SEARCH VEGSOURCE:

 

 

Follow Ups | Post Followup | Back to Discussion Board | VegSource
See spam or
inappropriate posts?
Please let us know.
  




From: TSS ()
Subject: APHIS.USDA.GOV TO R-CALF more BSeee
Date: February 8, 2005 at 1:57 pm PST

-------- Original Message --------
Subject: APHIS.USDA.GOV TO R-CALF more BSeee
Date: Tue, 8 Feb 2005 15:55:07 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


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

02/02/05 Response to R-CALF


Animal and Plant Health Inspection Service

February 2,2005

Response to R-CALF

Claim 1: Regarding OIE guidelines for
Minimal-Risk regions

To determine the risk category of a given country, the
OIE recommends that a thorough risk assessment be
conducted. This risk assessment should look at the
criteria outlined in the OIE Code, such as number of
years an effective feed ban has been in place, SRM
removal, number of BSE cases, etc., and analyze the
findings in their totality. The OIE guidelines are NOT
specific international mandates, as misinterpreted
by R-Calf, but rather are guidelines for countries to
conduct risk assessments of potential trading part-
ners. USDA's proposed rule, the final rule, and the
risk analysis documents published for public com-
ment contain an exhaustive analysis of all risk factors
of the OIE guidelines for minimal-risk countries or
zones and how Canada meets each individual
criterion.

USDA's risk analysis looked at the OIE chapter
in the manner it was intended to be used-that is, as
a set of guidelines and recommendations, and not a
prescriptive approach to regulation. Indeed, the
preamble to the USDA rule states, "We stated in our
proposal that we would use these standards (OIE
Code) as a combined and integrated evaluation tool,
basing a BSE minimal-risk classification on the
overall effectiveness of control mechanisms in place
(e.g., surveillance, import controls, and a ban on
the feeding of ruminant protein to ruminants). We
noted that this approach would differ from some of
the numerical guidelines specified by OIE in its rec-
ommendations for a BSE minimal-risk country or
zone..." For example, we have acknowledged that
Canada's feed ban falls short of meeting the OIE
feed ban criterion. USDA's minimal-risk criteria are
designed to consider an individual country's
specific situation and to analyze risk based on
the overall effectiveness of actions taken by the
country to prevent the introduction and spread
of BSE. In regions where BSE has been diagnosed,
USDA bases its evaluation on the overall effective-
ness of all control measures in place, as well as all
subsequent mitigation measures taken after the first
BSE case has been detected.

It is also important to note that there is no reason
to believe that ruminants were exposed to the
non-ruminant feed that may have been derived from
portions of the initial positive cow. Per the Canadian
assessment: "The carcass of the index case was

traced through the abattoir-renderer-feed mill-pro-
ducer continuum to its direct allocation into pet food
and poultry meal and its additional retail distribution
across 1,800 farm sites. As earlier described, the
associated cluster is typical of the pyramidal feed
production and distribution relationship in Canada.
Visits to the renderer and feed mills confirmed
adherence to the MBM feed ban legislation on
product receipt, segregation, labelling and distribu-
tion." Accordingly, there is no reason to believe that
ruminants were exposed to this feed.

Claim 2: Regarding OIE
recommendations for removal of
specified risk materials

R-Calf has completely misunderstood the SRM
removal recommendations of the OIE Code.

As a clarification, the OIE Article on SRM remov-
al recommends, for countries of moderate and high
BSE risk, the removal of tonsils and intestine at all
ages and the removal of brains, eyes, spinal cord,
skull and vertebral column from animals over 12
months of age. For countries determined to be of
minimal-risk (like Canada), the OIE in fact
recommends the removal of brains, eyes spinal
cord, skull and vertebral column ONLY from animals
that are 30 months of age and older at slaughter.
Comparing systems in the UK, which has reported
more than 185,000 cases and is classified as a high
risk country, with Canada, which has had four
indigenous BSE cases with an established
surveillance system, is misleading. Given the low
level of circulating BSE infectivity in minimal-risk
countries such as Canada, USDA can safely allow
trade in certain products with required mitigation
steps to further ensure that BSE does not affect
human or cattle health.

Claim 3: Regarding Canada's BSE
surveillance testing

USDA cannot stress enough that BSE tests are
not food safety tests - they are valid only for a
statistically based surveillance system. (It is
important to note that the removal of SRMs is the
single most important action that can be taken to
protect public health.) Europe and Japan have
included testing healthy cattle at slaughter in their
testing programs as a measure which they hope will
restore consumer confidence. These countries do
not conduct these tests for food safety purposes.

Current testing methodology can detect a positive
case of BSE approximately 3 months before the
animal begins to demonstrate clinical signs. The
incubation period for BSE - the time between ini-
tial infection and the manifestation of clinical signs
- is generally very long, on average about 4 years.
Accordingly, there is a long period during which
testing an infected animal with the current
methodology would, wrongly, produce negative
results. This is especially likely if the animal is
clinically normal at the time samples are obtained for
testing. One estimate is that current test methodol-
ogy would have a false negative test rate of 92% for
clinically normal adult cattle (i.e., if 100 BSE-infected
adult cattle were tested while clinically normal, 92%
of them would test negative even though they were,
in fact, infected). If, however, the animal is exhibiting
some type of clinical signs that could be consistent
with BSE, then the test is much more meaningful and
is not likely to produce false negative results. Since
current tests only determine the presence of BSE
shortly before the likely onset of symptoms, testing
apparently normal animals presented for slaughter is
not an effective use of the tests, and again, provides
no assurance of food safety.

The OIE is very clear in stating that the likelihood
of detecting BSE in cattle varies immensely among
cattle sub-populations, and testing healthy cattle at
slaughter is the least likely to produce results. For
example, based on European data, it is estimated that
finding BSE in cattle displaying clinical signs compat-
ible with BSE is 100 times more likely than finding it in
downers or dead on farms; and 5,000 to 10,000 times
more likely than finding it in healthy, 30 month old
cattle at slaughter.

Claim 4: Regarding international trade
relations

The Minimal-Risk Rule (and identifying Canada as
a minimal-risk region for BSE purposes) is designed
to apply appropriate public and animal health mitiga-
tions to ensure protection of public and animal health
while providing a standard for risk-based trade prac-
tices Unless USDA takes the lead to establish the
concept of Minimal-Risk Regions, based on risk
analysis, for animal pests and diseases‚¨especial-
ly for BSE‚¨the United States (which has multiple
effective mitigation measures in place) will be
vulnerable to having its exports treated no differ-
ently than those of countries with rampant levels
of pests and diseases. In implementing this rule,
the United States is clearly seeking to ensure that
ALL countries adopt scientifically sound, risk-based
import and export standards and apply them equiva-
lent?/. The United States cannot protest unjustified

measures applied to our products if we similarly apply
the same virtually impossible measures to others.

Furthermore, the OIE Code has never recom-
mended banning the trade of cattle or their products
even from countries with high BSE risk. Even under
the current OIE guidelines, the United States could
detect 50 or 60 BSE cases and not pose a threat of
spreading the disease to other countries via exports
because of the overall effectiveness of control mecha
nisms in place (e.g., surveillance, SRM removal,
import controls, and a ban on the feeding of ruminant
protein to ruminants). However, the United States'
one detection (even though it was of a non-U.S. ori-
gin cow) has given other countries the excuse to ban
our exports. Hence, there is a need to establish sci-
ence-based regulations. By any measure, the United
States presents a minimal risk of transmitting BSE.
Likewise, we are convinced that Canada poses a
minimal-risk to trading partners.

Resumption of imports from Canada may be seer
by other countries as reflecting the United States'
conviction as to the safety of U.S. and Canadian beef
products, since the same or equivalent sanitary
measures for BSE prevention are enforced by both
countries, and since Canada and the United States
are viewed by most countries as having a similar BSE
risk. As clearly outlined in the Minimal-Risk final rule,
USDA is confident that the animal and public health
measures that Canada has in place to prevent BSE,
combined with existing U.S. domestic safeguards and
additional safeguards provided in the final rule provid(
the utmost protections to U.S. consumers and
livestock. Consequently, USDA is optimistic that the
rule and the assurances and protections it affords will
ultimately alleviate certain restrictions on U.S. beef
imports imposed by several of our trading partners.

Claim 5: Regarding feed ban protections
in the United States

While APHIS is confident in both the U.S. and
Canadian feed ban, it is vital to remember that the
MBM feed ban is one important mitigation in a series
of interlocking, overlapping, and sequential barriers
to the introduction and establishment of BSE. The
total effect of these mitigations reflects the combined
results - in fact, the risk assessment examined the
following five barriers that must be compromised
before BSE could be transmitted to a U.S. cow from
a Canadian animal: (1) U.S. import restrictions; (2)
slaughter controls; (3) rendering inactivation; (4) feed
manufacturing controls; (5) dose limitations.

Furthermore, we fully agree that any feed ban
may not have perfect compliance - including in the
United States and Canada - but based on scientific
risk analyses in both countries we believe there is a

negligible risk that the BSE agent would amplify within
the system. When concluding this risk to be extreme-
ly low, the Harvard study included the assumption of
a "leaky" feed ban. Additionally, FDA data suggests
that compliance with the feed ban in the United States
has improved substantially over time. Even if an
infected animal were to be imported into the United
States from Canada, each of the remaining barriers
outlined above reduces the level of infectivity in the
system. APHIS remains confident that slaughter,
rendering, and feed manufacturing controls should
remove all of the residual risk in sequence.

And, R-Calf has again mis-stated OlE's recom-
mendation of SRM removal for young cattle from a
minimal-risk country such as Canada (addressed in
response to Claim #2).

Claim 6: Regarding the likely age of BSE
exposure

R-Calfs assumptions in applying the mean rate of
incubation to determine the time of exposure to the
BSE agent in the older cattle in Canada that have
tested positive for BSE are incorrect and are scientifi-
cally unsound.

Susceptibility to BSE infection in cattle declines
with age, and animals are most susceptible at a
young age. In addition to this difference in suscep-
tibility, the incubation period for BSE (i.e., the time it
takes for the animal to exhibit clinical signs of the dis-
ease) is contingent on the dose of the infectious agent
that an animal consumes. The combination of both
of these factors - age at exposure and dose received
- contribute to the incubation period. The incubation
period can vary widely, but is generally 3-8 years. As
noted in the APHIS risk assessment, an analysis of
the data collected in the UK outbreak estimates the
mean incubation period in that outbreak at 4.2 years,
with 7.5 years estimated as the higher end of the
incubation period. This assessment also noted that
the UK epidemic represented the most intense
exposure to BSE that has occurred, and that the
same level of exposure is not likely to occur in
Canada. The expected incubation period would be
expected to be shorter in the UK, given the higher
exposure, than in Canada.

The estimate of when an animal became infected
is not calculated simply by subtracting an assumed
mean incubation period from the date of its death. A
wider range of factors that are generally identified in
the epidemiological investigation must be considered.
These include an identification of feeding history,
among other factors. Unless there is significant
evidence to the contrary, it is generally assumed that
the time of infection is when the animal was most
susceptible - i.e., within the first year of its life.
Since Canadian cattle found positive for BSE have all

been older, this indicates a low initial exposure (low
exposure giving a longer incubation period). Only the
most recent positive animal was born after the imple-
mentation date of the Canadian feed ban, but evi
dence obtained in the epidemiological investigation
have indicated the presence of feed obtained prior to
the feed ban going into effect. Simitar to the situa-
tion in the United States and elsewhere, a significant
change in feed regulations can not immediately go
into effect with 100% compliance instantly.

The final rule does use modeling assumptions
to predict some infectivity rates, but it explains any
assumptions and the final decision does not rely
entirely on any individual assumption. The combina-
tion of all factors considered in Canada, including the
fact that the feed ban was implemented prior to iden-
tifying the first case, led to the determination that the
duration of the feed ban was adequate. Again, it is
vital to view the feed ban as important, but one of
several interlocking, redundant mitigation measures
to prevent BSE transmission to U.S. animals from
Canada.

Claim 7: Regarding BSE risk to consum-
ers

While there are uncertainties about BSE, USDA and
the international scientific community have learned
from Europe the primary pathways of spread of this
disease and put measures in place to prevent its
dispersion. Based on internationally accepted scien-
tific principles, and using guidelines recommended by
the OIE, the United States has published a final rule
(following extensive notice and comment rulemaking)
to allow trade in certain products from countries that
present a minimal risk. A thorough review of Canada
has shown it to be in the minimalrisk category.

The final rule does seek to prevent U.S. exposure to
BSE. In fact, USDA considered the following facts in
its analysis:

* Import restrictions sufficient to minimize
exposure to BSE: Since 1990, Canada has
maintained stringent import restrictions,
preventing the entry of live ruminants and
ruminant products, including rendered protein
products, from countries that have found BSE in
native cattle or that are considered to be at
significant risk for BSE.

* Surveillance for BSE at levels that meet or exceed
international guidelines: Canada has conducted
active surveillance for BSE since 1992 and

exceeded the level recommended in international
guidelines for at least the past 7 years.


* Ruminant-to-ruminant feed ban in place and
effectively enforced: Canada has had a ban on
the feeding of ruminant proteins to ruminants
since August 1997, with compliance monitored
through routine inspections.

* Appropriate epidemiological investigations, risk
assessments and risk mitigation measures
imposed as necessary: Canada has conducted
extensive investigations in response to any BSE
finding and has taken additional mitigation
measures in response. These risk mitigation
measures include, among others, prohibiting
specified risk materials in human food.

The U.S. Department of Agriculture (USDA) prohibits discrimination

in all its programs and activities on the basis of race, color, national
origin, sex, religion, age, disability, political beliefs, sexual orienta-
tion, or marital or family status. (Not all prohibited bases apply
to all programs.) Persons with disabilities who require alternative
means for communication of program information (Braille, large -^
print, audiotape, etc.) should contact USDA's TARGET Center at
(202) 720-2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of
Civil Rights, Room 326-W, Whitten Building, 1400 Independence
Avenue, SW, Washington, DC 20250-9410 or call (202) 720-5964
(voice and TDD). USDA is an equal opportunity provider and
employer.

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/r-calfstatement.pdf

IF YOU IGNORE THE SPIN, here are some facts;

Working Group Report on

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

CANADA

2004

snip...

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

Geographical BSE Risk of Canada

- 13 -

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

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

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

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

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenges

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

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

INTERACTION OF STABILITY AND EXTERNAL CHALLENGE IN CANADA

Period Stability External Challenge Internal challenge

1980 to 1990 Low Unlikely but not excluded

1991 to 1995 High

1996 to 2000 Extremely high

Likely and rapidly growing

2001 to 2003

Extremely

unstable

Very high Confirmed at a lower level

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

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

July 2000 (as updated in 2002).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

early 90s.

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

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

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

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

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

Geographical BSE Risk of Canada

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

lead to an internal challenge in the early 90s.

4.2 Risk that BSE infectivity entered processing

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

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

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

significantly in the mid 90's when domestic cattle, infected by imported
MBM, reached

processing. Given the low stability of the system, the risk increased
over the years with

continued imports of cattle and MBM from BSE risk countries.

4.3 Risk that BSE infectivity was recycled and propagated

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

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

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

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

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

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

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

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

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

into account.

GBR.

- 14 -

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

present stability and challenge

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

grow, even if no additional external challenges occur.

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

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

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

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

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

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

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

5.3 Recommendations for influencing the future GBR

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

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

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

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

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

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

Geographical BSE Risk of Canada

country.

Acknowledgment

snip...

CANADA

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


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

Publication date: 20 August 2004

Adopted July 2004 (Question N¬į 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 90‚¨"s when
domestic cattle, infected by imported MBM, reached processing. Given the
low stability of the system, the risk increased over the years with
continued imports of cattle and MBM from BSE risk countries.

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

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






Follow Ups:



Post a Followup

Name:
E-mail: (optional)
Subject:

Comments:

Optional Link URL:
Link Title:
Optional Image URL: