HR 875 IHCommentsClose CommentsPermalink

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

February 4, 2009CommentsClose CommentsPermalink

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

To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.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 ‘Food Safety Modernization Act of 2009’.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 THE FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of the food safety administration.CommentsClose CommentsPermalink





Sec. 102. Consolidation of food safety functions.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. Preventive 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 requirements.CommentsClose CommentsPermalink





Sec. 211. Accredited laboratories.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





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





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





Sec. 306. Food-Borne Illness Health Registry.CommentsClose CommentsPermalink





Sec. 307. Study on Federal resources.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. Reorganization plan.CommentsClose CommentsPermalink





Sec. 502. Transitional authorities.CommentsClose CommentsPermalink





Sec. 503. Savings provisions.CommentsClose CommentsPermalink





Sec. 504. Conforming amendments.CommentsClose CommentsPermalink





Sec. 505. Additional technical and conforming amendments.CommentsClose CommentsPermalink





Sec. 506. Regulations.CommentsClose CommentsPermalink





Sec. 507. Authorization of appropriations.CommentsClose CommentsPermalink





Sec. 508. Limitation on authorization of appropriations.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 and international trade;CommentsClose CommentsPermalink





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





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





(5) 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) the threat of intentional contamination of the food supply;CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





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





(1) to establish an agency within the Department of Health and Human Services 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 process, store, hold, and transport food in a manner that protects the public health of all people in the United States;CommentsClose CommentsPermalink





(C) lead an integrated, systemwide 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 within the Department of Health and Human Services for food safety leadership, both nationally and internationally; andCommentsClose CommentsPermalink





(E) provide an integrated food safety research capability, including internally generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments;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 date of the enactment of this Act, are performed by various components of the Food and Drug Administration and the National Oceanic and Atmospheric Administration;CommentsClose CommentsPermalink





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





(4) to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements of this law.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)(2).CommentsClose CommentsPermalink





(3) ADULTERATED-CommentsClose CommentsPermalink





(A) IN GENERAL- The term ‘adulterated’ has the meaning given that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).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 (other than a seafood processing establishment) that slaughters, for the purpose of producing food, animals that are not subject to inspection under the Federal Meat Inspection Act or poultry that are not subject to inspection under the Poultry Products Inspection Act.CommentsClose CommentsPermalink





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





(7) CATEGORY 3 FOOD ESTABLISHMENT- The term ‘category 3 food establishment’ means a food establishment (other than a category 1 or category 2 establishment) that processes cooked, pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-to-eat raw form, or other products that pose a risk of hazardous contamination.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 toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.CommentsClose CommentsPermalink





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





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





(13) FOOD ESTABLISHMENT-CommentsClose CommentsPermalink





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





(B) EXCLUSIONS- For the purposes of registration, the term ‘food establishment’ does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).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, quality, nutritional composition, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food;CommentsClose CommentsPermalink





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





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





(D) the provisions of this Act.CommentsClose CommentsPermalink





(16) FOREIGN FOOD ESTABLISHMENT- The term ‘foreign food establishment’ means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.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 slaughter, packing, preparation, or manufacture of food.CommentsClose CommentsPermalink





(20) 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

TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATIONCommentsClose CommentsPermalink

SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.

(a) Establishment-CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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

SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.

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





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





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





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





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





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





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





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





(B) the Center for Veterinary Medicine;CommentsClose CommentsPermalink





(C) the National Center for Toxicological Research; andCommentsClose CommentsPermalink





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





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





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





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

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

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





(1) develop, administer, and annually update 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, process, or distribute 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 of potentially hazardous contamination or practices extending from the farm or ranch to the consumer that may increase the risk of food-borne illness;CommentsClose CommentsPermalink





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





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





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





(6) opportunities for intentional contamination of food or food ingredients.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, as provided in section 202 of this Act;CommentsClose CommentsPermalink





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





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





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





(A) potentially hazardous substances that may contaminate food; andCommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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

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

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





(b) Registration Requirements-CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





(6) SUSPENSION OF REGISTRATION-CommentsClose CommentsPermalink





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





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





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





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





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





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

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

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





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





(1) to adopt preventive process controls that--CommentsClose CommentsPermalink





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





(B) are adequate to protect the public health;CommentsClose CommentsPermalink





(C) meet relevant regulatory and food safety standards;CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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

SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

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





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





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





(2) PERFORMANCE STANDARDS-CommentsClose CommentsPermalink





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





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





(i) as soon as practicable; orCommentsClose CommentsPermalink





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





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





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





(A) the list of contaminants under paragraph (1); andCommentsClose CommentsPermalink





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





(c) Performance Standards-CommentsClose CommentsPermalink





(1) IN GENERAL- The performance standards established under this section may 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 any zero tolerance performance standards in effect on the day before the date of the enactment of this Act, when necessary to protect against significant adverse health outcomes;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 on the basis of reliable information on the 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 under paragraph (1)(D), the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.CommentsClose CommentsPermalink





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





(d) Enforcement-CommentsClose CommentsPermalink





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





(2) INSPECTIONS- If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, 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 establish 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 statistically valid sampling of food and facilities to enforce performance standards. The inspection program shall be designed to determine if each food establishment--CommentsClose CommentsPermalink





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





(2) has continuous preventive control 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 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 otherwise 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 has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; andCommentsClose CommentsPermalink





(C) 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--CommentsClose CommentsPermalink





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





(B) be randomly inspected at least weekly.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--CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





(A) the criteria in paragraph (2), together with any evidence submitted from the individual food establishment supporting a request for an alternative inspection frequency, including the establishment’s record for implementing effective preventive process control systems;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 establishment’s record of compliance with food safety law, including compliance with applicable performance standards and the frequency of recalls.CommentsClose CommentsPermalink





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





(f) 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 transferred to the Administrator pursuant to section 102, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator--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 adulterated or misbranded, or otherwise fails to meet the requirements of this Act.CommentsClose CommentsPermalink





(g) 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 commercially valuable confidential information obtained by the Administrator.CommentsClose CommentsPermalink





(2) LIMITATION- The requirements under this subsection and subsection (f) do 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, or personnel data;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





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

SEC. 206. FOOD PRODUCTION FACILITIES.

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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





(1) be in writing;CommentsClose CommentsPermalink





(2) describe the reasons the variance is necessary;CommentsClose CommentsPermalink





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





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





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





(1) not sufficiently detailed to permit a determination;CommentsClose CommentsPermalink





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





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





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





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

SEC. 207. FEDERAL AND STATE COOPERATION.

(a) In General-CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





(D) sharing information on a timely basis--CommentsClose CommentsPermalink





(i) within public health and food regulatory agencies;CommentsClose CommentsPermalink





(ii) among such agencies;CommentsClose CommentsPermalink





(iii) with the food industry;CommentsClose CommentsPermalink





(iv) with healthcare providers; andCommentsClose CommentsPermalink





(v) with the public;CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





(f) 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 qualified personnel and services of those agencies in carrying out this Act.CommentsClose CommentsPermalink





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





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





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

SEC. 208. IMPORTS.

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





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





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





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





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





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





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





(c) Certification Standard-CommentsClose CommentsPermalink





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





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





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





(B) determine that the exporting country--CommentsClose CommentsPermalink





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





(ii) ensures sanitary operations of facilities;CommentsClose CommentsPermalink





(iii) utilizes testing and verification programs; andCommentsClose CommentsPermalink





(iv) administers an effective enforcement program.CommentsClose CommentsPermalink





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





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





(i) Enforcement- The Administrator may--CommentsClose CommentsPermalink





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





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





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





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





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





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





(1) a State or regional food authority; orCommentsClose CommentsPermalink





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





(l) Avoiding Conflicts of Interest With Certifying Agents-CommentsClose CommentsPermalink





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





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