[Congressional Record Volume 151, Number 38 (Wednesday, April 6, 2005)]
[Senate]
[Pages S3302-S3312]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN:
  S. 729. A bill to establish the Food Safety Administration to protect 
the public health by preventing food-borne illness, ensuring the safety 
of food, improving research on contaminants leading to food-borne 
illness, and improving security of food from intentional contamination, 
and for other purposes; to the Committee on Agriculture, Nutrition, and 
Forestry.
  Mr. DURBIN. Mr. President, a single food safety agency with authority 
to protect the food supply based on sound scientific principles would 
provide this country with the greatest hope of reducing foodborne 
illnesses and preventing or minimizing the harm from a bioterrorist 
attack on our food supply. Right now, our food is the safest in the 
world, but there are widening gaps in our food safety net due to 
emerging threats and the fact that food safety oversight has evolved 
over time to spread across several agencies. This mismatched, piecemeal 
approach to food safety could spell disaster if we do not act quickly 
and decisively.
  But don't take it from me. Former HHS Secretary Tommy Thompson told 
reporters in December as he resigned that he worries ``every single 
night'' about a massive attack on the U.S. food supply. ``I, for the 
life of me, cannot understand why the terrorists have not, you know, 
attacked our food supply, because it is so easy to do,'' Thompson said. 
``And we are importing a lot of food from the Middle East, and it would 
be easy to tamper with that,'' he said.
  No wonder he feels that way. Several Federal agencies, all with 
different and conflicting missions, work to ensure our food is safe. 
For example, there is no standardization for inspections--processed 
food facilities may see a Food and Drug Administration inspector once 
every 5 to 6 years, while meat and poultry operations are inspected 
daily by the U.S. Department of Agriculture.
  The Centers for Disease Control and Prevention (CDC) estimates that 
as many as 76 million people suffer from food poisoning each year. Of 
those individuals, approximately 325,000 will be hospitalized, and more 
than 5,000 will die. Factors such as emerging pathogens, an aging 
population at high risk for foodborne illnesses, an increasing volume 
of food imports, and people eating outside their homes more often 
underscore the need for us to take charge and shed the old bureaucratic 
shackles that have tied us to the overlapping and inefficient ad 
hoc food safety system of the past.

  That is why I come to the Senate floor today to introduce the Safe 
Food Act of 2005. My House counterpart, Representative Rosa DeLauro, is 
introducing the bill in the other body. This legislation would create a 
single, independent Federal food safety agency to administer all 
aspects of Federal food safety inspections, enforcement, standards-
setting and research in order to protect public health. The components 
of the agencies now charged with protecting the food supply, primarily 
housed at the Food and Drug Administration and the Agriculture 
Department, would be transferred to this new agency.
  The new Food Safety Administrator would be responsible for the safety 
of the food supply, and would fulfill that charge by implementing the 
registration and recordkeeping requirements of the 2002 bioterrorism 
law; ensuring slaughterhouses and food processing plants have 
procedures in place to prevent and reduce food contamination; regularly 
inspecting domestic food facilities, with inspection frequency based on 
risk; and centralizing the authority to detain, seize, condemn and 
recall food that is adulterated or misbranded. The Administrator would 
be charged with requiring food producers to code their products so 
those products could be traced in the event of a foodborne illness 
outbreak in order to minimize the health impact of such an event.
  The Administrator would also have the power examine the food safety 
practices of foreign countries and work with the states to impose 
various civil and criminal penalties for serious violations of the food 
safety laws. The Administrator would also actively oversee public 
education and research programs on foodborne illness.
  It is time to create a single food safety agency in this country. I 
am encouraged by a February 2005 Government Accountability Office 
report in which government officials in seven other high-income 
countries who have consolidated their food safety systems consistently 
state that the benefits of consolidation outweigh the costs.
  In this era of limited budgets, it is our responsibility to 
streamline the Federal food safety system. The United States simply 
cannot afford to continue operating multiple redundant systems. This is 
not about more regulation, a super agency, or increased bureaucracy. It 
is about common sense and the more effective marshaling of our existing 
resources.
  I urge my colleagues to join me in cosponsoring this legislation.
  I ask unanimous consent that the text of the bill be printed in the 
Record.

[[Page S3303]]

  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 729

       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 ``Safe Food 
     Act of 2005''.
       (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 FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services 
              and agencies.
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. Preventative 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.

                   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. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.
Sec. 510. Effective date.

     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;
       (3) the safety and security of the food supply requires an 
     integrated, system-wide approach to preventing food-borne 
     illness, a thorough and broad-based approach to basic and 
     applied research, and intensive, effective, and efficient 
     management of the Nation's food safety program;
       (4) 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) an aging and immune compromised population, with a 
     growing number of people at high-risk for food-borne 
     illnesses, including infants and children;
       (C) an increasing volume of imported food, without adequate 
     monitoring and inspection; and
       (D) maintenance of rigorous inspection of the domestic food 
     processing and food service industries;
       (5) Federal food safety standard setting, inspection, 
     enforcement, and research efforts should be based on the best 
     available science and public health considerations and food 
     safety resources should be systematically deployed in ways 
     that most effectively prevent food-borne illness;
       (6) the Federal food safety system is fragmented, with at 
     least 12 Federal agencies sharing responsibility for food 
     safety, and operates under laws that do not reflect current 
     conditions in the food system or current scientific knowledge 
     about the cause and prevention of food-borne illness;
       (7) the fragmented Federal food safety system and outdated 
     laws preclude an integrated, system-wide approach to 
     preventing food-borne illness, to the effective and efficient 
     operation of the Nation's food safety program, and to the 
     most beneficial deployment of food safety resources;
       (8) the National Academy of Sciences recommended in the 
     report ``Ensuring Safe Food from Production to Consumption'' 
     that Congress establish by statute a unified and central 
     framework for managing Federal food safety programs, and 
     recommended modifying Federal statutes so that inspection, 
     enforcement, and research efforts are based on scientifically 
     supportable assessments of risks to public health; and
       (9) the lack of a single focal point for food safety 
     leadership in the United States undercuts the ability of the 
     United States to exert food safety leadership 
     internationally, which is detrimental to the public health 
     and the international trade interests of the United States.
       (b) Purposes.--The purposes of this Act are--
       (1) to establish a single agency 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 produce food in a manner that protects the 
     public health of all people in the United States;
       (C) lead an integrated, system-wide approach to food safety 
     and to make more effective and efficient use of resources to 
     prevent food-borne illness;
       (D) provide a single focal point 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, to achieve the continuous improvement of 
     research on food-borne illness and contaminants;
       (2) to transfer to the Food Safety Administration the food 
     safety, labeling, inspection, and enforcement functions that, 
     as of the day before the effective date of this Act, are 
     performed by other Federal agencies; and
       (3) to modernize and strengthen the Federal food safety 
     laws to achieve more effective application and efficient 
     management of the laws for the protection and improvement of 
     public health.

     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)(3).
       (3) Adulterated.--
       (A) In general.--The term ``adulterated'' has the meaning 
     described in subsections (a) through (c) of section 402 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
       (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 that 
     slaughters animals for food.
       (6) Category 2 food establishment.--The term ``category 2 
     food establishment'' means a food establishment that 
     processes raw meat, poultry, seafood products, regardless of 
     whether the establishment also has a kill step, and animal 
     feed and other products that the Administrator determines by 
     regulation to be at high risk of contamination and the 
     processes of which do not include a step validated to destroy 
     contaminants.
       (7) Category 3 food establishment.--The term ``category 3 
     food establishment'' means a food establishment that 
     processes meat, poultry, seafood products, and other products 
     that the Administrator determines by regulation to be at high 
     risk of contamination and whose processes include a step 
     validated to destroy contaminants.
       (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 or manufactured toxin, virus, 
     parasite, prion, physical hazard, or other human pathogen 
     that when found on or in food can cause human illness, 
     injury, or death.
       (11) Contamination.--The term ``contamination'' refers to a 
     presence of a contaminant in food.
       (12) Food.--
       (A) In general.--The term ``food'' means a product intended 
     to be used for food or drink for a human or an animal.
       (B) Inclusions.--The term ``food'' includes any product 
     (including a meat food product, as defined in section 1(j) of 
     the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable 
     for use as human food that is made in whole or in part from 
     any animal, including cattle, sheep, swine, or goat, or 
     poultry (as defined in section 4 of the Poultry Products 
     Inspection Act (21 U.S.C. 453)), and animal feed.
       (C) Exclusion.--The term ``food'' does not include dietary 
     supplements, as defined in section 201(ff) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
       (13) Food establishment.--

[[Page S3304]]

       (A) In general.--The term ``food establishment'' means a 
     slaughterhouse, factory, warehouse, or facility owned or 
     operated by a person located in any State that processes food 
     or a facility that holds, stores, or transports food or food 
     ingredients.
       (B) Exclusions.--For the purposes of registration, the term 
     ``food establishment'' does not include a farm, restaurant, 
     other retail food establishment, nonprofit food establishment 
     in which food is prepared for or served directly to the 
     consumer, or fishing vessel (other than a fishing vessel 
     engaged in processing, as that term is defined in section 
     123.3 of title 21, Code of Federal Regulations).
       (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, 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 seq.) and of any other Act that are 
     administered by the Center for Veterinary Medicine of the 
     Food and Drug Administration;
       (C) the Poultry Products Inspection Act (21 U.S.C. 451 et 
     seq.);
       (D) the Federal Meat Inspection Act (21 U.S.C. 601 et 
     seq.);
       (E) the Egg Products Inspection Act (21 U.S.C. 1031 et 
     seq.);
       (F) the Sanitary Food Transportation Act of 1990 (49 U.S.C. 
     App. 2801 et seq.);
       (G) the provisions of the Humane Methods of Slaughter Act 
     of 1978 (Public Law 95-448) administered by the Food Safety 
     and Inspection Service;
       (H) the provisions of this Act; and
       (I) such other provisions of law related to and requiring 
     food safety, labeling, inspection, and enforcement as the 
     President designates by Executive order as appropriate to 
     include within the jurisdiction of the Administration.
       (16) Foreign food establishment.--The term ``foreign food 
     establishment'' means a slaughterhouse, factory, warehouse, 
     or facility located outside the United States that processes 
     food for consumption that is imported into the United States 
     or food ingredients.
       (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 harvesting, slaughter, packing, preparation, 
     or manufacture of food.
       (20) Safe.--The term ``safe'' refers to human and animal 
     health.
       (21) 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.
       (22) Validation.--The term ``validation'' means the 
     obtaining of evidence that the food hygiene control measure 
     or measures selected to control a hazard in food is capable 
     of effectively and consistently controlling the hazard.
       (23) Statistically valid.--With respect to a study, the 
     term ``statistically valid'' means evaluated and conducted 
     under standards set by the National Institute of Standards 
     and Technology.

          TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

     SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.

       (a) Establishment.--
       (1) In general.--There is established in the executive 
     branch an agency to be known as the ``Food Safety 
     Administration''.
       (2) Status.--The Administration shall be an independent 
     establishment (as defined in section 104 of title 5, United 
     States Code).
       (3) Head of administration.--The Administration shall be 
     headed by the Administrator of Food Safety, who shall be 
     appointed by the President, by and with the advice and 
     consent of the Senate.
       (b) Duties of Administrator.--The Administrator shall--
       (1) administer and enforce the food safety law;
       (2) serve as a representative to international food safety 
     bodies and discussions;
       (3) promulgate regulations to ensure the security of the 
     food supply from all forms of contamination, including 
     intentional contamination; and
       (4) oversee--
       (A) implementation of Federal food safety inspection, 
     enforcement, and research efforts, to protect the public 
     health;
       (B) development of consistent and science-based standards 
     for safe food;
       (C) coordination and prioritization of food safety research 
     and education programs with other Federal agencies;
       (D) prioritization of Federal food safety efforts and 
     deployment of Federal food safety resources to achieve the 
     greatest possible benefit in reducing food-borne illness;
       (E) coordination of the Federal response to food-borne 
     illness outbreaks with other Federal and State agencies; and
       (F) integration of Federal food safety activities with 
     State and local agencies.

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

       (a) Transfer of Functions.--For each Federal agency 
     specified in subsection (b), there are transferred to the 
     Administration all functions that the head of the Federal 
     agency exercised on the day before the effective date of this 
     Act (including all related functions of any officer or 
     employee of the Federal agency) that relate to administration 
     or enforcement of the food safety law, as determined by the 
     President.
       (b) Transferred Agencies.--The Federal agencies referred to 
     in subsection (a) are--
       (1) the Food Safety and Inspection Service of the 
     Department of Agriculture;
       (2) the Center for Food Safety and Applied Nutrition of the 
     Food and Drug Administration;
       (3) the part of the Agriculture Marketing Service that 
     administers shell egg surveillance services established under 
     the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
       (4) the resources and facilities of the Office of 
     Regulatory Affairs of the Food and Drug Administration that 
     administer and conduct inspections of food establishments and 
     imports;
       (5) the resources and facilities of the Office of the 
     Commissioner of the Food and Drug Administration that 
     support--
       (A) the Center for Food Safety and Applied Nutrition;
       (B) the Center for Veterinary Medicine; and
       (C) the Office of Regulatory Affairs facilities and 
     resources described in paragraph (4);
       (6) the Center for Veterinary Medicine of the Food and Drug 
     Administration;
       (7) the resources and facilities of the Environmental 
     Protection Agency that control and regulate pesticide 
     residues in food;
       (8) the part of the Research, Education, and Economics 
     mission area of the Department of Agriculture related to food 
     safety and animal feed research;
       (9) the part of the National Marine Fisheries Service of 
     the National Oceanic and Atmospheric Administration of the 
     Department of Commerce that administers the seafood 
     inspection program;
       (10) the Animal and Plant Inspection Health Service of the 
     Department of Agriculture; and
       (11) such other offices, services, or agencies as the 
     President designates by Executive order to carry out this 
     Act.

     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) administer a national food safety program (referred to 
     in this section as the ``program'') to protect public health; 
     and
       (2) ensure that persons who produce or process 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 and specific points of potential 
     contamination extending from the farm or ranch to the 
     consumer that may render food unsafe;

[[Page S3305]]

       (3) the potential for persistence, multiplication, or 
     concentration of naturally occurring or added contaminants in 
     food;
       (4) opportunities across the food production, processing, 
     distribution, and retail system to reduce potential health 
     risks; and
       (5) opportunities for intentional contamination.
       (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 and regular unannounced inspection of food 
     establishments;
       (2) enforce the adoption of process controls in food 
     establishments, based on best available scientific and public 
     health considerations and best available technologies;
       (3) establish and enforce science-based standards for--
       (A) substances that may contaminate food; and
       (B) safety and sanitation in the processing and handling of 
     food;
       (4) implement a statistically valid sampling program to 
     ensure that industry programs and procedures that prevent 
     food contamination are effective on an ongoing basis and that 
     food meets the standards established under this Act;
       (5) implement procedures and requirements to ensure the 
     safety and security of imported food;
       (6) coordinate with other agencies and State or local 
     governments in carrying out inspection, enforcement, 
     research, and monitoring;
       (7) have access to the surveillance data of the Centers for 
     Disease Control and Prevention, and other Federal Government 
     agencies, in order to implement a national surveillance 
     system to assess the health risks associated with the human 
     consumption of food or to create surveillance data and 
     studies;
       (8) develop public education risk communication and 
     advisory programs;
       (9) implement a basic and applied research program to 
     further the purposes of this Act; and
       (10) coordinate and prioritize food safety research and 
     educational programs with other agencies, including State or 
     local agencies.

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

       (a) In General.--The Administrator shall by regulation 
     require that any food establishment or foreign food 
     establishment engaged in processing food in the United States 
     be registered with the Administrator.
       (b) Registration Requirements.--
       (1) In general.--To be registered under subsection (a)--
       (A) in the case of a food establishment, the owner, 
     operator, or agent in charge of the food establishment shall 
     submit a registration to the Administrator; and
       (B) in the case of a foreign food establishment, the owner, 
     operator, or agent in charge of the foreign food 
     establishment shall--
       (i) submit a registration to the Administrator; and
       (ii) provide the name, address, and emergency contact 
     information of the United States agent for the foreign food 
     establishment.
       (2) Registration.--A food establishment or foreign food 
     establishment shall submit a registration under paragraph (1) 
     to the Administrator that--
       (A) identifies the name, address, and emergency contact 
     information of each food establishment or foreign food 
     establishment that the registrant operates under this Act and 
     all trade names under which the registrant conducts business 
     relating to food;
       (B) lists the primary purpose and business activity of each 
     food establishment or foreign food establishment, including 
     the dates of operation if the food establishment or foreign 
     food establishment is seasonal;
       (C) lists the types of food processed or sold at each food 
     establishment or, for foreign food establishments selling 
     food for consumption in the United States, identifies the 
     specific food categories of that food as listed under section 
     170.3 of title 21, Code of Federal Regulations; and
       (D) not later than 30 days after a change in the products, 
     function, or legal status of the food establishment or 
     foreign food establishment (including cessation of business 
     activities), notifies the Administrator of the change.
       (3) Procedure.--Upon receipt of a completed registration 
     described in paragraph (1), the Administrator shall notify 
     the registrant of the receipt of the registration, designate 
     each establishment as a category 1, 2, 3, 4, or 5 food 
     establishment, and assign a registration number to each food 
     establishment and foreign food establishment.
       (4) List.--The Administrator shall compile and maintain an 
     up-to-date list of food establishments and foreign food 
     establishments that are registered under this section. The 
     Administrator may establish regulations by which such list 
     may be shared with other governmental authorities.
       (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 registered person.
       (6) Suspension of registration.--
       (A) In general.--The Administrator may suspend the 
     registration of a food establishment or foreign food 
     establishment, including the facility of an importer, for 
     violation of a food safety law.
       (B) Notice and opportunity for hearing.--The Administrator 
     shall provide notice to a registrant immediately upon the 
     suspension of the registration of the facility and provide 
     registrant with an opportunity for a hearing within 3 days of 
     the suspension.
       (7) Reinstatement.--A registration that is suspended under 
     this section may be reinstated pursuant to criteria published 
     in the Federal Register by the Administrator.

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

       (a) In General.--The Administrator shall, upon the basis of 
     best available public health, scientific, and technological 
     data, promulgate regulations to ensure that food 
     establishments carry out their responsibilities to--
       (1) process food in a sanitary manner so that it is free of 
     dirt and filth;
       (2) limit the presence of potentially harmful contaminants 
     in food;
       (3) implement appropriate measures of preventative process 
     control to minimize and reduce the presence and growth of 
     contaminants in food and meet the performance standards 
     established under section 204;
       (4) process all fully processed or ready-to-eat food in a 
     sanitary manner, using reasonably available techniques and 
     technologies to eliminate any potentially harmful 
     contaminants; and
       (5) label food intended for final processing outside 
     commercial food establishments with instructions for handling 
     and preparation for consumption that will destroy 
     contaminants.
       (b) Regulations.--Not later than 1 year after the effective 
     date of this Act, the Administrator shall promulgate 
     regulations that--
       (1) require all food establishments to adopt preventative 
     process controls that are--
       (A) adequate to protect the public health;
       (B) meet relevant regulatory and food safety standards; and
       (C) limit the presence and growth of contaminants in food 
     prepared in a food establishment;
       (2) set standards for sanitation;
       (3) meet any performance standards for contaminants 
     established under section 204;
       (4) require recordkeeping to monitor compliance;
       (5) require sampling and testing at a frequency and in a 
     manner sufficient to ensure that process controls are 
     effective on an ongoing basis and that regulatory standards 
     are being met; and
       (6) provide for agency access to records kept by food 
     establishments and submission of copies of the records to the 
     Administrator, as the Administrator determines appropriate.
       (c) Processing Controls.--The Administrator may require any 
     person with responsibility for or control over food or food 
     ingredients to adopt process controls, if the process 
     controls are needed to ensure the protection of the public 
     health.

     SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

       (a) In General.--To protect the public health, the 
     Administrator shall establish by regulation and enforce 
     performance standards that define, with respect to specific 
     food-borne contaminants and foods, the level of food safety 
     performance that a person responsible for producing, 
     processing, or selling food shall meet.
       (b) Identification of Contaminants; Performance 
     Standards.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act, the Administrator shall identify the 
     food-borne contaminants and food that contribute 
     significantly to the risk of food-borne illness.
       (2) Performance standards.--As soon as practicable after 
     the identification of the contaminants under paragraph (1), 
     the Administrator shall establish appropriate performance 
     standards to protect against all food-borne contaminants.
       (3) Significant contaminants.--The Administrator shall 
     establish performance standards for the 5 contaminants that 
     contribute to the greatest number of illnesses or deaths 
     associated with raw meat, poultry, and seafood not later than 
     3 years after the date of enactment of this Act. The 
     Administrator shall revise such standards not less often than 
     every 3 years.
       (c) Performance Standards.--
       (1) In general.--The performance standards established 
     under this section shall 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 zero tolerances for fecal 
     matter, in addition to any zero-tolerance standards in effect 
     on the day before the date of enactment of this Act, when 
     necessary to protect against significant adverse health 
     outcomes;
       (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 in terms of ``best 
     reasonably achievable performance'', using best

[[Page S3306]]

     available technologies, interventions, and practices.
       (2) Best reasonably achievable performance standards.--In 
     developing best reasonably achievable performance standards, 
     the Administrator shall collect, or contract for the 
     collection of, data on current best practices and food safety 
     outcomes related to the contaminants and foods in question, 
     as the Administrator determines necessary.
       (3) Revocation by administrator.--All performance 
     standards, tolerances, action levels, or other similar 
     standards in effect on the date of enactment of this Act 
     shall remain in effect until revised or revoked by the 
     Administrator.
       (d) Enforcement.--
       (1) In general.--Not later than 1 year after the 
     promulgation of a performance standard under this section, 
     the Administrator shall implement a statistically significant 
     sampling program to determine whether food establishments are 
     complying with the performance standards promulgated under 
     this section. The program established under this paragraph 
     shall be at least as stringent as the Hazard Analysis and 
     Critical Control Point System requirements established under 
     part 417 of title 9, Code of Federal Regulations (or 
     successor regulation).
       (2) Inspections.--If the Administrator determines that a 
     food establishment fails to meet a standard promulgated under 
     this section, and such establishment fails to take 
     appropriate corrective action as determined by the 
     Administrator, the Administrator shall, as appropriate--
       (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 
     promulgate 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 sampling and testing 
     of food and food establishments, to determine if each food 
     establishment--
       (1) is operating in a sanitary manner;
       (2) has continuous systems, interventions, and processes in 
     place to minimize or eliminate contaminants in food;
       (3) is in compliance with applicable performance standards 
     established under section 203, and other regulatory 
     requirements;
       (4) is processing food that is safe and 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 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 
     destroyed or reprocessed them in a manner acceptable to the 
     Administrator; and
       (C) that 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 be randomly inspected at least daily.
       (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 be randomly inspected at least quarterly.
       (5) Category 5 food establishments.--A category 5 food 
     establishment shall be randomly inspected at least annually.
       (c) Establishment of Inspection Procedures.--The 
     Administrator shall establish procedures under which 
     inspectors or safety officers shall take random samples, 
     photographs, and copies of records in food establishments.
       (d) Alternative Inspection Frequencies.--With respect to a 
     category 2, 3, 4, or 5 food establishment, the Administrator 
     may establish alternative increasing or decreasing inspection 
     frequencies for subcategories of food establishments or 
     individual establishments, to foster risk-based allocation of 
     resources, subject to the following criteria and procedures:
       (1) Subcategories of food establishments and their 
     alternative inspection frequencies shall be defined by 
     regulation, subject to paragraphs (2) and (3).
       (2) Regulations of alternative inspection frequencies for 
     subcategories of food establishments under paragraph (1) and 
     for a specific food establishment under paragraph (4) shall 
     provide that--
       (A) category 2 food establishments shall be inspected at 
     least monthly; and
       (B) category 3, 4, and 5 food establishments shall be 
     inspected at least annually.
       (3) 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 produced in the proposed 
     subcategory of establishments; and
       (E) the overall record of compliance with the food safety 
     law among establishments in the proposed subcategory, 
     including compliance with applicable performance standards 
     and the frequency of recalls.
       (4) The Administrator may adopt alternative inspection 
     frequencies for increased or decreased inspection for a 
     specific establishment, subject to paragraphs (2) and (5) and 
     shall periodically publish a list of establishments subject 
     to alternative inspections.
       (5) In adopting alternative inspection frequencies for a 
     specific establishment, the Administrator shall consider--
       (A) the criteria in paragraph (3);
       (B) whether products from the specific establishment have 
     been associated with a case or an outbreak of food-borne 
     illness; and
       (C) the record of the establishment of compliance with the 
     food safety law, including compliance with applicable 
     performance standards and the frequency of recalls.
       (6) Before establishing decreased alternative inspection 
     frequencies for subcategories of establishments or individual 
     establishments, the Administrator shall--
       (A) determine, based on the best available evidence, that 
     the alternative uses of the resources required to carry out 
     the inspection activity would make a greater contribution to 
     protecting the public health and reducing the risk of food-
     borne illness than the use of resources described in 
     subsection (b);
       (B) describe the alternative uses of resources in general 
     terms when issuing the regulation or order that establishes 
     the alternative inspection frequency;
       (C) consider the supporting evidence that an individual 
     food establishment shall submit related to whether an 
     alternative inspection frequency should be established for 
     such establishment by the Administrator; and
       (D) include a description of the alternative uses in the 
     annual resource plan required in section 209.
       (e) Inspection Transition.--The Administrator shall manage 
     the transition to the inspection system described in this Act 
     as follows:
       (1) In the case of a category 1 or 2 food establishment, 
     the Administrator shall continue to implement the applicable 
     inspection mandates of the Federal Meat Inspection Act (21 
     U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 
     U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.) until--
       (A) regulations required to implement this section have 
     been promulgated;
       (B) the performance standards required by section 204(c) 
     have been promulgated and implemented for 1 year; and
       (C) the establishment has achieved compliance with the 
     other applicable provisions of the food safety law.
       (2) In the case of a category 1 or 2 food establishment 
     that, within 2 years after the promulgation of the 
     performance standards required by section 204(c), has not 
     achieved compliance with the food safety law, the 
     Administrator shall--
       (A) issue an order prohibiting the establishment from 
     operating pending a demonstration by the establishment that 
     sufficient changes in facilities, procedures, personnel, or 
     other aspects of the process control system have been made 
     such that the Administrator determines that compliance with 
     the food safety law is achieved; and
       (B) following the demonstration required in subparagraph 
     (A), issue an order authorizing the food establishment to 
     operate subject, at a minimum, to--
       (i) the inspection requirement applicable to the 
     establishment under subsection (b) (1) or (2); and
       (ii) such other inspection or compliance measures 
     determined by the Administrator necessary to assure 
     compliance with the applicable food safety law.
       (3) In the case of a category 3 food establishment, the 
     Administrator shall continue to implement the applicable 
     inspection mandates of the Federal Meat Inspection Act (21 
     U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 
     U.S.C. 451 et seq.), and the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.) until--
       (A) the regulations required to implement this section have 
     been promulgated;
       (B) the first resource plan under section 209 has been 
     submitted; and

[[Page S3307]]

       (C) for individual establishments, compliance with the food 
     safety law has been demonstrated.
       (4) In the case of a category 3 food establishment that, 
     within 1 year after the promulgation of the regulations 
     required to implement this section, have not demonstrated 
     compliance with the food safety law, the Administrator 
     shall--
       (A) issue an order prohibiting the establishment from 
     operating, pending a demonstration by the establishment that 
     sufficient changes in facilities, procedures, personnel, or 
     other aspects of the process control system have been made 
     such that the Administrator determines that compliance with 
     the food safety law is achieved; and
       (B) following the demonstration required in subparagraph 
     (A), issue an order authorizing the establishment to operate 
     subject, at a minimum, to--
       (i) the inspection requirement applicable to the 
     establishment under subsection (b)(3); and
       (ii) such other inspection or compliance measures 
     determined by the Administrator necessary to assure 
     compliance with the food safety law.
       (5) In the case of a category 4 or 5 food establishment, 
     the inspection requirements of this Act shall be implemented 
     as soon as possible after--
       (A) the promulgation of the regulations required to 
     implement this section;
       (B) the publication of the first resource plan under 
     section 209; and
       (C) the commencement of the first fiscal year in which the 
     Administration is operating with budgetary resources that 
     Congress has appropriated following consideration of the 
     resource plan under section 209.
       (f) Official Mark.--
       (1) In general.--
       (A) Establishment.--Before the completion of the transition 
     process under paragraphs (1) through (3) of subsection (e), 
     the Administrator shall by regulation establish an official 
     mark that shall be affixed to a food product produced in a 
     category 1, 2, or 3 establishment, subject to subparagraph 
     (B).
       (B) Prerequisite.--The official mark required under 
     subparagraph (A) shall be affixed to a food product by the 
     Administrator if the establishment has been inspected by the 
     Administrator in accordance with the inspection frequencies 
     under this section and the establishment is in compliance 
     with the food safety law.
       (C) Removal of official mark.--The Administrator shall 
     promulgate regulations that provide for the removal of the 
     official mark under this subsection if the Administrator 
     makes a finding that the establishment is not in compliance 
     with the food safety law.
       (2) Category 1, 2, or 3 food establishments.--In the case 
     of products produced in a category 1, 2, or 3 food 
     establishment--
       (A) products subject to Federal Meat Inspection Act (21 
     U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 
     U.S.C. 451 et seq.), the Egg Products Inspection Act (21 
     U.S.C. 1031 et seq.), and the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of 
     enactment of this Act shall remain subject to the requirement 
     under those Acts that they bear the mark of inspection 
     pending completion of the transition process under paragraphs 
     (1) through (3) of subsection (e);
       (B) the Administrator shall publicly certify on a monthly 
     basis that the inspection frequencies required under this Act 
     have been achieved; and
       (C) a product from an establishment that has not been 
     inspected in accordance with the required frequencies under 
     this section shall not bear the official mark and shall not 
     be shipped in interstate commerce.
       (3) Category 4 and 5 food establishments.--In the case of a 
     product produced in a category 4 or 5 food establishment the 
     Administrator shall provide by regulation for the voluntary 
     use of the official mark established under paragraph (1), 
     subject to--
       (A) such minimum inspection frequencies as determined 
     appropriate by the Administrator;
       (B) compliance with applicable performance standards and 
     other provisions of the food safety law; and
       (C) such other requirements the Administrator considers 
     appropriate.
       (g) Implementation.--Not later than 1 year after the 
     effective date of this Act, the Administrator shall issue 
     regulations to implement subsections (b) through (e).
       (h) 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 
     of the food safety agencies in effect on the day before the 
     date of enactment of this Act, upon presentation of 
     appropriate credentials and at reasonable times and in a 
     reasonable manner, to have access to and copy all records 
     maintained by or on behalf of such food establishment 
     representative in any format (including paper or electronic) 
     and at any location, that are necessary to assist the 
     Administrator--

       (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 
     unsafe, is adulterated or misbranded, or otherwise fails to 
     meet the requirements of this Act.
       (i) Protection of Sensitive Information.--
       (1) In general.--The Administrator shall develop and 
     maintain procedures to prevent the unauthorized disclosure of 
     any trade secret or confidential information obtained by the 
     Administrator.
       (2) Limitation.--The requirement under this subsection does 
     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, personnel data, or sales data (other than shipment 
     dates relating to sales);
       (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.
       (j) Bribery of or Gifts to Inspector or Other Officers and 
     Acceptance of Gifts.--Section 22 of the Federal Meat 
     Inspection Act (21 U.S.C. 622) shall apply under this Act.

     SEC. 206. FOOD PRODUCTION FACILITIES.

       In carrying out the duties of the Administrator and the 
     purposes of this Act, the Administrator shall have the 
     authority, with respect to food production facilities, to--
       (1) visit and inspect food production facilities in the 
     United States and in foreign countries to investigate 
     bioterrorism threats and for other critical food safety 
     purposes;
       (2) review food safety records as required to be kept by 
     the Administrator to carry out traceback and for other 
     critical 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.

     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 is safe; 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 personnel and services 
     of those agencies in carrying out this Act.
       (2) Training.--Agreements with a State under this 
     subsection may 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 enactment of this Act until the Administrator 
     evaluates such agreement and determines whether to maintain 
     or substitute such agreement.
       (e) Audits.--
       (1) In general.--The Administrator shall annually conduct a 
     comprehensive review of each State program that provides 
     services to

[[Page S3308]]

     the Administrator in carrying out the 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 food safety 
     laws and standards that are at least as stringent as those 
     under this Act.

     SEC. 208. IMPORTS.

       (a) In General.--Not later than 2 years after the effective 
     date of this Act, the Administrator shall establish a system 
     under which a foreign government or foreign food 
     establishment seeking to import food to the United States 
     shall submit a request for certification to the 
     Administrator.
       (b) Certification Standard.--A foreign government or 
     foreign food establishment requesting a certification to 
     import food to the United States shall demonstrate, in a 
     manner determined appropriate by the Administrator, that food 
     produced under the supervision of a foreign government or by 
     the foreign food establishment has met standards for food 
     safety, inspection, labeling, and consumer protection that 
     are at least equivalent to standards applicable to food 
     produced in the United States.
       (c) Certification Approval.--
       (1) Request by foreign government.--Prior to granting the 
     certification request of a foreign government, the 
     Administrator shall review, audit, and certify the food 
     safety program of a requesting foreign government (including 
     all statutes, regulations, and inspection authority) as at 
     least equivalent to the food safety program in the United 
     States, as demonstrated by the foreign government.
       (2) Request by foreign food establishment.--Prior to 
     granting the certification request of a foreign food 
     establishment, the Administrator shall certify, based on an 
     onsite inspection, the food safety programs and procedures of 
     a requesting foreign firm as at least equivalent to the food 
     safety programs and procedures of the United States.
       (d) Limitation.--A foreign government or foreign firm 
     approved by the Administrator to import food to the United 
     States under this section shall be certified to export only 
     the approved food products to the United States for a period 
     not to exceed 5 years.
       (e) Withdrawal of Certification.--The Administrator may 
     withdraw certification of any food from a foreign government 
     or foreign firm--
       (1) if such food is linked to an outbreak of human illness;
       (2) following an investigation by the Administrator that 
     finds that the foreign government programs and procedures or 
     foreign food establishment is no longer equivalent to the 
     food safety programs and procedures in the United States; or
       (3) following a refusal to allow United States officials to 
     conduct such audits and investigations as may be necessary to 
     fulfill the requirements under this section.
       (f) Renewal of Certification.--The Administrator shall 
     audit foreign governments and foreign food establishments at 
     least every 5 years to ensure the continued compliance with 
     the standards set forth in this section.
       (g) Required Routine Inspection.--The Administrator shall 
     routinely inspect food and food animals (via a physical 
     examination) before it enters the United States to ensure 
     that it is--
       (1) safe;
       (2) labeled as required for food produced in the United 
     States; and
       (3) otherwise meets requirements under the food safety law.
       (h) Enforcement.--The Administrator is authorized to--
       (1) deny importation of food from any foreign government 
     that does not permit United States officials to enter the 
     foreign country to conduct such audits and inspections as may 
     be necessary to fulfill the requirements under this section;
       (2) deny importation of food from any foreign government or 
     foreign firm that does not consent to an investigation by the 
     Administration when food from that foreign country or foreign 
     firm is linked to a food-borne illness outbreak or is 
     otherwise found to be adulterated or mislabeled; and
       (3) promulgate rules and regulations to carry out the 
     purposes of this section, including setting terms and 
     conditions for the destruction of products that fail to meet 
     the standards of this Act.
       (i) Detention and Seizure.--Any food imported for 
     consumption in the United States may be detained, seized, or 
     condemned pursuant to section 402.

     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 
     the national food safety program;
       (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--
       (A) in foreign establishments;
       (B) at the point of importation; and
       (C) at the point of production on farms, ranches, and 
     feedlots.
       (c) Grants.--The resource plan shall include 
     recommendations for funding to provide grants to States and 
     local governments to carry out food safety activities in 
     retail and food service facilities and the required 
     inspections in food establishments.
       (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.

       (a) In General.--The Administrator, in order to protect the 
     public health, shall establish requirements for a national 
     system for tracing food and food producing animals from point 
     of origin to retail sale, subject to subsection (b).
       (b) Applicability.--Traceability requirements shall--
       (1) be established in accordance with regulations and 
     guidelines issued by the Administrator; and
       (2) apply to food production facilities and food 
     establishments.
       (c) Relationship to Country of Origin Labeling.--Nothing 
     contained in this section prevents or interferes with 
     implementation of the country of origin labeling requirements 
     of subtitle D of the Agricultural Marketing Act of 1946 (7 
     U.S.C. 1638 et seq.).

                   TITLE III--RESEARCH AND EDUCATION

     SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.

       (a) In General.--The Administrator, acting in coordination 
     with the Director of the Centers for Disease Control and 
     Prevention and with the Research Education and Economics 
     mission area of the Department of Agriculture, shall--
       (1) have access to the applicable data systems of the 
     Centers for Disease Control and Prevention and to the 
     databases made available by a State;
       (2) maintain an active surveillance system of food, food 
     products, and epidemiological evidence submitted by States to 
     the Centers for Disease Control and Prevention based on a 
     representative proportion of the population of the United 
     States;
       (3) assess the frequency and sources of human illness in 
     the United States associated with the consumption of food;
       (4) maintain a state-of-the-art DNA matching system and 
     epidemiological system dedicated to food-borne illness 
     identification, outbreaks, and containment; and
       (5) have access to the surveillance data created via 
     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 effective 
     date of this Act, the Administrator shall establish 
     guidelines for a sampling system under which the 
     Administrator shall take and analyze samples of food--
       (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 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;
       (B) identify appropriate industry and regulatory approaches 
     to minimize hazards in the food supply; and
       (C) assess the public health environment for emerging 
     diseases, including zoonosis, for their risk of appearance in 
     the United States food supply.
       (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

[[Page S3309]]

       (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, 
     understanding, and acceptance 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 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 foods 
     found to pose a threat to the public health.

     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 for 
     the inspection and copying of a record as required under 
     section 205(h);
       (5) to fail to establish or maintain any record or to make 
     any report as required under section 205(h);
       (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 
     a testing or sampling of a food, equipment, or material in 
     contact with contaminated food under section 205(i);
       (8) to fail to comply with a provision, regulation, or 
     order of the Administrator under section 202, 203, 204, 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 such 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 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 Act, the officer or employee may order 
     the food detained.
       (3) Period of detention.--
       (A) In general.--A food may be detained for a reasonable 
     period, not to exceed 20 days, unless a longer period, not to 
     exceed 30 days, is necessary for the Administrator to 
     institute a seizure action.
       (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--
       (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 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 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.--The order 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)), the process 
     for the appeal of the detention order 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 
     the food is held, the food shall not be transferred by any 
     person from the port of entry into the United States, or from 
     the secure facility to which the food has been removed.
       (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

[[Page S3310]]

     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, provide notice of the finding of the Administrator 
     under paragraph (1)--
       (A) to consumers to whom the food was, or may have been, 
     distributed; and
       (B) to State and local public health officials.
       (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, 207, or 401 (or a regulation promulgated under that 
     section).
       (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 a Federal food safety law) 
     may be assessed a civil penalty by the Administrator of not 
     more than $10,000 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 or 
     fined not more than $10,000, 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 3 years or fined not more than 
     $100,000, 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 signed by, and 
     containing the name and address of, the person from whom that 
     person received in good faith the food, stating that the food 
     is not adulterated or misbranded within the meaning of this 
     Act.
       (c) Judicial Review.--
       (1) In general.--An order assessing a civil penalty 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

[[Page S3311]]

     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 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 may be 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.--No Federal employee, employee of a Federal 
     contractor or subcontractor, or any individual employed by a 
     company (referred to in this section as a ``covered 
     individual''), may be discharged, demoted, suspended, 
     threatened, harassed, or in any other manner discriminated 
     against, because of any lawful act done by the covered 
     individual to--
       (1) provide information, cause information to be provided, 
     or otherwise assist in an investigation regarding any conduct 
     that the covered individual reasonably believes constitutes a 
     violation of any law, rule, or regulation, or that the 
     covered individual reasonably believes constitutes a threat 
     to the public health, when the information or assistance is 
     provided to, or the investigation is conducted by--
       (A) a Federal regulatory or law enforcement agency;
       (B) a Member or committee of Congress; or
       (C) a person with supervisory authority over the covered 
     individual (or such other individual who has the authority to 
     investigate, discover, or terminate misconduct);
       (2) file, cause to be filed, testify, participate in, or 
     otherwise assist in a proceeding or action filed or about to 
     be filed relating to a violation of any law, rule, or 
     regulation; or
       (3) refused to violate or assist in the violation of any 
     law, rule, or regulation.
       (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 back pay, 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.--
       (1) In general.--The action shall be commenced in the 
     United States district court for the district in which the 
     defendant resides, is found, or has an agent.
       (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. DEFINITION.

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

     SEC. 502. REORGANIZATION PLAN.

       (a) Submission of Plan.--Not later than 180 days after the 
     effective date of this Act, the President shall transmit to 
     the appropriate congressional committees a reorganization 
     plan regarding the following:
       (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) Identification of any functions of agencies designated 
     to be transferred to the Administration pursuant to this Act 
     that will not be transferred to the Administration under the 
     plan.
       (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

[[Page S3312]]

     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 transition period.
       (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) Supercedes existing law.--Paragraph (1) shall apply 
     notwithstanding section 905(b) of title 5, United States 
     Code.

     SEC. 503. TRANSITIONAL AUTHORITIES.

       (a) Provision of Assistance by Officials.--Until the 
     transfer of an agency to the Administration, any official 
     having authority over or function relating to the agency 
     immediately before the effective date of this Act shall 
     provide the Administrator such assistance, including the use 
     of personnel and assets, as the Administrator may request in 
     preparing for the transfer and integration of the agency to 
     the Administration.
       (b) Services and Personnel.--During the transition period, 
     upon the request of the Administrator, the head of any 
     executive agency may, on a reimbursable basis, provide 
     services or detail personnel to assist with the transition.
       (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 effective date of this Act (and who continues to 
     be in office) or immediately before such designation, to act 
     in such office until the same is filled as provided in this 
     Act.
       (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. 504. 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, 
     permit, personnel action, agreement, grant, contract, 
     certificate, license, registration, 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 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, superceded, 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 laws 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 effective date of this Act shall 
     continue to apply following such transfer if they refer to 
     the agency by name.

     SEC. 505. 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.''.
       (b) Repeal of Certain Provisions.--Section 18 of the 
     Poultry Products Inspection Act (21 U.S.C. 467), section 401 
     of the Federal Meat Inspection Act (21 U.S.C. 671), and 
     section 18 of the Egg Products Inspection Act (21 U.S.C. 
     1047) are repealed.

     SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.

       Not later than 60 days after the submission of the 
     reorganization plan under section 502, 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. 507. REGULATIONS.

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

     SEC. 508. AUTHORIZATION OF APPROPRIATIONS.

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

     SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.

       For the fiscal year that includes the effective date 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 
     effective date of this Act, appropriations for those agencies 
     for the fiscal year that includes the effective date have not 
     yet been made.

     SEC. 510. EFFECTIVE DATE.

       This Act takes effect on the date of enactment of this Act.
                                 ______