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From: TSS ()
Subject: Statement By Agriculture Secretary Mike Johanns ON TRADING TSEs GLOBALLY February 9, 2005
Date: February 9, 2005 at 2:23 pm PST

-------- Original Message --------
Subject: Statement By Agriculture Secretary Mike Johanns ON TRADING TSEs GLOBALLY February 9, 2005
Date: Wed, 9 Feb 2005 16:08:03 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


##################### 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 Canada

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."

#
=============================

TSS

USDA News
oc.news@usda.gov
202 720-4623

USDA News
oc.news@usda.gov
202 720-4623

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########


ONCE AGAIN THE TRUTH ON BSE/TSE AKA MAD COW IN NORTH AMERICA

Working Group Report on

the Assessment of the Geographical BSE-Risk (GBR) of

CANADA

2004

snip...

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

- 13 -

On the basis of the available information, it has to be concluded that the country's

BSE/cattle system was extremely unstable until today, i.e., it would have recycled and

amplified BSE-infectivity very fast, should it have entered the system. The stability of the

BSE/cattle system in Canada overtime is as given in table 5 above.

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenges

In conclusion, the stability of the Canada BSE/cattle system in the past and the external

challenges the system has coped with are summarised in the table 6.

INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN CANADA

Period Stability External Challenge Internal challenge

1980 to 1990 Low Unlikely but not excluded

1991 to 1995 High

1996 to 2000 Extremely high

Likely and rapidly growing

2001 to 2003

Extremely

unstable

Very high Confirmed at a lower level

Table 6: Internal challenge resulting from the interaction of the external challenge and stability. The

internal challenge level is determined according to guidance given in the SSC-opinion on the GBR of

July 2000 (as updated in 2002).

From the interaction of the two parameters "stability" and "external challenge" a

conclusion is drawn on the level of "internal challenge" that emerged and had to be met

by the system, in addition to external challenges that occurred.

An external challenge resulting from cattle import could only lead to an internal

challenge once imported infected cattle were rendered for feed and this contaminated

feed reached domestic cattle. Cattle imported for slaughter would normally be

slaughtered at an age too young to harbour plenty of BSE infectivity or to show signs,

even if infected prior to import. Breeding cattle, however, would normally live much

longer and only animals having problems would be slaughtered younger. If being 4-6

years old when slaughtered, they could suffer from early signs of BSE, being

approaching the end of the BSE-incubation period. In that case, they would harbour,

while being pre-clinical, as much infectivity as a clinical BSE case. Hence cattle imports

could have led to an internal challenge about 3 years after the import of breeding cattle

(that are normally imported at 20-24 months of age) that could have been infected prior

to import. In case of Canada this implies that cattle imported in the mid eighties could

have been rendered in the late eighties and therefore led to an internal challenge in the

early 90s.

On the other hand imports of contaminated MBM would lead to an internal challenge in

the year of import, if fed to cattle. The feeding system is of utmost importance in this

context. If it could be excluded that imported, potentially contaminated feed stuffs

reached cattle, such imports might not lead to an internal challenge at all. In case of

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

Canada this implies that it was possible that imported MBM reached domestic cattle and

lead to an internal challenge in the early 90s.

4.2 Risk that BSE infectivity entered processing

A certain risk that BSE-infected cattle entered processing in Canada, and were at least

partly rendered for feed, occurred in the early 1990s when cattle imported from UK in

the mid 80s could have been slaughtered. This risk continued to exist, and grew

significantly in the mid 90'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.

4.3 Risk that BSE infectivity was recycled and propagated

A risk that BSE-infectivity was recycled and propagated exists since a processing risk

first appeared; i.e. in the early 90s. Until today this risk persists and increases fast

because of the extremely unstable BSE/cattle system in Canada.

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

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

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

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

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

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

into account.

GBR.

- 14 -

5.2 The expected development of the GBR as a function of the past and

present stability and challenge

. As long as the system remains unstable, it is expected that the GBR continues to

grow, even if no additional external challenges occur.

. Since recent improvements in the safety of MBM production in many countries or

significant recent reductions in the incidence of BSE are not taken into account for

the assessment of the external challenge, the external challenge assessed after 2001

could be overestimated and is the worst case assumption. However all current GBR

conclusions are not dependent on these assumptions in any of the countries assessed.

For future assessments and when the impact of the production, surveillance and true

incidence changes has been fully quantified, these developments should be taken

5.3 Recommendations for influencing the future GBR

. Enhancing the stability of the system, in particular by ensuring that cattle have no

access to mammalian MBM in combination with appropriate rendering and exclusion of

SRM and fallen stock from any feed chain could lead, over time, to a reduction of the

. Improved passive and active surveillance, i.e. sampling of animals not showing

signs compatible with BSE from "at-risk" cattle populations, such as adult cattle in

Annex to the EFSA Scientific Report (2004) 2, 1-15 on the Assessment of the

Geographical BSE Risk of Canada

country.

Acknowledgment

snip...

CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

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 increases.

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/573_en.html

USA

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

MEXICO

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

ONE YEAR PREVIOUSLY I SUBMITTED TO THE FDA ;

From: Terry S. Singeltary Sr. [flounder@wt.net]

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

To: fdadockets@oc.fda.gov

Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L

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

TO DOCKET 2003N-0312]

Greetings FDA,

snip...

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

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


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

SUPPRESSED PEER REVIEW OF HARVARD BSeee REPORT

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

* 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

snip...

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 receive
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
report.1
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
animal.
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
2004
On December 23, 2003, after learning about the positive BSE test, USDA
headquarters notified the Boulder District Office, which is the field office
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 tertiary
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
Potentially
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 primary
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, such
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 that
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 customer.
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 recalling
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
facilities
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, including
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
BSE
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)
Recalling
slaughterhouse
(WA) 1 R
(OR)
1 P
(WA) 1 P
(OR)
1 P
(OR)
11 R
(WA)
Secondary customers
(40 total)
Tertiary customers
(526 total)
1 R
(OR)
1 SF
(OR)
3 D
(OR)
3 D
(WA)
2 dual D
(OR)
59 R
(OR)
79 R
(WA)
5 R
(ID)
3 R
(UT)
4 R
(MT)
161 R
(WA)
8 R
(ID)
15 R
(OR)
2 R
(AK)
31 R
(OR) 8 R
(WA)
10 R
(NV)
5 R
(ID)
10 R
(CA)
2 R
(CA)
17 R
(OR)
5 R
(WA)
1 D
(NV)
11 R
(CA)
85 R
(NV)
3 D
(OR) 11 R
(OR)
2 D
(CA) 26 R
(CA)
2 R
(WA)
( ) 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
Recall
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
authorities.
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.
USDA and FDA
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
actions.
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
testing.
" Recalling company sends
carcasses to primary customer for
processing.
12/12/03 " Primary customer sends meat
products to two other primary
customers for further processing.
12/12 -
12/23/03
" Other primary customers distribute
recalled product to secondary
customers.
" Secondary customers distribute
recalled product to tertiary
customers.
12/23/03 " BSE test results are presumptively
positive.
" 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
customers.
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,
2003.
2/9/04 " All rendered material was disposed of
in landfill, except material shipped to
Asia.
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...

snip...

REPORTS

1. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51, October 7.tss
http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
Highlights - http://www.gao.gov/highlights/d0551high.pdf

TSS

P.S.

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 increases.

PLEASE SEE USA BSE GBR III MODERATE RISK IS GROWING

TSS




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