FDA FSVP Food Safety Hazards | United Safety Agents

FSVP FOOD SAFETY HAZARDS

The Foreign Supplier Verification Program (FSVP) is fundamentally concerned with food safety. Specifically, FSVP seeks to verify that the biological, chemical and physical hazards of imported food products are controlled in a manner that provides at least the same level of public health protection as the FDA’s domestic standards. This page contains a list of common food safety hazards. Contact USA with any questions.

Biological Hazards

BIOLOGICAL

HAZARDS

Salmonella spp. is the bacterium responsible for salmonellosis. An estimated 1,029,000 cases of foodborne salmonellosis occur annually in the United States (Scallan et al., 2011). Symptoms include: nausea, vomiting, abdominal cramps, diarrhea, fever, and headache. Symptoms start from 6 hours to 2 days after consumption of contaminated food and generally last from 4 to 7 days. The most severe form, typhoid fever, is caused by Salmonella Typhi. Everyone is susceptible to infection by Salmonella spp., but symptoms are most severe in the elderly, infants, and the infirmed. Infections by Salmonella spp. and other closely related bacterial pathogens, such as Shigella spp., E. coli, and Yersinia enterocolitica, can lead to chronic reactive arthritic symptoms in pre-disposed individuals.

E. Coli or to be more specific, pathogenic strains of Escherichia coli, are responsible for four types of illness: gastroenteritis or infantile diarrhea, caused by enteropathogenic E. coli (EPEC); travelers’ diarrhea, caused by enterotoxigenic E. coli; bacillary dysentery, caused by enteroinvasive E. coli (EIEC); and hemorrhagic colitis, caused by enterohemorrhagic E. coli (EHEC). EHEC is the most severe, with potential for serious consequences such as hemolytic uremic syndrome, particularly in young children. An estimated 205,800 foodborne cases from all four types of E. coli occur annually in the United States (Scallan et al., 2011). Symptoms vary for the different forms of illness, but include abdominal pain, diarrhea, vomiting, fever, chills, dehydration, electrolyte imbalance, high body fluid acidity, and general discomfort. Symptoms start from 8 hours to 9 days after consumption of contaminated food and last from 6 hours to 19 days, with both periods varying significantly between the illness types. Everyone is susceptible to all forms of infection from E. coli, but EPEC is most commonly associated with infants, and all types tend to result in more severe symptoms in the very young and elderly.

Listeria monocytogenes (L. monocytogenes) is the bacterium responsible for listeriosis. An estimated 1,600 foodborne cases of listeriosis occur annually in the United States (Scallan et al., 2011). L. monocytogenes produces mild flu-like symptoms in many individuals. However, in susceptible individuals, including pregnant women, newborns, and the immunocompromised, it can result in more severe symptoms, including septicemia, meningitis, encephalitis, spontaneous abortion, and stillbirth. Symptoms start from 3 days to 3 weeks after consumption of contaminated food. Mortality is high (approximately 25%) in those that display the more severe symptoms.

Brucella spp. is the bacterium responsible for brucellosis. An estimated 840 foodborne cases of brucellosis occur annually in the United States (Scallan et al., 2011) When sheep, goats, cows, or camels are infected with the pathogen, their milk becomes contaminated with the bacteria. The most common way for humans to be infected is by eating or drinking unpasteurized/raw dairy products from infected animals. Brucella can also enter the body through skin wounds or mucous membranes following contact with infected animals. Symptoms include: fever; sweats; malaise; anorexia; headache; pain in muscles, joints and/or back; and fatigue. Some signs and symptoms may persist for prolonged periods of time or may never go away.

Bacillus cereus (B. cereus) is the bacterium responsible for B. cereus food poisoning. An estimated 63,400 foodborne cases of B. cereus food poisoning occur annually in the United States (Scallan et al., 2011). There are two forms of illness, associated with two different toxins. In one form of illness, B. cereus produces an emetic toxin in the contaminated food; the emetic toxin causes nausea and vomiting, starting from 30 minutes to 6 hours after consumption of the food. In the other form of illness, associated with an infection due to high numbers of B. cereus in the contaminated food, B. cereus produces a diarrheal toxin in the intestines of the affected consumer after the consumer ingests food; the diarrheal toxin causes diarrhea, starting from 6 to 15 hours after consumption. Symptoms in both forms of illness last about 24 hours. Everyone is susceptible to B. cereus food poisoning.

Campylobacter jejuni (C. jejuni) is the bacterium responsible for campylobacteriosis. Symptoms include diarrhea, fever, abdominal pain, nausea, headache, and muscle pain. Symptoms start from 2 to 5 days after consumption of contaminated food and last from 7 to 10 days. An estimated 845,000 foodborne cases of campylobacteriosis occur annually in the United States (Scallan et al., 2011). A small percentage of patients develop complications that may be severe. These include bacteremia and infection of various organ systems, such as meningitis, hepatitis, cholecystitis, and pancreatitis. Autoimmune disorders are another potential long-term complication associated with campylobacteriosis; for example, Guillain-Barré syndrome (GBS). Everyone is susceptible to infection by C. jejuni. Campylobacteriosis occurs more frequently in the summer months than in the winter.

Clostridium botulinum (C. botulinum) toxin is the toxin responsible for a severe paralytic illness called botulism. C. botulinum is found in soil and grows best in low oxygen conditions. The bacteria form spores that can survive in a dormant state until exposed to conditions that support their germination and growth, such as in inadequately processed low-acid canned foods. Foodborne botulism is caused by eating foods that contain the botulinum toxin, which is formed during growth of C. botulinum. There are seven types of botulism toxin designated by letters A through G; only types A, B, E and F have caused botulism in humans. An estimated 55 foodborne cases of botulism occur annually in the United States (Scallan et al., 2011). Symptoms include: weakness; vertigo; double vision; difficulty in speaking, swallowing, and breathing; abdominal swelling; constipation; paralysis; and, possibly, death. Symptoms start from 18 to 36 hours after eating a contaminated food, but can occur as early as 6 hours or as late as 10 days after exposure. Everyone is susceptible to intoxication by C. botulinum toxin; only a few micrograms of the toxin can cause illness. Mortality is high; without the antitoxin and respiratory support, death is likely.

Shigella spp. is the bacterium responsible for shigellosis. Shigella infections may be acquired from eating contaminated food. Foods may become contaminated by infected food handlers who do not wash their hands before handling food. An estimated 131,000 foodborne cases of shigellosis occur annually in the United States (Scallan et al., 2011). Symptoms include: abdominal pain; cramps; diarrhea; fever; vomiting; blood, pus, or mucus in stools; continuous or frequent urges for bowel movement; and death. Symptoms start from 12 hours to 2 days after consumption of contaminated food and last from 1 to 2 weeks. Everyone is susceptible to infection by Shigella spp.

Staphylococcus aureus (S. aureus) is a common bacterium found on the skin and in the noses of many healthy people and animals. The bacterium is responsible for producing toxins as it grows in foods, causing staphylococcal food poisoning. An estimated 241,000 foodborne cases of staphylococcal food poisoning occur annually in the United States (Scallan et al., 2011). Symptoms include: nausea, vomiting, diarrhea, abdominal pain, and weakness. Staphylococcal toxins are fast-acting and can cause illness in as little as 30 minutes. Symptoms usually start within one to six hours after eating contaminated food. Everyone is susceptible to intoxication by S. aureus toxin, with more severe symptoms, including occasional death, occurring in infants, the elderly and debilitated persons.

Clostridium perfringens (C. perfringens) is the bacterium responsible for perfringens food poisoning. C. perfringens causes illness when large numbers of the bacteria are consumed in contaminated food. The bacterium then produces enough toxin in the intestines to cause illness. C. perfringens spores can survive high temperatures. During cooling and holding of food at warm temperatures, the spores germinate and the resulting vegetative cells of the bacteria grow. An estimated 966,000 foodborne cases of perfringens food poisoning occur annually in the United States (Scallan et al., 2011). Symptoms include: abdominal cramps and diarrhea. Symptoms typically start from 8 to 12 hours after eating a contaminated food, but can occur as early as 6 hours after exposure and last for about a day. Everyone is susceptible to perfringens food poisoning, but it is more common in the young and elderly, who may experience more severe symptoms lasting for one to two weeks.

Chemical Hazards

CHEMICAL

HAZARDS

Pesticides. Pesticide residues may be of concern in food crops and in foods of animal origin (as a result of pesticide residues in animal food). The term pesticide is used for products such as insecticides, fungicides, rodenticides, insect repellants, herbicides or weed killers, and some antimicrobials that are designed to prevent, destroy, repel, or reduce all types of pests (See EPA “Setting Tolerances for Pesticide Residues in Foods”) (EPA, 2015). Three federal government agencies share responsibility for the regulation of pesticides. Pesticides that have been registered (i.e., approved) with the U.S. Environmental Protection Agency (EPA) may be applied according to label directions directly to raw agricultural commodities or food (see 40 CFR 180). For a registered pesticide that could potentially result in residues in or on food, the EPA establishes a tolerance, which is the maximum amount of residue that is permitted in or on a food. FDA is responsible for enforcing pesticide tolerances for foods other than meat, poultry, and certain egg products, which are the responsibility of the U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS) (FDA, 2012d). A detailed description of how FDA enforces pesticide residues in animal food is available in CPG Sec. 575.100 Pesticide Residues in Food and Feed – Enforcement Criteria (FDA, 2015e). If pesticide residues are present in food in the absence of, or in excess of, a tolerance, the food is deemed adulterated under section 402(a)(2)(B) of the FD&C Act (21 U.S.C. 342(a)(2)(B)).

The most common reasons for adulteration of food products with pesticide residues are the improper treatment of raw materials with registered pesticides, and raw materials being exposed to prohibited pesticides. Fruits and vegetables that have been grown in the United States usually are in compliance with EPA’s pesticide tolerance regulations. If you obtain produce from a foreign country you should take steps to ensure that the imported produce will be in compliance with U.S. pesticide tolerance regulations, such as by considering pesticide residues to be chemical hazards that warrant preventive controls, such as supply-chain controls with a supplier verification program.

Animal drug residues may be of concern for foods of animal origin, including muscle meat, organ meat, fat/skin, eggs, honey, and milk. In the United States, animal drugs require approval by FDA before they can be administered to food-producing animals. Depending on the chemical property of the drug, residues of certain drugs can become concentrated during food manufacturing and processing. For example, if a fat-soluble, heat-stable drug residue is present in raw milk, the drug can get concentrated when the milk is converted to full fat cheese (Cerkvenik et al., 2004; Imperiale et al., 2004). Potential effects of drug residues range from short-term effects as a result of acute allergic reactions (e.g., penicillin) to long-term effects from drug resistant bacteria (Dayan, 1993). An example of an unapproved drug residue that has adulterated food is fluoroquinolone, which is an antibiotic that has not been approved for use on honey bees in the United States and has been detected in honey products from certain regions outside the United States (FDA, 2015a).

Drug residues in a food derived from an animal (such as milk) are considered a hazard if a tolerance has not been established for the particular drug-food combination, or if the tolerance level has been exceeded. Animal drugs used according to labeled directions should not result in residues in meat, poultry, milk, or egg products. When your hazard analysis identifies drug residues that require a preventive control, supply-chain controls with a supplier verification program could be an appropriate preventive control to manage the potential risk.

Heavy metals, including lead, cadmium, arsenic, and mercury, may be of concern in certain foods as a result of agricultural practices (e.g., use of pesticides containing heavy metals or because crops are grown in soil containing elevated levels of heavy metals due to industrial waste), or the leaching of heavy metals from equipment, containers or utensils that come in contact with foods. Consumption of heavy metals in foods can lead to adverse health consequences. For example, lead exposure can impair cognitive development in children (FDA, 2006a). Consumption of inorganic arsenic has been associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans.

When your hazard analysis identifies a heavy metal that requires a preventive control, the type of control would depend on how the heavy metal could get into your food product. In some cases, high levels of heavy metals may result from the environment (e.g., high lead levels in carrots that were grown in lead-contaminated soil). If your food product contains a food crop that is known to have been contaminated with a heavy metal through contaminated soil, a preventive control such as a supply-chain control with a verification program to ensure that the grower conducts an assessment of the growing region prior to its use for agriculture may be appropriate. In other cases, an unsafe level of a heavy metal such as lead could be introduced into a food product as a result of a food-contact surface constructed with lead solder. CGMP controls, such as the controls on equipment and utensils in 21 CFR 117.40, generally can control chemical hazards such as heavy metals that can leach from food-contact surfaces.

Mycotoxins and other natural toxins. Natural toxins, such as mycotoxins, histamines and other biogenic amines, and plant-produced substances (such as the toxin hypoglycin A found in the tropical fruit ackee) are well recognized as hazards in raw or processed agricultural commodities (FDA, 2005a; FDA 2005b; FDA, 2005c; FDA, 2005d). Mycotoxins are a common group of natural toxins that include aflatoxin, fumonisin, deoxynivalenol (vomitoxin), ochratoxin, and patulin (see Table 3-7). Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds) that can infect and proliferate on agricultural commodities (e.g., grains such as wheat and corn, peanuts, fruits, and tree nuts) in the field and during storage. Mycotoxins may produce various toxicological effects. Some mycotoxins are teratogenic, mutagenic, or carcinogenic in susceptible animal species and are associated with various diseases in domestic animals, livestock, and humans in many parts of the world. The occurrence of mycotoxins in human and animal foods is not entirely avoidable; small amounts of these toxins may be found on agricultural commodities. Occurrence of these toxins on commodities susceptible to mold infestation is influenced by environmental factors such as temperature, humidity, and the extent of rainfall during the pre-harvesting, harvesting, and postharvesting periods. The molds that produce mycotoxins typically grow and become established in the agricultural commodity during stressful growing and holding conditions, such as insect damage to the crop, drought stress, and wet storage (e.g., from condensation). Althoughmycotoxins are not a hazard requiring a preventive control during times and locations with good growing and harvest conditions, a preventive control such as supply-chain controls with a supplier verification program may be appropriate if you use agricultural commodities susceptible to mycotoxin formation, because growing and harvest conditions vary from year to year.

Histamines and other biogenic amines are produced from the breakdown of amino acids by bacteria in animal-derived foods (e.g., histamine is produced from the amino acid histidine). Effects of foodborne histamines or other biogenic amines generally are acute effects, including headache, nausea, heart palpitations, facial flushing, itching, urticaria (hives), and gastrointestinal upset. Consumption of certain cheeses, especially aged cheeses, has been associated with illness from histamines (Taylor and WHO, 1985; Stratton et. al, 1991). If you determine that cheeses you use as a raw material present a histamine hazard, you must identify and implement a preventive control (see 21 CFR 117.135(a)). If you purchase such cheeses,

we recommend a supply-chain control with a supplier verification program as well as temperature controls to minimize growth of histamine-producing microorganisms. An example of a natural toxin produced by a plant is hypoglycin A, a heat stable toxin found in the tropical fruit ackee. The level of hypoglycin A in the edible portion of the ackee fruit decreases as the fruit ripens. Only properly ripened and processed ackee products with hypoglycin A at negligible levels are safe for consumption (FDA, 2015f). Although some persons consume unripe ackee with no adverse effects, other persons who consume unripe ackee with hypoglycin A exhibit symptoms that range from mild (e.g., vomiting) to severe (e.g., vomiting with profound hypoglycemia, drowsiness, muscular exhaustion, and possibly coma and death).

Common Mycotoxins Associated with Commodities

Mycotoxins: Commodities Associated with Mycotoxins.

Aflatoxin: Peanuts, dried corn, tree nuts.

Ochratoxin: Coffee, raisins, cereal grains.

Fumonisins: Dried corn.

Deoxynivaleno: Wheat, barley.

Patulin: Apples.

Unapproved food additives and color additives. A substance (other than a food contact substance subject to a notification under section 409(h)) that is a food additive or a color additive must be used in accordance with a food additive regulation permitting that specific use or a color additive listing. Otherwise, the presence of that substance in food would make the food adulterated under section 402(a)(2)(C) of the FD&C Act (21 U.S.C. 342(a)(2)(C)). Under the PCHF requirements, an unapproved food or color additive is a chemical hazard (see 21 CFR 117.130(b)(1)(ii)). Some food and color additives are specifically prohibited from use in food because we have determined that the chemical additive poses a potential risk to public health (see 21 CFR part 189 and 21 CFR 81.10). Examples of such food and color additives are coumarin, safrole, and FD&C Red No. 4 (Red No. 4) (FDA, 2015b). We consider a prohibited food additive or color additive to be an unapproved food additive or color additive for the purposes of the PCHF requirements and, thus, to be a chemical hazard. You should consult 21 CFR if you have questions about the regulatory status or safety of a particular additive when formulating your food products. An additional resource for you is the Food Additive Status List on our website (FDA, 2014b).

Chemical hazards due to misformulation. A food ingredient can be a chemical hazard if it is added in excess of a maximum use level, regardless of whether the maximum use level is established due to food intolerance (such as for sulfites) or is otherwise a condition of safe use of a food additive, color additive, or GRAS substance. Control strategies to prevent misformulation of substances generally include process controls to ensure that excessive amounts are not added.

Radiological hazards rarely occur in the food supply; however, when they do occur, these hazards can present a significant risk when exposures occur over a period of time (WHO,2011). Consuming food contaminated with radionuclides will increase the amount of radioactivity a person is exposed to, which could have adverse health effects. The health effect depends on the radionuclide and the amount of radiation to which a person is exposed. For instance, exposure to certain levels of radioactive iodine is associated with increased risk of thyroid cancer (WHO, 2011). Radiological hazards can become incorporated into food through the use of water that contains the radionuclides during food production or manufacture. There are areas in the United States where high concentrations of some radionuclides, such as radium-226, radium-228, and uranium, can be detected in well water (Ayotte et al., 2007; Focazio et al., 2001). You should be aware of the condition of the water used for production and manufacture in your facilities. For example, if your facility uses well water and there are elevated levels of radionuclides in the well water, you should not use the water. The CGMPs require that water that contacts food, foodcontact surfaces, or food-packaging materials be safe and of adequate sanitary quality (see 21 CFR 117.37(a)).

Radiological hazards also may result from accidental contamination, e.g., contamination arising from accidental release from a nuclear facility or from damage to a nuclear facility from a natural disaster. In 2011, following damage to a nuclear power plant during an earthquake and tsunami in Japan, radioactivity was subsequently detected in foods, particularly milk, vegetables, and seafood produced in areas neighboring the plant (WHO, 2011). You should be vigilant regarding accidental releases of radiological hazards and their potential to contaminate your food product, either directly due to contamination of natural resources near your facility or as a result of raw materials and other ingredients that you obtain from a region that has experienced an accidental release of radiation.

Facility-Related Chemical Hazards. Industrial chemicals or other contaminants from the food processing environment can contaminate food during production – e.g., if chemicals used to clean a production line are not adequately removed from the production line or if heavy metals are leaching from containers or utensils. In this guidance, we do not discuss preventive controls for facility-related chemical hazards such as cleaning chemicals and the leaching of heavy metals from containers or utensils, because such hazards are usually addressed through CGMPs.

Heating Process contaminants. There are several process-related contaminants that are produced during heating of specific ingredients or finished foods that may be a health (e.g., cancer) concern. For example, acrylamide is formed during high-temperature cooking processes (including frying, roasting, or baking) due to interaction between sugars and amino acids that are naturally present in foods. Acrylamide is found mainly in foods made from plants, including potato products, grain products, and coffee. As noted in footnote 8, we have not included such contaminants in Table 3-6 as potential process-related chemical hazards that may require a preventive control as part of a food safety plan under part 117 because we believe that more information is needed regarding appropriate levels and effective controls. We have published a guidance document, Guidance for Industry: Acrylamide in Foods (FDA, 2016a) to help growers, manufacturers, and food service operators reduce acrylamide levels in certain foods. Control strategies to reduce acrylamide in food may include controlling temperatures during cooking and ingredient substitution.

Chemical hazards that may be intentionally introduced for purposes of economic gain. The PCHF requirements specify that you must consider, as part of your hazard identification, known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)). We recommend that you focus on circumstances where there has been a pattern of such adulteration in the past, suggesting a potential for intentional adulteration even though the past occurrences may not be associated with the specific supplier or the specific food product. Additional resources include a free on-line food fraud database made available by the U.S. Pharmacopeial Convention (USP)3 (USP, 2014 and USP, 2016), a report from the Congressional Research Service (Congressional Research Service, 2014), and a report that identifies 137 unique incidents in 11 food categories (Everstine et al., 2013). In determining whether a hazard that may be intentionally introduced for purposes of economic gain is a hazard requiring a preventive control, we recommend that your hazard analysis consider both the country of origin of an ingredient that may contain the hazard and any specific supplier associated with an ingredient containing that hazard. For example, one example is a widespread incident of economically motivated adulteration in which some milk firms in one country added melamine, a nitrogen-rich industrial by-product, to diluted dairy products to increase the apparent protein content (FDA, 2008). This adulteration resulted in significant public health consequences, with more than 290,000 ill infants and 6 deaths in that country. In light of this incident, we recommend that you include in your hazard analysis the potential for melamine to be an economically motivated adulterant in your food products when using milk products from a country where melamine adulteration has occurred and, based on the outcome of that hazard analysis, determine whether melamine is a hazard that must be addressed in your food safety plan. At present, we do not expect you to consider the potential for melamine to be a significant hazard when using domestic milk products, or milk products from other countries when there is no history of melamine adulteration associated with those countries.

If you determine through your hazard analysis that a hazard that may be intentionally introduced for purposes of economic gain is a hazard requiring a preventive control, we recommend that you address that hazard through your supply-chain program.

Food allergens. Researchers estimate that up to 15 million Americans and more than 17 million Europeans have food allergies (FARE, 2015). A number of foods contain allergenic proteins, which are natural constituents of the food that can pose a health risk to certain sensitive individuals. The symptoms of food allergies can include a tingling sensation in the mouth, swelling of the tongue and throat, nausea, difficulty in breathing, chest pain, hives, rash, itchy skin, vomiting, abdominal cramps, diarrhea, sudden drop in blood pressure, loss of consciousness, and, in severe cases, death. Symptoms of a food allergy usually come on suddenly, can be triggered by a small amount of food, and happen every time the food is eaten. The symptoms are the result of the body’s immune system reacting to a specific food or an ingredient in the food. Allergic consumers must avoid allergens to prevent potentially life threatening reactions. Undeclared food allergens are chemical hazards that can get into food because either: (1) The food manufacturer did not properly declare a food allergen ingredient on the product label; or (2) unintended (and, thus, undeclared) food allergens are present in a food due to incorrect labeling or due to allergen cross-contact. This section of this chapter provides a general discussion of food allergen hazards and common mechanisms to control them. For more detailed information, see Chapter 11 – Food Allergen Controls, which provides a comprehensive guide to food allergen control. An additional resource is “Managing Allergens in Food Processing Environments,” a publication of the Grocery Manufacturer’s Association (GMA, 2009).

The “Big Eight” food allergens The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 amended the FD&C Act and defined the following eight foods and any ingredients that contain protein derived from these eight foods (with certain exemptions noted in section 201(qq)(2) of the FD&C Act (21 U.S.C. 321(qq)(2)) as major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The eight foods or food groups cause more than 90% of the food allergies in the United States (FDA, 2015c) and are commonly referred to as “the big eight” food allergens. FDA has published guidance on labeling the food allergens identified in FALCPA – See “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004” (FDA, 2006b). Immediately below, we provide more information about each of “the big eight food allergens.”

Crustacea: The class of Crustacea, or shellfish, includes shrimp, crab, lobster, and crayfish. Crab and shrimp are the most commonly consumed shellfish in the United States. The major shellfish allergen is tropomyosin, a muscle protein that accounts for 20% of the dry weight of shrimp (GMA, 2009).
Egg: Most egg-allergic proteins are found in the egg white (albumin) rather than the yolk.
Fish: Different fish species (e.g., bass, cod, and flounder) have been found to have structurally-related proteins, and this may explain why individuals with a fish allergy are allergic to multiple types of fish. Cooking may reduce the allergenicity of fish, but it does not eliminate it.
Milk (Dairy): Cow’s milk contains a number of different proteins that are grouped into two categories: caseins, which constitute 80% of the total protein, and whey proteins, which make up 20%.
Peanut: Peanut seeds contain an average of about 29% protein, classified as albumins or globulins.
Soy: Globulins are the major proteins in soybeans.
Tree Nuts: Tree nuts include almonds, Brazil nuts, cashews, filberts/hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts. FDA lists the nuts considered “tree nuts” in its 2006 “Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)” (FDA, 2006b) and its 2013 Guidance for Industry: A Food Labeling Guide (FDA, 2013a).
Wheat: Wheat proteins include the globulins, prolamins (i.e., glutenin and gliadin), and glutelins. About 25% of wheat-allergic children react to other cereal grains (i.e., barley, oats, or rye). Gluten is a mixture of proteins that occur naturally in wheat, rye, barley and crossbreeds of these grains. It is associated with celiac disease, which affects as many as 3 million people in the United States by the body's natural defense system attacking the lining.

Physical Hazards

PHYSICAL

HAZARDS

Metal. Metal-to-metal contact during processing can introduce metal fragments into products. For example, metal fragments can break off during mechanical cutting and blending operations, and some metal equipment has parts that can break or fall off, such as wire-mesh belts. FDA’s Health Hazard Evaluation Board (FDA, 2005e; Olsen, 1998) has supported regulatory action against products with metal fragments of 0.3 inches (7 mm) to 1.0 inches (25 mm) in length. Such fragments have been shown to be a hazard to consumers. Metal hazards can be controlled by the use of metal detection devices or by regular inspection of at-risk equipment for signs of damage.

Glass fragments can be introduced into food whenever processing involves the use of glass containers. Normal handling and packaging methods, especially mechanized methods, can result in breakage. Ingesting glass fragments can cause injury to the consumer. FDA’s Health Hazard Evaluation Board has supported regulatory action against products with glass fragments of the same size noted for metal. Most products packed in glass containers are intended to be a ready-to-eat (RTE) commodity. In your hazard analysis, you should consider the potential for glass fragments to originate from sources other than glass containers used in packaging. For example, some facilities that do not pack in glass prohibit the presence of glass in the production environment to reduce the risk of glass getting into the product. You can address glass fragments originating from sources such as overhead light fixtures through CGMPs.

Hard plastic can be introduced into food when tools and equipment such as scoops, paddles, buckets or other containers develop fatigue, crack, and break as they wear. Hard plastic also can be introduced into food when plastic sieves and screens deteriorate. You should examine items to determine whether they are worn and remove worn items before they break, especially if they cannot be effectively cleaned (e.g., because of small cracks).

Aditional Resources

ADDITIONAL RESOURCES

Have questions? We're here to help.

Download the U.S. Food and Drug Administration's "Bad Bug Book". A resource and handbook of foodborne pathogenic microorganisms and natural toxins here.

Additional information and guidance about Food Safety Hazards can be found by visiting the United States Food and Drug Administration's website – https://www.fda.gov.

IMPORTANT Hazard profiles differ per product. Provided information is intended for reference only.