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What is "Mad Cow Disease" (Bovine Spongiform Encephalopathy/BSE)?
Mad Cow Disease is the commonly used name for Bovine Spongiform
Encephalopathy (BSE), a slowly progressive, degenerative,
fatal disease affecting the central nervous system of adult
cattle. Since 1990, the U.S. Department of Agriculture (USDA)
has conducted aggressive surveillance of the highest risk
cattle going to slaughter in the United States.
What causes BSE?
The exact cause of BSE is not known but it is generally
accepted by the scientific community that the likely cause
is infectious forms of a type of protein, prions, normally
found in animals cause BSE. In cattle with BSE, these abnormal
prions initially occur in the small intestines and tonsils,
and are found in central nervous tissues, such as the brain
and spinal cord, and other tissues of infected animals experiencing
later stages of the disease.
Was a second case of BSE identified in the U.S. in June
2005?
Yes, the USDA surveillance program identified the second
BSE case in the U.S. This cow was originally identified in
November 2004. Results from this animal were inconclusive
in screening tests, but negative in confirmatory immunohistochemical
tests. USDA recently conducted an additional confirmatory
test, Western Blot, and the results were positive for BSE.
USDA sent the samples to the Weybridge, UK lab where BSE
was confirmed. An epidemiological investigation to trace
the origins of the cow is underway. USDA confirms that the
cow was born before the U.S. instituted its ban on the use
of most mammalian protein in feed for ruminant animals-believed
to be the most critical protective measure in preventing
the spread of BSE among cattle.
Did meat and meat products from the June 2005 cow enter
the food supply?
No, the cow was presented at slaughter as non-ambulatory
(a downer). Therefore, in accordance with BSE regulations
established by USDA and FDA the material from the animal
did not enter the human food supply.
Was a case of BSE identified in the U.S. in December 2003?
Yes, the USDA surveillance program identified the first
BSE case in the U.S. in a dairy cow in Washington State.
The cow was bought from a farm in Canada.
Did meat and meat products from the 2003 BSE cow enter
the food supply?
As soon as the BSE case was identified, both USDA and FDA
activated their BSE Emergency Response Plans, and USDA immediately
recalled the meat. Meat that did enter the food supply was
quickly traced and was removed from the marketplace. Moreover,
all the organs in which infectious prions occur were removed
at slaughter and did not enter the food supply. Consumers
should feel very confident that the system of multiple firewalls
maintained by Federal agencies protects them from possible
exposure to BSE. In addition, we believe it is important
for consumers to also understand that scientific research
indicates that muscle meat is not a source of infectious
prions.
Will there be additional cases?
In 1998, USDA commissioned the Harvard Center for Risk Analysis
to conduct an analysis and evaluation of the U.S. regulatory
measures to prevent the spread of BSE in the U.S. and to
reduce the potential exposure of U.S. consumers to BSE. The
Harvard study concluded that, if introduced, due to the preventive
measures currently in place in the U.S., BSE is extremely
unlikely to become established in the United States.
FDA and other Federal agencies have been vigilant in strengthening
protective measures to reduce the U.S. consumer's risk of
exposure to BSE-contaminated food and cosmetic products.
Since 1989, USDA has banned imports of live ruminants, such
as cattle, sheep and goats, and most products from these
animals from countries known to have BSE. Subsequently, USDA
expanded this ban to include both countries with BSE and
countries at risk for BSE. In 1997, FDA prohibited, with
some exceptions, the use of protein derived from mammalian
tissues in animal feed intended for cows and other ruminants.
See the FDA/CVM website at www.fda.gov/cvm for
information on the "ruminant feed ban."
On Jan. 8, 2004, the USDA's Food Safety and Inspection Service
issued new rules to enhance safeguards against BSE. Details
on these rules may be found at USDA's website, www.usda.gov.
Also in 2004, FDA issued a rule that prohibits the use of
certain cattle material, because of the risk of BSE, in human
food and cosmetics.
Does BSE affect people?
There is a disease similar to BSE called Creutzfeldt-Jacob
Disease (CJD) that is found in people. A variant form of
CJD (vCJD) is believed to be caused by eating contaminated
beef products from BSE-affected cattle. To date, there have
been 155 confirmed and probable cases of vCJD worldwide among
the hundreds of thousands of people that may have consumed
BSE-contaminated beef products. The one reported case of
vCJD in the United States was in a young woman who contracted
the disease while residing in the UK and developed symptoms
after moving to the U.S.
What measures are being taken to ensure food safety in
the U.S. from BSE?
Since 1989, the FDA and other federal agencies have had
ongoing regulatory measures in place to prevent BSE contamination
of U.S. food and food products. Following the identification
in a Washington state dairy herd of a BSE-positive cow imported
from Canada, USDA issued new regulations containing additional
safeguards to further minimize risk for introduction of the
BSE agent into the U.S. food supply. See USDA's website www.usda.gov for
further information.
Similarly, FDA has prohibited the use of the cattle materials
that carry the highest risk of BSE in human food, including
dietary supplements, and in cosmetics. FDA's rule (and September
2005 amendments) prohibit use of the following cattle material
in human food and cosmetics:
- cattle material from non-ambulatory, disabled cattle,
- cattle material from organs from cattle 30 months of
age or older in which infectious prions are most likely
to occur, and the tonsils and the distal ileum of the small
intestine of cattle of all ages,
- cattle material from mechanically separated (MS) (beef),
and
- cattle material from cattle that are not inspected and
passed for human consumption
FDA's rule also requires that food and cosmetics manufacturers
and processors make available to FDA any existing records
relevant to their compliance with these prohibitions. FDA
has also published a proposal requiring manufacturers and
processors of food and cosmetics made with cattle material
to establish and maintain records demonstrating that their
products do not contain prohibited cattle material.
In September 2005, FDA amended the interim final rule to
allow use of the small intestine in human food and cosmetics,
provided the distal ileum has been removed. FDA also clarified
that milk and milk products, hide and hide-derived products
and tallow derivatives are not considered prohibited cattle
materials. Finally, in response to comments the agency has
reconsidered the method cited in the interim final rule for
determining insoluble impurities in tallow and is citing
a method that is less costly and requires less specialized
equipment.
Are the protective measures in place sufficient to ensure
the safety of the human food supply in light of the June
2005 BSE positive cow?
Yes, the protective measures put into place in July 2004
by FDA ensure that cattle materials that carry the highest
risk of transmitting the agent that causes BSE are excluded
from human food, including dietary supplements, and cosmetics.
These measures, along with similar measures established by
USDA, provide a uniform national BSE policy and ensure the
safety of human food.
Is the food in the U.S. likely to be a BSE risk to consumers?
FDA and other federal agencies have had preventive measures
in place to reduce the U.S. consumer's risk of exposure to
any BSE-contaminated meat and food products. Since 1989,
USDA has prohibited the importation of live animals and animal
products from BSE-positive countries. Subsequently, USDA
expanded the ban to include both countries with BSE and countries
at risk for BSE. Since 1997, FDA has prohibited the use of
most mammalian protein in the manufacture of ruminant feed.
In 2004, FDA issued a rule prohibiting the use of certain
cattle materials in human food and cosmetics, and USDA issued
a rule prohibiting certain cattle materials from use as human
food.
Is cow's milk a source of BSE?
Scientific research indicates that BSE is not transmitted
in cow's milk, even if the milk comes from a cow with BSE.
Milk and milk products, even in countries with a high incidence
of BSE are, therefore, considered safe.
Can milk be infected with BSE from a BSE-positive cow?
No detectable infectivity in cow's milk has been reported
from any BSE-infected cows. Infectious prions have not been
detected by bioassay of milk from cattle with BSE.
Does the use of bovine-derived ingredients in dietary supplements
mean that they are not safe?
No. The requirements that FDA has in place should give consumers
confidence that their food, including dietary supplements,
is safe. Most recently, FDA published a rule that prohibits
the use in human food, including dietary supplements, of
the cattle materials that have the highest risk of harboring
BSE infectivity. The rule applies to both imported and domestic
dietary supplements and their ingredients. Furthermore, most
ingredients used to produce dietary supplements and most
other food ingredients come from cattle that are slaughtered
when they are less than 30-months of age and, because of
their age, present little risk of being BSE-positive. It
is not a common occurrence for animals younger than 30 months
to develop BSE.
Since the BSE-positive cows were discovered in the U.S.,
does that mean that dietary supplements made with domestic
ingredients might be unsafe?
No. The requirements that FDA has in place should give consumers
confidence that their food, including dietary supplements,
is safe. Most recently, FDA published a rule that prohibits
the use in human food, including dietary supplements, of
the cattle materials that have the highest risk of harboring
BSE infectivity. Furthermore, most ingredients used to produce
dietary supplements and most other food ingredients come
from cattle that are slaughtered when they are less than
30-months of age and, because of their age, present little
risk of being BSE-positive.
Even though BSE-positive cows have been identified in the
U.S., one of which was imported, the risk to human health
from dietary supplements and other foods containing cattle-derived
ingredients is extremely low.
What steps is FDA currently taking to ensure the safety
of dietary supplements that contain bovine ingredients?
Most recently, FDA published a rule that prohibits the use
in human food, including dietary supplements, of the cattle
materials that have the highest risk of harboring BSE infectivity.
The rule applies to both domestic and imported dietary supplements
and their ingredients. In addition, most ingredients used
to produce dietary supplements and most other food ingredients
come from cattle that are slaughtered when they are less
than 30-months of age and, because of their age, present
little risk of being BSE-positive. Further, the restrictions
by USDA on the use of certain cattle and cattle tissues in
human food also reduce the risks that potentially infective
tissue would be used in dietary supplements. FDA also has
proposed a requirement that manufacturers and processors
that use cattle material in their products would be required
to keep records demonstrating that these materials do not
contain prohibited cattle material and that these records
be made available to FDA for inspection.
Given the BSE case in Washington State and the case in
Texas, should consumers be concerned about cosmetics made
using tallow from the rendering process?
No. The World Health Organization considers tallow to be
a low risk for transmission of BSE. Specifically, the rendering
process separates fats from proteins. Because the disease
is transmitted by prions, which are a type of protein, they
would be separated by the rendering process from the tallow
or fat, which is the portion that goes into cosmetics. Additionally,
the tallow is processed with excessive heat and pressure
which may further minimize any risk of infectivity prior
to use in cosmetics.
What about the use of gelatin, another bovine-related material,
in cosmetics and dietary supplements and other foods?
FDA's rule prohibiting the use of the cattle materials that
have the highest risk of harboring BSE infectivity in human
food applies to gelatin. Therefore, gelatin used in human
food may not be made from these cattle materials.
When and how did BSE in cattle occur?
BSE in cattle was first reported in 1986 in the United Kingdom
(UK). The exact origins of BSE remain uncertain, but it is
thought that cattle initially may have become infected when
fed feed contaminated with scrapie-infected sheep meat-and-bone
meal (MBM). Scrapie is a prion disease in sheep similar to
BSE in cattle. The scientific evidence suggests that the
U.K. BSE outbreak in cattle then was expanded by feeding
BSE-contaminated cattle protein (MBM) to calves. The definitive
nature of the BSE agent is not completely known. The agent
is thought to be a modified form of a protein, called a prion,
which becomes infectious and accumulates in neural tissues
causing a fatal, degenerative, neurological disease. These
abnormal prions are resistant to common food disinfection
treatments, such as heat, to reduce or eliminate their infectivity
or presence. Research is ongoing to better understand TSE
diseases and the nature of prion transmission.
Is BSE in cattle the same disease as CWD in deer and elk
in the U.S.?
BSE is a Transmissible Spongiform Encephalopathy (TSE),
a family of similar diseases that may infect certain species
of animals and people such as scrapie in sheep and goats,
BSE in cattle, chronic wasting disease (CWD) in deer and
elk, and variant Creutzfeldt-Jakob disease (vCJD) in people.
To date, there is no scientific evidence that BSE in cattle
is related to CWD in deer and elk. FDA is working closely
with other government agencies and the public health community
to address CWD in wild and domesticated deer and elk herds.
Wildlife and public health officials advise people not to
harvest, handle, or consume any wild deer or elk that appear
to be sick, regardless of the cause, especially in those
states where CWD has been detected.
What countries have reported cases of BSE or are considered
to have a substantial risk associated with BSE?
These countries are: Albania, Austria, Belgium, Bosnia-Herzegovina,
Bulgaria, Croatia, Czech Republic, Denmark, Federal Republic
of Yugoslavia, Finland, France, Germany, Greece, Hungary,
Ireland, Israel, Italy, Liechtenstein, Luxembourg, former
Yugoslavia Republic of Macedonia, The Netherlands, Norway,
Oman, Poland, Portugal, Romania, Slovak Republic, Slovenia,
Spain, Sweden, Switzerland, Japan, and United Kingdom (Great
Britain including Northern Ireland and the Falkland Islands).
Thanks to the U.S. Food and Drug Administration Center for
Food Safety and Applied Nutrition (CFSAN) for this article.
You can read the entire article here: http://www.cfsan.fda.gov/~comm/bsefaq.html
Cow image is provided by the Animal and Plant
Health Inspection Service.
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