H. R. 7143
IN THE HOUSE OF REPRESENTATIVES
September 26, 2008
Ms. DeLauro introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
Short title; table of contents
This Act may be cited as the
Food Safety Modernization Act of
Table of contents
The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.
Title I—ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
Sec. 101. Establishment of the food safety administration.
Sec. 102. Consolidation of food safety functions.
Sec. 103. Additional duties of the administration.
Title II—ADMINISTRATION OF FOOD SAFETY PROGRAM
Sec. 201. Administration of national program.
Sec. 202. Registration of food establishments and foreign food establishments.
Sec. 203. Preventive process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food establishments.
Sec. 206. Food production facilities.
Sec. 207. Federal and State cooperation.
Sec. 208. Imports.
Sec. 209. Resource plan.
Sec. 210. Traceback requirements.
Sec. 211. Accredited laboratories.
Title III—RESEARCH AND EDUCATION
Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.
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.
Sec. 501. Reorganization plan.
Sec. 502. Transitional authorities.
Sec. 503. Savings provisions.
Sec. 504. Conforming amendments.
Sec. 505. Additional technical and conforming amendments.
Sec. 506. Regulations.
Sec. 507. Authorization of appropriations.
Sec. 508. Limitation on authorization of appropriations.
Congress finds that—
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;
lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce and international trade;
recent ongoing events demonstrate that the food safety program at the Food and Drug Administration is not effective in controlling hazards in food coming from farms and factories in the United States and food and food ingredients coming from foreign countries, and these events have adversely affected consumer confidence;
the safety and security of the food supply require a systemwide approach to prevent food-borne illness involving the integrated efforts of Federal, State and local agencies; a thorough, broad-based, and coordinated approach to basic and applied science; and intensive, effective, and efficient management of the Nation’s food safety program;
the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to—
emerging pathogens and other contaminants and the ability to detect all forms of contamination;
the threat of intentional contamination of the food supply;
a growing number of people at high risk for food-borne illnesses, including an increasing population of aging and immune-compromised consumers, together with infants and children;
an increasing volume of imported food, without adequate monitoring, inspection, and systems for prevention of food safety problems; and
maintenance of rigorous inspection of the domestic food processing and food service industries;
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;
the Food and Drug Administration, an agency within the Department of Health and Human Services, has regulatory jurisdiction over the safety and labeling of 80 percent of the American food supply, encompassing all foods except meat, poultry, and egg products, as well as drugs, medical devices, and biologics;
rapid technological advance and the expansion and globalization of industries in all areas of Food and Drug Administration jurisdiction present challenges and require leadership beyond the capacity of any one agency or agency head to provide;
in the food safety area, the Food and Drug Administration implements provisions of the Federal Food, Drug, and Cosmetic Act that are 70 years old and that antiquated law limits the Food and Drug Administration’s role largely to reacting to and correcting food safety problems after they occur, rather than working with the food industry to systematically prevent problems;
the Food and Drug Administration’s effectiveness is further impaired by fragmentation of leadership and management within the Administration, as major food safety responsibilities are dispersed across the Administration’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and Office of Regulatory Affairs;
there is no official with the full-time responsibility and budget authority for food safety at the Food and Drug Administration and food safety competes unsuccessfully with the drug and medical device programs for senior agency management attention and resources; and
improving Federal oversight of food safety requires a modern food safety mandate, clear authorities, and a dedicated official within the Department of Health and Human Services with budget authority to manage an integrated organizational structure and report directly to the Secretary.
The purposes of this Act are—
to establish an
agency within the Department of Health and Human Services to be known as the
Food Safety Administration to—
regulate food safety and labeling to strengthen the protection of the public health;
ensure that food establishments fulfill their responsibility to process, store, hold, and transport food in a manner that protects the public health of all people in the United States;
lead an integrated, systemwide approach to food safety and to make more effective and efficient use of resources to prevent food-borne illness;
provide a single focal point within the Department of Health and Human Services for food safety leadership, both nationally and internationally; and
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 transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the date of the enactment of this Act, are performed by various components of the Food and Drug Administration and the National Oceanic and Atmospheric Administration;
to modernize and strengthen the Federal food safety law to ensure more effective application and efficient management of the laws for the protection and improvement of public health; and
to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements of this law.
In this Act:
The term Administration means the Food Safety Administration established under section 101(a)(1).
The term Administrator means the Administrator of Food Safety appointed under section 101(a)(2).
The term adulterated has the meaning given that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
The term adulterated includes bearing or containing a contaminant that causes illness or death among sensitive populations.
The term agency has the meaning given that term in section 551 of title 5, United States Code.
Category 1 food establishment
The term category 1 food establishment means a food establishment (other than a seafood processing establishment) that slaughters, for the purpose of producing food, animals that are not subject to inspection under the Federal Meat Inspection Act or poultry that are not subject to inspection under the Poultry Products Inspection Act.
Category 2 food establishment
The term category 2 food establishment means a seafood processing establishment or other food establishment (other than a category 1 establishment) not subject to inspection under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, that processes raw seafood or other raw animal products, whether fresh or frozen, or other products that the Administrator determines by regulation to pose a significant risk of hazardous contamination.
Category 3 food establishment
The term category 3 food establishment means a food establishment (other than a category 1 or category 2 establishment) that processes cooked, pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-to-eat raw form, or other products that pose a risk of hazardous contamination.
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).
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.
The term contaminant includes a bacterium, chemical, natural toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.
The term hazardous contamination refers to the presence of a contaminant in food at levels that pose a risk of human illness, injury, or death or are capable of reaching levels that pose such risk during the shelf life of the product.
The term food means a product intended to be used for food or drink for a human or an animal and components thereof.
The term food establishment means a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.
For the purposes of registration, the term food establishment does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).
Food production facility
The term food production facility means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.
Food safety law
The term food safety law means—
the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, quality, nutritional composition, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food under that Act;
the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any other Act that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;
the provisions of the Public Health Service Act that relate in any way to surveying, containing, or preventing food-borne illness; and
the provisions of this Act.
Foreign food establishment
The term foreign food establishment means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.
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)).
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).
The term process or processing means the commercial slaughter, packing, preparation, or manufacture of food.
The term State means—
the District of Columbia;
the Commonwealth of Puerto Rico; and
any other territory or possession of the United States.
ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
Establishment of the food safety administration
There is established in the Department of Health and
Human Services an agency to be known as the
Head of the administration
The Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate, for a term of 5 years, and who may be reappointed.
All the authorities and responsibilities assigned to the Secretary of Health and Human Services in the food safety law are hereby assigned to the Administrator.
Duties of Administrator
The Administrator shall—
administer and enforce the food safety law;
serve as the food safety leader within the Department of Health and Human Services and coordinator of all Department activities related to ensuring the safety, quality, and proper labeling of the food supply;
represent the United States in international food safety bodies and discussions;
promulgate regulations to ensure the safety and security of the food supply from all forms of contamination, including intentional contamination; and
oversee within the Department of Health and Human Services—
all activities related to foodborne illness surveillance and investigation of foodborne illness outbreaks;
implementation of food safety inspection, enforcement, and research efforts to protect the public health;
development of consistent and science-based standards for safe food;
coordination and prioritization of food safety research and education programs with other Federal agencies;
prioritization of food safety efforts and deployment of food safety resources to achieve the greatest possible benefit in reducing food-borne illness;
coordination of the response to food-borne illness outbreaks with other Federal and State agencies; and
integration of food safety activities with State and local agencies.
Consolidation of food safety functions
Transfer of Functions and Resources
For each component of the Department of Health and Human Services or the Department of Commerce specified in subsection (b), there are transferred to the Administration all functions, personnel, and assets (including facilities and financial resources) of those components as of the day before the date of the enactment of this Act (including all related functions of any officer or employee of the component) that relate to administration or enforcement of the food safety law, as determined by the President.
Transferred Functions and Resources
The components referred to in subsection (a) are—
the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;
the Center for Veterinary Medicine of the Food and Drug Administration;
the National Center for Toxicological Research of the Food and Drug Administration;
the personnel and assets of the Office of Regulatory Affairs of the Food and Drug Administration used to administer and conduct inspections of food establishments and imports and conduct laboratory analyses and other investigations relating to food safety;
the personnel and assets of the Office of the Commissioner of Food and Drugs used to support—
the Center for Food Safety and Applied Nutrition;
the Center for Veterinary Medicine;
the National Center for Toxicological Research; and
the personnel and assets of the Office of Regulatory Affairs described in paragraph (4); and
the personnel and assets of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce used to administer the seafood inspection program.
Renaming and reservation of agency identity
The Food and Drug Administration
in the Department of Health and Human Services is hereby renamed the Federal
Drug and Device Administration and may be referred to as
Sharing of facilities and resources
The Food Safety Administration and the Federal Drug and Device Administration shall enter into such agreements concerning the sharing of facilities and other resources as may be appropriate to make efficient use of such facilities and resources and achieve their respective missions.
Additional duties of the administration
Officers and Employees
The Administrator may—
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
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.
Experts and Consultants
The Administrator may—
procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and
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.
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.
The Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.
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.
ADMINISTRATION OF FOOD SAFETY PROGRAM
Administration of national program
The Administrator shall—
administer, and annually update a national food safety program (referred to in
this section as the
program) to protect public health;
ensure that persons who produce, process, or distribute food meet their responsibility to prevent or minimize food safety hazards related to their products.
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—
the severity of the potential health risks;
the sources of potentially hazardous contamination or practices extending from the farm or ranch to the consumer that may increase the risk of food-borne illness;
the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;
the potential for hazardous contamination to have cumulative toxic effects, multigenerational effects, or effects on specific categories of consumers;
opportunities across the food production, processing, distribution, and retail system to reduce potential health risks; and
opportunities for intentional contamination of food or food ingredients.
In carrying out the program, the Administrator shall—
adopt and implement a national system for the registration of food establishments and foreign food establishments, as provided in section 202 of this Act;
adopt and implement a national system for regular unannounced inspection of food establishments;
require and enforce the adoption of preventive process controls in food establishments, based on the best available scientific and public health considerations and best available technologies;
establish and enforce science-based standards for—
potentially hazardous substances that may contaminate food; and
safety and sanitation in the processing and handling of food;
implement a statistically valid sampling program with the stringency and frequency to independently monitor that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the standards established under this Act;
implement appropriate surveillance procedures and requirements to ensure the safety and security of imported food;
coordinate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;
implement a national system to identify the food products posing the greatest public health risk and to analyze the effectiveness of existing food safety programs, in conjunction with the Centers for Disease Control and Prevention and other Federal agencies;
develop public education, risk communication, and advisory programs;
implement an applied research program to further the purposes of this Act;
coordinate and prioritize food safety research and educational programs with other Federal agencies and with State and local governments; and
provide technical assistance to farmers and food establishments that are small business concerns (meeting the requirements of section 3(a) of the Small Business Act and the regulations promulgated thereunder) to assist with compliance with the requirements of this Act.
Registration of food establishments and foreign food establishments
Any food establishment or foreign food establishment engaged in manufacturing, processing, packing, or holding food for consumption in the United States shall register annually with the Administrator.
To be registered under subsection (a), a food establishment shall submit a registration or reregistration to the Administrator.
Registration under this section shall begin within 90 days of the enactment of this Act. Each such registration shall be submitted to the Secretary through an electronic portal and shall contain such information as the Secretary, by guidance, determines to be appropriate. Such registration shall contain the following information:
The name, address, and emergency contact information of each domestic food establishment or foreign food establishment that the registrant owns or operates under this Act and all trade names under which the registrant conducts business in the United States relating to food.
The primary purpose and business activity of each domestic food establishment or foreign food establishment, including the dates of operation if the domestic food establishment or foreign food establishment is seasonal.
The types of food processed or sold at each domestic food establishment or, for foreign food establishments selling food for consumption in the United States, the specific food categories of that food as listed under section 170.3(n) of title 21, Code of Federal Regulations, or such other categories as the Administrator may designate in guidance, action level, or regulations for evaluating potential threats to food protection.
The name, address, and 24-hour emergency contact information of the United States distribution agent for each domestic food establishment or foreign food establishment, who shall maintain information on the distribution of food, including lot information, and wholesaler and retailer distribution.
An assurance that the registrant will notify the Administrator of any change in the products, function, or legal status of the domestic food establishment or foreign food establishment (including cessation of business activities) not later than 30 days after such change.
Upon receipt of a completed registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, designate each establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration number to each domestic food establishment and foreign food establishment.
The Administrator shall annually compile a list of domestic food establishments and a list of foreign food establishments that are registered under this section. The Administrator may establish the manner of and any fees required for reregistration and any circumstances by which either such list may be shared with other governmental authorities. The Administrator may remove from either such list the name of any establishment that fails to reregister, and such delisting shall be treated as a suspension.
The disclosure requirements under section 552 of title 5, United States Code, shall not apply to—
the list compiled under paragraph (4); and
information derived from the list under paragraph (4), to the extent that it discloses the identity or location of a specific person.
Suspension of registration
The Administrator may suspend the registration of a domestic food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law that is either repeated or could result in serious adverse health consequences or death to humans or animals.
Notice and opportunity for hearing
The Administrator shall provide notice of an intent to suspend the registration of an establishment under this paragraph to a registrant and provide the registrant with an opportunity for an administrative hearing within 3 days. The Administrator may issue a written order of suspension following the hearing, if the Administrator finds that a violation described in subparagraph (A) has occurred.
The issuance of an order of suspension under subparagraph (B) shall be considered to be a final agency action subject to judicial review in accordance with the provisions of chapter 7 of title 5, United States Code.
A registration that is suspended under this section may be reinstated based on a showing that adequate process controls have been instituted that would prevent future violations and there are assurances from the registrant that the violations will not be repeated.
During the 6-month period following the date of the enactment of this Act, a food establishment is deemed to be registered in accordance with this section if the establishment is registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d).
Effective at the end of the 6-month period following the date of the enactment of this Act, section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is repealed.
Preventive process controls to reduce adulteration of food
The Administrator shall, upon the basis of best available public health, scientific, and technological data, promulgate regulations to ensure that food establishments carry out their responsibilities under the food safety law.
Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations that require all food establishments, within time frames determined by the Administrator—
to adopt preventive process controls that—
reflect the standards and procedures recognized by relevant authoritative bodies;
are adequate to protect the public health;
meet relevant regulatory and food safety standards;
limit the presence and growth of contaminants in food prepared in a food establishment using the best reasonably available techniques and technologies; and
are tailored to the hazards and processes in particular establishments or environments;
to establish a sanitation plan and program that meets standards set by the Administrator;
to meet performance standards for hazardous contamination established under section 204;
to implement recordkeeping to monitor compliance with regulatory requirements;
to implement recordkeeping and labeling of all food and food ingredients to facilitate their identification and traceability in the event of a recall or market removal;
to implement product and environmental sampling at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that regulatory standards are being met;
to label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy microbial contaminants; and
to provide for agency access to records kept by the food establishments and submission of copies of records to the Administrator, as the Administrator determines appropriate.
Specific hazard controls
The Administrator may require any person with responsibility for or control over food or food ingredients to adopt specific hazard controls, if such controls are needed to ensure the protection of the public health.
Performance standards for contaminants in food
To protect the public health, the Administrator shall establish by guidance document, action level, or regulation and enforce performance standards that define, with respect to specific foods and contaminants in food, the level of food safety performance that a person responsible for producing, processing, or selling food shall meet.
Identification of contaminants; performance standards
List of contaminants
Not later than 6 months after the date of the enactment of this Act, the Administrator shall publish in the Federal Register a list of the contaminants in foods that have the greatest adverse impact on public health in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act. Where appropriate, the Administrator shall indicate whether the risk posed by a contaminant is generalized or specific to particular foods or ingredients.
The Administrator shall establish by guidance document, action level, or regulation a performance standard for each contaminant in the list under paragraph (1) at levels appropriate to protect against the potential adverse health effects of the contaminant.
The Administrator shall establish a performance standard under subparagraph (A) for each contaminant in the list under paragraph (1)—
as soon as practicable; or
in the case of a contaminant described in subparagraph (C), by the date described in such subparagraph.
The list under paragraph (1) (and any revision thereto) shall identify the 5 most significant contaminants in the list (in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act). Not later than 3 years after a contaminant is so identified, the Administrator shall promulgate a performance standard under subparagraph (A) for the contaminant.
Not less than every 3 years, the Administrator shall review and, if necessary, revise—
the list of contaminants under paragraph (1); and
each performance standard established under paragraph (2) or
The performance standards established under this section may include—
health-based standards that set the level of a contaminant that can safely and lawfully be present in food;
zero tolerances, including any zero tolerance performance standards in effect on the day before the date of the enactment of this Act, when necessary to protect against significant adverse health outcomes;
process standards, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; and
in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance on the basis of reliable information on the best reasonably achievable performance, using best available technologies, interventions, and practices.
Best reasonably achievable performance standards
In developing best reasonably achievable performance standards under paragraph (1)(D), the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.
Revocation by Administrator
All performance standards, tolerances, action levels, or other similar standards in effect on the date of the enactment of this Act shall remain in effect until revised or revoked by the Administrator.
In conjunction with the establishment of a performance standard under this section, the Administrator shall develop a statistically valid sampling program with the stringency and frequency sufficient to independently monitor whether food establishments are complying with the performance standard and implement the program within 1 year of the promulgation of the standard.
If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, the Administrator shall, as appropriate—
detain, seize, or condemn food from the food establishment under section 402;
order a recall of food from the food establishment under section 403;
increase the inspection frequency for the food establishment;
withdraw the mark of inspection from the food establishment, if in use; or
take other appropriate enforcement action concerning the food establishment, including withdrawal of registration.
Newly identified contaminants
Notwithstanding any other provision of this section, the Administrator shall establish interim performance standards for newly identified contaminants as necessary to protect the public health.
Inspections of food establishments
The Administrator shall establish an inspection program, which shall include statistically valid sampling of food and facilities to enforce performance standards. The inspection program shall be designed to determine if each food establishment—
is operated in a sanitary manner;
has continuous preventive control systems, interventions, and processes in place to minimize or eliminate contaminants in food;
is in compliance with applicable performance standards established under section 204, and other regulatory requirements;
is processing food that is not adulterated or misbranded;
maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and
is otherwise in compliance with the requirements of the food safety law.
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):
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—
diseased animals are not offered for slaughter;
the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; and
applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
Category 2 food establishments
A category 2 food establishment shall—
have ongoing verification that its processes are controlled; and
be randomly inspected at least weekly.
Category 3 food establishments
A category 3 food establishment shall—
have ongoing verification that its processes are controlled; and
be randomly inspected at least monthly.
Category 4 food establishments
A category 4 food establishment shall—
have ongoing verification that its processes are controlled; and
be randomly inspected at least quarterly.
Category 5 food establishments
A category 5 food establishment shall—
have ongoing verification that its processes are controlled; and
be randomly inspected at least annually.
Establishment of inspection procedures
The Administrator shall establish procedures under which inspectors shall take random samples, photographs, and copies of records in food establishments.
Alternative inspection frequencies
With respect to a subcategory of food establishment under category 2, 3, 4, or 5, the Administrator may establish alternative increasing or decreasing inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources. Before establishing an alternative inspection frequency for a subcategory of food establishments or individual establishments, the Administrator shall take into consideration the evidence described in paragraph (2)(D) and the overall record of compliance described in paragraph (2)(E) for such subcategory. In establishing alternative inspection frequencies under this subsection, the Administrator shall comply with the following criteria and procedures:
Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).
In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider—
the nature of the food products being processed, stored, or transported;
the manner in which food products are processed, stored, or transported;
the inherent likelihood that the products will contribute to the risk of food-borne illness;
the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the proposed subcategory of establishments; and
the overall record of compliance with food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment and shall annually publish a list of establishments subject to alternative inspections.
In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider—
the criteria in paragraph (3), together with any evidence submitted from the individual food establishment supporting a request for an alternative inspection frequency, including the establishment’s record for implementing effective preventative process control systems;
whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and
the establishment’s record of compliance with food safety law, including compliance with applicable performance standards and the frequency of recalls.
The inspection mandates shall go into effect 2 years after the date of the enactment of this Act.
Maintenance and inspection of records
A food establishment shall—
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
permit the Administrator, in addition to any authority transferred to the Administrator pursuant to section 102, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator—
to determine whether the food is contaminated or not in compliance with the food safety law; or
to track the food in commerce.
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.
Maintenance of records
The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.
The records in paragraph (1) shall include records describing—
the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
the identity and quantity of ingredients used in the food;
the processing of the food;
the results of laboratory, sanitation, or other tests performed on the food or in the food establishment;
consumer complaints concerning the food or packaging of the food;
the production codes, open date codes, and locations of food production; and
other matters reasonably related to whether food is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
Protection of sensitive information
The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or commercially valuable confidential information obtained by the Administrator.
The requirements under this subsection and subsection (f) do not—
limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act;
have any legal effect on section 1905 of title 18, United States Code;
extend to any food recipe, financial data, pricing data, or personnel data;
limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403; or
limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.
Bribery of or gifts to inspector or other officers and acceptance of gifts
Any person or agent or employee thereof that gives, pays, or offers, directly or indirectly, to the Administrator or any employee or other designee thereof authorized to perform any duty under the food safety law any money or other thing of value, with intent to influence the discharge of any duty under such law, shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both. Any Administrator, employee, or other designee that solicits or accepts any money or other thing of value from any person, with intent to influence the discharge of any duty under the food safety law, shall be summarily discharged from office and imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
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—
visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;
review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;
set good practice standards to protect the public and animal health and promote food safety;
conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and
collect and maintain information relevant to public health and farm practices.
Inspection of records
A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator—
to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or
to track the food in commerce.
Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall—
consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;
require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;
include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water;
include, with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;
provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;
provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and
include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.
States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c). A request shall—
be in writing;
describe the reasons the variance is necessary;
describe the procedures, processes, and practices that will be followed under the variance to ensure produce is not adulterated; and
contain any other information required by the Administrator.
Approval or disapproval of variances
If the Administrator determines after review of a request under subsection (d) that the requested variance provides equivalent protections to those promulgated under subsection (c), the Administrator may approve the request. The Administrator shall deny a request if it is—
not sufficiently detailed to permit a determination;
fails to cite sufficient grounds for allowing a variance; or
does not provide reasonable assurances that the produce will not be adulterated.
The Administrator may coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.
Not later than 1 year after the date of the enactment of this Act, the Administrator shall by regulation establish procedures for equivalency with foreign countries that intend to export raw agricultural commodities and minimally processed produce to the United States.
Federal and State cooperation
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.
The Administrator shall work with States to—
continue, strengthen, or establish State food safety programs, especially with respect to the regulation of retail commercial food establishments, transportation, harvesting, and fresh markets;
continue, strengthen, or establish inspection programs and requirements to ensure that food under the jurisdiction of the State complies with the food safety law; and
support recall authorities at the State and local levels.
To assist in planning, developing, and implementing a food safety program, the Administrator may provide and continue to a State—
technical and laboratory assistance and training (including necessary materials and equipment); and
financial, in-kind, and other aid.
The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the qualified personnel and services of those agencies in carrying out this Act.
Agreements with a State under this subsection shall provide for training of State employees.
Maintenance of agreements
The Administrator shall maintain any agreement that is in effect on the day before the date of the enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.
Where necessary and appropriate to fulfill the provisions of this Act or other food safety law, the Administrator shall, as part of any service agreement, commission qualified State and local regulatory officials and inspectors to assist the Administrator in carrying out the food safety law and accord such commissioned officials and inspectors access to information in possession of the Administrator as if they were Federal employees.
The Administrator shall annually conduct a comprehensive review of each State program that provides services to the Administrator in carrying out responsibilities under this Act, including mandated inspections under section 205.
The review shall—
include a determination of the effectiveness of the State program; and
identify any changes necessary to ensure enforcement of Federal requirements under this Act.
No Federal Preemption
Nothing in this Act shall be construed to preempt the enforcement of State laws and standards regarding food safety that are at least as stringent as those under this Act.
All imported food under this Act shall meet requirements for food safety, inspection, labeling, and consumer protection that are at least equal to those applicable to food grown, manufactured, processed, packed, or held for consumption in the United States.
Not later than 2 years after the date of the enactment of this Act, the Administrator shall establish a system under which food products offered for importation into the United States shall be certified by the accredited foreign government in the country of export or by an accredited certifying agent meeting all applicable standards under this section.
Category 1, 2, and 3 food establishments shall secure certification of products from the accredited foreign government in the country where the products are produced and must enter the United States through ports designated by the Administrator.
Category 4 and 5 food establishments shall be certified either by—
the accredited foreign government in the country where the products are produced; or
a certifying agent that has been accredited under subsection (c).
Beginning not later than 5 years after the date of the enactment of this Act, food from category 4 and 5 food establishments that is not certified by an accredited entity described in subsection (c) shall not enter the United States except through ports of entry that are located in a metropolitan area with an accredited food testing laboratory.
A foreign government or third party agent requesting accreditation to certify food for entry into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of the foreign government or third party agent, respectively, has met standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to food produced in the United States.
Request by foreign government
Prior to accrediting a foreign government, the Administrator shall—
review and audit the food safety program of the requesting foreign government (including all statutes, regulations, and inspection authority); and
determine that the exporting country—
administers a food control program that requires food exporters to implement hazard control measures for physical, chemical, and biological contaminants;
ensures sanitary operations of facilities;
utilizes testing and verification programs; and
administers an effective enforcement program.
Request by a certifying agent
Prior to accrediting a certifying agent, the Administrator shall—
review the training and qualifications of auditors and other employees used by the agent;
ensure that any such auditors have completed such training as may be required by the Administrator for the conduct of food safety inspections; and
conduct reviews of internal systems and such other investigation as the Administrator deems necessary to determine that the certifying agent is capable of auditing food establishments—
to assess the adequacy of systems and standards in use; and
to ensure that food approved by the agent for import to the United States meets the requirements of this Act.
Certification to accompany each shipment
As a condition of accrediting any foreign government or certifying agent, such government or agent shall agree to issue a written and electronic certification to accompany each shipment intended for import to the United States from any food establishment which the government or agent certifies, subject to requirements set forth by the Administrator.
Following any accreditation under subsection (c), the Administrator may at any time—
conduct an on-site audit of any food establishment registered under section 202, with or without the certifying agent; or
require a certifying agent to submit an onsite audit report and any other reports or documents which the agent requires as part of the audit process, including documentation that the food establishment is in compliance with registration requirements and prior notice requirements for food imported to the United States.
A foreign government or other certifying agent accredited by the Administrator to certify food for import to the United States under this section may certify only the food products or food categories for importation to the United States that are specified in the grant of accreditation.
Withdrawal of accreditation
The Administrator may withdraw accreditation from a foreign government or certifying agent—
if food approved by the foreign government or certifying agent is linked to an outbreak of human illness;
following an investigation and finding by the Administrator that the programs of the foreign government, or a foreign food establishment certified by the certifying agent, are no longer equal to those applied to food grown, manufactured, processed, packed, or held in the United States; or
following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements of this section.
Renewal of accreditation
The Administrator shall audit foreign governments and certifying agents whenever needed, but no less than once every 3 years, to ensure the continued compliance with the requirements set forth in this section. Renewal of accreditation shall occur following each satisfactory audit.
Required routine inspection
The Administrator shall routinely inspect food before or at entry into the United States to ensure ongoing compliance with food safety law and where appropriate, as part of the audit of any certifying entity.
The Administrator may—
deny importation of food from any foreign country if the government of such country does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill requirements under this section;
deny importation of food from any foreign country or foreign food establishment that does not consent to a timely investigation by the Administration when food from that foreign country or foreign food establishment is linked to a food-borne illness outbreak or is otherwise found to be adulterated or misbranded;
promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the requirements of this Act; and
establish such fees as are necessary to carry out the implementation of the accreditation and inspection programs required under this section.
Detention and seizure
Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402 or recalled pursuant to section 403.
Entities eligible for accreditation as a certifying agent under subsection (c) may include—
a State or regional food authority; or
a foreign or domestic cooperative that aggregates the products of growers or processors for importation.
Avoiding Conflicts of Interest With Certifying Agents
To be eligible for accreditation under subsection (c), a certifying agent shall—
not be owned, managed, or controlled by any person that owns or operates an establishment whose products are to be certified by such agent;
have procedures to ensure against the use, in carrying out audits of food establishments under this section, of any officer or employee of such agent that has a financial conflict of interest regarding an establishment whose products are to be certified by such agent; and
annually make available to the Secretary, disclosures of the extent to which such agent, and the officers and employees of such agent, have maintained compliance with subparagraphs (A) and (B) relating to financial conflicts of interest.
The Secretary shall promulgate regulations not later than 18 months after the date of the enactment of this Act to ensure that there are protections against conflicts of interest between a certifying agent and the establishments whose products are to be certified by such agent. Such regulations shall include—
requiring that domestic audits performed under this section be unannounced;
a structure, including timing and public disclosure, for fees paid by food establishments to certifying agents to decrease the potential for conflicts of interest; and
appropriate limits on financial affiliations between a certifying agent and any person that owns or operates an establishment whose products are to be certified by such agent.
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.
Contents of plan
The resource plan shall—
describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of this Act;
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
describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities, at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205 and food production facilities under section 206—
in foreign establishments and production facilities; and
at the point of importation.
The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities and inspections of food establishments and food production facilities and include resources to audit such programs.
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.
The Administrator, in order to protect the public health, shall establish a national traceability system that enables the Administrator to retrieve the history, use, and location of an article of food through all stages of its production, processing, and distribution.
Traceability requirements under this section shall apply to food from food production facilities, food establishments, and foreign food establishments.
The Administrator shall establish standards for the type of information, format, and timeframe for food production facilities and food establishments to submit records to aid the Administrator in effectively retrieving the history, use, and location of an item of food.
Rule of construction
Nothing in this section shall be construed as requiring the Administrator to prescribe a specific technology for the maintenance of records or labeling of food to carry out the requirements of this section.
Availability of records for inspection
Any records that are required by the Administrator under this section shall be available for inspection by the Administrator upon oral or written request.
Demonstration of ability
The Administrator, during any inspection, may require a food establishment to demonstrate its ability to trace an item of food and submit the information in the format and timeframe required under paragraph (1).
Relationship to other requirements
Consistency with existing statutes and regulations
To the extent possible, the Administrator should establish the national traceability system under this section to be consistent with existing statutes and regulations that require recordkeeping or labeling for identifying the origin or history of food or food animals.
For purposes of this subsection, the Administrator should review the following:
Country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
The Perishable Agricultural Commodities Act of 1930 (7 U.S.C. 499a–t).
Country of origin labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).
The National Animal Identification System as authorized by the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.).
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.).
Establishment of program
The Administrator shall establish a program for accrediting laboratories to perform sampling and testing for purposes of this Act. Such program shall include—
standards for appropriate sampling and analytical procedures;
training and experience qualification levels for individuals who conduct sampling and analysis;
annual onsite visits to audit the performance of an accredited laboratory; and
such additional requirements as the Administrator determines to be appropriate.
To be accredited under this section, a laboratory shall—
prepare and submit an application for accreditation to the Administrator;
meet required tests and standards established by the Administrator; and
comply with such terms and conditions as are determined necessary by the Administrator.
The Administrator may approve State agencies or private, nonprofit entities as accrediting bodies to act on behalf of the Administrator in accrediting laboratories under this section. The Administrator shall—
in making such approvals—
oversee and review the performance of any accrediting body acting on behalf of the Administrator to ensure that such accrediting body is in compliance with the requirements of this section; and
have the right to obtain from an accrediting body acting on behalf of the Administrator and from any laboratory that may be certified by such a body all records and materials that may be necessary for the oversight and review required by subparagraph (A);
reevaluate accreditation bodies approved under paragraph (1) whenever—
the Administrator determines a laboratory accredited by the accrediting body is no longer in compliance with this section;
the Administrator determines the accrediting body is no longer in compliance with the requirements of this section; or
no less than once every 5 years; and
promptly revoke the approval of any accreditation body found not to be in compliance with the requirements of this section.
Revocation of accreditation
The Administrator shall revoke the accreditation of any laboratory that fails to meet the requirements this section.
RESEARCH AND EDUCATION
Public health assessment system
The Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with food safety and research programs of the Department of Agriculture, shall—
identify on an ongoing basis the priorities for collection of epidemiological data and for other food safety research and data collection that are most important to implementing the food safety law and reducing the public health burden of food-borne illness;
have full access for purposes of implementing the food safety law to the applicable data and data systems of the Centers for Disease Control and Prevention, including data made available to the Centers by a State;
provide appropriate support and input on the design and implementation by the Centers for Disease Control and Prevention and the States of an active surveillance system that provides information on the incidence and causes of food-borne illness which is timely, detailed, and representative of the population of the United States;
based on data and information obtained from the Centers for Disease Control and Prevention, the States, and other sources, assess the incidence, distribution, public health impact, and causes of human illness in the United States associated with the consumption of food, and conduct research and analysis to devise effective and feasible interventions to reduce food-borne illness;
maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment; and
utilize surveillance data created by means of monitoring and statistical studies conducted as part of its own inspection.
Public health sampling
Not later than 1 year after the enactment of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food—
to assist the Administrator in carrying out this Act; and
to assess the nature, frequency of occurrence, and quantities of contaminants in food.
The sampling system described in paragraph (1) shall provide—
statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and
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.
Assessment of health hazards
Through the surveillance system and analyses referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall—
rank food categories based on the hazard to human health presented by the food category and specific chemical and microbiological hazards associated with foods in those categories;
identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and
assess the conditions affecting the likelihood that emerging pathogens and diseases, including zoonosis, will affect the safety of the food supply and possible strategies for minimizing the potential risk to public health associated with emerging pathogens and diseases.
Components of analysis
The analysis under subsection (b)(1) may include—
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;
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;
a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and
use of comparative risk assessments.
Public education and advisory system
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.
The program shall provide—
information to the public regarding Federal standards and best practices, and promotion of public awareness and understanding of those standards and practices;
information for health professionals—
to improve diagnosis and treatment of food-related illness; and
to advise individuals at special risk for food-related illnesses; and
such other information or advice, including on safe food handling practices, to consumers and other persons as the Administrator determines will promote the purposes of this Act.
The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities—
to develop and distribute regional and national advisories concerning food safety;
to develop standardized formats for written and broadcast advisories;
to incorporate State and local advisories into the national public education program established under subsection (a); and
to present prompt, specific information regarding food found to pose a threat to the public health, including by identifying the retailers and food establishments where such food has been sold.
The Administrator shall conduct research to carry out this Act, including studies to—
improve sanitation and food safety practices in the processing of food;
develop improved techniques to monitor and inspect food;
develop efficient, rapid, and sensitive methods to detect contaminants in food;
determine the sources of contamination of contaminated food;
develop food consumption data;
identify ways that animal production techniques could improve the safety of the food supply;
draw upon research and educational programs that exist at the State and local level;
utilize the DNA matching system and other processes to identify and control pathogens;
address common and emerging zoonotic diseases;
develop methods to reduce or destroy harmful pathogens before, during, and after processing;
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
conduct other research that supports the purposes of this Act.
The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.
It is prohibited—
to manufacture, introduce, deliver for introduction, or receive into interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
to adulterate or misbrand any food in interstate commerce;
for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);
to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);
to refuse to permit entry to or inspection of a food establishment as required under section 205;
to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);
to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;
to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;
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;
to fail to comply with a recall or other order under section 403; or
to otherwise violate the food safety law.
Food detention, seizure, and condemnation
Administrative detention of food
The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food regulated under this Act that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this the food safety law, the officer, employee, or agent may order the food detained.
Period of detention
A food may be detained under paragraph (1) or (2) for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action.
The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.
Security of detained food
A detention order under this subsection—
may require that the food be labeled or marked as detained; and
shall require that the food be removed to a secure facility, if appropriate.
Food subject to an order
A food subject to a detention order under this subsection shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.
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.
Appeal of detention order
A person who would be entitled to be a claimant for a food subject to a detention order under subsection (a) if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334), may appeal the order to the Administrator.
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.
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.
A detention order under subsection (a) shall be considered to be terminated if, after 5 days, the Administrator has failed—
to provide an opportunity for an informal hearing; or
to confirm, modify, or terminate the order.
Effect of instituting court action
If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or section 304(a) of that Act (21 U.S.C. 334(a)) for a food subject to a detention order under subsection (a), the process for the appeal of the detention order with respect to such food shall terminate.
Condemnation of food
After confirming a detention order, the Administrator may order the food condemned.
Destruction of food
Any food condemned shall be destroyed under the supervision of the Administrator.
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.
Temporary holds at ports of entry
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.
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.
Prohibition on transfer
During the period in which food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.
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.
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.
Notification and recall
Notice to Administrator of violation
A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Administrator of the identity and location of the food.
Manner of notification
Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.
Recall and consumer notification
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—
cease distribution of the food;
notify all persons—
processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;
recall the food;
in conjunction with the Administrator, provide notice of the finding of the Administrator—
to consumers to whom the food was, or may have been, distributed; and
to State and local public health officials; or
take any combination of the measures described in this paragraph, as determined by the Administrator to be appropriate in the circumstances.
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—
have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator—
at the expense of the food establishment; or
in an emergency (as determined by the Administrator), at the expense of the Administration; and
by order, require, as the Administrator determines to be necessary, the person to immediately—
cease distribution of the food; and
notify all persons—
processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
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)—
to consumers to whom the food was, or may have been, distributed; and
to State and local public health officials; and
provide notice to the public of the names and addresses of retail locations at which recalled food products were available for sale.
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.
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—
persons that processed, distributed, or otherwise handled the food; and
persons to which the food has been transported, sold, distributed, or otherwise handled.
Informal hearings on orders
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.
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.
Post-hearing recall orders
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—
amend the order to require recall of the food or other appropriate action;
specify a timetable in which the recall shall occur;
require periodic reports to the Administrator describing the progress of the recall; and
provide notice of the recall to consumers to whom the food was, or may have been, distributed.
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.
Remedies not exclusive
The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.
The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 208, or 401 (or a regulation promulgated thereunder).
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.
Civil and criminal penalties
Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under the food safety law) may be assessed a civil penalty by the Administrator of not more than $1,000,000 for each such act.
Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
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.
Amount of penalty
Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering—
the gravity of the violation;
the degree of culpability of the person;
the size and type of the business of the person; and
any history of prior offenses by the person under the food safety law.
Review of order
The order may be reviewed only in accordance with subsection (c).
Except as provided in paragraphs (2) and (3), a person that knowingly produces or introduces into commerce food that is unsafe or otherwise adulterated or misbranded shall be imprisoned for not more than 1 year, fined in accordance with title 18, United States Code, or both.
A person that commits a violation described in paragraph (1) after a conviction of that person under this section has become final, or commits such a violation with the intent to defraud or mislead, shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
No person shall be subject to the penalties of this subsection—
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)—
the name, address, and contact information of the person from whom that person purchased or received the food;
copies of all documents relating to the person from whom that person purchased or received the food; and
copies of all documents pertaining to the delivery of the food to that person; or
if that person establishes a guaranty or undertaking signed by, and containing the name and address of, the person from whom the food was received in good faith, stating that the food is not adulterated or misbranded under the food safety law.
An order assessing a civil penalty against a person under subsection (a) shall be a final order unless the person—
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
simultaneously serves a copy of the petition by certified mail to the Administrator.
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.
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.
Collection actions for failure To pay
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.
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.
Penalties paid into account
shall deposit penalties collected under this section in an account in the Treasury; and
may use the funds in the account, without further appropriation or fiscal year limitation—
to carry out enforcement activities under the food safety law; or
to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
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.
Remedies not exclusive
The remedies provided in this section are in addition to, and not exclusive of, other remedies that may be available.
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.
No Federal employee, employee of a Federal contractor or subcontractor, or covered individual may be discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against, because of any lawful act done by the employee or covered individual to—
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 Federal regulatory or law enforcement agency;
a Member or committee of Congress; or
a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct);
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
refuse to violate or assist in the violation of any law, rule, or regulation.
For the purposes of this section, the term covered individual means an individual who is an employee of—
a food establishment;
a food production facility;
a retail food establishment other than a restaurant;
a nonprofit food establishment in which food is prepared for or served directly to the consumer;
a fishing vessel; or
an agent of any of the above.
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.
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.
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.
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.
Statute of limitations
An action under paragraph (1) shall be commenced not later than 90 days after the date on which the violation occurs.
A covered individual prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the covered individual whole.
Relief for any action described in paragraph (1) shall include—
reinstatement with the same seniority status that the covered individual would have had, but for the discrimination;
the amount of any backpay, with interest; and
compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.
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.
Administration and enforcement
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.
Inquiries and actions
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.
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.
Citizen civil actions
A person may commence a civil action against—
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
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.
In an action commenced under this section:
The action shall be commenced—
in the case of a civil action against a person, the United States district court for the district in which the defendant resides, is found, or has an agent; and
in the case of a civil action against the Administrator, any United States district court.
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.
The court may—
award damages, in the amount of damages actually sustained; and
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.
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.
Submission of plan
Not later than 180 days after the enactment of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:
The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.
Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.
The plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:
The timetable for transfer and identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred promptly to the Administration under the plan.
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.
Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.
Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.
Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.
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.
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).
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—
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
the end of the 12-month period beginning on the date of the enactment of this Act.
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.
Supersedes existing law
Paragraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.
Provision of assistance by officials
Until the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the date of the enactment of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.
Services and personnel
During the transition period, upon the request of the Administrator, the head of any executive agency may provide services or detail personnel to assist with the transition.
During the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the date of the enactment of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.
While acting pursuant to paragraph (1), such officers shall receive compensation at the higher of—
the rates provided by this Act for the respective offices in which they act; or
the rates provided for the offices held at the time of designation.
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.
Transfer of personnel, assets, obligations, and function
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.
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.
Completed administrative actions
The enactment of this Act or the transfer of functions under this Act shall not affect any order, determination, rule, regulation, tolerance, guidance, permit, personnel action, agreement, grant, contract, certificate, license, registration, user fees, privilege, or other administrative action issued, made, granted, or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions.
Subject to the authority of the Administrator under this Act—
pending proceedings in an agency, including notices of proposed rulemaking, and applications for licenses, permits, certificates, grants, and financial assistance, shall continue notwithstanding the enactment of this Act or the transfer of the agency to the Administration, unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance or modification could have occurred if such enactment or transfer had not occurred; and
orders issued in such proceedings, and appeals therefrom, and payments made pursuant to such orders, shall issue in the same manner on the same terms as if this Act had not been enacted or the agency had not been transferred, and any such order shall continue in effect until amended, modified, superseded, terminated, set aside, or revoked by an officer of the United States or a court of competent jurisdiction, or by operation of law.
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.
After the transfer of functions from a Federal agency under this Act, any reference in any other Federal law, Executive order, rule, regulation, directive, document, or other material to that Federal agency or the head of that agency in connection with the administration or enforcement of the food safety law shall be deemed to be a reference to the Administration or the Administrator, respectively.
Statutory reporting requirements
Statutory reporting requirements that applied in relation to such an agency immediately before the date of the enactment of this Act shall continue to apply following such transfer if they refer to the agency by name.
Section 5313 of title 5, United States Code, is amended
by inserting at the end the following new item:
Administrator of Food
Additional technical and conforming amendments
Not later than 60 days after the submission of the reorganization plan under section 501, the President shall prepare and submit proposed legislation to Congress containing necessary and appropriate technical and conforming amendments to the Acts listed in section 3(15) of this Act to reflect the changes made by this Act.
The Administrator may promulgate such regulations as the Administrator determines are necessary or appropriate to perform the duties of the Administrator.
Authorization of appropriations
There are authorized to be appropriated such sums as are necessary to carry out this Act.
Limitation on authorization of appropriations
For the fiscal year that includes the date of the enactment of this Act, the amount authorized to be appropriated to carry out this Act shall not exceed—
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
the amount appropriated for those agencies for that purpose for the preceding fiscal year, if, as of the date of the enactment of this Act, appropriations for those agencies for the fiscal year that includes such date have not yet been made.