##################### Bovine Spongiform Encephalopathy #####################
Release No. 0019.06
Contact:
Ed Loyd (202) 720-4623
Printable version
STATEMENT BY AGRICULTURE SECRETARY MIKE JOHANNS REGARDING U.S. BEEF EXPORTS
TO JAPAN
January 20, 2006
"We take this matter very seriously. We are conducting a thorough
investigation. Under U.S. regulations, the backbone, or vertebral column,
that was exported to Japan is not a specified risk material because it was
in beef under 30 months. However, our agreement with Japan is to export beef
with no vertebral column and we have failed to meet the terms of that
agreement.
"The processing plant that exported this product has been de-listed and
therefore can no longer export beef to Japan. We will take the appropriate
personnel action against the USDA Food Safety and Inspection Service
employee who conducted the inspection of the product in question and
approved it to be shipped to Japan.
"I am dispatching a team of USDA inspectors to Japan to work with Japanese
inspectors to reexamine every shipment currently awaiting approval, to
confirm compliance with the requirements of our export agreement with Japan.
"I have directed that additional USDA inspectors be sent to every plant that
is approved to export beef to review procedures and ensure compliance with
our export agreements and I am requiring that two USDA inspectors review
every shipment of U.S. beef for export to confirm that compliance. I have
also ordered unannounced inspections at every plant approved for beef
export.
"We are in communication with Japanese officials and we will continue that
dialogue to assure them that we take this matter very seriously and we are
acting swiftly and firmly.
"These additional inspection requirements in the U.S. will be applied to all
processing plants approved for beef export and all beef shipments designated
for export from the U.S."
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2006/01
/0019.xml
TSS
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From: TSS ()
Subject: Re: Japan to reimpose ban on all US beef imports
Date: January 20, 2006 at 6:58 am PST
Release No. 0019.06
Contact:
Ed Loyd (202) 720-4623
Printable version
STATEMENT BY AGRICULTURE SECRETARY MIKE JOHANNS REGARDING U.S. BEEF EXPORTS
TO JAPAN
January 20, 2006
"We take this matter very seriously. We are conducting a thorough
investigation. Under U.S. regulations, the backbone, or vertebral column,
that was exported to Japan is not a specified risk material because it was
in beef under 30 months. However, our agreement with Japan is to export beef
with no vertebral column and we have failed to meet the terms of that
agreement.
"The processing plant that exported this product has been de-listed and
therefore can no longer export beef to Japan. We will take the appropriate
personnel action against the USDA Food Safety and Inspection Service
employee who conducted the inspection of the product in question and
approved it to be shipped to Japan.
"I am dispatching a team of USDA inspectors to Japan to work with Japanese
inspectors to reexamine every shipment currently awaiting approval, to
confirm compliance with the requirements of our export agreement with Japan.
"I have directed that additional USDA inspectors be sent to every plant that
is approved to export beef to review procedures and ensure compliance with
our export agreements and I am requiring that two USDA inspectors review
every shipment of U.S. beef for export to confirm that compliance. I have
also ordered unannounced inspections at every plant approved for beef
export.
"We are in communication with Japanese officials and we will continue that
dialogue to assure them that we take this matter very seriously and we are
acting swiftly and firmly.
"These additional inspection requirements in the U.S. will be applied to all
processing plants approved for beef export and all beef shipments designated
for export from the U.S."
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2006/01
/0019.xml
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr." <
[email protected]>
To: <
[email protected]>
Sent: Friday, January 20, 2006 9:16 AM
Subject: Japan to reimpose ban on all US beef imports
##################### Bovine Spongiform Encephalopathy
#####################
Japan to reimpose ban on all US beef imports
Friday, January 20, 2006 9:18 a.m. ET
By Chikafumi Hodo
TOKYO (Reuters) - Japan will reimpose a ban on all U.S. beef imports just a
month after lifting it, following the discovery of animal parts in a recent
shipment that should have been removed due to the risk of mad cow disease.
More Stories About...
Secretary of State Robert Zoellick
Minister Shoichi Nakagawa
Prime Minister Junichiro Koizumi
The Agriculture Ministry said on Friday the ban would remain until it
receives more information from the United States. A U.S. embassy official in
Tokyo said the U.S. regretted the incident and would investigate it.
Japan had initially stopped all purchases of beef from the United States
after a case of the brain-wasting mad cow disease in December 2003, halting
annual trade worth about $1.4 billion. The ban lasted two years and became
an irritant in otherwise close and friendly U.S.-Japan relations.
The latest incident, which also comes as U.S. Deputy Secretary of State
Robert Zoellick is due to visit Japan on Sunday and Monday, could alarm
Japanese consumers as well as raise questions about Tokyo's decision to lift
the ban.
"It is regrettable that the United States has failed abide by the
agreement," a farm ministry official told a briefing, referring to a deal in
October 2004 between Japan and the U.S. on the resumption of beef imports.
"Any decision (to resume imports) would be after we receive information from
the U.S. government," the official said.
A total of 390 kg (860 lb) of beef imported from a meatpacker in New York
was found to contain parts of a spinal cord when it was inspected on arrival
at Narita International Airport near Tokyo, a Farm Ministry official said
earlier.
Experts believe humans can contract a fatal variant of mad cow disease,
formally known as bovine spongiform encephalopathy (BSE), by eating
contaminated meat.
Japan only imports U.S. beef from cattle aged 20 months or younger. It
requires all animal material linked to mad cow, including the spinal cord,
to be totally removed.
Washington acted quickly to try to ease concern in what was the United
States' top overseas beef market prior to the ban.
The United States is expected to conduct a full investigation into the
shipment, the U.S. Embassy in Tokyo said in a statement.
"We deeply regret the incident occurred. We expect that there will be a full
investigation by the U.S. Department of Agriculture and we look forward to
the results of that investigation," said the statement, read by an embassy
spokesman.
The United States will also work closely with Japanese authorities to ensure
that there is no repeat of this mistake, the statement said.
Japanese Prime Minister Junichiro Koizumi said earlier on Friday that
Agriculture Minister Shoichi Nakagawa wanted the United States to act
firmly.
"He also recommended, because preserving food safety and security for the
people is extremely important, calling on the United States to make a strong
response," Koizumi told reporters.
Small quantities of beef from the United States have started to enter Japan,
but consumers remain worried that safeguards there are not up to Japanese
standards.
(Additional reporting by Linda Sieg and Miho Yoshikawa)
Copyright © 2006 Reuters Limited. This story and its comments expire 30 days
after original publication date.
http://wireservice.wired.com/wired/story.asp?section=Breaking&storyId=114742
5&tw=wn_wire_story
----- Original Message -----
From: Terry S. Singeltary Sr.
To:
[email protected]
Cc:
[email protected] ;
[email protected] ;
[email protected] ;
[email protected] ;
[email protected] ;
[email protected]. ;
[email protected].
Sent: Wednesday, January 18, 2006 8:54 PM
Subject: BOVINE SPONGIFORM ENCEPHALOPATHY i.e. BSE aka MAD COW DISEASE USA
(a 'Big Mac' attack';-)
Greetings Honorable and Kind Friends, Colleagues, and Scientist of Japan,
A kind and warm greetings from Texas!
I wish to submit the following data for your information/truth.
Since GW et al insists on this stupid BSE/MRR policy (legal trading of all
strains of TSE),
I wish to submit to you, and the kind people of Japan, a 'big mac' of sorts
from the McDonalds Corp.,
it is a whopper ;-) ...
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle
03-025IFA
03-025IFA-2
Terry S. Singeltary
Page 1 of 17
From: Terry S. Singeltary Sr. [
[email protected]]
Sent: Thursday, September 08, 2005 6:17 PM
To:
[email protected].
Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
Risk Materials for Human Food and Requirements
for the Disposition of Non-Ambulatory Disabled Cattle
Greetings FSIS,
I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
Prohibition of the Use of Specified Risk Materials for Human Food and
Requirements for the Disposition of Non-Ambulatory Disabled Cattle
THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle
Broken bones and such may be the first signs of a sub clinical BSE/TSE
Non-Ambulatory Disabled Cattle ;
snip...FULL TEXT ;
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
the 'big mac' is in the file attachment. ...TSS
P.S. another email to follow. it is a submission of mine that nobody wants,
or will touch. anyway, i have no PhDs anyway. ...
with kindest regards,
I am sincerely,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
9 December 2005
Division of Dockets Management (RFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852
Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)
Substances Prohibited From Use in Animal Food and Feed
Dear Sir or Madame:
Serologicals Corporation is a global provider of biological products to life
science companies.
The Company's products are essential for the research, development and
manufacturing of
biologically based diagnostic, pharmaceutical and biological products.
customers include
many of the leading research institutions, diagnostic and pharmaceutical
companies throughout
the world. The Company's products and technologies are used in a wide
variety of applications
within the areas of neurobiology, cell signaling, oncology, angiogenesis,
apoptosis,
developmental biology, cellular physiology, hematology, immunology,
cardiology, infectious
diseases and molecular biology.
A number of our products are derived from bovine blood or other bovine
tissues sourced in the
United States, hence the overall health of the national herd is extremely
important to our
company as well as to our customers and their patients. Some of our bovine
based products are
used in the manufacture of vaccines and drugs for humans, hence it is
critical that all measures
are taken to assure these are safe and free from disease especially Bovine
Spongiform
Encephalopathy (BSE). The most effective way to insure this is to create a
system which
processes cattle that are BSE free. As a company there are a number of
precautions that we can
take by our strict specifications but many of the needed precautions require
the force of federal
regulation, hence we appreciate the opportunity to submit comments to this
very important
proposed rule.
After the identification of bovine spongiform encephalopathy (BSE) in
indigenous North
American cattle, the U.S. Department of Agriculture (USDA) responded rapidly
to implement
measures to protect public health in regard to food. Our company recognizes
and supports the
importance of the current feed ban which went into effect in August 1997.
However, given what
is known about the epidemiology and characteristically long incubation
period of BSE, we urge
5655 Spalding Drive * Norcross, GA 30092
678-728-2000 * 800-842-9099 * Facsimile 678-728-2299
www.serologicais.com
Division of Dockets Management (HFA-305)
Page 2
9 December 2005
the FDA to act without further delay and implement additional measures which
will reduce the
risk of BSE recycling in the US cattle herd.
We feel that for the FDA to provide a more comprehensive and protective feed
ban, specified
risk materials (SRMs) and deadstock must be removed from all animal feed and
that legal
exemptions which allow ruminant protein to be fed back to ruminants (with
the exception of
milk) should be discontinued.
SRMs, as defined by the USDA, are tissues which, in a BSE infected animal,
are known to either
harbor BSE infectivity or to be closely associated with infectivity. If SRMs
are not removed,
they may introduce BSE infectivity and continue to provide a source of
animal feed
contamination. Rendering will reduce infectivity but it will not totally
eliminate it. This is
significant as research in the United Kingdom has shown that a calf may be
infected with BSE
by the ingestion of as little as .OOl gram of untreated brain.
The current proposed rule falls short of this and would still leave a
potential source of infectivity
in the system. In fact by the FDA's own statement the exempted tissues which
are known to
have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount
to 10% of the
infectivity in an infected animal, This proposed rule would still allow for
the possibility that
cattle could be exposed to BSE through:
1. Feeding of materials currently subject to legal exemptions from the ban
(e.g., poultry
litter, plate waste)
2. Cross feeding (the feeding of non-ruminant rations to ruminants) on
farms; and
3. Cross contamination of ruminant and non-ruminant feed
We are most concerned that the FDA has chosen to include a provision which
would allow
tissues from deadstock into the feed chain. We do not support the provision
to allow the removal
of brain and spinal cord from down and deadstock over 30 months of age for
several reasons.
These are the animals with the highest level of infectivity in tissues which
include more than
brain and spinal cord. We do not feel that there can be adequate removal and
enforcement of this
regulation especially during warmer weather. In addition there is emerging
information that at
end stage disease, infectivity may also be included in additionai tissues
such as peripheral nerves
(Buschmann and Groschup, 2005).
Leaving the tissues from these cattle in the animal feed chain will
effectively nullify the intent of
this regulation. This point is illustrated by the 2001 Harvard risk
assessment model which
demonstrated that eliminating dead and downer, 4D cattle, from the feed
stream was a
disproportionately effective means of reducing the risk of re-infection "The
disposition of c&e
that die on the farm would also have a substantial influence on the spread
of BSE if the disease
were in traduced. " The base case scenario showed that the mean total number
ofID.50~ (i.e.,
dosage sufficient to infect SO percent of exposed cattte) from healthy
animals at slaughter
presented to the food/feed system was 1500, The mean total number of ID.50.s
from adult cattle
Division of Dockets Management (HFA-305)
Page 3
9 December 2005
deadstockpresented to the feed system was 3 7,000.
deadstock).
This illustrates the risk of "40 cattle" (i.e.,
From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard
Risk
Assessment, 200 1 Executive Summary
Serologicals and companies like ours which supply components of drugs and
biologicals have a
responsibility to the manufacturers of these products, the medical community
and their patients
as well as regulatory agencies throughout the world to provide the safest
products as possible.
Since there is no test for BSE in live cattle or for product, the regulatory
agencies throughout the
world expect us to reduce or eliminate risk via suurcing criteria, These
parameters may include
but not be limited to country of origin, herd of origin, age of the animal,
etc. The United States
is no longer a country with negligible risk, hence individual animal
criteria has become more
important. In fact other Centers of the FDA have stated that more attention
should be given to
sourcing from herds likely to be a source of BSE free animals. The
exemptions in the current
ban as well as in the newly proposed rule make this difficult if not
impossible as there are still
legal avenues for ruminants to consume potentially contaminated ruminant
protein. In addition,
the USDA still has not implemented a system of identification and
traceability.
Serologicals urges agencies of the US government to work with academia and
industry on
research in the following areas:
e Methods to inactivate TSEs agents which then may allow a product to be
used and even
fed to animals without risk
l Alternative uses for animal byproducts which would maintain value
Serologicals will continue to work with the FDA and other government
agencies to implement a
strong BSE risk control program, Serologicals would like to reiterate our
opinion that for the
FDA to provide a more comprehensive and protective feed ban, specified risk
materials (SRMs)
and deadstock must be removed from all animal feed and that legal exemptions
which allow
ruminant protein to be fed back to ruminants (with the exception of milk)
should be
discontinued. Thank you for the opportunity to submit these comments to the
public record.
Respectfully,
SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.p
df
C 435 Government of Japan Vol #: 36
snip...
The Food safety risk assessment related to the import of beef and beef offal
from the U.S.A. and Canada by the Food Safety Commission of Japan (FSC) was
completed on December 8, 2005. REGARDING the feed ban, the following was
noted as an ADDENDUM TO THE CONCLUSION ON THE RISK ASSESSMENT REPORT OF FSC:
"To prevent BSE exposure and amplification in U.S.A. and Canada, the use of
SRM must be prohibited COMPLETELY. The ban must be applied not only to
cattle feed but ALSO TO ALL OTHER ANIMAL FOOD/FEED that may cause
cross-contamination."
snip...
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000435-01-vol36.p
df
McDonald's Corp. submission are in the attachments..............tss
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