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From: TSS ()
Date: February 11, 2005 at 12:32 pm PST

JPN consumer union v US beef


The Consumers Union of Japan urged the government on Thursday not to remove its 14-month-old import ban on American beef as a result of what it says is U.S. pressure, according to Kyodo.

In a letter to the Ministry of Health, Labor and Welfare, and the Ministry of Agriculture, Forestry and Fisheries, the influential consumer group complained that a government study panel accepted a U.S. proposal to determine the age of cattle for removal of the ban "under U.S. pressure and without showing experts' scientific views."

Although panel members expressed skepticism about the U.S. proposal, the government panel decided to accept it as a result of the chairman's "comprehensive judgment," the consumers group said.

The decision "is not scientifically justifiable while politically motivated to comply with U.S. intention," the group concludes.

On Tuesday, the study panel, set up by the two ministries, said the U.S.-proposed age verification method is acceptable and can be used as a benchmark to determine a cow is 20 months or younger, presenting a decision that will pave the way for Japan's partial resumption of U.S. beef imports.

U.S. experts in January proposed a new method of specifying the age of U.S. cattle, saying if the United States exports the A40 grade of beef to Japan, chiefly from cattle aged 12 to 17 months, the meat should be free of mad cow disease, formally known as bovine spongiform encephalopathy.

Japan has banned American beef imports since December 2003 when the first U.S. case of the disease was found.

JPN begins US beef rulemaking

Japan-U.S. beef trade issue finally to move to rulemaking

The decision by Japanese officials this week to accept beef grading as a means of verifying cattle age is expected to clear the way for Japan's Food Safety Commission to begin its rulemaking to reopen the Japanese border to U.S. beef.

The rulemaking would modify Japan's policy requiring that all cattle be tested for bovine spongiform encephalopathy (BSE) before beef enters the Japanese food system to excuse from testing cattle that are 20 months of age or younger.

The rule would allow beef grading "A-20," "A-30" and "A-40" to be exported from the U.S. to Japan as those grades were demonstrated in USDA research to not come from cattle older than 20 months.

A conference call between Japanese and U.S. officials was scheduled yet this week to finalize remaining age verification questions, including gestation length, after which the U.S. position is that the technical work is done and Japanese rulemaking should begin, according to Chuck Lambert, USDA deputy undersecretary for marketing and regulatory programs.

Rules must reflect 21st century trades

Japan represents what historically is the largest beef export market for the U.S., and it's believed an agreement reopening the Japanese border will be the model for reopening other international markets, Lambert and Agriculture Secretary Mike Johanns said in remarks to the Cattle Industry Annual Convention & Trade Show last week in San Antonio, Texas.

Johanns said the U.S. rule to reopen its border to Canadian cattle reflects this thinking. "Trade is an eight-lane superhighway," he said, "and we can't go with a 'do as I say and not as I do' approach. That is not how trade works in the 21st century." The U.S. rule "reflects the belief that open borders open borders," he said, adding that the rulemaking and trade must be founded in science. "One cow must never again" do what the BSE discoveries have done to the North American beef industry, he said.

A-40 score verifies young cattle

Lambert said the beef grading work was included in the agreement Japan and the U.S. announced last October setting the framework for rulemaking in both countries and resumption of trade. He explained that 3,338 cattle of known birth dates were scored using carcass characteristics for physiological maturity, or age.

Scores were assigned from A-20 through C-00, with age increasing by letter and number. Cattle scoring A-40 were consistently younger than A-50, A-60, A-70, etc., and cattle scoring in the A grades were younger than those in the B and C grades, with C-00 cattle being the oldest of the sample. He said all A-40 cattle were 17 months old or younger, giving Japanese representatives "a three-month cushion" of assurance that any cattle scoring A-40 or lower would be 20 months or younger.

Japanese commission must assess, communicate risk

The Japanese Food Safety Commission must pursue a very deliberate process not unlike U.S. rulemaking, according to Dr. Shiro Inukai, chief representative to the North American office of the Japanese Agriculture & Livestock Corp. Inukai told Feedstuffs the agriculture and health ministries have asked the commission to issue a risk assessment concerning U.S. beef, i.e., a rule to allow U.S. beef to be imported into Japan, he said.

It will proceed to make this assessment and return it to the two ministries for official comment and, as part of risk communication, also open it to public comment. The commission then will evaluate all comments and release a final rule to the ministries and public to take effect at a date certain, he said. Inukai said the process is lengthy and suggested that it may be late this summer before the border is officially reopened to U.S. beef.

[[[Scores were assigned from A-20 through C-00, with age increasing by letter and number. Cattle scoring A-40 were consistently younger than A-50, A-60, A-70, etc., and cattle scoring in the A grades were younger than those in the B and C grades, with C-00 cattle being the oldest of the sample. He said all A-40 cattle were 17 months old or younger, giving Japanese representatives "a three-month cushion" of assurance that any cattle scoring A-40 or lower would be 20 months or younger.]]]



the myth that cattle under 30 months of age are free from BSE/TSE is
just that, a myth, and it's a false myth !

the youngest age of BSE case to date is 20 months old; As at: 31 May
2003 Year of onset Age youngest case (mnths) Age 2nd youngest case
(mnths) Age 2nd oldest case (yrs.mnths) Age oldest case (yrs.mnths) 1986
30 33 5.03 5.07 1987 30 31 9.09 10.00 1988 24 27 10.02 11.01(2) 1989 21
24(4) 12.00(2) 15.04 1990 24(2) 26 13.03 14.00 1991 24 26(3) 14.02 17.05
1992 20 26 15.02 16.02 1993 29 30(3) 14.10 18.10 1994 30(2) 31(2) 14.05
16.07 1995 24 32 14.09 15.05 1996 29 30 15.07 17.02 1997 37(7) 38(3)
14.09 15.01 1998 34 36 14.07 15.05 1999 39(2) 41 13.07 13.10 2000 40 42
17.08 19.09 2001 48(2) 56 14.10 14.11 2002 51 52 15.08 15.09(2) 2003 50
62 11.11 14.11

The implications of the Swiss result for Britain, which has had the most
BSE, are complex. Only cattle aged 30 months or younger are eaten in
Britain, on the assumption, based on feeding trials, that cattle of that
age, even if they were infected as calves, have not yet accumulated
enough prions to be infectious. But the youngest cow to develop BSE on
record in Britain was 20 months old, showing some are fast incubators.
Models predict that 200-300 cattle under 30 months per year are infected
with BSE and enter the food chain currently in Britain. Of these 3-5
could be fast incubators and carrying detectable quantities of prion.

3) sheep and goats less than 12
months of age for immediate slaughter; 4) sheep and goats for feeding to be
moved to a designated feedlot and then to slaughter at less than 12 months
of age;

even if one believes that scrapie does not transmit to humans (without
scientific proof and realizing scrapie transmits to primates) what about
the potential for BSE in sheep/goats and what about the many different
tissues that are infectious ?


Working Group Report on the Assessment of the Geographical BSE-Risk
(GBR) of CANADA 2004


On the basis of the available information, it has to
be concluded that the country's BSE/cattle system was
extremely unstable until today, i.e., it would have
recycled and amplified BSE-infectivity very fast,
should it have entered the system.

The stability of the BSE/cattle system in Canada overtime
is as given in table 5 above.


4.1 Interaction of stability and challenges

In conclusion, the stability of the Canada BSE/cattle system in the past
and the external challenges the system has coped with are summarised in
the table 6.


Period Stability External Challenge Internal challenge

1980 to 1990 Low Unlikely but not excluded

1991 to 1995 High

1996 to 2000 Extremely high

Likely and rapidly growing

2001 to 2003

Extremely unstable

Very high Confirmed at a lower level

Table 6: Internal challenge resulting from the
interaction of the external challenge and stability.
The internal challenge level is determined according
to guidance given in the SSC-opinion on the GBR of July
2000 (as updated in 2002).



5.1 The current GBR as function of the past stability and challenge

The current geographical BSE-risk (GBR) level is III, i.e. it is
confirmed at a lower level

that domestic cattle are (clinically or pre-clinically) infected with
the BSE-agent.

This assessment deviates from the previous assessment (SSC opinion,
2000) because at

that time several exporting countries were not considered a potential risk.

into account.



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)

Publication date: 20 August 2004

Adopted July 2004 (Question N° EFSA-Q-2003-083)

* 167 kB Report

* 105 kB Summary

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working
Group on the Assessment of the Geographical Bovine Spongiform
Encephalopathy (BSE) Risk (GBR) were asked by the European Commission
(EC) to provide an up-to-date scientific report on the GBR in the United
States of America, i.e. the likelihood of the presence of one or more
cattle being infected with BSE, pre-clinically as well as clinically, in
USA. This scientific report addresses the GBR of USA as assessed in 2004
based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached
domestic cattle in the middle of the eighties. These cattle imported in
the mid eighties could have been rendered in the late eighties and
therefore led to an internal challenge in the early nineties. It is
possible that imported meat and bone meal (MBM) into the USA reached
domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle
imports from BSE risk countries were slaughtered or died and were
processed (partly) into feed, together with some imports of MBM. This
risk continued to exist, and grew significantly in the mid 90â¬"s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is
likely but not confirmed that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent. As long as there are no
significant changes in rendering or feeding, the stability remains
extremely/very unstable. Thus, the probability of cattle to be
(pre-clinically or clinically) infected with the BSE-agent persistently




From: Terry S. Singeltary Sr. []

Sent: Tuesday, July 29, 2003 1:03 PM


Cc:;; BSE-L

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

TO DOCKET 2003N-0312]

Greetings FDA,


PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any

or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS


* GAO-05-51 October 2004 FOOD SAFETY (over 500 customers receiving
potentially BSE contaminated beef) - TSS 10/20/04

October 2004 FOOD SAFETY
USDA and FDA Need
to Better Ensure
Prompt and Complete
Recalls of Potentially
Unsafe Food


Page 38 GAO-05-51 Food Recall Programs
To examine the voluntary recall of beef products associated with the
December 2003 discovery of an animal infected with BSE, we analyzed the
distribution lists USDA collected from companies and the verification
checks it conducted to develop a diagram illustrating the location and
volume of recalled beef that reached different levels of the distribution
chain. We compared the distribution lists and verification checks to
identify how many customers listed on the distribution lists did not
the recalled beef and the number of customers not listed on distribution
lists that received the recalled beef. We interviewed USDA and FDA staff
involved with the recall to understand the timing of recall actions and the
challenges encountered during the recall.
To develop information on the 2002 recall of ground beef by a ConAgra
plant in Greeley, Colorado, we reviewed USDAs recall file and other
documents on the recall. We also met with the departments Office of
Inspector General and reviewed the Inspector Generals September 2003
We conducted our review from May 2003 through August 2004 in
accordance with generally accepted government auditing standards.
1U.S. Department of Agriculture, Office of Inspector General, Great
Plains Region Audit
Report: Food Safety and Inspection Service: Oversight of Production
Process and Recall at
ConAgra Plant (Establishment 969), Report No. 24601-2-KC (September 2003).
Page 39 GAO-05-51 Food Recall Programs
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE Appendix II
On December 23, 2003, USDA announced that a cow in the state of
Washington had tested positive for BSEcommonly referred to as mad
cow disease. This appendix describes the actions USDA took to recall the
meat and the actions FDA took with respect to FDA-regulated products,
such as animal feed and cosmetics, made from rendered parts of the
Beef Recall Was
Triggered by a BSEPositive
Sample from
One Cow
On December 9, 2003, the recalling company slaughtered 23 cows. USDA,
in accordance with its BSE surveillance policy at the time, took a
sample of
1 cow that was unable to walk, although the condition of the tested cow is
now disputed. USDA did not process the sample in its Ames, Iowa National
Veterinary Services Laboratory in an expedited manner because the cow
did not show symptoms of neurological disorder. USDA test results
indicated a presumptive positive for BSE on December 23, 2003.
Recall Begun in
December 2003 Was
Completed in March
On December 23, 2003, after learning about the positive BSE test, USDA
headquarters notified the Boulder District Office, which is the field
with jurisdiction over the recalling firm. The Boulder District began
gathering information about the recalling companys product distribution.
Field staff telephoned the recalling company and were on-site at 7:00 p.m.
The Boulder District initially thought 3 days of the recalling companys
production would have to be recalled, but further examination of facility
cleanup and shipping records revealed that it was only necessary to
recall 1
day of production. USDA recall staff convened at 9:15 p.m. and discussed
the science related to BSE and whether the recalling companys cleanup
practices were sufficient to limit the recall to 1 day of production.
Following USDAs determination to conduct a Class II recallthat is, the
beef posed a remote possibility of adverse health consequencesUSDA
contacted the recalling company to discuss recall details and the press
release. The press release and Recall Notification Report were released
that evening.
On December 24, 2003, USDAs Food Safety and Inspection Service (FSIS)
sent inspectors to the recalling companys primary customers to obtain
secondary customer distribution lists and product shipping records. USDA
conducted 100 percent verification checks for this recallit contacted
every customer that received the recalled meat. This level of verification
checks is well above the percentage of checks conducted by USDA district
offices for the Class I recalls we reviewed.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 40 GAO-05-51 Food Recall Programs
On December 26, 2003, USDA began checking the primary and secondary
customers of the recalling company that it was aware of, although the
entire product distribution chain was unknown. During the checks, USDA
tried to determine if the product was further distributed, and it used
verification checks to acquire distribution lists for secondary and
customers of the recalling company.
Verification checks continued until February 25, 2004. Three USDA
districts conducted these verification checks. The Boulder District
coordinated the checks and assigned checks to the Minneapolis District
Office for customers in Montana and to the Alameda District Office for
customers in California. USDA required that 100 percent of the primary
checks, 50 percent of the secondary checks, and 20 percent of the tertiary
checks be conducted on-site. According to USDA, more than 50 percent of
the secondary checks were actually conducted on-site. FDA officials
helped conduct verification checks. According to USDA, the recall took a
long time to complete because USDA contacted each customer at least
twice. USDA first contacted each customer to conduct the check and again
to verify product disposition.
On February 25, 2004, the Boulder District concluded that the recall was
conducted in an effective manner. On March 1, 2004, USDAs Recall
Management Division recommended that the agency terminate the recall,
and USDA sent a letter to the recalling company to document that USDA
considered the recall to be complete.
Recall Was
Complicated by
Inaccurate Distribution
Lists and Mixing of
Contaminated and
Noncontaminated Beef
USDA used distribution lists and shipping records to piece together where
the recalled product was distributed. According to USDA, one of the
recalling companys three primary customers was slow in providing its
customer list. USDA could not begin verification activities for that
customer without this list. Furthermore, some customers of the recalling
company provided USDA with imprecise lists that did not specify which
customers received the recalled product. As a consequence, USDA could
not quickly determine the scope of product distribution and had to take
time conducting extra research using shipping invoices to determine which
specific customers received the product.
Even when USDA determined the amount and location of beef, the agency
still had trouble tracking the beef in certain types of establishments,
as grocery store distributors. USDA could not easily track the individual
stores where those distributors sent the beef because of product mixing
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 41 GAO-05-51 Food Recall Programs
and the distributors record-keeping practices. Generally, distributors
purchase beef from multiple sources, mix it in their inventory, and lose
track of the source of the beef they send to the stores that they
supply. To
deal with this problem, USDA first identified the dates when recalled beef
was shipped to the distributors and then asked for a list of the stores
were shipped any beef after those dates. Consequently, some stores were
included in the recall that may never have received recalled beef.
The recall was also complicated by repeated mixing of recalled beef with
nonrecalled beef, thereby increasing the amount of meat involved in the
recall. The recalling company slaughtered 23 cows on December 9, 2003,
and shipped those and 20 other carcasses to a primary customer on
December 10, 2003. The recalling companys carcasses were tagged to
identify the slaughter date and the individual cow. The primary customer
removed the identification tags and mixed the 23 recalled carcasses with
the 20 nonrecalled carcasses. Because the carcasses could not be
distinguished, the recall included all 43 carcasses at the primary
After one round of processing at the primary customer, the meat from the
carcasses was shipped to two other processing facilities. Both
establishments further mixed the recalled meat from the 43 carcasses with
meat from other sources. In all, the mixing of beef from 1 BSE-positive cow
resulted in over 500 customers receiving potentially contaminated beef.
Imprecise distribution lists and the mixing of recalled beef combined to
complicate USDAs identification of where the product went. Specifically,
on December 23, 2003, USDAs initial press release stated that the
company was located in Washington State. Three days later, on December
26, 2003, USDA announced that the recalled beef was distributed within
Washington and Oregon. On December 27, 2003, USDA determined that one
of the primary customers of the recalling firm distributed beef to
in California and Nevada, in addition to Washington and Oregon, for a total
of four states. On December 28, 2003, USDA announced that some of the
secondary customers of the recalling company may also have distributed
the product to Alaska, Montana, Hawaii, Idaho, and Guam, for a total of
eight states and one territory.
On January 6, 2004, over 2 weeks from recall initiation, USDA determined
that the beef went to only six statesWashington, Oregon, California,
Nevada, Idaho, and Montanaand that no beef went to Alaska, Hawaii, or
Guam. To reach that conclusion, USDA used the distribution lists, shipping
records, and sales invoices that it received from companies to piece
together exactly where the recalled beef may have been sent. The lists
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 42 GAO-05-51 Food Recall Programs
showed that 713 customers may have received the recalled beef; 6 of those
may have received beef from more than one source. USDA determined that
176 customers on the lists did not actually receive recalled beef,
the customers in Guam and Hawaii. USDAs review also indicated that
recalled beef was probably not shipped to Alaska or Utah, and USDA
checked 2 retailers in Alaska and 3 retailers in Utah to confirm that
was the
case. In total, USDA conducted verification checks on 537 of the 713
customers on the lists. USDAs initial checks identified an additional 45
customers that may have received the recalled beef that were not included
on the distribution lists, for a total of 582 verification checks. Figure 4
summarizes USDAs verification efforts during the recall.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 43 GAO-05-51 Food Recall Programs
Figure 4: USDAs Recall Verification Checks by Location and Customer
Type for Meat Associated with the Animal Infected with
Note: USDA checked 15 primary, 40 secondary, and 526 tertiary customers
plus the recalling
company, for a total of 582 verification checks.
USDAs press release stated that the recall involved 10,410 pounds of beef
products, and the USDA recall coordinator for this recall told us that
downstream processors mixed the recalled beef with nonrecalled beef, for
a total of more than 38,000 pounds of beef that was distributed at the
secondary customer level. According to USDA officials involved with the
D = Distributor
R = Retailer
SF = Storage facility
P = Processor
Primary customers
(15 total)
(WA) 1 R
1 P
(WA) 1 P
1 P
11 R
Secondary customers
(40 total)
Tertiary customers
(526 total)
1 R
1 SF
3 D
3 D
2 dual D
59 R
79 R
5 R
3 R
4 R
161 R
8 R
15 R
2 R
31 R
(OR) 8 R
10 R
5 R
10 R
2 R
17 R
5 R
1 D
11 R
85 R
3 D
(OR) 11 R
2 D
(CA) 26 R
2 R
( ) Acronyms in parentheses are postal abbreviations for each state.
Source: GAO analysis of USDA verification check documents.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 44 GAO-05-51 Food Recall Programs
recall, the precise amount of meat that was sold at the retail level is
unknown because retailers at the tertiary level further mixed nonrecalled
meat with potentially contaminated meat. USDA told us that more than
64,000 pounds of beef was ultimately returned or destroyed by customers,
and that, because of the mixing, it was not able to determine how much of
the original 10,410 pounds of recalled beef was contained in the 64,000
pounds that were recovered.
FDAs Role in USDAs
Parts of the BSE-infected animal slaughtered on December 9, 2003, were
not used for food, but they were sent to renderers to be separated into raw
materials, such as proteins and blood. Rendered materials are used for
many purposes, including cosmetics and vaccines. FDA has jurisdiction
over renderers.
When USDA learned of the BSE-infected cow on December 23, 2003, the
agency immediately notified FDA. On December 24, 2003, FDA sent an
inspection team to a renderer that handled materials from the BSE cow.
Inspectors confirmed that the parts of the slaughtered BSE positive cow
were on the premises. FDA later identified a second company that
potentially rendered material from the slaughtered BSE cow. Both
renderers agreed to voluntarily hold all product processed from the
diseased cow and dispose of the product as directed by FDA and local
On January 7, 2004, 15 containers of potentially contaminated, rendered
material (meat and bone meal) were inadvertently loaded on a ship, and on
January 8, 2004, the ship left Seattle, Washington, for Asia. The renderer
initiated steps to recover the shipped material, so it could be disposed
of as
directed by FDA and local authorities. The ship carrying the material
returned to the United States on February 24, 2004, and the material was
disposed of in a landfill on March 2, 2004.
On January 12, 2004, FDA asked both renderers to expand their voluntary
holds to rendered materials processed from December 23, 2003, through
January 9, 2004, because they may have rendered some recalled meat or
trim that was recovered from retail establishments. Both renderers agreed
to the expanded product hold. In total, FDA requested that renderers
voluntarily hold approximately 2,000 tons of rendered material. FDA
confirmed that none of the potentially contaminated, rendered material
entered commerce, because FDA accounted for all rendered material. FDA
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 45 GAO-05-51 Food Recall Programs
reported that no recall was necessary because no product was distributed
commercially by the rendering companies.
Worked Together on
the Recall
USDA and FDA worked together in two ways. First, both agencies notified
each other if their investigations yielded any information about products
within the jurisdiction of the other agency. For instance, when conducting
the second round of verification checks, USDA tracked the disposition of
the product to renderers and landfills and notified FDA when the product
went to renderers. Second, FDA officials helped conduct verification
checks. FDA conducted 32 of the 582 verification checks (approximately 5
percent) for the USDA recall. Officials from both agencies indicated they
regularly interacted and shared information. Table 3 outlines the agencies
Table 3: Detailed Timeline of USDA, FDA, and Company Actions Related to
the Discovery of an Animal Infected with BSE
Date USDA recall actions FDA actions Company actions
12/9/03 " USDA samples cow for BSE. " BSE cow is slaughtered.
12/11/03 " Sample is sent to Ames, Iowa, for BSE
" Recalling company sends
carcasses to primary customer for
12/12/03 " Primary customer sends meat
products to two other primary
customers for further processing.
12/12 -
" Other primary customers distribute
recalled product to secondary
" Secondary customers distribute
recalled product to tertiary
12/23/03 " BSE test results are presumptively
" Recall meeting.
" Initiation of voluntary recall.
" Press release.
" FDA notified of BSE test results.
" FDA dispatches investigation teams.
12/24/03 " FDA inspects Renderer 1.
" FDA determines some rendered
material from Renderer 1 is intended
for Indonesia.
" FDA discovers some material may
have been sent to Renderer 2.
" Renderer 1 agrees to hold remaining
rendered material.
" Recalling company contacts
primary customers.
" Primary customers contact their
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 46 GAO-05-51 Food Recall Programs
12/25/03 " USDA receives confirmation from
reference lab in England that cow in
question is BSE positive.
12/26/03 " Verification checks begin
" USDA announces recalled product in
Washington State and Oregon.
" FDA begins process of comparing
records to ensure all products from
Renderers 1 and 2 are accounted for.
" Renderer 2 agrees to hold all material
that may have been derived from
BSE cow. None of the rendered
material has been distributed.
12/27/03 " USDA announces recalled product was
distributed in Washington State,
Oregon, California, and Nevada.
" FDA issues statement confirming that
the rendering plants that processed
all of the nonedible material from the
BSE cow have placed a voluntary
hold on all of the potentially infectious
product, none of which had left the
control of the companies and entered
commercial distribution.
12/28/03 " USDA announces recalled product was
distributed in Washington State,
Oregon, California, Nevada, Montana,
Idaho, Alaska, Hawaii, and Guam.
12/29/03 " Food Safety and Inspection Service
determines that the recalled meat
products were distributed to 42
locations, with 80 percent of the
products distributed to stores in
Oregon and Washington State.
12/31/03 " FDA offers assistance to USDA to
complete recall verification checks.
1/6/04 " USDA determines recalled product
was only distributed in Washington
State, Oregon, California, Nevada,
Montana, and Idaho.
1/8/04 " FDA is notified by the renderer that
some of the rendered material on
hold from Renderer 1 was
inadvertently shipped to Asia.
Renderer 1 commits to isolate and
return the rendered material.
" Rendering company notifies FDA of
shipment of product on hold.
(Continued From Previous Page)
Date USDA recall actions FDA actions Company actions
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 47 GAO-05-51 Food Recall Programs
Source: GAO analysis of USDA and FDA information.
1/12/04 " FDA advises Renderers 1 and 2 that
they may have rendered meat or trim
subject to recall from retail stores.
" FDA requests Renderers 1 and 2 to
place all rendered material from
December 23 to January 9 on hold.
" FDA determines neither renderer had
shipped rendered material
manufactured after December 23,
2/9/04 " All rendered material was disposed of
in landfill, except material shipped to
2/24/04 " Ship carrying rendered material
returns to U.S. port.
2/25/04 " Verification checks complete.
" USDA Boulder District Office
concludes recall is effective.
3/1/04 " Recall is closed.
3/2/04 " FDA observes disposal in landfill of
remaining rendered material...



1. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51, October 7.tss
Highlights -

increase in sporadic CJD over the
last decade or so here (excluding N. America).

BSE prions propagate as either variant CJD-like or sporadic CJD-like
prion strains in transgenic mice expressing human prion protein

Emmanuel A. Asante, Jacqueline M. Linehan, Melanie Desbruslais, Susan
Joiner, Ian Gowland, Andrew L. Wood, Julie Welch, Andrew F. Hill, Sarah
E. Lloyd, Jonathan D.F. Wadsworth and John Collinge1

MRC Prion Unit and Department of Neurodegenerative Disease, Institute of
Neurology, University College, Queen Square, London WC1N 3BG, UK 1
Corresponding author e-mail:

Received August 1, 2002; revised September 24, 2002; accepted October
17, 2002


Variant CreutzfeldtJakob disease (vCJD) has been recognized to date
only in individuals homozygous for methionine at PRNP codon 129. Here we
show that transgenic mice expressing human PrP methionine 129,
inoculated with either bovine spongiform encephalopathy (BSE) or variant
CJD prions, may develop the neuropathological and molecular phenotype of
vCJD, consistent with these diseases being caused by the same prion
strain. Surprisingly, however, BSE transmission to these transgenic
mice, in addition to producing a vCJD-like phenotype, can also result in
a distinct molecular phenotype that is indistinguishable from that of
sporadic CJD with PrPSc type 2. These data suggest that more than one
BSE-derived prion strain might infect humans; it is therefore possible
that some patients with a phenotype consistent with sporadic CJD may
have a disease arising from BSE exposure...

THE new findings of BASE in cattle in Italy of Identification of a
second bovine amyloidotic spongiform encephalopathy: Molecular
similarities with sporadic Creutzfeldt-Jakob disease

Adaptation of the bovine spongiform encephalopathy agent to primates
and comparison with Creutzfeldt- Jakob disease: Implications for
human health

THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy Fournier*,
Virginie Nouvel*,

Hermann Boe*, Domíníque Marcé*, François Lamoury*, Nicolas Kopp [Dagger

] , Jean-Jacques Hauw§, James Ironside¶, Moira Bruce [||] , Dominique

Dormont*, and Jean-Philippe Deslys* et al, that The agent responsible
for French iatrogenic growth hormone-linked CJD taken as a control is
very different from vCJD but is similar to that found in one case of
sporadic CJD and one sheep scrapie isolate;

Characterization of two distinct prion strains
derived from bovine spongiform encephalopathy
transmissions to inbred mice

Sarah E. Lloyd, Jacqueline M. Linehan, Melanie Desbruslais,
Susan Joiner, Jennifer Buckell, Sebastian Brandner,
Jonathan D. F. Wadsworth and John Collinge

John Collinge

MRC Prion Unit and Department of Neurodegenerative Disease, Institute of
University College, London WC1N 3BG, UK
Received 9 December 2003
Accepted 27 April 2004

Distinct prion strains can be distinguished by differences in incubation
period, neuropathology
and biochemical properties of disease-associated prion protein (PrPSc)
in inoculated mice.
Reliable comparisons of mouse prion strain properties can only be
achieved after passage in
genetically identical mice, as host prion protein sequence and genetic
background are known
to modulate prion disease phenotypes. While multiple prion strains have
been identified in
sheep scrapie and CreutzfeldtJakob disease, bovine spongiform
encephalopathy (BSE) is
thought to be caused by a single prion strain. Primary passage of BSE
prions to different lines
of inbred mice resulted in the propagation of two distinct PrPSc types,
suggesting that two
prion strains may have been isolated. To investigate this further, these
isolates were
subpassaged in a single line of inbred mice (SJL) and it was confirmed
that two distinct prion
strains had been identified. MRC1 was characterized by a short
incubation time (110±3 days),
a mono-glycosylated-dominant PrPSc type and a generalized diffuse
pattern of PrP-immunoreactive
deposits, while MRC2 displayed a much longer incubation time (155±1 days),
a di-glycosylated-dominant PrPSc type and a distinct pattern of
PrP-immunoreactive deposits
and neuronal loss. These data indicate a crucial involvement of the host
genome in modulating
prion strain selection and propagation in mice. It is possible that
multiple disease phenotypes
may also be possible in BSE prion infection in humans and other animals.


Human Prion Protein with
Valine 129 Prevents Expression
of Variant CJD Phenotype

Jonathan D. F. Wadsworth, Emmanuel A. Asante,
Melanie Desbruslais, Jacqueline M. Linehan, Susan Joiner,
Ian Gowland, Julie Welch, Lisa Stone, Sarah E. Lloyd,
Andrew F. Hill,* Sebastian Brandner, John Collinge

Variant Creutzfeldt-Jakob disease (vCJD) is a unique and highly distinctive
clinicopathological and molecular phenotype of human prion disease
associated with infection with bovine spongiform encephalopathy (BSE)-like
prions. Here, we found that generation of this phenotype in transgenic mice
required expression of human prion protein (PrP) with methionine 129.
Expression of human PrP with valine 129 resulted in a distinct phenotype
remarkably, persistence of a barrier to transmission of BSE-derived
prions on
subpassage. Polymorphic residue 129 of human PrP dictated propagation of
distinct prion strains after BSE prion infection. Thus, primary and
human infection with BSE-derived prions may result in sporadic CJD-like or
novel phenotypes in addition to vCJD, depending on the genotype of the
source and the recipient.


In conclusion, we have demonstrated
that BSE and vCJD prion infection in
transgenic mice can result in the propaga-
tion of distinct molecular and neuropatho-
logical phenotypes dependent on host PrP
residue 129 and possibly other, as yet
unidentified, disease modifying loci (10).
These data predict a critical role for PRNP
codon 129 in governing the thermodynamic
permissibility of human PrPSc conformation
that can be interpreted within a conforma-
tional selection model of prion transmission
barriers (17-19) (SOM text) and suggest
that there is no overlapping preferred
conformation for Val129 and Met129 human
PrP that can be generated as a result of
exposure to the vCJD/BSE prion strain.
Biophysical measurements suggest that this
powerful effect of residue 129 on prion
strain selection is likely to be mediated by
means of its effect on the conformation of
PrPSc or its precursors or on the kinetics of
their formation, as it has no measurable
effect on the folding, dynamics, or stability
of the normal cellular prion protein PrPC

Although caution must be exercised in
extrapolating from animal models, even
where, as here, faithful recapitulation of
molecular and pathological phenotypes is
possible, our findings argue that primary
human BSE prion infection, as well as sec-
ondary infection with vCJD prions by iatro-
genic routes, may not be restricted to a single
disease phenotype. These data, together with
the recent recognition of probable iatrogenic
transmission of vCJD prions to recipients of
blood {21, 22), including a PRNP codon 129
Met/Val heterozygous individual (22), re-
iterate the need to stratify all human prion
disease patients by PrPSc type. This surveil-
lance will facilitate rapid recognition of novel
PrPSc types and of any change in relative
frequencies of particular PrPSc subtypes in
relation to either BSE exposure patterns or
iatrogenic sources of vCJD prions.

References and Notes


To whom correspondence should be addressed.
E-mail: SCIENCE VOL 306 3 DECEMBER 2004

Chronic Lymphocytic Inflammation Specifies the Organ Tropism of Prions

Mathias Heikenwalder,1* Nicolas Zeller,1* Harald Seeger,1* Marco
Prinz,1* Peter-Christian Klöhn,2 Petra
Schwarz,1 Nancy H. Ruddle,3 Charles Weissmann,2 Adriano Aguzzi1!

1Institute of Neuropathology, University Hospital of Zürich, CH-8091
Zürich, Switzerland. 2Medical Research Council Prion
Unit, Department of Neurodegenerative Diseases, Institute of Neurology,
Queen Square, London WC1N 3BG, UK. 3Department
of Epidemiology and Public Health and Section of Immunobiology, Yale
University School of Medicine, New Haven, CT
06520, USA.

*These authors contributed equally to this work.
Present address: Institute of Neuropathology, Georg-August-Universität,
D-37073 Göttingen, Germany.
!To whom correspondence should be addressed. E-mail:

Prions typically accumulate in nervous and lymphoid
tissues. Because proinflammatory cytokines and immune
cells are required for lymphoid prion replication, we
tested whether inflammatory conditions affect prion
pathogenesis. We administered prions to mice with five
inflammatory diseases of kidney, pancreas or liver. In all
cases, chronic lymphocytic inflammation enabled prion
accumulation in otherwise prion-free organs.
Inflammatory foci consistently correlated with
lymphotoxin upregulation and ectopic induction of PrPCexpressing
FDC-M1+ cells, whereas inflamed organs of
mice lacking lymphotoxin-? or its receptor did not
accumulate PrPSc nor infectivity upon prion inoculation.
By expanding the tissue distribution of prions, chronic
inflammatory conditions may act as modifiers of natural
and iatrogenic prion transmission.


The above results indicate that chronic follicular
inflammation, induced by a variety of causes, specifies prion
tropism for otherwise prion-free organs. In most instances
infectivity tended to rise with time, suggesting local prion
replication. Organ-specific expression of one single proinflammatory
cytokine (LT?) or chemokine (SLC) sufficed to
establish unexpected prion reservoirs, suggesting
differentiation of ubiquitous stromal constituents into prionreplication
competent cells. In several instances, prion
concentration in individual inflamed organs approached that
of spleen long before any clinical manifestation of scrapie.
Inflamed non-lymphoid organs not only accumulated PrPSc,
but transmitted bona fide prion disease when inoculated into
healthy recipient mice.

Knowledge of the distribution of prions within infected
hosts is fundamental to consumer protection and prevention
of iatrogenic accidents. Based on the failure to transmit BSE
infectivity from any tissue but central nervous system,
intestinal, and lymphoid tissue (35), the risk to humans of
contracting prion infection from other organs has been
deemed small even in countries with endemic BSE. It may be
important now to test whether superimposed viral, microbial
or autoimmune pathologies of farm animals trigger
unexpected shifts in the organ tropism of prions. Conversely,
the lack of infectivity in burned out postinflammatory
pancreases suggests that anti-inflammatory regimens may
abolish ectopic prion reservoirs.

References and Notes ............snip...........end

/ / 20 January 2005 / Page 5 /

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States


Assigned vet wanted it tested.

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

SYSTEM broken around the Country.


APHIS inspectors do not follow through.

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

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.



January 30, 2001
Print Media:
Broadcast Media:
Consumer Inquiries:


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

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.

.1 gram lethal............OOPS again

course we cannot forget about those infamous postive,
positive, inconclusive, negatives, especially that last one
from... you guessed it, TEXAS, the STATE without the WB.

OOPS again...

kind regards,

still very disgusted in Bacliff Texas 77518

Terry S. Singeltary Sr.

Terry S. Singeltary Sr. wrote:

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

Release No. 0047.05

Statement By Agriculture Secretary Mike Johanns

February 9, 2005

"On Dec. 29, 2004, USDA released a final rule that 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.

"Our ongoing investigations into the recent finds of BSE in Canada in
animals over 30 months are not complete. Therefore, I feel it is
prudent to delay the effective date for allowing imports of meat from
animals 30 months and over.
"This action also addresses concerns over the portion of the
minimal-risk rule that would reopen the Canadian border for beef from
animals 30 months and over, while keeping it closed for imports of
older live cattle for processing in the United States. Some have
suggested that this part of the rule does not reflect the evidence
that beef from animals 30 months and over processed in Canada has the
same risk profile as beef from Canadian animals 30 months and over
processed in the United States.
"At the same time, I am asking U.S. officials to move forward in
consideration and development of a plan to allow imports of animals 30
months and older for slaughter as well as beef from over 30-month
animals as the next step in resuming full trade with Canada. As
always, decisions will be made based on the latest scientific
information and with the protection of public and animal health the
highest priority.

"We remain very confident that the combination of the rule's
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 protection to U.S. consumers and livestock. The removal
of Specified Risk Materials is the most effective barrier to protect
consumers, and therefore the rest of the rule will proceed as announced."



Release No. 0048.05

Joint Statement by Secretary Mike Johanns, United States Department of
Agriculture and Minister Andrew Mitchell, Agriculture and Agri-Food

February 9, 2005

"We were pleased today to have had an opportunity for our first
meeting to get better acquainted personally and to discuss matters of
mutual importance to agriculture in our two countries.

"Each country is the largest customer for the other's food and
agriculture products. In addition, our farm economies and our markets
are significantly integrated. Thus, it is important that we stay
keenly aware of developments and issues that affect us both and be
able to deal with them effectively.

"We enjoyed a candid discussion today. We discussed expanded
cooperation in pursuit of a successful conclusion to the Doha
negotiations, now entering a crucial phase. And, of course, we
discussed BSE broadly and the path forward following the March 7
implementation of the Minimal Risk Rule to return to normal beef and
cattle trade, while fully protecting our consuming public and our
livestock herds. We agreed that cooperation between the United States
and Canada to harmonize border and risk mitigation measures related to
BSE will provide a model for the world on how to safely trade in
animal and animal products while at the same time protecting both
public and animal health.
"We discussed Secretary Johanns' decision to delay the effective date
for allowing import of meat from animals 30 months of age and older.
We discussed moving forward in an expeditious manner in the
consideration and development of a plan to allow imports of animals 30
months of age and older for slaughter and meat from those animals as
the next step in resuming full trade with Canada. We agreed that
decisions will be made on the latest scientific information to assure
that the protection of public and animal health remains the highest
priority for both of our countries.

"We also discussed other issues affecting trade between our two
countries and we both agree that a strong working relationship between
us is critical to our farmers and ranchers and the economic health of
our food industries. We see this first meeting as an important
beginning, and we look forward to close cooperation in the future to
further strengthen this beginning."



202 720-4623

202 720-4623

kindest regards,
I am sincerely,

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


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