> October 12, 2004

Division of Dockets Management

U.S. Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

RE: Docket No. 2004N-0081, Use of Materials Derived From Cattle in Human
Food and Cosmetics

To Whom It May Concern:

The Animal Welfare Trust (AWT), a non-profit organization located in
Mamaroneck, NY, appreciates the opportunity to submit comments on the
U.S. Food and Drug Administration's (FDA) interim final rule on the Use
of Materials Derived From Cattle in Human Food and Cosmetics ("interim
final rule"). 69 Fed. Reg. 42288 (July 14, 2004). This interim final
rule prohibits the use of certain categories of materials obtained from
cattle. For the sake of human health and safety, and animal welfare, AWT
encourages the FDA [to expand the rule to prohibit the use of all
materials from all species of non-ambulatory livestock in human foods
and cosmetics]{.underline}.

The threat to human safety from the use of non-ambulatory animal
material was brought to national attention in December 2003, when the
first known case of bovine spongiform encephalopathy (BSE) in the U.S.
was discovered. BSE, belonging to a family of diseases known as
transmissible spongiform encephalopathies (TSEs), has caused multiple
deaths in the United Kingdom and other countries, and is the likely
cause of a new variant of Creutzfeldt-Jakob disease (vCJD) in humans.
Worldwide, there have been thousands of known cases of BSE. In the
United Kingdom, since 1986, 185,000 cattle were diagnosed with the
disease. Department for Environment, Food, and Rural Affairs, United
Kingdom. 2004.

Cows, sheep, pigs, and other animals can harbor TSEs. As mentioned in
the interim rule, TSEs are characterized by a long incubation period,
then a course of neurological symptoms, followed by death.
Non-ambulatory animals should be excluded from the food supply because
they are more likely than healthy animals to develop disorders such as
BSE. These disorders are difficult to diagnose solely by physical
examination, and testing every animal may not detect all variants of
disease.

BSE is not the only disease that non-ambulatory animals are more likely
than healthy ones to carry. Meat from downed animals has an increased
risk for containing pathogens such as *Salmonella* and *E. coli*.
Researchers have found *E. coli* to be more common in non-ambulatory
versus healthy cows at slaughter. *Applied and Environmental
Microbiology*; 2003; 69: 4683. Also, outbreaks of Salmonella Newport
have been traced to meat produced from slaughtered dairy cows and to
processing plants that slaughter a higher proportion of downed animals.
*New England Journal of Medicine*;1987; 316:565; *Journal of the
American Medical Association*;2002; 288:951.

Alongside the issue of human safety is that of animal welfare.
Non-ambulatory livestock are routinely dragged during transport to the
slaughterhouse, prodded with electric shocks, kicked, pushed, and are
not provided with adequate food, water, and veterinary care. This
treatment has been recognized to be inhumane by organizations such as
the American Veterinary Medical Association which holds the position
that "\[a\]t no time is a nonambulatory animal to be dragged." *See*
htttp://www.avma.org/policies/ animalwelfare.asp#food.

A ban on all non-ambulatory animal materials is not only supported by
many meat producers, animal welfare groups, and trade organizations, but
also by the general public and many legislators. A September 2003 Zogby
Poll reported that 77% of those surveyed found that it is unacceptable
that downed animals are being used for human food. A handful of states
including Indiana, Washington, Oregon, Colorado, and California have
enacted legislation restricting the transportation and/or marketing of
non-ambulatory animals. At the federal level, recently the Downed Animal
Protection Act (H.R. 2519 and S. 1298), which would prohibit the
marketing and slaughter for human food of all critically ill and injured
animals, received much support in Congress falling only a few votes
short of passage. Also, several restaurants including McDonald's, Burger
King, and Wendy's have discontinued buying meat from downed animals for
their hamburgers.

Additionally, no significant economic hardship would come from a
complete ban on non-ambulatory animal parts use in products regulated by
the FDA. There are an estimated 195,000 number of downed cattle per year
in the U.S. Hansen, Don and Bridges, Victoria, *A Survey Description of
Down-cows and Cows with Progressive or Non-progressive Neurological
Signs Compatible with a TSE from Veterinary-client Herd in 38 States*;
The Bovine Practitioner; 33(2); 179-87, 1999. In a 1999 study by the
California Department of Food and Agriculture, it was found that a net
average of only \$28.70 was realized for each downer cow leaving the
farm. U.S. Animal Health Association, Report of the Committee on Animal
Welfare, 1999 Committee Reports, *available at*
http://www.usaha.org/reports/reports99/r99anwel.html.

In conclusion, AWT urges the FDA to ban all human foods and cosmetics
products containing ingredients from slaughtered non-ambulatory cattle
and other animals. This would work to the benefit of human safety and
animal welfare. In addition, the ban would mirror public concerns and
would not create undue economic hardships.

Respectfully submitted,

Lydia S. Antoncic, Esq.

Director of Projects

Animal Welfare Trust