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From: TSS ()
Subject: Re: DURA MATER-ASSOCIATED CJD: FIRST REPORTED CASE FROM PORCINE SOURCE DURA
Date: April 19, 2006 at 7:12 pm PST

In Reply to: DURA MATER-ASSOCIATED CJD: FIRST REPORTED CASE FROM PORCINE SOURCE DURA posted by TSS on April 19, 2006 at 4:56 pm:

Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm -
05-20-2003

Subject: RE--[Docket No. 00D-1662] Xenotransplantation Products and
HUMAN/ANIMAL TSEs ''SUBMISSION''
Date: Mon, 07 Apr 2003 12:01:01 -0500
From: "Terry S. Singeltary Sr."
To: fdadockets@oc.fda.gov

IN regards to [Docket No. 00D-1662], i would
kindly like to make several further comments regarding
human/animal TSEs. my comments will be posted below the
snips of concern i have posted from [Docket No. 00D-1662]
Xenotransplantation Products and HUMAN/ANIMAL TSEs;

[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16542-16543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-84]


snip...


WITH ALL these factors, then add in the potential for not only
BSE/TSEs in USA cattle, but also the potential that CWD and
Scrapie could be transmitted to man, and what potential risks
these could pose via the medical/surgical/Xenotransplantation
arena, and then to think of surgical tools that would be used
in these Xenotransplantation and the _other_ humans they may be
used on LATER, with even possibly 2nd and 3rd passage of TSEs.
Serious thought and very critical precautions should be taken
before such Xenotransplantation take place, with regard to
human/animal Transmissible Spongiform Encephalopathies...

thank you,

i am sincerely,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
CJD WATCH


Research Project: Transmission, Differentiation, and Pathobiology of
Transmissible Spongiform Encephalopathies

Location: Virus and Prion Diseases of Livestock

Title: Evaluation of a Diet Free of Animal Protein in Germfree Swine

Authors
item Loynachan, A - IOWA STATE UNIVERSITY
item Pettigrew, J - UNIVERSITY OF ILLINOIS
item Wiseman, B - NEXTRAN, INC
item Kunkle, Robert
item Harris, D - IOWA STATE UNIVERSITY

Submitted to: Xenotransplantation
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: January 5, 2005
Publication Date: March 1, 2005
Citation: Loynachan, A.T., Pettigrew, J.E., Wiseman, B.S., Kunkle, R.A.,
Harris, D.L. 2005. Evaluation of a Diet Free of Animal Protein in Germfree
Swine. Xenotransplantation. 12:149-155.

Interpretive Summary: Basic research into the potential to use organs
harvested from swine for the purpose of transplantation to save human lives
has identified potential immunological and transmissible infectious disease
obstacles. BSE has been transmitted to swine following intracerebellar
inoculation, indicating the potential susceptibility of pigs to prion
infections. Although neither natural nor experimental oral transmission of
spongiform encephalopathies has been recorded in pigs, concerns about the
transmission of prion proteins in feed have led to the development of a diet
free of animal protein (DFAP). This study describes a method to rear
neonatal pigs in a manner that precludes exposure to environmental
microorganisms and animal-derived proteins. Twenty pigs were derived by
Cesarian-section and housed in sterile bubble-pens. Duplicate trials were
conducted in which germ-free pigs or pigs intentionally colonized exclusivel
y with the bacterium Lactobacillus paracasei subspecies paracasei were fed
either a traditional milk-based diet (Esbilac) or the experimental DFAP. On
the whole, the pigs in all groups remained healthy, however, two pigs fed
the DFAP developed mild diarrhea and gained less weight. The pigs were
euthanized at 16 days of age. Examinations revealed no evidence of
contamination or disease. The use of the probiotic, Lactobacillus paracasei,
did not confer any measurable growth advantage to pigs fed either diet. The
experimental DFAP was capable of sustaining life, but was not as efficacious
as the conventional milk-based diet as based upon weight gain and
feed-conversion.

Technical Abstract: Two experiments were conducted in which germfree pigs or
pigs monoassociated with Lactobacillus paracasei subspecies paracasei were
fed either a traditional milk-based diet (Esbilac) or an experimental diet
free of animal protein (DFAP). Throughout the 16-day study, animals' general
disposition, total weight gain, feed conversion, and bacterial contamination
were monitored. At the conclusion of the study the animals were euthanized,
necropsied and tissues sampled for L. paracasei isolation. General pig
disposition remained consistent between treatment groups and trials, except
for two animals that developed mild diarrhea during trial 1. All pigs
remained viable during the study irrespective of the diet fed or probiotic
inoculation. Germfree pigs fed the Esbilac diet gained on average a total of
1034 (+/- 63.0) g, and had a feed conversion ratio of 0.17 (+/- 0.01) g of
gain per 1 ml of diet. Germfree pigs fed the experimental diet gained on
average a total of 599 (+/- 151) g, and had a feed conversion ratio of 0.10
(+/- .02) g of gain per 1 ml of diet. Monoassociated pigs fed the Esbilac
diet gained on average a total of 862 (+ 70.3) g, and had a feed conversion
ratio of 0.14 (+/- 0.01) g of gain per 1 ml of diet. Monoassociated pigs fed
the experimental diet gained on average a total of 563 (+/- 96.8) g, and had
a feed conversion ratio of 0.09 (+/- 0.02) g of gain per 1 ml of diet. L.
paracasei established extensively in pigs fed either the Esbilac or
experimental diets. L. paracasei had no effect (p>0.05) on piglet growth and
did not display any interactions based on the diet fed. Statistical
differences (p<0.05) were noted on measured growth parameters between trial
1 and 2, and on measured growth parameters based on the diet fed. In
conclusion, a diet free of animal protein has been developed and has been
shown to be capable of sustaining life in piglets up to 16 days of age.


http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=17
0002

Subject: Source Animal, Product, Preclinical, and Clinical Issues Concerning
the Use of Xenotransplantation Products in Humans
Date: Fri, 04 Apr 2003 09:47:11 -0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: bloodcjd , cjdvoice@yahoogroups.com

Guidance for Industry

Source Animal, Product, Preclinical, and Clinical Issues Concerning the
Use of Xenotransplantation Products in Humans

snip...

# SOURCE ANIMAL CHARACTERIZATION

# General Considerations

The cross-species infectious potential of specific animal
pathogens should be a major consideration in the selection of the source
animal species. Anatomic and physiologic considerations are also of
importance. For example, whether an organ is of appropriate size and
will function adequately across species barriers are considerations, as
are certain immunologic concerns including the suitability of current
regimens in prevention of rejection of the nonhuman live cells, tissues
or organs. Please note that the species you use may be subject to other
federal laws and regulations (see, e.g., 16 U.S.C. 1538) such as those
covering endangered or protected species. You should consult all
relevant PHS and FDA guidance documents on this subject prior to
submitting an application, and specifically should consult the document,
“Guidance for Industry: Public Health Issues Posed by the Use of
Nonhuman Primate Xenografts in Humans” (reference 2) before submitting
an application to FDA that involves the use of nonhuman primates as
sources of a xenotransplantation product. (The term “xenograft” in the
above referenced document is synonymous with the term
“xenotransplantation product” in current use by DHHS and in this guidance.)

Due to potential infectious disease risks associated with the use
of xenotransplantation products, you should develop appropriate source
animal qualifications. These qualifications should include herd
management and programs for prevention and screening for infectious
agents. Although testing of the final xenotransplantation product for
infectious agents is crucial, appropriate control of animal sources and
husbandry provides important additional assurance for the safety of such
products by controlling infections by both known and potentially even
unknown agents. Therefore, the specific information supplied by the
sponsor regarding animal husbandry including housing, feeding,
veterinary care, drug and biologic treatment of source animal herds and
individual source animals, will be crucial for FDA evaluation of the
potential for safe use of cells, tissues, or organs from such source
animals.

The SAF, production process, and records are subject to FDA
inspection under section 704 of the Act (21 U.S.C. 374) and section
351(c) of the PHS Act (42 U.S.C. 262(c)).

# Animal Welfare Concerns

Another area of consideration for SAFs and manufacturers of
xenotransplantation products is the welfare of the source animals.
Procedures for animal husbandry, tissue harvesting, and termination of
animals should be approved by an appropriate Institutional Animal Care
and Use Committee, in accordance with the Animal Welfare Act (7 U.S.C.
2131, et seq.). In cases where funds are received from the PHS,
procedures must also comply with the PHS Policy on Humane Care and Use
of Laboratory Animals according to section 495 of the PHS Act (42 U.S.C.
289(d)). We recommend that the SAF be accredited by the AAALAC.
Standards for accredited facilities for when funds are received from the
National Institutes of Health are provided in the National Research
Council’s Guide for the Care and Use of Laboratory Animals (reference 4).

# Animal Origin

1. Animal and Herd Qualification

You should derive source animals only from closed herds
with documented health screening programs. Individuals with expertise in
infectious diseases of the species involved should develop a list of
viruses, bacteria (including the rickettsiae), mycoplasma, fungi,
transmissible spongiform encephalopathies (TSEs), and parasites for
which the herd is screened and supply this information to FDA as part of
the application to FDA (e.g., IND). You should consider all infectious
agents known to infect the source species. You should justify the
rationale for omitting agents that are found in the source animal
species from the herd screening program in the application to FDA
requesting investigational use (e.g., IND). For example, the geographic
location of the herd may allow exclusion of certain infectious agents.
You should obtain source animals from TSE-susceptible species only from
closed herds that are documented to be free from TSE diseases or
TSE-associated agents (see also section III.C.3.c.). You should not use
source animals obtained from geographic areas in which TSEs are known to
exist in the source species. In the application to FDA requesting
investigational use of the xenotransplantation product (e.g., IND), you
should describe and justify the frequency of the screening, the method
of assay, and the method of identifying which and what proportion of
animals are sampled. As data are accumulated that demonstrate product
safety, you may modify the screening program in consultation with the FDA.

2. Animal History

The sponsor should document the geographic origin, species,
strain, and genealogy of the source animal(s) and herd(s). The
documentation of source animal history should describe factors that may
pose risks to recipients, such as possible exposure of the predecessor
animals to sources of TSEs or other adventitious or infectious agents of
concern (see Definitions, section I.C.). Source animals should be bred
and raised in captivity and be derived from closed herds. You may use
artificial insemination, embryo transfer, cloning, or hysterotomy plus
foster feeding to establish animal herds with fewer endemic pathogens.
In particular, the PHS Guideline suggests that breeding programs use
caesarean-derived animals whenever possible (reference 1). You should
document the use of these procedures in the animal history.

3. Source Animals from Outside the U.S.

1. You should not use animals from outside the U.S. or
their first generation offspring as sources for the production of
xenotransplantation products unless they are of a species or strain not
available in the United States, or have specific qualities that provide
a unique and scientifically justified clinical advantage, such as
transgenic animals.

2. If the use of source animals from outside the U.S. is
necessary and justifiable, you should apply the same considerations for
these animals as for source animals bred in the U.S. (e.g., see section
III.D. for Animal Health and Husbandry). You should use a quarantine
period of sufficient length to demonstrate the absence of infectious
agents of concern, and you should perform extensive screening of the
animals. In the application to FDA requesting investigational use of the
xenotransplantation product (e.g., IND), you should submit thorough
documentation to demonstrate that such source animals have been derived
from closed herds, have been housed under appropriate conditions and
subjected to recommended health maintenance procedures and screenings,
and have not been fed rendered or recycled mammalian materials for at
least two generations. You should include in the screening agents that
are endemic in the country of origin. In the application to FDA
requesting investigational use of the xenotransplantation product (e.g.,
IND) you should describe methods and conditions of transport of imported
animals. Descriptions should include means of transport and husbandry
during transport including isolation, caging, handling, animal
treatment, and presence of other animals of the same or different
species. If animals from countries outside the U.S. are needed, you
should use them as founders for a domestic herd that will be
well-characterized for an extended period of time before use, using
procedures sufficient to validate the herd’s acceptability as source
animals.

3. You should not import source animals from any country
or geographic region where TSEs are known to be present in the source
species. The USDA has identified countries from which the importation of
ruminants and some ruminant products are restricted or prohibited (9 CFR
Parts 94 and 96).

4. You should consult the USDA and, when appropriate,
FDA’s Center for Veterinary Medicine (CVM) and CDC for their
requirements regarding importation of animals or animal tissues.

4. Range and Wild Animals

You should not use as source animals those that are raised
under free-ranging conditions. Such animals have a higher likelihood of
harboring infectious agents due to potential exposure of the source
animal to other animals, birds, insects, or other uncontrolled
environmental factors.

You should not use wild-caught animals as source animals.

5. Animal Sources Obtained from Slaughterhouses or Abattoirs

Animals from slaughterhouses or abattoirs are unsafe for
use as source animals. Appropriate documentation and histories of
animals from slaughterhouses may not be available because the animals
are often obtained from geographically divergent farms or markets, and
exposure to other animals or potential sources of infectious agents
during transit or after arrival at the slaughterhouse are unknown.
Therefore, you should not use such animals as source animals.

snip...

Consult the PHS Guideline (reference 1) for additional guidance and
information on testing recipients of xenotransplantation products.

1. Infectious Agents of Concern

Infectious agents of concern will differ among source animal
species and among cell or tissue types within each species. Therefore,
you should individualize clinical tests for the specific
xenotransplantation product in question. The categories of infectious
agents of concern include bacteria (including the rickettsiae), fungi,
mycoplasma, viruses, and the agent(s) causative for TSEs. Tests should
be available for agents known potentially to be present, including those
that are pathogenic in the source animal species and agents that are
known to infect human cells in vivo or in vitro. You should have the
capability to test for latent viruses or pathogens, and you should be
prepared to develop and validate clinical tests for new pathogens that
may not be recognized at the time of xenotransplantation. You should
identify specific infectious agents for which tests will be performed.
(See section VIII.F.3. for additional information on testing.)

snip...

# Risks to the Recipient and his/her Intimate Contacts

snip...

iii. It should include any known time course for the risks of disease
development and transmission. It should discuss infectious diseases with
protracted incubation periods including TSEs and other unusual pathogens.

http://www.fda.gov/cber/gdlns/clinxeno.htm#iii

[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16542-16543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-84]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1662]


``Guidance for Industry: Source Animal, Product, Preclinical, and
Clinical Issues Concerning the Use of Xenotransplantation Products in
Humans;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov
/2003/03-8167.htm


USA TISSUE DONOR HERDS???

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L


Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

snip...end


MRC-43-00 Text only version of this sitePrint this page
Issued: Monday, 28 August 2000
NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH
FINDINGS RELEVANT TO CJD AND BSE

A team of researchers led by Professor John Collinge at the Medical
Research Council Prion Unit1 report today in the Proceedings of the
National Academy of Sciences, on new evidence for the existence of a
‘sub-clinical’ form of BSE in mice which was unknown until now.

The scientists took a closer look at what is known as the ‘species
barrier’ - the main protective factor which limits the ability of
prions2 to jump from one species to infect another. They found the mice
had a ‘sub-clinical’ form of disease where they carried high levels of
infectivity but did not develop the clinical disease during their normal
lifespan. The idea that individuals can carry a disease and show no
clinical symptoms is not new. It is commonly seen in conventional
infectious diseases.

Researchers tried to infect laboratory mice with hamster prions3 called
Sc237 and found that the mice showed no apparent signs of disease.
However, on closer inspection they found that the mice had high levels
of mouse prions in their brains. This was surprising because it has
always been assumed that hamster prions could not cause the disease in
mice, even when injected directly into the brain.

In addition the researchers showed that this new sub-clinical infection
could be easily passed on when injected into healthy mice and hamsters.

The height of the species barrier varies widely between different
combinations of animals and also varies with the type or strain of
prions. While some barriers are quite small (for instance BSE easily
infects mice), other combinations of strain and species show a seemingly
impenetrable barrier. Traditionally, the particular barrier studied here
was assumed to be robust.

Professor John Collinge said: "These results have a number of important
implications. They suggest that we should re-think how we measure
species barriers in the laboratory, and that we should not assume that
just because one species appears resistant to a strain of prions they
have been exposed to, that they do not silently carry the infection.
This research raises the possibility, which has been mentioned before,
that apparently healthy cattle could harbour, but never show signs of, BSE.

"This is a timely and unexpected result, increasing what we know about
prion disease. These new findings have important implications for those
researching prion disease, those responsible for preventing infected
material getting into the food chain and for those considering how best
to safeguard health and reduce the risk that theoretically, prion
disease could be contracted through medical and surgical procedures."

ISSUED FRIDAY 25 AUGUST UNDER EMBARGO. PLEASE NOTE THAT THE EMBARGO IS
SET BY THE JOURNAL.

FOR FURTHER INFORMATION CONTACT THE MRC PRESS OFFICE ON 020 7637 6011
(OFFICE HOURS) OR 07818 428297 OR 0385 774357 (OUT-OF-OFFICE-HOURS) OR
PROFESSOR JOHN COLLINGE ON 020 7594 3760. PLEASE NOTE THAT OWING TO
TRAVEL COMMITMENTS PROFESSOR COLLINGE WILL ONLY BE AVAILABLE UNTIL 16.30
ON FRIDAY 25 AUGUST AND CONTACTABLE AGAIN ON MONDAY 28 AUGUST VIA THE
MRC PRESS OFFICE. DR ANDREW HILL (A CO-AUTHOR ON THE PAPER) FROM THE
DEPARTMENT OF PATHOLOGY AT THE UNIVERSITY OF MELBOURNE WILL BE AVAILABLE
ON 00 61 3 8344 3995 (DURING OFFICE HOURS) OR 00 61 3 9443 0009
(OUT-OF-OFFICE HOURS). PLEASE NOTE THAT AUSTRALIA IS TEN HOURS AHEAD OF
UK TIME.

NOTES FOR EDITORS

Professor Collinge is a consultant neurologist and Director of the newly
formed MRC Prion Unit based at The Imperial College School of Medicine
at St Mary’s Hospital. He is also a member of the UK Government’s
Spongiform Encephalopathy Advisory Committee (SEAC). The MRC prion unit
is was set up in 1999, and its work includes molecular genetic studies
of human prion disease and transgenic modelling of human prion diseases.

Prions are unique infectious agents that cause fatal brain diseases such
as Creutzfeldt-Jakob disease (CJD) in humans and scrapie and BSE (mad
cow disease) in animals. In some circumstances prions from one species
of animals can infect another and it is clear that BSE has done this to
cause the disease variant CJD in the UK and France. It remains unclear
how large an epidemic of variant CJD will occur over the years ahead.

The strain of prion used here to infect the mice is the Sc237 strain
(also known as 263K) which infects hamsters, and until now was assumed
not to infect mice.

This research was funded by the Medical Research Council and Wellcome Trust.

TSS

-------- Original Message --------
Subject: PRO/AH> BSE policy - USA: change considered (02)
Date: Wed, 20 Apr 2005 12:10:16 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTS.UNI-KARLSRUHE.DE


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

-------- Original Message --------
Subject: PRO/AH> BSE policy - USA: change considered (02)
Date: Wed, 20 Apr 2005 10:21:26 -0400 (EDT)
From: ProMED-mail
Reply-To: promedNOREPLY@promed.isid.harvard.edu
To: promed-ahead@promedmail.org

BSE POLICY - USA: CHANGE CONSIDERED (02)
*******************************************
A ProMED-maili post

ProMED-mail, a program of the
International Society for Infectious Diseases


[1]
Date: 18 Apr 2005
From: Terry S Singeltary Sr


An excellent commentary by Mod.TG et al.

I would kindly like to add that "subclinical TSE" [see: BSE, possible
subclinical infection (02) 20000901.1466 for reference and discussion], and
a downer that may have fallen and broken a leg, hip etc, due to the first
symptoms of a TSE, however far-fetched this may be, it is very possible,
and any cow going into the food chain, whether for animals or humans, is
one too many.

So, any relaxing of this downer ban is just not acceptable, unless -- as
Mod.TG points out -- 100 per cent testing with the most sensitive testing
to date, that is, western blot with the addition of phosphotungstic acid
precipitation step (Bio-Rad Deslys et al.) and/or the CDI Prusiner and
colleagues are boasting about.

However, even 100 per cent BSE/TSE testing will only be as good as the
tests being used, and the ones doing the testing. You have to want to find
it.

--
Terry Singletary


******
[2]
Date: 19 Apr 2005
From: Carol J Marcus-Sekura


Thank you for that informative discussion. I have a short comment about
animal feed: the US may not put downer cattle into pet food, but we do put
it into non-ruminant animal feed. Farmers are instructed not to feed it to
ruminants. This seems a risky approach, as mistakes will be made; some
staff may not know or understand the word ruminant, and smaller farms may
not want to purchase many types of feed.

A change in this policy to conform to international policies was
recommended by international groups after the US BSE incident, but to my
knowledge, it was not adopted by the US.

--
Carol J Marcus-Sekura, PhD
BASI
7413 Ottenbrook Terrace
Rockville, MD 20855


******
[3]
Date: 19 Apr 2005
From: Bill Hall


I note with considerable interest the posting concerning the proposed
changes in the US position on BSE, in particular the comment on the
reporting of BSE/TSE findings in the brains of market-age pigs.

Were you referring to the paper listed below (1), which reported lesions
induced by inoculation? If not, can you give the citation to the material
referred to?

"As to the concerns in the article that a ban on downer animals could be
extended to swine, perhaps it should. In a recent study of swine,
spongiform encephalopathy changes were noted in the brains of market swine,
despite the absence of any outward signs of clinical neurological disease."

1. Studies of the transmissibility of the agent of bovine spongiform
encephalopathy to pigs. J Gen Virol 2003; 84(Pt4): 1021-31. PMID: 12655106

--
William Hall BVSc MS
Manager, Research and Innovation Division
Australian Pork


******
[4]
Date: 19 Apr 2005
From: LuAnn McKinney


Great discussion between the 2 moderators... thank you!
I know that intracerebral injection will cause a 'Porcine' SE, but could
you please give us the reference for the "recent study of swine, spongiform
encephalopathy changes were noted in the brains of market swine, despite
the absence of any outward signs of clinical neurological disease." I've
missed that one and it's really, really important.

--
L McKinney, DVM, DACVP.


******
[5]
Date: 19 Apr 2005
From: Richard Llewellyn Brown


1. It would be worth finding out where the temptations to cut corners are
both in terms of numbers and type of conditions. So, for instance, if the
majority of cases are young animals with a clear cut bona fide recent
fracture, which everyone can see then one should cater for this. Just to
ban that beast is producing too much temptation: it looks edible!.To be on
the safe side you could hold the carcase in the freezer and not release
until a check of the CNS with a rapid technique has passed it. The producer
to pay some of the test costs.

2. If, however, a significant number are downer cows of 29 months and 29
days old then I would be very careful. We have found a quite a number of
downers which look pretty clear cut cases of paralysis, bright alert at the
head etc, they are in fact BSE. Admittedly these are older cattle.

3. Then you get the "from the blind side case". We even had one case (not
that it was going to slaughter) of an old cow with gangrenous mastitis
going off her legs. We thought she had paresis due to toxaemia but she also
had BSE. Surprise all round. Cross questioning of the farmer revealed a
slight hindleg lameness weakness which cured itself the year before. (If
she had been transported then ,what would have happened!) She had been a
lively character: otherwise little to note.

4. So I agree with the moderators there is a balance which neeeds to be
explained but I do suggest you look at the real life temptations which you
can only know if you know the types of cases you are dealing with and their
frequency.

Personally I would go for under 24 months, clear cut fracture, with vet
certificate and producer paid CNS testing :-OK to eat. All the rest no: too
open to abuse.

--
Richard Llewellyn Brown MRCVS
Huntly
Aberdeenshire
Scotland

******
[6]
Date: 19 Apr 2005
From: J Herrmann


A number of issues are worth mentioning here:
1) It is true that almost all "downer" cattle are not infected with BSE.
However, they traditionally carry a higher level of contamination with
zoonotic bacteria and often are more at risk for carrying anitbiotic
residues than are "walkers".

2) Cattle usually do not show symptoms of BSE until over 30 months of age
(the average age for BSE (+) cattle in the EU during 2003 was somewhere
around 55 months if I remember correctly).

3) The analytic sensitivity of our current tests, including
immunohistochemistry, ELISA and Western Blot, is such that adequate amounts
of abnormal prions usually do not accumulate until about 6 months prior to
clinical symptoms. Therefore there is a built in age limitation on the
sensitivity of current tests.

4) Given the age limitation of current tests methods, it is difficult to
justify testing the vast majority of US cattle that are processed each
year; about 85 per cent of the 30 million slaughtered each year are less
than 30 months of age.

5) USDA has focused on BSE testing cattle that may have clinical symptoms
of BSE despite the fact that symptoms are not pathognomonic for BSE. All 4
cows that were recently positive in North America (3 Canadian, one US) were
not specifically symptomatic for BSE.

6) USDA has made no concerted effort to survey the cattle that were born
before the ruminant feed restrictions of 1997-1998 and that could have had
direct exposure to contaminated meat and bone meal. Approximately 1-2
million of these cattle are slaughtered each year.

--
J Herrmann, DVM, MPH, DACT
University of Illinois
Former Congressional Science Fellow, United States Senate

--
ProMED-mail


[Regarding silent BSE, there remains more emotional hype about this disease
than there is solid evidence. However, the article in the footnote is
interesting and, although several years old, it is worth a read.

Title 21 of the Code of Federal Regulations part 589.2000 reads,
"(a)Protein derived from mammalian tissues means any protein containing
portion of mammalian animals, excluding: Blood and blood products; gelatin;
inspected meat products which have been cooked and offered for human food
and further heat processed (such as plate waste and used cellulosic food
casings); milk products whose only mammalian protein consists entirely of
porcine or equine products."

21 CFR 589.2000 continues: "(4) Feed manufacturer includes manufacturers of
complete and intermediate feeds intended for animals, and includes on-farm
in addition to off-farm feed manufacturing and mixing operations."

There are published newspaper accounts of farm mixing of pet food by
products being fed to cattle. According to the published accounts, the
paperwork from the pet food company, signed by the animal producers, stated
that it would not be fed to any ruminant animal such as cattle, goats, or
sheep. Tests confirmed ruminant DNA in the feed bunkers where cattle were
feeding. However, the article reported that, since the FDA could not
demonstrate a prion to a court of law that they would take no action
regarding on-farm mixing.

The newspaper accounts indicate that the FDA is not standing up to its own
published rules. One reason may be that they don't know what to do with a
group of cattle under 30 months old in a feedlot-type situation that have
been fed banned product. FDA is not usually in the habit of indemnifying
animals. That task usually is under the purview of the USDA. However, the
feed ban rule is an FDA rule, so why should USDA indemnify an owner when
they don't even have a rule to cover the circumstances?

If accounts such as these are published in newspapers, then the second
article in today's posting would be correct -- that we are not protected
from BSE by the feed ban.

As to postings 3 and 4, regarding my comment about swine: after multiple
relocations in a short time, it is difficult to put my hand on the article
upon which I based that statement. However, here are a couple of likely
candidates for that comment:

1) Studies of the transmissibility of the agent of bovine spongiform
encephalopathy to pigs. Gerald AH Wells, Stephen AC Hawkins, Anthony R
Austin, Stephen J Ryder, Stanley H Done, Robert B Green, et al:

2) The potential for transmissible spongiform encephalopathies in
non-ruminant livestock and fish. D Matthews, BC Cooke. Rev Sci Tech OIE
2003; 22(1): 283-96.
3) The neuropathology of experimental bovine spongiform encephalopathy in
the pig. Ryder SJ, Hawkins SA, Dawson M, Wells GA. J Comp Pathol 2000;
122(2-3): 131-43.

However, without regard to any of these, the report from a new study is
worth your time to read. It details transplanting swine organs to people
and the possibility of TSE disease being transmitted.

Research Project: Transmission, Differentiation, and Pathobiology of
Transmissible Spongiform Encephalopathies


National Animal Disease Center Virus and Prion Diseases of Livestock


Evaluation of a diet free of animal protein in germfree swine. Loynachan A,
Pettigrew J, Wiseman B, Kunkle R, Harris D. Xenotransplantation 2005; 12:
149-55. - Mod.TG]

[see also:
BSE policy - USA: change considered: 20050418.1094]

.......................tg/pg/sh


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

-------- Original Message --------

Subject: PRO/AH> BSE - USA: policy change considered (03)

Date: Fri, 22 Apr 2005 02:48:29 -0400 (EDT)

From: ProMED-mail

Reply-To: promedNOREPLY@promed.isid.harvard.edu

To: promed-ahead@promedmail.org

BSE- USA: POLICY CHANGE CONSIDERED (03)

***************************************

A ProMED-mail post

ProMED-mail, a program of the

International Society for Infectious Diseases

[1]

Date: 21 Apr 2005

From: David Adams

I note with interest the reply to the request for more information on the
recent study in which spongiform encephalopathy changes were noted in the
brains of market swine, despite the absence of any outward signs of
clinical neurological disease. This is indeed really, really important
because it has implications for the well-established knowledge about BSE
that has had pragmatic value in driving the eradication of this disease
from the world.

Further and more accessible information on the USDA project on
transplanting swine organs to people and the possibility of TSE disease
would be very welcome. [The web sites on the USDA research were provided in
the previous post. Readers are encouraged to look into new research on
their own. - Mod.TG]

In the meantime, a reminder may be worthwhile about established facts in
the epidemiology of BSE that make it both possible and feasible to
eradicate the disease and the causative agent. These established facts are:

1. The consumption by cattle of cattle derived by-products such as meat and
bone meal (MBM) that contain the causative agent is the only means of
transmission of BSE. The accumulated evidence on this point from field
observation and experimentation is virtually indisputable.

2. When the persistent and habitual re-feeding of cattle tissues back to
cattle ceases, transmission of the disease ceases. Feed bans are the
critical control point for BSE, as they block the potential transmission of
hypothetical sporadic BSE to other cattle. [Most feed bans are mammalian to
cattle, not just banning cattle by-products being fed to cattle. - Mod.TG]

3. Clinical cases of BSE may still appear after a ban on the feeding of MBM
and because of the long incubation period for the disease. These cases will
only occur in animals exposed to contaminated feed. [but this does not
explain calves born long enough after the ban that one cannot make the
argument that the dam was fed contaminated feed. - Mod.TG]

4. Clinical cases of BSE will no longer be seen once the generation of
animals exposed to the disease agent has died. Observations show that the
age cohort remaining 16 years after stoppage of the persistent and habitual
re-feeding of cattle tissues back to cattle has a disease prevalence of
zero.

5. The disease agent is not perpetuated in the environment and is
degradable. [Although the prion can be degraded at extremely high
temperatures and more easily in alkaline conditions, it has not been proven
to be degraded in the environment. - Mod.TG]

6. Amalgamated results of surveillance make the possibility of sporadic BSE
extremely remote. The hypothesis that sporadic disease is a class property
of the TSEs that applies to cattle is well on the way to being disproved.


7. Surveillance for disease in cattle is not a control measure in itself
but serves to accredit the impact of true control measures, which are
exclusion of the disease and its agent from an area and bans on feeding
cattle tissues back to cattle.

--
David Adams
Senior Principal Research Scientist
Office of the Chief Veterinary Officer
Department of Agriculture, Fisheries and Forestry - Australia
GPO Box 858, Canberra ACT 2601, Australia


******
[2]
Date: 21 Apr 2005
From: Paul Goldwater

An astounding aspect of "downer" cows is the fact that this condition or
group of conditions has been around for a long time, yet I can find no
report of downer cow brain pathology. Surely it is time for a comprehensive
study of the condition so that it can be properly defined
clinicopathologically. No relaxation of current prohibitions should occur
until we know more about downer cows.

--
Dr Paul N Goldwater, FRACP, FRCPA,
Medical Head, Virology, & Senior Consultant Clinical
Microbiologist/Physician in Infectious Diseases,
Microbiology & Infectious Diseases Department,
Children's, Youth and Women's Health Service,
The Women's & Children's Hospital,
North Adelaide, South Australia 5006.
email:
[I am unaware of any research of this type going on. Unless there is further
notice regarding the change of policy of the US, this thread is cut. -
Mod.TG]

[see also:
BSE policy - USA: change considered (02) 20050420.1105
BSE policy - USA: change considered: 20050418.1094]

...................tg/pg/sh


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are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
************************************************************
Visit ProMED-mail's web site at .
Send all items for posting to: promed@promedmail.org
(NOT to an individual moderator). If you do not give your
full name and affiliation, it may not be posted. Send
commands to subscribe/unsubscribe, get archives, help,
etc. to: majordomo@promedmail.org. For assistance from a
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