Canadian Food Inspection Agency (/eng/1297964599443/1297965645317)

Home

Food

Non-federally Registered

Product Inspection

Inspection Manual

Imported and Manufactured Food Program Inspection Manual

Chapter 4: Food Safety Hazards

This page is part of the Guidance Document Repository

(GDR).
Looking for related documents?
Search for related documents in the Guidance Document Repository (/industryguidance/eng/1374161650885/1374161737236?gp=2&gc=20&ga=49#gdr_results)

4.0 Scope
4.1 Biological Hazards
4.2 Chemical Hazards
4.3 Physical/Extraneous Material Hazards
4.4 Allergenic Hazards
4.5 Nutritional Hazards
4.6 Biotechnology-related Hazards/Novel Foods

4.0 Scope
Chapter 4 of this Manual is intended to provide inspectors with information on the various
types of hazards as they relate to food safety.
A food safety hazard refers to any agent with the potential to cause adverse health
consequences for consumers. Food safety hazards occur when food is exposed to
hazardous agents which result in contamination of that food. Food hazards may be
biological, chemical, physical, allergenic, nutritional and/or biotechnology-related.
Hazards may be introduced into the food supply any time during harvesting, formulation and
processing, packaging and labelling, transportation, storage, preparation, and serving.
For more information on Food Hazards, see the Reference Database for Hazard Identification
(This document is intended for internal use. CFIA (Canadian Food Inspection Agency) sta
can access this document using RDIMS (Records Documents Information Management
System) number 974917).

4.1 Biological Hazards

4.1.1 Bacteria
4.1.2 Viruses
4.1.3 Parasites
4.1.4 Other Biological Hazards - Prions
Biological hazards occur when hazardous or pathogenic organisms are introduced to food
and thus pose a food safety concern to consumers. Biological hazards include bacteria,
viruses and parasites of public health significance.
Biological hazards can be introduced to food from the environment (e.g. (for example) soil
bacteria, agricultural run-o) or from inadequate sanitation practices and cross contamination
during transportation, handling, processing, and storage (e.g. (for example), poor food
hygiene practices). The type and magnitude of microbial growth is determined in part by the
nature of the food, package conditions and storage environment.
Reference: Food-related Illness (http://www.hc-sc.gc.ca/fn-an/securit/ill-intox/index-eng.php)
(Health Canada)

4.1.1 Bacteria
Bacteria are single-celled microorganisms that exist in a range of habitats and can be freeliving (e.g. (for example) in soil, air, water) or symbiotic (e.g. (for example) in intestinal tract or
mucous membranes of animals and humans) and have a broad range of enzymatic,
biochemical and/or pathogenic properties. The principal bacteria associated with food borne
illnesses include:
Bacillus cereus
Campylobacter jejuni
Clostridium botulinum
Clostridium perfringens
Escherichia coli 0157:H7
Escherichia coli 0104:H4
Listeria monocytogenes
Salmonella spp. (species)
Shigella spp. (species)
Staphylococcus aureus
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulnificus
Yersinia enterocolitica
Cronobacter sakazakii

Ingesting food contaminated with pathogenic microorganisms and/or their toxic by-products
can lead to food-borne illness. These illnesses can take the form of infection or intoxication,
or both. Infectious microorganisms are detrimental to their host through mechanisms which
crowd out beneficial microorganisms, use up host resources, and destroy host tissue. A
food-borne illness caused by an infection can take days or weeks to manifest which often
makes it dicult to identify the causative agent. On the other hand, illness caused by
intoxication often occurs within hours of consuming the suspect food. Intoxications are
caused by toxins that are produced by the microorganism, either in the food itself or after
ingestion.

4.1.2 Viruses
In contrast to other microorganisms, active viruses consist of unique sections of DNA
(deoxyribonucleic acid) or RNA (ribonucleic acid) enclosed in a thin coat of protein, and
cannot exist independently of their living hosts. Depending on the combination of DNA
(deoxyribonucleic acid)/RNA (ribonucleic acid) and the protein coating, viruses can be very
infectious and often pathogenic. They reproduce by inserting themselves into a host cell and
altering the function of that cell to replicate the component pieces that make up the virus.
Viruses commonly associated with food safety issues include:
Bacteriophage
Enteric Virus (other than Hepatitis A and Noroviruses)
Hepatitis A virus
Norovirus
Norwalk virus
Rota virus
Viruses are typically introduced into food either through poor handling practices by people
infected with the virus (i.e. (that is to say) poor personal hygiene practices) or via
contaminated food ingredients (i.e. (that is to say) water).

4.1.3 Parasites
A parasite is any organism which obtains nourishment from its host organism in order to grow
and reproduce. Unlike symbiotic organisms, which reciprocate by supplying their hosts with
other resources the host would not otherwise be able to find, parasites do not supply the
host with any resources, usually to the detriment of the host. Parasites commonly associated
with food-borne illnesses include:
Cryptosporidium parvum
Giardia duodenalis or intestinalis
Taenia spp. (species)
Toxoplasma gondii
Trichinella spiralis

Entamoeba histolytica
Entamoeba coli
Parasites enter food through similar means as viruses (i.e. (that is to say), poor personal
hygiene practices and contaminated ingredients).

4.1.4 Other Biological Hazards - Prions

Other biological food safety hazards not belonging to the above mentioned categories
include prions, also known as proteinaceous infectious particles, which are infectious agents
made of protein. They are known to cause a number of diseases that aect both humans and
animals. BSE (bovine spongiform encephalopathy) or "Mad Cow Disease" is a progressive,
fatal disease of the nervous system of cattle. It is also known as a transmissible spongiform
encephalopathy (TSE). Other TSE (transmissible spongiform encephalopathy)s include
scrapie in sheep and chronic wasting disease in deer and elk. Creutzfeldt-Jakob disease in
humans is thought to be caused by consuming cattle infected with BSE (bovine spongiform
encephalopathy). Although the exact cause of BSE (bovine spongiform encephalopathy) is
unknown, it is associated with the presence of prions. There is no treatment or vaccine
currently available for the disease.

4.2 Chemical Hazards

4.2.1 Mycotoxins
4.2.1.1 Aflatoxin
4.2.1.2 Deoxynivalenol (Vomitoxin)
4.2.1.3 Ochratoxin A
4.2.1.4 Fumonisin
4.2.1.5 Patulin
4.2.2 Natural toxins
4.2.2.1 Glycoalkaloids
4.2.2.2 Other Natural Toxins
4.2.3 Marine Toxins
4.2.3.1 Decomposition
4.2.3.2 Microscopic Marine Algae
4.2.4 Environmental Contaminants
4.2.4.1 Arsenic
4.2.4.2 Cadmium
4.2.4.3 Lead
4.2.4.4 Mercury
4.2.5 Food Additives
4.2.6 Processing-induced Chemicals
4.2.6.1 Acrylamide

4.2.6.2 Ethyl Carbamate (Urethane)

4.2.6.3 Furan
4.2.7 Pesticides/Agricultural Products
4.2.8 Veterinary Drugs
Chemical hazards occur when chemicals are present in foods at levels that can be hazardous
to humans. Contamination may occur through various pathways:
The environment (air, soil, water),
Intentional use of chemicals, such as pesticides and veterinary drugs,
Manufacturing processes,
Addition of food additives.
In the food industry, there are various types of chemical hazards, some notable ones include:
Mycotoxins
Natural Toxins
Marine Toxins
Environmental Contaminants
Food Additives
Processing-induced chemicals
Pesticides/Agricultural Products and
Veterinary Drug Residues

4.2.1 Mycotoxins
Mycotoxins are natural toxins which are produced by fungi and can be toxic to humans and
animals. They are formed by moulds which grow on crops and foods under certain
conditions. There are number of mycotoxins present in the environment but only a few are
found in foods and they are usually associated with particular field crops like corn. The most
prominent mycotoxins which cause health concerns in humans are aflatoxin, deoxynivalenol,
ochratoxin, fumonisin and patulin.
Some of the general characteristics of mycotoxins are listed below.
resistant to heat
produced by fungi as secondary metabolites in response to competitive pressures from
other fungi/bacteria
can have antibiotic properties
can cause toxic damage to cells of humans and animals
can cause chronic eects such as various cancers, immunosuppression, growth
retardation, birth defects, renal dysfunction
can have serious long-term eects even at small concentrations
usually associated with particular crops (i.e. (that is to say) corn, cereal crops, apples)

Reference: Natural Toxins Health Canada (http://www.hc-sc.gc.ca/fn-an/securit/chemchim/toxin-natur/index-eng.php)

4.2.1.1 Aflatoxin
Aflatoxin is produced by the mould Aspergillus flavus. Commodities which have a high
potential for contamination with aflatoxin include tree nuts, peanuts, peanut butter, figs and
corn. It should be noted that contaminated feed can lead to elevated levels in milk as well.
The proliferation of Aspergillus and the corresponding production of aflatoxin are aected by
drought during the growing season and high humidity during storage.
Aflatoxin is a potential carcinogen associated with the development of liver cancer.

4.2.1.2 Deoxynivalenol (Vomitoxin)

Deoxynivalenol (DON) is produced by various species of mould, most notably, Fusarium
graminearum and F. (Fusarium) sporotrichioide. Fusarium species are widely dispersed and
their toxins reportedly occur in a wide variety of cereals, grains and in animal feeds. DON
(Deoxynivalenol) is classified in the trichothecene family of mycotoxins, a metabolite most
commonly found in crops, such as wheat, barley and corn.
DON (Deoxynivalenol) is not known to be carcinogenic. However it is a potent inhibitor of
protein and DNA (deoxyribonucleic acid) synthesis and is known to have immunosuppressive
and cytotoxic eects. Symptoms observed as a result of human exposure to these toxins are
vomiting, dermatitis, cough and rhinitis.

4.2.1.3 Ochratoxin A
Ochratoxin A (OTA) is a toxic metabolite formed by Aspergillus ochraceus, Penicillium
verrucosum and other mould species. It is one of the most commonly occurring mycotoxins
in improperly stored food.
OTA (Ochratoxin A) has been found in corn, peanuts and decaying vegetation. It has also
been found in mouldy cereals such as wheat, rye, barley, oats, and other commodities,
including bread, flour, beans, peas, rice, and coee and in samples of meat where the
slaughtered animal may have consumed feed contaminated with OTA (Ochratoxin A).
Ochratoxin A is a human carcinogen which has also been found to cause lesions as well as
teratogenic and neurotoxic eects.

4.2.1.4 Fumonisin
Fumonisin is a toxin produced by various species of mould, most notably Fusarium
verticilloides and Fusarium proliferatum. Fumonisin is one of the most frequent mycotoxins
found in corn. High levels of fumonisin are associated with hot and dry weather, followed by a
period of high humidity.

Fumonisin causes two animal diseases: porcine (pig) pulmonary edema and
leukoencephalomalacia in horses. This mycotoxin is a concern for humans as there is
evidence to suggest it may be carcinogenic, causing oesophageal and liver cancers, and may
contribute to neural tube defects in babies.

4.2.1.5 Patulin
Patulin is a toxic chemical produced by various mould species including Penicillium spp.
(species), Aspergillus spp. (species) and Byssochlamys spp. (species) It is heat stable at a pH
(potential hydrogen)<6 and will survive thermal processing. Patulin can be found in mouldy
fruits (i.e. (that is to say) apples, pears, peaches, grapes), as well as mouldy vegetables and
grains; however the major source of patulin contamination is from apples and apple
products. The use of mouldy fruit increases the likelihood of patulin contamination in juices or
ciders.
Patulin is known to be genotoxic, causing damage to DNA (deoxyribonucleic acid) and
chromosomes, which has led to theories that it may be carcinogenic.

4.2.2 Natural toxins

Natural toxins are biochemical compounds produced by plants in response to certain
conditions or stressors.
Reference: Natural Toxins Health Canada (http://www.hc-sc.gc.ca/fn-an/securit/chemchim/toxin-natur/index-eng.php)

4.2.2.1 Glycoalkaloids
Potatoes can contain natural toxins called glycoalkaloids. The major ones found in potatoes
are -solanine and -chaconine. These toxins are formed in response to stresses such as UV
(ultraviolet) light and damage (such as bruising), and cannot be destroyed by cooking. Toxin
concentrations are highest in the peel and sprout of the potatoes and can be seen as a
characteristic green color on those parts.
Exposure to glycoalkaloids can cause acute toxic eects such as burning in the mouth,
diarrhoea, severe stomach ache, vomiting and gastrointestinal irritation. Death from
glycoalkaloid poisoning is rare.

4.2.2.2 Other Natural Toxins

Other natural toxins are listed in the Table 1 below.

Table 1: Some Natural Toxins in Food Plants

Food commodity

Toxin

Ackee fruit

hypoglycin

Cassa root, bamboo shoots, stone fruit

cyanogenic glycoside

Fiddlehead

unidentified

Green beans, red kidney beans, white kidney

beans

lectin

Wild mushrooms

amanitins, gyromitrin, muscarine,

phallotoxins

Parsnip

furocoumarins

Rhubarb

oxalic acid

Cabbage, cauliflower, broccoli, mustard, turnip

goitrogens

4.2.3 Marine Toxins

Marine toxins are a group of toxins that sometimes accumulate in fish and shellfish. There are
two sources of marine toxins:
decomposition
microscopic marine algae (phytoplankton, including diatoms and dinoflagellates)

4.2.3.1 Decomposition
When certain fish, especially scombroid fish (i.e. (that is to say) tuna, bonito and mackerel),
start to decompose, histamine is formed. Histidine, a naturally-occurring amino acid, is
converted into histamine by an enzyme produced by certain bacteria during decomposition.
Histamine, in small doses, is necessary for the proper functioning of the human immune
system. However, histamine in higher does may trigger severe reactions when consumed
similar to those seen in allergic reactions such as rash, nausea, vomiting, diarrhoea,
headache, dizziness, burning throat, stomach pain and itchy skin. The presence of high levels
of histamine indicates that decomposition has occurred, even if the decomposition is not
obvious. Toxic amounts of histamine can form before a fish smells or tastes bad. As this
typically only occurs in scombroid fish, this is called Scombroid Poisoning.

4.2.3.2 Microscopic Marine Algae

Many marine toxins are produced by and can accumulate in fish and shellfish if they ingest
certain types of algae.
Table 2 lists some common marine toxins and the seafood they are commonly associated
with.

Table 2: Common Marine Toxins

Illness

Toxin

Seafood

Paralytic shellfish
poisoning (PSP)

Saxitoxin

Oysters, clams, scallops, mussels, cockles, whelks

Amnesic shellfish
poisoning (ASP)

Domoic
acid

Bivalve molluscan shellfish, clams, mussels,

oysters, scallops

Ciguatera poisoning

Ciguatoxin

Tropical fish such as barracuda, amberjack, red

snapper, grouper

Diarrhetic shellfish
poisoning (DSP)

Okadaic
acid

Various shellfish, cockles, mussels, oysters

Tetrodotoxin
poisoning

Tetrodotoxin

Puerfish, California newt, parrotfish, octopus,

starfish, angelfish, and xanthid crabs

Neurotoxic Shellfish
Poisoning

Brevetoxin

oysters, clams, and mussels

4.2.4 Environmental Contaminants

Environmental contaminants are chemicals that accidentally or deliberately enter the
environment, often, but not always, as a result of human activities. Some of these
contaminants may have been manufactured for industrial use and because they are very
stable, they do not break down easily. If released to the environment, these contaminants
may enter the food chain. Other environmental contaminants are naturally-occurring
chemicals, but industrial activity may increase their mobility or increase the amount available
to circulate in the environment, allowing them to enter the food chain at higher levels than
would otherwise occur.
Some examples of environmental contaminants include lead, arsenic, bromates, dioxins,
furans, mercury and polychlorinated biphenols (PCBs). Division 15 (Table 1) of the FDA (Food
and Drugs Act) contains maximum limits for some environmental contaminants in specific
commodities.
Reference: Environmental Contaminants Health Canada (http://www.hc-sc.gc.ca/fnan/securit/chem-chim/environ/index-eng.php)

4.2.4.1 Arsenic

Arsenic is a naturally occurring element widely distributed in the earth's crust and is generally
found in trace quantities in soil, rock, water and air. Arsenic can take two forms organic and
inorganic. Organic arsenic can be found in fish and shellfish and is the much less harmful
form of arsenic. Inorganic arsenic compounds are found throughout the environment and can
be released into the air through various processes such as volcanic action, mining of arseniccontaining minerals and ores and by industrial and commercial processes such as copper or
lead smelting, wood treatment and pesticide application.
Inorganic arsenic is a carcinogen, and long-term exposure increases the risk of cancers of
the skin, lungs, bladder, liver, kidney and prostate.

4.2.4.2 Cadmium
Cadmium is a rare element and is usually not found in nature in its pure state, but exists in
combination with other elements, forming compounds such as cadmium oxide, cadmium
chloride and cadmium sulphide. Cadmium is used in the manufacture of batteries, pigments,
coatings, plating, stabilizers for plastics, ore processing and smelting, thus it finds its way
into the environment through waste, waste water and soil uptake.
Most of the cadmium which enters the body is directly from plants grown in contaminated
soil, or indirectly, from meat-producing animals which have eaten plants grown in
contaminated soil. Cadmium and its compounds are highly toxic and are also suspected
carcinogens.

4.2.4.3 Lead
Lead is a toxic heavy metal and is found in the environment in sources such as dust and soil.
It can also be found in water and some food products (i.e. (that is to say) maple syrup and
honey), that may have come into contact with older plumbing and cookware that contains
lead-based solder. Lead may be found in older paint products as well.
Lead has been shown to cause neurological disorders, reproductive problems and
diminished intelligence. Infants and young children are particularly at risk because they
absorb a higher proportion of lead from food than adults, as they are still growing and
developing. Pregnant women are also susceptible. Other eects are impaired mental
function, visual motor performance and anaemia. Symptoms of exposure to lead may also be
subtle, such as irritability, headaches, insomnia, gastrointestinal upsets, learning, behavioural
and kidney problems.
For more information on lead, see Health Canada's website on Lead and Human Health
(http://www.hc-sc.gc.ca/ewh-semt/contaminants/lead-plomb/index-eng.php).

4.2.4.4 Mercury

Mercury is a heavy metal which occurs naturally in rocks and soils and can be found in lakes,
streams and oceans. Combustion of fossil fuels, mining, pulp and paper industries and
burning garbage can also release mercury into the environment.
There are traces of mercury in almost all foods, with very low levels in vegetables and fruits,
and high levels in certain types of fish such as shark, swordfish, marlin, escolar and orange
roughly, which absorb the mercury from the organisms they consume as well as the
surrounding water in which they live.
Mercury exists in several chemical forms. Two types are 'inorganic' and 'organic' mercury.
Methyl mercury ('organic' mercury) is the most common form of mercury found in the aquatic
environment and most fish have trace amounts present. It has been found that larger and
older fish tend to have the highest levels of mercury, due to bioaccumulation. Methyl mercury
is suspected to be a human carcinogen.
Exposure to mercury may cause several health eects: damage to the nervous system,
kidneys, and the developing foetus. Other eects include brain damage, irritability, tremors,
memory problems, changes in vision and hearing. Children are more sensitive to mercury
than adults.
For more information see Health Canada's website: Human Health Risk Assessment of
Mercury in Fish and Health Benefits of Fish Consumption (http://www.hc-sc.gc.ca/fnan/pubs/mercur/merc_fish_poisson-eng.php) as well as the information sheet on Mercury in
Fish (http://www.hc-sc.gc.ca/fn-an/securit/chem-chim/environ/mercur/cons-adv-etudeng.php).

4.2.5 Food Additives

A food additive is any chemical substance that is added to food during preparation or
storage and either becomes a part of the food or aects its characteristics for the purpose of
achieving a particular technical eect (See B.01.001 of the FDR (Food and Drug Regulations)
for a definition of 'food additive').
Substances that are used in food to maintain its nutritive quality, enhance its keeping quality
and make it attractive or to aid in its processing, packaging or storage are all considered to
be food additives. However, some substances that aid in the processing of food, under
certain conditions, are considered to be food processing aids, not food additives. Examples
of food additives include:
food colours (natural and synthetic)
pH (potential hydrogen) adjusting agents
preservatives
bleaching agents
food enzymes
glazing and polishing agents

emulsifiers
gelling agents
Division 16 of the FDR (Food and Drug Regulations) contains a positive listing of all of the
food additives that are permitted in food in Canada as well as the purpose, the level and the
specific commodities.
Note:
A processing aid is product that is used in the manufacturing process of food products,
but is not present in the finished food product, i.e. (that is to say) there is no residue
present at the end. A processing aid is not considered to be a food additive.
A flavour enhancer is considered to be a food ingredient under the Food and Drug
Regulations and is not currently regulated as a food additive in Canada for a number of
reasons; the level of use of these substances is small, the history of use is well established
and many international compendiums exist to substantiate their safe use.
Sometimes, food additives are found in food for which there is no provision in the FDR (Food
and Drug Regulations) or at levels which exceed the prescribed levels. In these situations, the
food may pose a risk to the consumer. Some examples of this type of situation include nonpermitted synthetic colours (Sudan, Rhodamine and Gardenia Yellow).
Reference: Food Additives Health Canada (http://www.hc-sc.gc.ca/fnan/securit/addit/index-eng.php)

4.2.6 Processing-induced Chemicals

Undesirable chemicals can be formed in certain foods during processing as a result of
reactions between compounds that are natural components of the food. In some cases an
undesirable chemical may be formed as a result of a food additive being intentionally added
to food and then reacting with another compound in the food. When foods are heatprocessed (baked, deep-fried, etc. (et cetera)), reactions occur between components of the
food, resulting in the desired flavour, appearance and texture of the food. However, some of
these reactions can lead to the production of undesirable compounds. Similarly, certain
storage or processing conditions may allow reactions to occur that could generate potentially
harmful compounds. Such chemicals can be collectively referred to as processing-induced
chemicals. Some of these chemical reactions involve naturally-occurring components in the
food, while other reactions may involve food additives, ingredients, or food packaging
materials that were intentionally used. For these reasons, the presence of processinginduced chemicals in food cannot always be avoided.
Examples of processing-induced chemicals include:
acrylamide

ethyl carbamate
furan
Reference: Processing-induced Chemicals Health Canada (http://www.hc-sc.gc.ca/fnan/securit/chem-chim/food-aliment/index-eng.php)

4.2.6.1 Acrylamide
Acrylamide is a chemical that naturally forms in certain foods, particularly plant-based foods
that are rich in carbohydrates and low in protein, during processing or cooking at high
temperatures Asparagine (a natural amino acid) reacts with naturally occurring sugar
(glucose) in the food and acrylamide is formed, but only if the temperature during the cooking
process is high enough. The highest concentrations of acrylamide have been detected in
potato chips and french fries, although it has been found in other foods as well including
baked and roasted foods.
Acrylamide is a health concern as, based on studies, it is a probable human carcinogen.
For more information, refer to Health Canada's Acrylamide and Food (http://www.hcsc.gc.ca/fn-an/securit/chem-chim/food-aliment/acrylamide/index-eng.php)

4.2.6.2 Ethyl Carbamate (Urethane)

Ethyl carbamate (urethane) is a chemical naturally formed during food processing especially
in alcoholic beverages such as wine, beer, whisky, fruit brandies, and fermented foods such
as bread and yogurt. Its presence was first identified in 1985.
Ethyl carbamate is formed by the spontaneous reaction of urea and ethanol. Urea is either
added to increase fermentation rates, or is excreted by yeast when the wine yeast
metabolises. Ethyl carbamate formation builds up over time and is exponentially accelerated
at elevated temperatures. Fermented products that are also heated during processing (such
as sherry "baking"), increases ethyl carbamate levels.
Ethyl carbamate is a health concern as it has been classified as a probable human
carcinogen.
For allowable levels of ethyl carbamate, see the Canadian Standards (http://www.hcsc.gc.ca/fn-an/securit/chem-chim/contaminants-guidelines-directives-eng.php)] ("Maximum
Limits") for various chemical contaminants in Foods, at Health Canada's website. The levels
range from 30 ppb (parts per billion) in wines to 400 ppb (parts per billion) in fruit brandies
and liquors.

4.2.6.3 Furan
Furan is a colourless, volatile organic compound that is used in some chemical
manufacturing industries and may also be found in low levels in some heat-treated foods,
such as canned or jarred foods. Furan in foods can form through multiple pathways that

involve dierent naturally-present starting compounds that undergo thermal degradation or

chemical rearrangement during food processing. The presence of furan in food is a potential
concern because of indications of liver toxicity, including carcinogenicity, in experimental
animals that were exposed to furan in their diet over a lifetime.
Note:
The chemical "furan" is dierent from "furans". "Furans" is an abbreviation of chlorinated
dibenzofurans and are chemically related to a group of chemicals called dioxins. Dioxins
and furans are environmental contaminants, not processing-induced food contaminants,
and have distinctly dierent chemical structures and behaviours than furan.

4.2.7 Pesticides/Agricultural Products

A pesticide is any substance or organism (including organisms derived through
biotechnology) that is used to control, destroy, repel or attract a pest or to mitigate the eects
of a pest. A pest is defined as an animal, plant or other organism that is directly or indirectly
injurious, noxious or troublesome (Pest Control Products Act, 2002)
Pesticides consist of insecticides, fungicides and herbicides. The following are examples of
pesticides on certain crop groups:
Azoxystrobin on peaches
Captan on cherries
Clethodim on beans
Thiocarbamate on apples
Pesticides play an important role in Canada's food supply by protecting food from pests and
diseases. When pesticides are used on food crops or when animals eat crops treated with
pesticides, residues may remain on or in the food. Health Canada's Pest Management
Regulatory Agency (PMRA) assesses the likelihood of health and environmental risks
associated with each pesticide before it is allowed to be used in Canada. The PMRA (Pest
Management Regulatory Agency) also determines whether the ingestion of the pesticide
residues that are most likely to remain on or in the food poses an unacceptable health risk,
and establishes a maximum residue limit (MRL).
An MRL (maximum residue limit) is an acceptable amount of the pesticide allowed to remain
on food when sold in Canada. The Pest Control Products Act (PCPA) defines a pest control
product and describes the maximum residue limits (MRLs) for many of these products. The
complete list of Health Canada's MRL (maximum residue limit)s regulated under the PCPA
(Pest Control Products Act) (http://www.hc-sc.gc.ca/cps-spc/pest/part/protectproteger/food-nourriture/mrl-lmr-eng.php) can be found on their website.

A major issue associated with pesticides is that they can accumulate in the food chain and
may contaminate the environment. A classic example is dichloro-diphenyl-trichloroethane or
DDT (dichloro-diphenyl-trichloroethane). This is one of the best known synthetic pesticides
which has prevented many deaths by helping control the insect vector that spread malaria,
but at the same time, its use was controversial. It was banned in 1972 due to the damage it
caused to wildlife, especially birds, as it builds up in plants and in the fatty tissues of birds
and other animals. DDT (dichloro-diphenyl-trichloroethane) is believed to be carcinogenic to
humans, and still remains in the environment today.

4.2.8 Veterinary Drugs

Veterinary drugs are often used in food-producing animals to control and/or prevent illness in
the animal. If these drugs are used inappropriately or the withdrawal time prior to slaughter is
not respected, residues from these drugs can be present in the food. These residues can be
the drug itself or metabolites that are produced by the drug as it is digested by the animal
and can be considered harmful to the consumer.
Veterinary drug residues are regulated under the Food and Drug Regulations. Table III (3) in
Division 15 lists the maximum residue limits (MRLs) of veterinary drugs for various foods. The
MRL (maximum residue limit)s are the maximum residue levels tolerated in food products and
tissues of animals that have been treated with veterinary drugs. This residue level is
considered to pose no adverse health eects if ingested daily by consumers over their
lifetime.
Reference: Veterinary Drugs Health Canada (http://www.hc-sc.gc.ca/dhp-mps/vet/indexeng.php)

4.3 Physical/Extraneous Material Hazards

Extraneous material covers all materials (excluding bacteria and their by-products (toxins),
viruses and parasites) which may be found in a food that are foreign to that particular food.
These materials are usually non-toxic but are associated with unsanitary conditions of
production, processing, handling, storage and distribution of food. Some examples of
extraneous materials that may be found in food are insects, hair, metal fragments, pieces of
plastic, wood chips and glass.
Extraneous material can be considered hazardous due to its hardness, sharpness, size or
shape. It may cause lacerations, perforations and wounds or may become a choking hazard.
The sale of food contaminated with injurious extraneous material may be considered to be a
violation of Section 4(1) (a) and/or Section 7 of the Food and Drugs Act.
The document Guidelines for the General Cleanliness of Food An Overview (http://www.hcsc.gc.ca/fn-an/res-rech/analy-meth/microbio/volume1-eng.php) outlines the current
guidelines and associated methods used by the CFIA (Canadian Food Inspection Agency) for

determining the general cleanliness of foods. It can be found on Health Canada's website in
Volume 1 of the Compendium of Analytical Methods.
Health Canada evaluates injurious extraneous material in food and it considers 2.0 mm
(millimetres) or greater as the threshold size for consideration as a health risk. For infant food,
any size of injurious extraneous material may be considered a risk. Besides size, the risk
associated with extraneous material is further evaluated through an assessment of shape,
hardness, material, source, target consumer groups, etc. (et cetera)
Extraneous materials can be dierentiated into two categories: unavoidable and avoidable
Unavoidable extraneous material may occur in food as a by-product of the processing
system or as something inherent to the product itself. Items such as stems in blueberries,
microscopic airborne debris, dirt on potatoes, or minute insect fragments in figs are common
examples of unavoidable extraneous matter.
Avoidable extraneous material is generally less tolerated than unavoidable because it is
preventable. It consists of foreign matter which should not be present if proper GMPs (good
manufacturing practices) are followed. Avoidable extraneous material may come in many
dierent forms such as small glass fragments, pieces of plastic, chunks of rubber, pieces of
jewellery, feather barbules, animal debris or any other unrelated foreign material.
Crystals, which appear to be glass, can sometimes form in certain food products such as
tuna (struvite), processed cheese, soya sauce and fish sauce. These are not glass; they are
mineral crystals. This can be verified by dissolving the crystals in heated vinegar or lemon
juice.

4.4 Allergenic Hazards

An allergen is any protein that is capable of producing an abnormal immune response in
sensitive segments of the population. Allergic reactions to food usually involve IgE
(immunoglobulin E) antibodies. Symptoms of an allergic reaction can range in severity from a
skin rash or slight itching of the mouth, to migraine headaches, to anaphylactic shock and
death. The type and severity of an allergic response is determined by many factors, including
dosage, route of administration, frequency of exposure, and genetic factors. This is not to be
confused with a food intolerance which is an abnormal physiological response to a specific
food. Symptoms of food intolerance may include cramps, diarrhoea and bloating.
Anaphylactic shock is the most severe adverse reaction to food and can be fatal if left
untreated. It generally occurs within minutes of consumption, but occasionally the reaction
may be delayed, with symptoms appearing several hours after the initial exposure. Initial
symptoms of an IgE (immunoglobulin E) mediated allergic reaction are characterized by
itching, hives, and/or swelling of the lips, palate, tongue, and throat. Once the food enters the
stomach and intestine, symptoms may include cramping, nausea, pain, and diarrhoea.

Subsequent systemic symptoms generally aect the pulmonary and cardiovascular system.
The most dangerous symptoms include breathing diculties and a drop in blood pressure or
shock.
Health Canada has defined the foods that represent 95% of allergic reactions in Canada.
These are termed 'priority allergens'.
Peanuts
Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine
nuts, pistachio nuts, and walnuts)
Sesame seeds
Milk
Eggs
Seafood (fish, crustaceans, and shellfish)
Soy
Wheat
Sulphites
Mustard 3
Other adverse reactions to food are not IgE (immunoglobulin E) mediated, but can also be
severe. For example, Celiac disease is an autoimmune disease in which the body produces
antibodies that attack its own tissues in the presence of gluten, which results in inflammation
of the gut. The inflammation and consequent damage to the gut result in a decreased ability
to absorb nutrients. Individuals with celiac disease can be nutrient deficient and have a wide
range of digestive symptoms. Consumption of certain grains containing gluten put these
individuals at increased risk of lymphoma and osteoporosis.
Reactions to sulphites are also non IgE (immunoglobulin E) mediated, but can be severe.
Sulphite sensitive individuals generally have asthma or other allergies and exposure to
sulphite can trigger an asthma attack.
There is no cure for food allergies (and Celiac Disease) and the only successful method for
sensitive individuals to manage food allergy is to practice complete avoidance of the specific
allergen. These individuals therefore rely on accurate information (e.g. (for example) ingredient
list) on food labels to manage food allergy. Inaccurate, undeclared or hidden allergens on
food labels can pose a significant health hazard to these individuals. Cross contamination
during processing, packaging, and storage can inadvertently produce products that contain
allergens which may not be reflected in the ingredients list on the food label. Strict adherence
to good manufacturing practices (GMP), Hazard Analysis Critical Control Points (HACCP),
and allergen prevention plans will reduce the likelihood of cross contamination.
Reference: Food Allergies Health Canada (http://www.hc-sc.gc.ca/fnan/securit/allerg/index-eng.php)

Footnote
3

Labelling requirement for mustard comes into force on August 4, 2012

4.5 Nutritional Hazards

Nutrients are essential to maintain good health and pertain to a group of substances which
includes carbohydrates, proteins, fats, vitamins and minerals.
Food fortification refers to the addition of one or more nutrients (vitamins, minerals, and
amino acids) to a food product and plays an important role in ensuring the health of
Canadians. Adding vitamins and minerals to food helps:
protect Canadians against nutritional deficiencies - for example, requiring all milk to be
fortified with vitamin D virtually eliminated childhood rickets since the 1970s;
maintain and improve the nutritional quality of the Canadian food supply - for example,
enriching flour with B vitamins and iron replaces those same nutrients lost in
processing;
reduce the risk of diet-related chronic diseases - for example, fortification contributes to
adequate intakes of calcium and vitamin D which help build strong bones and may
reduce the risk of osteoporosis.
In Canada, addition of these nutrients to food is regulated under the FDR (Food and Drug
Regulations). Where a nutrient has not been added to the prescribed amounts, i.e. (that is to
say), overage or underage, as permitted by the FDR (Food and Drug Regulations), or where
the nutrient is not present at the required amount at the end of the expected shelf-life of the
product, the impact may be classified as low, medium or high (e.g. (for example), from no
impact to weakness and slight skin discoloration to rickets, Carotenosis, and brain
abnormalities), depending on the quantity of the nutrient, the nature and type of deficiency or
excess. The health eects related to under-fortification are generally well understood,
however, over-fortification can be equally hazardous. For example, if women consume high
amounts of vitamin A shortly before or during pregnancy, it can lead to birth defects.
The current Food and Drug Regulations permit food fortification to:
replace nutrients lost in the manufacturing process;
act as a public health intervention;
ensure the nutritional equivalence of substitute foods; or
ensure the appropriate vitamin and mineral nutrient composition of foods for special
dietary purposes.

4.6 Biotechnology-related Hazards/Novel Foods

The definition of biotechnology used by CFIA (Canadian Food Inspection Agency) is:
"The application of science and engineering to the direct or indirect use of living organisms or
parts or products of living organisms in their natural or modified forms"
This definition of biotechnology takes into account that genetic modification refers to both:
1. indirect scientific processes that induce spontaneous mutations through, chemical
mutagenesis and other processes involving the indirect modification of the organisms'
original genome, and;
2. direct genetic manipulation via methods of inserting genes from the same, or from
dierent species and/or organisms.
The genetically modified (GM) food may cause hazard in developing allergenicity, transfer of
genes from GM (genetically modified) food to cells of the body or to bacteria in the in
gastrointestinal tract.
Typically it is understood that referring to products of biotechnology encompasses products
that have been, or are derived from, genetic modification and/or engineering. However, there
are instances where genetic modification or engineering is not used, but the process and/or
resulting product could be identified as a novel food. The term novel foods means:
Foods resulting from a process not previously used for food.
Products that do not have a history of safe use as a food.
Foods that have been modified by genetic manipulation, also known as GM (genetically
modified) foods, genetically engineered foods or biotechnology-derived foods.
Division 28 of the FDA/R (Food and Drugs Act and Regulations) requires that novel foods be
pre-approved for sale in Canada. Once approved, novel foods (including products of
biotechnology) are considered no dierent from their conventional counterparts and labelling
is voluntary. Although biotechnology is not new, its subsequent practical applications in
producing and manufacturing foods are a relatively new phenomenon. Consequently, it is
dicult to identify products of biotechnology in the Canadian marketplace other than by
identifying any label claims or physical characteristics that are unusual to the product, and
identify it as being novel
There have been several situations in the past whereby unapproved products of
biotechnology have entered into the Canadian marketplace. This can be the result of
improperly labelled source seed, misidentified field research trials, or the 'escape' of the
genetic material into other crops or the environment. Consequently, the volume of
unapproved material that inadvertently becomes intermingled with the conventional food
supply is usually present in relatively small amounts and is termed adventitious presence
(AP). In this scenario, HC (Health Canada) provides an opinion on the relative risk of the AP
(adventitious presence), and the resulting compliance and enforcement program is
implemented by inspectors with specific instructions as to how to identify, test and/or sample
the product Two recent examples of AP (adventitious presence) are:

1. Corn that was approved for feed, but not food in the US (United States), and not
approved for any use in Canada (Starlink corn). This corn was imported into Canada in
the form of flour and used to make taco shells and tortilla chips.
2. Rice crops became contaminated with GM (genetically modified) rice that was in the
trial phase and entered into the food supply (LLrice601).
In these instances, the primary concerns were associated with potential allergenicity and/or
toxicity arising from proteins or other products arising from unintended eects from genetic
insertion or from the inserted gene itself. All genetically modified products must undergo a
rigorous science-based safety assessment by Health Canada before they can be considered
as safe as their conventional counterparts for human consumption in the Canadian food
supply. Without completing the safety assessment, the relative risks associated with the
product cannot be accurately measured, and the product becomes a liability as its potential
hazards are unknown.
Reference: Biotechnology and Foods Health Canada (http://www.hc-sc.gc.ca/srsr/tech/biotech/food-aliment/index-eng.php)

Previous (/food/non-federally-registered/product-inspection/inspectionmanual/eng/1393949957029/1393950086417?chap=4)
Table of Contents (/food/non-federally-registered/product-inspection/inspectionmanual/eng/1393949957029/1393950086417)
Next

Share this page

Date modified:
2014-09-30