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From: TSS ()
Subject: TSE Regulations (Update): GAIN REPORT February 1-11, 2005
Date: February 11, 2005 at 12:11 pm PST

-------- Original Message --------
Subject: TSE Regulations (Update): GAIN REPORT
Date: Fri, 11 Feb 2005 09:58:54 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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


February 1-11, 2005


Transmissible Spongiform Encephalopaties


Introduction

In response to the public health threats resulting from transmissible
spongiform encephalopaties (TSEs), such as BSE (mad cow disease) which
is linked to new variant Creutzfeldt-Jakob disease in humans, the
European Commission issued legislation to ban Specified Risk Materials
(SRM) to guarantee the safety of the food chain. The ban prohibited the
use of SRMs (defined as the skull, tonsils, ileum and spinal cord of
cattle, sheep and goats aged over one year, and spleens of sheep and
goats) in any products sold in the EU. A comprehensive chronological
list of BSE/TSE legislation

in the EU is available on the European Commission's website.

In May 2001, Regulation 999/2001
,
the centerpiece of the EU TSE legislation intended to supersede all
existing TSE legislation, was adopted. Among other things, it
established criteria to classify the BSE status of member states and
third countries into one of five classification categories. Certain
requirements, including removal of SRM's, would then be applied to a
country depending on the classification. On June 28, 2003, the European
Parliament and the Council adopted Regulation 1128/2003

prolonging transitional measures with two years, until July 1, 2005, for
countries whose BSE status has not been determined yet. The extension
maintains the present level of public health protection as the
transitional measures on SRM's and slaughter methods are maintained
within the EU and in respect of third countries. The two-year extension
is designed for the Commission to continue its attempt to reach an
agreement at international level (OIE) on the determination of BSE
status of countries on the basis of risk. The Commission would at the
same time conclude the scientific risk assessments.


Impact on U.S. Trade

The United States is required to remove SRM's and MRM (mechanically
recovered meat) from animal products for export to the EU. The United
States fully expects to be placed in Category I or II once the
categorization is completed and would not be required to remove SRM's
and MRM once Regulation 999/2001 is fully implemented. However, in
August 2004 the European Food Safety Agency (EFSA) published new
scientific reports on the GBR classifications for seven countries (See
GAIN report E34050)
.
The U.S. was classified in level three which means "BSE is likely but
not confirmed or confirmed at a lower level". The risk assessment was
based on information submitted by the countries concerned, and relates
in particular to imports of bovines and meat and bone meal from the UK
and other BSE-risk countries. The scientific risk assessments of all
countries have not been fully concluded. For only one third of the
countries requesting the determination of the BSE status, the Scientific
Steering Committee
has adopted a
final opinion. However, even the application of transitional measures of
Regulation 999/2001 is extremely disruptive for the U.S. industry.


EU Legislation - Amendments to Framework Regulation 999/2001

In 2004, several new amendments were made to Regulation 999/2001. The
confirmation on January 28, 2005, in a press release Case of BSE in a
goat confirmed: Commission extends testing program
,
that BSE had been identified in a goat, which was slaughtered in France
in 2002, was already incorporated in two amendments. Another important
amendment set stricter rules for the import of cervid products from
Canada and the United States (see GAIN Report E35023
).

EC 876/2004 of 29 April 2004

 trade in ovine and caprine animals for breeding, which sets new rules
for the trade in goats and sheep, with the exception of sheep of the
ARR/ARR prion protein genotype, which are exempted.

EC 1492/2004 of 23 August 2004

 modification of eradication measures for bovine, ovine and caprine
animals, trade and import conditions for semen and embryos of ovine and
caprine animals and the list of specified risk materials. This
regulation under certain conditions allows for the exemption of culling
all animals of the cohort of a bovine infected with BSE, as well as
setting rules for ovine and caprine herds, in which BSE is identified
and the a movement restriction on herds identified with or suspected of
having scrapie, until the results of further investigation are
available. The regulation also restricts trade of live animals, ova and
semen of goats and sheep, with the exception of sheep of the ARR/ARR
prion protein genotype, which are exempted, starting January 1, 2005.
Furthermore, the regulation redefines the list of SRM to be removed from
bovines.

EC 1471/2004 of 18 August 2004

 introducing requirements for the import of cervid products from Canada
and the United States. This regulation imposes the removal of Specific
Risk Materials (SRM) from all cervid meats exported to the EU and limits
exports of wild game to areas free of Chronic Wasting Disease (CWD) from
January 1, 2005.

Under Regulation 1326/2001

(amended by Commission Regulation 1234/2003

setting the conditions for use of fishmeal, hydrolized proteins and
dicalcium phosphates in feed for non-ruminant farmed animals), the
transitional measures passed in July 2001, only countries recognized as
provisionally BSE-free (GBR-1) are not required to remove SRM's in order
to export to the EU. The EU currently recognizes New Zealand, Australia,
Norway, Chile, Argentina, Paraguay, Nicaragua, Botswana, Namibia and
Swaziland as provisionally BSE-free.


Background

On July 30, 1997, the European Commission adopted Commission Decision
97/534/EC, commonly knows as the Specified Risk Materials (SRM) ban. The
ban prohibited the use of SRMs in any products sold in the EU. The
original date of implementation was July 1, 2998, but this was delayed
due to controversy over product sector coverage. In addition to food and
feed, the ban would have significantly affected production of
pharmaceuticals, cosmetics, medical devices and fertilizers. In
September 1999, the EU implemented specific regulations for SRMs on
medical products for human use (Directive 99/820/EC). It also provided
guidelines on how companies would comply with this directive.

In June 2000, Commission Decision 2000/148/EC was adopted, which
repealed Commission Decision 97/534/EC, but set new requirements for
handling SRMs. This new measure limited the scope of the ban to food,
feed and fertilizer and required slaughterhouses and authorized meat
cutting and processing plants in all EU member states, regardless of
their BSE status, to remove the SRMs mentioned above. The measure became
effective October 1, 2001 for all EU member states. Initially the ban
did not apply to third countries. However in March 2001, the EU
published the results of their geographical BSE risk (GBR) assessment of
third countries exporting food, feed or fertilizer products to the EU.
The United States' BSE status is provisionally recognized as "unlikely,
but cannot be excluded (GBR-2)".


Reports

BSE/TSE Situation in the EU-25 - Update (GAIN report E35023
): This report
focuses on recent BSE/TSE events and legislation in the EU. A first case
of BSE was recently confirmed in a French goat, which was slaughtered in
2002. As a result the European Commission has adopted new legislation
with relation to TSE and scrapie in ovine and caprine herds, as well as
imposing trade restrictions on live animals, ova and semen of goats and
sheep. This report also offers an update on the BSE situation in the EU
for 2004.

EFSA publishes new report on the Geographical BSE Risk Assessment (GAIN
report E34050
):
In August 2004 the European Food Safety Agency (EFSA) published new
scientific reports on the GBR classifications for seven countries. The
U.S. was classified in level three which means "BSE is likely but not
confirmed or confirmed at a lower level". The risk assessment was based
on information submitted by the countries concerned, and relates in
particular to imports of bovines and meat and bone meal from the UK and
other BSE-risk countries.

European Commissioner Byrne's first regular BSE report of the year (GAIN
report E24044
):
On February 19, 2004, European Commissioner David Byrne's first regular
BSE report of the year was published, which indicates a 38 percent drop
in the overall number of BSE cases in the European Union. The report
also addresses: Evolution of BSE, Feed Ban, Increase of The Age Limit
for Removal of Vertebral Column, Geographical BSE Risk (GBR) Assessment,
BSE Status, BSE in USA, BSE in Portugal, BSE in the UK, Strain Typing of
Scrapie Cases in Sheep and Goats and New Member States.

Mad Cow Disease - The EU and the US (GAIN report E24002
):
Mad Cow Disease appears to have begun in the United Kingdom in the late
1980's, and subsequently spread through most of the EU. Great efforts
have been made by the EU to decrease the number of BSE-infected cattle
in recent years. Most recently a single dairy cow in the United States
was diagnosed with Mad Cow Disease. Data within this report facilitate
putting this finding into a worldwide context.


Links

BSE - U.S. Departments of Agriculture / FAS

BSE/Scrapie - European Commission / DG Health and Consumer Protection


http://www.useu.be/agri/srm.html

Approved Establishments:
- Approved Lists of Animal Product Establishments (GAIN report E35019)
http://www.useu.be/agr/estab.html

Livestock:
- Semi-Annual Report (GAIN report E35018)
http://www.useu.be/agr/livestock.html

UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
DIRECTIVE ?
WASHINGTON, DC REVISION ?
AMENDMENT ? CHANGE TRANSMITTAL SHEET
OTHER ?
FSIS Notices BOVINE SPONGIFORM ENCEPHALOPAHTY (BSE) FSIS 4-04 1/31/05
NOTICES 5-04
7-04
9-04
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

[Federal Register: January 28, 2005 (Volume 70, Number 18)]
[Proposed Rules] [Page 4047-4048]

> From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28ja05-34]
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Ch. III

[Docket No. 04-040N]


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

Greetings list members,

THIS does not surprise me one bit.

IN laymans terms, what they PROMISED they would do,
they aint gonna do now. they don't have to. this administration
has done this time and time again.
IN OTHER WORDS THE CONSUMER CRAPPED OUT AGAIN!

SIMPLY has nothing to do with science, but all to do
with ;


> 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.

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...


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


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

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