From: Glenn Lange [lange@fw.dnr.state.in.us]
Sent: Friday, May 23, 2003 4:17 PM
To: fdadockets@oc.fda.gov
Subject: Docket 03D-0186; Draft Guidance for Industry (#158): Use of
Material From Deer and Elk in Animal Feed

http://www.fda.gov/dockets/ecomments

To Whom It May Concern:                                      May 23,
2003

As Chief of Wildlife for the Division of Fish & Wildlife of the Indiana
Department of Natural Resources, I would like to comment on the FDA
Docket No. 03D-0186;  Draft Guidance for Industry (#158): Use of
Material From Deer and Elk in Animal Feed.

During 2002 the Indiana Department of Natural Resources, Division of
Fish & Wildlife and the Indiana Board of Animal Health jointly collected
approximately 3,300 White-tailed deer heads in Indiana for Chronic
Wasting Disease surveillance. Approximately 1/2 of these samples were
collected at deer processing plants while the bulk of the remaining
samples were collected at mandatory deer checking stations. The FDA
guidelines for 2002, which are very similar to the proposed guidance for
2003, prevented some processors and some deer hunters from giving us
access to deer heads due to concerns about a renderer product recall if
a tested head was found to be positive. The past and future guidances do
not recommend a recall if the same CWD infected deer is rendered without
being tested. Thus the guidance for 2003 (which would trigger a recall
of rendered product if a tested animal is found to be CWD positive,
section III.) does not prevent an infected deer in Indiana from going
into the animal food stream, it merely interferes with our ability to
collect samples to detect CWD early in an outbreak.

To further explain, our actual experience in 2002 showed that my
personnel that were engaged in CWD sampling of deer at meat lockers were
sometimes turned away by the plant owner, because the meat processors
knew that their renderer would not accept any animal from them if some
of their animals were being tested. My personnel then had to collect
heads at a location where fewer heads were available than would have
been the case at the initial processor. The net result was that my
personnel collected fewer heads for analysis than would have been
collected without the new regulation. Additionally, last fall we had
cases where hunters who donated their deer heads at deer checking
stations were subsequently turned away from meat processors for the same
reasons. As our sample size in 2003 is reduced due to a reluctance to
donate deer heads, we will not detect the disease until it has increased
in the population to balance the effect of the reduction in sample size.
Thus, under the guidance proposed for 2003, we will be less likely to
detect the disease at an early stage than would be the case if more
heads were available for testing. The reduction in our ability to detect
the disease will actually increase the probability that more infected
deer are rendered for a longer period of time than would be the case if
we could efficiently collect a large sample of heads for analysis.

I believe that the FDA should not recall feed products that contain
deer/elk from NON-ENDEMIC areas in the event that a positive is found
through routine surveillance, as the proposed approach only serves to
inhibit States' CWD monitoring programs. I urge the FDA to reconsider
their position on this issue as stated in section III. of the proposed
guidance, and not recall animal feed in the event that routine CWD
surveillance on free?ranging deer/elk in non?endemic areas turns up a
positive animal that has been rendered.

Sincerely,


Glenn Lange
Chief, Wildlife Section
Division of Fish and Wildlife
Indiana Department of Natural Resources
402 West Washington Street Room  W273
Indianapolis, IN 46204

glange@dnr.state.in.us
PH: 317 / 232-4080
Fax: 317 / 232 -8150