##### 158

##### Guidance for Industry

# Use of Material from Deer and Elk in Animal Feed

# 

Comments and suggestions regarding this guidance should be sent to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be
submitted electronically on the Internet at
<http://www.fda.gov/dockets/ecomments>. Once on this Internet site,
select \"\[03D-0186\]\[Use of Material from Deer and Elk in Animal
Feed\]\" and follow the directions. All written comments should be
identified with Docket No. 03D-0186.

For questions regarding this guidance, contact Burt Pritchett, Center
for Veterinary Medicine (HFV- 222), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 301-827-0177. E-mail:
<bpritche@cvm.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>.

U.S. Department of Health and Human Services

Food and Drug Administration\
Center for Veterinary Medicine\
September 15, 2003

#  158

# Guidance for Industry[^1]

# Use of Material from Deer and Elk in Animal Feed

#######  I. Introduction

> **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.**
>
> Under FDA's BSE feed regulation (21 CFR 589.2000) most material from
> deer and elk is prohibited for use in feed for ruminant animals. This
> guidance document describes FDA's recommendations regarding the use in
> all animal feed of all material from deer and elk that are positive
> for Chronic Wasting Disease (CWD) or are considered at high risk for
> CWD. The potential risks from CWD to humans or non-cervid animals such
> as poultry and swine are not well understood. However, because of
> recent recognition that CWD is spreading rapidly in white-tailed deer,
> and because CWD's route of transmission is poorly understood, FDA is
> making recommendations regarding the use in animal feed of rendered
> materials from deer and elk that are CWD-positive or that are at high
> risk for CWD.

#######  II. Background

> CWD is a neurological (brain) disease of farmed and wild deer and elk
> that belong in the animal family cervidae (cervids). Only deer and elk
> are known to be susceptible to CWD by natural transmission. The
> disease has been found in farmed and wild mule deer, white-tailed
> deer, North American elk, and in farmed black-tailed deer. CWD belongs
> to a family of animal and human diseases called transmissible
> spongiform encephalopathies (TSEs). These include bovine spongiform
> encephalopathy (BSE or "mad cow" disease) in cattle; scrapie in sheep
> and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD
> and vCJD) in humans. There is no known treatment for these diseases,
> and there is no vaccine to prevent them. In addition, although
> validated postmortem diagnostic tests are available, there are no
> validated diagnostic tests for CWD that can be used to test for the
> disease in live animals.

III. **Use in animal feed of material from CWD-positive deer and elk**

> Material from CWD-positive animals may not be used in any animal feed
> or feed ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food,
> Drug, and Cosmetic Act, animal feed and feed ingredients containing
> material from a CWD-positive animal would be considered adulterated.
> FDA recommends that any such adulterated feed or feed ingredients be
> recalled or otherwise removed from the marketplace.

IV. **Use in animal feed of material from deer and elk considered at
    high risk for CWD**

> Deer and elk considered at high risk for CWD include: (1) animals from
> areas declared by State officials to be endemic for CWD and/or to be
> CWD eradication zones; and (2) deer and elk that at some time during
> the 60-month period immediately before the time of slaughter were in a
> captive herd that contained a CWD-positive animal.
>
> FDA recommends that materials from deer and elk considered at high
> risk for CWD no longer be entered into the animal feed system. Under
> present circumstances, FDA is not recommending that feed made from
> deer and elk from a non-endemic area be recalled if a State later
> declares the area endemic for CWD or a CWD eradication zone. In
> addition, at this time, FDA is not recommending that feed made from
> deer and elk believed to be from a captive herd that contained no
> CWD-positive animals be recalled if that herd is subsequently found to
> contain a CWD-positive animal.

V.  **Use in animal feed of material from deer and elk NOT considered at
    high risk for CWD**

> FDA continues to consider materials from deer and elk NOT considered
> at high risk for CWD to be acceptable for use in non-ruminant animal
> feeds in accordance with current agency regulations, 21 CFR 589.2000.
> Deer and elk not considered at high risk include: (1) deer and elk
> from areas not declared by State officials to be endemic for CWD
> and/or to be CWD eradication zones; and (2) deer and elk that were not
> at some time during the 60-month period immediately before the time of
> slaughter in a captive herd that contained a CWD-positive animal.

[^1]: This guidance has been prepared by the Division of Animal Feeds in
    the Center for Veterinary Medicine (CVM) at the Food and Drug
    Administration.