[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7143 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 7143

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 26, 2008

 Ms. DeLauro introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
Agriculture, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food Safety 
Modernization Act of 2007''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.
        TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of the food safety administration.
Sec. 102. Consolidation of food safety functions.
Sec. 103. Additional duties of the administration.
            TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food 
                            establishments.
Sec. 203. Preventive process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.
Sec. 208. Imports.
Sec. 209. Resource plan.
Sec. 210. Traceback requirements.
Sec. 211. Accredited laboratories.
                   TITLE III--RESEARCH AND EDUCATION

Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
                         TITLE IV--ENFORCEMENT

Sec. 401. Prohibited acts.
Sec. 402. Food detention, seizure, and condemnation.
Sec. 403. Notification and recall.
Sec. 404. Injunction proceedings.
Sec. 405. Civil and criminal penalties.
Sec. 406. Presumption.
Sec. 407. Whistleblower protection.
Sec. 408. Administration and enforcement.
Sec. 409. Citizen civil actions.
                        TITLE V--IMPLEMENTATION

Sec. 501. Reorganization plan.
Sec. 502. Transitional authorities.
Sec. 503. Savings provisions.
Sec. 504. Conforming amendments.
Sec. 505. Additional technical and conforming amendments.
Sec. 506. Regulations.
Sec. 507. Authorization of appropriations.
Sec. 508. Limitation on authorization of appropriations.

SEC. 2. FINDINGS; PURPOSES.

    (a) Findings.--Congress finds that--
            (1) the safety of the food supply of the United States is 
        vital to the public health, to public confidence in the food 
        supply, and to the success of the food sector of the Nation's 
        economy;
            (2) lapses in the protection of the food supply and loss of 
        public confidence in food safety are damaging to consumers and 
        the food industry, and place a burden on interstate commerce 
        and international trade;
            (3) recent ongoing events demonstrate that the food safety 
        program at the Food and Drug Administration is not effective in 
        controlling hazards in food coming from farms and factories in 
        the United States and food and food ingredients coming from 
        foreign countries, and these events have adversely affected 
        consumer confidence;
            (4) the safety and security of the food supply require a 
        systemwide approach to prevent food-borne illness involving the 
        integrated efforts of Federal, State and local agencies; a 
        thorough, broad-based, and coordinated approach to basic and 
        applied science; and intensive, effective, and efficient 
        management of the Nation's food safety program;
            (5) the task of preserving the safety of the food supply of 
        the United States faces tremendous pressures with regard to--
                    (A) emerging pathogens and other contaminants and 
                the ability to detect all forms of contamination;
                    (B) the threat of intentional contamination of the 
                food supply;
                    (C) a growing number of people at high risk for 
                food-borne illnesses, including an increasing 
                population of aging and immune-compromised consumers, 
                together with infants and children;
                    (D) an increasing volume of imported food, without 
                adequate monitoring, inspection, and systems for 
                prevention of food safety problems; and
                    (E) maintenance of rigorous inspection of the 
                domestic food processing and food service industries;
            (6) Federal food safety standard setting, inspection, 
        enforcement, and research efforts should be based on the best 
        available science and public health considerations, and food 
        safety resources should be systematically deployed in ways that 
        most effectively prevent food-borne illness;
            (7) the Food and Drug Administration, an agency within the 
        Department of Health and Human Services, has regulatory 
        jurisdiction over the safety and labeling of 80 percent of the 
        American food supply, encompassing all foods except meat, 
        poultry, and egg products, as well as drugs, medical devices, 
        and biologics;
            (8) rapid technological advance and the expansion and 
        globalization of industries in all areas of Food and Drug 
        Administration jurisdiction present challenges and require 
        leadership beyond the capacity of any one agency or agency head 
        to provide;
            (9) in the food safety area, the Food and Drug 
        Administration implements provisions of the Federal Food, Drug, 
        and Cosmetic Act that are 70 years old and that antiquated law 
        limits the Food and Drug Administration's role largely to 
        reacting to and correcting food safety problems after they 
        occur, rather than working with the food industry to 
        systematically prevent problems;
            (10) the Food and Drug Administration's effectiveness is 
        further impaired by fragmentation of leadership and management 
        within the Administration, as major food safety 
        responsibilities are dispersed across the Administration's 
        Center for Food Safety and Applied Nutrition, Center for 
        Veterinary Medicine, and Office of Regulatory Affairs;
            (11) there is no official with the full-time responsibility 
        and budget authority for food safety at the Food and Drug 
        Administration and food safety competes unsuccessfully with the 
        drug and medical device programs for senior agency management 
        attention and resources; and
            (12) improving Federal oversight of food safety requires a 
        modern food safety mandate, clear authorities, and a dedicated 
        official within the Department of Health and Human Services 
        with budget authority to manage an integrated organizational 
        structure and report directly to the Secretary.
    (b) Purposes.--The purposes of this Act are--
            (1) to establish an agency within the Department of Health 
        and Human Services to be known as the ``Food Safety 
        Administration'' to--
                    (A) regulate food safety and labeling to strengthen 
                the protection of the public health;
                    (B) ensure that food establishments fulfill their 
                responsibility to process, store, hold, and transport 
                food in a manner that protects the public health of all 
                people in the United States;
                    (C) lead an integrated, systemwide approach to food 
                safety and to make more effective and efficient use of 
                resources to prevent food-borne illness;
                    (D) provide a single focal point within the 
                Department of Health and Human Services for food safety 
                leadership, both nationally and internationally; and
                    (E) provide an integrated food safety research 
                capability, utilizing internally generated, 
                scientifically and statistically valid studies, in 
                cooperation with academic institutions and other 
                scientific entities of the Federal and State 
                governments;
            (2) to transfer to the Food Safety Administration the food 
        safety, labeling, inspection, and enforcement functions that, 
        as of the day before the date of the enactment of this Act, are 
        performed by various components of the Food and Drug 
        Administration and the National Oceanic and Atmospheric 
        Administration;
            (3) to modernize and strengthen the Federal food safety law 
        to ensure more effective application and efficient management 
        of the laws for the protection and improvement of public 
        health; and
            (4) to establish that food establishments have 
        responsibility to ensure that all stages of production, 
        processing, and distribution of their products or products 
        under their control satisfy the requirements of this law.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Administration.--The term ``Administration'' means the 
        Food Safety Administration established under section 101(a)(1).
            (2) Administrator.--The term ``Administrator'' means the 
        Administrator of Food Safety appointed under section 101(a)(2).
            (3) Adulterated.--
                    (A) In general.--The term ``adulterated'' has the 
                meaning given that term in section 402 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 342).
                    (B) Inclusion.--The term ``adulterated'' includes 
                bearing or containing a contaminant that causes illness 
                or death among sensitive populations.
            (4) Agency.--The term ``agency'' has the meaning given that 
        term in section 551 of title 5, United States Code.
            (5) Category 1 food establishment.--The term ``category 1 
        food establishment'' means a food establishment (other than a 
        seafood processing establishment) that slaughters, for the 
        purpose of producing food, animals that are not subject to 
        inspection under the Federal Meat Inspection Act or poultry 
        that are not subject to inspection under the Poultry Products 
        Inspection Act.
            (6) Category 2 food establishment.--The term ``category 2 
        food establishment'' means a seafood processing establishment 
        or other food establishment (other than a category 1 
        establishment) not subject to inspection under the Federal Meat 
        Inspection Act, the Poultry Products Inspection Act, or the Egg 
        Products Inspection Act, that processes raw seafood or other 
        raw animal products, whether fresh or frozen, or other products 
        that the Administrator determines by regulation to pose a 
        significant risk of hazardous contamination.
            (7) Category 3 food establishment.--The term ``category 3 
        food establishment'' means a food establishment (other than a 
        category 1 or category 2 establishment) that processes cooked, 
        pasteurized, or otherwise ready-to-eat seafood or other animal 
        products, fresh produce in ready-to-eat raw form, or other 
        products that pose a risk of hazardous contamination.
            (8) Category 4 food establishment.--The term ``category 4 
        food establishment'' means a food establishment that processes 
        all other categories of food products not described in 
        paragraphs (5) through (7).
            (9) Category 5 food establishment.--The term ``category 5 
        food establishment'' means a food establishment that stores, 
        holds, or transports food products prior to delivery for retail 
        sale.
            (10) Contaminant.--The term ``contaminant'' includes a 
        bacterium, chemical, natural toxin or manufactured toxicant, 
        virus, parasite, prion, physical hazard, or other human 
        pathogen that when found on or in food can cause human illness, 
        injury, or death.
            (11) Hazardous contamination.--The term ``hazardous 
        contamination'' refers to the presence of a contaminant in food 
        at levels that pose a risk of human illness, injury, or death 
        or are capable of reaching levels that pose such risk during 
        the shelf life of the product.
            (12) Food.--The term ``food'' means a product intended to 
        be used for food or drink for a human or an animal and 
        components thereof.
            (13) Food establishment.--
                    (A) In general.--The term ``food establishment'' 
                means a slaughterhouse (except those regulated under 
                the Federal Meat Inspection Act or the Poultry Products 
                Inspection Act), factory, warehouse, or facility owned 
                or operated by a person located in any State that 
                processes food or a facility that holds, stores, or 
                transports food or food ingredients.
                    (B) Exclusions.--For the purposes of registration, 
                the term ``food establishment'' does not include a food 
                production facility as defined in paragraph (14), 
                restaurant, other retail food establishment, nonprofit 
                food establishment in which food is prepared for or 
                served directly to the consumer, or fishing vessel 
                (other than a fishing vessel engaged in processing, as 
                that term is defined in section 123.3 of title 21, Code 
                of Federal Regulations).
            (14) Food production facility.--The term ``food production 
        facility'' means any farm, ranch, orchard, vineyard, 
        aquaculture facility, or confined animal-feeding operation.
            (15) Food safety law.--The term ``food safety law'' means--
                    (A) the provisions of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 301 et seq.) related to and 
                requiring the safety, quality, nutritional composition, 
                labeling, and inspection of food, infant formulas, food 
                additives, pesticide residues, and other substances 
                present in food under that Act;
                    (B) the provisions of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any 
                other Act that are administered by the Center for 
                Veterinary Medicine of the Food and Drug 
                Administration;
                    (C) the provisions of the Public Health Service Act 
                that relate in any way to surveying, containing, or 
                preventing food-borne illness; and
                    (D) the provisions of this Act.
            (16) Foreign food establishment.--The term ``foreign food 
        establishment'' means any category 1 through 5 food 
        establishment or food production facility located outside the 
        United States that processes or produces food or food 
        ingredients for consumption in the United States.
            (17) Interstate commerce.--The term ``interstate commerce'' 
        has the meaning given that term in section 201(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
            (18) Misbranded.--The term ``misbranded'' has the meaning 
        given that term in section 403 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343).
            (19) Process.--The term ``process'' or ``processing'' means 
        the commercial slaughter, packing, preparation, or manufacture 
        of food.
            (20) State.--The term ``State'' means--
                    (A) a State;
                    (B) the District of Columbia;
                    (C) the Commonwealth of Puerto Rico; and
                    (D) any other territory or possession of the United 
                States.

        TITLE I--ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION

SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.

    (a) Establishment.--
            (1) In general.--There is established in the Department of 
        Health and Human Services an agency to be known as the ``Food 
        Safety Administration''.
            (2) Head of the administration.--The Administration shall 
        be headed by the Administrator of Food Safety, who shall be 
        appointed by the President, by and with the advice and consent 
        of the Senate, for a term of 5 years, and who may be 
        reappointed.
            (3) Delegation.--All the authorities and responsibilities 
        assigned to the Secretary of Health and Human Services in the 
        food safety law are hereby assigned to the Administrator.
    (b) Duties of Administrator.--The Administrator shall--
            (1) administer and enforce the food safety law;
            (2) serve as the food safety leader within the Department 
        of Health and Human Services and coordinator of all Department 
        activities related to ensuring the safety, quality, and proper 
        labeling of the food supply;
            (3) represent the United States in international food 
        safety bodies and discussions;
            (4) promulgate regulations to ensure the safety and 
        security of the food supply from all forms of contamination, 
        including intentional contamination; and
            (5) oversee within the Department of Health and Human 
        Services--
                    (A) all activities related to foodborne illness 
                surveillance and investigation of foodborne illness 
                outbreaks;
                    (B) implementation of food safety inspection, 
                enforcement, and research efforts to protect the public 
                health;
                    (C) development of consistent and science-based 
                standards for safe food;
                    (D) coordination and prioritization of food safety 
                research and education programs with other Federal 
                agencies;
                    (E) prioritization of food safety efforts and 
                deployment of food safety resources to achieve the 
                greatest possible benefit in reducing food-borne 
                illness;
                    (F) coordination of the response to food-borne 
                illness outbreaks with other Federal and State 
                agencies; and
                    (G) integration of food safety activities with 
                State and local agencies.

SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.

    (a) Transfer of Functions and Resources.--For each component of the 
Department of Health and Human Services or the Department of Commerce 
specified in subsection (b), there are transferred to the 
Administration all functions, personnel, and assets (including 
facilities and financial resources) of those components as of the day 
before the date of the enactment of this Act (including all related 
functions of any officer or employee of the component) that relate to 
administration or enforcement of the food safety law, as determined by 
the President.
    (b) Transferred Functions and Resources.--The components referred 
to in subsection (a) are--
            (1) the Center for Food Safety and Applied Nutrition of the 
        Food and Drug Administration;
            (2) the Center for Veterinary Medicine of the Food and Drug 
        Administration;
            (3) the National Center for Toxicological Research of the 
        Food and Drug Administration;
            (4) the personnel and assets of the Office of Regulatory 
        Affairs of the Food and Drug Administration used to administer 
        and conduct inspections of food establishments and imports and 
        conduct laboratory analyses and other investigations relating 
        to food safety;
            (5) the personnel and assets of the Office of the 
        Commissioner of Food and Drugs used to support--
                    (A) the Center for Food Safety and Applied 
                Nutrition;
                    (B) the Center for Veterinary Medicine;
                    (C) the National Center for Toxicological Research; 
                and
                    (D) the personnel and assets of the Office of 
                Regulatory Affairs described in paragraph (4); and
            (6) the personnel and assets of the National Marine 
        Fisheries Service of the National Oceanic and Atmospheric 
        Administration of the Department of Commerce used to administer 
        the seafood inspection program.
    (c) Renaming and Reservation of Agency Identity.--The Food and Drug 
Administration in the Department of Health and Human Services is hereby 
renamed the Federal Drug and Device Administration and may be referred 
to as ``FDA''.
    (d) Sharing of Facilities and Resources.--The Food Safety 
Administration and the Federal Drug and Device Administration shall 
enter into such agreements concerning the sharing of facilities and 
other resources as may be appropriate to make efficient use of such 
facilities and resources and achieve their respective missions.

SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.

    (a) Officers and Employees.--The Administrator may--
            (1) appoint officers and employees for the Administration 
        in accordance with the provisions of title 5, United States 
        Code, relating to appointment in the competitive service; and
            (2) fix the compensation of those officers and employees in 
        accordance with chapter 51 and with subchapter III of chapter 
        53 of that title, relating to classification and General 
        Schedule pay rates.
    (b) Experts and Consultants.--The Administrator may--
            (1) procure the services of temporary or intermittent 
        experts and consultants as authorized by section 3109 of title 
        5, United States Code; and
            (2) pay in connection with those services the travel 
        expenses of the experts and consultants, including 
        transportation and per diem in lieu of subsistence while away 
        from the homes or regular places of business of the 
        individuals, as authorized by section 5703 of that title.
    (c) Bureaus, Offices, and Divisions.--The Administrator may 
establish within the Administration such bureaus, offices, and 
divisions as the Administrator determines are necessary to perform the 
duties of the Administrator.
    (d) Advisory Committees.--
            (1) In general.--The Administrator shall establish advisory 
        committees that consist of representatives of scientific expert 
        bodies, academics, industry specialists, and consumers.
            (2) Duties.--The duties of an advisory committee 
        established under paragraph (1) may include developing 
        recommendations with respect to the development of new 
        processes, research, communications, performance standards, and 
        inspection.

            TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

    (a) In General.--The Administrator shall--
            (1) develop, administer, and annually update a national 
        food safety program (referred to in this section as the 
        ``program'') to protect public health; and
            (2) ensure that persons who produce, process, or distribute 
        food meet their responsibility to prevent or minimize food 
        safety hazards related to their products.
    (b) Comprehensive Analysis.--The program shall be based on a 
comprehensive analysis of the hazards associated with different food 
and with the processing of different food, including the identification 
and evaluation of--
            (1) the severity of the potential health risks;
            (2) the sources of potentially hazardous contamination or 
        practices extending from the farm or ranch to the consumer that 
        may increase the risk of food-borne illness;
            (3) the potential for persistence, multiplication, or 
        concentration of naturally occurring or added contaminants in 
        food;
            (4) the potential for hazardous contamination to have 
        cumulative toxic effects, multigenerational effects, or effects 
        on specific categories of consumers;
            (5) opportunities across the food production, processing, 
        distribution, and retail system to reduce potential health 
        risks; and
            (6) opportunities for intentional contamination of food or 
        food ingredients.
    (c) Program Elements.--In carrying out the program, the 
Administrator shall--
            (1) adopt and implement a national system for the 
        registration of food establishments and foreign food 
        establishments, as provided in section 202 of this Act;
            (2) adopt and implement a national system for regular 
        unannounced inspection of food establishments;
            (3) require and enforce the adoption of preventive process 
        controls in food establishments, based on the best available 
        scientific and public health considerations and best available 
        technologies;
            (4) establish and enforce science-based standards for--
                    (A) potentially hazardous substances that may 
                contaminate food; and
                    (B) safety and sanitation in the processing and 
                handling of food;
            (5) implement a statistically valid sampling program with 
        the stringency and frequency to independently monitor that 
        industry programs and procedures that prevent food 
        contamination are effective on an ongoing basis and that food 
        meets the standards established under this Act;
            (6) implement appropriate surveillance procedures and 
        requirements to ensure the safety and security of imported 
        food;
            (7) coordinate with other agencies and State or local 
        governments in carrying out inspection, enforcement, research, 
        and monitoring;
            (8) implement a national system to identify the food 
        products posing the greatest public health risk and to analyze 
        the effectiveness of existing food safety programs, in 
        conjunction with the Centers for Disease Control and Prevention 
        and other Federal agencies;
            (9) develop public education, risk communication, and 
        advisory programs;
            (10) implement an applied research program to further the 
        purposes of this Act;
            (11) coordinate and prioritize food safety research and 
        educational programs with other Federal agencies and with State 
        and local governments; and
            (12) provide technical assistance to farmers and food 
        establishments that are small business concerns (meeting the 
        requirements of section 3(a) of the Small Business Act and the 
        regulations promulgated thereunder) to assist with compliance 
        with the requirements of this Act.

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

    (a) In General.--Any food establishment or foreign food 
establishment engaged in manufacturing, processing, packing, or holding 
food for consumption in the United States shall register annually with 
the Administrator.
    (b) Registration Requirements.--
            (1) In general.--To be registered under subsection (a), a 
        food establishment shall submit a registration or 
        reregistration to the Administrator.
            (2) Registration.--Registration under this section shall 
        begin within 90 days of the enactment of this Act. Each such 
        registration shall be submitted to the Secretary through an 
        electronic portal and shall contain such information as the 
        Secretary, by guidance, determines to be appropriate. Such 
        registration shall contain the following information:
                    (A) The name, address, and emergency contact 
                information of each domestic food establishment or 
                foreign food establishment that the registrant owns or 
                operates under this Act and all trade names under which 
                the registrant conducts business in the United States 
                relating to food.
                    (B) The primary purpose and business activity of 
                each domestic food establishment or foreign food 
                establishment, including the dates of operation if the 
                domestic food establishment or foreign food 
                establishment is seasonal.
                    (C) The types of food processed or sold at each 
                domestic food establishment or, for foreign food 
                establishments selling food for consumption in the 
                United States, the specific food categories of that 
                food as listed under section 170.3(n) of title 21, Code 
                of Federal Regulations, or such other categories as the 
                Administrator may designate in guidance, action level, 
                or regulations for evaluating potential threats to food 
                protection.
                    (D) The name, address, and 24-hour emergency 
                contact information of the United States distribution 
                agent for each domestic food establishment or foreign 
                food establishment, who shall maintain information on 
                the distribution of food, including lot information, 
                and wholesaler and retailer distribution.
                    (E) An assurance that the registrant will notify 
                the Administrator of any change in the products, 
                function, or legal status of the domestic food 
                establishment or foreign food establishment (including 
                cessation of business activities) not later than 30 
                days after such change.
            (3) Procedure.--Upon receipt of a completed registration 
        described in paragraph (1), the Administrator shall notify the 
        registrant of the receipt of the registration, designate each 
        establishment as a category 1, 2, 3, 4, or 5 food 
        establishment, and assign a registration number to each 
        domestic food establishment and foreign food establishment.
            (4) List.--The Administrator shall annually compile a list 
        of domestic food establishments and a list of foreign food 
        establishments that are registered under this section. The 
        Administrator may establish the manner of and any fees required 
        for reregistration and any circumstances by which either such 
        list may be shared with other governmental authorities. The 
        Administrator may remove from either such list the name of any 
        establishment that fails to reregister, and such delisting 
        shall be treated as a suspension.
            (5) Disclosure exemption.--The disclosure requirements 
        under section 552 of title 5, United States Code, shall not 
        apply to--
                    (A) the list compiled under paragraph (4); and
                    (B) information derived from the list under 
                paragraph (4), to the extent that it discloses the 
                identity or location of a specific person.
            (6) Suspension of registration.--
                    (A) In general.--The Administrator may suspend the 
                registration of a domestic food establishment or 
                foreign food establishment, including the facility of 
                an importer, for violation of a food safety law that is 
                either repeated or could result in serious adverse 
                health consequences or death to humans or animals.
                    (B) Notice and opportunity for hearing.--The 
                Administrator shall provide notice of an intent to 
                suspend the registration of an establishment under this 
                paragraph to a registrant and provide the registrant 
                with an opportunity for an administrative hearing 
                within 3 days. The Administrator may issue a written 
                order of suspension following the hearing, if the 
                Administrator finds that a violation described in 
                subparagraph (A) has occurred.
                    (C) Judicial review.--The issuance of an order of 
                suspension under subparagraph (B) shall be considered 
                to be a final agency action subject to judicial review 
                in accordance with the provisions of chapter 7 of title 
                5, United States Code.
            (7) Reinstatement.--A registration that is suspended under 
        this section may be reinstated based on a showing that adequate 
        process controls have been instituted that would prevent future 
        violations and there are assurances from the registrant that 
        the violations will not be repeated.
    (c) Transitional Provision.--During the 6-month period following 
the date of the enactment of this Act, a food establishment is deemed 
to be registered in accordance with this section if the establishment 
is registered under section 415 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350d).
    (d) Repeal.--Effective at the end of the 6-month period following 
the date of the enactment of this Act, section 415 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350d) is repealed.

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

    (a) In General.--The Administrator shall, upon the basis of best 
available public health, scientific, and technological data, promulgate 
regulations to ensure that food establishments carry out their 
responsibilities under the food safety law.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Administrator shall promulgate regulations 
that require all food establishments, within time frames determined by 
the Administrator--
            (1) to adopt preventive process controls that--
                    (A) reflect the standards and procedures recognized 
                by relevant authoritative bodies;
                    (B) are adequate to protect the public health;
                    (C) meet relevant regulatory and food safety 
                standards;
                    (D) limit the presence and growth of contaminants 
                in food prepared in a food establishment using the best 
                reasonably available techniques and technologies; and
                    (E) are tailored to the hazards and processes in 
                particular establishments or environments;
            (2) to establish a sanitation plan and program that meets 
        standards set by the Administrator;
            (3) to meet performance standards for hazardous 
        contamination established under section 204;
            (4) to implement recordkeeping to monitor compliance with 
        regulatory requirements;
            (5) to implement recordkeeping and labeling of all food and 
        food ingredients to facilitate their identification and 
        traceability in the event of a recall or market removal;
            (6) to implement product and environmental sampling at a 
        frequency and in a manner sufficient to ensure that process 
        controls are effective on an ongoing basis and that regulatory 
        standards are being met;
            (7) to label food intended for final processing outside 
        commercial food establishments with instructions for handling 
        and preparation for consumption that will destroy microbial 
        contaminants; and
            (8) to provide for agency access to records kept by the 
        food establishments and submission of copies of records to the 
        Administrator, as the Administrator determines appropriate.
    (c) Specific Hazard Controls.--The Administrator may require any 
person with responsibility for or control over food or food ingredients 
to adopt specific hazard controls, if such controls are needed to 
ensure the protection of the public health.

SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

    (a) In General.--To protect the public health, the Administrator 
shall establish by guidance document, action level, or regulation and 
enforce performance standards that define, with respect to specific 
foods and contaminants in food, the level of food safety performance 
that a person responsible for producing, processing, or selling food 
shall meet.
    (b) Identification of Contaminants; Performance Standards.--
            (1) List of contaminants.--Not later than 6 months after 
        the date of the enactment of this Act, the Administrator shall 
        publish in the Federal Register a list of the contaminants in 
        foods that have the greatest adverse impact on public health in 
        terms of the number and severity of illnesses and number of 
        deaths associated with foods regulated under this Act. Where 
        appropriate, the Administrator shall indicate whether the risk 
        posed by a contaminant is generalized or specific to particular 
        foods or ingredients.
            (2) Performance standards.--
                    (A) Establishment.--The Administrator shall 
                establish by guidance document, action level, or 
                regulation a performance standard for each contaminant 
                in the list under paragraph (1) at levels appropriate 
                to protect against the potential adverse health effects 
                of the contaminant.
                    (B) Timing.--The Administrator shall establish a 
                performance standard under subparagraph (A) for each 
                contaminant in the list under paragraph (1)--
                            (i) as soon as practicable; or
                            (ii) in the case of a contaminant described 
                        in subparagraph (C), by the date described in 
                        such subparagraph.
                    (C) Significant contaminants.--The list under 
                paragraph (1) (and any revision thereto) shall identify 
                the 5 most significant contaminants in the list (in 
                terms of the number and severity of illnesses and 
                number of deaths associated with foods regulated under 
                this Act). Not later than 3 years after a contaminant 
                is so identified, the Administrator shall promulgate a 
                performance standard under subparagraph (A) for the 
                contaminant.
            (3) Review; revision.--Not less than every 3 years, the 
        Administrator shall review and, if necessary, revise--
                    (A) the list of contaminants under paragraph (1); 
                and
                    (B) each performance standard established under 
                paragraph (2) or
    (c) Performance Standards.--
            (1) In general.--The performance standards established 
        under this section may include--
                    (A) health-based standards that set the level of a 
                contaminant that can safely and lawfully be present in 
                food;
                    (B) zero tolerances, including any zero tolerance 
                performance standards in effect on the day before the 
                date of the enactment of this Act, when necessary to 
                protect against significant adverse health outcomes;
                    (C) process standards, such as log reduction 
                criteria for cooked products, when sufficient to ensure 
                the safety of processed food; and
                    (D) in the absence of data to support a performance 
                standard described in subparagraph (A), (B), or (C), 
                standards that define required performance on the basis 
                of reliable information on the best reasonably 
                achievable performance, using best available 
                technologies, interventions, and practices.
            (2) Best reasonably achievable performance standards.--In 
        developing best reasonably achievable performance standards 
        under paragraph (1)(D), the Administrator shall collect, or 
        contract for the collection of, data on current best practices 
        and food safety outcomes related to the contaminants and foods 
        in question, as the Administrator determines necessary.
            (3) Revocation by administrator.--All performance 
        standards, tolerances, action levels, or other similar 
        standards in effect on the date of the enactment of this Act 
        shall remain in effect until revised or revoked by the 
        Administrator.
    (d) Enforcement.--
            (1) In general.--In conjunction with the establishment of a 
        performance standard under this section, the Administrator 
        shall develop a statistically valid sampling program with the 
        stringency and frequency sufficient to independently monitor 
        whether food establishments are complying with the performance 
        standard and implement the program within 1 year of the 
        promulgation of the standard.
            (2) Inspections.--If the Administrator determines that a 
        food establishment fails to meet a standard promulgated under 
        this section, the Administrator shall, as appropriate--
                    (A) detain, seize, or condemn food from the food 
                establishment under section 402;
                    (B) order a recall of food from the food 
                establishment under section 403;
                    (C) increase the inspection frequency for the food 
                establishment;
                    (D) withdraw the mark of inspection from the food 
                establishment, if in use; or
                    (E) take other appropriate enforcement action 
                concerning the food establishment, including withdrawal 
                of registration.
    (e) Newly Identified Contaminants.--Notwithstanding any other 
provision of this section, the Administrator shall establish interim 
performance standards for newly identified contaminants as necessary to 
protect the public health.

SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.

    (a) In General.--The Administrator shall establish an inspection 
program, which shall include statistically valid sampling of food and 
facilities to enforce performance standards. The inspection program 
shall be designed to determine if each food establishment--
            (1) is operated in a sanitary manner;
            (2) has continuous preventive control systems, 
        interventions, and processes in place to minimize or eliminate 
        contaminants in food;
            (3) is in compliance with applicable performance standards 
        established under section 204, and other regulatory 
        requirements;
            (4) is processing food that is not adulterated or 
        misbranded;
            (5) maintains records of process control plans under 
        section 203, and other records related to the processing, 
        sampling, and handling of food; and
            (6) is otherwise in compliance with the requirements of the 
        food safety law.
    (b) Establishment Categories and Inspection Frequencies.--The 
resource plan required under section 209, including the description of 
resources required to carry out inspections of food establishments, 
shall be based on the following categories and inspection frequencies, 
subject to subsections (c), (d), and (e):
            (1) Category 1 food establishments.--A category 1 food 
        establishment shall be subject to antemortem, postmortem, and 
        continuous inspection of each slaughter line during all 
        operating hours, and other inspection on a daily basis, 
        sufficient to verify that--
                    (A) diseased animals are not offered for slaughter;
                    (B) the food establishment has successfully 
                identified and removed from the slaughter line visibly 
                defective or contaminated carcasses, has avoided cross-
                contamination, and has destroyed or reprocessed such 
                carcasses in a manner acceptable to the Administrator; 
                and
                    (C) applicable performance standards and other 
                provisions of the food safety law, including those 
                intended to eliminate or reduce pathogens, have been 
                satisfied.
            (2) Category 2 food establishments.--A category 2 food 
        establishment shall--
                    (A) have ongoing verification that its processes 
                are controlled; and
                    (B) be randomly inspected at least weekly.
            (3) Category 3 food establishments.--A category 3 food 
        establishment shall--
                    (A) have ongoing verification that its processes 
                are controlled; and
                    (B) be randomly inspected at least monthly.
            (4) Category 4 food establishments.--A category 4 food 
        establishment shall--
                    (A) have ongoing verification that its processes 
                are controlled; and
                    (B) be randomly inspected at least quarterly.
            (5) Category 5 food establishments.--A category 5 food 
        establishment shall--
                    (A) have ongoing verification that its processes 
                are controlled; and
                    (B) be randomly inspected at least annually.
    (c) Establishment of Inspection Procedures.--The Administrator 
shall establish procedures under which inspectors shall take random 
samples, photographs, and copies of records in food establishments.
    (d) Alternative Inspection Frequencies.--With respect to a 
subcategory of food establishment under category 2, 3, 4, or 5, the 
Administrator may establish alternative increasing or decreasing 
inspection frequencies for subcategories of food establishments or 
individual establishments, to foster risk-based allocation of 
resources. Before establishing an alternative inspection frequency for 
a subcategory of food establishments or individual establishments, the 
Administrator shall take into consideration the evidence described in 
paragraph (2)(D) and the overall record of compliance described in 
paragraph (2)(E) for such subcategory. In establishing alternative 
inspection frequencies under this subsection, the Administrator shall 
comply with the following criteria and procedures:
            (1) Subcategories of food establishments and their 
        alternative inspection frequencies shall be defined by 
        regulation, subject to paragraphs (2) and (3).
            (2) In defining subcategories of food establishments and 
        their alternative inspection frequencies under paragraphs (1) 
        and (2), the Administrator shall consider--
                    (A) the nature of the food products being 
                processed, stored, or transported;
                    (B) the manner in which food products are 
                processed, stored, or transported;
                    (C) the inherent likelihood that the products will 
                contribute to the risk of food-borne illness;
                    (D) the best available evidence concerning reported 
                illnesses associated with the foods processed, stored, 
                held, or transported in the proposed subcategory of 
                establishments; and
                    (E) the overall record of compliance with food 
                safety law among establishments in the proposed 
                subcategory, including compliance with applicable 
                performance standards and the frequency of recalls.
            (3) The Administrator may adopt alternative inspection 
        frequencies for increased or decreased inspection for a 
        specific establishment and shall annually publish a list of 
        establishments subject to alternative inspections.
            (4) In adopting alternative inspection frequencies for a 
        specific establishment, the Administrator shall consider--
                    (A) the criteria in paragraph (3), 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 preventative process 
                control systems;
                    (B) whether products from the specific 
                establishment have been associated with a case or an 
                outbreak of food-borne illness; and
                    (C) the establishment's record of compliance with 
                food safety law, including compliance with applicable 
                performance standards and the frequency of recalls.
    (e) Effective Date.--The inspection mandates shall go into effect 2 
years after the date of the enactment of this Act.
    (f) Maintenance and Inspection of Records.--
            (1) In general.--
                    (A) Records.--A food establishment shall--
                            (i) maintain such records as the 
                        Administrator shall require by regulation, 
                        including all records relating to the 
                        processing, distributing, receipt, or 
                        importation of any food; and
                            (ii) permit the Administrator, in addition 
                        to any authority transferred to the 
                        Administrator pursuant to section 102, upon 
                        presentation of appropriate credentials and at 
                        reasonable times and in a reasonable manner, to 
                        have access to and copy all records maintained 
                        by or on behalf of such food establishment 
                        representative in any format (including paper 
                        or electronic) and at any location, that are 
                        necessary to assist the Administrator--
                                    (I) to determine whether the food 
                                is contaminated or not in compliance 
                                with the food safety law; or
                                    (II) to track the food in commerce.
                    (B) Required disclosure.--A food establishment 
                shall have an affirmative obligation to disclose to the 
                Administrator the results of testing or sampling of 
                food, equipment, or material in contact with food, that 
                is positive for any contaminant.
            (2) Maintenance of records.--The records in paragraph (1) 
        shall be maintained for a reasonable period of time, as 
        determined by the Administrator.
            (3) Requirements.--The records in paragraph (1) shall 
        include records describing--
                    (A) the origin, receipt, delivery, sale, movement, 
                holding, and disposition of food or ingredients;
                    (B) the identity and quantity of ingredients used 
                in the food;
                    (C) the processing of the food;
                    (D) the results of laboratory, sanitation, or other 
                tests performed on the food or in the food 
                establishment;
                    (E) consumer complaints concerning the food or 
                packaging of the food;
                    (F) the production codes, open date codes, and 
                locations of food production; and
                    (G) other matters reasonably related to whether 
                food is adulterated or misbranded, or otherwise fails 
                to meet the requirements of this Act.
    (g) Protection of Sensitive Information.--
            (1) In general.--The Administrator shall develop and 
        maintain procedures to prevent the unauthorized disclosure of 
        any trade secret or commercially valuable confidential 
        information obtained by the Administrator.
            (2) Limitation.--The requirements under this subsection and 
        subsection (f) do not--
                    (A) limit the authority of the Administrator to 
                inspect or copy records or to require the establishment 
                or maintenance of records under this Act;
                    (B) have any legal effect on section 1905 of title 
                18, United States Code;
                    (C) extend to any food recipe, financial data, 
                pricing data, or personnel data;
                    (D) limit the public disclosure of distribution 
                records or other records related to food subject to a 
                voluntary or mandatory recall under section 403; or
                    (E) limit the authority of the Administrator to 
                promulgate regulations to permit the sharing of data 
                with other governmental authorities.
    (h) Bribery of or Gifts to Inspector or Other Officers and 
Acceptance of Gifts.--Any person or agent or employee thereof that 
gives, pays, or offers, directly or indirectly, to the Administrator or 
any employee or other designee thereof authorized to perform any duty 
under the food safety law any money or other thing of value, with 
intent to influence the discharge of any duty under such law, shall be 
imprisoned for not more than 5 years, fined in accordance with title 
18, United States Code, or both. Any Administrator, employee, or other 
designee that solicits or accepts any money or other thing of value 
from any person, with intent to influence the discharge of any duty 
under the food safety law, shall be summarily discharged from office 
and imprisoned for not more than 5 years, fined in accordance with 
title 18, United States Code, or both.

SEC. 206. FOOD PRODUCTION FACILITIES.

    (a) Authorities.--In carrying out the duties of the Administrator 
and the purposes of this Act, the Administrator shall have the 
authority, with respect to food production facilities, to--
            (1) visit and inspect food production facilities in the 
        United States and in foreign countries to determine if they are 
        operating in compliance with the requirements of the food 
        safety law;
            (2) review food safety records as required to be kept by 
        the Administrator under section 210 and for other food safety 
        purposes;
            (3) set good practice standards to protect the public and 
        animal health and promote food safety;
            (4) conduct monitoring and surveillance of animals, plants, 
        products, or the environment, as appropriate; and
            (5) collect and maintain information relevant to public 
        health and farm practices.
    (b) Inspection of Records.--A food production facility shall permit 
the Administrator upon presentation of appropriate credentials and at 
reasonable times and in a reasonable manner, to have access to and 
ability to copy all records maintained by or on behalf of such food 
production establishment in any format (including paper or electronic) 
and at any location, that are necessary to assist the Administrator--
            (1) to determine whether the food is contaminated, 
        adulterated, or otherwise not in compliance with the food 
        safety law; or
            (2) to track the food in commerce.
    (c) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Administrator, in consultation with the 
Secretary of Agriculture and representatives of State departments of 
agriculture, shall promulgate regulations to establish science-based 
minimum standards for the safe production of food by food production 
facilities. Such regulations shall--
            (1) consider all relevant hazards, including those 
        occurring naturally, and those that may be unintentionally or 
        intentionally introduced;
            (2) require each food production facility to have a written 
        food safety plan that describes the likely hazards and 
        preventive controls implemented to address those hazards;
            (3) include, with respect to growing, harvesting, sorting, 
        and storage operations, minimum standards related to fertilizer 
        use, nutrients, hygiene, packaging, temperature controls, 
        animal encroachment, and water;
            (4) include, with respect to animals raised for food, 
        minimum standards related to the animal's health, feed, and 
        environment which bear on the safety of food for human 
        consumption;
            (5) provide a reasonable period of time for compliance, 
        taking into account the needs of small businesses for 
        additional time to comply;
            (6) provide for coordination of education and enforcement 
        activities by State and local officials, as designated by the 
        Governors of the respective States; and
            (7) include a description of the variance process under 
        subsection (d) and the types of permissible variances which the 
        Administrator may grant under such process.
    (d) Variances.--States and foreign countries that export produce 
intended for consumption in the United States may request from the 
Administrator variances from the requirements of the regulations under 
subsection (c). A request shall--
            (1) be in writing;
            (2) describe the reasons the variance is necessary;
            (3) describe the procedures, processes, and practices that 
        will be followed under the variance to ensure produce is not 
        adulterated; and
            (4) contain any other information required by the 
        Administrator.
    (e) Approval or Disapproval of Variances.--If the Administrator 
determines after review of a request under subsection (d) that the 
requested variance provides equivalent protections to those promulgated 
under subsection (c), the Administrator may approve the request. The 
Administrator shall deny a request if it is--
            (1) not sufficiently detailed to permit a determination;
            (2) fails to cite sufficient grounds for allowing a 
        variance; or
            (3) does not provide reasonable assurances that the produce 
        will not be adulterated.
    (f) Enforcement.--The Administrator may coordinate with the agency 
or department designated by the Governor of each State to perform 
activities to ensure compliance with this section.
    (g) Imported Produce.--Not later than 1 year after the date of the 
enactment of this Act, the Administrator shall by regulation establish 
procedures for equivalency with foreign countries that intend to export 
raw agricultural commodities and minimally processed produce to the 
United States.

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.
    (b) State Action.--The Administrator shall work with States to--
            (1) continue, strengthen, or establish State food safety 
        programs, especially with respect to the regulation of retail 
        commercial food establishments, transportation, harvesting, and 
        fresh markets;
            (2) continue, strengthen, or establish inspection programs 
        and requirements to ensure that food under the jurisdiction of 
        the State complies with the food safety law; and
            (3) support recall authorities at the State and local 
        levels.
    (c) Assistance.--To assist in planning, developing, and 
implementing a food safety program, the Administrator may provide and 
continue to a State--
            (1) advisory assistance;
            (2) technical and laboratory assistance and training 
        (including necessary materials and equipment); and
            (3) financial, in-kind, and other aid.
    (d) Service Agreements.--
            (1) In general.--The Administrator may, under agreements 
        entered into with Federal, State, or local agencies, use on a 
        reimbursable basis or otherwise the qualified personnel and 
        services of those agencies in carrying out this Act.
            (2) Training.--Agreements with a State under this 
        subsection shall provide for training of State employees.
            (3) Maintenance of agreements.--The Administrator shall 
        maintain any agreement that is in effect on the day before the 
        date of the enactment of this Act until the Administrator 
        evaluates such agreement and determines whether to maintain or 
        substitute such agreement.
            (4) Commissioning.--Where necessary and appropriate to 
        fulfill the provisions of this Act or other food safety law, 
        the Administrator shall, as part of any service agreement, 
        commission qualified State and local regulatory officials and 
        inspectors to assist the Administrator in carrying out the food 
        safety law and accord such commissioned officials and 
        inspectors access to information in possession of the 
        Administrator as if they were Federal employees.
    (e) Audits.--
            (1) In general.--The Administrator shall annually conduct a 
        comprehensive review of each State program that provides 
        services to the Administrator in carrying out responsibilities 
        under this Act, including mandated inspections under section 
        205.
            (2) Requirements.--The review shall--
                    (A) include a determination of the effectiveness of 
                the State program; and
                    (B) identify any changes necessary to ensure 
                enforcement of Federal requirements under this Act.
    (f) No Federal Preemption.--Nothing in this Act shall be construed 
to preempt the enforcement of State laws and standards regarding food 
safety that are at least as stringent as those under this Act.

SEC. 208. IMPORTS.

    (a) In General.--All imported food under this Act shall meet 
requirements for food safety, inspection, labeling, and consumer 
protection that are at least equal to those applicable to food grown, 
manufactured, processed, packed, or held for consumption in the United 
States.
    (b) Certification System.--Not later than 2 years after the date of 
the enactment of this Act, the Administrator shall establish a system 
under which food products offered for importation into the United 
States shall be certified by the accredited foreign government in the 
country of export or by an accredited certifying agent meeting all 
applicable standards under this section.
            (1) Category 1, 2, and 3 food establishments shall secure 
        certification of products from the accredited foreign 
        government in the country where the products are produced and 
        must enter the United States through ports designated by the 
        Administrator.
            (2) Category 4 and 5 food establishments shall be certified 
        either by--
                    (A) the accredited foreign government in the 
                country where the products are produced; or
                    (B) a certifying agent that has been accredited 
                under subsection (c).
            (3) Beginning not later than 5 years after the date of the 
        enactment of this Act, food from category 4 and 5 food 
        establishments that is not certified by an accredited entity 
        described in subsection (c) shall not enter the United States 
        except through ports of entry that are located in a 
        metropolitan area with an accredited food testing laboratory.
    (c) Certification Standard.--
            (1) In general.--A foreign government or third party agent 
        requesting accreditation to certify food for entry into the 
        United States shall demonstrate, in a manner determined 
        appropriate by the Administrator, that food produced under the 
        supervision of the foreign government or third party agent, 
        respectively, has met standards for food safety, inspection, 
        labeling, and consumer protection that are at least equal to 
        standards applicable to food produced in the United States.
            (2) Request by foreign government.--Prior to accrediting a 
        foreign government, the Administrator shall--
                    (A) review and audit the food safety program of the 
                requesting foreign government (including all statutes, 
                regulations, and inspection authority); and
                    (B) determine that the exporting country--
                            (i) administers a food control program that 
                        requires food exporters to implement hazard 
                        control measures for physical, chemical, and 
                        biological contaminants;
                            (ii) ensures sanitary operations of 
                        facilities;
                            (iii) utilizes testing and verification 
                        programs; and
                            (iv) administers an effective enforcement 
                        program.
            (3) Request by a certifying agent.--Prior to accrediting a 
        certifying agent, the Administrator shall--
                    (A) review the training and qualifications of 
                auditors and other employees used by the agent;
                    (B) ensure that any such auditors have completed 
                such training as may be required by the Administrator 
                for the conduct of food safety inspections; and
                    (C) conduct reviews of internal systems and such 
                other investigation as the Administrator deems 
                necessary to determine that the certifying agent is 
                capable of auditing food establishments--
                            (i) to assess the adequacy of systems and 
                        standards in use; and
                            (ii) to ensure that food approved by the 
                        agent for import to the United States meets the 
                        requirements of this Act.
            (4) Certification to accompany each shipment.--As a 
        condition of accrediting any foreign government or certifying 
        agent, such government or agent shall agree to issue a written 
        and electronic certification to accompany each shipment 
        intended for import to the United States from any food 
        establishment which the government or agent certifies, subject 
        to requirements set forth by the Administrator.
    (d) Audits; Inspections.--Following any accreditation under 
subsection (c), the Administrator may at any time--
            (1) conduct an on-site audit of any food establishment 
        registered under section 202, with or without the certifying 
        agent; or
            (2) require a certifying agent to submit an onsite audit 
        report and any other reports or documents which the agent 
        requires as part of the audit process, including documentation 
        that the food establishment is in compliance with registration 
        requirements and prior notice requirements for food imported to 
        the United States.
    (e) Limitation.--A foreign government or other certifying agent 
accredited by the Administrator to certify food for import to the 
United States under this section may certify only the food products or 
food categories for importation to the United States that are specified 
in the grant of accreditation.
    (f) Withdrawal of Accreditation.--The Administrator may withdraw 
accreditation from a foreign government or certifying agent--
            (1) if food approved by the foreign government or 
        certifying agent is linked to an outbreak of human illness;
            (2) following an investigation and finding by the 
        Administrator that the programs of the foreign government, or a 
        foreign food establishment certified by the certifying agent, 
        are no longer equal to those applied to food grown, 
        manufactured, processed, packed, or held in the United States; 
        or
            (3) following a refusal to allow United States officials to 
        conduct such audits and investigations as may be necessary to 
        ensure continued compliance with the requirements of this 
        section.
    (g) Renewal of Accreditation.--The Administrator shall audit 
foreign governments and certifying agents whenever needed, but no less 
than once every 3 years, to ensure the continued compliance with the 
requirements set forth in this section. Renewal of accreditation shall 
occur following each satisfactory audit.
    (h) Required Routine Inspection.--The Administrator shall routinely 
inspect food before or at entry into the United States to ensure 
ongoing compliance with food safety law and where appropriate, as part 
of the audit of any certifying entity.
    (i) Enforcement.--The Administrator may--
            (1) deny importation of food from any foreign country if 
        the government of such country does not permit United States 
        officials to enter the foreign country to conduct such audits 
        and inspections as may be necessary to fulfill requirements 
        under this section;
            (2) deny importation of food from any foreign country or 
        foreign food establishment that does not consent to a timely 
        investigation by the Administration when food from that foreign 
        country or foreign food establishment is linked to a food-borne 
        illness outbreak or is otherwise found to be adulterated or 
        misbranded;
            (3) promulgate regulations to carry out the purposes of 
        this section, including setting terms and conditions for the 
        destruction of products that fail to meet the requirements of 
        this Act; and
            (4) establish such fees as are necessary to carry out the 
        implementation of the accreditation and inspection programs 
        required under this section.
    (j) Detention and Seizure.--Any food imported for consumption in 
the United States may be detained, seized, or condemned pursuant to 
section 402 or recalled pursuant to section 403.
    (k) Certifying Agents.--Entities eligible for accreditation as a 
certifying agent under subsection (c) may include--
            (1) a State or regional food authority; or
            (2) a foreign or domestic cooperative that aggregates the 
        products of growers or processors for importation.
    (l) Avoiding Conflicts of Interest With Certifying Agents.--
            (1) In general.--To be eligible for accreditation under 
        subsection (c), a certifying agent shall--
                    (A) not be owned, managed, or controlled by any 
                person that owns or operates an establishment whose 
                products are to be certified by such agent;
                    (B) have procedures to ensure against the use, in 
                carrying out audits of food establishments under this 
                section, of any officer or employee of such agent that 
                has a financial conflict of interest regarding an 
                establishment whose products are to be certified by 
                such agent; and
                    (C) annually make available to the Secretary, 
                disclosures of the extent to which such agent, and the 
                officers and employees of such agent, have maintained 
                compliance with subparagraphs (A) and (B) relating to 
                financial conflicts of interest.
            (2) Regulations.--The Secretary shall promulgate 
        regulations not later than 18 months after the date of the 
        enactment of this Act to ensure that there are protections 
        against conflicts of interest between a certifying agent and 
        the establishments whose products are to be certified by such 
        agent. Such regulations shall include--
                    (A) requiring that domestic audits performed under 
                this section be unannounced;
                    (B) a structure, including timing and public 
                disclosure, for fees paid by food establishments to 
                certifying agents to decrease the potential for 
                conflicts of interest; and
                    (C) appropriate limits on financial affiliations 
                between a certifying agent and any person that owns or 
                operates an establishment whose products are to be 
                certified by such agent.

SEC. 209. RESOURCE PLAN.

    (a) In General.--The Administrator shall prepare and update 
annually a resource plan describing the resources required, in the best 
professional judgment of the Administrator, to develop and fully 
implement the national food safety program established under this Act.
    (b) Contents of Plan.--The resource plan shall--
            (1) describe quantitatively the personnel, financial, and 
        other resources required to carry out the inspection of food 
        establishments under section 205 and other requirements of this 
        Act;
            (2) allocate inspection resources in a manner reflecting 
        the distribution of risk and opportunities to reduce risk 
        across the food supply to the extent feasible based on the best 
        available information, and subject to section 205; and
            (3) describe the personnel, facilities, equipment, and 
        other resources needed to carry out inspection and other 
        oversight activities, at a total resource level equal to at 
        least 50 percent of the resources required to carry out 
        inspections in food establishments under section 205 and food 
        production facilities under section 206--
                    (A) in foreign establishments and production 
                facilities; and
                    (B) at the point of importation.
    (c) Grants.--The resource plan shall include recommendations for 
funding to provide grants to States and local governments to carry out 
food safety activities and inspections of food establishments and food 
production facilities and include resources to audit such programs.
    (d) Submission of Plan.--The Administrator shall submit annually to 
the Committee on Appropriations of the Senate, the Committee on 
Appropriations of the House of Representatives, and other relevant 
committees of Congress, the resource plan required under this section.

SEC. 210. TRACEBACK REQUIREMENTS.

    (a) In General.--The Administrator, in order to protect the public 
health, shall establish a national traceability system that enables the 
Administrator to retrieve the history, use, and location of an article 
of food through all stages of its production, processing, and 
distribution.
    (b) Applicability.--Traceability requirements under this section 
shall apply to food from food production facilities, food 
establishments, and foreign food establishments.
    (c) Requirements.--
            (1) Standards.--The Administrator shall establish standards 
        for the type of information, format, and timeframe for food 
        production facilities and food establishments to submit records 
        to aid the Administrator in effectively retrieving the history, 
        use, and location of an item of food.
            (2) Rule of construction.--Nothing in this section shall be 
        construed as requiring the Administrator to prescribe a 
        specific technology for the maintenance of records or labeling 
        of food to carry out the requirements of this section.
            (3) Availability of records for inspection.--Any records 
        that are required by the Administrator under this section shall 
        be available for inspection by the Administrator upon oral or 
        written request.
            (4) Demonstration of ability.--The Administrator, during 
        any inspection, may require a food establishment to demonstrate 
        its ability to trace an item of food and submit the information 
        in the format and timeframe required under paragraph (1).
    (d) Relationship to Other Requirements.--
            (1) Consistency with existing statutes and regulations.--To 
        the extent possible, the Administrator should establish the 
        national traceability system under this section to be 
        consistent with existing statutes and regulations that require 
        recordkeeping or labeling for identifying the origin or history 
        of food or food animals.
            (2) Existing laws.--For purposes of this subsection, the 
        Administrator should review the following:
                    (A) Country of origin labeling requirements of 
                subtitle D of the Agricultural Marketing Act of 1946 (7 
                U.S.C. 1638 et seq.).
                    (B) The Perishable Agricultural Commodities Act of 
                1930 (7 U.S.C. 499a-t).
                    (C) Country of origin labeling requirements of 
                section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).
                    (D) The National Animal Identification System as 
                authorized by the Animal Health Protection Act of 2002 
                (7 U.S.C. 8301 et seq.).
            (3) Certain requirements.--Nothing contained in this 
        section prevents or interferes with implementation of the 
        country of origin labeling requirements of subtitle D of the 
        Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).

SEC. 211. ACCREDITED LABORATORIES.

    (a) Establishment of Program.--The Administrator shall establish a 
program for accrediting laboratories to perform sampling and testing 
for purposes of this Act. Such program shall include--
            (1) standards for appropriate sampling and analytical 
        procedures;
            (2) training and experience qualification levels for 
        individuals who conduct sampling and analysis;
            (3) annual onsite visits to audit the performance of an 
        accredited laboratory; and
            (4) such additional requirements as the Administrator 
        determines to be appropriate.
    (b) Requirements.--To be accredited under this section, a 
laboratory shall--
            (1) prepare and submit an application for accreditation to 
        the Administrator;
            (2) meet required tests and standards established by the 
        Administrator; and
            (3) comply with such terms and conditions as are determined 
        necessary by the Administrator.
    (c) Accrediting Bodies.--The Administrator may approve State 
agencies or private, nonprofit entities as accrediting bodies to act on 
behalf of the Administrator in accrediting laboratories under this 
section. The Administrator shall--
            (1) in making such approvals--
                    (A) oversee and review the performance of any 
                accrediting body acting on behalf of the Administrator 
                to ensure that such accrediting body is in compliance 
                with the requirements of this section; and
                    (B) have the right to obtain from an accrediting 
                body acting on behalf of the Administrator and from any 
                laboratory that may be certified by such a body all 
                records and materials that may be necessary for the 
                oversight and review required by subparagraph (A);
            (2) reevaluate accreditation bodies approved under 
        paragraph (1) whenever--
                    (A) the Administrator determines a laboratory 
                accredited by the accrediting body is no longer in 
                compliance with this section;
                    (B) the Administrator determines the accrediting 
                body is no longer in compliance with the requirements 
                of this section; or
                    (C) no less than once every 5 years; and
            (3) promptly revoke the approval of any accreditation body 
        found not to be in compliance with the requirements of this 
        section.
    (d) Revocation of Accreditation.--The Administrator shall revoke 
the accreditation of any laboratory that fails to meet the requirements 
this section.

                   TITLE III--RESEARCH AND EDUCATION

SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.

    (a) In General.--The Administrator, acting in coordination with the 
Director of the Centers for Disease Control and Prevention and with 
food safety and research programs of the Department of Agriculture, 
shall--
            (1) identify on an ongoing basis the priorities for 
        collection of epidemiological data and for other food safety 
        research and data collection that are most important to 
        implementing the food safety law and reducing the public health 
        burden of food-borne illness;
            (2) have full access for purposes of implementing the food 
        safety law to the applicable data and data systems of the 
        Centers for Disease Control and Prevention, including data made 
        available to the Centers by a State;
            (3) provide appropriate support and input on the design and 
        implementation by the Centers for Disease Control and 
        Prevention and the States of an active surveillance system that 
        provides information on the incidence and causes of food-borne 
        illness which is timely, detailed, and representative of the 
        population of the United States;
            (4) based on data and information obtained from the Centers 
        for Disease Control and Prevention, the States, and other 
        sources, assess the incidence, distribution, public health 
        impact, and causes of human illness in the United States 
        associated with the consumption of food, and conduct research 
        and analysis to devise effective and feasible interventions to 
        reduce food-borne illness;
            (5) maintain a state-of-the-art DNA matching system and 
        epidemiological system dedicated to food-borne illness 
        identification, outbreaks, and containment; and
            (6) utilize surveillance data created by means of 
        monitoring and statistical studies conducted as part of its own 
        inspection.
    (b) Public Health Sampling.--
            (1) In general.--Not later than 1 year after the enactment 
        of this Act, the Administrator shall establish guidelines for a 
        sampling system under which the Administrator shall take and 
        analyze samples of food--
                    (A) to assist the Administrator in carrying out 
                this Act; and
                    (B) to assess the nature, frequency of occurrence, 
                and quantities of contaminants in food.
            (2) Requirements.--The sampling system described in 
        paragraph (1) shall provide--
                    (A) statistically valid monitoring, including 
                market-based studies, on the nature, frequency of 
                occurrence, and quantities of contaminants in food 
                available to consumers; and
                    (B) at the request of the Administrator, such other 
                information, including analysis of monitoring and 
                verification samples, as the Administrator determines 
                may be useful in assessing the occurrence of 
                contaminants in food.
    (c) Assessment of Health Hazards.--
            (1) In general.--Through the surveillance system and 
        analyses referred to in subsection (a) and the sampling system 
        described in subsection (b), the Administrator shall--
                    (A) rank food categories based on the hazard to 
                human health presented by the food category and 
                specific chemical and microbiological hazards 
                associated with foods in those categories;
                    (B) identify appropriate industry and regulatory 
                approaches to minimize hazards in the food supply; and
                    (C) assess the conditions affecting the likelihood 
                that emerging pathogens and diseases, including 
                zoonosis, will affect the safety of the food supply and 
                possible strategies for minimizing the potential risk 
                to public health associated with emerging pathogens and 
                diseases.
            (2) Components of analysis.--The analysis under subsection 
        (b)(1) may include--
                    (A) a comparison of the safety of commercial 
                processing with the health hazards associated with food 
                that is harvested for recreational or subsistence 
                purposes and prepared noncommercially;
                    (B) a comparison of the safety of food that is 
                domestically processed with the health hazards 
                associated with food that is processed outside the 
                United States;
                    (C) a description of contamination originating from 
                handling practices that occur prior to or after the 
                sale of food to consumers; and
                    (D) use of comparative risk assessments.

SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.

    (a) Public Education.--
            (1) In general.--The Administrator, in cooperation with 
        private and public organizations, including the cooperative 
        extension services and building on the efforts of appropriate 
        State and local entities, shall establish a national public 
        education program on food safety.
            (2) Requirements.--The program shall provide--
                    (A) information to the public regarding Federal 
                standards and best practices, and promotion of public 
                awareness and understanding of those standards and 
                practices;
                    (B) information for health professionals--
                            (i) to improve diagnosis and treatment of 
                        food-related illness; and
                            (ii) to advise individuals at special risk 
                        for food-related illnesses; and
                    (C) such other information or advice, including on 
                safe food handling practices, to consumers and other 
                persons as the Administrator determines will promote 
                the purposes of this Act.
    (b) Health Advisories.--The Administrator, in consultation with 
other Federal departments and agencies as the Administrator determines 
necessary, shall work with the States and other appropriate entities--
            (1) to develop and distribute regional and national 
        advisories concerning food safety;
            (2) to develop standardized formats for written and 
        broadcast advisories;
            (3) to incorporate State and local advisories into the 
        national public education program established under subsection 
        (a); and
            (4) to present prompt, specific information regarding food 
        found to pose a threat to the public health, including by 
        identifying the retailers and food establishments where such 
        food has been sold.

SEC. 303. RESEARCH.

    (a) In General.--The Administrator shall conduct research to carry 
out this Act, including studies to--
            (1) improve sanitation and food safety practices in the 
        processing of food;
            (2) develop improved techniques to monitor and inspect 
        food;
            (3) develop efficient, rapid, and sensitive methods to 
        detect contaminants in food;
            (4) determine the sources of contamination of contaminated 
        food;
            (5) develop food consumption data;
            (6) identify ways that animal production techniques could 
        improve the safety of the food supply;
            (7) draw upon research and educational programs that exist 
        at the State and local level;
            (8) utilize the DNA matching system and other processes to 
        identify and control pathogens;
            (9) address common and emerging zoonotic diseases;
            (10) develop methods to reduce or destroy harmful pathogens 
        before, during, and after processing;
            (11) analyze the incidence of antibiotic resistence as it 
        pertains to the food supply and develop new methods to reduce 
        the transfer of antibiotic resistance to humans; and
            (12) conduct other research that supports the purposes of 
        this Act.
    (b) Contract Authority.--The Administrator may enter into contracts 
and agreements with any State, university, Federal Government agency, 
or person to carry out this section.

                         TITLE IV--ENFORCEMENT

SEC. 401. PROHIBITED ACTS.

    It is prohibited--
            (1) to manufacture, introduce, deliver for introduction, or 
        receive into interstate commerce any food that is adulterated, 
        misbranded, or otherwise unsafe;
            (2) to adulterate or misbrand any food in interstate 
        commerce;
            (3) for a food establishment or foreign food establishment 
        to fail to register under section 202, or to operate without a 
        valid registration;
            (4) to refuse to permit access to a food establishment or 
        food production facility for the inspection and copying of a 
        record as required under sections 205(f) and 206(a);
            (5) to fail to establish or maintain any record or to make 
        any report as required under sections 205(f) and 206(b);
            (6) to refuse to permit entry to or inspection of a food 
        establishment as required under section 205;
            (7) to fail to provide to the Administrator the results of 
        testing or sampling of food, equipment, or material in contact 
        with food, that is positive for any contaminant under section 
        205(f)(1)(B);
            (8) to fail to comply with a provision, regulation, or 
        order of the Administrator under section 202, 203, 204, 206, or 
        208;
            (9) to slaughter an animal that is capable for use in whole 
        or in part as human food at a food establishment processing any 
        food for commerce, except in compliance with the food safety 
        law;
            (10) to transfer food in violation of an administrative 
        detention order under section 402 or to remove or alter a 
        required mark or label identifying the food as detained;
            (11) to fail to comply with a recall or other order under 
        section 403; or
            (12) to otherwise violate the food safety law.

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

    (a) Administrative Detention of Food.--
            (1) Expanded authority.--The Administrator shall have 
        authority under section 304 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 334) to administratively detain and 
        seize any food regulated under this Act that the Administrator 
        has reason to believe is unsafe, is adulterated or misbranded, 
        or otherwise fails to meet the requirements of the food safety 
        law.
            (2) Detention authority.--If, during an inspection 
        conducted in accordance with section 205 or 208, an officer, 
        employee, or agent of the Administration making the inspection 
        has reason to believe that a domestic food, imported food, or 
        food offered for import is unsafe, is adulterated or 
        misbranded, or otherwise fails to meet the requirements of this 
        the food safety law, the officer, employee, or agent may order 
        the food detained.
            (3) Period of detention.--
                    (A) In general.--A food may be detained under 
                paragraph (1) or (2) for a reasonable period, not to 
                exceed 20 days, unless a longer period, not to exceed 
                30 days, is necessary for the Administrator to 
                institute a seizure action.
                    (B) Perishable food.--The Administrator shall 
                provide by regulation for procedures to institute a 
                seizure action on an expedited basis with respect to 
                perishable food.
            (4) Security of detained food.--
                    (A) In general.--A detention order under this 
                subsection--
                            (i) may require that the food be labeled or 
                        marked as detained; and
                            (ii) shall require that the food be removed 
                        to a secure facility, if appropriate.
                    (B) Food subject to an order.--A food subject to a 
                detention order under this subsection 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.
                    (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.
    (b) Appeal of Detention Order.--
            (1) In general.--A person who would be entitled to be a 
        claimant for a food subject to a detention order under 
        subsection (a) 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.
            (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.
            (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.
            (4) Termination.--A detention order under subsection (a) 
        shall be considered to be terminated if, after 5 days, the 
        Administrator has failed--
                    (A) to provide an opportunity for an informal 
                hearing; or
                    (B) to confirm, modify, or terminate the order.
            (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)) for a food subject to a 
        detention order under subsection (a), the process for the 
        appeal of the detention order with respect to such food shall 
        terminate.
    (c) Condemnation of Food.--
            (1) In general.--After confirming a detention order, the 
        Administrator may order the food condemned.
            (2) Destruction of food.--Any food condemned shall be 
        destroyed under the supervision of the Administrator.
            (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.
    (d) Temporary Holds at Ports of Entry.--
            (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.
            (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.
            (3) Prohibition on transfer.--During the period in which 
        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.
            (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.
            (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.

SEC. 403. NOTIFICATION AND RECALL.

    (a) Notice to Administrator of Violation.--
            (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.
            (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.
    (b) Recall and Consumer Notification.--
            (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--
                    (A) cease distribution of the food;
                    (B) notify all persons--
                            (i) processing, distributing, or otherwise 
                        handling the food to immediately cease such 
                        activities with respect to the food; or
                            (ii) to which the food has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of the food;
                    (C) recall the food;
                    (D) in conjunction with the Administrator, provide 
                notice of the finding of the Administrator--
                            (i) to consumers to whom the food was, or 
                        may have been, distributed; and
                            (ii) to State and local public health 
                        officials; or
                    (E) take any combination of the measures described 
                in this paragraph, as determined by the Administrator 
                to be appropriate in the circumstances.
            (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--
                    (A) have authority to control and possess the food, 
                including ordering the shipment of the food from the 
                food establishment to the Administrator--
                            (i) at the expense of the food 
                        establishment; or
                            (ii) in an emergency (as determined by the 
                        Administrator), at the expense of the 
                        Administration; and
                    (B) by order, require, as the Administrator 
                determines to be necessary, the person to immediately--
                            (i) cease distribution of the food; and
                            (ii) notify all persons--
                                    (I) processing, distributing, or 
                                otherwise handling the food to 
                                immediately cease such activities with 
                                respect to the food; or
                                    (II) if the food has been 
                                distributed, transported, or sold, to 
                                immediately cease distribution of the 
                                food.
            (3) Notification to consumers by administrator.--The 
        Administrator shall, as the Administrator determines to be 
        necessary--
                    (A) provide notice of the finding of the 
                Administrator under paragraph (1)--
                            (i) to consumers to whom the food was, or 
                        may have been, distributed; and
                            (ii) to State and local public health 
                        officials; and
                    (B) provide notice to the public of the names and 
                addresses of retail locations at which recalled food 
                products were available for sale.
            (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.
            (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--
                    (A) persons that processed, distributed, or 
                otherwise handled the food; and
                    (B) persons to which the food has been transported, 
                sold, distributed, or otherwise handled.
    (c) Informal Hearings on Orders.--
            (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.
            (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.
    (d) Post-Hearing Recall Orders.--
            (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--
                    (A) amend the order to require recall of the food 
                or other appropriate action;
                    (B) specify a timetable in which the recall shall 
                occur;
                    (C) require periodic reports to the Administrator 
                describing the progress of the recall; and
                    (D) provide notice of the recall to consumers to 
                whom the food was, or may have been, distributed.
            (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.
    (e) Remedies Not Exclusive.--The remedies provided in this section 
shall be in addition to, and not exclusive of, other remedies that may 
be available.

SEC. 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, 208, or 401 (or a regulation 
promulgated thereunder).
    (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.

SEC. 405. CIVIL AND CRIMINAL PENALTIES.

    (a) Civil Sanctions.--
            (1) Civil penalty.--
                    (A) In general.--Any person that commits an act 
                that violates the food safety law (including a 
                regulation promulgated or order issued under the food 
                safety law) may be assessed a civil penalty by the 
                Administrator of not more than $1,000,000 for each such 
                act.
                    (B) Separate offense.--Each act described in 
                subparagraph (A) and each day during which that act 
                continues shall be considered a separate offense.
            (2) Other requirements.--
                    (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.
                    (B) Amount of penalty.--Subject to paragraph 
                (1)(A), the amount of the civil penalty shall be 
                determined by the Administrator, after considering--
                            (i) the gravity of the violation;
                            (ii) the degree of culpability of the 
                        person;
                            (iii) the size and type of the business of 
                        the person; and
                            (iv) any history of prior offenses by the 
                        person under the food safety law.
                    (C) Review of order.--The order may be reviewed 
                only in accordance with subsection (c).
    (b) Criminal Sanctions.--
            (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, fined 
        in accordance with title 18, United States Code, or both.
            (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 5 years, fined in accordance with 
        title 18, United States Code, or both.
            (3) Exception.--No person shall be subject to the penalties 
        of this subsection--
                    (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)--
                            (i) the name, address, and contact 
                        information of the person from whom that person 
                        purchased or received the food;
                            (ii) copies of all documents relating to 
                        the person from whom that person purchased or 
                        received the food; and
                            (iii) copies of all documents pertaining to 
                        the delivery of the food to that person; or
                    (B) if that person establishes a guaranty or 
                undertaking signed by, and containing the name and 
                address of, the person from whom the food was received 
                in good faith, stating that the food is not adulterated 
                or misbranded under the food safety law.
    (c) Judicial Review.--
            (1) In general.--An order assessing a civil penalty against 
        a person under subsection (a) shall be a final order unless the 
        person--
                    (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; and
                    (B) simultaneously serves a copy of the petition by 
                certified mail to the Administrator.
            (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.
            (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.
    (d) Collection Actions for Failure To Pay.--
            (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.
            (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.
    (e) Penalties Paid Into Account.--The Administrator--
            (1) shall deposit penalties collected under this section in 
        an account in the Treasury; and
            (2) may use the funds in the account, without further 
        appropriation or fiscal year limitation--
                    (A) to carry out enforcement activities under the 
                food safety law; or
                    (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.
    (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.
    (g) Remedies Not Exclusive.--The remedies provided in this section 
are in addition to, and not exclusive of, other remedies that may be 
available.

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.

SEC. 407. WHISTLEBLOWER PROTECTION.

    (a) In General.--
            (1) Prohibition.--No Federal employee, employee of a 
        Federal contractor or subcontractor, or covered individual may 
        be discharged, demoted, suspended, threatened, harassed, or in 
        any other manner discriminated against, because of any lawful 
        act done by the employee or covered individual to--
                    (A) 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--
                            (i) a Federal regulatory or law enforcement 
                        agency;
                            (ii) a Member or committee of Congress; or
                            (iii) a person with supervisory authority 
                        over the covered individual (or such other 
                        individual who has the authority to 
                        investigate, discover, or terminate 
                        misconduct);
                    (B) 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; or
                    (C) refuse to violate or assist in the violation of 
                any law, rule, or regulation.
            (2) Definition.--For the purposes of this section, the term 
        ``covered individual'' means an individual who is an employee 
        of--
                    (A) a food establishment;
                    (B) a food production facility;
                    (C) a restaurant;
                    (D) a retail food establishment other than a 
                restaurant;
                    (E) a nonprofit food establishment in which food is 
                prepared for or served directly to the consumer;
                    (F) a fishing vessel; or
                    (G) an agent of any of the above.
    (b) Enforcement Action.--
            (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.
            (2) Procedure.--
                    (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.
                    (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.
                    (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.
                    (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.
    (c) Remedies.--
            (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.
            (2) Compensatory damages.--Relief for any action described 
        in paragraph (1) shall include--
                    (A) reinstatement with the same seniority status 
                that the covered individual would have had, but for the 
                discrimination;
                    (B) the amount of any backpay, with interest; and
                    (C) compensation for any special damages sustained 
                as a result of the discrimination, including litigation 
                costs, expert witness fees, and reasonable attorney's 
                fees.
    (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.

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.
    (b) Inquiries and Actions.--
            (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.
            (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.

SEC. 409. CITIZEN CIVIL ACTIONS.

    (a) Civil Actions.--A person may commence a civil action against--
            (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; 
        or
            (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.
    (b) Court.--In an action commenced under this section:
            (1) In general.--The action shall be commenced--
                    (A) in the case of a civil action against a person, 
                the United States district court for the district in 
                which the defendant resides, is found, or has an agent; 
                and
                    (B) in the case of a civil action against the 
                Administrator, any United States district court.
            (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.
            (3) Damages.--The court may--
                    (A) award damages, in the amount of damages 
                actually sustained; and
                    (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.
    (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.

                        TITLE V--IMPLEMENTATION

SEC. 501. REORGANIZATION PLAN.

    (a) Submission of Plan.--Not later than 180 days after the 
enactment of this Act, the President shall transmit to the appropriate 
congressional committees a reorganization plan regarding the following:
            (1) The transfer of agencies, personnel, assets, and 
        obligations to the Administration pursuant to this Act.
            (2) Any consolidation, reorganization, or streamlining of 
        agencies transferred to the Administration pursuant to this 
        Act.
    (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:
            (1) The timetable for transfer and identification of any 
        functions of agencies designated to be transferred to the 
        Administration pursuant to this Act that will not be 
        transferred promptly to the Administration under the plan.
            (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.
            (3) Specification of the funds available to each agency 
        that will be transferred to the Administration as a result of 
        transfers under the plan.
            (4) Specification of the proposed allocations within the 
        Administration of unexpended funds transferred in connection 
        with transfers under the plan.
            (5) Specification of any proposed disposition of property, 
        facilities, contracts, records, and other assets and 
        obligations of agencies transferred under the plan.
            (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.
    (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).
    (d) Effective Date.--
            (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--
                    (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); or
                    (B) the end of the 12-month period beginning on the 
                date of the enactment of this Act.
            (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.
            (3) Supersedes existing law.--Paragraph (1) shall apply 
        notwithstanding section 905(b) of title 5, United States Code.

SEC. 502. 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 date of the 
enactment 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.
    (b) Services and Personnel.--During the transition period, upon the 
request of the Administrator, the head of any executive agency may 
provide services or detail personnel to assist with the transition.
    (c) Acting Officials.--
            (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 date of the enactment 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.
            (2) Compensation.--While acting pursuant to paragraph (1), 
        such officers shall receive compensation at the higher of--
                    (A) the rates provided by this Act for the 
                respective offices in which they act; or
                    (B) the rates provided for the offices held at the 
                time of designation.
            (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.
    (d) Transfer of Personnel, Assets, Obligations, and Function.--
            (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.
            (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.

SEC. 503. SAVINGS PROVISIONS.

    (a) Completed Administrative Actions.--The enactment of this Act or 
the transfer of functions under this Act shall not affect any order, 
determination, rule, regulation, tolerance, guidance, permit, personnel 
action, agreement, grant, contract, certificate, license, registration, 
user fees, privilege, or other administrative action issued, made, 
granted, or otherwise in effect or final with respect to that agency on 
the day before the transfer date with respect to the transferred 
functions.
    (b) Pending Proceedings.--Subject to the authority of the 
Administrator under this Act--
            (1) pending proceedings in an agency, including notices of 
        proposed rulemaking, and applications for licenses, permits, 
        certificates, grants, and financial assistance, shall continue 
        notwithstanding the enactment of this Act or the transfer of 
        the agency to the Administration, unless discontinued or 
        modified under the same terms and conditions and to the same 
        extent that such discontinuance or modification could have 
        occurred if such enactment or transfer had not occurred; and
            (2) orders issued in such proceedings, and appeals 
        therefrom, and payments made pursuant to such orders, shall 
        issue in the same manner on the same terms as if this Act had 
        not been enacted or the agency had not been transferred, and 
        any such order shall continue in effect until amended, 
        modified, superseded, terminated, set aside, or revoked by an 
        officer of the United States or a court of competent 
        jurisdiction, or by operation of law.
    (c) Pending Civil Actions.--Subject to the authority of the 
Administrator under this Act, any civil action commenced with regard to 
that agency pending before that agency on the day before the transfer 
date with respect to the transferred functions shall continue 
notwithstanding the enactment of this Act or the transfer of an agency 
to the Administration.
    (d) References.--
            (1) In general.--After the transfer of functions from a 
        Federal agency under this Act, any reference in any other 
        Federal law, Executive order, rule, regulation, directive, 
        document, or other material to that Federal agency or the head 
        of that agency in connection with the administration or 
        enforcement of the food safety law shall be deemed to be a 
        reference to the Administration or the Administrator, 
        respectively.
            (2) Statutory reporting requirements.--Statutory reporting 
        requirements that applied in relation to such an agency 
        immediately before the date of the enactment of this Act shall 
        continue to apply following such transfer if they refer to the 
        agency by name.

SEC. 504. CONFORMING AMENDMENTS.

    (a) Executive Schedule.--Section 5313 of title 5, United States 
Code, is amended by inserting at the end the following new item: 
``Administrator of Food Safety.''.

SEC. 505. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.

    Not later than 60 days after the submission of the reorganization 
plan under section 501, the President shall prepare and submit proposed 
legislation to Congress containing necessary and appropriate technical 
and conforming amendments to the Acts listed in section 3(15) of this 
Act to reflect the changes made by this Act.

SEC. 506. REGULATIONS.

    The Administrator may promulgate such regulations as the 
Administrator determines are necessary or appropriate to perform the 
duties of the Administrator.

SEC. 507. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as are necessary 
to carry out this Act.

SEC. 508. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.

    For the fiscal year that includes the date of the enactment of this 
Act, the amount authorized to be appropriated to carry out this Act 
shall not exceed--
            (1) the amount appropriated for that fiscal year for the 
        Federal agencies identified in section 102(b) for the purpose 
        of administering or enforcing the food safety law; or
            (2) the amount appropriated for those agencies for that 
        purpose for the preceding fiscal year, if, as of the date of 
        the enactment of this Act, appropriations for those agencies 
        for the fiscal year that includes such date have not yet been 
        made.
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