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From: TSS ()
Subject: MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL FROM BSE GBR III COUNTRIES I.E. USA
Date: February 18, 2006 at 8:24 am PST

1

© SEAC 2006

SEAC 91/2

MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL

ISSUE

1. The Medicines and Healthcare Products Regulatory Agency

(MHRA) has asked the committee to:

• advise on the BSE risk to humans from medical implants that

include bovine material sourced from USA animals.

• comment on a scheme proposed by a British Standards

Institution (BSI) committee to determine whether the BSE

risk from a medical device utilising bovine material has been

minimised.

BACKGROUND

Regulatory position

2. Bovine material (e.g. pericardium, hide, tendons, blood vessels,

collagen and gelatine) is used in a number of medical devices,

ranging from orthopaedic footwear to cardiovascular implants.

Two EU directives apply to medical devices containing bovine

material:

• the Medical Devices Directive 93/42/EEC deals with medical

devices in general terms. It came into force fully in 1998.

• a supplementary Directive 2003/32/EC deals specifically with

transmissible spongiform encephalopathy (TSE) risks in

relation to medical devices. It came into force fully on 1 May

2005.

3. The Medical Devices Directive 93/42/EEC provides a framework

for the assessment of the safety, health protection and

performance characteristics of medical devices1. It is based on the

1 Defined as any instrument, apparatus, appliance, material or other article used for humans

for the purpose of diagnosis, prevention, treatment or alleviation of disease, or alleviation of,

or compensation for an injury or handicap, or investigation, replacement or modification of the

2

© SEAC 2006

principle that all risks must be eliminated or reduced as much as

possible, in line with the state of the art, and that any residual risks

must be acceptable when weighed against the benefits to patients.

Medical device manufacturers are responsible for meeting the

requirements of the Directive. Conformity is assessed and verified

by an independent third party (Notified Body) designated by the

Competent Authority in a Member State. A Certification of

Conformity (CE mark) is provided if the device meets the

requirements of the Directive2. In the UK, the Competent Authority

is the MHRA. There are a number of Notified Bodies.

4. A European Standard BS EN 12442 was adopted in 2000 to

support the requirements of the Medical Device Directive

93/42/EEC with respect to viruses and transmissible agents. It

provides guidance on risk management and on controls for

sourcing, collection and handling of, and inactivation procedures

for relevant animal tissues. SEAC commented on a draft of the

Standard in 1996 (see paragraph 25 below).

5. Directive 2003/32/EC was introduced to manage risks from

medical devices utilising tissues/derivatives originating from

animals susceptible to TSEs (e.g. cattle, sheep, goats, deer).

From 1 May 2005, statutory consultation and certification has been

required for material from TSE-susceptible animals used in a

device. This certification supplements the Certification of

Conformity required under the terms of Directive 93/42/EEC.

6. The certification involves an assessment of TSE risk by a Notified

Body, which should include:

• pre-clinical and clinical data to support use of the device,

• an assessment of compliance to relevant standards,

• a justification for the use of tissues/derivatives from a TSEsusceptible

species instead of a non-TSE-susceptible

species or a synthetic material,

• an evaluation of measures to minimise the risk of infection

including the source of the materials, veterinary controls,

anatomy or of a physiological process, and which does not achieve its principal intended

action on the human body by pharmacological, immunological or metabolic means (adapted

from 93/423/EEC).

2 The EC Animal By Product Regulation (Regulation EC No 1774/2002) also applies. It

indicates that materials used for the manufacture of medical devices should be category 3

material or equivalent (i.e. from animals fit for human consumption).

3

© SEAC 2006

feeding restrictions, harvesting practices, information on the

TSE-related infectivity of the tissue/derivative used, and the

effect of processing and methods to eliminate and/or

inactivate TSE agents.

7. A summary of the Notified Body’s assessment is also circulated to

all Competent Authorities in the EU, whose comments must be

given due consideration by the Notified Body in reaching a decision

on the final certification of the device.

8. Although Directive 2003/32/EC contains some specific technical

requirements relating to the assessment, there is a lack of specific

guidance on issues such as the acceptability of particular risk

estimation models and risk control measures, and the criteria

required to justify the use of material from TSE-susceptible

animals. Similarly, although compliance with European Standard

BS EN 12442 carries the presumption of conformity with the

regulations, the standard itself provides no such guidance.

Risk reduction methods for medical devices

9. Methods to inactivate TSE agents in the tissues/derivatives used in

medical devices are rarely a realistic option as the harsh

inactivation methods required tend to destroy the structure of the

tissues/derivatives. For many materials, the only practical risk

control measure is to use material from sources with a very

low/negligible risk of infection with TSE agents.

10. In the case of bovine material, MHRA is of the view that

minimisation of risk can be achieved by the use of material from:

(i) a closed herd, where controls are in place to prevent the

introduction of the BSE agent into an uninfected herd from factors

such as the feeding of meat and bone meal (MBM) and the

importation of animals with a risk of BSE infection arising from their

source3, or

(ii) countries/regions with a Geographical BSE Risk (GBR) of I i.e.

where the presence of one or more cattle clinically or pre-clinically

infected with the BSE agent is highly unlikely (see below).

11. The EC Scientific Steering Committee (SSC) in 2001 considered

materials from these sources to be safe for the manufacture of

medical devices4. The World Health Organisation (WHO) in 2003

3 http://europa.eu.int/comm/food/fs/sc/ssc/out56_en.html

4 http://europa.eu.int/comm/food/fs/sc/ssc/out239_en.pdf

4

© SEAC 2006

reached a similar conclusion5. However, apart from advice from

SEAC on the use of UK-derived material (see paragraph 26

below), no expert committee opinion is available on which to base

the evaluation of BSE risk arising from bovine tissues from other

sources.

Geographical BSE Risk

12. GBR is a qualitative indicator of the likelihood of the presence of

one or more cattle infected with BSE pre-clinically as well as

clinically at a given point in time in a country/region. Where the

presence of BSE is confirmed, the GBR gives an indication of the

level of infection (see table below). The GBR assessment method

was developed by the SSC (2000) and has been applied to

countries within the EU and elsewhere6. It is based on the

assumption that BSE originated in the UK, is only propagated

through the recycling of cattle tissues into animal feed and is only

transmitted via feed. Thus, for countries other than the UK, the

importation of contaminated feed and/or infected animals are the

only initial sources of BSE.

Table of Geographical BSE Risk levels

GBR

Level

Presence of one or more cattle clinically or pre-clinically

infected with the BSE agent in a geographical country/region

I Highly unlikely

II Unlikely but not excluded

IIIa Likely but not confirmed or confirmed at a lower level

IVa Confirmed at a higher level

a SSC considered the borderline between level III and IV as arbitrary, as no clear scientific

justification could be made for this differentiation. As a guide, it adopted a threshold between

levels III and IV of an incidence of 100 confirmed BSE cases/million within the cattle

population over 24 months of age in a country/region over a 12 month period.

13. The GBR level of a country is based on an assessment of factors

that could:

(i) lead to or prevent the introduction of the BSE agent into that

country (the external challenge) such as controls on the

importation of contaminated feed or infected animals, and,

(ii) help or inhibit its propagation in the country’s cattle herd (the

stability of the system) such as the structure and dynamics of the

cattle population, TSE surveillance systems, culling schemes as

well as feeding and rendering practices.

5 http://www.who.int/bloodproducts/publications/en/WHO_TSE_2003.pdf

6 http://europa.eu.int/comm/food/fs/sc/ssc/out113_en.pdf

5

© SEAC 2006

14. SSC and now EFSA reassesses GBRs over time. The UK is

designated GBR IV.

USA GBR

15. USA was initially assigned GBR II by the SSC in 20007. A

reassessment by EFSA in 2004 changed the level to GBR III8 (see

Annex 1). This was based upon:

(i) the extent of external challenge since 1980. The USA imported

cattle and MBM from BSE risk countries, including the UK, during

periods of time when a risk of importation of infected animals and

contaminated feed existed (see pages 2-8 of the technical annex at

Annex 1).

(ii) the stability of USA system to mitigate against the external

challenge since 1980. The USA system was considered extremely

unstable such that should BSE infectivity have entered the system

it would have recycled and amplified quickly (see pages 8-14 of the

technical annex at Annex 1).

16. In 2005, BSE was confirmed from a reanalysis of sample collected

as part of routine surveillance from a single native USA animal that

died in 20049 supporting the change in GBR level.

SEAC CONSIDERATION

Implantable medical devices containing bovine material

17. MHRA recently identified a range of implants (heart valves, heart

valve conduits, vascular grafts and pericardial patches) on the UK

market that use bovine tissue (mainly pericardium) sourced from

an open herd in the USA. The devices were certified by a Spanish

Notified Body despite objections being made about the source of

the material by the UK and other Member States. The basis for the

Spanish certification was that no alternative devices would be

available until the manufacturer found another bovine source (i.e.

from a closed herd or from a GBR I country). However, since

these implants were sourced from an open herd in a GBR III

country, MHRA took the view that the TSE-related risk had not

been minimised and the products were removed from the UK

market.

7 http://europa.eu.int/comm/food/fs/sc/ssc/out137_en.pdf

8 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_en.html

9 http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf

6

© SEAC 2006tss

18. The products will not be re-introduced on the UK market until

suitable alternatives are available. However, the devices can be

used in the UK on humanitarian grounds on a named patient basis

where no alternative treatment is available.

19. It is likely that in the past (prior to 1 May 2005 when the additional

certification under the terms of Directive 2003/32/EC was required)

that several thousand devices incorporating material from the

same and similar sources were implanted into patients in the UK.

BSE infectivity of bovine heart tissues

20. Few studies have examined the presence/absence of BSE

infectivity in bovine heart or pericardium (no studies have reported

the presence/absence of PrPSc in these tissues). SSC reviewed

data on the distribution of BSE infectivity in cattle (mostly data from

the VLA pathogenesis experiment) in 200210. It reported that no

infectivity, as assessed by mouse bioassay, was detected in the

heart of confirmed cases of BSE or in the heart, pericardium, mitral

valve or aorta from cattle after 18 and 32 months following oral

exposure to BSE. WHO (2003) classified bovine heart/pericardium

as tissues with no detected infectivity based on similar (the same)

data11.

21. In a more recent report12, no infectivity was found in the heart from

a single animal with clinical BSE using a mouse bioassay utilising a

transgenic mouse line expressing the bovine prion protein gene

(bioassay of the pericardium was not conducted13). This bioassay

is reported to be approximately 10 000 times more sensitive than

conventional mouse bioassay and approximately 10 times more

sensitive than cattle bioassay.

BSI committee scheme

22. The lack of specific guidance on risk assessment and control

measures in relation to use of material from TSE-susceptible

animals in medical devices has led to discrepancies in

implementation of the legislation (such as the situation described

above). A revision of the European standard BS EN 12442 is

under development and MHRA is pressing for this to facilitate more

10 http://europa.eu.int/comm/food/fs/sc/ssc/out296_en.pdf

11 http://www.who.int/bloodproducts/publications/en/WHO_TSE_2003.pdf

12 Buschmann & Groschup (2005) Highly bovine spongiform encephalopathy-sensitive

transgenic mice confirm the essential restriction of infectivity to the nervous system in

clinically diseased cattle. J. Infect. Diseases 192, 934-942.

13 Buschmann. Personal communication.

7

© SEAC 2006

consistent decisions to be made about the TSE risks associated

with medical devices.

23. A risk evaluation scheme incorporating an assessment of whether

the BSE risk has been minimised has been developed by the BSI

standards committee (see Annex 2) for discussions to revise the

standard. It aims to facilitate the application of more consistent

judgements about the acceptability of BSE risk arising from

medical devices that include material from TSE-susceptible

animals. The BSI committee proposes that where the BSE risk

has not been minimised in line with specified criteria, the risk may

only be judged acceptable when balanced by exceptional benefit

and feasibility considerations. Even when the risk is minimised, it

would be necessary (as with Directive 2003/32/EC) to demonstrate

a clinical benefit that cannot be achieved by other means.

PREVIOUS SEAC ADVICE ON BOVINE MATERIAL IN MEDICAL

DEVICES

24. At SEAC 9 (1991), the committee considered the use of bovine

material in non-food products (pharmaceuticals, medical devices

and cosmetics). The committee agreed that the human risk from

BSE would likely reside in the bovine tissues most likely to contain

the infective agent and where parenteral exposure could occur.

25. At SEAC 36 (1996), the committee considered a draft of the

European Standard BS EN 12442. The draft stated that use of

bovine tissues should take into account factors including the BSE

status of the country and herd of origin, the feeding history of the

herd, the age of the cattle used and the extent of inactivation of the

agent by processing. The committee suggested that the Standard

cover all TSEs.

26. At SEAC 42 (1997), the committee considered a report prepared

by the Medical Devices Agency (now part of the MHRA) on the

geographical sources of materials of bovine origin in medical

devices. The committee noted that all bovine products used in

medical devices were sourced from outside the UK. It was content

that UK raw materials were not used in these products.

ADVICE SOUGHT FROM THE COMMITTEE

27. The committee is asked:

8

© SEAC 2006

(i) to consider to what extent the TSE risk in relation to medical

implants utilising bovine pericardium14, and medical devices in

general utilising bovine material, that is sourced from the USA is

influenced by the following factors:

• the likelihood that the BSE agent is present in the tissue

used, if it is taken from infected cattle;

• the likelihood cattle in the USA are infected with BSE now

and were infected with BSE in the past (see Annex 1), in

particular whether sourcing from open herds in the USA

represents a significant risk now or from any particular time

in the past;

• implantation, rather than ingestion, of infectious material;

• any other significant factors?

(ii) to comment on the BSI committee proposal for the evaluation of

the BSE-risk from bovine material used in medical devices (see

Annex 2) and to consider:

• whether the BSE risk associated with a medical implant

utilising bovine material is minimised by sourcing material

from a closed herd or GBR I country, irrespective of the

infectivity of the tissue or the manufacturing methods used;

• whether the BSE risk associated with a medical device

contacting only intact skin is negligible even if the bovine

material is sourced from a GBR IV country, irrespective of

the infectivity of the tissue or the manufacturing methods

used;

• the extent to which additional control measures (e.g.

controlled harvesting and/or prion reduction processes)

would minimise the BSE risk for implants incorporating

bovine material sourced from open herds in GBR II and III

countries?

14 SEAC’s consideration of the risks from use of these materials in implantable devices may

be used by the CJD Incidents Panel when considering cases where such devices have been

implanted.

9

©tss SEAC 2006

SEAC 91/2 ANNEX 1

Scientific report of the European Food Safety Authority on the

assessment of the Geographical BSE Risk (GBR) of the United

States of America (USA) including

• report

• technical annex

These documents can also be found at:

http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_en.html

10

© SEAC 2006

SEAC 91/2 ANNEX 2

British Standards Institution committee proposal for the

determination that BSE risk from bovine material used in medical

devices is minimised

11

© SEAC 2006

UK comment on risk evaluation (new Clause 4.5 of ISO 22442-1) [Animal tissues and

their derivatives utilised in the manufacture of medical devices – Part 1: Analysis and

management of risk]

4.5. Risk Evaluation

4.5.1 General

Clauses 5, 6 and 7 of ISO 14971 apply. [This refers to requirements for risk evaluation, risk

control and evaluation of overall residual risk acceptability, in the international standard on

risk management for medical devices]

4.5.2 Evaluation of TSE Risk

For materials sourced from species that are susceptible to TSE, risk control measures shall

be reviewed and the overall TSE risk estimated and assessed in relation to the medical

benefits of the intended use and the feasibility of other treatment or supply options. Figure 1

identifies the risk control measures that can be applicable to a particular product and indicates

circumstances that may be judged to correspond to minimal BSE risk. The TSE risk may be

judged acceptable if the BSE risk has been minimised in accordance with Figure 1 and the

medical benefit arising from the intended use of the device cannot feasibly be achieved by

other means. Where the BSE risk has not been minimised, the TSE risk may only be judged

acceptable when balanced by exceptional benefit and feasibility considerations. The rationale

for the judgement that the TSE risk is acceptable shall be documented in the risk

management file.

Figure 1 (Normative): Circumstances leading to minimisation of BSE risk

(see attached flowchart)

Notes to Figure 1:

This flowchart can be used to determine whether the circumstances of sourcing, processing

and use of a particular device that incorporates bovine material minimise the BSE risk.

The infectivity of a starting tissue can be determined by reference to a literature survey (see

D.3.4).

The risk relating to geographical sourcing can be determined by reference to a literature

survey (see D.3.3). The terminology used in the flowchart is that used by the Scientific

Steering Committee of the European Union and corresponds to circumstances where the

presence of infection with the BSE-agent in a country has been determined as follows: GBR I:

highly unlikely; GBR II: unlikely but not excluded; GBR III: likely but not confirmed or

confirmed at a lower level; GBR IV: confirmed at a higher level.

A prion reduction process can be any process which, although not formally validated or

assured by the manufacturer, is known, by reference to a literature survey, to substantially

eliminate or inactivate prions.

A validated prion inactivation process is one which includes a prion elimination or inactivation

step that complies with relevant parts of Clause 6 of ISO 22442-3. [This clause (Elimination

and/or inactivation study of viruses and transmissible agents) requires that such studies must

substantiate the effectiveness of manufacturing steps and that validation data for the

elimination/inactivation of transmissible agents must be provided to support sterilization

processes. There are also requirements for protocols, study conduct and data interpretation.]

Controlled harvesting comprises a process that complies with Clauses 6, 7, 8, A.5 and A.6 of

ISO 22442-2. [These clauses contain requirements for collection, handling, storage and

transport of material, including the need for control of procedures by the manufacturer,

prevention of cross-contamination, environmental control and justification of the method of

stunning.] This is in addition to the routine veterinary surveillance and abattoir certification

required to ensure fitness for human consumption.

12

© SEAC 2006

Is exposure to

intact skin only ?

Has

infectivity been

detected in type of

tissue?

Is harvesting

controlled?

Is there

a prion reduction

process?

Yes No Risk is minimised Yes

No

Risk is not

minimised Yes

No

No

No

Has

infectivity been

detected in type of

tissue?

Yes

Risk is minimised No

Yes Risk is not

minimised

Has

infectivity been

detected in type of

tissue?

Yes

No Risk is minimised

Yes Risk is not

minimised

No

Is there

a validated prion

inactivation

process?

Yes

Has

infectivity been

detected in type of

tissue?

Risk is not

minimised Yes No Is harvesting

controlled?

Yes

Yes

No

Is there

a validated prion

inactivation

process?

Risk is minimised Yes

No

GBR I

Country or low risk

herd?

GBR II

Country?

GBR III

Country?

GBR IV

Country?

Start

Is there

a prion reduction

process?

No

Yes

No

No

Yes

Yes

Figure 1 (Normative): Circumstances leading to minimisation of BSE risktss

http://www.seac.gov.uk/papers/91-2.pdf

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@uni-karlsruhe.de

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

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;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

RBARNS@ORA.FDA.GOV
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

BSE issues in the U.S.,
How they were labelling ruminant feed?
Revising issues.

The conference opened up with the explaining of
the U.K. BSE epidemic winding down with about 30
cases a week.

although new cases in other countries were now
appearing.

Look at Germany whom said NO BSE and now have BSE.

BSE increasing across Europe.

Because of Temporary Ban on certain rendered product,
heightened interest in U.S.

A recent statement in Washington Post, said the
New Administration (old GW) has a list of issues.
BSE is one of the issues.

BSE Risk is still low, minimal in U.S. with a greater
interest in MBM not to enter U.S.

HOWEVER, if BSE were to enter the U.S.
it would be economically disastrous
to the render, feed, cattle, industries,
and for human health.

(human health-they just threw that in cause i was listening. I will now
jot down some figures in
which they told you, 'no need to write them down'.
just hope i have them correct. hmmm, maybe i hope
i don't ???)

80% inspection of rendering

*Problem-Complete coverage of rendering HAS NOT
occurred.

sizeable number of 1st time FAILED INITIAL INSPECTION,
have not been reinspected (70% to 80%).

Compliance critical, Compliance poor in U.K.
and other European Firms.

Gloria Dunason
Major Assignment 1998 goal TOTAL compliance.
This _did not_ occur. Mixed level of compliance,
depending on firm.

Rendering FDA license and NON FDA license

system in place for home rendering & feed
76% in compliance
79% cross contamination
21% DID NOT have system
92% record keeping
less than 60% total compliance

279 inspectors
185 handling prohibited materials

Renderer at top of pyramid, significant
part of compliance.
84% compliance

failed to have caution statement render
72% compliance & cross contamination
caution statement on feed, 'DO NOT FEED TO CATTLE'

56 FIRMS NEVER INSPECTED

1240 FDA license feed mills
846 inspected

"close to 400 feed mills have not been inspected"

80% compliance for feed.

10% don't have system.

NON-FDA licensed mills
There is NO inventory on non licensed mills.
approximately 6000 to 8000 Firms ???
4,344 ever inspected.
"FDA does not have a lot of experience with"

40% do NOT have caution statement 'DO NOT FEED'.

74% Commingling compliance

"This industry needs a lot of work and only half
gotten to"

"700 Firms that were falitive, and need to be
re-inspected, in addition to the 8,000 Firms."

Quote to do BSE inspection in 19 states by end
of January or 30 days, and other states 60 days.
to change feed status??? Contract check and ask
questions and pass info.

At this time, we will take questions.

[I was about the third or fourth to ask question.
then all B.S.eee broke loose, and i lost my train
of thought for a few minutes. picked back up here]

someone asking about nutritional supplements and
sourcing, did not get name. something about inspectors
not knowing of BSE risk??? the conference person assuring that Steve
Follum? and the TSE advisory Committee were
handling that.

Some other Dr. Vet, whom were asking questions
that did not know what to do???

[Dennis Wilson]
California Food Agr.
Imports, are they looking at imports?

[Conference person]
they are looking at imports,
FDA issued imports Bulletin.

[Linda Singeltary ??? this was a another phone in
question, not related i don't think]
Why do we have non-licensed facilities?

(conference person)
other feed mills do not handle as potent drugs???

Dennis Blank, Ken Jackson
licensed 400
non FDA 4400 inspected of a total of 6000 to 8000,

(they really don't know how many non licensed Firms
in U.S. they guess 6000 to 8000??? TSS)

Linda Detwiler
asking everyone (me) not to use emergency BSE number,
unless last resort.
(i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not'

Warren-Maryland Dept. Agr.
Prudent to re-inspect after 3 years.
concerned of Firms that have changed
owners.

THE END

TSS

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############

FROM New York TIMES

Subject: Re: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...
Date: Thu, 11 Jan 2001 22:02:47 -0700
From: "Sandy Blakeslee"
To: "Terry S. Singeltary Sr."
References: 1

Hi terry -- thanks for all your help. I know it made a difference with
the FDA getting out that release.

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Thursday, January 11, 2001 2:06 PM
Subject: BSE 50 STATE CONFERENCE CALL thread from BSE List and FDA
Posting of cut version...

> http://www.vegsource.com/talk/lyman/messages/8219.html


> http://www.vegsource.com/talk/lyman/messages/8220.html


> http://www.vegsource.com/talk/lyman/messages/8221.html


> http://www.vegsource.com/talk/lyman/messages/8222.html


> http://www.vegsource.com/talk/lyman/messages/8230.html

P.S. change the urls' above and they will work, change the lyman to madcow...TSS


>
> hi sandy,

>From the New York Times NYTimes.com, January 11, 2001

Many Makers of Feed Fail to Heed Rules on Mad Cow Disease
By SANDRA BLAKESLEE

Large numbers of companies involved in manufacturing animal feed are not
complying with regulations meant to prevent the
emergence and spread of mad cow disease in the United States, the Food
and Drug Administration said yesterday.

The widespread failure of companies to follow the regulations, adopted
in August 1997, does not mean that the American food supply is unsafe,
Dr. Stephen Sundlof, director of the Center for Veterinary Medicine at
the F.D.A., said in an interview.

But much more needs to be done to ensure that mad cow disease does not
arise in this country, Dr. Sundlof said.

The regulations state that feed manufacturers and companies that render
slaughtered animals into useful products generally may not feed mammals
to cud-chewing animals, or ruminants, which can carry mad cow disease.

All products that contain rendered cattle or sheep must have a label
that says, "Do not feed to ruminants," Dr. Sundlof said. Manufacturers
must also have a system to prevent ruminant products from being
commingled with other rendered material like that from chicken, fish or
pork. Finally, all companies must keep records of where their products
originated and where they were sold.

Under the regulations, F.D.A. district offices and state veterinary
offices were required to inspect all rendering plants and feed mills to
make sure companies complied. But results issued yesterday demonstrate
that more than three years later, different segments of the feed
industry show varying levels of compliance.

Among 180 large companies that render cattle and another ruminant,
sheep, nearly a quarter were not properly labeling their products and
did not have a system to prevent commingling, the F.D.A. said. And among
347 F.D.A.-licensed feed mills that handle ruminant materials - these
tend to be large operators that mix drugs into their products - 20
percent were not using labels with the required caution statement, and
25 percent did not have a system to prevent commingling.

Then there are some 6,000 to 8,000 feed mills so small they do not
require F.D.A. licenses. They are nonetheless subject
to the regulations, and of 1,593 small feed producers that handle
ruminant material and have been inspected, 40 percent
were not using approved labels and 25 percent had no system in place to
prevent commingling.

On the other hand, fewer than 10 percent of companies, big and small,
were failing to comply with the record-keeping
regulations.

The American Feed Industry Association in Arlington, Va., did not return
phone calls seeking comment.

http://www.nytimes.com/2001/01/11/science/11COW.html

Subject:
USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date:
Wed, 10 Jan 2001 14:04:21 -0500
From:
"Gomez, Thomas M."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de


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

USDA/APHIS would like to provide clarification on the following point
from
Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.

[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless
last resort. (i thought of calling them today, and reporting the whole
damn
U.S. cattle herd ;-) 'not']

Dr. Detwiler was responding to an announcement made during the call to
use
the FDA emergency number if anyone wanted to report a cow with signs
suspect
for BSE. Mr. Singeltary is correct that Dr. Detwiler asked participants
to
use the FDA emergency number as a last resort to report cattle suspect
for
BSE. What Mr. Singeltary failed to do was provide the List with Dr.
Detwiler's entire statement. Surveillance for BSE in the United States
is a
cooperative effort between states, producers, private veterinarians,
veterinary hospitals and the USDA. The system has been in place for
over 10
years. Each state has a system in place wherein cases are reported to
either the State Veterinarian, the federal Veterinarian in Charge or
through
the veterinary diagnostic laboratory system. The states also have
provisions with emergency numbers. Dr. Detwiler asked participants to
use
the systems currently in place to avoid the possibility of a BSE-suspect
report falling through the cracks. Use of the FDA emergency number has
not
been established as a means to report diseased cattle of any nature.

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############

Subject:
Re: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE
CALL Jan.9, 2001
Date:
Wed, 10 Jan 2001 13:44:49 -0800
From:
"Terry S. Singeltary Sr."
Reply-To:
Bovine Spongiform Encephalopathy
To:
BSE-L@uni-karlsruhe.de
References:
1


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

Hello Mr. Thomas,

> What Mr. Singeltary failed to do was provide
> the List with Dr. Detwiler's entire statement.

would you and the USDA/APHIS be so kind as to supply
this list with a full text version of the conference
call and or post on your web-site?
if so when, and thank you.
if not, why not?

> The system has been in place for over 10 years.

that seems to be a very long time for a system to be in
place, and only test 10,700 cattle from some 1.5 BILLION head (including
calf crop). Especially since French
are testing some 20,000 weekly and the E.U. as a whole,
are testing many many more than the U.S., with less
cattle, same risk of BSE/TSEs.

Why does the U.S. insist on not doing massive testing
with the tests which the E.U. are using?
Why is this, please explain?

Please tell me why my question was not answered?

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

It was a very simple question, a very important
question, one that pertained to the topic of
BSE/feed, and asked in a very diplomatic way.
why was it not answered?

If all these years, we have been hearing that
pharmaceutical grade bovines were raised for
pharmaceuticals vaccines etc. But yet the
USA cannot comply with feed regulations of
the ruminant feed ban, PLUS cannot even
comply with the proper labelling of the feed,
cross contamination etc.
Then how in the world can you Guarantee the feed
fed to pharmaceutical grade bovine, were actually
non ruminant feed?

Before i was ask to be 'disconnected',
i did hear someone in the background
say 'we can't'-- have him ask the question again.

could you please be so kind, as to answer these
questions?

thank you,
Terry S. Singeltary Sr. Bacliff, Texas USA

P.S. if you will also notice, i did not post that
emergency phone number and do not intend on passing
it on to anyone. I was joking when i said i should
call and report the whole damn U.S. Herd. So please
pass that on to Dr. Detwiler, so she can rest easily.

BUT, they should be reported, some are infected with TSE.
The U.S. is just acting as stupid as Germany and other
Countries that insist they are free of BSE.

TSS

Subject: Report on the assessment of the Georgraphical BSE-risk of the
USA July 2000 (not good)
Date: Wed, 17 Jan 2001 21:23:51 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

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

Greetings List Members and ALL EU Countries,

Because of this report, and the recent findings
of the 50-state BSE Conference call, I respectfully
seriously suggest that these Countries and the SSC
re-evaluate the U.S.A. G.B.R. to a risk factor of #3.

I attempted to post this to list in full text,
but would not accept...

thank you,
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

PART II

REPORT ON THE ASSESSMENT OF THE GEOGRAPHICAL BSE
RISK OF THE UNITED STATES OF AMERICA

- 29 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

EXECUTIVE SUMMARY

OVERALL ASSESSMENT

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

Stability: Before 1990 the system was extremely unstable because feeding
of MBM to cattle happened, rendering was inappropriate with regard to
deactivation of the BSE-agent and SRM and fallen stock were rendered for
feed. From 1990 to 1997 it improved to very unstable, thanks to efforts
undertaken to trace imported animals and exclude them from the feed
chain and intensive surveillance. In 1998 the system became neutrally
stable after the RMBM-ban of 1997.

External challenges: A moderate external challenge occurred in the
period before 1990 because of importation of live animals from
BSE-affected countries, in particular from the UK and Ireland. It cannot
be excluded that some BSE-infected animals have been imported by this
route and did enter the US rendering and feed production system. The
efforts undertaken since 1990 to trace back UK-imported cattle and to
exclude them from the feed chain reduced the impact of the external
challenge significantly.

Interaction of external challenges and stability: While extremely
unstable, the US system was exposed to a moderate external challenge,
mainly resulting from cattle imports from the UK. It can not be excluded
that BSE-infectivity entered the country by this route and has been
recycled to domestic cattle. The resulting domestic cases would have
been processed while the system was still very unstable or unstable and
would hence have initiated a number of second or third generation cases.
However, the level of the possible domestic prevalence must be below the
low detection level of the surveillance in place.

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent will remain at the current level.

JUSTIFICATION

1. DATA

The available information was suitable to carry out the GBR risk
assessment.

- 30 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

2. STABILITY

2.1 Overall appreciation of the ability to identify BSE-cases and to
eliminate animals at risk of being infected before they are processed

· Before 1989, the ability of the system to identify (and
eliminate) BSE cases was limited.
· Since 1990 this ability is significantly improved, thanks to a
good BSE-surveillance and culling system (contingency plan).
· Today the surveillance should be able to detect clinical
BSE-cases within the limits set by an essential passive surveillance
system, i.e. some cases might remain undetected.

2.2 Overall appreciation of the ability to avoid recycling
BSE-infectivity, should it enter processing

· Before 1997 the US rendering and feed producing system would not
have been able to avoid recycling of the BSE agent to any measurable
extent. If the BSE-agent was introduced the feed chain, it could
probably have reached cattle.
· After the introduction of the RMBM-to-ruminants-ban in August
1997 the ability of the system to avoid recycling of BSE-infectivity was
somewhat increased. It is still rather low due to the rendering system
of ruminant material (including SRM and fallen stock) and the persisting
potential for cross-contamination of cattle feed with other feeds and
hence RMBM.

2.3 Overall assessment of the Stability

· Until 1990 the US BSE/cattle system was extremely unstable as
RMBM was commonly fed to cattle, the rendering system was not able to
reduce BSE-infectivity and SRM were rendered. This means that incoming
BSE infectivity would have been most probably recycled to cattle and
amplified and the disease propagated.
· Between 1990 and 1995 improvements in the BSE surveillance and
the efforts to trace back and remove imported cattle gradually improved
the stability but
the system remained very unstable.
In 1998 the system became unstable because of an RMBM-ban introduced in
1997. After 1998 the ban was fully implemented and the system is
regarded to be neutrally stable since 1998. The US system is therefore
seen to neither be able to amplify nor to reduce circulating or incoming
BSE-infectivity.

3. CHALLENGES

A moderate external challenge occurred in the period 1980-1989 because
of importation of live animals from the UK. imports from other countries
are regarded to have been negligible challenges.
· As a consequence of this external challenge, infectivity could
have entered the feed cycle and domestic animals could have been exposed
to the agent. These domestic BSE-incubating animals might have again
entered processing, leading to an internal challenge since 1991.
· This internal challenge could have produced domestic cases of
BSE, yet prevalence levels could have been below the detection limits of
the surveillance system until now. (According to US calculations, the
current surveillance

-31 -

Report on the assessment of the Geographical BSE-risk of the USA July
2000

system could detect clinical incidence of 1-3 cases per year per million
adult cattle, i.e. in absolute numbers 43-129 cases per year). Between
1990 und 1995, with the exclusion of the imported animals from Europe
from the feed chain, the effect of the external challenges decreased.

4. CONCLUSION ON THE RESULTING RISKS

4.1 Interaction of stability and challenqe

· In the late 80s, early 90s a moderate external challenges met an
extremely unstable system. This would have amplified the incoming
BSE-infectivity and propagated the disease.
· With the exclusion of the imported animals from Europe from the
feed chain between 1990 and 1995 the effect of the external challenge
decreased.
· Before 1998 an internal challenge, if it developed, would have
met a still unstable system (inappropriate rendering, no SRM ban, RMBM
ban only after 1997) and the BSE-infectivity could have been recycled
and amplified.
· After 1998 the neutrally stable system could still recycle the
BSE-agent but due to the RMBM-ban of 1997 the BSE-infectivity
circulating in the system would probably not be amplified.

4.2 Risk that BSE-infectivity enters processing

· A very low processing risk developed in the late 80s when the
UK-imports were slaughtered or died. It increased until 1990 because of
the higher risk to be infected with BSE of cattle imported from the UK
in 1988/89, as these animals could have been processed prior to the
back-tracing of the UK-imports in 1990.
· From 1990 to 1995 a combination of surviving non-traced UK
imports and some domestic (pre-)clinical cases could have arrived at
processing resulting in an assumed constant low but non-negligible
processing risk.
· After 1995 any processing risk relates to assumed domestic cases
arriving at processing.
· The fact that no domestic cases have been shown-up in the
BSE-surveillance is reassuring - it indicates that BSE is in fact not
present in the country at levels above the detection limits of the
country's surveillance system. This detection level has been calculated
according to US-experts to be between 1 & 3 clinical cases per million
adult cattle per year.

Note: The high turnover in parts of the dairy cattle population with a
young age at slaughter makes it unlikely that fully developed clinical
cases would occur (and could be detected) or enter processing. However,
the theoretical infective load of the pre-clinical BSE-cases that
under this scenario could be processed, can be assumed to remain
relatively low.

4.3 Risk that BSE-infectivity is recycled and propagated

· During the period covered by this assessment (1980-1999) the
US-system was not able to prevent propagation of BSE should it have
entered, even if this ability was significantly improved with the
MBM-ban of 1997.
· However, since the likelihood that BSE-infectivity entered the
system is regarded to be small but non-negligible, the risk that
propagation of the disease
took place is also small but not negligible.

- 32 -

Report on the assessment of the Geographical BSE-risk of the USA
July
2000

5. CONCLUSION ON THE GEOGRAPHICAL BSE-RISK

5.1 The current GBR

The current geographical BSE-risk (GBR) level is II, i.e. it is unlikely
but cannot be excluded that domestic cattle are (clinically or
pre-clinically) infected with the BSE-agent.

5.2 The expected development of the GBR

As long as there are no changes in stability or challenge the
probability of cattle to be (pre-clinically or clinically) infected with
the BSE-agent remains at the current level.

5.3 Recommendations for influencin.q the future GBR

· As long as the stability of the US system is not significantly
enbanced above neutral levels it remains critically important to avoid
any new external
challenges.
· All measures that would improve the stability of the system, in
particular with regard to its ability to avoid recycling of the
BSE-agent should it be present in the cattle population, would reduce,
over time, the probability that cattle could be infected with the
BSE-agent. Possible actions include:
removal of SRMs and/or fallen stock from rendering, better rendering
processes, improved compliance with the MBM-ban including control and
reduction of cross-contamination.
· Results from an improved intensive surveillance programme,
targeting at risk sub-populations such as adult cattle in fallen stock
or in emergency slaughter, could verify the current assessment.

snip...

FULL TEXT about 16 pages
http://www.vegsource.com/talk/lyman/messages/8278.html
http://www.vegsource.com/talk/lyman/messages/8279.html
http://www.vegsource.com/talk/lyman/index.html

p.s. change url to, change lyman to madcow...tss

to keep up with this epidemic in both humans and animals,
one that will be with us for years to come, and soon will explain the
many demented people in the U.S.,
please go to;

most of these urls are dead now...tss

BSE NEWS
http://www.vegsource.com/wwwboard/lyman/wwwboard.html

CJD Watch
http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

CJD Watch message board
http://www.InsideTheWeb.com/mbs.cgi/mb172420

CJD NEWS
http://www3.bravenet.com/forum/show.asp?userid=qn99925

Moms death from hvCJD
http://www.vegsource.com/talk/lyman/messages/7252.html

'MOMS AUTOPSY REPORT'
http://www.vegsource.com/talk/lyman/messages/7548.html

CJD/BSE aka madcow disease in the U.S., please let me count the Ways$$$
PLEASE READ THIS...
http://www.whale.to/v/cjd2.html

SOMETHING TO CHEW ON

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

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

http://www.vegsource.com/talk/lyman/messages/8278.html

My submission to the MEETING OF PRION GODS,
on Jan. 18/19 2001

http://www.InsideTheWeb.com/messageboard/mbs.cgi?acct=mb172420&MyNum=978977689&P=No&TL=978977689

this message will self destruct in 10 seconds ;-)

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




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