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May 10, 1998
AMENDMENT TO PETITION NO. 98P-0151/CP1
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 amended
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 meat products concerned about the safety of meat
produced in the United States ("Petitioners").
Petitioners request that the FDA and USDA immediately
label all downed livestock 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. Petitioners'
initial petition requested that only downed cattle be
labeled as adulterated, but now seek to expand its request
to include all downed livestock for the reasons set
forth below. I.
INTRODUCTION
Petitioners estimate that more than 100 million livestock
are slaughtered in the United States each year. The
United States also has one of the highest degrees of
production and per capita meat consumption in the world.
Such levels of production and consumption create an
equally large responsibility to protect the health of
consumers by taking steps to ensure that animals slaughtered
for consumption are not diseased.
As noted in Petitioners' original petition, 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 animals which
collapse for unknown reasons and which are too sick
to stand back up. There are a host of problems affiliated
with these "downed" animals. Wholly aside from the humane
issue involved with the handling and processing of non-ambulatory
animals, "downed" animals may pose a serious threat
to human health. The illnesses that may cause animals
to collapse and lose their ability to move may pose
a health danger to the humans who consume these sick
animals. Petitioners noted in their original petition
that one such disease is bovine spongiform encephalopathy
(BSE) and that 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.
A recent study published after Petitioners filed their
original petition indicates, however, that animals other
than cattle could be susceptible to BSE. Petitioners
now seek to expand their original petition for this
reason. Moreover, the existing law and regulations cited
by Petitioners in the Original Petition are applicable
to all livestock.
The requested relief of labelling all downed livestock
as adulterated or condemned would impose no undue economic
hardship on any party. Downed animals 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
Animals Be Deemed Adulterated
As noted in the Original Petition, the existing statutory
and regulatory framework requires that downed livestock
immediately be eliminated from the nation's 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 animal 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. . . ."
(emphasis added).
Thus, downed or non-ambulatory animals (displaying
an inability to walk or stand) are properly classified
as "diseased" by the USDA. In turn, meat -- any meat
-- 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
livestock for human food. Although thousands of animals
become non-ambulatory every year often for unexplainable
reasons, many of these downed animals are 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 livestock should be labeled adulterated
or condemned and thus prohibited from entering the nation's
food supply.
B. Recent Research Indicates The Possibility That
Animals Other Than Cattle May Be Susceptible To BSE.
While existing law requires that downed animals be
labelled adulterated and disposed of accordingly, recent
information underscores the necessity for both the FDA
and the USDA to take steps to ensure that this is in
fact what occurs -- even in the event the downed animal
is not a cow.
On April 22, 1998, the results of a study were published
which raised that possibility that infected animals
other than cattle could be linked to Creutzfedlt-Jakob
disease (CJD), the human form of [BSE] or mad cow disease."
The study, conducted by Richard Race and Bruce Chesebro
of the National Institute of Allergy and Infectious
Diseases, underscores what many others have suggested
about BSE and its origin: more research is needed, but
the evidence gathered already is cause for concern:
Exposure to infectious prions does not always lead
to clinical disease, but a new report indicates that
prions can nonetheless persist in the brain. Hamster
prions were injected into mice and, although the mice
did not develop symptoms, the prions were present for
almost the entire life of the mice. What's more, when
brain extracts from these mice were injected back into
hamsters, the hamsters showed clinical symptoms. These
findings could have public health implications -- for
example, pigs and poultry, which do not develop disease
after eating bovine prions, may be acting as resolvers
for the infectious agent. (emphasis added)
Given the potential threat to humans which the world
has already seen come to fruition on Great Britain,
the FDA and USDA should have significant motivation
to take whatever steps are necessary to prevent the
introduction and use of any and all downed animals which
could be harboring dangerous diseases in the nation's
food supply. Because there exists 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 animals, downed animals
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 livestock are slaughtered annually in
the U.S. The number of downed animals 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 its
original petition be amended to request that the FDA
and USDA immediately undertake the following action:
label all downed livestock 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 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 diseases like BSE, or a variant strains of BSE
or other diseases, exist 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
Enclosures
cc: Bharat L. Patel, D.V.M., M.S.
Victoria Levine
Mr. Gene Baur (formerly Bauston)
Mr. Michael Baur
2356\002
PK3456.PETbc: Michael Friedman, M.D.
Mr. Stephen Sundloff
Mr. Tom Billy
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