See also
- Adulterant
- List of foodborne illness outbreaks by death toll - includes contamination incidents
- Counterfeit medications
Adulteration is a legal offense and when the food fails to meet the legal standards set by the government, it is said to have been Adulterated Food. One form of adulteration is the addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of the actual quality of the food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed. [1] In the case of seafood, adulteration may refer to species substitution (mislabeling), which replaces the species identified on the product label with another species, or undisclosed processing methods, in which treatments such as additives, excessive glazing, or short-weighting are not disclosed to the consumer. [2]
Historians have recognized cases of food adulteration in Ancient Rome and the Middle Ages. Contemporary accounts of adulteration date from the 1850s to the present day.
In the United States, the Food and Drug Administration (FDA), regulates and enforces laws on food safety as well as Food Defense. The FDA provides some technical definitions of adulterated food in various United States laws.
The Federal Food, Drug, and Cosmetic (FD&C) Act 1988) [3] provides that food is "adulterated" if it meets any one of the following criteria:
Food also meets the definition of adulteration if:
Further, food is considered adulterated if:
The Federal Meat Inspection Act and the Poultry Products Inspection Act of 1957 contain similar provisions [4] for meat and poultry products. [21 U.S.C. § 453(g), 601(m).
Generally, if a food contains a poisonous or deleterious substance that may render it injurious to health, it is considered to be adulterated. For example, apple cider contaminated with E. coli O157:H7 and Brie cheese contaminated with Listeria monocytogenes are adulterated. There are two exceptions to this general rule. First, if the poisonous substance is inherent or naturally occurring and its quantity in the food does not ordinarily render it injurious to health, the food will not be considered adulterated. Thus, a food that contains a natural toxin at very low levels that would not ordinarily be harmful (for instance, small amounts of amygdalin in apricot kernels) is not adulterated.
Second, if the poisonous or deleterious substance is unavoidable and is within an established tolerance, regulatory limit, or action level, the food will not be deemed to be adulterated. Tolerances and regulatory limits are thresholds above which a food will be considered adulterated. They are binding on FDA, the food industry, and the courts. Action levels are limits at or above which FDA may regard food as adulterated. They are not binding on FDA. FDA has established numerous action levels (for example, one part per million methylmercury in fish), which are set forth in its booklet Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed.
If a food contains a poisonous substance in excess of a tolerance, regulatory limit, or action level, mixing it with "clean" food to reduce the level of contamination is not allowed. Deliberately mixing adulterated food with good food renders the finished product adulterated (FDA, Compliance Policy Guide [CPG § 555.200]).
Filth and extraneous material include any objectionable substances in foods, such as foreign matter (for example, glass, metal, plastic, wood, stones, sand, cigarette butts), undesirable parts of the raw plant material (such as stems, pits in pitted olives, pieces of shell in canned oysters), and filth (namely, mold, rot, insect and rodent parts, excreta, decomposition). Under a strict reading of the FD&C Act, any amount of filth in a portion of food would render it adulterated. FDA regulations, however, authorize the agency to issue Defect Action Levels (DALs) for natural, unavoidable defects that at low levels do not pose a human health hazard [21 C.F.R. § 110.110]. These DALs are advisory only; they do not have the force of law and do not bind FDA. DALs are set forth in FDA's Compliance Policy Guides and are compiled in the FDA and Center for Food Safety and Applied Nutrition (CFSAN) Defect Action Level Handbook.
In most cases, DALs are food-specific and defect-specific. For example, the DAL for insect fragments in peanut butter is an average of thirty or more insect fragments per 100 grams (g) [CPG § 570.300]. In the case of hard or sharp foreign objects, the DAL, which is based on the size of the object and the likelihood it will pose a risk of choking or injury, applies to all foods (see CPG § 555.425).
A portion of food is adulterated if it omits a valuable constituent or substitutes another substance, in whole or in part, for a valuable constituent (for instance, olive oil diluted with tea tree oil); conceals damage or inferiority in any manner (such as fresh fruit with food coloring on its surface to conceal defects); or any substance has been added to it or packed with it to increase its bulk or weight, reduce its quality or strength, or make it appear bigger or of greater value than it is (for example, scallops to which water has been added to make them heavier).
The fact that a food is contaminated with pathogens (harmful microorganisms such as bacteria, viruses, or protozoa) may, or may not, render it adulterated. Generally, for ready-to-eat foods, the presence of pathogens will cause the food adulterated. For example, the presence of Salmonella on fresh fruits or vegetables or in ready-to-eat meat or poultry products (such as luncheon meats) will render those products adulterated.
For meat and poultry products, which are regulated by USDA, the rules are more complicated. Ready-to-eat meat and poultry products contaminated with pathogens, such as Salmonella or Listeria monocytogenes, are adulterated. (Note that hotdogs are considered ready-to-eat products.) For raw meat or poultry products, pathogens will not always be adulterated (because raw meat and poultry products are intended to be cooked, and proper cooking should kill pathogens). Raw poultry contaminated with Salmonella is not adulterated. However, USDA's Food Safety and Inspection Service (FSIS) has ruled that raw meat or poultry products contaminated with E. coli O157:H7 are adulterated. This is because normal cooking methods may not reduce E. coli O157:H7 below infectious levels. E. coli O157:H7 is the only pathogen that is considered an adulterant when present in raw meat or poultry products.[ citation needed ]
If food is adulterated, FDA and FSIS have a broad array of enforcement tools. These include seizing and condemning the product, detaining imported product, enjoining persons from manufacturing or distributing the product, or requesting a recall of the product. Enforcement action is usually preceded by a Warning Letter from the FDA to the manufacturer or distributor of the adulterated product. In the case of an adulterated meat or poultry product, FSIS has certain additional powers. FSIS may suspend or withdraw federal inspection of an official establishment. [5] Without federal inspection, an establishment may not produce or process meat or poultry products, and therefore must cease operations. With the exception of infant formula, neither the FDA nor FSIS has the authority to require a company to recall an adulterated food product. However, the ability to generate negative publicity gives them considerable powers of persuasion.
State regulators generally have similar enforcement tools at their disposal to prevent the manufacture and distribution of adulterated food. In addition, many states have the authority to immediately embargo adulterated food and to impose civil fines. Federal agencies often will coordinate with state or local authorities to remove unsafe food from the market as quickly as possible.
Escherichia coli O157:H7 is a serotype of the bacterial species Escherichia coli and is one of the Shiga-like toxin–producing types of E. coli. It is a cause of disease, typically foodborne illness, through consumption of contaminated and raw food, including raw milk and undercooked ground beef. Infection with this type of pathogenic bacteria may lead to hemorrhagic diarrhea, and to kidney failure; these have been reported to cause the deaths of children younger than five years of age, of elderly patients, and of patients whose immune systems are otherwise compromised.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
Foodborne illness is any illness resulting from the contamination of food by pathogenic bacteria, viruses, or parasites, as well as prions, and toxins such as aflatoxins in peanuts, poisonous mushrooms, and various species of beans that have not been boiled for at least 10 minutes.
Ground beef, minced beef or beef mince is beef that has been finely chopped with a knife, meat grinder, mincer or mincing machine. It is used in many recipes including hamburgers, bolognese sauce, meatloaf, meatballs, and kofta.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The 2006 North American E. coli outbreak was an Escherichia coli O157:H7 outbreak from prepackaged spinach. The outbreak occurred in September 2006, and its origin was an Angus cattle ranch that had leased land to a spinach grower. At least 276 consumer illnesses and 3 deaths have been attributed as a result from the outbreak.
Intralytix, Inc. is a privately owned biotech venture incorporated in the State of Maryland on July 28, 1998. Intralytix specializes in bacteriophage based products used to control bacterial pathogens in environmental, agricultural, food processing, and medical settings.
United States v. Forty Barrels and Twenty Kegs of Coca-Cola, 241 U.S. 265 (1916), was a federal suit under which the government unsuccessfully attempted to force the Coca-Cola Company to remove caffeine from its product.
Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry-to-market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market-to-consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer. Food safety, nutrition and food security are closely related. Unhealthy food creates a cycle of disease and malnutrition that affects infants and adults as well.
In China, the adulteration and contamination of several food and feed ingredients with inexpensive melamine and other compounds, such as cyanuric acid, ammeline and ammelide, are common practice. These adulterants can be used to inflate the apparent protein content of products, so that inexpensive ingredients can pass for more expensive, concentrated proteins. Melamine by itself has not been thought to be very toxic to animals or humans except possibly in very high concentrations, but the combination of melamine and cyanuric acid has been implicated in kidney failure. Reports that cyanuric acid may be an independently and potentially widely used adulterant in China have heightened concerns for both animal and human health.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
Raw meat generally refers to any type of uncooked muscle tissue of an animal used for food. In the meat production industry, the term ‘meat’ refers specifically to mammalian flesh, while the words ‘poultry’ and ‘seafood’ are used to differentiate between the tissue of birds and aquatic creatures.
Michael R. Taylor is an American lawyer who has played leadership roles in the US Food and Drug Administration, agrochemical company Monsanto, and law firm King & Spalding. He currently co-chairs the board of STOP Foodborne Illness, a non-profit that supports victims of serious illness and their families in efforts to strengthen food safety culture and practices in government and industry.
Kevin's Law was proposed legislation that would have given the United States Department of Agriculture the power to close down plants that produce contaminated meat.
The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970. The FSIS also acts as a national health department and is responsible for the safety of public food-related establishments as well as business investigation.
Escherichia coli is a gram-negative, rod-shaped bacterium that is commonly found in the lower intestine of warm-blooded organisms (endotherms). Most E. coli strains are harmless, but pathogenic varieties cause serious food poisoning, septic shock, meningitis, or urinary tract infections in humans. Unlike normal flora E. coli, the pathogenic varieties produce toxins and other virulence factors that enable them to reside in parts of the body normally not inhabited by E. coli, and to damage host cells. These pathogenic traits are encoded by virulence genes carried only by the pathogens.
The 1992–1993 Jack in the Box E. coli outbreak occurred when the Escherichia coli O157:H7 bacterium killed four children and infected 732 people across four US states. The outbreak involved 73 Jack in the Box restaurants in California, Idaho, Washington, and Nevada, and has been described as "far and away the most infamous food poison outbreak in contemporary history." The majority of the affected were under 10 years old. Four children died and 178 others were left with permanent injury including kidney and brain damage.
American Public Health Association v. Butz, 511 F.2d 331 was a United States Court of Appeals for the District of Columbia Circuit case argued on January 22, 1974, and decided on December 19, 1974.
Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry. Over the next few decades, the United States created several government agencies in an effort to better understand contaminants in food and to regulate these impurities. Many laws regarding food safety in the United States have been created and amended since the beginning of the 1900s. Food makers and their products are inspected and regulated by the Food and Drug Administration and the Department of Agriculture.