#122

#### Guidance for Industry

MANUFACTURE AND LABELING OF RAW MEAT FOODS FOR COMPANION AND CAPTIVE
NONCOMPANION CARNIVORES AND OMNIVORES

This guidance is intended to provide specific guidance on the
manufacture and labeling of foods that contain raw meat, or other raw
animal tissues, for consumption by dogs, cats, other companion or pet
animals, and captive noncompanion animal carnivores and omnivores.

Comments and suggestions regarding this document should be sent to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5600 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should
be identified with the Docket No. 02D-0468. Submit electronic comments
to http://www.fda.gov/dockets/comments.

For questions regarding this document, contact Dr. William J.
Burkholder, Division of Animal Feeds, (HFV-228), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Place, Rockville,
MD 20855, 301-827-0179 (email: William.Burkholder@fda.gov).

Additional copies of this guidance document may be requested from the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Place, Rockville, MD 20855 and may be
viewed on the Internet at <http://www.fda.gov/cvm>*.*

According to the Paperwork Reduction Act of 1995, a collection of
information should display a valid OMB control number. This guidance
contains no collections of information.

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##### U.S. Department of Health and Human Services

**Food and Drug Administration**

**Center for Veterinary Medicine**

**May 18, 2004**

**Revised November 9, 2004**

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#122

#### Guidance for Industry

MANUFACTURE AND LABELING OF RAW MEAT FOODS FOR COMPANION AND CAPTIVE
NONCOMPANION CARNIVORES AND OMNIVORES

**NOTE:** This guidance document is being revised to correct an
inadvertent error in the guidance dated May 18, 2004 as follows:

-   There was an error of fact in this guidance document originally on
    page 3, next to the last paragraph, last sentence. The sentence
    previously read: "Another study that cultured 10 raw meat diets
    based on chicken determined all 10 diets (100%) to be contaminated
    with *Salmonella* spp.^14^"

-   On page 4, next to the last paragraph, last sentence, the sentence
    now reads: "Another study that cultured 10 raw meat diets based on
    chicken determined 8 diets (80%) to be contaminated with
    *Salmonella* spp.^14^"

**May 18, 2004**

**Revised November 9, 2004**

**GUIDANCE FOR INDUSTRY**

## MANUFACTURE AND LABELING

## OF RAW MEAT FOODS FOR COMPANION AND CAPTIVE NONCOMPANION CARNIVORES AND OMNIVORES[^1]

# **I. Background**

Foods for carnivorous and omnivorous animals containing raw meat, or
other raw animal tissues, have been on the market for many years for use
by zoos, mink farms, dog racing facilities, and other professional
establishments. Some of these products may have included meat and other
tissues from mammals or poultry that have died other than from slaughter
or have otherwise been unfit for human consumption. Products containing
tissues from animals that have died other than by slaughter are
adulterated under Section 402(a) of the Federal Food, Drug, and Cosmetic
Act (FFDCA) and animal tissues otherwise unfit for human consumption may
be adulterated if not further processed to remove pathogenic
contaminants.

Previously it was presumed that raw meat or raw animal tissues were
primarily purchased and used by zoos, mink farms, dog racing facilities,
or other professional establishments, and that these entities were aware
of the potential risks of using such products, from both a food safety
and nutritional deficiency perspective, and could take measures to
mitigate those risks. However, an increasing trend is for use of raw
meat foods for companion and captive noncompanion animals by owners who
may not be as aware of the potential for harm. FDA is issuing this
guidance because of the health risks and potential for adulteration
including, but not limited to, when raw meat foods are used by pet
owners.

FDA does not believe raw meat foods for animals are consistent with the
goal of protecting the public from significant health risks,
particularly when such products are brought into the home and/or used to
feed domestic pets. Objective data derived specifically from commercial
raw meat pet foods are sparse for quantifying the magnitude of risk to
human and animal health from such products. Therefore, CVM also reviewed
data on the risks to humans, both from food-borne pathogens in general
and from food-borne pathogens relating to raw foods for humans. These
data are relevant because people are exposed to food borne pathogens in
animal feed when they come in contact with that feed, and animals, in
general, are affected by pathogens in the same manner as people. Based
on these data, CVM believes the risk to public health from feeding raw
meat products to animals warrants taking the precautionary measures
described in this guidance.

The Centers for Disease Control and Prevention has estimated that known
food borne pathogens account for 14 million illnesses, 60,000
hospitalizations and 1,800 deaths to humans in the United States each
year.^1^ Total food borne illness from both known and unknown pathogens
is likely to be responsible for 76 million cases, 325,000
hospitalizations and 5,000 deaths annually.^1^ Although *Salmonella*
spp. and *Escherichia coli*, are often thought of as causes of food
borne illness, likely because of their propensity to cause severe
disease, current data indicate viruses, particularly Noroviruses
(Norwalk-like viruses), are estimated to account for two-thirds (67%) of
all food borne illnesses.^1,2^ Known pathogenic bacteria account for 30%
of food borne illnesses, with *Campylobacter* spp., frequently
associated with poultry, being responsible for the majority of the
bacterial cases of food borne illness. Three percent of the total cases
of food borne illness are caused by parasites.^1,2^ In looking
specifically at deaths, the percentages are much different. Seventy-two
percent of the deaths from food borne illness are attributable to
bacteria, 21% to parasites and 7% to viruses.^1^ The estimated annual
cost of food borne illness has been placed in the range of 6.5 to 34.9
billion 1995 U.S. dollars**.**^3^ The scientific literature indicates
that the very young (infants and children), the elderly, the
immuno-compromised, and pregnant women are the members of the population
at greatest risk for contracting, and being more severely affected by,
food borne illnesses.^4,5^

The prevalence of pathogenic bacterial contaminants in raw meat and
poultry products sold for human consumption varies greatly, from less
than 1 percent to 100 percent, depending on the specific microbial
contaminant, the species of animal used to produce the raw product, the
degree to which the raw product has been processed, the number of times
the product has been handled, the facility producing the product, and
the methods used to sample the product and identify the specific
microbial contaminant.^6-12^ Overall prevalence of 10 to 20% is
frequently observed for raw human edible products being contaminated
with *Campylobacter*, *Escherichia coli* or *Salmonella* species,^8,9^
with products that undergo multiple steps in processing and handling
tending to be contaminated more frequently.^6^

In looking at data relating to raw foods for animal consumption, two
studies are particularly relevant. One study of 112 samples of raw meat
diets manufactured for racing greyhounds isolated *Salmonella* spp. from
50 of the samples (45%) and determined 70 of 106 samples (66%) to be
positive for *Salmonella* spp. by DNA probe analysis.^13^ Another study
that cultured 10 raw meat diets based on chicken determined 8 diets
(80%) to be contaminated with *Salmonella* spp.^14^

There are published reports of gastroenteritis and death to animals from
eating contaminated raw meat foods,^15-17^ and the scientific literature
makes it readily apparent that instances of food borne illness in
people, from food for human and animal consumption, are underreported
and often not associated with the source of infection.^1^ In addition to
infection by pathogenic organisms from direct contact with the diet
itself, there are also reports of the same pathogens isolated from raw
diets fed to dogs being found in the dog's feces^14,15^ and passage of
those organisms to people that have become ill.^18,19^ Thus, the
scientific literature indicates that feeding raw meat products carries a
risk to human and animal health that is significant given the
microbiological results from studies of ingredients that could compose
such products and the limited sampling of commercial raw pet foods
themselves. Therefore, for firms choosing to manufacture and market raw
meat and raw animal tissue products for animal food, more specific
guidance is warranted for how such products could be manufactured and
labeled in order to protect animals and people coming in contact with
the animals and the animal's food from risks involving food safety. This
guidance also addresses other risks posed by raw diets, such as
nutritional deficiency, and is designed to help ensure compliance with
other aspects of the law administered by FDA. The guidance is especially
warranted since these products are foods that do not require
pre-marketing approval or certification under current United States
laws.

**FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word "should" in Agency guidances means that
something is suggested or recommended, but not required.**

# 

**II. Guidance for manufacturing and labeling raw meat foods for
companion and captive noncompanion carnivores and omnivores**

# 

# 1. Manufacture

a.  Ingredient sources

    i.  All meat- and poultry-derived ingredients should be United
        States Department of Agriculture (USDA)/Food Safety and
        Inspection Service (FSIS)-inspected and [passed for human
        consumption]{.underline}.

    ii. We recommend that bones and other hard materials be ground.

    iii. All other ingredients should be suitable for use in animal
         feeds; that is, the ingredients should be of an appropriate
         grade that qualified experts would agree they are safe for use
         in raw food for animals.

b.  Manufacturing process

> Manufacturing facilities should take all measures necessary to prevent
> adulteration. These measures could include one or more of the
> following:

i.  irradiating the final packaged product as specified in 21 CFR Part
    579,

ii. participating in the USDA voluntary inspection program for Certified
    Products for Dogs, Cats, and Other Carnivora (9 CFR Part 355),

iii. following other Good Manufacturing Practices, such as those for
     human foods in 21 CFR Part 110, and/or

iv. implementing a Hazard Analysis and Critical Control Point (HACCP)
    plan.

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c.  Storage and transport

    i.  We recommend that, unless freeze-dried, product remain frozen at
        all times prior to use.

    ii. Product should be transported and stored in a manner to avoid
        microbial contamination and growth.

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1.  Labeling

> Labels must conform to all pertinent FDA regulations and statutes. In
> addition, it is recommended that the labels conform to all applicable
> Association of American Feed Control Officials (AAFCO) Model
> Regulations.

a.  Storage and Handling Information Statements

    i.  It is recommended that raw frozen meat and/or poultry products
        for animal consumption bear a statement, "Keep Frozen",
        displayed in a prominent manner on the principal display panel.

    ii. We recommend that raw frozen meat and/or poultry products for
        animal consumption conspicuously bear a statement under a
        heading "Handling Guidelines for Safe Use" on the outside of the
        immediate container, stating:

> "Some raw food products may contain bacteria that could cause illness
> to you or the animals you are feeding if mishandled. For your
> protection, follow these instructions for safest use.

1.  Keep frozen until ready to use.

2.  Thaw in refrigerator or microwave.

3.  Keep raw meat and poultry separate from other foods. Wash working
    surfaces, utensils (including cutting boards, preparation and
    feeding bowls), hands, and any other items that touch or contact raw
    meat or poultry with hot soapy water.

> 4\. Refrigerate leftovers immediately or discard."

b\. Ingredients and Guarantees

> i\) Ingredients must be listed in descending order of predominance by
> weight using their common or usual names as provided in 21 CFR
> 501.4(a). In general, FDA has recognized the AAFCO-defined names as
> the common or usual name as specified in Compliance Policy Guide
> 7126.08, Section 665.100. Ingredients not defined by AAFCO must be
> declared by their common or usual names as defined under 21 CFR 501.4
> and 21 CFR 102.5.
>
> ii\) States that have adopted or adapted the AAFCO Model Regulations
> have certain requirements regarding nutritional adequacy. Model
> Regulation PF7 states that dog and cat food labels must include a
> statement of nutritional adequacy or purpose of the product, except
> when the dog or cat food is clearly and conspicuously identified on
> the principal display panel as a \"snack\" or \"treat.\" This model
> regulation also says the nutritional adequacy statement must consist
> of either a claim that is substantiated as provided for by the Model
> Regulation or the statement: \"This product is intended for
> intermittent or supplemental feeding only.\"
>
> iii\) States that have adopted or adapted the AAFCO Model Regulations
> also have certain requirements regarding guarantees. Model Regulation
> PF4 states that a pet food or specialty pet food must list certain
> guarantees for crude protein, crude fat, crude fiber, and moisture. In
> addition, this model regulation says 1) a dog or cat food label must
> list other required or voluntary guarantees in the same order and
> units of the nutrients in the AAFCO Dog (or Cat) Food Nutrient
> Profiles; 2) guarantees for substances not listed in the AAFCO Dog (or
> Cat) Profiles, or otherwise not provided for in the Model Regulations,
> must be accompanied by an asterisk referring to the disclaimer "not
> recognized as an essential nutrient by the AAFCO Dog (or Cat) Food
> Nutrient Profiles;" and 3) the disclaimer must appear immediately
> after the last such guarantee in the same size type as the guarantees.
>
> c\. Claims
>
> i\) Based upon the claims made for a product, its intended use may
> bring it within the definition of a drug under Section 201(g)(1) of
> the FFDCA. An article's intended use may be shown, for example, by
> labeling claims, advertising matter, historical use, and by oral or
> written statements. It may also be shown by the circumstances under
> which the article is offered and used, regardless of labeling or
> advertising. We recommend that a manufacturer consult CVM if it is
> uncertain whether a claim is acceptable for food or is a drug claim.
>
> ii\) Claims that may imply the product itself has been inspected or
> certified by USDA or another regulatory body must not be false or
> misleading.

i.  Claims that the product is equivalent to food for human consumption
    must not be false or misleading (21 U.S.C. 403(a)(1)).

ii. We recommend that comparative claims be scientifically
    substantiated.

# **III. Considerations**

**Safety:** It is unlawful to introduce into interstate commerce any
food, including food for pets and for other animals, which is
adulterated (Section 301(a) of the FFDCA). Among the circumstances in
which a food will be deemed adulterated are when: (a) it contains any
poisonous or deleterious substance that may render it injurious to
health, unless the quantity does not ordinarily render the food
injurious to health; (b) it has been prepared, packed, or held under
unsanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health; and (c)
it is, in whole or in part, the product of a diseased animal or of an
animal that has died otherwise than by slaughter (Section 402(a) of the
FFDCA). These circumstances are particularly relevant to raw meat
products for animals, in large part because they are not heat treated
and because raw animal tissues may harbor many potentially pathogenic
organisms, including bacteria (e.g., *Salmonella, Escherichia coli*) and
parasites.^20^ FDA has promulgated a regulation specifying that meat
scraps, or other similar animal by-products, or blended mixtures of
these products are adulterated when they are found upon examination to
be contaminated with Salmonella microorganisms (21 CFR 500.35). Not only
are the animals consuming the product at risk of infection by organisms
contained in the raw tissues, but the people handling the product are
also at risk. Adequate heat treatment is the most effective and
efficient means of mitigating this risk. Because some processes
currently used, such as freezing or freeze‑drying, do not achieve the
same degree of effectiveness as heat treatment, the measures discussed
and recommended below are important in reducing the risk of infection
and the likelihood of the product being adulterated.

-   *Source of ingredients* -- There are generally three sources of
    animal tissues for raw meat foods for animals: meat obtained
    directly from human-food processing facilities; meat from animals
    that have died by means other than slaughter; and meat originally
    offered*,* but no longer suitable, for human consumption. All raw
    tissues, even those inspected by the USDA and judged acceptable for
    sale to people for their consumption after proper cooking, pose a
    risk of being contaminated with pathogenic organisms,^6,8,9^ and
    USDA requires safe handling instructions on raw meat products
    intended for human consumption (9 CFR 317.2(l)(3) and 9 CFR
    381.125). However, raw tissues obtained from mammals or poultry that
    have died other than from slaughter pose significantly increased
    risk of contamination with pathogenic organisms.^5,6^ Even when
    collected from a USDA-inspected slaughter facility, tissues that are
    typically not offered for human consumption, but instead are
    permitted for use in animal feed, may not be subjected to the same
    rigorous inspection needed to minimize the risk of contamination and
    disease transmission. Likewise, tissues that originally passed USDA
    inspection for human consumption, but that were later diverted for
    use in animal feeds, pose a risk for increased numbers of bacterial
    organisms, some of which may be pathogenic.^21^ To minimize risk, we
    recommend that only sources of animal tissue ingredients that come
    from a USDA-inspected facility and have passed USDA inspection for
    human consumption should be used for manufacturing foods that
    contain raw meat, or other raw animal tissues, for consumption by
    dogs***,*** cats, other companion or pet animals, and captive
    noncompanion animal carnivores and omnivores. In addition, we
    recommend that all other ingredients be suitable for use in animal
    feeds; that is, the ingredients are of an appropriate grade that
    experts qualified by scientific training and experience to evaluate
    the safety of substances directly or indirectly added to food would
    agree the ingredients are safe for use in raw food for animals.

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-   *Form of Ingredients* -- In addition to contamination issues, the
    physical form of ingredients may pose a safety concern. When bone is
    included in other than ground form, there is an increased risk of
    dental or gastrointestinal trauma.^9^ To mitigate these risks, we
    recommend only bone in ground form be used in foods that contain raw
    meat, or other raw animal tissues, for consumption by dogs, cats,
    other companion or pet animals, and captive noncompanion animal
    carnivores and omnivores.

*Manufacturing* -- Meats and animal tissues intended for animals other
than people are not subject to USDA inspection, except those pet foods
certified by USDA under its voluntary inspection program (9 CFR Part
355). Also, while FDA has Good Manufacturing Practice (GMP) regulations
in place for human foods (21 CFR Part 110) and for medicated feeds for
animals (21 CFR Part 225), FDA has not promulgated GMP regulations for
non-medicated animal feeds. Given the safety concerns noted above,
manufacturers of raw meat foods for animals should take all measures
necessary to prevent adulteration. Measures that would help minimize
contamination by pathogenic microorganisms and prevent the growth of
pathogens could include irradiating the product after final packaging as
provided for in 21 CFR Part 579, participation in the USDA's voluntary
inspection program (9 CFR Part 355), and practicing GMP's such as those
for human foods in 21 CFR Part 110. Development and implementation of a
HACCP program would be an effective and rational means of fostering food
safety through hazard identification and preventive controls. The
desired outcome is to reduce the risk of microbial contamination or
other adulteration for raw animal feed products. Manufacturers should
also be aware that products made from tissues of animal origin not
inspected and passed for human consumption may be subject to USDA
regulations for transporting and denaturing as specified in 9 CFR Part
325.

-   *Storage* *and handling* -- Proper transport and storage of the
    product by manufacturers, distributors, and retailers is necessary
    to prevent growth of pathogens and other microorganisms that would
    degrade product quality and likely adulterate the product. To best
    prevent growth of microorganisms, we recommend that products that
    are not freeze-dried be kept frozen at all times. Even when all
    safety precautions are taken, the risk of contamination and disease
    transmission is increased if the final purchaser (i.e., the pet
    owner or animal caretaker) does not properly handle the product
    after sale. This includes risk not only to the animal consuming the
    food, but also to the person preparing or otherwise touching the
    food, working surfaces, bowls, or utensils that come in contact with
    the food. Attention to strict hygienic measures becomes extremely
    important because the raw meat products fed to animals are not
    cooked. Studies have demonstrated that failure by food preparers to
    wash their hands after handling raw animal tissues is a
    statistically significant risk factor for members of the household
    to contract food borne illness.^22,23^

-   The USDA requires that instructions for handling and preparing raw
    meat and poultry products intended for consumption by people be
    printed on package labels as specified in 9 CFR 317.2(l)(3) and 9
    CFR 381.125. As stated in Section II, we recommend that similar
    instructions be on labels of raw meat foods for other animals to
    inform the purchaser of the risk of infection from contaminating
    microorganisms and how to mitigate that risk.

**Nutritional adequacy:** Manufacturers of products intended to be
offered as the sole source of nutrition for pets should substantiate the
nutritional adequacy of these products. There is significant risk of
nutritional deficiency or excess when such products are improperly
formulated.^24,25^ Calcium and phosphorus are often deficient in foods
based on raw meat, and should be supplemented accordingly. In addition
to the risk of physical trauma or impaction, large pieces of bone may
not allow for efficient digestion and absorption, possibly resulting in
nutritional deficiency when bone is intended to serve as a source of
dietary calcium. Essential fatty acids and some trace minerals may also
be deficient. Alternatively, foods based on raw meat could be excessive
in vitamin A if liver is used as a major ingredient and cause vitamin A
toxicity if fed for extended periods of time.^26^ Other fat soluble
vitamins may be either excessive or deficient as well.^24,25^

Although there have been claims made that raw meat foods are superior
with respect to providing adequate nutrition than other products
substantiated to be complete and balanced, FDA is not aware of
scientific evidence to support such claims. FDA has not issued
regulations specifying the requirements for substantiating nutritional
adequacy of sole source foods, but the Association of American Feed
Control Officials (AAFCO) has developed Model Regulations for Pet Food
and Specialty Pet Food. These model regulations require one of two
methods be used to substantiate nutritional adequacy of foods for dogs
and cats intended as the sole source of nutrients other than water. One
of the methods is to have the product contain nutrients in the ranges
specified in the AAFCO Dog Food Nutrient Profiles and Cat Food Nutrient
Profiles for the appropriate life stage of the animal. Although these
Nutrient Profiles were established on the presumption of the use of
ingredients common in the manufacture of conventional canned or extruded
pet foods, FDA knows of no basis to conclude that the minimum and
maximum concentrations of nutrients listed in the Profiles should be
altered for foods based on raw meat. Thus, under Model Regulation PF7 of
the Model Regulations for Pet Food and Specialty Pet Food proposed by
AAFCO, a raw meat diet intended as the sole source of nutrients for pet
dogs and cats must be formulated to meet the AAFCO Dog or Cat Food
Nutrient Profiles for the intended life stage(s), unless it has
successfully passed the appropriate feeding trials using AAFCO
protocols, which is the second method for substantiating nutritional
adequacy. We recommend raw meat foods intended as the sole, or primary,
source of nutrients for captive noncompanion animals be formulated to
contain nutrient contents established by authoritative scientific review
committees knowledgeable in the nutrient requirements of the specific
species when such information exists and is available. In the absence of
specific nutrient requirements and maximum tolerances, the AAFCO Cat
Food Nutrient Profiles may be a useful reference for estimating adequate
nutrient contents of foods for captive noncompanion animals.

Raw meat foods tend to be high in fat, resulting in increased caloric
density. Although the foods are generally highly digestible, less total
dry matter is required to supply a daily caloric need, which results in
less absolute quantities of other nutrients being consumed unless the
increase in caloric density is also accompanied by an increase in
concentrations of other required nutrients. Thus, as directed in the
profiles, it is recommended that product formulations used to
substantiate nutritional adequacy be compared to the AAFCO Dog or Cat
Nutrient Profiles Based on Calorie Content, not simply Profiles Based on
Dry Matter.

**Labeling and Claims:** Raw meat foods are subject to the labeling
requirements listed in 21 CFR Part 501. These include, but are not
limited to, the need for an accurate ingredient declaration as specified
in 21 CFR 501.4. In addition, states laws, many of which have adopted or
adapted the AAFCO Model Regulations for Pet Food and Specialty Pet Food,
usually set forth additional labeling requirements.

-   *Drug claims* -- Based upon the claims made for a product, its
    intended use may bring it within the definition of a drug under
    Section 201(g)(1) of the FFDCA. An article's intended use may be
    shown, for example, by labeling claims, advertising matter,
    historical use, and by oral or written statements. It may also be
    shown by the circumstances under which the article is offered and
    used, regardless of labeling or advertising. We recommend that a
    manufacturer consult CVM if it is uncertain whether a claim is
    acceptable for food or is a drug claim.

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-   *Other claims* -- We recommend that comparative claims with other
    products be scientifically substantiated. Claims that imply the
    product is "USDA certified," "USDA inspected," or "human grade" must
    not be false or misleading under Section 403(a)(1).

# 

# **References**

1\. Mead PS, Slutsker L, Dietz V *et al.* Food-related illness and death
in the United States. *Emerging Infectious Diseases* 5:607-625, 1999.

2\. Jones TF & Gerber DE. Perceived etiology of foodborne illness among
public health personnel. *Emerging Infectious Diseases* 7:904-905, 2001.

3\. Buzby JC & Roberts T. Economic costs and trade impacts of microbial
foodborne illness. *World Health Statistics Quarterly* 50:57-66, 1997.

4\. Trevejo RT, Courtney JG, Starr M *et al.* Epidemiology of
salmonellosis in California, 1990-1999: morbidity, mortality, and
hospitalization costs. *American Journal of Epidemiology* 157:48-57,
2003.

5\. Gerba CP, Rose JB & Haas CN. Sensitive populations: who is at the
greatest risk? *Internation Journal of Food Microbiology* 30:113-123,
1996.

6\. Duffy EA, Belk KE, Sofos JN *et al.* Extent of microbial
contamination in United States pork retail products. *Journal of Food
Protection* 64:172-178, 2001.

7\. Duffy EA, Belk KE, Sofos JN *et al.* Microbial contamination
occurring on lamb carcasses processed in the United States. *Journal of
Food Protection* 64:503-508, 2001.

8\. Zhao C, Ge B, de V, J. *et al.* Prevalence of *Campylobacter* spp.,
*Escherichia coli*, and *Salmonella* serovars in retail chicken, turkey,
pork and beef from the greater Washington, D.C. area. *Applied and
Environmental Microbiology* 67:5431-5436, 2001.

9\. White DG, Zhao S, Suddler R *et al.* The isolation of
antibiotic-resistant *Salmonella* from retail ground meats. *New Englan
Journal of Medicine* 345:1147-1154, 2001.

10\. Tamplin ML, Feder I, Palumbo SA *et al.* Salmonella spp. and
Eschericial coli biotype I on swine caracasses processed under the
hazard analysis and critical control point-based inspection models
project. *Journal of Food Protection* 64:1305-1308, 2001.

11\. Atanassova V, Meindl A & Ring C. Prevalence of *Staphylococcus
aureus* and staphylococcal enterotoxins in raw pork and uncooked smoked
ham - a comparison of classical detection and RFLP-PCR. *Internation
Journal of Food Microbiology* 68:105-113, 2001.

12\. Jorgensen F, Bailey R, Williams S *et al.* Prevalence and numbers
of *Salmonella* and *Campylobacter* spp. on raw, whole chickens in
relation to sampling methods. *Internation Journal of Food Microbiology*
76:151-164, 2002.

13\. Chengappa MM, Staats J, Oberst RD *et al.* Prevalence of
*Salmonella* in raw meat used in diets of racing greyhounds. *Journal of
Veterinary Diagnostics and Investigation* 5:372-377, 1993.

14\. Joffe DJ & Schlesinger DP. Preliminary assessment of the risk of
*Salmonella* infection in dogs fed raw chicken diets. *Canadian
Veterinary Journal* 43:441-442, 2002.

15\. Stone GG, Chengappa MM, Oberst RD *et al.* Application of
polymerase chain reaction for the correlation of Salmonella serovars
recovered from greyhound feces with their diet. *Journal of Veterinary
Diagnostics and Investigation* 5:378-385, 1993.

16\. Schiller CA, Wolff MJ, Munson L *et al.* Streptococcus
zooepidemicus infections of possible horsemeat source in red-bellied
tamarins and Goeldi\'s monkeys. *Journal of Zoo and Wildlife Medicine*
20:322-327, 1989.

17\. Shaw M, Montali RJ & Bush M. *Streptococcus zooepidemicus* in small
carnivorous mammals fed uncooked horsemeat. *Journal of Zoo Animal
Medicine* 15:161-164, 1984.

18\. Sato Y, Mori T, Koyama T *et al.* *Salmonella virchow* infection in
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[^1]: ^\*^ This guidance has been prepared by the Office of Surveillance
    and Compliance in the Center for Veterinary Medicine, Food and Drug
    Administration.