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The purpose of these pages is to introduce U.S. laws and international standards relating to food safety. There are several topics, however, such as food product labeling, that extend beyond this primary issue.

The discussion begins with some thoughts on "why we are concerned about the safety of our food."

Concerns about Food Safety

Everyone needs, and probably wants, assurance that the food we consume 1) will not make us sick, that it has not spoiled, nor does it contain micro-organisms or foreign substances that will harm us, and 2) will meet our needs for calories, vitamins, minerals, protein, fat, carbohydrates, and other nutrients. Restated, our concern is that the food we consume has been produced, processed, packaged, stored, and prepared in such ways as to protect its integrity, that it remains safe for us to consume, and that it will meet our nutritional needs.

Over the past 150 years, people have come to rely on others to produce, process, package, store, and prepare our foods (in 2007, only 51.2% of our (U.S.) food expenditures were for at-home consumption; see USDA ERS data at http://www.ers.usda.gov/AmberWaves/November08/Indicators/Indicators.htm).  Agriculture producers, food processors, retailers, and food preparers are commingling much larger quantities of food (e.g., hundreds of pounds of ground beef from numerous animals are mixed in a single vat), commingling more ingredients (e.g., preparing a ready-to-eat food may include grain, meat, eggs and dairy products), adding more substances (e.g., seasoning, color, vitamins, and preservatives), and distributing the food product over a large geographic area.  Thus a small quantity of contaminated meat, for example, could adversely impact a large quantity of product distributed to a large number of consumers over a wide geographic area. It is no longer a situation where each family produces, preserves and prepares its own food.  We know less about what we consume than our ancestors who had to grow, hunt, gather and prepare their own food. 

One reaction is that this shift in the past 150 years has not been an improvement.  This is based on the idea that our ancestors knew how their food was produced, preserved and prepared, and that with this information, they would not eat food they suspected was not safe.  But we also know that many of our ancestors became ill from eating their own food, so that method was not foolproof.

The shift to not producing and preparing our own food reflects our nation's (the world's?) industrialization and resulting urbanization.  The shift also reflects the associated mechanization of the agriculture and food industry (which coincides with the industrialization of other sectors of our economy).

• Embedded in "industrialization" is advances in technology; that is, advances in transportation technology that allows food to be moved further, and advances in food processing and storage technologies which allow different products to be produced in larger quantities, to be stored longer, and transported further.
• These technologies allow producers to provide food for more than themselves and to sell the excess to others.
• Industrialization provided employment opportunities that allow persons to earn an income with which to purchase food produced by someone else. The income also enables the worker to buy foods produced in other regions that can now be transported to the consumer. Restated, industrialized impacted consumer demand for food. Only 9.8% of U.S. disposable income was spent on food in 2007 (see http://www.ers.usda.gov/AmberWaves/November08/Indicators/Indicators.htm).
• In addition, we have a better understanding of the science behind food and food safety concerns.
  

The fundamental reason for addressing food safety is to minimize the risk that consumers become ill from the food they eat.  A closely related objective for food law is that consumers are provided adequate and accurate information they can use when deciding which foods they want to consume. These two objectives (i.e., reducing the risk that food is unsafe and providing consumers with information they can use in making their decisions) are the basis for U.S. food laws as well as the food laws of many other nations.

“The World Health Organization (WHO) and Food and Agriculture Organization (FAO) define food safety as food that is free from all hazards, whether chronic or acute, that may make food injurious to the health of the consumer.”  Elmi in Food safety: current situation, unaddressed issues and the emerging priorities at http://www.emro.who.int/Publications/EMHJ/1006/PDF/13%20Food%20safety.pdf citing Assuring food safety and quality: guidelines for strengthening national food control systems. Rome, Food and Agriculture Organization of the United Nations and World Health Organization, 2003.

This web page is an opportunity to briefly consider why food could be dangerous to a consumer.

“Sources of food contamination are almost as numerous and varied as the contaminants themselves. These include everything from preharvest conditions to contamination introduced during processing, packaging, transportation, and preparation. Some of CFSAN's current areas of food safety concern are:

• biological pathogens (e.g., bacteria, viruses, parasites)
• naturally occurring toxins (e.g., mycotoxins, ciguatera toxin, paralytic shellfish poison)
• dietary supplements (e.g., ephedra)
• pesticide residues
• toxic metals (e.g., lead, mercury)
• decomposition and filth (e.g., insect fragments)
• food allergens (e.g., eggs, peanuts, wheat, milk)
• nutrient concerns (e.g., vitamin D overdose, pediatric iron toxicity)
• dietary components (e.g., fat, cholesterol)
• radionuclides
• TSE-type diseases (e.g., chronic wasting disease in elk)
• product tampering.”

As will be explained in a subsequent section, the Center for Food Safety and Applied Nutrition (CFSAN) is part of the Food and Drug Administration (FDA) in the Department of Health and Human Services.

Why food would make a consumer ill?

The following list suggest reasons why a food product may lead to consumer illness.

• The food was produced from a spoiled or contaminated product; for example, it was produced from a diseased animal, a spoiled plant, a crop with a pesticide residue, or an animal with carryover medication.
• The food has spoiled as a result of natural processes.
• The food was contaminated by something that was added to the food or something that the food came in contact with.
  • A substance being added to the food during processing may have been inadvertently contaminated, such as a contaminated ingredient; the food also may be contaminated as a result of being processed with contaminated water or coming in contact with equipment or a surface that is contaminated.
  • A substance was intentionally added to aid production (such as applying a pesticide) or to enhance the product (such as adding a nutrient supplement e.g., adding a vitamin to a breakfast cereal), but the substance unexpectedly made the food dangerous to the consumer.
  • A substance was intentionally added to the food for economic gain for the processor, such as reducing the cost of producing the food. Some past examples include adding water to milk or using a lower quality flour (e.g., flour derived from beans rather than wheat) to produce a dough product.
  • Intentionally adding a substance for the purpose of making the consumer ill; that is, a malicious attacks on the food system.  An example would be a terrorist attack on the food system or a frustrated employee contaminating food being processed or prepared by the employer's business.
• The food was contaminated by something it came in contact with; e.g., dirty or contaminated equipment in a processing facility, packaging material that impacts the integrity of the food product, or unsanitary preparation practices at home or at an establishment where food is prepared for consumption away from home.

These several examples illustrate some of the situations that can result in unsafe food.

One of the difficulties is the inability for today's consumers to sense the quality of food they are buying.  Yes, we can smell and see food and with experience recognize whether it is spoiled; but we cannot necessarily see or smell whether the food is nutritious, whether it contains something that will make us ill, or contain something that will cause some individuals to have an allergic reaction.  Also as food is packaged, we may no longer be able to see, smell or feel it before we buy it (such as a can of vegetables).  An alternative method had to be devised to replace knowing how our food was produced and prepared.

Society addressed these concerns through local, state and federal government.  In the United States, states responded by adopting laws that addressed food safety issues. The federal government responded a little slower and later; but once the federal government stepped in, it preempted state regulation (a legal outcome that was envisioned about 220 years ago when our system of government was devised; that is, federal law preempts state law (U.S. Constitution, Art. VI), even though it is doubtful that the drafters of the Constitution envisioned the world we live in today).  It also is helpful to recognize that our future expectations about food will likely be increasingly influenced by international standards; this trend is discussed in more detail on other pages of this site.

The government response has not been to decide which foods we eat; instead, the response has been, in part, to require certain information about food items be disclosed so consumers can decide for themselves. The response also has been to encourage education so consumer are capable of making appropriate decisions; and producers, processors, and preparers will be stopped when the product they are producing is unsafe (based on our understanding of science).  Likewise, the response has been to not regulate what occurs on in our homes, but to try influencing consumer decisions and behavior through education.  We understand, for example, that improper food preparation in the home can result in a food safety problem.

Government response to concerns about food safety can be summarized as

• Prohibiting "adulterated" and "misbranded" food products,
• Requiring certain steps be taken in producing, processing and preparing food, and that certain information be provided, and
• Encouraging consumer education.

Adulterated

From a legal perspective, food is considered adulterated if it is rendered unsafe as a result of being contaminated by a substance that had been inadvertently or intentionally added to the product. 

Note that a basic principle of US food law is that “adulterated” food is prohibited from being marketed.  Authority for this concept can be found in federal statutory law at 21 USC §331.

“The following acts … are prohibited:
(a) The introduction or delivery … into interstate commerce of any food … that is adulterated or misbranded.
(b) The adulteration or misbranding of any food … in interstate commerce.
(c) The receipt in interstate commerce of any food … that is adulterated or misbranded …”

The definition of adulterated is not limited to adding substances.  A food product is also adulterated if something has been removed from the food, something that the consumer would normally expect the food to contain, something that now that it has been removed reduces the value of the food, something that has been removed without the processor informing the consumer that it has been removed.  For example, removing fat from milk but still selling the product as whole milk.  Reference to this concept can be found in federal statutory law at 21 USC §342(b)(1).

“A food shall be deemed to be adulterated … If any valuable constituent has been in whole or in part omitted or abstracted therefrom …”

The concept of “adulterated” is addressed in more detail in another section.

Misbranded

A second concern is whether consumers have adequate and accurate information on which to base their decisions about the food they want to consume.  The law recognizes this concern by prohibiting the sale of any food that is misbranded.  As stated previously, authority for this concept can be found in federal statutory law at 21 USC §331.

“The following acts … are prohibited:
(a) The introduction or delivery … into interstate commerce of any food … that is adulterated or misbranded.
(b) The adulteration or misbranding of any food … in interstate commerce.
(c) The receipt in interstate commerce of any food … that is adulterated or misbranded …”

In implementing this prohibition, US federal law prohibits the sale of food that is being promoted or marketed with misleading information.  The law requires that certain information be provided to consumers, generally as part of the product label.  The law also addresses this concern by promoting consumer education and regulating advertising claims.

Adulterating and misbranding of foods are discussed throughout these materials.  These two concepts provide the foundation for addressing the concerns about the safety of food and information about food products.

 

Consumer response to concerns about food safety generally are 1) to stop buying a product that is perceived as unsafe, as well as 2) to bring legal action against a food business that provided unsafe food which led to illness or death of the consumer. Both consumer responses have an adverse economic impact on the food business -- a motivator for food businesses that generally is equal to or stronger than government regulation.

The purpose of this site is to provide an overview of these responses. U.S. federal law is emphasized, but the role of the state and local governments also is addressed, as well as the influence of international response to food safety concerns.

The focus of this web site is on food safety law but the discussion will briefly address tangential topics; for example,

• the relationship between pesticide residue on food products and more general environmental laws;
• retail sale of food products and displaying unit prices;
• food standards and commodity grading; and
• interaction among biotechnology, the definition of adulterated foods, and intellectual property rights. 

These are only a few examples of where food safety issues blend with other legal issues.  The distinction between a food safety concern and a related issue is not always clear; in those situations, the best approach may be to remind ourselves that our focus is on the laws intended to assure a safe food supply.

Some Commonly-Used Terminology

The discussion has focused on food safety; sometimes there are references to food security, food protection, and similar terms.  A question is whether these terms have the same meaning and can be used interchangeably, or whether they are referencing different concepts.  Although there does not appear to be a general agreement as the meaning of the terms, I would offer some observations.

Food security appears to have at least two definitions.  Sometimes within the US, food security is used interchangeably with food safety.  Outside the US, food security often means the concern about assembling a food supply that meets the nutritional and caloric requirements of the consumers.  I would suggest we use the “international” definition of food security; that is, having enough food.

Food safety then can be used to mean the concern over whether the food will make the consumer ill.

Food protection is apparently defined as sheltering our food from intentional attacks that are intended to make the consumer ill.  Agro-security, bio-security and similar terms often are used to refer to concerns over intentional attacks on our food system.

Risk Analysis -- a strategy or systematic practice to reduce, eliminate, or avoid a risk to health; it recognizes that 1) the cost of guaranteeing safe food outweighs the benefits, 2) resources should be spent on addressing the food safety concerns that pose the greatest risks relative to the cost of managing the risk (see benefit-cost analysis), and 3) risk analysis consists of risk assessment, risk management, and risk communication.

Risk Assessment -- scientific process of estimating food safety hazards that can be detrimental to human health

Risk Management -- from a government's prespective is "the process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing control options, including regulatory measures."

Risk Communication -- "an interactive exchange of information and options throughout the risk analysis process concerning hazards and risks, risk-related factors and perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties."

Benefit-cost analysis -- analytical process that compares the cost of implementing an activity or practice against the benefits of implementing the activity or practices; by preparing a benefit-cost analysis for several alternative practices, a decision maker can identify which practice will provide greatest relative benefit.

There are no standard definitions for several terms and that can lead to confusion, this is especially the situation for “food security.”

Additional Readings that may be of Interest

• Interesting site with a discussion of food safety and food security -- http://foodafrica.nri.org/index.html
• World Events Helped Define Food Safety (2006 NAFFS Yearbook) at http://naffs.mytradeassociation.org/3/3_10/world-events-helped-defin.shtml

Organizing the topics

To keep this complex topic understandable, it may be helpful to categorize some of the topics.  For example,

• The food industry can be divided into several broad sectors, such as production of agriculture commodities (sometimes referred to as pre-harvest), processing of commodities into food products (sometimes referred to as post-harvest), and preparing products for consumption (food service and retail sector);
• The levels of government can be described as national government (such as the U.S. federal government), state and local governments, and emerging international standards;
• Agricultural commodities can be broadly categorized such as grain, meat, poultry, fish, dairy, eggs, fruit and vegetables;
• Some food products, such as infant formula, are subject to more thorough regulation than other food products;
• U.S. law generally fits "prohibited acts" fit into two broad categories of adulteration and misbranding; and
• Food may be rendered unsafe by natural processes, human carelessness, or malicious attacks, such as bio-terrorism intent on interrupting our food supply.

The next page continues this introduction by presenting additional key concepts or points.

Last updated January 18, 2010

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