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From: TSS ()
Subject: TESTIMONY OF THE HONORABLE MIKE JOHANNS USDA BEFORE THE U.S. SENATE COMMITTEE ON AGRICULTURE, NUTRITION & FORESTRY FEBRUARY 3, 2005
Date: February 22, 2005 at 2:52 pm PST

-------- Original Message --------
Subject: TESTIMONY OF THE HONORABLE MIKE JOHANNS USDA BEFORE THE U.S. SENATE COMMITTEE ON AGRICULTURE, NUTRITION & FORESTRY FEBRUARY 3, 2005
Date: Tue, 22 Feb 2005 16:29:55 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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


TESTIMONY OF THE HONORABLE MIKE JOHANNS
UNITED STATES DEPARTMENT OF AGRICULTURE
BEFORE THE U.S. SENATE
COMMITTEE ON AGRICULTURE, NUTRITION & FORESTRY
FEBRUARY 3, 2005


Chairman Chambliss, Mr. Harkin, 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, USDAs Chief
Economist and Dr. Ron DeHaven, Administrator of USDAs Animal and Plant
Health Inspection Service (APHIS). They will be available to assist in
answering any questions you might have.

Before I begin, I want to thank you all for the professionalism and
courtesy extended to Stephanie and me during my recent confirmation
process. I appreciate the close, positive working relationships that we
have begun forging, and thanks to the diligence of this Committee, it
was an honor and privilege for me to be the first Cabinet member
confirmed during President Bushs second term. It is, therefore, a
pleasure to return for my first hearing as Secretary.

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. I have also heard from this Committee
quite clearly on this topic, and I believe very strongly that we are all
on the side of American agriculture. The Committee and your constituents
have also posed some useful and valid questions that deserve thorough
examination, which this hearing will help provide.

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
science, sanitary and phytosanitary (SPS) restrictions will be used
arbitrarily by many nations, without any basis of protecting human or
animal health.

Accordingly, this hearing could not be timelier. 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 by continuing to use science as the basis for
decision making by U.S. regulatory authorities and our trading partners.

Almost exactly one year ago, Secretary Veneman appeared before this
Committee to discuss BSE. In the time since then, much has transpired:

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).

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 animals as possible over a 12-18 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 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 eight
months later, more than 200,000 animals have been tested, all of which
have been negative.

In order to help raise awareness about potential BSE cases among
animal-health professionals and livestock producers, 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 minimal-risk rule, which
designated Canada as the first minimal-risk region for BSE, and which
will become effective on March 7, 2005.

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 Canadas 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 Canadas willingness to cooperate
and assist us in these efforts.

The technical team is focusing both on the efficacy of Canadas feed ban
and its epidemiological investigation of the new BSE cases. The team is
composed of experts from APHIS in the areas of epidemiology,
transmissible spongiform encephalopathies (the family of diseases to
which BSE belongs), and official documentation.

An auditor from USDAs Agricultural Marketing Service (AMS) is also part
of the team, which will also be joined by representatives of USDAs
Foreign Agricultural Service (FAS) stationed in Canada. Technical
experts from the Department of Health and Human Services Food and Drug
Administration are accompanying the team in an advisory capacity.

We have been receiving regular updates from the team. We expect a final
report on feed ban issues in mid-February and the epidemiological report
by the end of March. These reports will be critical as we consider
whether any adjustments to current policies are warranted.

The Minimal-Risk Rule

As you are aware, USDAs 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.

Because the rule permits the import of live cattle under 30 months of
age and ruminant products from older animals, it is useful to note the
risk mitigation measures. These include: proper animal identification;
accompanying animal health certification that includes information on
individual animal identification, 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 the removal of specified
risk materials (SRMs) from cattle slaughtered in the United States.

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 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 Canadas compliance
with its BSE regulations. In addition to the investigation that I
already discussed, USDAs Food Safety and Inspection Service in December
2004 conducted an intensive audit of Canadas compliance with the BSE
requirements of the United States, with particular attention to SRM
removal. FSIS visited several facilities that slaughter only cattle
under 30 months of age and determined that they are effectively
implementing the BSE regulations.

This month, FSIS will conduct 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.

I am aware of concerns with the portion of USDAs minimal-risk rule that
would allow meat from animals over 30 months of age to be imported from
Canada, but continue the prohibition on the importation of live animals
of the same age for processing in the United States. Some have suggested
that going forward with this rule will change the historical
beef-trading patterns in North America to the detriment of U.S. packers.

As Secretary of Agriculture, I believe that the marketplace should
determine cross-border trading patterns. We must make every effort to
avoid policies that favor one group of packers over another. Decisions,
however, related to sanitary and phytosanitary measures must be based on
science.

I can assure you that I will be reviewing this issue very carefully in
the days ahead as we move closer to the March 7 implementation date.

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. Likewise, the most significant step we can take to prevent the
spread of BSE and bring about its complete eradication is the ruminant
to ruminant feed ban. It is because of the strong systems the United
States has put in place, especially these two essential firewalls, 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 national surveillance program and import restrictions. The
extensive risk assessment conducted as part of USDAs rulemaking process
also took into careful consideration the possibility that Canada could
experience additional cases of BSE.

In the risk analysis update for the final rule, USDA also considered the
additional risk protection from new slaughter 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 OIE 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
September 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. The cost-benefit analysis conducted as part of the
final rule indicates that U.S. beef imports from Canada are projected to
actually decrease slightly in 2005 (about 4 percent), as Canada shifts
its slaughter capacity to lower-yielding older cattle not eligible for
export to the United States.

At the same time since the border has been closed to live cattle since
May 2003, imports of fed and feeder cattle under 30 months are expected
to increase in 2005, which is expected to drive up U.S. beef production,
reduce beef prices slightly and, consequently, reduce cattle prices. Our
most recent forecast for all of 2005 is that fed cattle prices are
expected to average $82 per cwt, assuming the Canadian border opens on
March 7, 2005, and 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 USDAs 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. 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
continues to press this issue with Government of Japan officials in
Tokyo, and other U.S. Government officials continue to contact their
counterparts.

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 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.

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.

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.

###

http://www.usda.gov/agency/ocr/download/Johanns.BSE.020305.doc

July 14
Ann Veneman
,
Secretary of Agriculture Joint Hearing: House Committee on Agriculture
and House Committee on Government Reform Ongoing activities related to
Bovine Spongiform Encephalopathy (BSE)


http://www.usda.gov/agency/ocr/download/Veneman.BSE.071404.doc

February 24
The Honorable Elsa Murano
,
Under Secretary for Food Safety; Dr. Ron DeHaven
,
Deputy Administrator for
Veterinary Services
Animal and Plant Health Inspection Service; Dr. Keith Collins,
Chief
Economist
Senate Appropriations Committee
BSE


http://www.usda.gov/agency/ocr/download/Murano.22404.doc

http://www.usda.gov/agency/ocr/download/Dehaven.22404.doc

http://www.usda.gov/agency/ocr/download/KeithCollins.22404.doc

January 2004
January 27
The Honorable Ann M. Veneman,

Secretary, USDA

Senate Agriculture

Committee

BSE-positive cow found in Washington State and USDA's response
January 21
The Honorable Ann M. Veneman,

Secretary, USDA

House Agriculture

Committee

BSE-positive cow found in Washington State and USDA's response


http://www.usda.gov/agency/ocr/download/BSE.Veneman.012704.doc

http://www.usda.gov/agency/ocr/download/BSE.Veneman.012104.doc

June 19
Bobby Accord, Administrator, APHIS
House Resources Subcommittee on Fisheries, Conservation, Wildlife &
Oceans Chronic Wasting Disease; palentological resources


NO LINK

May 16
Dr. Jim Butler
, Duputy
Under Secretary for Marketing & Regulatory Programs
House Committee of Resources - Subcommittees on Forest and Forest Health
,
and Fishery Conservation, Wildlife and Oceans Chronic Wasting Disease


http://www.usda.gov/agency/ocr/download/MRP-Butler-5.16.02.pdf

http://resourcescommittee.house.gov/107cong/forests/2002may16/agenda.htm

ARCHIVES FROM 2001


NOT

http://www.usda.gov/agency/ocr/testimony2001.htm

???

MORE on that OTHER LITTLE OLD MAD COW FROM TEXAS (real player)

Assigned vet wanted it tested.

Gov. insp. over rided and decided not to test.

SYSTEM broken around the Country.

PROBLEMS NATION WIDE!

APHIS inspectors do not follow through.

http://www.npr.org/dmg/dmg.php?prgCode=ME&showDate=07-May2004&segNum=8&mediaPref=RM

May 13, 2004

Failure To Test Staggering Cow May Reflect Wider Problems
Rep. Waxman raises concerns that the recent failure of USDA to test an
impaired cow for BSE may not be an isolated incident, citing the failure
of USDA to monitor whether cows condemned for central nervous system
symptoms are actually tested for mad cow disease.

- Letter to USDA

http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf


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

THAT ONE TEXAS MAD COW IS ONLY TIP OF ICE BURG;

No mad cow results for nearly 500 cows

By Steve Mitchell
United Press International
Published 8/11/2004 11:23 AM


WASHINGTON, Aug. 11 (UPI) -- The U.S. Department of Agriculture failed
to test for mad cow disease or collect the correct portion of the brain
on nearly 500 suspect cows over the past two years -- including some in
categories considered most likely to be infected -- according to agency
records obtained by United Press International.

The testing problems mean it may never be known with certainty whether
these animals were infected with the deadly disease. Department
officials said these animals were not included in the agency's final
tally of mad cow tests, but the records, obtained by UPI under the
Freedom of Information Act, indicate at least some of them were counted...

snip...

--

Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com
Copyright © 2001-2004 United Press International


http://www.upi.com/view.cfm?StoryID=20040810-042935-2066r


FDA Statement

FOR IMMEDIATE RELEASE
Statement
May 4, 2004

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


Statement on Texas Cow With Central Nervous System Symptoms

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

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

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

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

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

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

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

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

####

rule

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

LATEST DATA shows .1 gram of infectious material is lethal to many
cows...TSS

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

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

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

FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT

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

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

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

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

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

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

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

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

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


Chapter 5


Center for Veterinary Medicine

Last Update: August 07, 2003


Animal Feeds


Warning Letters Issued for CGMP Violations

* On March 8, 2001, the FDAs New Orleans District Office issued a
Warning Letter to Prestage Farms, Inc., West Point, Mississippi.
The firm manufactures medicated and non-medicated feeds for its
own integrated swine enterprise. An FDA inspection of the facility
on February 21 - 22, 2001, disclosed significant deviations from
the Current Good Manufacturing Practice (CGMP) requirements for
Medicated Feeds. These deviations included: failure to perform
assays for the active drug ingredient in one product since 1999;
failure to perform appropriate investigations and/or corrective
actions for out of limit assays; and failure to have master
production records.
* The FDAs Dallas District Office issued a Warning Letter to Purina
Mills, St. Louis, Missouri, on March 23, 2001. The Warning Letter
followed the an FDA inspection of Purina Mills, Oklahoma City,
Oklahoma, on February 2-6, and 13-14, 2001. The firm failed to
follow Purina's SOP for Drug Sequencing Requirements. The SOP
provides for sequencing production (without flushing the mixer) of
animal feeds for a species for which a drug component of a prior
medicated feed is not approved. Additionally, the firm had
distributed bagged medicated feeds since June 2000, with faulty
tagging equipment and no control to ensure that all bagged feeds
were completely labeled.


Bovine Spongiform Encephalopathy (BSE)

To help prevent the establishment and amplification of BSE in the Unites
States, FDA implemented a final rule that prohibits the use of most
mammaliam protein in feeds for ruminant animals. This rule, Title 21
Part 589.2000 of the Code of Federal Regulations, became effective on
August 4, 1997.

On August 23, 2001, Department of Health and Human Services (DHHS)
Secretary Tommy Thompson unveiled a department-wide action plan
outlining new steps to improve scientific understanding of BSE, commonly
known as "mad cow disease," and related diseases known as TSEs. The plan
incorporates a comprehensive approach to further strengthen
surveillance, increase research resources, and expand existing
inspection efforts to prevent BSE and TSEs from entering or taking hold
in the U.S.


Warning Letters for BSE Violations


FDA Inspection Finds Numerous Violations of BSE Regulations

* On August 8, 2001, the FDAs Seattle District Office issued a
Warning Letter to the owner of an animal feed manufacturing
facility located in Tualatin, Oregon. FDA investigators conducted
an inspection on July 12, 2001, which disclosed violations of the
bovine feed ingredient regulations. The inspection revealed that
the firm failed to separate the receipt, processing, and storage
of products containing prohibited material from non-prohibited
material; failed to establish a written system, including
clean-out and flushing procedures, to avoid commingling and
cross-contamination of equipment; and failed to maintain records
sufficient to track the materials. In addition, the firm failed to
label products with the required cautionary statement, Do Not
Feed to Cattle or Other Ruminants.


Gamecock Feedmill Found Violating BSE Regulations

* On July 12, 2001, the FDAs Cincinnati District Office issued a
Warning Letter to the Carrollton Farmers Exchange, Carrollton,
Ohio, a feed mill. FDA investigators conducted an inspection on
June 25, 2001, which found the firm was manufacturing gamecock
feed containing prohibited proteins. The firm was not labeling the
gamecock feed with the cautionary statement, Do not Feed to
Cattle or Other Ruminants; was not flushing or sequencing after
manufacturing the feed, and was not maintaining distribution
information.


Warning Issued for Lack of Required BSE Cautionary Statement

* The FDAs New Orleans District Office issued a Warning Letter to
Shields Feed and Supply, Coffeeville, Alabama, on March 7, 2001.
An inspection conducted on February 1, 2001, of Shields animal
feed operation showed the finished product label lacked the
required ruminant cautionary statement. In addition, mixing and
distribution records were not maintained; no written procedures
were established for mixer cleaning; and the corn used for the
mixer cleaning was not labeled and quarantined.


Firm Warned for No Measures to Avoid Commingling of Feed

* On May 3, 2001, the FDAs Minneapolis District Office issued a
Warning Letter to Adrian Elevator, Inc., a Butterfield, Minnesota,
a manufacturer of animal feeds. On March 16, 2001, an inspection
conducted by the State of Minnesota (on behalf of FDA) found
significant deviations from the BSE regulations. The firm failed
to provide adequate measures to avoid commingling or
cross-contamination and failed to maintain adequate records to
assure that prohibited animal proteins were not incorporated into
feeds that may be used for ruminants. For example, there was no
documentation to verify that the amount of "flush" being used was
sufficient, and there were no procedures or documentation to
verify that production was properly sequenced and that flushes
were performed.


Warned Issued for Failure to Take Adequate Steps to Prevent BSE

* The FDAs Seattle District Office issued a Warning Letter on May
14, 2001, to Wallowa County Grain Growers, Inc., Enterprise,
Oregon, for violations FDA regulations regarding Animal Proteins
Prohibited in Ruminant Feed. An inspection of the firm on April 11
- 12, 2001, disclosed that the firm was not taking adequate steps
to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE) in that they failed to separate
the receipt, processing, and storage of the product containing
prohibited materials from non-prohibited material; failed to
establish a written system, including clean-out, and flushing
procedures to avoid commingling and cross-contamination of common
equipment; and failed to maintain records sufficient to track the
materials throughout the receipt, processing, and distribution of
product.


Contract Feed Manufacturer Found Violating BSE Regulations

On May 1, 2001, the FDAs Chicago District Office issued a Warning
Letter to Material Resources, a contract feed manufacturer in Washington
Park, Illinois. An inspection of the firm in March 2001, disclosed
several deviations from the BSE regulation. These included failure to
maintain written procedures and provide adequate means to prevent
commingling between feeds containing prohibited protein and all other
protein products. The firm also lacked adequate records to track
products that contained prohibited protein throughout their receipt and
processing.


Firm Warned for Lack of Written Procedures for Clean-Out to
Prevent Commingling

* On June 6, 2001, the FDAs Seattle District issued a Warning
Letter to Superior Feeds, Chester, Montana. The firm is an animal
feed manufacturing operation. An inspection of this firm on April
25, 2001, revealed that the firm failed to label their product
with the required statement, Do Not Feed to Cattle or other
Ruminants. In addition, the facility failed to maintain written
procedures specifying the clean-out or sequencing procedures used
to prevent commingling or cross-contamination of ruminant and
non-ruminant containing feeds.


FDA Inspection Discloses Hog Feed Lacks BSE Statement

* The FDAs Minneapolis District Office issued a Warning Letter on
May 30, 2001, to Round Lake Farmers Coop, Round Lake, Minnesota.
The firm manufacturers animal feeds. An inspection by the State of
Minnesota (on behalf of FDA) on March 30, 2001, found significant
deviations from the requirements for Animal Proteins Prohibited in
Animal Feed. The firm failed to label a hog feed with the required
BSE caution statement. In addition, they failed to establish and
implement procedures for handling prohibited animal proteins and
failed to maintain records sufficient to track the receipt of
products containing prohibited animal proteins.


Import Detentions


Possible Contamination of Fish Food Leads to Detention

The week of March 7, 2001, the FDAs New York District Upstate Import
Operations Branch detained three entries of fish food under Import Alert
99-25 (Detention Without Physical Examination of Animal Feed, Animal
Feed Ingredients And Other Products For Animal Use Consisting Or
Containing Ingredients of Animal Origin) due to possible contamination
with the infectious agent for BSE. The country of origin for the fish
food was the Federal Republic of Germany. The local
USDA/Philadelphia/PPQ Office was notified.


Vitamin Supplement for Pets Detained

* The week of February 14, 2001, the FDAs Atlanta District reported
the detention of 8,777 cartons of vitamin supplements for cats,
kittens, puppies, and older dogs. The detention included both dog
and cat treats. The detention was based on Import Alert 99-25
(BSE). The products were manufactured by Beaphar, Raalte,
Netherlands, and were valued at approximately $63,000.


Calf Ration Detained

The FDAs New York District Office reported that during the week of
March 21, 2001, FDA investigators detained an entry of Calf Starter
Ration and Calf Finisher Ration under Import Alert 99-25, since some of
the ingredients originated from France and The Netherlands (both of
which are listed on IA 99-25 as BSE susceptible countries). The
manufacturer of the feed was Grober Inc., Cambridge, Ontario, Canada,
and the consignee was Majestic View Farms in Milan, Pennsylvania. The
USDA/APHIS/PPQ Buffalo, New York office was contacted.


Recall of Various Animal Feed Products

* The FDAs Cincinnati District Office reported that The Hyland
Company, Coalton, Kentucky, conducted a recall of various animal
feed products, including Ultra Bloom and Endurance Plus horse
feeds, due to cross-contamination with prohibited bovine material.
The firm's corrective action involved the application of a
sticker-label that contained the required BSE warning statement on
the labels of their affected products. The firm initiated the
recall by telephone on July 25, 201, and letters on July 31, 2001.
* During an FDA inspection by the Cincinnati District Office
investigators determined that Central Farm Supply of Kentucky,
Inc., Louisville, Kentucky, had received poultry feed manufactured
by Burkmann Mills, Bowling Green, Kentucky, that contained
prohibited protein, but lacked the required caution statement. On
May 3, 2001, the district and the University of Kentucky
Regulatory Services Division met with the responsible parties of
the mill's parent firm, Burkmann Mills London, London, Kentucky.
During the meeting the firm volunteered to recall all feed
products manufactured at the Bowling Green mill due to the lack of
the required caution statement.


FDA Announces Animal Feed Recall

On January 30, 2001, FDA issued a Press Release announcing the results
of tests taken on feed used at a Texas feedlot that was suspected of
containing meat and bone meal from other domestic cattle -- a violation
of FDA's 1997 prohibition on using ruminant material in feed for other
ruminants. The results indicated that a very low level of prohibited
material was found in the feed fed to cattle.

FDA determined that each animal could have consumed, at most and in
total, five-and-one-half grams - approximately a quarter ounce -- of
prohibited material. These animals weigh approximately 600 pounds. It is
important to note that the prohibited material was domestic in origin
(therefore not likely to contain infected material because there is no
evidence of BSE in U.S. cattle), fed at a very low level, and fed only
once. The potential risk of BSE to such cattle was therefore exceedingly
low, even if the feed were contaminated.

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

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

FDA believes that Purina Mills acted responsibly by first reporting the
human error that resulted in the misformulation of the animal feed
supplement and then by working closely with State and Federal
authorities. This episode indicates that the multi-layered safeguard
system put into place is essential for protecting the food supply and
that continued vigilance needs to be taken, by all concerned, to ensure
these rules are followed routinely. FDA continues to work with USDA as
well as State and local officials to ensure that companies and
individuals comply with all laws and regulations designed to protect the
U.S. food supply.


Drug Residues


Warning Letters Issued for Illegal Drug Residues

Gentamicin

* The FDAs New England District Office issued a Warning Letter on
February 1, 2001, to D & K Farm, Middlefield, Connecticut, for
selling a dairy cow for slaughter as human food which had the
presence of Gentamicin. Gentamicin is not approved for use in
cattle. An FDA inspection of this dairy operation located in
Wallingford, Connecticut, disclosed that in November 2000, the
owner sold a dairy cow for slaughter as human to a livestock
dealer. USDA analysis of tissue samples collected from that animal
identified the presence of Gentamicin in the animals kidney at a
level of 4.74 ppm. The Warning Letter also noted that the owner
holds animals under conditions which are so inadequate that
diseased animals and/or medicated animals bearing potentially
harmful drug residues are likely to enter the food supply.

Penicillin

* On January 31, 2001, the FDAs New York District Office issued a
Warning Letter to Jay N. Martin, a producer and the owner of Jay
N. Martin, a.k.a. Horizon Dairy, in Clyde, New York. An FDA
inspection of the firm on November 20-22, and 27, 2000, confirmed
that the firm offered two dairy cows for slaughter with drug
residues. A USDA sample analyses indicated the presence of
penicillin at illegal levels in the kidneys of both slaughtered
cows, and streptomycin, for which there is no published tolerance.
* The FDAs Minneapolis District Office issued a Warning Letter on
August 28, 2001, to Paskewitz Cattle Company of Vesta,Minnesota.
The Warning Letter cited adulteration of two animals (a dairy cow
and a steer) with residues of penicillin that were above
tolerance. The investigation conducted by the Minnesota Department
of Agriculture found that Paskewitz Cattle did not keep adequate
records of their own drug treatment, and they did not have an
adequate system for handling purchased animals that may have been
treated with drugs.
* The FDAs Denver District Office issued a Warning Letter to DeJong
Dairy, Greeley, Colorado, on February 23, 2001, citing
adulteration charges due to the presence of penicillin residue in
a cow offered for slaughter. An FDA inspection of this dairy farm
on February 7 and 9, 2001, confirmed that the owner offered an
animal for slaughter in violation of the FD&C Act. Specifically,
on October 27, 2000, Mr. DeJong offered a cow for slaughter as
human food. USDA analysis of tissue samples collected from this
cow identified the presence of penicillin residues at 0.89 ppm in
the kidney. A tolerance of 0.05 ppm has been established for
residues of penicillin in the edible tissue of cows. The analysis
also identified the presence of gentamicin residue at 13.31 ppm in
the kidney. The Warning Letter also addressed poor animal
husbandry practices which lead to the residue. USDA condemned this
cow which was also diagnosed with septicemia, pneumonia,
pleuritis, peritonitis, hepatitis, nephritis, and lymphedenitis.
* The FDAs San Francisco District Office issued a Warning Letter to
Parreiro-Pinheiro & Sons Dairy, Tipton, CA. The dairy consigned
for sale for human food a cow that had penicillin residue in the
liver and kidney that were in excess of the allowable tolerance.
The FDAs San Francisco District Offices inspection found that
the dairy was not keeping complete medication records and lacked
an adequate drug inventory system. In addition, The FDAs San
Francisco District Offices investigation found that the dairy was
adulterated the drug, in that it was not being used in conformance
with its labeled instructions.

Sulfadimethoxine

* On June 15, 2001, the FDAs Denver District Office issued a
Warning Letter to North Point Dairy, Clovis, New Mexico, citing
adulteration charges due to the presence of sulfadimethoxine
residue in a cow offered for slaughter. An FDA inspection of this
dairy farm on April 17, 2001, confirmed that a cow was offered for
sale for slaughter as food in violation of the FD&C Act. USDA
analysis of tissues samples collected from this cow identified the
presence of sulfadimethoxine residue of 0.36 ppm in the liver and
0.34 ppm in the muscle. A tolerance of 0.10 ppm has been
established for residues of sulfadimethoxine in the edible tissues
of beef cows. The Warning Letter also addressed poor animal
husbandry practices, which led to the residue.

Neomycin

* The FDAs Florida District Office issued a tissue residue Warning
Letter on April 30, 2001, to Larson's Dairy, Inc., Okeechobee,
Florida. The FDA conducted an inspection of the diary farm on
March 27 and 28, 2001, which confirmed that the firm offered an
adulterated animal for sale or slaughter as food. USDA analysis of
the dairy calf confirmed the presence of Neomycin in the kidney at
the level of 153.12 ppm, more than 21 times the established
tolerance of 7.2 ppm. The FDAs Florida District Office's
investigation found the calf was fed medicated milk containing
Neomycin and Aureomycin.
* On June 22, 2001, the FDAs Baltimore District Office issued a
Warning Letter to Richard Edwards, owner of Oakland View Farm,
Ridgely, Maryland. Mr. Edwards sold veal calves for slaughter as
human food that were treated with Neomycin, a drug that is
unapproved for this use. In addition, an FDA inspection on May 30
- 31, 2001, revealed that Mr. Edwards did not maintain treatment
records showing the dosage rate, the date the drug was
administered, or the time period to withhold treated animals from
sale.

Streptomycin

* The FDAs New Jersey District Office issued a Warning Letter on
March 8, 2001, to Frank Carper, Cranbury, New Jersey. An FDA
inspection of this facility on October 24 and 27, 2000, confirmed
that a horse purchased and sold by Mr. Carper for use as human
food was adulterated due to the presence of streptomycin above
tolerance levels. USDA analysis of tissues from the equine
revealed that streptomycin in the kidney tissue at 0.38 ppm. The
tolerance level for streptomycin in the edible tissue of equines
is 0.0 ppm. Any animals shipped to USDA slaughter facilities are
considered to be for human consumption.


Consent Decree of Permanent Injunction Filed Against Joe
Sozinho Dairies


Firm Enjoined for Continuing to Sell Cattle With Violative
Drug Residue

On July 30, 2001, a Consent Decree of Permanent Injunction was filed in
the Eastern District of California against Joe Sozinho Sr., Danny
Sozinho, Dimas Sozinho, individuals d/b/a Joe Sozinho Dairy #1 and Joe
Sozinho Dairy #2. The FDAs San Francisco District Office conducted six
inspections in response to violative drug residues reported by USDA/FSIS
of Joe Sozinho Dairies resulting in two Warning Letters sent to the
firm. Despite repeated warnings during the FDA inspections, as well as
nine USDA/FSIS warning letters for illegal drug residues, the Sozinho's
failed to take adequate corrective action. Voluntary approaches were not
successful in correcting the animal husbandry and drug adulteration
problems by the Sozinho's.

The Consent Decree permanently restrains and enjoins the Sozinho's from
selling cattle for human food until all of the specifications of the
Decree are met which include an animal identification system, medication
record keeping system, drug inventory system, drug use system,
quarantine system, and animal sales certification system. In addition,
the Sozinho's reimbursed FDA's costs in the amount of $12,314.38 for
investigational expenses incurred subsequent to the 1994 inspection and
Warning Letter.

On February 1, 2002, the Sozinho Dairies and the United States filed a
stipulation settling a dispute concerning the Dairies' activities while
they were under an order of injunction. Under the Stipulation, the
Sozinhos admitted to continued violations of the law. They also admitted
delivering "at least 56 animals intended for use as food during a
thirty-six day period beginning on July 31, and ending on September 4,
2001." The United States had alleged in its motion for contempt that,
under the injunction, such deliveries were prohibited until FDA
inspected and cleared the Dairies to resume.

The Dairies were not cleared for such sales until December 2001. The
Injunction entered by the Court in July 2001 continues in effect. The
defendants have paid the U.S. Treasury fines in the amount of $140,000.


Ridge View Farms Consent Decree of Permanent Injunction


Consent Decree Provides FDA With Future Shutdown Authority

United States v. Ridge View Farms, Inc., Carol A. Castine, and Daniel A.
Castine (N.D.N.Y.) On August 7, 2001, the U.S. District Court for the
Northern District of New York entered a Consent Decree of Permanent
Injunction that prohibits the defendants from introducing any
food-producing animal into interstate commerce until they have
established a system for drug administration and record-keeping to
prevent the distribution of any animal containing illegal drug residues
in its edible tissues.

The Decree also requires the defendants to provide a copy of the Decree
to all persons to whom they have delivered cattle in the past year and
to any person to whom they deliver cattle in the future. In addition,
the Decree provides the government with the authority to require future
shutdown of operations and to impose fines in the event of further
violations.


Consent Decree Filed Against H & I Dairy

On November 28, 2000, a Consent Decree of Permanent Injunction was filed
in the Eastern District of California against Heduino Brasil (dba H & I
Dairy) of Tipton, California. Despite repeated warnings during FDA and
the State of California inspections, including six USDA warning letters
for illegal drug residue findings in cull cows sold or consigned for
slaughter, Mr. Brasil failed to take adequate corrective action. The
consent decree permanently restrains and enjoins Mr. Brasil from selling
cattle for human food until all the specifications of the decree are met
including animal identification, medication record keeping, drug
inventory, quarantine, and sales certification systems.


Arie C. Van Leeuwen Sentenced


Violation of Probation Leads to Prison Sentence

United States v. Arie C. Van Leeuwen, (E.D. Cal.) On July 9, 2001,
United States District Judge Robert E. Coyle sentenced Arie Van Leeuwen
to six months imprisonment and one year of supervised release for
probation violations. In 2000, Van Leeuwen pled guilty to two charges of
criminal contempt and one felony charge of introducing adulterated food
into interstate commerce, resulting from his repeated violations of the
statutory and regulatory requirements for administering new animal drugs
to food-producing animals.

Van Leeuwen admitted to the following probation violations: failure to
obey all laws; failure to submit certain monthly report forms; failure
to comply with home confinement conditions; and transporting animals to
cattle auctions in violation of the probation terms. In light of Van
Leeuwen's history of repeat violations, the Court sentenced him to six
months in prison followed by a year of supervised release that includes
mandatory attendance in dairy management classes.


http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/default.htm


Veterinary Drugs


Warning Letter to Veterinary Drug Firm

The FDAs New Orleans District Office Nashville Branch issued a Warning
Letter on April 10, 2001, to Classic Care Products, Inc., d.b.a. The
River City Co., Chattanooga, Tennessee, as the result of an inspection
of the firm on March 20 and 22, 2001. The inspection found topical
veterinary drug products being manufactured under inadequate conditions.
Deviations from the CGMPs included no component testing; no master
production records; failure to conduct stability studies on finished
products and to assign expiration dates based on these studies; and no
label control. The firm also was not registered and the veterinary drug
products were not listed.


Unapproved Veterinary Drugs Promoted on the Internet

On June 28, 2001, the FDAs Minneapolis District Office issued a Warning
Letter to Vets Plus, Inc., Knapp, Wisconsin. FDA conducted an inspection
of the firms veterinary drug and nutritional supplement manufacturing
facility on March 7 and 13, 2001.

The inspection disclosed that the firm was manufacturing veterinary
products that, based on the labels and well as product catalogs,
contained therapeutic and structure-function claims causing the products
to be unapproved new animal drugs. The firms web sites contained
numerous promotional statements and claims for four lines of products
marketed by the firm that established that the firm clearly intended the
product to be used as animal drugs. In addition, the firm failed to list
any of the products with the Center for Veterinary Medicine, and the
products were not manufactured in compliance with CGMP regulations.


Distributor of Prescription Veterinary Drugs Receives Warning

On August 27, 2001, the FDAs Philadelphia District Office issued a
Warning Letter to the president of Equirace Health and Speed Products,
Washington, Pennsylvania. The firm is an exclusive distributor of
prescription veterinary and human drugs to horse owners. The FDA
conducted an inspection of Equirace on December 5, 2000. The inspection
and a review of information from the New Mexico Livestock Board
disclosed that the firm was distributing prescription veterinary and
human drugs to lay persons without a lawful order from a licensed
veterinarian who has a valid veterinarian-client-patient relationship
with customers.

The Warning Letter advised the owner that Equiraces distribution
business violates several sections of the FD&C Act. For example, the
firms prescription veterinary drugs are misbranded because they are not
dispensed by or upon the lawful written or oral order of a licensed
veterinarian in the course of the veterinarians professional practice.
Although there was a licensed veterinarian at the firm, he did not have
a valid veterinarian-client-patient relationship with any of Equiraces
customers. The Warning Letter also noted that certain prescription
veterinary and human drugs offered for sale by Equirace were adulterated
because they were new animal drugs that were not approved by the FDA for
use in horses.


Illegal Veterinary Drugs Exported

On March 5, 2001, the FDAs San Juan District Office found that a
shipment of veterinary drugs from Santo Domingo to the U.S. Virgin
Islands, consisting of drugs such as antibiotics, hormones and dietary
supplements, contained numerous unapproved drugs for veterinary use. The
drugs were placed on hold by the U.S. Customs at the Aguadilla airport.
The shipment was exported under Custom's supervision.


FDA Assists Customs in Seizure of Illegal Vet Drugs

On July 10, 2001, the FDAs San Juan District Office, in conjunction
with U.S. Customs, detained and seized a shipment of veterinary drugs
not approved for sale in the U.S. that was imported from Santo Domingo.
U.S. Customs agents notified San Juan District Office that the shipment
was imported as "Hair Products," but actually contained veterinary
drugs. FDAs inspection of the shipment revealed that the veterinary
drugs were smuggled among a variety of soaps. The shipment, which was
originally thought to consist of a few bottles, contained a total of 793
bottles/pouches of a variety of illegal veterinary drugs. The shipment
was detained by FDA and seized by U.S. Customs agents. The value of the
shipment was approximately $7,000.


Importer Attempts to Re-Enter Vet Drugs Previously Refused Entry

On May 2, 2001, the FDAs San Juan District Office, in conjunction with
U.S. Customs Service seized a shipment of IVOMEC-F, a veterinary drug
not approved for sale in the U.S. The shipment was from importer
Hacienda Las Carolinas, Santo Domingo. The San Juan District Office was
notified by U.S. Customs agents that a shipment that had been refused
entry on February 10, 2001, and had been exported under Customs
supervision was re- introduced through the same port on March 16, 2001,
by the same importer. The value of the shipment was $3,500.00.


Seizure at Veterinary Pharmacy

On December 20, 2000, an FDA investigator accompanied the U.S. Marshals
Service in a seizure of unapproved new animal drugs at Veterinary
Pharmacy Corporation (d.b.a. Vet Rx Pharmacy), St. Peter, Minnesota. The
firm is a compounding pharmacy for veterinary drugs. The firm has a
history of serious violations of the FD&C Act, particularly the 1994
Animal Medicinal Drug Use Clarification Act (AMDUCA). The seized drugs,
valued at approximately $50,000, were intended for administration to
food-producing animals, and were unapproved new drugs in that they were
compounded from the bulk active ingredients. Such compounding violates
AMDUCA and the implementing regulations, 21 C.F.R. Part 530. The FDA
conducted inspections at the firm on June 27 - 29, and July 6 - 7, 2000.
These inspections disclosed the above violations.


Consent Decree of Condemnation and Permanent Injunction

U.S. v. Sulfadiozie Sodium and Veterinary Pharmacy Corp. d.b.a. Vet Rx
Pharmacy (D. Minn.) On February 28, 2002, a U.S. District Judge signed a
Consent Decree of Condemnation and Permanent Injunction against this
veterinary pharmacy and two corporate officers, as well as the drugs
seized in this action. The Decree orders the defendants to destroy the
seized drugs and enjoins them from engaging in compounding activities
that fail to conform to the AMDUCA regulations.

http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/cvm2.htm

http://www.fda.gov/ora/about/enf_story/archive/2001/ch5/cvm3.htm

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

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

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


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

PART 2


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


APHIS Statement: June 29 Inconclusive BSE Test is Negative

http://www.usda.gov/Newsroom/0275.04.html
07/02/2004

APHIS Statement: First Inconclusive BSE Test is Negative


http://www.usda.gov/Newsroom/0272.04.html
06/30/2004

APHIS Statement Regarding Second Inconclusive BSE Test


http://www.usda.gov/Newsroom/0266.04.html
06/29/2004

APHIS Statement Regarding First Inconclusive BSE Test


http://www.usda.gov/Newsroom/0198.04.html 06/25/2004


January 14, 2005

Dr. John R. Clifford, Deputy Administrator, Chief Veterinary Officer

Animal Plant Health Inspection Service

1400 Independence Ave. SW, Room 317-E

Jamie L. Whitten Federal Building

Washington, DC 20250

Dear Deputy Administrator Clifford,

We have a number of questions about your November 23, 2004 announcement
that a cow, which had tested ‚¨Snot negative‚¨Ě in two runs of the Bio-Rad
ELISA quick test for mad cow disease, was ‚¨Sindeed negative for BSE.‚¨Ě We
are concerned because New Scientist reported last June that the false
positive rate after such repeated testing is ‚¨Saround one in 100,000 for
Bio-Rad.‚¨Ě We would appreciate a chance to meet with you this month to
discuss the questions below.

1. You have indicated that the Biorad screening test was run twice and
got a positive result both times. Were the two runs conducted by the
same or different technicians? Did they use the same or different brain
samples?

2. When the immunohistochemistry (IHC) test was conducted, what was the
condition of the brain when it arrived at the National Veterinary
Services Laboratory in Ames, Iowa? Did scientists note any deterioration?

3. How many slides were made and examined for the IHC test? Were they
from only the obex, or other areas of the brain? Atypical strains of BSE
have been found in Italy and Japan where the level of PrPres in the obex
was low or non-detectable, unlike in traditional BSE. What portion(s) of
the brain were examined?

4. Experienced technicians can sometimes disagree on the interpretation
of IHC slides. Does one technician review the slides or more than one
technician? If the latter, how many? Did they all agree on the conclusion?

5. The World Organization of Animal Health, known as O.I.E., recognizes
use of immunoblotting (also know as Western Blot) as a further
confirmation of the IHC test, and it is used in Japan and most European
countries. USDA used the Western Blot test in December 2003 along with
IHC to confirm the first case of mad cow disease in the United States .
In Japan and Belgium cows that tested positive on two quick tests (in
both cases using a Bio-Rad test), negative on IHC, yet positive on
Western Blot and are considered to be confirmed BSE cases. Was Western
blot or any other technique besides IHC used to confirm or rule out a
positive result on this November 2004 cow? If so, what was the result?
If not used, why not?

6. Were all the procedures referred to in your March 15, 2004
announcement of protocols to confirm any suspect positives utilized,
particularly the reference to use of ‚¨Sfull battery of tests‚¨Ě that
includes, but is not limited to IHC? If not, what protocol was used and
what is your rationale for the differences?

7. Does USDA still have brain material from the cow in question? If so,
could it be sent to the World BSE reference laboratory in Weybridge,
United Kingdom for IHC and Western Blot analysis to confirm the USDA
finding? If not, why not?

8. Canadian press has reported that ‚¨SCanadian authorities have been told
that the cow, from Texas, didn‚¨"t have the metal ID tags that cows born
here are given.‚¨Ě Is this correct? What was the age of the cow and where
had it lived?

We would like to request a meeting with you between now and the end of
January about these questions, which are very important to consumer
confidence in the safety of the food supply.

Sincerely,

Jean Halloran, Director Michael Hansen, Ph.D.

Senior Research Associate

>From http://www.ars.usda.gov/is/AR/archive/dec04/tse1204.htm

Yamakawa, Y. et al. 2003. op cit.

De Bosschere, H., Roels, S. and E. Vanopdenbosch. 2004. Atypical case of
bovine spongiform encephalopathy in an East-Flemish Cow in Belgium. The
International Journal of Applied Research, 2(4). Accessed at
http://www.jarvm.com/articles/Vol2Iss1/DEBOSSCHERE.htm

In a technical briefing on the new BSE sureveillance plan, Dr. Ron
DeHaven clearly stated that USDA would use multiple tests that included
IHC: ‚¨SThe Department at NVSL will continue to use the
immunohistochemistry, or IHC, for quality control testing, and in
addition if any of the rapid screen test comes back with a suspect
positive then NVSL will use the IHC as well as other tests necessary to
confirm the results. . . Let me say up front that we expect that there
will be positive results on these screening tests, and that's just the
nature of the beast. That's because screening tests by design are
intended to be very sensitive and not to miss any positive animals. But
with that high degree of sensitivity also comes the possibility for
false positive test results. And again that's to be expected. any
suspect test results will be sent to NVSL for confirmatory testing with
the full battery of tests. That would include the IHC. From:
http://www.usda.gov/Newsroom/0106.04.html

>From
http://edmonton.cbc.ca/regional/servlet/View?filename=ed-mad-cow20041122

Greetings again,

I was told that they were to meet on Feb. 9, 2005 about these inconclusives.

I have heard nothing of the outcome. Maybe we will hear soon.

BUT of course we will never know the results of that first TEXAS mad

cow they covered up, the stumbling and staggering one they refused to

test, and decided to render, head and all...

Experts doubt USDA's mad cow results

By Steve Mitchell
Medical Correspondent

Published 11/24/2004 4:34 PM


WASHINGTON, Nov. 24 (UPI) -- U.S. Department of Agriculture officials
said a cow that initially tested positive for mad cow disease was found
to be negative on follow-up tests, but both domestic and international
experts told United Press International the way the agency handled the
situation leaves them skeptical about the validity of the results.

"The testing process does indeed make experts scratch their heads," said
Markus Moser, a molecular biologist and chief executive officer of the
Swiss firm Prionics, which manufactures tests for detecting mad cow
disease, also known as bovine spongiform encephalopathy.

"I think some, but not all, BSE people internationally have some degree
of cynical de facto doubt about everything the United States does or
doesn't do, mostly as a result of seeing so many similar situations
where countries at risk deny and deny and deny and then end up having
big problems," said Elizabeth Mumford, a veterinarian and BSE expert at
Safe Food Solutions in Bern, Switzerland, a company that provides advice
on reducing mad cow risk to industry and governments.
Several countries, including Germany and Austria, that had been thought
to be free of the disease, found out it was circulating in their herds
after they initiated large-scale testing.
The U.S. cow in question tested positive last week on two so-called
rapid tests manufactured by Bio-Rad Laboratories in Hercules, Calif. The
USDA said Tuesday the animal had tested negative on more sophisticated
confirmatory tests called immunohistochemistry or IHC tests.

John Clifford of the USDA said in a statement that the negative IHC
results "makes us confident that the animal in question is indeed
negative."

A U.S. veterinarian knowledgeable about mad cow tests told UPI that
experts she has spoken with are "very, very skeptical about" the USDA's
negative test result.

The veterinarian, who requested anonymity because she feared
repercussions for speaking out against the USDA, said the skepticism
arose because the agency did not run another kind of mad cow test called
a Western blot. The test sometimes can pick up positive cases that IHC
misses and the agency has used it in the past to rule out suspect cases.
Moser said a Western blot test would make sense for the United States,
where the prevalence of mad cow is thought to be low. Other countries --
including Australia, New Zealand, Canada and Mexico -- that are either
free of the disease or have low rates, have elected to use the Western
blot as part of their surveillance programs, he said.

The veterinarian said concerns also have emerged because the USDA has
not made a sample from the cow in question available for examination by
outside experts. She added that the USDA did not notify state officials,
as officials previously said they would about positive results on rapid
tests.
Knowledgeable people are saying "wait a minute, this doesn't add up
here," the veterinarian said.
At stake is the $70 billion U.S. beef industry, including a $3.3 billion
export market. More than 60 countries, including Japan, closed their
borders to U.S. beef last December after the first -- and so far only --
U.S. case of mad cow was detected.

Asked whether state officials were notified, USDA spokesman Ed Loyd told
UPI the agency had not released any information about the cow in
question. Loyd also said the false positives on the rapid test were not
unexpected. Since June, the USDA has reported three false positives out
of more than 121,000 cows tested.

Bio-Rad spokeswoman Sam Kennedy told UPI the company was unfamiliar with
the details of this incident and thus could not comment.

Mumford said experts were surprised the USDA did not send samples from
the cow in question for independent analysis by one of the three
worldwide labs recognized as the foremost authorities on mad cow testing
by the World Animal Health Organization. One of these facilities is
located in Weybridge, England, where the USDA had sent the first U.S.
case of mad cow disease for confirmation in December 2003.

Loyd said USDA officials who would know whether USDA planned to release
a sample for verification by an outside party could not be reached
Wednesday.

"Full transparency and cooperation would certainly promote the idea
internationally that the U.S. is doing everything it can do," Mumford
said. "But somehow the U.S. consumer doesn't seem to think that way, or
has been appeasable at least up until now, so there seems to be no
impetus to do anything more."

The concern is humans can contract a fatal brain illness known as
variant Creutzfeldt Jakob disease from eating beef products contaminated
with the mad cow pathogen.

Moser said despite USDA's reliance on the IHC test results, repeated
negatives on that test does not necessarily rule out the cow being
infected.

"The reason for this is that the IHC test ... is done on a different
piece of tissue" than that used for the rapid test, he said. Prions, the
pathogen thought to cause mad cow disease, tend to concentrate in a
region of the brain called the obex, so the different outcomes of the
different tests could be due to sampling a brain region that contains
little or no prions.
This could be made worse if the animal had lay dead for several days
before its brain was collected. The brain might be so degraded that it
would be difficult to locate the obex region for confirmatory testing
and a sample might mistakenly be taken from a region that contains no
prions.
"So with these samples, the confirmatory testing would be even less
reliable, not because of the confirmatory test itself, but because of
the sampling," he said.
--

E-mail sciencemail@upi.com

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