CAUTION - Very Long - FMD draft legislation conultation
- From: David P <me@xxxxxxxxxxx>
- Date: Thu, 24 Nov 2005 20:23:21 -0000
*****
HEADLINE SUMMARY OF CONSULTATION RESPONSES ON LEGISLATION TRANSPOSING
THE FOOT AND MOUTH DISEASE DIRECTIVE
The key pieces of draft legislation transposing the FMD Directive were
published for a full twelve week public consultation from 9 June to 1
September 2005. We received 35 external responses of which none raised
fundamental objections to the legislation as a whole. They generally
raised a series of detailed issues with the legislation or relating to
its practical implementation. These are highlighted below. For further
detail, please see the detailed summary at Annex A.
Responses and Outcomes
· There was widespread support for our intention to include
measures from existing legislation that proved useful in dealing with
the 2001 outbreak;
· Some questioned the need to amend the Secretary of State?s
discretion to slaughter susceptible animals kept on infected premises
only to a duty. However, this is a requirement of the Directive and does
not change UK policy;
· Most supported proposals not to impose additional controls on
the domestic trade of vaccinated animals. There was widespread support
for a vaccination strategy and Defra is working with retailers and
consumers representatives to avoid any discrimination against products
from vaccinated animals during an outbreak;
· Most supported a similar approach to cleansing and disinfection
to that used in 2001. Defra will ensure that the legislation enables a
local, flexible approach. Who meets the costs of cleansing and
disinfection will be addressed separately;
· Most agreed with the approach to common land used in 2001.
Defra will create flexible powers to gather animals on such land and
apply controls that are necessary and appropriate to local
circumstances;
· There were concerns that economic losses may arise from
treatments required for animal products for those caught in disease-
affected areas or where their animals were vaccinated. Defra aims to
strike a balance between effective disease control and enabling the
industry to function and will seek EC agreement to remove these
treatments after the early stages of an outbreak;
· Concerns were also raised on the effective operation of the
dairy industry under the new licensing requirements. Defra has agreed
with the EC to remove the ban on milk hygiene testing and will ensure
that licensing is carried out effectively;
· Some asked that Polymerase Chain Reaction (PCR) testing be used
to diagnose FMD, rather than clinical examination. At present, the
standard of PCR tests is not as stringent as required. Should they reach
this standard, the legislation would allow us to use them;
· There was a request that camelids should not be classed as FMD
susceptible animals. Defra is unable to do so due to the requirements of
the Directive. However, should the Directive change, we will amend the
legislation accordingly;
· The meat treatment requirements were criticised for being
overly complicated and we have attempted to simplify them where possible
and produce clear guidance;
· It was felt that the role of local authorities was not clear
enough and we have changed the legislation to bring out their important
role.
ANNEX A
DETAILED SUMMARY OF CONSULTATION RESPONSES ON LEGISLATION TRANSPOSING
THE FOOT AND MOUTH DISEASE DIRECTIVE
Background
1. The EU Foot and Mouth Disease (FMD) Directive sets out the
measures to be adopted in the event of a suspected or confirmed outbreak
of FMD within the EU. It replaces the previous EU measures to control
and eradicate FMD, taking account of recent scientific developments and
the experience gained in eradicating FMD during the 2001 outbreak.
2. 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.
3. The draft legislation transposing the Directive was published
for a full twelve week public consultation from 9 June to 1 September
2005. A further draft amendment to the Animal Health Act was published
on 25 August. The deadline for commenting on this piece of legislation
was extended to 15 September due to the short length of the document (3
pages) and the fact that its effect had been spelt out in the
consultation letter.
4. Defra will transpose the Directive fully, so fulfilling the UK?s
obligations under European law. However, the consultation set out the
limited areas where we have national discretion and asked for views on
how we should implement them. The consultation also sought economic data
on the costs of the control measures to inform our Regulatory Impact
Assessment (RIA), which we have revised as a result and will publish
shortly, and on the impact of the controls, particularly regarding
treatments of animal products from vaccinated animals or those in
disease affected areas.
5. During the consultation period, we also held a series of
meetings with a wide variety of stakeholder groups including
representatives of the farming industry, the veterinary profession, meat
and milk processors, retailers, consumers and other interested groups.
This summary also reflects relevant issues raised in those meetings,
full notes of which are available online at
www.defra.gov.uk/footandmouth/disease/strategies/minutes.htm.
Responses
6. We received 35 external responses to the consultation. No
respondent raised fundamental objections to the legislation as a whole
but generally a series of detailed issues where either we do have
national discretion or relating to the practical implementation of the
legislation. Many of these points have been very useful in developing
robust and practical legislation. We aim to set out here those more
significant issues raised and how Defra is taking account of them. A
full list of respondents and where you can obtain the responses
themselves is at the end of this summary.
Summary of responses and outcomes
Issue A: Measures retained from existing legislation to supplement the
Directive where veterinary advice was that they were essential in
controlling the 2001 outbreak.
Discussion: These measures include control of rodents, dogs and poultry,
closure of land including footpaths, control of mobile sheep shearing,
scanning and dipping and controls of gatherings of people and animals.
This represented the recommended option 3 of the RIA and received broad
support from respondents. Some respondents questioned why dogs in
particular needed to be controlled, rather than other non-susceptible
animals. One asked how rodents would be controlled. Others asked for
details of how widespread footpath closures would be.
Outcome: Defra will retain all of these measures in the draft
legislation. Their application will be proportionate to the risk of
disease spread and will not necessarily be limited to matters with a
rural focus. The controls on dogs relate to the fact that they are
common on farms and often make contact with livestock so represent a
significant risk of disease spread if they are allowed to run free in
areas which have disease. The requirement to keep dogs under control
only applies in Protection and Surveillance Zones which could simply be
keeping them on a lead. Rodent control creates a particular disease risk
if the inhospitable environment of an infected premises, subject to
slaughter and cleansing and disinfection, causes rodents to move off
those premises onto neighbouring farms. In such cases, rodents would be
controlled humanely by professional contractors. Footpaths would only be
closed in Protection Zones (PZs) which would be a minimum of 3km around
an infected premises and only larger if necessary for disease control
purposes. Furthermore, although local authorities would normally be
responsible for closing footpaths in these areas, this can only be done
with prior written consent from the Secretary of State.
Issue B: The amendment to the Animal Health Act 1981 to change the
Secretary of State?s discretion to slaughter susceptible animals to a
duty to slaughter such animals on infected premises, with certain
exemptions.
Discussion: Some respondents questioned the need to change the
discretion to slaughter to a duty, while a similar number supported the
change as necessary to fight disease. One respondent had a particular
concern that this duty would be imposed on premises that were
epidemiologically linked to an infected premises without a need for
further testing.
Outcome: Defra will seek to amend the 1981 Act as proposed to fulfil the
legal requirement of the FMD Directive that all susceptible animals on
infected premises must be slaughtered. However, the amendment will
include exemptions, such as for infected premises that are laboratories,
zoos, wildlife parks or similar institutions, and for rare breeds on
infected premises and for separate production units (those which are
sufficiently separate from the rest of the premises to pose no threat of
disease spread). In these cases, we would retain the discretion to
slaughter and would still do so except in exceptional veterinary
circumstances where these animals did not pose a significant risk of
disease spread. This amendment does not reflect any change in UK policy
which has always been to slaughter all susceptible animals on infected
premises to control disease. The duty to slaughter does not apply to
premises where disease has not been confirmed (such as dangerous
contacts, suspect or contiguous premises) where we would retain full
discretion to cull, vaccinate or place under observation as is justified
by the scientific and veterinary risk of disease spread. Although the
duty may be applied to epidemiologically linked premises that had not
been tested, this is also a requirement of the Directive and would
similarly not impose a duty on any premises where our policy would not
be to slaughter.
Issue C: Defra does not intend to impose additional controls on domestic
trade in vaccinated animals once the UK is FMD free.
Discussion: Most respondents agreed that additional domestic controls
were not necessary, over and above the ban on export of live vaccinated
animals required by the Directive. In particular, those respondents who
commented on this issue unanimously stressed the fact that products from
vaccinated animals do not pose any risk to human health. Animals are
already vaccinated against a number of diseases and then go into the
human food chain with no consequences. Many respondents also emphasised
the need for clear communication of this fact to the public to enable
the success of a vaccination campaign. However, concerns were raised
over the possibility of a two-tier market where vaccinated animals,
which would need to be tagged to prevent live export, might command a
lower price. One respondent felt that the UK?s international trade would
suffer if vaccinated animals were not tracked domestically.
Outcome: Defra?s intention is to restore trading conditions to as close
to normal as soon as possible following an outbreak, therefore we will
not be introducing any domestic controls on the trade in vaccinated
animals. These animals will be tracked through ear-tagging and marks in
cattle passports so there should not be any detrimental effects on the
UK?s long term international trading status of ?FMD free without routine
vaccination?. Defra also agrees strongly with the Food Standards Agency
(FSA) which has repeatedly stated that there is no risk to human health
from products from animals vaccinated against FMD. The treatments
required for products from vaccinated animals and animals from disease
affected areas are solely intended to prevent virus spread to
susceptible animals. Defra is working with organisations at every point
in the food chain to promote this message.
We are also engaging in continued dialogue with retailers and
consumers? representatives to prevent discrimination against products
from vaccinated animals and therefore remove any justification for price
differentials. In consultation meetings it was generally accepted that
vaccination is a vital part of the options available in fighting an FMD
outbreak. Its implications are now seen as practical ones regarding the
treatments required rather than the acceptability of treated products to
retailers and consumers. Much obviously depends on the scale of any
future outbreak and the market reaction at that time. Defra has recently
issued a statement in co-operation with consumer organisations
supporting the use of vaccination as part of the FMD control strategy.
Defra is also seeking to agree a similar statement with major retailers.
Issue D: Defra intends to repeat the cleansing & disinfection (C & D)
requirements in place during the 2001 outbreak but sought views on how
flexibly to do this.
Discussion: The majority of respondents supported this approach, with
some proposing a flexible system to take into account local needs, such
as listed farm buildings. Some respondents suggested that Defra should
meet the cost of C & D during the next outbreak. One respondent felt
that the disinfection regime was a waste of money. Others felt that the
C & D regime used in 2001 was successful because there was no
recrudescence of disease.
Outcome: Defra will ensure that the C & D requirements of the draft
legislation are generally limited to the minimum requirements of the
Directive and existing legislation and made as flexible as possible. We
will create a power for local requirements to be added on a more
flexible basis, through licence conditions and directions by local
inspectors. This will allow local knowledge and circumstances to inform
the approach taken. The draft legislation allows Defra either to pay the
costs of C & D itself or to require the occupier to do so. In the wider
context, Defra expects to publish its Farming Regulation and Charging
Strategy which will set out the Government's intention to work in
partnership with the farming industry in exploring risk sharing
mechanisms in tackling animal disease, including future financing
options and simplifications in the regulatory burdens on the farming
industry.
Issue E: Defra also intends to retain the controls over common and
unenclosed land used in 2001 but again sought views on this.
Discussion: The majority of respondents supported a similar approach to
that taken in 2001. One area of concern was whether we would define
commons as a single premises.
Outcome: As the Directive and existing legislation is largely silent on
controls on common and unenclosed land, Defra will include in the draft
legislation general powers for veterinary inspectors to gather animals
on such land and apply any controls they deem necessary to limit the
spread of disease in each zone of control. This would allow the response
to be proportionate and suited to local circumstances in the unique
situation of common and unenclosed land.
Issue F: Treatment of products from animals in Protection and
Surveillance Zones and vaccinated animals.
Discussion: We asked specific questions on the likely cost implications,
practical issues and level of demand for products from vaccinated
animals that have to be subject to various treatments to reduce the risk
of disease spread, such as heat treatment (cooking) or deboning and
maturation. During subsequent discussions with the industry, we reached
a consensus that these treatments are no more and no less than those
required for animals in PZs and Surveillance Zones (SZs). Although the
use of vaccination would be based largely on the veterinary and
scientific circumstances of the outbreak, its success would depend on
its acceptability to, and the preparedness of, the wider stakeholder
community including the farming industry, processors, retailers and the
general public as consumers. Some respondents expressed concern that
treated meat would not be a commercially viable alternative to
untreated, possibly imported, meat or other sources of protein. Others
suggested that Defra should investigate deboning and maturing as a
treatment for pig meat and the use of electrical stimulation in place of
maturation. Some respondents questioned why derogations from treatment
were not set out in the draft legislation.
Outcome: Defra has gathered some useful data on the costs associated
with the treatments which has informed the development of the RIA. It is
clear that many of these treatments may add significant costs to some
sectors if they are caught in an outbreak or vaccinated.. This is
especially the case for pig meat from PZs and VZs which can only be
cooked before marketing. The Directive does not recognise deboning and
maturing as an effective method of destroying FMD virus in pigmeat, on
the basis of veterinary advice. We will keep this issue, and electrical
stimulation, under review with our veterinary advisors and if the
European Commission decides to allow deboning and maturation of pig
meat, we will amend the legislation accordingly.
This would not be so serious an issue for beef where the carcase is more
suited to being deboned and matured. Some cuts of sheepmeat (eg leg and
shoulder) can also be treated in this way. However, the effect on the
industry as a whole, and therefore the market, will depend critically on
such variables as the size, geographical spread, seasonality and the
species affected in any future outbreak. New control measures, such as
the six day movement standstill, decrease the likelihood that a future
outbreak would be of the scale and spread of 2001 so these additional
costs should be limited compared to the overall benefit of increased
disease control that the treatments would give. Defra aims to strike a
balance between effective disease control and enabling the industry to
function and we will continue to work closely with the industry where
possible to mitigate the impact of these treatments.
During an outbreak, Defra will also seek all available derogations from
the European Commission from the treatments for all animal products.
These derogations apply 30 days after the establishment of the latest PZ
or SZ that applies and in Phase 3 of a Vaccination Zone (VZ). These
derogations are not set out in the legislation as we cannot refer in law
to a derogation which has not yet been granted. At the time these
derogations are granted, we will amend the legislation accordingly to
set out the precise terms of the decision.
Issue G: Practical operation of the dairy Industry.
Discussion: Milk testing is banned by the Directive other than at
laboratories testing for FMD. The Dairy Industry responded that if
compositional and hygiene testing cannot occur, the industry would not
be able to operate effectively. The Industry also requested that the
necessary authorisation required in disease affected areas for the
transport of milk and premises treating milk be granted in advance of an
outbreak and any route specified for milk tankers be as flexible as
possible.
Outcome: Defra and the dairy industry have contacted the Commission
which has now agreed to amend the Directive to allow milk testing under
hygiene and quota rules. Defra will pre-emptively reflect this change in
the draft legislation and will allow sampling and testing under
conditions which prevent disease spread. Defra is not able to give
authorisation for milk treatment and transport in PZs and SZs in advance
of any outbreak as such authorisation must depend on the circumstances
at the time and the risk of disease spread. However, Defra will continue
to work closely with the dairy industry and the FSA to set out clearly
the conditions expected of dairies and tankers and to carry out routine
inspections so as to minimise the amount of time needed to give such
authorisation. The route specified for milk tankers will be as flexible
as possible depending on the discretion of a local veterinary inspector.
Issue H: Polymerase Chain Reaction (PCR) testing.
Discussion: Some respondents suggested that PCR testing should be
mandatory in confirming disease rather than relying on clinical grounds
alone.
Outcome: The FMD Directive requires that diagnostic tests and standards
must be at least as stringent as those in the OIE manual. The Directive
also allows the EU Commission to adopt more stringent tests and
standards than those in the OIE manual. This has not been done but, if
it was, the Commission tests would become the new benchmark and replace
the OIE standard. Tests not in the OIE manual or adopted Community
standard are explicitly allowed, but only if they are shown to match or
exceed the sensitivity and specificity standards in the manual or
Community standards, whichever is the most stringent. Defra is working
with its veterinary advisors to study the efficacy of PCR testing and
should it be concluded that it meets these standards we could use it
under the new legislation. However, the Directive also permits us to
confirm disease by a link to an existing outbreak on clinical grounds
alone, in order to fully control disease in a fast-moving situation.
Issue I: Whether camelids (eg llamas and alpacas) are susceptible
species.
Discussion: There was a request that camelids be excluded from the
definition of FMD susceptible animals and not subject to the controls
imposed on such animals, including the new duty of compulsory slaughter
on infected premises.
Outcome: Camelids are clearly stated to be susceptible animals in the
Directive on the precautionary basis that the available evidence does
not conclusively prove that camelids are not capable of passing on FMD.
Therefore the UK is legally obliged to define camelids as susceptible
species. Should the Commission change this position in the Directive,
Defra will amend the legislation accordingly.
Issue J: Complexity of treatment requirements.
Discussion: One respondent felt that the transposition of the
requirement to treat meat was overly complex and did not accurately
reflect the requirements of the Directive.
Outcome: Defra accepts many of these comments in what is a particularly
complex area of the Directive. Defra has reviewed these provisions and
will re-draft them on the basis of these comments to make them fully
reflective of the Directive and easier to follow. Such treatments will
also be described clearly in accompanying guidance for the industry.
Issue K: Role of local authorities in a disease outbreak.
Discussion: Some respondents felt that the role of local authorities,
and in particular trading standards officers, should be reflected in the
legislation through explicit duties to ensure consistent application
across the country.
Outcome: Defra accepts these comments and welcomes the important role of
local authorities in a disease outbreak. We will amend the legislation
to place a duty on local authorities to carry out certain functions,
such as signage around zones, and also expand areas which are currently
reserved to Defra officials to include local authority officers as well,
to ensure a consistent approach and maximum flexibility.
List of respondents
Animal Health Resources Ltd
British & Irish Association of Zoos and Aquariums
British Cattle Veterinary Association
British Meat Processors Association
British Retail Consortium
British Veterinary Association
Captain Bryn Wayt
Central Association of Agricultural Valuers
Colchester Zoo
Compassion in World Farming
Country Land and Business Association
Dairy UK
Devon County Council
East of England Trading Standards Association
Elm Farm Research Centre
FARM
Foodaware
Kennel Club
Lake District National Park Authority
Local Authorities Coordinators of Regulatory Services
Meat and Livestock Commission
Mrs J H Wilson
Mrs Suzanne Greenhill
Ms Pat Innocent
National Farmers Union
National Foot and Mouth Group
National Milk Laboratories
National Pig Association
National Sheep Association
National Trust
Outdoors Industries Association
Rare Breeds Survival Trust
Royal Society for the Prevention of Cruelty to Animals
Society for General Microbiology
Specialist Cheesemakers Association
Copies of the responses are available from Defra?s Information Resource
Centre at Ergon House, Horseferry Road, London, SW1P 2AL
******
--
David
Visit http://www.farm-direct.co.uk for your local farmgate food
supplies.
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