agency within the Department of Health and Human Services, has regulatory jurisdiction over the safety and labeling of 80 percent of the American food supply, encompassing all foods except meat, poultry, and egg products, as well as drugs, medical devices, and biologics;

(8) rapid technological advance and the expansion and globalization of industries in all areas of Food and Drug Administration jurisdiction present challenges and require leadership beyond the capacity of any one agency or agency head to provide;

(9) in the food safety area, the Food and Drug Administration implements provisions of the Federal Food, Drug, and Cosmetic Act that are 70 years old and that antiquated law limits the Food and Drug Administration's role largely to reacting to and correcting food safety problems after they occur, rather than working with the food industry to systematically prevent problems;

(10) the Food and Drug Administration's effectiveness is further impaired by fragmentation of leadership and management within the Administration, as major food safety responsibilities are dispersed across the Administration's Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and Office of Regulatory Affairs;

(11) there is no official with the full-time responsibility and budget authority for food safety at the Food and Drug Administration and food safety competes unsuccessfully with the drug and medical device programs for senior agency management attention and resources; and

(12) improving Federal oversight of food safety requires a modern food safety mandate, clear authorities, and a dedicated official within the Department of Health and Human Services with budget authority to manage an integrated organizational structure and report directly to the Secretary.

(b) Purposes- The purposes of this Act are--

(1) to establish an agency within the Department of Health and Human Services to be known as the `Food Safety Administration' to--

(A) regulate food safety and labeling to strengthen the protection of the public health;

(B) ensure that food establishments fulfill their responsibility to process, store, hold, and transport food in a manner that protects the public health of all people in the United States;

(C) lead an integrated, systemwide approach to food safety and to make more effective and efficient use of resources to prevent food-borne illness;

(D) provide a single focal point within the Department of Health and Human Services for food safety leadership, both nationally and internationally; and

(E) provide an integrated food safety research capability, including internally generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments;

(2) to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the date of the enactment of this Act, are performed by various components of the Food and Drug Administration and the National Oceanic and Atmospheric Administration;

(3) to modernize and strengthen the Federal food safety law to ensure more effective application and efficient management of the laws for the protection and improvement of public health; and

(4) to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements of this law.

SEC. 3. DEFINITIONS.

In this Act:

(1) ADMINISTRATION- The term `Administration' means the Food Safety Administration established under section 101(a)(1).

(2) ADMINISTRATOR- The term `Administrator' means the Administrator of Food Safety appointed under section 101(a)(2).

(3) ADULTERATED-

(A) IN GENERAL- The term `adulterated' has the meaning given that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).

(B) INCLUSION- The term `adulterated' includes bearing or containing a contaminant that causes illness or death among sensitive populations.

(4) AGENCY- The term `agency' has the meaning given that term in section 551 of title 5, United States Code.

(5) CATEGORY 1 FOOD ESTABLISHMENT- The term `category 1 food establishment' means a food establishment (other than a seafood processing establishment) that slaughters, for the purpose of producing food, animals that are not subject to inspection under the Federal Meat Inspection Act or poultry that are not subject to inspection under the Poultry Products Inspection Act.

(6) CATEGORY 2 FOOD ESTABLISHMENT- The term `category 2 food establishment' means a seafood processing establishment or other food establishment (other than a category 1 establishment) not subject to inspection under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, that processes raw seafood or other raw animal products, whether fresh or frozen, or other products that the Administrator determines by regulation to pose a significant risk of hazardous contamination.

(7) CATEGORY 3 FOOD ESTABLISHMENT- The term `category 3 food establishment' means a food establishment (other than a category 1 or category 2 establishment) that processes cooked, pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-to-eat raw form, or other products that pose a risk of hazardous contamination.

(8) CATEGORY 4 FOOD ESTABLISHMENT- The term `category 4 food establishment' means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).

(9) CATEGORY 5 FOOD ESTABLISHMENT- The term `category 5 food establishment' means a food establishment that stores, holds, or transports food products prior to delivery for retail sale.

(10) CONTAMINANT- The term `contaminant' includes a bacterium, chemical, natural toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.

(11) HAZARDOUS CONTAMINATION- The term `hazardous contamination' refers to the presence of a contaminant in food at levels that pose a risk of human illness, injury, or death or are capable of reaching levels that pose such risk during the shelf life of the product.

(12) FOOD- The term `food' means a product intended to be used for food or drink for a human or an animal and components thereof.

(13) FOOD ESTABLISHMENT-

(A) IN GENERAL- The term `food establishment' means a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.

(B) EXCLUSIONS- For the purposes of registration, the term `food establishment' does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).

(14) FOOD PRODUCTION FACILITY- The term `food production facility' means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.

(15) FOOD SAFETY LAW- The term `food safety law' means--

(A) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, quality, nutritional composition, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food;

(B) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any other Acts that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;

(C) the provisions of the Public Health Service Act that relate in any way to studying, surveying, containing, or preventing food-borne illness; and

(D) the provisions of this Act.

(16) FOREIGN FOOD ESTABLISHMENT- The term `foreign food establishment' means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.

(17) INTERSTATE COMMERCE- The term `interstate commerce' has the meaning given that term in section 201(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).

(18) MISBRANDED- The term `misbranded' has the meaning given that term in section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).

(19) PROCESS- The term `process' or `processing' means the commercial slaughter, packing, preparation, or manufacture of food.

(20) STATE- The term `State' means--

(A) a State;

(B) the District of Columbia;

(C) the Commonwealth of Puerto Rico; and

(D) any other territory or possession of the United States.

TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION

SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.

(a) Establishment-

(1) IN GENERAL- There is established in the Department of Health and Human Services an agency to be known as the `Food Safety Administration'.

(2) HEAD OF THE ADMINISTRATION- The Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate, for a term of 5 years, and who may be reappointed.

(3) DELEGATION- All the authorities and responsibilities assigned to the Secretary of Health and Human Services in the food safety law are hereby assigned to the Administrator.

(b) Duties of Administrator- The Administrator shall--

(1) administer and enforce the food safety law;

(2) serve as the food safety leader within the Department of Health and Human Services and coordinator of all Department activities related to ensuring the safety, quality, and proper labeling of the food supply;

(3) represent the United States in relevant international food safety bodies and discussions;

(4) promulgate regulations to ensure the safety and security of the food supply from all forms of contamination, including intentional contamination; and

(5) oversee within the Department of Health and Human Services--

(A) in consultation with the Director of the Centers for Disease Control and Prevention, all activities related to foodborne illness surveillance and investigation of foodborne illness outbreaks;

(B) implementation of food safety inspection, enforcement, and research efforts to protect the public health;

(C) development of consistent and science-based standards for safe food;

(D) coordination and prioritization of food safety research and education programs with other Federal agencies;

(E) prioritization of food safety efforts and deployment of food safety resources to achieve the greatest possible benefit in reducing food-borne illness;

(F) coordination of the response to food-borne illness outbreaks with other Federal and State agencies; and

(G) integration of food safety activities with State and local agencies.

SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.

(a) Transfer of Functions and Resources- For each component of the Department of Health and Human Services or the Department of Commerce specified in subsection (b), there are transferred to the Administration all functions, personnel, and assets (including facilities and financial resources) of those components as of the day before the date of the enactment of this Act (including all related functions of any officer or employee of the component) that relate to administration or enforcement of the food safety law, as determined by the President.

(b) Transferred Functions and Resources- The components referred to in subsection (a) are--

(1) the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;

(2) the Center for Veterinary Medicine of the Food and Drug Administration;

(3) the National Center for Toxicological Research of the Food and Drug Administration;

(4) the personnel and assets of the Office of Regulatory Affairs of the Food and Drug Administration used to administer and conduct inspections of food establishments and imports and conduct laboratory analyses and other investigations relating to food safety and enforcement of the food safety law;

(5) the personnel and assets of the Office of the Commissioner of Food and Drugs used to support--

(A) the Center for Food Safety and Applied Nutrition;

(B) the Center for Veterinary Medicine;

(C) the National Center for Toxicological Research; and

(D) the personnel and assets of the Office of Regulatory Affairs described in paragraph (4); and

(6) the personnel and assets of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce used to administer the seafood inspection program.

(c) Renaming and Reservation of Agency Identity- The Food and Drug Administration in the Department of Health and Human Services is hereby renamed the Federal Drug and Device Administration and may be referred to as `FDA'.

(d) Sharing of Facilities and Resources- The Food Safety Administration and the Federal Drug and Device Administration shall enter into such agreements concerning the sharing of facilities and other resources as may be appropriate to make efficient use of such facilities and resources and achieve their respective missions.

SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.

(a) Officers and Employees- The Administrator may--

(1) appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and

(2) fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.

(b) Experts and Consultants- The Administrator may--

(1) procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and

(2) pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.

(c) Bureaus, Offices, and Divisions- The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.

(d) Advisory Committees-

(1) IN GENERAL- The Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.

(2) DUTIES- The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of new processes, research, communications, performance standards, and inspection.

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

(a) In General- The Administrator shall--

(1) develop, administer, and annually update a national food safety program (referred to in this section as the `program') to protect public health; and

(2) ensure that persons who produce, process, or distribute food meet their responsibility to prevent or minimize food safety hazards related to their products.

(b) Comprehensive Analysis- The program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of--

(1) the severity of the potential health risks;

(2) the sources of potentially hazardous contamination or practices extending from the farm or ranch to the consumer that may increase the risk of food-borne illness;

(3) the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;

(4) the potential for hazardous contamination to have cumulative toxic effects, multigenerational effects, or effects on specific categories of consumers;

(5) opportunities across the food production, processing, distribution, and retail system to reduce potential health risks; and

(6) opportunities for intentional contamination of food or food ingredients.

(c) Program Elements- In carrying out the program, the Administrator shall--

(1) adopt and implement a national system for the registration of food establishments and foreign food establishments, as provided in section 202 of this Act;

(2) adopt and implement a national system for regular unannounced inspection of food establishments;

(3) require and enforce the adoption of preventive process controls in food establishments, based on the best available scientific and public health considerations and best available technologies;

(4) establish and enforce science-based standards for--

(A) potentially hazardous substances that may contaminate food; and

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

(5) implement a statistically valid sampling program with the stringency and frequency to independently monitor that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the standards established under this Act;

(6) implement appropriate surveillance procedures and requirements to ensure the safety and security of imported food;

(7) coordinate and collaborate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;

(8) implement a national system to identify the food products posing the greatest public health risk and to analyze the effectiveness of existing food safety programs, in conjunction with the Centers for Disease Control and Prevention and other Federal agencies;

(9) develop public education, risk communication, and advisory programs;

(10) implement an applied research program to further the purposes of this Act;

(11) coordinate and prioritize food safety research and educational programs with other Federal agencies and with State and local governments; and

(12) provide technical assistance to farmers and food establishments that are small business concerns (meeting the requirements of section 3(a) of the Small Business Act and the regulations promulgated thereunder) to assist with compliance with the requirements of this Act.

SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND FOREIGN FOOD ESTABLISHMENTS.

(a) In General- Any food establishment or foreign food establishment engaged in manufacturing, processing, packing, or holding food for consumption in the United States shall register annually with the Administrator.

(b) Registration Requirements-

(1) IN GENERAL- To be registered under subsection (a), a food establishment shall submit a registration or reregistration to the Administrator.

(2) REGISTRATION- Registration under this section shall begin within 90 days of the enactment of this Act. Each such registration shall be submitted to the Secretary through an electronic portal and shall contain such information as the Secretary, by guidance, determines to be appropriate. Such registration shall contain the following information:

(A) The name, address, and emergency contact information of each domestic food establishment or foreign food establishment that the registrant owns or operates under this Act and all trade names under which the registrant conducts business in the United States relating to food.

(B) The primary purpose and business activity of each domestic food establishment or foreign food establishment, including the dates of operation if the domestic food establishment or foreign food establishment is seasonal.

(C) The types of food processed or sold at each domestic food establishment or, for foreign food establishments selling food for consumption in the United States, the specific food categories of that food as listed under section 170.3(n) of title 21, Code of Federal Regulations, or such other categories as the Administrator may designate in guidance, action level, or regulations for evaluating potential threats to food protection.

(D) The name, address, and 24-hour emergency contact information of the United States distribution agent for each domestic food establishment or foreign food establishment, who shall maintain information on the distribution of food, including lot information, and wholesaler and retailer distribution.

(E) An assurance that the registrant will notify the Administrator of any change in the products, function, or legal status of the domestic food establishment or foreign food establishment (including cessation of business activities) not later than 30 days after such change.

(3) PROCEDURE- Upon receipt of a completed registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, designate each establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration number to each domestic food establishment and foreign food establishment.

(4) LIST- The Administrator shall annually compile a list of domestic food establishments and a list of foreign food establishments that are registered under this section. The Administrator may establish the manner of and any fees required for reregistration and any circumstances by which either such list may be shared with other governmental authorities. The Administrator may remove from either list the name of any establishment that fails to reregister, and such delisting shall be treated as a suspension.

(5) DISCLOSURE EXEMPTION- The disclosure requirements under section 552 of title 5, United States Code, shall not apply to--

(A) the list compiled under paragraph (4); and

(B) information derived from the list under paragraph (4), to the extent that it discloses the identity or location of a specific person.

(6) SUSPENSION OF REGISTRATION-

(A) IN GENERAL- The Administrator may suspend the registration of a domestic food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law that is either repeated or could result in serious adverse health consequences or death to humans or animals.

(B) NOTICE AND OPPORTUNITY FOR HEARING- The Administrator shall provide notice of an intent to suspend the registration of an establishment under this paragraph to a registrant and provide the registrant with an opportunity for an administrative hearing within 3 days. The Administrator may issue a written order of suspension following the hearing, if the Administrator finds that a violation described in subparagraph (A) has occurred.

(C) JUDICIAL REVIEW- The issuance of an order of suspension under subparagraph (B) shall be considered to be a final agency action subject to judicial review in accordance with the provisions of chapter 7 of title 5, United States Code.

(7) REINSTATEMENT- A registration that is suspended under this section may be reinstated based on a showing that adequate process controls have been instituted that would prevent future violations and there are assurances from the registrant that the violations will not be repeated.

(c) Transitional Provision- During the 6-month period following the date of the enactment of this Act, a food establishment is deemed to be registered in accordance with this section if the establishment is registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d).

(d) Repeal- Effective at the end of the 6-month period following the date of the enactment of this Act, section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is repealed.

SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION OF FOOD.

(a) In General- The Administrator shall, upon the basis of best available public health, scientific, and technological data, promulgate regulations to ensure that food establishments carry out their responsibilities under the food safety law.

(b) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations that require all food establishments, within time frames determined by the Administrator--

(1) to adopt preventive process controls that--

(A) reflect the standards and procedures recognized by relevant authoritative bodies;

(B) are adequate to protect the public health;

(C) meet relevant regulatory and food safety standards;

(D) limit the presence and growth of contaminants in food prepared in a food establishment using the best reasonably available techniques and technologies; and

(E) are tailored to the hazards and processes in particular establishments or environments;

(2) to establish a sanitation plan and program that meets standards set by the Administrator;

(3) to meet performance standards for hazardous contamination established under section 204;

(4) to implement recordkeeping to monitor compliance with regulatory requirements;

(5) to implement recordkeeping and labeling of all food and food ingredients to facilitate their identification and traceability in the event of a recall or market removal;

(6) to implement product and environmental sampling at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that regulatory standards are being met;

(7) to label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy microbial contaminants; and

(8) to provide for agency access to records kept by the food establishments and submission of copies of records to the Administrator, as the Administrator determines appropriate.

(c) Specific Hazard Controls- The Administrator may require any person with responsibility for or control over food or food ingredients to adopt specific hazard controls, if such controls are needed to ensure the protection of the public health.

SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

(a) In General- To protect the public health, the Administrator shall establish by guidance document, action level, or regulation and enforce performance standards that define, with respect to specific foods and contaminants in food, the level of food safety performance that a person responsible for producing, processing, or selling food shall meet.

(b) Identification of Contaminants; Performance Standards-

(1) LIST OF CONTAMINANTS- Not later than 6 months after the date of the enactment of this Act, the Administrator shall publish in the Federal Register a list of the contaminants in foods that have the greatest adverse impact on public health in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act. Where appropriate, the Administrator shall indicate whether the risk posed by a contaminant is generalized or specific to particular foods or ingredients.

(2) PERFORMANCE STANDARDS-

(A) ESTABLISHMENT- The Administrator shall establish by guidance document, action level, or regulation a performance standard for each contaminant in the list under paragraph (1) at levels appropriate to protect against the potential adverse health effects of the contaminant.

(B) TIMING- The Administrator shall establish a performance standard under subparagraph (A) for each contaminant in the list under paragraph (1)--

(i) as soon as practicable; or

(ii) in the case of a contaminant described in subparagraph (C), by the date described in such subparagraph.

(C) SIGNIFICANT CONTAMINANTS- The list under paragraph (1) (and any revision thereto) shall identify the 5 most significant contaminants in the list (in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act). Not later than 3 years after a contaminant is so identified, the Administrator shall promulgate a performance standard under subparagraph (A) for the contaminant.

(3) REVIEW; REVISION- Not less than every 3 years, the Administrator shall review and, if necessary, revise--

(A) the list of contaminants under paragraph (1); and

(B) each performance standard established under paragraph (2).

(c) Performance Standards-

(1) IN GENERAL- The performance standards established under this section may include--

(A) health-based standards that set the level of a contaminant that can safely and lawfully be present in food;

(B) zero tolerances, including any zero tolerance performance standards in effect on the day before the date of the enactment of this Act, when necessary to protect against significant adverse health outcomes;

(C) process standards, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; and

(D) in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance on the basis of reliable information on the best reasonably achievable performance, using best available technologies, interventions, and practices.

(2) BEST REASONABLY ACHIEVABLE PERFORMANCE STANDARDS- In developing best reasonably achievable performance standards under paragraph (1)(D), the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.

(3) REVOCATION BY ADMINISTRATOR- All performance standards, tolerances, action levels, or other similar standards in effect on the date of the enactment of this Act shall remain in effect until revised or revoked by the Administrator.

(d) Enforcement-

(1) IN GENERAL- In conjunction with the establishment of a performance standard under this section, the Administrator shall develop a statistically valid sampling program with the stringency and frequency sufficient to independently monitor whether food establishments are complying with the performance standard and implement the program within 1 year of the promulgation of the standard.

(2) INSPECTIONS- If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, the Administrator shall, as appropriate--

(A) detain, seize, or condemn food from the food establishment under section 402;

(B) order a recall of food from the food establishment under section 403;

(C) increase the inspection frequency for the food establishment;

(D) withdraw the mark of inspection from the food establishment, if in use; or

(E) take other appropriate enforcement action concerning the food establishment, including withdrawal of registration.

(e) Newly Identified Contaminants- Notwithstanding any other provision of this section, the Administrator shall establish interim performance standards for newly identified contaminants as necessary to protect the public health.

SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.

(a) In General- The Administrator shall establish an inspection program, which shall include statistically valid sampling of food and facilities to enforce performance standards. The inspection program shall be designed to determine if each food establishment--

(1) is operated in a sanitary manner;

(2) has continuous preventive control systems, interventions, and processes in place to minimize or eliminate contaminants in food;

(3) is in compliance with applicable performance standards established under section 204, and other regulatory requirements;

(4) is processing food that is not adulterated or misbranded;

(5) maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and

(6) is otherwise in compliance with the requirements of the food safety law.

(b) Establishment Categories and Inspection Frequencies- The resource plan required under section 209, including the description of resources required to carry out inspections of food establishments, shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):

(1) CATEGORY 1 FOOD ESTABLISHMENTS- A category 1 food establishment shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that--

(A) diseased animals are not offered for slaughter;

(B) the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; and

(C) applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.

(2) CATEGORY 2 FOOD ESTABLISHMENTS- A category 2 food establishment shall--

(A) have ongoing verification that its processes are controlled; and

(B) be randomly inspected at least weekly.

(3) CATEGORY 3 FOOD ESTABLISHMENTS- A category 3 food establishment shall--

(A) have ongoing verification that its processes are controlled; and

(B) be randomly inspected at least monthly.

(4) CATEGORY 4 FOOD ESTABLISHMENTS- A category 4 food establishment shall--

(A) have ongoing verification that its processes are controlled; and

(B) be randomly inspected at least quarterly.

(5) CATEGORY 5 FOOD ESTABLISHMENTS- A category 5 food establishment shall--

(A) have ongoing verification that its processes are controlled; and

(B) be randomly inspected at least annually.

(c) Establishment of Inspection Procedures- The Administrator shall establish procedures under which inspectors shall take random samples, photographs, and copies of records in food establishments.

(d) Alternative Inspection Frequencies- With respect to a subcategory of food establishment under category 2, 3, 4, or 5, the Administrator may establish alternative increasing or decreasing inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources. Before establishing an alternative inspection frequency for a subcategory of food establishments or individual establishments, the Administrator shall take into consideration the evidence described in paragraph (2)(D) and the overall record of compliance described in paragraph (2)(E) for such subcategory. In establishing alternative inspection frequencies under this subsection, the Administrator shall comply with the following criteria and procedures:

(1) Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).

(2) In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider--

(A) the nature of the food products being processed, stored, or transported;

(B) the manner in which food products are processed, stored, or transported;

(C) the inherent likelihood that the products will contribute to the risk of food-borne illness;

(D) the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the proposed subcategory of establishments; and

(E) the overall record of compliance with food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.

(3) The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment and shall annually publish a list of establishments subject to alternative inspections.

(4) In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider--

(A) the criteria in paragraph (2), together with any evidence submitted from the individual food establishment supporting a request for an alternative inspection frequency, including the establishment's record for implementing effective preventive process control systems;

(B) whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and

(C) the establishment's record of compliance with food safety law, including compliance with applicable performance standards and the frequency of recalls.

(e) Effective Date- The inspection mandates shall go into effect 2 years after the date of the enactment of this Act.

(f) Maintenance and Inspection of Records-

(1) IN GENERAL-

(A) RECORDS- A food establishment shall--

(i) maintain such records as the Administrator shall require by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and

(ii) permit the Administrator, in addition to any authority transferred to the Administrator pursuant to section 102, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator--

(I) to determine whether the food is contaminated or not in compliance with the food safety law; or

(II) to track the food in commerce.

(B) REQUIRED DISCLOSURE- A food establishment shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant.

(2) MAINTENANCE OF RECORDS- The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.

(3) REQUIREMENTS- The records in paragraph (1) shall include records describing--

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

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

(C) the processing of the food;

(D) the results of laboratory, sanitation, or other tests performed on the food or in the food establishment;

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

(F) the production codes, open date codes, and locations of food production; and

(G) other matters reasonably related to whether food is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.

(g) Protection of Sensitive Information-

(1) IN GENERAL- The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or commercially valuable confidential information obtained by the Administrator.

(2) LIMITATION- The requirements under this subsection and subsection (f) do not--

(A) limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act;

(B) have any legal effect on section 1905 of title 18, United States Code;

(C) extend to any food recipe, financial data, pricing data, or personnel data;

(D) limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403; or

(E) limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.

(h) Bribery of or Gifts to Inspector or Other Officers and Acceptance of Gifts- Any person or agent or employee thereof that gives, pays, or offers, directly or indirectly, to the Administrator or any employee or other designee thereof authorized to perform any duty under the food safety law any money or other thing of value, with intent to influence the discharge of any duty under such law, shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both. Any Administrator, employee, or other designee that solicits or accepts any money or other thing of value from any person, with intent to influence the discharge of any duty under the food safety law, shall be summarily discharged from office and imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.

SEC. 206. FOOD PRODUCTION FACILITIES.

(a) Authorities- In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to--

(1) visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;

(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;

(3) set good practice standards to protect the public and animal health and promote food safety;

(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and

(5) collect and maintain information relevant to public health and farm practices.

(b) Inspection of Records- A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator--

(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or

(2) to track the food in commerce.

(c) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall--

(1) consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;

(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;

(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water;

(4) include, with respect to animals raised for food, minimum standards related to the animal's health, feed, and environment which bear on the safety of food for human consumption;

(5) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;

(6) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and

(7) include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.

(d) Variances- States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c). A request shall--

(1) be in writing;

(2) describe the reasons the variance is necessary;

(3) describe the procedures, processes, and practices that will be followed under the variance to ensure produce is not adulterated; and

(4) contain any other information required by the Administrator.

(e) Approval or Disapproval of Variances- If the Administrator determines after review of a request under subsection (d) that the requested variance provides equivalent protections to those promulgated under subsection (c), the Administrator may approve the request. The Administrator shall deny a request if it is--

(1) not sufficiently detailed to permit a determination;

(2) fails to cite sufficient grounds for allowing a variance; or

(3) does not provide reasonable assurances that the produce will not be adulterated.

(f) Enforcement- The Administrator may coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

(g) Imported Produce- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations to ensure that raw agricultural commodities and minimally processed produce imported into the United States can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to such commodities and produce produced in the United States.

SEC. 207. FEDERAL AND STATE COOPERATION.

(a) In General-

(1) AUTHORITY- The Administrator shall strengthen and expand food-borne illness surveillance systems to--

(A) inform and evaluate efforts to prevent food-borne illness; and

(B) enhance the identification and investigation of, and response to, food-borne illness outbreaks.

(2) FOOD-BORNE ILLNESS OUTBREAK- For purposes of this section, the term `foodborne illness outbreak' means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a common food.

(b) Food-Borne Illness Surveillance Systems- The Administrator, in collaboration with the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by--

(1) coordinating food-borne illness surveillance systems, including complaint systems, in order to--

(A) produce better information on illnesses associated with foods, including sources and risk factors for infections by emerging pathogens; and

(B) facilitate sharing of data acquisition and findings on a more timely basis among governmental agencies, including the Food Safety Administration, the Food Safety and Inspection Service, and State and local agencies, and with the public;

(2) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;

(3) developing improved epidemiological tools for obtaining quality exposure data, microbiological methods for classifying cases and detecting clusters, and improved tracebacks to rapidly and specifically identify contaminated food products;

(4) expanding capacity of such systems for implementation of fingerprinting strategies for food-borne infectious agents, including parasites and hepatitis A, in order to increase pathogen discovery efforts to identify new or rarely documented causes of food-borne illness;

(5) allowing timely public access to de-identified, aggregate surveillance data;

(6) at least annually, publishing current reports on findings from such systems;

(7) exploring establishment of registries for long-term case follow-up to better characterize late complications of food-borne illness;

(8) increasing participation in national networks of public health and food regulatory agencies and laboratories to--

(A) allow public health officials at the Federal, State, and local levels to share and accept laboratory analytic findings; and

(B) identify food-borne illness outbreaks and attribute such outbreaks to specific foods through submission of standardized molecular subtypes (also known as `fingerprints') of food-borne illness pathogens to a centralized database; and

(9) establishing a flexible mechanism for rapidly supporting scientific research by academic centers of excellence, which may include staff representing academic clinical researchers, food microbiologists, animal and plant disease specialists, ecologists, and other allied disciplines.

(c) Improving State Surveillance Capacity- The Administrator, in collaboration with the Director of the Centers for Disease Control and Prevention, shall improve capacity for surveillance in the States by--

(1) supporting outbreak investigations with needed specialty expertise, including epidemiological, microbiological, and environmental expertise, to assist identification of underlying common sources and contributing factors;

(2) identifying, disseminating, and supporting implementation of model practices at the State and local level for--

(A) facilitating rapid shipment of clinical isolates from clinical laboratories to State public health laboratories to avoid delays in testing;

(B) conducting rapid and more standardized interviewing of cases associated with major enteric pathogens, including prior to designation of clusters as food-borne illness outbreaks;

(C) conducting and evaluating rapid and standardized interviews of healthy control persons;

(D) sharing information on a timely basis--

(i) within public health and food regulatory agencies;

(ii) among such agencies;

(iii) with the food industry;

(iv) with healthcare providers; and

(v) with the public;

(3) developing, regularly updating, and disseminating training curricula on food-borne illness surveillance investigations, including standard sampling methods and laboratory procedures;

(4) integrating new molecular diagnostic tools for parasites into web-based consultation services for parasitic infections to accelerate the identification of these food-borne infectious agents;

(5) supporting research to develop and deploy new subtyping methods for salmonella, E. coli, campylobacter, and other pathogens, to increase the speed and accuracy of diagnoses;

(6) determining minimum core competencies for public health laboratories, and developing self-evaluation and proficiency-testing tools for such laboratories;

(7) facilitating regional public health laboratory partnerships to leverage resources, including equipment and physical space, and increase surge capacity;

(8) providing technical assistance, which may include the detailing of officers and employees of the Administrator, to State and local public health and food regulatory agencies;

(9) partnering with the Food Safety Administration to increase communication, coordination, and integration of food-borne illness surveillance and outbreak investigation activities; and

(10) developing and periodically updating response and interview procedures so that such procedures are standardized and tested.

(d) Program Activities- The Administrator shall carry out activities to support core food safety functions of State and local public health laboratories, including--

(1) establishing fellowships, stipends, and scholarships to address critical workforce shortages;

(2) training and coordination of State and local personnel;

(3) establishing partnerships between private and public laboratories to facilitate sharing of positive enteric specimens and improve surge capacity;

(4) strengthening capacity to participate in existing or new food-borne illness surveillance systems; and

(5) purchasing and maintaining data systems hardware and software and laboratory equipment.

(e) Plan To Improve Food Safety Capacity at the State and Local Level-

(1) GOALS- The Administrator shall leverage and enhance the food safety capacity and roles of State and local agencies and integrate State and local agencies as fully as possible into national food safety efforts, in order to achieve the following goals:

(A) Improve food-borne illness outbreak response and containment.

(B) Improve the contribution of food-borne illness surveillance and investigation to the prevention of food-borne illness.

(C) Strengthen oversight of food safety at the retail level.

(D) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards in food processing establishments, as part of a national strategy and plan to provide an adequate level of inspection and achieve compliance with safety standards in such establishments.

(E) Make more effective use of the Nation's combined food safety resources to reduce the burden of food-borne illness.

(2) SURVEY- In preparation for development of the plan required by paragraph (3), the Administrator shall, not later than 1 year after the date of enactment of this part, complete a survey of State and local capacities, and needs for enhancement, with respect to--

(A) staffing levels and expertise available to perform food safety functions;

(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;

(C) information systems to support data management and sharing of food safety information among State and local agencies and with counterparts at the Federal level;

(D) legal authorities of State and local agencies to support the roles of such agencies in a national food safety system; and

(E) organizational arrangements for managing and coordinating food safety activities.

(3) PLAN- Taking into account the goals established in paragraph (1), results from the survey required in paragraph (2), and consultations with State and local agencies and other food safety stakeholders, the Administrator shall, not later than 2 years after the date of enactment of this part, develop, publish, and begin implementation of a plan that includes the following elements:

(A) Criteria for assessing the adequacy of State and local capacity to perform food safety functions as part of a national food safety system.

(B) Priorities for enhancing the capacity of State and local agencies.

(C) Action plans for meeting the highest priority capacity needs, including budget requirements and financing plans that take into account Federal, State, and local resources.

(D) Improved coordination and information flow among Federal, State, and local agencies to strengthen food-borne illness surveillance, outbreak response, and investigation and to ensure that agencies at all levels have the information on origins and causes of food-borne illness that such agencies need to plan preventive measures.

(E) Integration of the inspection and compliance programs in food processing establishments of the Food Safety Administration and State and local agencies, including--

(i) joint planning and priority setting to ensure that the collective effort has the greatest possible impact on achieving compliance with food safety standards and reducing food-borne illness;

(ii) elimination of barriers to the free flow of information among the Food Safety Administration and State and local agencies with respect to inspection and compliance programs and integration of State and Federal inspection and laboratory data systems;

(iii) steps to expand, and ensure the vigor and consistency of, State inspection of processing establishments under contract to the Food Safety Administration; and

(iv) reliance by the Food Safety Administration on State inspection and food sample analyses in Federal enforcement activities.

(4) FOOD SAFETY CAPACITY BUILDING GRANTS- The Administrator shall make grants to State and local agencies to enhance State and local food safety capacity and programs and support achievement of the goals established in paragraph (1). In awarding such grants, the Administrator shall take into account the criteria and priorities established by the Administrator under paragraph (3).

(5) REPORT TO CONGRESS- Not later than 1 year after the date of enactment of this part, and on an annual basis thereafter, the Administrator shall submit to Congress a report that describes--

(A) progress made in implementing this section, including any obstacles to such implementation; and

(B) any legislative recommendations or additional resources needed for full implementation.

(f) Service Agreements-

(1) IN GENERAL- The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the qualified personnel and services of those agencies in carrying out this Act.

(2) TRAINING- Agreements with a State under this subsection shall provide for training of State employees.

(3) MAINTENANCE OF AGREEMENTS- The Administrator shall maintain any agreement described in paragraph (1) that is in effect on the day before the date of the enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.

(4) COMMISSIONING- Where necessary and appropriate to fulfill the provisions of this Act or other food safety law, the Administrator shall, as part of any service agreement, commission qualified State and local regulatory officials and inspectors to assist the Administrator in carrying out the food safety law and accord such commissioned officials and inspectors access to information in possession of the Administrator as if they were Federal employees.

SEC. 208. IMPORTS.

(a) In General- All imported food under this Act shall meet requirements for food safety, inspection, labeling, and consumer protection that are at least equal to those applicable to food grown, manufactured, processed, packed, or held for consumption in the United States.

(b) Certification System- Not later than 2 years after the date of the enactment of this Act, the Administrator shall establish a system under which food products offered for importation into the United States shall be certified by the accredited foreign government in the country of export or by an accredited certifying agent meeting all applicable standards under this section.

(1) Category 1, 2, and 3 food establishments shall secure certification of products from the accredited foreign government in the country where the products are produced and must enter the United States through ports designated by the Administrator.

(2) Category 4 and 5 food establishments shall be certified either by--

(A) the accredited foreign government in the country where the products are produced; or

(B) a certifying agent that has been accredited under subsection (c).

(3) Beginning not later than 5 years after the date of the enactment of this Act, food from category 4 and 5 food establishments that is not certified by an accredited entity described in subsection (c) shall not enter the United States except through ports of entry that are located in a metropolitan area with an accredited food testing laboratory.

(c) Certification Standard-

(1) IN GENERAL- A foreign government or third party agent requesting accreditation to certify food for entry into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of the foreign government or third party agent, respectively, can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to food produced in the United States.

(2) REQUEST BY FOREIGN GOVERNMENT- Prior to accrediting a foreign government, the Administrator shall--

(A) review and audit the food safety program of the requesting foreign government (including all statutes, regulations, and inspection authority); and

(B) determine that the exporting country--

(i) administers a food control program that requires food exporters to implement hazard control measures for physical, chemical, and biological contaminants;

(ii) ensures sanitary operations of facilities;

(iii) utilizes testing and verification programs; and

(iv) administers an effective enforcement program.

(3) REQUEST BY A CERTIFYING AGENT- Prior to accrediting a certifying agent, the Administrator shall--

(A) review the training and qualifications of auditors and other employees used by the agent;

(B) ensure that any such auditors have completed such training as may be required by the Administrator for the conduct of food safety inspections; and

(C) conduct reviews of internal systems and such other investigation as the Administrator deems necessary to determine that the certifying agent is capable of auditing food establishments--

(i) to assess the adequacy of systems and standards in use; and

(ii) to ensure that food approved by the agent for import to the United States meets the requirements of this Act.

(4) CERTIFICATION TO ACCOMPANY EACH SHIPMENT- As a condition of accrediting any foreign government or certifying agent, such government or agent shall agree to issue a written and electronic certification to accompany each shipment intended for import to the United States from any food establishment which the government or agent certifies, subject to requirements set forth by the Administrator.

(d) Audits; Inspections- Following any accreditation under subsection (c), the Administrator may at any time--

(1) conduct an on-site audit of any food establishment registered under section 202, with or without the certifying agent; or

(2) require a certifying agent to submit an onsite audit report and any other reports or documents which the agent requires as part of the audit process, including documentation that the food establishment is in compliance with registration requirements and prior notice requirements for food imported to the United States.

(e) Limitation- A foreign government or other certifying agent accredited by the Administrator to certify food for import to the United States under this section may certify only the food products or food categories for importation to the United States that are specified in the grant of accreditation.

(f) Withdrawal of Accreditation- The Administrator may withdraw accreditation from a foreign government or certifying agent--

(1) if food approved by the foreign government or certifying agent is linked to an outbreak of human illness;

(2) following an investigation and finding by the Administrator that the programs of the foreign government, or a foreign food establishment certified by the certifying agent, are no longer equal to those applied to food grown, manufactured, processed, packed, or held in the United States; or

(3) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements of this section.

(g) Renewal of Accreditation- The Administrator shall audit foreign governments and certifying agents whenever needed, but no less than once every 3 years, to ensure the continued compliance with the requirements set forth in this section. Renewal of accreditation shall occur following each satisfactory audit.

(h) Required Routine Inspection- The Administrator shall routinely inspect food before or at entry into the United States to ensure ongoing compliance with food safety law and where appropriate, as part of the audit of any certifying entity.

(i) Enforcement- The Administrator may--

(1) deny importation of food from any foreign country if the government of such country does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill requirements under this section;

(2) deny importation of food from any foreign country or foreign food establishment that does not consent to a timely investigation by the Administration when food from that foreign country or foreign food establishment is linked to a food-borne illness outbreak or is otherwise found to be adulterated or misbranded;

(3) promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the requirements of this Act; and

(4) establish such fees as are necessary to carry out the implementation of the accreditation and inspection programs required under this section.

(j) Detention and Seizure- Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402 or recalled pursuant to section 403.

(k) Certifying Agents- Entities eligible for accreditation as a certifying agent under subsection (c) may include--

(1) a State or regional food authority; or

(2) a foreign or domestic cooperative that aggregates the products of growers or processors for importation.

(l) Avoiding Conflicts of Interest With Certifying Agents-

(1) IN GENERAL- To be eligible for accreditation under subsection (c), a certifying agent shall--

(A) not be owned, managed, or controlled by any person that owns or operates an establishment whose products are to be certified by such agent;

(B) have procedures to ensure against the use, in carrying out audits of food establishments under this section, of any officer or employee of such agent that has a financial conflict of interest regarding an establishment whose products are to be certified by such agent; and

(C) annually make available to the Secretary, disclosures of the extent to which such agent, and the officers and employees of such agent, have maintained compliance with subparagraphs (A) and (B) relating to financial conflicts of interest.

(2) REGULATIONS- The Secretary shall promulgate regulations not later than 18 months after the date of the enactment of this Act to ensure that there are protections against conflicts of interest between a certifying agent and the establishments whose products are to be certified by such agent. Such regulations shall include--

(A) requiring that domestic audits performed under this section be unannounced;

(B) a structure, including timing and public disclosure, for fees paid by food establishments to certifying agents to decrease the potential for conflicts of interest; and

(C) appropriate limits on financial affiliations between a certifying agent and any person that owns or operates an establishment whose products are to be certified by such agent.

SEC. 209. RESOURCE PLAN.

(a) In General- The Administrator shall prepare and update annually a resource plan describing the resources required, in the best professional judgment of the Administrator, to develop and fully implement the national food safety program established under this Act.

(b) Contents of Plan- The resource plan shall--

(1) describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of this Act;

(2) allocate inspection resources in a manner reflecting the distribution of risk and opportunities to reduce risk across the food supply to the extent feasible based on the best available information, and subject to section 205; and

(3) describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities, at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205 and food production facilities under section 206--

(A) in foreign establishments and production facilities; and

(B) at the point of importation.

(c) Grants- The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities and inspections of food establishments and food production facilities and include resources to audit such programs.

(d) Submission of Plan- The Administrator shall submit annually to the Committee on Appropriations of the Senate, the Committee on Appropriations of the House of Representatives, and other relevant committees of Congress, the resource plan required under this section.

SEC. 210. TRACEBACK REQUIREMENTS.

(a) In General- The Administrator, in order to protect the public health, shall establish a national traceability system that enables the Administrator to retrieve the history, use, and location of an article of food through all stages of its production, processing, and distribution.

(b) Applicability- Traceability requirements under this section shall apply to food from food production facilities, food establishments, and foreign food establishments.

(c) Requirements-

(1) STANDARDS- The Administrator shall establish standards for the type of information, format, and timeframe for food production facilities and food establishments to submit records to aid the Administrator in effectively retrieving the history, use, and location of an item of food.

(2) RULE OF CONSTRUCTION- Nothing in this section shall be construed as requiring the Administrator to prescribe a specific technology for the maintenance of records or labeling of food to carry out the requirements of this section.

(3) AVAILABILITY OF RECORDS FOR INSPECTION- Any records that are required by the Administrator under this section shall be available for inspection by the Administrator upon oral or written request.

(4) DEMONSTRATION OF ABILITY- The Administrator, during any inspection, may require a food establishment to demonstrate its ability to trace an item of food and submit the information in the format and timeframe required under paragraph (1).

(d) Relationship to Other Requirements-

(1) CONSISTENCY WITH EXISTING STATUTES AND REGULATIONS- To the extent possible, the Administrator should establish the national traceability system under this section to be consistent with existing statutes and regulations that require recordkeeping or labeling for identifying the origin or history of food or food animals.

(2) EXISTING LAWS- For purposes of this subsection, the Administrator should review the following:

(A) Country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).

(B) The Perishable Agricultural Commodities Act of 1930 (7 U.S.C. 499a-t).

(C) Country of origin labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).

(D) The National Animal Identification System as authorized by the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.).

(3) CERTAIN REQUIREMENTS- Nothing contained in this section prevents or interferes with implementation of the country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).

SEC. 211. ACCREDITED LABORATORIES.

(a) Establishment of Program- The Administrator shall establish a program for accrediting laboratories to perform sampling and testing for purposes of this Act. Such program shall include--

(1) standards for appropriate sampling and analytical procedures;

(2) training and experience qualification levels for individuals who conduct sampling and analysis;

(3) annual onsite visits to audit the performance of an accredited laboratory; and

(4) such additional requirements as the Administrator determines to be appropriate.

(b) Requirements- To be accredited under this section, a laboratory shall--

(1) prepare and submit an application for accreditation to the Administrator;

(2) meet required tests and standards established by the Administrator; and

(3) comply with such terms and conditions as are determined necessary by the Administrator.

(c) Accrediting Bodies- The Administrator may approve State agencies or private, nonprofit entities as accrediting bodies to act on behalf of the Administrator in accrediting laboratories under this section. The Administrator shall--

(1) in making such approvals--

(A) oversee and review the performance of any accrediting body acting on behalf of the Administrator to ensure that such accrediting body is in compliance with the requirements of this section; and

(B) have the right to obtain from an accrediting body acting on behalf of the Administrator and from any laboratory that may be certified by such a body all records and materials that may be necessary for the oversight and review required by subparagraph (A);

(2) reevaluate accreditation bodies approved under paragraph (1) whenever--

(A) the Administrator determines a laboratory accredited by the accrediting body is no longer in compliance with this section;

(B) the Administrator determines the accrediting body is no longer in compliance with the requirements of this section; or

(C) no less than once every 5 years; and

(3) promptly revoke the approval of any accreditation body found not to be in compliance with the requirements of this section.

(d) Revocation of Accreditation- The Administrator shall revoke the accreditation of any laboratory that fails to meet the requirements this section.

TITLE III--RESEARCH AND EDUCATION

SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.

(a) In General- The Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with food safety and research programs of the Department of Agriculture, shall--

(1) identify on an ongoing basis the priorities for collection of epidemiological data and for other food safety research and data collection that are most important to implementing the food safety law and reducing the public health burden of food-borne illness;

(2) have full access for purposes of implementing the food safety law to the applicable data and data systems of the Centers for Disease Control and Prevention, including data made available to the Centers by a State;

(3) provide appropriate support and input on the design and implementation by the Centers for Disease Control and Prevention and the States of an active surveillance system that provides information on the incidence and causes of food-borne illness which is timely, detailed, and representative of the population of the United States;

(4) based on data and information obtained from the Centers for Disease Control and Prevention, the States, and other sources, assess the incidence, distribution, public health impact, and causes of human illness in the United States associated with the consumption of food, and conduct research and analysis to devise effective and feasible interventions to reduce food-borne illness;

(5) maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment; and

(6) utilize surveillance data created by means of monitoring and statistical studies conducted as part of its own inspection.

(b) Public Health Sampling-

(1) IN GENERAL- Not later than 1 year after the enactment of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food--

(A) to assist the Administrator in carrying out this Act; and

(B) to assess the nature, frequency of occurrence, and quantities of contaminants in food.

(2) REQUIREMENTS- The sampling system described in paragraph (1) shall provide--

(A) statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and

(B) at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.

(c) Assessment of Health Hazards-

(1) IN GENERAL- Through the surveillance system and analyses referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall--

(A) rank food categories based on the hazard to human health presented by the food category and specific chemical and microbiological hazards associated with foods in those categories;

(B) identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and

(C) assess the conditions affecting the likelihood that emerging pathogens and diseases, including zoonosis, will affect the safety of the food supply and possible strategies for minimizing the potential risk to public health associated with emerging pathogens and diseases.

(2) COMPONENTS OF ANALYSIS- The analysis under subsection (b)(1) may include--

(A) a comparison of the safety of commercial processing with the health hazards associated with food that is harvested for recreational or subsistence purposes and prepared noncommercially;

(B) a comparison of the safety of food that is domestically processed with the health hazards associated with food that is processed outside the United States;

(C) a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and

(D) use of comparative risk assessments.

SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.

(a) Public Education-

(1) IN GENERAL- The Administrator, in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, shall establish a national public education program on food safety.

(2) REQUIREMENTS- The program shall provide--

(A) information to the public regarding Federal standards and best practices, and promotion of public awareness and understanding of those standards and practices;

(B) information for health professionals--

(i) to improve diagnosis and treatment of food-related illness; and

(ii) to advise individuals at special risk for food-related illnesses; and

(C) such other information or advice, including on safe food handling practices, to consumers and other persons as the Administrator determines will promote the purposes of this Act.

(b) Health Advisories- The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities--

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

(2) to develop standardized formats for written and broadcast advisories;

(3) to incorporate State and local advisories into the national public education program established under subsection (a); and

(4) to present prompt, specific information regarding food found to pose a threat to the public health, including by identifying the retailers and food establishments where such food has been sold.

SEC. 303. RESEARCH.

(a) In General- The Administrator shall conduct research to carry out this Act, including studies to--

(1) improve sanitation and food safety practices in the processing of food;

(2) develop improved techniques to monitor and inspect food;

(3) develop efficient, rapid, and sensitive methods to detect contaminants in food;

(4) determine the sources of contamination of contaminated food;

(5) develop food consumption data;

(6) identify ways that animal production techniques could improve the safety of the food supply;

(7) draw upon research and educational programs that exist at the State and local level;

(8) utilize the DNA matching system and other processes to identify and control pathogens;

(9) address common and emerging zoonotic diseases;

(10) develop methods to reduce or destroy harmful pathogens before, during, and after processing;

(11) analyze the incidence of antibiotic resistence as it pertains to the food supply and develop new methods to reduce the transfer of antibiotic resistance to humans; and

(12) conduct other research that supports the purposes of this Act.

(b) Contract Authority- The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.

SEC. 304. WORKING GROUP ON IMPROVING FOODBORNE ILLNESS SURVEILLANCE.

Not later than 180 days after the date of enactment of this Act, the Administrator shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, consumer organizations, and academia. Such working group shall provide the Administrator, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of food-borne illness surveillance, including advice and recommendations on--

(1) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on food-borne illness and its causes that can be used to prevent food-borne illness;

(2) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;

(3) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to food-borne illness surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;

(4) key barriers to improvement in food-borne illness surveillance and its utility for preventing food-borne illness at Federal, State, and local levels; and

(5) specific actions to reduce barriers to such improvement, implement the working group's recommendations, with measurable objectives and timelines, and identification of resource and staffing needs.

SEC. 305. CAREER-SPANNING TRAINING FOR FOOD INSPECTORS.

(a) In General- The Administrator shall make a grant to an entity described in subsection (c) to provide training to Federal, State, and local food inspectors.

(b) Use of Funds- The Administrator may make a grant under this section to an applicant only if the applicant agrees to use the grant to provide regular, standardized, graduated, career-spanning training, based on a curriculum developed by the Association of Food and Drug Officials, to Federal, State, and local food inspectors.

(c) Eligible Entity- An entity described in this subsection is an entity that--

(1) is described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3));

(2) has the capability to train not less than 1,000 food inspectors per year; and

(3) offers both on-site and off-site training for food inspectors.

SEC. 306. FOOD-BORNE ILLNESS HEALTH REGISTRY.

(a) Purpose- The purpose of the registry under subsection (b) is to stimulate research on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.

(b) Registry- For the purpose described in subsection (a), the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall develop and maintain a registry, to be known as the Food-Borne Illness Health Registry, consisting of data on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.

SEC. 307. STUDY ON FEDERAL RESOURCES.

Not later than one year after the date of the enactment of this Act, the Comptroller General of the United States shall complete a study on the Federal resources being dedicated to food-borne illness and food safety research and submit a report on the results of such study to the Congress.

TITLE IV--ENFORCEMENT

SEC. 401. PROHIBITED ACTS.

It is prohibited--

(1) to manufacture, introduce, deliver for introduction, or receive in interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;

(2) to adulterate or misbrand any food in interstate commerce;

(3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;

(4) to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);

(5) to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);

(6) to refuse to permit entry to or inspection of a food establishment as required under section 205;

(7) to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);

(8) to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;

(9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;

(10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;

(11) to fail to comply with a recall or other order under section 403; or

(12) to otherwise violate the food safety law.

SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNATION.

(a) Administrative Detention of Food-

(1) EXPANDED AUTHORITY- The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food regulated under this Act that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.

(2) DETENTION AUTHORITY- If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this the food safety law, the officer, employee, or agent may order the food detained.

(3) PERIOD OF DETENTION-

(A) IN GENERAL- A food may be detained under paragraph (1) or (2) for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action.

(B) PERISHABLE FOOD- The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.

(4) SECURITY OF DETAINED FOOD-

(A) IN GENERAL- A detention order under this subsection--

(i) may require that the food be labeled or marked as detained; and