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From: TSS ()
Subject: Consultation on the proposed TSE Regulations (England) 2005
Date: June 16, 2005 at 8:32 am PST


Consultation on the proposed Transmissible Spongiform Encephalopathy (TSE) Regulations (England) 2005

To: Interested Parties

15 June 2005


Dear Sir/Madam

PUBLIC CONSULTATION ON THE PROPOSED TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) REGULATIONS (ENGLAND) 2005
1. This letter seeks your comments on the proposed TSE (England) Regulations 2005 which would replace the existing TSE (England) Regulations 2002 (SI 2002 No 843).

2. The draft Regulations attached at Annex A would consolidate and update the existing TSE (England) Regulations 2002; reduce repetition in the Regulations; restructure certain provisions; and address a number of other issues, in particular enforcement of feed controls and the appeals procedures. These draft Regulations include the provisions of the TSE (England) (Amendment) Regulations 2005 which were sent to you for comment on 8 March 2005; these provisions may be subject to some subsequent amendment in response to comments received during the consultation period.

3. The attached draft Regulations are subject to finalisation of detailed points of drafting, and clearance by Defra's legal division. It is not expected that any changes will be significant, but we will advise you of any changes shortly.

4. The draft Regulations are being sent out at this stage because of the importance of completing the necessary amendments by mid-ember, in advance of any change to the OTM Rule.

5. Separate consultations on proposals to make similar changes in Scotland, Wales and Northern Ireland are being carried out in those countries.

6. The Food Standards Agency has been fully involved in the preparation of these consultation papers.

Key Proposals
7. Many of the existing provisions of the TSE (England) Regulations 2002 have been included in the new draft TSE (England) Regulations 2005 (see Annex A). However, some provisions have been consolidated to avoid unnecessary repetition.

8. In addition, a number of deregulatory changes have been made in the draft Regulations, such as revoking the need for slaughterhouses extracting spinal cord from sheep and goats to be additionally licensed. These changes have been made in response to several factors including reviews of procedure, changes in European obligations, and detailed risk assessments.

9. Of particular note, are a number of changes that have been made in the feedingstuff section (Chapter 2) of the draft Regulations. These changes, and other feed enforcement issues, are set out in greater detail in Annex B. Your views are invited on a number of issues including:

the criteria for slaughtering animals exposed to prohibited materials, and the circumstances compensation should be paid (draft regulations 19 & 21);
continuing of the application of the feed ban to farmed animal species rather than individual animals (draft reg. 7 (3));
official inspections of vehicles used to transport processed animal proteins in bulk (see discussion point in Annex B);
horse feed manufacture on pet food manufacturing premises and other pet food handling issues (see discussion point in Annex B);
possession and handling of processed animal proteins on livestock premises (draft reg. 13); and
a proposal to moderate some controls on mammalian meat and bone meal (MBM) used in agricultural fertilisers (draft reg. 15).
10. Other major proposed changes in the draft 2005 Regulations are:

Provisions setting out abattoir occupiers' responsibilities for the sampling of 24 - 30 month bovine animals under the annual programme of monitoring for TSEs, in line with EU state aid rules and reflecting the present arrangements for cattle subject to emergency slaughter or found sick at ante-mortem inspection at abattoirs. These responsibilities include the taking of samples, and retention of carcases and body parts until the receipt of test results. These provisions complement the provisions for over thirty month (OTM) bovine animals set out in the TSE (England) Amendment Regulations, sent for comment to stakeholders on 8 March 2005;
A new provision which has the effect of limiting entitlement to compensation, for 24 - 30 month bovine animals that must be tested if they are subject to emergency slaughter or found sick at ante-mortem, to animals that have tested positive for a TSE. If a "no-test" result is received, for example because the brain stem sample was taken inadequately, there will be no automatic entitlement to compensation. This is in line with the provisions for OTM bovine animals as set out in the TSE (England) Amendment Regulations, issued for consultation on 8 March 2005. Entitlement to compensation for tested sheep and goats remains unchanged;
New provisions, for both OTM and 24 - 30 month animals, to enable appeals against a decision to withhold compensation. If the decision is taken to withhold compensation, a notice to this effect will be issued. This notice will be subject to appeal (see below for description of appeal procedure);
A revised provision on appeals procedures. Under the new procedures, an appeal may be made against a notice within 21 days of the notice being served. Appeals are either made by a written representation, by the person on whom the notice is served, to the Secretary of State or, if requested, by a hearing in front of an independent person who then reports to the Secretary of State. Unless the person appealing the notice gives their consent, the independent person appointed to hear the appeal shall not be an officer of the Secretary of State. The Secretary of State's decision on the appeal, and reasons for the decision, shall be given in writing to the appellant;
A requirement for operators of slaughterhouses to record the training received by staff in relation to the removal of SRM and an extension of these training and record keeping requirements to apply to cutting plants.
11. Finally, a number of clarifications have been made in the regulations.

Updated definitions for "mechanically recovered meat" (MRM) and "carcase" are examples of such clarification.

12. The partial Regulatory Impact Assessment (RIA), attached at Annex C, provides further detail on the above measures and gives information on other changes that have been made in the draft Regulations. We invite your comments on the proposed changes plus any additional estimates on benefits and costs likely to result from the changes. In particular we welcome feedback from the fertiliser and rendering industries on the likely value generated and amounts of material involved in the changes proposed to moderate controls on low-risk mammalian MBM in agricultural fertilisers.

Possible Additional Measures
13. To prepare for the possible replacement of the over thirty months rule with a robust system of BSE testing, the European Commission has made a proposal for a Decision to prohibit the placing on the market of products derived from cattle born or reared in the UK before 1 August 1996. If the Decision is adopted, we are proposing, as part of the national measures required to enforce it, to add a provision to these 2005 Regulations making it an offence to consign such an animal to an abattoir for slaughter for human consumption.

14. The MHS's enforcement function in respect of these Regulations will be subject to audit by the Food Standards Agency. Officials are currently considering whether the legal powers necessary for the purposes of this audit will be covered by new domestic legislation implementing the new EU Official Control Regulation (882/2004) which requires audit of the authorities responsible for enforcing feed and food law and animal health and welfare rules. If this is not appropriate, it may be necessary to include similar powers in the TSE Regulations.

15. Last year, the Department consulted stakeholders about a possible change to the way that compensation is paid for TB, EBL, Brucellosis and BSE. The Department received feedback on its proposals and further work is being undertaken to ensure that the final arrangements take into account some of the detailed concerns raised by stakeholders. Although not part of this consultation exercise, if new cattle compensation arrangements are agreed shortly, it is likely that they will be implemented by way of the consolidated TSE regulations, rather than as a separate amendment later on in the year.

16. Responses to this consultation are required by 6 September 2005. When responding, please state whether you are responding as a private individual or on behalf of an organisation or company.

All comments and views should be sent to:

Sinjini Mukherjee
Defra
BSE Division Branch C
Zone 311, 1A Page Street
London SW1P 4PQ
Tel 020 7904 6375
Fax 020 7904 6325
Or by email to: sinjini.mukherjee@defra.gsi.gov.uk

Background
17. The TSE (England) Regulations 2002 came into force on 19th April 2002. They provided the necessary powers to administer and enforce the provisions of Regulation (EC) 999/2001 concerning the prevention, control and eradication of TSEs.

18. In the three years which have elapsed since the introduction of the domestic legislation there have been a number of amendments made to both the EU TSE legislation and domestic legislation. The changes to European legislation have generally added more detail into the monitoring requirements and the control and eradication measures. Amendments made to the domestic legislation have inserted, amended and revoked regulations in response to domestic enforcement needs.

Confidentiality Statement
19. In line with Defra's policy of openness, at the end of the consultation period copies of the responses we receive may be made publicly available through the Defra Information Resource Centre, Lower Ground Floor, Ergon House, 17 Smith Square, London SW1P 3JR. The information they contain may also be published in a summary of responses.

20. If you do not consent to this, you must clearly request that your response be treated confidentially. Any confidentiality disclaimer generated by your IT system in e-mail responses will not be treated as such a request. You should also be aware that there may be circumstances in which Defra will be required to communicate information to third parties on request, in order to comply with its obligations under the Freedom of Information Act 2000 and the Environmental Information Regulations.

21. The Information Resource Centre will supply copies of consultation responses to personal callers or in response to telephone or e-mail requests (tel: 020 7238 6575, e-mail: defra.library@defra.gsi.gov.uk). Wherever possible, personal callers should give the library at least 24 hours' notice of their requirements. An administrative charge will be made to cover photocopying and postage costs.

Comments or Complaints about the Consultation Process
22. Comments or complaints about the consultation process (as opposed to comments about the issues which are the subject of the consultation) should be addressed to Lance Boxall , Defra's Consultation Co-ordinator, Area 7D Nobel House, 17 Smith Square, London SW1P 3JR.

BSE Division

Branch C

Page last modified: 16 June 2005
Page published: 15 June 2005

http://www.defra.gov.uk/corporate/consult/tseregs-2005/letter.htm

Dear Sir/Madam

PUBLIC CONSULTATION ON THE PROPOSED TRANSMISSIBLE SPONGIFORM

ENCEPHALOPATHY (TSE) REGULATIONS (ENGLAND) 2005

1. This letter seeks your comments on the proposed TSE (England) Regulations 2005

which would replace the existing TSE (England) Regulations 2002 (SI 2002 No 843).

2. The draft Regulations attached at Annex A would consolidate and update the existing

TSE (England) Regulations 2002; reduce repetition in the Regulations; restructure

certain provisions; and address a number of other issues, in particular enforcement

of feed controls and the appeals procedures. These draft Regulations include the

provisions of the TSE (England) (Amendment) Regulations 2005 which were sent to

you for comment on 8 March 2005; these provisions may be subject to some

subsequent amendment in response to comments received during the consultation

period.

3. The attached draft Regulations are subject to finalisation of detailed points of

drafting, and clearance by Defra’s legal division. It is not expected that any changes

will be significant, but we will advise you of any changes shortly.

4. The draft Regulations are being sent out at this stage because of the importance of

completing the necessary amendments by mid-September, in advance of any

change to the OTM Rule.

5. Separate consultations on proposals to make similar changes in Scotland, Wales and

Northern Ireland are being carried out in those countries.

6. The Food Standards Agency has been fully involved in the preparation of these

consultation papers.

To: Interested Parties Reference : CUL 297

15 June 2005

Key Proposals

7. Many of the existing provisions of the TSE (England) Regulations 2002 have been

included in the new draft TSE (England) Regulations 2005 (see Annex A). However,

some provisions have been consolidated to avoid unnecessary repetition.

8. In addition, a number of deregulatory changes have been made in the draft

Regulations, such as revoking the need for slaughterhouses extracting spinal cord

from sheep and goats to be additionally licensed. These changes have been made in

response to several factors including reviews of procedure, changes in European

obligations, and detailed risk assessments.

9. Of particular note, are a number of changes that have been made in the feedingstuff

section (Chapter 2) of the draft Regulations. These changes, and other feed

enforcement issues, are set out in greater detail in Annex B. Your views are invited

on a number of issues including:

• the criteria for slaughtering animals exposed to prohibited materials, and the

circumstances compensation should be paid (draft regulations 19 & 21);

• continuing of the application of the feed ban to farmed animal species rather than

individual animals (draft reg. 7 (3));

• official inspections of vehicles used to transport processed animal proteins in bulk

(see discussion point in Annex B);

• horse feed manufacture on pet food manufacturing premises and other pet food

handling issues (see discussion point in Annex B);

• possession and handling of processed animal proteins on livestock premises (draft

reg. 13); and

• a proposal to moderate some controls on mammalian meat and bone meal (MBM)

used in agricultural fertilisers (draft reg. 15).

10. Other major proposed changes in the draft 2005 Regulations are:

• Provisions setting out abattoir occupiers’ responsibilities for the sampling of 24 – 30

month bovine animals under the annual programme of monitoring for TSEs, in line

with EU state aid rules and reflecting the present arrangements for cattle subject to

emergency slaughter or found sick at ante-mortem inspection at abattoirs. These

responsibilities include the taking of samples, and retention of carcases and body

parts until the receipt of test results. These provisions complement the provisions

for over thirty month (OTM) bovine animals set out in the TSE (England)

Amendment Regulations, sent for comment to stakeholders on 8 March 2005;

• A new provision which has the effect of limiting entitlement to compensation, for 24

– 30 month bovine animals that must be tested if they are subject to emergency

slaughter or found sick at ante-mortem, to animals that have tested positive for a

TSE. If a "no-test" result is received, for example because the brain stem sample

was taken inadequately, there will be no automatic entitlement to compensation.

This is in line with the provisions for OTM bovine animals as set out in the TSE

(England) Amendment Regulations, issued for consultation on 8 March 2005.

Entitlement to compensation for tested sheep and goats remains unchanged;

• New provisions, for both OTM and 24 – 30 month animals, to enable appeals

against a decision to withhold compensation. If the decision is taken to withhold

compensation, a notice to this effect will be issued. This notice will be subject to

appeal (see below for description of appeal procedure);

• A revised provision on appeals procedures. Under the new procedures, an appeal may

be made against a notice within 21 days of the notice being served. Appeals are either

made by a written representation, by the person on whom the notice is served, to the

Secretary of State or, if requested, by a hearing in front of an independent person who

then reports to the Secretary of State. Unless the person appealing the notice gives

their consent, the independent person appointed to hear the appeal shall not be an

officer of the Secretary of State. The Secretary of State’s decision on the appeal, and

reasons for the decision, shall be given in writing to the appellant;

• A requirement for operators of slaughterhouses to record the training received by staff

in relation to the removal of SRM and an extension of these training and record

keeping requirements to apply to cutting plants.

11. Finally, a number of clarifications have been made in the regulations.

Updated definitions for "mechanically recovered meat" (MRM) and "carcase" are

examples of such clarification.

12. The partial Regulatory Impact Assessment (RIA), attached at Annex C, provides

further detail on the above measures and gives information on other changes that

have been made in the draft Regulations. We invite your comments on the

proposed changes plus any additional estimates on benefits and costs likely to

result from the changes. In particular we welcome feedback from the fertiliser

and rendering industries on the likely value generated and amounts of material

involved in the changes proposed to moderate controls on low-risk mammalian

MBM in agricultural fertilisers.

Possible Additional Measures

13. To prepare for the possible replacement of the over thirty months rule with a robust

system of BSE testing, the European Commission has made a proposal for a

Decision to prohibit the placing on the market of products derived from cattle born or

reared in the UK before 1 August 1996. If the Decision is adopted, we are proposing,

as part of the national measures required to enforce it, to add a provision to these

2005 Regulations making it an offence to consign such an animal to an abattoir for

slaughter for human consumption.

14. The MHS's enforcement function in respect of these Regulations will be subject to

audit by the Food Standards Agency. Officials are currently considering whether the

legal powers necessary for the purposes of this audit will be covered by new

domestic legislation implementing the new EU Official Control Regulation (882/2004)

which requires audit of the authorities responsible for enforcing feed and food law

and animal health and welfare rules. If this is not appropriate, it may be necessary

to include similar powers in the TSE Regulations.

15. Last year, the Department consulted stakeholders about a possible change to the

way that compensation is paid for TB, EBL, Brucellosis and BSE. The Department

received feedback on its proposals and further work is being undertaken to ensure

that the final arrangements take into account some of the detailed concerns raised by

stakeholders. Although not part of this consultation exercise, if new cattle

compensation arrangements are agreed shortly, it is likely that they will be

implemented by way of the consolidated TSE regulations, rather than as a separate

amendment later on in the year.

16. Responses to this consultation are required by 6 September

2005. When responding, please state whether you are responding as a private

individual or on behalf of an organisation or company.

All comments and views should be sent to:

Sinjini Mukherjee

Defra

BSE Division Branch C

Zone 311, 1A Page Street London SW1P 4PQ

Tel 020 7904 6375

Fax 020 7904 6325

Or by email to: sinjini.mukherjee@defra.gsi.gov.uk

Background

17. The TSE (England) Regulations 2002 came into force on 19th April 2002. They

provided the necessary powers to administer and enforce the provisions of

Regulation (EC) 999/2001 concerning the prevention, control and eradication of

TSEs.

18. In the three years which have elapsed since the introduction of the domestic

legislation there have been a number of amendments made to both the EU TSE

legislation and domestic legislation. The changes to European legislation have

generally added more detail into the monitoring requirements and the control and

eradication measures. Amendments made to the domestic legislation have inserted,

amended and revoked regulations in response to domestic enforcement needs.

Confidentiality Statement

19. In line with Defra's policy of openness, at the end of the consultation period copies of

the responses we receive may be made publicly available through the Defra

Information Resource Centre, Lower Ground Floor, Ergon House, 17 Smith Square,

London SW1P 3JR. The information they contain may also be published in a

summary of responses.

20. If you do not consent to this, you must clearly request that your response be treated

confidentially. Any confidentiality disclaimer generated by your IT system in e-mail

responses will not be treated as such a request. You should also be aware that there

may be circumstances in which Defra will be required to communicate information to

third parties on request, in order to comply with its obligations under the Freedom of

Information Act 2000 and the Environmental Information Regulations.

21. The Information Resource Centre will supply copies of consultation responses to

personal callers or in response to telephone or e-mail requests (tel: 020 7238 6575,

e-mail: defra.library@defra.gsi.gov.uk). Wherever possible, personal callers should

give the library at least 24 hours' notice of their requirements. An administrative

charge will be made to cover photocopying and postage costs.

Comments or Complaints about the Consultation Process

22. Comments or complaints about the consultation process (as opposed to comments

about the issues which are the subject of the consultation) should be addressed to

Lance Boxall , Defra’s Consultation Co-ordinator, Area 7D Nobel House, 17 Smith

Square, London SW1P 3JR.

BSE Division

Branch C

http://www.defra.gov.uk/corporate/consult/tseregs-2005/letter.pdf

Consultation on the proposed Transmissible Spongiform Encephalopathy (TSE) Regulations (England) 2005

http://www.defra.gov.uk/corporate/consult/tseregs-2005/index.htm

TSS




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