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From http://www.defra.gov.uk/corporate/consult/fmd-directive/letter.pdf


organisations on the attached list

Dear Consultee,

CONSULTATION ON THE TRANSPOSITION OF COUNCIL DIRECTIVE 2003/85

ON FOOT AND MOUTH DISEASE

1. Roy Hathaway wrote to you on 7 February 2003 to consult you on the EU proposal for a revised Directive (2003/85/EC) for the control of Foot and Mouth Disease(FMD). The consultation can be found on our website at

http://www.defra.gov.uk/corporate/consult/fmdcontrol/index.htm

. Following yourresponses, the FMD Directive was adopted in September 2003. I am now writing to consult you further on how the Government proposes to implement this Directive and to seek your views on the detailed transposing regulations. The consultation period will run until 1 September 2005.

2. We intend to implement the Directive fully, so fulfilling our obligations under European law, by December 2005. Therefore the areas on which there is scope to influence the way we implement the Directive are necessarily limited. However, this letter attempts to set out those areas where we do have some national discretion and the particular questions on which we want to know your views.

3. Please find attached drafts of the two most significant of the three pieces of legislation that would transpose the Directive, as well as a Regulatory Impact Assessment (RIA), which evaluates the costs and benefits of the different options in transposing the Directive. The proposed legislation is briefly summarised in this letter but a full summary is included in Annex 1 of the RIA.

The FMD Directive is available at: http://europa.eu.int/eurlex/pri/en/oj/dat/2003/l_306/l_30620031122en00010087.pdf

The Animal Health Act 1981 is at:

http://www.defra.gov.uk/footandmouth/pdf/ah_act_81.pdf

 

The Animal Health Act 2002 is at:

http://www.opsi.gov.uk/acts/acts2002/20020042.htm

 

4. This consultation covers England only. Separate consultations on similar provisionsare being undertaken in Wales, Scotland and Northern Ireland.

Summary of proposals for implementing the FMD Directive

5. The FMD Directive sets out the measures to be adopted in the event of a suspected or confirmed outbreak of FMD within EU territory. It amends the current EU measures to control and eradicate FMD, taking account of:

the most recent scientific developments in the field of disease control;

the experience gained in eradicating FMD during the 2001 outbreak; and

technical developments in laboratory diagnosis of FMD and vaccines.

6. In particular, the Directive moves emergency vaccination to the forefront of FMD control strategies, alongside the basic policy of slaughter of susceptible animals on infected premises and those identified as dangerous contacts. Transposing the Directive will replace (and thereby simplify) existing legislation (currently the FMD Order 1983 as amended by fourteen subsequent amendments) and introduce a number of ‘zones’ of different levels of control (such as protection or surveillance) where disease is either suspected, present or where vaccination is used. The Directive also introduces the following requirements:

New requirements of the FMD Directive

Prophylactic (routine) vaccination is banned - which allows the EU to maintain its internationally recognised trading status of being free from FMD without vaccination;

Member states must have arrangements in place for the possible use of emergency vaccination as soon as practicable once FMD has been confirmed;

Following emergency vaccination to live, disease free status can be regained six months (rather than the current twelve) after the last vaccination;

Special vaccination measures may be applied in zoos, wildlife parks and to allow conservation of rare breeds;

If the Secretary of State decides to authorise vaccination in an outbreak, she must specify whether vaccination is to be protective (to live) or suppressive (to die), the geographical area involved, the species of animal involved and the duration of the campaign;

Fresh meat and meat products from animals originating or produced in protection and surveillance zones cannot go into the food chain unless they undergo various specified treatments, including heat treatment;

Until the UK has regained FMD-free status, meat from vaccinated animals must be deboned and matured, in line with OIE rules (international animal health standard setting body);

Animal movements, except to slaughter, in certain zones are banned;

Collecting and transporting milk for sampling for milk hygiene purposes in laboratories not authorised to test for FMD virus is banned.

Transposing regulations for the FMD Directive

For technical legal reasons, the Directive will be transposed by three separate pieces of legislation:

The Animal Health Act (Amendment) Regulations 2005. This makes a minor technical amendment to the Animal Health Act 1981 (as amended by the Animal Health Act 2002). As a change to primary legislation, the text of this legislation requires the clearance of Parliamentary Counsel which we are currently seeking.

This is not, therefore, attached. However, the proposal is to change the Secretary of State’s current discretion to slaughter in certain situations (including on infected premises) to a duty to slaughter. There are certain exceptions which are set out in the Directive, for example in laboratories, zoos, wildlife parks, for rare breeds and for separate production units.

The Foot-and-Mouth Disease (Control of Vaccination) (England) Regulations

2005. These introduce the vaccination provisions of the Directive; and

The Foot-and-Mouth Disease (England) Order 2005. This implements the majority of the Directive and some additional provisions preserved from the FMD Order 1983 (see paragraph 11).

FMD Control Policy

7. This consultation does not change the Government’s FMD control policy, which was set out in its Response to the Reports of the FMD Inquiries in 2002. The policy on controlling FMD is that animals on infected premises and their dangerous contacts would be culled. However, we will consider the role of emergency vaccination from the very start of an outbreak. This is already in line with the FMD Directive. This consultation therefore implies no change to existing disease control policy.

8. Our FMD control strategy is set out in Defra’s Exotic Animal Disease Generic Contingency Plan. This Plan is consulted on, updated and published every year.

The Contingency Plan sets out very clearly the decision tree determining the disease control options that we would adopt in an outbreak. You can find these on our website, along with vaccination scenarios and a vaccination protocol, at

http://www.defra.gov.uk/corporate/consult/animaldisease-plan/index.htm

. These set out the circumstances in which we believe vaccination may be most useful and the scientific, policy and legal considerations around its use.

9. Many of the Directive’s requirements have already been met by administrative means and veterinary instructions. The Contingency Plan, and existing domestic legislation, would enable us to control FMD fully in accordance with the Directive should there be an outbreak in the UK before the Directive has been fully implemented. In such an event, the legislation dealing with the emergency vaccination elements of the Directive is ready to be brought into force immediately if necessary. The Contingency Plan would enable us to commence vaccination within 5 days of confirmation of disease, utilising our stocks of FMD antigens.

Issues to consider

10. The FMD Directive is a lengthy, detailed and often very specific piece of legislation that all parts of the United Kingdom are legally obliged to transpose. In many cases, it gives us little national discretion in the way we transpose it. However, there are areas where we do have some scope and therefore it is these issues where we particularly seek your views on the approach we propose.

11. In particular, the Directive sets out the minimum control measures which member states are required to apply and we are free to introduce additional measures.

There are several areas in existing legislation (the FMD Order 1983, as amended) which are not set out in the Directive but where our veterinary advice was that they were essential in controlling the 2001 FMD outbreak. As we do not wish to reduce our level of protection against a future disease outbreak, we propose to retain these requirements, as set out below, in addition to the provisions in the Directive:

Do you think we should retain the following elements of existing legislation (not required by the Directive) in controlling a future disease outbreak?

The requirement to control rats on premises where disease is suspected or on contact premises;

The requirement to control dogs and poultry in zones established around an infected premises;

Controls on shearing, dipping and scanning of sheep by mobile workers;

Provision to close land including footpaths (but only within an area of immediate risk around a minimum of 3km of an infected premises);

Powers to control shooting, stalking, drag hunting and other gatherings of people beyond the immediate infected area; and

Powers to control animal gatherings (markets, fairs, etc) beyond the immediate infected area.

12. There are also several other issues where we are seeking your views on the way we propose to implement the Directive:

Issues on which we are seeking your views

a. We intend to substantially repeat the cleansing and disinfection requirements in place during the 2001 outbreak. How should we retain these requirements?

We would also welcome your views as to the extent this should be achieved through specific requirements appearing on the face of the legislation or through more flexible methods adopted during an outbreak, for example by licence conditions or written directions from a veterinary inspector.

b. The Directive bans the export of vaccinated animals abroad for the whole of their lives, even when the UK is certified FMD free. During an FMD outbreak, the Directive also controls domestic trade in vaccinated animals and their products.

However, we believe it is important to restore trading conditions to as close as their normal state as soon as possible. We do not intend to impose additional controls on domestic trade in vaccinated animals when the country is FMD free.

c. Common and unenclosed land is currently regarded as holdings/premises within the scope of the proposed legislation. We intend to retain substantially controls on common and unenclosed land used in the 2001 FMD outbreak.

d. Will there be additional costs or income, and thus industry price differentials, arising from specified treatments, including heat treatment, required for products from FMD vaccinated animals until we regain FMD-free status, before placing them on the market? If so what would be their scale?

e. What practical issues are there in the livestock and meat processing industry arising from the requirement to apply specified treatments to products from FMD vaccinated animals?

f. What would be the demand, here or abroad, for meat and animal products treated as required by the Directive?

Responding to this Consultation

13. We intend to seek the views of key organisations during the consultation process through a series of meetings over June and July to discuss these issues in more depth, in addition to giving careful consideration to all written responses we receive.

In particular we will be gathering further data on the financial effect on individuals of some of the measures introduced by the Directive and we will be seeking to validate that data with stakeholders (see paragraph 9.5 of the attached RIA for more details).

14. This consultation letter and related information can also be found on the Defra

website at http://www.defra.gov.uk/corporate/consult/fmd-directive/index.htm

.

15. Responses and questions about the consultation should be addressed to:

Rhys Jackson

FMD Directive Transposition Team

Exotic Disease Prevention and Control Division

Area 611, 1a Page Street

London SW1P 4PQ

Tel: 0207 904 6946

Fax: 0207 904 8123

Or via e-mail to: rhys.jackson@defra.gsi.gov.uk

 

16. This consultation has been prepared in line with the Government’s code of practice

www.cabinetoffice.gov.uk/regulation/consultation/code.asp

 which requires that we:

Consult widely throughout the process, allowing a minimum of 12 weeks for written consultation at least once during the development of the policy;

Be clear about what proposals are, who may be affected, what questions are being asked and the timescale for responses;

Ensure that consultation is clear, concise and widely accessible;

Give feedback regarding the responses received and how the consultation process influenced the policy;

Monitor the department’s effectiveness at consultation, including through the use of a designated consultation co-ordinator;

Ensure the consultation follows better regulation best practice, including carrying out a Regulatory Impact Assessment if appropriate.

17. Complaints or comments relating to the consultation process should be sent to

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

Square, London SW1P 3JR or can be emailed to

consultation.coordination@defra.gsi.gov.uk.

 

18. In line with Defra's policy of openness, at the end of the consultation period copies of the responses we receive will 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.

19. 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 or the Environmental Information Regulations2004.

20. 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.

Yours sincerely

Simon Hewitt

Exotic Disease Prevention and Control Division

Direct Line: 020 7904 6019 GTN: 3290 6019

Fax: 020 7904 6076

Email: simon.hewitt@defra.gsi.gov.uk