- (Note - The problem of mad cow in medical products (and
elsewhere) is obviously severe. The FDA should have done this 10-12 years
ago. I have been cautioning and warning (with Dr. Patricia Doyle, PhD)
about this very real danger for over 10 years now. The measures below
don't go nearly far enough. Example of the half-baked 'logic' of
these new 'restrictions': ".... that would bar material that
has been found to harbor the highest concentrations of this fatal agent
in infected cattle."This is outrageous. So, the FDA is saying that
cattle parts with slightly less than the 'highest (whatever that actually
means) concentrations' of mad cow prions are OK TO KEEP ON USING.
How many prions does one have to ingest to develop mad cow and die a hideous
death? ONE, until proven otherwise. - Jeff Rense)
- The U.S. Food and Drug Administration is proposing to
limit the materials used in some medical products in order to keep them
free of the agent thought to cause mad cow disease, also known as bovine
spongiform encephalopathy or BSE.
- This is the latest in a series of BSE safeguards that
would bar material that has been found to harbor the highest concentrations
of this fatal agent in infected cattle. These materials would be prohibited
from use as ingredients in medical products or elements of product manufacturing.
- The proposed rule would cover drugs (prescription, over-the-counter,
and homeopathic), biologics (such as vaccines) and medical devices intended
for use in humans as well as drugs intended for use in ruminant animals
like cattle and sheep. Cattle can get mad cow disease, while sheep can
get a similar disease known as scrapie.
- "These measures build on a series of barriers FDA
and the U.S. Department of Agriculture have erected to further protect
humans from exposure to the fatal agent linked to BSE," said Andrew
von Eschenbach, M.D., Commissioner Food and Drugs. "This proposed
rule adds one more safeguard that will reduce the risk of transmission
- The cattle materials prohibited in the proposed rule
are those that pose the highest risk of containing infectious material
- -- the brain, skull, eyes and spinal cords from cattle
30 months and older;
- -- the tonsils and a portion of the small intestines
from all cattle regardless of their age or health;
- -- any material from "downer" cattle--those
that cannot walk;
- -- any material from cattle not inspected and passed
for human consumption;
- -- fetal calf serum if appropriate procedures have not
been followed to prevent its contamination with materials prohibited by
this proposed rule;
- -- tallow that contains more than 0.15 percent insoluble
impurities if the tallow is derived from materials prohibited by this proposed
- -- mechanically separated beef.
- To ensure that companies comply with these prohibitions,
FDA proposes to require that records be kept to demonstrate that any cattle
material used as an ingredient in these medical products or as part of
their manufacturing process meet the rule's requirements.
- Since 1996, strong evidence has accumulated for a causal
relationship between ongoing outbreaks of mad cow disease in Europe and
a disease in humans called variant Creutzfeldt-Jakob (vCJD) disease. Both
disorders, which are thought to be caused by an unconventional transmissible
agent, are invariably fatal brain diseases with incubation periods typically
measured in years. Transmission of the BSE agent to humans, leading to
vCJD, is believed to occur via ingestion of cattle products contaminated
with the BSE agent; however the specific products associated with this
transmission are unknown.
- About 200 cases of vCJD have been identified worldwide,
including three cases in the U.S. However, there is no evidence that those
three patients contracted the BSE agent in the U.S.
- FDA and USDA's efforts to help protect the public from
vCJD have included several other significant steps such as the FDA's 1997
ruminant feed regulation, which forbids the use of certain mammalian-origin
proteins in ruminant feed. Also, a 2005 interim final rule bans the use
of certain high-risk cattle material in food, dietary supplements and cosmetics.