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From: TSS (216-119-143-137.ipset23.wt.net)
Subject: BSE, TSEs in the USA and all of N. America HERE'S THE PROBLEM $
Date: September 2, 2004 at 11:52 am PST

-------- Original Message --------
Subject: BSE, TSEs in the USA and all of N. America HERE'S THE PROBLEM $
Date: Thu, 2 Sep 2004 13:47:22 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


######## Bovine Spongiform Encephalopathy #########

SECTION ONE
EXECUTIVE SUMMARY
The U.S. Food and Drug Administration (FDA) is considering regulatory
options to reduce
the risk of an outbreak of transmissible spongiform encephalopathies
(TSE) in the United States.
Many TSEs are believed to be transmissible through feed. Examples of
TSEs in animals include
bovine spongiform encephalopathy (BSE) in cattle, scrapie in sheep and
goats, chronic wasting
disease in mule deer and elk, and transmissible mink encephalopathy in
mink. FDA is considering
the following five regulatory options:
# A prohibition on the use of mammalian protein in ruminant feed. (For
convenience
in the discussion this is referred to as the mammalian prohibition.)
# A prohibition on the use of ruminant protein in ruminant feed (the
ruminant
prohibition).
# A prohibition on the use of designated tissues in ruminant feed. Under
this
prohibition, ruminant feed would not be recognized as safe if it
included designated
bovine tissues, including the brain, eyes, spinal cord, and distal
ileum; any material
from ovine, caprine, cervine, and mink; or any dead, dying, disabled, or
diseased
bovine (the partial ruminant prohibition).
# A prohibition on the use of protein from sheep, lamb, goat, deer, elk,
or mink in
ruminant feed. Thus, under this option, use of cattle protein is not
restricted (the
sheep/mink prohibition).
# A prohibition on the use of protein from sheep, lamb, and goats in
ruminant feed
(the sheep and goat prohibition).
The following industry sectors may be affected by the FDA regulatory
actions:
# Ruminant producers: Over 1.4 million enterprises are estimated to be
engaged in
ruminant production. This includes businesses engaged in the production
of beef
and dairy cattle, sheep and lamb, goats, and other ruminants. The
affected cattle
operations include farmers and ranchers, stocker operators, and cattle
feeders.
# Other livestock producers: The mammalian prohibition will restrict
marketing of
nonruminant mammal protein, thereby affecting additional livestock
producers,
most notably hog producers.
# Slaughtering and rendering industries: An estimated 4,011
establishments are
engaged in slaughtering activities. This total includes large integrated
packer/renderers, nonintegrated packers, and numerous small slaughterers
(commonly referred to as "locker" plants). There are also 282 independent
renderers.
# Feedmills: An estimated 30,000 facilities are engaged in feed
production for farm
or ranch animals. Of these, an estimated 5,000 are major commercial
feedmills and
the remainder are small retail feed dealers or other local feedmills.
Restrictions on marketing animal protein in the form of meat and
bonemeal (MBM) will
reduce the price of this product. The amount of the decline depends
greatly on public reaction to
the FDA rulemaking, a reaction that is largely unpredictable. To capture
the possible range of
public reaction and the related market shifts, low and high market
impact scenarios were estimated
in which the price of the restricted MBM falls by $25 per ton or $100
per ton. (This price decline
is considered only for the first three regulatory optionsCunder the
sheep/mink and sheep and goat
prohibitions, the quantity of prohibited MBM is so small that impacts on
the price of MBM will be
negligible.) At the $25 per ton price decline, the loss in commercial
value of the restricted MBM
product is an estimated $76.4 million per year under the mammalian
prohibition, $63.2 million per
year under the ruminant prohibition, and $28.8 million per year under
the partial ruminant
prohibition. At the $100 per ton price decline, the loss in commercial
value is an estimated $305.6
million per year under the mammalian prohibition, $252.8 million per
year under the ruminant
prohibition, and $115.4 million per year under the partial ruminant
prohibition. Under the
sheep/mink and sheep and goat prohibitions, the revenues losses are much
smaller, and are
estimated at $4.2 million per year and $0.1 million per year.
The regulatory options and the resulting market impacts will require
slaughterers and
renderers to decide whether to separate either mammalian or ruminant
tissues for separate
processing. Under the mammalian and ruminant prohibitions, it was
forecast that no slaughtering
or rendering establishments will choose to separate offal or otherwise
change their processing
operations. Under the partial ruminant prohibition, however, cattle
packer/renderers and large
cattle packers will separate ruminant tissues in order to preserve the
market value of their
nonrestricted animal protein. This change in processing will require
capital investments and
increase operating and transportation expenses. Depending on market
circumstances and the
regulatory option selected, an estimated 5 to 20 percent of major
commercial feedmills will also
make capital investments in expanded facilities to allow storage and use
of additional feed
ingredients to replace the mixed species MBM now used in ruminant feed.
Under the sheep/mink and sheep and goat prohibitions, the restricted
materials will be
excluded from rendering processes that manufacture mixed species MBM.
Most of this restricted
material, however, is already excluded from MBM used in ruminant feed
and, therefore, the
incremental economic impacts from these regulatory options are quite small.
The total annualized compliance costs under the various regulatory
options and market
scenarios are as follows:
# Under the mammalian prohibition, total compliance costs are estimated
at $31.6
million per year under either the low or high market impact scenarios.
# Under the ruminant prohibition, total compliance costs vary from $10.2
million per
year in the low market impact scenario to $27.6 million per year in the
high market
impact scenario. The difference is due to the forecast that only in the
high market
impact scenario will feedmills expand capacity.
# Under the partial ruminant prohibition, total compliance costs are
$23.5 million per
year in the low market impact scenario and $27.9 million per year in the
high
market impact scenario.
# Under the sheep/mink prohibition, total compliance costs, which
consist almost
entirely of disposal charges, are estimated at $5.1 million per year
under either
market scenario. Nearly all sheep, lamb, and goat offal is already
excluded from
MBM used in ruminant feed.
# Under the sheep and goat prohibition, total compliance costs are
estimated at $0.2
million per year under either scenario.
Renderers will pass much of the economic burden of new regulations and
reduced revenues
upstream to slaughterers, who will in turn pass them on to animal
producers. Regulatory impacts
also will be reflected in a decline in the demand price for
slaughter-weight cattle and, under the
mammalian prohibition, hogs. In the long run, a modest reduction in the
size of the affected
animal herds is forecast.
The small renderers that rely most heavily on ranchers and farmers dead
stock for raw
materials will attempt to increase charges to these groups. To avoid
these charges, ranchers and
farmers will dispose of more dead animals on their own land, thereby
reducing the amount of dead
stock going to rendering. Because of the reduction in their raw material
supply, some small
renderers will be vulnerable to failure.

http://www.fda.gov/cvm/index/bse/bse1.pdf

EDITORIAL
The Great Divide


Written by Ethan Dezotelle

Thursday, 02 September 2004


Two agricultural slugfests dominated the latter part of this? year’s
Legislative session: organic vs. genetically modified and small scale
vs. factory farming.
They are debates which haven’t died down in the ensuing months, and they
likely won’t go away in the immediate future. Now a new study released
by the Organization for Competitive Markets, “USDA INC: How Agribusiness
Has Hijacked Regulatory Policy at the U.S. Department of Agriculture,”
has added a new wrinkle to the debate.
The OCM’s report suggests exactly what many small-scale and organic
farmers have long thought – The United States Department of
Agriculture’s food-related regulatory appointees are putting the
interests of agribusiness before those of farmers.
The 37-page document is a jaw-dropper, especially if you’re someone
affected by the regulatory policies of the USDA, which is to say, if
you’re an American.
The study focuses on five case studies – so-called “Mad Cow Disease,”
the dominance of corporate meatpacking in the United States, meat
inspection policies, the biotech industry, concentrated animal feeding
operations – that?????? put USDA policies through the wringer and filter
out some downright disturbing notions.
The one that comes to dominate the report is that the revolving door of
officials who create USDA policy regarding these topics is a virtual
Who’s Who of agribusiness movers and shakers. Such connections between
policy makers and Big Ag are rife, and there is simply no counterbalance
to speak for farmers and ranchers.
Philip Mattera, the author of the report, draws up a list that is
sickeningly long of USDA appointees who came to their positions after
working in the world of agribusiness.
USDA Secretary Ann M. Veneman was a board member of Calgene, a biotech
company. Under Secretary J.B. Penn was an executive at Sparks Companies,
a consulting firm that works with agribusiness. Mary Waters, the USDA’s
assistant secretary for Congressional relations, spent time as a senior
director and legislative counsel for ConAgra Foods.
And the list goes on.
The report’s conclusion is, at the very least, bothersome – farmers and
consumers are vastly underrepresented by the organization that President
Abraham Lincoln established in 1862 to act as “the people’s department.”
American agriculture has been suffering for a long time now. With such
an infestation from within, it’s hard to look at its future as anything
but bleak.

To read the full report, visit www.competitivemarkets.com.

July 16, 2004

OCM’s 2004 Food and Agriculture Conference: Has USDA Been Hijacked by
Industry?


http://www.competitivemarkets.com/news_and_events/press_releases/2004/7-16-04OCMconf.htm

Dockets Entered On June 09, 2003


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 1
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm#2003d0186

-------- Original Message --------
Subject: DOCKET-- 03D-0186 -- FDA Issues Draft Guidance on Use of
Material From Deer and Elk in Animal Feed; Availability
Date: Fri, 16 May 2003 11:47:37 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov


Greetings FDA,

i would kindly like to comment on;

Docket 03D-0186

FDA Issues Draft Guidance on Use of Material From Deer and Elk in Animal
Feed; Availability

Several factors on this apparent voluntary proposal disturbs me greatly,
please allow me to point them out;

1. MY first point is the failure of the partial ruminant-to-ruminant feed
ban of 8/4/97. this partial and voluntary feed ban of some ruminant
materials being fed back to cattle is terribly flawed. without the
_total_ and _mandatory_ ban of all ruminant materials being fed
back to ruminants including cattle, sheep, goat, deer, elk and mink,
chickens, fish (all farmed animals for human/animal consumption),
this half ass measure will fail terribly, as in the past decades...

2. WHAT about sub-clinical TSE in deer and elk? with the recent
findings of deer fawns being infected with CWD, how many could
possibly be sub-clinically infected. until we have a rapid TSE test to
assure us that all deer/elk are free of disease (clinical and sub-clinical),
we must ban not only documented CWD infected deer/elk, but healthy
ones as well. it this is not done, they system will fail...

3. WE must ban not only CNS (SRMs specified risk materials),
but ALL tissues. recent new and old findings support infectivity
in the rump or ass muscle. wether it be low or high, accumulation
will play a crucial role in TSEs.

4. THERE are and have been for some time many TSEs in the
USA. TME in mink, Scrapie in Sheep and Goats, and unidentified
TSE in USA cattle. all this has been proven, but the TSE in USA
cattle has been totally ignored for decades. i will document this
data below in my references.

5. UNTIL we ban all ruminant by-products from being fed back
to ALL ruminants, until we rapid TSE test (not only deer/elk) but
cattle in sufficient numbers to find (1 million rapid TSE test in
USA cattle annually for 5 years), any partial measures such as the
ones proposed while ignoring sub-clinical TSEs and not rapid TSE
testing cattle, not closing down feed mills that continue to violate the
FDA's BSE feed regulation (21 CFR 589.2000) and not making
freely available those violations, will only continue to spread these
TSE mad cow agents in the USA. I am curious what we will
call a phenotype in a species that is mixed with who knows
how many strains of scrapie, who knows what strain or how many
strains of TSE in USA cattle, and the CWD in deer and elk (no
telling how many strains there), but all of this has been rendered
for animal feeds in the USA for decades. it will get interesting once
someone starts looking in all species, including humans here in the
USA, but this has yet to happen...

6. IT is paramount that CJD be made reportable in every state
(especially ''sporadic'' cjd), and that a CJD Questionnaire must
be issued to every family of a victim of TSE. only checking death
certificates will not be sufficient. this has been proven as well
(see below HISTORY OF CJD -- CJD QUESTIONNAIRE)

7. WE must learn from our past mistakes, not continue to make
the same mistakes...

REFERENCES

snip...END

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm#2003d0186

From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10
Accepted - Volume 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2

http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


TSS

######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########






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