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OIE TAHCC meeting October 2006 prior to next CC meeting

flounder

Well-known member
Subject: OIE TAHCC meeting October 2006 prior to next CC meeting March 2007 for consideration in the 75th General Session to be held in May 2007
Date: January 26, 2007 at 12:07 pm PST



Draft written comments of the Community on on the OIE Terrestrial Animal Health Code Commission meeting October 2006 prior to the next Code Commission meeting March 2007 for consideration in the 75th General Session to be held in May 2007


snip...


10. Bovine spongiform encephalopathy

a) Risk assessment recommendations (Appendix 3.8.5.)

Among a substantial number of comments suggesting modifications and better

linkage to Chapter 2.3.13., the Terrestrial Code Commission recognised it should

first address a comment from New Zealand requesting clarification of the purpose of

EN 11 EN

this Appendix in relation to a set of guidelines titled “BSE Questionnaire for country

status recognition” prepared by the Scientific Commission. The OIE has agreed to

conduct procedures to recognise the BSE status of Member Countries. In view of

this, the Terrestrial Code Commission was of the opinion that Appendix 3.8.5. on

factors to consider in conducting BSE risk assessment should be incorporated,

without further review by the Terrestrial Code Commission, into the documents used

for the official OIE categorisation of Member Countries.

Once such guidelines become available to Member Countries on the OIE website or

otherwise, the Terrestrial Code Commission will propose to Member Countries that

current Appendix 3.8.5. be dropped from the Terrestrial Code. It was agreed that any

detailed and very prescriptive documents should not be part of the Terrestrial Code.

b) Bovine spongiform encephalopathy (Chapter 2.3.13.)

Community comments:

The Community welcomes the work done by the Code Commission but strongly opposes

to the modification made related to the production of gelatine and ask the OIE Code

Commission to reconsider its position prior to the General Session in May 2007.

In addition the Community would welcome the OIE Code Commission to consider the

other comments made on the Chapter 2.3.13. of the Terrestrial Animal Health Code.

Some Member Countries requested clarification of the term “imported” appearing in

Article 2.3.13.2. point a) Release assessment. The Terrestrial Code Commission was

of the view that this should be addressed in Chapter 1.3.5. as it is a general

consideration in implementation of zone and compartment.

The Terrestrial Code Commission examined outstanding concerns raised by the EU

and Japan regarding the risk of potentially infected animals present in the age cohorts

born before the risk management measures were enforced. As a result, Articles

2.3.13.6., 2.3.13.7. and 2.3.13.12. were modified.

The Terrestrial Code Commission was informed by the EU that an article from

French scientists (D. Calavas, V. Supervie, E. Morignat, D. Costagliola & C. Ducrot)

has been accepted for publication in the Journal on Risk Analysis and will be

published very soon. This document will provide the scientific rationale for changes

made to the compliance period (i.e. the period of 7 years from the reporting of the

case changed to 11 years from the birth of the case - Article 2.3.13.3. paragraph 3 b).

A Member Country requested to exclude the transverse processes of the thoracic and

lumbar vertebrae and the wings of the sacrum from the definition of the vertebral

column in point 2 of Article 2.3.13.13. The Terrestrial Code Commission did not

adopt this recommendation because it doubted if the proposed definitions would be

universally practicable or enforceable.

EN 12 EN

The Terrestrial Code Commission examined comments from a Member Country

regarding the safety of gelatine irrespective of the origin of source material due to the

safety of the production process. Based on the supporting document and a risk

assessment recently published by the New Zealand Food Safety Authority (NZFSA,

2005, Wellington) and entitled “Officials’ Review of New Zealand’s BSE Country-

Categorisation Measure” (http://www.nzfsa.govt.nz/imported-food/bsecategorisation/

report/index.htm), the Terrestrial Code Commission decided to revise

Article 2.3.13.14. to allow all cattle bones to be used as a source material for the

production of gelatine, provided the cattle have passed ante-mortem and post-mortem

inspections.

The revised chapter, which is presented at Appendix IX, is circulated among

Member Countries for comment.

c) Surveillance for bovine spongiform encephalopathy (Appendix 3.8.4.)

The Terrestrial Code Commission examined comments received from Member

Countries on this Appendix. Noting that some questions remain on the usage of the

full BSurvE model instead of Appendix 3.8.4., the Terrestrial Code Commission


reiterated its intention as follows: Appendix 3.8.4. was developed using a modified

version of the BSurvE model so that it would be easily applicable to any Member

Country. However, the Terrestrial Code Commission does not see any problem in a

Member Country choosing to use the full BSurvE model to estimate its BSE

presence/prevalence. The reason why Appendix 3.8.4. does not make any reference

to the BSurvE model as an alternative method is that the concept of equivalence

underpins all chapters of the Terrestrial Code.

The Terrestrial Code Commission did not adopt country recommendations to modify

descriptions of cattle sub-populations, as those used in the Appendix are consistent

with commonly used terminology. The Terrestrial Code Commission did not adopt a

request to expand Table 1 (Appendix 3.8.4.) to provide a more detailed breakdown of

cattle sub-populations because it considered that additional detail and complexity

would not be helpful. Member Countries wishing to apply a more expanded version

for BSE surveillance can use the BSurvE model.

d) Supporting document

The Terrestrial Code Commission received a fully revised supporting document on

BSE prepared by a group of experts. The document was commissioned to provide

supporting scientific evidence for recent changes made to the chapter on BSE. All

Commission members expressed their sincere appreciation to the experts who

contributed to the drafting of the report.

The supporting document, which is presented at Appendix XXVIII, is circulated

among Member Countries for information.


snip...


http://ec.europa.eu/food/international/organisations/ah_pcad_oie563207_en.pdf




WHAT ABOUT BASE ???




18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...


64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.


http://www.seac.gov.uk/minutes/95.pdf



3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse


Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years. ***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp



SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html




There is a growing number of human CJD cases, and they were presented last
week in San Francisco by Luigi Gambatti(?) from his CJD surveillance
collection.

He estimates that it may be up to 14 or 15 persons which display selectively
SPRPSC and practically no detected RPRPSC proteins.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm



http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf



THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/





CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm





Volume 12, Number 12–December 2006


PERSPECTIVE


On the Question of Sporadic or Atypical Bovine SpongiformEncephalopathy and

Creutzfeldt-Jakob Disease


Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§

Strategies to investigate the possible existence of sporadic

bovine spongiform encephalopathy (BSE) require

systematic testing programs to identify cases in countries

considered to have little or no risk for orally acquired disease,

or to detect a stable occurrence of atypical cases in

countries in which orally acquired disease is disappearing.

To achieve 95% statistical confidence that the prevalence

of sporadic BSE is no greater than 1 per million (i.e., the

annual incidence of sporadic Creutzfeldt-Jakob disease

[CJD] in humans) would require negative tests in 3 million

randomly selected older cattle. A link between BSE and

sporadic CJD has been suggested on the basis of laboratory

studies but is unsupported by epidemiologic observation.

Such a link might yet be established by the discovery

of a specific molecular marker or of particular combinations

of trends over time of typical and atypical BSE and various

subtypes of sporadic CJD, as their numbers are influenced

by a continuation of current public health measures that

exclude high-risk bovine tissues from the animal and

human food chains.


SNIP...


http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e






O.I.E. .......... ??? GOD HELP US!


sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken.

MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS


http://www.oie.int/downld/SC/2005/bse_2005.pdf





THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.


AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country

makes some political hay about trade protocol, commodities and futures.


IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...


Page 95 of 98

8/3/2006

WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO
SRMs ???

a.. BSE OIE

see full text ;

http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic




IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the USDA/APHIS/FSIS/FDA/CDC/NIH

et al for many many years, or the incompetence of these agencies are so inept, either through ignorance and or just too overweight

with industry reps., they then should be all done away with and a single agency brought forth, and if not, how will you correct this

ongoing problem ?


please see full text 98 pages ;




http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf




http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678




http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381





Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf





THE BSE MRR policy is a policy that was implemented and put forth for the sole purpose of commodities and futures,

it was nothing more than a legal tool to trade BSE and other strains of TSE globally, because that is exactly what has taken place.

THERE WAS nothing science based about it. PLUS, the OIE has still failed to access CWD in deer and elk of what the ramifications

will be if and when it is documented as a zoonotic disease. I was told some years ago (5) by an official at OIE that this would

take place soon. still waiting. ...TSS







Rev. sci. tech. Off. int. Epiz., 2006, 25 (1), 83-92

A history of biological disasters

of animal origin in North America


http://www.oie.int/eng/publicat/rt/2501/PDF/06-ackerman83-91.pdf





Risk analysis of prion diseases in animals
Preface

Rev. sci. tech. Off. int. Epiz., 2003, 22 (1), 7-12 pdf

This special issue of the Scientific and Technical Review returns to a topic that was first reviewed by the journal in June 1992, five years after bovine spongiform encephalopathy (BSE) was first described and the same year that the epidemic reached its peak in the United Kingdom (UK). Although the BSE epidemic in the UK and in some other countries of Europe has subsided and entered a protracted elimination stage, the disease has been detected in fourteen other countries and has triggered some unparalleled actions to protect animal and human health. Furthermore, the repercussions of the epidemic continue to be felt throughout the world.

The present review is necessary because the history of BSE is a prime example of how to deal with uncertainty and how control measures are based on the best possible knowledge at a given time. Great advances have been made in the scientific understanding of the transmissible spongiform encephalopathies (TSEs) and prions since 1992 and have led to innovations in the diagnosis and management of these diseases. Rapid diagnostic tests are one example. Progress in the underlying science of the TSEs has been monumental since 1992.

The BSE experience has shown the great value of risk analysis in guiding a rational approach to animal disease control within countries and on the world scene. Risk analysis and the resulting standards of the OIE International Animal Health Code have provided the world with benchmarks for managing the risk of BSE and at the same time maintaining trade. However, risk analysis is not static and must be informed by advances in science in order to ensure topicality, quality and validity.

Hindsight may show whether the control measures flowing from risk analysis were either adequate or inadequate and proportionate or disproportionate in regard to the risks linked to BSE. The abiding lesson from BSE may, however, be the value of risk analysis as an evolving tool for dealing with certainties and uncertainties as knowledge unfolds. One of the functions of the OIE is to ensure that risk analysis and the resulting OIE Code standards do this very thing and can provide a means for harmony on animal health matters throughout the world. The present issue of the Review will provide working material not only for this hindsight but also for foresight in the form of risk assessment.

Bovine spongiform encephalopathy is the archetype for a class of emerging zoonotic diseases that may arise through factors in animal husbandry. Although the effects of the disease on cattle are sufficient alone to make it a major concern, its causal link with variant Creutzfeldt-Jakob disease in people places it on a higher plane of dread and fear compared with virtually every other disease of animals. This causal link was unclear when the Review examined the topic of the TSEs in 1992. Furthermore, BSE has cast a shadow on other contemporary TSEs in animals: scrapie in sheep and chronic wasting disease (CWD) in deer. What exactly are the public health implications from these two diseases?

Deep inroads into confidence about the safety of the human food supply have been created by BSE which has led to a range of food safety laws and policies in various countries. These actions may have been necessary but it must be emphasised that ultimate and decisive control of the public health risk from BSE lies in control measures applied to animals. These control measures will be most effective if they are informed by systematic risk analysis and permanent updating of the Code.

Fear and dread about BSE is said to have reduced confidence about the value of science in dealing problems in the living world. This drop in confidence may be true and the polemics surrounding BSE are unprecedented. Nevertheless, it is worthwhile reflecting upon the dire course of events if sound epidemiological investigations had not occurred in the UK, if a series of experiments to clarify key unknowns had not been initiated, if the weight of the world’s scientific research capacity had not been brought to bear on the problems, if the painstaking processes of risk assessment had not been undertaken and if there had not been well established international forums such as the OIE to co-ordinate international effort and cooperation.

Progress in understanding the complexities of the biology of the TSEs has been astounding since 1992 and has shown the immense value of comparative medicine in action. As a consequence, there is a dawning hope that TSEs could be removed as a problem at some time in the future. The proviso is that current efforts are not relaxed and that the TSEs continue to be treated with the seriousness they deserve. To this end, the OIE will persist with its tasks of guaranteeing the transparency of the animal disease status world-wide, collecting, analysing and disseminating veterinary scientific information, providing expertise and promoting international solidarity for the control of animal diseases and zoonoses, while guaranteeing the sanitary safety of world trade by developing sanitary standards for international trade in animals and animal products.

Bernard Vallat
Director General


http://www.oie.int/eng/publicat/RT/2201/A_R2210.htm




Chronic Wasting Disease

http://chronic-wasting-disease.blogspot.com/




vCJD USA THIRD CASE DOCUMENTED

http://vcjd.blogspot.com/




BSE ATYPICAL USA

http://bse-atypical.blogspot.com/




SCRAPIE USA

http://scrapie-usa.blogspot.com/




vCJD transfusion-asso.Fourth Case UK

http://vcjdtransfusion.blogspot.com/




vCJD case study highlights blood transfusion risk

http://vcjdblood.blogspot.com/




Transmissible Mink Encephalopathy TME

http://transmissible-mink-encephalopathy.blogspot.com/




MADCOW DISEASE USA SPONTANEOUS OR FEED ?

http://madcowspontaneousnot.blogspot.com/




CREUTZFELDT JAKOB DISEASE

http://creutzfeldt-jakob-disease.blogspot.com/





TSS
 

flounder

Well-known member
GAO ON USA BSE 2002

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




GAO 2003


http://www.gao.gov/new.items/d04259t.pdf




http://www.gao.gov/cgi-bin/getrpt?GAO-04-588T




* 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







2004

U.S. Department of Agriculture

Office of Inspector General

Great Plains Region

Audit Report

Animal and Plant Health Inspection Service

and

Food Safety and Inspection Service

Bovine Spongiform Encephalopathy (BSE)

Surveillance Program - Phase I


Executive Summary


Report No. 50601-9-KC

August 2004


Animal and Plant Health Inspection Service and Food Safety and Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase I

Results in Brief Since 1990, the U.S. Department of Agriculture’s (USDA) Animal and Plant

Health Inspection Service (APHIS) has led an interagency effort to monitor

Bovine Spongiform Encephalopathy (BSE), widely known as “mad cow

disease.” Central to this effort was the testing of cattle in a high-risk

category—those that exhibited a disorder in their central nervous systems

(CNS), such as difficulty standing, walking, etc., and cattle that died on the

farm from unclear causes. With the discovery of a BSE-infected animal in

December 2003, APHIS determined to expand its surveillance program to

test a larger number of high-risk animals. The goal of the program before

2004 had been to test 12,500 animals per year; under the expanded program,

the goal extends to over 200,000 animals to be tested in a 12 to 18 month

period.

The objectives of our audit were to determine whether the surveillance

program in place at the time of the December 2003 discovery of BSE was

adequately implemented and whether the expanded program will accomplish

its stated goal—to determine if “…BSE is actually present in the population

and if so, at what level.”

This is the first in a series of reports we are planning to issue on our

evaluation of USDA’s BSE surveillance activities. We could not fully

evaluate the first objective due to the absence of adequate documentation (see

General Comments Section) to support the basis for USDA’s BSE

surveillance plan prior to the discovery of the BSE-infected cow. Our

evaluation of the second objective was limited because the design and

implementation of the BSE surveillance program is still in a state of flux.

However, where possible, we assessed documents provided to us and

interviewed USDA personnel so that we could provide USDA with

recommendations on potential concerns and issues as it moves forward with

implementation.

USDA’s expanded surveillance program is based largely on a broadened plan

of sampling. This sampling plan has been announced as scientifically based

and representative of the population of U.S. cattle as a whole. However, we

concluded that several limitations inherent in the sampling plan need to be

clarified so that industry, the public, and U.S. trading partners understand

what the results of the testing actually imply.

• Sampling is not truly random because participation in the program is

voluntary. The BSE sampling plan, as designed, assumes each animal

USDA/OIG-A/50601-9-KC Page ii

has the same chance of being selected for BSE testing, which will not be

true if testing is voluntary. APHIS has the authority to collect samples,

but it has chosen not to exercise this authority, except at

federally-inspected slaughter facilities.

• Discovery of BSE cases will result in a statistical projection with either a

significantly lower confidence level or a significantly higher maximum

BSE prevalence level. By not discussing this, the plan’s statistical

statements may inadvertently overemphasize the implied “best-case

scenario.”

• As the plan is currently designed, APHIS cannot obtain a statistically

appropriate geographical representation of the U.S. cattle population.

Because the program is voluntary and the universe of high-risk cattle is

difficult to identify, obtain, and test, the surveillance plan needs to be

clarified and its conclusions relating to the prevalence of BSE may need

to be qualified.

• APHIS’ sampling plan assumes BSE is confined to the high-risk cattle

population; other studies show that healthy-looking animals may also

have BSE.

• APHIS’ plan to test 20,000 clinically normal cattle may give the incorrect

impression that these few tests will suggest a level of assurance higher

than warranted about the 45 million adult cattle in the United States.1

• APHIS cannot easily identify, obtain, or test cattle in its high-risk

population; therefore, the chances of detecting BSE, if it exists, may be

reduced and the projected maximum BSE prevalence rate may be

unreliable.

APHIS needs to fully disclose the assumptions that it made in designing its

sampling plan, and it needs to clarify the limitations that exist in the data it

will collect. Beyond its sampling design, however, lie significant challenges

for APHIS in its goal to determine if BSE exists in the United States at a

prevalence of at least one case per 10 million adult cattle. These

challenges—in identifying and testing the high-risk population of cattle—

were inherent in the operations of the surveillance program as it had been

conducted prior to June 2004, and still exist under the expanded program.

Cattle condemned at slaughter plants for CNS symptoms were not

always tested for BSE. This occurred because of confusion in testing

requirements and lack of coordination between APHIS and the agency

1 National Agricultural Statistics Service, Agricultural Statistics 2003, per Table 7-2 for 2002, 44,474,000

(equals 33,118,000 beef cows plus 9,112,000 milk cows plus 2,244,000 bulls).

USDA/OIG-A/50601-9-KC Page iii

that condemns cattle at slaughtering plants, the Food Safety and

Inspection Service (FSIS). Of the 680 cattle FSIS condemned for CNS

symptoms between fiscal years (FY) 2002 and 2004 (through

February 2004), we could validate that only 162 were tested for BSE.

USDA needs to increase testing of rabies-negative brain samples.

Rabies cases exhibit clinical signs not inconsistent with BSE, and a

negative rabies test means the cause of the cow’s disorder has not been

diagnosed. Nevertheless, this high priority population has not been

adequately pursued for BSE testing. Public health and State veterinary

diagnostic laboratories did not always submit rabies-negative samples for

BSE testing because there was no formal mechanism in place to ensure

the submissions.

A process for obtaining samples from animals that “died on the

farm” has not been developed. These samples are important because the

high-risk animals that die on the farm comprise the largest component of

the targeted high-risk population and the most difficult to identify,

obtain, and test. Identifying truly high-risk cattle that die on the farm

may be complicated by the reluctance of producers to submit them for

testing and the motivation to mischaracterize low-risk carcasses as “high

risk” since only the latter may qualify for reimbursement.

The age requirement for BSE testing should be standardized to prevent

confusion. Current testing guidance contains inconsistent age criteria for

testing cattle for BSE. Some documents emphasize testing of livestock

at 20 months of age, some at 24 months of age, and at least one—the

APHIS Surveillance Plan of March 2004—over 30 months of age. This

confusion has created and will continue to create a potential that some

cattle may not be subject to BSE testing.

We are recommending that APHIS implement management controls to

ensure that all high-risk animals, including those that test negative for rabies,

those condemned for CNS symptoms, and those that die on the farm from

unknown causes are sampled and tested in accordance with USDA policy and

the 2004 Surveillance Plan.

In reviewing APHIS’ management of the BSE surveillance program, we also

noted some areas of concern in program administration. Most critically, we

found that stronger controls were needed over the collection of test samples

and the recording of test information. We found cases in which test samplers

submitted nonviable samples and provided inaccurate or incomplete

information on their submission forms. We found other cases in which some

animals that had been tested for such non-high-risk symptoms as diarrhea and

inner ear infection were included in APHIS’ count of samples for the purpose

of meeting surveillance goals. Some information maintained in the

USDA/OIG-A/50601-9-KC Page iv

surveillance program’s database was the result of misentries. This database

was the source of APHIS’ reports on surveillance achievements.

We are recommending that APHIS expedite its development of a new

management information system to track and report its accomplishments

under the expanded surveillance program. We are also recommending that

APHIS implement performance measures and a continuous risk assessment to

enhance its management of the surveillance program and better assess the

program’s effectiveness.

Finally, we noted that, prior to June 1, 2004, APHIS did not have standard

written agreements in place to ensure consistent performance from

non-Federal laboratories and reasonable arrangements and charges from meat

plants and contractors who provide sampling services. Use of these entities

will increase as the 2004 surveillance program expands. Past arrangements

with meat plants and sampling contractors were made on a regional basis,

were sometimes informal, and resulted in costs ranging from $0 to $100 per

sample taken. We concluded that APHIS should impose a standardized

contract specifying the quality of work required and the costs the

Government is willing to incur for it.

The problems disclosed during our review, if not corrected, may negatively

impact the effectiveness of USDA’s overall BSE surveillance program,

impair its ability to perform risk assessments and program evaluations, and

reduce the credibility of any assertion regarding the prevalence of BSE in the

United States. These are complex challenges USDA needs to address as it

moves forward with implementation of its expanded BSE surveillance

program.

This audit was coordinated with the Office of Inspector General’s (OIG)

Investigations Division. OIG conducted two investigations to determine

whether employees of USDA and/or of the slaughter establishment misled or

provided false information concerning the identification of the BSE-positive

cow. In addition, OIG verified the procedures used by USDA and the

slaughter establishment to maintain the integrity of the brain tissue sample

from the slaughter establishment through delivery to the National Veterinary

Services Laboratories (NVSL) in Ames, Iowa. OIG also investigated the

circumstances surrounding the animal displaying possible CNS symptoms

that had not been tested in Texas. The results of these investigations will be

reported under separate cover.


Recommendations

In Brief We are recommending that APHIS fully disclose the assumptions that it

made in designing its sampling plan, and that it clarify the limitations that

exist in the data it will collect. We are also recommending that APHIS

implement management controls to ensure that all high-risk animals,

USDA/OIG-A/50601-9-KC Page v


snip...full text




http://www.usda.gov/oig/webdocs/50601-9-final.pdf





Audit Report

Animal and Plant Health Inspection Service

Oversight of the Importation

of Beef Products from Canada


Report No. 33601-01-Hy February 2005 UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL Washington D.C. 20250

DATE: February 14, 2005

REPLY TO

ATTN OF: 33601-01-Hy

SUBJECT: Oversight of the Importation of Beef Products from Canada

TO: W. Ron DeHaven

Administrator

Animal and Plant Health Inspection Service

Barbara J. Masters

Acting Administrator

Food Safety and Inspection Service

ATTN: William J. Hudnall

Deputy Administrator

Marketing and Regulatory Programs – Business Services

Ronald F. Hicks

Assistant Administrator

Office of Program Evaluation, Enforcement and Review

This report presents the results of our audit of oversight of the importation of beef products from Canada. Your response to the draft, dated February 9, 2005, is included as exhibit A. Excerpts of your response and the Office of Inspector General’s (OIG) position are incorporated into the Findings and Recommendations section of the report. Based on your response, management decision has been reached on all recommendations except No. 3. Please follow your agency’s internal procedures in forwarding documentation for final action to the Office of the Chief Financial Officer. Management decisions for the remaining recommendation can be reached once you have provided the additional information outlined in the report section OIG Position.

In accordance with Departmental Regulation 1720-1, please furnish a reply within 60 days describing the corrective actions taken or planned, and the timeframes for implementation of the remaining recommendation. Please note that the regulation requires management decision to be reached on all recommendations within 6 months of report issuance

/s/

ROBERT W. YOUNG

Assistant Inspector General

for Audit

USDA/OIG-A/33601-01-Hy Page i

Executive Summary

Animal and Plant Health Inspection Service’s Oversight of the Importation of Beef Products from Canada (Audit Report No. 33601-01-Hy)



Results in Brief This report presents the results of the Office of Inspector General’s (OIG) audit of the Animal and Plant Health Inspection Service’s (APHIS) oversight of the importation of beef products from Canada following the detection of a Canadian cow with bovine spongiform encephalopathy (BSE) in May 2003. In June 2004, we initiated several actions in response to concerns raised by four U.S. Senators that the U.S. Department of Agriculture (USDA) did not follow appropriate safety measures, beginning sometime in the fall of 2003, in allowing expanded Canadian beef imports into the United States. We reviewed USDA’s actions pertaining to the importation of Canadian products, including the use of risk mitigation1 measures.

On May 20, 2003, the Secretary halted imports of live cattle, other live ruminants, beef, and other ruminant products from Canada after a cow in Alberta was found to have BSE. Prior to this time, there was a free flow of trade between the United States and Canada for live cattle and beef. Due to the serious impact on trade, USDA officials sought a method to allow limited imports from Canada and determined to use the APHIS permit process as a vehicle to facilitate trade. At that time, APHIS did not have a history of issuing permits for the importation of edible meat and meat products. Veterinary import permits were generally issued for items derived from animals, such as blood, cells or cell lines, hormones, and microorganisms including bacteria, viruses, protozoa, and fungi.

On August 8, 2003, the Secretary of Agriculture (Secretary) announced a list of low-risk products, including boneless beef from cattle less than 30 months of age and veal meat from calves less than 36 weeks of age, which would be allowed into the United States from Canada, under certain predetermined conditions. In November 2003, USDA published a proposed rule in the Federal Register to create a low-risk category for countries with BSE, to place Canada on that list, and to allow imports of, among other things, low-risk beef products and live cattle under 30 months of age to resume. This rule for live animals and processed meat products was issued January 4, 2005.

The Secretary’s announcement on August 8, 2003, regarding low-risk products followed USDA’s review of the results of Canada’s epidemiological investigation into the detection of BSE in that country. Based on the results

1 Risk mitigations include such actions as certificates indicating the product is pure liver, Canadian Food Inspection Agency (CFIA) verification that calves were 36 weeks of age or less when slaughtered, and CFIA verification that animals are not known to have been fed prohibited products during their lifetime.

USDA/OIG-A/33601-01-Hy Page ii

of the investigation, as well as international guidelines2 that indicated that products derived from young animals do not pose a risk to human health, USDA issued permits to allow these low-risk products into the United States.

Subsequent to the Secretary’s announcement, APHIS issued 1,155 permits3 allowing the import of a variety of products from Canada, to include many items that had been included in the Secretary’s announcement as well as other items that were not initially identified as allowable low-risk products. In April 2004, a lawsuit was filed in U.S. District Court in Montana, which resulted in a temporary restraining order that identified the specific low-risk Canadian products that were eligible for import into the United States. The list of low-risk products was the same as the list posted on August 15, 2003, by APHIS on its website as a clarification of the Secretary’s August 8, 2003, announcement. On May 5, 2004, the District Court converted the temporary restraining order into a preliminary injunction. Among other things, the preliminary injunction included an exhibit listing the specific Canadian products that would be considered low-risk and details of required risk mitigations.

To accomplish our review of USDA’s actions pertaining to the importation of Canadian products, we interviewed officials from APHIS, the Food Safety and Inspection Service (FSIS), and the Office of the General Counsel (OGC). We analyzed APHIS records relating to the oversight of imported Canadian product, to include a review of the 1,155 import permits and associated documentation. We met with personnel from the U.S. Department of Homeland Security’s Customs and Border Protection (CBP) in Detroit, Michigan and Sweetgrass, Montana to understand their actions to enforce restrictions on the importation of ruminant products from Canada. We also visited FSIS import reinspection facilities located in Buffalo, New York; Detroit, Michigan; and Sweetgrass, Montana. At these facilities, we analyzed documentation on file for 12,427 shipments of ruminant products to determine whether the product imported from Canada met APHIS requirements. These facilities reinspected more than 646 million of the 802 million pounds of Canadian product presented for entry into the United States between September 2003 and September 2004.

From August 2003 to April 2004, APHIS officials allowed a gradual expansion in the types of Canadian beef products approved for import into the United States. The expansions in product type included processed products, bone-in product, and edible bovine tongues, hearts, kidneys, and lips. In October 2003, APHIS allowed bovine tongues despite the APHIS Transmissible Spongiform Encephalopathy (TSE) Working Group4

2 The International Office of Epizootics, the international standard-setting organization for animal health, established these guidelines.

3 As of September 16, 2004.

4 Created by APHIS to analyze risks of BSE to the United States, disseminate accurate information about TSEs, and act as a reference source for responding to questions about TSEs.

USDA/OIG-A/33601-01-Hy Page iii

conclusion in June 2003 that fresh or frozen bovine tongues were "moderate risk" products,5 even when the required risk mitigations were in place. Thus, bovine tongues, one of the items for which APHIS approved import permits, were deemed as posing a "moderate risk," and not a "low risk" by the APHIS TSE Working Group.

The Chairperson of the TSE Working Group explained that the risk status for bovine tongues changed from moderate to low some time between June and November 2003, although the change was not documented prior to the November 2003 issuance of APHIS’ "Risk Analysis: BSE Risk from Importation of Designated Ruminants and Ruminant Products from Canada into the United States." The risk analysis categorized bovine tongues as eligible product when Canadian inspection officials verify the risk mitigation, which is that tonsils are removed.

Additionally, APHIS allowed an expansion in the type of Canadian facilities that would be allowed to produce items for export to the United States. The gradual expansion occurred because the agency employees tasked with administering the permit process did not consider the initial announcement made by the Secretary to exclude products similar to those on the published list of low-risk products, if APHIS had concluded that the products posed similar risk levels. However, APHIS did not develop documentation to support the agency’s conclusions that the additional products were low-risk products. APHIS also did not have a review structure or other monitoring process in place to identify discrepancies between publicly stated policy and agency practice. According to APHIS officials, they considered the initial announcement made by the Secretary to be part of an effort to demonstrate to the world that such trade with Canada was safe and appropriate. Accordingly, they allowed the import of products they considered low risk in an attempt to further that greater effort. However, APHIS did not document the process it used to determine the additional products were low risk.

As a result of the "permit creep" that occurred between August 2003 and April 2004, APHIS issued permits for the import of beef tongue as well as other permits for products with questionable eligibility. Further, the agency allowed the import of products from Canadian facilities that produced both eligible and ineligible products, thus increasing the possibility that higher-risk product could be inadvertently exported to the United States. This practice contrasted with APHIS’ publicly stated policy that only Canadian facilities that limited production to eligible products would be allowed to ship to the United States. In addition, APHIS did not

5 "Recommendations of APHIS TSE Working Group for allowing certain commodities from Canada to be imported into the United States," dated June 16, 2003. When required risk mitigation measures are in place, to include various CFIA verifications, removal of tonsils, and random sample analysis by USDA of any suspicious tissue to confirm absence of specified risk materials, fresh and frozen bovine tongues have a "moderate" risk.

USDA/OIG-A/33601-01-Hy Page iv

communicate its decisions to all interested parties and USDA was criticized by segments of the public, the cattle industry, and the U.S. Congress.

APHIS issued permits to allow the import of beef cheek meat with questionable eligibility because the agency did not establish a clear working definition for the general term "boneless beef." Instead of coordinating with FSIS, APHIS reviewers relied upon their own understanding of the term. Some APHIS reviewers considered the term "boneless beef" broadly, to mean any bovine meat that did not contain a bone. Thus, some applicants who requested permits to import beef cheek meat and other products received permits allowing the import of "boneless beef or boneless beef trim." As a result, over 63,000 pounds of beef cheek meat with questionable eligibility entered U.S. commerce from Canada.

Further, we found that FSIS did not always communicate effectively about the eligibility status of beef cheek meat. FSIS distributed information to its import inspectors by way of a series of numbered memoranda, titled Part 4, Canada, BSE Restrictions, Revision 2 through Revision 11. Some of the issuances were supplemented by additional guidance, in the form of supplemental memoranda. However, in our opinion, FSIS managers did not ensure consistent interpretation of the provisions of the various memoranda, a factor that contributed to the entry of the previously mentioned 63,000 pounds of beef cheek meat with questionable eligibility. Because APHIS changed its instructions to FSIS frequently and did not document the direction provided to FSIS,6 it was even more difficult for FSIS to keep its field staff fully apprised of the status of product eligibility.

FSIS officials did not agree that the import inspectors misinterpreted the instructions in the numbered memoranda. Furthermore, FSIS officials asserted that the 63,000 pounds of beef cheek meat was eligible for import when it was imported from April to June 2004. However, they agreed that controls should be strengthened to better communicate the eligibility of product that frequently changed as beef cheeks did from August 2003 to July 2004. Two FSIS import inspectors we interviewed advised us that beef cheeks had been "going back and forth" regarding eligibility. APHIS notified FSIS that effective July 20, 2004, beef cheek meat was not an eligible product for import into the United States. According to APHIS direction, beef cheek meat has not been eligible for import since July 20, 2004. As of the date of this report, it is still not eligible for import. Some FSIS officials assert that the beef cheek meat was eligible product. In contrast, the APHIS National Incident Commander for BSE Enhanced Surveillance stated in an August 18, 2004 interview, that further discussion was still required with respect to the import of cheek meat and that no new

6 We found that APHIS did not document its direction to FSIS prior to April 2004 when the Ranchers-Cattlemen Action Legal Fund (R-CALF) filed a lawsuit against USDA in U.S. District Court in Montana.

scientific information on this topic had been considered by APHIS. Given the importance of the issues, ongoing litigation, and differences in scientific opinion, it would have been prudent for APHIS to write down its decisions about the eligibility status of beef cheek meat at points in time. However, the agency did not do so; or did not retain such documentation for our review.

In January 2005, FSIS assessed the shipments of beef check meat and concluded, "FSIS has no reason to believe that these four shipments7 of beef cheek meat are injurious to health." In its assessment, FSIS explained that in January 2004, the agency implemented interim final rules that prohibited the use of specified risk materials for human food. On the matter of beef cheek meat, the FSIS rule maintained that beef cheeks are not part of the skull, which is a specified risk material. The FSIS rule continued to allow the use of beef cheek meat for human food, provided that the meat is not contaminated with specified risk materials. FSIS further supported its conclusion on the basis that Canada had a pre-existing equivalent specified risk material system in place. However, as previously noted, beef cheek meat is not a product that is currently eligible to be imported into the United States.

APHIS issued 1,155 permits for the importation of ruminant products from Canada without ensuring that the agency had an appropriate system of internal controls to manage the process. The APHIS permit system was originally designed to allow for the import of research quantities (generally small amounts) of material into the United States. According to APHIS officials, this permit system handled approximately 400 permit requests annually. The procedures that APHIS had developed for handling permit requests for small amounts of product were not adequate to deal with the high volume of requests for large quantities of commercial use beef. The agency did not implement or finalize standard operating procedures for processing the large volume of permits. For example, APHIS did not establish controls to ensure that risk mitigation measures were consistently applied. We found that 8 of the 83 permits issued for bovine liver did not include the risk mitigation measure that the livers be from animals slaughtered after August 8, 2003.8 We also found that APHIS did not implement requirements to perform onsite monitoring of permit holders, Canadian facilities, or inspection personnel9 at U.S. ports of entry. As a result, there was reduced assurance that Canadian beef entering the United States was low-risk. Some product with questionable eligibility, as described above, entered U.S. commerce. ...snip...full text;


http://www.usda.gov/oig/webdocs/33601-01-HY.pdf




February 2005

MAD COW DISEASE

FDA’s Management of the Feed Ban Has

Improved, but Oversight Weaknesses

Continue to Limit Program Effectiveness

FDA has made needed improvements to its management and oversight of the

feed-ban rule in response to GAO’s 2002 report, but program weaknesses

continue to limit the effectiveness of the ban and place U.S. cattle at risk of

spreading BSE. Improvements made include FDA establishing a uniform

method of conducting compliance inspections and training FDA inspectors,

as well as state inspectors who carry out inspections under agreements with

FDA, on the new method. FDA also implemented new data-entry procedures

that are designed to more reliably track feed-ban inspection results.

Consequently, FDA has a better management tool for overseeing compliance

with the feed-ban rule and a data system that better conforms to standard

database management practices. However, various program weaknesses

continue to undermine the nation’s firewall against BSE. For example:

• FDA acknowledges that there are more feed manufacturers and

transporters, on-farm mixers, and other feed industry businesses that are

subject to the feed ban than the approximately 14,800 firms inspected to

date; however, it has no uniform approach for identifying additional

firms.

• FDA has not reinspected approximately 2,800, or about 19 percent, of

those businesses, in 5 or more years; several hundred are potentially

high risk. FDA does not know whether those businesses now use

prohibited material in their feed.

• FDA’s feed-ban inspection guidance does not include instructions to

routinely sample cattle feed to test for potentially prohibited material as

part of the compliance inspection. Instead, it includes guidance for

inspectors to visually examine facilities and equipment and review

invoices and other documents.

• Feed intended for export is not required to carry a caution label “Do not

feed to cattle or other ruminants,” when the label would be required if

the feed were sold domestically. Without that statement, feed containing

prohibited material could be inadvertently or intentionally diverted back

to U.S. cattle or given to foreign cattle.

• FDA has not always alerted USDA and states when it learned that cattle

may have been given feed that contained prohibited material. This lapse

has been occurring even though FDA’s guidance calls for such

communication.

• Although research suggests that cattle can get BSE from ingesting even a

small amount of infected material, inspectors do not routinely inspect or

review cleanout procedures for vehicles used to haul cattle feed.


http://www.gao.gov/highlights/d05101high.pdf




FULL TEXT;


http://www.gao.gov/new.items/d05101.pdf



BSE – An Emerging Issue: With the discovery of a BSE-infected cow in Washington State in

December 2003, the Department faces another challenge in food safety, as well as the related

impact on the health of the U.S. cattle population. OIG recently completed audit and

investigative reviews focusing on the BSE surveillance program’s purposes, objectives, policies,

procedures, and related management controls. During the audit we found the following

challenges in identifying, obtaining, and testing cattle in the high-risk population: cattle

condemned at slaughter were not always tested for BSE; there was no formal process for testing

rabies-negative samples for BSE; a process for obtaining samples from animals that “died on the

farm” has not been developed; and confusion may arise regarding non-standardized age

requirements for BSE.

Our investigation of the BSE-positive cow in Washington State did reveal procedural errors and

inconsistent descriptions that gave rise to some of the public concerns that the identification of

the BSE-positive cow may have been mishandled. We also investigated the cow identified as

having Central Nervous System (CNS) symptoms by an FSIS veterinarian in Texas that was not

tested for BSE after it had been slaughtered. Evidence shows that at the time of this incident,

communication problems occurred between the APHIS and FSIS employees involved. Taken

together, the statements of both APHIS and FSIS personnel and other evidence indicate

inconsistencies in their understanding of procedures for BSE tissue sampling of CNS suspect

cattle in certain circumstances, and the handling of the carcass pending test results.

Page 6

ACTION NEEDED TO ADDRESS THE CHALLENGE: FSIS needs to identify

management controls for all levels of the organization in monitoring HACCP, improving recall

activities, and completing an in-depth assessment of the organizational and control structure over

the imported meat and poultry process. FSIS has issued new or updated directives, which will

provide enhancements; however, the directives have not always been responsive to specific OIG

recommendations or provided enough detail for OIG to determine what will actually be

implemented.

For BSE, the Department needs to have a supportable methodology for assessing the

effectiveness of its overall surveillance program. A supportable methodology is essential to

provide credibility for any USDA assertion regarding the prevalence of BSE in the United States.

Also, performance measures and continuous risk analyses are needed to better target limited

resources and assess whether all program participants are fulfilling their respective roles and

responsibilities.




http://www.usda.gov/oig/webdocs/Management%20Challenges%20Final%20083004.pdf



HERE's what old stan the man had to say about it in Congressional Testimony


''DAMNING TESTIMONY'' ...TSS


Senator Michael Machado from California

''USDA does not know what's going on''.
''USDA is protecting the industry''.
''SHOULD the state of California step in''

Stanley Prusiner

''nobody has ever ask us to comment''

''they don't want us to comment''

''they never ask''

i tried to see Venemon, after Candian cow was discovered with BSE.
went to see lyle. after talking with him... absolute ignorance... then
thought i
should see Venemon... it was clear his entire policy was to get cattle
bonless beef prods
across the border... nothing else mattered...
his aids confirmed this... 5 times i tried to see Venemon, never worked...
eventually met with carl rove the political... he is the one that
arranged meeting
with Venemon... just trying to give you a sense of the distance... healh
public safety...
was never contacted...
yes i believe that prions are bad to eat and you can die from them...END

Dr. Stan bashing Ann Veneman - 3 minutes

http://maddeer.org/video/embedded/08snip.ram




Senator Michael Machado from California

''USDA does not know what's going on''.
''USDA is protecting the industry''.
''SHOULD the state of California step in''


http://maddeer.org/video/embedded/machado.html



THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/



CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm



PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."





18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...


64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.
Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a
mouse model it was possible to alleviate the pathological changes of prion
disease by suppressing expression of the prion protein gene after infection.


http://www.seac.gov.uk/minutes/95.pdf




3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the Exhibit
Hall


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse


Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years. ***These results indicate that BASE is
transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.

6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp





Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006


snip...



USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.


snip...


Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a B
 

flounder

Well-known member
Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE. Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the “gold standard.” Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols. However, OIG obtained evidence that indicated additional testing was prudent to ensure that USDA’s testing protocols were effective in detecting BSE and that confidence in USDA’s testing procedures was maintained. OIG came to this conclusion because the rapid tests produced six high positive reactive results, confirmatory testing conflicted with the rapid test results, and various standard operating procedures were not followed. Also, our review of scientific literature, other country protocols, as well as discussions with internationally recognized experts led us to conclude that confirmatory testing should not be limited when conflicting test results are obtained. To maintain objectivity and independence in our assessment, we requested the USDA Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue.

immunoblot.45 ARS performed the test at the National Animal Disease Center because NVSL did not have the necessary equipment46 (ultracentrifuge) to do the test. APHIS scientists observed and participated, as appropriate, in this effort. The additional tests conducted by ARS produced positive results. To confirm this finding, the Secretary requested the internationally recognized BSE reference laboratory in Weybridge, England, (Weybridge) to perform additional confirmatory testing. Weybridge conducted various tests, including their own IHC methods, as well as three Western blot methods. The tests confirmed that the suspect cow was infected with BSE. Also, Weybridge confirmed this case as an unequivocal positive case of BSE on the basis of IHC. As a result of this finding, the Secretary immediately directed USDA scientists to work with international experts to develop a new protocol that includes performing dual confirmatory tests in the event of another inconclusive BSE screening test. Finding 3 Rigid Protocols Reduced the Likelihood BSE Could be Detected APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE. APHIS Declares BSE Sample Negative Despite Conflicting Results When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted 45 The OIE SAF immunoblot is an internationally recognized confirmatory test, often referred to as a Western blot test. There are different types of Western blots; the OIE SAF immunoblot includes enrichment steps taken with the sample prior to the standard Western blot steps. 46 APHIS has now ordered the necessary equipment for NVSL. USDA/OIG-A/50601-10-KC Page 32

47 A positive control is a sample that is known to contain a given disease or react in the test. The sample then can be used to make sure that the test for that disease works properly. In the case of BSE, tissue infected with either scrapie or BSE can serve as a positive control for an IHC test for BSE since both are different forms of the same disease (transmissible spongiform encephalopathy or TSE).

another IHC test using BSE as a positive control.48 The test result was also interpreted as negative. Also, according to the NVSL scientists, the histological examination of the tissue did not detect lesions consistent with BSE. After the second negative IHC test, NVSL scientists supported doing additional testing. They prepared a plan for additional tests; if those tests had been conducted, BSE may have been detected in the sample. The additional tests recommended by NVSL scientists, but not approved by APHIS Headquarters officials, were the IHC using other antibodies (IHC testing using different antibodies ultimately produced positive results); IHC testing of additional regions of the brain (the cerebellum tested positive); regular and enriched (OIE-like) Western blots (the obex and cerebellum tested positive); and variable rapid tests (the obex and cerebellum tested positive with two different rapid tests). NVSL officials also recommended that the sample be sent to Weybridge for confirmatory testing (to conduct IHC and OIE Western blot tests). In June 2005, Weybridge conducted IHC testing with three different antibodies, including the antibody used in the United States (tested positive), the OIE Western blot (tested positive), a modified commercial kit Western blot (negative) and the NaPTA49 Western blot (tested positive). We obtained information as to the differing protocols used by other countries. We found that while APHIS determined that additional testing was unnecessary after the IHC test, other countries have used multiple tests to confirm positives. In Japan, for example, all reactive screening test samples are examined by both IHC and a Western blot (different from the OIE SAF immunoblot). In the United Kingdom (U.K.), IHC and Western blot (different from the OIE SAF immunoblot) tests are used for all animals that test positive with a screening test. When IHC and the Western blot fail to confirm a positive rapid test, the U.K. resorts to a third test, the OIE SAF immunoblot. With these procedures in place, both Japan and the U.K. have found BSE cases that were rapid test reactive, IHC negative, and finally confirmed positive with a Western blot. Evidence Indicated Additional Testing Would Be Prudent We also spoke with an internationally recognized BSE expert regarding the advisability of limiting confirmatory testing when conflicting results are obtained. This official expressed concern about limiting confirmatory tests to the IHC despite its status as one of the “gold standard” tests. He advised that the IHC is not one test; it is a test method that can vary significantly in sensitivity from laboratory to laboratory. New antibodies can improve or

USDA/OIG-A/50601-10-KC Page 33

48 The NVSL uses scrapie as the positive control as part of its normal IHC testing procedures. Due to the conflicting results between the ELISA and IHC tests, the NVSL conducted another IHC test with BSE as the positive control. Subsequently, the NVSL modified the Confirming Inconclusive Results from BSE Testing Laboratories at the NVSL SOP to show that all IHC tested BSE inconclusive samples from contract laboratories will use BSE as the positive control. 49 Sodium phosphotungstic acid.

USDA/OIG-A/50601-10-KC Page 34

reduce sensitivity, as can variations in many of the reagents50 used. He explained that his laboratory had experienced cases where an initial confirmatory IHC test was challenged by either a more extensive IHC test or “…applying a more sensitive immunoblot.” He emphasized the importance of having additional confirmatory testing to resolve discrepant results since there are many variables, and most of the variability appears to be due to test performance of the laboratory. OIG became concerned that APHIS relied on its confirmatory test methods when rapid screening tests produced high positive reactive results six times.51 Also, we found that APHIS did not pursue and/or investigate why the ELISA produced high reactive positives. An official from the manufacturer of the ELISA test kit told us that they requested, but did not receive, information on the inconclusive reported by USDA in November 2004. These officials requested this information in order to understand the reasons for the discrepant results. The Bio-Rad ELISA rapid screening test is internationally recognized as a highly reliable test and is the rapid screening test used for USDA’s surveillance effort. According to APHIS officials, they felt it would be inappropriate to collaborate on the one sample because Bio-Rad is a USDA-APHIS regulated biologics company and only one of several competing manufacturers. To maintain confidence in USDA’s test protocols, it would have been a prudent course of action for USDA to determine why such significant differing results were obtained. The fact that they did not pursue this matter caused concerns relating to testing quality assurance procedures. In this regard, we found lack of compliance with SOPs relating to laboratory proficiency and quality assurance (see Finding 4), and, in this case, the storage of sampled material and reporting of test results. We found that the NVSL did not prepare a report to document its confirmatory testing of the November 2004 sample. The SOP52 states that the BSE network laboratory initiating the inconclusive will receive a report of the case. NVSL officials could not explain why a final report had not been prepared. We also found that the inconclusive sample was frozen prior to IHC confirmatory testing. APHIS protocols state that samples are not to be frozen prior to laboratory submission. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals states that the tissues for histological or IHC examination are not to be frozen as this will provide artefactual53 lesions that may compromise the identification of vacuolation,54 and/or target site location. Although the sample was frozen, APHIS did not conduct a Western 50 A substance used in a chemical reaction to detect, measure, examine, or produce other substances. 51 The six high positive reactive results were from three tests of the submitted sample (multiple runs of the same test). 52 Confirming Inconclusive Results from Bovine Spongiform Encephalopathy Testing Laboratories at the NVSL SOP, dated August 13, 2004. 53 A structure or feature not normally present but visible as a result of an external agent or action, such as one seen in a microscopic specimen after fixation. 54 A small space or cavity in a tissue.

USDA/OIG-A/50601-10-KC Page 35

blot test on the sample. An NVSL official said freezing the sample does not make it unsuitable for IHC. APHIS determined that the sample was suitable for IHC and therefore, in accordance with its SOP, did not conduct a Western blot test. APHIS also handled the December 2003 BSE positive differently than the November 2004 sample. For the December 2003 BSE positive sample, APHIS conducted several confirmatory tests in addition to the IHC testing and histological examination (unlike the November 2004 sample tests, both of these were interpreted as positive). ARS performed two Western blots (Prionics Check Western blot and an ARS developed Western blot). When we questioned why the samples were handled differently, APHIS officials stated that the Western blots were done because the IHC in December 2003 was positive. The additional testing was done to further characterize the case, because it was the first U.S. case; the additional testing was not done to decide whether the case was positive or negative. We discussed our concerns with limiting confirmatory testing, particularly given conflicting results, with the APHIS Administrator and staff in May 2005. He explained that international standards recognized more than one “gold standard” test. In setting up its testing protocols, USDA had chosen one as the confirming test, the IHC test, and stayed with it. APHIS protocols only allow a Western blot in cases where the sample has become unsuitable for IHC tests (e.g., in cases where the brainstem architecture is not evident). International standards, he continued, accept a tissue sample as negative for BSE if its IHC test is negative. Once the test is run in accordance with protocols, additional tests undermine the USDA testing protocol and the surveillance program. He concluded that since APHIS’ protocols accepted the IHC test as confirming the presence or absence of BSE, no further testing was necessary. According to protocol, the tissue sample was determined to have tested negative for BSE. On June 24, 2005, USDA announced that the additional testing by the BSE reference laboratory in England confirmed the presence of BSE in the tissue sample. To obviate the possibility that a future sample would be declared negative and then found positive, the Secretary of Agriculture announced a change to APHIS’ testing protocols that same day. He called for “dual confirmatory tests in the event of another ‘inconclusive’ [reactive] BSE screening test.” He also indicated that he would reinforce proper procedures so that samples will not be frozen, and to spot-check the laboratories to see that they complete reports as required. APHIS issued a SOP on the new confirmatory testing protocols on November 30, 2005.


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf





BRITISH MEDICAL JOURNAL


BMJ


http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2




BMJ


http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1





[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf




[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf




THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf




PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf





9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf




Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm




Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm




03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf




03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf




Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: [email protected] Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf



03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf




In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf





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