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USDA Denies Petition
and Allows Diseased Animals into Human Food Supply
March 25, 1999
Kathryn Fugere
Goodin, MacBride, Squeri, Schlotz, & Ritchie
505 Sansome St., Suite 900
San Francisco, CA 94111
Dear Ms. Fugere,
FSIS reviewed the March 4, 1998, petition you submitted
on behalf of your clients Farm Sanctuary and Michael
Baur, asking the Food Safety and Inspection Service
(FSIS) to amend the Federal meat inspection regulations
to provide that all "downed" livestock be deemed adulterated
or condemned and, as a result, removed from the food
supply. FSIS has denied your request.
FSIS is not required under the Federal Food, Drug
and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.) or
its regulations concerning the products of a diseased
animal, to removed all downed cattle, without exception,
from the nation's food supply since FSIS is not bound
by the FFDCA's definition of adulteration (21 U.S.C.
342(a)(5)). By law, FSIS must apply the definition of
adulteration found in the Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.) to food and food products
from cattle, sheep, swine, goats, and equines. The definition
of adulteration found in the FFDCA is different from
that in the FMIA (compare 21 U.S.C. 342(a)(5) and 21
U.S.C. 601(m)(5) respectively). Unlike the FFDCA, the
FMIA does not automatically consider the products of
a diseased animal adulterated. Furthermore, under the
FMIA, as long as an animal, even a diseased animal,
depending upon the disease, has been passed for slaughter,
it is possible that the carcass, or a portion of it,
may be inspected and passed for human food.
It is obvious that the FFDCA and FMIA regulate different
foods and have different areas of concern. Case law
has made it clear that the two statutes have independent
construction and are not applicable to each other. In
United States v. 2,116 Boxes of Boned Beef, 516 F. Supp.
321, 344 (1981), the court up held the Department of
Agriculture's long standing position that, "There is
no requirement in the Federal Meat Inspection Act that
any procedures prescribed in the Federal Food, Drug
and Cosmetic Act be followed in issuing regulations
or taking other actions under the Federal Meat Inspection
Act." The court further pointed out that regulations
enacted under the FMIA are inapplicable in defining
adulteration under the FFDCA. Similarly, definitions
under the FFDCA are inapplicable to regulations promulgated
and interpreted under the FMIA. Thus, FSIS must apply
the definition of adulteration found in the FMIA, not
the FFDCA, to livestock brought into a federally inspected
slaughter establishment.
You suggest that 9 CFR 301 2(y) means that a non-ambulatory,
i.e. downed, animal is a diseased animal. Section 301
2(y) clearly includes both diseased and disabled livestock.
Some disabled or non-ambulatory animals are not diseased.
Rather, they are affected by a physical condition (e.g.,
a broken leg) and may not be diseased. Such "downers"
may not require any partial or complete condemnation.
Any non-ambulatory or otherwise disabled livestock that
are suspected of being affected with a disease or condition
which may require its condemnation, in whole or in part,
are handled as "U.S. Suspects" (9 CFR 301.2(xxx)). The
carcasses of "U.S. Suspects" are subjected to further
examination by FSIS veterinary medical officers after
slaughter to determine the appropriate disposition.
If products made from the carcasses of non-ambulatory
animals do not pose a threat to human health, then there
is no need to automatically condemn the carcasses simply
because they came from "downers". They can be examined,
and, if part or all of the meat from them is safe for
human consumption, then it can be used for human food.
The FMIA, FSIS regulations, and past practices clearly
provide for the slaughter and processing of diseased
animals for human food. Such animals may be slaughtered
and examined to determine if the meat from their carcasses
pose no threat to human health. If they post no threat,
the meat may be passed for human food when the disease
condition does not affect the whole carcass and the
diseased part can be removed to make a wholesome product
(21 U.S.C. 603, and 9 CFR 301.2(xxx), 309.2). Any livestock
showing symptoms of certain diseases must be identified
as "U.S. Condemned" and be disposed of according to
sections 309.8, 309.13, or 311 (9 CFR 309.4(a)). Section
311 deals with disposal of diseased or otherwise adulterated
carcasses or parts and states that the decision as to
the disposal of any diseased items not specifically
covered on part 311 shall be left to the veterinary
medical officer, who is to exercise judgement regarding
the disposition of all carcasses or parts to ensure
that only wholesome, unadulterated product is passed
for human food.
When an FSIS veterinary medical officer is presented
with a cow that is unable to rise, a differential diagnosis
of the etiology of the syndrome must be made. It is
not difficult to distinguish a recumbent cow due to
one of the acknowledged "downer cow" syndrome etiologies
from one that is affected with a central nervous system
(CNS) condition. If proper clinical observations are
combined with an adequate history and appropriate laboratory
test evaluations, a differential diagnosis is possible
in the vase majority of cases. Apparently, you assume
that FSIS veterinary medical officers are unable to
make a differential diagnosis of "downer cows." Such
reasoning contravenes long established principles of
veterinary medicine: differential diagnosis and attribution
of disease etiology. Moreover, regardless of the diagnosis,
all animals with CNS disorders are condemned on antemortem
inspection.
Your petition also stated that all downed cattle must
be labeled adulterated or condemned and removed from
the Nation's food supply because doing so is necessary
to prevent the transmission of deadly diseases to humans,
particularly bovine spongiform encephalopathy (BSE).
However, the consensus of the scientific literature
is that BSE does not exist in the U.S. BSE has not been
detected in this country, despite active surveillance
efforts for several years. Since 1990, nearly 6,500
specimens, from animals in 43 states, have been laboratory
tested by an ongoing BSE surveillance system in the
U.S. No evidence of BSE (in the form of characteristic
lesions) or related transmissible spongiform encephalopathies
(TSE) has been seen. In addition, the prevent BSE-contaminated
animals or animal products from entering the U.S., severe
restrictions exist on the importation of live ruminants
and ruminant products from countries where BSE is known
to exist.
No cases of BSE have been diagnosed in the United
States. In FY 1997, 137,663,099 livestock were slaughtered
in USDA inspected establishments. Of those, 358,270
(0.002603 percent) were labeled "U.S. Suspect". Only
827 red meat animals (0.000006 percent) were condemned
on antemortem inspection for CNS condition. In FY 1998,
1,340 read meat animals (0.000001 percent) were similarly
condemned. Regarding the other "serious diseases" listed
in your petition that may pose a serious health threat
to humans, none, including bovine leukemia virus, bovine
immunodeficiency virus, brucellosis, rabies, and Johne's
disease, are considered to be meat borne zoonotic diseases.
Thus, it would be extremely remote that any of those
diseases would be passed on by consumption of red meat
animals.
The U.S. has one of the most aggressive BSE surveillance
programs in the world, one that is designed to keep
the U.S. free of BSE. A United States Department of
Agriculture (USDA) BSE Working Group, in coordination
with other government, has been regularly reviewing
the available science and implementing appropriate regulatory
measures to prevent BSE. These measures include the
1989 ban on cattle and cattle products from countries
where BSE has been reported and active inspection, testing,
and education programs.
USDA has also entered into a cooperative agreement
with Harvard University's School of Public Health to
analyze and evaluate the Department's current measures
to prevent BSE. The two-year study will review current
scientific information, characterize the hazards of
BSE and other TSE agents to human and animal health,
assess the way BSE could potentially enter the U.S.,
and identify any additional measures that could be taken
to protect human and animal health.
Finally, you state that "downed animals represent
an extremely small percentage of all livestock slaughtered
and banning their use would cause no undue economic
hardship." This is incorrect. Condemning all meat and
meat products from a carcass with any degree of disease
would have a serious economic impact. Using your interpretation
of the term "downer", that is, any diseased animal is
a downer (based on the Federal Food, Drug and Cosmetic
Act and its implementing regulations), there would be
a substantial increase in the number of carcasses condemned.
For example, a large percent of the livers of livestock
(greater than 10 percent) are condemned because of disease
conditions. Under your definition, a diseased liver
would make an entire carcass adulterated. Such an interpretation
would most certainly impact meat availability and prices.
Thank you for allowing FSIS the opportunity to respond
to your petition and the questions it raised. You may
contact Victoria Levine, Petition Manager, Regulations
Development and Analysis Division, at (202) 720-5627,
if you have any questions.
Sincerely,
Daniel L Engeljohn, PhD.
Director, Regulations Development and Analysis Division
Office of Policy, Program Development and Evaluation
USDA, FSIS, Washington, DC 20250
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