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From: TSS ()
Subject: BSE OIE CHAPTER 2.3.13 (The Weakening of a already terribly flawwed BSE/TSE surveillance system)
Date: June 4, 2005 at 6:00 am PST

C H A P T E R 2 . 3 . 1 3 .

BOVINE SPONGIFORM ENCEPHALOPATHY

Article 2.3.13.1.

The recommendations in this Chapter are intended to manage the human and animal health risks

associated with the presence of the bovine spongiform encephalopathy (BSE) agent in cattle (Bos taurus

and B. indicus) only.

1) When authorising import or transit of the following commodities and any products made from these

commodities and containing no other tissues from cattle, Veterinary Administrations should not

require any BSE related conditions, regardless of the BSE risk status of the cattle population of the

exporting country, zone or compartment:

a) milk and milk products;

b) semen and in vivo derived cattle embryos collected and handled in accordance with the

recommendations of the International Embryo Transfer Society;

c) hides and skins;

d) gelatin and collagen prepared exclusively from hides and skins;

e) protein-free tallow (maximum level of insoluble impurities of 0.15% in weight) and derivatives

made from this tallow;

f) dicalcium phosphate (with no trace of protein or fat);

g) deboned skeletal muscle meat (excluding mechanically separated meat) from cattle 30 months of

age or less, which were not subjected to a stunning process, prior to slaughter, with a device

injecting compressed air or gas into the cranial cavity, or to a pithing process, and which were

subject to ante- and post-mortem inspection and were not suspect or confirmed BSE cases; and

which has been prepared in a manner to avoid contamination with tissues listed in

Article 2.3.13.13.;

h) blood and blood by-products, from cattle which were not subjected to a stunning process,

prior to slaughter, with a device injecting compressed air or gas into the cranial cavity, or to a

pithing process.

2) When authorising import or transit of other commodities listed in this chapter, Veterinary

Administrations should require the conditions prescribed in this Chapter relevant to the BSE risk

status of the cattle population of the exporting country, zone or compartment.

Standards for diagnostic tests are described in the Terrestrial Manual.

Article 2.3.13.2.

The BSE risk status of the cattle population of a country, zone or compartment should be determined on the

basis of the following criteria:

1) the outcome of a risk assessment (which is reviewed annually), based on Section 1.3., identifying all

potential factors for BSE occurrence and their historic perspective:

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a) Release assessment

Release assessment consists of assessing the likelihood that a transmissible spongiform

encephalopathy (TSE) agent has been introduced into the cattle population from a pre-existing

TSE in the indigenous ruminant population or via commodities potentially contaminated with a

TSE agent, through a consideration of the following:

i) the presence or absence of animal TSE agents in the country or zone or compartment and, if

present, their prevalence based on the outcomes of surveillance;

ii) meat-and-bone meal or greaves from the indigenous ruminant population;

iii) imported meat-and-bone meal or greaves;

iv) imported live animals;

v) imported animal feed and feed ingredients;

vi) imported products of ruminant origin for human consumption, which may have contained

tissues listed in Article 2.3.13.13. and may have been fed to cattle;

vii) imported products of ruminant origin for in vivo use in cattle.

Surveillance and other epidemiological investigations (especially surveillance for BSE conducted

on the cattle population) relevant to the above should be taken into account in carrying out the

assessment.

b) Exposure assessment

If the release assessment identifies a risk factor, an exposure assessment should be conducted,

consisting of assessing the likelihood of exposure of the BSE agent to cattle, through a

consideration of the following:

i) recycling and amplification of the BSE agent through consumption by cattle of meat-andbone

meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with

these;

ii) the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse

waste, the parameters of the rendering processes and the methods of animal feed

manufacture;

iii) the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants,

including measures to prevent cross-contamination of animal feed;

iv) the level of surveillance for BSE conducted on the cattle population to that time and the

results of that surveillance.

2) on-going awareness programme for veterinarians, farmers, and workers involved in transportation,

marketing and slaughter of cattle to encourage reporting of all cases showing clinical signs consistent

with BSE in target sub-populations as defined in Appendix 3.8.4.;

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3) the compulsory notification and investigation of all cattle showing clinical signs consistent with BSE;

4) the examination in an approved laboratory of brain or other tissues collected within the framework

of the aforementioned surveillance and monitoring system.

When the risk assessment (which takes into account the surveillance referred to in the release and

exposure assessments above) demonstrates non-negligible risk, the country should conduct Type A

surveillance in accordance with Appendix 3.8.4.

When the risk assessment (which takes into account the surveillance referred to in the release and

exposure assessments above) demonstrates negligible risk, the country should conduct Type B surveillance

in accordance with Appendix 3.8.4.

Article 2.3.13.3.

Negligible BSE risk

Commodities from the cattle population of a country, zone or compartment pose a negligible risk of

transmitting the BSE agent should the following conditions be met:

1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify

the historical and existing risk factors and the country has been demonstrated that appropriate

generic measures have been taken for the relevant period of time defined below to manage all risk

identified;

2) the country has demonstrated that Type B surveillance in accordance with Appendix 3.8.4. is in place,

3) EITHER:

a) there has been no case of BSE, or any case of BSE has been demonstrated to have been imported

and has been completely destroyed, and:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least

7 years; and

ii) it has been demonstrated, through an appropriate level of control and audit, that for at least

8 years meat-and-bone meal or greaves derived from ruminants has not been fed to ruminants;

OR

b) the last indigenous case of BSE was reported more than 7 years ago; and

i) the criteria in points 2) to 4) of Article 2.3.13.2. have been complied with for at least

7 years; and

ii) it has been demonstrated, thorough an appropriate level of control and audit, that for at

least 8 years meat-and-bone meal and greaves derived from ruminants has not been fed to

ruminants; and

iii) all BSE cases, as well as:

- all the progeny of female cases, born within 2 years prior to or after clinical onset of

the disease, and

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- all cattle which, during their first year of life, were reared with the BSE cases during

their first year of life, and which investigation showed consumed the same potentially

contaminated feed during that period, or

- if the results of the investigation are inconclusive, all cattle born in the same herd as,

and within 12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements

controlled, and when slaughtered or at death, are completely destroyed.

Article 2.3.13.4.

Controlled BSE risk

Commodities from the cattle population of a country, zone or compartment pose a controlled risk of

transmitting the BSE agent, should the following conditions be met:

1) a risk assessment, as described in point 1) of Article 2.3.13.2., has been conducted in order to identify

the historical and existing risk factors, and the country has not demonstrated that appropriate generic

measures have been taken for the relevant period of time defined below to manage all risks identified;

2) the country has demonstrated that Type A surveillance in accordance with Appendix 3.8.4. is in

place;

3) EITHER

a) there has been no case of BSE or any case of BSE has been demonstrated to have been imported

and has been completely destroyed, the criteria in points 2) to 4) of Article 2.3.13.2. are

complied with, and it can be demonstrated, through an appropriate level of control and audit,

that meat-and-bone meal and greaves derived from ruminants has not been fed to ruminants, but at

least one of the following two conditions applies:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;

ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves

derived from ruminants to ruminants have been in place for 8 years;

OR

b) there has been an indigenous case of BSE reported, the criteria in points 2) to 4) of

Article 2.3.13.2. are complied with, and it can be demonstrated, through an appropriate level of

control and audit that meat-and-bone meal and greaves derived from ruminants have not been fed

to ruminants, but at least one of the following two conditions applies:

i) the criteria in points 2) to 4) of Article 2.3.13.2. have not been complied with for 7 years;

ii) it cannot be demonstrated that controls over the feeding of meat-and-bone meal and greaves

derived from ruminants to ruminants have been in place for 8 years;

AND

iii) all BSE cases, as well as:

- all the progeny of female cases, born within 2 years prior to or after clinical onset of

the disease, and

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- all cattle which, during their first year of life, were reared with the BSE cases during

their first year of life, and which investigation showed consumed the same potentially

contaminated feed during that period, or

- if the results of the investigation are inconclusive, all cattle born in the same herd as,

and within 12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements

controlled, and when slaughtered or at death, are completely destroyed.

Article 2.3.13.5.

Undetermined BSE risk

The cattle population of a country, zone or compartment poses an undetermined BSE risk if it cannot be

demonstrated that it meets the requirements of another category.

Article 2.3.13.6.

When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary

Administrations should require:

for all commodities from cattle not listed in point 1) of Article 2.3.13.1.

the presentation of an international veterinary certificate attesting that the country or zone/compartment

complies with the conditions in Article 2.3.13.3.

Article 2.3.13.7.

When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary

Administrations should require:

for cattle

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.4.;

2) cattle selected for export are identified by a permanent identification system enabling them to be

traced back to the dam and herd of origin, and are not exposed cattle as described in point 2) c) iii) of

Article 2.3.13.4.;

3) in the case of a country, zone or compartment with an indigenous case, cattle selected for export were

born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and

greaves derived from ruminants had been effectively enforced.

Article 2.3.13.8.

When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary

Administrations should require:

for cattle

the presentation of an international veterinary certificate attesting that:

1) the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants has been banned

and the ban has been effectively enforced;

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2) all BSE cases, as well as:

a) all the progeny of female cases, born within 2 years prior to or after clinical onset of the disease,

and

b) all cattle which, during their first year of life, were reared with the BSE cases during their first

year of life, and, which investigation showed consumed the same potentially contaminated feed

during that period, or

c) if the results of the investigation are inconclusive, all cattle born in the same herd as, and within

12 months of the birth of, the BSE cases,

if alive in the country, zone or compartment, are permanently identified, and their movements controlled,

and when slaughtered or at death, are completely destroyed;

3) cattle selected for export:

a) are identified by a permanent identification system enabling them to be traced back to the dam

and herd of origin and are not the progeny of BSE suspect or confirmed females;

b) were born at least 2 years after the date from which the ban on the feeding of ruminants with

meat-and-bone meal and greaves derived from ruminants was effectively enforced.

Article 2.3.13.9.

When importing from a country, zone or compartment posing a negligible BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than that listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.3.;

2) ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat or

meat products originate.

Article 2.3.13.10.

When importing from a country, zone or compartment posing a controlled BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the country, zone or compartment complies with the conditions in Article 2.3.13.4.;

2) ante-mortem and post-mortem inspections were carried out on all cattle from which the fresh meat

and meat products originate;

3) cattle from which the fresh meat and meat products destined for export originate were not subjected to a

stunning process, prior to slaughter, with a device injecting compressed air or gas into the cranial

cavity, or to a pithing process;

4) the fresh meat and meat products do not contain:

a) the tissues listed in Article 2.3.13.13.,

b) mechanically separated meat from the skull and vertebral column from cattle over 30 months of

age,

all of which have been completely removed in a manner to avoid contamination of the fresh meat and

meat products.

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Article 2.3.13.11.

When importing from a country, zone or compartment with an undetermined BSE risk, Veterinary

Administrations should require:

for fresh meat and meat products from cattle (other than those listed in point 1) of Article 2.3.13.1.)

the presentation of an international veterinary certificate attesting that:

1) the cattle from which the fresh meat and meat products originate:

a) are not suspect or confirmed BSE cases;

b) have not been fed meat-and-bone meal or greaves;

c) were subjected to ante-mortem and post-mortem inspections;

d) were not subjected to a stunning process, prior to slaughter, with a device injecting compressed

air or gas into the cranial cavity, or to a pithing process;

2) the fresh meat and meat products do not contain:

a) the tissues listed in Article 2.3.13.13.,

b) nervous and lymphatic tissues exposed during the deboning process,

c) mechanically separated meat from the skull and vertebral column from cattle over 12 months of

age,

all of which have been completely removed in a manner to avoid contamination of the fresh meat and

meat products.

Article 2.3.13.12.

Ruminant-derived meat-and-bone meal or greaves, or any commodities containing such products, which

originate from a country, zone or compartment defined in Articles 2.3.13.4. and 2.3.13.5. should not be traded

between countries.

Article 2.3.13.13.

1) From cattle of any age originating from a country, zone or compartment defined in Articles 2.3.13.4. and

2.3.13.5., the following commodities, and any commodity contaminated by them, should not be

traded for the preparation of food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals,

or medical devices: tonsils and distal ileum, and protein products derived thereof. Food, feed,

fertilisers, cosmetics, pharmaceuticals or medical devices prepared using these commodities should

also not be traded.

2) From cattle that were at the time of slaughter over 30 months of age originating from a country, zone

or compartment defined in Article 2.3.13.4., the following commodities, and any commodity

contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,

pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral

column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical

devices prepared using these commodities should also not be traded.

3) From cattle that were at the time of slaughter over 12 months of age originating from a country, zone

or compartment defined in Article 2.3.13.5., the following commodities, and any commodity

contaminated by them, should not be traded for the preparation of food, feed, fertilisers, cosmetics,

pharmaceuticals including biologicals, or medical devices: brains, eyes, spinal cord, skull, vertebral

column and derived protein products. Food, feed, fertilisers, cosmetics, pharmaceuticals or medical

devices prepared using these commodities should also not be traded.

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Article 2.3.13.14.

Veterinary Administrations of importing countries should require:

for gelatin and collagen prepared from bones and intended for food or feed, cosmetics, pharmaceuticals

including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that the commodities came from:

1) a country, zone or compartment posing a negligible BSE risk; or

2) a country, zone or compartment posing a controlled BSE risk; and

a) skulls and vertebrae (except tail vertebrae) have been excluded;

b) the bones have been subjected to a process which includes all the following steps:

i) pressure washing (degreasing),

ii) acid demineralisation,

iii) prolonged alkaline treatment,

iv) filtration,

v) sterilisation at =138°C for a minimum of 4 seconds,

or to an equivalent process in terms of infectivity reduction.

Article 2.3.13.15.

Veterinary Administrations of importing countries should require:

for tallow and dicalcium phosphate (other than protein-free tallow as defined in Article 2.3.13.1.) intended

for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that it originates from:

1) a country, zone or compartment posing a negligible BSE risk; or

2) a country, zone or compartment posing a controlled BSE risk, and it originates from cattle which have

been subjected to ante-mortem and post-mortem inspection and has not been prepared using the

tissues listed in point 2 of Article 2.3.13.13.

Article 2.3.13.16.

Veterinary Administrations of importing countries should require:

for tallow derivatives (other than those made from protein-free tallow as defined in Article 2.3.13.1.)

intended for food, feed, fertilisers, cosmetics, pharmaceuticals including biologicals, or medical devices

the presentation of an international veterinary certificate attesting that:

1) they originate from a country, zone or compartment posing a negligible BSE risk measures; or

2) they have been produced by hydrolysis, saponification or transesterification using high temperature

and pressure.

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APPENDI X 3 . 8 . 4 .

SURVEILLANCE FOR BOVINE SPONGIFORM

ENCEPHALOPATHY

Article 3.8.4.1.

Introduction

1) Depending on the bovine spongiform encephalopathy (BSE) risk category of a country, zone or

compartment, surveillance for BSE may have one or more goals:

a) detecting BSE, to a pre-determined design prevalence, in a country, zone or compartment;

b) monitoring the evolution of BSE in a country, zone or compartment;

c) monitoring the effectiveness of a feed ban and/or other risk mitigation measures, in

conjunction with auditing, etc;

d) supporting a claimed BSE status;

e) gaining or regaining a higher BSE status.

2) When the BSE agent is present in a country or zone, the cattle population will comprise the following

sectors, in order of decreasing size:

a) cattle not exposed to the infective agent;

b) cattle exposed but not infected;

c) infected cattle, which may lie within one of three stages in the progress of BSE:

i) the majority will die or be killed before reaching a stage at which BSE is detectable by

current methods;

ii) some will progress to a stage at which BSE is detectable by testing before clinical signs

appear;

iii) the smallest number will show clinical signs.

3) The BSE status of a country, zone or compartment cannot be determined only on the basis of a

surveillance programme but should be determined in accordance with all the factors listed in

Article 2.3.13.2. The surveillance programme should take into account the diagnostic limitations

associated with the above sectors and the relative distributions of infected cattle among them.

4) With respect to the distribution and expression of the BSE agent within the sectors described above,

the following four subpopulations of cattle have been identified for surveillance purposes:

a) cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE;

b) cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk

without assistance; cattle over 30 months of age sent for emergency slaughter or condemned at

ante-mortem inspection (casualty, emergency slaughter or downer cattle);

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c) cattle over 30 months of age which are found dead on farm, during transport or at an abattoir

(fallen stock).

d) cattle over 36 months of age at routine slaughter.

5) A gradient is used to describe the relative value of surveillance applied to each subpopulation.

Surveillance should focus on the first subpopulation, but investigation of other subpopulations will

help to provide an accurate assessment of the BSE situation in the country, zone or compartment. All

countries should sample at least three of the four subpopulations. This approach is consistent with

Appendix 3.8.1. on surveillance and monitoring of animal health.

Article 3.8.4.2.

Description of cattle subpopulations

1) Cattle over 30 months of age displaying behavioural or clinical signs consistent with BSE

Cattle affected by illnesses that are refractory to treatment, and displaying progressive behavioural

changes such as excitability, persistent kicking when milked, changes in herd hierarchical status,

hesitation at doors, gates and barriers, as well as those displaying progressive neurological signs

without signs of infectious illness are candidates for examination. These behavioural changes, being

very subtle, are best identified by those who handle animals on a daily basis. Since BSE causes no

pathognomonic clinical signs, all countries with cattle populations will observe individual animals

displaying clinical signs consistent with BSE. It should be recognised that cases may display only

some of these signs, which may also vary in severity, and such animals should still be investigated as

potential BSE affected animals. The rate at which such suspicious cases are likely to occur will differ

among epidemiological situations and cannot therefore be predicted reliably.

This subpopulation, particularly cattle over 30 months of age, is the one exhibiting the highest

prevalence. The recognition greatly depends on the owner’s awareness and observation of suspect

animals. The reporting of these suspect animals when at the farm will depend on the owner’s

motivation based on cost and socio-economic repercussions.

2) Cattle over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without

assistance; cattle over 30 months of age sent for emergency slaughter or condemned at ante-mortem

inspection (casualty or emergency slaughter, or downer cattle)

These cattle may have exhibited some of the clinical signs listed above which were not recognised as

being consistent with BSE. Experience in countries where BSE has been identified indicates that this

subpopulation is the one demonstrating the second highest prevalence. For that reason, it is the

second most appropriate population to target in order to detect BSE.

3) Cattle over 30 months of age which are found dead on farm, during transport or at an abattoir (fallen

stock)

These cattle may have exhibited some of the clinical signs listed above prior to death, but were not

recognised as being consistent with BSE. Experience in countries where BSE has been identified

indicates that this subpopulation is the one demonstrating the third highest prevalence.

4) Cattle over 36 months of age at routine slaughter

Experience in countries where BSE has been identified indicates that this subpopulation is the one

demonstrating the lowest prevalence. For that reason, it is the least appropriate population to target

in order to detect BSE. However, sampling in this subpopulation may be an aide in monitoring the

progress of the epizootic and the efficacy of control measures applied, because it offers continuous

access to a cattle population of known class, age structure and geographical origin. Testing of routine

slaughter cattle younger than 36 months is of relatively very little value (Table 2).

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Within each of the above subpopulations, countries may wish to target cattle identifiable as imported

from countries or zones not free from BSE, cattle which have consumed potentially contaminated

feedstuffs from countries or zones not free from BSE, offspring of BSE affected cows and cattle

which have consumed feedstuffs potentially contaminated with other TSE agents.

When establishing a surveillance strategy, authorities must take into account inherent difficulties of

obtaining samples on farm. These difficulties include higher cost, necessity for education and

motivation of owners, counteracting potentially negative socio-economic implication. Authorities

must find ways to overcome these difficulties.

Article 3.8.4.3.

1) Implementation of type A surveillance

In order to implement efficiently a surveillance strategy for BSE, a country must use good quality

data (or reliable estimates) concerning the age distribution of its adult cattle population and the

number of cattle tested for BSE stratified by age and by subpopulation. The application of the

following procedure will allow the detection of BSE prevalence of at least one case per 100,000 in the

adult cattle population, at a confidence level of 95% in the country, zone or compartment of concern.

This Appendix utilises Tables 1 and 2 to determine a desired surveillance point target and the point

values of surveillance samples collected.

The approach assigns ‘point values’ to each sample, based on the subpopulation from which it was

collected and the likelihood of detecting infected cattle in that subpopulation. The number of points

a sample is assigned is determined by the subpopulation from which the sample is collected and the

age of the animal sampled. The total points accumulation is then periodically compared to the target

number of points for a country, zone or compartment.

A country should design its surveillance strategy to ensure that samples are representative of the herd

of the country, zone or compartment, and include consideration of demographic factors such as

production type and geographic location, and the potential influence of culturally unique husbandry

practices. The approach used and the assumptions made should be fully documented, and the

documentation retained for 7 years.

The points targets and surveillance point values in the appendix were obtained by applying the

following factors to a statistical model:

a) a prevalence of either at least one case per million or one case per 100,000 of the adult cattle

population;

b) a confidence level of 95%;

c) the pathogenesis, and pathological and clinical expression of BSE:

i) sensitivity of diagnostic methods used;

ii) relative frequency of expression by age;

iii) relative frequency of expression within each subpopulation;

iv) interval between clinical pathological change and clinical expression;

d) demographics of the cattle population, including age distribution;

e) influence of BSE on culling or attrition of animals from the cattle population via the four

subpopulations;

f) percentage of infected animals in the cattle population which are not detected.

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Although the procedure accepts very basic information about a cattle population, and can be used

with estimates and less precise data, careful collection and documentation of the data significantly

enhance their value. Since samples from clinical suspect animals provide many times more

information than samples from healthy or dead-of-unknown-cause animals, careful attention to the

input data can substantially decrease the procedure’s cost and the number of samples needed. The

essential input data are:

g) cattle population numbers stratified by age;

h) the number of cattle tested for BSE stratified by age and by subpopulation.

2) Maintenance (type B) surveillance

For countries which have demonstrated through risk assessment (including surveillance) that they

meet the requirements for ‘negligible risk without commodity-specific risk mitigation measures’,

surveillance should continue at a reduced, maintenance level.

In order to implement efficiently a maintenance surveillance strategy for BSE, a country must use

good quality data (or reliable estimates) concerning the age distribution of its adult cattle population

and the number of cattle tested for BSE stratified by age and by subpopulation. The application of

the following procedure will allow the detection of BSE prevalence of at least one case per 50,000 in

the adult cattle population, at a confidence level of 95% in the country, zone or compartment of

concern. This Appendix utilises Tables 1 and 2 to determine a desired surveillance point target and

the point values of surveillance samples collected.

Maintenance surveillance should focus on the higher prevalence subpopulations (especially clinical

suspects). The number of clinical suspect samples taken annually should approximate the number of

samples taken annually from clinical suspect cases during the time taken to reach the country, zone or

compartment’s BSE status (to a maximum of seven years).

Article 3.8.4.4.

1) Selecting the points target

The desired surveillance points target is selected from Table 1, which shows target points for adult

cattle populations of different sizes. A country’s adult cattle population size may be estimated or may

be set at one million because, for statistical reasons, one million is the point beyond which sample

size does not further increase with population size. The target depends on the design prevalence

chosen by the country.

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Table 1 Points targets for different adult cattle population sizes in a country, zone or compartment which

has not identified any BSE cases

Target points for country, zone or compartment

with 0 cases, 95% confidence

Adult Cattle Population Size

(24 months and older)

*DP

1/100,000

*DP

1/50,000

= 1,000,000 300,000 150,000

800,000 – 1,000,000 240,000 120,000

600,000 – 800,000 180,000 90,000

400,000 – 600,000 120,000 60,000

200,000 – 400,000 60,000 30,000

100,000 – 200,000 30,000 15,000

50,000 – 100,000 15,000 7,500

*DP is the maximum possible prevalence or "design prevalence".

2) Determining the point values of samples collected

Table 2 can be used to determine the point values of the surveillance samples collected. The

approach assigns point values to each sample according to the likelihood of detecting infection based

on the subpopulation from which the sample was collected and the age of the animal sampled. This

approach takes into account the general principles of surveillance described in Appendix 3.8.1. and

the epidemiology of BSE.

Because precise aging of the animals that are sampled may not be possible, Table 2 combines point

values into five age categories. The point estimates for each category were determined as an average

for the age range comprising the group. The age groups were selected on their relative likelihoods of

expressing BSE according to scientific knowledge of the incubation of the disease and the world BSE

experience. Samples may be collected from any combination of subpopulations and ages but should

reflect the demographics of the cattle herd of the country, zone or compartment. In addition, countries

should sample at least three of the four subpopulations.

The total points for samples collected may be accumulated over a period of a maximum of

7 consecutive years to achieve the target number of points determined in Table 1.

2005 OIE Terrestrial Animal Health Code

14

Table 2 Surveillance point values for samples collected from animals in the given subpopulation and

age category

Surveillance subpopulation

Routine

slaughter

*

Fallen

stock

**

Casualty

slaughter

***

Clinical

suspect

****

age = 1 year and < 2 years

0.01 0.2 0.4 N/A

Age = 2 years and < 4 years (young adult)

0.1 0.2 0.4 260

Age = 4 years and < 7 years (middle adult)

0.2 0.9 1.6 750

Age = 7 years and < 9 years (older adult)

0.1 0.4 0.7 220

Age = 9 years (aged)

0.0 0.1 0.2 45

* Article 3.8.4.2 4 ** Article 3.8.4.2 3

*** Article 3.8.4.2 2 **** Article 3.8.4.2 1

Surveillance points remain valid for 7 years (the 95th percentile of the incubation period).

Article 3.8.4.5.

To monitor the evolution of BSE in a country, zone or compartment once it is detected

To monitor the evolution of BSE in a country, zone or compartment once it is detected, a more intensive

sampling method needs to be used to determine disease prevalence. For countries that have determined

that BSE exists within their cattle population, the goal of surveillance shifts from one of detection to one

of monitoring the extent and evolution of the disease, and monitoring the effectiveness of control

measures such as feed bans and SRM removal policies.

2005 OIE Terrestrial Animal Health Code

15

APPENDI X 3 . 6 . 3 .

P R O C E D U R E S F O R T H E R E D UC TI O N O F I N F E C T I V I T Y O F

T R A N S M I S S I B L E S P O N G I F O R M E N C E P H A L O P A T H Y A G E N T S

Article 3.6.3.1.

Meat-and-bone meal

The following procedure should be used to reduce the infectivity of any transmissible spongiform

encephalopathy agents which may be present during the production of meat-and-bone meal containing

ruminant proteins:

1. The raw material should be reduced to a maximum particle size of 50 mm before heating.

2. The raw material should be heated under saturated steam conditions to a temperature of not less

than 133°C for a minimum of 20 minutes at an absolute pressure of 3 bar.

2005 OIE Terrestrial Animal Health Code

http://www.oie.int/downld/SC/2005/bse_2005.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Publication date: 20 August 2004
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Report

Summary
Summary of the Scientific Report

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

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

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

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


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


CANADA

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/563/sr02_biohaz02_canada_report_annex_en1.pdf

MEXICO

http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/scr_annexes/566/sr04_biohaz02_mexico_report_annex_en1.pdf


What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability Integrity Reliability
www.gao.gov/cgi-bin/getrpt?GAO-05-101.
To view the full product, including the scope
and methodology, click on the link above.
For more information, contact Robert A.
Robinson at (202) 512-3841 or
robinsonr@gao.gov.
Highlights of GAO-05-101, a report to
congressional requesters
February 2005
MAD COW DISEASE
FDA’s Management of the Feed Ban Has
Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness
FDA has made needed improvements to its management and oversight of the
feed-ban rule in response to GAO’s 2002 report, but program weaknesses
continue to limit the effectiveness of the ban and place U.S. cattle at risk of
spreading BSE. Improvements made include FDA establishing a uniform
method of conducting compliance inspections and training FDA inspectors,
as well as state inspectors who carry out inspections under agreements with
FDA, on the new method. FDA also implemented new data-entry procedures
that are designed to more reliably track feed-ban inspection results.
Consequently, FDA has a better management tool for overseeing compliance
with the feed-ban rule and a data system that better conforms to standard
database management practices. However, various program weaknesses
continue to undermine the nation’s firewall against BSE. For example:
• FDA acknowledges that there are more feed manufacturers and
transporters, on-farm mixers, and other feed industry businesses that are
subject to the feed ban than the approximately 14,800 firms inspected to
date; however, it has no uniform approach for identifying additional
firms.
• FDA has not reinspected approximately 2,800, or about 19 percent, of
those businesses, in 5 or more years; several hundred are potentially
high risk. FDA does not know whether those businesses now use
prohibited material in their feed.
• FDA’s feed-ban inspection guidance does not include instructions to
routinely sample cattle feed to test for potentially prohibited material as
part of the compliance inspection. Instead, it includes guidance for
inspectors to visually examine facilities and equipment and review
invoices and other documents.
• Feed intended for export is not required to carry a caution label “Do not
feed to cattle or other ruminants,” when the label would be required if
the feed were sold domestically. Without that statement, feed containing
prohibited material could be inadvertently or intentionally diverted back
to U.S. cattle or given to foreign cattle.
• FDA has not always alerted USDA and states when it learned that cattle
may have been given feed that contained prohibited material. This lapse
has been occurring even though FDA’s guidance calls for such
communication.
• Although research suggests that cattle can get BSE from ingesting even a
small amount of infected material, inspectors do not routinely inspect or
review cleanout procedures for vehicles used to haul cattle feed.
More than 5 million cattle across
Europe have been killed to stop the
spread of bovine spongiform
encephalopathy (BSE), commonly
called mad cow disease. Found in
26 countries, including Canada and
the United States, BSE is believed
to spread through animal feed that
contains protein from BSE-infected
animals. Consuming meat from
infected cattle has also been linked
to the deaths of about 150 people
worldwide. In 1997, the Food and
Drug Administration (FDA) issued
a feed-ban rule prohibiting certain
animal protein (prohibited
material) in feed for cattle and
other ruminant animals. FDA and
38 states inspect firms in the feed
industry to enforce this critical
firewall against BSE. In 2002, GAO
reported a number of weaknesses
in FDA’s enforcement of the feed
ban and recommended corrective
actions. This report looks at FDA’s
efforts since 2002 to ensure
industry compliance with the feed
ban and protect U.S. cattle.
What GAO Recommends
GAO recommends FDA, among
other things, develop procedures
for finding additional firms subject
to the feed-ban and using tests to
augment inspections. FDA said the
study was thorough but disagreed
on four of nine recommendations.
GAO continues to believe that,
given the discovery of BSE in North
America and the oversight gaps
described in the report, the
recommended actions are needed
to protect U.S. cattle from BSE.


3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,
but Oversight Weaknesses Continue to Limit Program Effectiveness.
GAO-05-101, Feb. 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-05-101
Highlights - http://www.gao.gov/highlights/d05101high.pdf


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



From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]

Greetings FDA,

snip...

PLUS, if the USA continues to flagrantly ignore the _documented_ science to date about the known TSEs in the USA (let alone the undocumented TSEs in cattle), it is my opinion, every other Country that is dealing with BSE/TSE should boycott the USA and demand that the SSC reclassify the USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_ any longer on this issue, should also be regarded with great suspicion as well. NOT to leave out the OIE and it's terribly flawed system of disease surveillance. the OIE should make a move on CWD in the USA, and make a risk assessment on this as a threat to human health. the OIE should also change the mathematical formula for testing of disease. this (in my opinion and others) is terribly flawed as well. to think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory. the OIE told me 2 years ago that they were concerned with CWD, but said any changes might take years. well, two years have come and gone, and no change in relations with CWD as a human health risk. if we wait for politics and science to finally make this connection, we very well may die before any decisions
or changes are made. this is not acceptable. we must take the politics and the industry out of any final decisions of the Scientific community. this has been the problem from day one with this environmental man made death sentence. some of you may think i am exaggerating, but you only have to see it once, you only have to watch a loved one die from this one time, and you will never forget, OR forgive...yes, i am still very angry... but the transmission studies DO NOT lie, only the politicians and the industry do... and they are still lying to this day...TSS


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


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

snip...

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

snip...

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

snip...

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

snip...

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

To be published in the Proceedings of the
Fourth International Scientific Congress in
Fur Animal Production. Toronto, Canada,
August 21-28, 1988

Evidence That Transmissible Mink Encephalopathy
Results from Feeding Infected Cattle

R.F. Marsh* and G.R. Hartsough

•Department of Veterinary Science, University of Wisconsin-Madison, Madison,
Wisconsin 53706; and ^Emba/Creat Lakes Ranch Service, Thiensville, Wisconsin 53092

ABSTRACT
Epidemiologic investigation of a new incidence of
transmissible mink encephalopathy (TME) in Stetsonville, Wisconsin
suggests that the disease may have resulted from feeding infected
cattle to mink. This observation is supported by the transmission of
a TME-like disease to experimentally inoculated cattle, and by the
recent report of a new bovine spongiform encephalopathy in
England.

INTRODUCTION

Transmissible mink encephalopathy (TME) was first reported in 1965 by Hartsough
and Burger who demonstrated that the disease was transmissible with a long incubation
period, and that affected mink had a spongiform encephalopathy similar to that found in
scrapie-affecied sheep (Hartsough and Burger, 1965; Burger and Hartsough, 1965).
Because of the similarity between TME and scrapie, and the subsequent finding that the
two transmissible agents were indistinguishable (Marsh and Hanson, 1969), it was
concluded that TME most likely resulted from feeding mink scrapie-infecied sheep.
The experimental transmission of sheep scrapie to mink (Hanson et al., 1971)
confirmed the close association of TME and scrapie, but at the same time provided
evidence that they may be different. Epidemiologic studies on previous incidences of
TME indicated that the incubation periods in field cases were between six months and
one year in length (Harxsough and Burger, 1965). Experimentally, scrapie could not be
transmitted to mink in less than one year.
To investigate the possibility that TME may be caused by a (particular strain of
scrapie which might be highly pathogenic for mink, 21 different strains of the scrapie
agent, including their sheep or goat sources, were inoculated into a total of 61 mink.
Only one mink developed a progressive neurologic disease after an incubation period of
22 mon..s (Marsh and Hanson, 1979). These results indicated that TME was either caused
by a strain of sheep scrapie not yet tested, or was due to exposure to a scrapie-like agent
from an unidentified source.

OBSERVATIONS AND RESULTS

A New Incidence of TME. In April of 1985, a mink rancher in Stetsonville, Wisconsin
reported that many of his mink were "acting funny", and some had died. At this time, we
visited the farm and found that approximately 10% of all adult mink were showing
typical signs of TME: insidious onset characterized by subtle behavioral changes, loss of
normal habits of cleanliness, deposition of droppings throughout the pen rather than in a
single area, hyperexcitability, difficulty in chewing and swallowing, and tails arched over
their _backs like squirrels. These signs were followed by progressive deterioration of
neurologic function beginning with locomoior incoordination, long periods of somnolence
in which the affected mink would stand motionless with its head in the corner of the
cage, complete debilitation, and death. Over the next 8-10 weeks, approximately 40% of
all the adult mink on the farm died from TME.
Since previous incidences of TME were associated with common or shared feeding
practices, we obtained a careful history of feed ingredients used over the past 12-18
months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy
cattle and a few horses. Sheep had never been fed.

Experimental Transmission. The clinical diagnosis of TME was confirmed by
histopaihologic examination and by experimental transmission to mink after incubation
periods of four months. To investigate the possible involvement of cattle in this disease
cycle, two six-week old castrated Holstein bull calves were inoculated intracerebrally
with a brain suspension from affected mink. Each developed a fatal spongiform
encephalopathy after incubation periods of 18 and 19 months.

DISCUSSION
These findings suggest that TME may result from feeding mink infected cattle and
we have alerted bovine practitioners that there may exist an as yet unrecognized
scrapie-like disease of cattle in the United States (Marsh and Hartsough, 1986). A new
bovine spongiform encephalopathy has recently been reported in England (Wells et al.,
1987), and investigators are presently studying its transmissibility and possible
relationship to scrapie. Because this new bovine disease in England is characterized by
behavioral changes, hyperexcitability, and agressiveness, it is very likely it would be
confused with rabies in the United Stales and not be diagnosed. Presently, brains from
cattle in the United States which are suspected of rabies infection are only tested with
anti-rabies virus antibody and are not examined histopathologically for lesions of
spongiform encephalopathy.
We are presently pursuing additional studies to further examine the possible
involvement of cattle in the epidemiology of TME. One of these is the backpassage of
our experimental bovine encephalopathy to mink. Because (here are as yet no agent-
specific proteins or nucleic acids identified for these transmissible neuropathogens, one
means of distinguishing them is by animal passage and selection of the biotype which
grows best in a particular host. This procedure has been used to separate hamster-
adapted and mink-udapted TME agents (Marsh and Hanson, 1979). The intracerebral
backpassage of the experimental bovine agent resulted in incubations of only four months
indicating no de-adaptation of the Stetsonville agent for mink after bovine passage.
Mink fed infected bovine brain remain normal after six months. It will be essential to
demonstrate oral transmission fiom bovine to mink it this proposed epidemiologic
association is to be confirmed.

ACKNOWLEDGEMENTS
These studies were supported by the College of Agricultural and Life Sciences,
University of Wisconsin-Madison and by a grant (85-CRCR-1-1812) from the United
States Department of Agriculture. The authors also wish to acknowledge the help and
encouragement of Robert Hanson who died during the course of these investigations.

REFERENCES
Burger, D. and Hartsough, G.R. 1965. Encephalopathy of mink. II. Experimental and
natural transmission. J. Infec. Dis. 115:393-399.
Hanson, R.P., Eckroade, R.3., Marsh, R.F., ZuRhein, C.M., Kanitz, C.L. and Gustatson,
D.P. 1971. Susceptibility of mink to sheep scrapie. Science 172:859-861.
Hansough, G.R. and Burger, D. 1965. Encephalopathy of mink. I. Epizoociologic and
clinical observations. 3. Infec. Dis. 115:387-392.
Marsh, R.F. and Hanson, R.P. 1969. Physical and chemical properties of the
transmissible mink encephalopathy agent. 3. ViroL 3:176-180.
Marsh, R.F. and Hanson, R.P. 1979. On the origin of transmissible mink
encephalopathy. In Hadlow, W.J. and Prusiner, S.P. (eds.) Slow transmissible
diseases of the nervous system. Vol. 1, Academic Press, New York, pp 451-460.
Marsh, R.F. and Hartsough, G.R. 1986. Is there a scrapie-like disease in cattle?
Proceedings of the Seventh Annual Western Conference for Food Animal Veterinary
Medicine. University of Arizona, pp 20.
Wells, G.A.H., Scott, A.C., Johnson, C.T., Cunning, R.F., Hancock, R.D., Jeffrey, M.,
Dawson, M. and Bradley, R. 1987. A novel progressive spongiform encephalopathy
in cattle. Vet. Rec. 121:419-420.

MARSH

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf


Greetings,


SO, the already terribly flawwed OIE BSE surveillance system is too burdensome for trade.
Aint that just too bad. SO, they decide to make it even weaker. The damn thing never worked
anyway. ALL one has to do is look at the documented BSE Countries that went by it. Did them
a lot of good.

TO think that a sample survey of 400 or so cattle in a population of 100 million, to think this will find anything, especially after seeing how many TSE tests it took Italy and other Countries to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to find 102 BSE cases), should be proof enough to make drastic changes of this system. the OIE criteria for BSE Country classification and it's interpretation is very problematic. a text that is suppose to give guidelines, but is not understandable, cannot be considered satisfactory...

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

http://brain.hastypastry.net/forums/archive/index.php/t-54550.html


THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. With Science like this, Japan would be fully justified in declining to be a member. ...


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA




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