|
September 27, 2004
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
RE: Docket #2004N-0081, Use of Materials Derived From
Cattle in Human Food and Cosmetics
To Whom It May Concern:
On behalf of Farm Sanctuary and its 100,000 members,
I wish to comment on the FDA's interim final rule on
the Use of Materials Derived From Cattle in Human Food
and Cosmetics, published in the Federal Register on
July 14, 2004.
The interim final rule identifies five categories of
materials to be prohibited from human food and cosmetics:
1) specified risk materials from certain cattle, 2)
small intestine of all cattle, 3) material from non-ambulatory
disabled cattle, 4) material from cattle not inspected
and passed for human consumption, and 5) mechanically
separated beef.
Farm Sanctuary strongly supports the proposed definition
of non-ambulatory disabled cattle and the prohibition
on the use of materials from these animals in dietary
supplements and cosmetics. We urge the FDA to broaden
this prohibition to include materials from all species
of non-ambulatory livestock. Furthermore, Farm Sanctuary
supports a prohibition on the use of specified risk
materials (SRMs) for food and recommends that all cattle
intestines be included in the ban and that the ban be
extended to SRMs from animals of all ages, not just
those 30 months and older. The rationale for these recommendations
is given below.
1. All non-ambulatory cattle should be excluded from
the food supply.
It is generally agreed that non-ambulatory cattle are
more likely to be infected with BSE than healthy cattle
and therefore pose a greater risk to public health.
During surveillance testing for the disease, BSE has
been found to be more common in downed than healthy
cattle. For example, in BSE testing conducted in Germany
in 2001, positive samples were detected in 0.48 percent
of sick cows, compared with 0.02 percent of dead cows,
and 0.002 percent of normal cows.
All downed animals must be excluded from the food supply
because government slaughterhouse veterinarians are
unable to determine by visual examination whether an
animal is safe to be slaughtered. Conditions that present
the most serious risk to public health - namely, bacterial
contamination and central nervous system disorders like
BSE - are difficult to diagnosis solely on the basis
of a cursory physical examination. The signs of BSE
often cannot be differentiated from the signs of the
many other diseases and conditions affecting downer
cattle. The Harvard Center for Risk Analysis estimated
that up to 50 percent of BSE cases could be missed on
ante-mortem inspection at slaughter.
Furthermore, testing every downed animal for BSE would
not necessarily provide adequate protection because
it is possible that a different variant of the disease
is currently present - or at some point may be present
- in the U.S. Individual laboratory tests have failed
to detect the disease under certain circumstances. For
example, the laboratory test currently employed by the
USDA failed to detect the disease when used recently
by authorities in Japan.
The fact that downed animals are at a higher risk for
BSE, and that visual examination and laboratory testing
cannot detect the disease with certainty, are the primary
reasons typically cited for banning materials from downed
cattle in the human food supply. However, there are
several other notable arguments for prohibiting the
use of materials from non-ambulatory animals, including
the following:
· Ban protects the public from other foodborne
disease - While the stated objective of the interim
final rule is to minimize human exposure to the BSE
agent, prohibiting downed animals from the food supply
will also eliminate a source of other foodborne diseases.
Research has documented a relationship between non-ambulatory
status and the presence of pathogens in cattle. For
example, E. coli has been found to be more common in
non-ambulatory versus healthy cows at slaughter (Applied
and Environmental Microbiology;2003;69: 4683). In addition,
outbreaks of Salmonella Newport, a strain of Salmonella
resistant to antibiotics, have been traced back 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).
· Ban lessens animal suffering - Due to their
size and weight, it is very difficult to move a downed
cow humanely. Non-ambulatory animals are frequently
subjected to unnecessary pain and distress during movement
from one location to another. This mistreatment often
results in injuries ranging from bruises and abrasions
to broken bones and torn ligaments. Downed animals that
leave the farm rarely receive veterinary attention.
Stockyards are reluctant to call veterinarians because
they do not own the animals, and don't want to be financially
responsible for services rendered. Because downers are
immobile, they cannot get to food and water. They may
lie for hours or even days without having their most
basic needs met, and many die of gross neglect.
· Ban provides incentive for better animal treatment
- Prohibiting the marketing of non-ambulatory animals
provides an economic incentive for better animal handling.
Dr. Temple Grandin, livestock expert and professor at
Colorado State University, has observed that 5-10 percent
of the dairies are responsible for 90-95 percent of
downed dairy cows (AWIC Bulletin;1998;9(1-2). This implies
that a vast majority of downers are preventable. In
fact, Dr. Grandin has estimated that 75 percent of all
downed cattle could be prevented by good management
(Journal of the American Veterinary Medical Association;1994;204:372).
· Industry supports a ban - A number of agriculture
industry groups, including the American Farm Bureau,
the American Meat Institute, the National Cattlemen's
Beef Association, the American Veal Association, the
Milk and Dairy Beef Quality Assurance Center, and the
National Pork Producers Council, have recommended that
non-ambulatory animals be euthanized on the farm and
not transported to market. These groups recognize the
negative impression conveyed by downers being dragged
to slaughter, and they also appreciate that preventing
animals from going down, by taking better care of them
in the first place, is ultimately good for business.
In a survey of readers of the industry newsletter Cow-Calf
Weekly, 80 percent of respondents agreed with the USDA
ban on marketing of non-ambulatory cattle (Beef Cow-Calf
Weekly;1/6/04).
· Ban has minimal economic impact - Many in
the meat industry are not opposed to ending commerce
in downers because they recognize that such a move would
have little economic impact on farmers. According to
an article in Dairy Herd Management, cull cow sales
account for only 4 percent of the annual income of dairies.
In studying the slaughter of non-ambulatory cattle in
California, Dr. Pam Hullinger of the California Department
of Food and Agriculture found that, on average, only
$28.70 profit was realized for each downed cow leaving
the farm (1999 Report of the Committee on Animal Health,
U.S. Animal Health Association).
· Public supports a ban - Prior to the discovery
of BSE in December 2003, most Americans were unaware
that non-ambulatory animals were routinely slaughtered
for human food. National public opinion polls conducted
by Zogby International in 2001 and 2003 for Farm Sanctuary
have shown that a large majority of Americans are opposed
to using downed animals for human food. In the 2003
survey, 77 percent of those surveyed indicated they
felt slaughtering animals too sick to stand or walk
was unacceptable.
· Local and state bans already in place - In
the past decade, five states (California, Colorado,
Indiana, Oregon, and Washington) have enacted legislation
restricting the transportation and/or marketing of non-ambulatory
animals. In addition, many large slaughter facilities
across the country have voluntarily stopped accepting
downed animals due to the animal suffering involved,
the safety risk to employees, and the negative public
perception.
2. Definition of non-ambulatory cattle should not be
changed to exclude animals down due to injury.
The proposed definition of non-ambulatory cattle is
"cattle that cannot rise from a recumbent position
or that cannot walk, including, but not limited to,
those with broken appendages, severed tendons or ligaments,
nerve paralysis, fractured vertebral column or metabolic
conditions." It is important that this definition
not be changed to exclude those animals thought to be
down due to injury alone. As mentioned earlier, it is
difficult to determine the cause of an animal's non-ambulatory
condition. In addition to obvious injuries, the animal
may be suffering from a not so obvious metabolic condition.
It may be incorrectly assumed that an animal is down
due to injury when, in fact, the reverse is true and
the injuries were caused by the animal going down due
to an undiagnosed health problem. Prohibiting the marketing
of all downers will also encourage producers to improve
the handling of animals to ensure that they don't become
injured.
3. Prohibition on downers should be extended to all
livestock.
It has been known since the 1940's that sheep in the
U.S. harbor "scrapie," a form of transmissible
spongiform encephalopathy (TSE). In addition, there
are reports of pigs harboring an apparent TSE at an
Albany, NY slaughterhouse in the 1980's. To date, surveillance
efforts in the U.S. to detect TSEs have been inadequate.
We have failed to test an appropriate number of animals
to determine the extent to which U.S. livestock species
may be infected. It is indeed possible that mad cow
disease has been spreading in the U.S. for at least
a decade.
In addition to the BSE variant recently discovered in
the Washington State cow, there are likely other variants
of BSE afflicting cattle, and other poorly understood
or unidentified TSE variants affecting other livestock
species. An atypical form of BSE has been detected in
a 23-month-old bull in Japan as well as two cattle in
Italy. Research published by Dr. Richard Marsh in 1993
suggested "the presence of an unrecognized BSE-like
disease in the United States," while an article
published by R.C. Cutlip et al in the Journal of Infectious
Diseases (1994;169:814) suggested that the agent causing
scrapie in sheep could cause neurological disease in
cattle.
Variants of BSE or other TSEs may be linked to cases
of classical Creutzfeldt-Jakob Disease (CJD) in the
U.S. and elsewhere. A study by French scientists, published
in 2001 (Proceedings of the National Academy of Sciences;
2001;98:4142), found a strain of scrapie also caused
brain damage in mice similar to the classical form of
CJD in humans. In another study conducted in Great Britain,
scientists injected BSE into mice whose brains had been
genetically engineered with human genes. One group of
mice became ill with the human form of mad cow, referred
to as the new variant CJD. These two studies suggest
that some of the hundreds of Americans who contract
classical CJD each year could have been infected by
BSE or TSE-infected meat.
It is indeed possible that some cases of CJD in the
U.S. are caused by eating meat from sheep suffering
from scrapie. Speculation exists that pigs may also
harbor mad cow disease and pass it on to humans. It
is known that pigs are susceptible to the disease; research
has shown that pigs can be infected by mad cow brains
(Veterinary Record; 1990;127:338). Epidemiological studies
have also suggested a link between sporadic CJD and
pork consumption. One study (American Journal of Epidemiology;
1985;122:443) analyzed peoples' diet histories and found
that those who included ham in their diet appeared 10
times more likely to develop CJD than those who didn't
eat ham. The researchers concluded, "The present
study indicated that consumption of pork as well as
its processed products (e.g., ham, scrapple) may be
considered as risk factors in the development of Creutzfeldt-Jakob
disease."
An article published in the National Hog Farmer in
February 2002 estimated the number of crippled hogs
presented at slaughter in the U.S. as 420,000/year.
If pigs do in fact harbor mad cow disease, these disabled
animals represent those at highest risk for transmitting
the disease to people. Given the research suggesting
a link between TSEs in animals other than cattle and
cases of CJD in humans, it appears appropriate to prohibit
the slaughter of all non-ambulatory animals, not just
cattle.
4. Prohibited cattle materials should include the entire
intestines of all cattle.
The interim final rule excludes the small intestine
of all cattle from human food. However, the European
Union has identified the entire intestine, from duodenum
to rectum, as specified risk material and prohibits
its inclusion in the food supply of member nations (Journal
of the European Communities, December 2000). According
to the Scientific Steering Committee of the European
Union, the intestine should be considered a primary
source of infectivity since BSE infection has been caused
by cattle ingesting contaminated feed. In classifying
the entire intestine as SRM, the EU Steering Committee
also notes that because slaughterhouse contamination
of other intestinal areas with matter from the ileum
can't be avoided, it is prudent to remove the entire
small and large intestine.
5. Prohibited cattle materials should include specified
risk materials from cattle of all ages.
The interim final rule prohibits the brain, skull,
eyes, trigeminal ganglia, spinal cord, vertebral column
(with exceptions), and the dorsal root ganglia of cattle
30 months of age and older from human food. However,
because only about 15 percent of cattle slaughtered
in the U.S. are over 30 months of age, this allows the
brains and other central nervous tissue from 30 million
animals a year to enter into the human food supply.
The age at which cattle develop clinical BSE varies
and the lower ranges of this age distribution includes
some cattle younger than 30 months of age. In fact,
at least two confirmed cases of BSE in Japan have occurred
in animals under 30 months of age. A total ban on SRM,
regardless of age of the animal, would best protect
the public since a blanket ban would significantly improve
enforcement and eliminate the need to determine the
age of each animal. Until a national animal identification
and tracking system is fully implemented, USDA personnel
will be responsible for determining age. If the appropriate
records are unavailable or unreliable, USDA officers
will be required to make a physical assessment to determine
age. Such an assessment is somewhat subjective. Even
with an animal identification system, errors are possible.
Furthermore, it is more efficient to process all carcasses
in a similar manner than identifying and segregating
parts coming from animals of a certain age. Therefore,
we recommend that SRMs from animals of all ages be excluded
from the human food supply.
Conclusion
Farm Sanctuary commends the FDA for taking action to
end the use of materials from non-ambulatory cattle
in human food and cosmetics. There is a strong connection
between the treatment of animals raised for food and
public health. Therefore, in order to further promote
the protection of both humans and animals, we urge the
FDA to finalize the ban and extend it to materials from
all non-ambulatory animals, not just cattle.
Thank you for allowing Farm Sanctuary the opportunity
to comment on a matter of great importance to our members.
Sincerely,
Gene Baur (formerly Bauston) , President
Farm Sanctuary, Inc.
| 
