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S. 287 (114th): Safe Food Act of 2015

The text of the bill below is as of Jan 28, 2015 (Introduced).


II

114th CONGRESS

1st Session

S. 287

IN THE SENATE OF THE UNITED STATES

January 28, 2015

(for himself, Mrs. Feinstein, Mrs. Gillibrand, and Mr. Blumenthal) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

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

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Safe Food Act of 2015.

(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 facilities.

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

Sec. 204. Performance standards for contaminants in food.

Sec. 205. Inspections of food facilities.

Sec. 206. Food production establishments.

Sec. 207. Federal and State cooperation.

Sec. 208. Foreign supplier verification program.

Sec. 209. Imports.

Sec. 210. Traceback.

Sec. 211. Food safety technology.

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. Mandatory recall authority.

Sec. 403. Injunction proceedings.

Sec. 404. Civil and criminal penalties.

Sec. 405. Presumption.

Sec. 406. Whistleblower protection.

Sec. 407. Administration and enforcement.

Sec. 408. 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.

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, systemwide approach to preventing foodborne 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 foodborne illnesses, including infants and children;

(C)

a concern regarding food fraud for economic gain, especially with mislabeling and intentionally misleading claims;

(D)

an increasing volume of imported food, without adequate monitoring and inspection; and

(E)

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 foodborne illness;

(6)

the Federal food safety system is fragmented, with at least 15 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 foodborne illness;

(7)

the fragmented Federal food safety system and outdated laws preclude an integrated, systemwide approach to preventing foodborne 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 related labeling to strengthen the protection of the public health;

(B)

ensure that food facilities 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, systemwide approach to food safety and to make more effective and efficient use of resources to prevent foodborne 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 foodborne 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.

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 given such term in—

(i)

section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) for food regulated under such Act;

(ii)

section 1(m) of the Federal Meat Inspection Act (21 U.S.C. 601(m)) for food regulated under such Act;

(iii)

section 4(g) of the Poultry Products Inspection Act (21 U.S.C. 453(g)) for food regulated under such Act; and

(iv)

section 4(a) of the Egg Products Inspection Act (21 U.S.C. 1033(a)) for food regulated under such Act.

(B)

Inclusion

In applying the definitions cited in subparagraph (A), poisonous or deleterious substances in food shall be treated as an added substance if the poisonous or deleterious substances are known to cause serious illness or death in persons, including in 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 facility

The term category 1 food facility means a facility that slaughters animals for food.

(6)

Category 2 food facility

The term category 2 food facility means a facility that processes—

(A)

raw meat, poultry, or seafood in a manner that may reduce but is not validated to destroy contaminants; or

(B)

other products that the Administrator determines by regulation to be at high risk of contamination.

(7)

Category 3 food facility

The term category 3 food facility means a facility—

(A)

that processes meat, poultry, or seafood, or other products that the Administrator determines by regulation to be at high risk of contamination; and

(B)

whose processes include one or more steps validated to destroy contaminants.

(8)

Category 4 food facility

The term category 4 food facility means a facility that processes food but is not a category 1, 2, or 3 food facility.

(9)

Category 5 food facility

The term category 5 food facility means a facility that stores, holds, or transports food prior to delivery for retail sale.

(10)

Contaminant

The term contaminant includes biological, chemical, physical, or radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food or color additives.

(11)

Contamination

The term contamination refers to a presence of a contaminant in food, which may occur naturally or be introduced into a food.

(12)

Feed facility

The term feed facility means a domestic or foreign feed manufacturer, processor, packer, warehouse, or other facility that—

(A)

if operating in the United States, manufactures, slaughters, processes, or holds animal feed or feed ingredients; or

(B)

if operating elsewhere, manufactures, slaughters, processes, or holds animal feed or feed ingredients intended for consumption in the United States.

(13)

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 and animal food that is made in whole or in part from any animal, including cattle, sheep, swine, goat, or poultry (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)), and animal feed.

(14)

Food facility

(A)

In general

The term food facility means a domestic or foreign food manufacturer, slaughterhouse, processor, packer, warehouse, or other facility that—

(i)

if operating in the United States, manufactures, slaughters, processes, or holds food or food ingredients; or

(ii)

if operating outside the United States, manufactures, slaughters, processes, or holds food intended for consumption in the United States.

(B)

Exclusions

For the purposes of registration, the term food facility does not include—

(i)

a farm, restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer; or

(ii)

a fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3(k) of title 21, Code of Federal Regulations).

(15)

Food production establishment

The term food production establishment means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.

(16)

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 FDA Food Safety Modernization Act (Public Law 111–353);

(F)

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

(G)

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

(H)

chapter 57 of title 49, United States Code;

(I)

Public Law 85–765 (commonly known as the Humane Methods of Slaughter Act of 1958) (7 U.S.C. 1901 et seq.);

(J)

the provisions of this Act; and

(K)

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.

(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 to it in—

(A)

section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) for food regulated under such Act;

(B)

section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)) for food regulated under such Act;

(C)

section 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)) for food regulated under such Act; and

(D)

section 4(l) of the Egg Products Inspection Act (21 U.S.C. 1033(l)) for food regulated under such Act.

(19)

Process

The term process or processing means the commercial 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 act of obtaining evidence that the process control measure or measures selected to control a contaminant in food is capable of effectively and consistently controlling the contaminant.

(23)

Statistically valid

The term statistically valid means evaluated and conducted under standards set by the National Institute of Standards and Technology.

I

Establishment of Food Safety Administration

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, labeling, 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 benefit in reducing foodborne illness;

(E)

coordination of the Federal response to foodborne illness outbreaks with other Federal and State agencies; and

(F)

integration of Federal food safety activities with State and local agencies.

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 and feed facilities and imports;

(5)

the Center for Veterinary Medicine of the Food and Drug Administration;

(6)

the resources and facilities of the Office of the Commissioner of the Food and Drug Administration, known as the Office of Food and Veterinary Medicine, 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);

(7)

the part of the Research, Education, and Economics mission area of the Department of Agriculture related to food and feed safety;

(8)

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;

(9)

the part of the Animal and Plant Inspection Health Service of the Department of Agriculture related to the management of animals going into the food supply; and

(10)

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

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 regulatory science and processes, research, communications, performance standards, and inspection.

II

Administration of food safety program

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 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;

(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 manage and 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 facilities and regular unannounced inspection of food facilities;

(2)

verify and enforce the adoption of preventive process controls in food facilities, based on the 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 performance 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)

access the surveillance data of the Centers for Disease Control and Prevention, and other Federal Government agencies, in order to develop and 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)

partner with relevant agencies to identify and prevent terrorist threats to food;

(9)

establish a process for providing a single point of contact to assist impacted consumers in navigating Federal, State, and local agencies involved in responding to or monitoring a foodborne outbreak;

(10)

develop public education risk communication and advisory programs;

(11)

implement a basic and applied research program to further the purposes of this Act; and

(12)

coordinate and prioritize food safety research and educational programs with other agencies, including State or local agencies.

202.

Registration of food facilities

(a)

In general

The Administrator shall require that all food and feed facilities register before the facility can operate in the United States or import food, feed, or ingredients into the United States.

(b)

Registration requirements

(1)

In general

To be registered under subsection (a)—

(A)

all food facilities covered under this Act shall comply with registration requirements in section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d);

(B)

for food facilities that have not registered under such section 415 prior to the date of enactment of this Act, the requirement in subparagraph (A) applies beginning on the day that is 180 days after the date of enactment of this Act; and

(C)

for food facilities that have registered under such section 415 prior to the date of enactment of this Act, such facilities shall file an amended registration within 180 days of such date of enactment to deliver the information required by paragraph (2).

(2)

Categories

In addition to the information required under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to be included in registration, a food facility shall—

(A)

list the facility’s primary purpose and business activity, including the dates of operation if the food facility is operating seasonally; and

(B)

list the types of food handled at the facility and identify the activities conducted in the facility, that are relevant to determining whether the facility is a category 1, 2, 3, 4, or 5 facility.

(3)

Procedure

Upon receipt of a completed or amended registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, review the activities identified in the registration, designate the facility as a category 1, 2, 3, 4, or 5 food facility for the purposes of inspection, and assign a registration number to each food facility.

(4)

List

The Administrator—

(A)

shall compile and maintain an up-to-date list of food facilities that are registered under this section, in accordance with section 415(a)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d(a)(5)); and

(B)

may establish regulations on how the list may be shared with other governmental authorities.

203.

Preventive process controls to reduce adulteration of food

(a)

In general

The Administrator shall review existing regulations on hazard analysis and process controls and amend existing regulations as appropriate, upon the basis of best available public health, scientific, and technological information, to ensure that those regulations are working effectively to—

(1)

ensure food facilities operate in a sanitary manner so that food is not adulterated;

(2)

limit the presence of contaminants in food;

(3)

meet the performance standards established under section 204;

(4)

ensure fully processed or ready-to-eat foods are processed using reasonably available techniques and technologies to eliminate contaminants;

(5)

label food intended for final processing outside commercial food facilities with instructions for handling and preparation for consumption that will destroy contaminants;

(6)

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 performance standards are being met; and

(7)

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

(b)

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.

204.

Performance standards for contaminants in food

(a)

Performance standards

Whenever the Administrator determines that a foodborne contaminant presents the risk of serious adverse health consequences or death to consumers, causes food to be adulterated, or could promote the spread of communicable disease described in section 361 of the Public Health Service Act (42 U.S.C. 264), the Administrator shall issue a performance standard (in the form of guidance, action levels, or regulations) to prevent or control the contaminant.

(b)

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 facilities are complying with the standards promulgated under this section.

(2)

Actions

If the Administrator determines that a food facility fails to meet a standard promulgated under this section, and such facility 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 facility under section 209(i);

(B)

order a recall of food from the food facility under section 402;

(C)

increase the inspection frequency for the food facility;

(D)

withdraw the mark of inspection from the food facility, if in use; or

(E)

take other appropriate enforcement action concerning the food facility, including suspension of registration.

(c)

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.

(d)

Revocation by administrator

All performance standards, tolerances, action levels, or other similar standards with respect to food in effect on the date of enactment of this Act shall remain in effect until revised or revoked by the Administrator.

205.

Inspections of food facilities

(a)

In general

The Administrator shall establish an inspection program, which shall include sampling and testing of food and food facilities, to determine if each food facility—

(1)

is operating in a sanitary manner;

(2)

has continuous systems, interventions, and processes in place to minimize or eliminate contaminants in food;

(3)

uses validated process controls and ongoing verification;

(4)

is in compliance with applicable performance standards established under section 204, process control regulations, and other requirements;

(5)

is processing food that is safe and not adulterated or misbranded;

(6)

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

(7)

is in compliance with the requirements of the applicable food safety law.

(b)

Facility categories and inspection frequencies

Inspections of food facilities under this Act shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):

(1)

Category 1 food facilities

A category 1 food facility 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 facility has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and destroyed or reprocessed contaminated carcasses 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 facilities

A category 2 food facility shall be randomly inspected at least daily.

(3)

Category 3 food facilities

A category 3 food facility shall—

(A)

provide documentation to the Administrator on request that ongoing verification shows that its processes are controlled; and

(B)

be randomly inspected at least monthly.

(4)

Category 4 food facilities

A category 4 food facility shall be randomly inspected at least quarterly.

(5)

Category 5 food facilities

A category 5 food facility shall be randomly inspected at least annually.

(c)

Establishment of inspection procedures

The Administrator shall establish procedures under which inspectors or safety officers inspect food facilities, which shall allow the taking of random samples, photographs, and copies of records in food facilities.

(d)

Alternative inspection frequencies

With respect to a category 2, 3, 4, or 5 food facility, the Administrator may establish alternative increased or decreased inspection frequencies for subcategories of food facilities or for individual facilities, to foster risk-based allocation of resources, subject to the following criteria and procedures:

(1)

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

(2)

Alternative inspection frequencies for subcategories of food facilities under paragraph (1) and for a specific food facility under paragraph (4) shall provide that—

(A)

category 2 food facilities shall be inspected at least monthly; and

(B)

category 3 and 4 food facilities shall be inspected at least annually.

(3)

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

(A)

the nature of the foods being processed, stored, or transported;

(B)

the manner in which foods are processed, stored, or transported;

(C)

the inherent likelihood that the foods will contribute to the risk of foodborne illness;

(D)

the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of facilities; and

(E)

the overall record of compliance with the food safety law among facilities 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 facility, subject to paragraphs (2) and (5), and shall annually publish a list of facilities subject to alternative inspections.

(5)

In adopting alternative inspection frequencies for a specific facility, the Administrator shall consider—

(A)

the supporting evidence that an individual food facility shall submit related to whether an alternative inspection frequency should be established for such facility by the Administrator;

(B)

whether products from the specific facility have been associated with a case or an outbreak of foodborne illness;

(C)

the record of the facility of compliance with the food safety law, including compliance with applicable performance standards and the frequency of recalls; and

(D)

the criteria in paragraph (3).

(6)

Before establishing decreased alternative inspection frequencies for subcategories of facilities or individual facilities, the Administrator shall—

(A)

describe the alternative uses of resources in general terms when issuing the regulation or order that establishes the alternative inspection frequency; and

(B)

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 foodborne illness.

(e)

Inspection transition

The Administrator shall manage the transition to the inspection system described in this Act as follows:

(1)

Regulations

The Administrator shall promulgate regulations to implement this section no later than 24 months after the date of enactment of this Act.

(2)

Limit on reduction in inspection frequency

For any food facility, the Administrator shall not reduce the inspection frequency from the frequency required pursuant to 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 the food facility has demonstrated 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.

(f)

Official mark

(1)

In general

(A)

Establishment

Before the completion of the transition process under subsection (e), the Administrator shall by regulation establish an official mark that can be affixed to a food produced in a category 1, 2, or 3 food facility if—

(i)

the facility is in compliance with the food safety law; and

(ii)

has been inspected in accordance with the inspection frequencies under this section.

(B)

Removal of official mark

The Administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if—

(i)

the Administrator makes a finding that the facility is not in compliance with the food safety law; or

(ii)

the Administrator suspends the registration of the facility.

(2)

Category 1, 2, or 3 food facilities

In the case of products manufactured, slaughtered, processed, or held in a category 1, 2, or 3 food facility—

(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 subsection (e);

(B)

the Administrator shall publicly certify on a monthly basis that the inspection frequencies required under this section have been achieved; and

(C)

a product from a facility 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 facilities

In the case of a product manufactured, slaughtered, processed, or held in a category 4 or 5 food facility, 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 as the Administrator considers appropriate.

(g)

Maintenance and inspection of records

(1)

In general

(A)

Records

A food facility shall—

(i)

maintain such records as the Administrator requires 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 facility representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator to determine whether the food is contaminated or not in compliance with the food safety law.

(B)

Required disclosure

A food facility 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 required by paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.

(3)

Requirements

The records required by 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 facility;

(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.

(h)

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 facility 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 402; or

(E)

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

(i)

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.

206.

Food production establishments

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 establishments, to—

(1)

visit and inspect food production establishments in the United States and in foreign countries for food safety purposes;

(2)

review food safety records as needed to carry out traceback and for other food safety purposes;

(3)

set good practice standards to protect the public and promote food safety;

(4)

partner with appropriate agencies to monitor animals, plants, products, or the environment, as appropriate; and

(5)

collect and maintain information relevant to public health and farm practices.

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 to a State—

(1)

advisory assistance;

(2)

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

(3)

financial assistance, 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 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.

208.

Foreign supplier verification program

(a)

In general

The Administrator shall require that each importer of products from a feed facility, food facility, or food producer establishment be in compliance with the foreign supplier verification program requirements under section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a).

(b)

Rule of construction

In applying subsection (a) with respect to products subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), references in section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) to sections 402, 403(w), 418, and 419 of such Act (21 U.S.C. 342, 343(w), 350g, and 350h) shall be construed to be references to the corresponding provisions of the food safety law, if any, that apply to such products, as determined by the Administrator.

(c)

Repeal of exemptions

Subsection (e) of section 805 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) is hereby repealed.

209.

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 seeking to certify food for importation into the United States shall submit a request for accreditation to the Administrator.

(b)

Accreditation standard

A foreign government requesting to be accredited to certify food for importation into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that the foreign government (or an agency thereof) is capable of adequately ensuring that eligible entities or foods certified by such government (or agency) meet the requirements of the food safety law.

(c)

Request by foreign government

Prior to granting accreditation to a foreign government under this section, the Administrator shall review and audit the food safety program of the requesting foreign government and certify that such program (including all statutes, regulations, and inspection authority) meets the standard specified in subsection (b).

(d)

Limitations

Any accreditation of a foreign government under this section shall—

(1)

specify the foods covered by the accreditation; and

(2)

be limited to a period not to exceed 5 years.

(e)

Withdrawal of accreditation

The Administrator may withdraw accreditation fully or partially from a foreign government if the Administrator finds that—

(1)

food covered by the accreditation is linked to an outbreak of human illness;

(2)

the programs or procedures of the foreign government no longer meet the standards of the food safety programs and procedures of the United States; or

(3)

the foreign government refuses 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 accreditation

The Administrator shall audit foreign governments accredited under this section at least every 5 years to ensure the continued compliance by such governments with the standard set forth in subsection (b).

(g)

Required routine inspection

The Administrator shall routinely inspect food or food animals by physical examination before the food or food animals enter the United States to ensure that the food or food animals—

(1)

are safe;

(2)

are labeled as required for food produced in the United States; and

(3)

otherwise meet the requirements of the food safety law.

(h)

Enforcement

The Administrator may—

(1)

deny importation of food from any country if the country’s government does not permit United States officials to enter the 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 country or foreign facility that does not consent to an investigation by the Administrator when food from that country or foreign facility is linked to a foodborne illness outbreak or is otherwise found to be adulterated or mislabeled; and

(3)

promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the standards of the food safety law.

(i)

Detention and seizure

Any food imported for consumption in the United States that fails to meet the standards of the food safety law may be detained, seized, or condemned.

210.

Traceback

(a)

In general

The Administrator, in order to protect the public health, shall establish requirements for a national system for tracing food, animals, or ingredients 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 establishments and food facilities.

211.

Food safety technology

(a)

In general

The Administrator shall establish and implement a program, to be known as the Food Safety Technology Program, to foster innovation in food technologies and foods that have the potential to improve food safety at the point of production, processing, transport, storage, or final preparation.

(b)

Program described

The program under this section shall consist of technical guidance to and consultation with technology developers to assist them in meeting requirements for approval of technologies and products described in subsection (a).

III

Research and education

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)

partner with relevant agencies to maintain or access an active surveillance system of food 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)

partner with relevant agencies to maintain or access a state-of-the-art partial or full genome sequencing system and epidemiological system dedicated to foodborne 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

Through the surveillance system referred to in subsection (a), the sampling system described in subsection (b), and other available data, the Administrator shall—

(1)

rank food categories based on the hazard to human health presented by the food category;

(2)

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

(3)

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

302.

Public education and advisory system

(a)

Public education

The Administrator shall—

(1)

in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, establish a national public education program on food safety; and

(2)

coordinate with other Federal departments and agencies to integrate food safety messaging into all food-related agricultural, nutrition, and health promotion programs.

(b)

Health advisories

The Administrator, in consultation with such 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.

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)

determine the food safety education needs of vulnerable populations, including children less than 10 years of age, pregnant women, adults 65 years of age and older, and individuals with compromised immune systems;

(9)

utilize the partial or full genome sequencing system and other processes to identify and control pathogens;

(10)

address common and emerging zoonotic diseases;

(11)

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

(12)

analyze the incidence of antibiotic resistance as it pertains to the food supply and develop new methods to reduce infection by antibiotic resistant bacteria in humans and animals; and

(13)

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.

IV

Enforcement

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 facility or foreign food facility to fail to register under section 202, or to operate without a valid registration;

(4)

to refuse to permit access to a food facility for the inspection and copying of a record as required under section 205(g);

(5)

to fail to establish or maintain any record or to make any report as required under section 205(g);

(6)

to refuse to permit entry to or inspection of a food facility 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(g)(1)(B);

(8)

to fail to comply with an applicable provision of, or a regulation or order of the Administrator under, section 202, 204, or 208;

(9)

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

(10)

to fail to comply with a recall or other order under section 402; or

(11)

to otherwise violate the food safety law.

402.

Mandatory recall authority

(a)

Voluntary procedures

If the Administrator determines that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Administrator shall provide the owner, operator, or agent in charge of the facility that created, caused, or was otherwise responsible for such food with an opportunity to cease distribution and recall such article.

(b)

Prehearing Order To Cease Distribution and Give Notice

(1)

In general

If the owner, operator, or agent in charge of the facility refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Administrator (if so prescribed), the Administrator may by order require, as the Administrator deems necessary, such person to—

(A)

immediately cease distribution of such article;

(B)

as applicable, immediately notify all persons manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and

(C)

to which such article has been distributed, transported, or sold, immediately cease distribution of such article.

(2)

Required additional information

(A)

In general

If an article of food covered by a recall order issued under paragraph (1)(B) has been distributed to a warehouse-based, third-party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession, the notice provided by the responsible party subject to the order issued under paragraph (1)(B) shall include such information as is necessary for the warehouse-based, third-party logistics provider to identify the food.

(B)

Rules of construction

Nothing in this paragraph shall be construed—

(i)

to exempt a warehouse-based, third-party logistics provider from the requirements of food safety law; or

(ii)

to exempt a warehouse-based, third-party logistics provider from being the subject of a mandatory recall order.

(3)

Determination to limit areas affected

If the Administrator requires an owner, operator, or agent in charge of the facility to cease distribution under paragraph (1)(A) of an article of food identified in subsection (a), the Administrator may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health.

(c)

Hearing on order

The Administrator shall provide the owner, operator, or agent in charge of the facility subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.

(d)

Post-Hearing Recall Order and Modification of Order

(1)

Amendment of order

If, after providing opportunity for an informal hearing under subsection (c), the Administrator determines that removal of the article from commerce is necessary, the Administrator shall, as appropriate—

(A)

amend the order to require recall of such article 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 to consumers to whom such article was, or may have been, distributed.

(2)

Vacating of order

If, after such hearing, the Administrator determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Administrator shall vacate the order or modify the order.

(e)

Rule regarding alcoholic beverages

The Administrator shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the Administrator has provided the Alcohol and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and recall such article under the Alcohol and Tobacco Tax and Trade Bureau’s authority.

(f)

Cooperation and consultation

The Administrator shall work with State and local public health officials in carrying out this section, as appropriate.

(g)

Public notification

In conducting a recall under this section, the Administrator shall—

(1)

ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification—

(A)

of the recall to consumers and retailers to whom such article was, or may have been, distributed; and

(B)

that includes, at a minimum—

(i)

the name of the article of food subject to the recall;

(ii)

a description of the risk associated with such article; and

(iii)

to the extent practicable, information for consumers about similar articles of food that are not affected by the recall;

(2)

provide to the public a list of retail consignees receiving products for which there is determined to be a reasonable probability that eating the food will cause serious adverse health consequences or death to humans or animals; and

(3)

if available, publish on the Internet website of the Administration an image of the article that is the subject of the press release described in paragraph (1).

(h)

No delegation

The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Administrator.

(i)

Effect

Nothing in this section shall affect the authority of the Administrator to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of the food safety law or under the Public Health Service Act (42 U.S.C. 201 et seq.).

(j)

Coordinated communication

(1)

In general

To assist in carrying out the requirements of this subsection, the Administrator shall establish an incident command operation or a similar operation that will operate not later than 24 hours after the initiation of a mandatory recall or the recall of an article of food for which the use of, or exposure to, such article will cause serious adverse health consequences or death to humans or animals.

(2)

Requirements

To reduce the potential for miscommunication during recalls or regarding investigations of a foodborne illness outbreak associated with a food that is subject to a recall, each incident command operation or similar operation under paragraph (1) shall use regular staff and resources of the Administration to—

(A)

ensure timely and coordinated communication within the Administration, including enhanced communication and coordination between different agencies and organizations within the Administration;

(B)

ensure timely and coordinated communication from the Administration, including public statements, throughout the duration of the investigation and related foodborne illness outbreak;

(C)

identify a single point of contact within the Administration for public inquiries regarding any actions by the Administrator related to a recall;

(D)

coordinate with Federal, State, local, and tribal authorities, as appropriate, that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall, including notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a commodity intended for use in a child nutrition program (as defined in section 25(b) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); and

(E)

conclude operations at such time as the Administrator determines appropriate.

(3)

Multiple recalls

The Administrator may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks.

(4)

Fees applicable to all facilities

Fees described in section 743 of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–31) for not complying with a recall order are applicable to all food facilities under this Act as if—

(A)

the term responsible party means owner, operator, or agent in charge of the facility; and

(B)

references to section 423 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350l) are references to section 402 of this Act.

403.

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.

404.

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 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 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.

405.

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.

406.

Whistleblower protection

Section 1012 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399d) shall apply with respect to any violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of this Act to the same extent and in the same manner as such section 1012 applies with respect to a violation of, or any act or omission an employee reasonably believes to be a violation of, any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

407.

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 (15 U.S.C. 46)), 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, 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.

408.

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.

V

Implementation

501.

Definition

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

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 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.

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.

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 from those orders, and payments made pursuant to such orders, shall be issued 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 the reporting requirements refer to the agency by name.

505.

Conforming amendments

Section 5313 of title 5, United States Code, is amended by adding at the end the following new item:

Administrator of Food Safety.

.

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 any food safety law to reflect the changes made by this Act.

507.

Regulations

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

508.

Authorization of appropriations

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

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.

510.

Effective date

This Act and the amendments made by this Act take effect on the date of enactment of this Act.