S 654 ISCommentsClose CommentsPermalink

To establish the Food Safety Administration 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.CommentsClose CommentsPermalink

February 15, 2007

Mr. DURBIN (for himself and Mr. SCHUMER) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and ForestryCommentsClose CommentsPermalink

To establish the Food Safety Administration 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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the `Safe Food Act of 2007'.CommentsClose CommentsPermalink





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





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink





Sec. 2. Findings; purposes.CommentsClose CommentsPermalink





Sec. 3. Definitions.CommentsClose CommentsPermalink

TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of Food Safety Administration.CommentsClose CommentsPermalink





Sec. 102. Consolidation of separate food safety and inspection services and agencies.CommentsClose CommentsPermalink





Sec. 103. Additional duties of the Administration.CommentsClose CommentsPermalink

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

Sec. 201. Administration of national program.CommentsClose CommentsPermalink





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





Sec. 203. Preventative process controls to reduce adulteration of food.CommentsClose CommentsPermalink





Sec. 204. Performance standards for contaminants in food.CommentsClose CommentsPermalink





Sec. 205. Inspections of food establishments.CommentsClose CommentsPermalink





Sec. 206. Food production facilities.CommentsClose CommentsPermalink





Sec. 207. Federal and State cooperation.CommentsClose CommentsPermalink





Sec. 208. Imports.CommentsClose CommentsPermalink





Sec. 209. Resource plan.CommentsClose CommentsPermalink





Sec. 210. Traceback.CommentsClose CommentsPermalink

TITLE III--RESEARCH AND EDUCATION

Sec. 301. Public health assessment system.CommentsClose CommentsPermalink





Sec. 302. Public education and advisory system.CommentsClose CommentsPermalink





Sec. 303. Research.CommentsClose CommentsPermalink

TITLE IV--ENFORCEMENT

Sec. 401. Prohibited Acts.CommentsClose CommentsPermalink





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





Sec. 403. Notification and recall.CommentsClose CommentsPermalink





Sec. 404. Injunction proceedings.CommentsClose CommentsPermalink





Sec. 405. Civil and criminal penalties.CommentsClose CommentsPermalink





Sec. 406. Presumption.CommentsClose CommentsPermalink





Sec. 407. Whistleblower protection.CommentsClose CommentsPermalink





Sec. 408. Administration and enforcement.CommentsClose CommentsPermalink





Sec. 409. Citizen civil actions.CommentsClose CommentsPermalink

TITLE V--IMPLEMENTATION

Sec. 501. Definition.CommentsClose CommentsPermalink





Sec. 502. Reorganization plan.CommentsClose CommentsPermalink





Sec. 503. Transitional authorities.CommentsClose CommentsPermalink





Sec. 504. Savings provisions.CommentsClose CommentsPermalink





Sec. 505. Conforming amendments.CommentsClose CommentsPermalink





Sec. 506. Additional technical and conforming amendments.CommentsClose CommentsPermalink





Sec. 507. Regulations.CommentsClose CommentsPermalink





Sec. 508. Authorization of appropriations.CommentsClose CommentsPermalink





Sec. 509. Limitation on authorization of appropriations.CommentsClose CommentsPermalink





Sec. 510. Effective date.CommentsClose CommentsPermalink

SEC. 2. FINDINGS; PURPOSES.

(a) Findings- Congress finds that--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(3) the safety and security of the food supply requires an integrated, system-wide approach to preventing food-borne illness, a thorough and broad-based approach to basic and applied research, and intensive, effective, and efficient management of the Nation's food safety program;CommentsClose CommentsPermalink





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





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





(B) an aging and immune compromised population, with a growing number of people at high-risk for food-borne illnesses, including infants and children;CommentsClose CommentsPermalink





(C) an increasing volume of imported food, without adequate monitoring and inspection; andCommentsClose CommentsPermalink





(D) maintenance of rigorous inspection of the domestic food processing and food service industries;CommentsClose CommentsPermalink





(5) 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;CommentsClose CommentsPermalink





(6) the Federal food safety system is fragmented, with at least 12 Federal agencies sharing responsibility for food safety, and operates under laws that do not reflect current conditions in the food system or current scientific knowledge about the cause and prevention of food-borne illness;CommentsClose CommentsPermalink





(7) the fragmented Federal food safety system and outdated laws preclude an integrated, system-wide approach to preventing food-borne illness, to the effective and efficient operation of the Nation's food safety program, and to the most beneficial deployment of food safety resources;CommentsClose CommentsPermalink





(8) the National Academy of Sciences recommended in the report `Ensuring Safe Food from Production to Consumption' that Congress establish by statute a unified and central framework for managing Federal food safety programs, and recommended modifying Federal statutes so that inspection, enforcement, and research efforts are based on scientifically supportable assessments of risks to public health; andCommentsClose CommentsPermalink





(9) the lack of a single focal point for food safety leadership in the United States undercuts the ability of the United States to exert food safety leadership internationally, which is detrimental to the public health and the international trade interests of the United States.CommentsClose CommentsPermalink





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





(1) to establish a single agency to be known as the `Food Safety Administration' to--CommentsClose CommentsPermalink





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





(B) ensure that food establishments fulfill their responsibility to produce food in a manner that protects the public health of all people in the United States;CommentsClose CommentsPermalink





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





(D) provide a single focal point for food safety leadership, both nationally and internationally; andCommentsClose CommentsPermalink





(E) provide an integrated food safety research capability, utilizing internally-generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments, to achieve the continuous improvement of research on food-borne illness and contaminants;CommentsClose CommentsPermalink





(2) to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the effective date of this Act, are performed by other Federal agencies; andCommentsClose CommentsPermalink





(3) to modernize and strengthen the Federal food safety laws to achieve more effective application and efficient management of the laws for the protection and improvement of public health.CommentsClose CommentsPermalink

SEC. 3. DEFINITIONS.

In this Act:CommentsClose CommentsPermalink





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





(2) ADMINISTRATOR- The term `Administrator' means the Administrator of Food Safety appointed under section 101(a)(3).CommentsClose CommentsPermalink





(3) ADULTERATED-CommentsClose CommentsPermalink





(A) IN GENERAL- The term `adulterated' has the meaning described in subsections (a) through (c) of section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).CommentsClose CommentsPermalink





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





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





(5) CATEGORY 1 FOOD ESTABLISHMENT- The term `category 1 food establishment' means a food establishment that slaughters animals for food.CommentsClose CommentsPermalink





(6) CATEGORY 2 FOOD ESTABLISHMENT- The term `category 2 food establishment' means a food establishment that processes raw meat, poultry, seafood products, regardless of whether the establishment also has a kill step, and animal feed and other products that the Administrator determines by regulation to be at high risk of contamination and the processes of which do not include a step validated to destroy contaminants.CommentsClose CommentsPermalink





(7) CATEGORY 3 FOOD ESTABLISHMENT- The term `category 3 food establishment' means a food establishment that processes meat, poultry, seafood products, and other products that the Administrator determines by regulation to be at high risk of contamination and whose processes include a step validated to destroy contaminants.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





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





(11) CONTAMINATION- The term `contamination' refers to a presence of a contaminant in food.CommentsClose CommentsPermalink





(12) FOOD-CommentsClose CommentsPermalink





(A) IN GENERAL- The term `food' means a product intended to be used for food or drink for a human or an animal.CommentsClose CommentsPermalink





(B) INCLUSIONS- The term `food' includes any product (including a meat food product, as defined in section 1(j) of the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable for use as human food that is made in whole or in part from any animal, including cattle, sheep, swine, or goat, or poultry (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)), and animal feed.CommentsClose CommentsPermalink





(C) EXCLUSION- The term `food' does not include dietary supplements, as defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).CommentsClose CommentsPermalink





(13) FOOD ESTABLISHMENT-CommentsClose CommentsPermalink





(A) IN GENERAL- The term `food establishment' means a slaughterhouse, 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.CommentsClose CommentsPermalink





(B) EXCLUSIONS- For the purposes of registration, the term `food establishment' does not include a farm, 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).CommentsClose CommentsPermalink





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





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





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





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





(C) the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);CommentsClose CommentsPermalink





(D) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);CommentsClose CommentsPermalink





(E) the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);CommentsClose CommentsPermalink





(F) the Sanitary Food Transportation Act of 1990 (49 U.S.C. App. 2801 et seq.);CommentsClose CommentsPermalink





(G) the amendments made by the Sanitary Food Transportation Act of 2005 (subtitle B of title VII of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users) (21 U.S.C. 301 note);CommentsClose CommentsPermalink





(H) the provisions of the Humane Methods of Slaughter Act of 1978 (21 U.S.C. 601 note) administered by the Food Safety and Inspection Service;CommentsClose CommentsPermalink





(I) the provisions of this Act; andCommentsClose CommentsPermalink





(J) such other provisions of law related to and requiring food safety, labeling, inspection, and enforcement as the President designates by Executive order as appropriate to include within the jurisdiction of the Administration.CommentsClose CommentsPermalink





(16) FOREIGN FOOD ESTABLISHMENT- The term `foreign food establishment' means a slaughterhouse, factory, warehouse, or facility located outside the United States that processes food for consumption that is imported into the United States or food ingredients.CommentsClose CommentsPermalink





(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)).CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





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





(20) SAFE- The term `safe' refers to human and animal health.CommentsClose CommentsPermalink





(21) STATE- The term `State' means--CommentsClose CommentsPermalink





(A) a State;CommentsClose CommentsPermalink





(B) the District of Columbia;CommentsClose CommentsPermalink





(C) the Commonwealth of Puerto Rico; andCommentsClose CommentsPermalink





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





(22) VALIDATION- The term `validation' means the obtaining of evidence that the food hygiene control measure or measures selected to control a hazard in food is capable of effectively and consistently controlling the hazard.CommentsClose CommentsPermalink





(23) STATISTICALLY VALID- With respect to a study, the term `statistically valid' means evaluated and conducted under standards set by the National Institute of Standards and Technology.CommentsClose CommentsPermalink

TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.

(a) Establishment-CommentsClose CommentsPermalink





(1) IN GENERAL- There is established in the executive branch an agency to be known as the `Food Safety Administration'.CommentsClose CommentsPermalink





(2) STATUS- The Administration shall be an independent establishment (as defined in section 104 of title 5, United States Code).CommentsClose CommentsPermalink





(3) HEAD OF 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.CommentsClose CommentsPermalink





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





(1) administer and enforce the food safety law;CommentsClose CommentsPermalink





(2) serve as a representative to international food safety bodies and discussions;CommentsClose CommentsPermalink





(3) promulgate regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; andCommentsClose CommentsPermalink





(4) oversee--CommentsClose CommentsPermalink





(A) implementation of Federal food safety inspection, enforcement, and research efforts, to protect the public health;CommentsClose CommentsPermalink





(B) development of consistent and science-based standards for safe food;CommentsClose CommentsPermalink





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





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





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





(F) integration of Federal food safety activities with State and local agencies.CommentsClose CommentsPermalink

SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY AND INSPECTION SERVICES AND AGENCIES.

(a) Transfer of Functions- For each Federal agency specified in subsection (b), there are transferred to the Administration all functions that the head of the Federal agency exercised on the day before the effective date of this Act (including all related functions of any officer or employee of the Federal agency) that relate to administration or enforcement of the food safety law, as determined by the President.CommentsClose CommentsPermalink





(b) Transferred Agencies- The Federal agencies referred to in subsection (a) are--CommentsClose CommentsPermalink





(1) the Food Safety and Inspection Service of the Department of Agriculture;CommentsClose CommentsPermalink





(2) the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;CommentsClose CommentsPermalink





(3) the part of the Agriculture Marketing Service that administers shell egg surveillance services established under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);CommentsClose CommentsPermalink





(4) the resources and facilities of the Office of Regulatory Affairs of the Food and Drug Administration that administer and conduct inspections of food establishments and imports;CommentsClose CommentsPermalink





(5) the resources and facilities of the Office of the Commissioner of the Food and Drug Administration that support--CommentsClose CommentsPermalink





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





(B) the Center for Veterinary Medicine; andCommentsClose CommentsPermalink





(C) the Office of Regulatory Affairs facilities and resources described in paragraph (4);CommentsClose CommentsPermalink





(6) the Center for Veterinary Medicine of the Food and Drug Administration;CommentsClose CommentsPermalink





(7) the resources and facilities of the Environmental Protection Agency that control and regulate pesticide residues in food;CommentsClose CommentsPermalink





(8) the part of the Research, Education, and Economics mission area of the Department of Agriculture related to food safety and animal feed research;CommentsClose CommentsPermalink





(9) the part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program;CommentsClose CommentsPermalink





(10) the Animal and Plant Inspection Health Service of the Department of Agriculture; andCommentsClose CommentsPermalink





(11) such other offices, services, or agencies as the President designates by Executive order to carry out this Act.CommentsClose CommentsPermalink

SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.

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





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





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





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





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(d) Advisory Committees-CommentsClose CommentsPermalink





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





(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.CommentsClose CommentsPermalink

TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

(a) In General- The Administrator shall--CommentsClose CommentsPermalink





(1) administer a national food safety program (referred to in this section as the `program') to protect public health; andCommentsClose CommentsPermalink





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





(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--CommentsClose CommentsPermalink





(1) the severity of the potential health risks;CommentsClose CommentsPermalink





(2) the sources and specific points of potential contamination extending from the farm or ranch to the consumer that may render food unsafe;CommentsClose CommentsPermalink





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





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





(5) opportunities for intentional contamination.CommentsClose CommentsPermalink





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





(1) adopt and implement a national system for the registration of food establishments and foreign food establishments and regular unannounced inspection of food establishments;CommentsClose CommentsPermalink





(2) enforce the adoption of process controls in food establishments, based on best available scientific and public health considerations and best available technologies;CommentsClose CommentsPermalink





(3) establish and enforce science-based standards for--CommentsClose CommentsPermalink





(A) substances that may contaminate food; andCommentsClose CommentsPermalink





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





(4) implement a statistically valid sampling program to ensure 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;CommentsClose CommentsPermalink





(5) implement procedures and requirements to ensure the safety and security of imported food;CommentsClose CommentsPermalink





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





(7) have access to the surveillance data of the Centers for Disease Control and Prevention, and other Federal Government agencies, in order to implement a national surveillance system to assess the health risks associated with the human consumption of food or to create surveillance data and studies;CommentsClose CommentsPermalink





(8) develop public education risk communication and advisory programs;CommentsClose CommentsPermalink





(9) implement a basic and applied research program to further the purposes of this Act; andCommentsClose CommentsPermalink





(10) coordinate and prioritize food safety research and educational programs with other agencies, including State or local agencies.CommentsClose CommentsPermalink

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

(a) In General- The Administrator shall by regulation require that any food establishment or foreign food establishment engaged in processing food in the United States be registered with the Administrator.CommentsClose CommentsPermalink





(b) Registration Requirements-CommentsClose CommentsPermalink





(1) IN GENERAL- To be registered under subsection (a)--CommentsClose CommentsPermalink





(A) in the case of a food establishment, the owner, operator, or agent in charge of the food establishment shall submit a registration to the Administrator; andCommentsClose CommentsPermalink





(B) in the case of a foreign food establishment, the owner, operator, or agent in charge of the foreign food establishment shall--CommentsClose CommentsPermalink





(i) submit a registration to the Administrator; andCommentsClose CommentsPermalink





(ii) provide the name, address, and emergency contact information of the United States agent for the foreign food establishment.CommentsClose CommentsPermalink





(2) REGISTRATION- A food establishment or foreign food establishment shall submit a registration under paragraph (1) to the Administrator that--CommentsClose CommentsPermalink





(A) identifies the name, address, and emergency contact information of each food establishment or foreign food establishment that the registrant operates under this Act and all trade names under which the registrant conducts business relating to food;CommentsClose CommentsPermalink





(B) lists the primary purpose and business activity of each food establishment or foreign food establishment, including the dates of operation if the food establishment or foreign food establishment is seasonal;CommentsClose CommentsPermalink





(C) lists the types of food processed or sold at each food establishment or, for foreign food establishments selling food for consumption in the United States, identifies the specific food categories of that food as listed under section 170.3 of title 21, Code of Federal Regulations; andCommentsClose CommentsPermalink





(D) not later than 30 days after a change in the products, function, or legal status of the food establishment or foreign food establishment (including cessation of business activities), notifies the Administrator of the change.CommentsClose CommentsPermalink





(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 food establishment and foreign food establishment.CommentsClose CommentsPermalink





(4) LIST- The Administrator shall compile and maintain an up-to-date list of food establishments and foreign food establishments that are registered under this section. The Administrator may establish regulations by which such list may be shared with other governmental authorities.CommentsClose CommentsPermalink





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





(A) the list compiled under paragraph (4); andCommentsClose CommentsPermalink





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





(6) SUSPENSION OF REGISTRATION-CommentsClose CommentsPermalink





(A) IN GENERAL- The Administrator may suspend the registration of a food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law.CommentsClose CommentsPermalink





(B) NOTICE AND OPPORTUNITY FOR HEARING- The Administrator shall provide notice to a registrant immediately upon the suspension of the registration of the facility and provide registrant with an opportunity for a hearing within 3 days of the suspension.CommentsClose CommentsPermalink





(7) REINSTATEMENT- A registration that is suspended under this section may be reinstated pursuant to criteria published in the Federal Register by the Administrator.CommentsClose CommentsPermalink

SEC. 203. PREVENTATIVE 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 to--CommentsClose CommentsPermalink





(1) process food in a sanitary manner so that it is free of dirt and filth;CommentsClose CommentsPermalink





(2) limit the presence of potentially harmful contaminants in food;CommentsClose CommentsPermalink





(3) implement appropriate measures of preventative process control to minimize and reduce the presence and growth of contaminants in food and meet the performance standards established under section 204;CommentsClose CommentsPermalink





(4) process all fully processed or ready-to-eat food in a sanitary manner, using reasonably available techniques and technologies to eliminate any potentially harmful contaminants; andCommentsClose CommentsPermalink





(5) label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy contaminants.CommentsClose CommentsPermalink





(b) Regulations- Not later than 1 year after the effective date of this Act, the Administrator shall promulgate regulations that--CommentsClose CommentsPermalink





(1) require all food establishments to adopt preventative process controls that are--CommentsClose CommentsPermalink





(A) adequate to protect the public health;CommentsClose CommentsPermalink





(B) meet relevant regulatory and food safety standards; andCommentsClose CommentsPermalink





(C) limit the presence and growth of contaminants in food prepared in a food establishment;CommentsClose CommentsPermalink





(2) set standards for sanitation;CommentsClose CommentsPermalink





(3) meet any performance standards for contaminants established under section 204;CommentsClose CommentsPermalink





(4) require recordkeeping to monitor compliance;CommentsClose CommentsPermalink





(5) require sampling and testing 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; andCommentsClose CommentsPermalink





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





(c) Processing Controls- The Administrator may require any person with responsibility for or control over food or food ingredients to adopt process controls, if the process controls are needed to ensure the protection of the public health.CommentsClose CommentsPermalink

SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

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





(b) Identification of Contaminants; Performance Standards-CommentsClose CommentsPermalink





(1) IN GENERAL- Not later than 6 months after the date of enactment of this Act, the Administrator shall identify the food-borne contaminants and food that contribute significantly to the risk of food-borne illness.CommentsClose CommentsPermalink





(2) PERFORMANCE STANDARDS- As soon as practicable after the identification of the contaminants under paragraph (1), the Administrator shall establish appropriate performance standards to protect against all food-borne contaminants.CommentsClose CommentsPermalink





(3) SIGNIFICANT CONTAMINANTS- The Administrator shall establish performance standards for the 5 contaminants that contribute to the greatest number of illnesses or deaths associated with raw meat, poultry, and seafood not later than 3 years after the date of enactment of this Act. The Administrator shall revise such standards not less often than every 3 years.CommentsClose CommentsPermalink





(c) Performance Standards-CommentsClose CommentsPermalink





(1) IN GENERAL- The performance standards established under this section shall include--CommentsClose CommentsPermalink





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





(B) zero tolerances, including zero tolerances for fecal matter, in addition to any zero-tolerance standards in effect on the day before the date of enactment of this Act, when necessary to protect against significant adverse health outcomes;CommentsClose CommentsPermalink





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





(D) in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance in terms of `best reasonably achievable performance', using best available technologies, interventions, and practices.CommentsClose CommentsPermalink





(2) BEST REASONABLY ACHIEVABLE PERFORMANCE STANDARDS- In developing best reasonably achievable performance standards, 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.CommentsClose CommentsPermalink





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





(d) Enforcement-CommentsClose CommentsPermalink





(1) IN GENERAL- Not later than 1 year after the promulgation of a performance standard under this section, the Administrator shall implement a statistically significant sampling program to determine whether food establishments are complying with the performance standards promulgated under this section. The program established under this paragraph shall be at least as stringent as the Hazard Analysis and Critical Control Point System requirements established under part 417 of title 9, Code of Federal Regulations (or successor regulation).CommentsClose CommentsPermalink





(2) INSPECTIONS- If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, and such establishment fails to take appropriate corrective action as determined by the Administrator, the Administrator shall, as appropriate--CommentsClose CommentsPermalink





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





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





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





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





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





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

SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.

(a) In General- The Administrator shall establish an inspection program, which shall include sampling and testing of food and food establishments, to determine if each food establishment--CommentsClose CommentsPermalink





(1) is operating in a sanitary manner;CommentsClose CommentsPermalink





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





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





(4) is processing food that is safe and not adulterated or misbranded;CommentsClose CommentsPermalink





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





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





(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):CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) diseased animals are not offered for slaughter;CommentsClose CommentsPermalink





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





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





(2) CATEGORY 2 FOOD ESTABLISHMENTS- A category 2 food establishment shall be randomly inspected at least daily.CommentsClose CommentsPermalink





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





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





(B) be randomly inspected at least monthly.CommentsClose CommentsPermalink





(4) CATEGORY 4 FOOD ESTABLISHMENTS- A category 4 food establishment shall be randomly inspected at least quarterly.CommentsClose CommentsPermalink





(5) CATEGORY 5 FOOD ESTABLISHMENTS- A category 5 food establishment shall be randomly inspected at least annually.CommentsClose CommentsPermalink





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





(d) Alternative Inspection Frequencies- With respect to a category 2, 3, 4, or 5 food establishment, 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, subject to the following criteria and procedures:CommentsClose CommentsPermalink





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





(2) Regulations of alternative inspection frequencies for subcategories of food establishments under paragraph (1) and for a specific food establishment under paragraph (4) shall provide that--CommentsClose CommentsPermalink





(A) category 2 food establishments shall be inspected at least monthly; andCommentsClose CommentsPermalink





(B) category 3, 4, and 5 food establishments shall be inspected at least annually.CommentsClose CommentsPermalink





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





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





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





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





(D) the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of establishments; andCommentsClose CommentsPermalink





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





(4) The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment, subject to paragraphs (2) and (5) and shall periodically publish a list of establishments subject to alternative inspections.CommentsClose CommentsPermalink





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





(A) the criteria in paragraph (3);CommentsClose CommentsPermalink





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





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





(6) Before establishing decreased alternative inspection frequencies for subcategories of establishments or individual establishments, the Administrator shall--CommentsClose CommentsPermalink





(A) determine, based on the best available evidence, that the alternative uses of the resources required to carry out the inspection activity would make a greater contribution to protecting the public health and reducing the risk of food-borne illness than the use of resources described in subsection (b);CommentsClose CommentsPermalink





(B) describe the alternative uses of resources in general terms when issuing the regulation or order that establishes the alternative inspection frequency;CommentsClose CommentsPermalink





(C) consider the supporting evidence that an individual food establishment shall submit related to whether an alternative inspection frequency should be established for such establishment by the Administrator; andCommentsClose CommentsPermalink





(D) include a description of the alternative uses in the annual resource plan required in section 209.CommentsClose CommentsPermalink





(e) Inspection Transition- The Administrator shall manage the transition to the inspection system described in this Act as follows:CommentsClose CommentsPermalink





(1) In the case of a category 1 or 2 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until--CommentsClose CommentsPermalink





(A) regulations required to implement this section have been promulgated;CommentsClose CommentsPermalink





(B) the performance standards required by section 204(c) have been promulgated and implemented for 1 year; andCommentsClose CommentsPermalink





(C) the establishment has achieved compliance with the other applicable provisions of the food safety law.CommentsClose CommentsPermalink





(2) In the case of a category 1 or 2 food establishment that, within 2 years after the promulgation of the performance standards required by section 204(c), has not achieved compliance with the food safety law, the Administrator shall--CommentsClose CommentsPermalink





(A) issue an order prohibiting the establishment from operating pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; andCommentsClose CommentsPermalink





(B) following the demonstration required in subparagraph (A), issue an order authorizing the food establishment to operate subject, at a minimum, to--CommentsClose CommentsPermalink





(i) the inspection requirement applicable to the establishment under subsection (b) (1) or (2); andCommentsClose CommentsPermalink





(ii) such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the applicable food safety law.CommentsClose CommentsPermalink





(3) In the case of a category 3 food establishment, the Administrator shall continue to implement the applicable inspection mandates of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) until--CommentsClose CommentsPermalink





(A) the regulations required to implement this section have been promulgated;CommentsClose CommentsPermalink





(B) the first resource plan under section 209 has been submitted; andCommentsClose CommentsPermalink





(C) for individual establishments, compliance with the food safety law has been demonstrated.CommentsClose CommentsPermalink





(4) In the case of a category 3 food establishment that, within 1 year after the promulgation of the regulations required to implement this section, have not demonstrated compliance with the food safety law, the Administrator shall--CommentsClose CommentsPermalink





(A) issue an order prohibiting the establishment from operating, pending a demonstration by the establishment that sufficient changes in facilities, procedures, personnel, or other aspects of the process control system have been made such that the Administrator determines that compliance with the food safety law is achieved; andCommentsClose CommentsPermalink





(B) following the demonstration required in subparagraph (A), issue an order authorizing the establishment to operate subject, at a minimum, to--CommentsClose CommentsPermalink





(i) the inspection requirement applicable to the establishment under subsection (b)(3); andCommentsClose CommentsPermalink





(ii) such other inspection or compliance measures determined by the Administrator necessary to assure compliance with the food safety law.CommentsClose CommentsPermalink





(5) In the case of a category 4 or 5 food establishment, the inspection requirements of this Act shall be implemented as soon as possible after--CommentsClose CommentsPermalink





(A) the promulgation of the regulations required to implement this section;CommentsClose CommentsPermalink





(B) the publication of the first resource plan under section 209; andCommentsClose CommentsPermalink





(C) the commencement of the first fiscal year in which the Administration is operating with budgetary resources that Congress has appropriated following consideration of the resource plan under section 209.CommentsClose CommentsPermalink





(f) Official Mark-CommentsClose CommentsPermalink





(1) IN GENERAL-CommentsClose CommentsPermalink





(A) ESTABLISHMENT- Before the completion of the transition process under paragraphs (1) through (3) of subsection (e), the Administrator shall by regulation establish an official mark that shall be affixed to a food product produced in a category 1, 2, or 3 establishment, subject to subparagraph (B).CommentsClose CommentsPermalink





(B) PREREQUISITE- The official mark required under subparagraph (A) shall be affixed to a food product by the Administrator if the establishment has been inspected by the Administrator in accordance with the inspection frequencies under this section and the establishment is in compliance with the food safety law.CommentsClose CommentsPermalink





(C) REMOVAL OF OFFICIAL MARK- The Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if the Administrator makes a finding that the establishment is not in compliance with the food safety law.CommentsClose CommentsPermalink





(2) CATEGORY 1, 2, OR 3 FOOD ESTABLISHMENTS- In the case of products produced in a category 1, 2, or 3 food establishment--CommentsClose CommentsPermalink





(A) products subject to Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of enactment of this Act shall remain subject to the requirement under those Acts that they bear the mark of inspection pending completion of the transition process under paragraphs (1) through (3) of subsection (e);CommentsClose CommentsPermalink





(B) the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this Act have been achieved; andCommentsClose CommentsPermalink





(C) a product from an establishment that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce.CommentsClose CommentsPermalink





(3) CATEGORY 4 AND 5 FOOD ESTABLISHMENTS- In the case of a product produced in a category 4 or 5 food establishment the Administrator shall provide by regulation for the voluntary use of the official mark established under paragraph (1), subject to--CommentsClose CommentsPermalink





(A) such minimum inspection frequencies as determined appropriate by the Administrator;CommentsClose CommentsPermalink





(B) compliance with applicable performance standards and other provisions of the food safety law; andCommentsClose CommentsPermalink





(C) such other requirements the Administrator considers appropriate.CommentsClose CommentsPermalink





(g) Implementation- Not later than 1 year after the effective date of this Act, the Administrator shall issue regulations to implement subsections (b) through (e).CommentsClose CommentsPermalink





(h) Maintenance and Inspection of Records-CommentsClose CommentsPermalink





(1) IN GENERAL-CommentsClose CommentsPermalink





(A) RECORDS- A food establishment shall--CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(ii) permit the Administrator, in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this Act, 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--CommentsClose CommentsPermalink





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





(II) to track the food in commerce.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





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





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





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





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





(C) the processing of the food;CommentsClose CommentsPermalink





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





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





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





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





(i) Protection of Sensitive Information-CommentsClose CommentsPermalink





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





(2) LIMITATION- The requirement under this subsection does not--CommentsClose CommentsPermalink





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





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





(C) extend to any food recipe, financial data, pricing data, personnel data, or sales data (other than shipment dates relating to sales);CommentsClose CommentsPermalink





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





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





(j) Bribery of or Gifts to Inspector or Other Officers and Acceptance of Gifts- Section 22 of the Federal Meat Inspection Act (21 U.S.C. 622) shall apply under this Act.CommentsClose CommentsPermalink

SEC. 206. FOOD PRODUCTION FACILITIES.

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--CommentsClose CommentsPermalink





(1) visit and inspect food production facilities in the United States and in foreign countries to investigate bioterrorism threats and for other critical food safety purposes;CommentsClose CommentsPermalink





(2) review food safety records as required to be kept by the Administrator to carry out traceback and for other critical food safety purposes;CommentsClose CommentsPermalink





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





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





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

SEC. 207. FEDERAL AND STATE COOPERATION.

(a) In General- The Administrator shall work with the States to carry out activities and programs that create a national food safety program so that Federal and State programs function in a coordinated and cost-effective manner.CommentsClose CommentsPermalink





(b) State Action- The Administrator shall work with States to--CommentsClose CommentsPermalink





(1) continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets;CommentsClose CommentsPermalink





(2) continue, strengthen, or establish inspection programs and requirements to ensure that food under the jurisdiction of the State is safe; andCommentsClose CommentsPermalink





(3) support recall authorities at the State and local levels.CommentsClose CommentsPermalink





(c) Assistance- To assist in planning, developing, and implementing a food safety program, the Administrator may provide and continue to a State--CommentsClose CommentsPermalink





(1) advisory assistance;CommentsClose CommentsPermalink





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





(3) financial, in kind, and other aid.CommentsClose CommentsPermalink





(d) Service Agreements-CommentsClose CommentsPermalink





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





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





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





(e) Audits-CommentsClose CommentsPermalink





(1) IN GENERAL- The Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out the responsibilities under this Act, including mandated inspections under section 205.CommentsClose CommentsPermalink





(2) REQUIREMENTS- The review shall--CommentsClose CommentsPermalink





(A) include a determination of the effectiveness of the State program; andCommentsClose CommentsPermalink





(B) identify any changes necessary to ensure enforcement of Federal requirements under this Act.CommentsClose CommentsPermalink





(f) No Federal Preemption- Nothing in this Act shall be construed to preempt the enforcement of State food safety laws and standards that are at least as stringent as those under this Act.CommentsClose CommentsPermalink

SEC. 208. IMPORTS.

(a) In General- Not later than 2 years after the effective date of this Act, the Administrator shall establish a system under which a foreign government or foreign food establishment seeking to import food to the United States shall submit a request for certification to the Administrator.CommentsClose CommentsPermalink





(b) Certification Standard- A foreign government or foreign food establishment requesting a certification to import food to the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of a foreign government or by the foreign food establishment has met standards for food safety, inspection, labeling, and consumer protection that are at least equivalent to standards applicable to food produced in the United States.CommentsClose CommentsPermalink





(c) Certification Approval-CommentsClose CommentsPermalink





(1) REQUEST BY FOREIGN GOVERNMENT- Prior to granting the certification request of a foreign government, the Administrator shall review, audit, and certify the food safety program of a requesting foreign government (including all statutes, regulations, and inspection authority) as at least equivalent to the food safety program in the United States, as demonstrated by the foreign government.CommentsClose CommentsPermalink





(2) REQUEST BY FOREIGN FOOD ESTABLISHMENT- Prior to granting the certification request of a foreign food establishment, the Administrator shall certify, based on an onsite inspection, the food safety programs and procedures of a requesting foreign firm as at least equivalent to the food safety programs and procedures of the United States.CommentsClose CommentsPermalink





(d) Limitation- A foreign government or foreign firm approved by the Administrator to import food to the United States under this section shall be certified to export only the approved food products to the United States for a period not to exceed 5 years.CommentsClose CommentsPermalink





(e) Withdrawal of Certification- The Administrator may withdraw certification of any food from a foreign government or foreign firm--CommentsClose CommentsPermalink





(1) if such food is linked to an outbreak of human illness;CommentsClose CommentsPermalink





(2) following an investigation by the Administrator that finds that the foreign government programs and procedures or foreign food establishment is no longer equivalent to the food safety programs and procedures in the United States; orCommentsClose CommentsPermalink





(3) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section.CommentsClose CommentsPermalink





(f) Renewal of Certification- The Administrator shall audit foreign governments and foreign food establishments at least every 5 years to ensure the continued compliance with the standards set forth in this section.CommentsClose CommentsPermalink





(g) Required Routine Inspection- The Administrator shall routinely inspect food and food animals (via a physical examination) before it enters the United States to ensure that it is--CommentsClose CommentsPermalink





(1) safe;CommentsClose CommentsPermalink





(2) labeled as required for food produced in the United States; andCommentsClose CommentsPermalink





(3) otherwise meets requirements under the food safety law.CommentsClose CommentsPermalink





(h) Enforcement- The Administrator is authorized to--CommentsClose CommentsPermalink





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





(2) deny importation of food from any foreign government or foreign firm that does not consent to an investigation by the Administration when food from that foreign country or foreign firm is linked to a food-borne illness outbreak or is otherwise found to be adulterated or mislabeled; andCommentsClose CommentsPermalink





(3) promulgate rules and regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of this Act.CommentsClose CommentsPermalink





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

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.CommentsClose CommentsPermalink





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





(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 the national food safety program;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) in foreign establishments;CommentsClose CommentsPermalink





(B) at the point of importation; andCommentsClose CommentsPermalink





(C) at the point of production on farms, ranches, and feedlots.CommentsClose CommentsPermalink





(c) Grants- The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities in retail and food service facilities and the required inspections in food establishments.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

SEC. 210. TRACEBACK.

(a) In General- The Administrator, in order to protect the public health, shall establish requirements for a national system for tracing food and food producing animals from point of origin to retail sale, subject to subsection (b).CommentsClose CommentsPermalink





(b) Applicability- Traceability requirements shall--CommentsClose CommentsPermalink





(1) be established in accordance with regulations and guidelines issued by the Administrator; andCommentsClose CommentsPermalink





(2) apply to food production facilities and food establishments.CommentsClose CommentsPermalink





(c) Relationship to Country of Origin Labeling- 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.).CommentsClose CommentsPermalink

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 the Research Education and Economics mission area of the Department of Agriculture, shall--CommentsClose CommentsPermalink





(1) have access to the applicable data systems of the Centers for Disease Control and Prevention and to the databases made available by a State;CommentsClose CommentsPermalink





(2) maintain an active surveillance system of food, food products, and epidemiological evidence submitted by States to the Centers for Disease Control and Prevention based on a representative proportion of the population of the United States;CommentsClose CommentsPermalink





(3) assess the frequency and sources of human illness in the United States associated with the consumption of food;CommentsClose CommentsPermalink





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





(5) have access to the surveillance data created via monitoring and statistical studies conducted as part of its own inspection.CommentsClose CommentsPermalink





(b) Public Health Sampling-CommentsClose CommentsPermalink





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





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





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





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





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





(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.CommentsClose CommentsPermalink





(c) Assessment of Health Hazards-CommentsClose CommentsPermalink





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





(A) rank food categories based on the hazard to human health presented by the food category;CommentsClose CommentsPermalink





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





(C) assess the public health environment for emerging diseases, including zoonosis, for their risk of appearance in the United States food supply.CommentsClose CommentsPermalink





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





(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;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





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





(D) use of comparative risk assessments.CommentsClose CommentsPermalink

SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.

(a) Public Education-CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) REQUIREMENTS- The program shall provide--CommentsClose CommentsPermalink





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





(B) information for health professionals--CommentsClose CommentsPermalink





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





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





(C) such other information or advice to consumers and other persons as the Administrator determines will promote the purposes of this Act.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





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





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





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





(4) to present prompt, specific information regarding foods found to pose a threat to the public health.CommentsClose CommentsPermalink

SEC. 303. RESEARCH.

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





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





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





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





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





(5) develop food consumption data;CommentsClose CommentsPermalink





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





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





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





(9) address common and emerging zoonotic diseases;CommentsClose CommentsPermalink





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





(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; andCommentsClose CommentsPermalink





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





(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.CommentsClose CommentsPermalink

TITLE IV--ENFORCEMENT

SEC. 401. PROHIBITED ACTS.

It is prohibited--CommentsClose CommentsPermalink





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





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





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





(4) to refuse to permit access to a food establishment for the inspection and copying of a record as required under section 205(h);CommentsClose CommentsPermalink





(5) to fail to establish or maintain any record or to make any report as required under section 205(h);CommentsClose CommentsPermalink





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





(7) to fail to provide to the Administrator the results of a testing or sampling of a food, equipment, or material in contact with contaminated food under section 205(i);CommentsClose CommentsPermalink





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





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





(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;CommentsClose CommentsPermalink





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





(12) to otherwise violate the food safety law.CommentsClose CommentsPermalink

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

(a) Administrative Detention of Food-CommentsClose CommentsPermalink





(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 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.CommentsClose CommentsPermalink





(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 Act, the officer or employee may order the food detained.CommentsClose CommentsPermalink





(3) PERIOD OF DETENTION-CommentsClose CommentsPermalink





(A) IN GENERAL- A food may be detained 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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(4) SECURITY OF DETAINED FOOD-CommentsClose CommentsPermalink





(A) IN GENERAL- A detention order--CommentsClose CommentsPermalink





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





(ii) shall require that the food be removed to a secure facility, if appropriate.CommentsClose CommentsPermalink





(B) FOOD SUBJECT TO AN ORDER- A food subject to a detention order shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.CommentsClose CommentsPermalink





(C) DELIVERY OF FOOD- This subsection does not authorize the delivery of a food in accordance with execution of a bond while the article is subject to the order.CommentsClose CommentsPermalink





(b) Appeal of Detention Order-CommentsClose CommentsPermalink





(1) IN GENERAL- A person who would be entitled to be a claimant for a food subject to a detention order if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334), may appeal the order to the Administrator.CommentsClose CommentsPermalink





(2) ACTION BY THE ADMINISTRATOR- Not later than 5 days after an appeal is filed under paragraph (1), the Administrator, after providing an opportunity for an informal hearing, shall confirm, modify, or terminate the order involved.CommentsClose CommentsPermalink





(3) FINAL AGENCY ACTION- Confirmation, modification, or termination by the Administrator under paragraph (2) shall be considered a final agency action for purposes of section 702 of title 5, United States Code.CommentsClose CommentsPermalink





(4) TERMINATION- The order shall be considered to be terminated if, after 5 days, the Administrator has failed--CommentsClose CommentsPermalink





(A) to provide an opportunity for an informal hearing; orCommentsClose CommentsPermalink





(B) to confirm, modify, or terminate the order.CommentsClose CommentsPermalink





(5) EFFECT OF INSTITUTING COURT ACTION- If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or section 304(a) of that Act (21 U.S.C. 334(a)), the process for the appeal of the detention order shall terminate.CommentsClose CommentsPermalink





(c) Condemnation of Food-CommentsClose CommentsPermalink





(1) IN GENERAL- After confirming a detention order, the Administrator may order the food condemned.CommentsClose CommentsPermalink





(2) DESTRUCTION OF FOOD- Any food condemned shall be destroyed under the supervision of the Administrator.CommentsClose CommentsPermalink





(3) RELEASE OF FOOD- If the Administrator determines that, through reprocessing, relabeling, or other action, a detained food can be brought into compliance with this Act, the food may be released following a determination by the Administrator that the relabeling or other action as specified by the Administrator has been performed.CommentsClose CommentsPermalink





(d) Temporary Holds at Ports of Entry-CommentsClose CommentsPermalink





(1) IN GENERAL- If an officer or qualified employee of the Administration has reason to believe that a food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, and the officer or qualified employee is unable to inspect, examine, or investigate the food when the food is offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Homeland Security to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, to enable the Administrator to inspect or investigate the food as appropriate.CommentsClose CommentsPermalink





(2) REMOVAL TO SECURE FACILITY- The Administrator shall work in coordination with the Secretary of Homeland Security to remove a food held in accordance with paragraph (1) to a secure facility as appropriate.CommentsClose CommentsPermalink





(3) PROHIBITION ON TRANSFER- During the period in which the food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.CommentsClose CommentsPermalink





(4) DELIVERY IN ACCORDANCE WITH A BOND- The delivery of the food in accordance with the execution of a bond while the food is held is not authorized.CommentsClose CommentsPermalink





(5) PROHIBITION ON REEXPORT- A food found unfit for human or animal consumption shall be prohibited from reexport without further processing to remove the contamination and reinspection by the Administration.CommentsClose CommentsPermalink

SEC. 403. NOTIFICATION AND RECALL.

(a) Notice to Administrator of Violation-CommentsClose CommentsPermalink





(1) IN GENERAL- A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Administrator of the identity and location of the food.CommentsClose CommentsPermalink





(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.CommentsClose CommentsPermalink





(b) Recall and Consumer Notification-CommentsClose CommentsPermalink





(1) VOLUNTARY ACTIONS- If the Administrator determines that food is in violation of the food safety law when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Administrator, the Administrator shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity to--CommentsClose CommentsPermalink





(A) cease distribution of the food;CommentsClose CommentsPermalink





(B) notify all persons--CommentsClose CommentsPermalink





(i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; orCommentsClose CommentsPermalink





(ii) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;CommentsClose CommentsPermalink





(C) recall the food;CommentsClose CommentsPermalink





(D) in conjunction with the Administrator, provide notice of the finding of the Administrator--CommentsClose CommentsPermalink





(i) to consumers to whom the food was, or may have been, distributed; andCommentsClose CommentsPermalink





(ii) to State and local public health officials; orCommentsClose CommentsPermalink





(E) take any combination of the measures described in this paragraph, as determined by the Administrator to be appropriate in the circumstances.CommentsClose CommentsPermalink





(2) MANDATORY ACTIONS- If a person referred to in paragraph (1) refuses to or does not adequately carry out the actions described in that paragraph within the time period and in the manner prescribed by the Administrator, the Administrator shall--CommentsClose CommentsPermalink





(A) have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator--CommentsClose CommentsPermalink





(i) at the expense of the food establishment; orCommentsClose CommentsPermalink





(ii) in an emergency (as determined by the Administrator), at the expense of the Administration; andCommentsClose CommentsPermalink





(B) by order, require, as the Administrator determines to be necessary, the person to immediately--CommentsClose CommentsPermalink





(i) cease distribution of the food; andCommentsClose CommentsPermalink





(ii) notify all persons--CommentsClose CommentsPermalink





(I) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; orCommentsClose CommentsPermalink





(II) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.CommentsClose CommentsPermalink





(3) NOTIFICATION TO CONSUMERS BY ADMINISTRATOR- The Administrator shall, as the Administrator determines to be necessary, provide notice of the finding of the Administrator under paragraph (1)--CommentsClose CommentsPermalink





(A) to consumers to whom the food was, or may have been, distributed; andCommentsClose CommentsPermalink





(B) to State and local public health officials.CommentsClose CommentsPermalink





(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food.CommentsClose CommentsPermalink





(5) AVAILABILITY OF RECORDS TO ADMINISTRATOR- Each person referred to in paragraph (1) that processed, distributed, or otherwise handled food shall make available to the Administrator information necessary to carry out this subsection, as determined by the Administrator, regarding--CommentsClose CommentsPermalink





(A) persons that processed, distributed, or otherwise handled the food; andCommentsClose CommentsPermalink





(B) persons to which the food has been transported, sold, distributed, or otherwise handled.CommentsClose CommentsPermalink





(c) Informal Hearings on Orders-CommentsClose CommentsPermalink





(1) IN GENERAL- The Administrator shall provide any person subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order.CommentsClose CommentsPermalink





(2) SCOPE OF THE HEARING- In a hearing under paragraph (1), the Administrator shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled.CommentsClose CommentsPermalink





(d) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





(1) AMENDMENT OF ORDER- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that there is a reasonable probability that the food that is the subject of an order under subsection (b), if consumed, would present a threat to the public health, the Administrator, as the Administrator determines to be necessary, may--CommentsClose CommentsPermalink





(A) amend the order to require recall of the food or other appropriate action;CommentsClose CommentsPermalink





(B) specify a timetable in which the recall shall occur;CommentsClose CommentsPermalink





(C) require periodic reports to the Administrator describing the progress of the recall; andCommentsClose CommentsPermalink





(D) provide notice of the recall to consumers to whom the food was, or may have been, distributed.CommentsClose CommentsPermalink





(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the order, the Administrator shall vacate the order.CommentsClose CommentsPermalink





(e) Remedies Not Exclusive- The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.CommentsClose CommentsPermalink

SEC. 404. INJUNCTION PROCEEDINGS.

(a) Jurisdiction- The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 207, or 401 (or a regulation promulgated under that section).CommentsClose CommentsPermalink





(b) Trial- In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.CommentsClose CommentsPermalink

SEC. 405. CIVIL AND CRIMINAL PENALTIES.

(a) Civil Sanctions-CommentsClose CommentsPermalink





(1) CIVIL PENALTY-CommentsClose CommentsPermalink





(A) IN GENERAL- Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under a Federal food safety law) may be assessed a civil penalty by the Administrator of not more than $10,000 for each such act.CommentsClose CommentsPermalink





(B) SEPARATE OFFENSE- Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.CommentsClose CommentsPermalink





(2) OTHER REQUIREMENTS-CommentsClose CommentsPermalink





(A) WRITTEN ORDER- The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.CommentsClose CommentsPermalink





(B) AMOUNT OF PENALTY- Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering--CommentsClose CommentsPermalink





(i) the gravity of the violation;CommentsClose CommentsPermalink





(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





(iv) any history of prior offenses by the person under the food safety law.CommentsClose CommentsPermalink





(C) REVIEW OF ORDER- The order may be reviewed only in accordance with subsection (c).CommentsClose CommentsPermalink





(b) Criminal Sanctions-CommentsClose CommentsPermalink





(1) IN GENERAL- Except as provided in paragraphs (2) and (3), a person that knowingly produces or introduces into commerce food that is unsafe or otherwise adulterated or misbranded shall be imprisoned for not more than 1 year or fined not more than $10,000, or both.CommentsClose CommentsPermalink





(2) SEVERE VIOLATIONS- A person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 3 years or fined not more than $100,000, or both.CommentsClose CommentsPermalink





(3) EXCEPTION- No person shall be subject to the penalties of this subsection--CommentsClose CommentsPermalink





(A) for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith, unless that person refuses to furnish (on request of an officer or employee designated by the Administrator)--CommentsClose CommentsPermalink





(i) the name, address and contact information of the person from whom that person purchased or received the food;CommentsClose CommentsPermalink





(ii) copies of all documents relating to the person from whom that person purchased or received the food; andCommentsClose CommentsPermalink





(iii) copies of all documents pertaining to the delivery of the food to that person; orCommentsClose CommentsPermalink





(B) if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food, stating that the food is not adulterated or misbranded within the meaning of this Act.CommentsClose CommentsPermalink





(c) Judicial Review-CommentsClose CommentsPermalink





(1) IN GENERAL- An order assessing a civil penalty under subsection (a) shall be a final order unless the person--CommentsClose CommentsPermalink





(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; andCommentsClose CommentsPermalink





(B) simultaneously serves a copy of the petition by certified mail to the Administrator.CommentsClose CommentsPermalink





(2) FILING OF RECORD- Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.CommentsClose CommentsPermalink





(3) STANDARD OF REVIEW- The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.CommentsClose CommentsPermalink





(d) Collection Actions for Failure To Pay-CommentsClose CommentsPermalink





(1) IN GENERAL- If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.CommentsClose CommentsPermalink





(2) LIMITATION ON REVIEW- In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.CommentsClose CommentsPermalink





(e) Penalties Paid Into Account- The Administrator--CommentsClose CommentsPermalink





(1) shall deposit penalties collected under this section in an account in the Treasury; andCommentsClose CommentsPermalink





(2) may use the funds in the account, without further appropriation or fiscal year limitation--CommentsClose CommentsPermalink





(A) to carry out enforcement activities under food safety law; orCommentsClose CommentsPermalink





(B) to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.CommentsClose CommentsPermalink





(f) Discretion of the Administrator to Prosecute- Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.CommentsClose CommentsPermalink





(g) Remedies Not Exclusive- The remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available.CommentsClose CommentsPermalink

SEC. 406. PRESUMPTION.

In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.CommentsClose CommentsPermalink

SEC. 407. WHISTLEBLOWER PROTECTION.

(a) In General- No Federal employee, employee of a Federal contractor or subcontractor, or any individual employed by a company (referred to in this section as a `covered individual'), may be discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against, because of any lawful act done by the covered individual to--CommentsClose CommentsPermalink





(1) provide information, cause information to be provided, or otherwise assist in an investigation regarding any conduct that the covered individual reasonably believes constitutes a violation of any law, rule, or regulation, or that the covered individual reasonably believes constitutes a threat to the public health, when the information or assistance is provided to, or the investigation is conducted by--CommentsClose CommentsPermalink





(A) a Federal regulatory or law enforcement agency;CommentsClose CommentsPermalink





(B) a Member or committee of Congress; orCommentsClose CommentsPermalink





(C) a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct);CommentsClose CommentsPermalink





(2) file, cause to be filed, testify, participate in, or otherwise assist in a proceeding or action filed or about to be filed relating to a violation of any law, rule, or regulation; orCommentsClose CommentsPermalink





(3) refused to violate or assist in the violation of any law, rule, or regulation.CommentsClose CommentsPermalink





(b) Enforcement Action-CommentsClose CommentsPermalink





(1) IN GENERAL- A covered individual who alleges discharge or other discrimination by any person in violation of subsection (a) may seek relief under subsection (c) by filing a complaint with the Secretary of Labor. If the Secretary of Labor has not issued a final decision within 180 days after the date on which the complaint is filed and there is no showing that such delay is due to the bad faith of the claimant, the claimant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy.CommentsClose CommentsPermalink





(2) PROCEDURE-CommentsClose CommentsPermalink





(A) IN GENERAL- An action under paragraph (1) shall be governed under the rules and procedures set forth in section 42121(b) of title 49, United States Code.CommentsClose CommentsPermalink





(B) EXCEPTION- Notification under section 42121(b)(1) of title 49, United States Code, shall be made to the person named in the complaint and to the person's employer.CommentsClose CommentsPermalink





(C) BURDENS OF PROOF- An action brought under paragraph (1) shall be governed by the legal burdens of proof set for in section 42121(b) of title 49, United States Code.CommentsClose CommentsPermalink





(D) STATUTE OF LIMITATIONS- An action under paragraph (1) shall be commenced not later than 90 days after the date on which the violation occurs.CommentsClose CommentsPermalink





(c) Remedies-CommentsClose CommentsPermalink





(1) IN GENERAL- A covered individual prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the covered individual whole.CommentsClose CommentsPermalink





(2) COMPENSATORY DAMAGES- Relief for any action described in paragraph (1) shall include--CommentsClose CommentsPermalink





(A) reinstatement with the same seniority status that the covered individual would have had, but for the discrimination;CommentsClose CommentsPermalink





(B) the amount of any back pay, with interest; andCommentsClose CommentsPermalink





(C) compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney's fees.CommentsClose CommentsPermalink





(d) Rights Retained by the Covered Individual- Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any covered individual under any Federal or State law, or under any collective bargaining agreement.CommentsClose CommentsPermalink

SEC. 408. ADMINISTRATION AND ENFORCEMENT.

(a) In General- For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.CommentsClose CommentsPermalink





(b) Inquiries and Actions-CommentsClose CommentsPermalink





(1) IN GENERAL- The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.CommentsClose CommentsPermalink





(2) POWERS- The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.CommentsClose CommentsPermalink

SEC. 409. CITIZEN CIVIL ACTIONS.

(a) Civil Actions- A person may commence a civil action against--CommentsClose CommentsPermalink





(1) a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; orCommentsClose CommentsPermalink





(2) the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.CommentsClose CommentsPermalink





(b) Court-CommentsClose CommentsPermalink





(1) IN GENERAL- The action shall be commenced in the United States district court for the district in which the defendant resides, is found, or has an agent.CommentsClose CommentsPermalink





(2) JURISDICTION- The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.CommentsClose CommentsPermalink





(3) DAMAGES- The court may--CommentsClose CommentsPermalink





(A) award damages, in the amount of damages actually sustained; andCommentsClose CommentsPermalink





(B) if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney's fees, reasonable expert witness fees, and penalties.CommentsClose CommentsPermalink





(c) Remedies Not Exclusive- The remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available.CommentsClose CommentsPermalink

TITLE V--IMPLEMENTATION

SEC. 501. DEFINITION.

For purposes of this title, the term `transition period' means the 12-month period beginning on the effective date of this Act.CommentsClose CommentsPermalink

SEC. 502. REORGANIZATION PLAN.

(a) Submission of Plan- Not later than 180 days after the effective date of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:CommentsClose CommentsPermalink





(1) The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.CommentsClose CommentsPermalink





(2) Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.CommentsClose CommentsPermalink





(b) Plan Elements- The plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:CommentsClose CommentsPermalink





(1) Identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred to the Administration under the plan.CommentsClose CommentsPermalink





(2) Specification of the steps to be taken by the Administrator to organize the Administration, including the delegation or assignment of functions transferred to the Administration among the officers of the Administration in order to permit the Administration to carry out the functions transferred under the plan.CommentsClose CommentsPermalink





(3) Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.CommentsClose CommentsPermalink





(4) Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.CommentsClose CommentsPermalink





(5) Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.CommentsClose CommentsPermalink





(6) Specification of the proposed allocations within the Administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food.CommentsClose CommentsPermalink





(c) Modification of Plan- The President may, on the basis of consultations with the appropriate congressional committees, modify, or revise any part of the plan until that part of the plan becomes effective in accordance with subsection (d).CommentsClose CommentsPermalink





(d) Effective Date-CommentsClose CommentsPermalink





(1) IN GENERAL- The reorganization plan described in this section, including any modifications or revisions of the plan under subsection (c), shall become effective for an agency on the earlier of--CommentsClose CommentsPermalink





(A) the date specified in the plan (or the plan as modified pursuant to subsection (c)), except that such date may not be earlier than 90 days after the date the President has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection (a); orCommentsClose CommentsPermalink





(B) the end of the transition period.CommentsClose CommentsPermalink





(2) STATUTORY CONSTRUCTION- Nothing in this subsection may be construed to require the transfer of functions, personnel, records, balances of appropriations, or other assets of an agency on a single date.CommentsClose CommentsPermalink





(3) SUPERCEDES EXISTING LAW- Paragraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.CommentsClose CommentsPermalink

SEC. 503. TRANSITIONAL AUTHORITIES.

(a) Provision of Assistance by Officials- Until the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the effective date of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.CommentsClose CommentsPermalink





(b) Services and Personnel- During the transition period, upon the request of the Administrator, the head of any executive agency may, on a reimbursable basis, provide services or detail personnel to assist with the transition.CommentsClose CommentsPermalink





(c) Acting Officials-CommentsClose CommentsPermalink





(1) IN GENERAL- During the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the effective date of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.CommentsClose CommentsPermalink





(2) COMPENSATION- While acting pursuant to paragraph (1), such officers shall receive compensation at the higher of--CommentsClose CommentsPermalink





(A) the rates provided by this Act for the respective offices in which they act; orCommentsClose CommentsPermalink





(B) the rates provided for the offices held at the time of designation.CommentsClose CommentsPermalink





(3) LIMITATION- Nothing in this Act shall be construed to require the advice and consent of the Senate to the appointment by the President to a position in the Administration of any officer whose agency is transferred to the Administration pursuant to this Act and whose duties following such transfer are germane to those performed before such transfer.CommentsClose CommentsPermalink





(d) Transfer of Personnel, Assets, Obligations, and Function-CommentsClose CommentsPermalink





(1) IN GENERAL- Consistent with section 1531 of title 31, United States Code, the personnel, assets, liabilities, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds that relate to the functions transferred under subsection (a) from a Federal agency shall be transferred to the Administration.CommentsClose CommentsPermalink





(2) UNEXPENDED FUNDS- Unexpended funds transferred under this subsection shall be used by the Administration only for the purposes for which the funds were originally authorized and appropriated.CommentsClose CommentsPermalink