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From: TSS ()
Subject: USDA Summary of Epidemiological Findings of North American BSE Positive Cattle
Date: May 2, 2005 at 7:37 pm PST

-------- Original Message --------
Subject: USDA Summary of Epidemiological Findings of North American BSE Positive Cattle
Date: Mon, 02 May 2005 21:43:55 -0500
From: "Terry S. Singeltary Sr."
To: BSE-L , paffairs@oig.hhs.gov, HHSTips@oig.hhs.gov, contactOIG@hhsc.state.tx.us


1 Executive Summary

On January 24, 2005 four USDA, Animal and Plant Health Inspection
Service (APHIS) epidemiologists traveled to Canada to thoroughly review
the Canadian epidemiological investigations of the four confirmed cases
of bovine spongiform encephalopathy (BSE) in North America. The team
evaluated the possibilities of any common links between these cases, and
also evaluated the likelihood of higher risk animals or feed exposure to
the United States.

The investigation team did not conclusively identify a point source of
potentially contaminated feed common to all four BSE cases. However,
there are feed exposure links between 3 of the cases, an association
that is difficult to dismiss. The team concluded that all four cases
appear to have resulted from the consumption of feed contaminated with
infected bovine tissues during the early part of the animals life (when
they are most susceptible) and either prior to or soon after
implementation of the Canadian feed ban. The information available
strongly suggests a localized exposure of BSE, based on the relatively
small geographical location, the temporal association, and the
clustering of all four cases.

The team evaluated whether higher risk animals may currently be present
in the United States. In the epidemiological investigations of all
cases, cattle of concern were those identified within the 4 birth
cohorts: animals born within one year before or after each case. Of the
859 potential cattle of concern initially identified, six cattle were
eliminated as part of the birth cohort, 11 are considered untraceable,
four are still alive in Canada and under observation by the Canadian
Food Inspection Agency (CFIA), 809 are either dead or slaughtered, and
29 are believed to have entered the United States. Of the 29 believed to
have entered the United States, 18 (62 percent) were definitively
identified and either depopulated or confirmed slaughtered.

Approximately 40,000 breeding cattle came into the United States from
the Alberta region between 1994 and 1998, with about 18,000 of those
entering during 1997 to 1998. These cattle could represent another group
of higher risk animals, as profiled by CFIA. Normal aging and attrition
would be expected to have removed the majority of these cattle from the
population. An age distribution model for United States cattle indicates
that less than three percent of these animals would be expected to
remain in the United States herd at this time.

The investigation team documented the importation of suspect
ruminant-origin meat and bone meal from a local renderer in Alberta,
Canada into the Pacific Northwest of the United States in early 1997. An
investigation with the importer determined that none of this product was
manufactured into ruminant feed. A vast majority of the product was
exported directly to Asia, and any remaining product was incorporated
into poultry feed.

Some of the data suggest that the Northwest region of the United States
could be considered within a broadly defined movement area that could be
at higher risk of exposure to BSE. While this region has historically
imported a substantial number of cattle from western Canada, and a small
portion of high-risk meat and bone meal was shipped to the area, the
U.S. feed ban and other mitigations have effectively minimized the risk
of transmission or amplification of the BSE agent.


2 Introduction

Bovine spongiform encephalopathy is an incurable, invariably fatal
degenerative neurological condition of cattle that was first diagnosed
in the United Kingdom (UK) in 1986. Since that initial diagnosis, BSE
has been identified in 20 other European countries and in non-European
countries such as Japan, Israel, Canada, and in the United States from
an imported cow. Clinical signs of BSE may initially be subtle and
confined to behavioral manifestations such as nervousness or aggression.
As the disease progresses, other signs may include head rubbing, ataxia,
weight loss, falling, decreased milk production, and muscle fasciculation.

BSE belongs to a group of diseases called transmissible spongiform
encephalopathies (TSE) that include such agents as scrapie in sheep,
chronic wasting disease (CWD) of cervids, and Creutzfeldt-Jakob disease
(CJD) in humans. Although the causative agent of BSE has not been fully
characterized, the protein-only or prion theory has dominated the
scientific literature. The current theory is that TSEs develop when
prion proteins, found on the surface of nerve cells in the brain, change
into an abnormal shape and accumulate within the nerve cells. This
abnormal prion then induces normal prions to change to the aberrant form
and further replicate, thereby behaving as an infectious agent.

BSE is believed to be primarily acquired via the oral route when cattle
consume feed that contains the abnormal protein (prion). Animal feed
becomes contaminated when BSE-infected animals are rendered into a
protein source that is subsequently incorporated into the manufacturing
of ruminant feed and fed back to cattle. Tissues of greatest risk of
containing the BSE agent include the brain, spinal cord, eyes, dorsal
root ganglion, other neurological tissue, and the distal ileum. The oral
infectious dose can be very small  in cattle, the ingestion of only 10
milligrams of infected brain material may cause BSE. In addition, one
study reported that the possibility of maternal transmission of the
agent to calves born to infected dams during the later stage of disease
cannot be ruled out. The incubation period of BSE has a wide range in
cattle, two to eight years, with an average of five to six years, and is
inversely proportional to the infectious dose.

BSE is diagnosed by the histopathological review of brainstem (the obex)
and by immunohistochemistry to detect the abnormal prion protein; there
is no ante mortem diagnostic testing available. In addition, there is no
effective treatment for BSE. Prevention of the disease is based on
prohibiting the consumption of the infectious agent by susceptible cattle.

One of the concerns of BSE infection in cattle is its zoonotic
potential. A novel variant of CJD (called vCJD), initially reported in
the UK in 1996, has been associated with the consumption of BSE-infected
tissue. Activities to address and prevent BSE infection in cattle have
been a direct response to protect public health.

On May 20, 2003, Canada reported its first indigenous case of BSE.
Following receipt of this notification, the United States Department of
Agriculture (USDA) immediately prohibited the importation of all live
ruminants, ruminant meat, ruminant meat products, and other ruminant
protein products from Canada. In November 2003, USDA published a
proposed rule that would allow importation of certain ruminant products
from minimal risk regions under specified conditions. This rule proposed
to list Canada as a BSE minimal risk region.

On December 29, 2004, USDA announced a final rule that established
conditions under which the United States will allow imports of certain
live ruminants and ruminant products from regions with effective BSE
prevention and detection measures. Canada was the first country
recognized as a minimal-risk region; therefore, it was to be eligible to
export certain live ruminants and ruminant products to the United States
beginning March 7, 2005. On March 2, a Montana District Court ruled to
temporarily enjoin implementation of the rule.

Canada subsequently reported two additional cases of BSE on January 2
and 11, 2005. USDA, in cooperation with the CFIA, sent two technical
teams to Canada in January 2005 to thoroughly evaluate the epidemiology
of the four North American BSE cases and Canadas ruminant-to-ruminant
feed ban program.

2.1 Objectives of mission
Four USDA, Animal and Plant Health Inspection Service (APHIS)
epidemiologists traveled to the CFIA headquarters office in Ottawa
during January 24 to 28, 2005. The objectives were three-fold: 1) to
thoroughly review the Canadian epidemiological investigations of the
four confirmed cases of BSE in Alberta and evaluate the possibility of a
point source exposure involving contaminated feed to explain them; 2) to
evaluate the likelihood that other related high risk cattle (if any)
from Canada are currently present in the United States; and 3) to
evaluate any feed issues that may have resulted in a possible exposure
to United States cattle. To accomplish these objectives, the
epidemiology team met with CFIA officials to obtain detailed information
on the various aspects of the investigations. This report will detail
the findings of the epidemiological review.

snip...

The source of rendered product must be described in an import permit
application. Canada imported MBM for the manufacture of livestock feeds
primarily from the United States during the time period 1988 to 2001.
Australia and New Zealand also provided some MBM to Canada but in much
smaller quantities. The sole source of imported MBM was from the United
States in 1988 to 1993 and in 2001. Australia or New Zealand or both
countries contributed product in 1994 to 2000. Denmark and Germany were
minor sources of non-ruminant MBM in 1997; however, both countries
provided product for aquaculture use only.

snip...

3.2.6 Feed Investigation
The CFIA staff determined that only three commercial sources of protein
were available to dairy cattle on the birth herd premises: 26 percent
Calf Starter, a 20 percent Protein Supplement block, and a 15 percent
Dairy Ration.

In general, calf starters do not intentionally contain any MBM and
therefore it is unlikely that this product was contaminated with
infected bovine tissue. However, the manufacturer of the calf starter
did handle MBM and products containing MBM from Renderer A at the same
time they manufactured the calf starter. The last documented purchase of
this product by the birth herd producer was December 20, 1996; the
producer indicated that the consumption of this product would have
occurred prior to the birth of the index case in early April 1997.

The 20 percent Protein Supplement block manufacturing process was also
reviewed by CFIA investigators. According to records of the
manufacturer, the last documented purchases of this product by the
producer were March 4, 1997 and March 13, 2001. The source of MBM for
this product is unknown since production records and formulation records
were unavailable in 2001 for products retailed in 1997. The producer
mentioned that one tub (block) would have been placed in the dry cow pen
in March 1997 and would have been consumed prior to the addition of the
index cow into that pen (mid-May 1997).

The producer reported that a 15 percent Dairy Ration was the sole
commercial source of protein for lactating cattle on his premises.
Renderer A supplied the MBM to a feed mill in Edmonton for the
manufacture of 32 percent Equalizer Pellets. Records indicate that the
equalizer supplement pellets would have been made with MBM prior to July
11, 1997 and without MBM after July 18, 1997. The pellets were then
shipped to a feed manufacturer for incorporation into a 15 percent Dairy
Ration. The Dairy Ration was purchased by the producer of the birth
cohort premises at regular intervals every seven to 14 days; therefore,
the index case had potential to be exposed to this ration post-weaning
in late April 1997.

3.2.7 Rendered material follow up
The Food and Drug Administration (FDA) is the agency responsible for
tracing rendered animal material. Over 2,000 tons of MBM and other
by-products that could have been derived from the carcass of the
infected animal were located and contained; none entered the animal feed
manufacturing process.

snip...

4 General Summary of Canadas response to BSE

4.1 Importation
There were 182 cattle imported into Canada from the UK between 1982 and
1990, at which point Canada banned all further cattle imports from the
UK. At that time, the importation ban was the primary control measure
initiated by CFIA to prevent the introduction of BSE into Canada.
Following the detection of BSE in a UK-born Canadian cow in 1993, all
remaining UK imports were traced. Those that were found alive were
slaughtered and incinerated or returned to the country of origin. Of
those that were not found alive, it was determined that 68 had
potentially gone into the rendering stream after being slaughtered (59)
or dying on farm (nine).

Additionally, 405 cattle were imported from mainland European countries
between 1979 and 1985 that were not known to contain BSE at the time but
in which it was subsequently detected. According to the OIE Code, CFIA
considered these imports to be of negligible risk.

Meat and bone meal of ruminant origin for livestock feed has not been
imported from the UK or any other country subsequently affected by BSE
since 1978. All MBM for livestock feed has come from Australia, New
Zealand, or the United States since that time; the vast majority has
been from the United States.

In 1991 the importation of beef products from European countries not
free of BSE was banned, and in 1994 a ban was imposed on the importation
of live cattle from countries where BSE had been diagnosed in native cattle.

In late 1996, an evaluation process was implemented that required
exporting countries to be recognized as BSE-free by Canada (using OIE
standards) in order to send live cattle to Canada. In late 1998, this
policy was amended to include live sheep and goats. Additionally, bovine
embryos were allowed to be imported from BSE-infected countries (other
than the UK) with restrictions; bovine specified risk materials,
livestock feeds containing mammalian protein, pet food, and
mechanically-separated meat were not allowed from BSE-infected
countries; bovine-origin meat, cell lines, and veterinary biologics were
allowed with conditions; and sheep and goat embryos were banned from
countries not recognized as free from BSE.

In 2000 the import ban was extended to include all animal protein
products, including blood meal and feather meal, from any species from
any country that Canada does not recognize as free of BSE.

snip...

5.2 Risk profile of a BSE case
The Canadian investigation of the recent four BSE cases defined several
risk factors for an animal likely to have BSE.

1) Importation from the United Kingdom.
The 182 animals imported to Canada prior to the import controls of the
early 1990s were traced in 1993. Many of this cohort had died or been
slaughtered and the remainder were destroyed upon tracing. The BSE
status of the origin herds was determined through UK records and risk
was assigned to the animals based on origin as well as age and
demographic factors. The final assessment indicated that 52 animals (the
largest group among the UK imports), including three of the highest risk
cattle, were shipped to Alberta. One of the highest risk Alberta trace
cattle tested positive for BSE in 1993 while the other two had already
died and potentially entered the feed supply. The UK birth herd of the
1993 Alberta case was found to have had two additional BSE positive
animals. The localization of the UK animals was considered to be a risk
factor for the local area around the rendering plants where they were
processed.

2) Purebred and dairy animals.
Livestock feeding practices in western Canada, before the feed ban, were
far more likely to provide MBM containing supplements to purebred and
dairy calves in the form of creep feed and other supplements. Range
calves on the other hand were generally grade animals and not provided
the more expensive feed products. This risk factor was further verified
by the four current cases which were identified as being purebred or
dairy animals.

3) Age and geographic area.
The CFIA predicted that their first case was representative of an
epidemic already in decline based on the time line of UK cases after
implementation of their feed ban. The CFIA further predicted that
additional cases would most likely occur in approximately the same
location and age group which proved to be the scenario that is unfolding.

4) Expression of clinical signs.
The Canadian surveillance targeted higher risk animals based on factors
such as central nervous system signs, downers, dead on farm, and so
forth in a similar manner to the United States.

snip...

6.2 Origin Assessments
· Of the 68 UK imported cattle that were potentially rendered (details
on page 13), the majority (58 or 85.3 percent) came from farms in the UK
that have never recorded a case of BSE, and 10 were sourced from farms
that had had at least one case of BSE diagnosed in cattle born on the
farm. Of those 10, two originated from an infected birth cohort; these
cattle were herdmates of the imported cow that was diagnosed with BSE in
Canada in 1993. Both of these animals were slaughtered prior to the
diagnosis of the imported case.
· The farm of origin was not identified for one animal and therefore its
status is unknown, but is assumed for the purposes of this report to
have been infected with BSE.
· The status of the farms of origin for the 70 cattle imported from the
UK and Ireland prior to 1982 (1979 to 1981) was not determined because
the animals were not considered a BSE risk at the time.

6.3 Rendering
It has been reported that in Alberta, prior to 2003, virtually all
ruminant-derived MBM had been processed in a low temperature or vacuum
rendering system. Such a system would potentially enhance the risk of
BSE amplification as it does not inactivate the infectious agent.

6.4 Feed ban implementation and implications of feeding practices
· A mammalian-to-ruminant feed ban (with the exception of pure porcine
and equine meal; and milk, blood, gelatin, and rendered animal fat from
all species) was introduced in 1997. Prior to this ban, rendering and
feeding practices would have allowed BSE to cycle through cattle.
· The feed ban would have resulted in a dramatic reduction in exposure,
significantly reducing further spread and amplification of the BSE
agent. Given the impact of the feed ban, its effective implementation,
likely age of infection, and the incubation period of BSE, the number of
BSE cases would be expected to peak approximately six years later, which
would be in 2003.
· The potential number of BSE cases remaining in the cattle population
in 2003 would be extremely small as only a few animals are likely to
have become infected prior to the feed ban and the majority of these
would have already been culled, slaughtered or died.

snip...

7.2 Investigation into other cattle of concern
As part of the Canadian investigations of these four cattle of Canadian
origin, 851 animals were initially identified as known or possible birth
cohorts (animals born within one year before or after each case). These
cattle were the animals that would be expected to have been exposed at a
young age to the source of infection for the index cases (247 for case
#1, 114 for case #2, 141 for case #3, and 349 for case #4).
Additionally, eight animals were identified as progeny born within two
years of the death of the case (a minor but potential route of infection
of BSE). Of these 859 total animals, six were eliminated as part of the
birth cohort; eight progeny were either dead or euthanized; 11 animals
were considered untraceable; four animals are still alive and under
observation by CFIA; 801 are confirmed dead or slaughtered; and 29 were
believed to have entered the United States. Of the cattle that entered
the United States, 18 (62.1 percent) were definitively identified and
either depopulated or confirmed slaughtered.

Based on the temporal and geographic distribution of the birth herds of
the recent BSE cases of Canadian origin, plus risk factors identified by
Canada, the highest risk category of animals within the United States
due to this occurrence would include, but not be limited to, purebred
cattle born between 1996 and 1998 (currently between six and nine years
of age, approximately) from the Provinces of either Alberta or Saskatchewan.

Although the exact number of animals meeting the risk factors described
above is unavailable, initial estimates from the APHIS-VS Import
Tracking System (ITS) suggest that roughly 40,000 breeding cattle came
into the United States from the Alberta region between 1994 and 1998 and
approximately 18,000 of those during 1997 to 1998. These imports could
generally represent the high risk animals that the Canadians have
profiled. Normal aging and attrition would be expected to have removed
the majority of these cattle from the population. Based on an age
distribution model for United States cattle, less than three percent
would be expected to remain in the United States herd at this time
[(0.03)(40,000) = 1,200 alive from 1994 to 1998 and (0.03)(18,000) = 540
alive from 1997 to 1998].

The initial destination in the United States of the breeding cattle can
be determined from the ITS; however, many of the animals were shipped to
dealers that re-shipped them to other addresses. If an assumption can be
made that most cattle remained near the initial destination, the data
could support CFIAs hypothesis that Canadas western movement area
includes the northwestern region of the United States, particularly
Washington, Idaho, and Montana.

snip...

7.3 Feed evaluation
The expense of moving MBM, a bulky, low-cost product, tends to localize
its distribution. In addition, financial factors may determine movement
of product. Based on the value of the Canadian dollar versus the United
States dollar, the exportation of feed from Canada to the United States
would be minimal when the value of feed and MBM was higher in Canada
than in the United States. During the time period 1994 to 2001, the
value of a ton of MBM in Canada ranged from $267.7 to $431.25 CDN while
the cost for the same amount of product in the United States ranged from
$140 to $270 per ton. Therefore, due to the large cost differential, MBM
would have been more likely imported into Canada from the United States
than exported from Canada.

Renderer A, the renderer associated with three of the four cases,
distributed MBM product primarily to feed mills and farms within its
local distribution area. However, two feed mills located outside of this
local distribution area also received MBM from Renderer A during the
same time period that the index cases were believed to have been exposed
(i.e., 1996 to 1997). One mill was located in British Columbia near the
United States border and the other was located in the United States
Pacific Northwest.

A search of the Plant Protection & Quarantine (PPQ) Automated Targeting
System for the years 1996 and 1997 indicated that seven shipments of MBM
from Renderer A entered the United States. Five separate shipments of
MBM, totalling 742,096 kg, were delivered to one distributor between
April and August 1996. This same system also documented the importation
of two additional shipments of MBM, totalling 153,035 kg, to the same
distributor in February and March 1997.

Although the 1996 shipments have not been traced further, tracing of the
material shipped in early 1997, the time period most closely related to
potential feed exposures for three of the four BSE cases, revealed that
the distributor directly exported protein commodities to Asia or
supplied product for local incorporation into poultry meal. In 1999, the
company expanded to include a pet food manufacturing company as a source
of product. This distributor has not produced any product intended for
cattle consumption.

Additional follow up with this distributor in early 2005, indicated that
in 1997 almost all (99 percent) MBM product went to the export market,
especially if it came through a Washington State port by rail. Only 1
percent of product was used to provide poultry producers in the Pacific
Northwest States. Therefore, it is extremely unlikely that any MBM
imported from Renderer A to this United States distributor in early 1997
was incorporated into feed intended for cattle in the United States.


04/29/05 USDA Summary of Epidemiological Findings of North American BSE
Positive Cattle


http://www.aphis.usda.gov/lpa/issues/bse/bse_epi_report_4-29-05.doc

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of Canada
Last updated: 08 September 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)
* 165 kB Report


EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of
Canada.
http://www.efsa.eu.int
1 of 6
Scientific Report of the European Food Safety Authority
on the Assessment of the Geographical BSE-Risk (GBR) of
CANADA
Question N° EFSA-Q-2003-083
Adopted July 2004
Summary
The European Food Safety Authority and its Scientific Expert Working
Group on the
Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE)
Risk (GBR)
were asked by the European Commission (EC), to provide an up-to-date
scientific report on
the GBR in Canada, i.e. the likelihood of the presence of one or more
cattle being infected
with BSE, pre-clinically as well as clinically, in Canada. This
scientific report addresses the
GBR of Canada as assessed in 2004 based on data covering the period
1980-2003.
The BSE agent was probably imported into the country middle of the
eighties and could have
reached domestic cattle in the early nineties. These cattle imported in
the mid eighties could
have been rendered in the late eighties and therefore led to an internal
challenge in the early
90s. It is possible that imported meat and bone meal (MBM) into Canada
reached domestic
cattle and led to an internal challenge in the early 90s.
A certain risk that BSE-infected cattle entered processing in Canada,
and were at least partly
rendered for feed, occurred in the early 1990s when cattle imported from
UK in the mid 80s
could have been slaughtered. This risk continued to exist, and grew
significantly in the mid
90s when domestic cattle, infected by imported MBM, reached processing.
Given the low
stability of the system, the risk increased over the years with
continued imports of cattle and
MBM from BSE risk countries.
EFSA concludes that the current GBR level of Canada is III, i.e. it is
confirmed at a lower
level that domestic cattle are (clinically or pre-clinically) infected
with the BSE-agent. As
long as the system remains unstable, it is expected that the GBR
continues to grow, even if no
additional external challenges occur.
Key words: BSE, geographical risk assessment, GBR, Canada, third countries
EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of
Canada.
http://www.efsa.eu.int
2 of 6
Background
History
In 1998, the EC asked the Scientific Steering Committee (SSC) to perform
a risk assessment
in order to establish the GBR of a country. In July 2000 the SSC adopted
its final opinion on
"The Geographical Risk of Bovine Spongiform Encephalopathy (GBR)" (as
updated in
January 2002). It describes a method and a process for the assessment of
the GBR and
summarises the outcome of its application. Detailed reports on the
GBR-assessments were
published on the Internet for each of these countries.
Determination of BSE status
In 2001, Regulation (EC) No 999/20011 established the rules for the
determination of BSE
status of a country. It determines certain measures concerning the
control of BSE and
concerning trade and importation of certain live animals and animal
products.
Annex II of this Regulation lays down the method for the determination
of BSE status. This
includes two steps: an initial risk assessment, and the evaluation of
additional criteria. The
method is similar to that laid down in the International Animal Health
Code of the
International Animal Health Organisation (OIE). The categorisation of
countries has been
deferred until July 2005 awaiting a review of the OIE categorisation
system. In the meantime
a number of transitional measures are in place, in particular concerning
specified risk material
and import conditions.
State of play
The Scientific Steering Committee issued an opinion on GBR (using the
methodology
established by the SSC in June 2000 and updated January 2002) for one
third of the countries
requesting the determination of their BSE status.
Prioritisation
The first priority is the re-assessment of GBR I countries, as currently
no TSE related import
restrictions (certification of absence of specific risk material (SRM))
apply to GBR I
countries. If the preliminary re-assessment indicates that the current
GBR I will not be
confirmed, any delay might have negative consequences on consumer health
protection.
Furthermore, the GBR assessment of neighbouring countries with intensive
trade contacts
should be dealt with at the same time, because the outcomes are
interdependent.
The major trading partners with a GBR II classification should be dealt
with as second
priority, in view of the SSC opinion on tallow derivatives and the draft
guidance note of
EMEA.
Terms of reference
In view of the above, the European Commission asks EFSA to advice on the
risk assessment
for the appearance of BSE in Canada.
1 Regulation (EC) No 999/2001 of the European Parliament and of the
Council laying down rules for the
prevention, control and eradication of certain transmissible spongiform
encephalopathies OJ L 147, 31.5.2001
and updates.
EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of
Canada.
http://www.efsa.eu.int
3 of 6
Assessment
EFSA refers to the Working Group Report (annex) prepared by the EFSA
Scientific Expert
Working Group on GBR for full details on the assessment.
External Challenge
Canada was exposed to a low external challenge for the period 1980-1990,
a high external
challenge for the period 1991-1995, an extremely high external challenge
for period 1996-
2000 and a very high external challenge for period 2001-2003.
Stability
For the overall assessment of the stability, the impact of the three
main stability factors, (i.e.
feeding, rendering and SRM-removal) and of the additional stability
factor surveillance has
to be estimated. On the basis of the available information it was
concluded that Canadas
BSE/cattle system was extremely unstable until today. This indicates
that BSE infectivity,
if imported, could have reached domestic cattle and probably would have
been recycled and
amplified.
Feeding
Until 1997, it was legally possible to feed ruminant Meat and Bone Meal
(MBM) to cattle and
a certain fraction of cattle feed (for calves and dairy cattle) is
assumed to have contained
MBM. Therefore feeding was Not OK. In August 1997 a ruminant MBM ban was
introduced but feeding of non-ruminant MBM to cattle remained legal as
well as feeding of
ruminant MBM to non-ruminant animals. This makes control of the feed ban
very difficult
because laboratory differentiation between ruminant and non ruminant MBM
is difficult if not
impossible. Due to the highly specialized production system in Canada,
various mammalian
MBM streams can be separated. Such a feed ban would therefore be
assessed as "reasonably
OK", for all regions where this highly specialized system exists.
However, several areas in
Canada do have mixed farming and mixed feed mills, and in such regions,
an RMBM ban
would not suffice. Additionally, official controls for cattle feeds to
control for the compliance
with the ban were not started until the end of 2003. Thus, for the whole
country, the
assessment of the feeding after 1997 remains "Not OK".
Rendering
The rendering industry is operating with processes that are not known to
reduce infectivity. It
is therefore concluded that the rendering was and is Not OK.
SRM-removal
SRM and fallen stock were and are rendered for feed. Therefore
SRM-removal is assessed as
Not OK.
BSE surveillance
Before 1989, the ability of the system to identify (and eliminate)
BSE-cases was limited.
Since 1990 this ability is improved, thanks to a specific (passive) BSE
surveillance. Today the
surveillance should be able to detect clinical BSE-cases within the
limits set by an essentially
passive surveillance system.
EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of
Canada.
http://www.efsa.eu.int
4 of 6
" Passive surveillance has been carried out since 1990. In 1993
surveillance was intensified
and has considerably improved with mandatory reporting and basic
compensation
ensured, awareness raising measures and education of veterinarians, and
a specific BSEsurveillance
program targeting cattle showing clinical signs that could be compatible
with
BSE.
" The initiated introduction of active surveillance should improve the
system significantly.
Conclusions
The European Food Safety Authority concludes:
1. A certain risk that BSE-infected cattle entered processing in Canada,
and were at least
partly rendered for feed, occurred in the early 1990s when cattle
imported from UK in
the mid 80s could have been slaughtered. This risk continued to exist,
and grew
significantly in the mid 90s when domestic cattle, infected by imported
MBM,
reached processing. Given the low stability of the system, the risk
increased over the
years with continued imports of cattle and MBM from BSE risk countries.
2. A risk that BSE-infectivity was recycled and propagated exists since
a processing risk
first appeared; i.e. in the early 90s. Until today, this risk persists
and increases fast
because of the extremely unstable BSE/cattle system in Canada.
3. The current geographical BSE-risk (GBR) level is III, i.e. it is
confirmed at a lower
level that domestic cattle are (clinically or pre-clinically) infected
with the BSE-agent.
4. This assessment deviates from the previous assessment (SSC opinion,
2000) because
at that time several exporting countries were not considered a potential
risk.
5. EFSA and its Scientific Expert Working group on GBR are concerned
that the
available information was not confirmed by inspection missions as
performed by the
Food and Veterinary office (FVO  DG SANCO) in Member States and other third
countries. They recommend including, as far as feasible, BSE-related
aspects in
future inspection missions.
Expected development of the GBR
As long as the system remains unstable, it is expected that the GBR
continues to grow,
even if no additional external challenges occur.
A table summarising the reasons for the current assessment is given below.
Documentation provided to EFSA
" Letter with the ref D(2003)KVD/ip/420722 from the European Commission
requesting a geographical risk assessment for the appearance of BSE in a
country.
" Country Dossier as prepared by the country in response to the EC and EFSA
data collection request.
EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of
Canada.
http://www.efsa.eu.int
5 of 6
" Other sources of data information i.e. exports from third countries
and Eurostat
data.
" SSC, July 2000. Final opinion on the Geographical Risk of Bovine
Spongiform Encephalopathy (GBR).
" SSC, January 2002. Updated opinion on the Geographical Risk of Bovine
Spongiform Encephalopathy (GBR).
Acknowledgment
Members of the EFSA Scientific Expert Working Group on GBR are
acknowledged for their
valuable contribution to this mandate. The members are: Didier Calavas,
Aline De Koeijer,
Michael Gravenor, John Griffin, Dagmar Heim, Matthias Kramer, Riitta
Maijala, Mo Salman,
Vittorio Silano, Emmanuel Vanopdenbosch, and Stig Widell.
Annex
Details of the assessment are presented in the report as prepared by the
EFSA GBR Expert
Working Group:
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563_en.html
EFSA Scientific Report (2004) 2, 1-6 on the Assessment of the
Geographical BSE Risk of Canada.
http://www.efsa.eu.int
6 of 6
Canada, Summary of the GBR Assessment, July 2004 GBR Level : III**
EXTERNAL CHALLENGE STABILITY INTERACTION of EXTERNAL
CHALLENGE and STABILITY
1980-1990: Low
1991-1995: High
1996-2000: Extremely high
2001-2003: Very high
1980-2003: Extremely unstable
Live cattle imports MBM imports Feeding Rendering SRM-removal BSE
surveillance
Any external challenge would have met the
extremely unstable system and infectivity
would have been recycled.
INTERNAL CHALLENGE
An internal challenge was unlikely but not
excluded from 1980-1990, likely and rapidly
growing from 1991-2000 and confirmed at a
lower level from 2001-2003.
EXPECTED DEVELOPMENT OF THE
GBR
From UK:
231 (CD*)
or
698 (other sources of
data)
From other BSE risk
countries:
2.378.023 (CD)
or
1.500.325 (other
sources of data).
*CD: country dossier
From UK:
0 ton (CD)
or
149 tons (other
sources of data)
From other BSE risk
countries:
298.175 tons (CD)
357.383 tons (other
sources of data)
1980-2003:
Not OK.
Feeding of MBM
to ruminant legally
possible until 1997.
1980-2003:
Not OK.
Processes used are
not known to
reduce infectivity.
1980-2003:
Not OK.
No SRM ban.
SRM and fallen
stock rendered into
feed.
1980-2000: Mainly
passive.
2001-2003:
Improving with
some testing of risk
group.
As long as the system remains unstable, it
is expected that the GBR continues to
grow, even if no additional external
challenges occur.
** It is confirmed at a lower level that domestic cattle are (clinically
or pre-clinically) infected with the BSE-agent

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/564/sr02_biohaz02_canada_report_v2_en1.pdf


* 108 kB Summary


Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working
Group on the Assessment of the Geographical Bovine Spongiform
Encephalopathy (BSE) Risk (GBR) were asked to provide an up-to-date
scientific report on the GBR in Canada, i.e. the likelihood of the
presence of one or more cattle being infected with BSE, pre-clinically
as well as clinically, in Canada. This scientific report addresses the
GBR of Canada as assessed in 2004 based on data covering the period
1980-2003.

The BSE agent was probably imported into the country middle of the
eighties and could have reached domestic cattle in the early nineties.
These cattle imported in the mid eighties could have been rendered in
the late eighties and therefore led to an internal challenge in the
early 90s. It is possible that imported meat and bone meal (MBM) into
Canada reached domestic cattle and led to an internal challenge in the
early 90s.

A certain risk that BSE-infected cattle entered processing in Canada,
and were at least partly rendered for feed, occurred in the early 1990s
when cattle imported from UK in the mid 80s could have been slaughtered.
This risk continued to exist, and grew significantly in the mid 90s
when domestic cattle, infected by imported MBM, reached processing.
Given the low stability of the system, the risk increased over the years
with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of Canada is III, i.e. it is
confirmed at a lower level that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as the system
remains unstable, it is expected that the GBR continues to grow, even if
no additional external challenges occur.

Publication date: 20 August 2004

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/564_en.html

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Publication date: 20 August 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)

* 167 kB Report


* 105 kB Summary

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working
Group on the Assessment of the Geographical Bovine Spongiform
Encephalopathy (BSE) Risk (GBR) were asked by the European Commission
(EC) to provide an up-to-date scientific report on the GBR in the United
States of America, i.e. the likelihood of the presence of one or more
cattle being infected with BSE, pre-clinically as well as clinically, in
USA. This scientific report addresses the GBR of USA as assessed in 2004
based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached
domestic cattle in the middle of the eighties. These cattle imported in
the mid eighties could have been rendered in the late eighties and
therefore led to an internal challenge in the early nineties. It is
possible that imported meat and bone meal (MBM) into the USA reached
domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle
imports from BSE risk countries were slaughtered or died and were
processed (partly) into feed, together with some imports of MBM. This
risk continued to exist, and grew significantly in the mid 90s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is
likely but not confirmed that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as there are no
significant changes in rendering or feeding, the stability remains
extremely/very unstable. Thus, the probability of cattle to be
(pre-clinically or clinically) infected with the BSE-agent persistently
increases.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html


- 7 -
2.3 Overall assessment of the external challenge
The level of the external challenge that has to be met by the BSE/cattle
system is
estimated according to the guidance given by the SSC in its final
opinion on the GBR
of July 2000 (as updated in January 2002).
Live cattle imports:
In total the country imported 2038 (other sources) or 1128 (CD) live
cattle from BSE
risk countries other than Canada, of which 327 (other sources) or 323
(CD) came
from the UK. From Canada the imports were >500,000 animals per year. The
numbers shown in table 1 are the raw import figures and are not
reflecting the
adjusted imports for the assessment of the external challenge. Broken
down to 5 year
periods the resulting external challenge is as given in table 3. This
assessment takes
into account the different aspects discussed above that allow to assume
that certain
imported cattle did not enter the domestic BSE-cattle system, i.e. were
not rendered
into feed. In the case of the USA, all the animals for which tracing
information
showed that they were not rendered were excluded from the external
challenge.
MBM imports:
In total the country imported 689 tons MBM (CD) or 2,230 tons MBM (other
sources)
from BSE risk countries other than Canada, of which 5 tons (CD) or 101
tons (other
sources) were exported from the UK (UK export data). From Canada, the
imports
were about 30 000 tons per year. The numbers shown in table 2 are the
raw import
figures and are not reflecting the adjusted imports for the assessment
of the external
challenge. Broken down to 5 year periods the resulting external
challenge is as given
in table 3. This assessment takes into account the different aspects
discussed above
that allow to assume that certain imported MBM did not enter the domestic
BSE/cattle system or did not represent an external challenge for other
reasons. As it
was illegal to export mammalian MBM from UK since 27/03/1996, exports
indicated
after that date should only have included non-mammalian MBM. In the case
of the
USA imported MBM from UK in 1989 and between 1997 and 1999 was not taken
into account.

snip...

- 9 -
Control of Feed bans and cross-contamination
" Since 1997, feed mills that are allowed to use RMBM, and also produce
cattle
feed (without RMBM), are inspected annually, other may also be
inspected. Two
types of violations were registered. One type not involving RMBM, the others
involving this, this mainly concerns cross-contamination problems. These
firms
were re-inspected soon. In several cases, products were recalled, sales
were closed
and/or products were destroyed. Cattle feed is not sampled to test for
presence of
" According to information provided in 1999/2000 by the feed producers, the
compliance is assumed by the US authorities to be in the order of
magnitude of
70% to ?90% since 1998, and 30% to ?70% before. Official control data
concerning rendering and feed mill industries were provided and show
that action
at shortcomings in the production processes (a few percent of the firms)
have
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
become severe by the beginning of 2003. However, samples from ruminant feed
are not regularly tested for the inclusion of MMBM. Reports from the feed
industry in 2000 and 2001 indicate significant shortcomings in the
implementation
of the ban in that period. This does confirm the known difficulty of
implementing
and enforcing such a feed ban.
" No examinations are performed to assess cross-contamination with RMBM
of the
protein (e.g. through non ruminant MBM) that enters cattle feed.
Rendering
" The domestic MBM production averages 3 million metric tons per year.
" Almost 60% of the MBM produced originate from ruminants (cattle 59%, sheep
0.6%), 20% from pigs and 20% from poultry.
Rendering processes
SRM and fallen stock

snip...

SRM and fallen stock

- 10 -
An SRM-ban for human food has been introduced in 2004. There was however
never an SRM ban for the feed chain.
" SRM are rendered together with other slaughter by-products and, in case of
independent renderers, together with fallen stock.
" It is planned to remove SRM from all animal feed, including pet-food.
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
Conclusion on the ability to avoid recycling
" Before 1997, US system would not have been able to avoid recycling of
the BSEagent
to any measurable extent. If the BSE-agent was introduced into the feed
chain, it could have reached cattle.
" After the introduction of the 1997 ban in August 1997, the ability to
avoid
recycling of BSE-infectivity was somewhat improved. However, the
rendering of
ruminant material (including SRM and fallen stock) is inadequate (non
pressurized), and cross-contamination potentials of cattle feed with
other feeds
remain.
" Therefore, the system is still unable to avoid recycling of
BSE-infectivity if
already present in the system or incoming.
processed
of about 140 million.
Husbandry systems

snip...

- 12 -
3.3 Overall assessment of the stability
For the overall assessment of the stability, the impact of the three
main stability
factors, (i.e. feeding, rendering and SRM-removal) and of the additional
stability
factor surveillance has to be estimated. Again, the guidance provided by
the SSC in its
opinion on the GBR of July 2000 (as updated in 2002) is applied.
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
- 13 -
Feeding
Until August 1997, RMBM was legally fed to cattle. Feeding was therefore
"not
OK". In August 1997 an RMBM-ban was introduced but feeding of non-ruminant
MBM to cattle remained legal as well as feeding of RMBM to non-ruminant
animals
(farm animals and pets). An RMBM ban is difficult to maintain, as only
labels can
distinguish the various MMBMs. This makes control of the feed ban very
difficult
because analytical differentiation between ruminant and non-ruminant MBM is
difficult if not impossible.
Due to the highly specialised production system in the USA, various
mammalian
MBM streams can be separated. Such a feed ban would therefore be assessed as
"reasonably OK", for all regions where this highly specialised system
exists.
However, several areas in the USA do have mixed farming and mixed feed
mills, and
in such regions an RMBM ban would not suffice. Additionally, official
controls for
cattle feeds to control for compliance with the ban started in 2002.
Thus, for the
whole country, the assessment of the feeding after 1997 remains "not
OK", but
improving.
Rendering
The rendering industry is operating with processes that are not known to
reduce
infectivity. It is therefore concluded that rendering was and is "not OK".
SRM-removal
SRM were and are still rendered for feed, as are (parts of) the fallen
stock. SRMremoval
is therefore regarded as "not OK".
BSE-surveillance
Before 1989, the ability of the system to identify (and eliminate)
BSE-cases was
limited. Since 1990 this ability is improved, thanks to a specific
(passive) BSE
surveillance. The initiated introduction of active surveillance in risk
populations
should improve the system significantly.
Stability of the BSE/cattle system in the USA over time
Stability Reasons
Period Level Feeding Rendering SRM removal BSE
surveillance
1980 to
2003
Extremely
unstable Not OK Not OK Not OK
Passive but
improving
with some
testing of risk
groups
Table 4: Stability resulting from the interaction of the three main
stability factors and the BSE
surveillance. The stability level is determined according to the
SSC-opinion on the GBR of July
2000 (as updated in 2002).
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
- 14 -
On the basis of the available information, it has to be concluded that
the country's
BSE/cattle system was extremely unstable until today, i.e., it would
have recycled and
amplified BSE-infectivity very fast, should it have entered the system.
The stability of
the BSE/cattle system in the USA overtime is as given in table 4.
The present assessment modifies the stability assessment of the previous
GBR report
in 2000 mainly due to a different perception of the impact of BSE
surveillance on
stability and of the efficiency of the RMBM feed ban.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenges
In conclusion, the stability of the USA BSE/cattle system in the past
and the external
challenge the system has coped with, are summarised in table 5 below.
From the interaction of the two parameters stability and external
challenge a
conclusion is drawn on the level of internal challenge that emerged
and had to be
met by the system, in addition to external challenges that occurred.
Interaction of stability and external challenge in the USA
Period Stability External Challenge Internal challenge
1980 to
1985
1986 to
1990
Moderate Possibly present
1991 to
1995 Very high
1996 to
2000
2001 to
2003
Extremely
unstable
Extremely high
Likely to be present and
growing
Table 5: Internal challenge resulting from the interaction of the
external challenge and stability.
The internal challenge level is determined according to guidance given
in the SSC-opinion on
the GBR of July 2000 (as updated in 2002).
An external challenge resulting from cattle import could only lead to an
internal
challenge once imported infected cattle were rendered for feed and this
contaminated
feed reached domestic cattle. Cattle imported for slaughter would
normally be
slaughtered at an age too young to harbour plenty of BSE infectivity or
to show signs,
even if infected prior to import. Breeding cattle, however, would
normally live much
longer and only animals having problems would be slaughtered younger. If
being 4-6
years old when slaughtered, they could suffer from early signs of BSE, being
approaching the end of the BSE-incubation period. In that case, they
would harbour,
while being pre-clinical, as much infectivity as a clinical BSE case.
Hence cattle
imports could have led to an internal challenge about 3 years after the
import of
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
- 15 -
breeding cattle (that are normally imported at 20-24 months of age) that
could have
been infected prior to import.
In the case of the USA a few potentially infected cattle were imported
from the UK
and more from other BSE-risk countries. Furthermore, large numbers of
imported
animals came from Canada. This implies that cattle imported in the mid
eighties could
have been rendered in the late eighties and therefore led to an internal
challenge in the
early 90s.
On the other hand imports of contaminated MBM would lead to an internal
challenge
in the year of import, if fed to cattle. The feeding system is of utmost
importance in
this context. If it could be excluded that imported, potentially
contaminated feed stuffs
reached cattle, such imports might not lead to an internal challenge at all.
In case of the USA this implies that it was possible that imported MBM
reached
domestic cattle and lead to an internal challenge in the early 90s.
If Canadian imports would be excluded from this assessment, we find that
the USA
receives a moderate challenge for all 5-year intervals since 1980, a
high challenge
between 1985 and 2000 and a low challenge thereafter. If combining these
moderate
to high challenges due to imports with the extremely unstable system,
the conclusion
would still be that the occurrence of an internal challenge is possible
during the early
80s and likely in the late 80s.
4.2 Risk that BSE infectivity entered processing
A processing risk developed in the late 80s/early 90s when cattle
imports from BSE
risk countries were slaughtered or died and were processed (partly) into
feed, together
with some imports of MBM. This risk continued to exist, and grew
significantly in the
mid 90s when domestic cattle, infected by imported MBM, reached
processing. Given
the low stability of the system, the risk increased over the years with
continued
imports of cattle and MBM from BSE risk countries.
4.3 Risk that BSE infectivity was recycled and propagated
A risk that BSE-infectivity was recycled and propagated exists since a
processing risk
first appeared, i.e. in the early 90s. Until today this risk persists
and increases fast
because of the extremely/very unstable BSE/cattle system in the USA.
5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK
5.1 The current GBR as function of the past stability and challenge
" The current geographical BSE risk (GBR) level is III, i.e. it is
likely but not
confirmed that domestic cattle are (clinically or pre-clinically)
infected with the
BSE-agent.
Note1: It is also worth noting that the current GBR conclusions are not
dependent on
the large exchange of imports between USA and Canada. External challenge
due to
exports to the USA from European countries varied from moderate to high.
These
Annex to the EFSA Scientific Report (2004) 3, 1-17 on the Assessment of the
Geographical BSE Risk of USA
challenges indicate that it was likely that BSE infectivity was
introduced into the
North American continent.
Note2: This assessment deviates from the previous assessment (SSC
opinion, 2000)
because at that time several exporting countries were not considered a
potential risk.
5.2 The expected development of the GBR as a function of the past
and present stability and challenge
" As long as there are no significant changes in rendering or feeding,
the stability
remains extremely/very unstable. Thus, the probability of cattle to be
(preclinically
or clinically) infected with the BSE-agent persistently increases.
" Since recent improvements in the safety of MBM production in many
countries
or significant recent reductions in the incidence of BSE are not taken into
account for the assessment of the external challenge, the external challenge
assessed after 2001 could be overestimated and is the worst case assumption.
However all current GBR conclusions are not dependent on these assumptions
in any of the countries assessed. For future assessments and when the
impact of
the production, surveillance and true incidence changes have been fully
quantified, these developments should be taken into account.

snip...

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/574/sr03_biohaz02_usa_report_annex_en1.pdf


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

TSS



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