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From: TSS ()
Subject: TESTIMONY OF THE HONORABLE MIKE JOHANNS USDA BEFORE U.S. HOUSE OF REPS. COMM. ON AGRICULTURE MARCH 1, 2005
Date: March 5, 2005 at 8:52 am PST

-------- Original Message --------
Subject: TESTIMONY OF THE HONORABLE MIKE JOHANNS USDA BEFORE U.S. HOUSE OF REPS. COMM. ON AGRICULTURE MARCH 1, 2005
Date: Sat, 05 Mar 2005 10:51:47 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: Agriculture@mail.house.gov


1
TESTIMONY OF THE HONORABLE MIKE JOHANNS
UNITED STATES DEPARTMENT OF AGRICULTURE
BEFORE THE U.S. HOUSE OF REPRESENTATIVES
COMMITTEE ON AGRICULTURE
MARCH 1, 2005
Chairman Goodlatte, Mr. Peterson, Members of the Committee, thank you for
holding this important hearing today and for the opportunity to testify
before you.
Accompanying me today are Dr. Keith Collins, USDA’s Chief Economist and
Dr. Ron
DeHaven, Administrator of USDA’s Animal and Plant Health Inspection Service
(APHIS). They will be available to assist me in answering any questions
you might have.
Before I begin, I want to thank you for the close, positive working
relationships
that we have begun forging. It is a pleasure to appear in my first
hearing before this
Committee as Secretary, and I look forward to building upon the
productive foundation
that we are establishing on behalf of American food and agriculture.
I have said frequently that addressing Bovine Spongiform Encephalopathy
(BSE)
issues, particularly as they relate to trade disruptions, would be my
top priority as
Secretary. The actions that the U.S. Department of Agriculture and the
federal
government are taking in regard to BSE are potentially precedent-setting
and could affect
international trade patterns for years to come, with important economic
implications for
our cattle producers and the entire beef industry. Therefore, our
actions must be
undertaken with the utmost deliberation, using science as the basis. In
the absence of that
scientific-foundation, sanitary and phytosanitary (SPS) restrictions
will be used arbitrarily
by many nations, without any basis of protecting human, animal and plant
life and health.
Accordingly, this hearing could not be timelier, and I appreciate the
opportunity it
provides to closely examine some useful and valid questions. I want to
be very clear that
while protecting human and animal health must remain our top priorities,
I am confident
that we can seek to return to normal patterns of international commerce
in beef and cattle
by continuing to use science as the basis for decision making by U.S.
regulatory
authorities and our trading partners.
Almost one year ago, on March 8, 2004, USDA published a notice reopening the
comment period on a rule to establish minimal-risk regions for BSE (the
“minimal-risk
rule”), following the December 23, 2003, discovery of a single case of
BSE in the United
States in a cow of Canadian origin.
In the time since then, much has transpired:
On March 15, 2004, consistent with the recommendations of an International
Review Team (IRT) of scientific advisers, USDA announced that beginning
June 1 it
would implement an enhanced BSE surveillance program to test as many
high-risk
2
animals as possible over a 12- to 18-month period. We wanted once and
for all to
clearly ascertain whether we had BSE in our cattle herd and, if so, how
prevalent it might
be. USDA began the work of setting up the infrastructure required,
including laboratory
equipment and certification, staff training, outreach efforts, and
licensing and approval of
rapid tests. The plan was reviewed by the IRT, which characterized it as
“comprehensive, scientifically based and address[ing] the most important
points
regarding BSE surveillance in animals.”
On June 1, 2004, the enhanced surveillance program began. Our goal is to
test as
many high-risk cattle as possible in 12-18 months. If we test 268,500
high risk animals
we will be able to detect the presence of as few as five targeted,
high-risk cattle with BSE
at a 99 percent confidence level. At the time, USDA officials
consistently stated that the
surveillance plan might uncover additional BSE-positive animals. To
date, some nine
months later, more than 242,000 high-risk animals have been tested, all
of which have
been negative.
In order to help raise awareness among animal-health professionals and
livestock
producers about potential BSE cases, education and outreach have also
been critical
components of these efforts. These activities have included
advertisements in industry
publications, media articles, presentations at trade shows, and other
materials. The role
of producers, renderers and others in helping obtain samples of
high-risk animals has
been indispensable to the success of our surveillance program, and the
cooperation we
have received has been outstanding.
On December 29, 2004, USDA announced the final rule establishing
minimal-risk
regions, which designated Canada as the first minimal-risk region for
BSE, and which
will become effective on March 7, 2005. Preparations are currently
underway to ensure a
coordinated and orderly reopening of the border on that date.
On January 2, 2005, Canada confirmed its second domestic case of BSE in
a cow
that was born in October of 1996 (the first since May 20, 2003). It was
followed nine
days later by a third case, an 81-month-old cow.
On January 24, 2005, USDA dispatched a technical team to Canada. We sent the
team to investigate the efficacy of Canada’s ruminant to ruminant feed
ban because the
animal was born shortly after the implementation of that ban and to
determine if there are
any potential links among the positive animals. We have appreciated Canada’s
willingness to cooperate and assist us in these efforts.
The team was composed of experts from APHIS and other relevant, partner
agencies.
Just last week, on February 25, we released the results of the
investigation relating
to Canada’s feed ban. Based on a review of inspection records and
on-site observations,
the team found that Canada has a robust inspection program, that overall
compliance with
the feed ban is good, and that the feed ban is reducing the risk of
transmission of BSE in
3
the Canadian cattle population. Where isolated issues were found to
exist, they were
related mostly to areas of documentation and record-keeping.
The team’s final epidemiological report investigating possible links of
the positive
animals is still pending, and will be helpful as USDA proceeds with a
rule allowing
imports of live cattle from animals 30 months of age and over.
The Minimal-Risk Rule
As you are aware, USDA’s minimal-risk rule has come under legal challenge. I
will address the process of promulgating the rule, which was
transparent, deliberative and
science-based.
Two rounds of public comment were conducted on the rule, with more than
3,300
comments received.
The final rule establishes criteria for geographic regions to be
recognized as
presenting minimal risk of introducing BSE into the United States. It
places Canada in
the minimal-risk category, and defines the requirements that must be met
for the import
of certain ruminants and ruminant products from Canada. A minimal-risk
region can
include a region in which BSE-infected animals have been diagnosed, but
where
sufficient risk-mitigation measures have been put in place to make the
introduction of
BSE into the United States unlikely.
As you are aware, the rule originally allowed the import of beef
products from
animals of all ages. However, on February 9, 2005, because our
investigation in Canada
would not be complete by March 7, I ordered that the portion of the rule
allowing beef
products from animals 30 months and over be delayed. USDA plans to move
forward
expeditiously with a plan including rule-making to allow imports of live
cattle from
animals over 30 months of age and over.
Because the rule that goes into effect on March 7 allows the import of
live cattle
under 30 months of age, it is useful to note the risk mitigation
measures. These include:
proper animal identification; accompanying animal health certification
that includes
information on age, origin, destination, and responsible parties; the
movement of the
cattle to feedlots or slaughter facilities in sealed containers; the
prohibition on cattle
moving to more than one feedlot in the United States; and just as in
U.S. cattle, the
removal of specified risk materials (SRMs) at slaughter.
For live sheep and goats under 12 months of age, all of the same mitigation
measures apply, except for the requirement that SRMs be removed from the
animal at
slaughter.
We remain very confident that the combination of all of these
requirements, in
addition to the animal and public health measures that Canada has in
place to prevent the
4
spread of BSE, along with the extensive U.S. regulatory food-safety and
animal-health
systems, provide the utmost protection to U.S. consumers and livestock.
USDA continues to undertake several steps to ensure Canada’s compliance with
its BSE regulations. In addition to the investigation that I already
discussed, USDA’s
Food Safety and Inspection Service in December 2004 conducted an
intensive audit of
Canada’s compliance with the BSE requirements of the United States, with
particular
attention to SRM removal. FSIS visited several facilities that slaughter
cattle under 30
months of age and determined that they are effectively implementing the BSE
regulations.
Last month, FSIS conducted a similar BSE audit of Canadian plants that
slaughter
cattle 30 months and older. Canada currently has only seven such plants
that are certified
to export meat to the United States.
The Role of Science
I simply cannot emphasize strongly enough the central role of science in
this
entire process, particularly with regard to the rigorous evaluation of risk.
Since the discovery of the first case of BSE in Great Britain in 1986,
we have
learned a tremendous amount about this disease. That knowledge has
greatly informed
our regulatory systems and response efforts.
We have learned that the single most important thing we can do to
protect human
health regarding BSE is the removal of SRMs from the food supply. It is
because of the
strong systems the United States has put in place already, especially
the removal of
SRMs from the human food supply and the prohibition of ruminant and
certain other
animal proteins in ruminant feed, that we can be confident of the safety
of our beef
supply and that the spread of BSE has been prevented in this nation.
After Canada reported its first case of BSE in May 2003, USDA conducted a
comprehensive risk analysis to review the potential threat it posed. The
initial analysis
followed the recommended structure of the World Organization for Animal
Health, or
OIE, and drew on findings from the Harvard-Tuskegee BSE risk assessment,
findings
from the epidemiological investigation of BSE in Canada, and information
on Canadian
BSE surveillance and feed ban, and history of imports of cattle and meat
and bone meal
from countries known to have BSE.
The results of that analysis, available on the USDA Website, confirmed that
Canada has the necessary safeguards in place to protect U.S. consumers
and livestock
against BSE. These mitigation measures include the removal of SRMs from
the food
chain supply, a ruminant-to-ruminant feed ban, a strong national
surveillance program
and import restrictions. The extensive risk assessment conducted as part
of USDA’s
rulemaking process also took into careful consideration the possibility
that Canada could
experience additional cases of BSE.
5
In the risk analysis update for the final rule, USDA also considered the
additional
risk protection from new slaughter requirement procedures, such as the
prohibition on the
use of downer animals for food.
The public commented on the risk assessment that accompanied the
proposed rule
and the Explanatory Note released following the finding of BSE in a cow
in Washington
State. Over a period of months, USDA carefully considered these
comments, and
responses were published with the final rule. The comments were
beneficial to the final
risk analysis. The risk analysis was reviewed internally at USDA and by
Dr. William
Hueston, an international expert on BSE and a member of the
International Review
Team.
The OIE recommends the use of risk assessment to manage human and animal
health risks of BSE. OIE guidelines, based on current scientific
understanding, recognize
that there are different levels of risk in countries or regions, and
suggest how trade may
safely occur according to the levels of risk. USDA used the OIE
guidelines as a basis in
developing our regulations defining Canada as a minimal risk country.
Cattle and Beef Trade Impacts
While SPS regulations protecting human and animal health are the foremost
concern, USDA also has examined the potential economic impacts of the
minimal-risk
rule and related BSE trade issues, as required by Executive Order 12866.
For more than three months following the May 20, 2003, BSE discovery in
Canada, all imports of Canadian ruminants and ruminant products were
barred. Then,
certain Canadian ruminant products for which there is inherently lower
risk were allowed
to enter under permit beginning August 2003.
For all of 2003, the United States imported 336,000 metric tons of beef from
Canada. Imports increased to an estimated 476,000 metric tons in 2004,
up nearly 42
percent and back to about the level that prevailed in years prior to 2003.
Because the border has been closed to live cattle since May 2003,
imports of fed
and feeder cattle under 30 months are expected to increase over historic
levels in 2005,
which is expected to drive up U.S. beef production, reduce beef prices
slightly and,
consequently, reduce cattle prices. The cost-benefit analysis of the
original minimal risk
rule was based on Canada’s cattle population as of July 1, 2004, and the
cross-border
price differential at that time. USDA now estimates that about 1.3
million Canadian
animals may be imported in all of 2005, down from previous estimates of
1.5 million to 2
million head.
In addition, delaying the effective date for resuming import of beef
products from
animals over 30 months has narrowed our projection of price effects. We
now project a
6
decline in fed cattle prices of 2.6 percent lower than if no additional
trade in live cattle
were to occur, down from 3.2 percent in the earlier projection. The
projection also
assumes that Asian markets do not open to our beef during 2005.
The precise economic effects will depend on the timing and volume of
cattle and
beef imports from Canada. If USDA’s price forecast turns out to be
correct, that would
be the third-highest annual fed cattle price on record. Cattle futures
prices may be less
affected than indicated by our forecast, as market prices have likely
already reflected
some probability of the border opening.
At the same time, I have been concerned about the effect that the
closure of the
border has been having on the restructuring of the cross-border beef
industry. We are
already seeing additional processing capacity in Canada, and further
delays will only
exacerbate that trend, leading to long-term change.
In addition, to the extent that we can continue to open markets that are
currently
closed to our beef, U.S. cattle price prospects will strengthen.
U.S. market-maintenance activities have been critical in helping restore
our beef
export markets. In 2003, the total export value of U.S. beef and
ruminant products was
$7.5 billion. After December 23, 2003, 64 percent of that market was
immediately
closed. Today, we have recovered well over a third of that, so that 41
percent of that
market ($3.1 billion) remains closed. Two countries – Japan ($1.5
billion) and Korea
($800 million) – account for nearly three-quarters of the existing closures.
Opening the Japanese Market
As a leader in the critical Asian markets, Japan is a vital market to
reopen to U.S.
beef exports. We are aware that the decision to resume trade in this
market will set an
important precedent for trade resumption in many other markets.
Therefore we have
endeavored to use science in our ongoing efforts. Efforts to re-open
this market have
drawn on resources across the federal government and at the highest
political levels. As I
have previously said, this issue has occupied much of my first few days
as Secretary.
Just last week, I met with Ambassador Kato and also wrote to my
counterpart, Minister
Shimamura, on the importance of this issue. At the same time, Ambassador
Baker
continued to press this issue with Government of Japan officials until
his very last days in
Tokyo, and other U.S. Government officials continue to contact their
counterparts. On
February 19, Secretary of State Rice personally raised this issue in a
meeting with the
Japanese Foreign Minister.
These efforts are just the latest in many policy discussions and technical
exchanges over the past 13 months. Indeed, the issue has been a major
focus of direct
discussions between President Bush and Japanese Prime Minister Koizumi.
On October 23, 2004, Japan and the United States developed a framework to
allow the resumption of bilateral beef trade following the conclusion of
regulatory
7
processes in both countries. As a step toward the resumption of normal
trade, the
agreement establishes an interim special marketing program, known as the
Beef Export
Verification (BEV) Program, to allow the United States to sell beef and
beef products to
Japanese importers from animals 20 months of age and under. Animal age
will be
determined through a combination of production records and physiological
(grading)
means. We are now working with Japanese officials to gain approval of
the BEV under
their regulatory process.
I have repeatedly pressed Japanese officials to set a date certain for the
resumption of U.S. beef exports to Japan. However, additional requests
from Japan for
data regarding grading and the plodding regulatory process that Japan
insists on using
could delay that process. Additional delays could further complicate
relations between
the United States and Japan.
While we are focusing on Japan because of our important trading
relationship and
its leadership role in the region, we are also pursuing efforts to
reopen all of the markets
that have been closed to us. We are actively engaged with Korea, Hong
Kong, Taiwan,
China, Egypt, and Russia and have specific actions underway in each
market to get trade
resumed. I would be pleased to provide Members upon request additional
detail on these
and other secondary markets. While the progress that has been made has
taken far longer
than we had hoped, progress is indeed being made. And, I have stated
that USDA, and
indeed the entire U.S. Government, will exert every effort to resolve
the matter at the
earliest possible time.
Conclusion
As traditional trade barriers such as tariffs are lowered, our focus to
eliminate
unjustified non-tariff barriers such as non-science based SPS regulatory
measures become
all the more important to maintain the flow of mutually beneficial
trade. For USDA, a
common touchstone across these issues is the need to maintain
consistency and
predictability, to base our domestic regulations on science and to
encourage the use of
science-based solutions within the international community. The United
States has long
been a leader in this regard, including negotiating the World Trade
Organization
Agreement on the Application of Sanitary and Phytosanitary Measures
during the
Uruguay Round.
Even before the discovery of a single case of BSE in the United States, USDA
had begun talking with other countries about the need for international
trade standards to
keep pace with the science, and we will redouble our efforts in this regard.
It is also critical that domestic trade rules reflect the current state
of knowledge
regarding BSE, and here the United States is leading, as well. We are
confident that trade
can be resumed with countries where BSE has been discovered, contingent
upon strong
protections within those countries, as well as the robust and effective
regulatory system
those imports are subject to when they enter the United States. These
facts are reflected
in the minimal-risk rule.
8
At the same time, we will continue to work with our trading partners to
ensure the
ongoing strength of their own BSE protection systems, especially the
removal of SRMs
and implementation of the feed ban. While trade opportunities are
multiplying in an
increasingly global marketplace, we must always remain mindful of our
paramount
responsibility to protect the public health and animal health.
In summary, I am confident that we are continuing to keep the protection of
public and animal health foremost in our concerns. It is critical that
we continue to use
science as a basis for our decisions and regulations, and that the
United States maintain
its leadership role in advancing our scientific understanding of these
kinds of SPS-related
issues and appropriate science-based responses.
Mr. Chairman, thank you once again for holding this important hearing. I
would
now be pleased to take any questions you or other members may have.
###TSS

http://agriculture.house.gov/hearings/109/h50301w1.pdf

Accompanied by:

Dr. Ron DeHaven, Administrator, Animal & Plant Health Inspection Service,

Dr. Keith Collins, Chief Economist

Mr. Chuck Kiker, Region 5 Director, R-CALF United Stockgrowers of
America, Beaumont, TX

http://agriculture.house.gov/hearings/109/h50301w2.pdf

Mr. Jim McAdams, President, National Cattlemen’s Beef Association,
Adkins, TX

http://agriculture.house.gov/hearings/109/h50301w3.pdf

Mr. Ken Bull, Vice President for Cattle Procurement, Cargill Meat
Solutions, Wichita, KS

http://agriculture.house.gov/hearings/109/h50301w4.pdf

Mr. Carl Kuehne, President, American Foods Group, Green Bay, WI

http://agriculture.house.gov/hearings/109/h50301w5.pdf

> The risk analysis was reviewed internally at USDA and by Dr. William
> Hueston, an international expert on BSE and a member of the
> International Review
> Team.

Will Hueston, quoted below on the PBS News Hour, is a tainted expert. He
represented the USDA on Oprah Winfrey’s show April 16, 1996, when
Oprah’s guest Howard Lyman warned that in the US cattle were being fed
to cattle and that unless the practice was halted mad cow disease would
come to the US. Lyman has been unfortunately proven correct.

A month later in May 1996, Lyman and Winfrey were sued for the
dubious crime of “food disparagement” under a Texas law lobbied
into place by the animal feed industry.

Will Hueston became a highly-paid ($25,000 I was told by one source)
expert witness for the cattle feed lot owners trying to convict Oprah
and win tens of millions of dollars from her. Oprah and Lyman eventually
won, but the case cost Oprah many millions of dollars and succeeded in
dampening US media coverage of mad cow threats.

Below is an article off my website reporting on the trial and on how
Hueston was reduced to tears by Oprah’s attorney after he compared the
scene during her TV show to a lynching. How embarrassing, but at least
he pocketed his fee and obviously hasn’t hurt his standing with the USDA
or the press.

------------------
http://www.prwatch.org/prwissues/1998Q1/oprah.html

Will Hueston, the USDA official who appeared on Oprah's mad cow segment,
used similar language during his courtroom testimony, complaining of a
"lynch mob mentality" because he had heard people in the studio audience
whispering that "You can't trust the government." In one of the most
bizarre moments of the trial, Winfrey's attorney reminded Hueston that
"lynch mob" was a term referring to the use of clubs, nooses and torches
against black slaves. Under cross-examination, Hueston burst into tears,
apologized to Winfrey, and attempted to portray himself as a civil
rights worker who had been persecuted as a child for having black friends.


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

Hueston continues to misrepresent the animal feed situation today in his
statement below on the PBS Newshour. For example in both the US and
Canada calves are still weaned on milk replacer and milk formula
containing cattle blood protein, even though blood can transmit mad cow
type disease.

The United States is completely hypocritical when it points the
finger at Canada and says mad cow is a Canadian problem. Neither
the US nor Canada has taken the steps necessary to stop the spread
of the disease which has probably been amplifying and spreading in
both countries for a decade.

The necessary steps to solve the problem of mad cow disease are
well known and are working in the EU countries and Japan: a
complete ban on the feeding of rendered slaughterhouse waste to
livestock and the testing of millions of animals.

Tyson, Cargil, AMI, NCBA and their friends in the White House continue
to oppose these steps for the sake of access to cheap feed from
slaughterhouse waste. USDA experts like Hueston continue to confuse and
falsely assure the public and the press.

John Stauber, co-author, Mad Cow USA

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

CANADIAN BEEF

PBS - USA


Will Hueston, a USDA consultant and BSE expert at the University of
Minnesota, says there's little danger to public health. Besides the
surveillance program, he says the source of contagion, feed supplements
that contained cattle parts, has been removed.

DR. WILL HUESTON: We were taking the parts of the cattle that we didn't
eat, that humans don't eat. We were cooking those to remove the fat, and
the material, the protein that was left was ground up and, in fact, used
as a protein supplement.

FRED DE SAM LAZARO: Which is now out of circulation?

DR. WILL HUESTON: -- is now out of circulation.


=========================

> Will Hueston, a USDA consultant and BSE expert at the University of
> Minnesota, says there's little danger to public health. Besides the
> surveillance program, he says the source of contagion, feed
> supplements that contained cattle parts, has been removed.

Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


January 12, 2005

Ref: 2005-DAL-WL-11

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. William L. Brown, Owner
Brown Cattle Company
1 Feed Lot Road
P.O. Box 281
Petrolia, TX 76377

Dear Mr. Brown:

An inspection of your ruminant feeding operation located at 1 Feed Lot
Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004
by an Investigator from the Food and Drug Administration (FDA). The
inspection found significant deviations from
the requirements set forth in Title 21, Code of Federal Regulations,
Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR
589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by
21 CFR 598.2000(a), to ruminants. This prohibited material consists of
human food processing waste, which is derived from corn dog
manufacturing and contains hot dogs and corn dogs. Inspected meat
products that have been cooked and offered for human food and further
heat processed for animal feed are not prohibited material. This is more
fully described in Guidance for Industry 76, which was previously
provided to your firm. The human food processing waste you are using has
not been further heat processed. The failure to further heat process
this material causes the feed to be adulterated within the meaning of
Section 402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act.

During our previous inspection on January 17, 2002, copies of the BSE
Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE
regulation, were provided to and discussed with you.

Failure to correct these violations may result in FDA taking regulatory
action without further notice including, but not limited to, seizure
and/or injunction.

It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date
you received this letter. Your response should specifically identify the
actions you are taking to correct the violations and provide specific
timeframes for achieving compliance. Also, as part of your written
response, you should provide information regarding the current feeding
practices followed at your facility and information pertaining to the
planned marketing of your animals. Your reply should be sent to Edwin
Ramos, Compliance Officer, at the above stated address. If you have any
questions concerning the stated matters, you may contact Mr. Ramos at
214-253-5218.

Sincerely,

/s/

Michael A. Chappell

Dallas District Director

http://www.fda.gov/foi/warning_letters/g5175d.htm


Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145

February 7, 2005

Ref: 2005-DAL-WL-12

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Dwayne Woody, Owner
W.W. Cattle Company
6391 Old Agnes Road
Poolville, TX 76487

Dear Mr. Woody:

An inspection of your feed manufacturing operation located at 6391 Old
Agnes Road, Poolville, Texas, was conducted on August 27 and September
2, 2004 by an Investigator from the Food and Drug Administration (FDA).
The inspection found significant deviations from the requirements set
forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). Because you failed to follow the
requirements of this regulation, the corn dogs containing cooked meat
and other ingredients used for manufacturing ruminant feed are
adulterated within the meaning of Section 402(a)(2)(C)(i) and misbranded
within the meaning of Section 403(a)(1) of the Federal, Food, Drug and
Cosmetic Act (the Act).

The use of protein derived from mammalian tissues, as defined in 21 CFR
589.2000(a)(1), as an animal feed ingredient or in animal feeds must
comply with the requirements of 21 CFR 589.2000. That regulation
provides that the use of protein derived from mammalian tissues in
ruminant feed is prohibited. The definition of “protein derived from
mammalian tissues” excludes inspected meat products which have been
cooked and offered for human food, such as the corn dogs you receive,
that have been further heat processed for use in animal feed. This
requirement was previously communicated to you in an April 3, 2001
letter from the Texas State Feed and Fertilizer Control Service. In the
absence of the required further heat processing, such products for use
in ruminant feeds are adulterated under Section 402(a)(2)(C)(i) of the Act.

Our inspection revealed that whole corn dogs which contain protein
derived from mammalian tissues and are sold by your firm to the
[redacted] for use in ruminant feed are not subjected to further
adulterated feed under Section 402(a)(2)(C)(i) of the Act.

In addition, because the whole corn dogs are not subjected to further
heat processing and are thus not exempt from the regulation, they must
bear the caution statement, “Do not feed to cattle or other ruminants.”
Our inspection revealed that they do not bear this caution statement,
which causes them to be misbranded animal feed under Section 403(a)(1)
of the Act.

Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr.
Billy J. Brooks, General Manager, and further discussed by personnel
from the Texas Feed and Fertilizer Control Service. Also, you received a
copy of the 21 CFR 589.2000, the BSE regulation which was again
explained in more specific detail. These serious violations of the law
may result in FDA taking regulatory action without further notice to
you. These actions include, but are not limited to, seizure and/or a
court injunction against further sale of protein derived from mammalian
tissues for use in ruminant feed or ruminant feed containing such
materials.

It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date
you received this letter. Your response should specifically identify the
actions you are taking to correct the violations that would involve the
continued use of corn dogs to manufacture ruminant feed and provide
specific timeframes for achieving compliance. Your reply should be sent
to Edwin Ramos, Compliance Officer, at the above stated address. If you
have any questions concerning the stated matters, you may contact Mr.
Ramos at 214-253-5218.

Sincerely,
/s/

Michael A. Chappell
Dallas District Director

http://www.fda.gov/foi/warning_letters/g5184d.htm

TSS

Public Health Service
Food and Drug Administration

New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520


December 9, 2004

WARNING LETTER NO. 2005-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Alan O. Bostick, President
Sunshine Mills, Inc.
500 6th Street SW
Red Bay, Alabama 35582

Dear Mr. Bostick:

On September 7 and 14, 2004, a United States Food and Drug
Administration (FDA) investigator inspected your animal feed
manufacturing facility, located at 2103 South Gloster Street, Tupelo,
Mississippi. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant
Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you
failed to follow the requirements of this regulation, products you
manufactured and/or distributed are misbranded within the meaning of
Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection indicated you manufacture products containing beef meat
and bone meal. Products that contain or may contain protein derived from
mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended
for use in animal feed, must be labeled with the cautionary statement
Do not feed to cattle or other ruminants. This is required by 21 CFR
589.2000(c)(1)(i). Your firm failed to label your non-ruminant products
with this required cautionary statement. Specifically, the products that
contained protein derived from mammalian tissues but lacked the required
statement included your Happy Fisherman and Premier catfish feeds.
Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required
cautionary statement causes them to be misbranded under Section
403(a)(1) of the Act.

The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring your overall operation and
products you manufacture and distribute are in compliance with the law.
A copy of FDAs Small Entity Compliance Guide is enclosed to assist you
in complying with the regulations.

You should take prompt action to correct these violations and establish
a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action, such as
seizure and/or injunction, without further notice.

We are aware you sent label corrections for the last shipment of each of
the mislabeled products. You also stated you plan [redacted] However,
you should notify this office in writing, within 15 working days of the
receipt of this letter, of the steps you have taken to bring your firm
into compliance with the law. Your response should include an
explanation of each step taken to correct violations and prevent their
recurrence. If corrective action cannot be completed within 15 working
days, state the reason for delay and date by which corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Please send your reply to the U.S. Food and Drug Administration,
Attention: Nicole F. Hardin, Compliance Officer, at the above address.
If you have questions regarding any issue in this letter, please contact
Ms. Hardin at (504) 253-4519.

Sincerely,

/s

H. Tyler Thornburg
District Director
New Orleans District

Enclosures:
FDA Form 483
FDAs Small Entity Compliance Guide
21 CFR 589.2000

cc:
[redacted]
General Manager
Sunshine Mills, Inc.
2103 South Gloster Street
Tupelo, Mississippi 38801

http://www.fda.gov/foi/warning_letters/g5105d.htm

TSS

PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-001-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 80 1ű2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________

PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags.
The product has no labeling. Recall # V-002-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated
September 27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 8 tons.
DISTRIBUTION
OH.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS


Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 9S9214421
Telephone: 425-486-8788
FAX: 425- 483-4996


November 18, 2004

VIA FEDEX

In reply refer to Warning Letter SEA 05-07

William B. Parrish, Chairman of the Board
Parrish & Heimbecker Limited
360 Main Street
Winnipeg, Manitoba, R3C 323 Canada

WARNING LETTER

Dear Mr. Parrish:

An inspection of your feed mill operation, Conway Feed, Inc., located at
18700 Main Street, Conway, Washington, conducted by a Washington State
Department of Agriculture Investigator, on June 17, 18 and 22, 2004,
under contract with the Food and Drug Administration (FDA), found
significant deviations from the requirements set forth in Title 21, Code
of Fedederal Regulations, Part 589.2000 (21 CFR 589.2000) Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Such deviations cause products being manufactured
and/or distributed by this facility to be adulterated within the meaning
of Section 402(a)(4) and misbranded within the meaning of Section 403(a)
and 403(f) of the Federal Food, Drug and Cosmetic Act (the Act).

Our investigation found that because you failed to adequately inspect
the label of a raw material, au ingredient with the cautionary
statement Do Not Feed to Cattle or Other Ruminants was used in the
manufacture of your finished product, Game Bird Crum/Pellet. Your final
product, however, did not have the cautionary statement. Because this
fish meal may have contained prohibited animal proteins, any product
produced with it must have the cautionary label. See 21 CFR 589.2000(d)(1).

The investigation also revealed that the label of your Game Bird
Crum/Pellet feed did not list fish meal as an ingredient. According to
the information we collected during the inspection fish meal is
routinely added to this ration. All ingredients are required to be
listed on the label in descending order of predominance by weight. See
21 CFR 501.4(a).

The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the
law. We have enclosed a copy of the FDAs Small Entity Compliance Guide
to assist you with complying with the regulation.

You should take prompt action to correct these violations, and you
should establish a system whereby such violations do not recur. Failure
to promptly correct these violations may result in regulatory action
without further notice, such as seizure and/or injunction.

You should notify this office in writing within 15 working days of
receipt of this letter, of the steps you have taken to bring your firm
into compliance with the Iaw. Your response should include an
explanation of each step being taken to correct the violations, and
prevent their recurrence. If corrective action cannot be completed in 15
working days, state the reason for the delay and the date by which the
corrections will be completed. Include copies of any available
documentation demonstrating that corrections have been made.

Please send your reply to the Food and Drug Administration, Attention:
Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell,
Washington 98021. If you have questions regarding any issue in this
letter, please contact Mr. Bruce Williamson at (425) 483-4976.

If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.

Sincerely,

/S/

Charles M. Breen
District Director

cc: Scott C. McKnight, General Manager
Conway Feed Inc.
18700 Main Street
Conway, WA 98238-0576

Enclosure: Form FDA 483
Small Entity Compliance Guide

http://www.fda.gov/foi/warning_letters/g5086d.htm


USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS


Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


VIA HAND DELIVERY

Our Reference No. 1000123954

June 23, 2004

Ronald M. Foster, Manager
Randall C. Boyce, Manager
Trevor O. Foster, Manager
George P. Foster, Manager
Fresno Farming LLC
P.O. Box 457
1000 Davis Street
Livingston, California

WARNING LETTER

Dear Mssrs. Foster, Boyce, Foster, and Foster:

The U.S. Food and Drug Administration (FDA) conducted an inspection of
your medicated animal feed mill operation, Fresco Farming LLC, located
in Traver, California from April 14, 2004 through May 6, 2004, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products
you manufactured and distributed are adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
because they were prepared, packed, or held under insanitary conditions
whereby they may have been rendered injurious to health.

Our inspection found the following violations of 21 C.F.R. 589.2000:

1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein
derived from mammalian tissues into animal protein or feeds that may be
used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).

* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
FDAs April/May 2004 inspection by removing the discharge hose
connection to the conveyer system that your firm had designated as
free of ruminant meat and bone meal .
* Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed
ingredients intended for ruminants. This dust system then
discharged collected product back into the two conveyor systems
via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross
connection and that it had been in place since April 2003. Your
firm removed the cross connection during FDAs April/May 2004
inspection.

2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating
products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until
the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This
observation was also noted during FDAs July/August 2003 inspection of
your firm.

* There are no written procedures for separating products that
contain prohibited material from ingredients used in ruminant
feeds from the time of receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after
mixing feeds containing prohibited material was not adequate to
prevent contamination of ruminant feed with prohibited material.

3. Failure to maintain records sufficient to track materials that
contain protein derived from mammalian tissues throughout their receipt,
processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i).
This observation was also noted during FDAs July/August 2003 inspection
of your firm.

* Specifically, your firm has failed to develop and implement
complete written procedures to separate ruminant meat and bone
meal from feed ingredients intended for ruminants from the time of
receipt until the time of distribution. The written procedures
that do exist fail to address the use of equipment common to
ruminant meat and bone meal and ruminant feed ingredients.

The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal
feed, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct these violations, and you
should establish a system whereby such violations do not recur. Failure
to promptly correct these violations may result in regulatory action
without further notice, such as seizure and/or injunction.

You should notify this office in writing within fifteen (15) working
days of receiving this letter of the steps you have taken to bring your
firm into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations and
prevent their recurrence. If corrective actions cannot be completed in
fifteen (15) working days, state the reason for the delay and the date
by which the corrections will be completed. Include copies of any
available documentation demonstrating that corrections have been made.

Please send your reply to the U.S. Food and Drug Administration,
Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, California 94502-7070. If you have questions regarding
this letter, please contact Ms. Kishida at (510) 337-6824.

Sincerely,

/s/

CD Moss, Acting DD for
Barbara J. Cassens
District Director
San Francisco District

cc:
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
C. Michael Blasco, Feed Mill Manager
Fresno Farming LLC
P.O. Box 430
Traver, California 93673

http://www.fda.gov/foi/warning_letters/g4849d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


July 12, 2004

WARNING LETTER
CHI-16-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Donald E. Hamilton, President/Owner
Illini Feeds, Inc.
P.O. Box 86, 1145 State Hwy. 94
Aledo, Illinois 61231

Dear Mr. Hamilton:

On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at
1145 State Highway 94, Aledo, Illinois. The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). The deviations cause the swine feed manufactured by your facility
to be misbranded within the meaning of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act).

Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured
at your facility. During the inspection, our investigator found that you
failed to label your non-ruminant products with the required caution
statement - Do not feed to cattle or other ruminants. [21 CFR
589.2000(d)(1)]

The above is not intended to be an all-inclusive list of violations. As
a manufacturer of materials intended for use in animal feed, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.

You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to
promptly correct this violation may result in regulatory action without
further notice, such as seizure and/or injunction.

During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited
material, and maintain tracking documents for all incoming ingredients,
including animal proteins prohibited in ruminant feed. Please notify
this office in writing within 15 working days of receiving this letter
of any further steps you have taken to assure that your firm is in
compliance with the law. Your response should also include an
explanation of each step taken to correct the violations, and prevent
their recurrence. Please include copies of any available documentation
such as written procedures, corrected labeling, etc., demonstrating that
corrections have been made. If corrections cannot be completed within 15
working days, state the reason for the delay and the date by which the
corrections will be completed.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.

Sincerely,

/s/

Scott J. MacIntire
District Director

http://www.fda.gov/foi/warning_letters/g4840d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


June 15, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. David W. Bernauer
CEO and Chairman of the Board
Walgreen co.
200 Wilmot Rd.
Deerfield, IL 60015

Dear Mr. Bernauer:

Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt.
Vernon, Illinois, by the Illinois Department of Public Health and the
U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and
March 2, 2004, documented numerous insanitary conditions which caused
the food and drug products stored there to become adulterated.

Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the
Act), rendering them adulterated. These adulterated fwd and drug
products: a) consisted in whole or in part of filthy substances,
including rodent fecal pellets, rodent hair, and insects, in violation
of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had
been held under insanitary conditions whereby they have become
contaminated with rodent filth, in violation of Sections 402(a)(4) and
501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].

Evidence of rodent activity documented throughout the old and new
warehouse included dead mice in traps, excreta pellets, and gnawed paper
material observed in, on, and near food and drugs stored in the
warehouse. Rodents gnaw holes were observed into several packaged food
products with rodent hairs at gnaw holes into products. Many more fecal
pellets were on food and drug packages and still more were found near
the stored foods, drugs, and cosmetics in the warehouse.

Other conditions observed during the inspection that could be
contributing factors to rodent infestation include damaged and/or poorly
fitting rail and truck dock doors, gaps around a conduit entry into the
building, and the structural condition of the concrete and expansion
gaps at floor/wall/support beam junctions in various areas of the
warehouse allowing the entry or harborage of pests. Additionally, the
investigators observed cobwebs, dead insects, dust, debris, product
spillage, and papers in the warehouse, indicating a general lack of good
sanitation practices.

Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do
not feed to cattle or other ruminants. Specifically, pet food products
were salvaged, repackaged, and donated to [redacted] and other similar
organizations in the area, without the proper labeling and agreement
that they would not be used for ruminants. Please refer to Title 21,
Code of Federal Regulations, Section 589.2000, concerning these
requirements.

Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material)
sampled from the warehouse during the inspection.

The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act
and its implementing regulations. The investigators reported that you
destroyed food products that showed evidence of contamination and began
to take some steps to correct the insanitary conditions in your
facility. We request that you take prompt action to correct all violations.

Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and
have taken to correct and prevent the recurrence of these objectionable
conditions. Provide the time within which corrections will be completed,
reasons why any corrective action cannot be completed, and documentation
to show that corrections have been made. Failure to take prompt action
to correct all violations may result in regulatory action without
further notice. Such action includes seizure and/or injunction.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.

Sincerely,

/s/

Scott J. MacIntire
District Director

cc:
Stephen J. Lawrence,
Distribution Center Manager
Walgreen Co.
5100 Lake Terrace NE
Mount Vernon, IL 62864-9665

http://www.fda.gov/foi/warning_letters/g4853d.htm


PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm
initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which
is prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.

=================================

PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm
initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the
mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html

PRODUCT
Custom deer feed made for a Wisconsin farm. The product was in bags
holding about 40 pounds each. Recall # V-122-4.
CODE
1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER
Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004.
Wisconsin State initiated recall is complete.
REASON
The recalled deer feed contained steamed bone meal which is prohibited
material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
515 pounds.
DISTRIBUTION
WI.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html

===========================================

PRODUCT
ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
Recall # V-115-4.
CODE
6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA
initiated recall is complete.
REASON
LACF Feiline Diet for non-domestic carnivores does not carry the BSE
warning statement.
VOLUME OF PRODUCT IN COMMERCE
1,620 cases.
DISTRIBUTION
KS.

=======================================

PRODUCT
Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in
part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate
27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed
27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint
supplement containing Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM". Recall # V-116-4.
CODE
All codes without the required cautionary statement are under recall.
RECALLING FIRM/MANUFACTURER
Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA
initiated recall is ongoing.
REASON
This animal feed product does not contain the required BSE cautionary
statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 cases 4-5 lb. Containers per case.
DISTRIBUTION
Venezuela, Nicaragua and Guatemala.

==============================================

PRODUCT
Calf Primer II-R (Monensin) sold in bulk. Recall # V-113-4.
CODE
93125 (1-7-04).
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, La Vergne, TN, by telephone on January 9,
2004. Firm initiated recall is complete.
REASON
Calf feed, which had a medicated swine feed inadvertently mixed into it,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
28,040 pounds.
DISTRIBUTION
TN.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html

TSS

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

_______________________________

PRODUCT

a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.

CODE

No coding information is used.

RECALLING FIRM/MANUFACTURER

Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm
initiated recall is ongoing.

REASON
Corn for feed may be contaminated with RUMINANT MEAT AND BONE MEAL.

VOLUME OF PRODUCT IN COMMERCE
Unknown.

DISTRIBUTION
Unknown.
____________________________

http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html


Greetings list members,

> VOLUME OF PRODUCT IN COMMERCE
> UNKNOWN.
>
> DISTRIBUTION
> UNKNOWN.

gotta love those USDA BSE/TSE triple fire walls ;-).....TSS


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


Geographical BSE Risk of USA
European Food Safety Authority
Scientific Expert Working Group on GBR
Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
UNITED STATES OF AMERICA
2004

snip...

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

snip...

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


Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
European Food Safety Authority
Scientific Expert Working Group on GBR
Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
2004


snip...


Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 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:
According to the CD the country imported in total over the period 1980
to 2003,
approximately 3.2 million live cattle from BSE - risk countries, of
which conclusively
none 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 - years periods the resulting external
challenge is as
given in table 3. This assessment takes into account the evidence that
certain
imported cattle did not enter the domestic BSE/cattle system, i.e. were
not rendered
into feed. In the case of Mexico, it is assumed that “cattle still
alive” (imports from
Spain) did not enter the rendering system.
MBM imports:
According to the CD the country imported in total over the period 1980 -
2003
approximately 826,000 tons MBM from BSE - risk countries (according to
“other
data”: ~ 919,000 tons), of which none came from the UK. 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 - years periods
the resulting
external challenge is as given in table 3. This assessment takes into
account the
evidence that certain imported MBM did not enter the domestic BSE/cattle
system or
did not represent an external challenge for other reasons. However, in
the case of
Mexico, there was not sufficient evidence to remove any quantities of
MBM from the
external challenge.
External Challenge experienced by MEXICO
External challenge Reason for this external challenge
Period Overall Level Cattle imports MBM imports Comment
1980 to 1985
1986 to 1990
Negligible
Negligible
Negligible
1991 to 1995 Very high
High Very high
Due to MBM imports
from USA since 1993
and cattle imports
from USA/Canada
since 1994
1996 to 2000 Extremely high Due to imports from
USA / Canada
2001 to 2003
Extremely high
Very high
Extremely high Due to imports from
USA / Canada
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).
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 8 -
On the basis of the available information, the overall assessment of the
external
challenge is as given in the table above.
3. STABILITY
3.1 Overall appreciation of the ability to avoid recycling of BSE
infectivity, should it enter processing
Feeding
Use of MBM in cattle feed
Until 11th October 2000, MBM could and was legally included in cattle feed.
Feed bans
The law prohibiting the use of ruminant MBM in ruminant feed was
published on 11th
October 2000. According to the FAO mission, implementation of the ban
began in
2002.
Potential for cross - contamination and measures taken against
In feed mills, lines are not always separated. According to the CD
flushing is used to
clean in - between lines, and feed mills carry out in - house controls.
According to the
CD, controls during transport and on farms are not regularly carried
out, but
inspections may occur on the farm. No details are provided on the kind
or frequency
of these control measures, the dates checking of cross contamination
began, or on the
results of these inspections.
Control of feed bans and cross - contamination
According to the CD, checks occur to ensure that plants do not use
ruminant MBM in
feed stuff production for ruminants. This may have been helped by
regulations
defined in 1999 that allowed ruminant feed production to use MBM only from
rendering plants that do not process ruminant material. However,
detailed outcomes of
control procedures, tests carried out or quality control are not provided.
It is concluded that cross contamination is possible.
Rendering
• A rendering industry exists in Mexico and raw bovine materials are
normally
rendered. This includes fat tissue, bones, horns and hooves but not
usually viscera,
eyes, brains or spinal cords. About 90 % of the rendered material is of
bovine
origin and the rest consists mainly of pork material. 58 plants produce
MBM, with
an annual production of between 150,000 and 250,000 tons per year. It is
estimated that about 6 % was destined for bovines in 2000.
• The rendering process standard (133° C/20min/3bar) is not applied.
According to the
CD, there are guidelines in place so that the standard process will be
used in the
event that a BSE case is discovered.
• According to the CD, regulations were introduced in 1999 to ensure
that the
processing of animal offal and its employment in animal food took place
in two
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 9 -
plant types: 1). plants processing material of ruminant origin plus
other species
(such as pig) and 2). plants processing only non-ruminant material. Plants
corresponding to the first category are prohibited from the preparation of
foodstuffs intended for ruminants. The fulfillment of this procedure is
checked
annually through veterinarians. Specific results of checking procedures
are not
supplied in the CD.
Specified Risk Material (SRM) and fallen stock
There is no SRM-ban. SRM is normally destined for human consumption.
According
to the CD, fallen stock from pasture and diseased animals are
incinerated and not
rendered.
Conclusion on the ability to avoid recycling
In light of the above information, it has to be assumed that the BSE
agent, should it
have entered Mexico, could have been recycled and potentially amplified.
3.2 Overall appreciation of the ability to identify BSE - cases and to
eliminate animals at risk of being infected before they are
processed
Cattle population structure
Detailed information is provided in the CD on the cattle population and
their
husbandry system. Approximately 30 million cattle is the national
population of
which the majority is for beef production, and approximately 6 % dairy.
Approximately 34 % of animals are over 24 months old. In dairy cattle,
59 % of the
milk production is derived from intensive production.
The average age and weight at slaughter varies according to rearing
system. Slaughter
tends to occur at approximately 3 years on extensive pasture, 2 years on
semiintensive,
1.3 years on intensive fattening, 6 - 7 years for dairy cows and 10
years for
breeding cows.
BSE surveillance
Notification of BSE is compulsory since 21 September 1994.
Awareness/training
measures were initially put in place in 1994 and increased in intensity
since 1997
(leaflets, training scheme on BSE - related issues, sampling manual).
Laboratory
personnel have been trained since 1997 in surveillance, diagnostic
techniques and risk
management in Mexico but also in Canada and USA. Since November 1998 a
trilateral agreement (Mexico - USA - Canada) on an exchange program in
relation to
BSE has been set up, that focuses on diagnostics and surveillance.
The methods used for BSE suspects are described. Since the end of 1996,
histopathology has been used. Together with Canada and USA, a project on
immunohistochemistry as a diagnostic technique has been jointly set up,
and the same
monoclonal commercial antibodies will be used in the three countries.
In the years 1996 to 2003, a total of 2047 animals have been tested for
BSE (1726 >
29 months of age), with active surveillance in place since 1997. Since
2000, some
fallen stock has also been targeted. No positive test results have occurred.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 10 -
The CD describes a program for increased BSE surveillance beginning in 2004
(“Program of Epidemiological Vigilance and Prevention of BSE for 2004”).
This is a
programme developed in conjunction with the “Commission of Mexico to the
United
States for the Prevention of Foot and Mouth Disease and other Exotic
Illnesses of
Animals”.
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, BSE-surveillance, has to be estimated. The guidance provided by
the SSC in
its opinion on the GBR of July 2000 (as updated in 2002) is applied.
Feeding:
Feeding MBM to cattle was legally possible until October 2000 and the
information
provided indicates that it was common practice for both dairy and beef
cattle.
Therefore feeding was assumed to be “not OK” for the period 1980-2000.
The feed
ban is of ruminant MBM only and good evidence of its effectiveness is
not provided.
Therefore feeding remains “not OK” also for the period 2000-2003.
Rendering:
Rendering is and was common practice in Mexico. Ruminant material is
included,
excluding most SRM and most fallen stock. The process used was and is
not adequate
for reducing BSE - infectivity. Therefore rendering is assessed as
having been "not
OK" throughout the reference period (i.e. 1980-2003).
SRM-removal:
There is no SRM ban. However, SRM is consumed by humans and it does not
tend to
enter the feed chain and fallen stock and diseased animals are
incinerated. Hence
SRM-removal it is assessed as "reasonably OK" throughout the reference
period
(i.e. 1980-2003).
BSE surveillance
There is some passive and active BSE surveillance. However, given the
large cattle
population size, the BSE surveillance system in Mexico is insufficient.
Recent plans
have been introduced to increase surveillance efforts since 2004.
On the basis of the available information it has to be concluded that
the country’s
BSE/cattle system was and is very unstable. Incoming BSE - infectivity
would have
been recycled and quickly amplified. The stability of the BSE/cattle
system in Mexico
overtime is as given in table 4.
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 11 -
Stability of the BSE/cattle system in MEXICO over time
Stability Reasons
Period Level Feeding Rendering SRM removal
BSE
surveillance
1980 to 2003 Very unstable
Not OK
Not OK
Reasonably OK
1996 – 2003:
passive and
some active
surveillance
Table 4: Stability resulting from the interaction of the three main
stability factors and the BSE
surveillance. The stability level is determined according to the SSC -
opinion on the GBR of July
2000 (as updated in 2002).
4. CONCLUSION ON THE RESULTING RISKS
4.1 Interaction of stability and challenges
In conclusion, the stability of the Mexico BSE/cattle system in the past
and the
external challenges the system has coped with are summarized in the
table 5 below.
From the interaction of the two parameters “stability” and “external
challenge” a
conclusion is drawn on the level of “internal challenge” that emerged
and had to be
met by the system, in addition to external challenges that occurred.
INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN MEXICO
Period Stability External Challenge Internal challenge
1980 to 1985
1986 to 1990
Negligible Highly unlikely
1991 to 1995 Very high
1996 to 2000
2001 to 2003
Very unstable
Extremely high
Likely to be present and growing
since 1993
Table 5: Internal challenge resulting from the interaction of the
external challenge and stability.
The internal challenge level is determined according to guidance given
in the SSC - opinion on
the GBR of July 2000 (as updated in 2002).
An external challenge resulting from cattle import could only lead to an
internal
challenge once imported infected cattle were rendered for feed and this
contaminated
feed reached domestic cattle. Cattle imported for slaughter would
normally be
slaughtered at an age too young to harbour large amounts 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
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 12 -
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 Mexico this implies
that an
internal challenge caused by live cattle imports (predominantly from USA
or Canada)
first occurred in the mid to late 1990’s and continued to the present.
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
Mexico this implies that an internal challenge caused by MBM imports
(predominantly from USA or Canada) first occurred around 1993 and
continued to the
present.
In view of the above - described consideration the combination of the
very / extremely
high external challenges with a very unstable system makes the
occurrence of an
internal challenge likely in Mexico from approximately 1993 onwards.
4.2 Risk that BSE infectivity entered processing
It is likely that BSE infectivity entered processing at the time of
imported ‘at - risk’
MBM (1993) and at the time of slaughter of imported live ‘at - risk’
cattle (mid to late
1990’s). The high level of external challenge is maintained throughout
the reference
period, and the system has not been made stable, leading to increased
internal
challenge.
4.3 Risk that BSE infectivity was recycled and propagated
It is likely that BSE infectivity was recycled and propagated from
approximately
1993. The risk has since grown consistently due to a maintained internal
and external
challenge and lack of a stable system.
5. CONCLUSION ON THE GEOGRAPHICAL BSE - RISK
5.1 The current GBR as function of the past stability and challenge
The current geographical BSE risk (GBR) level is III, i.e. it is likely
but not confirmed
that domestic cattle are (clinically or pre-clinically) infected with
the BSE-agent.
5.2 The expected development of the GBR as a function of the past
and present stability and challenge
• The GBR is likely to increase due to continued internal and external
challenge,
coupled with a very unstable system.
• 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
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
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
• Measures that improve the stability of the system, will, over time,
reduce the
probability that cattle get infected with the BSE-agent. Possible
actions include
- strict removal of SRM and/or fallen stock from rendering,
- pressurized rendering processes,
- significant improvement of ban on use of ruminant MBM in cattle feed,
supported by regular sampling of such feed for the non-occurrence of MBM.
• 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 fallen stock and emergency slaughter, by means of rapid screening, would
allow monitoring the efficiency of the stability enhancing measures.
Documentation...

snip...


http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


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

Greetings FDA,

snip...

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


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


GWs BSE MRR RULE $$$

THE BSE MRR IMPLEMENTATION THAT USDA ET AL ARE TRYING TO PUSH THROUGH IS
NOTHING MORE THAN
POLITICS AT IT'S FINEST, NOTHING THERE AT ALL ABOUT
SCIENCE. FUTURES AND COMMODITIES. TO DO AWAY WITH
AND BY REFUSING TO GO BY INTERNATIONAL BSE GBR GUIDELINES BY THIS
ADMINISTRATION SHOULD PUSH
EFSA OFFICIALS AND OIE TO ABANDON NORTH AMERICA
AS A TRADE PARTNER, DUE TO FLAGRANT VIOLATIONS
OF BSE GBR GUIDELINES, NORTH AMERICA BSE GBR
SHOULD BE RAISED TO BSE GBR IV IMMEDIATELY, UNTIL
THIS NONSENSE OR (noscience for reality) HAS CEASED AND
NORTH AMERICA STARTS COMPLYING WITH BSE/TSE RULES AND REGULATIONS THAT
HAVE BEEN IN PLACE FOR YEARS...

TERRY S. SINGELTARY SR.
P.O. BOX 42
BACLIFF, TEXAS USA 77518





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