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From: TSS ()
Subject: SEAC 99th meeting on Friday 14th December 2007
Date: December 12, 2007 at 10:16 am PST

SEAC 99th meeting on Friday 14th December 2007


1 09.30 Introduction SEAC Chair


Approval of draft minutes from SEAC 98


SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE


Draft open minutes of the 98th meeting held on 29th July 2007


23. The Chair summarised the discussion noting that SEAC agreed: • there are
no substantive new data to allow a reassessment of the infectivity of plasma
derivatives from fractionation of contaminated plasma. • only research that
measures the clearance of endogenous infectivity in blood would support a
reassessment of the infectivity of plasma derivatives. • the National
Haemophiliac Database could provide important data to assess the risks of
transmission of vCJD via plasma derivatives.


snip...


32. A member noted that from a public and consumer perspective SEAC has
always been seen as an exemplar of good practice for example by holding its
meetings in public and communicating its statements and decisions using
clear language. It was noted that the House of Commons report is not in
favour of consumer or lay representatives on all scientific committees as a
matter of course and it advises that their roles are re-evaluated. The
member noted that lay members are in fact important in ensuring that
information produced by committees can be understood by non-experts.
However, it is important to make clear that a single consumer representative
cannot represent the thoughts of all consumers. Periodic review of
scientific advisory committees, such as is


3
http://www.dti.gov.uk/files/file39981.pdf


4
http://www.publications.parliament.uk/pa/cm200506/cmselect/cmsctech/900/900-i.pdf

undertaken with SEAC, is important as a quality assurance mechanism.


see full text 14 pages ;


http://www.seac.gov.uk/papers/99-1.pdf

USE OF PREVIOUS SEAC OPINIONS ISSUE


1. Given the evolving nature of scientific understanding of transmissible
spongiform encephalopathies (TSEs), it is suggested that an agreed procedure
be in place setting out a time limit for the use of SDEAC advice by a
Government Department without referral back to the committee. It is
suggested this is needed because new data could have appeared since the
advice was given that would cause the committee to alter that advice.


CONSIDERATION

see full text page ;

http://www.seac.gov.uk/papers/99-6.pdf

REPORT FROM THE SEAC SHEEP SUBGROUP


31. Given the low prevalence of classical scrapie and assuming that BSE in
sheep would occur independently from that of classical scrapie, if BSE is or
was present in the national sheep flock, it would have been expected to
arise more frequently as a single infection rather than mixed with classical
scrapie. However, since BSE as a single infection in sheep has never been
found, it is highly unlikely that an appreciable number of mixed infections
of classical scrapie and BSE are present currently in sheep unless BSE and
classical scrapie are more efficiently transmitted together between sheep
compared with BSE in isolation but there are no data to suggest this may or
may not be the case. However, unpublished results from inoculations into
mice of a mixed inoculum compared with individual inocula indicate an
increased attack rate suggesting higher transmission efficiencies of mixed
strains is a possibility12.


Summary 33. The data from the strain typing study, while intriguing and not
fully explained, provide no evidence for the presence of BSE in sheep as a
single infection. Whilst these data may indicate the presence of mixed BSE
and classical scrapie infections, this is one of several possible
interpretations. These data should not give rise to concern that there is an
appreciable number of mixed BSE-12 classical scrapie infections that would
significantly influence estimates of the prevalence of BSE in the UK sheep
flock.


Unpublished Roslin Institute studies.

13 SEAC Sheep Subgroup statement (2006)
http://www.seac.gov.uk/statements/sheepsubgrp-statement131006.pdf


14 Opinion on the quantitative risk assessment on the residual BSE risk in
sheep meat and meat products. The EFSA Journal. (2007) 442, 1-44.
http://www.efsa.europa.eu/EFSA/Scientific_Opinion/biohaz_op_ej442_qra_sheep_en,3.pdf

Maternal transfer of classical scrapie prion protein via sheep milk
Background 34. The mechanisms for transmission of classical scrapie between
sheep are not fully understood, however there is evidence to suggest that
the risk of transmission is high during the neonatal period15. A study by
VLA is examining whether milk may be a significant route of transmission by
bottle feeding milk collected from ewes genetically susceptible to, and
infected with classical scrapie, to genetically susceptible TSE-free lambs.
Data 35. Early unpublished findings from the study suggest that milk may be
a route of transmission. Post mortem examination of three lambs that were
bottle-fed milk from classical scrapie infected ewes which died early in the
study from intercurrent disease revealed the presence of PrPSc in gut
lymphoid tissue in two lambs. The milk fed to these two lambs was from two
ewes that developed clinical signs of classical scrapie during lactation.
The milk fed to the third lamb was from a ewe with clinical signs of
classical scrapie at the beginning of lactation from which only a relatively
small volume of milk was produced. Somatic cell counts were high in at least
a proportion of the milk collected from the ewes. PrPSc was not found in a
control lamb, which also died from intercurrent disease, that was fed milk
from an uninfected ewe. Implications 36. These data suggest that PrPSc may
be transmitted from ewe to lamb via milk or colostrum. As a full lactation
was fed to the lambs it is not possible to determine whether transmission
occurred via colostrum and/or the subsequent milk. The study is at too early
a stage to assess whether classical scrapie develops as a result of this
exposure, although this should be considered likely.

snip...see full text 15 pages ;


http://www.seac.gov.uk/papers/99-2.pdf


SCIENTIFIC BASIS FOR CLASSICAL SCRAPIE CONTROLS


Scientific basis for relaxation of classical scrapie controls


AFSSA OPINION 13. The AFSSA opinion (Annex 1) describes three areas of
scientific uncertainty that have led to the conclusion that the proposed
changes to controls may significantly increase the risk to human health from
the slaughter of sheep from classical scrapie affected flocks for human
consumption. In summary, AFSSA considered that: • the tests to detect and
discriminate between BSE and classical and atypical scrapie are limited as
(i) their sensitivity has not been accurately determined, (ii) they may not
detect BSE in animals that are also infected with classical scrapie and
(iii) the conduct of the discriminatory test on the index case would not
guarantee the absence of BSE in the flock. Furthermore, as only brain tissue
is tested, the rapid tests cannot detect TSE infections during the
incubation period prior to accumulation of abnormal prion protein in the
brain. • although there are no epidemiological data to suggest a link
between classical scrapie strains and human TSEs, in view of the diversity
of classical scrapie strains and the lack of a robust prospective study to
examine potential links between these TSE strains and human TSEs, a link
cannot be ruled out. • the incidence of classical scrapie infections in
classical scrapie affected sheep flocks can be relatively high, particularly
in those animals of susceptible genotypes5 suggesting classical scrapie
infection may be widespread in affected flocks. 14. In view of these
considerations, AFSSA concluded that allowing animals from classical scrapie
affected flocks to be slaughtered for human consumption, particularly
without any restriction on genotype, would increase the human health risk
as: (i) the presence of BSE in a sheep cannot be ruled out by the
application of discriminatory tests as the sensitivity of the tests is not
known precisely and detection may be compromised when classical scrapie is
also present. (ii) classical scrapie infections can be widespread in sheep
flocks and as rapid TSE tests cannot identify infected animals in the early
part of the incubation period, it is possible that an appreciable number of
classical scrapie infected animals could enter the human food chain. (iii)
the transmission to humans of TSE strains other than BSE cannot be ruled
out.

5 Corbiere et al. (2007) Advanced survival models for risk-factor analysis
in scrapie. J. Gen Virol. 88, 696-705.


EFSA OPINION 15.


The EFSA Scientific Panel on Biological Hazards considered the AFSSA opinion
and in particular the evidence for possible links between classical or
atypical scrapie and human TSEs and the performance characteristics of
discriminatory tests for sheep TSEs (Annex 2). The Panel concluded that: •
there is no evidence for an epidemiological or molecular link between
classical and/or atypical scrapie and TSEs in humans. The BSE agent is the
only agent identified as zoonotic. However, in view of their diversity it is
currently not possible to exclude transmissibility to humans of other animal
TSE agents. • current discriminatory tests appear, up to now, to be reliable
for the differentiation of BSE from classical and atypical scrapie. However,
at the current stage of scientific knowledge, neither their diagnostic
sensitivity nor their specificity can be assumed to be perfect. KOM AG TSE
OPINION 16. KOM AG TSE considered the changes to classical scrapie controls
(Annex 4) and noted that recently published research by Reckzeh et al.
(2007)6 (Annex 4) showed that some sheep of susceptible genotypes that had
tested negative for TSE infection when brain samples were tested, were in
fact positive for TSE infection when peripheral tissues were tested. Thus,
the committee concluded that the current strategy of testing brain tissue
cannot exclude the presence of TSE infections at the stage of the incubation
period prior to involvement of the brain. Thus, the changes to classical
scrapie controls could allow classical scrapie infectivity into the human
food chain. 17. In addition, the committee noted that, although the EFSA
Biohazard Panel concluded that there are no indications of the existence of
zoonotic link between classical scrapie and human TSEs, as classical scrapie
strains are not uniform and are poorly defined, a zoonotic potential cannot
be ruled out. In view of this, the committee considered that consumer
exposure to classical scrapie should be avoided and was not in favour of the
changes to the classical scrapie controls that would allow this to occur.


6 Reckzeh et al. (2007) Rapid testing leads to the underestimation of the
scrapie prevalence in an affected sheep and goat flock. Vet. Microbiol. 123,
320-327.


PREVIOUS SEAC OPINIONS


snip...


Opinion of the French Food Safety Agency (AFSSA) on changes to the control
measures for sheep and goat herds in which a case of classical or atypical
scrapie has been detected

http://www.afssa.fr/Documents/ESST2006sa0343EN.pdf


Opinion of the Scientific Panel on Biological Hazards on certain aspects
related to the risk of transmissible spongiform encephalopathies (TSEs) in
ovine and caprine animals


snip...


5- Conclusions and opinion

On the following grounds:

- the discriminatory tests do not enable the presence of BSE to be ruled out
either in the
tested animal or by extension in the flock to which it belongs;

- the transmission to humans of TSE strains other than BSE cannot be ruled
out;

- the knowledge acquired of the genetic susceptibility of sheep to scrapie
and BSE should
be used, insofar as this is possible, to limit the risk of consumer
exposure,

The Committee is making the following recommendations:

Recommendations common to both types of control measure:

- permanent individual identification of all small ruminants belonging to
the herds
concerned.

- for sheep, genotyping for the four cordons (136, 141, 154 and 171) of all
animals in an
infected flock.

- all tests carried out on animals slaughtered or culled as part of the
control measures must
be effected with one of the rapid tests with the best sensitivity for the
detection of atypical
scrapie (currently Idexx, Biorad).

- conduct of a discriminatory test on all secondary cases identified.

- destruction of all positive animals.


snip...please see full text 9 pages ;


http://www.efsa.europa.eu/EFSA/Scientific_Opinion/biohaz_op_ej466_tse_ovine_caprine_en.pdf

Opinion of the KOM AG TSE Evaluation of the catalogue of measures after
detecting a TSE case Reckzeh et al. (2007) Rapid testing leads to the
underestimation of the scrapie prevalence in an affected sheep and goat
flock. Vet. Microbiol. 123, 320-327.


snip see full text 21 pages ;

http://www.seac.gov.uk/papers/99-3.pdf


Consideration of various options relating to relaxation of the total feed
ban


ISSUE

1. The Department for Environment, Food and Rural Affairs (Defra) the
devolved Rural Affairs Departments and the Food Standards Agency (FSA) have
asked SEAC to consider, in qualitative terms, the potential for further
transmissible spongiform encephalopathy (TSE) infections and epidemics to
arise as a result of possible implementation of various future options for
relaxing the TSE-related feed controls. This paper, prepared by Defra,
provides an overview of European Union (EU) proposals and relevant science.


BACKGROUND


snip...


Work Programme8 on TSEs in November 2006. In relation to the feed ban, the
document proposed discussions on:


i. Permitting a tolerance of “insignificant amounts” of animal protein,
including fish meal in feed, arising as a result of “adventitious” (e.g.
rodent/avian) or “technically unavoidable” (e.g. fish meal) contamination.

ii. The use of fish meal in feed for young ruminants on the basis of a
scientific assessment of their dietary needs and following an assessment of
the control aspects.

iii. Permitting a general tolerance level with regard to the “small
presence” of mammalian MBM in feed for farmed animals.


Currently it is not possible to expand on the terms “insignificant amount”
or “small presence”. Any future tolerance level would be determined to a
large extent by the sensitivity and specificity of the quantitative tests
available. Quantitative risk assessments (e.g. EFSA quantitative risk
assessment of animal BSE risk posed by mammalian MBM 2005) may also be taken
into account. Also it is not clear exactly what is envisaged under (iii) but
the UK Government’s current understanding is that it is a variation on (i)
in that an accepted “tolerance” level would be agreed below which the Member
State would not be obliged to investigate and assess the individual risk.


9. In January 2007, the TSE Regulation was amended by co-decision. This
provided a legal basis for the future options of (i) feeding fishmeal to
young ruminants only – a political compromise between the European
Commission which wanted the option of permitting the feeding of fish meal to
ruminants and the European Parliament which opposed the feeding of such
animal protein to herbivores on “ethical” grounds, but conceded to allowing
the option of feeding fish meal to young ruminants based on a scientific
assessment of their dietary needs – and (ii) the introduction of a
risk-based tolerance level for the presence of “insignificant” amounts of
animal protein in feed “caused through adventitious and technically
unavoidable contamination”. Apart from the circumstances outlined above (and
existing exemptions), the ban on feeding animal protein to ruminants
remained. The TSE Regulation required that rules for the prevention of cross
contamination and methods of sampling and analysis to check compliance,
should be based upon a European Commission report covering the sourcing,
processing, control and traceability of feedingstuffs of animal origin. The
recitals of the TSE Regulation were also amended to propose that “the
feeding to non-ruminants of certain PAP originating from non-ruminants
should be allowed taking into account the prohibition on intra-species
recycling…

8 http://ec.europa.eu/food/food/biosafety/bse/work_prog_tse_en.pdf


and the control aspects in particular linked to differentiation of PAP
specific to certain species”: this proposal could be agreed by the European
Commission and EU Member States. 10. At SEAC 98 (July 2007) following the
media coverage referred to in paragraph 7, SEAC “considered it important
that Defra should seek the views of SEAC should such a policy [of feeding
non-ruminant MBM to non-ruminants] be proposed as part of the TSE Roadmap”.
11. In July 2007, the European Parliament adopted a report9, which called on
the European Commission and the European Council to “lift the ban on feeding
fish meal and fish oil to ruminants” (although there is no ban on feeding
fish oil to ruminants). The report stressed that "there is no scientific
evidence to support a total ban on fish meal on the grounds that it may
transmit BSE or other TSEs". 12. In September 2007, the European Commission
tabled a proposal (SANCO/2017/2007) to permit the use of fish meal in milk
replacers for feeding to young ruminants before weaning, while maintaining
strict controls on the feeding of fish meal to adult ruminants, in line with
the requirements of the TSE Regulation. In November 2007, the European
Commission discussed an amended proposal (SANCO/2017/2007rev.1) to permit
the use of fish meal in milk replacers for feeding to young ruminants, with
Member States. The amended proposal indicated that it applied to milk
replacers administered in either dry or liquid form, provided to young
ruminants as a supplement or milk substitute before the completion of
weaning. The Commission explained that the European Food Safety Authority
had advised that a scientific assessment of the dietary needs of young
ruminants was outside its remit. Consequently, the Commission was
considering establishing a group of animal nutrition experts to carry out
this task. The European Commission indicated following additional training,
the qualitative performance of National Reference Laboratories had improved
beyond the position reported from the 2006 inter-laboratory trial. However,
no further progress could be made on tolerance proposals (e.g. an agreed
tolerance level for the presence of fish meal in adult ruminant feed) until
there had been a significant improvement in the performance of quantitative
tests and this could take at least a year. The European Commission undertook
to make data relating to the assessment of dietary needs (EFSA) and the
assessment of control aspects (further report from Community Reference
Laboratory for Animal Proteins) available to Member States in due course.

9 European Parliament (2007) European Parliament resolution of 10 July 2007
on industrial fisheries and the production of fishmeal and fish oil.
P6_TA-PROV(2007)0327


http://www.europarl.europa.eu/news/expert/infopress_page/033-9006-190-07-28-904-20070709IPR08984-09-07-2007-2007-false/default_en.htm


http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0327+0+DOC+XML+V0//EN&language=EN


snip...see full text 29 pages ;


http://www.seac.gov.uk/papers/99-4.pdf


Horizon scanning


ISSUE


1. To consider emerging scientific issues in relation to transmissible
spongiform encephalopathies (TSEs) and to raise awareness of issues SEAC may
consider in the future.


snip...


SEAC 99/5 ANNEX 1 DEFRA


To advise SEAC of possible animal-health related TSE developments in 2008.


BACKGROUND 1.


World Organisation for Animal Health (OIE)


The World Organisation for Animal Health is considering current trade
guidelines on scrapie and BSE in relation to the emergence of atypical forms
of the diseases. While it is unlikely that changes are required to
guidelines for BSE, significant revision will be required to take into
account the implications of atypical scrapie.


The OIE is expected to endorse the provisional recognition of the UK as
“controlled risk” for BSE, at its General Session in May 2008
.

2. European Union Many of the short term goals of the EU’s 2005 TSE Roadmap
have been achieved. Those outstanding include:


i) Revision of the BSE Monitoring Programme in Cattle The European
Commission is currently discussing a revision of the BSE monitoring
programme in cattle, with Member States, to achieve better targeting of the
surveillance activity and a reduction in the number of tests. We anticipate
that there will be an increase in the testing age limit for fallen stock and
date/age based changes to the testing age limit for cattle slaughtered for
human consumption. We envisage that SEAC will be consulted on significant
changes to the BSE monitoring programme in relation to cattle slaughtered
for human consumption.


ii) EU Feed Controls The European Commission is currently discussing the
feeding of fish meal to young ruminants, with Member States. The European
Commission intends to establish an expert group to examine the nutritional
aspects of the proposal. The Community Reference laboratory for animal
proteins in feed is working to improve the quantitative method and a further
inter-laboratory study is expected. The outcome of this work could pave the
way for the introduction of tolerances from 2008. Other research on feed
tests could support the feeding of non-ruminant PAP to non-ruminants in the
longer term. It may be necessary to consult SEAC again on specific
developments.


iii) EU Scrapie Controls


In April 2007, the EU’s Standing Committee on the food chain and animal
health adopted more proportionate control measures for scrapie. Following a
subsequent legal challenge from France, the European Court of First Instance
suspended the new measures relating to classical scrapie pending the hearing
of the main case. For sheep flocks in which classical scrapie has been
detected the remaining options are whole-flock cull and genotyping and
culling. For goats the only remaining option is whole-flock cull. The legal
case centred on scientific opinions from the French Food Safety Agency
(AFSSA) and the European Food Safety Authority (EFSA) and the application of
the precautionary principle. It highlights the importance of close liaison
between national risk assessment bodies and EFSA. The Commission is planning
to appeal against the judgement and seek acceleration of the main case.


snip...


3. TSEs in Cattle


We predict a continued decline in cases of BSE in the EU and estimate fewer
than 75 cases in UK by the end of 2007 (compared to 114 in 2006). The
majority of cases are still being detected in cattle born before the 1996
feed ban. The Older Cattle Disposal Scheme closes at the end of 2008 and we
are working with industry to maximise the uptake. The prevalence in
successive BARB birth cohorts is extremely low and appears to be decreasing.
However, as the pre-1996 cattle population declines, BARBs will form an
increasing percentage of the total number of cases.


The overall prevalence of atypical BSE appears low. Two cases of atypical
BSE have been detected in UK to date in older cattle. Oral challenge studies
are being planned in Europe and Japan which will provide further information
on the pathogenesis. While the aetiology of atypical BSE remains unknown the
long term consequences for the maintenance of key BSE controls remains
uncertain.


snip...full text 10 pages ;


http://www.seac.gov.uk/papers/99-5.pdf


8 12.15 Public Q&A SEAC Chair


9 13.20 Update on vCJD and sCJD epidemiology Dr R Knight (NCJDSU)


10 13.40 Update on NATA and other vCJD prevalence studies Professor N Gill
(HPA) Dr J Clewley (HPA)


11 14.30 Re-assessment of the potential risk of vCJD transmission via
dentistry Dr P Bennett (DH) Dr P Grove (DH)


A RE-ASSESSMENT OF THE POTENTIAL RISK OF VCJD TRANSMISSION VIA DENTISTRY
ISSUE


1. The Department of Health (DH) has asked SEAC to consider an interim
assessment of the potential risk of vCJD transmission via dental procedures.
This work builds on previous risk assessments on possible dental
transmission considered by SEAC.


BACKGROUND


Previous SEAC considerations of vCJD transmission via dentistry


snip...

The New DH Risk Assessment


8. The research on infectivity just noted forms one strand of a wider
programme at the HPA, which is also intended to quantify protein residues
found on dental instruments and the effectiveness of sterilisation in
reducing infectivity. Following SEAC 97 (May 2007), DH commissioned a
comprehensive re-assessment of the potential risks of vCJD transmission
associated with dentistry to take account of research at the HPA and
elsewhere. The assessment aims to clarify the range of plausible scenarios
for vCJD transmission via dental instruments that could occur, given what is
currently known, and to identify the most important factors affecting this
risk. The assessment will be used to identify the most important areas of
further work to address the uncertainties and any robust ways of cost
effectively reducing risks further.


9. This new interim risk assessment has been produced by DH analysts (annex
3) in collaboration with a Scientific Reference Group of independent experts
(Chaired by Professor Graham Medley). Members of the Group have expertise in
dentistry, instrument decontamination, human and animal prion diseases,
anatomy, public health, risk assessment modelling and epidemiology. This
group met three times to review and refine the modelling framework and agree
the risk assessment. The group provided advice on the inputs and assumptions
incorporated into the risk assessment, particularly where expert judgement
was required due to a lack of hard data. Under circumstances where key data
are absent, precautionary assumptions were agreed. As a number of large
uncertainties that strongly influence the quantification of risk remain, the
risk assessment is considered as interim and will be updated in the future
when new scientific evidence becomes available.


10. The assessment examines the risk that vCJD may be transmitted via dental
procedures by establishing plausible ranges for key parameters, including
(see sections 2 and 3 of the risk assessment):


• the vCJD infectivity of tissues of the oral cavity of infected patients


• the deposition of that material onto different types of dental instruments
and the effectiveness of standard cleaning and sterilisation processes used
in dental practice


• the mechanisms and efficiency of transfer of vCJD infectivity from
contaminated instruments used on subsequent patients


• the probability of transmission based on assessments of the number and
types of dental procedure conducted and the number of people who might be
carrying an asymptomatic vCJD infection.


Findings 11.


As there is lack of substantial data with which to accurately quantify many
of these parameters, plausible ranges for these parameters have been
established to take account of the often large uncertainties in the data.
The large uncertainties in many of these parameters strongly influence the
quantification of the risk.


12. Plausible scenarios built up using ranges for each of these factors
include many in which dental transmission would have no detectable effect on
the course of the vCJD outbreak (see section 4 of the risk assessment).
However, there are some which include a combination of pessimistic
assumptions as regards the infectivity of dental / oral tissues and the
effects of instrument decontamination which suggest that:


• there could be some hundreds of vCJD transmissions per annum via
dentistry - albeit against a background of several thousand existing vCJD
infections (not clinical cases of vCJD), or where


• dental transmission could generate a self-sustaining reservoir of vCJD
infection within the population.


13. The distinction between vCJD infections and clinical cases of vCJD is
important. If a large proportion of secondary transmissions result in
subclinical infections (either never developing into clinical disease or
doing so over an extended time-scale) and those infected are infectious, the
likelihood of a self-sustaining epidemic increases. The proportion of
individuals who might enter such a subclinical “carrier state” is unknown.
Key Assumptions and areas of uncertainty


14. Work on the risk assessment is on-going and new data should enable some
of the inputs and assumptions underpinning these scenarios to be revised.
Key areas of uncertainty are:


• Infectivity in relevant tissues. Of all the unknowns, that of overriding
importance is whether dental/oral tissues in patients incubating vCJD would
be infective, and if so at what level.

There are as yet no results of studies using human gingival and dental pulp
tissues, and these studies may extend into 2009 and 2010 respectively. This
is examined in section 2.3 of the risk assessment.


• Protein Residues on dental instruments. This is examined in section 2.2 of
the risk assessment.


• Efficacy of Autoclaving. This is examined in section 2.3 of the risk
assessment.


• Current prevalence of vCJD infection. This is examined in section 3.3 of
the risk assessment.


• Epidemiology of vCJD. This is examined in section 4 of the risk
assessment.


15. Suggested areas of further work to reduce the uncertainty in these key
areas are described in section 5 of the risk assessment together with a
preliminary analysis of possible interventions and risk reduction measures.


ADVICE SOUGHT FROM THE COMMITTEE


snip...


POSITION STATEMENT vCJD AND ENDODONTIC DENTISTRY


snip...


Endodontic instruments


5. Evidence suggests that the files and reamers used in endodontic
procedures are reused and are difficult to reliably decontaminate4.
Appreciable quantities of residual material remain adherent to the surface
after normal cleaning and sterilisation5. Thus, there is potential for
transfer of dental pulp between patients undergoing endodontic procedures.


vCJD infectivity in dental tissues


6. There are no data on vCJD infectivity in dental pulp. Although no
abnormal prions were found in a study of dental tissues, including dental
pulp, from vCJD cases6, dental pulp includes blood and peripheral nerve
tissue known to carry vCJD infectivity7,8. In addition, appreciable
infectivity has been found in the dental pulp of hamsters with hamster
scrapie9. Although it is possible that the peripheral nerve may only become
infective close to, or after, the onset of clinical vCJD, inflammation may
promote the propagation of prions10. Thus, although the data are limited and
indirect, it is reasonable to assume that the dental pulp of individuals
subclinically-infected with vCJD may be infectious although the level of
infectivity is unknown. Studies underway will provide direct data on the
infectivity in dental tissues from vCJD cases. level of infectivity is
unknown.


4 Letters et al. (2005) A study of visual and blood contamination on
reprocessed endodontic files from general dental practice. Br. Dent. J. 199,
522-525.
5 Smith et al. (2005) Residual protein levels on reprocessed dental
instruments. J. Hosp. Infect. 61, 237-241.
6 Head et al. (2003) Investigation of PrPres in dental tissues in variant
CJD. Br. Dent. J. 195, 339-343.
7 SEAC 91 minutes paragraph 9. www.seac.gov.uk/papers/papers.htm
8 Department of Health (2005) Assessing the risk of vCJD transmission via
surgery: an interim view. Unpublished.
9 Ingrosso et al. (1999) Transmission of the 263K scrapie strain by the
dental route. J. Gen. Virol. 80, 3043-3047.
10 Heikenwalder et al. (2005) Chronic lymphocytic inflammation specifies the
organ tropism of prions. Science. 307, 1107-1110.


Subclinical carrier state


7. A study of humanised mice showed that vCJD infections may not always
progress to clinical disease within the normal lifespan of the animals11.
Another study suggested that prion infections in mice that remain at a
subclinical level can be transmitted to other mice, resulting in clinical
disease12. Thus, there is evidence to suggest that individuals infected with
the BSE / vCJD agent may remain in a subclinical infection carrier state
instead of developing vCJD. A discrepancy between prevalence estimates based
on a survey of abnormal prion protein in appendix and tonsil tissue and data
on vCJD cases supports this hypothesis13. As no diagnostic test exists to
identify such individuals, they could over the course of their lives be
potential sources of numerous secondary infections arising from invasive
medical or dental procedures.


8. The prevalence of subclinical infection in the UK population is
uncertain. A recent estimate suggests the number of subclinical carriers may
be of the order of several thousand14. SEAC has strongly recommended that
further studies to ascertain better the prevalence of vCJD infection be
urgently considered15.


Transmission risks


9. The new DH analysis suggests that, on the basis that residual dental pulp
on endodontic files and reamers is transferred relatively efficiently to
patients on reuse, dental pulp is as infective as peripheral nerve tissue
and a subclinical carrier population for vCJD exists, a self-sustaining vCJD
epidemic arising from endodontic surgery is plausible. There are
uncertainties about the efficiency of vCJD transmission via endodontic
procedures, the vCJD infectivity of dental pulp and the existence of a
subclinical infection carrier state. However, even if a self-sustaining
epidemic were not possible, clusters of vCJD infections could arise from the
use of instruments contaminated with the vCJD agent from endodontic
procedures on infected patients. Interactions between this and other routes
of secondary transmission, such as blood transfusion and hospital surgery,
would make a self-sustaining epidemic more likely.


Potential risk reduction measures


10. Endodontic files and reamers have a limited lifespan, restricting the
number of possible secondary transmissions. Improving the effectiveness of
procedures used to decontaminate dental instruments would reduce the risk of
transmission. Restricting endodontic files and reamers to single use would
prevent potential secondary transmission via these instruments. Conclusions


11. A preliminary risk assessment produced by DH suggests that vCJD
transmission via endodontic dentistry may, under certain hypothetical but
plausible scenarios, be sufficient to sustain a secondary vCJD epidemic.
However, there are uncertainties around the data and assumptions
underpinning the assessment. Research underway will address some of these
uncertainties and allow the risk assessment to be refined. Once the research
is complete and / or other data become available, the risks should be
reassessed. A watching brief should be maintained.


12. It is unclear whether or not vCJD infectivity can be transmitted via
endodontic files and reamers. However, given the plausibility of such a
scenario and the large number of procedures undertaken annually, it would be
prudent to consider restricting these instruments to single use as a
precautionary measure. Since sufficiently rigorous decontamination of these
instruments is difficult, single use of these instruments would eliminate
this risk, should it exist.


SEAC May 2006

© SEAC 2007


New research


4. Preliminary, unpublished results of research from the Health Protection
Agency, aimed at addressing some of the uncertainties in the risk
assessments, were reviewed by SEAC (SEAC 97, May 2007). The prion agent used
in these studies is closely related to the vCJD agent. This research, using
a mouse model, shows that following inoculation of mouse-adapted bovine
spongiform encephalopathy (BSE) directly into the gut, infectivity
subsequently becomes widespread in tissues of the oral cavity, including
dental pulp, salivary glands and gingiva, during the preclinical as well as
clinical stage of disease.


5. It is not known how closely the level and distribution of infectivity in
the oral cavity of infected mice reflects those of humans infected with
vCJD, as there are no comparable data from oral tissues, in particular
dental pulp and gingiva, from human subclinical or clinical vCJD cases.
Although no abnormal prion protein was found in a study of human dental
tissues, including dental pulp, salivary glands and gingiva from vCJD
cases22, the relationship between levels of infectivity and abnormal prion
protein is unclear23. Infectivity studies underway using the mouse model and
oral tissues that are presently available from human vCJD cases will provide
some comparable data. On the basis of what is currently known, there is no
reason to suppose that the mouse is not a good model for humans in respect
to the distribution of infectivity in oral tissues. Furthermore, the new
data are consistent with published results from experiments using a hamster
scrapie model24.


6. A second set of experiments using the same mouse model showed that
non-invasive and transient contact between gingival tissue and fine dental
files contaminated with mouse-adapted BSE brain homogenate transmits
infection very efficiently. It is not known how efficient gingival
transmission would be if dental files were contaminated with infectious oral
tissues and then subsequently cleaned and sterilised, a situation which
would more closely model human dental practice. Further studies using the
mouse model that would be more representative of the human situation,
comparing oral tissues with a range of doses of infectivity, cleaned and
sterilised files and the kind of tissue contact with instruments that occurs
during dentistry, should be considered.


7. SEAC considered that the experiments appear well designed and the
conclusions justified and reliable, while recognising that the research is
incomplete and confirmatory experiments have yet to be completed. It is
recommended that the research be completed, submitted for peer-review and
widely disseminated as soon as possible so others can consider the
implications. Nevertheless, these preliminary data increase the possibility
that some oral tissues of humans infected with vCJD may potentially become
infective during the preclinical stage of the disease. In addition, they
increase the possibility that infection could potentially be transmitted not
only via accidental abrasion of the lingual tonsil or endodontic procedures
but a variety of routine dental procedures.


20 Department of Health (2006) Dentistry and vCJD: the implications of a
carrier-state for a self-sustaining epidemic. Unpublished.
21 SEAC (2006) Position statement on vCJD and endodontic dentistry.
http://www.seac.gov.uk/statements/statement0506.htm

22 Head et al. (2003) Investigation of PrPres in dental tissues in variant
CJD. Br. Dent. J. 195, 339-343.
23 SEAC 90 reserved business minutes.

Implications for transmission risks

snip...


11. The new research also suggests that dental procedures involving contact
with other oral tissues, including gingiva, may also be capable of
transmitting vCJD. In the absence of a detailed risk assessment examining
the potential for transmission via all dental procedures, it is not possible
to come to firm conclusions about the implications of these findings for
transmission of vCJD. However, given the potential for transmission by this
route serious consideration should be given to assessing the options for
reducing transmission risks such as improving decontamination procedures and
practice or the implementation of single use instruments.


12. The size of the potential risk from interactions between the dental and
other routes of secondary transmission, such as blood transfusion and
hospital surgery, to increase the likelihood of a self-sustaining epidemic
is unclear.

13. It is likely to be difficult to distinguish clinical vCJD cases arising
from dietary exposure to BSE from secondary transmissions via dental
procedures, should they arise, as a large proportion of the population is
likely both to have consumed contaminated meat and undergone dentistry.
However, an analysis of dental procedures by patient age may provide an
indication of the age group in which infections, if they occur, would be
most likely to be observed. Should the incidence of clinical vCJD cases in
this age group increase significantly, this may provide an indication that
secondary transmission via dentistry is occurring. Investigation of the
dental work for these cases may provide supporting data. There is no clear
evidence, to date, based on surveillance or investigations of clinical vCJD
cases, that any vCJD cases have been caused by dental procedures but this
possibility cannot be excluded.


Conclusions


14. Preliminary research findings suggest that the potential risk of
transmission of vCJD via dental procedures may be greater than previously
anticipated. Although this research is incomplete, uses an animal model
exposed to relatively high doses of infectivity, and there are no data from
infectivity studies on human oral tissues, these findings suggest an
increased possibility that vCJD may be relatively efficiently transmitted
via a range of dental procedures. Ongoing infectivity studies using human
oral tissues and the other studies suggested here will enable more precise
assessment of the risks of vCJD transmission through dental procedures.


15. Guidance was issued to dentists earlier this year recommending that
endodontic files and reamers be treated as single use which, provided it is
adhered to, will remove any risk of a self-sustaining epidemic arising from
re-use of these instruments. To minimise risk it is critical that
appropriate management and audit is in place, both for NHS and private
dentistry.


16. It is also critical that a detailed and comprehensive assessment of the
risks of all dental procedures be conducted as a matter of urgency. While
taking into account the continuing scientific uncertainties, this will allow
a more thorough consideration of the possible public health implications of
vCJD transmission via dentistry and the identification of possible
additional precautionary risk reduction measures. The assessment will
require continued updating as more evidence becomes available on the
transmissibility of vCJD by dental routes, and on the prevalence of
infection within the population. A DH proposal to convene an expert group
that includes dental professionals to expedite such an assessment is
welcomed. Given the potential for transmission via dentistry, consideration
should be given to the urgent assessment of new decontamination technologies
which, if proved robust and effective, could significantly reduce
transmission risks.


SEAC June 2007


27 SEAC Epidemiology Subgroup (2006) position statement of the vCJD
epidemic. http://www.seac.gov.uk/statements/state260106subgroup.htm

28 DH (2007) Precautionary advice given to dentists on re-use of instruments
http://www.gnn.gov.uk/environment/fullDetail.asp?ReleaseID=279256&NewsAreaID=2&NavigatedFromDepartment=False


see full text 17 pages ;


http://www.seac.gov.uk/papers/99-7.pdf


SEAC 99th meeting on Friday 14th December 2007

DECEMBER 14, 2007, 10 year Anniversary of my Moms death 'confirmed' from Heidenhain Variant Creutzfeldt Jakob Disease


Greetings,


AS one of them _lay_ folks, one must only ponder ;


"WITH the Nor-98 now documented in five different states so far in the USA
in 2007, and with the TWO atypical BSE H-BASE cases in Texas and Alabama,
with both scrapie and CWD running rampant in the USA, IS there any concern
from SEAC with the rise of sporadic CJD in the USA from ''UNKNOWN
PHENOTYPE'', and what concerns if any, in relations to blood donations,
surgery, optical, and dental, do you have with these unknown atypical
phenotypes in both humans and animals in the USA ???"


"Does it concern SEAC, or is it of no concern to SEAC?"

"Should it concern USA animal and human health officials?"


snip...


----- Original Message -----
From: xxxxxxxxxx
To: flounder9@verizon.net
Sent: Thursday, November 22, 2007 5:39 AM
Subject: QUESTION FOR SEAC


Mr Terry S Singeltary Sr.,
Bacliff,
Texas 77518
USA.

Dear Mr Singeltary,


"Thank you for your e-mail of yesterday with the question for SEAC. I can
confirm that this will be asked at the meeting on your behalf and the
question and answer will appear in the minutes of the meeting which will be
published on the SEAC Internet site."


snip...end...TSS


Archive Number 20071105.3602
Published Date 05-NOV-2007
Subject PRO/AH/EDR> Prion disease update 2007 (07)

PRION DISEASE UPDATE 2007 (07)
******************************
A ProMED-mail post

snip...

[2] USA: National Prion Disease Pathology Surveillance Center
Date: June 2007
Source: National Prion Disease Pathology Surveillance Center (USA) [edited]

CJD Cases examined
----------------------
Year / Referrals / Prion disease / Sporadic / Familial / Iatrogenic / vCJD

1996 / 42 / 32 / 26 / 4 / 0 / 0
1997 / 115 / 68 / 57 / 9 / 0 / 0
1998 / 93 / 53 / 45 / 7 / 1 / 0
1999 / 114 / 69 / 61 / 8 / 0 / 0
2000 / 151 / 103 / 89 / 14 / 0 / 0
2001 / 208 / 116 / 106 / 9 / 0 / 0
2002 / 255 / 143 / 118 / 23 / 2 / 0
2003 / 272 / 174 / 132 / 41 / 0 / 0
2004 / 334 / 183 / 157 / 21 / 0 / 1*
2005 / 352 / 195 / 152 / 37 / 1 / 0
2006 / 372 / 186 / 143 / 30 / 0 / 1**
2007 / 120 / 68 / 35 / 7 / 0 / 0
TOTAL / 2428*** / 1390**** / 1121 / 210 / 4 / 2

*Acquired in UK
** Acquired in Saudi Arabia
*** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007.
**** Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1
from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36
type pending (2 from 2005, 8 from 2006, 26 from 2007).

Notes:

-- Cases are listed based on the year of death when available. If the
year of death is not available, the year of sample receipt is used.

-- Referrals: Cases with possible or probable prion disease from
which brain tissue or blood in the case of familial disease were submitted.

-- Inconclusive: Cases in which the samples were not sufficient to
make a diagnosis.

-- Non-vCJD type unknown are cases in which the tissue submitted was
adequate to establish the presence but not the type; in all cases,
vCJD could be excluded.

--
Communicated by:
Terry S. Singeltary Sr.

[In submitting these data, Terry S. Singeltary Sr. draws attention to
the steady increase in the "type unknown" category, which, according
to their definition, comprises cases in which vCJD could be excluded.
The total of 26 cases for the current year (2007) is disturbing,
possibly symptomatic of the circulation of novel agents.
Characterization of these agents should be given a high priority. - Mod.CP]


http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963

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

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


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


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


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to

comment on the CDC's attempts to monitor the occurrence of emerging

forms of CJD. Asante, Collinge et al [1] have reported that BSE

transmission to the 129-methionine genotype can lead to an alternate

phenotype that is indistinguishable from type 2 PrPSc, the commonest

sporadic CJD. However, CJD and all human TSEs are not reportable

nationally. CJD and all human TSEs must be made reportable in every

state and internationally. I hope that the CDC does not continue to

expect us to still believe that the 85%+ of all CJD cases which are

sporadic are all spontaneous, without route/source. We have many TSEs in

the USA in both animal and man. CWD in deer/elk is spreading rapidly and

CWD does transmit to mink, ferret, cattle, and squirrel monkey by

intracerebral inoculation. With the known incubation periods in other

TSEs, oral transmission studies of CWD may take much longer. Every

victim/family of CJD/TSEs should be asked about route and source of this

agent. To prolong this will only spread the agent and needlessly expose

others. In light of the findings of Asante and Collinge et al, there

should be drastic measures to safeguard the medical and surgical arena

from sporadic CJDs and all human TSEs. I only ponder how many sporadic

CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535


THE PATHOLOGICAL PROTEIN

Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam


CHAPTER 14 LAYING ODDS

Answering critics like Terry Singeltary, who feels that the U.S. under-
counts CJD, Schonberger conceded that the current surveillance system
has errors but stated that most of the errors will be confined to the older
population.

http://www.thepathologicalprotein.com/


doi:10.1016/S1473-3099(03)00715-1
Copyright © 2003 Published by Elsevier Ltd.
Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

Available online 29 July 2003.
Volume 3, Issue 8, August 2003, Page 463


“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my
mom to hvCJD (Heidenhain variant CJD) and have been searching for answers
ever since. What I have found is that we have not been told the truth. CWD
in deer and elk is a small portion of a much bigger problem." ...


http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext


http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/http://www.neurology.org/cgi/eletters/60/2/176#535


Like lambs to the slaughter

31 March 2001
Debora MacKenzie
Magazine issue 2284

FOUR years ago, Terry Singeltary watched his mother die horribly from a
degenerative brain disease. Doctors told him it was Alzheimer's, but
Singeltary was suspicious. The diagnosis didn't fit her violent symptoms,
and he demanded an autopsy. It showed she had died of sporadic
Creutzfeldt-Jakob disease.

Most doctors believe that sCJD is caused by a prion protein deforming by
chance into a killer. But Singeltary thinks otherwise. He is one of a number
of campaigners who say that some sCJD, like the variant CJD related to BSE,
is caused by eating meat from infected animals. Their suspicions have
focused on sheep carrying scrapie, a BSE-like disease that is widespread in
flocks across Europe and North America.

Now scientists in France have stumbled across new evidence that adds weight
to the campaigners' fears. To their complete surprise, the researchers found
that one strain of scrapie causes the same brain damage in mice as sCJD.

"This means we cannot rule out that at least some sCJD may be caused by some
strains of scrapie," says team member Jean-Philippe Deslys of the French
Atomic Energy Commission's medical research laboratory in
Fontenay-aux-Roses, south-west of Paris.

Hans Kretschmar of the University of Göttingen, who coordinates CJD
surveillance in Germany, is so concerned by the findings that he now wants
to trawl back through past sCJD cases to see if any might have been caused
by eating infected mutton or lamb. ...


http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html


DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)
USA: Loch in der Mauer
Die BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas
verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehörden
sind lax.
Link auf diesen Artikel im Archiv:
http://service.spiegel.de/digas/find?DID=18578755


"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA
regulations. ...


http://service.spiegel.de/digas/servlet/find/DID=18578755


Thu Dec 6, 2007 11:38

FDA IN CRISIS MODE, AMERICAN LIVES AT RISK


http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html


FDA SCIENCE AND MISSION AT RISK

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf


2 January 2000

British Medical Journal

U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well


http://www.bmj.com/cgi/eletters/320/7226/8/b#6117

15 November 1999

British Medical Journal

vCJD in the USA * BSE in U.S.


http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406


Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in
the United States

http://cjdusa.blogspot.com/


CJD QUESTIONNAIRE

http://cjdquestionnaire.blogspot.com/


SCRAPIE USA

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


NOR-98 ATYPICAL SCRAPIE CASES USA

http://nor-98.blogspot.com/


CREUTZFELDT JAKOB DISEASE MAD COW BASE UPDATE USA

http://cjdmadcowbaseoct2007.blogspot.com/


Transmissible Mink Encephalopathy TME

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


CHRONIC WASTING DISEASE

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


TSEAC MEETING


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

From: Terry S. Singeltary Sr.

To: FREAS@CBER.FDA.GOVCc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov

Sent: Wednesday, November 29, 2006 1:24 PM

Subject: TSE advisory committee for the meeting December 15, 2006 [TSSSUBMISSION]
November 29, 2006

Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al,

a kind and warm Holiday Greetings to you all. i kindly wish to submit the following to the TSE advisory committee for the meeting December 15, 2006, about the assessment for potential exposure to vCJD in human plasma-derived antihemophilic factor (FVIII) products manufactured from U.S. plasma donors and related communication material ;

http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-20251.htm

i see the media picked up on this as a 'low risk', from what the gov. agency perceived to be to them;

http://www.newsday.com/news/health/ats-ap_health14nov27,0,7955259.story?coll=ny-leadhealthnews-headlines

however, i seem to disagree. from my primitive ciphering, i see it anotherway. this is a huge catastrophic risk. 3 in 160 is 1.9%. so call that 2% which is 1 in 50 or twenty per thousand or 20,000 per million. also, what about the mixed genotypes/mixed susceptibility? what about the silent carriers that donated tainted blood? what about the sporadic CJDs of UNKNOWN strain or phenotype? this risk assessment is just more BSe to me. just another in a long line of ...

Greetings again Dr. Freas et al at FDA,


THIS was like closing the barn door after the mad cows got loose. not only the red cross, but the FDA has failed the public in protecting them from the TSE aka madcow agent. TSE agent i.e. bse, base, cwd, scrapie, tme, and any sub strains thereof. we do not know if these strains will or have transmitted to humans as subclinical TSE or clinical disease, and we do not know if they have or will transmit second, third, forth passage via friendly fire i.e. multiple potential routes via medical, surgical, pharmaceutical etc. IF you remember correctly Dr. Freas et al, i called this long ago, almost 6 years ago ;


PDF]Freas, William TSS SUBMISSION

Terry S. Singeltary Sr. [flounder@wt.net]
Monday, January 08, 200l 3:03 PM freas ...Freas, William
From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Monday, January 08,200l 3:03 PM

To: freas@CBS5055530.CBER.FDA.GOV

Subject: CJD/BSE (aka madcow) Human/Animal TSE?s--U.S.--Submission

To Scientific Advisors and Consultants Staff January 2001 Meeting (short version)


Greetings again Dr. Freas and Committee Members,

I wish to submit the following information to the Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version). I understand the reason of having to shorten my submission, but only hope that you add it to a copy of the long version, for members to take and read at their pleasure, (if cost is problem, bill me, address below). So when they realize some time in the near future of the 'real' risks i speak of from human/animal TSEs and blood/surgical products.

snip...

I am beginning to think that the endless attempt to track down and ban, potential victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, eyelid test, anything at whatever cost, we need a test FAST. DO NOT let the incubation time period of these TSEs fool you. To think of Scrapie as the prime agent to compare CJD, but yet overlook the Louping-ill vaccine event in 1930's of which 1000's of sheep where infected by scrapie from a vaccine made of scrapie infected sheep brains, would be foolish. I acquired this full text version of the event which was recorded in the Annual Congress of 1946 National Vet. Med. Ass. of Great Britain and Ireland. From the BVA and the URL is posted in my (long version). ...


http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

see full text ;

http://tseac.blogspot.com/


vCJD case study highlights blood transfusion risk

http://vcjdblood.blogspot.com/


[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


9/13/2005

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


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

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


Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA

https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed

Subject: Importation of Whole Cuts of Boneless Beef from Japan [Docket No.
05-004-1] RIN 0579-AB93 TSS SUBMISSION
Date: August 24, 2005 at 2:47 pm PST
August 24, 2005

Importation of Whole Cuts of Boneless Beef from Japan [Docket No. 05-004-1]
RIN 0579-AB93 TSS SUBMISSION


Greetings APHIS ET AL,

My name is Terry S. Singeltary Sr.


I would kindly like to comment on [Docket No. 05-004-1] RIN 0579-AB93 ;


snip...


THE USA is in a most unique situation, one of unknown circumstances with
human and animal TSE. THE USA has the most documented TSE in different
species to date, with substrains growing in those species (BSE/BASE in
cattle and CWD in deer and elk, there is evidence here with different
strains), and we know that sheep scrapie has over 20 strains of the typical
scrapie with atypical scrapie documented and also BSE is very likely to have
passed to sheep. all of which have been
rendered and fed back to animals for human and animal consumption, a
frightening scenario. WE do not know the outcome, and to play with human
life around the globe with the very likely TSE tainted products from the
USA, in my opinion is like playing Russian roulette, of long duration, with
potential long and enduring consequences, of which once done, cannot be
undone. These are the facts as I have come to know through daily and
extensive research of TSE over 9 years, since 12/14/97.
I do not pretend to have all the answers, but i do know to continue to
believe in the ukbsenvcjd only theory of transmission to humans of only this
one strain from only this one TSE from only this one part of the globe, will
only lead to further failures, and needless exposure to humans from all
strains of TSE, and possibly many
more needless deaths from TSE via a multitude of proven routes and sources
via many studies with primates and rodents and other species.

MY personal belief, since you ask, is that not only the Canadian border, but
the USA border, and the Mexican border should be sealed up tighter than a
drum for exporting there TSE tainted products, until a validated, 100%
sensitive test is available, and all animals for human and animal
consumption are tested. all we are doing is the exact same thing the UK did
with there mad cow poisoning when they exported it all over the globe, all
the while knowing what they were doing. this BSE MRR policy is nothing more
than a legal tool to do just exactly what the UK did, thanks to the OIE and
GW, it's legal now. and they executed Saddam for poisoning ???

go figure. ...

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

Comment Submitted
Comment Receipt

Thank you. Your comment on Document ID: APHIS-2006-0041-0001 has been
sent. Comment Tracking Number: APHIS-2006-0041-DRAFT-0028

Attachments:
C:\My Music\My Documents\APHIS-2006-0041_January 28.doc


If you wish to retain a copy of the receipt, use the following link to
print a copy for your files. Print

http://www.regulations.gov/fdmspublic/component/main


THE only difference between the UK poisoning the globe, and the USA, it is
now legal with GWs and OIEs BSE MRR policy ;

IT's O.K. to poison 3rd world countries ;


http://www.bseinquiry.gov.uk/files/yb/1994/05/20002001.pdf


On 20 February 1990, Dr Pickles wrote to Ms Verity
(APS/CMO). Dr Pickles minute included the following:
1. Mr Meldrum is arguing that MAFF have already taken all the
necessary and responsible steps to warn importing countries
of the BSE dangers in UK meat and bone meal. Yet the action taken
so far overseas suggest the message has not got
through, or where it has this has been late. The first nation
that woke up to the danger did so a year after our own feed
ban. It seems even now several EC countries neither ban our
imports or the general feeding of ruminant protein. It also
seems the OIE and CVO have yet to inform the rest of the world.
2. I do not see how this can be claimed to be responsible. We
do not need an expert group of the Scientific Veterinary
Committee to tell us British meat and bone meal is unsafe for
ruminants. I fail to understand why this cannot be tackled
from the British end which seems to be the only sure way of doing
it, preferably by banning exports. As CMO says in his
letter of 3 January surely it is short sighted for us to risk
being seen in future as having been responsible for the
introduction of BSE to the food chain in other countries. [79]

http://www.bse.org.uk/dfa/dfa25.htm

http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

OLD DOCKET SUBMISSION TSS


Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE
SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, that BSE transmission to the 129-methionine

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf


Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt


# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food
Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html


Daily Dockets - 04/10/03

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


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1
Terry S. Singeltary Sr.
Vol #:1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


01N-0423 Substances Prohibited from use in animal food/Feed Ruminant


EMC 1 Terry S. Singeltary Sr. Vol#: 3


http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm

TSS





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