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Introduction to Food Law

Concerns about Food Safety
Overview of Key Points

US Food System
Scope of the Challenge:  Farm-to-Table

How US Law is Created

Finding US Food Safety Law Information

Overview of US Food Law
Government "Players" in US Food Law
Requirements for Food Businesses
Producer/Processor/Preparer Liability
Looking Forward/Future Issues


Overview of Key Points

This page lists some of the key points emphasized in this study of food laws.

1.  Food laws will not guarantee that food is safe; it is too expensive to guarantee that all food is safe for consumption.  The less expensive approach, but still politically and socially accepted, is for food laws to reduce the risk of unsafe food.

  • To understand the risk of unsafe food and to manage that risk requires an application of science, such as biology, microbiology, chemistry, pathology, engineering, etc.


2.  U.S. food law has defined the food industry into four sectors:

  • production sector which produces agricultural commodities (e.g., farms, ranches, vineyards, feedlots)
  • processing sector (e.g., food manufacturers that process, transport and store food products)
  • retail and food service sector (e.g., grocery stores, restaurants, cafeterias), and
  • consumers.

These categories may not have been explicitly intended but have emerged as U.S. food law has evolved since the late 1800s.


3.  Government oversight of the four sectors can be summarized as follows; note that the government oversight strategy varies by sector and the oversight strategies are changing.

  • production sector -- primary strategy has been to educate producers so the commodities are safe for consumption; the educational programs have been facilitated by federal agencies and state universities.  However, this strategy is evolving to include more 1) direct government regulation and 2) influence from processors who insist that producers follow steps to reduce the risk that agricultural commodities are unsafe for consumption.
  • processing sector -- primarily regulated by U.S. federal law in coordination with state law and municipal health codes; the primary U.S. federal agencies are 1) the U.S. Food and Drug Administration (FDA) and 2) the Food Safety Inspection Service (FSIS) with the U.S. Department of Agriculture (USDA).
  • retail and food service sector -- primarily regulated by state law and municipal health codes with increasing guidance from the FDA, and
  • consumers -- the primary strategy is 1) to educate the consumers about food safety (and nutrition) and 2) to provide consumers information so consumers can make informed decisions.  Consumers decide whether to participate in educational programs; federal, state and municipal laws direct what information food businesses must provide consumers.


4. Federal law dominates the regulation of food safety in the United States but there is close interaction with state and local authorities, plus an expanding role and impact of international food standards.

  • The basic approach to addressing food safety has not changed much over the past 100 years since the first U.S. federal laws were adopted in the early 1900s, but the laws have been refined/amended.
  • The major prohibitions in food safety laws are the sale of adulterated and misbranded food products; adulterated and misbranded have broad definitions and address a number of food safety concerns.


5. Food must be in compliance with the laws of the jurisdiction where the food is located.

  • Food that is moved among government jurisdictions (such as food that is transported from one nation to another nation) is subject to more than one set of food laws. Complying with more than one set of requirements can complicate the movement of food among jurisdictions.
  • Nations are trying to harmonize their food laws to reduce the challenge of complying with a variety of food laws, and thereby advance the availability of food through international trade.


6. The two U.S. federal agencies with primary responsibility for food safety in the UnitedStates are

The Environmental Protection Agency also has an expanding role (see EPA Topics -- Food Safety). In addition, the National Center of Infectious Diseases in the Centers for Disease Control and Prevention (CDC) provides information about food-borne illnesses and responds to outbreaks of food-borne illnesses.

  • The FSIS/USDA has primary responsibility for meat, poultry, and eggs; FDA has primary responsibility for most other food products.  The line defining the jurisdictions between these two agencies feels blurred in some situations.

"FDA's responsibility in the food area generally covers all domestic and imported food except meat, poultry, and frozen, dried and liquid eggs, which are under the authority of the U.S. Department of Agriculture (USDA's Food Safety and Inspection Service (FSIS), the labeling of alcoholic beverages (above 7% alcohol) and tobacco, which are regulated by the U.S. Department of the Treasury's Bureau of Alcohol, Tobacco, and Firearms (ATF), and the U.S. Environmental Protection Agency (EPA), which establishes tolerances for pesticide residues in foods and ensures the safety of drinking water." Excerpt from Center for Food Safety and Applied Nutrition

Also see USDA and HHS Agencies Work Together to Examine the Jurisdiction of Certain Food Categories and FDA and FSIS battle over sandwich jurisdiction.

  • On some issues, FDA and FSIS/USDA use similar approaches (such as defining adulterated); on other issues, the two agencies use very different approaches (e.g., inspections of processing firms and food products).


7. The initial focus of U.S. food safety laws in the early 1900s was on manufactured or processed food products. That is still a major emphasis today, but with our understanding that food can become unsafe at many different points in the food system, the focus of food safety is expanding to also encompass production of agriculture commodities and final food preparation. Thus, the need to address food safety extends from farm-to-table.

  • "In addition to a focus on public health, another important principle on which all of our food safety activities are based is the need to take a farm-to-table approach." Excerpt from Principles Underlying the USDA Food Safety Strategy.
  • For example, consider all the persons involved in producing a pizza. The primary ingredients may be cheese, ground beef, pork sausage, tomato sauce, spices, green peppers, mushrooms, olive oil and crust.

    Now think about the steps involved with each ingredient.

    • Olives raised in Italy, processed into oil, transported to the United States, stored and moved again; finally the package is opened and the oil applied to the crust.
    • Wheat is raised on a North Dakota farm, transported to the elevator, shipped by rail to a mill for grinding; the flour is trucked to the frozen dough processing firm where it is mixed with water and other ingredients, packaged and frozen; the dough is then sent to the pizza manufacturing business.
    • The calf is born in Montana, backgrounded in South Dakota with 1,200 other calves, and finished with 10,000 feeders in Kansas; it is slaughtered in Nebraska and the meat is shipped to Texas where it is combined with meat from Arkansas, ground and shipped to the pizza manufacturing business.
    • The tomato is raised in California (or Spain), processed into paste, transported to ...

    And the list goes on -- also consider the pig, green pepper, mushroom, spices, and especially the cheese (that is, the dairy industry). How many dozens of processes, businesses, and people are involved in producing the pizza? Each step (production, processing, packaging, storage, transportation) could render the final product unsafe. How do we assure the pizza will not make the consumer ill?

    • The safety of food cannot be guaranteed or fully assured. To reach that level of safety is too expensive. The best that can be done at this time is to reduce the likelihood or risk of a food-related health problem. Perhaps the last question in the previous paragraph should read "how do we minimize the risk that the pizza will make the consumer ill?"

8. The decisions about what to eat will be made by the consumer, not a government authority; but the law requires that information about the food product be available so consumers can make an informed choice.


9. Government inspection of the food industry continues to be an important strategy, but one must understand the recent shift of responsibility to the firms with the adoption of Hazardous Analysis and Critical Control Points (HACCP) plan requirements.


7. Other U.S. federal agencies have a role in addressing food safety concerns; e.g., Federal Trade Commission, Animal and Plant Health Inspection Service, Agricultural Marketing Service, National Marine Fisheries Service, and Customs & Border Protection.

  • Likewise, the role of state and local authorities in addressing food safety cannot be overlooked, e.g., Food Code.
  • In addition, global trade of agriculture commodities and food products raises issues about accepting imports and preparing to export.


8. As stated previously, it is too expensive to guarantee that food is safe. The alternative is to strive to reduce the risk that the food is unsafe. Since the 1990s, much has been written about addressing food safety on the basis of Risk Analysis. The following statements introduce this concept.

“The risk analysis process comprises three separate elements: risk assessment, risk management and risk communication. It is widely recognized as the fundamental methodology underlying the development of food safety standards. Decisions are needed to determine what the hazards are and to identify their immediate, interim and long-term effects on human health (risk assessment); to establish the appropriate measures of control to prevent, reduce or minimize these risks (risk management); and to determine the best way to communicate this information to the affected population (risk communication).” Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm.

The following statements are drawn from "Introductions to Food Safety Risk Analysis" at http://www.foodrisk.org/risk_analysis/intro.cfm.

Risk analysis is defined … as "A process consisting of three components: risk assessment, risk management and risk communication."1

  • Risk assessment is defined … as "A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization."
    • Hazard identification is "The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods."
    • Hazard characterization is "The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable."
    • Exposure assessment is "The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant."
    • Risk characterization is "The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment."1

  • Risk management is defined … as "The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options."1

The World Health Organization (WHO) includes the following statements about risk management (at http://www.who.int/foodsafety/micro/riskmanagement/en/index.html).

"The four components of risk management frameworks can be summarized as follows:

  • Preliminary risk management activities comprise the initial process. It includes the establishment of a risk profile to facilitate consideration of the issue within a particular context, and provides as much information as possible to guide further action. As a result of this process, the risk manager may commission a risk assessment as an independent scientific process to inform decision-making.
  • Evaluation of risk management options is the weighing of available options for managing a food safety issue in light of scientific information on risks and other factors, and may include reaching a decision on an appropriate level of consumer protection. Optimization of food control measures in terms of their efficiency, effectiveness, technological feasibility and practicality at selected points throughout the food-chain is an important goal. A cost-benefit analysis could be performed at this stage. [emphasis added]
  • Implementation of the risk management decision will usually involve regulatory food safety measures, which may include the use of HACCP. Flexibility in the choice of individual measures applied by industry is a desirable element, as long as the overall programme can be objectively shown to achieve the stated goals. Ongoing verification of the application of food safety measures is essential.
  • Monitoring and review is the gathering and analyzing of data so as to give an overview of food safety and consumer health. Monitoring of contaminants in food and foodborne disease surveillance should identify new food safety problems as they emerge. Where there is evidence that required public health goals are not being achieved, redesign of food safety measures will be needed. "

Overview of HACCP by the National Agricultural Library, USDA:  A Focus on Hazard Analysis and Critical Control Point (HACCP)

  • Risk communication is defined … as "The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions."1 Excerpts from “Introductions to Food Safety Risk Analysis” at http://www.foodrisk.org/risk_analysis/intro.cfm.

Consumers require access to adequate information about potential hazards and appropriate precautions to be taken in the final preparation and serving of food. In addition, consumers need to be aware of and to understand food safety control measures implemented by their government in the interest of consumers' health.

Communication provides the public with the results of expert scientific review of food hazard identification and assessment of the risks to the general population or to specific target groups such as infants or the elderly. Certain people, such as those who are immunodeficient, allergic or nutritionally deficient, require particular information. Communication provides the private and public sectors with the information necessary for preventing, reducing or minimizing food risks to acceptably safe levels through systems of food quality and safety management by either mandatory or voluntary means. It also provides sufficient information to permit the populations with the greatest level of risk from any particular hazard to exercise their own options for achieving even greater levels of protection.”  Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm

Some resources to learn more about risk analysis:

These excerpts introduce the three concepts of risk assessment, risk management and risk communication, but the discussion is at a relatively high level that may not have much practical application for food businesses.  For example, risk management for a food business would not likely focus on public policy, but instead would address “business strategies and practices that minimize the likelihood that a food product is rendered unsafe as a result of the business’ activity.”  Risk communication, at a business level, may focus on consumer information about the product and its safe handling, as well as public explanation and reassurance when a problem has arisen.  Risk assessment at the firm level may focus on studying the firm's current production practices to determine whether they may lead to an unsafe food product.  Like the definitions presented above, risk assessment at the firm level likely has several components.  The firm also needs to assess the benefits and cost of various risk management practices. Thus the components of risk analysis introduced above may be appropriate for food businesses, but they may have different meanings at the firm level.

The following statement seems to address risk management more at the firm level, rather than the policy level, but even this statement may require some revision to clearly state the application of risk management at the firm level.

“The goal of the risk management process is to establish the significance of the estimated risk, to compare the costs of reducing this risk to the benefits gained, to compare the estimated risks to the societal benefits derived from incurring the risk and to carry out the political and institutional process of reducing the risk.”  Excerpt from http://www.fao.org/docrep/w8088e/w8088e07.htm

My attempt at describing the application of risk analysis at the firm level.

  • Risk Analysis – the idea that risk of unsafe food will never be eliminated so businesses will focus on the hazards that pose the greatest risks, and strategies or practices that provide the greatest reduction in risk (i.e., benefit).
  • Risk Assessment – careful study of the firm's current production practices to determine whether they may lead to an unsafe food product or an food-related health problem.
  • Hazard Identification – process of assessing risk of chemical, physical, biological or any other form of attack that may render food unsafe.
  • CARVER + Shock – process of assessing the risk of intentional attack on the food business
  • Risk Management – business strategies and practices that minimize the likelihood that a food product is rendered unsafe as a result of the business’ activity; some of these practices may be mandated; others may be adopted by the firm after a benefit/cost analysis.
  • Benefit/cost analysis – a numeric analysis to identify hazards that pose the greatest risk of unsafe food and the business practices that result in the greatest reduction of the risk of producing an unsafe food or creating a food-related health problem.
    • The business practice that is used reduce the risk of unsafe food is the "cost" in a benefit/cost analysis; the value of reducing the risk is the "benefit." The food business would be expected to direct its limited resources to the business practices that produce the greatest value of reduced risk. Restated, the firm would direct its resources to the activities that offer the greatest benefit/cost ratio.
  • Risk Communication – may likely involve 1) consumer information (education) about the product and its safe handling, and 2) public explanation and reassurance when a problem arises. It may be better to refer to point 2 of risk communication as crisis communication.


9. Two other thoughts that are increasingly underpinning the effort to minimize the risk of a food-borne illness: 1) base our efforts to minimize risk on our understanding of science and 2) maintain sufficient information (records) to track the movement of a food product through the food industry (traceability).


Closing thought:

Are the legal requirements imposed on the food industry the result of our understanding of science or motivated by economic and political interests?


The next page continues with an overview of the U.S. food system.


Last updated December 27, 2010

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