|
Press Release from the FDA
January 26, 2003
EXPANDED "MAD COW" SAFEGUARDS ANNOUNCED TO STRENGTHEN
EXISTING FIREWALLS AGAINST BSE TRANSMISSION
HHS Secretary Tommy G. Thompson today announced several new
public health measures, to be implemented by the Food and
Drug Administration (FDA), to strengthen significantly the
multiple existing firewalls that protect Americans from exposure
to the agent thought to cause bovine spongiform encephalopathy
(BSE, also known as mad cow disease) and that help prevent
the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S.
Department of Agriculture (USDA) and HHS, have been extremely
effective in protecting the American consumer from exposure
to BSE. The first firewall is based on import controls started
in 1989. A second firewall is surveillance of the U.S. cattle
population for the presence of BSE, a USDA firewall that led
to the finding of the BSE cow in December. The third firewall
is FDA's 1997 animal feed ban, which is the critical safeguard
to help prevent the spread of BSE through cattle herds by
prohibiting the feeding of most mammalian protein to ruminant
animals, including cattle. The fourth firewall, recently announced
by USDA, makes sure that no bovine tissues known to be at
high risk for carrying the agent of BSE enter the human food
supply regulated by USDA. The fifth firewall is effective
response planning to contain the potential for any damage
from a BSE positive animal, if one is discovered. This contingency
response plan, which had been developed over the past several
years, was initiated immediately upon the discovery of a BSE
positive cow in Washington State December 23.
The new safeguards being announced today are science-based
and further bolster these already effective safeguards. Specifically,
HHS intends to ban from human food (including dietary supplements),
and cosmetics a wide range of bovine-derived material so that
the same safeguards that protect Americans from exposure to
the agent of BSE through meat products regulated by USDA also
apply to food products that FDA regulates.
FDA will also prohibit certain currently allowed feeding
and manufacturing practices involving feed for cattle and
other ruminant animals. These additional measures will further
strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections
against BSE even stronger," Secretary Thompson said.
"Although the current animal feed rule provides a strong
barrier against the further spread of BSE, we must never be
satisfied with the status quo where the health and safety
of our animals and our population is at stake. The science
and our own experience and knowledge in this area are constantly
evolving. Small as the risk may already be, this is the time
to make sure the public is protected to the greatest extent
possible."
"Today we are bolstering our BSE firewalls to protect
the public," said FDA Commissioner Mark B. McClellan,
M.D., Ph.D. "We are further strengthening our animal
feed rule, and we are taking additional steps to further protect
the public from being exposed to any potentially risky materials
from cattle. FDA's vigorous inspection and enforcement program
has helped us achieve a compliance rate of more than 99 percent
with the feed ban rule, and we intend to increase our enforcement
efforts to assure compliance with our enhanced regulations.
Finally, we are continuing to assist in the development of
new technologies that will help us in the future improve even
further these BSE protections. With today's actions, FDA will
be doing more than ever before to protect the public against
BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two
interim final rules that will take effect immediately upon
publication, although there will be an opportunity for public
comment after publication.
The first interim final rule will ban the following materials
from FDA-regulated human food, (including dietary supplements)
and cosmetics:
* Any material from "downer" cattle. ("Downer"
cattle are animals that cannot walk.)
* Any material from "dead" cattle. ("Dead"
cattle are cattle that die on the farm (i.e. before reaching
the slaughter plant);
* Specified Risk Materials (SRMs) that are known to harbor
the highest concentrations of the infectious agent for BSE,
such as the brain, skull, eyes, and spinal cord of cattle
30 months or older, and a portion of the small intestine and
tonsils from all cattle, regardless of their age or health;
and
* The product known as mechanically separated beef, a product
which may contain SRMs. Meat obtained by Advanced Meat Recovery
(an automated system for cutting meat from bones), may be
used since USDA regulations do not allow the presence of SRMs
in this product.
The second interim final rule is designed to lower even
further the risk that cattle will be purposefully or inadvertently
fed prohibited protein. It was the feeding of such protein
to cattle that was the route of disease transmission that
led to the BSE epidemic in United Kingdom cattle in the 1980's
and 1990's.
This interim final rule will implement four specific changes
in FDA's present animal feed rule. First, the rule will eliminate
the present exemption in the feed rule that allows mammalian
blood and blood products to be fed to other ruminants as a
protein source. Recent scientific evidence suggests that blood
can carry some infectivity forBSE.
Second, the rule will also ban the use of "poultry
litter" as a feed ingredient for ruminant animals. Poultry
litter consists of bedding, spilled feed, feathers, and fecal
matter that are collected from living quarters where poultry
is raised. This material is then used in cattle feed in some
areas of the country where cattle and large poultry raising
operations are located near each other. Poultry feed may legally
contain protein that is prohibited in ruminant feed, such
as bovine meat and bone meal. The concern is that spillage
of poultry feed in the chicken house occurs and that poultry
feed (which may contain protein prohibited in ruminant feed)
is then collected as part of the "poultry litter"
and added to ruminant feed.
Third, the rule will ban the use of "plate waste"
as a feed ingredient for ruminants. Plate waste consists of
uneaten meat and other meat scraps that are currently collected
from some large restaurant operations and rendered into meat
and bone meal for animal feed. The use of "plate waste"
confounds FDA's ability to analyze ruminant feeds for the
presence of prohibited proteins, compromising the Agency's
ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of
cross-contamination of ruminant and non-ruminant animal feed
by requiring equipment, facilities or production lines to
be dedicated to non-ruminant animal feeds if they use protein
that is prohibited in ruminant feed. Currently, some equipment,
facilities and production lines process or handle prohibited
and non-prohibited materials and make both ruminant and non-ruminant
feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further
layer of protection against BSE, FDA will in 2004 step up
its inspections of feed mills and renderers. FDA will itself
conduct 2,800 inspections and will make its resources go even
further by continuing to work with state agencies to fund
3,100 contract inspections of feed mill and renderers and
other firms that handle animal feed and feed ingredients.
Through partnerships with states, FDA will also receive data
on 700 additional inspections, for a total of 3,800 state
contract and partnership inspections in 2004 alone, including
annual inspections of 100 percent of all known renderers and
feed mills that process products containing materials prohibited
in ruminant feed.
"We have worked hard with the rendering and animal
feed production industries to try and achieve full compliance
with the animal feed rule," said Dr. McClellan, "and
through strong education and a vigorous enforcement campaign,
backed by additional inspections and resources, we intend
to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a
BSE positive cow in Washington state December 23, FDA inspected
and traced products at 22 facilities related to that positive
cow or products from the cow, including feed mills, farms,
dairy farms, calf feeder lots, slaughter houses, meat processors,
transfer stations, and shipping terminals. Moreover, FDA has
conducted inspections at the rendering facilities that handled
materials from the positive cow, and they were found to be
fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS
intends to work with Congress to consider proposals to assure
that these important protective measures will be implemented
as effectively as possible.
FDA is also continuing its efforts to assist in the development
of better BSE science, to achieve the same or greater confidence
in BSE protection at a lower cost. For example, to enhance
the ability of our public health system to detect prohibited
materials in animal feed, FDA will continue to support the
development and evaluation of diagnostic tests to identify
prohibited materials. These tests would offer a quick and
reliable method of testing animal feeds for prohibited materials
and for testing other products for contamination with the
agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced
today with stakeholders in workshops, videoconferences, and
public meetings. In addition, FDA published an Advance Notice
of Proposed Rulemaking in November 2002 (available online
at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm
concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links
to other related websites are available at http://www.fda.gov.
|
