#### U.S. Food and Drug AdministrationU.S. Department of AgricultureMarch 3, 2000

**United States Food Safety System**(Table of Contents)
 U.S. Food Safety System
- Synthesis: The United States FoodSafety System   United States Food Safety System
 
I. Synthesis: The United States Food Safety  System
The United States Constitution prescribes the responsibilities of the government'sthree branches: executive, legislative and judicial, which all have roles that underpinthe nation's food safety system. Congress, the legislative branch, enacts statutesdesigned to ensure the safety of the food supply. Congress also authorizes executivebranch agencies****to implement statutes, and they may do so by developing andenforcing regulations. When enforcement actions, regulations, or policies lead todisputes, the judicial branch is charged to render impartial decisions. General U.S. lawsand statutes and Presidential Executive Orders establish procedures to ensure thatregulations are developed in a transparent and interactive manner with the public.Characteristics of the U.S. food safety system include the separation of powers amongthese three branches and transparent, science-based decision-making, and publicparticipation. 

The U.S. food safety system is based on strong, flexible, and science-based federal andstate laws and industry's legal****responsibility to produce safe foods. Federal,state, and local authorities have complementary and interdependent food safety roles****inregulating food and food processing facilities. The system is guided by the followingprinciples: (1) only safe and wholesome foods may be marketed; (2) regulatorydecision-making in food safety is science-based; (3) the government has enforcementresponsibility; (4) manufacturers, distributors, importers and others are expected tocomply and are liable if they do not; and (5) the regulatory process is transparent andaccessible to the public. As a result, the U.S. system has high levels of publicconfidence. 

Precaution and science-based risk analyses are long-standing and important traditionsof U.S. food safety policy and decision-making. U.S. food safety statutes, regulations,and policies are risk-based and have precautionary approaches embedded in them. 

The agencies' well-qualified science and public health experts work cooperatively toensure the safety of U.S. food. Scientists from outside government are regularly consultedto provide additional recommendations regarding technical and scientific methods,processes, and analyses used by regulators. The cutting-edge science that informs U.S.regulators is routinely shared internationally through interactions with organizationslike the Codex Alimentarius Commission, World Health Organization, the Food andAgriculture Organization, and the International Office for Epizootics.

The U.S. routinely and effectively deals with technological advances, emergingproblems, and food safety incidents. It is enhancing early warning systems about pathogensin food. The legislation granting authorities to agencies generally enables them to reviseregulations and guidance consistent with advances in technology, knowledge, and need toprotect consumers. 

U.S. food agencies are accountable to the President, to the Congress which hasoversight authority, to the courts which review regulations and enforcement actions, andto the public, which regularly exercises its right to participate in the development ofstatutes and regulations by communicating with legislators, commenting on proposedregulations, and speaking out publicly on food safety issues.
**II. United States Food Safety System
Introduction**
The U.S. food safety system is based on strong, flexible, science-based laws andindustry's legal responsibility to produce safe foods. Coordinated interactions amongfederal authorities having complementary and interdependent food safety missions, inpartnership with their state and local government counterparts, provide a comprehensiveand effective system. The implementation of the statutes and the food safety system overmany years has resulted in very high levels of public confidence in the safety of food inthe U.S.

Principal federal regulatory organizations responsible for providing consumerprotection are the Department of Health and Human Services' (DHHS) Food and DrugAdministration (FDA), the U.S. Department of Agriculture's (USDA) Food Safety andInspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS), and theEnvironmental Protection Agency (EPA). The Department of Treasury's Customs Serviceassists the regulatory authorities by checking and occasionally detaining imports based onguidance provided. Many agencies and offices have food safety missions within theirresearch, education, prevention, surveillance, standard-setting, and/or outbreak responseactivities, including DHHS's Centers for Disease Control and Prevention (CDC) and NationalInstitutes of Health (NIH); USDA's Agricultural Research Service (ARS); Cooperative StateResearch, Education, and Extension Service (CSREES); Agricultural Marketing Service (AMS);Economic Research Service (ERS); Grain Inspection, Packers and Stockyard Administration(GIPSA); and the U.S. Codex office; and the Department of Commerce's National MarineFisheries Service (NMFS).

The FDA is charged with protecting consumers against impure, unsafe, and fraudulentlylabeled food other than in areas regulated by FSIS. FSIS has the responsibility forensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled.EPA's mission includes protecting public health and the environment from risks posed bypesticides and promoting safer means of pest management. No food or feed item may bemarketed legally in the U.S. if it contains a food additive or drug residue not permittedby FDA or a pesticide residue without an EPA tolerance or if the residue is in excess ofan established tolerance. APHIS' primary role in the U.S. food safety network of agenciesis to protect against plant and animal pests and diseases. FDA, APHIS, FSIS, and EPA alsouse existing food safety and environmental laws to regulate plants, animals, and foodsthat are the results of biotechnology.
**A. Laws And Implementing Regulations

The three branches of U.S. government -- legislative, executive, and judicial -- allhave roles to ensure the safety of the U.S. food supply. Congress enacts statutes designedto ensure the safety of the food supply and that establish the nation's level ofprotection. The executive branch departments and agencies are responsible forimplementation, and may do so by promulgating regulations, which the U.S. publishes in the*Federal Register* and which are also electronically available. Characteristics ofthe U.S. food safety system are the separation of powers and science-baseddecision-making. Agency decisions under U.S. food safety laws can be appealed to thecourts which are empowered to settle such disputes.

Food safety statutes enacted by Congress provide regulatory agencies with broadauthority but also set limits on regulatory actions. The statutes are drafted to achievespecific objectives. Food safety agencies then develop regulations that give specificdirection and establish specific measures. When new technologies, products, or healthrisks must be addressed, agencies have the flexibility to revise or amend regulationsgenerally without need for new legislation. Agencies are able to maintain theirstate-of-the-art scientific methods and analyses because changes of this type can be madeat the administrative/technical level.

Major U.S. food safety authorizing statutes include the Federal Food, Drug, andCosmetic Act (FFDCA), the Federal Meat Inspection Act (FMIA), the Poultry ProductsInspection Act (PPIA), the Egg Products Inspection Act (EPIA), Food Quality Protection Act(FQPA), and Public Health Service Act. 

Procedural statutes, which regulatory agencies must follow, include the AdministrativeProcedure Act (APA), the Federal Advisory Committee Act (FACA), and the Freedom OfInformation Act (FOIA). The APA specifies requirements for rulemaking (i.e., the processby which federal agencies formulate, amend, or repeal a regulation and the processpermitting any interested party to petition for the issuance, amendment, or repeal of aregulation). Substantive regulations promulgated by an agency under the APA have the forceand effect of law. FACA requires that certain kinds of groups whose advice is relied uponby the government be chartered as advisory committees, that they be constituted to providebalance, to avoid a conflict of interest, and to hold committee meetings in public with anopportunity for comment from those outside the committee. The FOIA provides the publicwith a statutory right to access federal agency information. 

U.S. food safety programs are risk-based to ensure the public is protected from healthrisks of unsafe foods. Decisions within these programs are inherently science-based andinvolve risk analyses. Risk assessment is useful in understanding the magnitude of theproblem faced, and it assists the agency in determining an appropriate risk managementresponse. 

The regulatory development process is conducted in an open and transparent manner.Regulations are developed and revised in a public process that not only allows, butencourages, participation by the regulated industry, consumers, and other stakeholdersthroughout the development and promulgation of a regulation. In developing new regulationsand revising existing regulations, the agencies often provide the public a preliminarydiscussion and opportunity for comment by publishing an Advance Notice of ProposedRulemaking (ANPR). It lays out the issues, presents the agency's suggested resolution, andsolicits alternative solutions. The information received from the public is used by theagency to decide whether and how to pursue rulemaking further. All significant publiccomments must be addressed in the final regulation. The next steps are publication of aproposed regulation and publication of a final regulation, which is enforceable, withopportunities for public comment. The APA requires that the final regulation be justifiedby policy rationale, scientific bases, and legal authority.

When confronted by a particularly complex issue where advice is needed from experts whoare not part of the agency, the regulatory agency may choose to hold a public meeting orconvene an advisory committee meeting. Open, public meetings, structured according to theagency's needs, bring together experts and stakeholders via an informal process. Thesemeetings are used to receive the public's input on a specific subject area or on theagency's future programs. An advisory committee meeting is structured more formally.Public meetings and advisory committee meetings are announced in the *Federal Register*and the meetings are held in public unless an exempt issue, such as trade secrets,confidential commercial information, or personal medical information, is being discussed. 

If a person or organization wishes to challenge an agency decision, the complainant maytake the agency to court. Thus, even after an agency issues a final regulation whichresponds to all comments received, an individual or organization may still challenge theagency decision. This legal action involves the third branch of the federal government,the judicial branch. The judiciary (the federal court system) plays a critical role in theregulatory process in that it reviews an agency's action in light of the substantive lawand procedural requirements. An independent judge or panel examines the whole agencyrecord of activity detailing what the agency did and why. If the court finds that theagency did not follow its statutory mandates, fulfil the procedural requirements, or havea rational basis for its action, the judicial system can overturn the agency's action. Thejudicial system also serves as a forum for agency-initiated enforcement actions.

Just as it is the responsibility of the food industry to sell only safe food, it islikewise its responsibility to obey applicable laws and regulations.
**B. Risk Analysis And the U.S.'s Precautionary Approach

1. Risk Analysis**
Science and risk analysis are fundamental to U.S. food safety policymaking. In recentyears, the federal government has focused more intently on risks associated with microbialpathogens and on reducing those risks through a comprehensive, farm-to-table approach tofood safety. This policy emphasis was based on the conclusion that the risks associatedwith microbial pathogens are unacceptable and, to a large extent, avoidable; and thatmultiple interventions would be required throughout the farm-to-table chain to make realprogress in reducing foodborne pathogens and the incidence of foodborne disease. Thiseffort followed many years of concentration on managing chemical hazards from the foodsupply by regulation of additives, drugs, pesticides, and other chemical and physicalhazards considered potentially dangerous to human health. It reflects the recognition thatthe approaches to analyses and review of biological hazards and safety concerns differfrom those presented by chemicals.

The President's Food Safety Initiative, announced in 1997, recognized the importance ofrisk assessment in achieving food safety goals. The Initiative called for all federalagencies with risk management responsibilities for food safety to establish theInteragency Risk Assessment Consortium. The Consortium is charged with advancing thescience of microbial risk assessment by encouraging research to develop predictive modelsand other tools.

The U.S. government has completed a risk analysis on *Salmonella**enteritidis*in eggs and egg products which included the first farm-to-table quantitative microbialrisk assessment. It is also conducting a risk analysis for *E. coli* 0157:H7 inground beef and has entered into a cooperative agreement with Harvard University for arisk assessment of the transmission of Bovine Spongiform Encephalopathy by foods. The U.S.is also carrying out a risk analysis for *Listeria monocytogenes* in a variety ofready-to-eat foods.

Regulatory agencies also have made progress in implementing various risk managementstrategies. An example can be found in Hazard Analysis Critical Control Point (HACCP)regulations. Instead of including in the text of the regulation those specific stepsindustry must take under a HACCP system, food safety agencies provide general requirementsand direct those being regulated to apply the guidelines and develop specific steps toachieve an effective HACCP program. HACCP systems are a risk management tool because theyenable the user to identify hazards reasonably likely to occur and to develop acomprehensive and effective plan to prevent or control those hazards. 

Performance standards for pathogen reduction and control represent another riskmanagement tool. For example, the U.S. has in place pathogen reduction performancestandards for *Salmonella* that slaughter plants and raw ground product must meet,and it also tests product to ensure that these standards are met. In the future, thegovernment may establish performance standards for other pathogens of public healthconcern and define what food establishments that produce, process, or handle food mustachieve.

Fair and objective regulatory decisions regarding food safety standards andrequirements rely on risk analysis performed by competent authorities, qualified to makescientifically sound decisions. Risk analysis consists of risk assessment, riskmanagement, and risk communication, which are interdependent.

Risk Assessment B Risk assessments are conducted in an objective manner. However,since data and scientific knowledge on any issue are never totally complete, an assessmentof absolute risk is impossible. By explicitly considering uncertainties in the data andanalyses, decisions can be made regarding the amount of uncertainty that is acceptable.U.S. policy decisions on procedures used for risk assessment can also ensure that risksare unlikely to be underestimated.

The first component of risk assessment, hazard identification, requires decisions onthe effort expended to identify hazards. In the U.S., these are established by law andexperience. Laws regarding the use of new food ingredients or pesticides require aprescribed effort to uncover any hazards before introduction into the food supply. Forproducts already on the market, hazards may be identified by experience (e.g., emergingpathogens) that require efforts to control risk.

The second component, hazard characterization, considers data regarding the potentialhazard at different exposure levels and modes, including which data are most relevant forcharacterizing the hazard. While human data are always most relevant, animal data areusually used to characterize a hazard. The U.S. generally relies on data from the mostsensitive species to characterize the risk. Where a safety threshold cannot be assumed,the U.S. may rely on linear mathematical models that are not likely to underestimate arisk. It is important to use the most realistic data and models consistent with currentscientifically sound knowledge. When information is not available that can identify whichis most realistic, data or models that can be shown not to underestimate hazards are used.

The third component, exposure assessment, must differentiate between short termexposure for acute hazards and long term exposure for chronic hazards. For acute hazards,such as pathogens, data on levels of pathogens causing illness in vulnerable populationgroups are important. For chronic hazards, such as chemicals that may cause cumulativedamage, a lifetime averaged exposure is relevant. 

Risk Management B Risk management is exercised by highly qualified regulatoryauthorities with the sole objective to provide high levels of protection to the U.S.consumer. Management of risk is necessary when much, some, little, or no data areavailable thus requiring knowledgeable experienced experts capable of makingscientifically defensible decisions in the interest of public health. Risk managementprinciples are set by law or by the risk manager's expert judgement to reduce risk to thelowest practical, or achievable, level. 

U.S. laws require that the safe use of a food additive, an animal drug, and a pesticidebe established before marketing; therefore risk management decisions are based on verysubstantial scientific evidence. For hazardous substances that are inherent components offoods (e.g., low levels of natural toxicants produced in potatoes) or unavoidablecontaminants of food (e.g., mercury in fish, aflatoxin in grains), government interventionoccurs when presence of a substance reaches a level known to present significant risk. Thequantity and quality of scientific evidence may vary with the type of risk managementdecision. 

As an example of risk management, every year the U.S. federal food agencies worktogether to develop a comprehensive, risk-based, annual sampling plan to detect drug andchemical residues in U.S. food. Violative residue information is used as the basis forstandard-setting and for enforcement and other follow-up activities. 

Risk Communication B Routine risk communication is inherent in the transparentregulatory process which is more fully described in Part D entitled,"Transparency." Transparent standards are employed to ensure fairness to allmembers of the food industry while protecting public health. U.S. law requires thegovernment to allow and consider comment on the factual basis for a decision when itestablishes regulations. Anyone can comment, including persons outside the U.S. There mustbe a substantial basis in law and fact for every rule. Information relied on by thegovernment is made available for anyone to review. Government scientists use publiccommunication media to explain to the public the science behind regulations. 

When there is a need for emergency risk communication, alerts are conveyed through anationwide telecommunication system linking all levels of the food safety system with thenationwide media so all citizens are made aware of the risk, and through globalinformation sharing mechanisms by which international organizations (WHO, FAO, Office ofInternational Epizootics and the World Trade Organization, if appropriate), regions suchas EU, and individual countries are informed immediately. 

Risk communication is critical during the risk assessment and management stages. TheU.S. is committed to openness and transparency of its work to protect the public fromfood-related health risks. For example, regulatory agencies provide public notification ofrecalls of food products. Information about recalls is also provided on the agency'swebsite, as are frequent reports of regulatory and enforcement actions taken againstregulated food establishments. EPA's pesticides website contains the full risk analysisfor specific pesticides, and risk analyses procedures have been made available to thepublic for comment. Where appropriate, risk analyses processes have been modified inresponse to these comments.

Another example of risk management are U.S. federal agency activities on the emergingissue of resistance from the use of antimicrobials in animals. Antimicrobial riskmanagement includes establishment of monitoring and resistance thresholds before a drugcan be approved; continuous monitoring of resistance in enteric bacteria from humans andfood animals; obtaining information on factors responsible for promoting resistance; andtaking regulatory actions as needed, including restrictions on a drug or removing it fromthe market.
**2. Precautionary Approach**
(**This approach is described in detail in the annex on Precaution In U.S. Food SafetyDecision Making.)**
The genesis of many health, safety, and environmental laws is associated with theprevention of undesirable events and the protection of public health and the environment.Specific prevention and protection measures reflect differing provisions of law,regulation, and circumstances. However, they all are risk-based. The precautionaryapproach is exercised in a variety of ways.

An example of the U.S. precautionary approach to risk is the control system foringredients in food and feed, such as the feeding prohibition of certain animal proteinsto ruminants to prevent the introduction of BSE in this country. In implementing thisprohibition through a regulation, the government followed existing APA procedures toexplain in the *Federal Register* why it is proposed to take the action, including adescription of the risk, and to evaluate the comments received from industry, academia,private citizens, and government agencies before publishing its final regulation. 

Another illustrative example of the precautionary approach is the pre-market approvalrequirements established by law for food additives, animal drugs, and pesticides. Theproducts are not allowed on the market unless, and until, they are shown by producers tobe safe to the satisfaction of the regulatory authorities. When the petition is reviewed,data are evaluated to determine exposure to the additive, including exposure to all likelyimpurities in the additive. The degree of testing considered necessary depends on theclass of chemical and exposure. The data or the lack of data drive a decision forapproval. The evaluation of all is documented. The final decision explaining the basis forall significant conclusions is published in the *Federal Register*. Personsdisagreeing with the decision may file an objection with the reasons for disagreeing andrequest a hearing. After administrative remedies for appeal are exhausted, the governmentmay be challenged in court on its approval or denial of a petition.
**C. Dealing With New Technologies, Products, and Responding to Problems**
In achieving the nation's farm-to-table food safety objective, the federal governmentis only one part of the equation. Federal agencies collaborate with state and localagencies and other stakeholders to encourage food safety practices and to offer assistanceto industry and consumers on practices that promote food safety.

The U.S. recognizes the regulated industry as a stakeholder and as the partyprincipally responsible for food safety. Establishments are responsible for producing foodproducts that meet regulatory requirements for safety. The government's role is to setappropriate standards and do what is necessary to verify that the industry is meetingthose standards and other food safety requirements. Consistent with modernization ofinspection systems and the farm-to-table initiatives, federal agencies use their resourcesas efficiently and effectively as possible to protect the public from foodborne illness.As an extension of HACCP, the U.S. is testing new meat and poultry inspection models todetermine whether or not additional protections can be provided consumers throughredeployment of some in-plant resources to the distribution segment of the farm-to-tablechain, which includes transportation, storage, and retail sale of products.

Federal food safety agencies regularly enter into partnerships with states and otherssuch as grower organizations and public interest groups to encourage improved productionpractices, to develop and foster food safety measures that can be taken on the farm and inmarketing channels to decrease public health hazards in food, to develop and implementsafer pest management practices, and to develop good agricultural practices to minimizepesticide residues and microbial risks.

The country's emergency response capability is sound and being enhanced continually.For example, U.S. food safety regulatory agencies participate in FoodNet, a network whoseobjectives are to determine the frequency and severity of foodborne diseases and theproportion of common foodborne diseases that result from eating specific foods anddescribe the epidemiology of new and emerging bacterial, parasitic, and viral foodbornepathogens.

Information on possible foodborne disease outbreaks from FoodNet and reports to stateand local health departments are followed up by those health departments in cooperationwith federal food agency authorities to determine the course and nature of the outbreak.Appropriate public advisories are issued and enforcement actions taken about the productsinvolved as soon as possible.

In addition, a new technique has been developed using pulsed-field gel electrophoresis(PGE), which permits CDC to match distinctive patterns of pathogenic materials that causefoodborne illness. Using these "fingerprinting" techniques, the single casualfactor of a foodborne illness outbreak can be traced using epidemiological investigationand PGE. This has led to intervention and, in at least one recent case, cessation of aserious foodborne illness outbreak. Both FoodNet and PulseNet are basic building blocksfor the U.S. system of foodborne illness prevention.
**D. Transparency**
Various U.S. statutes and executive orders establish procedures to ensure thatregulations are developed in an open, transparent, and interactive manner and that, asappropriate, the regulatory process is similarly open to the public. Regulations and theirimplementation must lead to fulfillment of objectives for the public good such asprotecting health, safety, and environment. 

The APA specifies requirements for rulemaking (i.e., the process by which federalagencies formulate, amend, or repeal a regulation and the process permitting anyinterested party to petition for the issuance, amendment, or repeal of a regulation).Substantive regulations promulgated by an agency under the APA have the force and effectof law. Under the APA, a notice of proposed rulemaking must be published in the *FederalRegister*, an official daily publication which is available through subscription andthrough the Internet at no cost. All regulations and legal notices issued by federalagencies and the President are published in the *Federal Register*. In addition,though the Internet is not an official publication, U.S. government agencies makeextensive use of it to provide information on regulatory activities and enhance thetransparency of their processes.

The President issued an Executive Order to strengthen agencies' processes forpromulgating regulations. Also, several states require analysis of the impacts ofregulations: there are requirements to analyze the impact of the regulation on smallbusiness (the Regulatory Flexibility Act); the impact of the regulation on the environment(the National Environmental Policy Act); and the impact of any information collectionrequirements contained in the regulation (the Paperwork Reduction Act). 

FACA requires that certain kinds of groups whose advice is relied upon by thegovernment for establishing regulations be chartered as an advisory committee, beconstituted to provide balance and to avoid conflicts of interest, and to hold itsadvisory meetings in public with an opportunity for comment from those outside thecommittee. 

FOIA's purpose is to expand the areas of public access to information beyond thoseoriginally set forth in the APA. Any person residing in the United States has a right ofaccess to a wealth of government information and records, subject only to certain limitedexemptions. 

To ensure the broadest possible participation by the public, agencies publish theirproposals on Internet sites and call attention to the proposed or final rule through pressreleases. The U.S. news media and interest groups follow the *Federal Register* andagency Internet sites closely and publish information about proposed and finalregulations. In addition, U.S. agencies may hold public meetings to solicit input frominterested persons. Meetings often include media coverage. For example, numerous publicmeetings were held to solicit input on the Food Safety Strategic Plan being developed bythe President's Council on Food Safety; on the draft Guide to Minimize Microbial FoodSafety Hazards for Fresh Fruits and Vegetables; as part of the process to develop the FoodSafety Initiative; and on bioengineered foods, among other topics. 

Regulatory agencies often offer guidance on ways to achieve compliance with regulatoryrequirements. Such guidance may describe situations where a food could become adulteratedor misbranded or may describe data that would be needed to establish safety. Although suchguidance does not have the effect of law (one need not follow it to demonstrate that afood is safe and lawful, provided that all statutory and regulatory requirements are met),such advice is helpful to the food industry and to the consumer.

The Codex Alimentarius Commission (Codex) is the major international body for promotingthe health and economic interests of consumers while encouraging fair international tradein food. Within the United States, Codex activities are coordinated by officials fromUSDA, HHS, and EPA. The U.S. Codex Office provides information via the *Federal Register*and the Internet concerning the Codex and its activities internationally and in the U.S.
**E. System Accountability**
U.S. food agencies are highly accountable to government's three branches and to thepeople: - U.S. food agencies are accountable to the President B the chief executive B who has    constitutional responsibility to assure that laws are faithfully executed; who appoints    senior officials, and whose Office of Management and Budget clears significant    regulations.
- U.S. food agencies are accountable to the Congress, the legislative branch of the U.S.    government, which provides the food agencies their authority and budget; whole committees    hold frequent oversight hearings; and the Senate must confirm the nomination of cabinet    officers and senior officials.
- U.S. food agencies are accountable to the courts, the judicial branch of the U.S.    government, which review food agency regulations and enforcement actions.
- Most importantly, U.S. food agencies are accountable directly to members of the public,    who regularly exercise their right to participate in the development of laws and    regulations, such as commenting on proposed regulations; whose guidance is sought in    frequent public meetings; and who provide strong support for food safety regulation, the    nutrition label, and other regulatory initiatives. 

 See the Table of Contentsfor additional U.S. Food Safety System documents
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