SEARCH VEGSOURCE:

 

 

Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.
  




From: TSS ()
Subject: Transcript of lies from Agriculture Secretary Mike Johanns To the National Restaurant Association et al on BSE - Washington, DC March 18, 2005
Date: March 20, 2005 at 12:22 pm PST

-------- Original Message --------
Subject: Transcript of lies from Agriculture Secretary Mike Johanns To the National Restaurant Association et al on BSE - Washington, DC March 18, 2005
Date: Sun, 20 Mar 2005 14:10:49 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE


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

Release No. 0099.05
Contact:
Office of Communications (202)720-4623

Transcript of remarks of Agriculture Secretary Mike Johanns To the
National Restaurant Association and National Food Processors Association
Food Safety Summit - Washington, DC

March 18, 2005

SEC. MIKE JOHANNS: "That was a great introduction. It's great to be here
with you today, ladies and gentlemen.

"Now it was mentioned that I grew up on a farm in Iowa. I guess there
are some Iowans here. Right?

[Applause.]

"Well, I've got an assignment for you. When you go back to Iowa I still
have a sister Pat who is farming back there? Tell her I found work in
Washington, all right?

[Laughter.]

"It was also a great opportunity for me to meet the commissioner as he
was leaving, and one of the things I said to him was, we look forward to
working together.

"Ladies and gentlemen, I appreciate this invitation because I had a
wonderful working relationship with the Nebraska restaurant industry
when I was governor of the state of Nebraska. And in fact they were very
early enthusiastic supporters of me, not only in my candidacy but during
the time I was governor. And I really, really enjoyed working with a
first-class industry there.

"I will also tell you that your previous head guy Herman Cain-- that
probably rings a bell in this room -- was also a personal friend of
mine. In fact, he was a keynote speaker at an annual restaurant event in
Nebraska, and he got up there and he said, ladies and gentlemen, you can
ask me never to come back again but I want you to know something-- I
support Mike Johanns for governor.

"And I always appreciated that from Herman. So it is good to be with you.

"I want to start out today and just say thank you. If I had no other
message today, I'd want to be able to express my appreciation. When I
would speak to your industry on an annual basis and I did, one of the
things I would do is I'd provide updated figures of the impact that the
industry has on the economy. And when I look across what your industry
does in our nation is job creation and economic development. It is
absolutely magnificent.

"So if I had no other message, you gave me one minute to be up here
today, I'd tell you how much I appreciate that all across your
communities you are creating good things.

"The other thing I wanted to say is, I know enough about this industry
to know that every time there is a fundraising effort, every time there
is a group of Boy Scouts or Girl Scouts or 4-H or FFA that get together
for a purpose, they are calling somebody in your industry to see if you
would make a contribution, either monetary or otherwise. And in my
experience, you always step up and that also is enormously appreciated.
It tells me volumes about the character of your industry. So thank you.

"I also want to say thanks to your commitment to safe food. Through the
years I've worked a lot with the industry. That includes safety issues
and again you were always there. I want you to know it's something that
you and I have in common. One of the things that excited me most when
President Bush asked me to join his team was this passion about the
issues that the USDA deals with each and every day. He of course
understands the importance of food safety to your businesses and to
American producers and the consumers.

"That's why I'm so humbled, and I am so proud to be able to speak here
on his behalf about the important issues that we face together --
underscore together -- in the next few months and the next few years.

"Well, promises. I need to start there. You have one promise today. My
door is always going to be open to you. I'll always listen, and I will
always respect your views because that's the way I do business. That's
how I believe that a servant should act treating those we serve with
respect and in a dignified manner and with equality.

"Ladies and gentlemen, the fact is food safety is one of the most
important examples I can offer of the importance of partnership. None of
us can do it alone because simply put the federal government can't take
on this task alone. Nowhere has the importance of this partnership been
more critical than our response relative to BSE.

"In Nebraska, after the first discovery in the United States, everyone
wondered what would happen. Would consumers be still safe? Would people
continue buying beef? Would exports be banned forever? Would the
industry be harmed or affected?

"Fortunately the USDA and its partners swung into action immediately
with many critical actions -- the ban of specified risk materials, ban
on downer cattle, increased surveillance. I'm happy to report to you
today after an enhanced surveillance of now nearly, the last year we've
tested about 275,000 cattle, and we haven't found another case. We began
the processing of a national animal identification system. We did
promotions and public information campaigns designed to get information
into hands of the public.

"And now in our country a year later, more than a year later, the market
for beef remains amazingly strong.

"There is a big reason for that. Americans rightly feel safe eating
beef. That confidence has helped sustain not just the industry but the
retail and the restaurant industries. Now we must do all we can to work
together to maintain, and I would suggest even increase, that confidence.

"So how do we go about doing that? First and foremost we need to base
the hard decisions on vigorous sound science. In a rapidly changing
world marketplace, science is truly a universal language that must guide
our rules and policies. We must not be guided by subjectivity or the
politics of a given moment.

"That's why I am proud to announce today that the USDA's Ag Research
Service is redirecting almost $2 million in funding for the BSE research
program. The funding will be used in a spectrum of important efforts.

"About $750,000 will go toward a new bio-containment facility now under
construction at the ARS, National Animal Disease Center in Ames, Iowa.
The funds will also fund collaborative projects with laboratories in
Great Britain and Italy and in Spain. This funding, I might say, by the
way comes on the heels of the President's 2006 budget proposal, which
would increase BSE research by $7.3 million. That's 155 percent over 2005.

"That scientific basis for understanding BSE is also critical in other
ongoing efforts to reopen markets to our American beef products and to
resume normalized trade with our trading partners. We have the framework
in place to get us there, and ladies and gentlemen we have the science
on our side.

"I said recently at an event that I spoke at that trade is not only a
two-way street these days; it is in fact a superhighway. But you know,
there's something about it that's pretty straightforward. We can't treat
Asia one way and our neighbors another way. We can't proclaim to the
world, ladies and gentlemen, 'Do as I say but not as I do.'

"The Canadian regulatory response to BSE has largely mirrored the U.S.
response over the years, not just recently. And measures such as the ban
on ruminant-to-ruminant feeding are substantially similar. I have the
utmost confidence in the safety of the beef supply.

"Without science governing international trade, borders can remain
closed arbitrarily. We know the effects of that. And any short-term
gains that may be realized could result in long-term damage to this
industry. The scientific approach we are taking with the Canadian
Minimal Risk Rule is no different than what we should expect from
markets for American beef around the world.

"But as you know, the rule has met resistance. Two weeks ago the Senate
voted, in a very close vote I might add, to disapprove the rule that
would have reopened the border. The House has not yet voted, and the
President has stepped up and promised to veto the disapproval resolution
were it ever to reach his desk.

"In the meantime however, a court injunction is still preventing us from
moving forward, an injunction that we announced yesterday will be appealed.

"The Minimal Risk Rule is based on sound science, and our highest
priority is and will always be protecting human health and animal health
and consumer confidence.

"A USDA team traveled to Canada after the latest BSE discoveries there
and confirmed that Canada is in compliance of its feed ban. Our decision
to open the border conforms to OIE international standards. But the
bottom line is this. We can't destroy trade and expect anything good to
come out of that.

"Trade based on sound science is good for American producers, consumers,
retailers, American food establishments, and it is good for our economy.
Of course BSE is only one of the issues that we are dealing with today.
As the world gets smaller the potential threats to our food supply do loom.

"And the tools we need to combat these risks must become ever more
sophisticated. Along those lines I would like to make yet another
announcement today. USDA is awarding $5 million to 17 institutions to
establish a new Food Safety Research and Response Network. This network
spearheaded by North Carolina State University will include a team of
more than 50 food safety experts from 18 colleges and universities who
will investigate several of the most common food-related pathogens. The
group also will serve to conduct focused research to control major
episodes of food-borne illnesses.

"These episodes are not restricted to accidental outbreaks. They could
include health problems associated with acts of bioterrorism and the
deliberate contamination of ag commodities.

"Our commitment to food safety is also reflected in our President's
budget. In addition to the BSE funds I already mentioned, the budget
includes nearly $600 million for the Food and Ag Defense Initiative, an
increase of $144 million over 2005.

"The Food and Ag Defense Initiative is a comprehensive approach to food
safety and the protection of our food supply. Let me identify for you
its goals: Enhancing, monitoring and surveillance of pest and diseases
in plants and animals; expanding research on emerging animal diseases;
increasing the availability of vaccines; establishing a system to track
select disease agents of plants; expanding the unified federal/state
diagnostic network to all 50 states; and the completion of the National
Centers for Animal Health in Ames, Iowa.

"Part of the initiative is the Food Emergency Response Network. We call
it FERN. Just last month we announced the next major step in the
development of FERN, a partnership, I might add, with the FDA, which
will further develop and enhance bioterrorism surveillance. And it will
establish an integrated laboratory system to monitor the food supply and
share data and assist in handling samples in the event that there would
be an emergency.

"We believe that our efforts are showing real results. Americans today
know that their food is safe, and we're making progress. We're making it
even safer for our future. Last month our Food Safety and Inspection
Service released data showing a 43 percent decrease in e-coli in ground
beef regulatory samples. This is in line with data released by the
Centers for Disease Control and Prevention last year showing a 36
percent reduction in e-coli illnesses in 2003.

"And a dramatic decrease in e-coli-related recalls has occurred. This is
something that we can all be very proud of.

"I want you to know that I am equally proud of the thousands of USDA
employees and inspection personnel across this country who are doing
everything they can to protect public health. They are reminders that
there is a concrete goal. It is not about how much we spend necessarily,
and it's not necessarily about how many programs we start. It's about
safe and secure food supply. It's about consumers who are supremely
confident in the food they buy in our grocery stores and order at our
restaurants.

"I never intend to lose sight of these goals and to every step that we
can prudently take to ensure that we continue our efforts to reach them.
My friends, we are truly in this together, and I will tell you I'm very
proud to stand beside you.

"Ensuring the safety of our food supply is very important to all of us
whether we are feeding ourselves or we are feeding our families. It is
important not just because it's good business. It is good business, an
important business. But it's also important because it's the right thing
to do, and we will do it together.

"Thank you very, very much."

[Applause.]


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/0/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F03%2F0099.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM


Release No. 0092.05
Contact:
Office of Communications (202)720-4623

Transcript of remarks by Agriculture Secretary Mike Johanns To the
Alabama Farmers Federation Washington, DC - March 16, 2005


snip...

"I can tell you that as of last week, that enhanced testing over the
last year we have tested about 263,000 animals. I will also tell you
that of the 263,000 animals that have been tested we have not found
another case of BSE. We have not found another case of BSE.

"I will also be very candid with you. That was a surprise to the USDA.
When the enhanced testing was started, there was a lot of public
discussion that it's possible we could find another case or more of a
BSE animal. But it hasn't occurred; we haven't found another animal.

"In addition as you know, we began the process of creating a national
identification system for animals. And that is going on in your state,
it's going on really across the United States. And the USDA has been a
partner in that effort, and we're going to continue to move that agenda.

"I just believe we're at a point in our nation's history where a
national identification is going to be part of what the customer wants.

"So now we're more than a year later after that one animal was found.
The market for American beef does remain strong. Why? Because Americans
rightfully feel that they are safe in eating American beef.

"My job is to do everything we can to help move us forward and to
maintain and to increase that confidence.

"Let there never be any doubt-- human health and animal safety will
always be the top priority with USDA. Just let there be no doubt about
that. But you know, ladies and gentlemen, in order for us to best
protect health and safety, in order for us to make sure that we have
access to other markets for our beef products, we have to base our
decisions upon sound science.

"In a rapidly changing world marketplace, and it seems like it changes
not by the day but by the hour, science is the universal language that
must guide our rules and our policies rather than the subjective
feelings of a given country or the politics of the given moment.

"I'll also share with you that our President has been a great partner in
this initiative. Much to my pleasure he included $7.3 million in his
budget for 2006 to increase BSE research. That's a 155 percent increase.
And we're also working very, very hard to reopen markets to American
beef products. Let me kind of walk down through the statistics for you.

"In 2003 the total export value of U.S. beef and ruminant products was
$7.5 billion. That's what we exported, $7.5 billion. After the animal
was found on December 23, 2003, 64 percent of that market was
immediately closed-- 64 percent. Think about that if you will, put that
in context.

"We've got a $7.5 billion market, we find one animal, and 64 percent we
don't have access to, like that. Not overnight. I mean, literally like
that those markets closed.

"We never want that to happen again. Isn't our role to continue to urge
the international community to base their decision upon science? Today
we've recovered well over a third of that market. The USDA has worked
hard in the months since that event, and a third of the market has been
recovered.

"And there remains about $3.1 billion that remains closed that we have
not been able to reopen. You've heard the story after story about Japan.
It's an important market, been a great market for our products through
the years. Japan alone represents nearly half of that, and as a leader
in Asia it's very, very crucial that we resume a normal trading
relationship to beef with that country.

"Now we have the framework in place to get us there, and we have the
science on our side. What remains is a consistent, strong effort on the
part of the American team. Now ladies and gentlemen, I was sworn in on
January 21st. I was actually confirmed on Inaugural Day January 20th. On
January 27th, the weekend intervening, it was almost immediately I met
with the Japanese ambassador, Ambassador Kato, who's a fine man I might
add. And we talked about the need to establish the date for the
reopening of that marketplace.

"I want you to know however that this effort did not start with me. It
started long before I arrived as Secretary. That was just the latest in
a series of policy meetings and technical exchanges including
discussions right at the top between our President and the Japanese
Prime Minister. And I want to guarantee to you that our focus, my focus,
will not shift until the job is done.

"Now let me talk about another trading partner. And let me also take an
opportunity to put this in context. The trading partner I'm going to
talk about now is our largest trading partner. You don't define this
relationship by trade that involves millions and millions of dollars
going back and forth across the border, benefiting both sides. You
define this relationship as being your number one trading partner, and
you define it by defining it in terms of billions of dollars, not
millions of dollars. Billions of dollars of trade.

"We were visiting and I was meeting people; one of the things they said
to me is, we need to do everything we can to make sure this is a level
playing field where this is a country that we've traded with. What
country am I talking about? I'm talking about Canada.

"I believe very, very strongly that restoring trade with Canada is in
the best interest of American consumers and the beef industry. There's
been recent events as you know a federal court recently entered an
order, and the Justice Department is deciding how best to proceed from
that. I'll just tell you, I was very disappointed with that event. I was
also disappointed with the Senate vote on this issue.

"It is very, very important that we put this issue in the context of
what we are dealing with and what this is all about. Remember my
discussion with you about sound science? This rule very, very clearly
specifies that it's with animals under 30 months and product under 30
months, and the science is just virtually unanimous that that is safe
product.

"It just is. It's just the state of scientific affairs. So it is very
important that we act consistently as we work with our trading partners.

"Now I learned long ago, folks, that deciding not to act is a decision.
You may not think it at the time; you may think well putting this off is
something that I can do. But that in and of itself is a decision.

"So what is the impact of this delay? I recently had a hearing before
the House Ag Committee on BSE, and I was asked a question. The question
pointed out to me and the House member was kind of laying the groundwork
when he said, 'You know Mr. Secretary, we understand that in Canada
they've increased their processing capacity by 20 percent, they're
anticipated to increase the processing capacity by an additional 10
percent. That would be 30 percent.'

"I'll add into that, ladies and gentlemen, that just yesterday I read
some comments from a gentleman by the name of Andy Mitchell who has my
job in Canada. He's the ag minister up there; they call them ministers
instead of secretaries. They're investing millions of dollars to promote
their beef worldwide. One of their provinces is also investing millions
of dollars to promote their processing role.

"But this congressman laid this groundwork, and then he said, 'Mr.
Secretary, I wanted to ask you, what's the impact of moving processing
to Canada, the processing of beef to Canada?'

"I said, 'Well, Congressman, I'm going to start out and just apologize
for this answer because it's so obvious. I'm embarrassed to even put it
out there for you, but it is the right answer.' I said, 'Where the
processing is, is where the cattle are at.'

"In our state, the state I came from, we're the largest processor in the
United States. We process a lot of beef. We're also one of the largest
cattle producers-- cow, calf and fat cattle. It's not accidental; it's
just the way it works. You have the processing, you're going to grow the
beef industry. Right?

"That's what Canada is doing.

"And delaying this decision, quite honestly, is going to have some
pretty profound impacts because they're not going to slow down. They're
a very proud industry, and they do a lot of things right with their
industry just like we do. They're not going to slow down; they're going
to continue to do everything to make sure that not only does that
industry survive but it thrives.

"And I said, 'you know I worry about the fact that a year from now the
next round of hearings before the Senate and House will be along the
lines of, Mr. Secretary how did we ever let the processing go to Canada?'

"Some way, some how, we've got to bring some equilibrium to what we're
doing here. Like I said, delaying a decision is a decision and it has
some pretty profound impacts.

"Now fortunately again our President is showing courage that is so
typical of him, and he has promised to veto it, if that disapproval
resolution were to reach his desk. We're going to do everything we can
to fight that court injunction.

"Trade is a two-way street. In fact in a speech I gave awhile back I
said, not only is trade a two way street, it's a superhighway. And you
need to be paying attention to what you're doing with one country
because it can have some pretty profound impacts on what you're trying
to do with other countries.

"So we're going to continue to work to do everything we can to make sure
that markets are open to you. You need foreign markets for your
products, and we're going to do everything we can to make sure that's a
level playing field. I'm going to do everything I can personally to be
involved in that. And I just ask for the support of the Congress and
your support to make that happen.


snip...

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/0/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005%2F03%2F0092.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=TRANSCRIPTS_SPEECHES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM

Greetings list members,

> "The Minimal Risk Rule is based on sound science, and our highest
> priority is and will always be protecting human health and animal
> health and consumer confidence.
>

This is a lie !

> "Fortunately the USDA and its partners swung into action immediately
> with many critical actions -- the ban of specified risk materials, ban
> on downer cattle, increased surveillance. I'm happy to report to you
> today after an enhanced surveillance of now nearly, the last year
> we've tested about 275,000 cattle, and we haven't found another case.


MORE lies. the june 2004 BSE 'enhanced' surveillance was nothing more
than a enhanced effort at covering up any BSE/TSE in the USA.

all one has to do is look at that TEXAS MAD COWs, the stumbling and
staggering one they refused to test at all, and then the other positive,
positive,
inclonclusive, negatives. THEN we must not overlook the Aug. 4, 1997
FAILED ruminant to ruminant feed ban, that has failed from day one.
THE GAO just confirmed this again in 2005 for the 3rd time. how many times
does it take???

Johann and Rice are nothing more than puppets on a string, that do not know
what science is, only what GW tells them. EVERY country out there should
strictly enforece the BSE GBR risk assessments, and should ban all
North American beef, until this BSe MRR policy is no more.

> First and foremost we need to base the hard decisions on vigorous
> sound science. In a rapidly changing world marketplace, science is
> truly a universal language that must guide our rules and policies. We
> must not be guided by subjectivity or the politics of a given moment.


like the pot calling the kettle black. the bush administration and the MRR
policy is based on nothing more than trade policy and that the USA is now
in the same boat all other BSE countries have been in for years, except now
the USA does not want to go by the BSE GBR guidelines, which by
the way was based on 'sound science', something the MRR policy is NOT
based on.

> vigorous sound science


vigorous sound science IS NOT refusing to do a WESTERN BLOT
on a very suspicious rapid test, especially two postive ones.

vigorous sound science IS NOT sending a staggering and stumbling
cow, one highly suspicious of BSE/TSE to the render after one official
is asking for a test, but highter ups refuse this request.

vigorous sound science IS NOT still continuing to feed cows to cows,
when ones country is infested with TSEs, and all of which have been
rendered and fed back to other animals for human/animal consumption
for the last 2 1/2 decades.

vigorous sound science IS NOT what this administration and it's MRR
policy is about, it's about nothing more than opening up its borders
at all cost, including human health.

HELL, we have 'SOUND SCIENTIST' around the globe, some saying
(personal communications no source _for now_ ...tss)


> Historically, yes. The IHC was the gold standard at one point, but we
> have shifted to the Western blot. It requires less work, it is more
> sensitive and its results are reproducible. IHC relies on
> localization. If you have a weak signal case, you may get lucky and
> test a spot with a high concentration of prions. But the opposite it
> true too; you can miss an infection by testing a sample with low
> concentrations. Western blot is much better for low signal situations.


snip...

> It’s not logical. If you have two consecutive questionable screenings,
> you do another test. I can only advise, it’s management’s duty at USDA
> to make the decisions. But when you have a discrepancy between the
> rapid test and the IHC, it is only logical to confirm it with another
> test.


snip...

> It’s a fairly recent development. Only recently has the Western blot
> test become sensitive enough, with the addition of phospohtungstic
> acid precipitation step. The Bio-Rad test (which Deslys helped
> develop) is extremely sensitive, and the standard Western blot is
> extremely reliable with high-signal test results. However, it had to
> be made more sensitive for low-signal (samples with low density of
> malformed prions) samples. It has been made more sensitive.
>
> Reproducibility is the problem with the IHC test. It is not
> standardized; depending on the lab and its protocols, or even on the
> technician involved in the test, one can get conflicting results.

MORE SOUND SCIENCE FROM TOP TSE SCIENTIST AROUND
THE GLOBE ;

>biochemical detection of PrPSc is indeed
>likely to be more sensitive than immunohistochemistry. In the case of
>variegated, punctate distribution of the agent, morphological methods may
>indeed be an asset.
>

snip...

>In my laboratory, we routinely run
>phosphotungstic acid precipitation followed by Western blotting.
>


BUT NO, not after the first USA MAD COW was confirmed by WB,
THE USA NOW REFUSES THIS ENHANCED METHOD OF
DETECTING TSEs. THEY would rather be stuck in time ;


Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf


THE first mad cow old dave capped, was a healthy walker, sub-clinical
TSE that was only tested due to where the animal had been capped.
otherwise that animal too would not have been discovered.

A person would have to be a damn idiot to believe that was the only
mad cow in the USA, and even a bigger idiot to believe Johann et al
and this BSee on the MRR. IF GW et als insane BSE MRR policy
goes into effect, its not the fear of Canadian cattle across the border
i fear the most, it is the BSE MRR policy itself. GWs Pandora's box
will then be open, and if other countries follow through with Pandora's
box, they will reep what they sow, the legal trading of all strains of
TSEs. remember, the new atypical TSE in cattle called aBSE or BaSE
or BASE, this TSE is showing up in older cattle, it is NOT detected by
IHC, and the pathology is NOT similar to nv/v CJD, but IS VERY
similary to sporadic CJD. so this is why in my opinion GW et al now
refuse to use WB and why they are force feeding the globe this BSE
MRR (legal trading of all TSEs Globally) policy, what i call GWs
Pandora's Box of Mad Cow diseases. imagine, all the strains of
sheep scrapie in the USA, all the undocumented strains of CWD,
BSE in cattle and not to forget the other stain Marsh found from
feeding downer cattle to mink, this was different than BSE. maybe
a little TME mixed in. so, you mix all this, oh hell, i almost forgot that
DECLARATION OF EMERGENCY OF ATYPICAL TSE IN VERMONT
SHEEP, maybe a few of those might be mixed in too, all this, and you
have, GWs MRR POLICY of PANDORA'S BOX OF MAD COW DISEASES,
courtesy of the USA GW et al. NOW, you might ask, what does the OIE
say about this insane policy ???

ALL this reeks of cover-up........

> You have the processing, you're going to grow the beef industry. Right?
>
> "That's what Canada is doing.
>


snip...

Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
CANADA

snip...

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 11 -

snip...

- 2 -
2. EXTERNAL CHALLENGES
2.1 Import of cattle from BSE-Risk2 countries
An overview of the data on live cattle imports is presented in table 1
and is based on
data as provided in the country dossier (CD) and corresponding data on
relevant exports
as available from BSE risk countries that exported to Canada. Only data
from risk
periods are indicated, i.e. those periods when exports from a BSE risk
country already
represented an external challenge, according to the SSC opinion on the
GBR (SSC July
2000 and updated January 2002).
• According to the CD, 231 cattle were imported from UK during the years
1980 to
1990 and no cattle imports from UK were recorded after 1990.
• According to Eurostat, altogether 198 cattle have been imported from
the UK during
the years 1980 to 1990, Additionally 500 were recorded in 1993; this
import is
1 For the purpose of the GBR assessment the abbreviation “MBM” refers to
rendering products, in particular
the commodities Meat and Bone Meal as such; Meat Meal; Bone Meal; and
Greaves. With regard to imports
it refers to the customs code 230110 “flours, meals and pellets, made
from meat or offal, not fit for human
2 BSE-Risk countries are all countries already assessed as GBR III or IV
or with at least one confirmed
Annex to the EFSA Scientific Report (2004) 2, 1-14 on the Assessment of the
Geographical BSE Risk of Canada
- 3 -
mentioned in Eurostat and the updated UK export statistic as male
calves, but not
mentioned in the original UK export statistics. According to the CD,
detailed
investigations were carried out and it is very unlikely that the 500
calves have been
imported. Therefore, they were not taken into account.
• According to the CD, in 1990 all cattle imported from UK and Ireland
since 1982
were placed in a monitoring program.
• Following the occurrence of the BSE index case in 1993 (imported from
UK in 1987
at the age of 6 months), an attempt was made to trace all other cattle
imported from
UK between 1982 and 1990.
• Of the 231 cattle imported from the UK between 1980 and 1990, 108
animals had
been slaughtered and 9 had died. From the remaining, 37 were exported,
76 were
sent to incineration and one was buried; these were not entering the
rendering system
and therefore not taken into account.
• According to the CD, 16 cattle were imported from Ireland (according
to Eurostat
20), of which 9 were slaughtered, 3 died. The remaining 4 were
incinerated and did
therefore not enter the rendering system. According to the CD, the 6
animals which
were imported in 1990 according to Eurostat, were never imported.
• Moreover 22 cattle have been imported from Japan (through USA), of
which 4 were
exported (excluded from the table) and 14 were destroyed and therefore
not entering
the rendering system, 4 were slaughtered.
• Of 28 imported bovines from Denmark, 1 was destroyed and 1 was
exported. Of the
19 buffalos imported in 2000, 1 was incinerated and the others were
ordered to be
destroyed.
• Additionally in total 264 cattle according to the CD (276 according to
other sources)
were imported from Austria, France, Germany, Hungary, Italy, The
Netherlands and
Switzerland.
• The numbers imported according to the CD and Eurostat are very
similar. Some
discrepancies in the year of import can be explained by an extended
quarantine;
therefore it is likely that imports according to Eurostat in 1980 and
imports
according to the CD in 1981 are referring to the same animals.
• Additionally, between 16.000 and 340.000 bovines have annually been
imported
from US, almost all are steers and heifers. In total, between 1981 and
2003,
according to the CD more than 2.3 million, according to other sources
1.5 million
cattle have been imported.
• According to the CD, feeder/slaughter cattle represent typically more
than 90% of
the imported cattle from the USA; therefore, only 10% of the imported
cattle have
been taken into account.

snip...


Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 5 -
2.2 Import of MBM or MBM-containing feedstuffs from BSE-Risk
countries
An overview of the data on MBM imports is presented in table 2 and is
based on data
provided in the country dossier (CD) and corresponding data on relevant
exports as
available from BSE risk countries that exported to Canada. Only data
from risk periods
are indicated, i.e. those periods when exports from a BSE risk country
already
represented an external challenge, according to the SSC opinion on the
GBR (SSC, July
2000 and updated January 2002).
According to the CD, no imports of MBM took place from UK since 1978
(initially
because of FMD regulations).
• According to Eurostat data, Canada imported 149 tons MBM from the UK
in the
period of 1993 to 2001. According to up-dated MBM statistics from UK
(August
2001) no mammalian MBM was exported to Canada from 1993 – 1996. As it was
illegal to export mammalian meat meal, bone meal and MBM from UK since
27/03/1996, exports indicated after that date should only have included
nonmammalian
MBM. Therefore, these imports were not taken into account.
• According to the CD, imports of MBM have taken place from Denmark,
Germany,
France, Japan and US.
• According to Eurostat Canada imported MBM from Denmark, Belgium,
France and
Ireland.
• According to the CD further investigations concluded that all imported
MBM from
Denmark consisted of pork and poultry origin and was directly imported for
aquaculture, the imported MBM from France was feather meal, the imported
MBM
from Germany was poultry meal for aquaculture and the imported MBM from
Belgium was haemoglobin; therefore these imports were not taken into
account.
• The main imports of MBM were of US origin, according to the CD around
250.000
tons, according to other sources around 310.000 tons between 1988 and 2003.

snip...

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 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 according to the CD more than 2.3 million,
according to
other data 1.5 million live cattle from BSE risk countries, of which 231
(CD)
respectively 698 (other sources) came from the UK. 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
Canada, the 500 cattle
imported from UK according to Eurostat were not taken into account and
it is assumed
that all incinerated, buried, exported animals and the animals still
alive did not enter the
rendering system and were therefore excluded from the external challenge.
MBM imports:
In total the country imported according to the CD around 300.000 tons,
according to
other sources nearly 360.000 tons of MBM from BSE risk countries, of
which 149 tons
came from the UK. The majority consisted of MBM imported from the US. 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 meat meal, bone
meal and
MBM from UK since 27/03/1996, exports indicated after that date should
only have
included non-mammalian MBM. In the case of Canada all imported MBM from UK,
Germany, Belgium, Denmark and France was not taken into account.
On the basis of the available information, the overall assessment of the
external
challenge is as given in table 3 below.
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 8 -
External Challenge experienced by CANADA
External challenge Reason for this external challenge
Period Overall Level Cattle
imports
MBM
imports
Comment
1980 to 1990 Low Low Negligible
1991 to 1995 High Moderate High
1996 to 2000 Extremely
high High Extremely
high
2001 to 2003 Very high High Very high
Table 3: External challenge resulting from live cattle and/or MBM
imports from the UK and other BSE risk
countries. The challenge level is determined according to the
SSC-opinion on the GBR of July 2000 (as
updated in January 2002).
3. STABILITY
3.1 Overall appreciation of the ability to avoid recycling of BSE
infectivity, should it enter processing
Feeding
The annual Canadian production of MBM is approximately 575,000 tons of
which
approx. 40,000 tons are exported each year, mainly to USA.
Use of MBM in cattle feed
• Before the feed ban, dairy cattle received supplementary feed
containing MBM
during their productive life (maximum 200-400 g MBM per day). Beef
cattle in the
western part of the country do not usually receive complementary feed.
Beef cattle
in the eastern part receive normally no supplement protein but the
calves could have
access to creep feeds containing MBM, after weaning the ratios may have
contained
supplemental protein containing MBM (100-400 g per day).
• According to the CD, MBM is mainly fed to pigs and poultry and
included in pet
food.
• According to the CD, only a proportion of dairy cattle may have
received MBM.
Feed bans
• Before 1997, there was no legal restriction to include MBM into cattle
feed.
• An MBM-ban was introduced in August 1997; it is forbidden since to feed
mammalian MBM to ruminants except if of pure porcine, equine and non
mammalian origin, i.e. in practice a ruminant-to-ruminant ban (RMBM-ban).
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 9 -
Potential for cross-contamination and measures taken against
• Cross-contamination in the about 600 feed mills is assumed to be
possible as long as
cattle and pig feed is produced in the same production lines, and premises.
• Cross-contamination during transport is possible, particularly if the
same trucks are
used for transporting ruminant MBM (RMBM) and non-ruminant MBM (porcine or
poultry MBM which still might be included into cattle feed) or for
transporting
pig/poultry feed and cattle feed.
• On-farm cross-contamination is regarded to be possible.
• Cross-contamination of cattle feed with RMBM can not be excluded.
Hence, as
reasonable worst case scenario, it has to be assumed that cattle, in
particular dairy
cattle, can still be exposed to RMBM and hence to BSE-infectivity,
should it enter
the feed chain.
Control of Feed bans and cross-contamination
• With the introduction of the RMBM ban (1997) the feed mills
(approximately 600)
were checked for compliance with the ban, including good manufacturing
practices
(GMP) and record keeping, i.e. the separation in production of MBM
containing
ruminant material (RMBM) from non-ruminant MBM.
• The feed mills had previously – since 1983 – been regularly checked in
relation to
production of medicated feed.
• No examinations are performed to assess cross-contamination with RMBM
of the
protein (e.g. non ruminant MBM) that enters cattle feed. Differentiation
would
anyway be difficult.
Rendering
Raw material used for rendering
• Ruminant material is rendered together with material from other
species, but
according to the CD only in the production of MBM prohibited for use in
ruminant
feeds.
• Slaughter by-products, including specified risk material (SRM) and
fallen stock are
rendered.
• The country expert estimated that 20% of the rendering plants,
processing 20% of
the total amount of raw material, are connected to slaughterhouses.
Their raw
material is more than 98 % animal waste from these slaughterhouses while
less than
2 % is fallen stock. No estimation was given for the remaining 80% of
the rendering
capacity.
• There are 32 rendering plants of which 3 are processing blood
exclusively.
Rendering processes
• The rendering systems (parameters) were specified for 6 plants
producing mixed
MBM, none of these fulfilled the 133/20/3 standard. Of these, 5 have
dedicated
facilities to produce products for use in ruminant feed and products not
permitted for
use in ruminant feed.
• The remaining plants process porcine or poultry material exclusively.
SRM and fallen stock
• There is an SRM ban for human food in place since 2003.
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
• However, SRM are rendered together with other slaughter waste and
fallen stock.
However, according to the CD, MBM with SRM is not permitted to be fed to
ruminants.
Conclusion on the ability to avoid recycling
• Between 1980 and 1997 the Canadian system would not have been able to
avoid
recycling of the BSE-agent to any measurable extent. If the BSE-agent was
introduced into the feed chain, it could have reached cattle.
• Since 1997 this ability gradually improved with the introduction of
the ruminant
MBM ban and its implementation.
• Since cross-contamination cannot be excluded, and as SRM is still
rendered by
processes unable to significantly reduce BSE-infectivity, the system is
still unable to
avoid recycling of BSE-infectivity already present in the system or
incoming.
3.2
BSE surveillance
laboratory tests).
i.e. formalin fixation.

snip...


In 1990, when BSE was made notifiable, this awareness was extended to
suspicions of BSE.
" Since 1993 the number of brains examined per year did exceed the number
recommended by OIE (300 - 336 for countries with a cattle population
over 24
months of age of 5.0 to 7.0 Million)

PLEASE NOTE BEFORE GOING ANY FURTHER THAT MOST EVERY COUNTRY THAT WENT
BY THOSE SAME OIE BSE GUIDELINES HAVE BSE NOW. THE ONLY REASON IT WAS
NOT DETECTED SOONER
IN THESE COUNTRIES WERE BECAUSE OF THESE SAME OIE GUIDELINES. SIMPLY PUT,
THEY ARE WRONG IN RELATIONS TO TSEs. IT'S NOTHING MORE THAN AN EXCUSE,
ONE THAT FLIES ABOUT LIKE A COW WOULD...TSS


in all years, except in 1995 (table 4).
year 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
samples 225 645 426 269 454 759 940 895 1´020 1´581 3´377 3´361
Table 4: Number of bovine brains annually examined for CNS diseases,
including BSE.
" According to the CD approx. 98% of the examined cattle were older than
24 months
and approx. 90% exhibited neurological symptoms. Although the
identification
system of Canada does not document the birth date or age of the animals,
according
to the CD, examination of the dentition is used to ascertain the
maturity of the
animals.
" The list of neurological differential diagnoses for the 754 brains
examined in 1997
included encephalitis (70 cases), encephalomalacia (19), hemophilus (7),
hemorrhage (2), listeriosis (38), meningoencephalitis (36), rabies (22),
tumors (2),
other conditions (135) and no significant findings (423).
" Compensation is paid for suspect BSE cases as well as for animals
ordered to be
destroyed (90-95% of market value with a maximum of 2,500 Can$ per cow).
" Diagnostic criteria developed in the United Kingdom are followed at ADRI,
Nepean. According to the very detailed protocol for the collection,
fixation and
submission of Bovine Spongiform Encephalopathy (BSE) specimens at abattoirs
under inspection by the Canadian Food Inspection Agency, the specimen
shall be
shipped to National Center for Foreign Animal Disease, Winnipeg, Manitoba.
" In 2003, around 3000 animals from risk populations have been tested.
" According to the CD, it is aimed to test a minimum of 8000 risk
animals (animals
with clinical signs consistent with BSE, downer cows, animals died on
farm animals
diseased or euthanized because of serious illness) in 2004 and then
continue to
progressively increase the level of testing to 30,000.
" In May 2003, Canada reported its first case of domestic BSE. A second
case was
detected in the US on 23 December 2003 and traced back to Canadian
origin. Both
were born before the feed ban and originated from Western Canada.
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 January 2002) is applied.
Until 1997, it was legally possible to feed ruminant 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.
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 12 -
Due to the highly specialised 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 specialised 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.
" 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 BSE-surveillance programme targeting cattle showing clinical
signs that
could be compatible with BSE.
" The initiated introduction of active surveillance should improve the
system
significantly.
Stability of the BSE/cattle system in CANADA over time
Stability Reasons
Period Level Feeding Rendering SRM
removal
BSE
surveillance
1980 to 2000 Mainly
passive
2001 to 2003
Extremely
unstable Not OK Not OK Not OK
Improving
with some
testing of
risk groups
Table 5: 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) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 13 -
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 Canada overtime is as given in table 5 above.
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenges
In conclusion, the stability of the Canada BSE/cattle system in the past
and the external
challenges the system has coped with are summarised in the table 6.
INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN CANADA
Period Stability External Challenge Internal challenge
1980 to 1990 Low Unlikely but not excluded
1991 to 1995 High
1996 to 2000 Extremely high
Likely and rapidly growing
2001 to 2003
Extremely
unstable
Very high Confirmed at a lower level
Table 6: 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).

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.
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 breeding cattle
(that are normally imported at 20-24 months of age) that could have been
infected prior
to import. In case of 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
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 14 -
Canada this implies that it was possible that imported MBM reached
domestic cattle and
lead to an internal challenge in the early 90s.
4.2 Risk that BSE infectivity entered processing
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.
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 unstable BSE/cattle system in Canada.
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
confirmed at a lower level
that domestic cattle are (clinically or pre-clinically) infected with
the BSE-agent.
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 the system remains unstable, it is expected that the GBR
continues to
grow, even if no additional external challenges occur.
" 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 has been fully quantified, these developments should
be taken
into account.
5.3 Recommendations for influencing the future GBR
" Enhancing the stability of the system, in particular by ensuring that
cattle have no
access to mammalian MBM in combination with appropriate rendering and
exclusion of
SRM and fallen stock from any feed chain could lead, over time, to a
reduction of the
GBR.
" Improved passive and active surveillance, i.e. sampling of animals not
showing
signs compatible with BSE from at-risk cattle populations, such as
adult cattle in
Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the
Geographical BSE Risk of Canada
- 15 -
fallen stock and emergency slaughter, by means of rapid screening, would
allow
monitoring the efficiency of stability enhancing measures.
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.
" 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.

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

snip...

What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDA’s Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO’s 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at
risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nation’s firewall against BSE. For example:
• FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
• FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
• FDA’s feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
• Feed intended for export is not required to carry a caution label “Do not
feed to cattle or other ruminants,” when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
• FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDA’s guidance calls for such
communication.
• Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDA’s enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA’s
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf


GAO says US barriers to mad cow disease are full of holes

Robert Roos * News Editor

Note: This story was updated March 1, 2002, to include additional
information about recent federal actions to prevent mad cow disease.

Feb 28, 2002 (CIDRAP News) – Congress's General Accounting Office (GAO)
concludes in a new report that the United States remains vulnerable to
bovine spongiform encephalopathy (BSE), or mad cow disease, because of
inadequate import barriers and weak enforcement of rules to contain any
BSE-contaminated products that might reach US shores.

"The continuing absence of BSE in the United States today cannot be
sufficiently ensured by current federal prevent efforts," states the
report, released Feb 26. "The introduction and spread of BSE in the
United States could stem from cattle and cattle-derived products from
countries that subsequently developed BSE and from gaps in import
controls, animal testing, and feed ban enforcement. As a result of these
problems, consumers may unknowingly eat foods that contain central
nervous system tissue from a diseased animal."

The report says that about 1,000 cattle and 125 million pounds of beef
entered the United States from countries that later found cases of BSE.
Further, hundreds of firms have violated a ban on putting meat and bone
meal in cattle feed, and the Food and Drug Administration (FDA) has done
little to enforce the ban, the GAO says.

The GAO investigated the government's BSE prevention efforts at the
request of Sens. Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Dick
Durbin, D-Ill. Durbin promised to introduce a bill to strengthen BSE
prevention efforts. "We can't have the world's most reliable food supply
without an equally reliable system of regulation and oversight," Durbin
said in a Feb 26 news release.

Agriculture Secretary Ann Veneman took issue with the report on several
counts, saying the GAO didn't fully consider recent actions that federal
agencies have taken to strengthen BSE safeguards. She also said the GAO
didn't appropriately recognize a Harvard University report issued last
year that determined the risk of BSE in the United States to be very low.

Eating meat from animals with BSE is considered a risk factor for
variant Creutzfeldt-Jakob disease in humans. BSE prevention steps in the
United States began in 1989 with a ban on the importation of live
ruminants (cattle, sheep, and goats) and ruminant meat and bone meal
from the United Kingdom and other countries with BSE. In 1997 the ban
was extended to the rest of Europe, and the FDA banned the use of most
mammalian protein in feed for ruminants the same year. In addition, the
FDA and the US Department of Agriculture (USDA) screen cattle-derived,
FDA-regulated products imported from countries where BSE exists, the GAO
report says.

Over the past 20 years, the nation imported about 1,000 cattle, 125
million pounds of beef, and 23 million pounds of inedible meat
byproducts from countries where BSE was later found, the GAO determined.
Some contaminated animals or products may have entered the country
because BSE's incubation period is up to 8 years, the report says.

In particular, the nation imported 242 cattle from Japan between 1993
and 1999. After Japan reported its first BSE cases in September 2001,
the USDA managed to locate most of the imported cattle, but 24 animals
had already gone to slaughter or rendering.

"In addition to the BSE risk posed by past imports, a small but steady
stream of BSE-risk material may still be entering the United States
through international bulk mail," the GAO says. USDA inspectors at
international bulk mail facilities can spot organic matter with special
x-ray scanners, but inspectors are not on duty at all times and they can
screen only a fraction of the stream of incoming packages, the report
states. In a 6-month period last year, 570 of 116,000 packages screened
at one facility contained "at-risk beef or beef-derived products."

Risky items also can slip through federal ports of entry when shipments
are inaccurately labeled or through lack of inspection, the GAO
reported. For example, sampling by the US Customs Service in fiscal 1999
showed that information on beef shipments was wrong in over 21% of
cases. Further, in fiscal year 2000 the FDA inspected only 1% of the 4
million imported food entries under its jurisdiction and less than 1% of
the 146,000 shipments of animal drugs and feeds.

BSE prevention efforts also include USDA testing of cattle tissue. The
GAO says the USDA has increased its testing program but does not test
many cattle that die on farms, which are assumed to pose an increased
risk because they are usually older and often die of unknown causes.
Some cattle that die on farms are collected and rendered into products
that include animal feed, the report says.

The GAO finds serious fault with the FDA's enforcement of the ban on
mammalian protein in cattle feed. Since 1997, FDA and state personnel
have conducted more than 12,000 inspections at more than 10,576 firms
(eg, renderers, feed mills) and found 364 firms in violation, the report
states. The FDA estimates that at least another 1,200 firms that should
be subject to the ban have not been identified.

"FDA did not take prompt enforcement action to compel firms to comply
with the feed ban," the GAO says. By April 2001 (when the GAO
investigation began), the agency's only enforcement steps had been to
issue two warning letters, though the pace picked up after that. Several
firms repeatedly violated the rules but did not receive warning letters.
Further, the FDA has no overall enforcement strategy that sets penalties
and deadlines.

"Even if FDA were to actively enforce the federal ban, its inspection
database is so severely flawed that—until corrected—it should not be
used to assess compliance," the report says. It includes a long list of
problems with the database; for example, entries for about 45% of all
inspections lack information to uniquely identify the firms inspected.

In other findings, the GAO concluded that the United States acted as
much as 5 years earlier than other countries to bar imports of animals
and animal feed ingredients from countries with BSE cases. However, the
nation has a "more permissive" feed ban than other countries in that
cattle feed can contain protein from horses and pigs. The FDA is
currently reviewing this provision, the report notes.

The report recommends a number of steps to address the problems it
describes. Among other things, it suggests that the secretary of
agriculture consider using public service announcements or labels to
inform consumers that certain beef cuts and products may contain central
nervous system (CNS) tissue. The GAO also suggests that the FDA consider
requiring labeling of regulated products, including food, cosmetics, and
drugs, that contain CNS tissue.

Agriculture Secretary Veneman critiqued the GAO report in a statement
released the same day (Feb 26). "The report fails to appropriately
recognize the conclusions and recommendations made last year by Harvard
University in its comprehensive, 3-year study on BSE," she said. "The
Harvard Risk Analysis showed that the risk of BSE occurring in the
Untied States is extremely low and that early government protection
systems have been largely responsible for keeping BSE out of the United
States and would prevent it from spreading if it ever did enter the
country."

Veneman also said that despite extensive USDA comments on the draft
report, "scientific and technical errors" survived in the final report.
Further, the report "does not appropriately consider the additional
actions that have been taken by federal agencies to strengthen BSE
programs," she added.

The USDA described a number of recent actions related to BSE in a
separate news release (see link below). That release says the FDA has
"significantly improved" its database on firms' compliance with the
animal feed rule. The improved database will be fully operational in
April and will allow the FDA to track compliance more effectively,
officials said. In addition, the FDA is receiving an extra $15 million
for BSE prevention efforts this year, bringing the total to $19 million,
and is hiring 115 people this year to help in those efforts.

The USDA also issued a set of responses to the recommendations in the
GAO report. The agency rejected the idea of labeling beef and beef
products that may contain CNS tissue, stating, "The presence of CNS
tissue does not mean that the product is infectious for BSE. Labeling
and warning statements should be reserved for known hazards."

In response to another GAO recommendation, the USDA said it is already
increasing its testing of tissue samples from animals that die on farms.
The agency said that the number of cattle brains tested this year will
be more than double last year's total, and that "A focus of this
increased surveillance is to obtain more samples from animals that die
on farms."

Regarding the Harvard study of BSE risk in the United States, the GAO
report says the agency did not try to validate the model or assumptions
used by the Harvard researchers. However, the report says the Harvard
authors acknowledged that their conclusions "could be influenced by a
number of model assumptions that could not be verified with
confidence—including assumptions about US measures to prevent the
introduction and spread of BSE." The Harvard researchers also noted that
compliance with the animal feed ban is the leading source of uncertainty
in their assessment, the GAO report states.

See also:

GAO Web site with link to report (type 02-183 in
Report # search box at top right, then hit Go)

Ann Veneman's statement on GAO report
http://www.usda.gov/documents/NewsReleases/2002/02/0071.doc

USDA news release, "USDA continues to strengthen BSE protection systems"
http://www.usda.gov/documents/NewsReleases/2002/02/0070.doc

USDA fact sheet with responses to GAO recommendations
http://www.usda.gov/documents/NewsReleases/2002/02/fs0071.doc


USDA BSE BIBLE

OH, THE BIBLE THAT USDA ET AL GOES BY,
The Harvard BSE Risk Assessment, bought and paid for,
in part or whole, by your local cattle dealer.
THEY NEVER speak much of thie PEER REVIEW of the
Harvard BSE risk assessment ;

snip...

Identification and
Characterization of
Variability,
Uncertainty, Critical
Assumptions, and 9 Data Gaps
Although generally several comments can be relevant to this topic,
we provide only specific comments on variability, uncertainty,
critical assumptions, and data gaps that mainly influence the risk.
We number their comments to differentiate the them.
9.1 KEY SOURCES OF VARIABILITY AND
UNCERTAINTY
1) In Section 3.2 of the H-T BSE study report, the authors list 15
sources of uncertainty that they evaluated individually for influences
on the model predictions for two outcomes:
Z the total number of cattle that become infected after the
introduction of 10 infected animals at the beginning of the
period, and
Z the amount of BSE infectivity (quantified in terms of the
number of cattle oral ID50s) in food produced for human
consumption over that period.
In addition to varying the parameters to reflect a best case and
worse case, the authors considered the impact of different sources
of infection on the model’s predictions, described in Section 3,
Pages 71-79 and compared the model’s predictions with alternative
9-1
Review of the Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States — Final Report
scenarios. The parameters evaluated in the sensitivity (uncertainty)
analysis are listed in detail in the synopsis.
2) The method used for evaluating the contributions of
uncertainty in inputs to uncertainty in model predications has key
shortcomings. The chosen method in the BSE risk assessment model
is to evaluate the influence of one individual uncertainty source
while setting all of the other assumptions or uncertainty sources to
their base-case values. For example, when considering the impact
of the uncertainty in maternal BSE transmission rate on the model
prediction, the other 14 uncertainty sources are set to their basecase
point estimates. This kind of analysis should be referred to as
“sensitivity analysis,” not as “uncertainty analysis” as described in
the report. Although uncertainty analysis and sensitivity analysis are
closely related, they are two different disciplines. Uncertainty
analysis assesses the uncertainty in model outputs that derives from
uncertainty in all inputs when simulated simultaneously. Sensitivity
Analysis assesses the contributions of the inputs to the total
uncertainty in analysis outcomes (Cullen and Frey, 1999).
Therefore, the results from the BSE model “uncertainty analysis” do
not represent the full range of uncertainty in the risk of animal or
human exposed to BSE associated with simultaneous contributions
from all uncertainty inputs. Instead, what is reported is an
individual contribution of one uncertainty input to the partial
uncertainty in the model output, the risk such as associated with
animal or human exposure to BSE.
3) Variability refers to the heterogeneity of values with respect
to time, space, or a population. For example, in exposure
assessment, variable quantities include the rate at which individuals
consume specific dietary items and the body weights of the
individuals (Cullen and Frey, 1999). Variability can be represented
by a frequency distribution showing the variation in a characteristic
of interest over time, space. Uncertainty arises due to lack of
knowledge regarding the true value of a quantity. For example,
there may be uncertainty regarding the proportion of animals that
die on the farm that are rendered. Uncertainty can be quantified as
a probability distribution representing the likelihood that the
unknown quantity falls within a given range of values (Frey, 1997).
Although the BSE model evaluates the impact of how comparison of
various uncertainty sources influences the model predication, there
9-2
Section 9 — Identification and Characterization of Variability, Uncertainty,
Critical Assumptions, and Data Gaps
is no distinction between variability and uncertainty in the model
inputs or outputs. In typical practice, in an exposure or risk
assessment model, the model inputs can be divided into those that
are variable, those that are uncertain, and those with some aspects
of each (Bogen and Spear, 1987; IAEA, 1989; Morgan and Henrion,
1990; Finkel, 1990; Frey, 1992). For example, in the BSE model,
maternal BSE transmission rate is variable across different mothers,
but it is also uncertain because there is no knowledge regarding its
true value. It is not possible to determine whether there are
variables that are misspecified as uncertain that instead should have
been arranged distribution for variability because there is not
enough description of the characteristics of most of the input
variables. Therefore, based upon the information presented in the
model documentation, it is not possible to determine which inputs
should be arranged distributions for variability and/or uncertainty.
Variability and uncertainty have different ramifications for decisionmakers
(Cullen and Frey, 1999). Uncertainty forces decisionmakers
to judge how probable it is that risks will be overestimated
or underestimated for every member of the exposed population,
whereas variability forces them to cope with the certainty that
different individuals will be subjected to risks both above and below
any reference point one chooses (NRC, 1994). Therefore, it is
recommended that both sources of variability and uncertainty be
identified and distinguished and that variability and uncertainty
analysis be done in the BSE risk assessment model.
4) In Section 2, at the beginning of Page 26, the authors state
the uncertainty in ascertaining the potential risk posed by oral
exposure to Chronic Wasting Disease (CWD):
Ascertaining the potential risk posed by oral
exposure to CWD is further complicated by the
following sources of uncertainty. First, there are no
accurate statistics documenting the number or type
of deer and elk killed by hunters. Second, the type
of deer and elk that can be hunted in different
geographic areas varies. Third, the disposition of
deer and elk remains after slaughter is uncertain.
Finally, the prevalence of the disease in all but the
highest risk areas is unknown.
The authors have found no data for key sources of uncertainty.
9-3
Review of the Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States — Final Report
5) On Page 55 at the end of the first paragraph, the authors
state, “Our base case assumes that clinical BSE cases would be
detected at AM inspection 90 percent of the time. Because this
value is highly uncertain, our uncertainty analysis evaluates the
impact of using a wide range of values on the results of our
simulation (see Section 3.2.2).” However, it was found that only
two values were evaluated.
6) Table 2.18-1 (Appendix 1, Page 31) specifies joint
probability as a percentage but Table 2.2.2.3 (Appendix 2, Page 8)
specifies it as a probability. (Also, the reviewers wonder if the
decimal point is in the correct place.) Consistency among the units
or measures of the probability would be nice.
7) The authors have done a sensitivity analysis where they
altered the parameter values one at a time to determine the effect on
the model’s predictions, varied values defining the source of
infectivity to determine the effect on the model’s predictions, and
compared the model’s prediction for other scenarios. These are all
important means to determine the model’s behavior and reliability.
The sources of variability are largely only considered individually,
so synergistic effects cannot be assessed. The authors have been
careful to select “reasonable” values for the best and worst cases,
but allowing a greater range of variability would provide a better
understanding of the behavior of the model and its stability.
8) Key sources of variability that have been omitted are
accidents that can sometimes happen and the intentional
introduction of prions to feed or water; and a long-term change in
practices by producers, processing establishments, and/or renderers
that might result in prolonged exposure. Because of these
omissions, one may wonder whether a more parsimonious model
might be as predictive.
9) In the case of variability and uncertainty, the risk of infection
through imported animals is addressed in a defensible manner, even
though the probability of this incursion is not estimated. However,
the age at infection ignores the information and the uncertainty of
the incubation period and is not addressed. The summary of these
aspects, perhaps somewhat harshly, is that the synthesis and critical
review of the literature needs more attention.
9-4
Section 9 — Identification and Characterization of Variability, Uncertainty,
Critical Assumptions, and Data Gaps
10) Little information regarding the distributions of BSE model
inputs and simulation techniques was provided for the so-called
“uncertainty analysis.” Therefore, key questions that should be
addressed include the following: (1) How was the value of an input
altered? (2) What sampling techniques were used? It is necessary to
clearly list the distribution assumptions and parameters (if used) and
to clearly describe related simulation techniques when doing
uncertainty analysis. The description in the report regarding the
“uncertainty analysis” of the BSE model is not clear enough for users
or reviewers to understand how the “uncertainty analysis” (if any) is
done.
9.2 CRITICAL ASSUMPTIONS
1) Surveillance efficiency, recognition rate of “clinical cases,”
and level of inactivation by local rendering are overestimated. Also,
with respect to recognition rate (where only the very typical cases
will be recognized), it is assumed that 90 percent (in the case of
worst case, 50 percent) of the BSE clinical cases will be detected in
the ante-mortem inspection, which is way off from the general
feeling in the EU on this topic.
2) In discussing fracContaminate on Page 16, Appendix 1, the
authors state that flushing and cleaning leave only 0.1 percent of the
prohibited material behind. This cross-contamination as compared
to European demonstrated rates is grossly underestimated, unless
flushing and cleaning are done in a very different (and probably
uneconomical) way.
3) The readability of the report could be improved by
tabulating all assumptions, as was done for the slaughter process
assumptions (Table 3-8, Page 68) and the render and feed
production assumptions (Table 3-9, Page 69). On Page 67 (second
paragraph, first line), the authors refer to 15 sets of assumptions, but
present only seven bullets (does a bullet represent a set?). If each
item within a bullet is summed, 17 assumptions can be identified.
Also, the authors set parameters to three values: base case, best
case, and worst case. But the justification for the specific values
assigned is weak, because little data are available. Without hard
data, the detailed list of assumptions for this process has heuristic
9-5
Review of the Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States — Final Report
value but does not particularly strengthen the predictive value of the
model.
4) The authors assume that “conditions affecting the spread of
BSE in the U.S. would remain unchanged for the 20 years following
its introduction” (Executive summary, Page i, third paragraph, sixth
line). This is a huge assumption and probably unrealistic. As with
most agents of disease, especially newly discovered agents
(emerging diseases), prevalence increases over time largely because
of more and improved testing over time. This has not been
incorporated into the model. Often, agents, once thought rare, are
found to be ubiquitous (e.g., E. coli O157:H7). The public health
goal then is to prevent the agents from spreading or accumulating in
critical locations, including animals, during critical periods of time.
9.3 IMPORTANT DATA GAPS
1) The authors state, “There exist considerable data gaps for
many important model assumptions” (Page 87). The authors have
done a commendable job of incorporating the available data, but
this also has limited the scope of the model and/or has resulted in
giving certain factors more weight (a larger contribution to the
results) than perhaps is warranted.
2) On Pages 22 and 23 the introduction risks are discussed.
The import of risk material from the UK is assessed properly, but the
import of risk material from third countries seems largely ignored.
The EU concluded long ago that lots of risk material from the UK
was transported via third countries. Switzerland, for example,
mainly got infected via France not directly from the UK. Thus, the
introduction risk is probably underestimated, although it is plausible
that this risk still remains very low.
3) An analysis of all imported MBM and feed in the 1980s
would be welcomed. Confirming evidence that imported MBM was
only used in pet food would also be useful.
4) “Tallow” at least deserves some more comments (Page 34),
given the fact that traces of protein are certainly in there and that
international flow of these products is even more difficult to
quantify.
9-6
10
Usefulness of the
Results for Risk
Management
Reviewers had concerns regarding omission of certain factors and
overemphasis of a few. For example, the model considers the rare
scenario of pneumatic stunning but ignores the more plausible
bioterrorism scenario. We number the reviewers’ comments to
differentiate them.
1) Because there have been extensive evaluations of the BSE
sources leading to the possible BSE infectivity, different scenarios,
and various risk management strategies, the results from the BSE risk
assessment model can be useful to some extent for risk managers to
evaluate options and select strategies to manage the risk of animals
or humans exposed to the infected BSE products or materials if
results from the BSE model are correct. For example, the BSE risk
assessment model was used to evaluate the effect of the
implementation of specified risk material bans on potential human
exposure of BSE. The results from these analyses indicate that there
is a dramatic effect if the bans were used, which provided
implication for risk managers in determining whether the bans
should be implemented. From the base-case analysis, it was found
that the greatest potential source of infectivity in the feed system is
animals that die on the farm and are rendered. These results will be
helpful for risk managers in selecting the appropriate management
strategies in order to reduce the potential risk of animal or human
exposed to BSE. For example, in this case, information from the risk
analysis results will help risk managers determine whether it is
necessary to prohibit the rendering of animals that die on the farm.
10-1
Review of the Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States — Final Report
However, because the BSE model could not distinguish between
variability and uncertainty, and because not enough documentation
is given to show if the BSE model is correctly implemented, the
accuracy of risk analysis results from the BSE model needs further
evaluation; therefore, the implications for risk management are
limited. For example, key questions that should be addressed in the
documentation include: (1) How do we know that the results are
correct? (2) What is the variability across different individuals or
different scenarios? (3) What is the uncertainty in model outputs that
derives from uncertainty in all inputs?
2) The strength of the H-T BSE study is in offering a tool to
characterize measures that can potentially contribute to reduce
spread of BSE infectivity. Also, it helps in identifying pathways or
practices that could contribute most to the spread of a potentially
introduced infectivity. As such, the model and its application are
very useful.
3) A model is relevant if it leads or might lead to a different
conclusion or reaffirms a previous conclusion. The model tells us
no more than our current experience tells us. No BSE has been
detected in the U.S. currently, nor is it likely to occur given existing
practices, so it is not surprising that results of the simulations reveal
that the risk is low, especially when the assumptions are based on
mistakes in rendering and other practices.
4) The risk management aspects have been adopted from
measures instituted in other countries, notably driven by those in
the UK and more latterly in the European Union member states.
The various effects of the risk management procedures have been
assessed in quantitative terms where possible and those with the
most uncertainty identified, notably the misfeeding rate. The risk
management practice of preventing the importation of feedstuffs
potentially contaminated with meat and bone meal has not been
addressed. Similarly, there is no assessment of the true adherence
of the “FDA feed ban” or suggestions as to how this could be
assessed in light of the analytical treatment of the potential leakage
of infected material in the risk assessment model. This said,
consideration has been given to assessing the relative effects of the
risk management practices included in the model.
10-2
Section 10 — Usefulness of the Results for Risk Management
5) The model presents the regulations and “prevailing”
production and processing practices only in general terms. No
regulations appear in the model in detail, and the consequences of
changes in regulation only could affect, for instance, the crude
probability that a BSE-infected animal of a given age passed
inspection. Likewise, no regulation factors for rendered material are
included in the model, only probabilities that rendering mistakes are
made. Emphasis has been placed on practices that increase risk but
not on factors that may reduce risk. The model would have greater
value if the authors had included factors that would allow questions
that ask, “what if regulations are changed?” How would such
changes in regulation reduce the likelihood of prion accumulation
and spread? What are the links between regulation and risk? What
effect would testing cows before parturition have on the variable
ProbTrans?
6) As with most agents of disease, especially newly discovered
agents (emerging diseases), prevalence increases over time largely
because of more and improved testing over time. Regulations and
practices also can change. This has not been incorporated into the
model.
Further, the activities of many researchers are focused on
developing diagnostic tests to detect the agents, products of the
agents, or factors associated with the agents. The model does not
include the probability that such diagnostic tests will become
available during the period simulated.
7) Although the risk of BSE in the U.S. currently appears to be
low, but one of the goals of model building can be to think outside
the box—to test plausible, even if unlikely, assumptions.
10-3

11 User Friendliness of
the Model

snip...

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf


FDA Statement

FOR IMMEDIATE RELEASE
Statement
May 4, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


Statement on Texas Cow With Central Nervous System Symptoms

On Friday, April 30 th , the Food and Drug Administration learned that a
cow with central nervous system symptoms had been killed and shipped to
a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately
began an investigation. On Friday and throughout the weekend, FDA
investigators inspected the slaughterhouse, the rendering facility, the
farm where the animal came from, and the processor that initially
received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been
rendered into "meat and bone meal" (a type of protein animal feed). Over
the weekend FDA was able to track down all the implicated material. That
material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest
because cattle with bovine spongiform encephalopathy or BSE, also known
as "mad cow disease," can exhibit such symptoms. In this case, there is
no way now to test for BSE. But even if the cow had BSE, FDA's animal
feed rule would prohibit the feeding of its rendered protein to other
ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and
informing the firm that FDA will not object to use of this material in
swine feed only. If it is not used in swine feed, this material will be
destroyed. Pigs have been shown not to be susceptible to BSE. If the
firm agrees to use the material for swine feed only, FDA will track the
material all the way through the supply chain from the processor to the
farm to ensure that the feed is properly monitored and used only as feed
for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian
protein out of animal feed for cattle and other ruminant animals. FDA
established its animal feed rule in 1997 after the BSE epidemic in the
U.K. showed that the disease spreads by feeding infected ruminant
protein to cattle.

Under the current regulation, the material from this Texas cow is not
allowed in feed for cattle or other ruminant animals. FDA's action
specifying that the material go only into swine feed means also that it
will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates
closely with the U.S. Department of Agriculture on all BSE issues. The
animal feed rule provides crucial protection against the spread of BSE,
but it is only one of several such firewalls. FDA will soon be improving
the animal feed rule, to make this strong system even stronger.

####

rule

OOPS!

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

------------------------------------------------------------------------

Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported
that a cow
in Washington state had tested positive for bovine spongiform
encephalopathy (BSE, or mad cow disease). As a result, information on
this Web page stating that no BSE cases had been found in the United
States is now incorrect. However, because other information on this page
continues to have value, the page will remain available for viewing.

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT

Today the Food and Drug Administration announced the results of tests
taken on feed used at a Texas feedlot that was suspected of containing
meat and bone meal from other domestic cattle -- a violation of FDA's
1997 prohibition on using ruminant material in feed for other ruminants.
Results indicate that a very low level of prohibited material was found
in the feed fed to cattle.

FDA has determined that each animal could have consumed, at most and in
total, five-and-one-half grams - approximately a quarter ounce -- of
prohibited material. These animals weigh approximately 600 pounds.

It is important to note that the prohibited material was domestic in
origin (therefore not likely to contain infected material because there
is no evidence of BSE in U.S. cattle), fed at a very low level, and fed
only once. The potential risk of BSE to such cattle is therefore
exceedingly low, even if the feed were contaminated.

According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
Commissioner, "The challenge to regulators and industry is to keep this
disease out of the United States. One important defense is to prohibit
the use of any ruminant animal materials in feed for other ruminant
animals. Combined with other steps, like U.S. Department of
Agriculture's (USDA) ban on the importation of live ruminant animals
from affected countries, these steps represent a series of protections,
to keep American cattle free of BSE."

Despite this negligible risk, Purina Mills, Inc., is nonetheless
announcing that it is voluntarily purchasing all 1,222 of the animals
held in Texas and mistakenly fed the animal feed containing the
prohibited material. Therefore, meat from those animals will not enter
the human food supply. FDA believes any cattle that did not consume feed
containing the prohibited material are unaffected by this incident, and
should be handled in the beef supply clearance process as usual.

FDA believes that Purina Mills has behaved responsibly by first
reporting the human error that resulted in the misformulation of the
animal feed supplement and then by working closely with State and
Federal authorities.

This episode indicates that the multi-layered safeguard system put into
place is essential for protecting the food supply and that continued
vigilance needs to be taken, by all concerned, to ensure these rules are
followed routinely.

FDA will continue working with USDA as well as State and local officials
to ensure that companies and individuals comply with all laws and
regulations designed to protect the U.S. food supply.

------------------------------------------------------------------------
OOPS!

http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

> FDA has determined that each animal could have consumed, at most and
> in total, five-and-one-half grams - approximately a quarter ounce --
> of prohibited material. These animals weigh approximately 600 pounds.
>

r i g h t ...............not


BSE/TSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news] (audio realplayer LISTEN)

http://www.vegsource.com/talk/madcow/messages/9912425.html


From: TSS (216-119-144-34.ipset24.wt.net)
Subject: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE
(PRIMATE STUDY)
Date: January 27, 2005 at 7:03 am PST

Risk of oral infection with bovine spongiform encephalopathy agent in
primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown,
Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob
disease (vCJD)--is compounded by incomplete knowledge about the
efficiency of oral infection and the magnitude of any bovine-to-human
biological barrier to transmission. We therefore investigated oral
transmission of BSE to non-human primates. We gave two macaques a 5 g
oral dose of brain homogenate from a BSE-infected cow. One macaque
developed vCJD-like neurological disease 60 months after exposure,
whereas the other remained free of disease at 76 months. On the basis of
these findings and data from other studies, we made a preliminary
estimate of the food exposure risk for man, which provides additional
assurance that existing public health measures can prevent transmission
of BSE to man.

Published online January 27, 2005

http://www.thelancet.com/journal/journal.isa

TSS


United Press International: USDA vet: Texas mad cow breach not unique...
Published 5/4/2004 5:01 PM WASHINGTON

http://www.upi.com/view.cfm?StoryID=20040504-012834-2365r


United Press International: USDA orders silence on mad cow in ...
Published 5/11/2004 10:16 PM WASHINGTON

http://www.upi.com/view.cfm?StoryID=20040511-015527-4917r


Feds reviewing Texas mad cow breach - (United Press International)
By Steve Mitchell United Press International.
Washington, DC, May. 5 (UPI) -- The US Department ...

http://washingtontimes.com/upi-breaking/20040505-064316-1509r.htm


No mad cow tests at Texas firm in 2004

By Steve Mitchell
United Press International
Published 5/14/2004 11:06 AM

WASHINGTON, May 14 (UPI) -- The U.S. Department of Agriculture did not
test any cows for mad cow disease in the past seven months at the same
Texas facility where federal testing policies for the deadly disorder
were violated last month, United Press International has learned.

http://www.upi.com/view.cfm?StoryID=20040513-065401-5285r

USDA Ordered that Suspected Mad Cow in Texas Not Be Tested.
USDA's San Angelo vets and techs ordered not to test suspect cow.
by Daniel ...

USDA Ordered that Suspected Mad Cow in Texas Not Be Tested

USDA's San Angelo vets and techs ordered not to test suspect cow

by Daniel Yovich on 5/5/04 for Meatingplace.com

It was a trio of Agriculture Department staff < two veterinarians and one
technician < who were supposed to follow agency protocol by testing what
they determined was an older cow that likely had a central nervous system
disorder when it arrived April 27 at the Lone Star Beef plant in San Angelo,
Texas.

One government source and another within the industry, both of whom say they
have firsthand knowledge of events that day, said the final call on not to
test the animal was made by an APHIS supervisor in Austin, Texas, after an
APHIS technician at the plant advised her supervisor she was preparing to
take a tissue sample from the culled animal for BSE testing. Both sources
spoke to Meatingplace.com on condition of anonymity, and USDA officials did
not return telephone calls Tuesday seeking comment and confirmation of the
allegations.

What USDA has confirmed is that the agency's standard operating procedures
call for animals condemned due to a possible CNS disorder be kept until
APHIS officials can collect samples for testing. That clearly was done in
this case. The animal sat for more than 90 minutes and less than two hours
after it was condemned, stunned and killed before the APHIS tech told Lone
Star Beef management to dispose of the animal "in a routine manner."

As a condemned cow, there was never any chance that the meat from the animal
would enter the food chain. What is less clear is what went wrong at USDA
and why.

USDA spokesman Ed Loyd said the agency was conducting an investigation into
the issue < attempting to establish a timeline and chronology of who was
involved and who made the decisions last week in San Angelo.

What is clear, in the mind of the two sources who spoke to Meatingplace.com
, is that all three of USDA's key decision makers on the ground at the San
Angelo plant were overruled by a staffer with more authority in Austin.

"Everybody expected a test, and then the word came that there wasn't going
to be any test," one source said. "I'm not sure why that decision was made,
and I'm not going to speculate about the reasons for it. But I think what
USDA is going to find is that the final decision was made up the food chain,
and I think a lot of people will be interested in why that decision was
made."


http://www.organicconsumers.org/madcow/notest050704.cfm


Forums - Congressman Waxman's Letter and Texas Mad Cow
http://www.prwatch.org/forum/showthread.php?t=4292&goto=nextnewest
June 12th, 2004, 01:59 PM, #1. Terry. Registered User. Join Date: Oct
2002. Location:
Bacliff, Texas. Posts: 408. Congressman Waxman's Letter and Texas Mad
Cow. ...


Letter and Texas Mad Cow
http://www.prwatch.org/forum/archive/index.php/t-4359.html
Forums > Books by PR Watch Staff > Mad Cow USA > Congressman Waxman's
Letter
and Texas Mad Cow. View Full Version : Congressman Waxman's ...

-------- Original Message --------
Subject: MAD COW CONFIRMED TEXAS COW (rumor)
Date: Mon, 22 Nov 2004 17:16:23 -0600
From: "Terry S. Singeltary Sr."
Reply-To: BSE-L

http://www.vegsource.com/talk/madcow/messages/93583.html


Re: MAD COW CONFIRMED TEXAS COW (rumor)

http://www.vegsource.com/talk/madcow/messages/93584.html


BSE ( test results ;-) Texas Animal Health Commission News Release ...

Counting that one and the other positive, positive, inconclusive, and
finally
declared and documented as negative cows (NO WB), the USA in my ...

http://www.vegsource.com/talk/madcow/messages/93884.html

Re: ''INCONCLUSIVE'' IS NEGATIVE or so they claim...OFFICIAL ...

would not be telling us of any 'inconclusive', but > they ... because
the likelihood >
of it > being positive was very ... tell you why, they wanted a negative
so bad ...

http://www.vegsource.com/talk/madcow/messages/93990.html


Forums - Mad Cow USA
... 2nd Positive Inconclusive Negative For Bse Usa; 1st Positive
Inconclusive Is Negative; ...
PUBLIC COMMENTS ON USDA’S DOWNED ANIMAL BAN: [Docket No. ...

http://www.prwatch.org/forum/archive/index.php/f-11.html


Forums - Dr. Ron DeHaven DOING THE MAD COW TEXAS TWO-STEP AGAIN
... Dec 2, that IHC- DOES NOT MEAN IT IS NEGATIVE. ... so many
errors (i am assuming X meant
inconclusive), why are ... at the sheep that tested IHC- but were
positive''. ...

http://www.prwatch.org/forum/showthread.php?t=5264


CJD WATCH... positive and histopathology and immunohistochemistry
negative) with the ... 2005 positive
The case was confirmed on ... Origin of infection: unknown or
inconclusive. ...

http://disc.server.com/discussion.cgi?disc=167318;article=1927;title=CJD%20WATCH

Re: BSE 'INCONCLUSIVE' IN USA, FROM TEXAS ???

... Date: February 1, 2005 at 3:08 pm PST. In Reply to: Re: BSE
'INCONCLUSIVE' IN USA,
FROM TEXAS ??? posted by TSS on November 19, 2004 at 9:41 am: ...

http://www.vegsource.com/talk/madcow/messages/93989.html


BSE 'INCONCLUSIVE' IN USA, FROM TEXAS ???

http://www.vegsource.com/talk/madcow/messages/93563.html


Forums - View Single Post - Re: MAD COW CONFIRMED TEXAS COW (rumor ......
Harrison >> November 22, 2004 >> >> Test results for the BSE
inconclusive are not ...
was just this...damn, >> i will not sleep tonight/// >> TSS >> >>

http://www.prwatch.org/forum/showpost.php?p=12049&postcount=3


Forums - Bse Usa 'inconclusive' Test Reported Nov. 18, 2004
... Because this test is only an inconclusive test result, we ...
animal presented for slaughter is sampled for BSE, holding the ...
tss USDA News oc.news@usda.gov

http://www.prwatch.org/forum/showthread.php?t=5160


Nebraska Outdoor Forum: Study of Atypical Bse Project Number: 3625
.. ars.usda.gov/is/AR/archive/dec04/ TSS Terry S ... mice from the
experimental cow brain
had been inconclusive. ... clinical signs of brain lesions
characteristic of BSE. ...

http://www.ngpc.state.ne.us/cgi-bin/ultimatebb.cgi?ubb=get_topic;f=12;t=000385


CJD WATCH

... that the USA is now facing, an epidemic of > ''INCONCLUSIVE''
TSEs...TSS > > Terry
S ... 5:15 this evening, we were notified that an >> inconclusive BSE
test result ...


http://disc.server.com/discussion.cgi?disc=167318;article=1490;title=CJD%20WATCH


-------- Original Message --------
Subject: US CHOICE OF MAD COW TEST QUESTIONED
Date: Wed, 24 Mar 2004 16:12:06 -0600
From: "Terry S. Singeltary Sr."
Reply-To: BSE-L


US CHOICE OF MAD COW TEST QUESTIONED

SNIP...END


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW
BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

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

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########





Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: