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March 4, 1998
PETITION REQUESTING IMMEDIATE ACTION
REGARDING THE INTRODUCTION OF DOWNED CATTLE INTO THE
FOOD SUPPLY
VIA FEDERAL EXPRESS
Michael Friedman, M.D., Commissioner
United States Food and Drug Administration
Dockets Management Branch, Room 1-23
12420 Parklawn Drive
Rockville, Maryland 20857
Hon. Daniel Glickman, Secretary
United States Department of Agriculture
Room 200-A, Admin. Bldg.
14th Street & Independence Avenue, S.W.
Washington, D.C. 20250
Dear Commissioner Friedman and Secretary Glickman:
Pursuant to the applicable Food and Drug Administration
(FDA) regulations, 21 C.F.R. Section 10.30 (1995), and
the United States Department of Agriculture (USDA) regulations,
7 C.F.R., Subtitle A, Section 1.28 (1995), this petition
is submitted on behalf of Farm Sanctuary, a 501 (c)(3)
non-profit organization, its members across the United
States, and Michael Baur, a regular consumer of beef
products concerned about the safety of beef produced
in the United States ("Petitioners").
Petitioners request that the FDA and USDA immediately
label all downed cattle as adulterated pursuant to 21
U.S.C. 342 (a). This action is not only required by
existing statutes and the USDA definition of "diseased
livestock," but it will also take an important step
in further protecting the health of the nation by reducing
the possibility of the spread of bovine spongiform encephalopathy
(BSE), also known as "Mad Cow Disease," and Creutzfeldt-Jakob
Disease:
I. INTRODUCTION
The United States has 100 million cattle and one of
the highest degrees of production and per capita beef
consumption in the world. Such levels of production
and consumption create an equally large responsibility
to protect the health of beef consumers by taking steps
to ensure that animals slaughtered for consumption are
not diseased.
Tens of thousands of "downed" cattle are slaughtered
for human food in the United States every year. "Downed"
is an industry term describing non-ambulatory cattle
which collapse for unknown reasons and which are too
sick to stand back up. There are a host of problems
affiliated with these "downed" cattle. Wholly aside
from the humane issue involved with the processing of
non-ambulatory cattle, "downed" cattle may pose a serious
threat to human health. The illnesses that may cause
cattle to collapse and lose their ability to move may
pose a health danger to the humans who consume these
sick animals. One such disease is bovine spongiform
encephalopathy (BSE).
The recent "Mad Cow" epidemic in Great Britain dramatically
illustrates the danger posed by food-borne illnesses
such as BSE and the need for preventive regulatory measures
to prevent the spread of disease. So far, over twenty
people have died in the epidemic. The resulting panic,
in which millions feared for their safety, devastated
the British beef market and affected beef consumption
worldwide. Both domestic and international media assailed
the British government for its failure to take simple
protective measures to ensure the health of its citizens.
In recognition of the threat of transmissible spongiform
encephalopathies (TSEs), the Food and Drug Administration
(FDA) banned the use of certain animal proteins in ruminant
feed in August of 1997. Although this ban represents
a commendable step in the direction of preventing the
transmission of TSEs, further measures are required
to insure compliance with FDA prohibitions on introducing
diseased animals into the food supply. Moreover, it
still may not foreclose all the avenues of TSE transmission.
For this reason, Petitioners believe that the relief
requested in the instant petition is necessary.
The requested relief of labelling all downed cattle
as adulterated or condemned would impose no undue economic
hardship on any party. Downed cattle represent an extremely
small percentage of all livestock slaughtered. By contrast,
even if there were some economic hardship related to
the requested relief, this consideration is far outweighed
by the potential threat to human health should the requested
relief not be granted.
II. ARGUMENT SUPPORTING THE REQUESTED ACTION
A. Existing FDA Regulations Require That Downed Cattle
Be Deemed Adulterated
The existing statutory and regulatory framework requires
that downed cows immediately be eliminated from the
nationžs food supply. The Federal Food, Drug and Cosmetic
Act (the "Act"), 21 U.S.C. 331, provides: The following
acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction
into interstate commerce of any food, drug, device,
or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug,
device, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food,
drug, device, or cosmetic that is adulterated or misbranded,
and the delivery or proffered delivery thereof for pay
or otherwise.
(g) The manufacture within any Territory or any food,
drug, device, or cosmetic that is adulterated or misbranded.
21 U.S.C. 331 (emphasis added). The Act goes on
to define "adulterated" food as: A food shall be deemed
to be adulterated--
(a)
(1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but
in case the substance is not an added substance such
food shall not be considered adulterated under this
clause if the quantity of such substance in such food
does not ordinarily render it injurious to health; ...
or
(4) if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious
to health; or
(5) if it is, in whole or in part, the product of a
diseased animal or of an animal which has died otherwise
than by slaughter.
21 U.S.C. 342 (emphasis added).
Under existing USDA regulations, a downed cow is already
considered a "diseased animal." 9 C.F.R. section 301.2
(y) defines diseased livestock as animals displaying
any of the following symptoms:
(1) central nervous system disorder;
(2) abnormal temperature (high or low);
(3) difficult breathing;
(4) abnormal swelling;
(5) lack of muscular coordination;
(6) inability to walk normally or stand; and
(7) any of the conditions for which livestock is required
to be condemned on ante-mortem inspection. . . .ž
(emphasis added)
Thus, downed or non-ambulatory cattle (displaying
an inability to walk or stand) are properly classified
as "diseased" by the USDA. In turn, beef produced from
"diseased animals" should fall under the statutory definition
of adulterated (i.e., "the product of a diseased animal")
in section 342. Although such adulterated food is specifically
forbidden from entering into interstate commerce, there
is no present rule absolutely prohibiting the slaughter
of downed cattle for human food. Although thousands
of cattle become non-ambulatory every year often for
unexplainable reasons, many of these downed cattle are
ultimately slaughtered and sold for human consumption.
In light of the statutory language expressly prohibiting
the introduction of any food containing substances derived
in whole or in part from a diseased animal, all products
and by-products from downed cattle should be labeled
adulterated or condemned and thus prohibited from entering
the nationžs food supply.
B. There Is An Important Reason For Enforcing These
Existing USDA Classifications:
The Elimination Of Downed Cattle From the Food Supply
In The United States May Prevent The Transmission
of Deadly Diseases To Humans.
1. A Form of Mad Cow Disease May Exist in US. Downed
Cattle.
For 10 years, even preceding the British outbreak
of "Mad Cow Disease," certain scientific evidence has
suggested that a version of the disease may exist in
U.S. cattle. This evidence takes the form of interspecies
transmission of TSEs. In fact, the history of transmissible
mink encephalopathy (TME), a species specific TSE, in
the United States influenced the FDA to ban the use
of certain animal proteins in ruminant feed.
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. 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, Wisconsin 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 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
infected mink from the Stetsonville, Wisconsin farm.
Within two years, both became "downed." Then, Marsh
fed brain tissue from these affected cattle to minks,
and found that minks exhibited a like disease within
seven months. Referring to this, Marsh wrote, "[t]he"
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. Marsh, however,
was not funded to conduct further research in this area.
Marsh's research has been bolstered by research involving
sheep infected with scrapie (a related brain disease
in sheep). Although vertical transmission of BSE from
mother to calf has been documented, it is generally
believed that Britain's BSE outbreak was caused by feeding
rendered animal protein, either from sheep tissues with
scrapie, or BSE-infected bovine tissues, to cattle.
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. Yet,
strains of scrapie in the U.S behave differently in
cattle than those in Great Britain. Experiments using
calves intracerebrally inoculated with brain suspension
from sheep infected with U.S.-origin scrapie agent developed
a BSE-like illness. The clinical and histologic signs
of this illness, however, were different than those
observed in cattle with BSE in Great Britain. The inoculated
cattle became "downed," not "mad." Thus, this evidence
suggests that a downer cow may in fact have a form of
mad cow disease.
Given this possibility, the proposed relief is all
the more important because current surveillance efforts,
including slaughterhouse inspection procedures, are
inadequate to detect certain diseases in farm animals.
Despite the fact that downed cattle are considered "suspect"
and thus subject to additional observation, ante-mortem
inspection of downed cattle commonly takes five minutes
or less. It would be very difficult to identify central
nervous system (CNS) symptoms in this amount of time,
especially since a downed cattle's state of immobility
further hinders one's ability to identify CNS symptoms.
More importantly, although there are observable clinical
signs of BSE, the disease can only be confirmed following
histologic examination of the brain.
2. There Is Little Doubt That Consumption of BSE Contaminated
Meat Poses A Significant Health Risk.
The Mad Cow epidemic in Britain has demonstrated the
very real threat of human disease through exposure to
BSE. Creutzfeldt-Jakob disease (CJD) is a progressive,
degenerative and invariably fatal brain disease. Scientists
now believe that CJD can be contracted by humans who
eat the meat of animals infected with bovine spongiform
encephalopathy (BSE).
Cases of CJD are not always easily diagnosed because
the clinical signs resemble other degenerative brain
diseases. The most common misdiagnosis of CJD is Alzheimer's
disease. Figures from 1979-90 show that CJD was listed
on death certificates of 2,164 people in the U.S. The
great majority of the diseased were over fifty (the
mean age was 67), but 23 were in their thirties and
3 were in their twenties. Thus, the reported cases may
be underestimated, particularly because CJD is not a
reportable disease. In light of this preliminary data,
one must deal with the possibility that some of those
misdiagnosed with Alzheimeržs, actually have CJD.
Not surprisingly, then, due to the nature of the disease
and its severity, scientists are calling for increased
monitoring of the number of occurrences of CJD. According
to the head of neuropathology at Yale Medical School,
Dr. Laura Manuelidis, "the agents' ability to transform
[means] that public health authorities tracking the
invariably fatal diseases in human populations should
be on the lookout for diverse signs of brain pathology,
lest they miss new cases and underestimate the incidence
of the disease.
Given the potential threat to humans which the world
has already seen come to fruition in Great Britain,
the FDA and USDA should have significant motivation
to take whatever steps are necessary to prevent the
introduction and use of downed cattle in the nationžs
food supply. Given the many unexplained reasons for
the phenomenon and the now documented and scientifically
accepted threat of the transmission of TSEs to humans
from the consumption of diseased cattle, downed cattle
pose too great a risk to permit any food production
from them.
III. ENVIRONMENTAL IMPACT STATEMENT
The enforcement actions here requested will not cause
the release of any substance into the environment. They
are categorically excluded from the requirement of environmental
documentation under 21 C.F.R. 25.24 (a)(4) and (8).
IV. COST-BENEFIT ANALYSIS
Millions of cattle are slaughtered annually in the
U.S. The number of downed cattle killed each year is
small in comparison. Downed animals represent an extremely
small percentage of all livestock slaughtered, and banning
their use would cause no undue economic hardship. Even
if there is some economic hardship, this consideration
is outweighed by the potential threat to human health.
V. SPECIFIC REQUEST FOR AGENCY ACTION
Based on the foregoing, Petitioners request that the
FDA and USDA immediately undertake the following action:
label all downed cattle as adulterated pursuant to 21
U.S.C. 342 (a). The general delegation of power to
the FDA and the USDA to take the actions requested herein
is found at 21 U.S.C. 37l, et seq. and 21 U.S.C.
111 respectively. In addition, the FDA is the "lead"
agency in deciding markets under the auspices of the
Federal Food, Drug and Cosmetic Act (FFDCA). The Secretary
of Agriculture's opinion regarding the usefulness of
keeping downed cattle from entering the food supply
and preventing the recycling of bovine protein through
non-ruminants and then allowing it to be fed back to
cattle is only one of the many factors which the FDA
must consider in responding to this petition.
Petitioners are concerned that economic priorities
have tended to take precedence over the health of consumers.
Petitioners are further concerned that, like in Britain,
a powerful economic incentive exists to ignore evidence
that BSE, or a variant of BSE, exists in the United
States. Citizens and consumers have a right to trust
their government and rely on the safeguards that it
establishes. In order to protect the citizens of this
nation, Petitioners request that the agency undertake
the aforementioned actions.
Very truly yours,
GOODIN, MACBRIDE, SQUERI SCHLOTZ, & RITCHIE, LLP
BY: Kathryn A. Fugere
Attorneys for Petitioners
2356\002
PK2210.PETbc: Michael Friedman, M.D.
Mr. Stephen Sundloff
Mr. Tom Billy
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