Questo documento è un estratto del sito web EUR-Lex.
Documento 52013SC0161
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health
/* SWD/2013/0161 final */
COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Animal Health /* SWD/2013/0161 final */
1. Procedural
issues and consultation of interested parties.. 4 1.1. Consultation of Member
States' Experts. 5 1.2. Animal Health Advisory
Committee. 5 1.3. Animal Health Law
Stakeholder Steering Group. 6 1.4. Inter-Service Steering
Group (ISSG) 6 1.5. General on-line
consultation. 6 1.6. Consultation of
competent authorities of MS and the industry on administrative burdens. 7 1.7. Other opportunities used
for consultation. 7 1.8. IAB opinion. 7 2. Policy
context, problems identified, and subsidiarity.. 11 2.1. Background and context 11 2.1.1. Nature and size of the sectors concerned. 11 2.1.2. Overview of legislative framework and ongoing
developments. 13 2.2. Problem definition. 14 2.2.1. High Complexity of the current CAHP. 15 2.2.2. Lack of a single overall strategy. 21 2.2.3. Insufficient focus on disease prevention. 24 2.2.4. Rules for intra-EU trade of live terrestrial
animals are sub-optimal 27 2.3. Who is affected by the
current policy?. 30 2.4. The right and
justification for EU action. 30 2.4.1. Treaty basis. 30 2.4.2. Subsidiarity test 30 3. Objectives.. 34 3.1. General objectives. 34 3.2. Specific objectives. 35 3.3. Operational objectives: 35 4. Options.. 36 4.1. Option 1 - Do nothing. 36 4.2. Option 2 – Simplification
of existing legislation with no major content or policy changes. 36 4.3. Option 3 – Existing
legal framework with more self-regulation. 36 4.4. Option 4 - Flexible
general legislative framework on animal health issues (AHL) 37 4.5. Option 5 - Prescriptive
general legislative framework on animal health issues (AHL) 37 4.6. Key elements of the
different options. 37 5. Impact
analysis.. 41 5.1. Option 1 – No Change. 41 5.2. Option 2 –
Simplification of existing legal framework with no significant policy change. 43 5.3. Option 3 – Existing
legal framework with more self-regulation. 43 5.3.1. Economic impacts. 45 5.3.2. Social Impacts. 46 5.3.3. Environmental impacts. 46 5.4. Option 4 – flexible
general legislative framework for animal health issues. 46 5.4.1. Economic impacts. 47 5.4.2. Social Impacts. 50 5.4.3. Environmental impacts. 50 5.5. Option 5 – prescriptive
general legislative framework for animal health issues. 51 5.5.1. Economic impacts. 51 5.5.2. Social impacts. 53 5.5.3. Environmental impacts. 53 6. How do
the options compare?.. 54 7. How
will the option implemented be assessed?.. 56 ANNEX I Glossary
of technical terms and abbreviations.. 58 ANNEX II Key
Messages from the evaluation of the Community Animal Health Policy (CAHP) 60 ANNEX III Summary
of chronology of main exchanges with representatives of specific sectors likely
to be affected by the new AH Law... 62 ANNEX IV Summary
document of the stakeholders' steering group: "Problem identification
during the creation of the animal health law". 64 ANNEX V Summary
of Consultation Responses.. 73 ANNEX VI Summary
of the questionnaire on artificial insemination and related issues 110 ANNEX VII Vaccination
policy.. 122 ANNEX VIII Additional
assessment on Intra-EU trade.. 151 ANNEX IX Key
elements of the new Animal Health Law, including indicative list of existing
legislation affected.. 162 ANNEX X Preliminary
structure of the legislative proposal – options 4 and 5 172 ANNEX XI
Additional assessment on biosecurity.. 173
1.
Procedural issues and consultation of interested
parties
The proposal for
action on the EU animal health policy is the result of a long series of
considered analyses. In 2004, the
Commission launched an independent evaluation to assess the performance of the
Community Animal Health Policy (CAHP)[1]
over the previous decade and its coherence with other EU policy interventions.
The aim was to identify elements of the CAHP which could be further improved
and to propose options to achieve these improvements. The summary of the key
messages of the CAHP evaluation is attached at Annex II, and also discussed in
further detail below. Among other
things, the CAHP evaluation recommended that a single strategy for animal
health be developed to prevent piecemeal and crisis-driven development of
policy. The EU Animal Health Strategy 2007-2013 (AHS) "Prevention is
better than cure" was the result[2]. The AHS provides
for the adoption of a "single regulatory framework for animal health with
a greater focus on incentives than penalties, consistent with other EU policies
and converging to international standards" and which will "define and
integrate common principles and requirements of existing legislation". In
their reaction to the Commission Communication on the new Strategy, the
European Parliament[3],
the Council[4]
and the European Economic and Social Committee[5]
welcomed this initiative. Subsequently, the Action Plan for the implementation
of the Strategy[6]
confirmed that "the main objective of the Strategy is the development of
an EU Animal Health Law (AHL)". From the very
start of the process, key stakeholders, Member States (MS) Competent Authorities
(CA), international organisations and trading partners have been closely
involved and have played a crucial role in the discussion. In addition,
economic and social stakeholders such as European associations with an interest
in animal health and welfare and the interested public have been consulted on a
number of occasions in accordance with the Commission’s standards for
consultation. This exercise represents a considerable
contribution to the so-called "fitness check" of the food safety and
health policy and legislation. At the same
time, it reflects the priorities of Smart Regulation[7] by aiming to simplify
the existing legal framework while reflecting stakeholders' expectations in
reducing administrative burdens. And finally, it
reflects Commission priorities such as the smart growth objective of the Europe
2020 strategy[8]
by helping the sector to become more resilient due to active prevention
measures and risk management. This Impact
Assessment (IA) follows the structure given in the Commission’s IA guidelines[9]. It aims to consider the
economic, social and environmental aspects of EU policy on animal health in an
integrated and proportionate way.
1.1.
Consultation of Member States' Experts
CA of the MS have been involved in the
preparation of this initiative from an early stage. Preparatory work started in the frame of the
expert working group meetings of the Chief Veterinary Officers of the MS
(CVOs). Several working groups were created (in the so-called Adelbrecht
process) in order to obtain guidance from the CVOs on the implementation of the
new AHS. Commission officials also participated in the working groups. The
conclusions of the various working groups on issues such as prioritization of
EU intervention and categorization of animal diseases, biosecurity and the use
of the veterinary fund are publicly available.[10] As a continuation of this work, several seminars
were organised by the EU presidencies to discuss major issues related to the AHL
proposal. These led to the adoption of the set of CVO Conclusions on
biosecurity and incentives for prevention (October 2009)[11] and on animal disease surveillance systems (April 2010)[12]. Furthermore, as explained in greater detail under
point 1.3, representatives of several MS formed part of the AHL Steering Group.
MS have been updated regularly by the Commission
on the development of the AHL during both the Council and Commission CVO meetings
and the Standing Committee of the Food Chain and Animal Health (SCOFCAH).
1.2.
Animal Health Advisory Committee
The Animal Health Advisory Committee was created
as a working group of the Advisory
Group on the Food Chain and Animal and Plant Health[13]. It is chaired by a Commission representative, with the special
participation of three representatives of CVOs from three MS (the past, present
and future Presidencies). The list of other key stakeholders is publicly
available[14] as are the agendas, the
presentations, the summaries and the participants for each meeting[15]. A consultation and regular update on the progress
of the work was provided at numerous meetings of this Committee[16] in order to ascertain stakeholders’ perceptions of the issues identified,
to collect views about the possible options to solve them and to sound out
stakeholders on the likely acceptability of the various options. Ad hoc bilateral meetings were held with the
representatives of the specific sectors likely to be affected, including key
associations (see summary of chronology of main exchanges in Annex III).
1.3.
Animal Health Law Stakeholder Steering Group
An AHL Stakeholder Steering Group was set up to assist the Commission Services during the impact assessment
process. Its assistance was particularly important in the definition of problems. This group comprised experts from national
veterinary authorities, experts from international organizations and other
interested stakeholders. In particular, delegates from the national
veterinary authorities of Germany, Italy, Hungary, Denmark, the United Kingdom,
Belgium, Sweden, Slovenia, Lithuania, Finland, the Netherlands, France and
Switzerland participated, as well as delegates from the following
international, economic or non-governmental organisations: COPA-COGECA
(European farmers and European agri-cooperatives), OIE (World Organization for
Animal Health), UECBV (European Livestock and Meat Trading Union), FVE
(Federation of Veterinarians of Europe), FESASS (European Federation for Animal
Health and Sanitary Security), IFAH-Europe (International Federation for Animal
Health Europe), FEAP (Federation of European Aquaculture Producers), AVEC (Association
of Poultry Processors and Poultry Trade in the EU countries), Vier Pfoten (Four
Paws international). The steering
group had 4 meetings during the first part of 2009, and working papers were used
during the meetings to focus on and consider particular factors.[17] The work of the steering group is summarised in a document
entitled "Problem identification during the creation of the AHL"
which can be found in Annex IV.
1.4.
Inter-Service Steering Group (ISSG)
Given the
crosscutting nature of the issues concerned, the Commission set up an ISSG to
provide specialised input and to bring a wider perspective to the process. Five meetings of
the ISSG were held (31 October 2008, 10 February 2009, 9 July 2009, 5 July 2010,
14 April 2011) in order to obtain other services’ views about the issues
identified, the possible options and likely impacts in addition to a formal 'Consultation
Inter-Service' (CIS) on the AHL consultation document in August / September
2009. The following services
were invited: SG, SJ, AGRI, COMP, ENTR, ENV, RTD, MARKT, MARE, OLAF, TRADE,
RELEX, ELARG. As far as possible, the comments expressed by the various DGs
represented at the five meetings have been taken into account in this document.
1.5.
General on-line consultation
A general
consultation addressed to the general public, stakeholders, MS and third countries
was carried out from 23 October to 31 December 2009 via an online Interactive
Policy Making tool.[18] The outcome of this consultation was used as part of the analysis
of impacts. The statistics and a summary of the main findings are available at
Annex V.
1.6.
Consultation of competent authorities of MS and
the industry on administrative burdens
Two
questionnaires were developed in order to collect readily available data on
administrative burdens and administrative costs for the competent authorities
and the operators.[19] Data on compliance costs incurred by operators when implementing
current EU animal health legislation and data concerning the expected potential
impact of the proposal on administrative burdens for enterprises and competent
authorities were also requested in the questionnaires. Where relevant,
the results of this consultation have been used to analyse the impacts of the
different proposed options and to identify opportunities for cost reduction.
1.7.
Other opportunities used for consultation
EU producers of semen,
ova and embryos were the target of a separate questionnaire for gathering data
to compare possible options for animal health rules for intra-EU trade. The
submitted data was used to assess the impacts of the different options
identified. An ad-hoc meeting between the Commission services and the RepVet
group of COPA-COGECA was organised to explain the different possible options in
order to facilitate answering the questionnaire. The results of that
questionnaire can be found in Annex VI. A task force of
experts assisted the Commission in the development of an expert paper[20] on EU vaccine/antigen banks
for major animal diseases (such as foot and mouth disease, classical swine
fever etc.). Based on that work a questionnaire on emergency vaccination policy
prepared by Commission services was addressed to the EU CVOs. The analysis of
the replies can be found in Annex VII (part 2).[21] In addition to
the discussions at CVO level, special emphasis was given to the concept of
surveillance and its introduction in the new AHL during the Task Force for
Animal Disease Surveillance (TFADS). This Task Force was created in November
2008 to support the MS and the Commission services. Two meetings of this expert
group, which took place on 16-17 December 2009 and 17-18 May 2010, reflected on
the ways in which surveillance should be introduced in the new AHL. This
provided expertise and experience on animal disease surveillance in the context
of animal disease management, and summaries of the meetings can be found here: http://ec.europa.eu/food/animal/diseases/surveillance/index_en.htm.
In addition, the Spanish Presidency held a seminar on animal disease
surveillance as part of the Working Party of Chief Veterinary Officers.
1.8.
IAB opinion
The draft IA
report was discussed at the meeting of the IAB on 13 July 2011. Following this
meeting the board issued an opinion on the draft IA emphasising four main
points to be addressed in the final version of the IA report. These four main
points have been addressed in this revised version of the IA as follows: (1) Strengthen
the evidence regarding the seriousness of problems: -
The background of evaluation of existing law and
development of strategy is now more clearly explained in the first paragraph to
the IA. -
More extensive explanations are now given on the
problems generated by the lack of a single and fully coherent EU legal
framework. -
A summary of the key findings of the CAHP
evaluation has now been annexed to the IA (new Annex II) to better explain the
background to the development of the AH strategy, the thinking behind the AHL
and the stakeholders views collected in this exercise. -
The summary of the main findings of the
stakeholder consultation is now annexed to the IA rather than a reference made to
a web-link (new Annex V). -
The results from the stakeholder consultation
have now also been referred to in each relevant problem identified; including
showing how many would support a change in the existing legislation. Examples
have also been added of particular problems highlighted by the AHL steering
group. -
In Point 2.2.1., a paragraph has now been added
to explain who is affected by regulatory over-complexity and how. (2) Clarify what
each option involves and add a simplification only option: -
A new 'simplification only' option 2 has been
added in sections 4 and 5 and explanations are given for why this is not a
viable option. -
A new point 4.6 has been introduced to explain
more clearly the new elements that would be introduced by each option. -
Changes have been made to the legislation table (now
Annex IX), to outline more precisely the changes planned in the new legislation.
In this new Annex IX an introductory chapter has also been added to explain the
key new elements of the future AHL, in accordance with options 4 and 5. Some
details are also provided to outline the elements of the existing legislation
and map them onto the new AHL and/or the delegated and implementing acts that
should follow it, although full details cannot be provided at this stage. -
A new Annex X has been introduced showing the
structure of the new AHL in accordance with options 4 and 5. (3) Present
adequate information regarding vaccination issues: -
The current EU approach to vaccination has been explained
and assessed in new Part 1 of Annex VII. -
The conclusions of this assessment are presented
in the main text of the IA. (4) Properly assess
administrative burden arising from familiarisation activities: -
In point 5.4.1. and 5.5.1., a short explanation
has been provided why familiarisation costs for the new AH framework law have
not been quantified by the Standard Cost Model (SCM) but rather identified as
being part of the business-as-usual costs for business and competent
authorities alike, given the individual and different natures of animal diseases
and subsequent frequent adaptations of the legal framework. The IA executive
summary has been changed accordingly to reflect the changes of the main report.
In addition, this version of the IA includes several improvements to better
respond to the IA Quality Checklist for IAB Opinion. The Impact
Assessment was re-submitted to the IAB in September 2011 with these amendments
made. Some further changes were requested by the IAB and have been addressed as
follows: (1) Clarify
what the preferred option involves in terms of non-commercial actors,
biosecurity and future Impact Assessments. - More analysis
has been made in section 5.4.1 of the impact of option 4 on non-commercial
actors, particularly in economic impacts. - Option labels
in the Annex XI on biosecurity have been changed for clarity, and the options
linked back specifically to options in the main text. - A set of
sub-options in table 4.1 has been removed where its impacts have not been
separately analysed. - A paragraph
has been added at the start of Annex IX to give examples of where further
impact assessments might be required. (2) Present
further evidence regarding the seriousness of particular problems. - An FVE report
has been cited as evidence around the lack of consistency in training for
veterinarians in section 2.2.1.5. - Some more
explanation of the problems faced in regulatory over-complexity has been made
in section 2.2.1.6, using Food and Veterinary Office (FVO) reports as evidence.
(3)
Consistently describe vaccination options - The main text
of the report has been linked more explicitly to Annex VII on vaccination,
particularly in table 4.1 in section 1. - The option
labels in Annex VII have been changed to provide more clarity and for ease of
linkage with the main text. - Annex VII has
more analysis of stakeholder views and the need for subsidiarity. (4) Better
explain administrative burden analysis - The impacts of
new information obligations have been covered more explicitly in section 5.4.1
in examining the analysis of economic impacts of the preferred option 4. (D) Procedure and presentation - A sentence has been added at the end of
section 7 to cover the proposed evaluation timetable.
2.
Policy context, problems identified, and
subsidiarity
2.1.
Background and context
2.1.1.
Nature
and size of the sectors concerned
Across the EU,
the farming sector is the largest user of animals with at least 2 billion birds
(chickens, laying hens, turkeys, etc.) and 334 million mammals (pigs, sheep,
goats, cattle, fur animals, etc.). There are 13.7 million animal holdings in
the EU.[22] The value of
livestock farming output in the EU is €149 billion[23] of which pigs and poultry
(subject to specific EU provisions) represent 38% (i.e. €57.6 billion). Animal
output value represents 41% of the overall agricultural output (€363 billion in
2008). According to
Eurostat, total aquaculture production in the European Union (EU-27) in 2005
was 1,272,455 tonnes (live
weight). This includes production of crustaceans, molluscs, and finfish[24]. The
total value of production is estimated as €3,159bn. Pet animals
represent the second largest type or usage of animals, by number, in the EU.
There are around 120 million dogs and cats, and approximately 35 million pet
birds. The annual value of cat and dog sales in the EU is estimated at €1.3
billion and the sector is estimated to generate direct employment of 300,000
persons, including 32,000 dog breeders. Many fewer
animals are used for experimentation (pharmaceutical and cosmetic industries
and public research bodies): around 12 million animals in the EU, of which most
are rodents. There are between 2,000 and 3,000 zoos in the EU and there are an
estimated 800,000 captive wild animals. The fur farming sector also farms a
significant number of animals, covering about 7,200 farmers and producing
around 32 million pelts per year[25].
No reliable data could be obtained for circuses or other activities such as
animals used in sports, shows, etc. EU intervention
is currently focused primarily on the prevention and control of major transmissible
diseases that can have significant health and economic impacts at EU level. Animal
diseases do not recognize borders and present a constant threat to all of the sectors
above. They pose a direct risk to animal and often public health, but also can
have other negative but indirect impacts, such as economic or social effects.
The unpredictable occurrence and behaviour of animal disease epidemics and the still
insufficient reliability of modelling studies, despite the recent progress made
in this field, makes forecasting their frequency and impact very difficult. The impacts of
an animal disease outbreak can vary widely due to a variety of factors
including the epidemiological characteristics of the disease, the structure of the
sectors affected and the nature of the control measures imposed. These impacts
can include negative effects for animal and human health, costs to livestock
farmers and related industries of dealing with disease and of business
disruption, public sector costs of eradication and monitoring, and changes in
consumption patterns. Often, disease outbreaks also have significant impacts on
international trade of animals and animal products. Finally, many animal
diseases also affect wild animals, and may have detrimental effects on wild
animal populations. Thus they can have a negative environmental impact, for
example, on biodiversity. Some of the
consequence of past animal health crises have been used to illustrate the potential
scale of the impacts of animal disease outbreaks. §
BSE (1996-1997):
for UK only, GBP£3.5 billion (0.5% of GDP). The disease also caused a serious
fall in consumer confidence across the whole EU and the deaths of more than 200 people
in the last 15 years. §
FMD (2001-2002):
for UK only, GBP£10-12 billion (1.2% of GDP) mainly in agriculture / food chain
(30%) and tourism (50%). §
SARS (2003): (cost
of lost GDP: US$18bn in East and Southeast Asia (0.6% of GDP) (Asian
Development Bank); estimated global economic impact US$30bn (World Health
Organisation, 2003). Around 800 people ultimately died from the illness. §
Avian flu in the Netherlands (2003): 30 million birds and direct economic costs of more than €150
million. A veterinarian died due to this disease. The EU emergency
fund[26]
makes financial contributions to MS during animal disease outbreaks[27]. It would usually make a
contribution of 50% (with the remaining 50% covered by the MS) of the direct
costs to animal keepers for certain specified diseases. Table 1.1 below sets
out contributions since 2000. As shown, the total amount paid since 2000 is
just over €1 billion. However, it should be noted that of this, €664 million
(63% of total) was paid between 2002-2005 in relation to Foot and Mouth
outbreaks in 2001. Table 1.1: EU
Emergency Fund Payments by Disease from 2000-2010 Year of Payment || Payments in €m Avian Influenza || Bluetongue - disease, surveillance & vaccination || Classical swine fever || FMD || Newcastle disease || Other Diseases || Grand Total 2000 || 13.79 || || 47.05 || || || || 60.84 2001 || 17.00 || 0.73 || 6.28 || || || || 24.01 2002 || || 11.46 || 11.42 || 400.44 || 0.42 || 0.57 || 424.32 2003 || 4.76 || 0.47 || 1.78 || 67.82 || || || 74.84 2004 || 55.92 || 4.14 || 8.92 || 78.73 || 1.00 || || 148.71 2005 || 18.23 || 2.65 || 4.16 || 119.96 || 0.65 || || 145.64 2006 || 0.05 || 0.10 || 1.63 || || || || 1.78 2007 || 1.00 || 4.27 || 5.00 || || 0.22 || 1.20 || 11.69 2008 || 8.65 || 51.00 || 3.32 || 0.46 || 0.14 || || 63.56 2009 || 3.90 || 36.36 || 0.04 || || 0.36 || || 40.66 2010 || 1.27 || 31.75 || 0.02 || 0.72 || || 17.18 || 50.94 Grand Total || 124.57 || 142.93 || 89.63 || 668.14 || 2.79 || 18.95 || 1,046.99 Animals must
fulfil specific animal health conditions when they are moved between MS or
imported from third countries. Indeed there are areas within the EU with
different health statuses (for example, freedom from certain animal diseases).
These conditions ensure that animals do not pose any risk during movement and
they are moved only to an area of equal or lower health status than their place
of origin. The conditions are attested by official veterinary certificates
accompanying the consignment of the animals from their origin to their
destination. These specific
rules for movements are sometimes considered burdensome, especially in the case
of frequent cross-border movements between two adjacent MSs with a similar or identical
health status. The most often cited examples of movements of this kind are
those of pigs and poultry between Germany and the Netherlands; cattle between France,
Belgium and Luxembourg; animals for slaughter between Austria and Germany; and
cattle, pigs and sheep between Ireland and Northern Ireland (in the UK). More
detailed analysis (along with some assessment of policy options referred to in
Section 4 later) is available in Annex VIII.
2.1.2.
Overview
of legislative framework and ongoing developments
The current EU
animal health legislative framework involves almost 50 basic directives and
regulations, some of them adopted as early as 1964. The veterinary acquis
communautaire now covers more than 400 acts: -
c. 50 basic acts that lay down horizontal and
vertical principles of animal health which apply to intra-Community trade,
imports, disease eradication, veterinary controls, notification of diseases and
financial support of terrestrial and aquatic animal. A provisional list of
legislation expected to be affected by the new legal framework is attached in
Annex IX; -
c. 200 acts of general application that lay down
implementing rules such as the ones that specify lists of third countries, or
the rules on veterinary certification; -
c. 200 acts of special application that lay down
more specific provisions such as rules on protection or transitional measures. This set of animal
health legislation interacts with the current legal framework on animal welfare,
food safety, public health, animal nutrition, veterinary medicinal products, environmental
protection, official controls, the Common Fisheries Policy (CFP) and the Common
Agricultural Policy (CAP). A new proposal would need to successfully interlink
with all these sets of legislation, especially with Regulation (EC) No.
882/2004[28],
so as to increase consistency for official controls (checks) related to animal
health. For the aquatic
sector, Directive 2006/88/EC was adopted in 2006, bringing together disease
control and trade provisions (intra-EU movements and import). This amalgamation
was a new concept, which has proven to work fairly successfully, so no policy
changes are being proposed in this area. Therefore, this Impact Assessment
largely focuses on policies relating to terrestrial animals.
2.2.
Problem definition
As noted in
Section 1 above, problems with the existing animal health framework and
suggestions for improvements to it have been identified in a number of fora.
Subsequent to the evaluation of the CAHP and the development of the EU AHS
2007-2013, stakeholders and competent authorities of the MS were then further
asked to identify problems with current legislation on animal health in the scope
of the AHL Steering Group. The replies served as a basis to develop the "Annotated
agenda for a wide stakeholder consultation" in which stakeholders were
asked to raise any issues of concern as regards current legislation on animal
health. The summary of this consultation is available at Annex V. The CAHP
Evaluation and the stakeholders' consultation broadly agreed that the current
system functioned well, however a number of issues were identified that could
be improved. Some relate to the general policy approach whilst others relate to
specific legal acts or diseases. Some of these issues should be addressed by
stakeholders as part of their responsibility to prevent animal diseases, but others
relate to the responsibilities of the EU and of CA. As the AHS
recommends that the AHL should be a general horizontal legislative framework, this
impact assessment focuses on the main problems identified in the general policy
approach. Some of the more specific problems identified during the wide
stakeholders' consultation have been used in this impact assessment as examples
of the general problems. Others will be addressed, if needed, in subsequent
legislative proposals and impact assessments – see Annex IX for more details. As noted above,
a summary of the key messages from the CAHP is available at Annex II; however the
main thematic issues identified during the CAHP evaluation were: -
The high complexity of the current CAHP -
The lack of an overall strategy -
An insufficient focus on disease
prevention, with a particular focus on the need for increased biosecurity. A specific
policy issue was also identified both in the evaluation and in the consultation
with stakeholders in the framework of the AHL preparatory work: -
Issues related to intra-EU trade in
live animals. These trade issues
cut across the general problems identified in the first three bullets. As such,
further more specific analysis was carried out on intra-EU trade, which is
presented in overview in section 5 and in detail in Annex VIII.
2.2.1.
High
Complexity of the current CAHP
As described
above, current EU animal health legislation is very complex, with over 400 pieces
of legislation, but no single horizontal law containing the overarching
principles, main objectives and tools of animal health policy. This means that legal
measures are spread among very many different pieces of legislation with
different subject matters, including a mixture of horizontal and vertical
issues, trade (intra-EU and international), disease control measures and
specific safeguard measures. Within the
current framework there are not always clear links to other relevant
legislation, and there can be a lack of consistency and transparency across the
various existing animal health legislation. The existing veterinary legislation and
policies were widely perceived to be very complex by stakeholders across the
board during the evaluation of the CAHP. The high
complexity of the current system means it can be difficult for stakeholders (whether
CA, veterinary professionals or farmers and operators 'on the ground') to
understand their roles and responsibilities. Since this complexity and lack of
clarity are caused by the shortcomings of the existing legal framework, they cannot
be adequately mitigated by means of training or other familiarisation exercises
only. Consequently, the current complexity has the potential to jeopardise the
achievement of the EU's animal health objectives. All the specific
problems identified below within the overall problem of 'high complexity of the
current CAHP' relate to the implementation of the current legislation, with the
exception of the lack of rules on professional qualifications and training for
official veterinarians (see 2.2.1.5), which relates to a lack of legislation. 2.2.1.1. Large number of pieces of EU animal health legislation Driver: Large
number of pieces of EU animal health legislation but no single horizontal law. Problem:
Potential high administrative burden for stakeholders to understand legislation. The absence of a
single horizontal act containing the overarching principles means that obligations
are scattered in different legal acts. This can mean that the rules can be
unclear or difficult to comprehend for animal keepers and owners. They may need
to consult many different pieces of legislation or consult a specialist before
they can fulfil their obligations. Some obligations are laid down in
legislation dealing with disease outbreaks which could be outside their
day-to-day areas of activity. There can also be a lack of clarity about the
relationship between animal health legislation and other pillars of
legislation. So it can potentially be difficult for stakeholders to fully
comprehend their roles and responsibilities in the current animal health
framework. Nevertheless, this situation can vary between MS according to the
manner in which they have transposed directives, with some potentially offering
more coherence than others. Nevertheless, it
is clear that the time spent by animal keepers and operators familiarising
themselves with their statutory obligations represents an administrative
burden. This could be through the time spent by operators reading legislation
(or more likely guidance about the legislation), or the cost of consulting
legal experts. When aggregated across the several million animal keepers,
operators and related business operators in the EU, this is clearly a
considerable administrative burden. 2.2.1.2. Responsibilities and obligations of animal keepers and
owners are not always clearly spelled out Driver: Existing
roles and responsibilities differ across existing legislation and in many cases
are not clearly laid down and consequently interpreted differently in different
MS. Problems: Animal
keepers' legal responsibilities as they are expressed in the current legal
framework do not reflect the totality of the role of keepers and operators in
animal disease prevention and management. Differences in responsibilities between
MS may lead to varying costs of complying with obligations between keepers in
different MS. Animal keepers and
owners, especially farmers, are well placed to prevent and detect animal
diseases, but they can also contribute to the frequency and scale of disease
outbreaks. Current EU and/or national legislation already sets certain obligations
for animal keepers and owners, such as: -
notifying the keeping or possession of animals, -
notifying the relevant authority of the presence
or suspected presence of certain diseases without delay, -
providing regular care for and supervision of
the animals, -
handling animals with a certain standard of care, -
reporting the dispatch and/or arrival of animal consignments, -
keeping records and registers and providing for
the identification and traceability of animals, -
having a baseline knowledge of animal diseases
and how to prevent them. Most of these
obligations are laid down in Directives and Decisions which are then transposed
by MS, but some others are not regulated at EU level. For example, there are
currently very few mechanisms at EU level which actively involve animal keepers
in the rapid notification of suspected animal disease or on-farm preventive
measures, but many of these types of mechanism exist at national or regional
levels. The current
framework creates a particular problem. Because many of the obligations are in
Directives, they can be transposed into MS legislation differently. MS sometimes
interpret the obligations in different ways so there are disparities in
obligations related to animal health for animal keepers and owners between MS. These
inconsistencies between MS mean that the responsibilities of animal keepers
vary across the EU, which can alter the costs of complying with legislation.
This in turn leads to an uneven playing field for livestock keepers in
different MS in relation to the cost and responsibilities of national animal
health requirements. During the
stakeholder consultation, there was wide support for clarifying these
responsibilities, with 78.4% of respondents replying 'agree' or 'strongly
agree' to the proposal to clearly setting out obligations of animal
keepers/owners/operators. In particular many of the stakeholders stressed the
need to establish obligations for operators as well as for animal keepers. The
impacts on small farmers have to be taken into consideration. Furthermore, the
third countries replying to the questionnaire stressed that these obligations
should not be imposed on third country operators. 2.2.1.3 Rules for commercial farming do not always apply in a
proportionate manner to non-commercial animal keeping Driver: To
establish better consistency and proportionality to address risk posed by
non-commercial animal keeping. Problem:
Non-commercial animal keeping usually entails a different kind and level of
disease risk compared to industrial farming and the administrative burdens
imposed on non-commercial animal keeping is not always proportionate to the
level of disease risk. During the
consultations, concerns were raised that surveillance and disease control
measures are applied identically to both commercial and non-commercial holdings
(such as hobby and backyard holdings). The necessity of the current application
of measures to non-commercial farming (such as for example the obligation to
identify and register certain animals and the holding registration), was
questioned, given the different levels of risk that they pose. To ensure
appropriate animal health in the EU and for effective prevention and control of
animal disease, at least a basic level of control measures need to be applied
to both categories of holdings as they can both be affected by disease and
become a source of wider infection. In some circumstances, non-commercial
holdings can pose a lower risk of spreading diseases compared to industrial
holdings: for example, because of fewer movements, less contact with other
animals (especially with industrially farmed animals), animals being kept in
smaller groups and more contact between the keepers and the animals (see
studies on the spread of Avian Influenza). On the other hand there are
circumstances where high numbers of small non-commercial holdings can present a
potentially major risk of spreading diseases to industrial farming. An example
of this might be small-scale pig production. The risk of disease can arise from
potentially lower biosecurity levels in such holdings such as increased
wildlife contact, less supervised movement control, swill feeding, uncontrolled
disposal of carcasses, etc. Current practices
also raise some questions about intra-EU movements, specifically whether
different conditions should be applied to commercial and non-commercial
movements. Some species of animals are considered not to represent a high risk
for spreading animal diseases, or are kept or bred in certain particular and
well controlled biologically secure conditions (for example, laboratories, zoos,
circuses etc.). Pet animals are often moved in a different context, that is to
say, they move in accompanying their owners on their journeys. So they have
little contact with farmed (or in fact any other) animals and the risk of
spreading disease is much lower. However, the movements do need to be somewhat traceable
and controllable in case of disease outbreaks posing risks to animal or human
health. The stakeholder
consultation showed a high level of support for the Commission's approach for
differentiated rules for commercial and non-commercial movements, providing
possibilities for risk based exemptions on a case-by case basis (74.5% of
respondents agreed or strongly agreed with the suggested approach). However, a
certain extent of uneasiness was observed as a significant percentage of
respondents argued that changes could lead to an increased risk of animal
disease spread and possible outbreaks. (for full details see 2.8 in Annex V). 2.2.1.4. Unclear definition of the role of veterinary services
including the tasks and duties of official veterinarians, and other veterinary
practitioners. Driver: Inconsistency in the role of veterinary services across
existing EU legislation. Problems: Legal uncertainty about roles of veterinary services,
possible conflicts of interest and limits to the development of veterinary
networks. EU legislation
(such as Council Directive 90/425/EEC, Regulation (EC) No 882/2004, Council
Directive 64/432/EEC, and Regulation (EC) 854/2004)
gives different definitions of ‘competent authority’, ‘official veterinarian’,
‘approved veterinarian’ and 'official auxiliary'. This lack of legal clarity
has paved the way for different interpretations by the MS, and an uncertainty
about the roles of the various segments of veterinary services during animal
disease outbreaks. For example, the majority of MSs' veterinary practitioners
or technicians are authorised to perform a range of official veterinary
activities, including sampling (for example, in the cases of brucellosis,
tuberculosis, Aujeszky’s disease and the tuberculosis skin test), vaccination (for
example, for Bluetongue) and also some clear-cut official controls, such as
regular hygiene checks on dairy farms, or health checks of animals prior to
intra-EU trade dispatch. In other MS, official tasks such as these are only
performed by official veterinarians. The steering group consultation also raised concerns that a
veterinary practitioner might face a ‘conflict of interest’ when certifying animals
in his or her care; for example if carrying out work as an official
veterinarian but also undertaking private veterinary work, perhaps for the same
client. Different roles for veterinary services across the EU could
limit veterinary coordination and the development of networks for the
surveillance, prevention, early detection, control and notification of disease. At the same
time, all MS are members of the World Organisation for Animal Health (OIE). The
OIE Terrestrial and Aquatic Animal Health Codes provide existing frameworks to
which EU rules should be aligned in order to ensure that MS are fulfilling
their obligations as OIE members, which, amongst other positive benefits,
facilitates trade with third countries. The Terrestrial Animal Health Code defines
the concept of ‘Veterinary Services’ as the governmental and non-governmental organisations that
implement animal health and welfare measures and other
standards and recommendations in the two OIE codes in the territory. The
Veterinary Services are under the overall control and direction of the Veterinary Authority.
Private sector veterinary organisations, veterinarians, veterinary paraprofessionals
or aquatic animal health professionals are therefore included in Veterinary
Services and they are normally accredited or approved by the Veterinary Authority to
deliver the delegated functions. The tasks
of veterinary services include many programming and management activities,
including international certification, and particularly the organisation of a
veterinary network for the prevention, control and notification of disease
outbreaks. International trade in animals, animal products and products of
animal origin is based on international (OIE) standards, where the first step
in fulfilling import conditions is a successful evaluation of the veterinary
services in a given potential exporting country. Without that evaluation, health
certification is not reliable and export is therefore not possible under OIE
rules. However, it has
to be noted that in aquaculture, apiculture and some other animal categories (such
as animals used in scientific experiments) control activities may be carried
out not only by veterinarians but by other professions and services. In this
regard, international standards and recommendations set in the OIE Terrestrial
and Aquatic Codes have to be taken into account. This variety in
the structure of differing veterinary services, their relationships nationally,
intra-EU and internationally, and the differences in their roles and
responsibilities, adds to the complexity of the current context. During the
stakeholder consultation, 81.7% of respondents agreed with the suggestion to
clarify the tasks and duties of official veterinarians and veterinary
practitioners (for full details see 2.3 in Annex V). Stakeholders are of the
view that there is a need to clarify and harmonise certain veterinary tasks
EU-wide. This is in particular valid for "export certification" and
international trade. 2.2.1.5. Lack of rules on the professional qualifications and
training for official and approved veterinarians Driver:
Diverging national standards for qualification and training for official and
approved veterinarians. Problem: Differences
between levels of health protection across MS due to the differences in
veterinary qualifications, ongoing training and professional development. Official, approved
and authorised veterinarians need in-depth and regularly updated knowledge and
skills to perform official tasks and official controls adequately. This
knowledge will be gained first through undergraduate veterinary education and
then by postgraduate studies and/or vocational training. Differences in these
qualifications between MS mean that there can be differing levels of health
protection and impartiality throughout the EU. The Federation
of Veterinarians of Europe (FVE) and the European Association of Establishments
for Veterinary Education (EAEVE) run an evaluation system of veterinary schools
in MSs with a view to providing an independent and fair accreditation system.
The latest published evaluation, in 2009, concluded that while many veterinary
schools in the EU are world-class, some 16% are at one or more points
inadequate[29].
This variability in education can lead to inconsistency in the knowledge of
those who qualify as vets. Regulation (EC)
No 882/2004 already envisages appropriate and, as necessary, additional
training for staff performing official control tasks. In addition, there are
specific provisions on the professional qualifications and continuing education
of official veterinarians, but this is limited to those responsible for fresh
meat controls in establishments covered by Regulation (EC) No 854/2004. These
provisions may need to be extended to other areas of competence of official
veterinarians to ensure that official tasks are performed in an adequate and
uniform way throughout the EU. At the same time it has to be noted that in
aquaculture, apiculture and some other animal categories (i.e. experimental
animals), control activities may be carried out not only by veterinarians but
by other professions and services. This would have to be taken into account as
necessary in defining the required qualifications and ongoing professional
development. During the
stakeholder consultation, there was wide support for extending the requirements
for professional qualification and for veterinary training for officials
veterinarians in all areas, and to those authorised to perform official tasks
in the field of animal health, with 81.0% of respondents replying 'agree' or
'strongly agree'. Many supported a broader harmonised EU approach for all those
that perform official tasks; this includes not only veterinarians but also
other professionals. On the other hand, others warn that MS already have
continuous professional developments for veterinarians in place and that
additional regulation at EU level is unnecessary. If training is to be introduced,
it should be output / target oriented towards proper enforcement and should not
generate unnecessary costs. (for full details see 2.4 in Annex V). 2.2.1.6. Specific animal health conditions relating to imports are
difficult to understand, and apply Driver: Animal
health conditions on imports are unclear and difficult to apply. Problem:
Administrative burden for third countries, importers and competent authorities
to understand and comply with conditions. Animal health
import requirements for live animals, animal products and products of animal
origin are based on the need to prevent the introduction of animal diseases into
the EU. These specific requirements are scattered in different pieces of
legislation and sometimes within the texts of import certificates instead of
the legal act itself. This makes the
rules difficult to understand and apply for competent authorities and business
operators in MS and third countries. For example, the Food and Veterinary
Office (FVO) has regularly made recommendations to MS to improve their import
controls. Many of the issues causing the recommendations appear to arise from
misunderstandings due to a lack of clarity rather than wilful disregard. In
addition, the complexity adds an administrative burden to operators, who can
find it difficult to establish what the requirements for import actually are. The
introduction of basic animal health requirements would reduce the
administrative familiarisation burden on operators who are running import
businesses, and grant more consistency in import policy. The time spent
by the concerned parties understanding animal health import conditions
represents an administrative burden for business operators and competent
authorities in both MS and third countries which has the potential to be
reduced through simplification, harmonisation of the controls, and the
introduction of electronic forms. During the
stakeholder consultation, 75.1% of respondents replied 'agree' or 'strongly
agree' to the proposals to make the import conditions clearer and simpler. For
full details of the proposals see 2.12 and 2.9 in Annex V. Stakeholders especially
highlighted the issue of competitiveness: they are of the view that EU
operators face stricter standards than international standards. Imports of special
animal categories also have to be considered carefully, and exemptions only
granted taking into consideration the risks involved (e.g. protected and
endangered species, wild animals, etc). They emphasised the need for clear
definitions to avoid misunderstanding in import conditions (for example, llamas
should not be considered as ruminants).
2.2.2.
Lack
of a single overall strategy
The final report of the CAHP evaluation highlighted the lack
of a single general approach behind the CAHP measures. Instead, the CAHP was
perceived to be a patchwork of specific measures and actions, with insufficient
clarity in its overall direction. The setting of priorities for the CAHP has
consisted of a mixture of longer-term components such as eradication programmes
or contingency planning but also of short-term or crisis-driven elements. Resources, personnel and management attention have tended
to follow animal health crises with a reducing focus on the definition and
achievement of longer-term strategic objectives. Consequently, this apparent
lack of a clear long-term strategy and prioritisation system could lead to
sub-optimal prioritisation and allocation of resources. All of the problems identified below which relate to the
lack of a single overall strategy are areas where EU law exists only in
piecemeal fashion (for example, relating only to certain diseases); or where
there is no existing law. 2.2.2.1. Lack of categorisation and prioritisation of animal
disease policy Driver: Lack of
prioritisation of different animal disease control and policy measures. Problem: Sub-optimal
allocation of resources for disease control. As described above, the CAHP evaluation highlighted the absence of a
clear system for prioritising resources for animal health policy interventions,
such as categorisation of animal diseases and animal-related threats, (or reliable
scientific grounds for such categorisation). This means that resources have
sometimes been allocated on short-term, political or crisis-driven grounds,
which do not fully reflect evidence based on scientific risk assessments and cost-benefit
analysis. The management of less high-profile diseases might therefore be
de-prioritised as a consequence. This sub-optimal allocation of resources for
disease control under the current system could lead to more negative impacts of
animal diseases than if resource allocation were optimally prioritised. In many cases,
the existing legal framework is too rigid and cannot adapt to new developments,
including new scientific developments. The AHL Steering Group mentioned certain
examples of these problems in their discussions in July 2009, for example: the
rules on swine vesicular disease, which they felt to be disproportionate to the
risks the disease poses; and protective measures for Newcastle Disease, which
they felt to be outdated. A bluetongue
case study is outlined in the box below to illustrate a short term
crisis-driven allocation of resources. Bluetongue disease Bluetongue is an insect-transmitted
disease which appeared in North-Western Europe for the first time ever in
summer 2006 when a virus strain, probably originating in sub-Saharan
Africa, appeared in the Netherlands. That summer was exceptionally warm and
these unusual climatic conditions may have exacerbated the conditions for the
virus to flourish. That year 2,000 farms were affected, and in the following
year 60,000 farms were affected, from the UK to the Czech Republic.
Infections caused high mortality in sheep and goat populations. In Belgium it is estimated that
the mortality rate in 2007 amounted to one sixth of the national sheep and goat
population. Economic losses in the Netherlands were estimated at €130 million
in 2006 and 2007. In 2007, a BTV-8 outbreak in France was estimated to cost
€1.1 billion. Losses there were largely due to the
inability to trade cattle on the international market. In the EU in 2008, a total of 45,000
outbreaks were reported. That number dropped to 1,118 in 2009 and only 120 in
2010. The success is credited primarily to the vaccination campaigns in the MS.
A co-financed EU programme was adopted, initially funded by the "emergency
fund", and later by annual programmes in all affected areas. This appears
to be the main factor leading to the near-disappearance of the disease in the
EU in 2010. It has been argued that a more
preventative approach to Bluetongue could have prevented much of the mortality
and costs of the disease that the emergency measures required. 2.2.2.2. Poor coordination of animal disease surveillance Driver: Lack of coordination between different surveillance
systems and actors. Problem: Sub-optimal use of surveillance to reduce the risk
and impact of disease outbreaks. Animal health surveillance is an essential tool to detect and
control animal diseases, to monitor disease
trends, to support claims for freedom from disease
or infection, to provide data
for use in risk analysis, for animal
and/or public health purposes, and to substantiate the rationale for sanitary
measures. Therefore, surveillance is a key element of any animal health policy
that gives priority to a preventive approach, early detection and quick
response. Animal disease
surveillance is one of the cornerstones of Pillar 3 of the AHS 2007-2013. Several
activities (as noted above in section 1.7) have been carried out to identify the
main challenges for surveillance and how they could be addressed: -
The current picture of animal disease
surveillance in the EU is rather complex and the purposes or objectives of
surveillance systems are not always sufficiently clear in current legislation (for
example, there are surveillance systems which are EU harmonised vs. those not
harmonised; compulsory vs. voluntary; surveillance in free areas vs. monitoring
in not-free areas; EU co-financed vs. not EU co-financed; active vs. passive;
farmed animals vs. wildlife and so on). It can therefore be difficult for
stakeholders and competent authorities to understand their roles and responsibilities.
-
The current surveillance systems may not be
sustainable, as they do not necessarily make best use of available resources,
nor optimally set priorities; so the affordability, sustainability and
communication of surveillance activities need to be addressed. Support and
engagement of the veterinary authorities and stakeholders, in particular
farmers and trading partners, is essential and should be actively sought. During the
stakeholder consultation, 67.3% of respondents replied 'agree' or 'strongly
agree' to the proposals to improve animal health surveillance. Full details are
in part 2.6 of Annex V. Stakeholders suggested that the surveillance should be
developed in partnership with them. Some have asked for a cautious approach in introducing
surveillance network in order not to be too prescriptive. 2.2.2.3. Insufficient harmonisation of EU legislation with
international standards Driver: All MS
are members of the OIE, so EU legislation should aim to better align with the
existing OIE Health Codes for the sake of consistency with international trade
rules and competitiveness of the EU farming industry. Problem: In
certain respects, convergence of standards represents a trade-off with animal
health standards, but lack of convergence may lead to lack of competitiveness
and even international trade disputes. MS are members
of the OIE and as a result should align their rules to the existing OIE Code.
As such the standards of the OIE Health Codes should be reflected in EU
legislation. Some current differences in EU legislation and OIE standards are
set out in the box below. The potential problem
that arises from these differences is in the difficulty of achieving the
optimal balance between aligning with OIE standards and maintaining EU health
standards. This amounts to a trade-off between maintaining good relations with
third countries, hence maintaining the competitiveness of the EU farming
industry and avoiding potential trade disputes; and maintaining current animal
health standards within the EU. During the
stakeholder consultation, 82.3% of respondents replied 'agree' or 'strongly
agree' to the proposals to aligning EU standards with international standards
(while not lowering EU standards) and to promoting EU standards in
international fora, particularly the OIE. Whilst EU trade and import legislation generally reflects OIE standards, sometimes there are differences. For example: - The OIE only carries out a paper evaluation as the basis for determining disease-free countries or zones. The EU does not consider this sufficient and generally carries out its own on-the-spot inspections before granting its trading partners this status. - The EU has its own level of protection for certain imports, based on scientific risk assessment, which is often higher than that which can be achieved solely by applying OIE standards or guidelines. An example is that the EU does not accept that the import of bone-in beef from a country carrying out vaccinations against foot and mouth disease is safe, whereas under certain conditions this would be possible under the OIE code. - The EU can act faster and indeed can be more flexible than the OIE in certain instances, such as in recognising different regions of a country or reinstating disease-free status following a satisfactory outcome of an inspection by the Food and Veterinary Office. - The definition of certain disease incubation periods or other time intervals and the approaches to evaluating competent authorities for animal health is different in OIE and EU standards. - There are differences in veterinary roles and standards as highlighted earlier. - Diagnostic tests in EU legislation do not always mirror the prescribed tests in the OIE manual. 2.2.2.4. Emerging, re-emerging and exotic diseases are not duly
considered in current legislation Driver: Lack of
flexibility and appropriate tools to respond to, control and monitor emerging
and exotic animal diseases. Problem:
Potential for larger scale and more frequent exotic disease outbreaks. Public
authorities and animal keepers know less about diseases which are not commonly
present in the EU (typically known as exotic diseases) or are currently unknown
(emerging diseases), than about diseases which are endemic in the EU. This
means that MS and the EU have lower preparedness for dealing with outbreaks of
exotic or emerging diseases. This can contribute to larger scale outbreaks of
exotic diseases than if there was more adequate crisis-preparedness. General EU
measures for the control of certain animal diseases are laid down in Directive
92/119/EEC but these measures refer only to a limited list of emerging and/or
exotic diseases for the EU and some of these measures do not prescribe the
right tools to deal with certain exotic diseases. The rigidity of current rules
limits the possibilities for the EU to play a more proactive role to prevent
the spread and introduction of such diseases or to react in the event of a new
animal disease. This could lead to delays in taking the appropriate measures to
control them. In addition, past crises have shown the need to put in place
clear and flexible rules for controlling and monitoring animal diseases that
can be adapted to every conceivable situation and to varying regional factors. A
good example is that of bluetongue, which was outlined in 2.2.2.1 above. Other
examples were highlighted by the AHL Steering Group in their meeting in July
2009 for which they felt the existing legislation is too rigid and the EU
relatively unprepared. These included Rift Valley Fever, and the rules for
African Horse Sickness. During the
stakeholder consultation, 86.1% of respondents replied 'agree' or 'strongly
agree' to the proposals to reflect emerging diseases in the AHL and to update
certain disease control directives that are outdated or disproportionate. Full
details are available in 2.10 of Annex V.
2.2.3.
Insufficient
focus on disease prevention
Freedom from
animal diseases is widely considered to be a global public good, as it
protects the health of animals and public health as highlighted in the "One
World – One Health" concept developed by the WHO (World Health
Organisation), OIE (World Organisation for Animal Health) and FAO (Food and
Agriculture Organisation)[30].
Its importance is not limited to the rural economy but impacts on the whole of society.
Animal diseases and related control measures can be costly to the livestock
sector, and to competent authorities which currently cover most of the costs of
crisis response. Additionally, freedom from certain animal diseases is a
necessary condition for animals and animal products before they are traded
within the EU and with third countries. While animal
health crises will always occur, the CAHP evaluation highlighted the need to
focus more on disease prevention and rapid and effective risk management in
order to reduce the incidence and scale of animal disease outbreaks. Recent work
to put in practice the "One World – One Health" concept clearly show
that the emphasis is shifting away from crisis response to building the systems
and capacity to prevent and respond more effectively to future outbreaks of
diseases. The issues
identified below are all problems caused by a mixture of both the content and
implementation of existing legal powers; and because legal powers to provide an
overall coherent view of all animal diseases are lacking. 2.2.3.1. Poor coordination of animal disease surveillance and
monitoring Driver: Lack of
coordination between different surveillance systems and actors. Problem:
Sub-optimal use of surveillance to reduce the risk and impact of animal disease
outbreaks. As noted above
in 2.2.2.2, surveillance is an essential tool to detect and control animal
diseases. Its present sub-optimal use means the EU's ability to prevent disease
outbreaks before they occur is not at its full potential. The improvement of
surveillance systems is widely supported by stakeholders, as noted above. 2.2.3.2. Insufficient on-farm biosecurity measures to prevent
outbreaks on farms and in the farming industry Driver: Lack of
comprehensive rules on farm biosecurity measures to reduce impact of disease
outbreaks. Problem:
Inefficient use of biosecurity on-farm and in the farming industry, and
increased risk of disease outbreaks. Farmers (animal
keepers in general) are often the best placed persons to prevent and detect
animal diseases. Currently, very few mechanisms exist at EU level that actively
encourage animal keepers to take preventive disease measures. Mechanisms to
achieve on-farm biosecurity at other levels within the EU are mainly voluntary
or industry-led schemes, which typically achieve a lower uptake than statutory
measures. The lack of
biosecurity measures is driven by two factors: -
Many farmers and animal keepers lack sufficient
information about biosecurity measures they could implement. In particular they
are unlikely to be aware of the costs of implementing biosecurity measures
compared to the benefits of reduced animal diseases. This can lead to farmers
implementing fewer biosecurity measures than would be beneficial to them
(because the on-farm benefits would exceed the implementation costs). This can
lead to a lower level of biosecurity than is optimal and a higher risk of
on-farm disease outbreaks. -
With optional or voluntary biosecurity schemes,
farmers can choose the level of on-farm biosecurity they implement. Without
specific mandates or incentives to take into account the wider benefits (public
benefits) of their biosecurity measures, farmers are unlikely to implement
additional measures above those that benefit them directly (private benefits).
For example, certain measures might reduce the likelihood of disease outbreaks
spreading to other farms and therefore lead to an overall lower cost of disease
to society as a whole. So farmers implement on-farm biosecurity measures based
on the private benefits they receive on their farm, not fully taking into
account public benefits to others or to wider society. This also leads to a
lower level of biosecurity than is socially optimal and a higher risk of
on-farm disease outbreaks spreading to other farms. Still very few
mechanisms, regulatory or not, exist to rate holdings with respect to their
level of biosecurity within the EU. Those mechanisms that do exist do not
recognise or assist those who wish to achieve higher than minimum (additional)
standards (and may even create an uneven playing field for them). More data and
analysis on this issue are available in Annex XI. During the
stakeholder consultation, 75.8% of respondents replied 'agree' or 'strongly
agree' to the proposal of a legal framework introducing voluntary biosecurity
on farms, and a minimum criteria for biosecurity measures (adapted to local
circumstances). Detailed stakeholder views and conclusions are presented in
Points 2.5. and 3.5 of Annex V. 2.2.3.3. Applicability and acceptability of the current
vaccination strategy for control of animal diseases Driver: The
willingness of MS and stakeholders to use vaccination as a tool to control
animal disease outbreaks, which is often linked to the availability and
reliability of vaccines and differentiating diagnostic tests. Problem:
Sub-optimal level of use of vaccination for major animal diseases, increasing
the impact of animal disease outbreaks, when they occur. The use of vaccination
to control major epidemic diseases has been the subject of very intense debate
in the EU in the last twenty years. The main reasons why vaccination is not often
applied by MS are the
poor availability of certain vaccines and associated DIVA[31] tests; concern over potential
trade blocks (of imports of vaccinated animals and/or products of vaccinated
animals) by third countries; and consumer perception in the EU. Nevertheless, it
is widely agreed that in many cases vaccination could be used as a means of
preventing animal diseases. But more importantly, vaccination could also be the
best means of preventing and minimising negative impacts of animal diseases once
they occur by preventing further spread of disease. The principle 'vaccination
is better than unnecessary culling' was agreed during the creation of the AHS
and its Action Plan.[32]
In order to address the issue of availability of vaccines, a task force of experts was created to assist the Commission in the
development of an expert policy paper[33]
on EU vaccine/antigen banks for major animal diseases. The main conclusions reached
in this process were: -
For most of the relevant infectious diseases,
existing legislation regarding emerging vaccination should be amended so that
vaccination becomes a more realistic and viable option in the event of a
crisis. -
The mechanisms of accessing the
vaccines/diagnostics have to be clarified. A procedure should be established to
assure guaranteed supply. A detailed
analysis of vaccination policy and further data are presented in Part 1 of
Annex VII. Stakeholders' views concerning vaccination are collated in
Point 2.15 of Annex V. As referred to previously, the questionnaire and a
summary of the outcome of this consultation with the CVOs can be found in Part
2 of Annex VII to this document. This approach is
widely supported by stakeholders – there is wide agreement that vaccination
should be used in a flexible way, taking into account its advantages and
disadvantages and encouraged where it is strategically sensible to do so. 2.2.3.4. No consistent provisions for training on animal health
for people dealing with animals Driver: Animal
keepers often have a lack of access to information and training on animal
health. Problem:
Potential for sub-optimal on-farm animal health measures to prevent and control
animal diseases, with increased potential for disease outbreaks. Current EU
legislation focuses on training for people dealing with or handling animals in
dealers’ premises, assembly centres and during transport. However, there are no
provisions for training of people dealing with animals at farm level in order
to achieve a higher level of awareness of the potential health, social and
economical impacts that animal diseases might have and the measures that they
themselves can implement to prevent them. This potential lack of awareness can lead
to poor implementation of the rules, and the risk of animal health and welfare
problems, such as late reporting of animal disease
outbreaks. This can result in measures for controlling the diseases being delayed
and therefore have an increased impact. During the
stakeholder consultation, a voluntary approach to better training was regarded
as the most adequate solution by the majority of stakeholders (see Point 2.2.
in Annex V). However, a significant share preferred that training should be
compulsory in the AHL, expressing at the same time concerns on funding. The
importance of flexibility to adapt provisions to differing circumstances was
highlighted by a majority of stakeholders.
2.2.4.
Rules
for intra-EU trade of live terrestrial animals are sub-optimal
Whilst the
previously described problems fit under the thematic headings, the steering
group highlighted problems with intra-EU trade that fell under several of these
different categories. Therefore rather than addressing these thematically, the
issues related to trade have been grouped together. The issues here are areas
where the existing law is not optimal, but any proposals for better coherence
would not necessarily expand the EU's powers further. 2.2.4.1. Current animal health rules for intra-EU trade Driver: Current
animal health rules for intra-EU trade for live terrestrial animals are not
always proportionate to the animal health risks posed by movements. Problem: Current
rules limit the single market for live terrestrial animals, and the
administrative burden for traders and competent authorities is not always
proportionate to the level of animal health risk posed by different types of
movements. Current animal
health provisions for commercial movements of live terrestrial animals between MS
are largely based on the "intra-EU trade" concept. Under this
approach, before live terrestrial animals are moved between MS they must fulfil
certain animal health requirements established in the EU legislation. Veterinary
checks and examination are required to ensure the animal meets these
requirements and a certificate is issued before the movement is allowed. A notification
of the movement must be made in national identification and registration
databases and into the TRACES[34]
system. The current EU
legislation allows MS to maintain, to a certain extent, animal health rules on
national movements in live animals, provided that these national rules comply
with the relevant provisions on the control of diseases that are regulated at
EU level. The current
system with different requirements for movements within the MS to that across MS
does not fit well with the concept of the single market. Although border
veterinary checks between MS were abolished long ago and certain certification
rules for the EU movements are more straightforward than those for
international trade; the movements system still contains different market
approaches to trade within MS than for trade across MS. Furthermore,
this system was criticised during the CAHP evaluation for being complicated,
expensive for operators and burdensome from an administrative perspective for
operators and competent authorities, and because this administrative burden was
not proportionate to the health risks posed by such movements. This is most
obviously the case for movements of animals between two MS with an identical
health status (in an extreme example, even movements across a border between
holdings of the same owner, or cross-border transhumance) and movements of
animals for direct slaughter. These are largely known in the EU, for example
between Germany and the Netherlands; Belgium and Luxembourg; Austria and Germany; in the island of Ireland; Slovenia and Austria; France and Italy; the special case of moving reindeer between Finland and Sweden; and many others. In these cases,
an argument can be made that the health status guarantees for the relevant
animals may not need to be so demanding. However, in some
cases the measures may be proportionate to the animal health risk posed, for
example when animals or their products are moved between holdings or zones of a
different health status, or for specific categories of animals, where a health
status is of particular or specific relevance and where appropriate health
guarantees have to be provided. A balanced
solution ought to be sought for the health risks involved in a particular
movement, reducing some complexity of the procedures and costs attached to it
and preserving a transparent and simple system that can be easily applied in
practice. More data, a special analysis and examples on this issue are
available in Annex VIII. 2.2.4.2. Duplication of procedures and electronic certification Driver: Lack of
harmonisation of procedures and certification for intra-EU movements. Problem: Current
system is difficult to use and unclear, with a high administrative burden for
users through duplication of procedures. The diverse
information systems on animal health within the EU and in the international framework
(TRACES and ADNS in the EU; WAHIS-WAHID for the OIE; and national databases for
animal identification and registration) sometimes create multiplication of
effort for MS, as the same notification has to be entered in several databases.
In addition, despite the high number of information systems, they do not
provide information fit for purpose for EU and MS risk managers to support
decision making on disease prevention and control measures. Furthermore, electronic
certification could be considered as an option to simplify veterinary
procedures greatly. The TRACES system could enable electronic certification and
so simplify the process, but a legal basis for doing this is currently lacking.
The collection,
processing and use of information on animal health does not function optimally
and does not deliver its full potential value. For example, the CAHP evaluation recommended exploring
further the possibility of developing integrated electronic systems that could
lead to better traceability and a reduction of administrative burdens for
operators. However, there would be considerable technical and other
difficulties to be overcome. Prior to proceeding, such integration efforts
would have to be subject of a detailed technical feasibility study/impact
assessment, as there are risks in integrating the electronic systems for EU
procedures applied in animal movement (e.g. data overload, security issues)
that require further technical analysis. 2.2.4.3. Concept of compartmentalisation is not widely recognised
in EU law Driver:
Compartments used in some production systems are not widely recognised in EU
law. Problem:
Legislation does not reflect lower disease risks of compartments, so
compartmentalisation is not well incentivised in the current legal framework. In the context
of better biosecurity a new concept of "compartmentalisation" was developed
at international level and described in the OIE Health Codes. A compartment is a
group of one or more animal establishments which are subject to a common
biosecurity management system, with a distinct health status for a specific disease
or diseases which require surveillance. These control and biosecurity measures are
usually applied to facilitate international trade. In practical
terms this implies that a compartment might be considered as a homogeneous
production unit with respect to health status, veterinary control measures and
trade, as all establishments in the compartment have the same distinct status,
which is known throughout the compartment. This concept has
not been introduced into the EU legislation except in Directive 2005/94/EC
related to the measures for Avian Influenza, and Directive 2006/88/EC related
to aquaculture animals. It could also be extended to other diseases and used by
the MS for the purposes of international and intra-EU trade, and for better control
and eradication of animal diseases. There is
currently a lack of legal powers to provide an overall coherent approach for
compartmentalisation for all relevant diseases.
2.3.
Who is affected by the current policy?
The current policy and the issues associated with it as
identified above particularly affect stakeholders involved in keeping live
animals and in the production of, trade in, and import or export of live
animals, animal products and products of animal origin. Non-commercial animal
keepers and holdings such as pet owners, zoos, backyard farmers, and hobby
farmers are also affected. Under present legislation, animal keepers have a degree of
responsibility for prevention and control of animal diseases. In general,
non-professional animal keepers usually have a lower level of biosecurity and
awareness of hazardous practices compared to the professional sector. Competent authorities in the MS in charge of implementing
and controlling the implementation of animal health rules are also a set of key
stakeholders. Trading partners and competent authorities in third
countries are affected by the EU's import conditions for live animals, animal
products and products of animal origin. Veterinarians, both official (state) or private, other
veterinary professionals, technicians and the wider veterinary industries also
play a key role in the delivery of EU animal health policy.
2.4.
The right and justification for EU action
2.4.1.
Treaty
basis
Articles 43, 114
and 168 of the Treaty on the Functioning of the European Union (TFEU) provide
the legal basis for the EU legislative measures on animal health, as they are
an essential part of EU agricultural, public health and consumer protection,
trade and single market policy. -
Article 43
provides the basis for the EU legislative measures on the Common Agricultural
Policy. This article also became the basis for veterinary legislation as the
CAHP is considered from a legal perspective to be part of the Common
Agricultural Policy, so adopting the same legislative and administrative
procedures. -
Article 114 provides
the legal basis for the establishment and functioning of the internal market
and the approximation of provisions laid down by the law, regulation or
administrative actions in this respect. -
Article 168 on
health protection refers to the protection of human health from all causes that
may damage it, including those related to animal health. The legal basis for
veterinary and plant health measures directly aimed at protecting public health
were adopted under the co-decision procedure as a result of this article.
2.4.2.
Subsidiarity
test
Necessity
test - Why can the objectives not be achieved by MS? In very general
terms, good animal health generates not only private benefits for the
particular animal keepers and owners concerned with individual animals, but is
a public good with wider societal benefits. The transmissible nature of many
animal diseases means that a common approach, rather than a series of
individual actions, is likely to have the greatest overall benefits. The value of a
harmonised EU approach to the control of major transmissible diseases has been
confirmed by judgements of the Court of Justice and by reports of the Court of
Auditors, the farming, agricultural and food industries, the European
Parliament, and other stakeholders; with the Commission's role in policy making
becoming increasingly accepted both within the EU and internationally. Veterinary
legislation at EU level has led to harmonised rules which apply to all MS and has
replaced a complex web of national and regional rules. This harmonisation has
helped to reduce the administrative burden for operators, traders,
veterinarians and veterinary-related industries. A harmonised animal
health policy has played a key role in the establishment of the single market,
facilitating intra-EU trade in animals and animal products (meat, milk, etc.) by
setting up harmonised animal health conditions and promoting the success of the
CAP. The development of harmonised EU animal health standards has progressed in
parallel with the development of intra-EU trade and trade with third countries.
The necessity of
continued EU level action is demonstrated by the fact that if MS were to
introduce national rules including possible restrictive measures in the event
of an animal disease outbreak, serious disruption would likely occur to trade
in animals, animal products and products of animal origin as well as to related
agricultural and industrial activities such as farming and slaughter. This
could also have consequent effects on exports of live animals due to the credibility
of EU measures in third countries being jeopardised, while in the long run the
EU would lose the power to negotiate at international level. Animal disease
outbreaks that have occurred in the past have shown that MS may be subject to
internal pressures which might not allow them to adopt the most effective
disease control measures. This problem occurs particularly when certain
outbreak scenarios are not provided for in EU legislation. In this situation, there
could be increased spread of animal disease and additional costs and losses for
the farming, agricultural and food industries as well as costs for MS and the
EU. Added
value test - Can objectives be better achieved by the
EU? The benefits of
harmonised rules for the prevention, notification, control and eradication of
animal diseases at EU level have been demonstrated during animal disease
outbreaks in recent times. The response to these crises showed the EU's
capability to react quickly, limiting the spread of diseases and minimising
their impacts. This was largely due to the harmonised approach to disease
control, including providing financial compensation for the losses on farms due
to disease eradication measures. The current system also enables the
development of sustainable surveillance and monitoring programmes by providing
co-financing at the EU level. In the past, the EU harmonised approach to
disease control has enabled the EU to defend the interests of its MSs on the
international scene. For example, the EU has been able to negotiate the
regionalisation approach for disease control measures with several third
countries on many occasions. This approach looks at the evidence for where
diseases actually occur, treating regions individually according to risk, not
simply a single country or territory as a disease-ridden or disease-free block.
This has meant that in the case of a disease outbreak in a part of the EU,
other parts of the EU have been able to continue to trade without restrictions
with third countries. These benefits of these negotiations could not have been
achieved without the EU acting as a coherent block. The main tools
that have enabled the achievement of the benefits mentioned above are: ·
The establishment of an enhanced system for
animal identification and traceability and of TRACES, ·
The functioning of the Animal Disease
Notification System (ADNS), ·
Veterinary Fund expenditure. Furthermore, the
AHL envisages the introduction of a disease categorisation and prioritisation exercise
for evaluating the value of EU intervention in relation to animal diseases and
related threats. This exercise would categorise animal diseases according to their
impact on the economy, trade, human health, society, animal welfare and the
environment. It would also take into account the feasibility of implementing
successful control measures. Categorisation is a risk management exercise which
would be compulsory prior to determining: -
whether a disease should be dealt with at the EU
level, by MS and/or at the private level; -
if at EU level, the nature of EU intervention (such
as legislation, enforcement regulation, eradication, awareness, training,
cooperation or research). The AHL aims to
establish a general framework for the prevention, control and eradication of
animal diseases. This framework will be built on outcome-based rules, avoiding
over-prescriptiveness, and leaving room for MS to regulate or set more detailed
legislation when necessary, so providing for the flexibility to adapt the rules
to national, regional or local circumstances. On the other
hand, rules on trade must necessarily have a certain level of detail and precision
to reduce the risk of different implementation practices by operators and
competent authorities and subsequent distortion of competition and possible
reduction in the coherence of the approach to tackling disease. Boundary
test - Impact on other geographical areas and other
policy areas Trans-boundary
animal diseases are a permanent threat for livestock keepers and MS as they can
have major economic implications for both the private and public sectors. They
can easily spread from one country to another and can reach pandemic
proportions. Wild animals can play an important epidemiological role in the
transmission of animal diseases and their movements are extremely difficult to
control or restrict between MS (for example, the spread of avian influenza
through wild birds). Global trade and movements of people and goods increase
the risk of rapid disease spread over greater distances. For this reason
control measures and harmonised surveillance systems are needed at EU level.
Past evidence of cases where MS failed to control the spread of the disease (in
the absence of an EU-wide framework) show that such cases may lead to
significant cross-border impacts in terms of animal health and possibly also
public health. The EU, as the
largest global importer of food and animal feed, needs to protect itself
against the possible introduction of exotic animal diseases and public health
risks through the trade in live animals and animal products. The EU has
harmonised rules for imports of live animals and animal products. Their objective
is to make sure that the same principles for import are applied in all MS in
order to prevent animals carrying transmissible diseases that are dangerous for
livestock or humans from entering EU territory. All types of
micro-organisms (viruses, bacteria, parasites) causing animal diseases are
covered by this impact assessment. Invasive alien species other than
micro-organisms, but also causing diseases are not covered by this impact
assessment. This issue is currently being assessed by DG Environment and will
be addressed separately to the envisaged animal health law's scope of animal
health and pathogens. DG Sanco has worked closely with DG Environment to ensure
a joined-up approach. The new AHS for
the EU endorses the concept of the OIE and the World Bank of animal health as a
"global public good", which means that good animal health benefits
everyone. It accepts that the functioning of animal health services should be a
public investment priority. The implementation of the strategy requires public
authorities in the EU to take a common approach. Furthermore, the roles and
responsibilities of all actors have to be clear and consistently enforced throughout
the EU for the sake of better prevention of animal diseases. In light of
these different elements, EU action is justified, as it is clear that MS cannot
achieve this satisfactorily acting alone and that the EU would achieve a
consistent approach more effectively and efficiently.
3.
Objectives
Having
established in section 2 above that there are a number of aspects of EU animal
health policy that could be improved, and that the EU has both the basis to act
and can add value by doing so, we now turn to the objectives of what animal
health policy is actually trying to achieve. The EU as a
whole is working towards the agreed objectives of Europe 2020[35]. Animal health objectives
should uphold these crucial overarching objectives by reducing the risk of the
negative economic, social (including public health) and environmental impacts
of poor animal health or animal disease outbreaks; and consequently by
supporting the economic security and success of animal keepers, particularly
farmers. It is worth
reiterating here that animal health objectives do not stand in isolation. Good
animal health is a critical factor in ensuring the viability and sustainability
of the internal market; and particularly of the food sector, which is the
largest single economic sector in the EU. There is inevitably overlap and
interaction with other areas of policy, such as animal welfare, food safety,
animal nutrition, veterinary medicines, and official controls, but also with
wider agricultural and environmental issues.
3.1.
General objectives
The general objectives of EU animal health policy are
outlined in the EU AHS 2007-2013, and are: -
to ensure a high level of public health and food
safety by minimising the incidence of biological and chemical risks to humans; -
to promote animal health by preventing/reducing
the incidence of animal diseases, and in this way to support farming and the
rural economy; -
to improve economic
growth/cohesion/competitiveness assuring free circulation of goods and
proportionate animal movements; -
to promote farming practices and animal welfare
which prevent animal health related threats and minimise environmental impacts in
support of the EU Sustainable Development Strategy. These general
objectives demonstrate that the basis for EU action is wider than simply
preventing public or animal health problems from arising or ensuring the
economic security of farmers. The scope of any new measures will need to
encompass not just kept animals (including production animals, animals used for
work, sport, recreation or display, companion animals and animals used in
research); but also, to an extent, wild animals, where their poor health has
the potential to jeopardise any of these objectives.
3.2.
Specific objectives
The specific objectives of the new legislation are: -
to establish a single, simplified, transparent
and clear regulatory framework that sets out systematically the objectives,
scope and principles of the regulatory intervention; based on good governance
and compliant with international (e.g. OIE) standards; focusing on long-term
preventative measures and working together with all relevant stakeholders; -
to introduce overarching general principles
allowing a simplified legal framework in order to be prepared for the new
challenges, i.e. to enable quick reaction in case of emerging diseases; whilst ensuring
the same quality of reaction as provided for in current legislation. -
to ensure consistency amongst the horizontal
principles of the legislation in the field of animal health, animal welfare and
food safety policies as well as broader EU policies on climate change and
sustainability; -
to reduce the economic and social impact of
animal diseases on public health, animal welfare, economy and society as far as
possible by enhancing disease awareness, preparedness, surveillance and emergency
response systems at national and EU level; -
to ensure the smooth functioning of the internal
market of animals and animal products, with a high level of protection of animal
health and public health and supporting the objectives of Europe 2020.
3.3.
Operational objectives:
-
to integrate the new prevention-driven and
incentive-oriented approach into the core of animal health policy; -
to provide for a clear and balanced distribution
of roles and responsibilities between competent authorities, EU institutions,
the farming sector, animal owners and others; -
to introduce disease categorization as the basis
for EU intervention; -
to provide for effective mechanisms for a rapid
response to disease events, including new challenges, such as emerging
diseases; -
to ensure effective emergency preparedness and
early response to animal diseases threats and zoonoses, including use of
vaccines as appropriate; -
to introduce simplified procedures, wherever
possible for technical and other reasons, taking into account the specificity
of small farmers and micro businesses; -
to ensure that the new legal framework provides
enough flexibility to adapt smoothly to future scientific and technological
developments; -
to reduce the risk of trade disruption by seeking
an appropriate level of convergence with relevant international standards,
while ensuring a firm commitment to high standards of animal health.
4.
Options
In order to
solve the problems identified and achieve the above-mentioned operational
objectives, we have considered four policy options below. It is worth noting
here that the development of any new measures will need to have taken evidence
into account (where it exists), particularly scientific evidence; but also
social, economic and ethical considerations. Option 1: Do nothing (i.e: continue with current policy) Option 2: Simplification of existing legislation
with no major content or policy changes Option 3: Existing legal framework with more self-regulation Option 4: A new flexible general legislative framework on animal health
issues, based on achieving certain animal health outcomes Option 5: A new prescriptive legislative framework on animal health issues,
based on setting specific processes and standards for animal health policy.
4.1.
Option 1 - Do nothing
Current animal
health rules would remain, with technical updates and adaptations made as
necessary but without a horizontal framework establishing overall strategic
objectives. Where possible, existing
regulatory tools would be used to tackle problems identified.
4.2.
Option 2 – Simplification of existing
legislation with no major content or policy changes
This option would enable the bringing together of all the
existing Animal Health Legislation into one large piece of legislation, but
would not make any significant changes to the content of the legislation
itself. Minor changes would only be made as circumstances required, and in
order to comply with the Lisbon Treaty. This would slightly improve clarity of
the legal framework but would not solve the problems highlighted in the AHS and
in Section 2 of this document.
4.3.
Option 3 – Existing legal framework with more self-regulation
This option
would complement the current animal health policy and existing legislation with
additional initiatives of a non-regulatory nature. Under
this option, the use of self-regulation tools[36] such
as the drafting of guidelines by the Commission, or by stakeholders with the
Commission and/or MS acting as facilitators, would be envisaged in order to
cover some of the gaps and inefficiencies of the current animal health
legislation. These guidelines would focus on different aspects of day-to-day
management at the farm level that may be challenging and would encourage best
practice. They would take into account the risks associated with certain types
of production and would explain how to contribute to disease prevention and
implement more effective biosecurity and surveillance measures. As now, MS
would have the ability to regulate certain issues at national level.
Legislation would be updated individually as necessary to comply with new
requirements (such as the new decision-making processes following the
introduction of the Lisbon Treaty), or with technological developments.
4.4.
Option 4 - Flexible general legislative
framework on animal health issues (AHL)
Under this
option, a new legal framework would set out the principles and objectives for
animal health policy required to achieve desired outcomes. The
outcomes, such as certain animal health and linked public health standards,
would be agreed at EU level. However, the framework would be flexible to allow
MS to set their own specific rules in certain cases to achieve these outcomes.
It envisages that these specific rules would be based on veterinary risk
assessment and cost benefit analysis to best suit particular situations in MS. This general
legislative framework of the AHL would not include detailed and specific
legislative provisions such as particular disease control measures for specific
diseases, specific identification and registration rules for each animal species,
or specific measures on movements within the EU for particular species and so
on. These specific measures would be laid down at a later stage by means of
delegated or implementing acts under the procedure foreseen in Articles 290 and
291 of the TFEU. These acts would be subject to an Impact Assessment where
appropriate.
4.5.
Option 5 - Prescriptive general legislative
framework on animal health issues (AHL)
Under this
option, a new comprehensive legal framework would set out the principles and objectives
of animal health. This framework would set specific standards for animal health
rules and procedures which would be required across MS, with
little flexibility for MS to adapt the rules to their differing circumstances. In
this case the legal framework would be much more prescriptive and detailed but
would cover more or less the same or similar content as the previous option. Like option 4,
this general legislative framework of AHL would likely not contain detailed and
specific legislative provisions. These rules would be laid down at a later
stage by means of delegated or implementing acts under the procedure foreseen
in Articles 290 and 291 of the TFEU and subject to an impact assessment where
appropriate. A more detailed overview of what could be included in delegated or
implementing acts can be found in table IX.1 presented in Annex IX.
4.6.
Key elements of the different options
Table 4.1 below
shows in more detail how various elements of animal health policy would be implemented
under each of options 3, 4 and 5. Options 1 and 2 are not considered as they
would not entail changes in policy or approach, and so there would be no
substantive changes to these aspects of policy. Separately, the new
elements of a legislative framework under both options 4 and 5 are set out in
more detail in Annex IX. The possible structure of the AHL and its empowering
provisions is also schematically presented in Annex X. Under option 4
the legislative framework would set out the desired animal health outcomes with
flexibility for MS to set rules and standards appropriate to their situations.
Under option 5 the legislative framework would set out the desired animal
health standards for animal health policy, which MS will be required to
implement. Table 4.1:
Aspects of animal health policy in relation to options 3-5 Aspect of Animal Health Policy || Option 3 || Option 4 || Option 5 Clarification of owners' obligations || Guidelines clarifying keepers' obligations in existing legislation || Set framework of animal health outcomes for which the keepers' obligations have to be set || All keepers have the same obligations - set to maintain higher health standards Training for animal keepers || Guidelines about training for keepers || All keepers must be able to provide a particular level of animal health protection, with training if necessary || All keepers must undertake training to achieve a particular level Clarify vets' responsibilities || Guidelines about vet responsibilities for different types of vet || Vet responsibilities clarified under the basis of not having conflict of interest in light of national organisational structures || All vets have the same responsibilities across EU Vet training || Guidelines about training of vets performing official controls || Requirement for training for all veterinarians performing official tasks ensures same quality of animal health protection throughout EU || All vets undertake identical training for official tasks On-farm biosecurity (also see Annex XI) || Guidelines about best on-farm biosecurity practices, incl. information about costs and benefits of each practice || All keepers must introduce a certain level of biosecurity measures to ensure the health of their animals as appropriate for their type of farming and local circumstances. || All keepers must introduce a certain defined set of on-farm biosecurity measures Prioritise surveillance || Develop non-legislative surveillance strategy/principles for surveillance priority - encourage stakeholders to follow them. || Set basic principles and increase co-ordination of surveillance based on risks and ensuring particular level of animal health protection. Encourage surveillance networks to develop along these principles || Develop EU-wide surveillance system and harmonised surveillance networks Intra-EU trade || No change without altering the legislation. Possible clarification about the use of assembly centres || Allow derogations for certain types of Intra-EU movements in live terrestrial animals based on risk and economic analysis || Move to placing on the market concept for Intra-EU trade in live terrestrial animals Exotic and emerging diseases || Guidelines about best practice for exotic disease controls, develop non-legislative tools to improve disease preparedness and encourage exotic disease research || Develop legislative tools to improve preparedness and react quickly to exotic disease outbreaks; flexibility for MS to adapt tools to their own conditions || Develop tools to deal and to react to exotic diseases - the same obligations across EU Categorisation of diseases || Encourage national CAs and stakeholders to use results of disease categorisation tool to prioritise resources between diseases not covered by EU legislation || Categorise diseases (for intervention) at EU level || Categorise diseases (for intervention) at EU and MS level and fix the tool which is used to categorise diseases Principles for animal health import requirements || Guidelines for importers and TCs clarifying requirements and best practice for imported products || Legislation consolidates and defines animal health standards for imported commodities || Consolidation of criteria into a single transparent document. Allow for higher standards than the international based on risk assessment Compartmentalisation || Improve information about potential for compartments under existing legislation (poultry for AI, aquaculture) || Extend compartments to more animal diseases and species - compartments have flexibility over which measures they implement as long as an EU defined health status is achieved. || Extend compartments to more animal diseases and species - compartments must comply with defined animal health measures Align with OIE standards || Possible only with small /partial modifications in current legislation || Alignment where possible, higher standards in EU legislation only allowed on risk and CBA evidence base || Align EU legislation to OIE framework where it doesn't compromise health standards Non-commercial farming || Encourage best-practice amongst non-commercial farming and develop guidelines for these || Definition and principles for non-commercial farming based on risk outcomes and flexible for MS conditions. Derogations from registration/ movement/ identification requirements for commercial farms where low risk to anima/human health. || Definition and rules set for non-commercial farms harmonised for the EU Vaccination strategy (also see Annex VII) || Raise awareness about the safety of vaccinated meat and alter market perception of vaccinated meat (affect the demand side of vaccine disconnect). || Legal strategy to harmonise the use of vaccines based on their impact on disease control. Options B.i. (providing flexible approach for different diseases of Union concern with EU vaccine bank) and B.ii (without EU vaccine bank) in Annex VII || EU level vaccination strategy, same approach for use of vaccines across the EU. Options A.i (providing a single vaccination policy for all diseases with EU vaccine bank) and A.ii (without EU vaccine bank) in Annex VII. Of course,
elements of the options could be combined for different policy aspects. For
example, a flexible legislative framework could be introduced (option 4) but
with encouragement for self-regulation for, say, improved biosecurity measures
(following the principle of option 3) and perhaps some specific detailed rules
on the face of the law for, say, animal trade and movements (in accordance with
the principle of option 5). Other combinations are of course possible.
5.
Impact analysis
The analysis
below sets out the impacts of the different options. Options 1 (no change) and
2 (simplification only) are briefly analysed and related back to the existing
problems already identified in Chapter 2. The reduction in the instance of
animal disease is such a crucial outcome that a short introduction on the
overall impact on the reduction of animal disease is necessary for each of the
options 3-5. The analysis will then look at the economic, social and
environmental impacts of each option. As mentioned above, additional analysis
on intra-EU trade is also available in Annex VIII, and on biosecurity in Annex
XI. The potential effects of changes were felt to be so potentially
wide-ranging in these areas that some further scrutiny of the possible impacts
was felt necessary.
5.1.
Option 1 – No Change
To allow for a proper
comparison of the options, Option 1, continuing with current animal health
policy, is being used as the policy baseline and the impacts of the other
options will be assessed in relation to it. The no change option
has already been specifically rejected by both the impact assessment for the AHS
and the CAHP assessment, and would therefore be extremely difficult to justify.
No change will mean a continuation of the current EU level approach to tackling
animal health issues and the problems identified in Chapter 2.2. Some
illustrations of the possible consequences of 'no change' are set out below and
add to the evidence that option 1 is not a desirable approach because of the
potentially high-impact consequences of continuing with the current framework.
Choosing this option would mean accepting the lack of a coherent, comprehensive
approach to the EU’s work in the field of animal health. The major objectives
and principles of the CAHP, including the protection of animal health and also
the associated public health aims would not be achieved. The roles and
responsibilities of all actors involved in animal health will continue to lack
clarity and there will be an insufficient focus on
disease prevention. The EU will have to face the new
challenges for animal and public health described in Chapter 2 with the current
legal and financial instruments that would not necessarily be fit for purpose. This option will not provide sufficient incentives for farmers and
animal keepers to take optimal preventative disease measures. This in turn could
lower public opinion of the EU farming industries, which has already been dented
in recent crises. Furthermore, an
adaptation of basic acts to the new regulatory procedure on the execution of
powers based on the Treaty of Lisbon is necessary. This fact in itself requires
at least certain legislative changes in the current animal health legislation
and therefore doesn't support the no-change scenario. In the boxes
below we use some hypothetical examples to illustrate
the potential impact of this option. The option doesn't promote a effective and
pro-active approach to emerging and exotic diseases, or encourage the optimal
preventive approaches or categorization of risks. There would be impacts on
public health, on consumption, and on trade, as well as economic costs. Possible consequences of a human influenza pandemic caused by a virus of avian or mammal origin Influenza viruses are a large family of viruses able to infect many species of birds and mammals, including humans. Wild aquatic birds are the main reservoir of influenza viruses. These viruses may also spread to mammals and adapt to the new hosts. When a new influenza virus able to be transmitted between humans emerges, it may rapidly spread throughout the world causing a human pandemic. During previous pandemics, great variations have been seen in mortality rates, severity of illness, and patterns of spread. The mortality of the previous century’s three pandemics varied enormously, from less than 1 million to some 50 million deaths. One consistent feature reported in all cases, nonetheless, was the rapid surge in the number of fatalities and their exponential increase over a very brief time, often measured in weeks. Most recent estimates indicate that the “Spanish” flu outbreak of 1918 that was caused by a virus of avian origin could have been responsible for the death of 50 million people, or 2.5% of the global population of the time. The recent fears of a devastating incoming pandemic originated from the emergence of a new avian influenza virus type H5N1 in south-east Asia in the mid 1990s which was capable of infecting and causing disease not only in birds but also in humans (due to bird-to-human transmission). From 2003 this virus began spreading westwards to more than 50 countries in Asia, Europe and Africa. According to data from the WHO, by 3 June 2011, a total of 556 human cases of H5N1 avian influenza had been reported, causing a total of 325 deaths. This represents a high case-fatality rate of 58%. Several incursions of this virus, mainly due to the spread via migratory birds, also occurred in the EU in 2006-2010, in poultry and other birds. However, the disease was successfully contained and eradicated, thanks to enhanced surveillance and control measures, and no human cases occurred. However, while the scientific community was mainly focussing on the potential pandemic risk posed by the H5N1 virus, in 2009 the 'swine 'flu' pandemic caused by the H1N1 influenza virus, which included genes of bird, human and pig origin, emerged in Mexico and then spread all over the world (human-to-human transmission). Eventually the pandemic caused by this virus was much less serious than feared at first, although it caused at least 18,000 deaths, with a case fatality rate of 0.03%. Recently, the H5N1 virus circulating in Egypt – where 145 human cases have been reported in the last years - showed increased ability to bind to human cells, which may indicate an increased pandemic potential. Scientists continue to recommend closely following the evolution of this virus and to intensify the efforts to eradicate it from birds in those countries in Asia and Africa where it is currently endemic. Pandemics, like the viruses that cause them, are largely unpredictable and it is therefore impossible to predict with any accuracy the origin of the next pandemic and its impact. However, all estimates, from the best-case to the worst-case scenario, show that losses would be very extensive. These consequences might be prevented or their impacts diminished by more effective preventive mechanisms and better tools for rapid response to emerging risks. Examples of impact of disease outbreaks on trade · The UK had developed a significant export trade in beef and live cattle during the early 1990s. By 1995, annual exports of beef of 300,000 tonnes were worth almost £600 million. There was also a substantial trade in live calves from the British dairy herd to the rest of Europe, worth some £70 million per year. This trade completely collapsed when the European Union imposed a ban on all UK exports worldwide as a consequence of the BSE crisis. (Source: DEFRA) · In 2003 Classical Swine Fever (CSF) outbreaks in the Netherlands, Belgium, Germany, France and Spain resulted in a drop of 15% in live animal exports (Source: Europa- Agriculture Trade Statistics).
5.2.
Option 2 – Simplification of existing legal
framework with no significant policy change
Option 2 assumes
that there would be a simplification of the existing legal framework, by
bringing together the several pieces of existing legislation into one overall
piece of legislation but without addressing policy options and developments set
out in the AHS. The benefits
associated with this option are solely those from the simplification of the
legislation. By bringing together all the existing legislation into one place, there
would be some improved simplicity for those stakeholders searching for
legislation who weren't already aware where it would be. However, it is
difficult to see how this would actually work in practice. The existing
legislation has no single set of principles of overarching coherence and so to
put everything in one piece of legislation would lead to a long list of the
existing acquis, really achieving very little in the way of genuine simplification.
If option 2 is
chosen the EU would run a reputational risk as a key opportunity would be
missed to address the deficiencies in the current legislation which have been
widely criticised, and the problems due to the lack of a single overall policy
(Section 2.2.2.), the insufficient focus on disease prevention (Section 2.2.3.)
and the shortcomings of the current rules on intra-EU trade (Section 2.2.4.).
Even the problem of the large number of pieces of legislation and complexity of
the current legal framework discussed in Section 2.2.1. would not be solved, as
any new piece of law is not by definition more coherent unless work is done to
identify and set out the principles of the animal health policy and create a
new, overarching legal framework. The approach of
option 2 would not solve the problems that have emerged during the evaluation
of the CAHP and highlighted by the stakeholders during the recent consultations.
5.3.
Option 3 – Existing legal framework with more self-regulation
Self-regulation
is defined by the Commission as "voluntary agreements between private bodies
to solve problems by taking commitments between themselves". This option
is composed mainly of non-regulatory actions that will be carried out with the
resources currently available and will not create additional administrative
burdens. These actions would include the Commission and/or MS either developing
guidance and best practice to improve animal health measures or encouraging
stakeholders to do so. These would be complementary to the existing animal
health legal framework and would aim to achieve better prevention of animal
diseases. In general
terms, offering guidance and promoting best practices for animal health
measures will make animal keepers and other actors in the food chain better
informed about animal health measures and disease risks and so take more
responsibility for their actions. If animal keepers are more aware of best
practices for preventing diseases, they are more likely to implement measures,
such as biosecurity and surveillance, which would be worthwhile for them in
terms of reducing the frequency and impact of animal diseases. However, these
actions will not be mandated. They rely on the willingness of stakeholders to
develop guidance in the first place; and the co-operation of animal keepers in
voluntarily following this guidance, under circumstances where it may not
always be in their direct interest to do so. Therefore the actual effects of
this option being put into practice are very uncertain, ranging from no change
at all at one end to a potentially fairly positive impact at the other.
Nevertheless, even if some significantly positive self-regulatory schemes were
to get successfully underway, working within the existing legal framework would
be likely to prove challenging. As part of this
option, we can assume that certain legislative changes would be necessary (for
example, to align with the new co-decision requirements as agreed under the Lisbon Treaty, or because of technological developments). However, these would be carried
out individually for each piece of legislation rather than trying to coherently
combine them into a new overarching framework as envisaged in options 4 and 5. If we assume
that some change takes place under option 3, there should be a reduction in the
scale and frequency of animal disease outbreaks. This is largely because
increased guidance and information is likely to improve understanding and
take-up of preventative disease measures. The likely
reduction in the scale and frequency of animal disease outbreaks is due to: ·
The clarification of owners' obligations –
keepers are more likely to understand their obligations and comply with them. ·
The increased likelihood of additional training
being taken by animal keepers. ·
The increase in understanding of biosecurity and
keepers' likely take-up of best practice in biosecurity. ·
The increase in understanding of the importance
of surveillance and better individual surveillance measures being taken. ·
Better information sharing about emerging and
exotic diseases and their possible impacts. ·
Encouraging better information-sharing and best
practice among non-commercial farmers. ·
Increased take-up of vaccination where
appropriate. However, as
mentioned above, under self-regulation there would be no mandates or incentives
for stakeholders to implement best practices recommended in guidelines (if
guidelines are developed at all). This means that each stakeholder is only
likely to improve his animal health practices when it is worthwhile for him as
an individual to do so – i.e. the projected reduction in the costs of animal
disease to the individual stakeholder is higher than the costs of implementing
preventative measures. They have no incentive to consider the wider benefits of
reduction in animal disease, for example benefits to other stakeholders,
competent authorities, consumers and rural economies. Therefore, the
improvement in animal health practices would be lower than required to reduce
the impact of animal diseases by the socially optimal amount, and there is a
smaller reduction in animal diseases compared to using mandates or incentives. It is very
difficult to accurately quantify this reduction in animal disease outbreaks, as
the scale and frequency of disease outbreaks depend on an extremely complex set
of factors, on top of the aforementioned uncertainties inherent in this option.
Furthermore it
needs to be mentioned that an adaptation of basic acts to the new regulatory
procedure on the execution of powers based on the Treaty of Lisbon is
necessary. This fact in itself requires at least certain legislative changes to
the current animal health legislation.
5.3.1.
Economic
impacts
Assuming that
some action towards self-regulation does happen, the possible economic impacts
of option 3 divide into two aspects: ·
the impacts on farming and the rural economy;
and ·
the impact on the promotion of growth and
cohesion within the EU. Of these, the
first (the impacts on farming and the rural economy) would largely be positive
impacts. The reduction in the scale and frequency of animal disease outbreaks
that option 3 could be expected to deliver will have positive ramifications in
several areas. It is impossible to quantify these savings but there will be
benefits to: ·
The farming sector, through: o
Direct financial benefits of reduced disease
instance o
Benefits through simplification of
administrative burdens (although this is initially partially offset by extra
costs of adjusting to any new system and developing guidance) o
Development of new, more efficient practices ·
Wider food chain stakeholders, particularly
assembly centres; transporters and dealers; slaughterhouses; and food
processing companies. ·
The rural economy, particularly through possible
improved rural employment opportunities and benefits to rural tourism (or
rather, fewer disbenefits because of the lack of movement restrictions or other
stigma associated with disease outbreaks). With respect to
the promotion of growth and cohesion within the EU, there might be some
positive impacts from clarifying the use of assembly centres for live
movements, which may enhance intra-EU trade. However, there will be some
initial negative impacts from familiarising and implementing any new
guidelines. Because of the uncertainty of whether and how these factors would
be implemented under self-regulation, and their complex interaction, it is
difficult to say whether the overall positive economic impact of any measures
would outweigh the familiarisation and implementation costs.
5.3.2.
Social
Impacts
The social
impacts of any positive self-regulation measures stem directly from the
aforementioned potential reduction in animal disease instances. Any reduction
in animal disease would consequently reduce any associated public health risks.
So the impact (if any) is positive, but indirect and impossible to quantify.
5.3.3.
Environmental
impacts
First, the best
practice guidelines envisaged in option 3 are likely to include aspects related
to appropriate environmental management of the farm, especially regarding the
use of veterinary medicinal products and better hygiene (management of slurry,
etc) to minimise the environmental impact of farming practices. Therefore, if
these guidelines are in fact developed, we can assume a positive environmental
impact from the effects of improved environmental management. Assuming that
there is a reduced instance of animal disease outbreaks, we can extrapolate
several other positive environmental impacts. However, as noted previously,
this is an assumption that is uncertain and impossible to quantify.
Nevertheless, the likely positive impacts include the below. Animal diseases
found in kept animals can have negative impacts on wildlife (for example, the
impact of avian flu on wild birds). Thus reducing the incidence of such
diseases should have a two-fold beneficial effect; both in the reduction of
wildlife disease and the protection of biodiversity, and subsequent reduction
of the risk of diseased wildlife re-infecting kept animals and even humans.
Guidelines on best practices should also help farmers to better understand the
importance of their role in interacting with and protecting wildlife and
biodiversity. Reduced animal
disease instance would also lead to fewer health-related welfare problems,
thereby overall improving animal welfare. In addition, if new guidelines
promote better use of vaccination, this will also have a preventative effect on
both animal diseases and also the associated welfare problems. We can also
assume that biosecurity guidelines would be included in any self-regulatory
guidance scheme. It is very difficult to predict what the environmental impacts
of improved biosecurity measures would be. On the one hand, we have already
identified the positive environmental impacts from the lower instance of animal
disease outbreaks. On the other hand, increased biosecurity measures might
include the increased use of disinfectants or chemicals which could potentially
have harmful effects on the surrounding environment.
5.4.
Option 4 – flexible general legislative
framework for animal health issues
Option 4 covers
a new flexible general legislative framework as envisaged in the AHS. This is
expected to have more definite and deeper impacts than option 3 because it will
enable legislative changes in animal health policy, which option 3 cannot bring
about. It will also mandate certain aspects of animal health policy which
option 3 only makes voluntary. And although it potentially has similar outcomes
to option 5 in terms of animal health; it offers greater flexibility and
subsequently a potentially lower administrative burden. As noted previously, Table
4.1 and Annex IX show in more detail which measures option 4 would specifically
entail. However, the longer-term impacts of option 4 cannot be fully quantified
at present because many of the specific rules of a general framework law on
animal health will be developed subsequent to the law's introduction.
Nevertheless, some general points about the overall direction of travel, and
whether its effects are likely to be positive or negative, can be made in
respect of its economic, social and environmental impacts.
5.4.1.
Economic
impacts
The economic
impacts of option 4 are expected to be largely positive. First, there are
the benefits expected from reduced disease instance. These are much as outlined
in 5.3.1, but because option 4 would have more definite and deeper outcomes,
and is expected to have a greater impact in any case, we can say that the
impacts from prevention of animal diseases would be of a similar nature, but
more pronounced. However, for the reasons outlined above, it is very difficult
to quantify them any further than in relative terms. Overall,
resources will be better targeted according to risk, saving time and money.
This is true of surveillance, where a more risk-based approach will be
encouraged; and contingency planning and categorisation/prioritisation of diseases
where legislative tools will be developed to improve readiness for disease
outbreaks in accordance with their risk of actually occurring. A vaccination
strategy will be developed to harmonise the use of vaccines based on their
impact on disease control. The safety of products of animal origin from vaccinated
animals could be emphasised to encourage the industry to increase use of
vaccines, when relevant and possible. This would likely have positive economic
impacts in the reduction of the instance of animal disease and all the
associated impacts mentioned elsewhere in this analysis. However, there would
still exist certain barriers to trade with countries who do not wish to import
meat from vaccinated animals due to negative consumer perception and/or
associated risks of spreading disease, so this may have a negative economic
impact. An impact of
option 4 which needs some further analysis is that of administrative burden.
Undoubtedly there would be some negative economic impact from the initial administrative
burden of familiarisation with the new legislative framework for farmers and
other animal keepers as well as competent authorities. However, due to the very nature of animal disease, regular updates
of valid rules are standard procedure which means that one-off familiarisation costs are likely to be limited
and integrated into business-as-usual costs (see feature box below). As regards to the costs of
familiarisation with new legislation, due to the very nature of animal diseases
and continuously evolving legislation, these are largely part of
business-as-usual costs. However, a special effort might be needed for CA to
adequately manage the implementation of new legislation. In order to support MS
in this task, while generating EU added value by fostering experience exchange,
the Commission services maintain the 'Better Training for Safer Food'
initiative[37]
to train and advice officials in MS and third countries on EU requirements. A practical example is the training
on zoonoses which was provided in 2009 and 2010 for more than 300 Member States'
officials, focusing on microbiological criteria and the control of zoonoses,
with a total cost of just over €2m for the two years. Ongoing training activities should
only be adapted to the needs deriving from the adoption of the new legislative
framework. Nevertheless, in
the long term, the more coherent strategic framework should make more sense to
those learning about their obligations for the first time (for example, for new
entrants to farming). Overall and in the long term, it is fair to assume that a
flexible and outcome-based framework will impose a lower administrative burden
on farming and related industries and animal keepers than the prescriptive
framework of option 5. This is because its inherent flexibility means
obligations and requirements could be tailored to national or regional
circumstances, enabling MSs to adapt any administrative obligations to that
which is only strictly necessary according to a reasonable assessment of risk. However, this
could lead to them setting lighter touch regulation, or fewer requirements than
at EU level, because they do not wish to impose higher burdens than other MSs
thereby placing their livestock industry at a competitive disadvantage. In
addition, they might not fully consider the impacts of diseases on other MS
when deciding level of controls – so they implement fewer controls that would
be optimal for the EU as a whole (taking into account the full costs of disease
spread). There are two
examples that were felt particularly important to analyse in more detail:
biosecurity and trade. With respect to biosecurity, a questionnaire was carried
out to seek the views of relevant stakeholders about the level of burden that
the possible introduction of biosecurity plans would bring. The results are
shown in detail in Annex XI and demonstrate mixed views. While many
stakeholders thought that biosecurity plans would represent overall cost
savings, others thought that they would impose too many costs. These mixed
views suggest that the possibility of option 4, allowing MSs to introduce
biosecurity plans if they felt it beneficial, would be the best option for all
parties. More will be said about this in the analysis relating to option 5
below. Intra-EU trade
in animals was the other issue to be looked at in more detail, as it might be
particularly affected. Under option 4, possible derogations to remove the
burden of health certification could be introduced in a combination of the AHL
itself and secondary legislation. Nevertheless, derogations would refer to
specific sectors or types of movements, and so for each category of movement which
is allowed derogation, a full individual risk and economic assessment would
need to be carried out. However, it is
possible to estimate the unit saving per consignment if a particular derogation
for health certification was introduced. The overview of the administrative
burden at present is available in Annex VIII. The unit reduction in
administrative burden is set out in Table 5.2 below following the Standard Cost
Model template. The administrative burden saving to operators is estimated to
be €120 per consignment sent, and the saving to the competent authority
estimated at €128. These are based on the time estimates received from the
administrative burden questionnaires during the consultation period and are
estimates of the savings related to removing certification for particular
procedures which are considered low risk, for example, moving animals for
slaughter. For illustrative
purposes, the following table applies the unit cost saving to different types
of movements to illustrate the potential annual reduction in administrative
burden that could be realised if various derogations were introduced. They are
based on the annual number of consignments sent between MS from information in
TRACES. As derogations would usually be introduced in a secondary level of
legislation these benefits would not be immediately realised when the AHL was
adopted, but they are indicative of the direction of travel proposed. Table 5.2: Illustrative reduction in administrative burden saving
for different categories of movements, based on movement figures in 2009.
Savings figures represent estimated annual cost savings. || Number of Consignments || Savings to Operator || Savings to Competent Authority || Total Savings Bovine - direct to slaughter || 16,939 || 2,036,068 € || 2,170, 733 € || 4,206,801 € Bovine - all slaughter || 28,314 || 3,403,343 € || 3,628,439 € || 7,031,782 € Bovine - all movements w/out assembly centre || 92,618 || 11,132,684 € || 11,868,997 € || 23,001,680 € All species - movements less than 3 hours || 115,726 || 13,910,265 € || 14,830,287 € || 28,740,552 € All species - less than 3 hours and to slaughter || 68,052 || 8,179,850 € || 8,720,864 € || 16,900,714 € All movements to slaughter || 321,838 || 38,684,928 € || 41,243,540 € || 79,928,467 € Of which: || Bovine || 28,314 || 3,403,343 € || 3,628,439 € || 7,031,782 € || Equine || 3,537 || 425,147 € || 453,267 € || 878,414 € || Goats || 621 || 74,644 € || 79,581 € || 154,225 € || Poultry || 52,364 || 6,294,153 € || 6,710,447 € || 13,004,599 € || Sheep || 8,721 || 1,048,264 € || 1,117,596 € || 2,165,860 € || Swine || 78,691 || 9,458,658 € || 10,084,252 € || 19,542,910 € There would also
be other economic impacts. The law would introduce some obligations to acquire
particular knowledge for all veterinarians performing official tasks across the
EU. Therefore it would be easier for vets to move around between MS to perform
official tasks. This has both economic and social impacts, as it would improve
the flexibility of the vet labour market in responding to supply and demand
peaks and troughs (especially in times of animal disease outbreaks, when a
great deal of veterinary resource may be needed in a particular place). Unpublished data
from the Federation of Veterinarians of Europe (FVE)[38] in 2010 shows that the total
number of veterinarians in the 27 EU MS is 187,175. Of this number, around
25,000 work in the public veterinary services. However, it is worth noting that
a large proportion of veterinarians working in private or general practice
(around 112,000) also carry out some official public tasks as official or
authorised veterinarians. All these categories of veterinarians will be
affected to some extent by the changes described above. The obligation
to have a basic knowledge of animal health matters would not generally be over
and above what is expected in good practice. Therefore, veterinarians and the
vast majority of commercial farmers would not expect to be affected by this
requirement, as their training and education, working experience and/or
acquired knowledge would be sufficient to meet the basic requirements. These
measures will concentrate on improving the knowledge of those carrying out
activities which represent a higher health risk (such as assembly operations),
and new entrants. It should also require those (relatively few) individuals who
present health risks through lack of knowledge and bad practice to improve
their standards. Those who would be affected are exactly those who pose the
most risk, so this obligation is proportionate and sensible for disease
prevention. It is not
envisaged that this measure would impose significant or disproportionate economic
impacts on non-commercial farmers or other keepers of animals. While they will
be required to have some basic knowledge about animal health where appropriate,
it will not be over and above what good practice would dictate. In line with
the risk-based approach of the framework, pet animals are proposed to be exempt
from the requirements for registration, approval, record-keeping and
register-keeping; movement certification where their movements are
non-commercial; and in some cases, the requirements for import into the Union. As well as pets, other small-scale and low-risk situations would or could be granted
derogations from requirements such as registration of premises, movement
certification and identification requirements. In some cases, MS would be able
to decide at what level these derogations would apply, ensuring that local
contexts were taken into account. Thus this option
aims to achieve the optimum balance between reducing disease risk, but
minimising costs and adapting to local circumstances.
5.4.2.
Social
Impacts
As noted above,
there should be a slightly positive social effect with respect to the
flexibility of the veterinary labour market and in particular, some benefits
from achieving a consistently safe standard across the EU in animals and animal
products.
5.4.3.
Environmental
impacts
Assuming that
there is a reduced instance of animal disease outbreaks, we can extrapolate
several other positive environmental impacts. However, as noted previously,
this is an assumption that is uncertain and impossible to quantify. We can
nevertheless assume that the flexible AHL will have a greater impact on animal
disease than option 3, and the likely positive impacts include the below. First, a better
structured vaccination policy, setting up a flexible legal framework for
vaccination, will provide the possibility of different approaches to be used
for different diseases under different circumstances. The AHL will give the
possibility to animal keepers to use vaccination for all diseases, and promote
the vaccination option whenever feasible. For diseases relevant for Union
intervention the AHL will take a flexible approach by choosing the best option
to address a particular disease in particular circumstances on a case by case
basis; for example, by allowing either a general preventive vaccination,
introducing compulsory vaccination, or providing for emergency vaccination
only, etc). For more details see Annex VII. Reduced animal
disease instance would also lead to fewer health-related welfare problems,
thereby in overall terms improving animal welfare. In addition, if new
guidelines promote better use of vaccination, this will also have a
preventative effect on both animal diseases but also the associated welfare
problems. We can also
assume that improved biosecurity would be encouraged in some form in a flexible
manner. It is very difficult to predict what the environmental impacts of
improved biosecurity measures would be. On the one hand, we have already
identified the positive environmental impacts from the lower instance of animal
disease outbreaks. On the other hand, increased biosecurity measures might
include the increased use of disinfectants or chemicals which could have
harmful effects on the surrounding environment. More stringent biosecurity
measures can, however, have negative impacts on animal welfare. For example, housing
pigs or poultry indoors all year round could have negative welfare impacts. All the above
could also result in better overall health of animals, which would contribute
to the reduced use of antimicrobial agents in animals and thus indirectly,
reducing the level of antimicrobial resistant microorganisms in animals. As with option
3, the reduction of the incidence of animal disease should have a two-fold beneficial
effect on wildlife, through the reduction in animal disease in wildlife, the
associated health and welfare benefits and the protection of biodiversity; and the
subsequent reduction of the risk of diseased wildlife re-infecting kept animals
and even humans.
5.5.
Option 5 – prescriptive general legislative
framework for animal health issues
Option 5 is a
prescriptive legal framework setting out specific requirements for animal
health. More details about the measures that option 5 would entail are
available in Table 4.1 above. Analysis of the
impacts of option 5 does come up against some of the same problems as with the
other options; namely, that it is a wide-ranging legislative proposal with many
different aspects. Most of the details will be covered in delegated or
implementing legislation and cannot be fully described in this impact
assessment. Those specific proposals with significant anticipated impacts are
likely to undergo their own specific impact assessment before introduction. In
this assessment, while the general direction of travel can be extrapolated, the
specific levels at which certain requirements would be set are as yet
impossible to develop and assess. Option 5 is
likely to lead to a significant reduction in the instance of animal disease in
the EU. This has the associated benefits already described in options 3 and 4.
However, option 5 is likely to have a significant administrative burden. In
addition, more prescriptive rules are liable to become obsolete much more
quickly with environmental and technological changes as they are less flexible.
The main focus in the assessment of this option is to determine whether the
projected reduction in disease is worth the associated implementation and
ongoing costs, including the potential administrative burden.
5.5.1.
Economic
impacts
Option 5 should
entail a reduction in animal disease, but as for the other options, this is
extremely difficult to quantify. It is difficult to assert with any confidence
that requiring the same standards across the board, as in option 5, will have a
better or worse effect than a well-executed risk-based approach, as in option 4.
It depends at what level resources are applied and standards are set. However,
one could assert that (assuming the same level of resources applied to each
option) a good risk-based application of resources, with riskier areas assigned
more time and attention; will have a more beneficial effect than a uniform
standard applied across the board, with riskier and less risky areas assigned a
similar level of resources. As with option 4,
if option 5 were to be introduced, there would be a transitional administrative
burden associated with animal keepers and competent authorities familiarising
themselves with the new legislation. However, and as for option 4, due to the
very nature of animal disease, regular updates of valid rules are standard
procedure, which means that one-off familiarisation
costs are likely to be negligible and integrated into business-as-usual costs. Also, over time, and particularly for those new to animal keeping, a
more coherent framework should be easier to understand compared with option 1
(no change). Nevertheless,
option 5 envisages very comprehensive training for farmers, even those who have
many years of experience. This would be an enormous administrative burden for
the farmers themselves. If the MSs were obliged to provide or source the
training, it would also be a massive burden for them. We can very roughly extrapolate a
range for the potential administrative burden of providing training. We will assume that training is
required by many farm personnel working with animals. There are 16.4m persons
who work regularly on farm holdings (Eurostat). If we assume that 45-55% of
these farmers work with animals at some point, we get a figure of 7.4-9.0m
persons. Of these farm personnel working with animals, we might assume that
20-40% would be exempted because of previous education, professional
development or training, or 'grandfather rights'. This would leave a range of
4.4m - 7.2m people requiring training. We will also assume that every person
will have one day's training and we can assume that a day's training costs
€200-400 per person to put on. So total administrative burden
(number of people x cost per person) is estimated to be in the range of €886m -
€2.89bn. This ignores the costs of lost labour to those taking the training,
and the cost of developing it and setting it up. So even if it were possible to use
existing mechanisms for training delivery such as the Farm Advisory Service[39], this is an enormous sum and
would be very difficult to justify imposing on MSs unless there were very
significant benefits expected. As it is, although some benefits would likely
arise, it is virtually impossible to demonstrate that the added value of this
extent of training would be in the region of billions of euros. In addition, the
lack of flexibility in the ability of animal keepers to implement differing
measures for differing circumstances would likely mean that in many cases,
keepers would be implementing measures very unlikely to benefit them or their
neighbours, perhaps measures altogether unnecessary. Some animal keepers such
as 'hobby' or backyard keepers, and perhaps even those with family pets, would
also have to accept a new administrative burden. The
administrative burden for MSs is potentially very large with this option. The
size of the burden would depend on exactly how it were to be implemented, but
if there were requirements for MSs to provide training for animal keepers; as
well as developing, administering and enforcing new animal health measures in
biosecurity and surveillance; the burdens would be very significant. For
example, the specific analysis of the possible administrative burden on MSs
with respect to possible biosecurity requirements was carried out through a
questionnaire to the MSs, as mentioned above, and the full results can be seen
in Annex XI. The questionnaire results show mixed opinions among stakeholders.
While some felt that biosecurity plans would be beneficial overall, others felt
that the costs involved would be disproportionate. Therefore, on the basis of
these results, it would be difficult to justify imposing biosecurity plans as
an obligatory requirement for all relevant holdings and operators in all MSs. On the positive
side, the new prescriptive law would likely remove some of the obstacles to
animal movements, promoting a more harmonised single market. However, with a
prescriptive and comprehensive system of movements there are likely to be
'winners' and 'losers' among those who are differently affected by the new
requirements, some of whom will benefit economically, but some who will bear
additional costs (see also Table VIII.2 and Figure VIII.2 of Annex VIII). There
will also be a positive economic impact from a more harmonised veterinary
expertise. If vets are required to undergo identical training for official
tasks, this will promote their free movement and, as with option 4, enable the
supply of vets to better follow peaks and troughs in demand according to
circumstances such as disease outbreaks. More detail on this is below in the
social impacts.
5.5.2.
Social
impacts
The prescriptive
legislative framework will set out the knowledge and skills which must be
attained in the professional qualifications and training for official and
approved veterinarians at EU level. Ensuring that veterinarians have the same
knowledge and skills throughout the EU will make it easier for official and
approved veterinarians to work in other MS without compromising health
standards. Additionally, as these veterinarians all acquire more comparable
knowledge and skills, this will improve the functioning of the veterinary
labour market as it will reduce the barriers to veterinarians moving between MS.
As noted in option 4, most veterinarians would be affected to some degree, and
a large proportion of them work full time in public veterinary services or do some
public veterinary work.
5.5.3.
Environmental
impacts
There should
largely be positive health and environmental impacts from the implementation of
option 5, very similar to those outlined in option 4. On the one hand, more
mandated actions might be expected to produce more positive environmental
impacts of the kind outlined in relation to option 4. However, the increased
rigidity of option 5 may mean that measures are less adaptable to particular
environmental circumstances, perhaps leading to some negative environmental
impacts. It is very difficult to assess even the relative direction of travel
here, let alone to quantify the expected impacts. This is also
relevant for possible vaccination policy options, which would in this option
envisage a single vaccination policy for all diseases. This option is
considered in a detailed evaluation in Annex VII and assessed as not
realistic.
6.
How do the options compare?
Below in Table
6.1 is a general summary analysis of options 3-5 against the suggested
assessment criteria of effectiveness, efficiency, and coherence with
overarching EU objectives, strategies and priorities. Options 1 and 2 are not
considered here because they self-evidently do not meet the objectives set out
in Section 3. Table 6.1:
Comparison of Options 3-5 Objectives || Option 3 || Option 4 || Option 5 Effectiveness || Option 3 has a range of outcomes from no change compared to the baseline, to a relatively significant self-regulatory system. Its effectiveness in relation to achieving the objectives is therefore more likely to be positive than negative. + || Option 4 is likely to be effective in achieving or working towards these objectives. + || Option 5 is likely to be effective in achieving or working towards these objectives, but may be less likely to maintain this effectiveness in the long term because of its lack of flexibility. + Efficiency || Its efficiency depends on the amount of resources devoted to getting a self-regulatory system up and running. However, it will not require time consuming regulatory change. +/- || The flexible framework will require limited familiarisation costs; because this will mainly be undertaken within already existing training networks (e.g. BTSF, etc).It is likely to be more understandable and efficient in the longer term for stakeholders, both animal keepers and MS. ++ || Option 5 is likely to require more administrative burden to familiarise and implement. While it will allow for more coherence in the legislation and may lead to an overall benefit, the lack of flexibility means that as circumstances change, more resource will be required to change the legislation. + Coherence with EU objectives || It would not achieve the objectives set out in the EU AHS of bringing together all AH legislation under one framework. - || Would achieve the EU AH strategy goal of bringing together all AH legislation into a coherent and flexible framework. Is in line with flexible approach taken elsewhere and is most likely to achieve the operational objectives in section 3. ++ || Would achieve the EU AH strategy goal of a single legislative framework but the lack of flexibility means it is less likely to achieve some of the operational objectives as it is less able to be adapted to changing circumstances in the future. + Overall, option 4
seems to be the option most likely to deliver a good level of effectiveness,
efficiency and coherence with EU objectives. It should achieve the main
objectives of delivering the clarity and coherence of an overall strategy and
framework, but leaving flexibility to allow for particular circumstances in
particular MS or regions, and to adapt to rapidly changing circumstances. Therefore,
it is also the option which best respects the principles of subsidiarity and
proportionality. Option 3, while offering more continuity with the present
context, simply lacks any guarantee of positive outcomes, and retains the
existing confusing myriad of legislation. Option 5 would deliver the objective
of simplicity with an overarching strategy and framework, but is likely to be too
rigid to adapt successfully to differing circumstances across the Union and changes in the long term, so potentially undermining its own objectives. The beauty of
option 4 is in its flexibility. As noted previously, the nature of the
overarching enabling framework means that it is possible for certain specific
policy measures to use the tools outlined in general terms in options 3 or 5.
The tools of option 3 (some self-regulatory schemes or elements) could be
introduced or encouraged if a particular issue was felt to be unnecessary or
inappropriate to be specifically covered in legislation
The more prescriptive legislative framework described
in option 5 could be introduced for particular issues, species or diseases
under delegated or implementing legislation under the flexible legislative
framework if more detailed measures were necessary or appropriate.
7.
How will the option implemented be assessed?
The option
implemented will need to achieve, or clearly work positively towards achieving,
the objectives set out in Section 3. The AHS sums up
the purpose of performance indicators well: "Simple and reliable
performance indicators will help to measure progress towards the strategy’s
goals, guide policy, inform priorities, target resources and focus discussion […]
They will cover both hard indicators of animal health (e.g. disease prevalence,
number of animals culled due to disease) and softer indicators tracking the
confidence, expectations and perceptions of European citizens. It must be
recognised that uncertainties and unforeseeable events may affect achievement
of the performance indicators." It is very
difficult to prescribe a set of precise indicators here that will definitively
show that such a wide-ranging initiative such as the AHL has succeeded in its
objectives; and additionally that any improvement in the indicators is directly
attributable to the AHL. This is partly because of the complexity of the
interlinked measures and their effects; and partly because the objectives could
be completely undermined by external events out of the direct control of the EU
or its MSs. Not only are there peaks and troughs in certain indicators (such as
animal disease outbreaks) that might not be indicative of the direct effects of
the AH Law; there are also other wider factors (for example, political or
economic issues either within or outside the EU) that may affect the general
direction of travel in some indicators. Nevertheless, a
series of measurements over a fairly generous timeframe should give an
indication of the general direction of travel. Those indicators could be, as
the strategy says, hard indicators or soft indicators. Examples of hard
indicators of success are: -
the proportion of EU veterinary expenditure for
eradication and monitoring measures compared to costs of emergency measures
(data from emergency veterinary fund); -
restrictions (number of areas x length of
restrictions) due to outbreaks of regulated notifiable diseases (data from
ADNS/ADIS); -
the number of large scale disease outbreaks and
of animals culled due to eradication measures (data from emergency veterinary
fund); -
overall costs and losses for the EU, MS and
farmers and other stakeholders due to animal disease outbreaks -
animal consignments moved across borders under
the simplified regime; -
the number of training sessions taken up by
animal keepers, especially farmers. Several 'soft'
perception indicators could be developed around the objectives outlined in
section 3, particularly the operational objectives. These would need to cover
the perceptions of the relevant stakeholders about the success or otherwise of
each objective – sometimes a wide range of stakeholders, sometimes more narrow.
For a genuinely useful indicator, a baseline would need to be taken either
before or at the moment that the AHL is implemented, and comparisons in
perceptions taken at future points in time. As noted above,
this impact assessment is necessarily a wide-ranging overview. When specific
secondary legislative measures are introduced, more specific impact assessments
will need to be completed, and as part of this, much more specific indicators
for each measure. It is envisaged
that an evaluation should take place around five years after the implementation
of the AHL, and the results will be made available for future decision-making.
ANNEX I Glossary
of technical terms and abbreviations
ADIS || Animal Disease Information System ADNS || Animal Disease Notification System AGRI || EU Commission's Directorate General for Agriculture and Rural Development AHAC || Animal Health Advisory Committee AHL || Animal Health Law AHS || Animal Health Strategy 2007-2013 AI || Avian Influenza ASF || African Swine Fever AVEC || Association of Poultry Processors and Poultry Trade in the EU countries BSE || Bovine Spongiform Encephalopathy BT || Bluetongue disease CA || Competent Authority CAP || Common Agricultural Policy CAHP || Community Animal Health Policy CBA || Cost Benefit Analysis CLITRAVI || Liaison Centre for the Meat Processing Industry in the European Union Compartment || an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or diseases for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade COPA-COGECA || European farmer and agri-cooperatives organisation CSF || Classical Swine Fever CVO || Chief Veterinary Officer DEFRA || Department for Environment, Food and Rural Affairs, United Kingdom DG || Directorate General EAZA || European Association of Zoos and Aquaria EFBA || European Fur Breeders' Association EFSA || European Food Safety Authority EMA || European Medicines Agency ENTR || EU Commission's Directorate General for Enterprise and Industry ENV || EU Commission's Directorate General for Environment EUROSTAT || The statistical office of the European Union FAO || Food and Agriculture Organisation FEAP || Federation of European Aquaculture Producers FEDIAF || European Pet Food Industry Federation FESASS || European Federation for Animal Health and Sanitary Security FMD || Foot and Mouth Disease FVE || Federation of Veterinarians of Europe FVO || Food and Veterinary Office HPAI || Highly Pathogenic Avian Influenza IA || Impact Assessment IAB || Impact Assessment Board IFAH - Europe || International Federation for Animal health Europe Intra-EU trade || Movements of animal and products between EU Member States ISSG || Inter-Service Steering Group LPAI || Low Pathogenic Avian Influenza LS /SJ || The European Commission’s Legal Service MS || Member State / Member States NCD || Newcastle Disease OIE || World Organisation for Animal Health OIE PVS || The OIE Tool for the Evaluation of Performance of Veterinary Services OLAF || European Anti-Fraud Office RepVet group || Veterinarians representing sectors of artificial insemination of their respective MS (in the framework of COPA-COGECA) RTD || EU Commission's Directorate General for Research and Innovation SANCO || EU Commission's Directorate General for Health and Consumers SARS || Severe Acute Respiratory Syndrome caused by Corona virus SCFCAH || Standing Committee of the Food Chain and Animal Health SG || European Commission Secretariat-General SVD || Swine Vesicular Disease TFADS || Task Force for Animal Disease Surveillance TFEU || Treaty on the Functioning of the European Union TRADE || EU Commission's Directorate General for Trade TRACES || Trade Control and Expert System of the EU The Treaty || Treaty on European Union UECBV || The European Livestock And Meat Trading Union Vier Pfoten || For Paws international WAHIS-WAHID || World Animal Health Information System and World Animal Health Information Database WHO || World Health Organisation WTO || World Trade Organisation WTO-SPS || World Trade Organisation - Sanitary & Phytosanitary Agreement
ANNEX II Key
Messages from the evaluation of the Community Animal Health Policy (CAHP)
The following key points have emerged from this evaluation:
Over the time period reviewed by this evaluation (1995-2004),
the Community Animal Health Policy (CAHP) has become increasingly
successful in terms of achieving the outcomes it is seeking to pursue.
Although policy improvements were mainly stimulated by the need to respond
to some major crises that occurred in the Community during this period,
the results can be considered to have been positive. Thus, for example,
there has been a considerable reduction over time in the prevalence of a
significant number of animal diseases and a considerably better structured
response to crises. Following the CSF, FMD and AI crises all relevant
"vertical" legislation on the control of these diseases was
revised and updated, taking into account the lessons learnt, including
those on vaccination and contingency planning. It is also an achievement
that over time the Commission’s role in respect of the policy has come to
be increasingly widely accepted both within the EU and internationally.
This having been said, until now the policy has consisted of a
series of interrelated policy actions/actors at institutional and civil
society level operating under a large umbrella of legislation and
formal/informal networks but without a definition of strategy for the
whole and limited assessment of the success of actions taken in terms of
review and feedback on performance. The evaluation has demonstrated the
need to develop a clear and transparent strategy accompanied by a
communication strategy which improves stakeholder engagement and
involvement in decision-making. In addition, future actions need to be
informed by a review of the achievement of outcomes in relation to past
actions.
The evaluation has highlighted the many linkages inherent in
the policy e.g. between what happens in third countries, what happens at
EU borders and what actions are taken to secure animal health status
within the EU. In future better consistency between actions to improve
animal health and welfare in the EU and international competitiveness
could be achieved by pursuing simplified rules and better regulation and
carrying out impact assessments before introducing new legislation.
Subsidiarity aspects have been a key theme underlying the
various policy areas covered by this evaluation. With principles and rules
laid down at EU level but implemented by Member States, enforcement issues
have often been identified as a key parameter in allowing flexibility at
MS/regional/local level while the Commission’s role is crucial in
guaranteeing that a common approach and standards apply across the
Community.
In terms of strategic focus, while it is clear that crises will
always recur, the evaluation has highlighted the need to move towards a
policy which is more focused on effective risk management/disease
prevention. This can be achieved via better risk based targeting of
funding (using cost effectiveness and cost benefit analysis), measures and
incentives at all levels as well as early detection of exotic and
new/emerging disease threats. This involves better prioritisation of
actions relating to disease eradication and surveillance, research and
development, controls on illegal entry of potentially risk carrying
materials but also more generally creating a stronger culture of
bio-security at all levels.
Following analysis undertaken in particular under Part II of
this evaluation, a key component in the creation of such a culture of
bio-security would be the introduction of a harmonised framework for cost
and responsibility sharing. This could be structured so as to allow
implementation in line with subsidiarity at Member State and regional
level. A key component of such a cost and responsibility sharing framework
as well as the idea of better overall prioritisation of actions would be
the introduction of a disease classification system. This would allow
greater focus on those diseases which can be considered to have high ‘EU
relevance’ in terms of the need for coordinated action at EU level due to
their potential impact on human health and potential
supra-national/supra-regional economic impact.
More specific actions which could be considered for the future
would include:
§
Further alignment of EU rules more closely with
OIE guidelines and standards; §
A gradual move towards integrated electronic
identification and certification procedures for intra-Community trade; §
The streamlining of texts going through the
Standing Committee procedures; §
Providing specific support for bio-security
measures at farm level via existing funds; §
Providing specific support to third countries to
assist them in upgrading their animal health status to meet EU and
international (OIE) requirements; §
Negotiating export conditions at Community
level; §
Targeting illegal (commercial) imports/fraud. A preliminary assessment of the advantages/disadvantages,
feasibility, stakeholder acceptance and needs for further assessment has also
been undertaken for each of these actions. The full CAHP evaluation and supporting documents are available at: http://ec.europa.eu/food/animal/diseases/strategy/final_report_en.htm
ANNEX III Summary
of chronology of main exchanges with representatives of specific sectors likely
to be affected by the new AH Law
No || Action || Time (1) Stakeholders' Steering group (1st meeting) || 18 February 2009 (2) Animal Health Advisory Committee meeting || 6 March 2009 (3) Stakeholders' Steering group (2nd meeting) || 25 March 2009 (4) Stakeholders' Steering group (3rd meeting) || 19 May 2009 (5) FESSAS (Fédération Européenne pour la Santé Animale et la Sécurité Sanitaire) general assembly || 12 June 2009 (6) Animal Health Advisory Committee meeting || 15 June 2009 (7) Stakeholders' Steering group (4th meeting) || 3 July 2009 (8) CVO meeting || 3 September 2009 (9) Special Advisory Committee meeting (Consultation kick-off) || 29 September 2009 (10) Informal CVO meeting, Jonkoping, Sweden || 21-23 October 2009 (11) Animal Health Advisory Committee meeting || 9 November 2009 (12) CVO meeting || 10 November 2009 (13) Thorough stakeholders consultation in the frame of the preparation of the impact assessment || 23 October to 31December 2009 (14) FVE (Federation of Veterinarians of Europe) - General Assembly || 13 November 2009 (15) DG AGRI – Advisory group on beekeeping || 18 November 2009 (16) Administrative burden/costs and compliance cost questionnaires for CA and operators – informal consultation with the members of ISSG || 20 November to 3 December (17) Meeting: Veterinary education – DG Markt, DG EAC || 23 November 2009 (18) Administrative burden/costs and compliance cost questionnaires – sent to the MS and stakeholders || 5 December 2009 (19) CVO meeting || 8 December 2009 (20) Fédération Nationale des groupements de défense sanitaire || 9 December 2009 (21) COPA–COGECA (Comité des organisations professionnelles agricoles - Confédération générale de la coopération agricole) working party on animal health and welfare || 9 December 2009 (22) Task Force Animal Disease Surveillance: surveillance in general || 17 December 2009 (23) CVO meeting || 14 January 2010 (24) Animal Health Advisory Committee meeting (if and as necessary, depending on progress) || 8 February 2010 (25) Rencontre avec les éleveurs de l'Aisne 02, France || 15 January 2010 (26) Meeting veterinary education: EAC || 15 February 2010 (27) DG AGRI - Simplification WG with MS experts || 23 March 2010 (28) Informal CVO meeting – Sevilla, Spain || 13-15 April, 2010 (29) Meeting FESSAS || 22 April 2010 (30) Intra-SANCO meeting || 10 May 2010 (31) Task Force Animal Disease Surveillance: surveillance in the EU AHL || 17-18 May 2010 (32) COPA–COGECA working party on animal health and welfare || 19 May 2010 (33) COPA –COGECA RepVet meeting || 19 May 2010 (34) CVO meeting || 16 June 2010 (35) Inter-Service steering group meeting || 5 July 2010 (36) Animal Health Advisory Committee meeting || 18 June 2010 (37) Rep Vet meeting and EU AI Vets conference || 15-16 September 2010 (38) COPA-COGECA – Export working group || 10 October 2010 (39) Meeting COPA-COGECA working party on animal health and welfare || 4 November 2010 (40) AHL WG meeting with EU MS, Switzerland, Norway and Iceland || 10 December 2010 (41) Council WG on bee health || 1 February 2011 (42) AHL WG meeting with EU MS, Switzerland, Norway and Iceland || 4 February 2011 (43) Animal Health Advisory Committee meeting || 17 February 2011 (44) CVO meeting || 18 February 2011 (45) AHL WG meeting with EU MS, Switzerland, Norway and Iceland || 4 March 2011 (46) Commission CVO meeting || 22 March 2011 (47) COPA-COGECA working party on animal health and welfare || 30 March 2011 Minutes of these meeting, consultation results,
summaries, conclusions and presentations used to steer the discussions are
available upon request.
ANNEX IV Summary
document of the stakeholders' steering group: "Problem identification during
the creation of the animal health law"
|| EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate D – Animal Health and Welfare D1 - Animal Health and Standing Committees Brussels 03/07/2009 WORKING DOCUMENT on PROBLEM
IDENTIFICATION DURING
THE CREATION OF THE ANIMAL HEALTH LAW (point
4 of the Programming document[40]
of
the Animal Health Strategy 2007-2013) Steering Group on the EU Animal Health Law Brussels, 3
July 2009 This
document does not necessarily represent the views of the Commission Services Problem identification (group) || Problem definition || Objectives/Solutions (following the discussion of the SG) || Relevance for the AHL/Remarks Complexity of the legislation || Current legislation is composed of 60 basic legal acts and more than 400 implementing acts and safeguard rules. In the absence of a horizontal legal act the legislation is scattered among many legal measures with a different subject-matter, a mixture of horizontal and vertical issues including trade (intra-Community and international), disease control measures and specific safeguard measures. || To establish a horizontal act containing the general principles, main objectives, and tools. To merge common provisions scattered through different Directives To clarify links with other legislation || Yes Burdensome implementation || Identification, Registration and Traceability systems are often perceived as too burdensome, costly || To establish a reliable system for food producing animals based on the risks for human and animal health and not only on grounds of costs Costs borne by all beneficiaries not only livestock owners (measures considered as Global Public Good). || Yes No for detailed provisions Bovine identification system is too complex and resource-demanding (notification obligations, documents, finances). || Bovine identification simplification || AHS Action plan: Steering group on electronic identification of bovine animals. Disease control and preventive measures currently applied to hobby and /or backyard farms might be too restrictive but on the other hand, these measures might be necessary in order to address risks. || To clarify a need for the differentiation or unification of disease control measures on commercial and non-commercial farming to address risks in a proper way. || Yes Current animal health rules for zoo's and circus' animals require the registration of the movements of these animals inside a country. || To clarify the scope the rules of identification and registration of certain categories of animals || Yes There are several existing databases and computerised systems (TRACES, I+R, ADNS) which are not interconnected and require different notification processes, which often leads to duplications and unnecessary burden. || Need for alignment of ADIS with the OIE database - WAHIS/WAHID as Regional Core System. || Yes Steering group on ADIS Integration national I&R databases and TRACES. To verify the possibilities for unified I&R system (EU 27), and possible links linked to the animal health information system (long term). || Steering group on Electronic certification and Inter-operability of bovine databases No unified legal basis for TRACES (outdated, originating from ANIMO and SHIFT). || To provide for an appropriate legal base for TRACES and TRACES procedures. || Yes No - for detailed provisions. Need to modernise and simplify certification || Electronic certificates possibly in TRACES To simplify wording in the certificates as far as possible. || Yes AHS Action plan: Steering group on electronic certification Unclear responsibilities || Responsibilities of the competent authorities not always clear (control obligations) || To clarify the roles and responsibilities of different actors as regards official controls and other supervision or testing activities not directly linked to the verification of compliance with the existing legislation. || Yes (see also part on convergence with international standards: Veterinary services to be considered as a Global Public Good). The role and the tasks of the approved veterinarians need to be to be clarified in relation to the official controls (Regulation (EC) No. 882/2004). || Clarify and adjust the roles of official veterinarians, approved veterinarians and other official control bodies covering the full scope of the animal health law. || Yes Need for a better and clearer coordination between different surveillance systems and actors. || To establish a better surveillance network where the roles of all actors are clear in order to achieve an effective preparedness for control and eradication of animal diseases. || Yes The responsibilities of animal keepers/farmers/owners/operators/animal transporters/dealers and veterinarians are not clear. || The roles and responsibilities of all actors need to be clarified. || Yes The role of NGOs and farmers associations is not clear. || To clarify the role of NGOs, industry associations. || Yes EFSA's role is not clear as regards animal health and welfare. || To define EFSA's role as regards animal health and welfare risk analysis. || Yes Rigidity of legislation to adapt to new circumstances and developments, including scientific developments || Legislation is too rigid to be adapted to scientific developments and new circumstances. || Legislative instrument to establish general principles to be directly applicable, while specific control rules should be easily modifiable (comitology). || Yes No - for detailed provisions. Flexibility for appropriate urgent response in case of disease outbreaks has to be at least maintained. Provisions of the bluetongue directive do not reflect the current health situation and this result in spread of the disease. || Revision of the rules for control and eradication o bluetongue. || Yes - for general provisions. Rules on Swine Vesicular Disease are disproportionate to the risk. || Set proportionate rules for SVD. || Yes – for general provisions. Prioritisation exercise Protective measures for NCD are outdated (Directive 92/66/EEC) || Set new and updated rules for NCD || Yes - for general provisions Procedure for standardisation of used laboratory tests is too complicated. || To simplify procedures for standardisation as far as possible, use of diagnostic manuals and ISO references OIE and Codex (CCMAS) references. || Yes – for general provisions Certain rules for intra-Community trade are inflexible and difficult to implement. || Trade facilitation mechanisms and cross-border facilitation: reduced controls for trade between territories with the same health status, possibilities to supply certain categories of animals cross-border, surveillance, I+R rules, biosecurity. || Yes There is a need to clarify the use of bilateral agreements for intra-Community trade in order to ensure a proper functioning of the Single Market. || Clarification of the use of bilateral agreements. || Yes Need of import certificate for animals accompanying their owners and for certain products for personal consumption in all cases even if they do not pose any risk. || The obligations for import certificates and possibilities for derogation to the general rule to be set in the AHL. || Yes – for general provisions Directives 2002/99/EC and 92/65/EEC Directive 92/65/EEC is "unworkable": trade conditions for many animal species are not clear or not useful and create unnecessary administrative burden. || Directive 92/65/EEC to be improved radically. || Yes - for general provisions Limited convergence with the international standards (See also part on "Unclear responsibilities") || Current legislation does not recognize Veterinary services as a public good in line with the OIE provisions || To set provisions on: - Staff resources - Coordination/cooperation between the CA - Training or guidelines for vet. Services - Definition and distribution of responsibilities || Yes OIE Chapter 3.1., 3.2., OIE PVS Tool (Evaluation of veterinary services). Duplications, overlaps, inconsistencies with other policy areas exist (such as zoonoses, animal nutrition, animal welfare, official control regulation.) || Need to review the categories of animals for intra-Community trade (especially Bov, Ov, Sus and equidae) as they are not consistent with the import rules (and the OIE). || To review the categories of animals for intra-Community trade to make them consistent with the international trade rules and standards where relevant. || Yes No – for detailed provisions The concept of what is considered as" trade" and the definition of "non-commercial movement" are not clear. || Concepts as "trade" and "non-commercial" movement to be clarified. || Yes Provisions for intra-Community trade and import of equidae are inconsistent. (Directive 90/426/EEC). || Amend the provisions for intra-Community trade and imports of equidae. || Yes No – for detailed provisions Rules for movements of pet animals younger than 3 months are not harmonised There are no rules for pet animals others than dogs, cats and birds || Revision of the rules for the movement of pet animals to better adapt them to the risks. || No Regulation (EC) No. 998/2003 Prevention-driven approach || Biosecurity needs to be applied as a preventive tool and not only when an outbreak occurs || - Possible application of HACCP - principles system for biosecurity on-farms - Biosecurity guidelines on EU level - To encourage the drafting and application of biosecurity guidelines at MS/regional/other levels. || Yes Need to provide incentives for prevention of animal diseases. || To provide incentives for the adoption of biosecurity and other preventive measures, financial incentives, trade incentives, reduced number of controls. || Yes The concept of compartment is currently only applicable to the poultry sector as regards Avian influenza. || Introduction of the concept of compartment for other diseases/species. || Yes Early detection of animal diseases and the current surveillance network needs to be improved || Animal keepers (including hobby keepers) need to be registered and to implement preventive measures including surveillance adapted to their activities. || Yes Compulsory veterinary supervision of holdings/herds. || Need to put in place a clear vaccination strategy for the different diseases. || - Vaccination as a possible tool - vaccination strategies - exit strategies || Yes (general principles) Remark: Task force on the reinforcement of the EU antigen/vaccine banks Sufficient rendering capacity is not always available for crisis events || Ensure sufficient rendering capacity for crisis events, so that dead animals are not buried or burned, in order to efficiently prevent the spread of diseases. || No Provision included in the new regulatory proposal for animal by-products Epidemiological unit and the definition of holding are not clearly set in the EU legislation. || Epidemiological unit to be clearly defined (align to the OIE Code definition) || Yes Current legislation allows moving around sick bee-colonies. || To amend rules in order to prevent further spread of bees' diseases || Yes - for general provisions Emerging diseases not properly addressed – in particular Rift Valley Fever (Directive 92/119/EEC) and rules for AHS. || Emerging diseases should be reflected || Yes - for general provisions Prioritisation exercise Other diseases as PRRS, E. multilocularis, Gyrodactilus salaries are not properly addressed in the current rules for control and eradication. || To assess the need to address other diseases. || No – with the exception of general principles. Prioritisation of diseases The re-grouping of animals in assembly centres may pose a threat for the spread of animal diseases. || To explore options in order to address this potential risk. || Yes No – for detailed provisions The system of identification of companion animals is not harmonised and is not compulsory for all species and this might lead to animal health and welfare threats (including illegal trade). || The relevance of identification of companion animals needs to be highlighted from different perspectives (animal health, animal welfare, public health and illegal trade). || Yes Provisions for the certification of game birds are unclear, disease surveillance programmes for some of the diseases need to be evaluated (Directive 90/539/EEC). || Provisions of Directive 90/539/EEC to be revised || Yes No – for detailed provisions Need to minimize opportunities for mistakes and fraud in the certification process. || Certificates reflecting clearly the trade conditions and clear adequate items that could be honestly signed by a veterinarian || Yes No – for detailed provisions Un-availability of Veterinary medicines due to insufficient markets (minor uses/ minor species) Public interest of having reliable vaccines and diagnostic tools Need for DIVA vaccines to deal with different animal diseases || DG ENTR || No (DG ENTR) Misuse of veterinary medicines can trigger the appearance/spread of antimicrobial resistant organisms. || Promoting responsible use of antimicrobials || Yes Rules for imports of pathogens including aquatic animals' pathogens are not harmonised. || To harmonize provisions for imports of pathogens. Directive 92/118/EEC || Yes No – for detailed provisions Rules for imports and trade of reptiles and amphibians and trade of deer/ other ruminants are not harmonized. (Directive 92/65). || Review provisions of to better adapt them to risks. || Yes No – for detailed provisions Others || There are no common horizontal rules and standards on basic knowledge on animal health for people dealing with animals. || To establish rules or training for the persons involved with animals. To promote/encourage training To raise awareness of the need to have appropriate training programmes. || Yes For official control staff: 882/2004 For veterinarians: Decision 90/424/EEC No specific provisions on the qualifications of official and/or approved veterinarians in the field of animal health / animal welfare (Rules governing the qualifications of official veterinarians already exist in the Regulation (EC) No. 854/2004 for the veterinary public health) || To set rules governing the qualifications of official veterinarians in the field of animal health / animal welfare similar to those already existing in the Regulation (EC) No. 854/2004 || Yes
ANNEX V Summary
of Consultation Responses
|| EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Animal health and welfare Animal health and standing committees Working document on the "Annotated
agenda for
stakeholders’ consultation" Summary of the consultation questionnaire on
the new EU Animal Health Law Brussels, March 2010 This document does not necessarily
represent the views of the Commission Services Please note that this
document has been established for information and consultation purposes only.
It has not been adopted or in any way approved by the European Commission and
should not be regarded as representative of the Commission Services either. The
European Commission does not guarantee the accuracy of the information
provided, nor does it accept responsibility for any use made thereof. 1.
Introduction The wide stakeholders' consultation on possible
approaches for the new Animal Health Law (AHL) included 14 major issues that
were collected by the Commission in previous discussions with the AHL
Stakeholders' steering group. The consultation document "Annotated
agenda for wide Stakeholders' consultation was presented to the Animal Health
Advisory Committee on 29 September, 2009. This document was published on the Commission
website and was available through the Commission's IPM tool (Interactive Policy
Making) as of 23 October 2010 until the end of 2009. The consultation was
concluded at the end of 2009 / beginning of 2010. During this period the Commission received 153
responses. Structure of responding entities is presented in Table 1. Comments presented below are summarised
regardless of the fact whether they were made by the participants of the
consultation that have supported Commission's preliminary approach or rejected
it. Status of submitting entity: -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || An economic/business operator || 17 || (11.1%) || (11.1%) || An organisation || 110 || (71.9%) || (71.9%) || Other (please specify) || 26 || (17%) || (17%) || || || || If
an organisation, nature thereof:
-single choice reply- (compulsory) || || || Number of requested records || Requested records (110) || % of total number records (153) || || EU national veterinary authority || 7 || (6.4%) || (4.6%) || Other national veterinary authority || 6 || (5.5%) || (3.9%) || International organisation || 4 || (3.6%) || (2.6%) || Industry organisation on EU level || 13 || (11.8%) || (8.5%) || Industry organisation on national level || 23 || (20.9%) || (15%) || Non-governmental organisation EU level || 12 || (10.9%) || (7.8%) || Non-govt. organisation national level || 28 || (25.5%) || (18.3%) || Other organisation (please specify) || 17 || (15.5%) || (11.1%) 2.
Results
of the consultation Results and summary of different questions are
presented in the following points 2.1. Responsibilities and obligations of animal keepers and owners Ø Proposed approach for comments The Community Animal Health Law would
clearly set out the obligations of animal keepers/owners/operators and those
would be applied equally in all Member States. Ø Statistics Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 45 || (29.4%) || (29.4%) || Agree || 75 || (49%) || (49%) || Neutral || 9 || (5.9%) || (5.9%) || Disagree || 15 || (9.8%) || (9.8%) || Strongly disagree || 4 || (2.6%) || (2.6%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 4 || (2.6%) || (2.6%) Ø Comments Rules: ·
To establish the roles and responsibilities of
the operators in a Regulation would allow for more clear and practical rules,
will help to limit/prevent actions under political pressure and will establish
a level of playing field for operators in the EU ensuring a smooth functioning
of the internal market as the animal health policy will be implemented in a
uniform way across the EU. ·
A Directive establishing general principles to
be applied equally in the MS would be better option as it provides for greater
flexibility to adapt it to different circumstances in the Member States
(different species and production systems, economic needs, territorial needs
need for quick action in case of emerging threats). ·
This issue should be left to be regulated by the
MS so they can agree the roles and responsibilities in conjunction with their
livestock industry. To lay down the roles and responsibilities of the operators
at EU level will create an inflexible system. ·
The EU should only regulate the aspects that
could have an impact at EU level (e.g.: trans-boundary animal diseases). MS
should be able to set higher standards than the EU ones. ·
There is no need for establishing these rules as
current legislation sets clear obligations for operators. ·
A licensing system for farmers accredited by
experts should be established (linked to knowledge, training, etc). ·
Transitional period needs to be provided. ·
Responsibilities of operators other than animal
keepers such as transport operators, handlers of animals and trader must be
defined as well. ·
Roles and responsibilities should be defined for
all animal owners/keepers (keepers of wild animals, hobby-keepers, etc.) ·
Obligations should be output based and not
prescriptive. They should be practical, proportionate, and science-based,
adapted to different situations in the Member States and should avoid
disproportionate burden. ·
The roles and responsibilities should be linked
to EU compensation after animal disease outbreaks. ·
Some disease incursions are out of control of
the farmers (e.g. bluetongue virus). ·
Animals registered in the national databases
should always be linked to a responsible person (owner, keeper). ·
When establishing roles and responsibilities of
operators it should be specified how they need to liaise with the
veterinarians. Operators should be obliged to take appropriate professional
advice to manage risks. ·
Should be clear that notification of an outbreak
will not have negative consequences: encourage early reporting. ·
Animal health and animal welfare rules should be
separate. ·
Coherence with food law needs to be ensured. ·
The rules for use and availability of veterinary
medicines are also important. Roles and responsibilities should be laid down
together with obligations and privileges emerging from them and linked with
setting the right conditions to fulfil these responsibilities (scale and
intensity of the production, level of biosecurity, disease status and self
control measures) ·
Third countries replying to the questionnaire
highlighted that these obligations should not be imposed to third country
operators exporting animals and animal products to the EU. Impacts: ·
The Member States should be responsible for
ensuring and demonstrating full implementation (including control of the system
and sanctions in case of non-compliance).This could generate administrative
burdens and have negative impact in other controls due to lack of resources. ·
The consequences for small farmers should be
taken into account. Traceability requirements should be adapted to them and
simplified, if not they risk disappearing and they play a crucial social role
in rural areas. Same considerations apply for hobby holdings. ·
The impact would depend on the current situation
in the Member States and on the different sectors, on new obligations been
introduced or just a clarifying the current ones and also is the fulfilment of
these roles and responsibilities would be linked to the EU financial
compensation after animal disease outbreaks. ·
To clarify the roles and responsibilities of the
operators will benefit animal welfare and animal disease control. Specific
sector concerns: Zoos ·
The specialized and unique role of zoos must be
considered in the AHL (zoo animals are not part of the food chain but part of
breeding-conservation programmes). There is a need to clarify when animals kept
in zoos would fall under the definition of the animal health law.
Implementation of AH legislation for these animals varies considerably amongst
the MS and this makes the movement within the EU difficult (transport is rare
and not as risky as farmed animals, part of breeding and conservations
programmes). Knowledge of applicability at customs level and local level is
poor. Negative consequence to these specificities are not taken into account. 2.2. Training on animal health and welfare for people dealing with
animals Ø Proposed approach for comments The animal health law could introduce the
possibility of training people dealing with animals, and give incentives and
tools (guidelines) to the Member States for such training. Increased awareness
of potential threats related to animal diseases among staff dealing with
animals is one of the basic pillars of effective and efficient early detection
systems. Ø Statistics Do you support this preliminary approach?
-single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 26 || (17%) || (17%) || Agree || 88 || (57.5%) || (57.5%) || Neutral || 9 || (5.9%) || (5.9%) || Disagree || 18 || (11.8%) || (11.8%) || Strongly disagree || 6 || (3.9%) || (3.9%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 5 || (3.3%) || (3.3%) Ø
Comments Financial
issues: ·
The impact of training provisions would depend
on its funding. The Rural Development Fund is used for this purpose in some
MSs. The use of funds from the Better Training for Safer Food programme should
be considered. ·
Funding and training centres are needed in the
MSs. ·
Training requirements should be linked to
compensation after animal disease outbreaks. ·
There should be a compensation of business hours
lost due to training for animal keepers. ·
Training at work should be possible. ·
Cost-effective means to provide training should
be explored (webpages, etc) ·
There will be no big impacts in the MSs as
training systems are already in place. ·
An assessment of the availability and quality of
training in the Member States (MSs) will need to be carried out. Target group ·
Low motivation of farmers for attending training
could be an issue, especially for those with "worst" preventive
behaviour. ·
Training is needed mainly for non-commercial
activities and extensive farming. ·
It's necessary to take into account the
knowledge that they already have (different level of knowledge, experience and
education of the farmers). Experience and "learning by doing" should
be recognized. ·
Accessibility of training to small farmers, in
remote areas needs to be guaranteed (not to discourage them from quitting the
activity). Negative social and economic impacts are expected if training
requirements and access to training are not adapted to them. ·
An important target group for training is the
staff working in abattoirs (early detection of animal diseases). ·
How to ensure and control training of pet
owners, temporary staff? ·
Training is needed especially for new farmers. ·
Zoo staff is very experienced and qualified.
Training is already available for them but more harmonization will be welcomed.
·
Stricter rules on training should apply for
professional keepers than for non-professional ones. ·
Target-groups for training are too large: only
for commercial activities. Better not to include animal welfare. Compulsory Vs voluntary. Level
at which training should be regulated. ·
Training needs are too specific (depending on
the activity, the experience and knowledge of the animal keepers) to be
addressed at EU or MS level; it will be better done by the industry. ·
Training should be compulsory to ensure equal
implementation in the MSs. ·
Training should be voluntarily in the first
place and after a transitional period should become compulsory. ·
Training should be a requisite in order to
obtain a compulsory licence to keep animals. Training should be part of a farm
assurance scheme including farm visitation scheme. ·
Combination of options is suggested: compulsory
training plus incentives provided. ·
Obligatory provision should be basic and
relevant level of awareness (not to detailed obligations). ·
Training should be laid down just as an
objective in the Animal Health Law and then the MSs will choose the means to
attain it. ·
The EU should lay down the minimum content of
training and then the MSs will decide for whom it will be compulsory. ·
Training should be voluntary to allow for
flexibility to integrate existing mechanisms. Content ·
An important aspect would be the quality and
relevance of the training provided as it has to be adapted to the type of
activity. ·
Farmers need to be aware of the legislative
developments and their obligations and of the economic consequences of animal
diseases (epidemic and endemic). ·
There is a need to reinforce the
links/confidence between animal keepers and veterinarians. ·
Competence and training are two different
things. The frequency of the training and continuous training are important
issues to be considered. ·
Guidelines should be provided to the MSs. ·
Training is not output-based, is expensive and
cumbersome. The key issue is to have a well functioning veterinary services and
laboratory infrastructure at reasonable prices. ·
All training requirements should be coordinated
so that animal keepers can combine (animal welfare, animal health…). 2.3.
The role of the veterinary services -
clarifying the tasks and duties of official veterinarians and private
veterinary practitioners Ø Proposed approach for comments The basic tasks and responsibilities of official and/or
approved veterinarians should be laid down in Regulation (EC) No 882/2004,
while specific provisions could be regulated in the animal health law. The new legal framework should make clear what specific tasks and duties in the field of animal health a
veterinary practitioner can undertake as an official/designated/approved
veterinarian and under what conditions. This system should be comparable and
should not vary between the Member States. EU legislation should
take into account the internationally recognised (OIE) standards for these
specific tasks and duties, which enable the EU Member States’ international
trade to flow smoothly. Ø
Statistics Do you support
this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 24 || (15.7%) || (15.7%) || Agree || 101 || (66%) || (66%) || Neutral || 9 || (5.9%) || (5.9%) || Disagree || 11 || (7.2%) || (7.2%) || Strongly disagree || 2 || (1.3%) || (1.3%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 5 || (3.3%) || (3.3%) Ø
Comments ·
There is a widely perceived need to harmonise
and clarify certain veterinary tasks EU-wide. This is valid in particular for
the "export certification". In general certain tasks are perceived as
purely official, while the others have a certain official character (need to
remain under authority control) but can be performed by veterinary
practitioners. ·
Conflict of interest shall be avoided. However,
opinions diverge on whether one should achieve that through professional
standards and conduct or through the EU or national legislation. ·
Certain perceive that MS should have more
freedom to organise their services as they wish (principle of subsidiarity).
The focus should be given towards an output based and not prescriptive
approach. ·
Quality standards of the veterinary services
should be set - especially in relation to certification scheme. ·
Veterinarians are not always perceived to be best
placed responsible persons for all animals, especially aquatic animals and
apiculture. In addition, certain roles can be trusted to other staff such as
technicians, animal keepers. ·
One should avoid higher administrative and
compliance costs. Higher number of official veterinarians is unlikely;
therefore we should aim for an optimal use of all available resources in order
to achieve best possible results and ensure the coverage of all areas
(including remote areas) with the veterinary services. System should be able to
adapt to rural production, small farms. ·
New system should take into account possible
public-private partnerships as Animal Health Services, which are lately being
developed in some countries. ·
For international trade compliance with the OIE standards
is very important. 2.4. Professional qualifications and training for official and approved
veterinarians Ø
Proposed approach for comments The Animal Health Law would extend the
requirements for professional qualifications and for veterinary training to
official veterinarians in all areas and to those authorised to perform official
tasks in the field of animal health, similar to the existing provisions of
Regulation (EC) No 854/2004. Additionally it could provide basic requirements
for Continuing Professional Development (CPD) for veterinarians Ø
Statistics Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 34 || (22.2%) || (22.2%) || Agree || 90 || (58.8%) || (58.8%) || Neutral || 13 || (8.5%) || (8.5%) || Disagree || 4 || (2.6%) || (2.6%) || Strongly disagree || 2 || (1.3%) || (1.3%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 9 || (5.9%) || (5.9%) Ø
Comments: ·
Education and training for veterinarians are
very important but should be adapted to the level of public tasks assigned to a
professional; for example approved veterinarians don't need the same level of
training as the official veterinarians. The trainings should therefore be
output / target oriented towards proper enforcement and shouldn't generate
unnecessary costs. ·
Basic requirements of the AHL should secure the
quality of the veterinary services and acting of veterinary professionals. ·
We should aim to establish a harmonised EU
approach for all those that perform official tasks and these include besides
veterinarians some other professionals, especially linked to certain working
areas, as for example aquaculture, apiculture, etc. Training programmes should
be flexible and adjusted to specific needs. ·
A need for an EU-wide minimum requirements
(which should not be too low) for undergraduate and post-graduate training was
expressed. However, MS shall have the possibility to deliver this output, and
keep the flexibility for its organisation and financing. ·
Many MS already have continuous professional
developments of veterinarians put in place and for those it seems that the
additional regulation at the EU level would be redundant. ·
Some are of the view that it is necessary to
regulate all steps of veterinary education, including accreditation of the
veterinary schools. ·
Many participants emphasised that good
qualifications of veterinarians are well perceived by the farmers and this
strengthens the public opinion on food safety. 2.5. Biosecurity measures to prevent outbreaks on farms and not only deal
with them when they occur Ø
Proposed approach for comments: The Animal
Health Strategy aims for preventive and incentive-oriented approaches.
Therefore a legal framework should aim for the voluntary introduction of
biosecurity measures at farms. The implementation of these measures could be
encouraged by providing incentives such as trade-facilitation mechanisms and
reducing the number of controls. The animal health law would set the minimum
criteria for biosecurity measures, allowing them to be adapted to local
circumstances. Ø
Statistics: Do you support this preliminary
approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 25 || (16.3%) || (16.3%) || Agree || 91 || (59.5%) || (59.5%) || Neutral || 12 || (7.8%) || (7.8%) || Disagree || 16 || (10.5%) || (10.5%) || Strongly disagree || 3 || (2%) || (2%) || Not relevant || 0 || (0%) || (0%) || No opinion || 6 || (3.9%) || (3.9%) Ø Comments: Controls ·
Reductions of controls plus trade-facilitation mechanisms
lead to increased risks. ·
Controls should be maintained: to ensure
implementation of biosecurity measures. ·
Controls need to be reviewed in order to
simplify, check of they provide added-value or if they are obsolete and
duplicated. Scope ·
Biosecurity should also be applied on transport
and holdings other than farms. ·
It is also important to manage and reduce the
risk at Member States level (import controls strengthened, animal disease
eradication programmes, etc.) ·
Large commercial farms should apply maximum
biosecurity standards and incentives will be provided to them, while small
farms and hobby farms should apply minimum standards adapted to their
circumstances. ·
Small holdings with poor biosecurity represent a
high risk. ·
These options are not applicable for zoos and
aquariums (different risks also: low density, animals do not enter the food
chain: different measures needed: ex: visitors). Directive 92/65 is not
properly implemented and therefore there are no incentives for zoos applying
biosecurity measures. ·
Interaction of animals kept on zoos and wild
animals are not covered by the Directive 92/65. ·
Special status for genetically important
livestock (indigenous breeds) should be granted. Incentives ·
At MS level, sanitary actors (veterinarians, administration
and professional organizations) should encourage and motivate farmers for the
adoption of biosecurity measures, for example by linking biosecurity measures
to increased farm profitability and better animal health. ·
Incentives such as access to markets are
important to ensure effective and wide-spread implementation of minimum
standards. ·
The objective should be to discourage the
transport of animals, not to increase it as this represents a risk for animal
health and welfare. Reward should be granted to farms with close-production
cycles as they avoid animal movements. Specialization and intensification of
farms: increases the development of fast spreading disease (highly pathogen
virus) ·
Incentives must be conditioned to risk analysis
carried out after biosecurity measures are in place. ·
An important incentive for the implementation of
biosecurity measures would be to exempt from certain restrictions farmers with
excellent biosecurity measures in a restricted zone if they did not get the
disease. It is also important to grant financial compensation for farms in
surveillance/ restricted zones. ·
Trade facilitation mechanisms and reduced
controls can only be granted if the Competent Authorities have certainty of the
correct implementation of biosecurity measures. This will imply reporting
requirements from farmers to the competent authorities (increased
administrative burden for farmers that has to be compensated with less costs
due to reduced controls and saving in acquisition of trade-certificates). ·
Financial support from the EU would be needed to
implement biosecurity measures. Need also for denial or reduction of
compensation in case of disease outbreaks to holdings where biosecurity
measures are not adhere to. Impact ·
Rules on biosecurity measure should be designed
in partnership with the industry to allow for adaptation to their own
circumstances and minimize costs. ·
Implementation of biosecurity measures would be
an economic burden for farmers. Therefore, rules should be science-based,
cost-effective, easy to implement ·
Investments will depend on sector/ MS and of the
farm status-quo but will be compensated through better animal health and
welfare. ·
Balance between costs of diseases and investment
costs needs to be calculated before implementing biosecurity measures. ·
Implementation of biosecurity measures would
have benefits day to day and also when outbreaks occur. ·
Implementation of biosecurity measures would be
a challenge for several structures (veterinary services, farmers) but they are
crucial for future development. Rules ·
Efficacy would depend on the definition and
content of biosecurity measures (avoid inconsistent, highly variable
definitions and insufficient controls). ·
Quarantine, testing before introduction of new
animals, vectors control are important measures. ·
Rules should be outcome-based and not
prescriptive. ·
Same rules should apply for third country
imports. ·
Biosecurity measures have to be equally
implemented to be effective. ·
Role of the veterinary surgeon (advice,
recommend which biosecurity measures are more suitable for each holding) should
be recognized. ·
Important to link with financial issues. ·
Biosecurity should not be introduced at the
costs of animal welfare (free-range, outdoor keeping, more sterile environment
and less contact animal keeper-animals). ·
Biosecurity measures should be measurable in
order to be able to assess compliance. ·
Role of veterinary practitioners should be
officially recognized. ·
HACCP should be applied for larger farms that
will be audited (instead of trade-related controls) . ·
Collection and transport of animals can only be
done if they come from holdings with similar biosecurity status. ·
Surveillance and controls should be risk-based. Compulsory/voluntary ·
Combination of options 2 and 3 is suggested as
the best approach by various stakeholders. ·
Biosecurity measures should be compulsory (EU
minimum standards) and then Member States can impose higher requirements. ·
Promoting implementation (soft-regulation) is
the best option. ·
Biosecurity needs to be adapted to the type of
farm (certain level of biosecurity to be obligatory and equally applied in the
EU; industry that wants to go further could do it through guidelines (and in
this way participation of farmers will be encouraged). ·
Assurance systems should be developed in order
to ensure and control implementation. ·
Training and guidance are better tools than
Regulation. ·
Should be responsibility of the Member States to
develop a non-legislative framework. ·
Minimum standards should be mandatory and on top
of that voluntary standards with incentives provided. ·
Compulsory minimum requirements are inflexible
for adapting them to different premises (example: laboratories). ·
MS should introduce long-term health management
plans, regular visitation of veterinary practitioners for all livestock
enterprises. ·
Companion and hobby animals should also be taken
into account. ·
Biosecurity measures should be prerequisite for
trade with animals and animal products. ·
Implementing a legal framework with few
exemptions is better than to establish minimum criteria and unmanageable
national guidelines. ·
Minimum requirements should be laid down for
high-risk holdings (traders, market shows, transport…) taking into account
animal density, size of the enterprises or farms. 2.6. Animal disease surveillance needs to be improved Ø
Proposed approach for comments: Without
prejudice to Directive 2003/99/EC as regards zoonoses, the best way to improve
animal disease surveillance seems to be to extend the scope and purpose of
surveillance networks as set out in Article 14 of Directive 64/432/EEC, which
is currently envisaged only for bovine animals and pigs, to other species of
terrestrial animals/diseases. Animal keepers (including hobby keepers) would be
registered and preventive measures suited to their activities introduced,
including surveillance. The new Animal Disease Information System would support
this approach by clarifying and facilitating reporting. The introduction of
surveillance networks will support the implementation of trade-facilitation
mechanisms. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 19 || (12.4%) || (12.4%) || Agree || 84 || (54.9%) || (54.9%) || Neutral || 19 || (12.4%) || (12.4%) || Disagree || 14 || (9.2%) || (9.2%) || Strongly disagree || 9 || (5.9%) || (5.9%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 7 || (4.6%) || (4.6%) Ø
Comments: In some cases
preliminary approach of the Commission to strengthen the surveillance system
was supported, but on the other hand there was some diversity of opinions in
relation to Commission's option 3 (suggested surveillance network). Many of
those supporting the preliminary approach have, instead of option 3, rather
chosen options 1 – EU wide compulsory surveillance for certain diseases (in
eleven cases) or 4 – to develop soft regulatory approach "guidelines"
(in nine cases). ·
Proposed approach for surveillance network
appears to be too prescriptive, detailed and to a certain extent too
authoritative. What we should aim for is robust disease surveillance, providing
solid grounds for early warning and detection of diseases. ·
There is a perception of a limited applicability
for all animal species. Specificities of different production channels and
production types should be taken into account, i.e. for hobby farms, backyards,
horse keeping, laboratory animals, zoos, fur animals, companion animals,
wildlife, endangered species etc. ·
Specific disease situation have to be taken into
account, partnership with stakeholders established and appropriate
consideration taken on the private surveillance. ·
Surveillance should be structured in a way that
it would provide minimum EU requirements on one hand and open the possibilities
for additional provisions in the Member States (basic health statuses and
additional health guarantees). ·
The purpose and expected outcomes of
surveillance should be clearly defined. ·
Some consulted prefer to have a soft regulatory
approach (option 4) ·
Surveillance system should be cost effective and
linked to the level of threat of a certain disease (in particular zoonotic
agents) 2.7. Intra-Community trade / placing on the market concept Ø
Proposed approach Option 1: Similarly to
the approach already introduced for aquaculture
animals in Directive 2006/88/EC, the concept of intra-Community trade in live
terrestrial animals would be replaced by the concept ‘placing on the market’. 1.
Proposed approach Option 2: Maintain the
concept of intra-Community trade as the basis for regulating commercial
movements of terrestrial animals between Member States. However, the
implementation of enhanced biosecurity measures and surveillance schemes and
subsequent trade facilitation mechanisms should, in principle, narrow the gaps
between the rules governing intra-Community trade and those on national
movements in live terrestrial animals, and eventually make it possible in the
long term to move towards a ‘placing on the market’ system for live terrestrial
animals, too. Ø
Statistics: - Option 1 – placing on the market Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 13 || (8.5%) || (8.5%) || Agree || 46 || (30.1%) || (30.1%) || Neutral || 16 || (10.5%) || (10.5%) || Disagree || 48 || (31.4%) || (31.4%) || Strongly disagree || 10 || (6.5%) || (6.5%) || Not relevant || 3 || (2%) || (2%) || No opinion || 17 || (11.1%) || (11.1%) - Option 2:
Intra-Community trade Do
you support this preliminary approach? -single
choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 19 || (12.4%) || (12.4%) || Agree || 53 || (34.6%) || (34.6%) || Neutral || 27 || (17.6%) || (17.6%) || Disagree || 25 || (16.3%) || (16.3%) || Strongly disagree || 6 || (3.9%) || (3.9%) || Not relevant || 4 || (2.6%) || (2.6%) || No opinion || 19 || (12.4%) || (12.4%) Comments concerning statistics: The results from
the IPM tool as presented above show separate analysis of the answers received
for each of the two options presented in the consultation paper. However, many
replied on both questions with the same answer, as for example: neutral, no
opinion, acceptable or unacceptable in both cases. Finally, only 108 of 153
received clearly expressed their view for one or another option and of those 65
opted to keep the Intra-Community trade system and 43 chosen the introduction
of placing of the market approach. From presented
data it can be concluded that the views on both approaches are rather divided,
but a tendency towards the Intra-Community trade concept. Additional remarks ·
New EU AHL should pave a pathway towards the
placing on the market concept but should not introduce it at this stage yet. ·
Possible introduction of HACCP-like concepts is
not welcomed, has not been proven as a right approach for small holdings and it
brings too many costs for operators. ·
Certain categories and/or species of animals are
perceived as low risk and should therefore in view of consulting parties be
exempted from the general movement rules, especially when these animals are
kept in controlled environment – for example laboratory animals). For some
specific rules would be needed (bees, zoo animals, etc.) ·
Differentiation for commercial and
non-commercial movements is important. ·
EU legislation should lay down minimal health
requirements and recognise initiatives for reaching higher biosecurtiy and
health standards. On the
placing on the market ·
This concept is at this stage perceived as too
risky, hazardous, and premature. The animals can not be compared to products of
animal origin they involve more health risks. ·
There are doubts if the system is feasible for
terrestrial animals. ·
Problem in certification of specific health
provisions especially in terms of export of animals are envisaged. ·
Placing on the market concept would suit only
certain types of holdings or trade partners; while for the others it would
represent a big additional burden, limiting them with the sourcing of animals
and national movements. ·
Suggested system appears too costly for the
majority of holdings across the EU. ·
It would be more difficult to apply the placing
on the market for terrestrial animals than it was for aquatic animals.
Terrestrial animals involve, which consequently leads to more diseases. The
system introduced for aquaculture, has already shown deficiencies, which might
be even bigger in case of more complex situation on terrestrial side. ·
Placing on the market could be introduced by
imposing animal health surveillance schemes (including regular veterinary
visits on farms), recording, traceability, good hygiene practices and be
strongly supported by regionalisation. ·
In case of placing on the market, clear
provisions should be set for movement of animals from holdings with low health
status to those with high health status. ·
Placing on the market approach is perceived as
beneficial as the holdings will need to comply with higher standards that will
bring more advantages to welfare of animals. 2.8. Differentiation or uniformity of trade rules and disease control
measures on commercial and non-commercial farming Ø
Proposed approach for comments: Diseases do not
distinguish between different categories of holdings and all holdings might be
at risk of getting and spreading disease. The optimal way forward seems to be
to apply disease control measures and the same rules on movement for all
holdings; however, opportunities for risk-based exemptions on a case-by-case
basis might be achievable for certain diseases or animals. The Animal Health
Law would need to provide for basic principles on when and how a certain
category of animal or product movement can be exempted from the general rule.
Detailed provisions should be set in subsequent legislation and made
sufficiently flexible and controllable. Ø
Statistics: Do you support this preliminary approach?
-single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 30 || (19.6%) || (19.6%) || Agree || 84 || (54.9%) || (54.9%) || Neutral || 15 || (9.8%) || (9.8%) || Disagree || 13 || (8.5%) || (8.5%) || Strongly disagree || 4 || (2.6%) || (2.6%) || Not relevant || 0 || (0%) || (0%) || No opinion || 7 || (4.6%) || (4.6%) Ø
Comments: ·
EU legislation for these categories of animals
should allow for stricter Member States rules. ·
AHL should not go beyond guidelines and basic
principles on when and how a certain category of animals/ products should be
subjected to stricter rules. ·
Harmonized EU approach is needed. ·
This issue should be left to be regulated by the
MSs (hobby, zoo, etc). Rules have to be flexible to acknowledge local
circumstances. ·
Proportionality is vital. ·
Definition of commercial and hobby holdings
needs to be established (any holding that is part of the food production chain
should be considered as commercial). Definition should be sound and
enforceable. ·
An important issue is who will be responsible to
grant the exemptions. ·
Risk-evaluation to establish exemptions should
be harmonized, acknowledge risk evaluating principles. ·
Avoid having at the end a two-tier system. ·
Requiring application of derogation case-by-case
is too heavy administrative system. ·
High administrative burden costs for small/hobby
farms, cost beneficial at all levels in the long-run. ·
Impacts of differentiating rules: minimum risk
for disease spreading, decrease bureaucracy. ·
Exemption should be generic, based on the size
of the holding, no case-by-case basis, similar to hygiene package. ·
Possible adaptation with regard to
compartmentalization principle should be considered. ·
The EU should clearly state those animals and
diseases for which exemptions would apply. ·
Specific rules for categories of animals
different from farm animals should be provided. ·
Certain category of animals could be exempted if
they apply self-imposed higher level of biosecurity and health status. ·
Hobby-farmers, pet owners: low disease
awareness, low knowledge on biosecurity, important to find a relevant,
realistic way to include these groups, avoid practical increasing of
administrative burden for competent authorities and farmers. ·
The new Regulation should contain tools for
performing risk-based analysis and surveillance schemes for movements of
non-commercial farming. ·
To give hobby holdings a formal status, that
would place them under the general rules and allow for derogations. Arguments
against differentiation of measures: ·
AH rules should apply equally, regardless of
whether the animals are kept for commercial or non-commercial purposes. ·
Trans-boundary transport of pets can spread
pathogens. ·
No animals should be exempted from monitoring
and surveillance. Zoo, circus and pet animals should be controlled when they are
moved (at least randomly). ·
Surveillance and monitoring also needed for wild
animals. ·
Outbreak and spreading of animal diseases in
non-commercial holdings could have major implications for commercial ones
(establishment of restricted and surveillance zones). ·
To differentiate between commercial and
non-commercial animals is difficult (hobby farmers often engage in limited
commercial activities. ·
Horse transport should maintain strict health
regulations. Arguments in
favour of differentiation ·
More flexible for zoos/hobby animals: not
intended for the food chain. ·
Ornamental fish, kept in home aquarium should be
exempted for general rules. ·
Exceptions should apply also to some specific
traditional small farms (free-range, organic) in the poultry/eggs sector. ·
Contact movements at non-commercial farms are
far less than in commercial holdings. ·
Laboratory animals represent minimum risk (not
traded, confined). ·
Differentiation animals for slaughter and other
animals: limited risk, deserve to be treated differently. ·
Diseases are normally concentrated in commercial
holdings. ·
Zoos do not represent a risk for agricultural
holdings, is the other way around, they are relatively small population of
endangered species applying already strict animal health rules. Zoos usually do
not exchange animals with agricultural holdings. ·
Breeding programmes for endangered species are
jeopardized by unclear legislation, lack of uniform application and slow
decision-making process: animal exchanges are difficult or even impossible:
compromised welfare conditions and obstruction of conservation initiatives. ·
All holdings do not pose the same risks for
animal diseases spreading (hosts specificity, opportunities for disease
transmission, new animals, transport, stocking densities). ·
Some control measures are not suitable for zoo
animals (compulsory slaughter is not adequate; vaccination and surveillance
are better). ·
Indigenous livestock breeds need a special
status in the event of disease: if not, negative impact in biodiversity,
special breeds will disappear. 2.9. Animal health requirements for trade and import for certain animal
species under Directive 92/65/EC Ø Proposed approach for comments: The future
Animal Health Law should establish clear general rules on trade for these
"special" species and categories of animals, and clarify which
species could be exempted by special animal health rules, while leaving more
specific provision to implementing rules. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || Number of requested records || Requested records (153) || % of total number records (153) || Strongly agree || 41 || (26.8%) || (26.8%) || Agree || 76 || (49.7%) || (49.7%) || Neutral || 12 || (7.8%) || (7.8%) || Disagree || 3 || (2%) || (2%) || Strongly disagree || 2 || (1.3%) || (1.3%) || Not relevant || 2 || (1.3%) || (1.3%) || No opinion || 17 || (11.1%) || (11.1%) Ø
Comments: General remarks: ·
EU rules for these categories of animals should
be consistent with the OIE standards. ·
Transit of animals from third country to third
country through the EU should be taken into account. ·
Traceability of animal movements is a key issue.
Use of TRACES for every type of animal movement should be required. ·
We have to be careful that the new law does not
encourage transport of wild/exotic animals. Conditions for transport should be
taken into consideration as well. ·
Wild animals need sedation and special handling
before moving them and this should also be taken into account when laying down
rules. Risk of
"special species" imports: ·
A risk-based approach should be followed when
establishing rules for these categories of animals. ·
Basic rules should apply also for animals not
entering the food-chain if they represent a risk to the health of
food-producing animals or for food-safety. ·
As changes in ecosystems can lead to disease
risks, a clear and justified need should be demonstrated for importation of
"special species". ·
Imports of exotic animals may not have an
immediate health risk, but in the long term could have huge consequences. ·
Exemptions to the rules have to be as limited as
possible: exotic species could be a major reservoir of exotic pathogens and the
origin of epizootic disease in the EU animal populations. ·
Prevention aspects of animal health legislation
should apply to all species. ·
This review should not lead to a ban on imports
from species already authorised. Degree of
harmonization of the rules: ·
Rules should be completely harmonized for these
species, including implementing rules, otherwise is not possible to have a
harmonized border control and intra-Community trade control system and to avoid
market distortion. ·
The EU should lay down minimum requirements for
these categories of animals and the MS should be able to apply stricter rules
based on their animal disease situation. ·
Same rules should apply for all MS, but allowing
them to review exemptions for certain species if they are considered to be an
increased disease-threat. ·
Directive 92/65 is not implemented properly by
the Member States and this makes movement of animals impossible sometimes and
therefore breeding/conservation programmes are endangered. This legal act
should be changed from Directive to Regulation. There is a need for uniform
implementation of the rules, also targeting movements of zoo animals across MS. ·
Basic general rules should apply to all species.
MSs starting to import new species should present and discuss this with the
rest of the MS. Not only the species but also the conditions for importation
should be specified. Specific sector
remarks: ·
Important to establish a clear definition of the
species to avoid misunderstandings (e.g.: llamas are not ruminants). ·
Wild equidae should be accommodated into
Directive 92/65. Some species such as the American bison are kept in zoos and
also for commercial purposes. Experts should be consulted before laying down
rules to avoid problems. Legislation should reflect the correct taxonomy; to
treat a whole taxonomic class as if they were domestic animals has no sense. ·
Laboratory animals are almost always maintained
at a very high health status, which is closely monitored and controlled and
therefore exemptions from restrictions should apply for those animals. ·
Ornamental fish should have a different status
than fish. ·
Specific needs of the horse sector should be
taken into account. Extent of horse movements is huge compared to exotic pets
and zoo animals. All horses shouldn't be treated the same (wild ponies,
slaughter horses, competition horses), they have hugely varied health status
and disease risks. ·
The possibility for bilateral agreements on
cross-border movement of certain species as reindeer should however remain
possible, but rules on traceability should be laid down to ensure rapid tracing
in disease outbreaks. 2.10.
Emerging, re-emerging and exotic diseases Ø
Proposed approach for comments: Emerging
diseases should be reflected in the new Animal Health Law and linked to the
ongoing exercise to set priorities for EU intervention and categorise diseases.
Certain provisions of the current Directive 92/119/EEC can be considered as a
basis for developing a solid and concise legal framework for horizontal control
principles for emerging, re-emerging and exotic diseases, taking into
consideration the OIE rules on notification. The provisions of certain disease
control directives that are outdated, disproportionate, not flexible enough or
not aligned with international standards should be revised and aligned with
general principles to be set out in the Animal Health Law. In addition, some
technical adaptations to existing rules in the chapter of simplification will
be needed. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 43 || (28.1%) || (28.1%) || Agree || 89 || (58.2%) || (58.2%) || Neutral || 7 || (4.6%) || (4.6%) || Disagree || 3 || (2%) || (2%) || Strongly disagree || 0 || (0%) || (0%) || Not relevant || 0 || (0%) || (0%) || No opinion || 11 || (7.2%) || (7.2%) Ø Comments: ·
Basic EU animal health legislation is too rigid
(difficult to change) to accommodate all emerging and re-emerging diseases.
Detailed provisions should be flexible and should therefore be laid down in
lower level legislation. Strategies to control different types diseases are
different and this needs to be taken into account. Member States should have a
possibility to introduce national measures for control of specific diseases. ·
Framework AHL should provide general rules for
different groups of diseases (like vector borne diseases, highly contagious
diseases with direct transmission, etc.). It should take into consideration
wildlife as a permanent reservoir of disease agents, different exotic animal
species and pet animals that might introduce new diseases especially zoonotic
agents. ·
Definition of emerging diseases should be
constructed carefully and can include non-infectious diseases and antimicrobial
resistance. ·
AHL should include latest scientific knowledge
and risk based measures within the EU and in imports. ·
AHL disease control rules should align as far as
possible with the OIE. Where scientifically justified a higher health status
should be set. ·
Vaccination policy should be less restrictive
and the importance of vaccination strengthened. More emphasis should be given
to vaccine development. ·
Innovation is important for the animal health
sector in particular in developing new diagnostic kits, vaccines. EU should aim
for latest diagnostic and vaccination technologies and should influence in this
respect international organisations. ·
Disease categorisation and prioritisation are
very important tools and the result needs to be included in the AHL. ·
OIE disease situation information should be
introduced into the TRACES system, which can be used as a proper control tool
for preventing the introduction of exotic diseases into the EU. ·
More passive surveillance should be used for
diagnosis of emerging diseases. 2.11.
Review and simplification of current
rules on identification and registration of animals Ø
Proposed approach for comments: Current
provisions would be essentially confirmed, without lowering current
traceability standards. However, basic principles and objectives for
identification and registration of animals would be clearly laid down in the
Animal Health Law, while specific provisions for different species or
categories of animals would be established by Comitology. This would ensure
policy coherence, better understanding of the animal owners and more successful
enforcement. In the meantime, current legislation would remain in place. Ø
Statistics Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 22 || (14.4%) || (14.4%) || Agree || 92 || (60.1%) || (60.1%) || Neutral || 16 || (10.5%) || (10.5%) || Disagree || 7 || (4.6%) || (4.6%) || Strongly disagree || 4 || (2.6%) || (2.6%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 11 || (7.2%) || (7.2%) Ø
Comments: ·
The Commission's approach was generally
supported. However, only basic principles, objectives and outcomes should be
set in the AHL; excluding many detailed provisions or rules for identification. ·
Traceability is perceived as an imperative but
it can be achievable with different means. Individual identification of all
species is not always necessary. ·
Identification and registration of pet animals
was largely perceived as a necessary step further for animal health and welfare
reasons. ·
Identification of non-food animals is seen as
necessary for these animals might represent a health threat for other animals
and humans. ·
All elements of identification and registration
system (identification mark, documents, and database) are not suitable for all
species and categories of animals. Therefore careful consideration should be
given to what extent these provisions would apply to all animals like fur
animals, bees, aquatic animals, poultry, etc. ·
Data collected for identification and
registration should be used for other purposes and not only traceability.
Identification and registration databases of the member states should be
connected within the EU. ·
Specificity has to be recognised especially for
equidae, where an existing system complying with the international standards
for registered horses is already in place. More emphasis should be given to its
implementation. ·
AHL should give consideration to special animal
categories like zoo animals, where an international approach has been created (ISIS system; ZIMS database). Special arrangement for domestic animals kept in zoos is
suggested. ·
A good balance of efficiency, feasibility and
costs should be established. 2.12.
Specific animal health conditions relating
imports Ø
Proposed approach Regulation (EC)
No 882/2004 provides the legal framework for general import conditions and
controls. These provisions would be supplemented by specific import conditions
set out in the new animal health law. These rules are to allow appropriate
flexibility, while all the technical provisions are to be set in subsequent
legislation and in line with the OIE recommendations as far as possible.
Flexibility and tailor-made rules based on risk assessment should ensure the
desired level of protection, while at the same time reducing the burden for
operators. The Animal
Health Law should make explicit the specific principles to be observed when
setting import conditions based on animal health concerns (i.e. what animal
health grounds warrant the limitation of trade with non-EU countries) and the
principle that import conditions must be risk-based and therefore adjustable to
the level of risk. The Animal
Health Law should cross-refer to the principles and procedures laid down in Regulation
882/2004 for collecting information on the basis of which import conditions are
set and the arrangements for setting general and specific import conditions by
sectoral (delegated) legislation. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 27 || (17.6%) || (17.6%) || Agree || 88 || (57.5%) || (57.5%) || Neutral || 18 || (11.8%) || (11.8%) || Disagree || 6 || (3.9%) || (3.9%) || Strongly disagree || 0 || (0%) || (0%) || Not relevant || 0 || (0%) || (0%) || No opinion || 14 || (9.2%) || (9.2%) Ø
Comments: Rules ·
Flexibility is required to allow Member States
to apply additional conditions if necessary, based on a scientific risk
analysis. ·
Principles and procedures should all be the same
for all MS and clear for all operators, to avoid delays in animal transport and
problems. ·
Details on import requirements to be established
in bilateral agreements. ·
Simplification is welcomed, but without lowering
standards while increasing rules for the EU operators. ·
All import requirements (specific rules for
imports and controls) should be laid down in Regulation 882/2004 to remain a
coherent set. ·
AHL should lay down main requirements; specific
requirements should be left for implementing rules. ·
Harmonized procedures and intensity of controls
should be the same across al MS. ·
Good pre-import testing and monitoring are
essential. ·
Stakeholders and importers should be consulted
to make sure that the conditions are easy to understand and accessible and not
"lost" in a complicated legal act dealing with very different range
of issues. Simplification should not be only for Competent Authorities, but
also for operators. ·
List of risks by species and sector is a good
start. ·
Proper enforcement of the legislation is a key
point. ·
Efficient identification of imported animals is
essential. ·
Imports of live animals and animal products are
the biggest threat for animal health in the EU. ·
Sanctions to MS not complying not implementing
the rules, not supporting the veterinary services shall be defined and applied. ·
EFSA should be consulted to carry out
risk-assessment in relation to imports. Import
conditions and competitiveness of EU business. ·
Rules on general import condition should be
based first on scientific risk assessment and international standards. ·
Import conditions should be similar to the
requirements imposed to EU farmers and food business operators by the EU
legislation. This may regard the registration, training, surveillance and
monitoring: in that way control of disease risks of imports will be improved
and will create a level of playing field. ·
Community standards are higher than
international ones: this means higher costs for EU producers. ·
The concepts used for risk analysis in the EU and
in third countries are not the same. ·
Imported products and animals should comply with
the same standards as the EU ones (animal welfare, animal health and food
safety, environment). ·
Third countries should apply regionalization as
the EU does. ·
Requirements for internal movements should be
equal to import conditions (not having higher standards for intra EU trade than
for imports). Impact ·
Simplification of import regulation likely to
facilitate border controls and improve AH status in the Community. ·
Impact on bilateral trade between MS should be
taken into account. Specific sector needs ·
Specificities of the horse sector should be
taken into account. ·
Occasional imports of zoo animals are needed to
ensure long-term genetic variability (conservation/breeding programmes for
endangered species). Disease risks should not be extrapolated from domestic to
wild animals, experts should be consulted. ·
Genetically important livestock should have a
special treatment, also in the OIE Code. 2.13.
Converegence of the EU legislation with
international standards Ø
Proposed approach In order both to achieve its desired level
of protection in relation to imports and fulfil its international obligations
the EU should: ·
align the EU legislation with the international
standards as far as possible (OIE, Codex) while at the same time not lowering
its health standards which have already been achieved; and ·
promote its standards in the international fora
and in particular the OIE, with the aim to ensure the maximum possible
convergence between the EU and international standards. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 43 || (28.1%) || (28.1%) || Agree || 83 || (54.2%) || (54.2%) || Neutral || 13 || (8.5%) || (8.5%) || Disagree || 4 || (2.6%) || (2.6%) || Strongly disagree || 2 || (1.3%) || (1.3%) || Not relevant || 0 || (0%) || (0%) || No opinion || 8 || (5.2%) || (5.2%) Ø Comments: ·
OIE convergence is by the majority welcomed.
However, the current EU health standards should not be lowered where the EU has
reached higher standard. Only few expressed the need to review current higher
EU standards to see if they can be adjusted to a level provided for in
international standards. ·
When creating new measures, higher standards
than the OIE can be introduced only after a risk assessment. In these cases all
efforts should be engaged to reach the consensus to modify relevant
international standards. ·
Moreover some emphasise that the internal EU
rules should not be more stringent than the import rules unless specifically
justified (if possible with quantitative analysis). The goal of the subsequent
requirements should be to minimize risk to acceptable level. ·
OIE recommendations focus on outputs
(achievements) rather than tools and EU legislation should follow this
approach. ·
The ones that disagree with the approach mostly
stress that the EU has achieved higher health and quality standards in the
past. Their perception is that these standards should not be lowered and the
EU position not weakened. ·
EU influence in the international forums should
be more proactive aiming at achieving higher standards at the international
level. EU membership is perceived as a beneficial step forward. However, EU
can't be too patronising and impose so high standards, which can have negative
effects for less developed countries. ·
Concept of aligning with international standards
should not limit the onset of private standards at a higher level. ·
Definitions in the AHL should be in line with
the OIE standards. ·
In terms of OIE animal welfare constitutes an
important element of OIE convergence.. ·
Emerging diseases presenting threat to
biodiversity of animal species are an important element. OIE already follows
this approach; co-operation with other international organisations should be
considered. ·
Responses of countries in case of disease
outbreaks should be comparable; EU currently applies much more reasonable
measures towards than some countries apply towards the EU. 2.14.
The definition of 'epidemiological unit'
and 'holding' in EU legislation Ø
Proposed approach The Animal
Health Law should refine existing concepts of herd and holding and establish
cross-links between them. he concept and definition of ‘epidemiological unit’
for animal health purposes is of fundamental importance to taking all measures
necessary on biosecurity, registration of animals and their movements,
surveillance and definition of the animal health status of the relevant
population and, as a consequence, granting incentives for prevention, as
highlighted in several points in this document. Therefore, based on these
concepts, the Animal Health Law should ensure a coherent and consistent
definition of ’epidemiological unit’. Ø
Statistics: Do you
support this preliminary approach? -single choice reply- (compulsory) || || || Number of requested records || Requested records (153) || % of total number records (153) || || Strongly agree || 27 || (17.6%) || (17.6%) || Agree || 81 || (52.9%) || (52.9%) || Neutral || 20 || (13.1%) || (13.1%) || Disagree || 4 || (2.6%) || (2.6%) || Strongly disagree || 0 || (0%) || (0%) || Not relevant || 1 || (0.7%) || (0.7%) || No opinion || 20 || (13.1%) || (13.1%) Ø
Comments: ·
Epidemiological unit has to be defined for each
pathogen. ·
The definition of epidemiological unit should be
based on the OIE definition to be accepted internationally. ·
Work in partnership with the OIE to agree on a
definition that suits also EU purposes. ·
There should be flexibility in the definition to
adapt it to different systems/species. It would be necessary also to define a
list of common basic criteria in order to adopt similar approaches for each
species, together with the definition of epidemiological unit. ·
All relevant terms describing animal populations
should be considered when defining epidemiological unit. ·
A clear and undisputable definition should be
established in the AHL to avoid misunderstandings and problems. ·
The new definition should take into account
already existing definitions and arrangements in the MS and their
particularities. ·
It's too difficult to establish a definition
that will fit in all cases, is better to rely on barriers to slow down the
spreading of diseases and stand-still requirements that are easier to
standardise. ·
The consequences of establishing this definition
have to be assessed carefully (e.g. implications for movement reporting burden
that this could have).It is important to identify current patterns of land use
within each MS and use this to assess the impacts of moving towards the use of
a prescribed definition of a holding. ·
To refine the definition of herd and holding is
necessary but to define epidemiological unit at EU level is too complicated. ·
Pet owners of small number of animals should be
excluded from the scope of the definition; otherwise it would be extremely
complicated. ·
Definition of approved areas in Directive 92/65
may help in order to establish a definition of epidemiological unit. ·
Panel of internationally recognized scientists
and epidemiologist to find what could be the best possible definition. ·
Definition for pet animals is easier than for
large commercial holdings that should be registered. ·
General rules to exempt certain parts of
holdings from restrictions should be laid down in relation to the
characteristics of each disease or disease group and specific implementation
rules left to the MS. ·
One herd per holding and holding becomes
epidemiological unit. ·
To define epidemiological unit will have no use
for animal disease control purposes, as all animals in the holding will have to
be killed in case of an outbreak. 2.15.
Is there any other issue that you would
like to raise or that you feel that should be addressed by the Animal Health
Law and that is not included in the document? General
principles: ·
A new "general framework law" should
be established, with the aim to merge animal health, animal welfare and food
safety into a single framework. These three areas can't be separated. Therefore
they need to be put together into the same legal text, since they address the
same actors and stakeholders (animal keepers, traders, veterinarians, etc.).
General food law shall be re-constructed for that purpose. ·
AHL shall include general principles, similar to
the ones set out in a general food law (Regulation (EC) No. 178/2002). ·
AHL shall include veterinary checks regime and
prevention principles through controls on permitted imports. ·
AHL should contain budgetary / financial
questions – emergency funding rules. ·
A clear and reactive chain of command of
veterinary services needs to be set. Coherence with
other legislation and policies: ·
Coherence between animal and public health
legislation addressing primary production needs to be drawn up (coherence of
animal health certification and providing food chain information). It shall
establish a single sending of information and link databases. ·
Relation between the AHL, food and feed safety,
zoonoses should be established. Monitoring and surveillance schemes in all
areas should be adjusted to each other and be comparable. ·
AHL should integrate with other Commission
activities under the framework of DG AGRI, ENTR, and ENVI. Relation animal
health animal welfare: ·
Clear reference and link between animal health
and animal welfare needs to be established in the AHL. ·
Comprehensive definition of health and welfare
should be set out: "freedom of diseases or abnormality and state of wellbeing
by meeting physical, physiological and psychological elements. ·
Link should be established to protection of
laboratory animals. Focus on
prevention: ·
Disease prevention is a shared effort of all MS;
good implementation and control are needed. ·
Focus on prevention should not take away need to
focus on eradication. Eradication is a starting point for prevention.
Prevention and biosecurity should be promoted as beneficial to farmer in
day-to-day life. One health
concept: ·
Include "One health" concept – diseases
spread from animals to humans and from domestic animals to wildlife and vice
versa. This needs to be considered in the legislation. Vaccination: ·
Vaccination policy should be clarified and
vaccination should not be prohibited, when it is proved to be effective and it
doesn't harm health. ·
Vaccination of animals after outbreaks should be
more protective; emergency measures and special marking of animal products
remain in place for too long period and influence the trade with products of
vaccinated animals. This causes unjustifiable economic losses. ·
Hobby keepers want to use preventive vaccination
to protect their animals and this should be allowed. This same is valid for
protection of rare breeds. ·
Vaccination should be designated as a strong
preventative tool. ·
There is no reason for products, which originate
from vaccinated animals to be distinguished with special labelling. These
products don't constitute public health risks. ·
There are considerable differences between
health statuses of vaccinated and non-vaccinated areas, which result in trade
implications. ·
A level of proving of disease freedom after
vaccination for creation diseases is too high (for example 100% for FMD, which
is un-realistic). Wildlife: ·
Wild animals present health risk and the AHL
shall provide the same approach to them as to the commercial animals, in
particular in relation to disease control measures (TB testing) ·
More attention should be given to wild animals
and non-commercial categories of animals. Horses: ·
EU animal health policy is unclear about the
status of the horses and doesn't reflect commercial, racing, breeding, sporting
and leisure movements of horses. ·
Distinction between breeding and registered
horses is not needed; only slaughter horses need a different approach. ·
Provisions of directive 90/426/EEC to be
included into the bilateral trade or veterinary agreements, which would reduce
day-to day practical problems and costs, facilitate exchanges and allow
flexibility. Specific animal
categories: ·
Bees and beekeeping are special areas of
expertise. The AHL should also provide legal framework for them, but allowing
specific rules at a higher level of detail as a subsequent step. ·
Zoo animals and aquatic animals from aquariums
need modified arrangements. Movements of those animals do not usually have the
nature of commercial movements and animals don't end in food chain. Related to
this protection of rare species need to be taken into the consideration.
Furthermore, transport of these animals can't be considered as commercial operation. ·
Some categories of animals presenting lover
health risks per se and some of them leave in controlled environment, these
elements should be taken into account accordingly (i.e. fur animals, laboratory
animals). ·
Amphybians and other "exotic" companion
animals have often in the past constituted health risks, especially for humans
(salmonella infections) and other animals. Movements: ·
All movements represent risks; therefore
national movements should be included in the AHL. ·
Animal identification and registration databases
should be connected in order to facilitate animal movements across the EU. ·
For animal health and welfare reasons movements
of animals should be limited to only one assembly operation. ·
Rules should be established for gathering of
animals at international level like international exhibitions. Disease control
measures: ·
An automatic abolishment of emergency measures
after a certain period elapses after the outbreak should be introduced into
legislation. ·
Stand-still requirements for pigs in directive
91/119/EEC should be reviewed. ·
The new law should replace detailed rules for
disease control, especially those from the Regulation (EC) No. 2005/76,
Directive 2005/94/E, 2003/85/EC, 200/75/EC with more general provisions,
allowing more flexibility. ·
Measures to control Rift Valley Fever have to be
put in place. ·
Rules for suppression of tuberculosis should be
up-dated. Laboratories and
tests: ·
More flexibility should be introduced for tests
in a framework of directive 90/429 for porcine semen. ·
AHL should include provisions to ensure quality
of laboratory reagents. Audits and
controls: ·
Internal audits should ensure harmonised
application of EU rules in the MS. ·
Better enforcement measures should be put in
place in the AHL. ·
More flexibility should be allowed on a level
and frequency of controls (example Regulation (EC) No. 1082/2003 – controls on
identification of bovine animals). VMPs and
antimicrobial resistance: ·
AHL should include chapter on veterinary
medicinal products – holistic approach needed. ·
Prevention part should include rules for use of
antibiotics, with a link to prevent developing of antimicrobial resistance. ·
Availability of VMPs, vaccines and biocides
should be regulated by the AHL. ·
AMB resistance: status of MRSA in MS differs.
Continuation of work on eradication and fighting diseases. Facilitating trade
only adds to spreading. Import: ·
Import certificates for aquatic animals are too
complicated. Signing authorities in third countries can't understand them. Stakeholders: ·
AHL should contain a chapter dealing with the
relationship with stakeholders to ensure transparency, easier implementation of
legislation across the EU). An instrument similar to the Animal Health Advisory
Committee would be advisable. Private
standards: ·
New animal health legislation should give room
for private quality systems. 3.
Conclusions 3.1. Responsibilities and obligations of animal keepers and owners Results of the
consultation show a general support of stakeholders on the proposed approach by
the Commission to clarify roles and responsibilities of animal keepers and
owners. However, some discrepancies on the degree of harmonisation of this
subject were observed. The need to establish obligations also for operators
other than animal keepers and owners was highlighted by several stakeholders. 3.2. Training for people dealing with animals Although the
voluntary approach was regarded as the most adequate one by the majority of
stakeholders, a significant share would prefer that compulsory training for
people dealing with animals is established in the AHL. Concerns on the funding
for training activities were expressed by some stakeholders. The majority of
stakeholders highlighted the importance to provide flexibility to adapt
training provisions to specific circumstances. 3.3. The role of the veterinary services - clarifying the tasks and
duties of official veterinarians and private veterinary practitioners Consultation
shows a need to clarify and harmonise certain veterinary tasks EU-wide. This is
valid in particular for the "export certification" and international
trade. Certain veterinary tasks are perceived as purely official, while the
others have a certain official character (need to remain under authority's
control) and can be performed by veterinary practitioners, other experts, where
relevant (i.e. for aquaculture, apiculture) or other staff, such as
technicians. All resources should be used in an optimal way in order to ensure
proper territorial coverage and a good quality of veterinary services in line
with the OIE provisions. 3.4. Professional qualifications and training for official and approved
veterinarians Education
and training for veterinarians are very important but should be flexible, adjusted
to specific needs and adapted to the level of public tasks assigned to a professional;
approved veterinarians don't need the same level of training as the official
veterinarians. These trainings should therefore be output / target oriented
towards proper enforcement and shouldn't generate unnecessary costs. Training
should be provided also to other professionals responsible for certain working
areas with a lack of veterinarians, such as for example aquaculture,
apiculture, etc. Many MS already have already introduced continuous
professional developments of veterinarians and for those it seems that the
additional regulation at the EU level would be redundant. 3.5.
Biosecurity measures to prevent outbreaks
on farms and not only deal with them when they occur Although the voluntary approach was regarded as the most adequate
one by the majority of stakeholders, a significant share would prefer that
compulsory biosecurity measures are established in the AHL. A combination of
options 2 and 3 was suggested as the best approach by various stakeholders.
Some stakeholders are against providing trade-facilitation mechanisms as they
consider that this would increase animal diseases risk. Discrepancies on the
scope for implementation of biosecurity measures and on the level at which this
should be regulated were observed. 3.6. Surveillance There is a substantial
support towards the Commission's approach to strengthen the surveillance,
however the views on the necessity to introduce surveillance network were more
diverged. It seems that even this approach would largely be welcomed but should
aim for a robust system for disease surveillance that would be able to adjust
to different production types and different diseases. Room for additional
provisions and specific solutions at the level of Member States should be
preserved, using at the same time, where possible a soft-regulatory approach. 3.7. Intra-Community trade / placing on the market concept From presented statistical
data it can be concluded that the views on both approaches are rather divided,
but there is a tendency towards the keeping of Intra-EU trade concept. The
overall feeling is that the new EU AHL should pave a pathway towards the
placing on the market but should not yet introduce it at this stage. This
concept is perceived as too risky, hazardous, and premature. The animals can
not be compared to products of animal origin they involve more health risks.
There are doubts if the system is feasible for terrestrial animals as it
already shows problems with aquaculture. In addition, it could create further
problems related to inability of the certification of specific health
provisions for export of animals. A fear exist that placing on the market would
suit only certain types of holdings or trade partners; while for the others it
would represent a big additional burden, limiting them with the sourcing of
animals and national movements. On the other hand the concept is well perceived
from the animal welfare perspective, expecting the farms to obtain better
conditions for animals. 3.8. Differentiation or uniformity of trade rules and disease control
measures on commercial and non-commercial farming The majority of
the replies support differentiation of measures for commercial and
non-commercial holdings. However, a significant percentage of the replies argue
that this will imply an increased risk of animal disease outbreaks and
spreading. Discrepancies were also observed on the risk attached to
non-commercial farming activities. 3.9.
Animal health requirements for trade and
import for certain animal species under Directive 92/65/EC Results of the consultation show a
general support of stakeholders on the proposed approach by the Commission,
however discrepancies were observed on the risks attached to these
"special species" imports and on the level at which the exemptions
should be granted. 3.10.
Emerging, re-emerging and exotic diseases Framework
AHL should provide general rules for different groups of diseases (like vector
borne diseases, highly contagious diseases with direct transmission, etc.).
Basic EU animal health legislation is too rigid (difficult to change) to
accommodate all emerging and re-emerging diseases. It should take into
consideration wildlife as a permanent reservoir of disease agents, different
exotic animal species and pet animals that might introduce new diseases
especially zoonotic agents. Vaccination policy should be less restrictive and
the importance of vaccination strengthened. More emphasis should be given to
vaccine development and innovation. 3.11.
Review and simplification of current
rules on identification and registration of animals The Commission's
approach was generally supported. However, only basic principles, objectives
and outcomes should be set in the AHL; excluding detailed provisions or rules
for identification. Traceability is perceived as an imperative but it can be
achievable with different means; individual identification is not always
necessary. Specificity of species should be considered and a good balance of
efficiency, feasibility and costs should be established. Identification and
registration of pet animals, zoo animals and some others, was largely perceived
as a necessary step further for animal health and/or welfare reasons. 3.12.
Convergence of the EU legislation with
international standards OIE convergence
is by the majority welcomed and should apply for animal health and welfare.
However, the current EU health standards should not be lowered where the EU has
reached higher standard. Only few expressed the need to review current higher
EU standards to see if they can be adjusted to a level provided for in
international standards. When creating new measures, higher standards than the
OIE can be introduced only if scientifically justified. In these cases the EU
should take a proactive role and all efforts should be engaged to reach the
consensus to modify the relevant international standards. EU membership in the
OIE is perceived as a beneficial step forward. Concept of aligning with
international standards should not limit the onset of private standards at a
higher level. 3.13.
Specific animal health conditions
relating to imports General support
to the Commissions' proposed approach was observed in the replies. Concerns
were expressed on the fact that EU operators have to face stricter rules than
international standards. Discrepancies on the level of detail of the legislation
needed at EU level were also observed. 3.14.
The definition of 'epidemiological unit'
and 'holding' in EU legislation Although there was a general agreement to the proposed approach by
the Commission, the majority of replies highlighted the difficulties in
establishing a definition of epidemiological unit that could be adapted to all
animal species and relevant diseases and the implications that this definition
could have for movement registration and disease control measures. End
ANNEX VI Summary
of the questionnaire on artificial insemination and related issues
|| EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate D - Animal health and welfare Unit D1 - Animal health and Standing Committees EU Animal Health Law – consultation process Commission staff working document Summary of the replies to Questionnaire on the
potential impacts (economic and social) that the introduction of the
"placing on the market" concept could have for semen collection and
storage centres, embryo collection and production team Brussels, 10
September 2010 This document does not necessarily
represent the views of the Commission Services Please
note that this document has been established for information and consultation
purposes only. It has not been adopted or in any way approved by the European
Commission and should not be regarded as representative of the Commission
Services either. The European Commission does not guarantee the accuracy of the
information provided, nor does it accept responsibility for any use made
thereof. Summary of the replies to Questionnaire on the potential impacts
(economic and social) that the introduction of the "placing on the
market" concept could have for semen collection and storage centres,
embryo collection and production teams The
Commission, in the context of preparatory activities for the new EU Animal
Health Law, launched a wide stakeholders' consultation, the so called
"Annotated agenda for stakeholders' consultation". The intra-EU trade
vs. the "placing on the market" concept was presented in this
consultation with the aim to obtain the views of interested parties. A specific questionnaire
addressed to producers of semen, ova and embryos was distributed to the Rep Vet
group of COPA-COGECA. In this questionnaire operators were asked to express
their views about the "placing on the market" vs. intra-EU trade
question and to provide quantitative data that would enable us to assess
impacts of possible changes of the concepts to your respective sector. Replies were received from
operators of several Member States Belgium, Czech Republic, France, Germany, Poland, Spain, Sweden, the Netherlands, Hungary and United Kingdom. Also operators
from Norway and Switzerland replied to the questionnaire. Intra-EU trade / placing on the
market concept Ø
Problem dimension Current animal health provisions for
commercial movements of live terrestrial animals and control of their diseases
are largely based on the Intra-EU trade concept. This concept is based on
fulfilment of the animal health requirements established in the EU legislation
and subsequent certification prior to the movement of live animals between
Member States. The EU legislation allows Member States to maintain, to a
certain extent, animal health rules on national movements in live animals,
provided that these national rules comply with the relevant provisions on the
control of diseases that are regulated at EU level. The concept of intra-EU trade
is different from the one of ‘placing on the market’, which is currently used
in food safety legislation for products of animal origin (hygiene package and
for live aquaculture animals). In this case the general rule is that the
products or animals in question have to comply with the same harmonised
standards when placed on the market, regardless whether this is a national
market or a market of another Member State(s). For example, Directive
2006/88/EC introduces certain prerequisites for placing on the market animals
and products obtained from aquaculture production, such as an obligation to
hold an authorisation, recording and traceability obligations and obligations
to implement good hygiene practice, in addition to the animal health
surveillance scheme. Ø
Potential solutions /
options Option 1: Similarly to the approach already
introduced for aquaculture animals in Directive 2006/88/EC, the concept of intra-EU
trade in live terrestrial animals would be replaced by the concept ‘placing on
the market’. There are two important sets of
requirements to be met to support this option: ·
basic standards for
holding of origin, and prerequisites for authorisation such as good hygiene
practices (biosecurity) and surveillance obligation on farms regardless of the
destination of the animals being dispatched (within the same Member State or in
another Member State), and ·
standards for accepting
animals into the holding, region, or zone at destination, taking into
consideration the animal’s health status, and biosecurity and surveillance
information. This approach would shift more responsibilities onto operators
(animal keepers) and standards could be better met if a ‘HACCP approach’ were put
in place in primary production, too. However, flexibility could be introduced to
ensure that these additional standards do not lead to an additional burden on those
operators who move animals only locally. Do you support this preliminary approach? -
Agree: 3
representatives (plus NO and CH) -
Neutral: 3
representatives -
Strongly disagree: 2
representatives -
Not relevant : 1
representative Option 2: Maintain the concept of intra-EU trade as the basis
for regulating commercial movements of terrestrial animals between Member
States. However, the implementation of enhanced biosecurity measures and
surveillance schemes and subsequent trade facilitation mechanisms should, in
principle, narrow the gaps between the rules governing intra-EU trade and those
on national movements in live terrestrial animals, and eventually make it
possible in the long term to move towards a ‘placing on the market’ system for live
terrestrial animals, too. Do you support this preliminary
approach? -
Agree: 2
representatives -
Neutral: 4
representatives -
Disagree: 1
representative Comments: Representatives
in favour of the first option are from Member States where same rules apply for
intra-EU trade and national trade. No changes are expected for national trade
while for intra-EU trade they perceive simplification of procedures as an
advantage. Opinions
against the first option are based on the difficulties for small farms to make
the necessary investments for complying with all the requirements to be
authorised for intra-EU trade. Concerns on the measures to be taken in case of
an epidemic disease spread were also expressed. For some, current situation creates unfair competition
(different requirements for trade within the Member States depending on the Member State). Can you specify the main differences between the national and EU
approved centres (if relevant)? Member
States applying the same standards are: Czech Republic, France, Germany (almost, certain differences for horses), Poland, Spain, and the Netherlands (but for the Netherlands representative it would be unacceptable to apply the same rules
to storage tanks for use in the same farm where collected). Member States with different rules for
intra EU trade and trade within the Member State are: -
Hungary: different requirements for black and
white areas. For them, applying intra-EU trade rules to national movements
would imply significant investments for the farms that cannot be afforded, due
to the low profitability of the activity. They estimate decrease on AI for
pigs. -
UK: semen for national use is subjected to
lower standards than semen for intra-EU trade. The use of semen collected and
stored in the same holding is common practice and is not regulated. Could you estimate the
possible economic and social impacts of introducing the concept of placing on
the market? (Meaning that in order to trade nationally the centres would have
to comply with the same requirements as those for intra-EU trade?) Special rules would have to be provided for semen
produced before the legislative changes. For artificial insemination within the herd or farms
it seems disproportionate to apply the standards required for intra-EU trade
but on the other hand full traceability has to be ensured. Questions on how additional guarantees will be applied
in a credible way. Semen for exports to third countries will still be
subjected to certification. Porcine: concerns were expressed on the use of
antibiotics and PRRS positive boar stations. Conclusion: Placing on the market seems more feasible for bovine
and porcine semen. However, this view is not shared by all contributors, as in
certain Member States placing on the market could also have a considerable
impact for bovine an porcine semen use. For the rest of the species negative
impacts on society, the economy and biodiversity are expected due to the need
for investments needed to change protocols and equipment and the fact that
valuable genetic material will be lost because of non-compliance with EU
standards. DATA Estimate of the number of semen collection centres
approved for intra-EU trade and the number of semen collection centres
approved/authorised only for national trade within your Member State BELGIUM Species || Intra-EU || National Porcine || 3 || 30 Bovine || 3 || Sheep || || 1 Goats || || Rabbits || || Bees || || Equine || 16 || 102 Total || 22 || 133 CZECH REPUBLIC Species || Intra-EU || National Porcine || 20 || 20 Bovine || 8 || 8 Sheep || || Goats || || Rabbits || || Bees || || Equine || 5 || 5 Total || 33 || 33 FRANCE Species || Intra-EU || National Porcine || 23 || 23 Bovine || 32 || 32 Sheep || 11 || 11 Goats || 2 || 2 Rabbits || || Bees || || Others || || Total || 68 || 68 GERMANY Species || Intra-EU || National Porcine || 38 || 11 Bovine || 37 || 4 Sheep || 2 || Goats || || Rabbits || || Bees || || Equine || 139 || 92 Total || 216 || 107 POLAND Species || Intra-EU || National Porcine || 12 || Bovine || 10 || Sheep || || Goats || || Rabbits || || 1 Bees || || Others || || Total || 22 || 1 SPAIN Species || Intra-EU || National Porcine || 37 || 0 Bovine || 9 || 0 Sheep || 8 || 0 Goats || 7 || 0 Rabbits || || 0 Bees || || 0 Equine || 21 || 0 Total || 82 || 0 SWEDEN Species || Intra-EU || National Porcine || 3 || Bovine || 2 || 1 Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 5 || 1 THE NETHERLANDS Species || Intra-EU || National Porcine || 5 || 0 Bovine || 5 || 0 Sheep || 0 || Goats || 0 || Rabbits || 0 || Bees || 0 || Equine || 22 || 80 Total || 32 || 80 HUNGARY Species || Intra-EU || National Porcine || 6 || 4 Bovine || 3 || Sheep || 1 || Goats || || Rabbits || 1 || Bees || 1 || Others || || Total || 12 || 4 UNITED KINGDOM Species || Intra-EU || National Porcine || 14 || 1 Bovine || 9 || 1 Sheep || 3 || Goats || || Rabbits || || Bees || || Equine || 22 || Total || 48 || 2 Estimate
of the number of semen storage centres approved for intra-EU trade in your Member States and the number of semen storage centres approved/authorised only for national
trade in your Member State BELGIUM Species || Intra-EU || National Porcine || 5 || 41 Bovine || 4 || 5 Sheep || || 1 Goats || || Rabbits || || Bees || || Equine || 16 || 80 Total || 25 || 127 CZECH REPUBLIC Species || Intra-EU || National Porcine || || Bovine || 11 || 11 Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 11 || 11 FRANCE Species || Intra-EU || National Porcine || 23 || more than 23 Bovine || 67 || 67 Sheep || 11 || 11 Goats || 2 || 2 Rabbits || || Bees || || Others || || Total || 103 || 80 GERMANY Species || Intra-EU || National Porcine || || no data Bovine || 20 || no data Sheep || || no data Goats || || no data Rabbits || || no data Bees || || no data Others || || no data Total || 20 || no data POLAND Species || Intra-EU || National Porcine || 12 || Bovine || 10 || Sheep || || Goats || || Rabbits || || 1 Bees || || Others || || Total || 22 || 1 SPAIN Species || Intra-EU || National Porcine || || Bovine || 21 || 0 Sheep || || Goats || || Rabbits || || Bees || || Equine || 1 || 0 Total || 22 || 0 SWEDEN Species || Intra-EU || National Porcine || 4 || Bovine || 7 || all DYI + ai co-ops Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 11 || THE NETHERLANDS Species || Intra-EU || National Porcine || 1 || Bovine || 7 || all inseminators and private farmers for DYS AI Sheep || 0 || Goats || 0 || Rabbits || 0 || Bees || 0 || Others || || Total || 8 || HUNGARY Species || Intra-EU || National Porcine || || Bovine || 6 || Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 6 || 0 UNITED KINGDOM Species || Intra-EU || National Porcine || 4 || no data Bovine || 10 || 4 (and on-farm) Sheep || 3 || no data Goats || || Rabbits || || Bees || || Others || || Total || 17 || 0 Estimate of the number of embryo collection and
production teams approved for intra-EU trade in your Member States and the number of embryo collection and production teams approved/authorised only for
national trade within your Member State BELGIUM Species || Intra-EU || National Porcine || || Bovine || 4 || Sheep || || Goats || || Rabbits || || Bees || || Equine || 12 || Total || 16 || 0 CZECH REPUBLIC Species || Intra-EU || National Porcine || || Bovine || 3 || 3 Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 3 || 3 FRANCE Species || Intra-EU || National Porcine || 1 || 1 Bovine || 37 || 37 Sheep || 2 || 2 Goats || 2 || 2 Rabbits || || Bees || || Others || || Total || 42 || 42 GERMANY Species || Intra-EU || National Porcine || 2 || no data Bovine || 40 || no data Sheep || 6 || no data Goats || || no data Rabbits || || no data Bees || || no data Equine || 10 || no data Total || 58 || no data POLAND Species || Intra-EU || National Porcine || || Bovine || 4 || Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 4 || 0 SPAIN Species || Intra-EU || National Porcine || || Bovine || 13 || 0 Sheep || || Goats || || Rabbits || || Bees || || Equine || 2 || 0 Total || 15 || 0 SWEDEN Species || Intra-EU || National Porcine || || research Bovine || 3 || a couple Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 3 || 0 THE NETHERLANDS Species || Intra-EU || National Porcine || 0 || 0 Bovine || 8 || 20 Sheep || || Goats || || Rabbits || || Bees || || Equine || 3 || 30 Total || 11 || 50 HUNGARY Species || Intra-EU || National Porcine || || Bovine || 2 || 1 Sheep || || Goats || || Rabbits || || Bees || || Equine || || Total || 2 || 1 UNITED KINGDOM Species || Intra-EU || National Porcine || || Bovine || 23 || 16 Sheep || || Goats || || Rabbits || || Bees || || Others || || Total || 23 || 16
ANNEX VII Vaccination
policy
Part 1 EU
vaccination policies – background and additional assessment I. BACKGROUND OF THE ANIMAL VACCINATION
POLICY WITHIN THE EU I.1 Introduction The EU animal
health policy has been developed progressively and supported by harmonised
legislation since the early 1960s. This policy is fundamental to ensuring the
health and welfare of animals, profitability for farmers, food safety, the
functioning of the EU single market and the possibility of exporting animals
and animal products. EU strategies
for the control of major animal diseases of food producing animals often rely
on strict surveillance and rapid containment of disease outbreaks. This is
achieved by means of a 'stamping out' policy consisting in the culling of the
animals in the infected and other at-high risk farms. In this way the confirmed
and possible sources of infection are eliminated and the disease agent is
eradicated. This strategy is suitable for diseases which occur rather
sporadically, but which are easily spread from farm to farm and across state
borders, such as classical swine fever (CSF), foot-and-mouth disease (FMD) and
Avian Influenza (AI). By using the stamping out policy, the affected MS can
quickly regain their "disease free status". For these diseases, the EU
policy foresees only a rather limited use of vaccines, mainly in cases of
emergency. In fact, the Commission has put in place vaccine banks for FMD and
CSF, so that vaccines could be made rapidly available to MS in case of need. Conversely,
regular vaccination against other diseases is widely applied in the MS in
accordance with EU disease control legislation. For example, vaccination
against Brucellosis has proven to be an effective tool not only to control and
facilitate its eradication in livestock but also to protect human health, as
the disease can be transmitted to humans. Another example is the substantial
investment of resources in the vaccination of wildlife against rabies. This
significantly improved the rabies situation in Europe, reducing risk to human
health and making travelling with pets easier. Vaccination is
used in accordance with the EU legislation to control and eradicate diseases
with large production losses, such as Aujeszky's Disease, Infectious Bovine
Rhinotracheitis (IBR), etc. For many
diseases, vaccination of farmed, sports or pet animals is not regulated by EU
legislation and it is usually applied because of industry standards or
veterinary recommendation e.g. equine influenza, equine herpes virus,
parvovirosis for dogs, etc.. I.2. The reasons behind the EU "non-vaccination"
policy against major animal diseases Before the
strategies against major animal diseases were established at EU level in the
last few decades, MS routinely using vaccination against diseases such as CSF
and FMD had faced considerable problems in trade with other MSs and third
countries which were not applying vaccination and were considered as "free
from the disease". Trade in vaccinated animals and their products was
considered unsafe, because vaccinated animals – although not showing signs of
disease - can still become infected with the virus in the field, leading to a "masked
infection". In the late '80s
EU legislation was therefore adopted that included the prohibition of
prophylactic vaccination against FMD and CSF. The Single Market in cattle,
pigs, sheep and goats and their products was established in the early '90s thanks
to this "non-vaccination" policy and to the improvement in the
disease situation, leading to the achievement of the "disease free
status" across the EU (except the areas where limited outbreaks of disease
occurred, which were however "regionalized"). In this way EU farmers could
trade more easily and transparently not only within the EU but also with third
countries, leading to considerable economic benefits. Resources were therefore
focused on the prompt eradication of new introductions of diseases when they occurred,
rather than investing in very extensive and expensive vaccination campaigns and
surveillance of vaccinated populations. I.3. The impact of major animal health crises
on the "non-vaccination" policy At the end of the
'90s and beginning of the 2000s serious animal disease outbreaks in the EU (CSF
in 1997-98 and 2001-02, FMD in 2001, AI in 1999 and 2003) resulted in the
destruction of many millions of animals, many on the grounds of prevention of
disease spread rather than because they were infected, in accordance with the
'stamping out' policy. This raised serious economic and ethical concerns. Those
crises highlighted the need to review disease control policies, including the
approach to vaccination. The serious
problems encountered in controlling those outbreaks were caused by a
combination of factors, including: - the dramatic raise of the global trade (legal
and illegal) in animals and their products, resulting in an increased risk of
introduction of diseases to the EU and their spread within the EU; - the difficulty in controlling diseases in areas
at higher risk due to a high density of animals and/or insufficient biosecurity
measures at farm level; - the presence of diseases in the wild fauna
(e.g. CSF in wild boar, AI in wild birds) in the EU and/or in many neighbouring
countries, combined with increased contact between wildlife and domestic
animals; - insufficient disease preparedness in the MS. Several
corrective actions have been taken in the last years to address these problems
both at EU and MS level, including a more flexible approach to vaccination, with
results that can be considered by and large positive. For example, as from the early
2000s the EU has supported the development of a vaccination strategy of wild
boar against CSF, by means of legislation and funding. This strategy has led to
a major improvement of the disease situation in Europe, both in wild and
domestic pigs. Nevertheless, legislation
adopted after 2000 (on BT in 2000, on CSF in 2001, FMD in 2003 and AI in 2005)
confirmed that vaccination is not to be routinely used against these diseases,
as the benefits would not justify the costs. However, there is now a wider possibility
than in the past to use vaccines, both as an emergency response to outbreaks
which might get out of control and, for some diseases, namely AI and
Bluetongue, also as a prevention tool. This revised
approach was also made possible by technical developments such as better
quality and purity of vaccines, new marker vaccines (which allow diagnostic
tests to detect infection in vaccinated animals) and diagnostic tests allowing
more effective surveillance in vaccinated populations. At the same time,
legislation on trade in vaccinated animals and their products has become more
flexible and less punishing when vaccination is used. Indeed, in certain cases,
like BT (and also rabies), vaccination is envisaged by the legislation as a
tool for facilitating movement and trade of animals, if certain conditions are
met. It must be
mentioned, however, that despite the additional flexibility introduced in the
legislation on the possible use of vaccines, there is still limited experience of
their emergency use for some diseases (CSF, FMD, AI). This makes difficult or
even prevents its use by MS. Fears also exist that other MSs will not accept
the flexibility of legislation allowing the application of only minimal trade
restrictions on products originating from vaccinated animals. In this regard,
some MSs have traditionally shown a quite negative attitude vis-à-vis
vaccination. Even if this is overcome, traders may still be cautious of
possible trade restrictions from third countries, while retailers may refuse to
buy products from vaccinated animals, as they are also concerned about negative
reactions of consumers (although these reactions would not be justified by the
scientific evidence). All this would finally affect the decision (that is
largely up to the affected Member State(s)) to use or not vaccines in case of
an emergency. This is true of CSF and FMD in particular. I.4. International
standards and impact on international trade The Terrestrial
Code of the World Organisation for Animal Health (OIE) is revised every year.
With respect to vaccination, when an approved vaccine exists its use is
permitted, and the code only requires that the health certificates accompanying
animals contain the relevant information about any vaccinations. In some cases
laboratory testing of animals is required and/or that the surveillance of the
territory is adapted according to the vaccination policy adopted. EU legislation
largely reflects OIE standards on vaccination and its effects on trade in
animals and animal products. However, third countries may be very reluctant to
fully accept OIE standards, even when the OIE (in parallel with the EU) has
been very open and rapid in adapting them to new technical developments. The positions of
trading partner countries regarding vaccination policies and their impact on
trade are widely diverse, depending on the country and on the disease. It can
be said that vaccination still increases the risk of trade barriers being
applied (even if unjustified). The barriers that are technically justified and
supported by EU legislation and OIE standards are usually not insurmountable.
However, in some circumstances they may be sufficiently severe to discourage
vaccine use, particularly in MSs which have strong interests in export. II. ADVANTAGES AND DISADVANTAGES OF VACCINATION In summary,
on the bases of the lessons learned in the last two decades, the advantages and
disadvantages of vaccination as a control tool against major epidemic diseases
can be summarised as follows: Advantages: a)
Reduction of clinical disease and mortality and
associated losses; b)
Reduction of risk of infection; c)
Reduction of virus excretion from vaccinated
animals and spread to other animals/farms; d)
Possible reduced risk of disease outbreaks of
major size, of massive killing of animals and of direct and indirect economic
losses (although the limited experience in the emergency use of vaccines does
not allow definite conclusions to be drawn). Disadvantages: a)
Vaccination may be technically challenging to
administer and require several injections to build up immunity (e.g. cumbersome
individual vaccination of large numbers of poultry or vaccination of dangerous
animals); b)
The immune response induced by vaccination is
not always fully satisfactory so it is possible for some vaccinated animals to
still get infected; c)
It may mask the occurrence of infection and thus
delay its detection; d)
It may require vaccination of a high number of
animals to establish sufficient protection of the population ('herd immunity'); e)
It may induce a false sense of security and thus
encourage relaxation of biosecurity and surveillance measures; f)
The vaccine strain may not always match the virus
in circulation – e.g. there are several different FMD virus strains which will
make vaccination expensive, when several vaccine strains are needed. g)
Where vaccination does not prevent the
possibility of infection, a suitable surveillance programme must be installed
to prove absence of infection. III. PRACTICAL EXAMPLES OF THE EU POLICY
DEVELOPMENTS ON VACCINATION The examples of
AI, ND, CSF, FMD and BT are used below to demonstrate how the EU legislation
foresees different vaccination possibilities according to the nature of the
disease agent, available vaccines, acceptable vaccination policies and consequences
for economy and trade; and how this legislation has evolved in the last decade. III. 1.
Avian Influenza and Newcastle Disease The approach to
vaccination against AI and ND, the two most important highly contagious poultry
diseases in the world, is entirely different. Vaccination against AI is used only very seldom. This
is due to a number of factors i) until 2000, AI was a very rare disease in
the EU and therefore a preventive vaccination had never been justified; ii) AI vaccination prevents the disease but does not fully protect
against infection. This could lead to undetected virus spread; therefore costly
surveillance is required to detect infected animals in a vaccinated population;
iii) vaccines that would allow an easy and cheap application are not
yet available (currently injection of each individual bird is needed); and iv) the use of a vaccine may lead trading partners to impose trade
restrictions Preventive routine vaccination against ND is used widely and fully
supported by the industry. This is due to a number of factors: i) several ND outbreaks occurred in various MS, causing
serious losses; ii) the risk of continuous spill-over from wild birds
into domestic poultry farms; iii) cheap, effective vaccines are available; and iv) the OIE Code does not establish significant trade restrictions
in relation to vaccination. The different
approach towards these two poultry diseases is reflected in the requirements
for intra-EU trade and imports into the EU. III.2. Classical Swine Fever Following the
CSF crises of 1997-98, the experience gained through oral vaccination of wild
boars against CSF (mainly in Germany) and the development of marker vaccines
for domestic pigs allowed more flexibility towards vaccination in EU
legislation (Council Directive 2001/89/EC). If wild boar are
vaccinated against CSF, EU legislation does not impose trade restrictions on unvaccinated
domestic pigs and their products in addition to the restrictions normally
applied in an area where the disease occurs in the wild boar. Trade in pig meat
is not restricted. As regards vaccination
of domestic pigs, Directive 2001/89/EC introduced the use of marker vaccines
and a discriminatory test which were developed in the late 1990s/early 2000s. If a marker
vaccine is used, which allows identification of infected animals in a
vaccinated population; trade in pig meat from vaccinated animals may regularly
take place, provided that the herd of origin is shown to be disease-free via
discriminatory testing. III.3. Foot
and mouth disease (FMD) In the early
'90s, after FMD was eradicated from Europe, the EU adopted a policy prohibiting
prophylactic vaccination against FMD. For this disease, in addition to the
policy considerations explained in chapter 1 above, the adoption of a policy of
prophylactic vaccination posed (and still poses) serious technical problems,
notably because of the several distinct strains of virus existing outside
Europe. This causes significant uncertainties as regards which vaccine strains
ought to be used for such vaccination. For these
reasons, following the FMD crisis in 2001, the prohibition of prophylactic
vaccination was confirmed, even though new FMD control legislation was adopted (Directive
2003/85/EC) which moved emergency vaccination further to the forefront of the
disease control measures. MSs had to review their contingency plans to be
better prepared for emergency vaccination. MS have retained a substantial degree
of sovereignty over the decision whether to employ vaccination or not; however
they now have the legal obligation to put in place all necessary arrangements
for a possible emergency vaccination at the very early stage of an outbreak and
not wait until it becomes evident that the outbreak is out of control. However, so far
FMD emergency vaccination has not been used, e.g. during the UK 2007 FMD
outbreak or the BG 2011 outbreak, as in both cases it was possible to
successfully contain the disease in small areas and then eradicate it by means
of a limited stamping out of the infected animals and those at high risk. III.4. Bluetongue BT is an insect
transmitted disease of wild and domestic ruminants; its expansion in the EU follows
the climate changes observed over the last years. In the last decade this
disease has shown a tendency to become endemic in southern Europe; however, it
is also able to cause major epidemics in central and even northern Europe, as observed in 2007-2008. Given that it is
transmitted by insects this disease cannot be effectively controlled by
stamping-out. Vaccination is the most efficient veterinary measure that can be
implemented in an infected territory, together with surveillance. The wide use
of the vaccine is explicitly foreseen by EU legislation. Whether to use
vaccines or not is in principle up to the MS. However, harmonised vaccination
programmes are preferred and if EU co-financing is requested, a harmonised
approach is required. Vaccination can
be used for the purpose of controlling the disease, to facilitate safe trade under
certain conditions or even with the objective of eradicating the disease from
limited regions. Vaccination is currently possible after virus introduction in
an area, while it is forbidden in disease-free areas because of the safety
problems posed by the "live-attenuated" vaccines. These consist in
live although attenuated viruses which may spread from vaccinated to
unvaccinated animals and cause undesired side effects. Newly developed "inactivated
virus" vaccines are undoubtedly safer than the "live-attenuated"
ones and are the best choice when available. However, the availability of
inactivated vaccines is for the moment limited to only a few serotypes of the
BT virus. In 2010 the
Commission proposed a change in legislation to facilitate the use of
inactivated vaccines and also make their use possible in disease-free areas.
The proposal is still under discussion in the European Parliament and Council. IV. FUTURE
APPROACHES FOR THE AHL The CAHP evaluation has already addressed the issues of vaccination
and the relevance of vaccine banks. It also noticed that although significant
funds were spent on this issue, MS very seldom used vaccination during crises. The
AHS has clearly emphasised the need for better preparedness for animal disease
related emergencies, which must be dealt with swiftly and effectively by means
of an agreed approach. Taking fast-track decisions by the Commission and MS for
emergency action is of high value in limiting and controlling animal-related
threats at EU level. In response to ethical concerns and the growing demand for improved
animal welfare, the EU has already moved to a more flexible approach towards
vaccination, as well as improving its policy to control major animal diseases.
One of the objectives of the AHS is to reduce the risk of massive culling and
destruction of animals. However, different elements (e.g. vaccine availability
and effectiveness, demands for validated tests able to differentiate infected
from vaccinated animals, OIE international guidelines and possible trade
implications, cost-effectiveness analysis, possible risks related to the use of
vaccines) have to be considered before a decision is taken as regards the use
of vaccines. This decision can therefore be taken only on a case-by-case basis,
in line with the principles agreed at EU level. In line with the
AHS's Action Plan, EU vaccine banks for emergency situations shall be strengthened
in addition to those already existing for FMD and CSF. An expert group has
produced a "policy paper on the necessity of EU vaccine banks". It recommended
EU vaccine banks for five major diseases, namely FMD, AI, CSF, African Horse
Sickness and BT. An extensive consultation on this subject with the CVOs took
place and the results of both activities are presented in Part 2 of this Annex. The "added
value" of vaccine banks established at EU level is widely recognised and
it is therefore likely that follow-up to the recommendations of the policy paper
will be welcomed by MS and other stakeholders. Objectives Following the
commitments of the AHS, EU legislation must establish a comprehensive and
flexible legal framework for vaccination policy and vaccine banks in the EU that
could be used for different diseases and circumstances, taking into account the
following aspects for each different disease: -
Nature of disease agents and related
availability and reliability of vaccines, including availability of valid tests
to differentiate vaccinated from infected animals -
Susceptible animal species and their natural
environment (domesticated, wild animals) -
Purpose of vaccination: preventive
(prophylactic) or emergency vaccination -
Possible risks related to vaccine use -
Different approaches and control measures for endemic
and exotic diseases, considering economic implications -
Relevance of the disease for EU intervention in
terms of the importance of the disease (disease categorisation) or animal
categories (livestock, farmed animals versus pet animals and animals kept for
hobby and sport / recreation) -
Emergency preparedness: need for vaccine bank at
EU level -
Ethical considerations concerning stamping out
eradication measures -
Consumers acceptance of products originating
from vaccinated animals -
Cost-effectiveness analysis (including
vaccination costs). Policy
options on vaccination: A.i. AHL
provides a single vaccination policy for all diseases and provides a legal
basis for vaccine banks. A.ii. AHL
provides a single vaccination policy for all diseases and doesn't provide a
legal basis for vaccine banks. Both options
A.i. and A.ii. fit most comfortably into of option 5 in the main impact
assessment – a prescriptive legal framework. B.i. AHL sets up
a flexible legal framework for vaccination, providing possibilities for different
approaches to be used for different diseases under different circumstances and
provides a legal basis for vaccine banks. B.ii. AHL sets
up a flexible legal framework for vaccination, providing possibilities for
different approaches to be used for different diseases under different
circumstances and does not provide a legal basis for vaccine banks. Both options
B.i. and B.ii. are possible sub-sets of option 4 in the main impact assessment,
providing a flexible legal framework. C. AHL shall not
set the vaccination policy at all. Assessment
of impacts: Options A.i.
and A.ii. AHL provides a single vaccination policy for all diseases, with or
without a legal basis for vaccine banks. Following the
information, analysis and examples provided in sections 1 to 3 above it is very
clear that a single vaccination policy valid for all diseases cannot
exist. This is for many reasons, for example; the differences amongst diseases
and their appearance or absence in the EU, vaccination possibilities, vaccine
development and availability, the relevance of diseases for EU intervention,
different uses of animals, economic consequences, ethical considerations, and
so on. To provide one single policy would be nonsense. B.i. AHL sets
up a flexible legal framework for vaccination, providing possibilities for
different approaches to be used for different diseases under different
circumstances and provides a legal basis for vaccine banks EU legislation
on vaccination should be rapidly adapted to new developments, including new
scientific evidence and experience gained with disease control. Furthermore,
the EU legislation would take into account the divergence of situations and
approaches for vaccination possibilities. Vaccination against major animal
diseases shall remain flexible, giving the MS the clear possibility of
vaccinating and the responsibility to decide to do so when it is feasible and
desirable. EU rules must
also foresee the possibility for a rapid adaption to take account of technical
developments of new vaccines and diagnostic tests. An inability to quickly
include new available tools due to an inflexible and outdated legal framework
would put the credibility of the EU in cases of emergencies at significant risk.
As regards the
lack of consumer acceptance of products from vaccinated animals, the EU legal
framework cannot solve this issue, but can contribute to better understanding
of the safety and benefits of a well-implemented vaccination policy. EU
intervention should be limited to major diseases, taking into account disease
categorisation. Emergency
preparedness can only be achieved if a clear legal basis for vaccine banks is
provided for the diseases on a case-by case basis, where this is considered
necessary. B.ii. AHL
sets up a flexible legal framework for vaccination, providing possibilities for
different approaches to be used for different diseases under different
circumstances and does not provide a legal basis for vaccine banks. As for option B.i,
the possibility of vaccination would be available, decisions on its use left to
the MS, and a flexible approach is applied but no legal basis for vaccine banks
is provided. This omission would compromise the EU emergency preparedness and
ability to react quickly. C. AHL shall
not set the framework for vaccination policy at all.
To withdraw any
kind of EU framework for vaccination policy would be extremely unpopular
amongst the MS and other stakeholders. This option does not uphold the
objectives of the AHS which confirmed the value of a coherent approach at EU
level. Table
VII.1: Pros and Cons of Options Considered || Options A.i. and A.ii || Option B.i || Option B.2 || Option C Pros || § EU approach ensured § Health status harmonised || § EU approach ensured § Flexible legal framework for vaccination possibilities § Measures can be adjusted to changed circumstances, different diseases and vaccine developments § Flexibility for the MS ensured; quite broad freedom of choice ensured for animal keepers § Better emergency preparedness § Better availability of vaccines § Costs for the MS can be lower (no need for national vaccine banks) || § EU approach partially ensured § Flexible legal framework for vaccination possibilities § Measures can be adjusted to changed circumstances, different diseases and vaccine developments § Flexibility for the MS ensured; quite broad freedom of choice ensured for animal keepers § In short term lower cost for the reasons of absence of vaccine / antigen banks || § No interference from legislation § Full flexibility for the MS and full freedom of choice for animal keepers Cons || § Burdensome for animal keepers and veterinary services; it would affect all vaccinations of all animals and all diseases with substantial practical problems § No freedom of choice for animal keepers and MS (no subsidiarity) § High costs § Non-flexible, rigid § Loss of prioritisation possibly leading to waste of resources § Unrealistic due to: different animal species, different uses and relevance for the EU intervention variety of diseases, disease agents, development / availability of vaccines, vaccination options, trade impacts || § Costs of vaccine banks at EU level (purchase, maintenance) § Freedom of choice for animal keepers is limited to some diseases (harmonised EU intervention) || § Difficult availability of vaccines § Weaker emergency preparedness due to lack of vaccine banks § Inability to react quickly, higher costs and negative welfare impacts if disease occurs and vaccine is not available || § AHS objectives not met § Possible negative impact on health situation in the EU § Consequential trade implications (confidence of trade partners) V.
CONCLUSIONS 1.
The EU policy on vaccination against animal
diseases only concerns a limited number of diseases of major importance because
of their tendency to spread irrespective of national borders and of their trade
impact. There is no proposal to address vaccination for diseases other than
this limited set. 2.
In order to avoid large-scale killing of animals
as a disease control measure as much as possible, in the last decade EU
legislation has already included several elements of flexibility to facilitate
the use of vaccines both as a preventative and an emergency tool, as shown
during the recent epidemics of highly pathogenic avian influenza H5N1 and BT. 3.
The EU policy and legislation, however, must
duly consider the technical specifications and limits of the available vaccines
and accompanying diagnostic tests, as well as the practical feasibility of
vaccination and its costs. 4.
In reality, there are obstacles and limitations
to the use of vaccines against some major diseases (CSF, FMD, AI) that are not
dependent on legislation. 5.
Inappropriate use of vaccines may pose
additional risks and jeopardise disease control, have a negative impact on safe
trade from areas in which the vaccine has been used and ultimately make large-scale
killing of animals inevitable. 6.
Subsidiarity is important to maintain because of
particular local contexts and the need for MS to develop their own particular
rules on vaccination accordingly. 7.
However, EU legislation must also allow for the
possibility of rapidly assessing and permitting the use of vaccination for
newly developed vaccines and accompanying diagnostic tests. 8.
In addition, quick availability of reliable
vaccines in case of emergencies is essential. Therefore, future policy has to
continue to make use of these concepts and promote them in order to avoid
massive killing of animals as much as possible. 9.
The legal basis for the MS and the farmers has
to mirror this strategy. Only option B.i (the preferred option) fulfils all
elements and addresses the concerns raised in the CAHP evaluation, AHS and
stakeholders' consultation (see "Vaccination" under Point 2.15 of
Annex V). 10.
This option B.i is also the one most in line
with the risk-based preferred option (option 4) for the AHL as a whole: a
coherent and flexible EU approach providing proportionality and subsidiarity,
but with support at EU level (through the vaccine bank) providing added value
over and above what MS can achieve by themselves 11.
However, the future EU law cannot resolve issues
such as a lack of consumer acceptance of products from vaccinated animals (this
is a task for a good communication strategy), but can contribute to better
understanding of the safety and benefits of a well-implemented vaccination
strategy. Part 2 Questionnaire to EU CVOs on emergency
vaccination policy and an analysis of the replies || EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate D — Animal Health and Welfare D1-Animal Health and Standing Committees Brussels, 30 June 2010 SANCO/7117/2010 Results of the QUESTIONNAIRE for Chief Veterinary Officers of the EU Member States and Norway to collect information and opinions on: vaccine AND/OR DIAGNOSTIC BANKS for major
animal disease (point 24 of the Programming document[41] for the Animal Health Strategy 2007-2013) This document does not necessarily
represent the views of the Commission Services Please
note that this document has been established for information and consultation
purposes only. It has not been adopted or in any way approved by the European
Commission and should not be regarded as representative of the Commission
Services either. The European Commission does not guarantee the accuracy of the
information provided, nor does it accept responsibility for any use made thereof. I. Introduction The European
Commission launched an external evaluation to review its animal health policy
in 2005. Based on the results of this evaluation, strategic aims and objectives
for animal health were set out in the Commission Communication on the new EU
Animal Health Strategy where ‘Prevention is better than cure’. Identifying problems
before they emerge while being ready to manage major animal disease outbreaks
and crises is one of the expected outcomes of the Animal Health Strategy. It is
widely agreed that in many cases, the best means of combating animal diseases
once they occur is in accordance with the principle that ‘vaccination is better
than unnecessary culling’. The recently published
"Expert Opinion on Vaccine and/or diagnostic Banks for major Animal
diseases has been presented to the Member States during the SCFCAH meeting in
May 2010. It can be found on the
SANCO web page: http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm Based
on the above-mentioned document questions arose. Therefore DG SANCO Unit D1
wished to consult the Chief Veterinary Officers of the EU Member States (and
Norway, as an agreement is in place between the EU and Norway in relation to
the EU animal diseases vaccine banks) in charge of implementing animal health
legislation on those questions. 23
Member States and Norway responded to this questionnaire, resulting in a
response rate of 86%. In the following document the opinions and have been
gathered and are presented in both graphical and descriptive form. The
information and opinions given serve as valuable base for the discussion
between Commission and Member States. Moreover, they will be used by the
Commission Services as inputs to finalise a policy paper on possible options
for the reinforcement of the EU antigen and vaccine banks and on the
establishment of EU reserves for essential diagnostics for certain diseases.
Following this
introduction the second part presents the key messages of the paper produced by
a group of experts (see page 3). In the third part the answers to all
questions will be analysed separately (see pages 4–17). The fourth part
attempts to summarize the opinion of all participating countries in form of 12
conclusions (see page 18). Thank you for your participation and
for your valuable contribution to this process! II. Key Messages Of The Expert Opinion The key messages of the "Expert Opinion on Vaccine and/or
diagnostic Banks for major Animal Diseases" are as agreed among the
experts:
Vaccination
is a fundamental tool in a strategy to control and eradicate major
emerging diseases.
Emergency
vaccination has to be considered as one tool in a whole range of measures
as a part of a complex strategy to control and eradicate major animal
diseases.
Emergency
vaccination for most relevant infectious diseases should in general be
seen in a new light, directly linked to the availability of effective
diagnostic tools substantiating that vaccinated animals, or meat and other
products obtained from vaccinated animals, are free from pathogens and can
be traded safely.
Emergency
vaccination has to be understood as vaccinate-to-live, meaning that
vaccinated animals are kept to the end of a normal production cycle, and
that their meat and other products can be marketed.
Diagnostic
banks for particular infectious diseases are necessary to supplement
vaccine banks to enable a holistic strategy of disease control and
eradication.
The
establishment and maintenance of vaccine and diagnostic banks must be part
of a strategic plan prepared during ‘peace time’, ready for an emergency.
The
issue of vaccine and diagnostic banks can only be treated in the context
of a control and eradication strategy specific to each major animal
disease (e.g. FMD, CSF, AI) and various outbreak scenarios.
For
most of the relevant infectious diseases, existing legislation regarding
emerging vaccination should be amended so that vaccination becomes a
realistic option in the event of a crisis.
Trade
issues regarding vaccinated animals or fresh meat and meat products
obtained from vaccinated animals should be resolved.
Relevant
legislation regarding veterinary medicinal products is not well suited to
approve the use of vaccines in emergency situations.
The
current review of legislation dealing with veterinary medicinal products
is an ideal opportunity to introduce a mechanism to approve vaccines for
emergency use at European level.
Proposals
to be considered could include alternatives to vaccine banks, such as
vaccine master seed stocks and ‘mock up’ authorisations for particular
vaccines.
Vaccination
and testing should replace unnecessary culling.
III.
Results Of The Questionnaire 1. Support Of
National Legislation Do
your national legislation and contingency plans support the use of an EU
vaccine bank in your strategy to control and eradicate major emerging diseases? ·
In 20
(83%) of the responses of participating countries it was stated that the use of
an EU vaccine bank is supported by their national legislation and contingency
plans, even though the term "EU vaccine bank" is not specifically
mentioned yet. However, stamping out policy was still mentioned as the first
option by two Member States. ·
In
general, the option of emergency vaccination is already included in the
contingency plans of the respective countries for a variable number of
diseases; so do some countries currently consider vaccination only for FMD,
others list up to four out of the following diseases: FMD, AI, CSF, ASF and
BT. ·
One
out of four countries where present national legislation does not include
provisions for the use of an EU vaccine bank stated that amendments of national
legislation and of contingency plans are possible, whenever required. 2.
Vaccination In A New Light, Linked To Diagnostics Do you think that emergency vaccination for most of
the relevant infectious diseases should in general be seen in a new light,
directly linked to the availability of effective diagnostic tools? ·
23 (96%) responses share the opinion
that vaccination has to be seen in a new light, (Q2 was not answered by one
country, 4%). The availability to effective and safe diagnostic tools that help
to distinguish between vaccinated and infected animals or detect possible
carriers in vaccinated animals are seen as absolute prerequisite. ·
This
change of view is not only linked to the availability of effective diagnostic
tools, but also technical, economical, commercial, societal issues and the
global strategy of disease control have to be kept in mind. Tradability has to
be granted. ·
DIVA
vaccines are specifically mentioned as pre-requirement for a change in control
strategies. One opposing response clearly expressed reservation against the use
of DIVA vaccines, but promoted the strategy of prior testing in combination
with a well established surveillance system. ·
The importance
to share practical experience gained from successful vaccination campaigns to
support decision making was mentioned. Furthermore, more research should be
done in this area. 3. Diseases To Be Considered Do you consider that the
list of infectious diseases identified in the expert paper for which vaccine
and diagnostic banks should be available in the EU in the near future is
appropriate (or correctly identified)? Note: the expert paper lists the following diseases: FMD, AI, CSF, AHS, BT and
ASF. ·
20
(83%) responses agreed with the list of infectious diseases identified in the
expert paper. One response stressed the need to concentrate efforts and
resources on the major diseases listed and not to include others (at the
moment). ·
4
(17%) responses proposed to add one or more of the following diseases: Rabies,
Peste des Petits Ruminants, Rift Valley Fever, Sheep Pox, Aujeszky's Disease,
Crimean-Congo haemorrhagic fever and zoonoses in general. ·
The
stored vaccines / diagnostics should be timely available both to prevent spread
of an "old" re-introduced disease (as Rabies) and of "new"
diseases that might be introduced in future. ·
In
addition it was pointed out that certain vector-borne diseases might have a
higher probability to occur in future due to climate change and that for such
emerging diseases sufficient diagnostic knowledge should be made available. Furthermore,
terrorist threats should be considered. 4. Vaccination To Complement / Replace Culling Do you agree with the principle that emergency
vaccination in combination with testing, at least in cases where vaccination
does not prevent infection, should complement or wherever possible replace
culling (except the infected herd)? ·
21 (87%)
responses support the principle that emergency vaccination can be part of a
control strategy if the disease status of vaccinated animals can be assessed
unambiguously. ·
The
opposing 3 (13%) responses stress that vaccination can complement but not
necessarily replace culling. The latter issue was also mentioned by countries
which agree with the principle; emergency vaccination must be always part of
measures which prevent spreading of the disease and/or pathogen, ensure safe
animal products and protect public health. ·
Decision
has to be taken case by case (country specific decision according to
epidemiological situation, density of susceptible population, disease specific
factors, etc.) ·
Costs
and benefits of vaccination and culling should be compared. 5. Emergency
Vaccination For Vaccinate-To-Live Do you agree that emergency vaccination, except where
specifically carried out as suppressive vaccination to damp down virus shedding
from infected animals, should be understood as vaccinate-to-live,
meaning that vaccinated animals are kept to the end of a normal production
cycle, and that products derived from vaccinated animals can be marketed
without additional requirements? ·
In 18
(75%) responses consented that emergency vaccination should be understood as vaccinate-to-live
in the above mentioned sense. A Vaccinate-to-live strategy also complies
with a sustainable food production cycle. ·
Sound
diagnostic regime constitutes the pre-requisite so that a specified degree of
freedom from infectious agent can be granted. ·
International
trading partners have to be included into the debate. ·
However,
for certain diseases countries additional requirements and / or restrictions
are preferred; specifically for FMD or zoonotic agents as AI. One possible
restriction mentioned was that trade of vaccinated animals should only take
place between countries with the same disease status. ·
It
has to be assured that no public health issues arise (residues of vaccine or
vaccine components) 6. Legislation As Obstacle Do you consider that for most of the relevant
infectious diseases, some of the existing legislation regarding emergency
vaccination is an obstacle for vaccination-to-live and therefore should
be amended? ·
15
(63%) responses report obstacles of the existing legislation, specifically
restrictions on the trade in vaccinated animals and products thereof in
combination with the duration of the restrictions. ·
The
remaining 9 (38%) responses think believe that legislation gives enough
flexibility to apply vaccination-to-live approach. However, limited acceptance
of the market is still a major problem. ·
It
has been proposed to amend legislation as a first step to make vaccination-to-live
a reasonable option for the Member States. In a second step trade issues
regarding vaccinated animals or fresh meat and meat products obtained from
vaccinated animals should be resolved. ·
FMD,
CSF and AI legislation are in particular concerned. ·
The
BT history was mentioned as a positive example for the changed way of thinking
regarding vaccination. 7. Use Of EU Banks In Emergency Situation In case of an emergency situation would
you consider the use of vaccines and/or diagnostics from EU banks if there is no
immediate alternative and/or by bridging the period until you can obtain
vaccines and diagnostic tests through your own budget? ·
All
except one response (23; 96%) consider the use of vaccines and / or diagnostics
under certain circumstances and if a range of pre-requisites are met. ·
Following
pre-requisites were pointed out: >
A
quick decision about the availability in case of an emergency has to be taken
(“chain of command” at EC level); >
National
marketing authorisation of vaccine is obtained; diagnostics would have to be
OIE recognised or equivalent; >
Quality
and quantity: vaccines must be effective and available in large enough amounts
to be successfully applied in high-risk areas; >
National
laboratories must be familiar with the handling of used diagnostics; >
Sufficient
financial resources can be dedicated by the Member State for this purpose. ·
Reported
situations where the use of vaccines and / or diagnostics from EU banks would
be considered are: >
The outbreak
already has spread beyond the primary outbreak; occurrence in different parts
of the country; >
If
national vaccine / diagnostics reserves do not protect against outbreak strain
or if an exotic disease has to be dealt with; >
The
use of vaccine depends on disease: a clear yes for FMD, but as well for CSF and
AI; >
If
the products are not immediately commercially available at an affordable price. 8. National Bank vs. EU Bank Would you consider giving up a national vaccine or
diagnostic bank in favour of a centralised EU bank if legislation on
contingency planning so allows? ·
This
question is not applicable to 7 (29%) countries as they responded not to have a
national vaccine and / or diagnostic bank. ·
15
(63%) of the remaining 17 responses take the closure of their national banks in
consideration, for 2 (8%) countries this is no option. ·
Centralised
banks appear to be reasonable from an economical point of view (e.g. reduction
of spoilage due to the short shelf-life); nevertheless an economical evaluation
should be undertaken to describe costs of establishment and maintenance of a
centralised bank for the single participating country and the EU. ·
Moreover,
aspects such as management and technical support are probably favourable
compared to national banks. ·
Agreement
exists on the need of clear criteria how vaccines and diagnostics can be
assessed, particularly in the case when more than one Member State is affected by or at risk of introduction of a disease. ·
As
regards of diagnostics, several countries consent that these should remain
within the responsibility of national reference laboratories. An adequate
amount of diagnostics should be available both for routine and for emergency
situations. ·
Several
of those countries witch currently hold vaccine banks point out that the
quantity of stored vaccines will be a crucial factor – national vaccine banks
could only be closed if a centralised bank can provide enough vaccine in a
short amount of time. Another influential factor will be the effectiveness of
the EU bank. So far no experience is available on this point. 9. Master Seed Stocks
And ‘Mock Up’ Authorisation For which diseases do you consider that master seed
stocks and ‘mock up’ authorisations would be appropriate (instead of ready to
use vaccines): -
Favour
for master seed stocks depends on: > How long production and
distribution of vaccines would take in case of emergency; >
Serotypes
(AI and BT). -
Possibilities
for master seed stocks to be tested in line with the European Pharmacopoeia
should be examined with scrutiny. Moreover, discussion has to be started on who
will be in charge of the availability and quality control of the seeds.
-
Several
countries agree that for FMD ready to use vaccine should be available in the
vaccine bank as emergency vaccination might be required in a very short period
of time; serotypes A & O are specifically indicated. For the more rarely
occurring serotypes seed stock is seen as a good option. -
-
Other
diseases for which master seed stocks and mock-up authorisations are mentioned
as desirable: oral vaccines for CSF and Rabies. 10. Rapid Decision On Distribution Of Vaccine Do you agree that the Commission should be fully
empowered to make rapid decisions on the distribution of the vaccines available
in stock after consultation with the Member States concerned or at direct risk
because of an outbreak? ·
18
(75%) responses agree to fully empower the Commission to take decisions as long
as concerned Member States are consulted. ·
6
(25%) responses request that not only the directly concerned but all Member
States should be consulted before decisions are taken. This could be done via
SCoFCAH and / or a CVO meeting. To assure that rapid decisions can be taken
teleconferences or written procedures were mentioned as an alternative to a
live meeting. Besides SCoFCAH consideration of the epidemiological situation
was mentioned as second axis to come to a decision. ·
Several
responses claimed that irrespective of any outbreak scenario procedures on how
to distribute vaccines or tests between Member States must be agreed on in
advance. 11. EURL To Supplement Vaccine Banks Do you think diagnostic banks for particular
infectious diseases should be within the remit of the EURL to supplement
vaccine banks, if diagnostic kits are not commercially available? ·
23
(96%) responses agree that the EURL is the appropriate institution to ensure
that diagnostic kits for particular infectious diseases are made accessible if
not commercially available. ·
Additionally,
it was pointed out that it is mandatory that all Member States have an
effective diagnostic capability for the diseases that are considered of
importance for the EU. Therefore, other national laboratories could be entitled
to cooperate with EURL, on the basis of documented expertise and capacity. ·
The
reason given for the opposition of one country (4%) is that the primary
function of the EURL should remain to provide expertise. 12. Guarantees For Safe Trade Do you think that vaccinated animals and their
products could be traded safely if appropriate diagnostic tool and surveillance
schemes were available and used properly, so that this surveillance gives the
appropriate guarantees that those animals and products are not infected? ·
The
opinion was shared in 19 (79%) responses that a combination of appropriate
diagnostic tools with surveillance schemes offers the possibility that
vaccinated animals and their products could be traded safely. ·
Conditions: >
Clearly
defined rules for movement of animals and animal products in the framework of
eradication measures; >
Dependent
from disease, vaccine (DIVA, live), international acceptance, availability of
approved tests; >
Traceability
is indispensable for every vaccinated animal. ·
3 (13%)
responses did not agree, 2 (8%) responses could only envisage trade of
products, but not of live animals. ·
BT
and AHS were examples given for current legislation that already allows
vaccinated animals and their products to be traded safely. 13. Authorisation Of Vaccines In your view vaccination-to-live with vaccines from an EU vaccine
bank and subsequent intra-EU trade in vaccinated animals and their products
could only take place provided that vaccines used have received the following authorisation
for being placed on the market: ·
A
large majority of responses (22; 92%) shares the opinion that EMA authorisations
could ensure the required standards. In addition, international acceptance was
deemed to be more forthcoming following an EMA authorisation rather than any of
the other three options. ·
Besides
this positive reputation of EMA opinions vary considerably: whereas several
Member State only opt for EMA authorisation other Member States have the
opinion that in an emergency situation any authorisation is welcome if a
minimum of guarantees regarding quality and safety of the vaccines can be
assured. The national authorisation in the case of BT has shown that the system
worked excellently; an EMA authorisation is deemed as not absolutely necessary. 14. Movement Within National Market Would you in general accept moving vaccinated animals
or products obtained from vaccinated animals within your national market? ·
18
(75%) responses report general acceptance of movement of vaccinated animals or
their products. ·
Conditions
quoted are: >
If
tested with approved tests and with an appropriate surveillance scheme in
place, giving a guarantee of freedom (of infectious agent) and safety of
products; >
After
discussion with stakeholders; >
No
negative implications for international trade. ·
Comments
in those 6 responses (25%) which would not accept such movement include the
need for additional guarantees for absence of virus circulation in the country.
This should be decided on the disease in question. In case of BT vaccinated
animals could be placed on the market. ·
One
response emphasized that moving of products would be acceptable but not of live
animals as important trading partners request for non-vaccinated animals.
Furthermore, special conditions for products and live animals were claimed with
regard to FMD 15. Unsolved
Trade Issues Please explain briefly which are in your opinion the
main still unsolved trade issues related to vaccination by disease and problem
(maximum 3). ·
In
total 51 comments were made in relation to trade in all 24 responses. The
comments quoted both >
already
existing and >
possible
future trade hindrances if vaccination would be applied. ·
As
several levels of trade-related issues were addressed they were summarized in
three categorical levels in Table 1: 1.) technical level, 2.) legislative level
and 3.) customer (or user-end) level. This structured form should highlight the
different stages which have to be taken in consideration. ·
Procedure
of categorisation: One category was selected for every comment. In case a
comment addressed more than one trade issues it was grouped into the category
which mentions the cause, i.e. not the consequence. Example:
"a safe vaccine to enhance international trade" would be categorised
as "1a.) safe vaccine and diagnostics" as "to enhance
international trade" is the consequence. ·
This
categorisation is only indicative. ·
Comments
given in relation to specific diseases are listed separately below Table 1. Table 1: Summary of trade-related comments Level || Description || Number of quotations 1.) Technical level || Sum: 21 || a.) General comment made || 1 b.) Safe vaccine and diagnostics Vaccines have a high protective efficacy and matching diagnostics are highly sensitive and specific. Movement of vaccinated animals can be allowed given that vaccine and diagnostics properly applied and according surveillance scheme is in place. || 9 c.) Distinguishability Applied vaccines and / or diagnostics allow distinguishing between infected and non-infected animals despite vaccination. || 8 d.) Identification and traceability Identification and registration of vaccinated animals, products are traceable. || 3 2.) Legislative level || Sum: 7 || a.) Acceptance and authorisation Vaccinated animals are accepted as safe in the legislation, vaccines have received authorisation accordingly. || 4 b.) Discrimination Vaccinated animals have comparable conditions in relation to trade as non-vaccinated animals originating from the regions which share the same disease status. || 3 3.) Customer level || Sum: 21 || a.) General comment made || 5 b.) Consumer || 3 c.) Industry / retail || 2 d.) EU – wide market Trade of vaccinated animals and their products between Member States || 1 e.) Trade with third countries Trade of vaccinated animals and their products with third countries || 8 Specific case || i.) Loss of "disease-free" status for EU/MS EU/MS may lose its/their “disease-free” status if vaccinated animals/products were traded within the EU, thus resulting in disadvantages in the trade with third countries as third countries may consider the EU as one economic and epidemiological entity. || 2 Addition:
Trade-Related Issues Mentioned By Disease ·
FMD: Vaccination
and DIVA testing on farm level; Carrier status. ·
AI: Trade
issues in relation to meat; Lack of acceptance of regionalisation by third countries. ·
CSF: Absence
of DIVA vaccine; traceability and transparency still open questions; Trade of meat products
from free compartments from countries not free; Time
period till permission of trade of live pigs is regained when vaccination is
applied. ·
ASF: Trade
of meat products from free compartments from countries not free; ·
BT: No
individual records about vaccinated animals if traded between Member States; Vertical transmission; Trade of live animals in absence of effective
surveillance. ·
AHS: Vertical
transmission; No DIVA capability. 16. Movement Between Member States Would you in general accept vaccinated animals or
products obtained from vaccinated animals originating from other Member States
into your national market where this is not expressively forbidden by OIE
rules? ·
Out
of the 18 responses (see Q14) that in general would accept the nation-wide
trade of animals plus products which were vaccinated in their own country 16
(67%) also consider the possibility to accept animals or products thereof that
were vaccinated in another Member State. It has to be highlighted that only 2
responses express their preference to act differently depending on the outbreak
location. ·
It
was pointed out that it has to be distinguished between preventive vaccination
and emergency vaccination – for emergency vaccination a clearly stipulated
system of movement and processing has to be defined case by case, disease by
disease. ·
Furthermore
Member States with a similar disease status should fulfil similar conditions to
be able to move animals and their products between Member States. ·
In
addition to the conditions listed under Q14 it would be welcomed if a certain
time period would be determined after which trade can be allowed to obtain
guarantees that there is no virus circulation at the place of origin. Also the
vaccination of live animals should be made traceable (as by recording in TRACES
and in a central register), see present BT legislation as an example. ·
The
position that trade of live animals should be limited to regions following the
same vaccination policy is among those responses which do not favour trade of
vaccinated animals between Member States. 17. Necessity Of Mitigating Measures Do you believe that mitigating measures applied to
the product (e.g. deboning and maturation and/or removal of the head from the
food chain) are needed to market meat from vaccinated animals? ·
15
(63%) responses state not to believe that additional mitigation measures are
needed to be able to market meat from vaccinated animals. ·
Again
this will depend largely on the disease in question and the animal health
status of the affected country. So it was proposed that a differentiation could
be made between vaccinated animals from countries which are free of the disease
after containing the disease with a good vaccination plan and a surveillance
scheme in place and countries where the disease is still present. ·
Exception:
several countries think that for FMD deboning and maturation is certainly necessary. ·
Scientific
evidence on the animal health safety of products derived from vaccinated animals
still has to be provided in many cases. 18. Further Comments Do you have any further comments on the issue of vaccine and/or
diagnostic banks for major animal diseases? ·
The
following sections present a summary of concerns (18.1) and open questions (18.2)
which were not specifically addressed by an earlier question and/or mentioned
as a further comment under this open question. ·
Furthermore
a collection of factors which are deemed important to take the decision for
vaccination is listed up (18.3); this list tries to grasp the essential points
mentioned in the participating countries' comments. ·
Numerous
actions to be undertaken by the Commission, Member States and scientific and
industry partners were highlighted in the questionnaires. In 18.4. an attempt
was made to assign these tasks to the specific group. It has to be kept in mind
that these lists are not indicative and make no claim to be complete. ·
All
comments made under this point and all numerous comments made under the
remaining question shall be summarized in the following four categories: >
18.1 Concerns >
18.2 Open
questions >
18.3 Factors
important to take decision for vaccination >
18.4 Action
needed 18.1Concerns ·
Vaccinate-to-live
could be connected with an excessive additional administrative burden. ·
Insufficient
data available convincing scientific evidences with vaccinate-to-live strategy. ·
Safe
trade if appropriate diagnostic tool and surveillance schemes were available:
surveillance systems do have limitations. Therefore the risk is always present,
but it may be considered as reduced enough to accept this trade. ·
A
centralised EU decision process may risk paying less attention to local
national conditions. ·
The
financial consequences for a bank of this size (30-40 million doses) are likely
to be high and the likelihood of it being used low. Concerns related to specific disease ·
FMD:
With the numerous strains of this disease even a well stocked bank may not hold
the right antigen to vaccinate against the field strain seen in an outbreak. ·
AI:
vaccinated birds would still be capable of spreading disease. Mutation of
influenza viruses could render a vaccine less useful. Furthermore practical
issues around delivering vaccine by injection to individual birds have to be
considered; another matter of concern was the length of time until immunity
would be developed after vaccination. 18.2Open Questions ·
Which
subtypes for vaccine and for diagnostic purpose should be stored? Is it
necessary to keep all serotypes (e.g. for BT)? ·
How
quickly can Member States gain access to vaccine? Where would the banks be
located? How much time is needed to make up vaccine? How can the issue be
solved when more than one Member State demand vaccines or diagnostics? How
quickly can the vaccines provide immunity? ·
How
will the master seed stock be accessible? Which producers are empowered to
process antigens to vaccine? ·
How
will the EU banks work in relation to banks that are held by individual member
states? ·
How
to organize re-stocking of vaccines and diagnostic kits? ·
Can
master seed be tested in should in accordance with the European Pharmacopoeia
already when laid down? Who will be in charge of the availability and quality
control of the master seed? ·
What
costs arise for the Member States as a user of the EU banks? How can a practical
financing system look like? Where does the funding come from if EURL
supplements vaccine bank with diagnostics that are not available commercially? 18.3Factors Important
To Take Decision For Vaccination ·
Epidemiological
situation >
One
single infected premise (culling) vs. more extensive outbreak (vaccination) >
High
animal density vs. low animal density >
Phase
of the outbreak: acute stage where vaccination could lower risk of spread vs.
later stage when outbreak is under control and the focus lies on regaining
disease free status to support trade. >
Endemicity
of disease or new outbreak ·
Type
of vaccine >
DIVA
/ marker vaccine >
Live
vs. attenuated vaccine >
Quality
of vaccine / it's ability to prevent both infection and disease ·
Matching
validated diagnostic tests >
Sensitivity
and specificity to differentiate between infected and non-infected animals >
User-friendliness:
a high number of samples can be analysed in a reasonable time period >
Availability
in big enough quantities at reasonable price ·
Effective
surveillance scheme in place ·
Disease >
For
BT generally accepted. ·
Risk
– benefit calculation ·
Assuring
conditions >
If
tradability is granted >
If
disease / pathogen spread can be prevented >
If
safe animal products can be ensured to protect public health 18.4Action needed 18.4.1
Action of Member States and European Commission needed ·
If vaccination
is applied rules have to be set up for animal products, animal by products,
foodstuffs and feeding stuffs. ·
The
proposal for the vaccine and diagnostic bank has to be clearly defined: >
which
subtypes of virus should be part of the stock; >
the source
of the virus and amendment of the storage subtypes; >
which
diagnostics the national laboratories need to be familiar with; >
an
optimal balance between vaccine, “mock up” authorisations and vaccine
alternatives has to be developed and evaluated; >
how
to assure that the bank is arranged in an effective, dynamic (e. g. dimension
and updating) and cost saving way, as regards the priority of diseases. ·
A
cost/benefit analyses for setting up the banks is needed. ·
The
mechanisms of accessing the vaccines/diagnostics have to be clarified. ·
It
has to be agreed on how quick decision about the availability of vaccines and
diagnostics in case of an emergency can be taken (“chain of command” at EC
level) ·
Prior
to trade clear requirements have to be set up for a specified degree of
“freedom from infectious agent”, i.e. introduction of a “disease free” status
with vaccination. ·
Additional
rules for Identification & Registration and movement control of vaccinated
animals have to be adopted. ·
Risk
mitigating measures should be defined for animals and products if a vaccinate-to-live
strategy is applied. ·
If
such rules are defined for vaccinate-to-live, standards for the vaccinate-to-kill
policy should also be set up. 18.4.2
Action Of Member States Needed ·
The
Member States should prepare contingency plans with their vaccination strategy
during peacetime and share them with the other Member States and the Commission
to make their principles of vaccination and testing during an emergency
situation transparent to all Member States. ·
The
effective operation of the vaccine bank and the allocation of vaccines should
be tested in simulation exercises. 18.4.3
Involvement of science (and industry) ·
Science
/ industry should be motivated as safe vaccines are required. ·
Scientific
institutions must be able to provide support service (risk assessments,
epidemiological information, tracing, etc.) so that decisions can be taken on a
sound basis. ·
Specifically,
the risk of virus transmission through vaccinated animals and the role of
products in the spread of the disease should be assessed. ·
Wider
social and economic consequences of vaccination should be considered. IV. Draft
Conclusions From The Questionnaire The following 12
conclusions were drawn from the information and opinions gathered from all
participating countries: ·
Vaccine
and diagnostic banks should be set up in a manner that best storing standards
of stored equipment can be guaranteed / should be strived for. ·
Vaccination
should be understood to complement and not replace current disease control
strategies. ·
Vaccines
need to be safe; spread of disease by vaccinated animals will jeopardize
reliability of the whole strategy. ·
Vaccines
and / or matching diagnostics must allow distinguishing between infected and
non-infected animals in a reliable manner. ·
National
and international acceptance should be improved in a way that vaccinated
animals and products obtained from vaccinated animals can be traded at
comparable / similar conditions as non-vaccinated animals and their products. ·
Authorisation
of vaccine should be done by EMA procedure; this has to go hand in hand with
quick availability in emergency situations. ·
Decision
to vaccinate should be taken case by case. ·
Third
countries and stakeholders have to be involved in the discussion at an early
stage. ·
If emergency
vaccination is conceived as vaccinate-for-live, a realistic exit
strategy should be outlined, taking in consideration international trade and
additional resources needed. ·
The
mechanisms of accessing the vaccines/diagnostics have to be clarified. A
procedure should be established to assure guaranteed supply. ·
Requirements
for vaccination in context with FMD have to be discussed separately from other
infectious diseases due to the special role of this disease. ·
An
evaluation of EU banks has to be undertaken in relation to its cost -
effectiveness; a financing plan has to be set up.
ANNEX VIII Additional
assessment on Intra-EU trade
Background The concept of
free movement applies in theory to almost all aspects of life in the EU.
However, for reasons of protecting both animal and human health, movement within
the EU is not considered possible for live animals and their products without
fulfilling certain health requirements. Current animal health regulations
require specific health obligations to be respected when animals and their
products are moved between the MS (which vary dependent on the context, but
might include, for example, certification by an official veterinarian at place
of origin, notification of the movement or provision of relevant data to the
relevant authority and/or non-discriminatory checks at the destination). This
is due to disease control provisions which aim to reduce the risk of those
movements spreading diseases and the according consequences for the health of
other animals and/or humans in other countries or territories. Some of the most
common routes of transmission for infectious agents are direct animal-to-animal
contact and indirect contact through equipment, persons, transporters, etc.
This is most often caused by the movement of infected animals towards with
non-infected animals, and being in close physical or indirect contact. Economic
forces can lead to animals being moved over large distances, and this increases
the possibility of the geographical spread of disease. Besides the health and
welfare considerations themselves, disease outbreaks or poor animal (or human)
health can have significant negative impacts on international trade and
national economies. This current concept
of 'Intra-Community Trade' is therefore used for movement of animals and
products and it retains certain international trade rules for movements within
the EU (although border checks have long since been abolished). The legislation
allows MS to develop their own animal health and movement rules and requirements
in their own territories to a large extent, and does not interfere with them unless
there is a financial contribution from the EU for surveillance and eradication programmes,
there is an EU level eradication programme, or if the animals may be traded
across borders within the EU at a later stage. The current system has been
widely criticised as being too prescriptive and somewhat outdated, most notably
in the CAHP evaluation in 2006. Nevertheless, the current system has proven itself
to be very useful, successful and relatively safe, for example, enabling the
near-eradication of brucellosis, bovine leucosis, and bovine tuberculosis in
some areas of the EU. The current
system for the movement of terrestrial animals is very different from the
'placing on the market' concept. This concept was introduced in general feed
and food law for products of animal origin, and later also for aquatic animals
and animal by-products for reasons of animal health. The current system for
terrestrial animals of 'Intra-Community Trade' uses MS as the basic
geographical unit for deciding on certification requirements. 'Placing on the
market' for aquatic animals instead specifies 'zones' with similar health
statuses, which may or may not be based around MSs' borders. Animals moving
within a zone, independent of whether it is within the same MS, do not need
certification (although the movement does need to be notified to TRACES if
crossing a national border). There are certain guarantees required when moving
from one type of zone to another. This means that the administrative burden
required with a particular movement could be more in proportion with the health
risk it potentially poses. However, certification is required for movements
within a MS if an animal is moving to a different health zone. Current
Intra-EU trade in live terrestrial animals: evidence Trade in live terrestrial animals has increased in the EU since the
creation of the single market (1993). The enlargement of the EU has provided
further opportunities for such trade. According to TRACES, trade in live
terrestrial animals within the EU increased on average by 9% per year between
2005 and 2009. However, part of this expansion can be explained by the
progressive development of the TRACES system since its start in 2004. In 2009, 36
million farm animals (28 million swine, 4 million cattle, 0.08 million equine,
4 million sheep and 0.1 million goats) and 731 million poultry were transported
between EU MSs (see Figure VI.1) Figure VIII.1 Source: TRACES According to
TRACES, 46% of farm animals and 51% of poultry transported within the EU in
2009 were intended for slaughter. Of consignments of bovine animals destined
for slaughter in 2009, 56% went directly to slaughter whilst the remaining 44%
passed through at least one Assembly Centre operation. In 2005 75% of bovine
consignments destined for slaughter went directly there, but the proportion has
decreased since then. Table VIII.1 Intra-EU trade in animals destined for
slaughter (heads of animals) in 2009 Equine || Bovine || Swine || Sheep || Goats || Poultry || Total || Total excl poultry 57,058 || 652,193 || 12,669,820 || 2,941,629 || 81,403 || 377,511,981 || 393,914,084 || 16,402,103 As a percentage of total intra-EU trade: 72% || 18% || 46% || 69% || 78% || 52% || 51% || 46% Source: TRACES For this
analysis, we will largely focus on the number of consignments sent and received
for intra-EU trade in live terrestrial animals. This is because European policy
on intra-EU trade in live terrestrial animals is based on consignments rather
than animals. Trade in live
terrestrial animals takes place in order to exploit the price differentials
which exist between livestock markets. Both buyers in recipient MS and sellers
in producing MS can benefit financially from this trade. The table below shows
selected MS that were the main senders and recipients of intra-EU consignments
(for all species) during 2009. Interestingly, some of these MS have a large
trade deficit (Italy) or surplus (France and Denmark). Yet other MS both sent
and received a similarly large number of consignments, leading their net figure
to be relatively small (Spain). Table VIII.2 Total number of consignments of animals
sent and received by certain MSs in 2009 || BE || DE || DK || ES || FR || IT || NL Consignments sent || 16,040 || 50,074 || 31,684 || 18,500 || 74,047 || 2,536 || 74,193 Consignments received || 40,515 || 83,057 || 240 || 21,208 || 9,589 || 65,693 || 44,483 Net consignments sent || -24,475 || -32,983 || 31,444 || -2,708 || 64,458 || -63,157 || 29,710 Source: TRACES Together these 7
MS were involved in approximately ¾ of all consignments sent and ¾ of all
consignments received in 2009. The high degree of concentration of movements in
these MSs was true for all the different movement purposes of all species. MS which send a
high proportion of consignments do not necessarily represent the nations with
the largest livestock sectors. This is shown in the chart below, where the size
of the circles represents the number of consignments sent by each MS. Figure VIII.2:
Total number of consignments originating from each MS, displayed depending on
the number of holdings and value of production in the MS (2007) Source: Eurostat and TRACES As comprehensive
national internal movement data is very time consuming to consolidate, the size
of livestock sectors has been used as a rough proxy for the total amount of
movements, both national and intra-EU. It is reasonable to expect that MS with
larger livestock sectors would, on average, have a larger volume of movements
of live terrestrial animals than MS with smaller livestock sectors. From the
chart above, we can see that there are some MS which have a relatively large
livestock sector but a relatively small level of intra-EU movements. We could
infer therefore that these MS have a relatively large level of national
movements, compared to their intra-EU movements. Movements over
short distances are particularly highlighted when discussing intra-EU trade in
live terrestrial animals. In 2008, 116,000 bovine, swine and poultry
consignments made journeys of less than 3 hours. This accounts for 38% of all
consignments of these species. Of these short movements, 59% of them (68,000)
were destined for slaughter. However, these
proportions vary when you look at different species, as illustrated in the
chart below. A higher proportion of poultry movements last for less than 3
hours than the proportion for other species – 63% of poultry consignments
compared to 30% of bovine and 32% of swine consignments in 2008. Figure VIII.3: Proportion of bovine,
swine and poultry consignments in 2008 separated by type of movement and
journey time Source: TRACES Examples of
notable movements between adjacent MS are those of pigs and poultry between Germany and the Netherlands, cattle between France and Italy, and sheep between Ireland and the United Kingdom (particularly Northern Ireland). As shown in the table below, these
movements account for a large proportion of an individual MS's trade in live
terrestrial animals, for a particular species. Table VIII.3 Particular examples of high
density cross-border movements From: || To: || Species || Total no. sent (2009) || % of all EU movements of this species || % of total movements of this species from this MS || % of total movements of this species to this MS Netherlands || Germany || Pigs || || || || No. Consignments || 33,660 || 27% || 69% || 55% No. Animals || 7,122,498 || 26% || 62% || 50% Germany || Netherlands || Poultry || || || || No. Consignments || 21,635 || 27% || 89% || 90% No. Animals || 164,389,846 || 22% || 85% || 89% France || Italy || Bovine || || || || No. Consignments || 34,591 || 27% || 73% || 68% No. Animals || 970,058 || 26% || 75% || 67% United Kingdom || Ireland || Sheep || || || || No. Consignments || 1,282 || 10% || 83% || 100% No. Animals || 347,845 || 8% || 84% || 100% Source: TRACES Questions about
intra-EU trade and the 'placing on the market' concepts in relation to germinal
products were asked in the questionnaire for operators in various MSs and its
results are presented in Annex V above. Problem
definition: Intra-Community
trade approach for animals and animal products is criticised by stakeholders
and MSs as being too burdensome and outdated The current system
of Intra-Community trade has often been criticised as being outdated and putting
too many burdens on animal keepers and operators. The different rules
for animals and products within a particular MS and between MSs do not fit well
with the concept of the EU single market. Though veterinary checks at borders between
MS were abolished long ago, and certain certification rules for movements have
been eased; to a certain extent the system still supports different market approaches
in different MSs. Furthermore, it has been criticised as too burdensome for
both the competent authorities and animal keepers to implement systematically and
for individual animal movements. For example, there is an obligation for the
animal to have a veterinary check and examination before it is moved to comply
with animal health and welfare provisions; there is also an obligation to have
a health certificate in each particular case of movement; and a requirement to
notify the movement to both the national identification and registration
databases and to the TRACES system. This procedure is perceived as complicated,
expensive and administratively burdensome for both operators and competent
authorities. In addition, the system doesn't differentiate in what burdens it
imposes according to the level of health risk of a particular type of movement. In many cases,
those measures which can be perceived as burdensome may be justified,
especially when animals or their products are moved between holdings or zones with
different health statuses. In these cases it is appropriate that health status
guarantees are provided to prevent the spread of disease and protect animal and
human health. On the other hand, in many cases the level of bureaucracy
associated with the movements cannot be said to be proportionate to the risk
involved. For example, there are cases of movements of animals between two
adjacent holdings in neighbouring MS with the same health status (or even owned
by the same person) which pose extremely low risk of disease spread. Movements
of animals between MSs of the same health status for direct slaughter is also
very low risk because of the low likelihood of contact with live animals at
destination. Table VI.1 shows that a high proportion of intra-EU animal
movements (with the exception of bovine movements) are for direct slaughter.
Many of the high density cross-border movements highlighted in Table VII.3 also
fall into these low-risk categories. Policy
Options: 1.
Keep Intra-EU Trade regime unchanged 2.
Keep Intra-EU Trade regime but introduce some
facilitation mechanisms (such as derogations from the requirement for health
certification) for low risk movements such as for slaughter or between adjacent
zones of two MS of the same health status, with the possible use of bilateral
agreements. 3.
Introduce Intra-EU movements regime, retaining
certain elements of the current certification requirements for movements
between MSs but introducing some facilitation mechanisms (such as derogations
from the requirement for health certification) for low risk movements. These
could include movements for slaughter, for certain low-risk products such as
bovine semen, hatching eggs or day-old chicks, or between adjacent zones of two
MS of the same health status (such as through the introduction of cross-border
zones), without the possibility of bilateral agreements. 4.
Introduce 'placing on the market' concept to
live animal movements. Assessment
of impacts: Option 1:
Keep Intra-EU trade regime unchanged The Intra-Community
Trade concept has been in past years proven to be relatively effective in
ensuring that, as far as possible, only animals with the appropriate level of
health are moved. It has therefore provided industry and authorities with
sufficient health guarantees for those animals which are moved, and so avoided
many preventable diseases outbreaks in the EU. On the other
hand, as we have seen, certain burdens of administration and certification are
imposed for some low-risk movements which are difficult to justify on the basis
of upholding health standards. As an example, the same health certification
requirements would be necessary for animals being moved from one side of the EU
to the other, from one MS with a very different health status from the destination
MS; as for animals being moved to an adjacent holding, perhaps even owned by
the same person, but which happens to be across a national border. Option 2:
Keep Intra-EU Trade regime but introduce some facilitation mechanisms (such as
derogations from the requirement for health certification) for low risk
movements such as for slaughter or between adjacent zones of two MS of the same
health status, with the possible use of bilateral agreements. This option
would retain Intra-EU Trade provisions (as described and assessed in Option 1)
but would aim to enable MS to resolve cross-border issues with the use of
bilateral arrangements (agreements or other measures). In addition,
exemptions, derogations or simpler procedures could be permitted for movement
of animals for direct slaughter. However, even if the health certification
requirements were removed, there would still be obligations for veterinary
checks at origin because of animal welfare requirements. This system
would lead to bilateral solutions where there is felt by MSs to be a particular
need (where there is a lot of low-risk cross-border trade, including much of
that shown in Table VI.3). While this might facilitate those particular
movements, it would likely entail different approaches from each pair of MSs
concerned, with limited transparency of these agreements and the movements
concerned to the EU. It could also lead to complicated solutions to specific
problems, with possible impacts on the single market. Option 3: Introduce
Intra-EU movements regime, retaining certain elements of the current
certification requirements but introducing some facilitation mechanisms (such
as derogations from the requirement for health certification) for low risk
movements such as for slaughter or between adjacent zones of two MS of the same
health status (such as through the introduction of cross-border compartments),
without the possibility of bi-lateral agreements. This option
would set some basic principles for all cross-border movements; keeping certification
as a baseline requirement, but applying it in a much more risk-based manner.
This baseline requirement would ensure that movement controls are retained
where it is important to do so, thus retaining the low level of risk of animal
disease outbreaks as at present. More derogations
would be introduced for low-risk movements. Examples of low-risk movements
which could be released from the certification obligations could include
animals moved directly to slaughter and the movement of bovine semen, hatching
eggs, and day-old chicks, which all pose very minimal health risks. There might
also be the possibility of removing certain cross-border administrative burdens
where there is a high frequency of certain low-risk trade patterns by
introducing cross-border compartments. Examples will include many of those
high-density cross-border movements shown in Table VI.3. Subsidiarity
would largely be retained for national movements, allowing MSs to maintain
their own specific requirements where particular issues are concerned.
Exceptions would include identification and registration requirements,
traceability and registration of holdings. Certification would also be retained
for welfare certification, in line with current requirements. In addition,
certain elements of the 'placing on the market' concept could be introduced for
operators entering quality assurance schemes. For example, a farm (or other
operator such as an assembly centre) which is participating in a quality
assurance scheme might be able to obtain a 'licence' which would enable it to
guarantee (with a 'stamp') any products it exports, rather than getting
individual certification guarantees for every consignment. Their health status
and compliance with the relevant scheme would need to be guaranteed through
regular inspection. Option 4:
Change to 'placing on the market' The 'placing on
the market' concept was introduced in general feed and food law for products of
animal origin and in the animal health area for aquatic animals and animal by-products.
This concept doesn't require animal health certification for each consignment,
but (for aquaculture animals) their health status is defined by which 'zone'
they originate in. For foodstuffs, health marking is used which is based on
systematic surveillance and control of the Competent Authority, and not linked
to individual cases or consignments. These zones may or may not align with
national borders. In practice, to guarantee the status of a particular zone,
this means compliance with higher standards for all animals and products in all
cases unless there are possibilities for exemptions. So, movements are within
or between health zones rather than cross-border; and no particular guarantees
or certification are required other than verification of the origin. This system was
developed with the aim of protecting consumers and ensuring the same level of
protection and the same quality of products across the EU. This is fairly
straightforward to achieve with products, which undergo certain production or
treatment processes and remain in a controlled environment. It is less
straightforward but still possible with aquaculture animals which are often
kept and particularly transported in an isolated environment, and this concept
was indeed introduced for aquaculture animals in Directive 2006/88/EC. This
Directive regulates specific areas of aquaculture businesses, which are on the
whole more uniformly industrialised and business-focused than terrestrial
farms. But even in this case, certain certification requirements and TRACES
notifications have been preserved for movements between zones with different
health statuses. If this were to
be introduced for terrestrial animals, it would enable a much more risk-based
approach to be taken to movements. Health zones would be established which
would set out which areas were high or low risk for particular diseases.
Animals making a low risk movement would then have a lower burden of proof of
status. Rather than rigid rules for crossing national borders, administrative
requirements would be genuinely based on the risk that a particular movement
posed of spreading disease. However, there would be additional certification
requirements for certain national movements, when moving between different
health zones. However, this
approach is felt by stakeholders (see consultation on artificial insemination
and related issues in Annex V) to be inapplicable to terrestrial
animals. This is partly because terrestrial animals are in constant contact and
interaction with their natural environment, including both wild fauna and
flora. So, it is much more challenging to isolate them from their environment
and guarantee the health status of a particular geographical area. But it is
also because the overall context is much more complex in terms of the large
number of species and their interactions, more varied production types, complexity
of different diseases and their epidemiology, the current system of disease
free statuses, etc. The health zones for each disease for each animal would be
different, leading to a complicated multi-layered map of different health
zones. The picture would also be constantly changing. In addition, the burden
of understanding the requirements when moving animals is on the operator,
rather than on the certifying veterinarian, as at present. This has the
potential to introduce an unnecessarily large administrative burden on animal
keepers and dealers. The possibility
here is that by introducing a system based on genuinely risk-based measures, a
much greater degree of complexity would inevitably (and necessarily) be
introduced. This complexity would have the potential to totally undermine any
benefit that is obtained from attempting to introduce a more proportionate
system. Table VIII.4
Pros and Cons of Each Option Considered || Option 1 || Option 2 || Option 3 || Option 4 Pros || § Safe, consistent and controllable system § Animals and products checked before dispatch to verify health status § Low risk of disease transmission § Guarantees provided in certification serve for further assurance for third countries should the animals subsequently be moved out of the EU § Allows MSs flexibility to determine their own internal requirements concerning movements (should there be specific local circumstances such as lots of backyard or hobby keepers or less developed areas, etc) || § Would retain safety and health standards § Would resolve the administrative burden and expense problems of option 1 for low-risk short distance movements and movements for slaughter § Would not put health status of MSs at risk § Might discourage long distance movements which would have a positive impact on animal welfare || § Enables MS to maintain specific solutions for particular issues § Facilitates movements by removing certain administrative burdens § Allows new options for sector development § Introduces a more modern approach towards the single market § Retains movement controls where important to do so, ensuring good health management § Provides a better and more proportionate risk-based system || § Higher standards applied in all holdings and by all operators § Consistency: the same standards would apply across the EU § Would resolve some of the problems of Intra-Community Trade by providing a more proportionate risk-based system § Potentially less burdensome for movements between MS with the same health status § Potentially encourages movements § Good for big traders who often move animals across borders within the EU – potential reduction of administrative burden Cons || § Often burdensome, sometimes unjustifiably so § Often expensive for MSs and stakeholders § Many notification duplications, such as for both the EU-wide TRACES system and national databases, increasing administrative burden and the likelihood of conflicting information being held § Not really necessary for short and low risk cross border movements and movements to slaughterhouses || § Less consistent and controllable system (especially in the case of health problems such as a disease outbreak). § Opaque system in terms of its comprehensibility across the EU § Many potential bilateral agreements, causing inconsistency and confusion. § Possible problems of certification/guarantees not being available to other MSs and countries outside the EU if animals are subsequently moved. § Limitations of uses of the exemption for animal welfare reasons || § Could be difficult to obtain an overview if different movement rules for different types of movements Reduction of administrative burden is somewhat limited because of the continued welfare obligations § Certification and therefore administrative burden still retained to a certain extent § Could increase the risk of limited control systems being in place and therefore increase the risk of lowering health status || § Less understandable controllable system § Could potentially lead to lower health statuses if certification is lifted for low-risk movements § Veterinary checks for welfare purposes would still be required, so administrative burden is only partly lifted § Less flexibility for MS to decide on their own national requirements § Could be more burdensome for national movements if more certification required § Disadvantageous for small and medium average farms, which don't often move animals outside national territory, because increased administrative burden Summary It is clear that
the burden of certification is not appropriate in all current cases of
movements. Our goal is to find a solution that eases this burden and simplifies
the system where appropriate, without introducing an overly complex and
confusing system, which would undermine the goal of simplification. While no
option is entirely without its disadvantages, option 3 seems to offer us the
most appropriate solution. Option 1 offers no change to the status quo. Option
2, although easing some administrative burden, risks introducing a level of
complexity for derogations which might lead to confusion at EU level and lack
of transparency in an animal health emergency. Option 4 moves to a completely
risk-based system but introduces a vast degree of complexity in the assessment
and understanding of risk which undermines the gains made from easing
certification administrative burdens. However, option 3 would allow the removal
or easing of administrative burden in low-risk cases, without introducing the
opaqueness of option 2, or the vast complexity that option 4 would entail.
Therefore, option 3 is the preferred option. Consultation:
Consultation on
this issue took place in the following forums: Ø within the Animal Health Law Steering group (January – July 2009) Ø in the framework of wide stakeholders' consultation (September –
December 2009) Ø administrative burden and administrative costs assessment including
special assessment for the sector for production of germinal products (December
2009 – March 2010) Ø consultation of the sector for artificial insemination on Intra-EU
trade and placing on the market concepts (May-September 2010) Ø Animal Health Advisory Committee (2008-2010) Ø Chief Veterinary Officers (2008-2010)
ANNEX IX Key elements of the new Animal Health Law, including
indicative list of existing legislation affected
1. New
key elements of the new AHL
An overview of the
new key elements of the new AHL, if options 4 and/or 5, as explained in chapter
4 of the Impact assessment is given below: -
Clarify and codify the obligations of animal
keepers/owners/operators. -
Introduce an obligation to obtain knowledge on
animal health for animal keepers, operators and staff dealing with animals in
order to increase awareness of potential threats related to animal diseases. -
Clarify and enhance farm level biosecurity
measures to reduce the risk of on-farm outbreaks. -
Introduce disease categorisation and
prioritisation and new principles for the EU intervention, to ensure a coherent
approach to disease management. -
Clarify and simplify general disease control
rules. -
Establish an efficient legal framework to
facilitate timely, adequate and efficient response towards emerging and exotic
diseases, in light of the disease categorisation and prioritisation exercise. -
Introduce a new regulatory approach concerning
EU-wide surveillance, to enhance surveillance while ensuring that resources are
used as efficiently as possible, including the further development of
"surveillance networks". -
Clarify and codify the basic principles and
objectives for identification and registration of animals. -
Clarify and simply the rules on movements of
live terrestrial animals within the EU to better reflect the actual risk of
disease spread, taking into account the burden on operators and competent
authorities related to the movement of animals. [Different options were
considered and assessed in Annex VIII.] -
Clarify and codify the general animal health
requirements for import of live animals and products thereof, based on
assessment of animal health risks of trade with third countries, while leaving
the legal framework for general import controls and procedures to be provided
by Regulation (EC) No 882/2004. -
Extend the concept of compartments to other
animal species and diseases, beyond existing legislation for poultry and avian
influenza and aquaculture, to allow for increased flexibility in disease
control and encourage the enhancement of animal health standards. -
Align the EU legislation with the international
standards as far as appropriate (OIE) without lowering EU health standards
which have already been achieved.
2. The new
AHL and its relationship with the current European Animal health legislation
Currently,
animal health issues are regulated in 49 different legal acts from the Council
and European Parliament. Following a preliminary assessment, the issues covered
by these legal acts would be dealt with in the following manner under the AHL:
-
For 16 legal acts, the main provisions would be
integrated in the AHL, while Annexes and certain specific articles would be
integrated in delegated/implementing acts or subject to deregulation. -
For 11 legal acts, only the basic principles and
a legal basis to lay down delegated/implementing acts would be included in the
AHL, whereas the majority of the provisions would be included in
delegated/implementing acts or subject to deregulation. -
For 7 legal acts, all provisions would be
included in delegated/implementing acts or subject to deregulation. The AHL
would only contain a legal basis to lay down those rules. -
For 3 legal acts, the majority of the provisions
would be included in the general control framework regulation of Regulation
(EC) No 882/2004 and the rest included in delegated or implementing acts. -
7 legal acts are obsolete and would be repealed. -
5 legal acts would remain unchanged due their
particular nature, but the main principles of the AHL will apply and they might
be integrated with the AHL at a later stage. To summarise, following
this exercise the AH acquis, which today consists of 49 basic legal acts, will
be reduced to one single legal act (AHL) and 5 specific basic acts, which may
also in the future be integrated into the AHL. In addition, an exercise will be
initiated to establish a simplified and streamlined set of delegated and
implementing acts replacing relevant parts of the above mentioned basic acts
and the large body of current implementing acts. A list of these
49 legal acts, indicating their relevance for the AHL or its subsequent
legislation is reported below. Table IX.1 Indicative
list of existing legislation affected by the Animal Health Law Much of the
legislation mentioned below will simply be replaced by the AHL. However, some
material changes to the legal framework are envisaged. A full list of
proposed delegated and implementing acts to be prepared under the AHL has yet
to be fully drawn up. Nevertheless, where material changes are envisaged to the
current legal framework and their impacts have not specifically been assessed
in this impact assessment, further impact assessments would be prepared. For
example, impact assessments would be needed if delegated powers are used to
significantly change the approach to vaccination for particular diseases; if
the requirements for electronic certification significantly changed; or if the
certification and identification requirements around animal movements were to
be considerably amended. No || Celex number || Title of the existing legislation || Preliminary assessment: relevance for the AHL (basic act) or its subsequent legislation 1. || 31964L0432 || Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine || AHL: Articles setting health requirements for movements and trade principles Obsolete: Articles transitional provisions and amendments Delegated or implementing acts: Annexes; detailed health provisions set out in certain articles 2. || 31977L0391 || Council Directive 77/391/EEC of 17 May 1977 introducing Community measures for the eradication of brucellosis, tuberculosis and leucosis in cattle || Delegated and implementing acts 3. || 31978D0642 || Council Decision 78/642/EEC of 25 July 1978 on health protection measures in respect of the Republic of Botswana || Obsolete, repeal needed 4. || 31978L0052 || Council Directive 78/52/EEC of 13 December 1977 establishing the Community criteria for national plans for the accelerated eradication of brucellosis, tuberculosis and enzootic leukosis in cattle || Delegated and implementing acts 5. || 31979L0110 || Council Directive 79/110/EEC of 24 January 1979 authorizing the Italian Republic to postpone the notification and implementation of its national plans for the accelerated eradication of brucellosis and tuberculosis in cattle || Obsolete, repeal needed 6. || 31980L1095 || Council Directive 80/1095/EEC of 11 November 1980 laying down conditions designed to render and keep the territory of the Community free from classical swine fever || Delegated and implementing acts 7. || 31981L0006 || Council Directive 81/6/EEC of 1 January 1981 authorizing the Hellenic Republic to communicate and to implement its national plans for the accelerated eradication of brucellosis and tuberculosis in cattle || Obsolete, repeal needed 8. || 31982L0894 || Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community || AHL: All articles Delegated or implementing acts: Annexes 9. || 31989D0455 || Council Decision 89/455/EEC of 24 July 1989 introducing Community measures to set up pilot projects for the control of rabies with a view to its eradication or prevention || Obsolete, repeal needed 10. || 31989L0556 || Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species || AHL: Articles setting health requirements for movements and trade principles Delegated or implementing acts: Annexes; detailed health provisions set out in certain articles 11. || 31189L0608 || Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between that latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters || AHL: No. Will be introduced in the new version of Regulation (EC) No. 882/2004 on official controls in feed and food area Zootechnical aspects to be considered in zootechnical legislation 12. || 31989L0662 || Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market || AHL: Article 9 - Safeguard provisions and parts of Article 3 – rules for movements All other text will be a part of official controls legislation (new Regulation 882/04 and/or delegated act); certain parts in the AHL 13. || 31990D0424 32009D0470 || Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field Council Decision of 26 June 1990 on expenditure in the veterinary field || AHL: No A separate legislative proposal for financial rules (initiative following the AHL). 14. || 31990D0678 || Council Decision 90/678/EEC of 13 December 1990 recognizing certain parts of the territory of the Community as being either officially swine fever free or swine fever free || Obsolete, formal repeal needed 15. || 31990L0423 || Council Directive 90/423/EEC of 26 June 1990 amending Directive 85/511/EEC introducing Community measures for the control of foot-and-mouth disease, Directive 64/432/EEC on animal health problems affecting intra- Community trade in bovine animals and swine and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat or meat products from third countries || Obsolete, formal repeal needed 16. || 31990L0425 || Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market || AHL: Article 10 - Safeguard provisions and parts of Article 3 – rules for movements All other text will be a part of official controls legislation (new Regulation 882/04 and/or delegated act); certain parts in the AHL 17. || 31990L0426 || Council Directive 90/426/EEC of 26 June 1990 on animal health conditions governing the movement and import from third countries of equidae || AHL: Articles setting health requirements for movements and trade principles Obsolete: Articles transitional provisions and amendments Delegated or implementing acts: Annexes and detailed health provisions laid down in some articles 18. || 31990L0429 || Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra- Community trade in and imports of semen of domestic animals of the porcine species || AHL: Articles setting health requirements for movements and trade principles Delegated or implementing acts: Annexes; detailed health provisions set out in certain articles 19. || 32010L0158 || Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs || Delegated or implementing acts: Annexes and detailed health provisions laid down in some articles 20. || 31991D0666 || Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines || Delegated or implementing acts 21. || 31991L0068 || Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals || AHL: Articles setting health requirements for movements and trade principles Obsolete: Articles transitional provisions and amendments Delegated or implementing acts: Annexes and detailed health provisions laid down in some articles 22. || 31992D0438 || Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC || AHL: No New legal basis in official controls regulation (new Regulation 882/2004) 23. || 31992L0035 || Council Directive 92/35/EEC of 29 April 1992 laying down control rules and measures to combat African horse sickness || AHL: only a legal basis and broad outlay of the measures Delegated act and implementing acts: all text of the directive including annexes 24. || 31992L0065 || Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC || AHL: Articles setting health requirements for movements and trade principles Obsolete: Articles transitional provisions and amendments Delegated or implementing acts: Annexes and detailed health provisions laid down in some articles 25. || 31992L0066 || Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 26. || 31992L0102 32008L0071 || Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals Council Directive 2008/71/EEC of 15 July 2008 on the identification and registration of pigs || AHL: legal basis of animal identification, registration and traceability Delegated and implementing acts: Provisions of existing regulation Temporarily remains untouched 27. || 31992L0118 || Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC || Delegated and implementing acts 28. || 31992L0119 || Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease || AHL: basic principles of disease control set up in Articles Delegated an implementing acts: Annexes and detailed rules laid down in articles 29. || 31995D0410 || 95/410/EC: Council Decision of 22 June 1995 laying down the rules for the microbiological testing by sampling in the establishment of origin of poultry for slaughter intended for Finland and Sweden || Delegated and implementing acts 30. || 31996L0093 || Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products || AHL: No Legal basis in new Regulation (EC) No 882/2004 on official 31. || 31997L0012 || Council Directive 97/12/EC of 17 March 1997 amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine || Same as Directive 64/432/EEC 32. || 31998L0099 || Council Directive 98/99/EC of 14 December 1998 amending Directive 97/12/EC amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine || Same as Directive 64/432/EEC 33. || 32000D0258 || Council Decision 2000/258/EC of 20 March 2000 designating a specific institute responsible for establishing the criteria necessary for standardising the serological tests to monitor the effectiveness of rabies vaccines || Delegated or Implementing acts 34. || 32000L0075 || Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 35. || 32000R1760 || Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 || AHL: legal basis of animal identification, registration and traceability Delegated and implementing acts: Provisions of existing regulation Remains untouched 36. || 32001L0089 || Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (Text with EEA relevance) || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 37. || 32009R0999 || Regulation 999/2001/EC - laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalophaties || Remains untouched 38. || 32002L0060 || Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (Text with EEA relevance) || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 39. || 32002L0099 || Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption || AHL: Major part of the text of articles Delegated and implementing acts: Annexes 40. || 32003L0085 || Council Directive 2003/85/EC of 29 of September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance.) || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 41. || 32003R0998 || Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC || AHL: Legal basis for movements, import and disease control rules Delegated and implementing acts: Detailed rules and annexes 42. || 32004L0068 || Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (Text with EEA relevance.) || AHL: Major part of the text of articles Delegated and implementing acts: Annexes 43. || 32004R0021 || Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC || AHL: legal basis of animal identification, registration and traceability Delegated and implementing acts: Provisions of existing regulation Remains untouched 44. || 32005L0094 || Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC || AHL: only a legal basis and broad outlay of the disease control measures Delegated act and implementing acts: all text of the directive including annexes 45. || 32006L0088 || Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals || AHL: articles governing aquaculture production, health rules for movements, import, diseases control rules. Delegated / implementing acts: annexes and some detailed provisions form articles 46. || 32008L0073 || Council Directive 2008/73/EC of 15 July 2008 simplifying procedures of listing and publishing information in the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and Directives 2001/89/EC, 2002/60/EC and 2005/94/EC || With the adoption of AHL: obsolete for the articles amending animal health directives. Remains in place for the Articles amending zootechnical legislation 47. || 32009R1069 || Regulation (EC) No of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No. 1774/2002 (Animal by-products regulation) || Remains untouched – a link in the AHL 48. || 32003L0099 || Directive of the European Parliament and of the Council 2003/99 on the monitoring of zoonoses and zoonotic agents amending Council Decision 90/424 and repealing Council Directive 92/117 || Remains untouched 49. || 32003R2160 || Regulation of the European Parliament and of the Council (EC) No. 2160/2003 on the control of salmonella and other specified food-borne zoonotic agents || Remains untouched
ANNEX X Preliminary
structure of the legislative proposal – options 4 and 5
Part I General rules ¾
Subject matter scope etc. ¾
General principles ¾
General responsibilities ¾
Categorisation and prioritisation Part II Surveillance and disease freedom ¾
Surveillance general obligations (operators +
MS) ¾
Notification (national + Union) ¾
Surveillance and eradication programmes ¾
Disease free Member States and zones Part III Disease prevention, control and
eradication ¾
Disease preparedness (contingency plans,
simulation, union vet experts) ¾
Vaccination ¾
Emergency measures ¾
Control measures A diseases ¾
Control measures B and C diseases Part IV Requirements concerning
establishments, identification and registration of animals and movements Title 1
Terrestrial animals ¾
Registration, approval, traceability ¾
Movement within the Union Title 2 Aquatic
animals ¾
Registration and approval ¾
Movement within the Union Title 3
Other animals ¾
Part 2 and 3 shall apply to extent relevant for
species concerned for a disease of Union concern Part V Introduction and Export Part VI Transitional measures and final
provisions
ANNEX XI Additional
assessment on biosecurity
Background Following the
external evaluation of the Community Animal Health Policy, the vision of the AHS
is to improve the prevention of animal health related problems before they
happen: the principle of 'prevention is better than cure'. Biosecurity and
systematic surveillance are the main elements in putting this principle into
practice. It is difficult
to give a single definition of biosecurity, because of the wide use of the
concept in many areas (human, animal, plant health) for different needs and
objectives and using the differing available tools and resources. Biosecurity
can be described as a wide set of preventive and control measures, but can also
be the prevention of the risk of spreading one specific pathogen by using only
one tool, such as disinfection, for example. In general,
biosecurity is a set of precautions taken to minimise the risk of the
introduction and spread of diseases to humans, animals or plants. This can
consist of management measures or physical and/or chemical measures and the
measures used are often dependent on the nature of disease, its transmission
methods and epidemiology, and climatic conditions. These measures
could include: Management measures to reduce disease risks due to direct and
indirect contact with potentially disease-carrier or infected animals, vectors,
equipment, means of transport, persons, or other objects such as: -
procedures for entering / exiting the holding
for persons, vehicles, animals; -
rules for movement within the different parts of
the holding; -
rules and procedures for using equipment; -
quarantine, isolation or separation of new
animals; -
conditions for accepting the animals on
holdings/farms including standstill; -
isolation of sick animals; -
safe disposal of carcasses; -
in the case of aquatic animals, measures on
water supply and discharge; Physical protection and hygiene barriers such as: -
Keeping indoors, fencing-in, providing cover for
animals; -
cleaning and disinfection, de-infestation and
pest control; -
in the case of aquatic animals, natural or
artificial barriers from surrounding water courses that prevent aquatic animals
from entering or leaving the farm, including measures against flooding or
infiltration of water from surrounding water courses. Benefits of biosecurity: While health protection benefits from biosecurity measures have been
known throughout history, it is not easy to measure their exact effect in terms
of the reduction of risk of disease outbreaks occurring, or the reduction of
the impact of a disease outbreak once it has occurred. Specific case studies in
controlled circumstances would be extremely difficult, and very costly to
perform. Even if they were feasible, the results obtained could provide
evidence only for a particular disease and species under certain specific
climatic conditions and so could not be extrapolated very widely. But we can illustrate the effects of a lack of effective biosecurity
behaviours. Widespread movements of animals with relatively poor biosecurity
management measures in the very early stages of FMD in the UK in 2001 led to the extensive spread of the disease in a very short time. The relevant movements
are presented in a chart below. Chart XI.1 Spread of foot
and mouth disease by livestock moved through markets before 23 February 2001 Source: UK Department for Environment, Food and Rural Affairs
(DEFRA) In addition, we can demonstrate that a lack of biosecurity leading
to the rapid spread of disease such as that shown above can lead to serious
economic losses for the agricultural industries, as well as potentially serious
wider consequences. In section 5.1 of the report we show the economic effects
of some serious outbreaks. Below is a further demonstration of the effects of
the recent AI outbreak on poultry consumption. Impacts of recent Avian Influenza outbreaks
on consumption (source: Eurostat) A special Eurobarometer survey conducted in
March/April 2006 on consumers' responses in the EU- 27 following the world HPAI
(Highly Pathogenic Avian Influenza) outbreaks revealed that nearly a fifth
of citizens had reduced their consumption of poultry meat (18% on average, with
large country differences). Although three quarters of this group did so only
on a temporary basis, some 13% intended to cut down on consumption permanently.
Sales of poultry and eggs were reported in early 2006 to have fallen by 70% in Italy and by 20% in France, following announcements of AI outbreaks in other parts of Europe/the
world. The Italian farmers' association estimated that the industry was losing
€6m a day, and that it had lost a total of about €650m so far. Disadvantages
of requiring more stringent biosecurity measures: Additional costs and burdens for the operators are the main reason
not to require more stringent biosecurity measures. These costs and burdens
would vary across the agricultural sector, since many operators have already
established well-developed biosecurity systems, but others have no systematic
biosecurity schemes. The schemes in highly industrialised food production and
intensive farming, such as intensive poultry or pig production, are very
well-developed and require a high level of biosecurity from the operator. As an
example see the 'Guide to Good Hygiene Practice for the Prevention and Control
of Pathogenic Microorganisms with particular Reference to Salmonella in Gallus
gallus (Broilers) reared for meat - on farms'[42],
or the examples of biosecurity schemes in the Danish pig industry, as presented
at the CVO seminar in Sweden by the Danish Agricultural Council[43]. These industrial sectors
would not incur much additional cost or have large adjustments to make. But on
the other hand, much extensive animal production and particularly 'backyard' or
small family holdings, might find it expensive, time-consuming and problematic
to introduce new schemes. The benefits (including both the health benefits and
wider economic benefits from reduced disease impact) of introducing such a requirement
would need to be balanced with the additional costs. Therefore this issue was
specifically addressed in the questionnaire addressed to operators and
Competent Authorities. The results are presented below. Sometimes
stringent biosecurity measures may have some negative consequences on animal welfare,
for example, if animals are continually kept indoors. Biosecurity – data on administrative
burdens and costs Biosecurity potential administrative burden –
questionnaire results At present, few biosecurity rules or incentives exist at EU level,
and there are a variety of biosecurity guidelines set at other levels, both at
national level and by industry. A questionnaire by the European Commission to
collect information about on-farm biosecurity[44]
found that many biosecurity guidelines already exist, but there is little
consistency between guidelines in terms of their scope, coverage, degree of
obligation, strength of the biosecurity measures and by whom they are
organised. For example, the questionnaire found that current guidelines were
mainly organised by national and local veterinary authorities and by industry,
and that coverage varied for different species and production systems. Nearly
half the guidelines were designed to cover specific animal diseases, but many
also covered both infectious and non-infectious diseases and good husbandry
more generally. Questionnaire results During the consultation period, questionnaires were
issued to MS CA and Operators in MS to help provide estimates for any additional
administrative burden following from the proposals in the AHL. The following
section sets out the results of the questionnaire which are relevant to
biosecurity. The biosecurity administrative burden calculation in the IA is
based on these results. Competent Authority administrative burden Forty-two MS Competent
Authorities responded to the questionnaire. Twenty-three of these were Central
Authorities and the remaining respondents were at regional or local level. Competent Authorities
estimated the average time (in hours) and the personnel needed for developing
protocols or guidelines for the drafting of on-farm biosecurity plans. For all
respondents, time to develop guidelines ranged from 16 hours to 2,400 hours.
The median time for central Competent Authorities was 200 hours. The proposed biosecurity
schemes would require Competent Authorities to assess the biosecurity plans
drafted by operators, as a desk exercise, and also perform a field inspection
of the implementation of the biosecurity plan. Responding Competent Authorities
estimated that on average each plan would take 13 hours to assess. On average,
this broke down as around 7 hours of official veterinarian time, and 6 hours of
policy staff, approved veterinarians, technicians and others' time. For the
field inspection, two thirds of all respondents thought that the Competent Authority
should approve biosecurity plans. Estimates for the time to verify plans on the
spot ranged from 30 minutes to 40 hours. The average time to verify the plans
was 16 hours. All respondents to the
Competent Authority questionnaire thought that training would be necessary.
They all thought that official veterinarians would need training, and the
majority thought other types of personnel would also need training. All respondents
wanted training to be organised at a national level, and nearly half also
wanted training at regional or EU level. The questionnaire did not ask
Competent Authorities to estimate the duration of training. Operators' administrative
burden Forty-three unique, and
substantially completed, questionnaires were used to estimate the
administrative burden of the biosecurity requirements. Nearly one half of
respondents were animal breeders or animal producers; the remaining respondents
covered a range of stakeholder groups, including industry representatives,
transporters, and zoos. Of course, this is a self-selecting group of
respondents, so it cannot be claimed that this is representative of the EU as a
whole. However, it gives an interesting indication of relevant views. The cost of drafting a
plan was, on average €2,000, although a large range of
costs were estimated and varied across sectors. There was a positive skew in
the responses to this question – most results were clustered around low
drafting costs but there were a few estimates for much higher drafting costs. A similar pattern was observed with the estimated implementation
costs, although the range of costs was much wider – from 'working time' only to
a maximum of €365,000. The median implementation cost for all respondents was
€10,750, although this varied between different sectors represented in the
questionnaire. Several respondents also highlighted that there were likely to
be ongoing costs of maintaining higher biosecurity standards. Chart XI.2: Median implementation
cost of biosecurity plans by sector Just over half of all
respondents thought that biosecurity plans would represent cost savings. Those
that thought biosecurity plans would represent cost savings gave, on average,
lower and less varied costs of drafting and implementing plans. The two box
plots below show how the drafting and implementation costs varied on whether
operators believed biosecurity plans would represent a cost advantage: Charts XI.3 Distribution
of drafting costs and implementation costs Operators were also asked
whether they would require external human resources help or training to help fulfil
the proposed biosecurity requirements. There was no
overall consensus about whether these would be required in order to draft and
implement biosecurity plans. There were different preferences for the type of
human resources and training required, but many respondents stated that they
would require assistance on several different levels. Incentives: Biosecurity benefits the farming industry as a whole, but individual
farmers do not always have a personal incentive to optimise their biosecurity
measures. We discuss this in some detail in the main text of the impact
assessment. Options Considered:
Promote existing best practices for biosecurity at EU level,
and encourage stakeholders to further develop these, but with no
introduction of additional legal measures.
Establish a legal framework for the voluntary introduction of
biosecurity measures at farms. Encourage implementation by providing
incentives such as trade-facilitation mechanisms and reducing the number
of controls. Legislation would set minimum criteria for biosecurity
measures, allowing them to be adapted to local circumstances. Guidelines
at EU/national level would be drafted to facilitate compliance with this
obligation.
Lay down the obligation to adopt biosecurity measures for all
EU farms. Legislation to establish the minimum criteria for biosecurity
measures, providing some flexibility to adapt them to local circumstances.
Guidelines at EU/national level would be drafted to facilitate compliance
with this obligation.
Assessment
of options: Option A: Promote existing best
practices for biosecurity at EU level, and encourage stakeholders to further
develop these, but with no introduction of additional legal measures. This option
would not impose any additional burdens or costs to the food production sector
EU-wide other than those which they voluntarily incur, but would not meet the
objectives of the AHS nor meet the expectations of the industry. Above all, it
would not fit with the prevention principle, and would retain existing animal
disease risks. This option is a
sub-set of option 3 in the main impact assessment text – using the existing
legal framework but promoting best practice guidelines. Option B: Establish a legal framework
for the voluntary introduction of biosecurity measures at farms. Encourage
implementation by providing incentives such as trade-facilitation mechanisms
and reducing the number of controls. Legislation would set minimum criteria for
biosecurity measures, allowing them to be adapted to local circumstances.
Guidelines at EU/national level would be drafted to facilitate compliance with
this obligation. This option aims
at introducing basic biosecurity rules in order to protect against the risk of
spreading diseases and to ensure farmers within the EU take their
responsibilities seriously. It could be a flexible option adjusted to local
circumstances in MS, and also be adjusted to the differing needs of specific
sectors (poultry, pigs, bovines, semen collection centres, etc). It would also
promote a higher level of biosecurity for those who wish to enter quality
assurance schemes and benefit from incentives such as easier trade, possible additional
financial and health benefits, lower production losses, and international trade
advantages. This option would entail certain obligatory costs and burdens, but
to a much lesser extent than for option C (see below), and only for those
sectors which have few existing biosecurity guidelines or requirements for
primary production in animal health and food safety. The flexibility
of this option avoids the universal implementation of potentially large costs
that option C entails (see below). The decision about whether a higher level of
biosecurity is economically worthwhile is therefore left to the individual
farmer or manager, and will encourage the implementation of plans where
benefits will be gained. This option is a
sub-variant of option 4 in the main text of the Impact Assessment – a flexible
framework. Option C: Lay the down the obligation to
adopt biosecurity measures for all EU farms. Legislation to establish the
minimum criteria for biosecurity measures, providing some flexibility to adapt
them to local circumstances. Guidelines at EU/national level would be drafted
to facilitate compliance with this obligation. This option
would likely reduce the risks of spreading animal diseases (assuming widespread
compliance with the legislation) as it would require a relatively high level of
biosecurity (every farm or holding drafting their own plan as envisaged in the
questionnaire outlined above). Different production systems in different
geographical contexts entail very different levels of biosecurity risk, and
therefore an appropriate level of biosecurity for a particular farm or holding
can vary very significantly. The measures taken need to be adjusted to local
circumstances. Nevertheless, it
would impose very significant costs and administrative burdens in some sectors,
particularly those who do not currently have widespread biosecurity measures or
self-regulated guidelines or plans. It is difficult to extrapolate exactly the
administrative burden associated with implementing this option EU wide.
However, it is clear from the answers to the questionnaires above that many
stakeholders consider that this would be an unnecessary and burdensome option.
Leaving aside the need for Competent Authorities to develop guidance, the
average time needed by them to assess and verify each plan would on average be
29 hours. If the number of agricultural holdings across the EU is 7,310,000[45],
this amounts to 212,000,000 hours. The cost to operators is more difficult to assess as some operators
will already have quite significant measures in place, while others would need
to introduce considerable changes. Taking the average cost of drafting and
implementing a plan as €12,750, this would represent a total cost of €93.2bn
across EU farming. In 2009, the gross value added (GVA)
at producer prices of all EU farming amounted to €125 billion45. So,
the estimated costs of introducing biosecurity plans would represent some 75%
of the total annual GVA of agricultural output. It would be extremely hard to
demonstrate that the benefits of introducing universal biosecurity plans would
generate anything like the total costs involved, so under these assumptions,
these measures can be said to be completely
disproportionate. Another thing to
consider in setting a very high regulatory bar is the serious risk of
non-compliance. The potentially large costs involved in implementing
biosecurity plans across the board risks a high level of non-compliance, thus
undermining the objective of the legislation and the credibility of the EU. This option is a
sub-set of the strict framework of option 5 in the main text of the impact
assessment. Table XI.1:
Options Compared || Option A || Option B || Option C Pros || § no additional costs or burdens for farmers § does not entail the negative impacts of biosecurity measures on welfare (for example keeping animals continually indoors) || § introduction of a basic level of protection against the risks of spreading diseases § farmers taking more responsibility § incentives for those who wish to develop more advanced systems § beneficial impacts on animal welfare, since fewer diseases § system more tailored to specific circumstances; subsidiarity respected § avoids imposing disproportionate burdens on local farming practices and local economies || § harmonised biosecurity systems, preventive approach taken EU-wide § higher protection against the risks of spreading disease and therefore lower expected incidence of disease § fewer diseases leading to fewer associated animal welfare problems § farmers taking more responsibility Cons || § current risks of health threats persist § costs because of impacts of diseases, when they occur (direct and indirect costs for farmers) § negative impacts on animal welfare, when more animals are sick; necessity to cull animals in restricted zones due to welfare reasons, etc. || § a certain level of additional costs and burdens introduced in many cases § possible negative impacts of biosecurity measures on welfare (for example: keeping animals indoors) || § very high additional costs and/or burdens for many farmers EU-wide § no incentives for those who wish to do more than the minimum required § rigid biosecurity measures may negatively impact animal welfare Summary Option B is
clearly the most viable option. Option C is too administratively burdensome for
many sectors, requiring them to make very large and potentially expensive
changes which are not necessarily proportionate to the risk they bear. And to
do nothing, as in option A, would mean continuing with the present situation,
which, while not causing massive problems, could be improved. Option B offers a
good solution: requiring a basic level of biosecurity which could be tailored
to specific MSs, sectors, production methods, and other circumstances; but is
not too unnecessarily administratively burdensome. It would also encourage
those who wish to introduce biosecurity measures at a higher level than the
legal baseline. Consultation Consultation on
this issue took place in the following forums: Ø within the Animal Health Law Steering group (January – July 2009) Ø in the framework of wide stakeholders' consultation (September –
December 2009) Ø administrative burden and administrative costs assessment including
special assessment for the sector for production of germinal products (December
2009 – March 2010) Ø Seminar on biosecurity; Chief Veterinary Officers (2009) Ø Animal Health Advisory Committee (2008-2010) [1] http://ec.europa.eu/food/animal/diseases/strategy/cahpeval_en.htm [2] http://ec.europa.eu/food/animal/diseases/strategy/index_en.htm [3] EP Resolution 2007/2260(INI) [4] Doc.15481/07 ADD 1 [5] NAT/376 – EU Animal Health Strategy [6] COM (2008) 545 final, http://ec.europa.eu/food/animal/diseases/strategy/documents_en.htm [7] COM(2010) 543 final "Smart Regulation in the European
Union" [8] COM(2010) 2020 "Europe 2020 - A strategy for smart,
sustainable and inclusive growth" [9] SEC(2009)92 of 15 January 2009 [10] http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm,
under point 3.1, 5 and 17 respectively [11] 15000/2/09 REV2, http://register.consilium.europa.eu/pdf/en/09/st15/st15000-re02.en09.pdf [12] 9547/10, http://register.consilium.europa.eu/pdf/en/10/st09/st09547.en10.pdf [13] Article 4.2 of Commission
Decision 2004/613/EC of 6 August 2004 [14] http://ec.europa.eu/food/animal/diseases/strategy/participants_en.htm [15] http://ec.europa.eu/food/animal/diseases/strategy/animal_health_advisory_committee_en.htm [16] 19 May 2008, 3 November
2008, 6 March, 15 June, 29 September 2009, 8 February, 18 June 2010, 14
February 2011 [17] http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_steering_group_en.htm.
Meetings held on 18 February, 25 March, 19 May and 3 July. [18] http://ec.europa.eu/food/animal/diseases/strategy/pillars/consultation_process_en.htm [19] http://ec.europa.eu/food/animal/diseases/strategy/pillars/consultation_process_en.htm.
Addressees had the possibility to respond from 19 December 2009 to 15 March
2010 [20] http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm [21] SANCO/7117/2010 [22] Data from Eurostat 2007, Number of farms and heads by economic
size of farm (ESU):.
http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-AF-07-001/EN/KS-AF-07-001-EN.PDF [23] Data 2008 from the evaluation report. [24] Finfish is the aggregate term for freshwater, diadromous and
marine fish [25] Data from European Fur Breeders Association, Annual Report 2010 [26] 2009/470/EC: Council Decision of 25 May 2009 on
expenditure in the veterinary field (Codified version), OJ L 155,
18.6.2009, p. 30–45 [27] The way the EU supports the control and eradication of animal
disease outbreaks is not addressed in this document as it is the subject of a
separate piece of work to revise Council Decision 2009/470/EC. [28] On official controls to ensure the verification of compliance
with inter alia animal health rules, OJ No L 165, 1 p. 30.04.2004 [29] http://www.fve.org/news/position_papers/education/060_oie_education%20_conference_october_2009_presentation_jvaarten.pdf
[30] See Contributing to One World, One Health, A
Strategic Framework for Reducing Risks of Infectious Diseases at the
Animal–Human–Ecosystems Interface, at: http://www.oie.int/downld/AVIAN%20INFLUENZA/OWOH/OWOH_14Oct08.pdf. [31] Differentiating Infected from Vaccinated Animals [32] The European Parliament (EP Resolution 2007/2260(INI)), the
Council (Doc.15481/07 ADD 1) and the European Economic and Social Committee
(NAT/376 – EU Animal Health Strategy) and stakeholders [33] The summary of the paper produced by this group of experts was
presented to the delegates of Member States during the SCFCAH meeting on 3 May
2010.
http://ec.europa.eu/food/animal/diseases/strategy/pillars/antigen-vaccine-banks-task-force_en.htm
DG SANCO consulted the Chief Veterinary Officers of the EU Member States in
charge of implementing animal health legislation on the use of vaccination as a
control tool for major epidemic diseases. [34] TRACES is the intra-trade system for cross-border trade in
animals. TRACES allows the competent authorities of the different Member States
to inform each other of cross-border movements of animal submitted to
veterinary certification. [35] http://ec.europa.eu/europe2020/index_en.htm [36] Self regulation is defined in the Commission's publication
"Better Regulation: Simply Explained" (2006) as "voluntary
agreements between private bodies to solve problems by taking commitments
between themselves". [37] Council Regulation (EC) No 882/2004 Art. 51 [38] FVE: Interim report on veterinary demography, 2010 -
unpublished [39] As outlined in Art 12 of Council Regulation (EC) No 73/2009 of
19 January 2009 establishing common rules for direct support schemes for
farmers under the common agricultural policy and establishing certain support
schemes for farmers [40] http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm [41] http://ec.europa.eu/food/animal/diseases/strategy/pillars/action_en.htm. [42] http://www.avec-poultry.eu/Default.aspx?ID=4764 [43] http://www.agricultureandfood.dk/ [44] Questionnaire to collect data on: "On-farm biosecurity
guidelines for animal keepers" based on point 11.1 of the Programming
document of the Animal Health Strategy.
http://ec.europa.eu/food/animal/diseases/strategy/docs/draft_questionaire.pdf [45] Eurostat Pocketbooks Agricultural Statistics 2008/09
http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-ED-10-001/EN/KS-ED-10-001-EN.PDF