CHAPTER 3.

Animal Food Safety Hazards

Slide 1
This chapter will focus on types of hazards potentially associated with animal food and will provide
background information that will be useful during the hazard identification process.

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Chapter 3

Slide 2
In this module, participants will develop: 1) an understanding of what should be considered during
hazard analysis; 2) the ability to recognize that hazards vary among animal species; 3) and an
awareness of potential biological, chemical (including radiological), and physical hazards in animal
food.

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 Animal Food Safety Hazards

Note that when the Preventive

Controls for Animal Food rule refers
to ‘you,’ as it does in this section,
the ‘you’ is the owner, operator, or
agent in charge of the facility.

The owner, operator, or agent in

charge of the facility is responsible
for the hazard analysis described in
this section. However, the owner,
operator, or agent in charge of the
facility may designated the
responsibility of conducting the
hazard analysis to the Preventive
Controls Qualified Individual, as
long as they recognize that the
ultimate responsibility rests with
the owner, operator, or agent in
Slide 3
The Hazard Analysis section begins on page 56345 of Appendix 1. Specifically, You must conduct a
hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other
information, known or reasonably foreseeable hazards for each type of animal food manufactured,
processed, packed, or held at your facility to determine whether there are any hazards requiring a
preventive control; and the hazard analysis must be written.
The majority of the hazard analysis requirements, including additional hazard evaluation
components, will be covered in Chapter 5: Hazard Analysis and Preventive Controls Determination.
For this chapter, the focus is on the fact that a hazard analysis must be conducted to identify known
or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed,
or held at a facility. This first step narrows down an entire universe of hazards to those that are
known or reasonably foreseeable.

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While these 3 categories of hazards

are utilized throughout this
chapter, there are additional
definitions associated with
biological hazards that can be found
in 21 CFR 507.3. These include
pathogen, microorganism, and
environmental pathogen.

Slide 4
Hazard analysis involves the identification and further evaluation of hazards. Potential hazards in
animal food will be classified into three broadly defined categories: biological hazards, chemical
hazards, and physical hazards. The regulation provides examples for each of these categories, but
this is not an exhaustive list of all known or reasonably foreseeable hazards. The regulation
specifically draws out that some hazards are more relevant in one species compared to another. A
key takeaway is that when considering hazards, it is important to consider the manufacturing
environment and the species for which the animal food is intended when considering hazards.

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Slide 5
Finally, the hazard analysis must consider known or reasonably foreseeable hazards that may be
present in the animal food for any of the following reasons: 1) the hazard occurs naturally; 2) the
hazard may be unintentionally introduced; or 3) the hazard may be intentionally introduced for
purposes of economic gain.

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A key component of this definition

is that a hazard may cause illness or
injury to humans or animals. A
consideration for severity is part of
the hazard analysis process that will
be described later, but both the
impact on animal and human
health must be considered at this
stage.

Slide 6
Because this is a chapter about hazards, it is appropriate to introduce the definition of hazard found
in 21 CFR 507.3, which can be found on page 56338 of Appendix 1. A hazard means any biological,
chemical (including radiological), or physical agent that has the potential to cause illness or injury in
humans or animals.
A key part of this definition is that it specifies an agent can be a hazard if it causes illness or injury
in humans or animals. The hazard analysis must consider those hazards that may potentially
impact human health due to their role in handling animal food or the edible products (meat, milk,
eggs) from animals consuming the food. However, the hazard analysis must also consider the
impact on the animal itself. For this reason, some hazards for animal food may be different than
those for human food. While human food is only required to consider hazards for a single species
(humans), the hazard analysis for animal food often requires the consideration for multiple animal
species and humans who may be impacted.

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 Animal Food Safety Hazards

Slide 7
The definition for a known or reasonably foreseeable hazard is found on page 56339 of Appendix 1.
This is a further classification of a hazard. Distinction between this term and the term hazard is key
in the hazard identification and evaluation process that is discussed throughout this chapter. A
known or reasonably foreseeable hazard is “a biological, chemical (including radiological), or
physical hazard that is known to be, or has the potential to be, associated with the facility or the
animal food.” The critical component of the definition is the known or potential association with the
facility or the animal food.

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Slide 8
Once a facility has identified a known or reasonably foreseeable hazard, the next step of the hazard
analysis process is to determine if the hazard is a hazard requiring a preventive control. There is a
specific definition for this hazard category, which was updated in a technical amendment. The
updated definition can be found on page 3717 of the technical amendment (Appendix II).
The first key component of this long definition is that the determination is to be made by “a person
knowledgeable about the safe manufacturing, processing, packing, or holding of animal food…” This
fits the definition of a Preventive Controls Qualified Individual.
Next, the definition calls out that the establishment of preventive controls is dependent upon “an
assessment of the severity of the illness or injury to humans or animals if the hazard were to occur
and the probability that the hazard will occur in the absence of preventive controls.” Possible
methods to assess severity and probability is described in chapter 5.
The definition goes on to clarify that the hazard can be controlled by either one or multiple controls,
which either “significantly minimize or prevent the hazard in animal food.”
Finally, the definition states that a hazard requiring a preventive control has necessary “components
to manage those controls.” There is flexibility as the management components are as appropriate
to the animal food, the facility, and the nature of the preventive control and its role in the facility’s
food safety system.

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Slide 9
Preventive Controls are those risk-based, reasonably appropriate procedures, practices, and
processes that a person knowledgeable about the safe manufacturing, processing, packing, or
holding of animal food would employ to significantly minimize or prevent the hazards identified
under the hazard analysis that are consistent with the current scientific understanding of safe food
manufacturing, processing, packing, or holding at the time of the analysis.
Preventive controls can be categorized by the method employed to control the hazard: process
controls (which mitigate hazards through an action during the process itself), sanitation controls
(which mitigate hazards through active sanitation procedures to prevent cross-contamination),
supply-chain-applied controls (which requires control of the hazard at the supplier level), or other
controls (which control hazards through different means other than those previously specified).
There will be more discussion of the types of preventive controls and their required management
components in the next chapters.

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Slide 10
As can be seen, there are many definitions for the various categories of hazards. This slide
graphically depicts the hazard analysis process. The process starts with the most general category
of hazards – those that have the potential to cause illness or injury to humans or animals. Then, the
hazard category gets narrowed to those hazards that are known or reasonably foreseeable based on
the types of animal food the facility manufactures, processes, packs or holds. Finally, the
combination of severity and probability are considered when further refining hazards to those that
require a preventive control. Hazards requiring a preventive control are those that must be
significantly minimized or prevented with preventive controls.
This chapter will focus on hazards, and identifying which hazards are known or reasonably
foreseeable in different types of animal food. The determination if they require a preventive control
will be described fully in Chapter 5: Hazard Analysis and Preventive Controls Determination.

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Slide 11
As participants reflect on the hazard definition, it is important to understand that there are some
animal food regulations that will not be discussed thoroughly in this curriculum because they are
not likely to lead to food safety concerns. For example, there are specific labeling requirements for
both medicated and non-medicated animal foods. These labeling requirements must be met in
accordance with various rules, but in some cases, mislabeling or economic fraud is not considered a
food safety concern. One such instance is if an ingredient manufacturer intentionally mislabels
chicken byproduct meal as duck meal because the two have similar nutrient profiles and duck meal
commands a higher price. In this case, the mislabeling is economic fraud and is a regulatory
violation of other rules, but does not necessarily constitute a hazard within the Preventive Controls
for Animal Food rule. Conversely, mislabeling beef meal as pork meal may be considered a hazard if
it is sold to a ruminant feeder who then feeds it to beef cattle in violation of the BSE rule.
Furthermore, there are occasional examples where undesirable situations are not necessarily
hazards, such as poor product quality. For example, a pelleted goat food manufacturer may not
properly cool pellets after thermal processing and prior to packaging. As a result, the product may
exhibit poor pellet quality, but would not cause potential illness or injury to humans or animals, and
would therefore not meet the definition of a hazard.

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The Reportable Food Registry (RFR)

is an electronic portal for industry
to report when there is a
reasonable probability that a food
will cause serious adverse health
consequences or death. The RFR
applies to all FDA-regulated
categories of human and animal
food, except dietary supplements
and infant formula.

Who Should Use the Reportable

Food Registry?
Registered Food Facilities that
manufacture, process, pack, or hold
food for human or animal
consumption in the United States
under section 415(a) of the FD&C
Slide 12 Act (21 U.S.C. 350d) are required to
report when there is a reasonable
When beginning the hazard analysis process, it is helpful to probability that the use of, or
understand the types of hazards that have previously been exposure to, an article of food will
associated with the types of animal food that is manufactured, cause serious adverse health
processed, packaged, or hold. A good resource for this data is consequences or death to humans
the Reportable Food Registry, or RFR. This is an electronic or animals.
portal for Industry where all facilities that manufacture,
process, pack, or hold animal food must report hazards. Specifically, they must report to this portal
if there is a reasonable probability that the use of, or exposure to, animal food will cause Serious
Adverse Health Consequences or Death to Humans or Animals. These are often abbreviated as
SAHCODHA hazards. Since its inception, there have been four annual reports published at the time
of this curriculum’s development: 2009-2010, 2010-2011, 2011-2012, and 2012-2013, which can
be found on the FDA website. A fifth annual report summarizing data from September 2009 to
September 2014 was made available on May 24, 2016, but data in this curriculum is from the
reports from 2009 to 2013.
There were a total of 96 RFR reports for animal food from 2009-2013. Forty percent of all RFR
reports for animal food during this time were due to Salmonella contamination. Other major
reporting categories included nutrient deficiencies or toxicities (21%), unapproved drug
contamination (13%), aflatoxin (10%), and foreign objects, such as metal or glass (5%). All the
remaining RFR reports, such as improper labeling, non-compliance with BSE regulations, mold,
cleaning solution contamination, or pest activity, totaled 11%. An understanding of the total scope
of RFR reports is helpful to prioritize focus during hazard analysis.

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 Animal Food Safety Hazards

The Reportable Food Registry (RFR)

is one example of a type of
reference that may be used to
identify known or reasonably
foreseeable hazards in different
types of animal food, but other
resources are likely needed. These
resources will be described in
Chapter 5.

Slide 13
This slide shows the same data, but broken down by the numerical occurrence of RFR reports
associated with either pet food or other animal food. As participants can see, all the Salmonella RFR
reports were associated with pet food, and that hazard was over five times more prevalent than any
other hazard. Part of the reason for the greater proportion of Salmonella reports in pet food is its
potential implications on human health, which is described more fully later in the chapter.
Conversely, either nutrient deficiencies or toxicities or unapproved drug contamination accounted
for 80% of the other animal food hazards. The RFR reports can be evaluated by breaking down
those hazards associated with specific animal species. For example, sheep food was associated with
six total RFR reports during these years. Of those, five were due to copper toxicity and one to
unapproved drug contamination.
While the RFR annual reports are useful, there are many other resources to consider when
identifying hazards. For example, more recent recalls from 2015 reference Listeria monocytogenes
as a hazard associated with pet food, especially raw, fresh, or frozen dog and cat food. Other
resources, such as scientific literature, industry whitepapers, and guidance for industry are
available and are important to consider. Those resources and others are discussed in more detail
during the hazard identification and evaluation section of Chapter 5: Hazard Analysis and
Preventive Controls Determination.

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Chapter 3

This is a general list of example

hazards. Some of the hazards on
this list are not associated with all
types of animal food, while there
are other hazards that may be
known or reasonably foreseeable
hazards for a type of animal food or
a facility that are not listed. This is
not meant to be a comprehensive
list. Each facility must conduct a
hazard analysis specific to that
facility.

Many of hazards discussed in this

chapter are referenced directly in
the Preventive Controls for Animal
Food rule or the Preamble due to
their association with animal food
Slide 14 in the past.
The Preventive Controls for Animal Food rule discusses the three categories of hazards and examples
of each. This list of example hazards in animal foods is based on the examples in the rule, RFR
reports, scientific literature, and other resources. Specifically, biological hazards can include
undesirable microorganisms, such as Salmonella spp. and Listeria monocytogenes. Chemical hazards
can include mycotoxins, pesticides, process-related or industrial chemicals, drug carryover, and
nutrient deficiencies and toxicities. Finally, physical hazards can include stones, glass, and metal. In
the next section, each of these hazard categories are discussed more fully, starting with the
biological hazards.
As previously described, biological hazards can include undesirable microorganisms, such as
Salmonella spp. and Listeria monocytogenes. Based on data from the RFR reports, biological hazards
are most commonly associated with pet food. The discussion of biological hazards will start with
the hazard responsible for most of those RFR reports, Salmonella.

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 Animal Food Safety Hazards

FDA Compliance Policy Guide Sec.

690.800 Salmonella in Food for
Animals contains further
background and examples of
pathogenic Salmonella serotypes
that have been associated with
disease in the particular animal
species consuming these animal
foods.
There are additional definitions that
are associated with biological
hazards that can be found in 21 CFR
507.3.

Microorganisms: means yeasts,

molds, bacteria, viruses, protozoa,
and microscopic parasites and
includes species that are
Slide 15 pathogens.
Salmonella is a bacteria that may cause salmonellosis when the
pathogen is consumed. It thrives in warm, humid Undesirable microorganisms:
environments, but can survive and form spores in low- includes those microorganisms that
moisture situations. Because of this, dehydrated or freeze- are pathogens, that subject animal
food to decomposition, that
dried ingredients or finished foods may be contaminated when
indicate that animal food is
they are rehydrated.
contaminated with filth, or that
In humans, symptoms of salmonellosis include nausea, otherwise may cause animal food
vomiting, abdominal cramps, minimal diarrhea, fever, and to be adulterated.
headache. Certain vulnerable populations, such as children, the
elderly, and individuals with compromised immune systems, are particularly susceptible to
acquiring salmonellosis from pet food, and may experience more severe symptoms. Salmonella also
has widespread occurrence in animals, especially poultry and swine. Animals may be infected
either clinically, where they show symptoms similar to those in humans, or asymptomatically but
are still at a potential for shedding and spreading the bacteria.
The role of Salmonella in animal food as a potential hazard to both humans and animals is described
in the FDA Compliance Policy Guide Sec. 690.800: Salmonella in Food for Animals. It describes that
certain animal foods, such as pet food, pose a high risk to human health when they are
contaminated with Salmonella because they are direct human contact foods. This means that there
is a high likelihood that humans will come in direct contact with these foods, such as through direct
ingestion by people or from hands or utensils that are contaminated when feeding pets.
Salmonella-contaminated animal food can cause illness in animals that consume that food. Whether
Salmonella causes illness in an animal depends on the serotype. A serotype is a further classification
of a broad species of bacteria. For example, there are more than 2,500 different serotypes of
Salmonella that differ from one another by small variations in structure and function. Those
serotypes that cause disease in a particular species are referred to as pathogenic for that animal
species.

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Slide 16
Serotype differentiation is important. FDA considers a pet food or a pet food ingredient to be
adulterated when it is contaminated with any serotype of Salmonella and will not undergo a
commercial heat step that will kill the Salmonella. This is partially because pet food is a direct
human contact food.
Alternatively, FDA considers other animal food to be adulterated only when it is contaminated with
a Salmonella serotype considered to be pathogenic to the animal species intended to consume the
animal food. Unlike pet foods, the majority of food for other animals is not thermally-processed.
When it is, the intent of the process is typically to improve nutrient availability to the animal or
other quality aspects of the animal food by pelleting, extruding, or expanding the product. Thus,
thermal processing in most foods for other animals is not intended as a Salmonella control step.

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Slide 17
The Compliance Policy Guide lists current examples of animal foods and the pathogenic Salmonella
serotypes that have been associated with disease in the particular animal species consuming these
animal foods. While these are currently the listed serotypes, FDA stipulates that all other Salmonella
serotypes should be evaluated on a case-by-case basis.

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Chapter 3

For more information, refer to:

Nemser SM, Doran T, Grabenstein
M, McConnell T, McGrath T,
Pamboukian R, Smith AC, Achen M,
Danzeisen G, Kim S, Liu Y, Robeson
S, Rosario G, McWilliams Wilson K,
Reimschuessel R. Investigation of
Listeria, Salmonella, and toxigenic
Escherichia coli in various pet
foods. Foodborne Pathog Dis. 2014
Sep;11(9):706-9.

Slide 18
L. monocytogenes is unique in that it can survive in both the presence and absence of oxygen. The
bacteria can grow and proliferate in frozen and refrigerated environments. Listeriosis in animals
may result in swelling of the brain, neurological-related circling, and late-term abortions.
While the RFR reports in the annual summaries published through 2013 do not implicate Listeria
monocytogenes, more recent data has associated the pathogen with raw, fresh, and frozen pet foods.
For example, there were 4 voluntary recalls of raw, fresh, or frozen pet food associated with L.
monocytogenes in 2015. Furthermore, a peer-reviewed research paper published in 2014
demonstrated that 16.3% of the 196 raw cat and dog foods sampled were positive for the pathogen.
This recent addition of a biological hazard underscores that reanalysis of the hazard identification
and evaluation may be necessary as new information becomes available.

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 Animal Food Safety Hazards

In most regions, radiological

hazards are not likely to be hazards
requiring a preventive control.
When they are, the most common
way these radionuclides are
incorporated into animal food is
through use of water that contains
a radionuclide. Radiological hazards
also may result from accidental
contamination, such as
contamination arising from
accidental release from a nuclear
facility or damage to a nuclear
facility from a natural disaster.

The Preamble of the Preventive

Controls for Animal Food Rule
describes decomposition as
Slide 19 “microbial breakdown of the
While biological hazards were most associated with pet foods, normal food product tissues and
the subsequent enzyme-induced
chemical hazards were responsible for the RFR reports in
chemical changes.
other animal foods. Chemical hazards can include radiological
These changes are manifested by
hazards. This curriculum does not cover radiological hazards abnormal odors, taste, texture,
in depth because they are not likely to be known or reasonably color, etc., and can lead to reduced
foreseeable in most regions. More common chemical hazards food intake or rejection of the food
include substances such as pesticide, drug carryover, natural by the intended animal species,
toxins, decomposition, unapproved food or color additives, resulting in illness or death.”
and nutrient deficiencies or toxicities. Specific hazards
discussed here include mycotoxins, chemical contamination from pesticides and process-related or
industrial chemicals, drug carryover, and nutrient deficiencies or toxicities. However, it should be
recognized that chemical hazards can vary widely and certainly may extend to examples not
discussed in this chapter.

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Slide 20
The hazard analysis process must consider known or reasonably foreseeable hazards that may be
present. Examples of naturally occurring, unintentionally introduced, and intentionally introduced
hazards are shown above. These reasons for introduction must be considered for all hazards,
regardless if they are biological, chemical, or physical in nature.
Mycotoxins are an example of a hazard that occurs naturally and will be discussed in more detail in
the next four slides.

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 Animal Food Safety Hazards

While molds and their growth are

biological systems, any mycotoxins
produced by those molds are
considered to be chemical hazards.
Not all molds produce mycotoxins.
Even molds that may potentially
produce mycotoxins do not
produce those toxins except under
specific temporal conditions. Thus,
molds are not considered biological
hazards within this curriculum,
while mycotoxins are considered
chemical hazards.

Slide 21
Mycotoxins are naturally-occurring hazards that are a result of specific growing conditions
encouraging mold growth in different grains. Some molds, such as aspergillus spp. and fusarium
spp., occasionally produce mycotoxins during specific environmental conditions. While these molds
may be present without producing mycotoxins, their growth and production of the toxin occurs
with specific temporal conditions. For example, fusarium molds that produce zearalenone and
deoxynivalenol are more likely to occur during cool, wet conditions, while aspergillus molds that
produce aflatoxin are more likely to occur in hot environments. Mycotoxins can cause serious
illness in humans and animals at very low dosages. The severity of illnesses depends upon the type
of mycotoxin present and the animal’s physiology. The types of illnesses that may result from these
toxins are discussed next.

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Slide 22
There are several different types of mycotoxins, and severity of illnesses they cause may vary
depending upon their concentration and the animal consuming the animal food. Aflatoxins is
commonly found in peanuts, corn, wheat, cottonseed, and nuts. Deoxynivalenol, or DON, is
sometimes called vomitoxin and is most commonly found in corn, wheat, barley, and oats.
Fumonisin is most commonly found in corn, wheat, sorghum, barley, and oats. Ochratoxin A is most
commonly found in wheat, barley, oats, corn, and dry beans. Another mycotoxin, T-2, which rapidly
metabolizes to HT-2, is found most commonly in barley, wheat and oats. Finally, zearalenone is
commonly found in corn, wheat, barley, and rye. Most recalls and RFR reports have been associated
with aflatoxin due to its frequency of occurrence and severity of illness, which is why it is focused
on the most during this chapter.

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 Animal Food Safety Hazards

Action Levels for Poisonous or

Deleterious Substances in Human
and Animal Feed contains
information on levels of chemicals
that are prohibited in certain foods.
These levels are based on FDA’s
assessment of long term and short
term effects of consuming the
specific chemical.

This slide depicts action levels for

aflatoxin, but there are advisory
and caution levels for other
mycotoxins that can be found in
FDA guidance or precautionary
levels that may be found in
scientific literature. Each facility
Slide 23 should consider the mycotoxins
Aflatoxins may cause different levels of illness within animals, that are relevant to the ingredients
they utilize and the intended
but its implications in human health mark its severity. For
species. The facility should also
example, aflatoxins may cause organ failure and mortality in
consider that there may be additive
some animal species, such as dogs and cats, while others may effects of different types of
experience less severe symptoms, such as depressed milk mycotoxins.
production in dairy cows. However, aflatoxin can be
transmitted from the animal food through milk, meat, and
eggs. This is concerning because aflatoxin is one of the most potent naturally-occurring carcinogens
known to man. The danger of this toxin to both human and animal health has resulted in the FDA
setting levels for the toxin in different types of animal food. These levels are described in the FDA
Compliance Policy Guide Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds. If an animal
food has an aflatoxin concentration above that outlined for an intended animal species, the FDA
may take regulatory action.
The animal’s phase of production and physiology may affect how aflatoxin is metabolized, and thus
its impact on illness or injury to humans or animals. Therefore, there are different action levels for
different species and production phases. The specific levels from the Compliance Policy Guide are
listed above. For example, the action level for corn and peanut products intended for finishing beef
cattle is 300 parts per billion (ppb), while the action level for immature animals and other animals,
such as dairy cattle and pets, is just 20 ppb.

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Chapter 3

FDA Guidance for Industry

establishes limits and levels for
deoxynilvalenol and fumonisins in
animal food. Other resources to
help determine appropriate
threshold levels for different
species and physiological states of
animals include the CAST Task
Force Report referenced on the
slide and A Guide for Grain
Elevators, Feed Manufacturers,
Grain Processors and Exporters
from the National Grain and Feed
Association.

Slide 24
There are also FDA advisory or guidance levels for other mycotoxins, but they are less stringent
than those for aflatoxin. Still, those mycotoxins may have dramatic impacts on animal health.
Deoxynivalenol concentrations above threshold levels may result in vomiting, diarrhea, animal food
refusal, and decreased milk production in animals. Fumonisins can also cause animal food refusal.
Horses are particularly susceptible to fumonisins, as they can lead to equine
leukoencephalomalacia, or ELEM. Because horses cannot metabolize the toxin well, concentrations
greater than 2 parts per million (ppm) in food for horses may cause drowsiness, blindness, circling,
staggering, and death within 48 to 72 hours. Ochratoxin A is known to result in mortality and
decreased weight gain in many animals, as well as poor egg production and poor egg quality in
layer chickens. The T-2/HT-2 described earlier can lead to mortality and infertility in certain
species. Finally, zearalenone has been associated with estrogenic effects that lead to embryonic
death and the inhibition of fetal growth, as well as infertility. These symptoms are most commonly
observed in swine, but can occur in other species.

The type and concentration of a mycotoxin – as well as its interaction within each animal species –
impact the likeliness for its consideration as a hazard. The hazard analysis must consider temporal
conditions, particularly in the case for mycotoxins, as their presence may change due to
geographical location and annual environmental conditions.

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Slide 25
While mycotoxins are an example of chemical hazards that are naturally occurring, some hazards
are unintentionally-introduced by humans or the manufacturing process. These include pesticides
and process-related or industrial chemicals, drug carryover, and nutrient deficiencies or toxicities.

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Compliance Policy Guide Sec.

575.100 Pesticide Residues in Food
and Feed contains information for
the maximum amount of a
pesticide residue that may be
present in raw agricultural
commodities and animal food.
The 7 violative pesticide levels
included o-phenylphenol in chicken
food and raisin pomice, piperonyl
butoxide in soybean meal, acephate
in vitamin E, pirimiphos-methyl in
soluble wheat protein, and
diphenylamine in canola meal.

Slide 26
Pesticides may be introduced by direct contamination from facility pesticide programs, from
contaminated grains, or from contamination of animal-based products due to tissue accumulation.
Dioxins and process-related chemicals, such as chlorinated pesticides, are toxic industrial
pollutants that may be found in the environment and accumulate in fat tissue. While these are all
concerns, FDA pesticide surveillance suggests that a very small percentage of animal food have
pesticide levels that exceed permitted levels. For example, of 328 animal food samples collected in
fiscal year 2012, seven contained violative pesticide levels that exceeded an EPA tolerance or FDA
action level (FDA Pesticide Monitoring Program Fiscal year 2012 Pesticide Report).

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Slide 27
Drug carryover is also a chemical hazard that is usually unintentionally-introduced. All medicated
animal foods must be manufactured and distributed in accordance with the Current Good
Manufacturing Requirements that are found in 21 CFR Part 225. An example of a drug carryover
hazard is monensin poisoning in horses. Monensin sodium is an animal drug approved for use in
cattle and poultry. However, there have been instances of monensin contamination in food for
horses, where it is very toxic with 2 to 3 mg per kg of body weight likely resulting in death. Early
stages of monensin poisoning in horses include elevated heart rate, muscle wasting, and edema, or
swelling, around the eyes. Because monensin sodium is so toxic to horses, particular care must be
used when a facility manufactures food for horses and animal food containing monensin sodium.
This may include procedures to minimize the carryover of monensin from one batch of animal food
to the next, such as the use of sequencing or flushing procedures.

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Chapter 3

The nutrient deficiencies or

toxicities used in this chapter are
those listed directly in the
Preventive Controls for Animal
Food rule as examples. These
nutrient deficiencies and toxicities
have caused animal illness in the
past.

Slide 28
Other unintentionally-introduced chemical hazards may include nutrient deficiencies or toxicities.
This is a hazard category that is unique to animal food because nutrient deficiencies or toxicities are
a greater risk in animals than humans.

Consider this example: humans may reach their nutrient requirements through a variety of foods
consumed throughout the day. For example, a person may choose to eat a serving of fruit, protein
(eggs or bacon), and carbohydrate (toast) for breakfast, a salad full of nutritious vegetables and
protein (chicken) for lunch, and have a dinner including a serving of protein (beef), carbohydrate
(potatoes), dairy (glass of milk), and healthy fat (cheese).

Meanwhile, a single bag of animal food may be the single source of nutrients for an animal over a
number of days or weeks. Therefore, it is essential that the diet be wholesome and safe – but also
meet the animal’s nutrient requirements.

Some animals have particularly sensitive nutrient requirements, especially to vitamins and
minerals. For example, common nutrient deficiencies or toxicities that will be discussed are
inadequate thiamine in cats, excessive vitamin D in dogs, and excessive copper in food for sheep. In
addition to the animal’s sensitivity to the nutrient, some animal food manufacturing processes may
impact the stability of sensitive nutrients, such as vitamins, and lead to nutrient deficiencies.

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 Animal Food Safety Hazards

Slide 29
Thiamine, sometimes referred to as vitamin B1, is a vitamin that is considered an essential nutrient
for many animal species. Essential nutrients are ones that cannot be produced by the body and that
must be supplied to an animal at a minimum level to maintain healthy bodily functions. Thiamine is
an essential nutrient for cats.

Thiamine has been demonstrated to be rapidly destroyed when subjected to heat and water. These
are environmental conditions common to the commercial processes for canned cat food production,
and up to 90% of thiamine may be destroyed during the retort process of manufacturing canned cat
food. Thiamine deficiency in cats typically manifests itself as ventriflexion, or a curled neck as
shown in the picture, followed by seizure and death. Careful maintenance and monitoring of
thermal processing parameters are necessary to maintain maximum thiamine activity in cat food.

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Chapter 3

It is accepted that many nutrients,

particularly many vitamins and
minerals, are very difficult to
analyze consistently. The
Association of American Feed
Control Officials (AAFCO) Official
Publication lists acceptable
analytical methods and range of
analytical variation for various
nutrients and drugs.

Slide 30
Although some essential nutrients must be fed at a minimum level for proper body function, some
essential nutrients can be toxic to animals when fed at high levels. Having too much of a vitamin
can be a hazard as well. Excessive vitamin D has been recognized as a potential hazard in dog food.
Because the digestive tract absorbs vitamin D in proportion to the quantity of calcium, over-
consumption of vitamin D by dogs causes excessive Ca absorption. This ultimately may lead to
hypercalcemia, or hardening, of smooth muscle. Further impacts may include kidney failure and
disorders of the cardiovascular and nervous system.

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 Animal Food Safety Hazards

Slide 31
Copper is required, but also potentially toxic, for all animal species. Because molybdenum is
responsible for clearing copper from the liver, an overconsumption of copper in ratio to
molybdenum may lead to copper toxicity and oxidation of hemoglobin. Copper toxicity can be both
chronic and acute. This means that the accumulation of the mineral in the liver can cause toxicity if
lower, but still toxic, levels are fed over many days or weeks. However, rapid, sudden death can
occur from very high doses in a matter of hours. The picture in the slide shows two kidney, one that
is healthy, and one that is shiny and blue in color due to the oxidized hemoglobin that is
characteristic of copper toxicity.

While all species may be impacted by copper toxicity, sheep are particularly sensitive to excessive
copper because they have inherently lower molybdenum concentrations compared to other
species. A typical sheep diet of 20% grain and 80% forage contains approximately 15 ppm copper
with no added copper. When molybdenum levels are approximately 3 ppm, the tolerance level of
copper for sheep is typically 20 to 25 ppm. Sheep fed diets with lower molybdenum levels would
have a lower copper tolerance.

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Chapter 3

When considering hazards

intentionally introduced for
purposes of economic gain, a
facility is not expected to consider
all possible hazards that could fit
this category. The preamble of the
Preventive Controls for Animal Food
rule states, “…the requirement to
consider hazards intentionally
introduced for purposes of
economic gain is narrow. Such
hazards will be identified in rare
circumstances, usually in cases
where there has been a pattern of
economically motivated
adulteration in the past.”

Slide 32
The focus to this point has been on chemical hazards that occur naturally or are unintentionally-
introduced, however, there is the rare activity where a hazard is intentionally-introduced for
purposes of economic gain. The most well-known example of this was the pet food recall in 2007
due to melamine contamination. This wide recall was due to a single overseas supplier that blended
melamine into product labeled as wheat gluten to elevate the crude protein level of the ingredient.
The ingredient was later purchased by pet food manufacturers. The combination of melamine with
cyanuric acid in the ingredient resulted in more than 8,500 reported animal deaths. The original
intent of adding the melamine was to falsify protein content. The unexpected result was that it
created a major animal food safety concern. This was a clear incident when a supplier intentionally
introduced a hazard for economic gain. Using visual inspection and verified suppliers may have
prevented this hazard from entering the animal food supply.

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 Animal Food Safety Hazards

Slide 33
Now that biological and chemical hazards have been discussed, the focus will shift to the final
category, physical hazards.

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Chapter 3

Slide 34
Physical hazards, when present, may result in animal illness or injury. Typically, physical hazards in
animal food are not associated with human health concerns, but they are concerns for the animals
consuming the food. These physical hazards can include items like stones, which may be introduced
with ingredients from fields and cause choking or broken teeth in animals. Broken glass may be
introduced from broken light bulbs or other glass in the ingredient or animal food manufacturing
facility and result in cuts to the animal. Finally, metal may be introduced at a number of locations
because nearly the whole animal food manufacturing process occurs using equipment with metal
parts. Metal can result in several injuries to animals when consumed, such as cuts or broken teeth.

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 Animal Food Safety Hazards

Slide 35
That ends our discussion on animal food safety hazards. Remember that a hazard is defined as any
biological, chemical (including radiological), or physical agent that has the potential to cause illness
or injury in humans or animals. Biological hazards in animal food may include Salmonella spp. and
Listeria monocytogenes. Chemical hazards may include naturally-occurring hazards, such as
mycotoxins, unintentionally-introduced hazards, such as drug carryover and copper toxicity, and
intentionally-introduced for purposes of economic gain, such as melamine. Finally, physical hazards
in animal food may include stones, glass, and metal. Now that the participants have a fuller
understanding of hazards associated with different types of animal foods, the next chapter will
describe the hazard identification and evaluation process.

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