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From: TSS (
Subject: Proposed amendments to EC Regulation 999/2001 on transmissible spongiform encephalopathies – goat specified risk material (SRM)
Date: December 10, 2004 at 1:53 pm PST

-------- Original Message --------
Subject: Proposed amendments to EC Regulation 999/2001 on transmissible spongiform encephalopathies – goat specified risk material (SRM)
Date: Fri, 10 Dec 2004 08:08:52 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy

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

Proposed amendments to EC Regulation 999/2001 on transmissible
spongiform encephalopathies – goat specified risk material (SRM)
Friday, 10 December 2004

Comments are sought on proposed possible changes to EC Regulation
999/2001 following an announcement by the European Commission of a
possible finding of Bovine Spongiform Encephalopathy (BSE) in a French
goat. It is proposed that these changes will only be implemented if BSE
is confirmed in the suspect animal.

All comments and views should be sent to:
David Roy
Animal Food Chain and Novel Foods Branch
Food Standards Agency Scotland
6th Floor
St Magnus House
25 Guild Street
AB11 6NJ

Tel: 01224 285138
Fax: 01224 285168

Responses are requested by: 6 March 2005

Consultation details
The proposals extend the list of tissues that are designated as
specified risk material (SRM) in goats, and increase the level of TSE
monitoring in goats. The Agency is consulting only on the proposed
changes to goat SRM.

Responses are required by 6 March 2005. However, it would be very
helpful to receive your responses, even if these are only preliminary,
by 7 January 2005. This will enable your views to be fed into early
discussions of the proposal at the meeting of the EU Standing Committee
on the Food Chain and Animal Health (SCoFCAH), which is likely to be
held in mid January.

However, if you are unable to respond by mid January we would still like
to have your comments because it may be possible to feed these into the
decision making process.

Publication of responses to the consultation
All comments received may be made available for public examination. If
you would prefer your comments not to be made publicly available, please
indicate this in your letter, explaining the reasons.

EC Regulation 999/2001 (as amended) lays down Community-wide rules for
the prevention, control and eradication of certain transmissible
spongiform encephalopathies (TSEs). These rules are amended as necessary
in light of new findings and emerging scientific evidence.

On 28 October 2004, the European Commission announced a possible finding
of BSE in a French goat. In accordance with EU procedures, the finding
was submitted to the Community Reference Laboratory (CRL) in Weybridge
for evaluation by an expert panel. The Commission issued a subsequent
announcement on 26 November stating that the expert panel had met and
concluded that currently available results were incomplete and a further
two months were required before all the results could be properly
interpreted. The results of the CRL evaluation are therefore expected in
the New Year.

Although BSE had never before been found naturally occurring in goats,
there has for some time been acknowledgement of the possibility that it
could exist, masked by scrapie. This is because it is likely that some
goats ate the same feed that spread BSE in cattle, and laboratory
experiments have shown that BSE can be transmitted to sheep and goats.
As a result, precautionary measures, such as SRM controls, have been in
place for some time to minimise any potential risk to public health.

In its opinion of April 2002, the EC Scientific Steering Committee (SSC)
recommended additional measures to protect public health in the event
that BSE should become likely in small ruminants. In view of the
possible finding of BSE in a French goat, the Commission is proposing
that the additional measures recommended in the SSC opinion should be
implemented, if the finding of BSE is confirmed.

The draft EC proposal was discussed at an EU TSE Working Group meeting
on 30 November and will be subject to further discussions at SCoFCAH in
December and January. It is unlikely that SCoFCAH will vote on the
proposal until the views of the CRL expert panel are known. These are
expected at the end of January 2005.

One effect of the proposal will be a change to the list of tissues that
are designated as Specified Risk Material (SRM) in goats. As the
proposal currently stands, the list of tissues designated SRM in goats
will be extended to include:

* the whole alimentary canal

* the organs, including lymph nodes, of the thoracic and abdominal

* the pre-femoral and pre-scapular lymph nodes

* the entire head

* the tonsils

These tissues would be designated SRM in goats of all ages. Spinal cord
will remain SRM in goats over 12 months of age.

At present, only the spleen and ileum are designated SRM in goats of all
ages, while the skull (including the brain and eyes), tonsils and spinal
cord are designated SRM in goats aged over 12 months of age.

At this stage, the FSA is inclined to support the extension of the
tissues to be classified as SRM. The EC proposals would remove most of
the tissues that are associated with BSE infectivity in an infected
animal. Unlike in cattle, the lymph nodes in sheep and goats have been
shown to carry TSE infectivity in infected animals. However, removal of
all lymph nodes would not be practicable.

We would welcome your views on any benefits or drawbacks likely to
result from the changes set out above and in the attached Regulatory
Impact Assessment (RIA), in particular, on the potential cost of the
proposals and practical aspects of removing the additional SRM. Your
views will help to formulate the UK negotiating position on this issue.
It will not be possible to accurately assess the impact of the measures
without this feedback.

We apologise for the short interim deadline but this is driven by the EU
timetable. If you are unable to meet the interim deadline, your comments
are still important to us and can be fed into the process at a later
stage. Even if you were able to make preliminary comments it would still
be possible to send more detailed comments later.

If the proposals do become European law then domestic legislation, in
this case the TSE (Scotland) Regulations 2002 (and equivalent
legislation in England, Wales, and Northern Ireland), will require
amendment to take account of the new European Regulation. In addition to
informing you of the Commission proposals, we are also informing you of
a possible new domestic requirement, relating to goats, if the
Commission proposals receive a positive vote. At present, there is no
difference between tissues designated SRM in goats and tissues
designated SRM in sheep. That position will change if the proposals
relating to goat SRM are accepted. As it would be difficult to
differentiate between sheep and goats once carcasses have been dressed,
it would be necessary to introduce an additional measure to enable such
differentiation for enforcement purposes. We would therefore need to
consider introducing a 'goat stamp' to aid correct identification and
removal of SRM. This stamp would probably be applied by the Meat Hygiene
Service. We would welcome your views on this proposal and any effects –
positive or negative – it might be likely to have.

* Proposed amendments to EC Regulation 999/2001 on transmissible
spongiform encephalopathies – goat specified risk material (SRM)

Regulatory Impact Assessment (pdf 11kb)

Office Note


A The Present Position with respect to Scrapie
A] The Problem

Scrapie is a natural disease of sheep and goats. It is a slow
and inexorably progressive degenerative disorder of the nervous system
and it ia fatal. It is enzootic in the United Kingdom but not in all

The field problem has been reviewed by a MAFF working group
(ARC 35/77). It is difficult to assess the incidence in Britain for
a variety of reasons but the disease causes serious financial loss;
it is estimated that it cost Swaledale breeders alone $l.7 M during
the five years 1971-1975. A further inestimable loss arises from the
closure of certain export markets, in particular those of the United
States, to British sheep.

It is clear that scrapie in sheep is important commercially and
for that reason alone effective measures to control it should be
devised as quickly as possible.

Recently the question has again been brought up as to whether
scrapie is transmissible to man. This has followed reports that the
disease has been transmitted to primates. One particularly lurid
speculation (Gajdusek 1977) conjectures that the agents of scrapie,
kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of
mink are varieties of a single "virus". The U.S. Department of
Agriculture concluded that it could "no longer justify or permit
scrapie-blood line and scrapie-exposed sheep and goats to be processed
for human or animal food at slaughter or rendering plants" (ARC 84/77)"
The problem is emphasised by the finding that some strains of scrapie
produce lesions identical to the once which characterise the human

Whether true or not. the hypothesis that these agents might be
transmissible to man raises two considerations. First, the safety
of laboratory personnel requires prompt attention. Second, action
such as the "scorched meat" policy of USDA makes the solution of the
acrapie problem urgent if the sheep industry is not to suffer



1: J Infect Dis 1980 Aug;142(2):205-8

Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to
nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of
sheep and goats were transmitted to squirrel monkeys (Saimiri
sciureus) that were exposed to the infectious agents only by their
nonforced consumption of known infectious tissues. The asymptomatic
incubation period in the one monkey exposed to the virus of kuru was
36 months; that in the two monkeys exposed to the virus of
Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and
that in the two monkeys exposed to the virus of scrapie was 25 and
32 months, respectively. Careful physical examination of the buccal
cavities of all of the monkeys failed to reveal signs or oral
lesions. One additional monkey similarly exposed to kuru has
remained asymptomatic during the 39 months that it has been under

PMID: 6997404

Adaptation of the bovine spongiform encephalopathy agent to primates and
comparison with Creutzfeldt- Jakob disease: Implications for human
health THE findings from Corinne Ida Lasmézas*, [dagger] , Jean-Guy
Fournier*, Virginie Nouvel*, Hermann Boe*, Domíníque Marcé*, François
Lamoury*, Nicolas Kopp [Dagger ] , Jean-Jacques Hauw§, James Ironside¶,
Moira Bruce [||] , Dominique Dormont*, and Jean-Philippe Deslys* et al,
that The agent responsible for French iatrogenic growth hormone-linked
CJD taken as a control is very different from vCJD but is similar to
that found in one case of sporadic CJD and one sheep scrapie isolate;

Infected and Source Flocks

As of September 30, 2004, there were 67 scrapie infected and source
flocks (figure 3
There were a total of 100** new infected and source flocks reported for
FY 2004 (figure 4
The total infected and source flocks that have been released in FY 2004
are 77 (figure 5
The percent of new infected and source flocks cleaned up or on clean up
plans was 96%. In addition, as of September 30, 2004, 368 scrapie cases
have been confirmed and reported by the National Veterinary Services
Laboratories (NVSL) in FY 2004, of which 54 were RSSS cases (figure 6
and figure 7
Thirteen cases of scrapie in goats have been reported since 1990 (figure
One new goat case was reported in FY 2004. New infected flocks, source
flocks, and flocks released for FY 2004 are depicted in chart 4
One new goat case was reported in FY 2004. Approximately 3,058 animals
were indemnified comprised of 47% non-registered sheep, 44% registered
sheep, 6% non-registered goats and 1% registered goats.

Scrapie: Ovine Slaughter Surveillance (SOSS)

The Center for Epidemiology and Animal Health (CEAH) released the
results of the Phase II: SOSS study The objective of
SOSS was to estimate the national and regional prevalence of scrapie in
mature cull ewes. Prior to the SOSS study, the prevalence of scrapie in
the United States was estimated to be 0.07 percent (based on information
from NAHMS Sheep 96, unpublished data). The SOSS study estimate for the
national prevalence in mature ewes is 0.20 percent. The prevalence phase
of the SOSS study started April 1, 2002, and continued through March 31,
2003. During this time period, samples were collected from 12,508 mature
sheep at 22 slaughter facilities, as well as a major livestock market.

Of the 12,508 sheep tested, 33* were found to be scrapie positive: 27
black face; 3 mottled face; 1* white face; and 2 of unknown face color.
Note: The raw prevalence is higher than the weighted prevalence. The
difference is the result of weighting each positive based on the number
of sheep sampled and the number of sheep killed at each plant.

Regulatory Scrapie Slaughter Surveillance (RSSS)
RSSS started April 1, 2003. It is a targeted slaughter surveillance
program which is designed to identify infected flocks for clean-up.
Samples have been collected from 34,661 sheep since April 1, 2003, of
which results have been reported for 28,677. Samples have been submitted
from 42 plants (figure 9
The state identified on the tag of sampled animals is shown in figure 10
There have been 77 NVSL confirmed positive sheep. There have been 54
NVSL confirmed positive cases in FY 2004. Face colors of these positives
were 46 black, 6 mottled, and 2 white. The Six Month Rolling Average of
Percent Scrapie Positive Black and Mottled Faced Sheep is shown in chart
The number of RSSS samples collected by month**, region and total in FY
2004 are shown in chart 7

Scrapie Testing

In FY 2004, 28,430 animals have been tested for scrapie: 25,178 RSSS;
2,687 regulatory field cases; 461 regulatory third eyelid biopsies; 13
third eyelid validations; and 91 necropsy validations (chart 8

Animal ID

As of September 30, 2004, 90,322 sheep and goat premises have been
assigned identification numbers in the Scrapie National Generic
Database. Official eartags have been issued to 64,040 of these premises.

*This number was decreased by one case as a result of a clerical error
compared to the FY 2003 annual report.
**Differences appear between this report and the September 2004 report
due to late reporting of RSSS testing and quality review of status data
As of May 2004 we are reporting only NVSL confirmed positive cases.

Greetings list members,

Thought I should let the list know that Dr. Detwiler kindly replied to
my question about the delayed 'atypical' TSE testing in the Vermont
sheep and tried to explain what caused the delay. If I interpreted it
correctly, seems it was the fault of the U.K. ;

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

Subject: Sheep
Date: Sat, 12 Jun 2004 14:26:04 EDT

Mr. Singeltary. I hope this finds you well. As you are aware I left the
USDA last year. I can only update you on the sheep before that time.
Contact was established with the UK on doing the bioassay studies. They
agreed. However, we were prioritized after their own needs, hence the
delay. I am aware that there are now additional labs in Europe running
the mouse bioassay strain typing. You will have to contact USDA for
further word.

Linda Detwiler


My reply to Dr. Detwiler;

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

Subject: Re: Sheep
Date: Sat, 12 Jun 2004 13:53:57 -0500
From: "Terry S. Singeltary Sr."
References: <>

hello Dr. Detwiler, thanks for your kind reply.
> However, we were prioritized after their own needs, hence the delay.
not sure i understand that?
> You will have to contact USDA for further word. already done that,
and there answer was;

> >Dear Mr. Singeltary,
> >The Western blot tests on these animals were completed in April of this
>year. That means that we can begin the mouse inoculations. To get the
>results of the Western blot tests, you will need to submit a Freedom of
>Information Act request through our FOIA office. The FAX number there is
> >Have a nice day,
> >Jim Rogers

and with my previous attempts for information via the FOIA through this
administration (as you are probably very well aware of) they have all
been ignored/refused. so any further attempts would be fruitless i am
sure. thanks anyway... kindest regards, Terry wrote: >
Mr. Singeltary. snip... end

SO we must wait another two years, and maybe more...


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