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From: TSS ()
Subject: Japan to reimpose ban on all US beef imports
Date: January 20, 2006 at 6:54 am PST

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.

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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.

----- Original Message -----
From: Terry S. Singeltary Sr.
Cc: ; ; ; ; ; ;
Sent: Wednesday, January 18, 2006 8:54 PM

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

Terry S. Singeltary

Page 1 of 17

From: Terry S. Singeltary Sr. []

Sent: Thursday, September 08, 2005 6:17 PM


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 ;

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
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.
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.
James J. Kramer, Ph.D.
Vice President, Corporate Operations

C 435 Government of Japan Vol #: 36


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."


McDonald's Corp. submission are in the attachments..............tss

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