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From: TSS ()
Subject: Opinion of the Scientific Panel BIOHAZ on the revision of the Geographical BSE risk [1]
Date: March 31, 2007 at 7:00 pm PST

Opinion of the Scientific Panel BIOHAZ on the revision of the Geographical BSE risk [1]


Last updated: 30 March 2007
Publication Date: 30 March 2007

Adopted on 7 March 2007. (Question Nº EFSA-Q-2004-150)

Opinion
Summary
Annex 1
Annex 2
Annex 3
Annex 4
Annex 5

Summary

The Geographical BSE-Risk assessment (GBR) is an indicator of the likelihood of the presence of one or more bovines being infected with Bovine Spongiform Encephalopathy (BSE), pre-clinically as well as clinically, at a given point in time, in a country.

The methodology (SSC GBR), developed by the previous Scientific Steering Committee (SSC) of the European Commission between 1998 and 2002, categorizes the assessed countries into four different risk levels.

The European Food Safety Authority (EFSA) requested its Panel on Biological Hazards (BIOHAZ) to review and update the SSC GBR method, taking into account the World Organisation for Animal Health (OIE) Terrestrial Animal Health Code (Chapter 2.3.13 and appendix 3.8.5 to that chapter) and quantitative surveillance data and models. The Panel was requested to publish a draft document for public consultation, and to consider the comments received when finalising the method.

The Working Group (WG) under the EFSA BIOHAZ Panel proceeded by evaluating the SSC GBR method and, based on this evaluation, suggested possible amendments and improvements. In interpreting and addressing the terms of reference, the BIOHAZ Panel considered experience gained from previous assessments, new data and information, developments in EU policies, and the development of the OIE Terrestrial Animal Health Code.

The BIOHAZ Panel and its WG produced a stand-alone document describing the EFSA GBR methodology. The main purpose of this document is to describe the basic methodology to carry out the risk assessment. Where necessary, the document provides the rationale and scientific basis for specific parts of the methodology. This stand-alone document serves as the set of instructions that can be used by the members of any international independent expert group responsible for assessing a country, as well as by the contact points in the countries being assessed.

The BIOHAZ Panel agreed to refer to SSC GBR as the previous method and EFSA GBR as the revised method.

The main changes of the EFSA GBR with respect to the SSC GBR can be summarized in three main categories: changes in the external challenge assessment, changes in the stability assessment and changes in the categories of assessment. Furthermore the EFSA GBR considers the possibility of assessing zones such as defined in the OIE Terrestrial Animal Health Code.

The revised challenge assessment in the EFSA GBR methodology introduces an adjustment for the size of the challenged cattle population; defines in more detail the steps for the assessment (i.e. acquisition of import data, determination of whether the imports entered the BSE/Cattle system, estimation of the infectivity level in the imported material); clarifies the rules for the inclusion or exclusion of the imported material or animals; and introduces a weighting factor for the scaling of these imports.

The changes in the stability assessment consist of the utilization of a semi-quantitative approach, instead of the previous mostly qualitative approach to assess the impact of practices related to the BSE infection (Specified Risk Materials utilization, Rendering system and Feeding system).

The EFSA GBR no longer categorizes the countries. It assesses the overall challenge and the number of expected BSE cases and infections over time in a country, and includes an estimation of the future course of the infection.

_____________________________

[1] For citation purposes: Opinion of the Scientific Panel on Biological Hazards on the revision of the Geographical BSE risk assessment (GBR) methodology, The EFSA Journal (2007), 463, 1-35

http://www.efsa.europa.eu/en/science/biohaz/biohaz_opinions/ej463_gbr_methodology.html

The EFSA Journal (2007) 463, 1-35

Opinion of the Scientific Panel on Biological Hazards on the revision of the

Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 35

SUMMARY

The Geographical BSE-Risk assessment (GBR) is an indicator of the likelihood of the

presence of one or more bovines being infected with Bovine Spongiform Encephalopathy

(BSE), pre-clinically as well as clinically, at a given point in time, in a country.

The methodology (SSC GBR), developed by the previous Scientific Steering Committee

(SSC) of the European Commission between 1998 and 2002, categorizes the assessed

countries into four different risk levels.

The European Food Safety Authority (EFSA) requested its Panel on Biological Hazards

(BIOHAZ) to review and update the SSC GBR method, taking into account the World

Organisation for Animal Health (OIE) Terrestrial Animal Health Code (Chapter 2.3.13 and

appendix 3.8.5 to that chapter) and quantitative surveillance data and models. The Panel was

requested to publish a draft document for public consultation, and to consider the comments

received when finalising the method.

The Working Group (WG) under the EFSA BIOHAZ Panel proceeded by evaluating the SSC

GBR method and, based on this evaluation, suggested possible amendments and

improvements. In interpreting and addressing the terms of reference, the BIOHAZ Panel

considered experience gained from previous assessments, new data and information,

developments in EU policies, and the development of the OIE Terrestrial Animal Health

Code.

The BIOHAZ Panel and its WG produced a stand-alone document describing the EFSA GBR

methodology. The main purpose of this document is to describe the basic methodology to

carry out the risk assessment. Where necessary, the document provides the rationale and

scientific basis for specific parts of the methodology. This stand-alone document serves as the

set of instructions that can be used by the members of any international independent expert

group responsible for assessing a country, as well as by the contact points in the countries

being assessed.

The BIOHAZ Panel agreed to refer to SSC GBR as the previous method and EFSA GBR as

the revised method.

The main changes of the EFSA GBR with respect to the SSC GBR can be summarized in

three main categories: changes in the external challenge assessment, changes in the stability

assessment and changes in the categories of assessment. Furthermore the EFSA GBR

considers the possibility of assessing zones such as defined in the OIE Terrestrial Animal

Health Code.

The revised challenge assessment in the EFSA GBR methodology introduces an adjustment

for the size of the challenged cattle population; defines in more detail the steps for the

assessment (i.e. acquisition of import data, determination of whether the imports entered the

BSE/Cattle system, estimation of the infectivity level in the imported material); clarifies the

rules for the inclusion or exclusion of the imported material or animals; and introduces a

weighting factor for the scaling of these imports.

The changes in the stability assessment consist of the utilization of a semi-quantitative

approach, instead of the previous mostly qualitative approach to assess the impact of practices

related to the BSE infection (Specified Risk Materials utilization, Rendering system and

Feeding system).

The EFSA Journal (2007) 463, 1-35

Opinion of the Scientific Panel on Biological Hazards on the revision of the

Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 3 of 35

The EFSA GBR no longer categorizes the countries. It assesses the overall challenge and the

number of expected BSE cases and infections over time in a country, and includes an

estimation of the future course of the infection.

FULL TEXT 35 PAGES ;

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0004.File.dat/biohaz_op_ej463_gbr_revision_en.pdf

Annex I to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 1 of 3

ANNEX I

INTERPRETATION OF THE TERMS OF REFERENCE

In deliberating the terms of reference the Working Group/Biological Hazards Panel noted the

following points:

A. Experience gained from previous GBR-assessments

1. The GBR methodology as developed by the Scientific Steering Committee (SSC) and

used up to now by the SSC GBR Peer group and the EFSA GBR expert group was

found to be a helpful and evidence based assessment tool for assessing the BSE risk

in cattle of a country.

2. The SSC GBR methodology worked well for assessing the risk from cattle and MBM

exports from Category 3 European countries. However, the risk from exports from

countries with large cattle populations was overstated and this needed to be corrected.

3. The assessment of the stability needed to be more flexible to allow for partial

improvements in stability to be taken into account. For example, under the SSC GBR

methodology, a rendering system was only considered to be ok if it was operating at

133°C degrees, 3 bar for 20 minutes. While these are the recommended operating

conditions, it should be recognized in the assessment of the stability in the GBR

methodology that conditions such as a temperature of 120°C degrees at rendering will

also lead to an improvement in stability.

4. The SSC GBR method was geared to identify or predict a potential first case in a

certain country but the future GBR method should also allow the expert group to

assess “an expected future development of the risk over time” i.e. be able to allow the

expert group to declare a decrease of the risk in a certain country.

5. The SSC GBR method could benefit from an increased transparency, i.e. the tables in

the report did not reflect the actual inputs as taken into account but were the raw data.

The tables with the final data were not included in the report. However, an

explanation was provided in the body of the report where an indication was given that

certain animals or MBM imports were deducted from the risk factors. Adding a table

with the final data of the imported commodities taken into account in the risk

assessment may increase the transparency of the reports.

6. The GBR classification of countries will change over time depending on their imports

of cattle and MBM and their stability. In turn, the risk posed by exports from those

countries could have a domino effect on the GBR classification of their trading

partners. The BSE-cases, confirmed in Austria, Finland, Sweden and Slovenia that

were initially classified as GBR II, underlined the appropriateness of this statement.

The explanation for these cases was that imports into these countries from GBR III

countries were not regarded as external challenge when the GBR of these countries

was assessed. Therefore there is a need for an ongoing reassessment of the GBR of

individual countries.

It was concluded that for an update of the GBR methodology, the following points in

particular would need to be clarified:

Annex I to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 3

a. General:

• Type and quality of data that is needed from the country being assessed

• Assessment of the possible other transmission routes

b. External challenge assessment

• Indication of criteria for exclusion/inclusion of imports of animals and MBM

• Determination of the time when an internal challenge became possible (R1) or likely

(R2) in the exporting country

• Determination of the time when the internal challenge decreased from R2 to R1, and

the possible development of a newly defined risk period.

• The inclusion of a dilution factor for the more realistic evaluation of the risk due to

introduction of BSE infectivity in a large cattle population by using an extended R1.

• Surveillance systems of the exporting countries.

• Stability of the exporting countries e.g., determination whether a challenge

originating from a GBR category 3 country outside of Europe represents a similar

challenge as the challenge from a GBR category 3 country within Europe.

• Estimation of the risk from exporting countries when they are not yet formally

categorised

c. Stability in the country being assessed

• Overall appreciation of the ability to prevent recycling and entry, and overall

assessment of the stability; especially the effect of different control measures e.g.

MBM ban, SRM removal.

d. Surveillance in the country being assessed

• Assessment of the surveillance system of the country being assessed and its results

e. GBR categorisation

• Appropriateness to have 4 categories as defined in the current GBR methodology

• Criteria for improving the GBR classification over time

• Appropriateness to define BSE risk status for compartments of animals and its

relationship to the classification of a geographical area.

B. New information and methods available – epidemiology and surveillance

1. Since 2001 BSE surveillance has been intensified in many countries which give a better

perspective of geographical risk.

2. BSE surveillance software, BSurvE, has been developed to analyse the results from the

TSE surveillance in the EU and to design the most cost effective surveillance. The generic

idea is that all surveillance results are weighted in a points system and that the necessary

points can be achieved by surveillance in healthy cattle, fallen stock, emergency slaughter

and clinical suspects. This tool enables a better assessment of the surveillance and

planning of the most cost effective surveillance given a certain design prevalence, and also

to validate the results of the risk assessment, albeit retrospectively.

Annex I to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 3 of 3

C. Consideration of developments in EU policy and the OIE methodology

1. The European Commission’s TSE Roadmap published in July 2005 clarified the

objectives of the EU for TSE control policies (EC, 2005). These include (a) a reduction in

the number of tested bovines without sacrificing the epidemiological information to be

gained, thus still continuing to measure the effectiveness of the measures in place and (b)

better targeting of the surveillance activities. The Roadmap also includes the strategic goal

for BSE Risk Assessment for different countries, namely, “Simplification of the

categorisation criteria and conclusion of the categorisation of the countries before 1 July

2007”. The Roadmap notes that the objective of a categorisation system according to the

BSE risk is to define trade rules that afford the necessary guarantees to protect animal and

public health for the importing countries. The Roadmap further states that the conditions

for such trade are already laid down in the current recommendations of the Terrestrial

Animal Health Code (“Code”) of the World Organisation for Animal Health (OIE).

2. The CVO/ EU Parliament dialogue September 2005 concluded that the BSE classification

should be based on OIE guidelines wherever possible. In line with this conclusion, the

EFSA considered that an updated GBR assessment method should as much as possible

match the outline of the OIE already presented with the intention to harmonize with the

existing method. However, it was noted that OIE takes both risk assessment and risk

management parameters into account. The EFSA Biological hazards panel agreed that the

EFSA GBR methodology would only deal with the risk assessment elements.

3. The approach of OIE is documented in Chapter 2.3.13 of the OIE terrestrial animal health

code (the general and new BSE Surveillance Chapter of the OIE (OIE, 2005). At the OIE

General Session in May 2006, an agreement was reached on the simplified categorisation

procedure including the requirements on surveillance within the different categories. OIE

Classifications will be based on a risk assessment, a functioning MBM ban to ruminants,

the presence of indigenous cases and the quality of the surveillance. The categorisation

procedure includes three categories:

Category 1: Countries with a negligible BSE risk and surveillance programme detecting a

design prevalence of 1 per 50,000. The country must have had a functioning ruminant

meat and bone meal ban for at least 8 years and no indigenous case of BSE born within the

last 11 years.

Category 2: Countries with a controlled BSE risk and surveillance programme detecting

a design prevalence of 1 per 100,000. The country must have a functioning ruminant meat

and bone meal ban.

Category 3: Countries with an undetermined BSE risk.

Based on this new OIE standard the current provisions under the TSE Regulation will be

amended. Following adoption of the new categorisation criteria, the countries will be

categorised starting with the major trading partners. EC indicated (as mentioned in the TSE

road map) that it considers OIE should play a major role in these re-assessments. Following

this self-tasking mandate, EFSA received further input and clarification from the EC in a letter

from DG Sanco (D(2005)/KVD/cin/42 1007, 20-10-2005) clarifying the EC’s intention to ask

the OIE to take the lead in this work. However, the letter further states that in the event that

OIE fails to assess all countries or these assessments are significantly delayed, EFSA would

be the most appropriate body to carry out these risk assessments.

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0006.File.dat/biohaz_op_ej463_gbr_revision_annex1_en.pdf

Annex II to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 1 of 4

ANNEX II

EFSA GBR – COMPARED TO SSC GBR

In the EFSA GBR the gist of the change in comparison with the SSC GBR is to analyse the data

whenever possible quantitatively, while the rules based assessment is a fallback procedure if a

quantitative assessment is not possible i.e., relevant data is not available..

Changes of external challenge assessment

In the SSC GBR methodology the magnitude (indicated as R values) of the external challenge was

regarded independent from the size of the challenged BSE/cattle system and in particular the size

and structure of the total cattle population.

In the EFSA GBR methodology, this aspect is taken into account by using different weighting factor

(w) values (instead of the R values used in the SSC GBR) depending on the size of the challenged

bovine population, including two population sizes: (1) more than 10 million cattle and (2) less than

10 million cattle. For a not very high challenge with no change in the stability in the exporting

country, the progression period to a higher w value is extended by one 5 year period for countries

with a very large cattle population (more than 10 million of cattle): so the w weighting factor

increases in that case only after two 5 year periods instead of one 5 year period (i.e., from R1 to R2)

in the former SSC GBR methodology.

In the SSC GBR methodology, the external challenge was assessed in a global way. In the EFSA

GBR methodology, the external challenge is assessed in three clearly defined steps:

• Step 1: Acquisition of import data concerning live cattle and MBM from BSE-risk countries.

The same approach as in the SSC GBR methodology is followed, but imports from countries that

have not been assessed before might be considered as posing a risk due to imports from BSE risk

countries and this can be taken into account as external challenge.

• Step 2: Determination whether the imports entered the BSE/cattle system.

Although in the former SSC GBR methodology, some possibility for deduction were mentioned (i.e.

cattle slaughtered under the age of 24 months), now it is clearly stated that other types of

information such as common practices adopted in the country being assessed or recording systems

may also be used to support the proposal for deduction. In cases where the available information

indicates but does not conclusively show that the animals or MBM did not enter the fed chain, only

a proportion of the imports may be deducted depending on the quality of the data. This was not

possible under the SSC methodology.

The acceptable and unacceptable reasons for the exclusion are in the EFSA GBR methodology

clearly defined, both for live cattle and MBM.

• Step 3: Estimation of the level of infectivity in the imported material.

In the EFSA GBR methodology, not only the number of live cattle exported from BSE risk

countries is taken into account, but also the type of intervention measures that are taken by the

exporting country to prevent the spread of the agent to live animals ad subsequent to the animal

products. A new terminology , instead of the “R” values used in the SSC GBR methodology, for the

scaling of the external challenge is introduced; w or weighting factor, whereby if w =1, this

Annex II to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 4

represents 1 “Risk Unit”. This w value can be estimated using BSurvE or another appropriate

method if yearly prevalence estimates are available for the exporting country. Otherwise an

estimation based on a rules system is proposed. Weighting factors are calculated taken into account

the risk from imported live cattle and MBM, ranging from 0 (very low) up till = or > 10.000 (very

high)

1. Changes of stability assessment

As for the assessment of the impact of SRM removal, fallen stock and feeding in the EFSA GBR

methodology a semi-quantitative approach is proposed, using the most recent data on BSE

infectivity distribution in an infected bovine, as well as the updated results from the attack rate

studies are taken into account, i.e. the fact that as little as 0.1 g and probably also 0.01 g of infected

brain is enough to infect cattle orally. In the SSC GBR methodology, only a qualitative approach

was used (OK, reasonable OK, not OK).

In contrast with the SSC GBR methodology, in the EFSA GBR methodology, also the basic

reproduction ratio of infection of BSE is assessed, taking into account the three main stability

factors SRM removal, rendering and feeding.

A tree approach is developed, in which a reduction factor for each of the main control measures is

multiplied, resulting in the calculation of the total effect of all the control measures together. This

result represents basically the basic reproduction ratio.

The reduction factors are defined for the different levels of application of the three control

measures:

• SRM removal: reduction factor between 1 (no SRM removal) and maximum 0.001 (full

compliance, including control measures, and exclusion of fallen stock).

• Rendering: reduction factor between 1 and maximum 0.001 (133/20/3 fully applied or no

rendering).

• Feeding: reduction factor between 1 and 0.001 (optimal feed ban).

The EFSA GBR methodology includes a more formal method for assessing the interaction between

challenge and stability.

2. Changes in categories of assessments

The EFSA GBR no longer includes categorization in contrast with SSC GBR which included 4

categories.

The table below provides an overview on the evolution of the SSC GBR methodology over time

(1998-2002) based on revisions carried out by the Scientific Steering Committee (SSC).

SNIP...FULL TEXT 4 PAGES ;

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0007.File.dat/biohaz_op_ej463_gbr_revision_annex2_en.pdf

Annex III to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 20

Information useful when completing this questionnaire:

• It would be appreciated if all information could be provided in English. This will

allow timely consideration of the information and finalisation of the assessment.

• This questionnaire may be requested electronically from, and response to this

questionnaire would be preferable also be submitted in electronic form to, the

following e-mail address: efsa-gbr@efsa.europa.eu

• Please supply a contact address of the responsible authority for the applicant country

using the following template: ............SNIP..........FULL TEXT 20 PAGES ;

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0001.File.dat/biohaz_op_ej463_gbr_revision_annex3_en.pdf

the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 1 of 7

ANNEX IV

EXAMPLES OF THE OUTCOME USING THE EXCEL SHEET REGARDING THE BSE-RISK FOR

HYPOTHETICAL COUNTRIES

These examples are generated using the accompanying spreadsheet model ‘Geographical BSE risk

calculator’ and are for illustrative purpose only. The data used in these examples are purely

fictitious and do not want, in any case, represent the reality. This spreadsheet includes a suite of

tools to help carry out the GBR assessment. Specifically, there are individual worksheets for:

1. The input, storage and tabulation of all cattle imports from BSE risk countries (cattle (1)

worksheet)

2. The input, storage and tabulation of all MBM imports from BSE risk countries (MBM (1)

worksheet)

3. The input, storage and tabulation of those cattle imports that are considered to pose a risk (cattle

FINAL worksheet)

4. The input, storage and tabulation of those MBM imports that are considered to pose a risk

(MBM FINAL worksheet)

5. The calculation of weighting factors to enable the risk from different countries, years and from

MBM and cattle to be combined (weighting factors worksheet)

6. The initial exposure assessment, that calculates the risk that BSE was imported (challenge) each

year based on all known imports (RISK table (1) worksheet)

7. The final exposure assessment , that calculates the risk that BSE was imported (challenge) each

year based on those imports considered a true risk (RISK table FINAL worksheet).

8. The final main conclusions of the GBR based on the interaction between the challenge and the

stability over time (challenge-stability interaction worksheet).

9. The comparison of the main conclusions with alternative scenarios to allow a basic sensitivity

analysis (Sensitivity Analysis worksheet).

The model has been developed to store the main data for the exposure assessment (imports from

BSE risk countries), to automatically carry out all the main calculations and to automatically

generate the output graphs summarising the GBR conclusions. Instructions for use are included in

notes within the spreadsheet.

Annex IV to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 7

COUNTRY I : Little challenge and stable system ..........SNIP.......FULL TEXT 7 PAGES ;

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0002.File.dat/biohaz_op_ej463_gbr_revision_annex4_en.pdf

Annex V to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 1 of 2

ANNEX V

COMMENTS RECEIVED AND MODIFICATIONS DONE AFTER THE PUBLIC CONSULTATION

As referred under Chapter 3 of the Opinion, “Approach to the mandate”, a preliminary draft

was put on the EFSA web for public consultation on 17th November 2006 and remained open

for comments until 14th January 2007.

The methodology was revised following consideration of the comments received and the

results of test runs of the new methodology of on a few countries dossiers.

In total 59 comments on different chapters and sections of the Opinion were received from six

Countries: Australia, Belgium, Chile, Germany, Italy and Japan.

The comments concerned mainly the following topics with respect to the different parts of

Chapter 4 (“The EFSA GBR methodology”):

• Calculation or estimation of reduction factors and weighting factors, with special attention

for the rendering system at 133°C, 20 minutes, 3 bars and other conditions for rendering;

• Quality of the import data (EUROSTAT, dossiers of the country, certificate provided by

the Competent Authorities.);

• Criteria for excluding certain live animal or MBM from the external challenge;

• Use of the Reproduction Ratio of the infection in the frame of BSE;

• Categorization of Countries/regions/compartments in risk status categories of unlikely,

likely and increasing, likely and decreasing;

• Use of surveillance data or models, including BsurvE model, and their contribution to the

estimation of the prevalence of BSE infection;

• Rules for the interaction between challenge and stability.

Taking into account all the comments and the results of pilot assessments, the methodology

was revised and adapted on the following aspects:

• The likelihood for vertical transmission, in the beginning of the UK epidemic estimated to

occur at a maximum level of 10%, later considered to be negligible is better documented

under section 4.2;

• For the definition of compartment and zones reference is made to OIE;

• Reasons to accept the exclusion of certain cattle and/or MBM are clarified under section

4.4.2 A and 4.4.2 B;

• The assumption of one live animal being comparable to one tonne for export from UK

during the reference period 1988 – 1993 is explained in section 4.4.3;

• Some additional elements have been included with respect to the assessment of the

stability factors (SRM removal, rendering, feeding) under section 4.5 and under section

4.6.1 for the assessment of their impact on stability;

Annex V to The EFSA Journal (2007) 463

Revision of the Geographical BSE risk assessment (GBR) methodology

www.efsa.europa.eu Page 2 of 2

• The possibility for the modification of the reduction factors on a case by case basis;

• The guidelines on the interaction between challenge and stability have been clarified in

section 4.7 and the calculation formulae behind the Excel worksheet to assess the expected

prevalence in the past and in the future have been adapted accordingly.

• A new quantitative approach was applied for the interaction between stability and

challenge.

• The surveillance data are only to be used to support the assessment outcome, in particular

for confirming an increasing or decreasing trend of the BSE risk, and not as a help for

making a formal decision between risk categories as these are no longer defined in the

methodology.

• The outcome of the assessment is no longer a categorization but an indication of the

likelihood of BSE being present in a country/region, the reasons (which import in which

period), the period of increasing or decreasing risk, the evolution over time, including a

graph on the interaction of stability and challenge, and expected cases per million of cattle.

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/ej463_gbr_methodology.Par.0003.File.dat/biohaz_op_ej463_gbr_revision_annex5_en.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)


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.europa.eu/en/science/tse_assessments/gbr_assessments/573.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada

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 to provide an up-to-date scientific report on the GBR in Canada, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Canada. This scientific report addresses the GBR of Canada as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into the country middle of the eighties and could have reached domestic cattle in the early nineties. 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 90s. It is possible that imported meat and bone meal (MBM) into Canada reached domestic cattle and led to an internal challenge in the early 90s.

A certain risk that BSE-infected cattle entered processing in Canada, and were at least partly rendered for feed, occurred in the early 1990s when cattle imported from UK in the mid 80s could have been slaughtered. 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 Canada is III, i.e. it is confirmed at a lower level that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as the system remains unstable, it is expected that the GBR continues to grow, even if no additional external challenges occur.

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/564.Par.0001.File.dat/sr02_biohaz02_canada_report_v2_en1.pdf

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico

Last updated: 8 September 2004
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 Mexico, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in Mexico. This scientific report addresses the GBR of Mexico as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into Mexico and could have reached domestic cattle. These cattle imported could have been rendered and therefore led to an internal challenge in the mid to late 1990s. It is possible that imported meat and bone meal (MBM) into Mexico reached domestic cattle and leads to an internal challenge around 1993.

It is likely that BSE infectivity entered processing at the time of imported ‘at - risk’ MBM (1993) and at the time of slaughter of imported live ‘at - risk’ cattle (mid to late 1990s). The high level of external challenge is maintained throughout the reference period, and the system has not been made stable. Thus it is likely that BSE infectivity was recycled and propagated from approximately 1993. The risk has since grown consistently due to a maintained internal and external challenge and lack of a stable system.

EFSA concludes that the current geographical BSE risk (GBR) level is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. The GBR is likely to increase due to continued internal and external challenge, coupled with a very unstable system.

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0003.File.dat/sr04_biohaz02_mexico_report_summary_en1.pdf

http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/565.Par.0004.File.dat/sr04_biohaz02_mexico_report_v2_en1.pdf

SUPPRESSED peer review of Harvard BSE study October 31, 2002

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf


USA MAD COW STRAIN MORE VIRULENT TO HUMANS THAN UK STRAIN


18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7
December 2006 are now available.


snip...

64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.

Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...

http://www.seac.gov.uk/minutes/95.pdf


3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse

Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western Reserve
University

Bovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE strain
discovered recently in Italy, and similar or different atypical BSE cases
were also reported in other countries. The infectivity and phenotypes of
these atypical BSE strains in humans are unknown. In collaboration with
Pierluigi Gambetti, as well as Maria Caramelli and her co-workers, we have
inoculated transgenic mice expressing human prion protein with brain
homogenates from BASE or BSE infected cattle. Our data shows that about half
of the BASE-inoculated mice became infected with an average incubation time
of about 19 months; in contrast, none of the BSE-inoculated mice appear to
be infected after more than 2 years.

***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotype
of 'UNKNOWN' strain growing. ...


http://www.cjdsurveillance.com/resources-casereport.html

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

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


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


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

THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r


CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm

PAUL BROWN COMMENT TO ME ON THIS ISSUE

Tuesday, September 12, 2006 11:10 AM


"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."


OR, what the Honorable Phyllis Fong of the OIG found ;


Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II

and

Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf


BRITISH MEDICAL JOURNAL


Re: vCJD in the USA * BSE in U.S. 15 November 1999


Terry S Singeltary
retired

Send response to journal:
Re: U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well...

In reading the recent article in the BMJ about the potential BSE tests being developed in the U.S. and Bart Van Everbroeck reply. It does not surprize me, that the U.S. has been concealing vCJD. There have been people dying from CJD, with all the symptoms and pathological findings that resemble U.K. vCJD for some time. It just seems that when there is one found, they seem to change the clarical classification of the disease, to fit their agenda. I have several autopsies, stating kuru type amyloid plaques, one of the victims was 41 years of age. Also, my Mom died a most hideous death, Heidenhain Variant Creutzfeldt Jakob disease. Her symptoms resemble that of all the U.K. vCJD victims. She would jerk so bad at times, it would take 3 of us to hold her down, while she screamed "God, what's wrong with me, why can't I stop this." 1st of symptoms to death, 10 weeks, she went blind in the first few weeks. But, then they told me that this was just another strain of sporadic CJD. They can call it what ever they want, but I know what I saw, and what she went through. Sporadic, simply means, they do not know. My neighbors Mom also died from CJD. She had been taking a nutritional supplement which contained the following; vacuum dried bovine BRAIN, bone meal, bovine EYE, veal bone, bovine liver powder, bovine adrenal, vacuum dried bovine kidney, and vacuum dried porcine stomach. As I said, this woman taking these nutritional supplements, died from CJD. The particular batch of pills that was located, in which she was taking, was tested. From what I have heard, they came up negative, for the prion protein. But, in the same breath, they said their testing, may not have been strong enough to pick up the infectivity. Plus, she had been taking these type pills for years, so, could it have come from another batch?

CWD is just a small piece of a very big puzzle. I have seen while deer hunting, deer, squirrels and birds, eating from cattle feed troughs where they feed cattle, the high protein cattle by products, at least up until Aug. 4, 1997. So why would it be so hard to believe that this is how they might become infected with a TSE. Or, even by potentially infected land. It's been well documented that it could be possible, from scrapie. Cats becoming infected with a TSE. Have you ever read the ingredients on the labels of cat and dog food? But, they do not put these tissues from these animals in pharmaceuticals, cosmetics, nutritional supplements, hGH, hPG, blood products, heart valves, and the many more products that come from bovine, ovine, or porcine tissues and organs. So, as I said, this CWD would be a small piece of a very big puzzle. But, it is here, and it most likely has killed. You see, greed is what caused this catastrophe, rendering and feeding practices. But, once Pandora's box was opened, the potential routes of infection became endless.

No BSE in the U.S.A.? I would not be so sure of that considering that since 1990;

Since 1990 the U.S. has raised 1,250,880,700 cattle;

Since 1990 the U.S. has ONLY checked 8,881 cattle brains for BSE, as of Oct. 4, 1999;

There are apprx. 100,000 DOWNER cattle annually in the U.S., that up until Aug. 4, 1997 went to the renders for feed;

Scrapie running rampant for years in the U.S., 950 infected FLOCKS, as of Aug. 1999;

Our feeding and rendering practices have mirrored that of the U.K. for years, some say it was worse. Everything from the downer cattle, to those scrapie infected sheep, to any roadkill, including the city police horse and the circus elephant went to the renders for feed and other products for consumption. Then they only implemented a partial feed ban on Aug. 4, 1997, but pigs, chickens, dogs, and cats, and humans were exempt from that ban. So they can still feed pigs and chickens those potentially TSE tainted by-products, and then they can still feed those by-products back to the cows. I believe it was Dr. Joe Gibbs, that said, the prion protein, can survive the digestinal track. So you have stopped nothing. It was proven in Oprah Winfrey's trial, that Cactus Cattle feeders, sent neurologically ill cattle, some with encephalopathy stamped on the dead slips, were picked up and sent to the renders, along with sheep carcasses. Speaking of autopsies, I have a stack of them, from CJD victims. You would be surprised of the number of them, who ate cow brains, elk brains, deer brains, or hog brains.

I believe all these TSE's are going to be related, and originally caused by the same greedy Industries, and they will be many. Not just the Renders, but you now see, that they are re-using medical devices that were meant for disposal. Some medical institutions do not follow proper auto- claving procedures (even Olympus has put out a medical warning on their endescopes about CJD, and the fact you cannot properly clean these instruments from TSE's), and this is just one product. Another route of infection.

Regardless what the Federal Government in the U.S. says. It's here, I have seen it, and the longer they keep sweeping it under the rug and denying the fact that we have a serious problem, one that could surpass aids (not now, but in the years to come, due to the incubation period), they will be responsible for the continued spreading of this deadly disease.

It's their move, it's CHECK, but once CHECKMATE has been called, how many thousands or millions, will be at risk or infected or even dead. You can't play around with these TSE's. I cannot stress that enough. They are only looking at body bags, and the fact the count is so low. But, then you have to look at the fact it is not a reportable disease in most states, mis-diagnosis, no autopsies performed. The fact that their one-in-a- million theory is a crude survey done about 5 years ago, that's a joke, under the above circumstances. A bad joke indeed........

The truth will come, but how many more have to die such a hideous death. It's the Government's call, and they need to make a serious move, soon. This problem, potential epidemic, is not going away, by itself.

Terry S. Singeltary Sr.
P.O. Box 42, Bacliff, Texas 77518 USA
flounder@wt.net

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


U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well... 2 January 2000


Terry S Singeltary
retired
Send response to journal:
Re: U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well...

In reading your short article about 'Scientist warn of CJD epidemic' news in brief Jan. 1, 2000. I find the findings in the PNAS old news, made famous again. Why is the U.S. still sitting on their butts, ignoring the facts? We have the beginning of a CJD epidemic in the U.S., and the U.S. Gov. is doing everything in it's power to conceal it.

The exact same recipe for B.S.E. existed in the U.S. for years and years. In reading over the Qualitative Analysis of BSE Risk Factors-1, this is a 25 page report by the USDA:APHIS:VS. It could have been done in one page. The first page, fourth paragraph says it all;

"Similarities exist in the two countries usage of continuous rendering technology and the lack of usage of solvents, however, large differences still remain with other risk factors which greatly reduce the potential risk at the national level."

Then, the next 24 pages tries to down-play the high risks of B.S.E. in the U.S., with nothing more than the cattle to sheep ratio count, and the geographical locations of herds and flocks. That's all the evidence they can come up with, in the next 24 pages.

Something else I find odd, page 16;

"In the United Kingdom there is much concern for a specific continuous rendering technology which uses lower temperatures and accounts for 25 percent of total output. This technology was _originally_ designed and imported from the United States. However, the specific application in the production process is _believed_ to be different in the two countries."

A few more factors to consider, page 15;

"Figure 26 compares animal protein production for the two countries. The calculations are based on slaughter numbers, fallen stock estimates, and product yield coefficients. This approach is used due to variation of up to 80 percent from different reported sources. At 3.6 million tons, the United States produces 8 times more animal rendered product than the United Kingdom."

"The risk of introducing the BSE agent through sheep meat and bone meal is more acute in both relative and absolute terms in the United Kingdom (Figures 27 and 28). Note that sheep meat and bone meal accounts for 14 percent, or 61 thousand tons, in the United Kingdom versus 0.6 percent or 22 thousand tons in the United States. For sheep greater than 1 year, this is less than one-tenth of one percent of the United States supply."

"The potential risk of amplification of the BSE agent through cattle meat and bone meal is much greater in the United States where it accounts for 59 percent of total product or almost 5 times more than the total amount of rendered product in the United Kingdom."

Considering, it would only take _one_ scrapie infected sheep to contaminate the feed. Considering Scrapie has run rampant in the U.S. for years, as of Aug. 1999, 950 scrapie infected flocks. Also, Considering only one quarter spoonful of scrapie infected material is lethal to a cow. Considering all this, the sheep to cow ration is meaningless. As I said, it's 24 pages of B.S.e.

To be continued...

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


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

Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al.
JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtos


JOURNAL OF NEUROLOGY

MARCH 26, 2003


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

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net


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

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

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

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

phenotype that is indistinguishable from type 2 PrPSc, the commonest

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

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

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

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

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

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

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

intracerebral inoculation. With the known incubation periods in other

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

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

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

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

should be drastic measures to safeguard the medical and surgical arena

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

CJDs in the USA are type 2 PrPSc?


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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

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

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

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

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

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;

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


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

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


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


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


THE SEVEN SCIENTIST REPORT ***


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf


PAUL BROWN M.D.

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf

9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf


Embassy of Japan
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm


Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of
Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...
http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf


03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.
http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov Subject: [Docket
No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al
[Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and
...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf


In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:
732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf

EXPORTATION AND IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS:
BSE; MRR AND IMPORTATION OF COMMODITIES, 65758-65759 [E6-19042]

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=3854


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=3381


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=498


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0702&L=sanet-mg&T=0&P=10277


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=9972


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=4492


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2583


http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=2470


----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr.
Sent: Thursday, March 29, 2007 3:44 PM
Subject: BSE; MRR; Importation of Live Bovines and Products Derived from Bovines Commodities


Sent: Sunday, January 28, 2007 9:12 PM
Subject: BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 COMMENT SUBMISSION

----- Original Message -----
From: Terry S. Singeltary Sr.
To: Terry S. Singeltary Sr.
Sent: Thursday, March 29, 2007 3:27 PM
Subject: BSE; MRR; Importation of Live Bovines and Products Derived from Bovines Commodities


Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities
Docket Type RULE
Document ID APHIS-2006-0041-0397
Views
Add Comments
How To Comment
Title Comment from Leonard Boswell, Rick Larsen, Randy Kuhl, and 10 more members of Congress
Abstract
Type PUBLIC SUBMISSIONS
Sub-Type Public Comment
CFR Citation
Effective Date
Paperwork Control No.
Received Date
RIN
Federal Register Number
Date Posted 03/19/2007
Comment Start Date 01/09/2007
Comments Due 03/12/2007


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648021622c&disposition=attachment&contentType=pdf

Title Comment from Stephanie Herseth, Member of Congress


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=0900006480216224&disposition=attachment&contentType=pdf


Comment from Nancy K Peterson, Montana Department of Agriculture

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648021621a&disposition=attachment&contentType=pdf


Comment from Edward J Farrell on behalf of Canadian Cattlemen's Association


Indeed, with respect to United States-Canada bilateral trade, this proposed rule is best

viewed as one more step in the normalization of the trade in beef and cattle between the United

States and Canada, which was interrupted in May 2003 when a BSE-positive cow was found in

Alberta, Canada. Prior to that discovery, the trade in cattle and beef products between Canada

and the United States was substantial. In the five year period 1999 to 2003 the United States

imported 1,643,905 tons of beef and beef products, and 5,454,405 head of cattle from Canada.

During the same period Canada imported 485,539 tons of beef and beef products, and 756,048

head of cattle from the United States. This level of trade is indicative of the integration of the

North American beef and cattle complex. Because of this historical integration of the North

American market, as well as the virtually identical BSE mitigations in place in Canada and the

United States, the United States and Canada share virtually identical risk profiles for BSE - i.e.,

low and declining.


snip...

Cattle imports from Canada under the proposed rule may be smaller than has been

estimated by the United States. Fewer imports from Canada would moderate the impacts

summarized. Sumner notes however, that the positive impacts remain for both producers and

consumers.

Finally, both producer and consumer gains in the United States would be even larger if

the proposed restrictions on date of birth were removed from the proposed rule for cattle for

immediate slaughter. Sumner shows that removing these restrictions would enhance the

benefits of relaxing border restrictions and result in even larger gains for beef and cattle

producers and consumers.

Turning now to our specific comments: First, USDA is proposing to specify in

3 93.436(b)(2), in addition to the options for permanent identification already included, that

cattle imported from BSE minimal risk regions can be identified with a tattoo on the inside of

one ear, that identifies the exporting country. CCA supports this additional identification option,

and, in general, encourages flexibility in the approval of alternate means of identification. As

such CCA believes that the administrator of APHIS should be required, upon request, to evaluate

alternate means of identification, and if they are found to be functionally equivalent to existing

methods, be required to approve them. Section 93.436(b)(2)(iii) should be amended accordingly.

Second, as proposed, the regulation would remove the requirement that the sealing of the

means of conveyance for cattle imported for immediate slaughter be done in the region of export.

Instead, it is proposed that such sealing be done at the port of entry. CCA supports this revision

which would revert to the procedures used prior to May 2003. Sealing at the port of entry would

likely reduce both the amount of time cattle will be in a sealed container and the probability that

a seal would need to be broken prior to reaching a designated slaughter facility.

Third, CCA supports USDA's proposal to allow the importation of bovine blood and

blood products from BSE minimal risk regions, but would encourage the incorporation of

administrative flexibility in the final rule to allow for the adoption of alternative, less restrictive

mitigations, should the Administrator determine them to be scientifically justified.

Fourth, CCA supports the proposals' removal of the requirements in 5 94.19(a)(2), (b)(2),

and (f), that bovine meat byproducts, meat food products and whole or half carcasses intended

for importation from BSE minimal risk regions, be derived from animals from which the entire

small intestine was removed at slaughter, instead requiring only that specified risk materials

(SRMs) be removed. As the preamble to the proposed regulation correctly notes, only the distal

ileum of the small intestine is a specified risk material, and thus is the only portion of the

intestine that need be removed to meet the SRM removal requirement. However, the proposed

regulation would require that an additional 80 inches of the uncoiled and trimmed small

intestine, as measured from the cecocolic junction, be excised. CCA believes that it is likely

unnecessary to excise so much additional intestine in order to ensure the complete removal of the

distal ileum. However, even if this provision is adopted as proposed, it should include a

delegation of authority to the Administrator to approve as a qualifying procedure any procedure

that effectively removes the distal ileum while requiring the excision of less than 80 inches of the

small intestine.

Fifth, CCA supports in principal the proposed amendment to 5 96.2 of the regulations, to

allow for the importation of casings derived from bovines from BSE minimal risk regions.

However, as the proposal would require that such casings be derived from the part of the small

intestine that is eligible for use as human food, a standard which requires the removal of 80

inches of the small intestine from the cecocolic junction, CCA reiterates its belief that it is

unnecessary to excise so much additional intestine to ensure removal of the SRM distal ileum,

and restates the proposed delegation of authority to the Administrator discussed above.

Sixth, we note that nowhere in the current regulations nor the proposed regulations is

there provision for an exemption for beef and beef products imported for personal use. Such an

exemption of 5 kg has been adopted by the Canadian regulatory authorities to address a

significant concern of tourists and truckers crossing between the countries. Under current U.S.

regulation any meat product, even a partially eaten sandwich, must be confiscated at the U.S.

border crossing, clearly sending a very negative and unjustified signal about the safety of the

beef products seized. CCA therefore requests that such an exemption for personal use be

included in the final regulation.

Finally, the regulation should clarify, either through regulatory or preamble language, the

right to transship cattle from Canada to third countries under the same conditions established for

slaughter cattle. Such animals would not enter U.S. commerce as either food or feed as their

transport would be in sealed conveyance. This would obviate the need for permanent

identification by brand, tattoo or otherwise as required for cattle entering the U.S. herd.

In the penultimate paragraph of its "Report on Measures Relating to Bovine Spongiform

Encephalopathy (BSE) in the United States," (Feb. 2,2004), the International Panel reviewing

the Washington State BSE case found in December 2003 recommended "that the U.S. should

demonstrate leadership in trade matters by adopting import/export policy in accordance with

international standards, and thus encourage the discontinuation of international trade barriers

when countries identify their first case of BSE". USDA will demonstrate this type of leadership

by adopting this rule, with the modifications proposed that are supported by the comprehensive

risk mitigations that are in place in the United States. In so doing USDA will provide a template

to open export markets based on sound science, rather than to see those markets regulated based

on irrational fear and economic self-interest. The United States and Canada must continue to

work together to successfully construct a North American system governed by science, so that

decision making is based on science, not speculation, and international markets are led to the

adoption of a rational and sustainable trade policy for cattle and beef.

March 12,2007 Respectfully submitted,


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=090000648021367a&disposition=attachment&contentType=pdf

COMMENT FROM TERRY S. SINGELTARY SR. 1/09/2007


snip...

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

go figure....


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


see full text ;


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3412&disposition=attachment&contentType=crtext

ATTACHMENT TO SINGELTARY COMMENT 1/09/2007


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


A statistically significant excess of cases of CJD in cattle farmers has been reported in the UK

since 1990. Of concern, four of these six cases were known to have had BSE-affected animals in

their herds. However, analysis of the clinical and pathological features of these cases showed that

none had the nvCJD phenotype. This observation has been strengthened by recent molecular

biological data that demonstrated that the PrP glycosylation pattern characteristic of both BSE

and nvCJD was not present in any of these cases. Furthermore analysis of the incidence of CJD

in dairy farmers from other European countries, in which BSE is rare or absent, reveals a similar

excess of cases. This observation suggests that dairy farmers may be at increased risk of CJD for

reasons other than exposure to the BSE agent. One possible explanation for the apparent excess

of cases in dairy farmers, particularly in the UK, is that case ascertainment in this group has been

better than in other groups because of concern of a possible link between the bovine and human

diseases.

snip...


http://www.bseinquiry.gov.uk/files/ws/s201a.pdf

Subject: ANOTHER FARMER DIES OF MAD COW DISEASE i.e. sporadic CJD
Date: March 29, 2007 at 8:00 am PST

'MAD COW' DEATH LINK


March 29, 2007 02:15am


A YORKE Peninsula man who had worked as a farmer has died from a rare illness linked with mad cow disease.

The man, aged in his late 50s, died in the Royal Adelaide Hospital on Sunday, after becoming ill in late January.
Communicable Diseases branch director Dr Ann Koehler said an autopsy had confirmed the man died from Creutzfeldt-Jakob Disease, a variant of which is called mad cow disease in other countries.

The death was the first in the state attributed to the disease for at least two years.


http://www.news.com.au/adelaidenow/story/0,22606,21466465-2682,00.html


----- Original Message -----
From: XXXXXXXX XXXXXXXXXXXX(SEAC)
To: 'flounder9@verizon.net'
Sent: Friday, February 23, 2007 8:13 AM
Subject: RE: SEAC ANNUAL REPORT 2006


Dear Mr Singeltary

Thank you for your email about a possible relationship between BASE and
sCJD.

SEAC is continually informed about and considers the emerging science on
both animal and human TSEs. The committee regularly receives updates from
the UK's National CJD Surveillance Centre Unit on the epidemiology of vCJD
and sCJD and is also aware of emerging research on BASE. It is envisaged
that SEAC will conduct a detailed consideration of the available science and
the possible animal and human health implications of BASE at its meeting on
10th May 2007.

Yours sincerely

XXXXXXXXXXXXXX


----------------------------------------------------------------------------
----
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: 02 February 2007 16:44
To: Bovine Spongiform Encephalopathy
Cc: SEACsecretariat (AHEG); cjdvoice@yahoogroups.com;
BLOODCJD@YAHOOGROUPS.COM; madcow@lists.iatp.org; Sustainable Agriculture
Network Discussion Group
Subject: SEAC ANNUAL REPORT 2006


Date: February 2, 2007 at 8:25 am PST
SEAC ANNUAL REPORT 2006 (ignoring the obvious)


http://www.seac.gov.uk/publicats/annualreport2006.pdf


i guess the sporadic CJD cases have all be resolved, and the route and cause
classified.
to this day, i cannot figure this out. if BSE farmers died from sporadic
CJD, and now another study seems to point
that BSE and BASE may be the same thing, and that BASE does not produce vCJD
like pathology, but pathology resembling that of sporadic CJD, then why does
SEAC still seem to put sporadic CJD on the back burners ??? IN fact, SEAC
could not even speak about it in there 2006 report. would it not seem
prudent to mention these findings in this 2006 SEAC report ;


Other work presented suggested that BSE and bovine amyloidotic spongiform
encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the
prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A
MUTATION FOUND IN CASES OF SPORADIC CJD.


snip...


http://www.seac.gov.uk/minutes/95.pdf


***These results indicate that BASE is transmissible to humans and suggest
that BASE is more virulent than
classical BSE in humans.***


6:30 Close of Day One


http://www.healthtech.com/2007/tse/day1.asp


64. A member noted that at the recent Neuroprion meeting, a study was
presented showing that in transgenic mice BSE passaged in sheep may be more
virulent and infectious to a wider range of species than bovine derived BSE.


http://www.seac.gov.uk/minutes/95.pdf


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

genotype can lead to an alternate phenotype that is indistinguishable

from type 2 PrPSc, the commonest _sporadic_ CJD;


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


I STILL think to ignore these findings below is not only rediculous, but
indeed very suspicious ;


CJD FARMERS WIFE 1989


http://www.bseinquiry.gov.uk/files/yb/1989/10/13007001.pdf


http://www.bseinquiry.gov.uk/files/yb/1989/10/13003001.pdf


cover-up of 4th farm worker ???


http://www.bseinquiry.gov.uk/files/yb/1995/10/23006001.pdf


http://www.bseinquiry.gov.uk/files/yb/1995/10/20006001.pdf


CONFIRMATION OF CJD IN FOURTH FARMER


http://www.bseinquiry.gov.uk/files/yb/1995/11/03008001.pdf


now story changes from;

SEAC concluded that, if the fourth case were confirmed, it would be
worrying, especially as all four farmers with CJD would have had BSE
cases on their farms.

to;

This is not unexpected...

was another farmer expected?

http://www.bseinquiry.gov.uk/files/yb/1995/11/13010001.pdf


4th farmer, and 1st teenager

http://www.bseinquiry.gov.uk/files/yb/1996/02/27003001.pdf


2. snip...


Over a 5 year period, which is the time period on which the advice
from Professor Smith and Dr. Gore was based, and assuming a
population of 120,000 dairy farm workers, and an annual incidence
of 1 per million cases of CJD in the general population, a
DAIRY FARM WORKER IS 5 TIMES MORE LIKELY THAN
an individual in the general population to develop CJD. Using the
actual current annual incidence of CJD in the UK of 0.7 per
million, this figure becomes 7.5 TIMES.

3. You will recall that the advice provided by Professor Smith in
1993 and by Dr. Gore this month used the sub-population of dairy
farm workers who had had a case of BSE on their farms -
63,000, which is approximately half the number of dairy farm
workers - as a denominator. If the above sums are repeated using
this denominator population, taking an annual incidence in the general
population of 1 per million the observed rate in this sub-population
is 10 TIMES, and taking an annual incidence of 0.7 per million,
IT IS 15 TIMES (THE ''WORST CASE'' SCENARIO) than
that in the general population...


http://www.bseinquiry.gov.uk/files/yb/1995/01/31004001.pdf


CJD YOUNG PEOPLE

in the USA, a 16 year old in 1978;

ALSO IN USA;

(20 year old died from sCJD in USA in 1980 and a 16 year
old in 1981. see second url below)

in France, a 19 year old in 1982;

in Canada, a 14 year old of UK origin in 1988;

in Poland, cases in people aged 19, 23, and 27 were identified in
a retrospective study (published 1991), having been originally
misdiagnosed with a viral encephalitis;

Creutzfeldt's first patient in 1923 was aged 23.

http://www.bseinquiry.gov.uk/files/yb/1995/10/27013001.pdf


20 year old died from sCJD in USA in 1980 and a 16 year
old in 1981. A 19 year old died from sCJD in
France in 1985. There is no evidence of an iatrogenic
cause for those cases....

http://www.bseinquiry.gov.uk/files/yb/1995/10/04004001.pdf

FOR SEAC TO continue to flounder with this ukbsenvcjd only theory, when we
know that sporadic CJD's were proven long ago to transmit via the medical
and surgical arena, will only continue to spread this agent around the globe
via a multitude of proven routes and sources.

IN my opinion, for SEAC to continue to go down this same road, year after
year, and continue to ignore sporadic CJD's, and continue to say that "BSE
in the UK sheep population is most likely to be zero, or very low if present
at all." "Consequently, any impact of the schemes on human health from
removing BSE from sheep is likely to be negligible." when in fact they do
not know. and in fact science is showing that in "transgenic mice BSE
passaged in sheep may be more virulent and infectious to a wider range of
species than bovine derived BSE." IN my opinion this continued neglect of
other TSEs in human and animals, the continued belief in this ukbsenvcjd
only theory, and the risk thereof, is reckless, dangerous, and in my mind,
criminal. SEAC has failed the public terribly in this regard. ...TSS

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Friday, February 02, 2007 10:43 AM
Subject: SEAC ANNUAL REPORT 2006


Date: February 2, 2007 at 8:25 am PST
SEAC ANNUAL REPORT 2006 (ignoring the obvious)


http://www.seac.gov.uk/publicats/annualreport2006.pdf


i guess the sporadic CJD cases have all be resolved, and the route and cause classified. to this day, i cannot figure this out. if BSE farmers died from sporadic
CJD, and now another study seems to point that BSE and BASE may be the same thing, and that BASE does not produce vCJD like pathology, but pathology resembling that of sporadic CJD, then why does SEAC still seem to put sporadic CJD on the back burners ??? IN fact, SEAC could not even speak about it in there 2006 report. would it not seem prudent to mention these findings in this 2006 SEAC report ;

........SNIP.........END............TSS

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




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