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From: TSS ()
Subject: GWs BSE MRR POLICY SHOULD WARRANT EFSA TO RAISE NORTH AMERICA BSE GBR RISK LEVEL TO BSE GBR IV ASAP !
Date: February 13, 2005 at 2:45 pm PST

-------- Original Message --------
Subject: GWs BSE MRR POLICY SHOULD WARRANT EFSA TO RAISE NORTH AMERICA BSE GBR RISK LEVEL TO BSE GBR IV ASAP
Date: Sun, 13 Feb 2005 16:45:26 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: wiesner1@mindspring.com, Anne-Laure.Gassin@efsa.eu.int, Carola.Sondermann@efsa.eu.int

Greetings,

I think it is time for the EFSA Scientific Expert Working Group on GBR
Assessment of the Geographical BSE-Risk (GBR) to reclassify
North America as BSE GBR IV, due to GWs deregulation of it
via his MRR Minimal Risk Region NO SCIENCE approach to this
deadly disease. IF this MRR policy follows through, other countries
pick it up, i am here to tell you we will be trading different strains
of TSEs
at a much much higher rate than we have been. I understand the GBR
IV is for a 'higher level' of confirmation, BUT, if you can show proof of
a non-compliance of confirmation, as with those TEXAS MAD COWS,
and the other 500 + UPI documented via FOIA, I think it only fair to the
other countries that have fought this disease for decades to eradicate, to
reclassify North America as BSE GBR IV. Everything that has been done
the last 3 decades to eradicate this damn disease will have been for
nothing if this MRR policy of GWs follows through ...

thank you,

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

here is an article translated via worldlingo and the pasted text in
spanish below that.

does this mean USDA/APHIS will no longer carry out any kind of
inspection on Mexican plants, nor their products?

NO border inspections on either side?

Mexican beef has "carte blanche"?

DO i understand this correctly?


This is what I got from worldlingo, COULD BE ERRORS...
En the taking of protest to the new directive table of the National
Association of Establishments Type Inspection Federal (ANETIF), the
Secretary of Agriculture, Javier Usabiaga, informed that a recent
verification of U.S.A. corroborated the advances of Mexico in the meat
product supervision, with which lapses the reinspection of the 100
percent of Mexican meat products in the entry points to that country.
The ANETIF gave recognition to Usabiaga by its support to promotional
campaigns in favor of the Mexican meat and to obtain favorable results
in processes of certification from countries to which meat products are
sent, like the United States.

After an audit to the Mexican System of Federal Inspection of meats and
meat products, the Department of Agriculture of the United States
certificated that the systems of official verification of both countries
are equivalent, which allows that Mexico is recognized to consider and
to enlist establishments that wish to export towards that country. The
Secretary of Agriculture, Cattle ranch, Rural Development, Fishing and
Feeding, Javier Usabiaga Stream presented previous in IX the General
Assembly Ordinary the National Association Establishments Type
Inspection Federal (ANETIF), organism that through its salient
President, Gina Heron, gave a recognition to the civil employee by the
support of the SAGARPA to promotional campaigns for the consumption of
registered meat and to the recovery of his status of trustworthiness
before the north American. This authority homologation gives prestige to
the Mexican sanitary system, facilitates the access to third countries,
makes agile the export and avoids costs to processors for the
unnecessary visits of the American inspectors to the plants.

When taking protest to the new ANETIF directive board, headed by Alvaro
Ley Lopez, the holder of the SAGARPA indicated that by the favorable
results of the audit the Service of Inspection for the Safetey of Foods
(Food Safety Inspection Service) raised the suspension on eligibility of
Mexico to consider establishments that wish to export meat towards
U.S.A. and lapsed the reinspection of the 100 percent of Mexican meat
products in the entry points to that country. With the previous thing,
said Usabiaga, is clear that our system of health and nourishing
inocuidad continues being one of our main assets in the sector, every
time "to us opens the doors to the exports, make us more competitive,
put to us in line with the new world-wide tendencies, but mainly it
gives to certainty to the Mexican consumer" Then him to indicate that
the Government of President Fox has worked arduously to make reality
this competitive advantage, emphasized that the meat result of the audit
to the Mexican system of meat inspection and products, made altogether
with personnel of the National Service of Health, Inocuidad and
Agro-alimentary Quality, takes to that the Mexican Government acts
cautiously in the recognition of new establishments that they try to
export meat products.

It clarified that from 28 from February to 15 of March personal of
Service of Inspection for Security of Foods of Department of Agriculture
of the United States will return to make new audit to verify that
fulfillment has given to observations made to establishments audited, as
well as to state possible new establishments that is enlisted by
SAGARPA, with base in authority that recognizes him north American
government. El Secretary Usabiaga it gave to know, on the other hand,
which the SAGARPA prepares an audit similar to the establishments of the
United States that enters the greater volumes of meat of head of cattle,
pig and birds which they are exported to Mexico, like part of the
program of mutual recognition that is established between both
countries. Ante affiliated of ANETIF, it commented that "we are in the
same line of work to grant certainty to the producer and the investors
in this type of establishments, through the tools of public policy and
programs that the Federal Government has made his available to fortify
the system of signs TIF, absolutely necessary very substantively to
improve the security of the meat foods that are consumed in our country."

Finally, it emphasized that it is obligation of this productive segment
and the government to conserve and to improve status sanitary and to
follow improving constantly it, "not only by the privilege to continue
being one of the best ones in the world, but to maintain us to the
vanguard of the new demands of consumption at world-wide level".
President Saliente of ANETIF, Gina Heron, recognized the determined
support of the Secretariat of Agriculture the consolidation of the
promotional campaigns for the Mexican meat "If it is TIF is Better" and
"Mexico, Supreme Quality", that offers to its partners others and better
alternatives of markets. Also, the work of the dependency stood out to
resolve the audit that will allow reenlisting establishments that were
declassified to export towards the United States, as well as to include
any plant that its part fulfills the norm of that nation. For, the
incoming President of the ANETIF, Alvaro Law Lopez, showed that in its
new stage the organism will work by a permanent and solid entailment
with the federal authorities with proactively and correspondence in the
subject of the inocuidad and the modernization of the industry of the
meat to favor the public health. They were in the event the Director in
Head of the National Service of Health, Inocuidad and Quality Agro
alimentary (SENASICA), Javier Trujillo Arriaga; the President of Consejo
Nacional Agropecuario (CNA), Jaime Yesaki; and the Chief of a main
directorate of Inocuidad and Agro-alimentary Quality, Acuícola and Pes


Mxrev120 -2/11/2005


Export Requirements for Mexico


Eligible/Ineligible Products

Eligible Products

1.

Fresh/frozen meat and meat products including only those beef and
beef meat products identified below.

2.

Fresh/frozen beef meat and beef meat products, including boneless
beef and boneless beef products, further processed products,
tripe, trimmings, heart, kidneys, lips, diaphragm, tongue and
cheek meat derived from animals less than 30 months of age and
produced under an approved Agricultural Marketing Service (AMS)
Beef Export Verification (BEV) program. Also, veal, bone-in and
boneless derived from animals less than 36 weeks of age and
produced under the AMS, BEV program. Inedible tallow and livers
may be derived from animals of any age and do not have to be
produced under the AMS, BEV program. In some cases, these eligible
products may be limited to specific ports of entry which are
further defined in the Documentation Section. In all cases
producing establishments, with the exception of inedible tallow
and livers, must be on an AMS approved list in order to be
eligible to export. In addition, beef and beef products containing
beef imported from establishments in Australia and New Zealand are
eligible for export. These imported products must be processed in
U.S. plants with an approved AMS, BEV program for Mexico.
Information about the BEV program and a list of BEV approved
establishments can be obtained from the following website:
http://www.ams.usda.gov/lsg/arc/bev.htm.

If FSIS inspection personnel become aware of concerns that an AMS
approved BEV establishment is not properly executing its BEV
program, AMS should be notified at ARCBranch@usda.gov
. Inspection personnel should include
their immediate supervisor on messages to AMS. The following
information should be included in the message:

FULL TEXT;

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http:/OFO/export/mexico.htm


FULL TEXT SPANISH ARTICLE;

SECRETARÍA DE AGRICULTURA, GANADERÍA,
DESARROLLO RURAL, PESCA Y ALIMENTACIÓN
Coordinación General de Comunicación Social
Municipio Libre No. 377, PB, Ala B, Col. Santa Cruz Atoyac, Deleg.
Benito Juárez,
C.P. 03310, México, D.F.,Tel.91.83.10.00, Ext. 33055, 33056, 33062
http://www.sagarpa.gob.mx
comusoc@sagarpa.gob.mx - cs.informacion@sagarpa.gob.mx
NUM. 046/05 México, D.F., a 9 de febrero de 2005
CERTIFICA ESTADOS UNIDOS A MÉXICO PARA QUE
DICTAMINE ESTABLECIMIENTOS CON CAPACIDAD
PARA EXPORTAR CARNE A ESE PAÍS
" En la toma de protesta a la nueva mesa
directiva de la Asociación Nacional de
Establecimientos Tipo Inspección Federal
(ANETIF), el Secretario de Agricultura,
Javier Usabiaga, informó que una
verificación reciente de EUA corroboró los
adelantos de México en la supervisión de
productos cárnicos, con lo que se deja sin
efectos la reinspección del 100 por ciento
de los productos cárnicos mexicanos en los
puntos de entrada a ese país.
" Entregó la ANETIF reconocimiento a
Usabiaga por su apoyo a campañas
promocionales a favor de la carne
mexicana y para lograr resultados
favorables en procesos de certificación de
parte de países a los que se envían
productos cárnicos, como Estados Unidos.
Tras una auditoría al Sistema de Inspección Federal de carnes y productos
cárnicos mexicano, el Departamento de Agricultura de los Estados Unidos
certificó que los sistemas de verificación oficial de ambos países son
equivalentes, lo que permite que México sea reconocido para dictaminar y
enlistar establecimientos que deseen exportar hacia ese país.
2
El Secretario de Agricultura, Ganadería,
Desarrollo Rural, Pesca y Alimentación, Javier
Usabiaga Arroyo dio a conocer lo anterior en
la IX Asamblea General Ordinaria de la
Asociación Nacional de Establecimiento Tipo
Inspección Federal (ANETIF), organismo que
a través de su Presidenta saliente, Gina
Garza, entregó un reconocimiento al
funcionario por el apoyo de la SAGARPA a
campañas promocionales para el consumo de
carne certificada y a la recuperación de su
estatus de confiabilidad ante la autoridad
estadounidense.
Esta homologación da prestigio al sistema sanitario mexicano, facilita
el acceso a
países terceros, agiliza la exportación y evita costos a procesadores por lo
innecesario que resulta que inspectores estadounidenses visiten las plantas.
Al tomar protesta a la nueva mesa directiva de la ANETIF, encabezada por
Álvaro Ley López, el titular de la SAGARPA señaló que por los resultados
favorables de la auditoría el Servicio de Inspección para la Seguridad
de los
Alimentos (Food Safety Inspection Service) levantó la suspensión sobre
elegibilidad de México para dictaminar establecimientos que deseen exportar
carne hacia EUA y dejó sin efectos la reinspección del 100 por ciento de los
productos cárnicos mexicanos en los puntos de entrada a ese país.
Con lo anterior, dijo Usabiaga, queda claro que nuestro sistema de sanidad e
inocuidad alimentaria sigue siendo uno de nuestros principales activos en el
sector, toda vez que nos abre las puertas a las exportaciones, nos hace más
competitivos, nos pone en línea con las nuevas tendencias mundiales, pero
sobre todo le da certeza al consumidor mexicano
.
Luego de indicar que el Gobierno del Presidente Fox ha trabajado arduamente
para hacer realidad esta ventaja competitiva, enfatizó que el resultado
de la
auditoría al sistema de inspección mexicano de carne y productos cárnicos,
realizada en conjunto con personal del Servicio Nacional de Sanidad,
Inocuidad y
Calidad Agroalimentaria, lleva a que el Gobierno Mexicano actúe
cautelosamente
en el reconocimiento de nuevos establecimientos que pretendan exportar
productos cárnicos.
3
Aclaró que del 28 de febrero al 15 de
marzo personal del Servicio de Inspección
para la Seguridad de los Alimentos del
Departamento de Agricultura de Estados
Unidos volverá a realizar una nueva
auditoría para verificar que se haya dado
cumplimiento a las observaciones
realizadas a los establecimientos
auditados, así como el constatar los
posibles nuevos establecimientos que
sean enlistados por la SAGARPA, con
base en la autoridad que le reconoce el
gobierno estadounidense.
El Secretario Usabiaga dio a conocer, por otro lado, que la SAGARPA prepara
una auditoría similar a los establecimientos de Estados Unidos que
ingresan los
mayores volúmenes de carne de res, porcino y aves que se exportan a México,
como parte del programa de reconocimiento mutuo que está establecido entre
ambos países.
Ante afiliados de ANETIF, comentó que estamos en la misma línea de trabajo
para otorgar certidumbre al productor y a los inversionistas en este tipo de
establecimientos, a través de las herramientas de política pública y
programas
que el Gobierno Federal ha puesto a su disposición para fortalecer el
sistema de
rastros TIF, absolutamente necesario para mejorar sustantivamente la
seguridad
de los alimentos cárnicos que se consumen en nuestro país.
Finalmente, subrayó que es obligación de este segmento productivo y del
gobierno conservar y mejorar el estatus sanitario y seguirlo mejorando
constantemente, no sólo por el privilegio de seguir siendo uno de los
mejores en
el mundo, sino por mantenernos a la vanguardia de las nuevas demandas de
consumo a nivel mundial.
La Presidenta Saliente de ANETIF, Gina Garza, reconoció el decidido apoyo de
la Secretaría de Agricultura a la consolidación de las campañas
promocionales
para la carne mexicana Si es TIF es Mejor y México, Calidad Suprema, que
brinda a sus socios otras y mejores alternativas de mercados. Igualmente,
resaltó la labor de la dependencia para solventar la auditoría que permitirá
reenlistar establecimientos que estaban desclasificados para exportar hacia
Estados Unidos, así como incluir cualquier planta que cumpla con la
normativa
de esa nación.
4
Por su parte, el Presidente entrante de la ANETIF, Alvaro Ley López,
manifestó
que en su nueva etapa el organismo trabajará por una permanente y sólida
vinculación con las autoridades federales con proactividad y
correspondencia en
el tema de la inocuidad y la modernización de la industria de la carne para
favorecer la salud pública.
Estuvieron en el evento el Director en Jefe del Servicio Nacional de
Sanidad,
Inocuidad y Calidad Agroalimentaria (SENASICA), Javier Trujillo Arriaga; el
Presidente del Consejo Nacional Agropecuario (CNA), Jaime Yesaki; y la
Directora General de Inocuidad y Calidad Agroalimentaria, Acuícola y
Pesquera
del SENASICA, Amada Vélez, entre otros.
*****


European Food Safety Authority
Scientific Expert Working Group on GBR
Working Group Report on
the Assessment of the Geographical BSE-Risk (GBR) of
MEXICO
2004

snip...

MBM imports:
According to the CD the country imported in total over the period 1980 -
2003
approximately 826,000 tons MBM from BSE - risk countries (according to
other
data: ~ 919,000 tons), of which none came from the UK. The numbers shown in
table 2 are the raw import figures and are not reflecting the adjusted
imports for the
assessment of the external challenge. Broken down to 5 - years periods
the resulting
external challenge is as given in table 3. This assessment takes into
account the
evidence that certain imported MBM did not enter the domestic BSE/cattle
system or
did not represent an external challenge for other reasons. However, in
the case of
Mexico, there was not sufficient evidence to remove any quantities of
MBM from the
external challenge.

snip...

Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
- 8 -
On the basis of the available information, the overall assessment of the
external
challenge is as given in the table above.
3. STABILITY
3.1 Overall appreciation of the ability to avoid recycling of BSE
infectivity, should it enter processing
Feeding
Use of MBM in cattle feed
Until 11th October 2000, MBM could and was legally included in cattle feed.
Feed bans
The law prohibiting the use of ruminant MBM in ruminant feed was
published on 11th
October 2000. According to the FAO mission, implementation of the ban
began in
Potential for cross - contamination and measures taken against
In feed mills, lines are not always separated. According to the CD
flushing is used to
clean in - between lines, and feed mills carry out in - house controls.
According to the
CD, controls during transport and on farms are not regularly carried
out, but
inspections may occur on the farm. No details are provided on the kind
or frequency
of these control measures, the dates checking of cross contamination
began, or on the
results of these inspections.
Control of feed bans and cross - contamination
According to the CD, checks occur to ensure that plants do not use
ruminant MBM in
feed stuff production for ruminants. This may have been helped by
regulations
defined in 1999 that allowed ruminant feed production to use MBM only from
rendering plants that do not process ruminant material. However,
detailed outcomes of
control procedures, tests carried out or quality control are not provided.
It is concluded that cross contamination is possible.
Rendering
" A rendering industry exists in Mexico and raw bovine materials are
normally
rendered. This includes fat tissue, bones, horns and hooves but not
usually viscera,
eyes, brains or spinal cords. About 90 % of the rendered material is of
bovine
origin and the rest consists mainly of pork material. 58 plants produce
MBM, with
an annual production of between 150,000 and 250,000 tons per year. It is
estimated that about 6 % was destined for bovines in 2000.
" The rendering process standard (133° C/20min/3bar) is not applied.
According to the
CD, there are guidelines in place so that the standard process will be
used in the
event that a BSE case is discovered.
" According to the CD, regulations were introduced in 1999 to ensure
that the
processing of animal offal and its employment in animal food took place
in two
Annex to the EFSA Scientific Report (2004) 4, 1-13 on the Assessment of the
Geographical BSE Risk of Mexico
plant types: 1). plants processing material of ruminant origin plus
other species
(such as pig) and 2). plants processing only non-ruminant material. Plants
corresponding to the first category are prohibited from the preparation of
foodstuffs intended for ruminants. The fulfillment of this procedure is
checked
annually through veterinarians. Specific results of checking procedures
are not
supplied in the CD.
Specified Risk Material (SRM) and fallen stock
There is no SRM-ban. SRM is normally destined for human consumption.
According
to the CD, fallen stock from pasture and diseased animals are
incinerated and not
rendered.
Conclusion on the ability to avoid recycling
In light of the above information, it has to be assumed that the BSE
agent, should it
have entered Mexico, could have been recycled and potentially amplified.

snip...

FULL TEXT;


MEXICO


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


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

snip...

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).

snip...


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.


snip...

3.3 Overall assessment of the stability
For the overall assessment of the stability, the impact of the three
main stability
factors (i.e. feeding, rendering and SRM - removal) and of the
additional stability
factor, BSE-surveillance, has to be estimated. The guidance provided by
the SSC in
its opinion on the GBR of July 2000 (as updated in 2002) is applied.
Feeding:
Feeding MBM to cattle was legally possible until October 2000 and the
information
provided indicates that it was common practice for both dairy and beef
cattle.
Therefore feeding was assumed to be not OK for the period 1980-2000.
The feed
ban is of ruminant MBM only and good evidence of its effectiveness is
not provided.
Therefore feeding remains not OK also for the period 2000-2003.
Rendering:
Rendering is and was common practice in Mexico. Ruminant material is
included,
excluding most SRM and most fallen stock. The process used was and is
not adequate
for reducing BSE - infectivity. Therefore rendering is assessed as
having been "not
OK" throughout the reference period (i.e. 1980-2003).
SRM-removal:
There is no SRM ban. However, SRM is consumed by humans and it does not
tend to
enter the feed chain and fallen stock and diseased animals are
incinerated. Hence
SRM-removal it is assessed as "reasonably OK" throughout the reference
period
(i.e. 1980-2003).
BSE surveillance
There is some passive and active BSE surveillance. However, given the
large cattle
population size, the BSE surveillance system in Mexico is insufficient.
Recent plans
have been introduced to increase surveillance efforts since 2004.
On the basis of the available information it has to be concluded that
the countrys
BSE/cattle system was and is very unstable. Incoming BSE - infectivity
would have
been recycled and quickly amplified. The stability of the BSE/cattle
system in Mexico
overtime is as given in table 4.


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 Nð 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


http://www.efsa.eu.int/press_room/press_release/575_en.html

SUPPRESSED PEER REVIEW OF HARVARD BSeee REPORT

October 31, 2002
Review of the Evaluation of the
Potential for Bovine Spongiform
Encephalopathy in the United States
Conducted by the Harvard Center for Risk Analysis,
Harvard School of Public Health and Center for
Computational Epidemiology, College of Veterinary
Medicine, Tuskegee University
Final Report
Prepared for
U.S. Department of Agriculture
Food Safety and Inspection Service
Office of Public Health and Science
Prepared by
RTI
Health, Social, and Economics Research
Research Triangle Park, NC 27709
RTI Project Number 07182.024

snip...

The study concerned lists as three main routes, also the scrapie
transmission and the spontaneous BSE case, at the same level of
ranking as the above listed priority routes.
Just one example of this inconsistency with what we consider major
risks: It has not been addressed what happens in Mexico in terms of
MBM exposure, whereas it is stated that from 750,000 up to 2.5
millions of animals are imported annually (p. 22) from Mexico (and
Canada). More or less only a conclusion is presented that it is
extremely unlikely that these animals pose a risk of introducing BSE
in the USA. Maybe they dont pose any risk, but what if they had
been fed contaminated starter ratios as calves in Mexico? Even if
they would not live until patent clinical stages, they could introduce
infectivity into the system, which is, as we concluded in the SSC, in
the case of the US, not very stable.
4) A recent study has shown that prions can be found in the
muscle of BSE-infected mice. Such a finding in cattle would
dramatically alter the structure of the model and the risk estimates.

snip...

2.7 BASIC ASPECTS OF BSE
1) The feeling one obtains from reading this report is that the
primary objective was to construct a relatively complex quantitative
simulation model. This approach ignores some basic aspects of
BSE. The overriding one is that if a cattle population becomes
infected and MBM is fed to cattle, then no rendering system is
capable of effectively inactivating the BSE agent. Transmission to
and amplification by cattle is therefore possible. There is a lack of
discussion on and assessment of the probability of the introduction
of the BSE agent into the U.S. cattle population from imported
animals, animal products, and animal feedstuffs. This is somewhat
2-7
Review of the Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States  Final Report
fundamental and would have provided additional basis for the risk
assessment.
2.8 TREATMENT OF LITERATURE AND EXPERT
KNOWLEDGE
1) The review and synthesis of the published literature and
expert knowledge is somewhat patchy. One is left with the notion
that there has been insufficient consultation with researchers in the
field, which could have provided an ongoing peer review. One is
concerned that this could be used to generate criticisms that are
somewhat inevitable in such a politically laden subject. It would be
preferable to see the review and synthesis of the knowledge
available mapped on to the basic components of the risk
assessment. This is done to some extent but mainly on the detail
rather than the broader risks.
2) Many assumptions in the report were based on expert
judgments. However, the basis for using these judgments in the BSE
risk assessment should be explained as fully as possible.

snip...

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


GAO says US barriers to mad cow disease are full of holes

Robert Roos * News Editor

Note: This story was updated March 1, 2002, to include additional
information about recent federal actions to prevent mad cow disease.

Feb 28, 2002 (CIDRAP News)  Congress's General Accounting Office (GAO)
concludes in a new report that the United States remains vulnerable to
bovine spongiform encephalopathy (BSE), or mad cow disease, because of
inadequate import barriers and weak enforcement of rules to contain any
BSE-contaminated products that might reach US shores.

"The continuing absence of BSE in the United States today cannot be
sufficiently ensured by current federal prevent efforts," states the
report, released Feb 26. "The introduction and spread of BSE in the
United States could stem from cattle and cattle-derived products from
countries that subsequently developed BSE and from gaps in import
controls, animal testing, and feed ban enforcement. As a result of these
problems, consumers may unknowingly eat foods that contain central
nervous system tissue from a diseased animal."

The report says that about 1,000 cattle and 125 million pounds of beef
entered the United States from countries that later found cases of BSE.
Further, hundreds of firms have violated a ban on putting meat and bone
meal in cattle feed, and the Food and Drug Administration (FDA) has done
little to enforce the ban, the GAO says.

The GAO investigated the government's BSE prevention efforts at the
request of Sens. Tom Harkin, D-Iowa, Richard Lugar, R-Ind., and Dick
Durbin, D-Ill. Durbin promised to introduce a bill to strengthen BSE
prevention efforts. "We can't have the world's most reliable food supply
without an equally reliable system of regulation and oversight," Durbin
said in a Feb 26 news release.

Agriculture Secretary Ann Veneman took issue with the report on several
counts, saying the GAO didn't fully consider recent actions that federal
agencies have taken to strengthen BSE safeguards. She also said the GAO
didn't appropriately recognize a Harvard University report issued last
year that determined the risk of BSE in the United States to be very low.

Eating meat from animals with BSE is considered a risk factor for
variant Creutzfeldt-Jakob disease in humans. BSE prevention steps in the
United States began in 1989 with a ban on the importation of live
ruminants (cattle, sheep, and goats) and ruminant meat and bone meal
from the United Kingdom and other countries with BSE. In 1997 the ban
was extended to the rest of Europe, and the FDA banned the use of most
mammalian protein in feed for ruminants the same year. In addition, the
FDA and the US Department of Agriculture (USDA) screen cattle-derived,
FDA-regulated products imported from countries where BSE exists, the GAO
report says.

Over the past 20 years, the nation imported about 1,000 cattle, 125
million pounds of beef, and 23 million pounds of inedible meat
byproducts from countries where BSE was later found, the GAO determined.
Some contaminated animals or products may have entered the country
because BSE's incubation period is up to 8 years, the report says.

In particular, the nation imported 242 cattle from Japan between 1993
and 1999. After Japan reported its first BSE cases in September 2001,
the USDA managed to locate most of the imported cattle, but 24 animals
had already gone to slaughter or rendering.

"In addition to the BSE risk posed by past imports, a small but steady
stream of BSE-risk material may still be entering the United States
through international bulk mail," the GAO says. USDA inspectors at
international bulk mail facilities can spot organic matter with special
x-ray scanners, but inspectors are not on duty at all times and they can
screen only a fraction of the stream of incoming packages, the report
states. In a 6-month period last year, 570 of 116,000 packages screened
at one facility contained "at-risk beef or beef-derived products."

Risky items also can slip through federal ports of entry when shipments
are inaccurately labeled or through lack of inspection, the GAO
reported. For example, sampling by the US Customs Service in fiscal 1999
showed that information on beef shipments was wrong in over 21% of
cases. Further, in fiscal year 2000 the FDA inspected only 1% of the 4
million imported food entries under its jurisdiction and less than 1% of
the 146,000 shipments of animal drugs and feeds.

BSE prevention efforts also include USDA testing of cattle tissue. The
GAO says the USDA has increased its testing program but does not test
many cattle that die on farms, which are assumed to pose an increased
risk because they are usually older and often die of unknown causes.
Some cattle that die on farms are collected and rendered into products
that include animal feed, the report says.

The GAO finds serious fault with the FDA's enforcement of the ban on
mammalian protein in cattle feed. Since 1997, FDA and state personnel
have conducted more than 12,000 inspections at more than 10,576 firms
(eg, renderers, feed mills) and found 364 firms in violation, the report
states. The FDA estimates that at least another 1,200 firms that should
be subject to the ban have not been identified.

"FDA did not take prompt enforcement action to compel firms to comply
with the feed ban," the GAO says. By April 2001 (when the GAO
investigation began), the agency's only enforcement steps had been to
issue two warning letters, though the pace picked up after that. Several
firms repeatedly violated the rules but did not receive warning letters.
Further, the FDA has no overall enforcement strategy that sets penalties
and deadlines.

"Even if FDA were to actively enforce the federal ban, its inspection
database is so severely flawed thatuntil correctedit should not be
used to assess compliance," the report says. It includes a long list of
problems with the database; for example, entries for about 45% of all
inspections lack information to uniquely identify the firms inspected.

In other findings, the GAO concluded that the United States acted as
much as 5 years earlier than other countries to bar imports of animals
and animal feed ingredients from countries with BSE cases. However, the
nation has a "more permissive" feed ban than other countries in that
cattle feed can contain protein from horses and pigs. The FDA is
currently reviewing this provision, the report notes.

The report recommends a number of steps to address the problems it
describes. Among other things, it suggests that the secretary of
agriculture consider using public service announcements or labels to
inform consumers that certain beef cuts and products may contain central
nervous system (CNS) tissue. The GAO also suggests that the FDA consider
requiring labeling of regulated products, including food, cosmetics, and
drugs, that contain CNS tissue.

Agriculture Secretary Veneman critiqued the GAO report in a statement
released the same day (Feb 26). "The report fails to appropriately
recognize the conclusions and recommendations made last year by Harvard
University in its comprehensive, 3-year study on BSE," she said. "The
Harvard Risk Analysis showed that the risk of BSE occurring in the
Untied States is extremely low and that early government protection
systems have been largely responsible for keeping BSE out of the United
States and would prevent it from spreading if it ever did enter the
country."

Veneman also said that despite extensive USDA comments on the draft
report, "scientific and technical errors" survived in the final report.
Further, the report "does not appropriately consider the additional
actions that have been taken by federal agencies to strengthen BSE
programs," she added.

The USDA described a number of recent actions related to BSE in a
separate news release (see link below). That release says the FDA has
"significantly improved" its database on firms' compliance with the
animal feed rule. The improved database will be fully operational in
April and will allow the FDA to track compliance more effectively,
officials said. In addition, the FDA is receiving an extra $15 million
for BSE prevention efforts this year, bringing the total to $19 million,
and is hiring 115 people this year to help in those efforts.

The USDA also issued a set of responses to the recommendations in the
GAO report. The agency rejected the idea of labeling beef and beef
products that may contain CNS tissue, stating, "The presence of CNS
tissue does not mean that the product is infectious for BSE. Labeling
and warning statements should be reserved for known hazards."

In response to another GAO recommendation, the USDA said it is already
increasing its testing of tissue samples from animals that die on farms.
The agency said that the number of cattle brains tested this year will
be more than double last year's total, and that "A focus of this
increased surveillance is to obtain more samples from animals that die
on farms."

Regarding the Harvard study of BSE risk in the United States, the GAO
report says the agency did not try to validate the model or assumptions
used by the Harvard researchers. However, the report says the Harvard
authors acknowledged that their conclusions "could be influenced by a
number of model assumptions that could not be verified with
confidenceincluding assumptions about US measures to prevent the
introduction and spread of BSE." The Harvard researchers also noted that
compliance with the animal feed ban is the leading source of uncertainty
in their assessment, the GAO report states.

See also:

GAO Web site with link to report (type 02-183 in
Report # search box at top right, then hit Go)

Ann Veneman's statement on GAO report
http://www.usda.gov/documents/NewsReleases/2002/02/0071.doc

USDA news release, "USDA continues to strengthen BSE protection systems"
http://www.usda.gov/documents/NewsReleases/2002/02/0070.doc

USDA fact sheet with responses to GAO recommendations
http://www.usda.gov/documents/NewsReleases/2002/02/fs0071.doc

http://www.cidrap.umn.edu/cidrap/content/other/bse/news/gaorept.html


Report Abstract

Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory Areas Would Strengthen U.S. Prevention Efforts GAO-02-183
January 25, 2002
PDF Accessible Text


Bovine spongiform encephalopathy (BSE), also known as mad cow disease,
has been found in cattle in 23 countries. Countries with BSE have
suffered large economic losses because of declines in both beef exports
and domestic beef sales. The U.S. Department of Agriculture (USDA) and
the Food and Drug Administration (FDA) have primary responsibility for
preventing the introduction of BSE-contaminated cattle, beef, and
cattle-derived products into the United States. GAO found that FDA has
not acted promptly to force firms to keep prohibited proteins out of
cattle feed and to label animal feed that cannot be fed to cattle. FDA's
data on inspections are severely flawed, and FDA is unaware of the full
extent of industry compliance. If BSE was discovered in U.S. cattle,
many consumers might refuse to buy domestic beef; beef exports could
decline dramatically as could sales in related industries, such as
hamburger chains and frozen dinner manufacturers. Furthermore, some
people might develop mad cow disease if infected cattle were to enter
the food supply. The United States acted as many as five years earlier
than did other countries to impose controls over imports of animals and
animal feed ingredients from countries that had experienced mad cow
disease. Similarly, U.S. surveillance efforts to test cattle brains for
mad cow disease met internationally recommended testing targets earlier
than did other countries. However, the United States' feed ban is more
permissive than that of other countries, allowing cattle feed to contain
proteins from horses and pigs. FDA is reviewing whether these
ingredients should continue to be allowed in cattle feed. Finally, as in
most countries that are BSE-free, cattle brains and other central
nervous system tissue can be sold as human food.

Subject Terms
International trade regulation
International economic relations
Contaminated foods
Feed additives
Food industry
Food inspection
Health hazards
Variant Creutzfeldt-Jacob Disease
Consumer protection
Bovine Spongiform Encephalopathy
Animal diseases
Cattle

http://www.gao.gov/docdblite/summary.php?recflag=&accno=A02630&rptno=GAO-02-183

http://www.gao.gov/new.items/d02183.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


PART of june 2004 usda enhanced bse/tse cover-up.
part of the program was to start NOT confirming with WB,
due to the first confirmed finding. same with the other mad cows
in TEXAS i.e. the stumbling and staggering one they refused
to test and rendered;

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


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

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


No mad cow results for nearly 500 cows

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


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

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

snip...

--

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


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


OR those positive, positive, inconclusive, negatives from TEXAS that
no WB were used on???

INTERESTING comments in this old newspaper article i ran
across ;

Nov 22 2004 07:09 PM MST CBC News

USDA approves live cattle, border reopening could take months

snip...

Also on Monday, the USDA said test results on a suspected case of mad
cow are inconclusive, which means further tests will be done. Canadian
authorities have been told that the cow, from Texas, didn't have the
metal ID tag that cows born here are given.

snip...

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

Release No. 0508.04

Statement by John Clifford, Deputy Administrator- Animal & Plant Health
Inspection Service

November 23, 2004


"The USDA National Veterinary Services Laboratories (NVSL) in Ames,
Iowa, has determined that the inconclusive screening test sample
reported on Nov. 18 has tested negative for BSE upon confirmatory testing.
"The Nov. 18 sample is the first that has tested inconclusive under an
APHIS protocol announced in August that calls for public reporting of
screening results only after two reactive screens. NVSL used the
immunohistochemistry (IHC) test, an internationally-recognized gold
standard test for BSE, and received a negative result on Nov. 22.
Because the Nov. 18 screening test results were reactive in both the
first and second screens, NVSL scientists made the recommendation to run
the IHC test a second time. On Nov. 23 they reported the second IHC test
was negative. Negative results from both IHC tests makes us confident
that the animal in question is indeed negative for BSE.

"APHIS began an enhanced surveillance program on June 1 and to date has
tested over 121,000 samples for BSE. Screening tests are designed to be
extremely sensitive and false positives are not unexpected. APHIS has
reported three inconclusives including the Nov. 18 sample and all have
tested negative on confirmatory testing."


#


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

I am hearing more and more about TEXAS and those inconclusives of
late? I am wondering if they are still being investigated???

COULD HAVE been a cow like that Belgium Atypical BSE cow and
the cows from Japan that were also Atypical ;

ELISA +
SAF -
HP -
IHC -
WB +

8. 6/10/2003 Holstein Steer 13/10/2001 23 mths
No clinical signs WB+, IHC-, HP-


9. 4/11/2003 Holstein Steer 13/1/2002
21 mths No clinical signs WB+, IHC-, HP-

ODD how the USA used WB on the cow old dave capped,
and sent it to Weybridge, but not the others?

WONDER where the cow brains of those atypicals that WB were not
used on are?

course we will never know about that one mad cow from TEXAS that
went to render, head and all, without testing, the stumbling and staggering
one...

EXTENSION OF EFFECTIVE DATE FOR BOVINE SPONGIFORM
ENCEPHALOPAHTY (BSE) FSIS NOTICES
FSIS is extending the expiration date for the following FSIS Notices
until February 1,
2006:


FSIS Notice 4-04, Awareness Meeting Regarding New Regulations That
Prohibit Non-
Ambulatory Disabled Cattle and the Use of Certain Materials From Cattle
for Human
Food

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/4-04.htm


FSIS Notice 5-04, Interim Guidance For Non-Ambulatory Disabled Cattle
and Age
Determination

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/5-04.htm


FSIS Notice 7-04, Questions and Answers For FSIS Notice 4-04 Regarding
FSIS's BSE
Regulations

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/7-04.htm


FSIS Notice 9-04, Verification Instructions For The Interim Final Rule
Regarding
Specified Risk Materials (SRMs) In Cattle

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/9-04.htm


These notices are due to expire February 1, 2005. However, it is
necessary for the
notices and instructions provided in them to remain in effect until FSIS
takes final action
on the interim final rule, Prohibition of the Use of Specified Risk
Materials for Human
Food and Requirements for the Disposition of Non-Ambulatory Disable
Cattle. Once
the Agency does so, FSIS will reissue the relevant information from
these notices in a
FSIS Directive.
Philip S. Derfler /s/
Assistant Administrator
Office of Policy, Program, and Employee Development
DISTRIBUTION: Inspection Offices, T/A Inspectors, OPI: OPPED
Plant Mgt., T/A Plant Mgt., TRA, ABB, PRD, Import
Offices


http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/BSE_FSIS_Notice_Extension.pdf

Regulatory Flexibility Act; Amended Plan for Reviewing Regulations Under
Section 610 Requirements

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Schedule of regulations to be reviewed under section 610
requirements of the Regulatory Flexibility Act; amended.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing an
amended scheduling plan for reviewing regulations under Section 610 of
the Regulatory Flexibility Act, as amended. These provisions require
that all Federal agencies review existing regulations that have a
significant economic impact on a substantial number of small entities to
determine whether the associated impact can be minimized.

FOR FURTHER INFORMATION CONTACT: For further information contact Dr.
Quita Bowman Blackwell, Director, Directives and Economic Analysis
Staff, FSIS, U.S. Department of Agriculture, 300 12th Street, SW, Room
112, Washington, DC 20250-3700, (202) 720-5627.

SUPPLEMENTARY INFORMATION:
Background

Section 610 of the Regulatory Flexibility Act (RFA), as amended (5
U.S.C. 601-612), requires that all Federal agencies review any
regulations that have been identified as having a significant economic
impact upon a substantial number of small entities as a means to
determine whether the associated impact can be minimized by considering
the following factors: (1) The continued need for the rule; (2) the
nature of the complaints or comments received concerning the rule from
the public; (3) the complexity of the rule; (4) the extent to which the
rule overlaps, duplicates, or conflicts with other Federal rules; and
(5) the length of time since the rule has been initially evaluated or
the degree to which technology, economic conditions, or other factors
have changed in the area affected by the rule.
On April 2, 2002, FSIS published in the Federal Register (67 FR 15501) a
scheduling plan for reviewing regulations under the 610 provisions. At
that point, the Agency had determined to review all rules deemed
economically significant, regardless of whether the Agency had stated
that the rule would impose a significant economic impact on a
substantial number of small entities or not. After further
consideration, FSIS now believes that it would be more effective and
beneficial if the Agency concentrated its reviews under Section 610 of
the RFA on those final and interim final rules that the Agency has
identified as having a significant economic impact on a substantial
number of small entities.
Accordingly, FSIS has amended its plan for reviewing the Agency rules
that it has identified as having a significant economic impact on a
substantial number of small entities.

Schedule of FSIS' Regulations Identified for Review Under the RFA'S 610
Provisions
----------------------------------------------------------------------------------------------------------------

CFR parts affected and legal
authority Regulation title Publication citation and date Review date
----------------------------------------------------------------------------------------------------------------

9 CFR 304, 308, 310, 320, 327, 381, Pathogen Reduction; Hazard 61 FR
38806; July 25, 1996... 2005
416, 417; 21 U.S.C. 451-470, 601- Analysis and Critical
695; 7 CFR 2.18, 2.53. Control Point (HACCP)
Systems.
9 CFR 430; 7 U.S.C. 450; 7 U.S.C. Control of Listeria 68 FR 34208; June
6, 2003.... 2007
1901-1906; 21 U.S.C. 451-470, 601- monocytogenes in Ready-to-
695; 7 CFR 2.18, 2.53. Eat Meat and Poultry
Products.
9 CFR 309, 310, 311, 318, 319; 21 Prohibition of the Use of 69 FR 1862;
January 12, 2004. 2008
U.S.C. 601-695; 7 U.S.C. 138f, 450, Specified Risk Materials for
1901-1906; 7 CFR 2.17, 2.18, 2.53, Human Food and Requirements
2.55. for the Disposition of Non-
Ambulatory Disabled Cattle.
9 CFR 301, 318, 320; 21 U.S.C. 601- Meat Produced by Advanced 69 FR
1874; January 12, 2004. 2009
695; 7 U.S.C. 138f, 450, 1901-1906; Meat/Bone Separation
7 CFR 2.7, 2.18, 2.53. Machinery and Meat Recovery
(AMR) Systems.
----------------------------------------------------------------------------------------------------------------


Additional Public Notification

Public awareness of all segments of rulemaking and policy development is
important. Consequently, in an effort to ensure that the public and in
particular minorities, women, and persons with disabilities, are aware
of this notice, FSIS will announce it on-line through the FSIS Web page
located at http://www.fsis.usda.gov.

FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health

[[Page 4048]]

professionals, scientific professionals, and other individuals who have
requested to be included.
The update also is available on the FSIS web page. Through Listserv and
the web page, FSIS is able to provide information to a much broader,
more diverse audience.

Done at Washington, DC, on January 24, 2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05-1613 Filed 1-27-05; 8:45 am]


http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/OPPDE/rdad/FRPubs/04-040N.htm


USDA RELEASES RULE TO ESTABLISH MINIMAL-RISK REGIONS FOR BOVINE
SPONGIFORM ENCEPHALOPATHY

Recognizes Canada as Minimal-Risk Region, Making it Eligible to Export
to the United States

http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/12/0525.xml

TSS





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