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From: TSS ()
Subject: manipulation of publication of TSE science ?
Date: September 26, 2006 at 8:17 am PST


CAN I URGE YOU TO AVOID THE NAME ''SPONGIFORM'' encephalopathy. ...


http://www.bseinquiry.gov.uk/files/yb/1987/06/15002001.pdf


http://www.bseinquiry.gov.uk/files/yb/1987/06/05001001.pdf

Page 22, line 22:

“I was not worried about sort of any confidence being broken because I felt it was all

being done within a confidential”.

Line 25:

“It had decided and sent to him with the explicit statement”.

Page 23, line 1:

“but there is was no harm in his knowing about where we have had got to”

snip...

" The transcript, page 111 lines 23 et seq, deals with my response to a question from

Professor Ferguson-Smith. In responding to that question I used the word "peripheral"

in the colloquial sense meaning "at the extremities" and had in mind muscle meat. To

a clinician or pathologist, peripheral nerves are those outside the central nervous

system (CNS).

Meat, as cut from a body, contains muscle fibres but also fibrous tissue, vascular

components and nervous components such as afferent and motor nerves and nerve

endings. Previous studies by Hadlow et al on scrapie in sheep (1982) and goats are

summarised in the SEAC report of 1995 on transmissible spongiform

encephalopathies which was entitled "A Summary of Present Knowledge and

Research". The reference appears in Table 5.2 page 65 of that report. I also had in

mind the systematic studies on experimental scrapie in mice by Kimberlin and Walker

reported in papers such as "Pathogenesis of mouse scrapie. Evidence for spread of

infection from central to peripheral nervous system" J. general Virology (1983) 64,

713 -716 and "Pathogenesis of Scrapie in Mice after intra-gastric infection" Virus

research (1989) 12,213 -220.These report the amounts of infectivity in different

tissues in sick animals and before disease appeared. In particular, there was none in

muscle. In 1990, I therefore assumed that there would be less infectivity in apparently

healthy cattle than in those that were sick.

In 1990 SEAC members similarly assumed that there would be even less infectivity in

the nerve roots (and the dorsal root ganglia mentioned by Professor Ferguson-Smith)

ithan in the CNS and still less in the more distant peripheral nerves. They had no

knowledge of the variations in the amount of infectivity at different times as the

disease spread through an animal and, in particular, at different points in the

peripheral nervous system of cattle."

http://www.bseinquiry.gov.uk/files/ws/s011d.pdf

(we now know that the TSE agent has been documented in muscle tissue and other tissues besides the CNS in many species. ...TSS)


scrapie like syndrome 'cover up'

http://www.bseinquiry.gov.uk/files/yb/1987/06/04001001.pdf


IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1987/07/10002001.pdf

IN CONFIDENCE
IS THERE A SCRAPIE-LIKE DISEASE IN CATTLE ?

http://www.bseinquiry.gov.uk/files/yb/1987/06/10004001.pdf


CONCLUSIONS
1. ALL PATHOLOGICAL STUDIES TO DATE SUPPORT THE VIEW THAT BSE IS THE BOVINE HOMOLOGUE OF SCRAPIE IN SHEEP. ...

http://www.bseinquiry.gov.uk/files/yb/1988/12/31001001.pdf

18. Following the conference, we prepared the full paper we had presented, for publication in

a book of this European Commission-sponsored conference and sent it to our superiors

for approval. (The correspondence which ensued in April and May 1991 is found at

YB91/4.16/1.1;YB91/4.22/2.1;YB91/4.30/1.1;YB91/5.3/3.1). Specifically, despite detailed

arguments supporting our statements, the following ultimatum was faxed to us from the

then Assistant Chief Veterinary Officer, making it plain that he was taking into account the

views of the then CVO:

“We are not willing for the paper to be published unless these references are

removed. This may be unacceptable to the authors, in which case permission to

publish is refused.”

19. Despite protestations that the body of the text would no longer agree with the already

published abstract, and our detailed knowledge on the subject notwithstanding, the edict

stood. We were left with little alternative but to amend the paper, which by this time had

missed the original deadline for submission and was in danger of not being published at all

(see correspondence above).

20. Subsequent to its publication in the conference book (ref 5), the paper was also published

in a refereed journal (ref 7). The original abstract from ref 5 was then also altered to agree

with the altered text. Specifically the words “with BSE” were removed from the phrase

“epidemiological association with BSE”. I had left MAFF before this paper was ever

published.

21. This episode was described in Dispatches (Channel 4, 9pm Thursday 11th December

1997), and on two separate occasions in. The Independent newspaper (YB97/12.11/1.1

and YB98/1.26/1.1).

Outright rejection of manuscripts submitted for publication, during

"Refereeing/Scrutineering" by Journals

22. The peer review system is in itself generally reasonable. However, an issue of real concern

is that the Veterinary Record , the main channel of information for the veterinary

profession, failed to provide an open forum for discussion of the TSEs throughout the

period of the terms of reference of the Inquiry.

23. The following is a chronology of papers submitted to the Veterinary Record, but which

went unpublished:

5

1988: Letter entitled ‘Scrapie, Time to take HB Parry Seriously’ (YB88/6.8/4.1)

http://www.bseinquiry.gov.uk/files/ws/s067.pdf

Time to take HB Parry Seriously’ (YB88/6.8/4.1)

If the scrapie agent is generated from ovine DNA and thence causes disease in other species, then perhaps, bearing in mind the possible role of scrapie in CJD of humans (Davinpour et al, 1985), scrapie and not BSE should be the notificable disease. ...

http://www.bseinquiry.gov.uk/files/yb/1988/06/08004001.pdf

H. B. Parry, Scrapie Disease in Sheep--Historical, Clinical, Epidemiological, Pathological and Practical Aspects of the Natural Disease (Academic Press, London, 1983).

http://www4.fao.org/cgi-bin/faobib.exe?database=faobib&rec_id=243466&search_type=ef_copy&de_worksheet=LOAN&de_copy_init=ECLOA&de_mail_pft=maill&lang=eng

Title: SCRAPIE - TRANSMISSIBLE HEREDITARY DISEASE OF SHEEP
Author(s): PARRY HB
Source: NATURE 185 (4711): 441-443 1960
Document Type: Article
Language: English
Cited References: 7
Publisher: MACMILLAN MAGAZINES LTD, PORTERS SOUTH, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
Subject Category: MULTIDISCIPLINARY SCIENCES
IDS Number: ZQ043

ISSN: 0028-0836


Journal of the Royal Society ofMedicine Volume 78 April 1985 347

Letters to the Editor

Oncogenes in scrapie and

Creutzfeldt-Jacob disease

From Dr S J Oppenheimer

Department of Tropical Paediatrics

Liverpool School of Tropical Medicine

http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1289692&blobtype=pdf

From a historical viewpoint it

should be noted that this point was first made

strongly in relation to scrapie by Parry (1962,

1983), to whose work Oppenheimer rightly draws

attention.

R M RIDLEY

H F BAKER

T J CROW

http://www.pubmedcentral.org/picrender.fcgi?artid=1290018&blobtype=pdf

1983


BSE CONSULTANT

APPROVAL OF MATERIAL FOR PUBLICATIONS

All material for publication including written works to be published in scientific journals, books, proceedings of scientific meetings, abstracts of verbally delivered papers and the like should be scrutinized for risk to the Ministry before dispatch to the publishers.............

full text;

http://www.bseinquiry.gov.uk/files/yb/1983/10/12001001.pdf


- 10 -

19. On 18th February, 1987 (YB87/2.18/1.1) I reported to Dr Watson and Dr Shreeve on a further

case which we had received from Truro VIC. The brain had shown neuronal vacuolation and

in brain extracts there were fibrils that were similar in size and appearance to SAFs from sheep

with scrapie. The Virology Department was studying the brain further and considering a

transmission study. A few weeks before this, I had discussed the possibility of a transmission

study with Michael Dawson, a research officer in the Virology Department and an expert in

viral diseases in sheep, and we were considering carefully the safety aspects. In my note I

raised the question of whether we should disclose the information we had more widely to the

VIS because this may assist in getting any other cases referred to CVL but there was the

difficulty that we knew very little about the disorder and would be unable to deal with queries

that might be raised.

20. On 23rd February, 1987 (YB87/2.23/1.1) I sent Mr Wells a note asking him to prepare a

statement for publication in Vision, the in-house newsheet prepared by the VIS for the SVS,

setting out details of what we had discovered. On 24th February, 1987 (YB87/2.25/2.1) Gerald

Wells indicated in a note to me that he had discussed the proposed article with Mr Dawson and

they both believed that it could be damaging to publish anything at that stage. They believed

cases would be referred to CVL in any event because they were unusual and they did not feel

"Vision" was an appropriate publication because its confidentiality was questionable and might

lead to referrals to veterinary schools rather than CVL. Gerald Wells was also concerned

about the resources available in his section to deal with referred cases. I replied

(YB87/2.25/2.1) indicating a draft statement was needed by the Director before a decision on

publication could be made. Gerald Wells prepared a draft statement (YB87/3.2/2.1) and sent it

to me on 2nd March, 1987. In his cover note (YB87/3.2/1.1) he commented that he believed

the distribution of any statement about the new disease outside of CVL to be premature

because there was so little information available about the new disease. I passed on a copy of

Gerald Wells' note to Dr Watson (YB87/3.2/3.1). I discussed the matter of publication with Dr

Watson. No decision had been taken to publish any material at that stage and I sent a note to

Gerald Wells letting him know the position and confirming that his views and those of Michael

Dawson would be taken into account when a decision was taken.

- 11 -

21. In March, 1987 serious consideration was given to possible transmission (e.g. to hamsters) and

other experiments (other than the collection of epidemiological data by the VIS and

clinicopathology which had been in progress since the first cases were recognised in November,

1986).

22. On 23rd April, 1987 I sent a report (YB87/4.23/1.1) to Dr Watson and Dr Shreeve informing

them that nine control brains were being examined for SAFs and a cow which appeared to be

affected with BSE had been purchased for observation. The cow had come from the farm

where the original cases had developed and had arrived at CVL on 22nd April, 1987.

23. On 15th May, 1987 Dr Watson informed me that the proposed "Vision" draft would be

circulated to VICs in England and Wales if it was approved by management. On 22nd May,

1987 I was copied in on a note (YB87/5.22/2.1) from B.M Williams, (who I believe was Head

of the VIS at this time but retired shortly after this), to Dr Watson. This confirmed that the

draft prepared for publication in Vision was approved but that the final paragraph should be

amended to make it clear that knowledge of the new disease should not be communicated to

other research institutes or university departments. At a meeting with Dr Watson on 2nd June,

1987 he informed me that no communication should be made with NPU until after the meeting

with the CVO on 5th June, 1987 (see my note of 3rd June, 1987 – YB87/6.3/1.1). We needed

much more data and information to answer inevitable queries. ...


http://www.bseinquiry.gov.uk/files/ws/s071.pdf

http://www.publications.parliament.uk/pa/cm199900/cmselect/cmsctech/465/465m48.htm


The Cultural Politics of Science and Decision-Making

An Anglo-German Comparison of Risk Political Cultures

 The BSE Case


by

Kerstin Dressel

sine-Institute Munich, Germany

kerstin.dressel@sine-institut.de

The following report include excerpts of a thesis submitted in fulfilment of the requirements for the degree of

Doctor rerum politicarum (Dr. rer. pol.)

at the Ludwig-Maximilians-University of Munich

supervisor: Prof Dr Ulrich Beck

Institute for Sociology, Munich, Germany

The British case study was prepared at the Centre for the Study of Environmental Change at Lancaster University, UK,

Supervisor: Prof Dr Brian Wynne

kindly supported by a grant of the Economic and Social Research Council, UK

Munich, 2nd October 2000


© Kerstin Dressel, 2000  all rights reserved.


http://bse.airtime.co.uk/dressel.htm#9

The BSE Inquiry / Statement No 67
Dr Iain McGill (scheduled to give oral evidence 08 June 98)
THE BSE INQUIRY
Statement by I S McGill
Curriculum Vitae
1. A brief CV is enclosed with this statement as Annex 1.
Periods particularly concerned with TSEs are as follows:
Spring/Summer 1988 Final Year Elective Research project
The astrocytic reaction in BSE and its comparison
with natural scrapie of sheep.
Royal Veterinary College (RVC), London University.
Performed at Pathology Dept, MAFF, CVL, Weybridge
Jan 1990 - Jun 1991 Veterinary Research Officer
Central Veterinary Laboratory (CVL), Weybridge.
Employer: MAFF
Funding Body: MAFF
Aug 1991 - Dec 1992 Post Doctoral Research Worker
Institute of Psychiatry, London University.
Employer: Institute of Psychiatry
Funding Body: AFRC
1994 - 1998 Director, Prion Interest Group
Independent Research Organisation.
Privately financed.
Incorporated as scientific wing of
Shift Ltd in 1995 : Company reg no 291 6731
Statement of Interests
2. I have no links of any nature with the farming community (other than
those from my work
with farms as a vet student or as a qualified vet) nor with the feedstock,
pet food or
rendering industries.
Advice to Governmental Committees
3. I have had no involvement in UK Governmental committees.I did, however,
act as
rapporteur for a conference of international experts held in 1990 at the
CVL. This was
held under the auspices of the Gibbs Committee, organised by Dr CJ Gibbs of
the National
2
Institutes of Health, Bethesda, USA. My draft report from this conference
was passed on
to MAFF. (The final report is at YB90/3.12/1.1)
How I became involved in work on TSEs.
4. In 1987/88, my final year at the RVC, the work of Gerald Wells and his
colleagues at the
CVL on BSE was the subject of much discussion. I approached Richard Barlow
Professor of Pathology at RVC, who had decades of experience in scrapie
research, with a
view to carrying out my final year elective research project outside the
RVC, with the
team at the CVL. He agreed to co-supervise a project with Gerald Wells.
5. The report of this work is available and also held in RVC library. The
external examiner
for this research was Dr W B Martin, at that time sitting on the Southwood
Committee.
This research achieved first place in the year in professional examinations
and contributed
to the award of the Cecil Aulden Second Prize (second place throughout
BVetMed
degree).
6. Once qualified, I worked for 18 months in practice, and then returned to
the Pathology
Department of the CVL in January 1990, to continue my work with Mr Wells.
Commissioning and Funding
Work at CVL, Weybridge, commissioned by MAFF
7. At CVL most of the projects I worked on were commissioned and directly
funded by
MAFF. All the research I pursued was as an employee of MAFF, excepting work
during
my final year at the RVC, when I was supported by a student grant.
8. I think it is worthwhile making a few salient points about my day to day
work for MAFF.
The facilities of the Pathology Department and the quality of technical and
administrative
support were in general excellent and the scientists I worked with were of a
uniformly
high calibre. Once the decision to fund a project had been reached, there
were no
restraints on rapidly seeking tangible results.
9. Publications arising from such work include references 2, 5, 7, 8 & 10 in
the list of
publications to be found at the end of this statement.
Uncommissioned Work at CVL, Weybridge
10. As I was not always encouraged to pursue work I regarded as essential, I
also worked on
projects (either practical or theoretical) beyond the narrow confines of
specific MAFF
commission. Often this was possible within my daily routine, but I would
periodically
have to ‘clock off’ from my MAFF job and work in my own time rather than
leave the
matter untouched.
11. Publications arising from non-commissioned work started whilst I was
still an employee of
MAFF include :
3
(i) Wood LJN, McGill IS, Done SH and Bradley R (1997). Neuropathology of
scrapie: a study of the distribution patterns of brain lesions in 222 cases
of natural
scrapie in sheep, 1982-1991; ref 12.
The project as a whole was commissioned by MAFF, but my own involvement was
voluntary (see para. 31).
(ii) Heretical Model of Scrapie (1991) paper to the annual conference of the
Association of veterinary Teachers and Research Workers, Scarborough 1991,
referred to in the Veterinary Record, 128, pp368-369.
See paras 52 et seq for details of research proposed to MAFF at this time.
(iii) Stack MJ, Aldrich AM, Davis LA (1997). Comparison of detergent and
protease
enzyme combinations for the detection of scrapie-associated fibrils from the
central
nervous system of sheep naturally affected with scrapie. Journal of
Comparative
Pathology, 1997, 116, pp.181-189 (J/CP/116/181).
12. Although this is not acknowledged in the published article, I introduced
Mick Stack to the
use of Subtilisin Carlsberg enzyme for SAF extraction, initially from
formalin-fixed
tissue. Following a theoretical discussion with Dr (now Professor) Ian Shaw
in 1991 I had
pioneered such use of this enzyme. My conceptual role (not commissioned by
MAFF) in
this work illustrates the sometimes unexpected fruits of the free pursuit of
scientific (as
opposed to Government) ideas.
Work at the Institute of Psychiatry funded by an AFRC Grant
13. Publications arising from this work include references 3, 4, 6 & 9 in
the attached list of
publications.
14. Two publications submitted to the Veterinary Record during this period
went unpublished.
(See para 22).
Constraints on publication of results
" Internal approval"
15. Every paper generated within MAFF is sent for approval by superiors; the
more serious
the topic (for example if the disease is zoonotic or notifiable), the higher
it is sent before
approval is given or refused. I only outline the system in operation within
MAFF at that
time, and it is not my intention to criticise individuals who were
performing their ascribed
roles within the structure of MAFF.
16. I would like to illustrate the process of ‘approval’ with reference to
the identification of
FSE and subsequent publication of findings. The first case of FSE was
discovered at
Bristol University by Janet Wyatt (now Bradshaw) working with Dr Geoff
Pearson and
others. Material was referred to Gerald Wells in April 1990 for his expert
opinion and he
passed histological sections to me for comment.
4
17. Over the next six months, the Bristol and Liverpool Veterinary Schools
(and possibly
others) and the CVL independently examined their archives of feline brains
to determine
whether this disease existed prior to the BSE epidemic, or whether it was a
new disease.
Neuropathological evidence suggested it was a new disease. This, along with
epidemiological and biochemical data, led Gerald Wells and myself to prepare
a paper for
an international TSE conference in Brussels including the indication that
there might be a
causal link between BSE and FSE. The abstract of this paper was faxed to
Brussels prior
to the conference for publication in a booklet for delegates. This abstract
(ref 5) includes
the suggestion of this link.
18. Following the conference, we prepared the full paper we had presented,
for publication in
a book of this European Commission-sponsored conference and sent it to our
superiors
for approval. (The correspondence which ensued in April and May 1991 is
found at
YB91/4.16/1.1;YB91/4.22/2.1;YB91/4.30/1.1;YB91/5.3/3.1). Specifically,
despite detailed
arguments supporting our statements, the following ultimatum was faxed to us
from the
then Assistant Chief Veterinary Officer, making it plain that he was taking
into account the
views of the then CVO:
“We are not willing for the paper to be published unless these references
are
removed. This may be unacceptable to the authors, in which case permission
to
publish is refused.”
19. Despite protestations that the body of the text would no longer agree
with the already
published abstract, and our detailed knowledge on the subject
notwithstanding, the edict
stood. We were left with little alternative but to amend the paper, which by
this time had
missed the original deadline for submission and was in danger of not being
published at all
(see correspondence above).
20. Subsequent to its publication in the conference book (ref 5), the paper
was also published
in a refereed journal (ref 7). The original abstract from ref 5 was then
also altered to agree
with the altered text. Specifically the words “with BSE” were removed from
the phrase
“epidemiological association with BSE”. I had left MAFF before this paper
was ever
published.
21. This episode was described in Dispatches (Channel 4, 9pm Thursday 11th
December
1997), and on two separate occasions in. The Independent newspaper
(YB97/12.11/1.1
and YB98/1.26/1.1).
Outright rejection of manuscripts submitted for publication, during
"Refereeing/Scrutineering" by Journals
22. The peer review system is in itself generally reasonable. However, an
issue of real concern
is that the Veterinary Record , the main channel of information for the
veterinary
profession, failed to provide an open forum for discussion of the TSEs
throughout the
period of the terms of reference of the Inquiry.
23. The following is a chronology of papers submitted to the Veterinary
Record, but which
went unpublished:
5
1988: Letter entitled ‘Scrapie, Time to take HB Parry Seriously’
(YB88/6.8/4.1)
24. In this letter I stated that BSE had been officially confirmed as a TSE
(when much of the
veterinary profession still favoured a variety of alternate hypotheses). I
also suggested
that scrapie should be made a notifiable disease, and drew attention to the
work of HB
'James' Parry and the possibility that natural scrapie in sheep might be of
genetic origin.
25. I withdrew the letter following advice from Professor Barlow (who as far
as I can recall
had been contacted by MAFF and the Veterinary Record) that it might not be
in my
interests to pursue publication at that moment in time.
26. I received a letter from the then editor, Edward Boden, questioning my
permission to
release the information that BSE was indeed a proven TSE. I had no
permission, though
was unaware that any was needed, to inform my profession of this urgent and
important
fact.
1992: McGill and Wood
27. This paper summarises views as to why an open debate on TSEs and in
particular scrapie
were and remain essential. We drew attention to the work of Parry, Prusiner
and others,
and outlined novel explanations for recent research findings in light of
such work. We
suggested that not all the relevant questions were being asked in the
interpretation of data.
In particular, the possibility that the infectious agent was being generated
de novo from the
genome (the PrP gene) in certain families of sheep, was still not being
considered, despite
a body of scientific data going back over 30 years. It was to be a further 5
years before
publications from Government laboratories would start to cite Parry’s work
as a possibly
correct theory.
28. The refereeing process for this work was at the time not transparent,
and I have yet to be
informed as to why this remains unpublished.
29. 1992 Book review commissioned - on “Sub-Acute Spongiform
Encephalopathies” Eds.
Bradley, Savey & Marchant, Kluwer Academic Publishers, Dorchelt, for the
Commission
of the European Communities.
30. On 13th May 1992, I was commissioned by the Veterinary Record to review
this book
(YB92/5.13/1.1). After approximately 100 hours work for this review, an
editorial
decision was taken not to publish. Ironically, this book contained the very
paper by
Gerald Wells and myself over which "censorship" has been alleged.
Prolonged delay during "Refereeing/Scrutineering" of manuscripts submitted
for
publication
1997 Wood McGill Done and Bradley (ref 12).
31. This work was started in 1990 to screen for putative BSE in sheep, by
James Wood, a
colleague in the Pathology Department at CVL, although it was not finally
published until
1997. James sought my assistance in light of my greater experience in TSE
pathology. I
worked many many months to get this paper into print (YB95/6.29/2.1;
YB96/9.19/2.1)
6
refereeing process took two years, hardly an acceptable delay for crucial
work in this
field. The referees’ comments (YB95/6.29/2.2) themselves require scrutiny.
One
scrutineer seemed to referee the paper in a balanced way, whilst the other
seemed more
intent on pushing his/her own opinions onto the paper.
32. Publication was finally expedited in the summer of 1996, when the
politically sensitive
question of whether or not BSE had indeed gone into the sheep population
started to be
asked in the public domain. This paper finally appeared (with some important
omissions
and watering down) in 1997, seven years after it was started, and two years
after it was
submitted. It was jointly funded by MAFF and the Prion Interest Group.
33. Had my ongoing research into sheep scrapie been funded and/or the McGill
and Wood
1992 paper been published, stimulating debate and further investigations,
this paper would
most certainly have appeared by 1995. Further work based on it could have
determined
by 1997 whether or not, and if so to what extent, BSE had gone into sheep.
34. In addition, the work may by now have led to a rapid diagnostic test and
a great deal of
information on the actual (as opposed to the theoretical/experimental)
causes of sheep
scrapie and the fundamental biology of this entire group of diseases. Some
of the work
suggested in 1991 has still not been started.
Aspects of TSE work with which I was involved
Analysis of the astrocytic response in BSE and its comparison with natural
scrapie.
35. I worked as a neuropathologist with Gerald Wells to establish that
astrocytic reaction, one
of the fundamental triad of neuropathological changes occurring in TSEs, was
indeed
present in BSE. This work was accomplished using antibodies to GFAP (a
structural
component characteristic of astrocytes) to quantify previously qualitative
interpretations
that an astrocytic reaction was present. The astrocytic reaction in natural
sheep scrapie
was assessed in parallel.
Published: 1988 RVC library.
1991 (Wells, Wilesmith and McGill) - details of astrocytic response in BSE
1997 (Wood, McGill, Done and Bradley) - details of astrocytic response in
natural sheep
scrapie
Surveillance for emerging scrapie-like diseases in animals in the UK
36. Working with Gerald Wells and other pathologists from the State
Veterinary Service, I
was involved with surveillance for neurological disease of animals in the
UK. This was
with particular reference to surveillance for, and subsequent confirmation
of TSEs.
During my time of employment, novel TSEs arose in domestic cats and in
exotic ungulates
in zoological collections. I also became involved in the investigation of a
putative TSE in
hound packs detected by Robert Higgins.
FSE, and BSE in exotic ungulates published in reviews:
1991 (Wells and McGill) ref 5
7
1992 (Wells and McGill) ref 7
FSE discussed in para 15.
37. Putative TSE in hounds - work started 1990 –(see para 41)
Robert Higgins, a Veterinary Investigation Officer at Thirsk, had been
working on a
hound survey in 1990. Gerald Wells and I myself received histological
sections from this
survey along with the accompanying letter (YB90/11.28/1.1) dated November
1990. This
letter details spongiform changes found in brains from hunt hounds failing
to keep up with
the rest of the pack, along with the results of SAF extractions from fresh
brain material
from these same animals. SAFs were not found in brains unless spongiform
changes were
also present. The spongiform changes were not pathognomonic (ie. conclusive
proof) for
prion disease, as they were atypical, being largely present in white matter
rather than grey
matter in the brain and spinal cord. However, Tony Scott, then head of
electron
microscopy work on TSEs, had no doubt that these SAFs were genuine and that
these
hounds therefore must have had a scrapie-like disease. I reviewed all the
sections myself
(original notes appended) and although the pathology was not typical, I
could not exclude
the possibility that this was a scrapie-like disorder, as white matter
vacuolation is seen in
TSEs and Wallerian degeneration was also present in the white matter of the
hounds,
another feature of scrapie.
38. I reviewed the literature on hound neuropathology, and discovered that
micrographs and
descriptive neuropathology from papers on ‘hound ataxia’ mirrored those in
material from
Robert Higgins’ hound survey. Dr Tony Palmer (Cambridge) had done much of
this
work, and I obtained original sections from hound ataxia cases from him.
This enabled me
provisionally to conclude that Robert Higgins had in all probability
detected hound ataxia,
but also that hound ataxia itself was possibly a TSE. Gerald Wells confirmed
in ‘blind’
examination of single restricted microscopic fields that there was no
distinction between
the white matter vacuolation present in BSE and scrapie cases, and that
occurring in
hound ataxia and the hound survey cases.
39. Hound ataxia had reportedly been occurring since the 1930’s, and a known
risk factor for
its development was the feeding to hounds of downer cows, and particularly
bovine offal.
Circumstantial evidence suggests that bovine offal may also be causal in
FSE, and TME in
mink. Despite the inconclusive nature of the neuropathology, it was clearly
evident that
this putative canine spongiform encephalopathy merited further
investigation.
40. The inconclusive results in hounds were never confirmed, nor was the
link with hound
ataxia pursued. I telephoned Robert Higgins six years after he first sent
the slides to CVL.
I was informed that despite his submitting a yearly report to the CVO
including the
suggestion that the hound work be continued, no further work had been done
since 1991.
This was surprising, to say the very least.
41. The hound work could have provided valuable evidence that a scrapie-like
agent may have
been present in cattle offal long before the BSE epidemic was recognised.
The MAFF
hound survey remains unpublished.
Histopathological support to various other published MAFF experiments
8
42. These included neuropathological examination of material from
experiments studying the
attempted transmission of BSE to chickens and pigs (CVL 1991) and to mice
(RVC
1994).
Neuropathological findings in cattle with clinically suspect but
histologically unconfirmed
bovine spongiform encephalopathy
43. This was my main project during my employment at MAFF.
44. At this time, approximately 10% of cattle suspected of having BSE were
not being
diagnosed as BSE-positive. The purpose of this work was to establish what
other diseases
were being clinically mistaken for BSE and causing these cattle to be taken
as suspects
under the BSE Order.
45. Upon closer examination, three of the 200 ‘BSE-negative’ brains proved
positive for
spongiform changes diagnostic of BSE (see YB87/12.14/1.2; YB87/12.15/2.1).
This
represents an overall diagnostic accuracy of 99.85%, exceeding the 99.6%
previously
published for the same standard diagnostic technique. Despite this, at the
behest of MAFF
managers, the emphasis of the study and its provisional title had to be
changed, from
accurately representing the whole negative 10%, to a study examining this
10% minus any
mention whatsoever of BSE-affected cattle going undiagnosed. I therefore had
to
reluctantly locate and analyse three new BSE-negative suspect brains.
46. Discussion of this would according to MAFF officials have resulted in
‘lack of clarity’ and
opened up debate as to the accuracy of diagnosis.
47. Although this may seem a minor consideration, it illustrates the
kneejerk and perhaps
unnecessary culture of secrecy operating within MAFF at that time.
48. As it was also a theoretical possibility that cases of BSE might exist
without the
characteristic spongiform changes, a further purpose of this work was to
examine selected
cases using immunocytochemistry for PrP to determine if any had BSE but
lacked the
characteristic pathology. Although the sensitivity of the technique used has
increased
dramatically since then, none were found at this time, and this was one of
the important
findings of the paper which was published.
49. In a number of informal conversations at that time, managers within MAFF
let me know
that the upper echelons of MAFF “had had it up to here with you scientists
finding out
about new diseases”. As a Veterinary Research Officer employed in disease
surveillance, I
had considered that to be my job.
Published 1993 (McGill and Wells) ref 10
Theoretical models of TSE diseases
50. Published in the Veterinary Record 1991 (J/VR/128/368) as editorial of
AVTRW
conference. In 1991 Martin Alder, new editor of the. Veterinary Record ,
published a very
favourable account of my theoretical paper presented at AVTRW 1991 in
Scarborough
under the heading “Heretical Model of Scrapie”. The Chairman of this session
was Bill
9
Blakemore, Cambridge Vet School. It was printed (after consultation with me)
in an
editorial article “Fruits of Research On Show in Scarborough”. He devoted
considerably
more column inches to work by myself and Kenton Morgan than to work reported
by
NPU, although they had presented far more papers. It was to be the last time
my name
would appear in the Veterinary Record until 1997.
Unpublished 1988, 1992
Establishing that human prion disease can exist without characteristic
pathology.
51. This was the first conclusive proof that prion diseases can indeed exist
without any of the
characteristic pathology, extending the phenotypic diversity of prion
disease.
Published 1992 (Lantos, McGill et al) ref. 6
Setting up in vitro models of human prion diseases (GSS, familial CJD) in
neuroblastoma
cells in culture
(Resigned half way through project)
Neuropathology of natural sheep scrapie.
Started 1990, submitted 1995, published 1997 (Wood, McGill et al) ref 12
See para 11 for details of this work.
Contact with / Advice to Government
Contact with CVL / MAFF
52. I maintained regular contact with scientists at the CVL until 1997.
53. I cannot catalogue all the information, advice or recommendations I
offered to MAFF or
CVL between 1988 and 1997, as there is too much to include. However, I could
illustrate
with the following summary of two substantive suggestions for research.
Research on the biochemical/physical nature of “strains”
54. Prior to their publication as an editorial in the Veterinary Record, a
summary of these
ideas was presented to the CVL management for funding as a ‘blue sky’ PhD
project in
Spring 1991. The proposal was not taken up. This was the first occasion on
which I
proposed research to the Government in writing.
An abattoir survey for incidence of BSE
55. I suggested in 1990 that to improve the provision of control material I
should collect 20
cattle heads from a local abattoir.The purpose of this was to provide
BSE-negative
material to act as controls for our (CVL’s) BSE work. However,
neuropathological
examination of these brains might also have given an indication of the
number of cattle
incubating BSE which were entering the human food chain. This research had
actually
been recommended in the Interim Report of the Tyrrell Committee, June 89.
10
56. I was instructed a few days after suggesting this to my head of
department that I was not
the first person to have thought of that, and that a decision had been taken
not to do that
research. I was also instructed, for some reason, not to put it in writing.
57. Budgets could hardly have been an issue contributing to the rejection of
this proposal, as
tongueless cattle heads were free, being banned from human consumption.
Contact with AFRC
58. I had contact with the AFRC in several capacities:
My work at the Institute of Psychiatry was funded by an AFRC grant.
Attending BSE Programme conferences in 1992 and 1994.
Submitted a further grant application to the AFRC in 1991.
59. This proposal was to continue research on natural scrapie, with which I
had been involved
at CVL (eventually published 1997; ref 12). I was to collaborate with John
Powell
(molecular neurobiologist) and David Male (co-author of the standard
Immunology text
worldwide: Roitt, Brostoff and Male). All five referees gave positive
statements about the
proposal, which was alpha-rated (see YB92/12.10/1.1 and YB92/12.17/1.1).
60. This was the second time that I suggested substantial investigations on
the TSEs to the
government in writing. Once more the proposal was not taken up.
61. In view of the continuing uncertainties as to the degree to which BSE
has affected the
sheep population, it would perhaps have been wise to fund this application
at that time.
62. Some of this work has still not been initiated, although the paper
(Wood, McGill et al
1997), after a two year delay from submission to publication, and the
original 1992 AFRC
grant submission, both described a unique series of characterised sheep
brains affected
with naturally occuring TSEs. The majority of them are natural scrapie
although further
work on this series of brains would give an indication of whether BSE was
also occurring
in sheep in the 1980s and early 1990s. Events have moved forward since this
grant
application was submitted, both in the nvCJD and scrapie fields, but this
still represents a
crucial question in the epidemiology of both scrapie and BSE which remains
unanswered.
This work should, in my opinion, be initiated forthwith, and further work
based on these
results pursued vigorously as results are obtained.Refer to discussion also
at para 31.
Additional Comments
63. I could perhaps sum up MAFF’s approach to BSE with an observation which
is by no
means original:
“Absence of evidence” is not the same as “evidence of absence”
Publications
1. McGill IS (1986) The Shortcut to Elitism. The Guardian, December 1st,
p12.
11
2. Wells GAH, Wilesmith, JW & McGill IS (1991) Bovine spongiform
encephalopathy - a neuropathological perspective. Brain Pathology, 1, 69-78
3. McGill IS (1991) Bovine Spongiform Encephalopathy. In: Practical Food
Hygiene,
Ed. Dickens T, Croner Publications Ltd, Kingston, UK, pp. 435-436
4. McGill IS & Whatley SA (1991) Understanding the causes of brain disease.
The
Independent, August 16th, p. 20
5. Wells GAH & McGill IS (1991) Recently described scrapie-like
encephalopathies of
animals - case definitions. In: Sub-acute Spongiform Encephalopathies, Eds.
Bradley
R, Savey M & Marchant B, Kluwer Academic Publishers, Dorchelt, pp. 11-24.
6. Lantos P, McGill IS, Janota I, Doey J, Collinge J, Bruce M, Whatley SA,
Anderton BH, Clinton J, Roberts GW & Rosser N (1992) Prion protein
immunocytochemistry helps to establish the true incidence of prion disease.
Neuroscience Letters, 147, 67-71
7. Wells GAH & McGill IS (1992) Recently described scrapie-like
encephalopathies of
animals - case definitions. Research in Veterinary Science, 53, 1-10
8. Pollin MM, McGill IS & Wells GAH (1992) The differential
neurohistological
diagnoses of clinically suspect but unconfirmed BSE. Neuropathology and
Applied
Neurobiology, 18, 633 (abstract)
9. Guha M & McGill IS (1992) Book review of Black's Veterinary Dictionary
(17th
Edition), Ed, West GP, A & C Black, London. Reference Reviews, 6, 26
10. McGill IS & Wells GAH (1993). Neuropathological findings in cattle with
clinically
suspect but histologically unconfirmed bovine spongiform encephalopathy
(BSE).
Journal of Comparative Pathology, 108, 241-260
11. McGill IS (1995) Ayurvedic Medicine - The Documentary. Natural Medicine
Society
News, Spring 1995
12. Wood LJN, McGill IS, Done SH and Bradley R (1997) Neuropathology of
scrapie:
a study of the distribution patterns of brain lesions in 222 cases of
natural scrapie in
sheep, 1982-1991. Veterinary Record 140, 167-174
13. McGill IS, Hobson J (1998) Multi-centre evaluation of a herbal skin gel
for veterinary
practice - a questionnaire survey. Veterinary Times, 28, 1, 20-21
14. McGill IS (1998) BSE and Censorship. The Independent January 26th 1998,
p14
(YB98/1.26/1.1).
12
ANNEX 1:
CURRICULUM VITAE: IAIN STEWART McGILL
Education & Qualifications
1975 - 1982 Southend High School for Boys
GCE O-Levels (1980): 9 (6 A, 3 B)
GCE A-Levels (1982): Biology (A), Physics (A), Chemistry (A)
GCE S-Level (1982): Biology (2)
1982 - 1984 Royal Veterinary College, University of London
1984 - 1985 Kings College, University of London
B.Sc(Hons), II(i) Neuroscience and Immunology
1985 - 1988 Royal Veterinary College, University of London
B.Vet.Med., MRCVS.
Distinctions : Medicine , Clinical Pathology (Elective Subject)
First place for research project
Cecil Aulden Second Prize
Professional Experience
1988 - 1989 Veterinary Surgeon -- Blue Cross Animal Hospital, Victoria,
London
In addition to clinical duties, I upgraded clinical pathology services
within the hospital and established an interpretive service for laboratory
data for other clinicians.
1990 - 1991 Veterinary Research Officer -- MAFF Central Veterinary
Laboratory,
Weybridge, Surrey.
In this post I worked as a neuropathologist with Gerald Wells and William
Hadlow, in a large
interdisciplinary team researching the prion diseases of animals.
My work concentrated on the neuropathological characterisation of Bovine
Spongiform
Encephalopathy (BSE), the prion diseases of other animals and their
differential diagnosis.
This gave me good general experience of neurological disease, its diagnosis
and pathological
characteristics in a wide range of animals and an introduction to many
fields of neuroscience
research. Although broad-based, my research in these varying disciplines was
centred on the
Prion protein and its gene, and associated molecular pathology in the prion
diseases.
I described, amongst other things, the first cases in the UK of a chlamydial
disease of cattle
putatively equivalent to Sporadic Bovine Encephalomyelitis (see McGill and
Wells, 1993).
13
Additional responsibilities included:
Liaison with the Consultant Pathology Unit for neuropathological
surveillance, including
rabies diagnosis for the British Isles and characterisation of novel
diseases such as blue eared
pig disease.
Conducting occasional seminars introducing scrapie and BSE diagnosis for
visiting scientists
from abroad.
Rapporteur for The Gibbs Committee on Subacute Spongiform Encephalopathies
(held at
CVL in summer 1990).
Papers presented at AVTRW conferences at Scarborough (1990 & 1991), at
European
Community Seminar on Spongiform Encephalopathies, Brussels, (1991) and
International Pig
Veterinary Society, Holland, (1991).
Aug 91 - Dec 92 Research Worker (post-doctoral level)
Department of Neuroscience, Institute of Psychiatry, London
In this post I continued to follow my interest in the prion diseases, and
gained a good
grounding in both theoretical and practical molecular biology. I cloned PrP
genes from blood
samples taken from individuals with PrP mutations causal of familial CJD or
GSS and
transfected them into neuroblastoma cells in culture to investigate the
disease process in vitro.
I continued to work with colleagues from other disciplines, particularly
Neurology and
Neuropathology, and with Professor Peter Lantos and others established for
the first time that
prion disease can exist without its characteristic pathology (Lantos, McGill
et al, 1992).
Positions of responsibility included:
Lecturing on a course entitled "Molecular Mechanisms of Neurodegeneration",
to both
internal and external scientists, and as part of the London University M.Sc.
Neuroscience
course.
Lecturing on scrapie-like diseases as part of the London University M.Sc. in
Animal Health at
the RVC.
Liaison and research collaboration between the IOP and my previous employers
at CVL,
Weybridge.
Sole responsibility for the organisation and funding of the 1992/1993
seminar series for the
Department of Neuroscience, in which leading researchers from around the UK
were invited
to give seminars.
Paper presented at AFRC BSEP meeting, Reading, April 1992.
1994 - Present Scientific and Veterinary Consultant
14
(Spring 94) Acted as neuropathological consultant for research on the
transmissibility of BSE in collaboration with Dr David White and
Professor Neil Eddington at the Royal Veterinary College, University
of London.
(Summer 94) Veterinary Surgeon, Blue Cross Animal Hospital (Victoria,
London)
(Oct 94 - Dec 94) Lecturer in anatomy and histology, Optics Department, City
and
Islington College (London).
(1995) Re-established the Prion Interest Group (originally founded at the
Institute of Psychiatry in 1991) as a private organisation, continuing
research on prions.
Filmed and directed a documentary in India/Europe about Ayurvedic
medicine.
Acted as a locum veterinarian for the PDSA and the Veterinary Centre
Caterham.
(Jan 96 - Present) Veterinary Consultant to Ayuvet (UK) Ltd., co-ordinating
clinical and
laboratory research into the Ayurvedic system of medicine and its
application in European veterinary medicine. Continued co-ordination
of the Prion Interest Group.
Issued on behalf of the witness by:
The BSE Inquiry Press Office
6th Floor Hercules House
Hercules Road
London SE1 7DU
Tel: 0171 261 8377 / 8383
Fax: 0171 803 0893
Website: http://www.bse.org.uk
email: inquiry@bse.org.uk

http://www.bseinquiry.gov.uk/files/ws/s067.pdf

USDA USA

Gerald Wells: Report of the Visit to USA, April-May 1989

snip...

The general opinion of those present was that BSE, as an
overt disease phenomenon, _could exist in the USA, but if it did,
it was very rare. The need for improved and specific surveillance
methods to detect it as recognised...

snip...

It is clear that USDA have little information and _no_ regulatory
responsibility for rendering plants in the US...

snip...

3. Prof. A. Robertson gave a brief account of BSE. The US approach
was to accord it a _very low profile indeed_. Dr. A Thiermann showed
the picture in the ''Independent'' with cattle being incinerated and thought
this was a fanatical incident to be _avoided_ in the US _at all costs_...

snip...

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf

Suppressed peer review of Harvard study October 31, 2002

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


Subject: USDA BSE inconclusive MRR policy
Date: August 25, 2006 at 3:52 pm PST

USDA BSE inconclusive MRR policy


BESIDES THE TEXAS MAD COW THAT WAS RENDERED AND NEVER TESTED;


On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA. ...


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

BESIDES the Texas mad cow that sat on the shelf for 7+ months before the Honorable Phyllis Fong of the OIG finally did the end around Johanns et al and finally had Weybridge bring that negative cow back from the dead to finally being a confirmed mad cow (hint, hint, getting MRR implemented first), was this simply another bumbling of BSE protocol, or just same old same old;


Jim Rogers (202) 690-4755

USDA Press Office (202) 720-4623

Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test Results
July 27, 2005


snip...

Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing. As we have previously experienced, it is possible for an IHC test to yield differing results depending on the “slice” of tissue that is tested. Therefore, scientists at our laboratory and at Weybridge will run the IHC test on additional “slices” of tissue from this animal to determine whether or not it was infected with BSE. We will announce results as soon as they are compiled, which we expect to occur by next week.

I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in. On that point, I would like to emphasize that while that time lag is not optimal, it has no implications in terms of the risk to human health. The carcass of this animal was destroyed, therefore there is absolutely no risk to human or animal health from this animal.


snip...


http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html


"The sample was submitted to us by a private veterinarian. As an extension of our enhanced surveillance program, accredited private veterinarians who often visit farms in remote areas collect samples when warranted. The sample in question today was taken from a cow that was at least 12 years of age and experienced complications during calving.

"The veterinarian treated the sample with a preservative which readies it for testing using the immunohistochemistry test, an internationally recognized confirmatory test for BSE.

"Neither the rapid screening test nor the Western blot confirmatory test can be conducted on a sample that has been preserved. Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing.

"As we have previously experienced, it is possible for an IHC test to yield differing results, depending on the slice of tissue that is tested. Therefore scientists at our laboratory and at Weybridge will run the IHC test on additional slices of tissue from this animal to determine whether or not it was infected with BSE.

"We will announce results as soon as they are compiled, which we expect to occur by next week.


snip...


http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml

NOW, all the above announced July 27, 2005. SO, the other 'inconclusive' sample has been sitting on the shelf since April, some 4 months earlier, give or take a few days. NOW, what has been going on while this other inconclusive BSE/BASE mad cow sits on the shelf. Lets look at that BSE MRR COMMODITY time frame ;-)


7/20/05 USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Farm Raised Cervids from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Camelids from Canada PDF


7/15/05 Importation of Bovines (Cattle or Bison) from Canada for Feeding PDF BSE Minimal-Risk Regions and the Importation of Live Animals Importers, Brokers, and Other Interested Parties PDF BSE Minimal-Risk Regions and the Importation of Live Animals Accredited Veterinarians or Other Interested Parties PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Cattle or Bison for Feeding from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Cattle, Bison, Sheep and Goats for Immediate Slaughter from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Sheep and Goats for Feeding from Canada PDF Animal Products Implementation: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities from Canada PDF Johanns Announces Next Steps for Importing Canadian Cattle Transcript of Tele-News Conference with Agriculture Secretary Mike Johanns Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities— FINAL RULE— 9 CFR Parts 93, 94, 95, and 96 [Docket No. 03-080-3] Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Partial Delay of Applicability [Docket No. 03-080-6] — Final rule; partial delay of applicability — 9 CFR Parts 94 and 95
Published March 11, 2005 — 70 FR 12112-12113 Text | PDF • Risk Document PDF • Economic Analysis PDF • Appendices to economic analysis PDF • Final environmental assessment PDF • Final Rule on BSE and Minimal-Risk Regions (Factsheet) • Questions and Answers for Minimal Risk/Canada Rule • Port of Entry for Eligible Ruminants 7/14/05 Secretary Johanns Statement on Ninth Circuit Court Ruling


04/01/05 Canada, Mexico And United States Release Harmonized North American BSE Strategy Harmonization of a BSE Strategy (PDF)


03/17/05 U.S. Government Requests Appeal In Minimal-Risk Rule Case


03/04/05 BSE Minimal-Risk Regions and Importation of Live Animals and Commodities From Canada Delay of Effective Date (Memo)


03/03/05 Statement By Agriculture Secretary Mike Johanns Regarding The Temporary Injunction Issued By The U.S. District Court For The District Of Montana Regarding USDA's Minimal-Risk Rule

KEEP THEM DOGGIES ROLLING, RAWHIDE, ye ha !


NOT to forget ;


It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. ......


http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html


r i g h t ............


sounds like a recording ;


Subject: REPORT OF THE COMMITTEE ON SCRAPIE November 9, 2005 USAHA
Date: February 12, 2006 at 1:03 pm PST

REPORT OF THE COMMITTEE ON SCRAPIE

Chair: Dr. Jim Logan, Cheyenne, WY

Vice Chair: Dr. Joe D. Ross, Sonora, TX

Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN.

The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance.

The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings.

Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories.

For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS.

To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections. ........


snip...


http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf


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 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


USDA ANNOUNCES BSE TEST RESULTS AND NEW BSE CONFIRMATORY TESTING PROTOCOL

WASHINGTON, June 24, 2005 -- Agriculture Secretary Mike Johanns today announced that the U.S. Department of Agriculture has received final test results from The Veterinary Laboratories Agency in Weybridge, England, confirming that a sample from an animal that was blocked from the food supply in November 2004 has tested positive for bovine spongiform encephalopathy (BSE). Johanns also directed USDA scientists to work with international experts to thoughtfully develop a new protocol that includes performing dual confirmatory tests in the event of another "inconclusive" BSE screening test.


http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB/.cmd/ad/.ar/sa.retrievecontent/.c/6_2_1UH/.ce/7_2_5JM/.p/5_2_4TQ/.d/1/_th/J_2_9D/_s.7_0_A/7_0_1OB?PC_7_2_5JM_contentid=2005/06/0232.xml&PC_7_2_5JM_navtype=RT&PC_7_2_5JM_parentnav=LATEST_RELEASES&PC_7_2_5JM_navid=NEWS_RELEASE#7_2_5JM

HOWEVER, when Dr. Detwiler tried to tell them this in 2003, they shot the messenger ;

USDA 2003

We have to be careful that we don't get so set in the way we do things that
we forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip.............


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado


2005

=============================


AFTER this administration put Dr. Detwiler out to pasture cause she did not agree with there BSE protocols, she was so wrong, she now works to make sure our beef at McDonald's is safe cause McDonalds saw the writing on the wall ;

International Scientific Advisory Council
McDonald's International Scientific Advisory Council adds further strength to our beef safety program by providing independent expert scientific and medical advice on bovine spongiform encephalopathy (BSE).

COUNCIL MEMBERS

Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences Center, University of Toronto. Specialist in motor neuron diseases and the cell biology of amyloid encephalopathies, including prion illnesses. Author of over 250 publications. Recipient of the 2000 Jonas Salk Prize for biomedical research.

Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for quality assurance and food safety programs for the retail division for fresh beef, pork, poultry and ready-to-eat meats.

Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of Veterinary Medicine, University of Maryland. Also provides private animal health consulting services, with specializations in transmissible spongiform encephalopathies, emergency preparedness, and animal product issues related to imports and exports. Formerly Senior Staff Veterinarian, Emergency Programs Staff, U.S. Department of Agriculture Animal and Plant Health Inspection Service, the unit principally responsible for surveillance, prevention, and education activities related to BSE. Member of various international working groups and advisory committees on TSEs. Author of numerous articles on the issues.

Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine, Senior Assistant Chairman, Department of Internal Medicine, Hospital Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in public health and foodborne illnesses. Fellow, Infectious Diseases Society of America. Fellow, American College of Physicians. Member, Society of Healthcare Epidemiology of America. Author or co-author of more than 140 scientific publications.

Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192 Ltd., an organization that provides expert advice on public and animal health, particularly with respect to BSE. Formerly Chief Veterinary Officer, Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie eradication program and served in numerous other senior-level staff and advisory positions related to TSEs. Author of a book on prions and prion diseases in humans and animals.

Dr. David Kessler. Dean, School of Medicine, Yale University and former Commissioner, U.S. Food and Drug Administration. Author of A Question of Intent (on federal tobacco regulation efforts) and numerous articles in major medical journals. Member, Board of Directors, Elizabeth Glaser Pediatric AIDS Foundation, Doctors of the World, National Center for Addiction and Substance, Henry Kaiser Family Foundation. Recipient of numerous medical public service awards, including the American Heart Association National Public Affairs Special Recognition Award, American Academy of Pediatrics Excellence in Public Service Award, and American Cancer Society Medal of Honor.

Dr. Colin Masters. Professor and Head, Department of Pathology, University of Melbourne. Specialist in neuropathology. Member, numerous national and international medical professional societies.

Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing, Government of Uruguay and Delegate to the OIE, the UN's principal agency for animal diseases.

Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and Leader, Meat Science Section, Department of Animal Science, Texas A&M University. Specialist in meat quality/consistency, food safety and nutrition. Past President, American Meat Science Association; member, Institute of Food Technologists, American Society of Animal Science, HACCP Alliance. Author or co-author of more than 250 articles and co-author of the Laboratory Manual for Meat Science. Recipient of numerous awards for research and teaching.

Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of Public Health Sciences, and Director, Stroke Research Center, Wake Forest University School of Medicine. President, International Stroke Society; member and past-president, World Federation of Neurology; member and past-president American Neurological Association; fellow, Royal College of Physicians; master, American College of Physicians. Author of Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor Handbook of Clinical Neurology. Former editor, Journal of the Neurological Sciences.


http://www.mcdonalds.com/corp/values/socialrespons/resrecog/expert_advisors0/international_scientific.html


September 13,2004

USDA, FSTS

Docket Clerk

300 12* Street, SW

Room 102, Cotton Annex

Washington, DC 20250

04-021ANPR

04-021ANPR-70

Richard L. Crawford

Re: Docket No: 04-02 1 ANPR Federal Measures to Mitigate BSE Risks: Considerations

for Further Action

Dear Sir or Madame:

On behalf of McDonald’s Corporation, which operates more than 13,000 restaurants in

the United States, we appreciate the opportunity to submit comments to this very

important Advance Notice of Proposed Rulemaking (ANPRM). 69 Fed. Reg. 42288 (July

14,2004).

In previous comments submitted to FSIS regarding the removal of SRI&, McDonalds

fully supported this rule and its immediate implementation. The removal of SRMs from

human food is the primary firewall to protect the US consumer from being exposed to the

BSE agent. While we applaud the requirement for SRM removal, we feel that it is

equally important for FSIS to insure that each slaughterplant which processes cattle have

systems in place which prevent cross contamination between edible tissue and SRMs.

This should include but not be limited to the use of separate equipment, such as knives,

blades, etc. where appropriate. In addition, it is also important that appropriate and

effective disinfection procedures for equipment used to handle SRMs be developed and

approved for use.

It is our opinion that requiring SRM removal without a procedure to prevent cross

contamination is inadequate as a protective public health measure. The TSE agents

@ions) are sticky and highly resistant to disinfection. If SRMs such as brain and spinal

cord are allowed to contact equipment and other surfaces such as deboning tables which

then are used to handle and process edible tissue this could allow contamination and

negates the intention of the ban. This is true not only in plants slaughtering fed cattle

both under and over 30 months but also in plants slaughtering predominately older cattle.

It is important that measure be taken to prevent cross contamination between carcasses

and SRms in the cull plants. McDonalds requires their suppliers to prevent cross

contamination and audits against certain measurable standards such as requiring spinal

cord to bc removed on the kill floor. We would be willing to share these standards with

FSIS as an example.

FSIS Docket No. 04-02 1 ANPR

dooqhl- =w c1qo -

McDonalds again recommends that dura (the covering around the brain and spinal cord)

be added to the list of SRMs. While skull and vertebral column are included as SRMs,

dura is not. If dura is not removed prior to processing on the fabrication floor, it may

come loose and be incorporated into ground product. Bovine dura was never tested for

infectivity. It was assumed that due to direct contact with spinal cord, it may serve as a

vehicle to transmit disease. In addition, human dura has been the source of human to

human transmission of Creutzfeldt-Jakob Disease (CJD). (personal communication - Dr.

Danny Matthews, UK, VLA) Our ISAC committee recommended that McDonalds add

the removal of dura as a specification in the production of our product.

McDonalds urges the USDA to make the appropriate adjustments in the SRM ban if new

scientific findings and/or the results of the increased surveillance warrant a change.

In regards to imported meat products from other countries, McDonalds suggests that no

SRM exemption be made for countries based on BSE risk. The long incubation period

and limited surveillance in many countries can limit the ability to accurately determine

risk. Also, the risk level of a country could potentially change over night if the trading

patterns of a country changed. It seems logistically impossible to maintain a system

which could continually monitor the world’s trading patterns. In addition, science has

not provided all of the answers in regards to the transmission of BSE. Requiring SRMs

to be removed from imported products for human food is prudent. If the US would wait

until disease is confirmed the exposure would already have occurred.

Thank you for the opportunity to comment on these very important issues.

Richard L. Crawford

Corporat,e Vice President, Government Relations

McDonalds Corporation

1 Kroc Drive

Oak Brook, Illinois 60523

FSIS Docket No. 04-021ANPR


http://www.fda.gov/ohrms/dockets/dailys/04/sep04/092104/04n-0264-c00140-vol22.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/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r

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

CDC - Afterthoughts about Bovine Spongiform Encephalopathy and ...
Afterthoughts about Bovine Spongiform Encephalopathy and Variant Creutzfeldt-Jakob Disease. Paul Brown Senior Investigator, National Institutes of Health, ...


http://www.cdc.gov/ncidod/eid/vol7no3_supp/brown.htm


December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

As scientists and Irecognized experts who have worked in the field of TSEs for

decades, we are deeply concerned by the recent discoveries of indigenous BSE infected

cattle in North America and appreciate the opportunity to submit comments to this very

important proposed rule We strongly supported the measures that USDA and FDA

implemented to protect public health after the discovery of the case of bovine spongiform

encephalopathy (BSE) found in Washington State in 2003. We know of no event or

discovery since then that could justify relaxing the existing specified risk material

(SRM) and non-ambulatory bans and surveillance that were implemented at that time.

Further, we strongly supported the codification of those changes, as well as additional

measures to strengthen the entire feed and food system. The discovery of additional

cases of indigenous BSE in North America since that time has validated our position and

strengthened OUT convictions.

We caution against using the 18 month enhanced surveillance as a justification to relax or

impede further actions. While this surveillance has not uncovered an epidemic, it does

not clear the US cattle herd from infection. While it is highly likely that US and

Canadian cattle were exposed to BSE prior to the 1997 feed ban, we do not know how

many cattle were infected or how widely the infection was dispersed. BSE cases are

most likely clustered in time and location, so while enhanced surveillance provides an 18

month snapshot, it does uot negate the fact that US and Canadian cattle were exposed to

BSE. We also do not know in any quantitative or controlled way how effective the feed

ban has been, especially at the farm level. At this point we cannot even make a thorough

assessment of the USDA surveillance as details such as age, risk category and regional

distribution have not been released.


see full text 18 pages ;


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

[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY


http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao

[2]

[GAO-05-101 ] Mad Cow Disease: FDA's Management of the Feed Ban Has Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness
Size: 104986 , Score: 1000 , TEXT , PDF , SUMMARY

http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.88&filename=d05101.txt&directory=/diskb/wais/data/gao


[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

03-025IFA
03-025IFA-2
Terry S. Singeltary


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

Subject: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket No. 2002N-0273 C-534 VOL 45 (PhRMA) and Entered On February 17, 2006
Date: March 10, 2006 at 5:23 pm PST

Marie A. Vodicka, PhD

Assistant Vice President

Biologics & Blotechnology

Scientlflc & Regulatory Affairs

SCIENCE & REG AFFAIRS

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rrn . 1061

Rackville, MD 20862


Re: Substances Prohibited from Use in Animal Food or Feed, Proposed Rule, Docket

No. 2002N-0273

February 14, 2006

Dear Sir or Madam :

The Pharmaceutical Research and Manufacturers of America (PhRMA) is providing

comment to the proposed rules issued. ......


snip...


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf

Subject: Docket No: 2002N-0273 (formerly Docket No. 02N-0273) Substances Prohibited From Use in Animal Food and Feed PAUL BROWN
Date: January 20, 2006 at 9:31 am PST

December 20,2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)

Substances Prohibited From Use in Animal Food and Feed

Dear Sir or Madame:

As scientists and Irecognized experts who have worked in the field of TSEs for

decades, we are deeply concerned by the recent discoveries of indigenous BSE infected

cattle in North America and appreciate the opportunity to submit comments to this very.........


snip...


Given that BSE can be transmitted to cattle via an

oral route with just .OO1 gram of infected tissue, it may not take much infectivity to

contaminate feed and keep the disease recycling. ........


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


THE SEVEN SCIENTIST REPORT ***


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

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

NOT TO SPEAK OF THE 11,000+ TONS OF MAD COW TAINTED FEED RECALL JUST ANNOUNCES ;


Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA, MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html


The BSE MRR policy is nothing more than a legal tool to trade _all_ strains of TSE Globally. The BSE MRR policy must be repelled and the BSE GBR risk assessment must be enhanced to include all TSE, especially the atypical BSE/TSE showing up in cattle, since the USA BSE GBR risk is III and the fact both typical and atypical BSE/TSE has been documented in the bovine in the USA. ...tss

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report
Summary
Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.


Publication date: 20 August 2004


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

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




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