FDA's New Proposed Measures to Stop Mad Cow Are 'Too Little, Too Late"

FDA waited more than a month after the discovery of the first US mad cow to
take today's action. The steps announced today should have been taken years
ago and they still fall far short of what is needed. The US should follow
the lead of the EU nations by banning all feeding of slaughterhouse waste to
livestock, and testing millions of US cattle for mad cow disease. Any thing
less is still too little, and way too late.

Huge loopholes remain in the feed rule: Apparently blood, meat, bonemeal,
blood meal and other byproducts from ruminants can still be fed to pigs,
with pigs fed to pigs and also to ruminants. FDA says pigs don't get TSE
diseases, but that's absurd. In laboratories its easy to infect pigs with
TSEs, so they do get TSE diseases, and feeding pigs to pigs risks amplifying
and spreading sporadic strains already in pigs.

Also, I see no closure of the loophole that lets TSE-infected deer, elk,
cattle and sheep be rendered and fed to pets, pigs and poultry.

Even if there is 99% compliance with the 1997 regs, they are primarily a
feed mill labeling requirement. There is no effective policing or
enforcement at the farm, ranch and feedlot level to make sure that properly
labeled feed is not being misfed.

John Stauber, co-author, Mad Cow USA
608-238-7376

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John Stauber, Executive Director
Center for Media & Democracy
520 University Avenue #227, Madison, WI 53703
Phone(608)260-9713 Fax260-9714 http://www.prwatch.org/
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HHS: Expanded 'Mad Cow' Safeguards Announced to Strengthen Existing
Firewalls Against BSE Transmission

http://releases.usnewswire.com/GetRelease.asp?id=138-01262004

1/26/04 4:52:00 PM

To: National Desk, Health Reporter

Contact: FDA Press Office, 301-827-6242

WASHINGTON, Jan. 26 /U.S. Newswire/ -- 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 Dec. 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 for BSE.

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 Dec. 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 .

------

Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news .

http://www.usnewswire.com/

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/© 2004 U.S. Newswire 202-347-2770/