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February 7, 1997
Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Dr.
Rm. 1-23
Rockville, MD 20857
RE: Proposed Rule to Ban Substances in Animal Food
[Docket No. 96N-0135]
Dear Madam or Sir:
I am writing on behalf of Farm Sanctuary, a national
non-profit organization which works to stop irresponsible
agricultural practices.
While we commend the Food and Drug Administration (FDA)
for proposing to ban the use of certain rendered products
in the feed of ruminants, we write today because we
believe the agency must take additional measures to
ameliorate the risk of bovine spongiform encephalopathy
(BSE) or a similar disease from spreading in the U.S.
RECOMMENDATIONS:
To begin with, we would recommend that the use of rendered
products in poultry feed be carefully examined, particularly
because poultry litter is used in cattle feed. The ruminant
to ruminant feed ban should also apply to ruminant protein
recycled through poultry.
We also strongly oppose the "No Action" alternative
described in the proposed rule, and dispute the contention
that, "...BSE has not been detected in cattle in
the U.S. despite an extensive surveillance effort that
has been in place for several years." In 1985,
there was an incident involving minks in Wisconsin and
follow up research indicating the likelihood of an unrecognized
BSE-like disease in U.S. cattle. Evidence suggests that
cattle in the U.S. afflicted with a BSE-like disease
become "downed" (i.e. they are unable to stand
and walk without assistance) instead of "mad"
like in Britain. Given this possibility, we recommend
that the FDA prohibit the use of downed animals for
food. (This is discussed in further detail below.)
THE "NO ACTION" ALTERNATIVE IS SUPPORTED
BY INSUFFICIENT EVIDENCE:
We do not believe there has been "an extensive
[BSE] surveillance effort" in the U.S. as FDA asserts.
In fact, only an extremely small number of animals have
been tested for BSE. The effectiveness of this surveillance
effort is also questionable because it has focused on
symptoms typical of Mad Cow Disease in Britain. It is
possible that a U.S. variant of BSE may cause other
symptoms. Specifically, U.S. cattle may not display
jittery ("mad cow") behavior like British
cattle, and they may not have the same sponge-like brain
lesions. We believe the U.S. surveillance program needs
to be expanded to, among other things, include detailed
post-mortem studies of "suspect" cattle who
are slaughtered for human consumption.
One of the FDA's alternative proposals prohibits only
tissues shown to transmit spongiform encephalopathies
(eg. brain, eyes, spinal cord) from being used in the
feed of ruminants. We would caution against this because
it is possible that other, as yet undiscovered, tissues
harbor the infective agent. This possibility was recently
bolstered by evidence of vertical transmission of BSE
from cow to calf. It is also possible, if not likely,
for tissues which are considered safe to be contaminated
during slaughter and processing. A recent Texas A &
M study found that captive bolt stunning, the most commonly
used method in cattle slaughterplants, causes head trauma
which spreads brain material throughout the animals'
bodies.
THE U.S. MAY HAVE ITS OWN VARIANT OF BSE IN DOWNED
COWS:
The FDA's surveillance effort has not adequately considered
that downed cattle may harbor a variant of BSE. Farm
Sanctuary investigators have travelled throughout the
U.S. documenting the presence of nonambulatory livestock
(often referred to as "downed animals") at
stockyards and slaughterhouses. These are severely incapacitated
animals who are unable to stand and walk on their own.
They are routinely used for human food, a practice we
believe poses human health risks, including the potential
threat of a BSE-like disease. Our concern that downed
cattle may harbor a variant of BSE is based largely
on evidence that downed cattle have caused encephalopathy
in minks.
The history of transmissible mink encephalopathy (TME)
in the U.S., justifies the FDA prohibiting the use of
mink by- products in ruminant feed. We commend the FDA
for proposing this action, however, we believe it is
also important for the FDA to heed evidence that these
TME outbreaks may have been precipitated by infected
cattle.
Since 1947, 11 U.S. mink farms are known to have been
affected by TME. Nine of these were in Wisconsin, one
was in Minnesota, and one was in Idaho. It is likely
that these outbreaks were caused by contaminated feed,
given that farms affected by the disease commonly shared
the same feed source. Information was not available
about feed ingredients for six of the eleven affected
farms, but on the other five, a common ingredient was
found: meat from downed cattle.
The last TME outbreak recorded in the U.S. occurred
in Stetsonville, WI in 1985. This incident was subsequently
studied by Dr. Richard Marsh of the Department of Animal
Health and Biomedical Sciences at the University of
Wisconsin, Madison. His research was published (Dev
Biol Stand. Basel, Karger, 1993, vol 80, pp 111-118)
and provides compelling evidence that downed cattle
in the U.S. may harbor a variant of BSE.
Marsh inoculated two cattle with brain material from
TME infected mink from the Stetsonville, WI farm. Within
two years, both cattle became "downed". Then,
Marsh fed brain tissue from these affected cattle to
minks, and found that minks exhibited a TME-like disease
within seven months. Referring to this, Marsh wrote,
"These findings are compatible with the Stetsonville
incident of TME being caused by feeding mink infected
cattle tissue and they suggest the presence of an unrecognized
BSE-like disease in the United States (emphasis added)".
Unfortunately, Marsh was not funded to conduct further
research in this area.
It should be noted that minks have historically served
as "sentinel animals" for harmful substances
in the environment. For example, they were the first
species to show the deleterious effects of PCBs on reproduction.
It is possible that these "sentinel animals"
are telling us something about downed cows.
Marsh's research is bolstered by evidence that sheep
infected with scrapie (the related brain disease in
sheep) in the U.S. cause cattle to become "downed"
instead of "mad". Many scientists believe
BSE was spread in Britain when sheep infected with scrapie
were fed to cows. In the U.S., scientists wondered whether
scrapie from U.S. sheep would also cause Mad Cow Disease,
so they inoculated cattle with scrapie from U.S. sheep.
The inoculated cattle became "downed," not
"mad". R.C. Cutlip et al reported, "Thus,
undiagnosed scrapie infection could contribute to the
'downer-cow' syndrome [in the U.S.]..." (Journal
of Infectious Diseases 1994; 169:814-20).
Tens of thousands of downed cattle are slaughtered
for human food in the U.S. every year. These animals
are not examined for BSE, and the reason for their nonambulatory
state is usually unknown. We are concerned that some
of these animals may be infected with a BSE-like disease.
If downed cattle in the U.S. harbor a variant of BSE,
and if the disease can cross the species barrier from
cattle to humans as recent findings in Britain suggest,
the human health implications could be disastrous. Accordingly,
we believe it is necessary for FDA to prohibit the use
of downed cattle for human food.
THE FDA SHOULD NOT ALLOW SHORT TERM ECONOMIC CONSIDERATIONS
TO HINDER OR PREVENT NECESSARY ACTION TO PROTECT HUMAN
HEALTH:
Downed animals represent an extremely small percentage
of all livestock slaughtered, and banning their use
would provide no undue economic hardship. Even if there
is some economic hardship, this consideration must not
outweigh the threat to human health.
Tragically, short term economic considerations have
tended to hinder government and industry action necessary
to protect consumers. A January 20, 1997 article from
Feedstuffs stated:
A report of the European Parliament's inquiry into
bovine spongiform encephalopathy (BSE) was released
in Brussels, Belgium, last week, placing blame for the
management of the cattle disease squarely on the British
government; the European Union Agricultural Council,
made up of member states' farm ministers, and the European
Commission. The report from the inquiry charged that
British and European officials gave "priority to
the interests of market management, as opposed to the
potential human health risks existing in the light of
the numerous scientific uncertainties concerning the
possible effects of BSE on humans. There is a considerable
body of material confirming this attitude." Furthermore,
the inquiry committee said, "The present committee
considers that the commission has displayed negligence
with respect to the adoption and monitoring of human
and animal health protection measures."
We are distressed that economic priorities have tended
to take precedence over the health of consumers. We
are also concerned that, like in Britain, a powerful
economic incentive exists to ignore evidence that BSE,
or a variant of BSE, exists in the U.S.
CONCLUSION:
We urge the FDA to examine the scientific evidence
regarding BSE carefully and to act in the interest of
American consumers. We cannot afford to make the same
mistakes that were made in Britain.
Sincerely,
Gene Baur (formerly Bauston) ,
Executive Director
Farm Sanctuary, Inc.
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